MIRA INFORM REPORT
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Report Date : |
11.10.2011 |
IDENTIFICATION DETAILS
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Name : |
ISIS PHARMACEUTICALS, INC. |
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Registered Office : |
2855 Gazelle Court, Carlsbad, CA 92010 |
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Country : |
United States |
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Financials (as on) : |
31.12.2010 |
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Date of Incorporation : |
10.01.1989 |
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Legal Form : |
Public Parent Company |
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Line of Business : |
Subject is engaged in antisense technology, exploiting a drug
discovery platform to create a pipeline of drugs |
RATING & COMMENTS
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MIRAs Rating : |
B |
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RATING |
STATUS |
PROPOSED CREDIT LINE |
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26-40 |
B |
Capability to overcome financial difficulties seems comparatively
below average. |
Small |
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Status : |
Moderate |
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Payment
Behaviour : |
No Complaints |
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Litigation : |
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NOTES :
Any query related to this report can be made
on e-mail : infodept@mirainform.com
while quoting report number, name and date.
ECGC Country Risk Classification List March 31st, 2011
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Country Name |
Previous Rating (31.12.2010) |
Current Rating (31.03.2011) |
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United States |
a1 |
a1 |
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Risk Category |
ECGC
Classification |
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Insignificant |
A1 |
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Low |
A2 |
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Moderate |
B1 |
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High |
B2 |
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Very High |
C1 |
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Restricted |
C2 |
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Off-credit |
D |
Company name & address
ISIS Pharmaceuticals, Inc.
2855 Gazelle Court
Carlsbad, CA 92010
United States
Tel: 760-931-9200
Fax: 760-603-2700
Web: www.isispharm.com
Synthesis
Employees: 370
Company Type: Public Parent
Corporate Family: 5
Companies
Traded: NASDAQ: ISIS
Incorporation Date:
10-Jan-1989
Auditor: Ernst & Young LLP
Financials in: USD
(Millions)
Fiscal Year End:
31-Dec-2010
Reporting Currency: US
Dollar
Annual Sales: 108.5
1
Net Income: (61.3)
Total Assets: 550.5 2
Market Value: 675.7
(30-Sep-2011)
Business Description
Isis
Pharmaceuticals, Inc. (Isis) is engaged in antisense technology, exploiting a
drug discovery platform to create a pipeline of drugs. The Company operates in
two business segments: Drug Discovery and Development and Regulus Therapeutics
Inc. Within the Drug Discovery and Development segment, its drug discovery
platform enables the Company to identify drugs, providing potential targets to
treat a range of diseases. As of March 31, 2011, the Company had 24 drugs in
development. Its partners are licensed to develop, with the Company’s
support, 11 of these 24 drugs. The Company and Alnylam established Regulus
Therapeutics Inc. as a company focused on the discovery, development and
commercialization of microRNA therapeutics. For the fiscal year ended 31
December 2010, ISIS Pharmaceuticals, Inc.'s revenues decreased 11% to $108.5M.
Net loss from continuing operations increased 75% to $61.3M. Revenues reflect
lower research & development revenue under collaborative agreements,
decrease in licensing & royalty revenue. Higher loss reflects an increase
in research & development expenses and a substantial rise in interest
expenses.
Industry
Industry Biotechnology and Drugs
ANZSIC 2006: 1841 - Human
Pharmaceutical and Medicinal Product Manufacturing
NACE 2002: 2442 - Manufacture
of pharmaceutical preparations
NAICS 2002: 325412 -
Pharmaceutical Preparation Manufacturing
UK SIC 2003: 24421 -
Manufacture of medicaments
US SIC 1987: 2834 -
Pharmaceutical Preparations
Key Executives
(Emails Available)
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Name |
Title |
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Stanley T. Crooke |
Chairman of the Board, President, Chief Executive Officer |
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B. Lynne Parshall |
Chief Financial Officer, Chief Operating Officer, Secretary, Director |
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Richard B. Lai Fatt |
Vice President of Corporate Development, Business Development and
Strategic Marketing |
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C. Frank Bennett |
Senior Vice President - Antisense Research |
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Martin Bedigian |
Vice President and Chief Medical Officer |
Significant Developments
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Topic |
#* |
Most Recent Headline |
Date |
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Class Action Lawsuit |
1 |
Isis Pharmaceuticals Files Patent Infringement Suit Against Santaris
Pharma A/S And Santaris Pharma A/S Corp |
23-Sep-2011 |
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Strategic Combinations |
3 |
Isis Pharmaceuticals And CHDI Foundation Renew Drug Development
Collaboration For Huntington's Disease |
11-Aug-2011 |
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Products |
6 |
sanofi-aventis' Genzyme and Isis Pharmaceuticals Inc. Announce
Submission of European Marketing Authorization Application for Mipomersen
(Kynamro) |
28-Jul-2011 |
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Other Pre-Announcement |
4 |
Isis Pharmaceuticals Reaffirms FY 2011 Guidance-Conference Call |
5-Aug-2011 |
* number of significant developments within the last 12 months
News
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Title |
Date |
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Isis
Pharmaceuticals Assigned Patent |
8-Oct-2011 |
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Isis
Pharmaceuticals and BioMed Realty Trust Celebrate Grand Opening of New
R&D Facility in Carlsbad, California |
28-Sep-2011 |
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Isis files
patent infringement lawsuit against Santaris |
27-Sep-2011 |
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Isis
Pharmaceuticals Hosts Dr. Kastelein to Review Mipomersen Longterm Data
Presented at ESC Congress 2011 - Final |
26-Sep-2011 |
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Event Brief
of Isis Pharmaceuticals Hosts Dr. Kastelein to Review Mipomersen Long-term
Data Presented at ESC Congress 2011 - Final |
26-Sep-2011 |
Financial Summary
As
of 30-Jun-2011
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Key Ratios |
Company |
Industry |
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Current Ratio (MRQ) |
4.47 |
3.42 |
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Quick Ratio (MRQ) |
4.44 |
2.80 |
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Debt to Equity (MRQ) |
0.97 |
0.38 |
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Sales 5 Year Growth |
22.00 |
18.88 |
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Net Profit Margin (TTM) % |
-63.68 |
10.79 |
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Return on Assets (TTM) % |
-11.33 |
0.86 |
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Return on Equity (TTM) % |
-27.11 |
9.14 |
Stock Snapshot
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1 - Profit & Loss Item Exchange Rate: USD 1 = USD 1
2 - Balance Sheet Item Exchange Rate: USD 1 = USD 1
Corporate Overview
Location
2855 Gazelle Court
Carlsbad, CA, 92010
United States
Tel: 760-931-9200
Fax: 760-603-2700
Web: www.isispharm.com
Quote Symbol - Exchange
ISIS - NASDAQ
Sales USD(mil): 108.5
Assets USD(mil): 550.5
Employees: 370
Fiscal Year End: 31-Dec-2010
Industry: Biotechnology
and Drugs
Incorporation Date: 10-Jan-1989
Company Type: Public
Parent
Quoted Status: Quoted
Chairman of the Board, President,
Chief Executive Officer: Stanley
T. Crooke
Company Web Links
Company Contact/E-mail
Corporate History/Profile
Employment Opportunities
Executives
Financial Information
Home Page
Investor Relations
News Releases
Products/Services
Contents
Industry Codes
Business Description
Product Codes
Brand/Trade Names
Financial Data
Market Data
Key Corporate Relationships
Additional Information
Industry Codes
ANZSIC 2006 Codes:
1841 - Human Pharmaceutical and Medicinal Product Manufacturing
6910 - Scientific Research Services
NACE 2002 Codes:
7310 - Research and experimental development on natural sciences
and engineering
2442 - Manufacture of pharmaceutical preparations
NAICS 2002 Codes:
325412 - Pharmaceutical Preparation Manufacturing
541710 - Research and Development in the Physical, Engineering, and
Life Sciences
US SIC 1987:
2834 - Pharmaceutical Preparations
8731 - Commercial Physical and Biological Research
UK SIC 2003:
24421 - Manufacture of medicaments
7310 - Research and experimental development on natural sciences
and engineering
Business Description
Isis Pharmaceuticals,
Inc. (Isis), incorporated in January 10, 1989, is engaged in antisense
technology, exploiting a drug discovery platform to create a pipeline of drugs.
The Company operates in two business segments: Drug Discovery and Development
and Regulus Therapeutics Inc. Within the Drug Discovery and Development
segment, its drug discovery platform enables the Company to identify drugs,
providing potential targets to treat a range of diseases. As of March 31, 2011,
the Company had 24 drugs in development. Its partners are licensed to develop,
with the Company’s support, 11 of these 24 drugs. The Company and Alnylam
established Regulus Therapeutics Inc. as a company focused on the discovery,
development and commercialization of microRNA therapeutics.
Mipomersen
Mipomersen is a
first-in-class apo-B synthesis inhibitor in development. Mipomersen is a
second-generation antisense drug Isis discovered and licensed to Genzyme.
Mipomersen is being developed to treat patients with very high cholesterol, at
high cardiovascular risk and who cannot reduce their LDL-C sufficiently with
available lipid-lowering therapies. Together with Genzyme, the Company has
evaluated mipomersen in four positive Phase III studies. Together with Genzyme,
Isis also evaluated mipomersen in two additional phase III studies in patients
with heterozygous FH and in patients with high cholesterol at high risk for
coronary heart disease who were on substantial lipid lowering therapy.
ISIS-CRP
ISIS-CRP is an
antisense drug that targets C-reactive protein (CRP), a protein produced in the
liver. CRP levels increase during inflammatory disorders, and excessive amounts
of CRP have been linked to coronary artery disease. The Company evaluated
ISIS-CRP in a Phase I blinded, randomized, placebo-controlled, dose-escalation
study designed to assess the safety and pharmacokinetic profile of its drug.
BMS-PCSK9
BMS-PCSK9 is an
antisense drug that specifically targets proprotein convertase subtilisin/kexin
type 9, or PCSK9, a protein involved in the metabolism of cholesterol and
low-density lipoprotein (LDL). PCSK9’s role is to break down the cell surface
receptor that captures LDL particles.
ISIS-FXI
ISIS-FXI is an
antisense drug designed to treat clotting disorders. It targets Factor XI, a
clotting factor produced in the liver that is a component of the coagulation
pathway.
ISIS-APOCIII
ISIS-APOCIII is an
antisense drug designed to lower triglycerides to treat hypertriglyceridemia.
ISIS-APOCIII targets apolipoprotein C-III (apoC-III), a protein synthesized in
the liver that plays a central role in the regulation of serum triglycerides.
As of December 31, 2010, the Company was evaluating ISIS-APOCIIIRx in a Phase I
study.
ISIS-PTP1B
The Company’s
program in metabolic disease targets protein tyrosine phosphatase-1B, PTP-1B, a
phosphatase that regulates insulin receptor signaling. PTP-1B is responsible
for turning off the activated insulin receptor, so reducing PTP-1B enhances
insulin activity. Its advanced antisense drug in its PTP-1B program is ISIS
113715. In two Phase II studies, treatment with ISIS 113715 improved glucose
control in patients with type 2 diabetes.
ISIS-GCGR
ISIS-GCGR is an
antisense drug that targets GCGR, or glucagon receptor. The Company reported
Phase I data in which its advanced GCGR drug produced a improvement in
glucagon-induced blood glucose levels.
ISIS-GCCR
ISIS-GCCR is an
antisense drug that targets GCCR, or glucocorticoid receptor. Antisense inhibitors
of GCCR use the tissue distribution of oligonucleotides that allows the
antisense drugs to antagonize glucocortocoid action primarily in liver and fat
tissue.
ISIS-SGLT2
ISIS-SGLT2 is an
antisense drug that targets sodium glucose co-transporter type 2 (SGLT2), which
is the major transporter for blood sugar re-absorption in the kidney. As of
December 31, 2010, the Company was evaluating ISIS-SGLT2Rx in a Phase I study
designed to assess the safety and activity of the drug in healthy volunteers by
measuring the effect on glucose excretion in urine.
ISIS-FGFR4
ISIS-FGFR4 is an
antisense drug that targets fibroblast growth factor receptor 4 (FGFR4), in the
liver and fat tissue. FGFR4 helps regulate energy expenditure and body weight.
OGX-011
OGX-011 is a
second-generation antisense drug that targets clusterin, a secreted protein
that acts as a cell-survival protein and is over-expressed in response to
anti-cancer agents. OncoGenex evaluated OGX-011 in five Phase II studies in
combination with various cancer therapies for prostate, NSCLC and breast
cancer. OncoGenex has also evaluated OGX-011 in a Phase I/II combination study
in patients with NSCLC. During the year ended December 31, 2010, OncoGenex and
Teva initiated two Phase III clinical studies of OGX-011 in cancer patients
with prostate.
LY2181308
LY2181308 is an
antisense drug that targets survivin, which plays a role in cancer cell death.
Isis licensed its anti-cancer drug, LY2181308, to Eli Lilly and Company as part
of the companies’ antisense drug discovery research collaboration in cancer.
Eli Lilly and Company is evaluating LY2181308 as a combination therapy in two
separate randomized Phase 2 studies: one, in patients with advanced/metastatic
NSCLC who failed first line chemotherapy treatment; second, in patients with
hormone refractory prostate cancer who receive docetaxel for first line
chemotherapy.
ISIS-EIF4E
ISIS-EIF4E targets
the gene that is responsible for producing the protein eIF-4E, which is
over-expressed in a variety of cancers, including prostate, lung, ovarian,
liver, breast, head and neck, bladder, colon, thyroid and lymphoma. Eli Lilly
and the Company completed a Phase I study of ISIS-EIF4ERx in patients with
cancer. During 2010, the Company initiated a Phase II program of ISIS-EIF4ERx
in patients with NSCLC and prostate cancer.
OGX-427
OGX-427 is a
second-generation antisense drug targeting heat shock protein 27, or Hsp27,
which is a cell survival protein that is over-produced in response to many
cancer treatments, including hormone ablation therapy, chemotherapy and
radiation therapy. OncoGenex is evaluating OGX-427 in patients with cancer. In
June 2010, OncoGenex reported preliminary results from a Phase I study of
OGX-427 in patients with a variety of cancers.
ISIS-STAT3
The Company
designed ISIS-STAT3 to treat cancer by inhibiting the production of a gene
critical for tumor cell growth and survival. In preclinical studies, ISIS-STAT3
demonstrated antitumor activity in animal models of human cancer.
ISIS-SOD1
ISIS-SOD1 is an
antisense drug that targets superoxide dismutase (SOD1), a molecule associated
with an inherited, aggressive form of amyotrophic lateral sclerosis (ALS). The
United States Food and Drug Administration (FDA) granted ISIS-SOD1 Orphan Drug
designation for the treatment of ALS.
ISIS-SMN
ISIS-SMN is an
antisense drug designed to treat spinal muscular atrophy (SMA), a neuromuscular
disorder and the genetic cause of infant mortality. ISIS-SMN increases the
production of the SMN protein by modulating the splicing of a closely related
pre-mRNA, SMN2.
ISIS-GSK1
ISIS-GSK1 is an
antisense drug designed to treat an undisclosed serious and rare disease.
ISIS-GSK1 is the first drug to enter development under its partnership with
GlaxoSmithKline (GSK).
ACHN-490
ACHN-490 is a
aminoglycoside (neoglycoside), drug that Achaogen is developing for the
treatment of multi-drug resistant gram-negative bacterial infections.
Aminoglycosides are a group of antibiotics that inhibit bacterial protein
synthesis and that clinicians use to treat serious bacterial infections.
ATL1102
ATL1102 is an
antisense drug that Antisense Therapeutics Limited (ATL), is developing for the
treatment of multiple sclerosis (MS). ATL1102 inhibits CD49d, a subunit of Very
Late Antigen-4 (VLA-4).
ATL1103
ATL1103 is an
antisense drug that targets the growth hormone receptor (GHr), a receptor that,
when inhibited, reduces the level of circulating insulin-like growth factor-1
(IGF-1) produced in the liver. ATL has completed pre-clinical toxicology
studies on the compound.
EXC 001
EXC 001 is an
antisense drug that targets connective tissue growth factor (CTGF), a growth
factor that is over-expressed in damaged skin or tissue following a traumatic
event. The Company co-discovered EXC 001 and licensed it to Excaliard for the
local treatment of fibrotic diseases, including scarring.
iCo-007
iCo-007 is an
antisense drug that targets c-Raf kinase. In July 2010, iCo received approval
to initiate a Phase II study on iCo-007 in patients with diabetic macular
edema.
More Business Descriptions
Isis
Pharmaceuticals, Inc. (Isis) is engaged in antisense technology, exploiting a
drug discovery platform to create a pipeline of drugs. The Company operates in
two business segments: Drug Discovery and Development and Regulus Therapeutics
Inc. Within the Drug Discovery and Development segment, its drug discovery
platform enables the Company to identify drugs, providing potential targets to
treat a range of diseases. As of March 31, 2011, the Company had 24 drugs in
development. Its partners are licensed to develop, with the Company’s
support, 11 of these 24 drugs. The Company and Alnylam established Regulus
Therapeutics Inc. as a company focused on the discovery, development and
commercialization of microRNA therapeutics. For the fiscal year ended 31
December 2010, ISIS Pharmaceuticals, Inc.'s revenues decreased 11% to $108.5M.
Net loss from continuing operations increased 75% to $61.3M. Revenues reflect
lower research & development revenue under collaborative agreements,
decrease in licensing & royalty revenue. Higher loss reflects an increase
in research & development expenses and a substantial rise in interest
expenses.
Establishments
primarily engaged in the wholesale distribution of prescription drugs,
proprietary drugs, druggists' sundries, and toiletries.
Isis
Pharmaceuticals is a biopharmaceutical company that researches and develops
therapeutic drugs for conditions, including inflammatory, metabolic, and
cardiovascular diseases, and cancer. Founded in 1989, Isis owns more than 1,500
issued patents worldwide, and discovers and develops ribonucleic acid-based
drugs. Its drug discovery and development division provides antisense
inhibitors from its RNA-based technology. Its IBIS T5000 biosensor system is
capable of identifying infectious organisms and is used by government agencies
in biowarfare defense, epidemiological surveillance and forensics. The
biosensor system is also used in pharmaceutical process control, hospital-associated
infection control, and infectious disease diagnostics. Isis Pharmaceuticals is
headquartered in Carlsbad, Calif.
Researcher,
developer, and producer of RNA-related human therapeutics. Commercialized
products include Vitravene(R) (fomivirsen), to treat CMV-induced retinitis in
AIDS patients; products in development include compounds in pre-clinical and
all phases of clinical development to treat a variety of health conditions,
including infectious, inflammatory, and metabolic diseases and cancer. Parent/holding
company with high-tech operating units involved in pharmaceuticals. Products
are sold to the medical industry.
Product Codes
Product Code Product
Description
BIO-IM-B CMV-induced retinitis product -
Vitravene(R)
BIO-IM-C Anticancer compounds
BIO-MS-CN Oligonucleotide agents
PHA-AI-V Antiviral agents
PHA-GI Inflammatory bowel disease agents
ZZZ-HC Parent/Holding Company
Brand/Trade Names
Icis - Jewelry
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ISIS
Pharmaceuticals, Inc.
The Strategic
Initiatives report is created using technology to extract meaningful insights
from analyst reports about a company's strategic projects and investments. More
about Strategic Initiatives
Strategic Initiatives
Partnerships
This collaboration
builds upon earlier successful alliances in which CHDI, provided funding to
support Isis' early work in HD.Under the terms of the new collaboration, Isis
will receive funding from CHDI to identify and conduct IND-enabling studies on
an antisense drug targeting the huntingtin gene. In addition, Isis is eligible
to be reimbursed by CHDI for approximately $2 million of HD research-related
expenses Isis incurred after the earlier collaboration ended in 2010. Upon
completion of IND-enabling studies, Isis and CHDI expect to continue to
collaborate on the clinical development of drugs arising from the
collaboration. Alex Kiselyov, director of chemistry at CHDI, said,
"Reducing the amount of mutant huntingtin, the protein that causes
Huntington's disease, is an integral part of CHDI's therapeutic portfolio.
Genzyme is on
track to file for marketing approval of mipomersen in both the U.S. and Europe
in the first half of next year. We believe that the initial market for
mipomersen represents a significant financial opportunity, and we are excited
to bring this new medicine to an underserved patient population," "We
continue to maintain a strong financial position in large part due to our
partnership successes that have continued to generate new revenue for us. For
example, our 2010 revenue includes the amortization of upfront fees from our
new collaboration with GSK and new sublicensing revenue from Regulus' alliance
with sanofi-aventis. In addition, we have earned $13 million in milestone
payments from our partners. We earned many of these milestone payments in the
middle of this year.
• Data from two
Phase III studies of mipomersen was presented at the 79th European
Atherosclerosis Society Congress. The data highlight the potential of
mipomersen in lowering Lp (a) and potentially reducing the necessity for
lipid-apheresis. • Isis initiated Phase I studies on ISIS-PTP1BRx and
ISIS-TTRRx, the first drug selected as part of its collaboration with GSK. Upon
Phase I initiation, Isis earned a $5 million milestone payment from GSK. •
Isis and GSK expanded their collaboration by initiating a sixth program to
discover and develop drugs to treat rare and infectious diseases and Isis
received a $3 million payment from GSK.
Upon Phase I
initiation, Isis earned a $5 million milestone payment from GSK. • Isis and
GSK expanded their collaboration by initiating a sixth program to discover and
develop drugs to treat rare and infectious diseases and Isis received a $3
million payment from GSK. • The Isis and GSK collaboration was awarded the
Breakthrough Alliance Award of 2011 as the breakthrough deal of 2010.May 05,
2011Isis Pharmaceuticals Reports Net Loss Of $20m For Q1 2011Isis
Pharmaceuticals, Inc. (Isis) reported a net loss of $20m, or $0.20 per share,
for the first quarter of 2011, compared to a net loss of $9.6m, or $0.10 per
share, for the same period of 2010. Total revenue was $21.1m for the first
quarter of 2011, compared to $29.9m for the same period of 2010.
Lynne Parshall,
COO and CFO of Isis, said, "2010 was another strong year for Isis. We
exceeded our financial guidance for the year while continuing to significantly
advance all areas of our business. Our most notable accomplishment was the
successful completion of the initial Phase III program for mipomersen, which brings
this important medicine closer to commercialization.”Nov 16, 2010Isis And
Xenon Collaborate To Develop Antisense Drugs Against Hemojuvelin And
HepcidinIsis Pharmaceuticals, Inc. (Isis) has formed a new collaboration to
discover and develop antisense drugs as new treatments for the common disease
anemia of inflammation (AI) with Xenon Pharmaceuticals Inc. (Xenon), clinical
genetics-based drug development company.Under the terms of the agreement, Isis
will receive an undisclosed upfront payment in the form of a convertible
promissory note from Xenon to discover and develop antisense drugs to the
targets hemojuvelin and hepcidin. Upon the identification of a development
candidate, Xenon has the option to exclusively license the development and
worldwide commercialization rights for these antisense drugs from Isis.
This collaboration
builds upon earlier successful alliances in which CHDI, provided funding to
support Isis' early work in HD.Under the terms of the new collaboration, Isis
will receive funding from CHDI to identify and conduct IND-enabling studies on
an antisense drug targeting the huntingtin gene. In addition, Isis is eligible
to be reimbursed by CHDI for approximately $2 million of HD research-related
expenses Isis incurred after the earlier collaboration ended in 2010. Upon
completion of IND-enabling studies, Isis and CHDI expect to continue to
collaborate on the clinical development of drugs arising from the
collaboration. Alex Kiselyov, director of chemistry at CHDI, said,
"Reducing the amount of mutant huntingtin, the protein that causes Huntington's
disease, is an integral part of CHDI's therapeutic portfolio. Antisense
oligonucleotides show considerable potential in this regard and we're excited to
work further with Isis to develop this approach as a therapy for HD.” Frank
Bennett, senior vice president of research at Isis, said, "We are pleased
to be working again with CHDI to identify a potential new therapy for
Huntington's disease, a condition for which there is currently only very limited
treatment options available.
Such a weak
financial performance would affect the company’s expansion plans and limit
its growth.Strategic collaborationsISIS has established corporate partnerships
with major pharmaceutical companies. The company entered into collaborations
with leading pharmaceutical companies like Bristol-Myers Squibb, Eli Lilly and
Genzyme Corporation and biotechnology companies like Alnylam Pharamceuticals,
Inc, OncoGenex and iCo Therapeutics Inc. The company is developing several Antisense
drugs such as OGX-011, OGX-427, LY2181308 and ISIS-EIF4ERx ( LY2275796) in the
area of cancer treatment with the help of these agreements. With the
collaboration with Merck, ISIS is developing product candidates for hepatitis C
virus. The company is also developing other pipeline drugs namely ATL/TV1102
for multiple sclerosis, iCo 007 for ocular disease, ISIS 333611 for ALS
(amyotrophic lateral sclerosis). In February 2010, Regulus entered into a
strategic alliance with GlaxoSmithKline (GSK) to develop and market microRNA
therapeutics targeting microRNA 122, or miR-122, for hepatitis C viral
infection.
• Isis initiated
Phase I studies on ISIS-PTP1BRx and ISIS-TTRRx, the first drug selected as part
of its collaboration with GSK. Upon Phase I initiation, Isis earned a $5
million milestone payment from GSK. • Isis and GSK expanded their
collaboration by initiating a sixth program to discover and develop drugs to
treat rare and infectious diseases and Isis received a $3 million payment from
GSK. • The Isis and GSK collaboration was awarded the Breakthrough Alliance
Award of 2011 as the breakthrough deal of 2010.May 05, 2011Isis Pharmaceuticals
Reports Net Loss Of $20m For Q1 2011Isis Pharmaceuticals, Inc. (Isis) reported
a net loss of $20m, or $0.20 per share, for the first quarter of 2011, compared
to a net loss of $9.6m, or $0.10 per share, for the same period of 2010.
The building is
expected to qualify for Silver LEED certification from the US Green Building
Council.Aug 11, 2011Isis And CHDI Foundation Renew Drug Development
collaboration For Huntington's DiseaseIsis Pharmaceuticals, Inc and CHDI Foundation,
Inc, a non-profit biomedical research organization dedicated to the development
of therapeutics for HD, announced a renewal of their collaboration to discover
and develop an antisense drug for the treatment of Huntington's disease (HD), a
fatal neurodegenerative disorder. This collaboration builds upon earlier
successful alliances in which CHDI, provided funding to support Isis' early
work in HD.Under the terms of the new collaboration, Isis will receive funding
from CHDI to identify and conduct IND-enabling studies on an antisense drug
targeting the huntingtin gene. In addition, Isis is eligible to be reimbursed
by CHDI for approximately $2 million of HD research-related expenses Isis
incurred after the earlier collaboration ended in 2010. Upon completion of
IND-enabling studies, Isis and CHDI expect to continue to collaborate on the
clinical development of drugs arising from the collaboration.
The building was
designed to be science-centric with modern design features to foster
interdisciplinary collaborations, including ample space to promote innovation,
creative use of outdoor space that provides informal meeting areas for people
to exchange ideas, bright and innovative laboratories with modern mobile bench
cabinetry that can be moved to accommodate scientists' needs, and a fitness
course that surrounds the entire campus. In addition, the eco-friendly campus
includes environmentally sensitive design features, including solar panels,
maximum use of natural lighting, and drought-resistant native landscaping
designed to take advantage of the City of Carlsbad's local water reclamation
plant. The building is expected to qualify for Silver LEED certification from
the US Green Building Council.Aug 11, 2011Isis And CHDI Foundation Renew Drug
Development collaboration For Huntington's DiseaseIsis Pharmaceuticals, Inc and
CHDI Foundation, Inc, a non-profit biomedical research organization dedicated
to the development of therapeutics for HD, announced a renewal of their
collaboration to discover and develop an antisense drug for the treatment of
Huntington's disease (HD), a fatal neurodegenerative disorder. This
collaboration builds upon earlier successful alliances in which CHDI, provided
funding to support Isis' early work in HD.Under the terms of the new collaboration,
Isis will receive funding from CHDI to identify and conduct IND-enabling
studies on an antisense drug targeting the huntingtin gene.
Product
In addition, for
our current partnered programs we have the potential to earn more than $3.5
billion in future milestone payments. We also will share in the future
commercial success of our inventions and drugs resulting from these
partnerships through earn out, profit sharing, and/or royalty arrangements. Our
strong financial position is a result of the persistent execution of our
business strategy and our inventive and focused research and development
capabilities. Beyond drug development, we create significant shareholder value
through products that incorporate our inventions that other companies are developing
and commercializing. For example, together with Alnylam, we created and jointly
own Regulus.
We have the
opportunity to share in Regulus’ successes as Regulus advances its partnered
drug programs forward and to benefit from the appreciation in the value of our
investment in Regulus. We protect our proprietary RNA-based technologies and
products through our substantial patent estate. As an innovator in RNA-based
drug discovery and development, we design and execute our patent strategy to
provide us with extensive protection for our drugs and our technology. With our
ongoing research and development, our patent portfolio continues to grow. The
patents not only protect our key assets—our technology and our drugs—they
also form the basis for lucrative licensing and partnering arrangements.
These drugs offer
new approaches to treat disease and broaden our therapeutic focus. For example,
the new drugs we added to our cardiovascular franchise expand our
cardiovascular approach beyond managing cholesterol and other atherogenic
lipids to reducing inflammatory and thrombotic factors, which can contribute
significantly to cardiovascular disease. Because we can discover more drugs
than we can develop ourselves, our partnership strategy allows us to focus on
our key therapeutic areas while also creating an expansive pipeline with
multiple partnerships. We focus our research and development efforts primarily
in cardiovascular, metabolic, severe and rare, and neurodegenerative diseases,
and cancer while our partners are developing antisense drugs in these and other
areas, including inflammatory disease. The clinical success of mipomersen, the
lead drug in our cardiovascular franchise, is a clear example of the power of
our RNA-based technology.
Sales and Distribution
-based drug
development company.Under the terms of the agreement, Isis will receive an
undisclosed upfront payment in the form of a convertible promissory note from
Xenon to discover and develop antisense drugs to the targets hemojuvelin and
hepcidin. Upon the identification of a development candidate, Xenon has the
option to exclusively license the development and worldwide commercialization
rights for these antisense drugs from Isis. In addition to license and option
fees, Isis will be eligible to receive development and commercial milestones
and royalties on sales of drugs licensed to Xenon under the collaboration as
well as a portion of sublicense revenue. Simon Pimstone, president and CEO of
Xenon, said: "We are excited to be working with Isis, a world leader in
the discovery and development of RNA-targeted therapeutics. Using our human
genetics platform, we validated hemojuvelin and hepcidin as new targets for the
treatment of anemia of inflammation where inhibition of these targets in the
liver is predicted to treat AI by promoting red blood cell production.
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Helpful |
Harmful |
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Internal Origin |
Strengths |
Weaknesses
Limited
Manufacturing Facilities |
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External Origin |
Opportunities |
Threats |
Overview
ISIS is a
biopharmaceutical company engaged in the development of drugs to treat
cardiovascular diseases and cancer with the help of its patented ribonucleic
acid (RNA) based drug discovery technologies. The company continues to leverage
its innovative Antisense technology to develop products and generate revenues
by out-licensing the technology. However, if the company is not able to compete
effectively, its revenues may be adversely affected.
Strengths
Intellectual Property
Strong patent
portfolio creates market exclusivity to the proprietary drug candidates giving
the company a competitive edge over its competitors. Isis leverages its huge portfolio
of patents to protect its technologies and generate revenues through licensing.
ISIS holds more than 1,600 issued patents worldwide. The company is one of the
owners of largest antisense and RNA patent holdings in the pharmaceutical
industry. Isis’ major patents cover antisense mechanisms, biology, chemistry,
inhibitors of gene expression and the manufacture of antisense drugs. Till
2010, the company recorded revenue more than $398m through the licensing of its
intellectual property. Thus the patent portfolio of the company has immense
importance as it protects Isis' RNA-based drug discovery technologies. This in
turn helps the company in revenue generation through milestone licensing fees.
Patented Antisense Technology
ISIS leverages on
its patented Antisense technology which has distinct competitive advantages
over existing and emerging technologies and approaches. One of the key
strengths of Isis is its dominance in the advanced RNA-based technology through
its Antisense technology. Antisense technology has immense importance in drug
discovery and development. The technology is broadly used in the pharmaceutical
industry as a tool especially in functional genomics. Antisense is also used as
highly specific drugs across broad range indications. Antisense drugs
differentiate the targets based on their genetic sequence. Thus, targeting the
potential area is significantly greater. Antisense reduces time to identify
lead drug candidates in the discovery phase of development. Antisense is also
efficient in the area of manufacturing. The company has undertaken several
antisense drug discovery programs which had focus on various cardiovascular,
metabolic, cancer, neurodegenerative, inflammation and other diseases. Using
Antisense technology, the company is designing and developing drugs which bind
to RNA instead of protein. The antisense drugs target a broad range of diseases
and selectively target one and only one gene product. ISIS develops a patented
portfolio of drugs which could interrupt the production of disease-causing
proteins without disrupting other proteins that are needed for the body’s
normal functions.
Focused R&D
ISIS leverages on
its patented Antisense technology which has distinct competitive advantages
over existing and emerging technologies and approaches. One of the key
strengths of Isis is its dominance in the advanced RNA-based technology through
its Antisense technology. Antisense technology has immense importance in drug
discovery and development. The technology is broadly used in the pharmaceutical
industry as a tool especially in functional genomics. Antisense is also used as
highly specific drugs across broad range indications. Antisense drugs
differentiate the targets based on their genetic sequence. Thus, targeting the
potential area is significantly greater. ISIS the leader in the discovery and
development of an exciting new class of drugs called antisense drugs. With the
company's proprietary drug discovery platform the company can rapidly identify
drugs, providing a wealth of potential targets to treat a broad range of
diseases. The company focuses its efforts in therapeutic areas where its drugs
will work best, efficiently screening many targets in parallel and carefully
selecting the best drugs. The company combines this efficiency with its
rational approach to select disease targets. It can build a large and diverse
portfolio of drugs designed to treat a variety of health conditions, including
cardiovascular, metabolic, inflammatory, ocular, severe and rare, and
neurodegenerative diseases, and cancer. The company also continues to improve
its scientific understanding of drugs and other disease targets, including the
biological processes the company's disease targets use and the impact of its
drugs on these processes. The company has approved products in various projects
undertaken, such as Cardiovascular, metabolic, Cancer, Neurodegenerative,
Inflammation & Other. For the year ended 2010 the company has spent
$145.16m on research and development as compared to $134.62m in 2009 indicating
an increase of 7.83% over that in 2009.
Weaknesses
Limited Manufacturing Facilities
Any potential
difficulties experienced by the company in manufacturing could have a material
adverse effect on its financial position and business operations. Currently,
the company has limited manufacturing capacities. It has a 28,704 square foot
drug substance manufacturing facility located in Carlsbad, California. For
commercialization of any drugs in future, the company may have to establish
commercial manufacturing sites or contract with third party manufacturers.
Increase and maturity of drug development pipeline will create the need for
clinical trial and commercial manufacturing capacity. The scale of current
contract manufacturers is limited and it needs to be increased for commercial
production. Any failures to comply with the FDA's current Good Manufacturing
Practices regulations may result in considerable delay or termination of
marketing approval for potential products. This may adversely affect revenues
and margins.
Dependence on Third Parties for Clinical Trials
ISIS’s
dependence on third parties for the commercial manufacture of its product
candidates could reduce its profit margins and its ability to develop and
deliver products in a timely manner. For clinical trials, the company is
dependent upon the contract research organizations, independent clinical
investigators and other third-party service providers. Medpace, a primary
clinical research organization, is handling the clinical trials for mipomersen.
In case, the third parties are not able to complete their activities on time or
as per the regulatory requirements, it may delay the approvals or termination
of trials. Any failure of third parties in clinical trials or a termination of
the contract may adversely affect the development, approval and commercialization
of the product pipeline.
Weak Financial Performance
Weak financial
performance would have adverse impact on the profitability of the company and
would result in decrease of investors confidence. ISIS exhibited a weak
financial performance for the fiscal year ended 2010, reflecting its inability
to fulfill operational and business expansion needs. The company reported
revenues of $108.47m for the fiscal year ended December 2010, indicating a
decrease of 10.8% over that in 2009. The operating loss of the company was
$48.36m in 2010, as against an operating loss of $27.54m in 2009. The net loss
of the company was $61.25m in 2010, as against a net profit of $155.07m in
2009. The company has been incurring losses as it is not able to generate
sufficient revenues to meet expenses. The decrease in the operating and net
profit affected the company’s profitability. The operating margin of the
company decreased to (44.58%) in 2010 from (22.65)% in 2009. The company’s
return on equity decreased to (25.05%) in 2010 from 53.15% in 2009. Its return
on assets and return on fixed assets decreased to (11.13%) and (71.81%) in
2010, respectively from 23.60% and 45.10% in 2009. The company’s return on
capital employed decreased to (-70.50%) in 2010 from 2.02% in 2009. Drastically
declining profitability ratios indicate that the company has been
underperforming and is not able to deliver the value as expected by its
shareholders. Such a weak financial performance would affect the company’s
expansion plans and limit its growth.
Opportunities
Changing Demographics
The increasing
number of people aged above 65, who consume disproportionately more medicines
and are more prone to chronic diseases, holds significant market potential for
the company. People above 65 are the single largest group of customers for
pharmaceutical companies as they consume three times more prescription drugs
per head than those aged below 65. According to the United Nations Population
Division, people aged 60 were projected to account for 22% of the total world
population by 2050, up from 11% in 2007. Globally, people aged 80 years and
older, are projected to increase by 233% between 2008 and 2040. In the US, the
Census Department projected that the 65 and older segment of the population
will expand from 38.7 million in 2008 to 72.1 million by 2030, when all of the
baby boomers (Americans born from 1946 through 1964) will be 65 and older.
Strategic Collaborations
ISIS has
established corporate partnerships with major pharmaceutical companies. The
company entered into collaborations with leading pharmaceutical companies like
Bristol-Myers Squibb, Eli Lilly and Genzyme Corporation and biotechnology
companies like Alnylam Pharamceuticals, Inc, OncoGenex and iCo Therapeutics
Inc. The company is developing several Antisense drugs such as OGX-011,
OGX-427, LY2181308 and ISIS-EIF4ERx ( LY2275796) in the area of cancer
treatment with the help of these agreements. With the collaboration with Merck,
ISIS is developing product candidates for hepatitis C virus. The company is
also developing other pipeline drugs namely ATL/TV1102 for multiple sclerosis,
iCo 007 for ocular disease, ISIS 333611 for ALS (amyotrophic lateral
sclerosis). In February 2010, Regulus entered into a strategic alliance with
GlaxoSmithKline (GSK) to develop and market microRNA therapeutics targeting
microRNA 122, or miR-122, for hepatitis C viral infection. Strategic
collaborations will support the advance Antisense drug discovery and clinical
development programs. Expanded use of Antisense technology through
collaborations may result in new drugs for patients in need and increase in
productivity. In March 2010, the company collaborated with GlaxoSmithKline to
develop innovative new therapeutics against targets for rare and serious
disease like infectious diseases and some conditions causing blindness, using
Isis's antisense drug discovery platform. In June 2010, Alnylam
Pharmaceuticals, Inc. and Isis Pharmaceuticals, Inc. announced that, as a
result of the newly formed alliance Regulus has established with
sanofi-aventis, each company will receive a payment of $1.8m from Regulus. In
addition, Alnylam and Isis are each eligible to receive a similar percentage of
potential future success-based payments from the alliance. In November 2010
Isis Pharmaceuticals and Xenon Pharmaceuticals Inc collaborate to discover and
develop antisense drugs as novel treatments for the common disease anemia of
inflammation (AI).
Diversified Product Pipeline
ISIS has a
diversified pipeline portfolio, which is expected to result in significant
revenue increases once these pipeline products are approved. The company is
developing product candidates across different therapeutic areas such as
cardiovascular, metabolic, cancer, inflammation and others. In the
cardiovascular segment, the company has Mipomersen, a first-in-class apo-B
synthesis inhibitor for reducing LDL-cholesterol. Mipomersen exhibited positive
data in two Phase 3 studies in patients with FH. It is also developing ISIS-CRP
for coronary artery disease in phase I. In January 2010, the company added a
new cardiovascular drug, ISIS-APOCIIIRx, to its development pipeline.
ISIS-APOCIIIRx treats hypertriglyceridemia, or high levels of triglycerides
(TG) , an independent risk factor for cardiovascular disease. In the metabolic
area, the company pipeline drugs for diabetes and obesity which include ISIS
113715 which targets PTP-1B for treating type 2 diabetes; ISIS-GCGRRx, an
antisense drug which targets glucagon receptor (GCGR); ISIS-GCCRRx, an
antisense drug targeting the glucocorticoid receptor (GCCR) and ISIS-SGLT2Rx,
an antisense drug that targets sodium glucose co-transporter type 2 (SGLT2). In
oncology, ISIS has OGX-011 that targets clustering, licensed to Teva
Pharmaceutical Industries Ltd., and LY2181308 that targets survivin, licensed
to Eli Lilly and Company, ISIS-EIF4ERx (formerly LY2275796) that targets
eukaryotic initiation factor-4E, licensed to Eli Lilly and Company, OGX-427
that targetsheat shock protein 27. In the inflammation segment, the company is
developing Alicaforsen for Ulcerative Colitis and ATL1102 for Multiple
sclerosis in phase II clinical trials; and AIR645 for Asthma in phase I
clinical trials. Its antisense drugs for neurodegenerative diseases are
ISIS-SOD1Rx to treat amyotrophic lateral sclerosis (ALS) and ISIS-SMNRx to
treat spinal muscular atrophy (SMA). Other antisense drugs in development
includes ACHN-490 for treating multi-drug resistant gram-negative bacterial
infections, AIR645 to treat human respiratory diseases, Alicaforsen for treating
a wide variety of inflammatory disorders, including ulcerative colitis and
pouchitis, ATL/TV1102 for treating multiple sclerosis, iCo-007 for treating
diabetic macular edema and diabetic retinopathy; EXC 001 for treating fibrotic
diseases like scarring. The company is aggressively expanding its product
pipeline and moves drugs through the clinic to build the pipeline which has
been the basis of its financial success.
Threats
Emergence of Biogenerics / Biosimilars
The proposed
regulatory approval for the introduction of biogenerics / biosimilars, generic
versions of biologic drugs, increases the threat of uncertainty to the company.
Until recently, there was no generic competition to the biotech industry as
there was no regulatory framework in place to approve generic version of
biotech drugs. Most regulators felt that biologic drugs, unlike the
pharmaceutical drugs, are hard to copy as they are manufactured from living
cells which are hard to replicate. However, the situation is changing fast with
European regulatory authority approving Omnitrope, a generic version of human
growth protein, and issuing guidelines for approving generic versions of select
biologic drugs. The move towards establishing such a regulatory framework in
the US is likely to intensify in the near future with Barack Obama, who is in
favor of increased utilization of generics to control the rising healthcare
costs, making it one of his top priorities. In March 2009, two separate
biosimilar legislations were introduced in the senate. Both the bills aim to
establish a regulatory pathway for biosimilars and give the FDA the authority
to approve biosimilars.
Uncertain R&D Outcomes
Adverse or
inconclusive results from preclinical testing or clinical trials may
substantially delay or halt the development of the company's various product
candidates, consequently affecting its timeliness for profitability. The
outcome of clinical trials is always a subject of uncertainty. After the
discovery of a new compound, substantial amount of money and a great deal of
time are required to successfully launch a new product. Moreover, it may become
necessary to discontinue clinical development if the effectiveness of a drug is
not proven as initially expected, or if serious adverse effects arise. In
addition, pharmaceuticals are subject to legal restrictions in each country and
authorization from local regulatory authorities is a prerequisite for a product
launch in every country. It is difficult to accurately foresee when approvals
for a new product can be obtained.
Increased Pricing Control
ISIS’s ability
to price its drugs is under significant threat following the increased level
scrutiny over the cost effectiveness of treatments from government as well
private payers. Spurred by rising healthcare costs, European governments in
particular, have established semi-independent organizations to evaluate if the
drugs prices are in-line with the kind of results they deliver. Though US has
not established any such organizations, the US private payers are controlling
the patients access to the drugs by evaluating the cost effectiveness of
various drugs and placing them in various tiers, with different tiers requiring
different levels of contributions from patients. Further, US payers are running
programs which incentivize patients to use certain preferred drugs.
Tightening of the FDA’s Regulatory Oversight
Increased
regulation of the drug market could increase the company’s costs and reduce
revenue as getting drugs to market becomes a long and more expensive process.
Following intense public scrutiny after Vioxx recall, the congress passed the
Food and Drug Administration Amendments Act of 2007 (FDAAA), which
significantly expanded the FDA’s regulatory oversight. The amendment empowers
FDA to mandate drug companies to study the safety of medicines further and
issue new label warnings when safety issues arise. Under the amendment, FDA
stipulates that every drug application should include a post-market risk
management program for three years after launch. Moreover, increased safety
concerns have led FDA to delay approvals for several therapies with the agency opting
to issue “approvable letters” instead of giving the final approval. The
approvable letters mandate manufacturers to submit more clinical data for FDA
to approve the final product. The additional data required by the agency
entails further trials, thereby delaying the product launch by several months
to years. Currently, pharmaceutical companies spend $1 billion on an average
and 8 years to develop a new drug. On February 23, 2010, President Obama
released new healthcare reform proposals which include a combination of
provisions from both the Senate and House of Representatives bills passed in
late 2009. The proposals include restricting the coverage and reimbursement of
products by Medicare, Medicaid and other government programs. This could translate
into additional healthcare reform costs to be borne by pharmaceutical and
biotechnology companies and reduce the number of years of data exclusivity for
innovative biological products, potentially leading to earlier biosimilar
competition.
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Credit Report as of 02/01/2011
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Location |
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1896 Rutherford Rd |
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County: |
San Diego |
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MSA: |
San Diego, CA |
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Phone: |
760-931-9200 |
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Fax: |
760-603-2700 |
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URL: |
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ABI: |
448237735 |
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Annual Sales: |
$108,473,000 (USD) |
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Employees: |
300 |
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Facility Size(ft2): |
40,000+ |
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Facility Own/Lease: |
Own |
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Business Type: |
Public |
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Location Type: |
Headquarter |
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Ticker: |
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Exchange: |
NASDAQ |
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Recommended
Credit Limit * |
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$50,000 (USD) |
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Primary Line Of
Business: |
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SIC: |
5122-03 - Pharmaceutical Products-Wholesale |
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NAICS: |
424210 - Druggists' Goods Merchant Whols |
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Secondary Lines
Of Business: |
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SICs: |
8742-13 - Marketing Programs & Services |
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9999-66 - Federal Government Contractors |
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NAICS: |
541613 - Marketing Consulting Svcs |
Table of Contents
Profile Links
Similar Businesses in the Area
Closest Neighbors
External Links
http://isispharm.com
Stock Quote (ISIS)
Similar Businesses in the Area *
CSI Pharmaceutical
2525 Fortune Way
Vista, CA 92081-8466
Biopharm Solutions
Inc
1386 Poinsettia Ave Ste: A
Vista, CA 92081-8506
Carlsbad
Technology Inc
5923 Balfour Ct
Carlsbad, CA 92008-7304
Genentech Inc
1 Antibody Way
Oceanside, CA 92056-5701
Sabre
Pharmaceutical
2233 Faraday Ave
Carlsbad, CA 92008-7214
Medinox Inc
6120 Paseo Del Norte Ste: B2
Carlsbad, CA 92011-1148
ISIS
Pharmaceuticals Inc
2282 Faraday Ave
Carlsbad, CA 92008-7208
Ambio Pharm Inc
1635 Corte Orchidia
Carlsbad, CA 92011-4064
* Similar Businesses are
defined as the closest businesses sharing the same six-digit primary SIC code (
5122-03 - Pharmaceutical Products-Wholesale) regardless of size.
Closest Neighbors
Genoptix Medical
Laboratory
2110 Rutherford Rd
Carlsbad, CA 92008-7328
Athleisure Inc
2081 Las Palmas Dr
Carlsbad, CA 92011-1519
Epeius
Biotechnologies
1890 Rutherford Rd
Carlsbad, CA 92008-7344
1 800 Taxicab Inc
2185 Faraday Ave Ste: 110
Carlsbad, CA 92008-7206
Cal West
Management & Sales
2185 Faraday Ave Ste: 140
Carlsbad, CA 92008-7206
Residence Inn
2000 Faraday Ave
Carlsbad, CA 92008-7229
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Corporate
Family |
Corporate
Structure News: |
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Total Corporate Family Members: 5 |
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Company Name |
Company Type |
Location |
Country |
Industry |
Sales |
Employees |
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Parent |
Carlsbad, CA |
United States |
Biotechnology and Drugs |
108.5 |
370 |
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Subsidiary |
Carlsbad, CA |
United States |
Biotechnology and Drugs |
121.6 |
250 |
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Subsidiary |
Carlsbad, CA |
United States |
Biotechnology and Drugs |
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28 |
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Competitors Report
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Company Name |
Location |
Employees |
Ownership |
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Human Genome Sciences |
Rockville, Maryland, United States |
1,100 |
Public |
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Merck & Co., Inc. |
Whitehouse Station, New Jersey, United
States |
91,000 |
Public |
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Novartis AG |
BASEL, Switzerland |
121,000 |
Public |
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Pfizer Inc. |
NEW YORK, New York, United States |
110,600 |
Public |
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Roche Holding Ltd. |
Basel, Switzerland |
80,653 |
Public |
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The Procter & Gamble Company |
Cincinnati, Ohio, United States |
129,000 |
Public |
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VIA Pharmaceuticals, Inc. |
Roswell, Georgia, United States |
6 |
Public |
Executive report
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Board of
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Chairman of the Board, President, Chief Executive Officer |
Chairman |
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Independent Director |
Director/Board Member |
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Director |
Director/Board Member |
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Independent Director |
Director/Board Member |
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Independent Director |
Director/Board Member |
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Chief Financial Officer, Chief Operating Officer, Secretary, Director |
Director/Board Member |
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Independent Director |
Director/Board Member |
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Independent Director |
Director/Board Member |
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Executives |
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Chairman of the Board, President, Chief Executive Officer |
Chief Executive Officer |
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Chief Financial Officer, Chief Operating Officer, Secretary, Director |
Operations Executive |
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Vice President Manufacturing and Operations |
Operations Executive |
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Vice President-Finance |
Finance Executive |
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Web Master |
Human Resources Executive |
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Human Resources Manager |
Human Resources Executive |
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Senior Human Resources Generalist |
Human Resources Executive |
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Account Manager |
Sales Executive |
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Vice President of Corporate Development, Business Development and
Strategic Marketing |
Marketing Executive |
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Manager-Corporate Communications |
Corporate Communications Executive |
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Senior Manager Information Technology |
Information Executive |
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Senior Information Technology Project Engineer |
Information Executive |
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Senior Scientist, Medicinal Chemistry |
Research & Development Executive |
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Clinical Scientist |
Research & Development Executive |
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Senior Vice President - Antisense Research |
Research & Development Executive |
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Vice President Metabolic Diseases and
Research and Development |
Research & Development Executive |
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Senior Scientist, Toxicology |
Research & Development Executive |
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Vice President of Clinical Research and
Chief Medical Officer |
Research & Development Executive |
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Assistant Director Business Development |
Business Development Executive |
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Director-Business Development |
Business Development Executive |
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Vice President-Legal & General Counsel |
Legal Executive |
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Assistant Director, Manufacturing |
Manufacturing Executive |
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Director Quality Assurance and Complinace |
Quality Executive |
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Vice President and Chief Medical Officer |
Medical Specialist |
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Director of Molecular Pharmacology |
Medical Specialist |
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Contact |
Other |
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Contact |
Other |
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Senior Vice President - Development |
Other |
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Contact |
Other |
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Contact |
Other |
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Vice President |
Other |
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Associate Director |
Other |
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Director |
Other |
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Senior Infrastructure Storage Support |
Other |
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Manager, Office Services |
Other |
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Significant Developments
Isis
Pharmaceuticals Files Patent Infringement Suit Against Santaris Pharma A/S And
Santaris Pharma A/S Corp
Sep 23, 2011
Isis
Pharmaceuticals announced that it has filed a patent infringement lawsuit
against Santaris Pharma A/S and Santaris Pharma A/S Corp. in the United States
District Court of the Southern District of California . Isis' infringement suit
against Santaris is based upon Santaris' activities providing antisense drugs
and antisense drug discovery services to several pharmaceutical companies. As
alleged in the complaint, these activities are not protected under the
exemption from patent infringement for drug development.
Isis
Pharmaceuticals And CHDI Foundation Renew Drug Development Collaboration For
Huntington's Disease
Aug 11, 2011
Isis
Pharmaceuticals and CHDI Foundation, Inc. announced a renewal of their
collaboration to discover and develop an antisense drug for the treatment of
Huntington's disease (HD), a fatal neurodegenerative disorder. This
collaboration builds upon earlier successful alliances in which CHDI, a
non-profit biomedical research organization dedicated to the development of
therapeutics for HD, provided funding to support Isis' early work in HD. Under
the terms of the new collaboration, Isis will receive funding from CHDI to
identify and conduct IND-enabling studies on an antisense drug targeting the
huntingtin gene. In addition, Isis is eligible to be reimbursed by CHDI for approximately
$2 million of HD research-related expenses Isis incurred after the earlier
collaboration ended in 2010. Upon completion of IND-enabling studies, Isis and
CHDI expect to continue to collaborate on the clinical development of drugs
arising from the collaboration.
Isis Pharmaceuticals Reaffirms FY 2011
Guidance-Conference Call Aug 05, 2011
Isis
Pharmaceuticals announced that it is on track to meet guidance for fiscal 2011.
According to I/B/E/S Estimates, analysts were expecting the Company to report
revenue of $117 million for fiscal 2011.
sanofi-aventis'
Genzyme and Isis Pharmaceuticals Inc. Announce Submission of European Marketing
Authorization Application for Mipomersen (Kynamro)
Jul 28, 2011
Genzyme, a
sanofi-aventis company, and Isis Pharmaceuticals Inc. announced that Genzyme
has submitted a marketing authorization application (MAA) to the European
Medicines Agency seeking approval for the 200 mg weekly dose of mipomersen for
the treatment of homozygous and severe heterozygous familial hypercholesterolemia.
Genzyme and Isis also announced that, if the necessary approvals are granted,
mipomersen would be marketed under the brand name Kynamro, the registered name
that has been submitted to health authorities for the investigational agent.
Isis Pharmaceuticals Initiates Phase One Study Of
ISIS-PTP1BRx to Treat Type Two Diabetes Jul 21, 2011
Isis
Pharmaceuticals announced that it has initiated a Phase 1 clinical study for
ISIS-PTP1BRx, an antisense drug for the treatment of type 2 diabetes targeting
protein tyrosine phosphatase-1B, PTP-1B. ISIS-PTP1BRx is designed to increase
the body's sensitivity to the natural hormone insulin, resulting in better
glucose control for patients with type 2 diabetes. Because of its mechanism
ISIS-PTP1BRx has the potential to contribute to the treatment of type 2
diabetes without causing weight gain or hypoglycemia. The reductions in LDL-C
produced by PTP-1B inhibition should also provide an added benefit to patients.
Earlier Phase 2 studies of ISIS 113715 provided evidence of the therapeutic
potential of inhibiting PTP-1B. In those studies, PTP-1B inhibition improved
glucose control and reduced LDL-C in both newly diagnosed diabetic patients and
in patients who were taking sulfonylureas. Those studies also showed that
PTP-1B inhibition did not cause weight gain, another substantial advantage in
the treatment of diabetic patients who are frequently obese and at high
cardiovascular risk. The initial clinical development plan for ISIS-PTP1BRx
will focus on treating diabetic patients who are inadequately controlled on
insulin, helping them utilize insulin more efficiently; and patients who are
beginning to fail oral therapies, extending the time they have before becoming
dependent on insulin.
Isis
Pharmaceuticals Reaffirms FY 2011 Guidance-Conference Call
May 06, 2011
Isis
Pharmaceuticals announced that it is on track to meet guidance for fiscal 2011.
According to Reuters Estimates, analysts were expecting the Company to report
revenue of $121 million for fiscal 2011.
sanofi-aventis And
Isis Pharmaceuticals Inc Announces Data From Two Mipomersen Phase 3 Trials Apr
05, 2011
sanofi-aventis and
Isis Pharmaceuticals Inc. announced data from two phase 3 studies of mipomersen
in patients who had high cholesterol levels while on lipid-lowering therapy
were presented at American College of Cardiology. In the study in patients with
severe heterozygous familial hypercholesterolemia (heFH), mipomersen reduced
LDL-C, primary endpoint, by 36% compared with a 13% increase for placebo
(p<0.001). This study, also met each of its secondary endpoints. Frequently
observed adverse events were injection site reactions, flu-like symptoms and
elevations in liver transaminases, as seen in previous studies. This
double-blind, placebo-controlled trial included 58 patients with severe heFH,
who were already taking maximally tolerated lipid-lowering medications. Severe
heFH patients were defined as those who had LDL-C levels ? 300 mg/dL or those
who had LDL-C levels ? 200 mg/dL with coronary heart disease (CHD) or other
forms of clinical atherosclerotic disease. Patients were randomized 2:1 to
receive a self-administered 200 mg subcutaneous injection of mipomersen or
placebo weekly for 26 weeks. This study was conducted at 26 sites in North America,
Europe,South Africa. Patients treated with mipomersen had an average LDL-C at
baseline of 276 mg/dL. At the end of trial, these patients had an average LDL-C
level of 175 mg/dL, representing an average LDL-C reduction of 101 mg/dL (36%).
Isis Pharmaceuticals Issues FY 2011 Revenue
Guidance In Line With Analysts' Estimates-Conference Call Feb 28, 2011
Isis
Pharmaceuticals announced that for fiscal 2011, it expects revenue to increase
by more than $10 million. The Company reported revenue of $108.47 million in
fiscal 2010. According to Reuters Estimates, analysts were expecting the
Company to revenues of $120.35 million for fiscal 2011.
Isis
Pharmaceuticals Initiates Phase 1 Clinical Trial Of ISIS-FXIRx To Treat
Clotting Disorders Feb 02, 2011
Isis Pharmaceuticals
announced the initiation of a Phase 1 study of ISIS-FXIRx, an antisense drug
designed to treat clotting disorders. ISIS-FXIRx inhibits the production of
Factor XI, a clotting factor that is an important component of the coagulation
pathway. Because of its role in the intrinsic coagulation pathway, inhibition
of Factor XI could offer an effective approach for preventing the formation of
blood clots with a lower risk of bleeding.
Isis
Pharmaceuticals Adds Two New Drugs To Development Pipeline Jan 06, 2011
Isis
Pharmaceuticals announced that it has added two new drugs to its development
pipeline, ISIS-FGFR4Rx and ISIS-STAT3Rx. ISIS-FGFR4Rx is designed to treat
obesity by increasing metabolism, particularly by increasing lipid and fat
burning. ISIS-FGFR4Rx specifically blocks the production of fibroblast growth
factor receptor 4 (FGFR4) in the liver and fat tissue. In addition,
ISIS-FGFR4Rx should not reduce FGFR4 expression in the central nervous system
(CNS) or heart, thereby avoiding the CNS and cardiovascular side effects
associated with many obesity drugs in development.
Isis
Pharmaceuticals Initiates Broad Phase 2 Program Of ISIS-EIF4ERx In Cancer Jan
04, 2011
Isis
Pharmaceuticals announced the initiation of two Phase 2 studies of ISIS-EIF4ERx
in patients with non-small cell lung cancer and prostate cancer. These studies
are part of Isis' broad Phase 2 development program designed to evaluate
ISIS-EIF4ERx in multiple types of cancer. ISIS-EIF4ERx targets eukaryotic
initiation factor-4E (eIF-4E), a traditionally undruggable target that is
thought to promote tumor growth and metastasis in many cancers. The first Phase
2 study is evaluating the safety and efficacy of ISIS-EIF4ERx in combination
with carboplatin and paclitaxel in patients with non-small cell lung cancer.
The second Phase 2 study is evaluating the safety and efficacy of ISIS-EIF4ERx
in combination with docetaxel and prednisone in patients with
castrate-resistant prostate cancer. Each randomized, controlled study will
enroll approximately 100 patients. The endpoints for both studies include
progression-free survival, response rates, overall survival, time to
progression and the reduction of a variety of biomarkers. ISIS-EIF4ERx targets
the gene that is responsible for the production of a protein, eIF-4E, which is
over-expressed in a variety of cancers, including prostate, lung, ovarian,
liver, breast, head and neck, bladder, colon, thyroid and lymphoma.
Isis
Pharmaceuticals Initiates Phase 1 Clinical Trial of ISIS-APOCIIIRx to Treat
Hypertriglyceridemia Dec 21, 2010
Isis
Pharmaceuticals announced the initiation of a Phase 1 study of ISIS-APOCIIIRx,
an antisense drug designed to lower triglycerides to treat a variety of
diseases associated with elevated triglycerides. Hypertriglyceridemia, a
condition characterized by elevated levels of triglycerides, is an independent
risk factor for cardiovascular disease and is a component of numerous
cardiovascular and metabolic diseases, including metabolic syndrome.
ISIS-APOCIIIRx inhibits the production of apolipoprotein C-III (apoC-III), a
traditionally undruggable target that plays a central role in the regulation of
triglycerides.
Isis
Pharmaceuticals And Xenon Pharmaceuticals Inc. Collaborate To Develop Antisense
Drugs Against Hemojuvelin And Hepcidin Nov 16, 2010
Isis
Pharmaceuticals and Xenon Pharmaceuticals Inc. announced a new collaboration to
discover and develop antisense drugs as novel treatments for the common disease
anemia of inflammation (AI). Under the terms of the agreement, Isis will
receive an undisclosed upfront payment in the form of a convertible promissory
note from Xenon to discover and develop antisense drugs to the targets
hemojuvelin and hepcidin. Upon the identification of a development candidate,
Xenon has the option to exclusively license the development and worldwide
commercialization rights for these antisense drugs from Isis. In addition to
license and option fees, Isis will be eligible to receive development and
commercial milestones and royalties on sales of drugs licensed to Xenon under
the collaboration as well as a portion of sublicense revenue.
Isis
Pharmaceuticals Comments Q4 2010 Revenue Guidance Nov 04, 2010
Isis
Pharmaceuticals announced that it expect that its revenue in the fourth quarter
of 2010 will be less than in earlier quarters.
Press clippings
Isis Pharmaceuticals Assigned Patent
U.S. Fed News: 08 October 2011
[What follows is the full text of the news story.]
By US Fed News
ALEXANDRIA, Va.,
Oct. 8 -- Isis Pharmaceuticals, Carlsbad, Calif., has been assigned a patent
(8,030,467) developed by Punit P. Seth, Carlsbad, Calif., Eric E. Swayze,
Encinitas, Calif., and Balkrishen Bhat, Carlsbad, Calif., for "5'-modified
bicyclic nucleic acid analogs."
The abstract of
the patent published by the U.S. Patent and Trademark Office states: "The
present invention provides 5'-modified bicyclic nucleoside analogs and
oligomeric compounds comprising at least one of these nucleoside analogs. In
preferred embodiments the nucleoside analogs have either (R) or (S)-chirality
at the 5'-carbon. These bicyclic nucleoside analogs are useful for enhancing
properties of oligomeric compounds including for example enhanced nuclease
resistance."
Isis files patent infringement lawsuit against
Santaris
Datamonitor Pharmaceutical & HealthWire: 27
September 2011
[What follows is the full text of the news story.]
Isis
Pharmaceuticals, Inc. has filed a patent infringement lawsuit against Santaris
Pharma A/S and Santaris Pharma A/S Corp. in the US District Court of the Southern
District of California.
Isis' infringement
suit against Santaris is based upon Santaris' activities providing antisense
drugs and antisense drug discovery services to several pharmaceutical
companies. As alleged in the complaint, these activities are not protected
under the exemption from patent infringement for drug development.
In the filed
complaint, Isis alleges infringement of US Patent No. 6,326,199, entitled
"Gapped 2' Modified Oligonucleotides" and US Patent No. 6,066,500,
entitled "Antisense Modulation of Beta Catenin Expression" as the
basis of its action.
"Since Isis'
inception, our commitment has been to create a platform technology that has the
power to change drug discovery and the treatment of disease. We have actively
protected our inventions resulting in a substantial patent estate. A key
element of our business is to make our patented technology available to
researchers and drug developers who want to work in the antisense field. This
strategy has resulted in a broad constellation of collaborative relationships
with large and small companies advancing antisense drugs and the antisense
technology platform," said B. Lynne Parshall, COO and CFO of Isis.
Event Brief of Isis Pharmaceuticals Hosts Dr.
Kastelein to Review Mipomersen Long-term Data Presented at ESC Congress 2011 -
Final
FD (Fair Disclosure) Wire: 26 September 2011
[What follows is the full text of the news story.]
PARTICIPANTS
. Stanley Crooke,
Isis Pharmaceuticals, Inc., Chairman, CEO . Kristina Lemonidis, Isis Pharmaceuticals,
Inc., Director IR . John Kastelein, University of Amsterdam, Chairman, Vascular
Medicine .
Nicholas Bishop, Cowen & Company, Analyst . Carol Werther, Summer Street
Research, Analyst . Arthur Pancoe, Morgan Stanley, Analyst . Lynne Parshall, Isis
Pharmaceuticals, Inc., COO, CFO . Andy Schopick, Nutmeg Securities, Analyst
OVERVIEW
Co. hosted a call
in which Dr. John Kastelein reviewed Mipomersen long-term data presented at ESC
Congress 2011.
PRESENTATION SUMMARY
S1. Overview
(S.C.) 1. Highlights:
1. Most patients
in Phase III studies were provided opportunity
to roll over into
open-label extension study.
2. Dr. John
Kastelein:
1. Professor of Medicine and Chairman of Department of Vascular Medicine
at Academic Medical Center in University of Amsterdam.
2. Holds Strategic Chair of Genetics of Cardiovascular Disease.
3. In 1995, set up foundation for identification of patients with
Familial Hypercholesterolemia. 1. Currently holds position on Board of
Directors of that group. 2. Since inception, foundation diagnosed over 12,000
individuals with FH.
4. Involved as principal investigator and significant consultant to Co.
on Mipomersen since beginning of Phase II trials with Mipo.
S2. Additional Highlights (J.K.) 1. Overview:
1. For patients with FH, small differences in LDL levels make
large impact on CHD risk.
1. 30% lowering for heterozygous FH patients makes tremendous impact on
risk for future heart attacks.
2. Many big pharma companies tried to find small molecules to
inhibit ApoB synthesis in liver because Co. now knows if one
can inhibit production of ApoB, basically inhibits VLDL
synthesis, LDL levels and also lipoprotein-a levels.
1. Important in terms of patients with FH because almost all FH patients
have elevated Lp(a) levels of which Co. knows that they contribute to CV risk
seen in these patients.
2. Inhibiting ApoB synthesis in heterozygous FH is anti-atherogenic
strategy.
3. Small 20-mer:
1. There are 20 oligonucleotides linked in specific sequence that are
capable of basically linking, finding its partner in liver and that creates
recognition by an enzyme that all have in liver cells, RNase H that then
destroys double strand and production of ApoB is no longer possible.
4. (indiscernible) is Mipomersen that is injected subcutaneously,
then finds its way to its sense strand, forms a duplex based
on Watson and Crick hybridization, but since there is little
mismatch, it basically activates an enzyme RNase H and that
destroys everything and hence no ApoB is produced.
5. Hetrozygous FH:
1. Total number of 225 patients screened. 1. About half enrolled.
2. Once one has established diagnosis of heterozygous FH, vast majority
of patients qualify for studies like this. 1. Randomization takes place of
active treatment towards placebo in 2:1 ratio.
3. Basic treatment period 26 weeks. 1. Afterwards there was safety
follow-up.
4. All patients received Mipomersen 200 milligram or placebo for 26
weeks. 1. Afterwards every patient received Mipomersen 200 milligram.
6. Reduction in LDL cholesterol over 28 weeks (full-analysis
set):
1. Increase in placebo arm of about 5.2%. 1. Usually seen in patients
and studies like this over six-month period.
2. Always slight relaxation in diet.
3. Will see slight creep-up of LDL levels.
4. In treated arm,
in Mipomersen 200 milligram arm, can realize approx. 30% lowering of LDL. 1.
Since baseline LDLs are high, in absolute terms, 30% is massive reduction in
terms of cholesterol load and hence of CVD risk.
5. There are large
number of people who respond way better than mean 30%.
6. Mipomersen will
be initially directed towards people with severely elevated LDL cholesterol and
severely elevated CVD risk. 1. These patients will be followed in tertiary
clinics where lipids will be measured every three months.
7. If one sees
difference in lipid and lipoprotein profile of 40%, 50% or 60%, then there is
added bonus and added impetus for physician and patient to keep on drug like
that, in fact there are people and this is true for any drug that will not
respond that favorably, basically minority of patients who have basically
responses under 10% or something and one would not continue a drug like that.
8. In terms of
efficacy, this drug basically surpasses most other drugs that are currently used
in this patient population. 2. Other Details:
1. Patients were
enrolled or rolled over from placebo-controlled
studies straight
into open-label extension study, from
homozygous FH,
heterozygous FH and severe heterozygous FH
study.
1. Currently there
are 55 patients still continuing treatment well over one year.
2. Two-year
efficacy data in terms of LDL, ApoB and
lipoprotein-a.
1. There is
approximate 20% change in lipoprotein-a and approx. 30% change in ApoB and LDL
cholesterol.
2. Decrease in lipoprotein-a
will contribute to CVD risk reduction that is concerned by LDL or ApoB.
3. There is weeks
26, 52, 76 and 104 and there is numbers of patients that have reached that end
point going from 60 to 30 to 37 to 22. 1. Not indicative of drop out rates. 2.
Patients that have received treatment for full period of time and have reached
depth and NMR spectroscopy or MRI endpoint.
3. Percentage
change from baseline in liver fat:
1. At beginning it
was 5%, at six months 12%. 1. Once beyond one-year mark, liver fat goes down
again. 2. Compatible with data obtained in rodents where basically
beta-oxidation machinery in liver takes a long time to be upregulated, but once
upregulated, beta-oxidation is capable of taking care of triglycerides that
have accumulated in liver and starts breaking them down.
2. After two
years, percent change from baseline in liver fat is same as after six months.
1. Basically returning back to its original levels.
4. Other safety profile remains consistent with all Phase III
studies.
5. In Dallas Heart Study, study in general population, median
liver fat at baseline 5.6%.
1. Not true, that
in general population there is zero liver fat. 1. There is not at all and
definitely not in US, but (Indiscernible) normal US population baseline liver
fat is 5.6%. 3. Interim Summary:
1. With Mipomersen
200 milligram, sees continued robust lipid
lowering activity
even at two years where all atherogenic
lipoproteins go
down, LDL, Lp(a), triglycerides, non-HDL and
there is no loss
of activity.
1. Line flat for
ApoB and LDL over two years.
2. Pre-clinical
observations (indiscernible) of liver adaptation are becoming now apparent in
long-term clinical experience.
3. Liver fat
(indiscernible) stabilized or even decreased with continued dosing.
4. Not everybody
shows increase in liver fat. 1. Increases that occurred in patients occurred
always in dose with fastest and greatest ApoB LDL changes, which is compatible
with molecular mechanism.
QUESTION AND
ANSWER SUMMARY
OPERATOR: (Operator Instructions). Nicholas Bishop,
Cowen and Company.
NICHOLAS BISHOP,
ANALYST, COWEN & COMPANY: Hi, good afternoon and thanks for the
presentation of the data. I was wondering if you could clarify a little bit. In
the long-term extension, what were the reasons for the discontinuations of the
69 patients?
STANLEY CROOKE,
CHAIRMAN, CEO, ISIS PHARMACEUTICALS, INC.: There were a wide variety. John can
provide more detail. But remember, in a study like this you expect if you just
look at the literature 15% to 30% dropouts per year. Obviously those studies on
subcu drugs come mostly from the RA literature, where you have pain as a
motivator.
So there are
patients who drop out for social reasons. They are changing a job or they are
moving or whatnot.
Then there are --
there were some dropouts early on in the study, principally in people who were
placebos who rolled over and then had extremely rapid and aggressive responses,
and hit a -- and dropped out around those issues. What we have observed over
time is -- and of course later in the study we allowed dose adjustments, but
early in the study we did not.
So there were
dropouts that you would expect because of social issues. There were the
dropouts tied to some of the rapid responses in some of the placebo rollover patients.
And then of course we just have a lot of people who haven't gotten to the next
checkpoint. John, do you want to add anything to that?
JOHN KASTELEIN,
CHAIRMAN, VASCULAR MEDICINE, UNIVERSITY OF AMSTERDAM: Yes, I think it is very
important to put this into a clinical perspective. So just to give you an
indication, I have done a lot of trials in FH with ezetimibe, with statins,
with CETP inhibitors, with all sorts of drugs. In an FH study, in a one-year FH
study, normal dropout is 12%; and this is experienced over about 10 years. So
for an oral drug in a population at a high risk for recurrent events, even in a
population like that dropout rates is about 12%.
So if you now go
to a population like Stan was referring to, rheumatoid arthritis, people that
have a lot of pain and have to take a subcutaneous drug, dropout rates are
somewhere between indeed 15% and 30%. Now if you roll over from a placebo
straight into a 200-milligram dose, of course some people will have side
effects tied to these rapid responses.
That is not the
normal clinical situation. In the normal clinical situation you would allow
dose titration; you would allow skipping of a dose. Because you know that a 30%
decrease of LDL in a patient with let's say a baseline of sometimes 160 or so,
it's very important for that patient.
So unfortunately
these trials do not mimic the clinical situation correctly in that sense. They
force you to do up, from one day placebo to next day 200 milligrams. They don't
allow you dose titrations. They also don't allow you basically what you would
normally do in your own clinic.
So I think that
with dropout rates in the lower range -- in CS6 dropout rates in the lower
range of the 15% to 30% range are in fact incredibly good as far as I am
concerned, because these patients don't have pain. All they have is their own
high risk -- and their family members that they see are at high risk, of
course. But that is what I wanted to add.
STANLEY CROOKE:
Yes, I agree with John. I think what we are -- we are looking at CS6 and we're
just very encouraged by the long-term compliance that we are seeing. The other point to remember is that we are
planning -- we and Genzyme are planning to do much more than we have in the
past in terms of patient and physician and nurse education about how to use a
subcu drug. And the presentation of the drug is being improved.
So we look at this
as extraordinarily encouraging and are very, very excited by the fact that most
people are continuing to use mipomersen and use it well. I don't know if we
have answered your question, but hopefully we have.
NICHOLAS BISHOP:
No; thank you, that is very helpful. And if I could ask one other while we have
the benefit of Dr. Kastelein on the line. I wonder if you could perhaps
speculate for us what you think the key issues that might be discussed during
the regulatory proceedings at the EMA and FDA are in heterozygous and
homozygous FH populations.
JOHN KASTELEIN:
Yes, it is. It is. Yes.
STANLEY CROOKE: So
we are doing everything that we need to do. So we are very pleased.
NICHOLAS BISHOP:
Have you had an opportunity to do any additional biopsies or assays of
inflammation on any of these patients?
JOHN KASTELEIN:
That is of course -- as you know, there is not a single medical ethical
committee in the world who will allow a liver biopsy in a human subject just
for exploratory investigation. So the answer is no.
But I can tell you
one thing. If you see liver fat coming down, there is actually no need to do a
liver biopsy.
Also if there
would be frank liver inflammation, you would have to see it represented somehow
also in inflammatory parameters -- general inflammatory parameters in the
circulation, which is something that is not seen at long-term either.
So yes, one of our
limitations in the clinic is that we cannot simply go out and stick people with
a liver needle. We will need a clinical rationale to do that; and we no longer
have that if liver fat is going down.
NICHOLAS BISHOP:
Okay, thank you very much.
STANLEY CROOKE: I
do think we reported that we did have a number of patients that did have liver
biopsies. I think it was five; and the biopsies were all clearly no
inflammation and no significant problems with the liver. So it is a teeny
sample, but it is still a pretty large sample for a drug of any sort. And again, everything we see is very
comforting.
NICHOLAS BISHOP:
Okay, thank you very much.
OPERATOR: Carol Werther, Summer Street.
CAROL WERTHER,
ANALYST, SUMMER STREET RESEARCH: Thanks for taking my question. I was
wondering; when you get the drug approved, will you be able to titrate it? Or
will it be in just one concentration?
STANLEY CROOKE:
The drug will be provided in one concentration, 200 milligrams per mL. I am sure the label will say 200
milligrams a week is the recommended dose.
What we will have
experience with by then -- and quite a bit I hope -- is the notion of, if you
have an extremely rapid response, the ability to delay a dose or give a dose --
or hold a dose, as it were. We have not done intra-patient dose titration studies,
so we would not be able to recommend that.
I think what John
was referring to is the real practice of medicine. And I will let John comment
on that, since he practices medicine and I no longer do.
JOHN KASTELEIN:
Yes, I think that what is very interesting in this drug is that there is a wide
variation in efficacy. I mean you have seen that on the waterfall plot. In fact
there is also a wide variation in what happens after someone drops down very
rapidly in terms of LDL and ApoB. Sometimes
you see AST and ALT going up.
So I think that
both for efficacy and safety this is a typical, I would say ideal drug for
single-patient management where of course the moment -- when you see LDLs and
ApoB drop down as some people did by 60% to 80%, and you see AST and ALT going
up, the first thing a doctor would do is to skip the next dose.
So yes. Although
of course it will be probably vials of 200 milligram that are recommended to be
given once weekly, the physicians that will use this drug will all be
specialists, mostly trained in tertiary centers with large numbers of FH
patients. So you can build experience
quite rapidly with skipping doses or just -- or maybe even give the next dose
three or four days later or something. So yes; I mean it is really individualized
medicine in those terms. Yes.
CAROL WERTHER:
Okay, thank you. Also may I just ask, what percentage of patients had to come
off the drug due to ALT elevations? I heard you say that now you can dose
through a lot of that. But was -- just remind me; I am pretty sure there were
no bilirubin increases. Correct?
STANLEY CROOKE: Oh no, no, no. No bilirubin; no super-high ALTs. None.
JOHN KASTELEIN:
No. There has never been a Hy's Law. I mean, absolutely not.
That is another
interesting issue is that of course -- and I have been around in drug
development for a long time. Everybody is scared to death of the liver per se,
and AST and ALT increases; and we have a lot of experience with that in
nicotinic acid, in statins, in fibrates.
It is very
interesting is that with all the AST and ALT elevations we for example see in
80 milligrams of Lipitor, 3.5%, which is a small percentage, but since millions
of people taking them, imagine the number of people that have AST and ALT
elevations on 80 milligrams of Lipitor. Never ever has this led to any
toxicity.
The problem is
that most people confuse toxicity with what we call a transaminitis or a liver
enzyme elevation. We don't even know what it in fact it means, why the liver
does this, that there is a little increase in AST and ALT.
So as long as
there is no Hy's Law -- meaning that the production capacity of the liver is
damaged, and that albumen goes down, and clotting factors go down, and
bilirubin goes up -- yes, that is not good of course. But these AST and ALT elevations
are almost always asymptomatic.
If they herald
that there is a little accumulation of triglycerides in the liver, it is
something to pay attention to. We have done that in the studies, and we now see
that they go down after two years.
But in fact the
elevation of AST and ALT per se doesn't mean a thing. It means that there is an enzyme -- the concentration of an
enzyme going up in fact in the circulation. But we have actually no idea what
it means for the liver, not even with all the statins.
So in those terms
-- when people say yes, there is liver toxicity because AST and ALT go up -- it
is simply not true. It has nothing to do with toxicity at all. So I think that
that is also important to stress that.
That clinically --
in our lipids clinic we see now 6,000 patients per year. We see AST and ALT
elevations all the time. We start to pay less and less attention to them,
unless of course as you are referring to there is a bilirubin increase with it.
But that is exceedingly rare.
If that is the case
then usually there is like this -- that is real liver toxicity. And for that
reason drugs are discontinued in their development, like the PPARs for example
and some other drugs recently.
CAROL WERTHER: May
I just ask if you have available an oral MTP inhibitor and mipomersen, how
would you use them in clinical practice?
JOHN KASTELEIN:
The oral MTP inhibitor? We actually know that oral MTP inhibitors in all cases
-- and you only need the publication on the homozygous study from Dan Rader's
group in the New England Journal to see that -- will lead to steatosis. So by definition, if you inhibit MTP
what you will see is that there will be steatosis.
There is simply
not enough research done to understand how we can control this. So for now, I
think the MTP inhibitors are used in the severest of the severest, where
steatosis of the liver you can balance it against imminent death at the age of
14, for example.
It is a very
different issue when you go to heterozygous FH of course, and you consider
treatment for 15 years or 20 years, as for example with mipomersen in this
heterozygous FH study. So this is a
question that cannot be answered at the current time.
There is simply
not enough data -- actually I don't think there is any data at all -- in
heterozygous FH or patients at lower risk than the homozygous, how we would
ever use an MTP inhibitor, and what we would do with the liver-fat accumulation
that we have seen in that New England Journal paper. It is simply impossible to
tell.
CAROL WERTHER:
Okay, thank you very much.
STANLEY CROOKE: I
think we have time for one more question.
OPERATOR: Arthur Pancoe, Morgan Stanley.
ARTHUR PANCOE,
ANALYST, MORGAN STANLEY: Yes, I had two questions. With the present knowledge,
what do you think the market for your drug -- what are you expecting?
And a like
question. When is this going before or being filed with the FDA?
STANLEY CROOKE:
Well, let me answer the second question. We
have already filed in Europe and we will file very shortly in the US. We and
Genzyme are just putting the finishing touches on the document now.
The first question
of the market, I think what we can say there is we believe that the initial
indications for mipomersen make it a very, very meaningful product. We can see a period of very significant
growth in the revenues for mipomersen as we expand its indication and we have a
clear plan that will get us there. Lynne?
LYNNE PARSHALL,
COO, CFO, ISIS PHARMACEUTICALS, INC.: I just wanted to add, Art, that in
sanofi's R&D day in the slides that they presented on mipomersen just a
week ago, they said that the market for the initial indications, the homozygous
and the severe in the US and Europe, was about 40,000 patients.
ARTHUR PANCOE: How
much is this, patient year, this drug?
STANLEY CROOKE: I'm
sorry, we can't hear you.
ARTHUR PANCOE: How
much -- what is the yearly cost of this drug?
STANLEY CROOKE: We
haven't said that, Art. It won't be decided by us; it would be decided by
Genzyme. And it won't be decided until -- I mean finally decided until the drug
is approved.
But having said
that, a reduction of 100 milligrams per deciliter of LDL is a 50% or more
reduction in cardiovascular risk. That is an incredible value and we expect
Genzyme to price mipomersen as a high-value provider in a small group of
severely ill patients. So we are expecting a Genzyme high-value price.
ARTHUR PANCOE: Do
you still -- people in US market for some reason is substantially lower than
Europe? I know there is disagreement on that.
STANLEY CROOKE:
No, there should be no disagreement. We have -- based on very productive
interactions with both the US and European regulators, we believe the
indication that we will receive in Europe will be slightly broader than the
indication in the US, and therefore the initial European market may be a bit
larger than the US.
ARTHUR PANCOE: I thank you for the help.
STANLEY CROOKE: You bet. I
understand -- we will take one more question and then we do have to quit.
OPERATOR: Andy Schopick.
ANDY SCHOPICK,
ANALYST, NUTMEG SECURITIES: Dr. Kastelein and perhaps Dan as well, I just
wanted to ask whether you have any increasing concerns concerning potential
competitive lipid-lowering drugs that are attempting to be advanced through the
regulatory process. Is there anything out there that you would care to comment
on or that would be of a competitive concern to you at this time?
JOHN KASTELEIN:
Well, of course and you probably know that better than I do, there are a large
number also of RNA-based therapies for all sorts of targets currently in
development. Some very exotic ones -- siRNA, LNA, and all sorts for both ApoB
and also Dr. Crooke himself is working on c3 and Lp(a). I mean so there is a
lot coming.
And of course
there is the thyroxine receptor agonists. So yes, there is a lot of development
currently going on. But it is all very early, and we will have to see how they
all will translate in terms of efficacy and safety.
Of course the LDL
market is a very attractive market. There is no doubt about it. So there will
continuously be novel compounds being developed here.
I mean there is
even a whole lot of discovery going on to find even newer targets than are
currently being developed. I think it is
really quite early to put them in contrast.
I think the
closest thing we have is the MTP inhibitor for homozygous FH. As you know there is no orphan drug
indication for homozygous FH in Europe, and I can -- so that I know is not
going to be possible.
I don't know about
the United States; but maybe Stan can comment on that. And the rest of these
drugs are years behind. So it is very hard for me to comment on that.
ANDY SCHOPICK: I
think you just did. Thank you.
STANLEY CROOKE:
Just to amplify just a bit, mipomersen is a drug in registration. The other
drugs that people are talking about are in early development, as John said.
They all have issues.
When we conceived
of putting together our lipidology franchise, we dreamt of having an antisense
inhibitor for every major lipid problem, and I think we are going to do that.
The next one will be APOC3 Lp(a); and then PCSK9. Our view is that people with
triglycerides need a different drug than people with an LDL problem. And then
there are people with Lp(a) that have a different problem.
These people that
we are talking about treating can use all the help they can get. So in our mind
when we began our PCSK9 development, our idea was that there would be some
folks who get treated with a combination of ApoB and PCSK9 at some point.
So yes, there are
some drugs in early development. We will see how they do. But I think the key
point is there is plenty of room because there is plenty of need for lots of
drugs. And we intend to fill most of that space with our own drugs.
JOHN KASTELEIN: I
think also -- sorry to be a bit lengthy here, but I just -- all of these drugs,
as Stan said, have specific issues and have specific difficulties in their
development. So the best way to go in that situation is top-down. You start
with homozygous FH; then severe heterozygous or LDL apheresis-eligible; then
you go to heterozygous FH; and then slowly you trickle down into
hypercholesterolemia per se. That probably means that the development of these
other drugs are not going to go fast, simply because we will have to see what
their -- mainly their safety and their applicability is in those severe
conditions before we can go to, let's say, run-of-the-mill hyperlipidemia.
That is -- and
therefore we are talking here about a drug that is currently in registration
and has all the experience in homozygous, severe heterozygous, heterozygous FH;
and basically also in patients with simply run-of-the-mill
hypercholesterolemia. But we will start using it in clinical practice at the
top of the line, at the highest risk, with the highest LDLs.
And then slowly,
once we have some experience with the drug, we will go down to lower and lower
LDL cholesterol levels. And that is the way how this will go clinically, I
think.
STANLEY CROOKE:
Thanks, John. With that I do think we are out of time, and I want to bring the
call to a close. I think the main point from this call is that the more
experience we get with mipomersen, the better it looks. The more experience we
get with mipomersen, the more comfortable we are with its safety profile.
And I believe the
continuing evaluation of mipomersen in the open-label study will be key data
that will provide comfort to everyone about the long-term safety and efficacy
of mipomersen. So we're very, very pleased with the results that we have and
look forward to sharing the progress that we make as we register mipomersen
with you over the next few months.
OPERATOR: Thank you all. Ladies and gentlemen, thank you for your participation in today's
conference. This concludes the presentation. You may now disconnect and have a
good day.
[Thomson Financial
reserves the right to make changes to documents, content, or other information
on this web site without obligation to notify any person of such changes.
In the conference
calls upon which Event Briefs are based, companies may make projections or
other forward-looking statements regarding a variety of items. Such
forward-looking statements are based upon current expectations and involve
risks and uncertainties. Actual results may differ materially from those stated
in any forward-looking statement based on a number of important factors and
risks, which are more specifically identified in the companies' most recent SEC
filings. Although the companies may indicate and believe that the assumptions
underlying the forward-looking statements are reasonable, any of the
assumptions could prove inaccurate or incorrect and, therefore, there can be no
assurance that the results contemplated in the forward-looking statements will
be realized.
Isis files patent infringement lawsuit against
Santaris Pharma
EquityBites: 26 September 2011
[What follows is the full text of the news story.]
Antisense
technology company Isis Pharmaceuticals Inc (Nasdaq:ISIS) announced on Friday
that it has filed a patent infringement lawsuit against Santaris Pharma A/S and
Santaris Pharma A/S Corp in the US District Court of the Southern District of
California.
Isis said that its
infringement suit against Santaris is based upon Santaris' activities providing
antisense drugs and antisense drug discovery services to several pharmaceutical
companies. As alleged in the complaint, these activities are not protected
under the exemption from patent infringement for drug development.
In the filed
complaint, Isis alleges infringement of its US Patent No 6,326,199, entitled
'Gapped 2' Modified Oligonucleotides' and US Patent No. 6,066,500, entitled
'Antisense Modulation of Beta Catenin Expression' as the basis of its action.
Isis is reportedly
the owner or exclusive licensee of approximately 1,550 issued patents worldwide
that cover all facets of antisense drugs. One portion of Isis' patent estate
includes patents covering basic oligonucleotide chemical modifications, drug
designs that optimise therapeutic properties of antisense drugs and the use of
antisense compounds in drug discovery.
BRIEF: Isis Pharma
files patent suit against Santaris
North County Times
(Escondido, CA): 23 September 2011
[What follows is
the full text of the news story.]
Sept. 23--Isis
Pharmaceuticals Inc. said Friday it has filed a patent infringement lawsuit
against Santaris Pharma A/S and Santaris Pharma A/S Corp. Isis filed the suit
in the U.S. District Court of the Southern District of California, the company
said in a statement.
Isis says in the
suit that Santaris has infringed on patents for Isis' gene-blocking antisense
technology, which stops production of disease-causing proteins by selectively
suppressing genetic activity.
Santaris provides
antisense drugs and antisense drug delivery technology to several
pharmaceutical companies. These activities are not protected by a patent
infringement exemption for drug development, the lawsuit said.
Call staff writer
Bradley J. Fikes at 760-739-6641.
Isis Pharmaceuticals Files Patent Infringement Suit
Against Santaris Pharma
PR Newswire US: 23 September 2011
[What follows is the full text of the news story.]
CARLSBAD, Calif.,
Sept. 23, 2011 /PRNewswire/ -- Isis Pharmaceuticals, Inc. (NASDAQ: ISIS)
announced today it has filed a patent infringement lawsuit against Santaris
Pharma A/S and Santaris Pharma A/S Corp. in the United States District Court of
the Southern District of California. Isis' infringement suit against Santaris
is based upon Santaris' activities providing antisense drugs and antisense drug
discovery services to several pharmaceutical companies. As alleged in the
complaint, these activities are not protected under the exemption from patent
infringement for drug development.
Isis is the
leading antisense company. Through its commitment to innovation in antisense
technology, Isis has generated a large patent estate that provides the Company
with extensive protection for its drugs and technology. Isis is the owner or
exclusive licensee of approximately 1,550 issued patents worldwide that cover
all facets of antisense drugs. One portion of Isis' patent estate includes
patents covering basic oligonucleotide chemical modifications, drug designs
that optimize therapeutic properties of antisense drugs, and the use of
antisense compounds in drug discovery. In the filed complaint, Isis alleges
infringement of U.S. Patent No. 6,326,199, entitled "Gapped 2' Modified
Oligonucleotides" and U.S. Patent No. 6,066,500, entitled "Antisense
Modulation of Beta Catenin Expression" as the basis of its action.
"Since Isis'
inception, our commitment has been to create a platform technology that has the
power to change drug discovery and the treatment of disease. We have actively
protected our inventions resulting in a substantial patent estate. A key
element of our business is to make our patented technology available to
researchers and drug developers who want to work in the antisense field. This
strategy has resulted in a broad constellation of collaborative relationships
with large and small companies advancing antisense drugs and the antisense
technology platform," said B. Lynne Parshall, COO and CFO of Isis. "A
necessary component of our strategy is that we vigorously pursue infringement
of our intellectual property. The exemption from patent infringement for drug
development was created to encourage rapid introduction of generic medicines.
We allege Santaris' activities are not protected by this exemption and that
case law affirms our position."
ABOUT ISIS PHARMACEUTICALS, INC.
Isis is exploiting
its leadership position in antisense technology to discover and develop novel
drugs for its product pipeline and for its partners. Isis' broad pipeline
consists of 24 drugs to treat a wide variety of diseases with an emphasis on
cardiovascular, metabolic and severe and rare/neurodegenerative diseases, and
cancer. Isis' partner, Genzyme, plans to commercialize Isis' lead product,
mipomersen, following regulatory approval, which is expected in 2012. Isis'
patents provide strong and extensive protection for its drugs and technology.
Additional information about Isis is available at www.isispharm.com.
ISIS PHARMACEUTICALS' FORWARD-LOOKING STATEMENT
This press release
includes forward-looking statements regarding Isis' intellectual property
position and its value in drug discovery and development. Any statement
describing Isis' goals, expectations, financial or other projections,
intentions or beliefs, including the planned commercialization of mipomersen,
is a forward-looking statement and should be considered an at-risk statement.
Such statements are subject to certain risks and uncertainties, particularly
those inherent in the process of discovering, developing and commercializing
drugs that are safe and effective for use as human therapeutics, and in the
endeavor of building a business around such drugs. Isis' forward-looking
statements also involve assumptions that, if they never materialize or prove
correct, could cause its results to differ materially from those expressed or
implied by such forward-looking statements. Although Isis' forward-looking
statements reflect the good faith judgment of its management, these statements
are based only on facts and factors currently known by Isis. As a result, you
are cautioned not to rely on these forward-looking statements. These and other
risks concerning Isis' programs are described in additional detail in Isis'
annual report on Form 10-K for the year ended December 31, 2010 and its most
recent quarterly report on Form 10-Q, which are on file with the SEC. Copies of
these and other documents are available from the Company.
In this press
release, unless the context requires otherwise, "Isis,"
"Company," "we," "our," and "us" refers
to Isis Pharmaceuticals and its subsidiaries, including Regulus Therapeutics
Inc., its jointly owned subsidiary.
Isis
Pharmaceuticals and BioMed Realty Trust Open R&D Facility in Carlsbad Oaks
North Business Park
Professional Services Close-Up
25 September 2011
[What follows is
the full text of the article.]
Civic leaders
joined senior management from Isis Pharmaceuticals, Inc. and BioMed Realty
Trust, Inc. to celebrate the completion of a new 176,000 square foot
build-to-suit corporate and research facility on Gazelle Court in the Carlsbad
Oaks North Business Park in Carlsbad.
According to the
Company, among the featured speakers at the ceremony were Stanley T. Crooke,
M.D., Ph.D., Chairman and Chief Executive Officer, and B. Lynne Parshall, Chief
Operating Officer and Chief Financial Officer, of Isis; Matt Hall, Mayor of the
City of Carlsbad; and Alan D. Gold, Chairman and Chief Executive Officer of
BioMed.
The complex
consolidates the majority of Isis' operations into a single facility, which
will foster the company's collaborative approach to drug discovery and
development. Isis and BioMed broke ground on the new building in June 2010.
"Our new
facility combines functional and efficient design features to meet our current
and future needs and foster our collaborative approach to drug discovery and
development," said Dr. Crooke. "Completed ahead of schedule and below
budget by BioMed, our real estate partner since 2005, our new corporate home
provides the ideal environment for us to continue to innovate and create the
medicines of tomorrow. We are very pleased to share this special occasion for
all of us at Isis with Mayor Hall and the other civic leaders from the City of
Carlsbad, representatives from the San Diego life science community, our
construction partners and, of course, Isis employees and their families."
"Isis
Pharmaceuticals is a major player in the life sciences industry and the
regional economy. We couldn't be more pleased that Isis chose Carlsbad as the
location for this stunning new facility," said City of Carlsbad Mayor Matt
Hall. "The city is proud of the partnership we've enjoyed with Isis
Pharmaceuticals and BioMed Realty Trust to take this building from concept to
today's grand opening in less than two years."
Speaking on behalf
of BioMed, Gold remarked, "The grand opening of this magnificent 176,000
square foot laboratory and office facility is the culmination of strong
collaboration with Isis, one of our most valued long-term tenants. We salute
Dr. Crooke and all of the Isis team, are proud to play a part in fulfilling
their mission to create a healthier future, and look forward to supporting
their real estate needs in Carlsbad for many years to come."
BioMed Realty Trust is a real estate investment
trust (REIT) focused on Providing Real Estate to the Life Science Industry.
BioMed Realty Trust:
biomedrealty.com
Isis:
isispharm.com
Close-Up Media,
Inc.
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7340 Financial Asset Investors
Construction
completed on Isis research facility
San Diego Business
Journal
12 September 2011
By Pippin, Emily
[What follows is
the full text of the article.]
DPR Construction
announced that construction is complete on the 176,000-square-foot,
state-of-the-art research facility for Isis Pharmaceuticals Inc. in Carlsbad.
Developed by BioMed Realty Trust Inc., the build-to-suit project is the first
structure in the new Carlsbad Oaks North Business Park development.
"Like DPR,
Isis is committed to forward-thinking design solutions and reducing its carbon
footprint," said Jeff Cole, project engineer on the Isis Pharmaceuticals
research and development facility. "We incorporated numerous sustainable features
throughout the campus and were careful to adhere to the Isis principles of
embracing openness and defining science as the center of their mission."
The
state-of-the-art research facility consolidates the majority of the
Carlsbad-based Isis Pharmaceuticals into one building to streamline operations
and management. It also increases BioMed's total leased space with Isis to
approximately 204,700 square feet. The new facility has become the corporate
home of Isis Pharmaceuticals, which develops programs focused on treating
cardiovascular, metabolic and severe neurodegenerative diseases as well as
cancer since 1989.
Highlights of the
176,000-square-foot facility include an open environment and flexible designs,
laboratories, an outdoor meeting and dining area and walking trail. The
structure is anticipating Leadership in Energy and Environmental Design
certification from the U.S. Green Building Council for incorporating the latest
in sustainable technologies and practices. In addition, the interior and exterior
spaces seamlessly integrate to give an open campus feel to the facility, as
well as maximize function density and take advantage of its beautiful ocean
views.
Designed by the
architectural firm DGA of San Diego, DPR provided construction services on the
groundbreaking Isis Pharmaceuticals project. DPR Construction began building
this cutting-edge research and design facility in June 2010.
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Isis
Pharmaceuticals Inc Files Patent Application for Modulation of Surviving
Expression
Indian Patent News
17 August 2011
[What follows is the full text of the article.]
New Delhi, Aug. 17
-- USA based Isis Pharmaceuticals Inc filed patent application for modulation
of surviving expression. The inventors are Paul K Legaard, Balkrishen Bhat,
Bharvin Kumar Patel and Eric Swayze.
Isis
Pharmaceuticals Inc filed the patent application on Dec. 6, 2005. The patent
application number is 02531/KOLNP/2005 A. The international classification
number is A61K.
According to the
Controller General of Patents, Designs & Trade Marks, "Compounds and
compositions are provided for modulating the expression of surviving. The
compounds, exemplified by those acting through an RNAi antisense mechanism of
action, include double-stranded and single-stranded constructs, as well as
siRNAs, canonical siRNAs, blunt-ended siRNAs and single-stranded antisense RNA
compounds. Methods of using these compounds for modulation of surviving
expression and for treatment of diseases associated with expression of
surviving are provided."
About the Company
Isis
Pharmaceuticals, Inc. (Isis) is engaged in antisense technology, exploiting a
drug discovery platform created to generate first-in-class drugs. The Company
operates in two business segments: Drug Discovery and Development, and Regulus Therapeutics
Inc. (Regulus). Within the drug discovery and development segment, Isis is
exploiting a drug discovery platform created to generate a range of
first-in-class drugs for the Company and its partners. Isis can identify drugs,
providing targets to treat a range of diseases. As of December 31, 2009, the
Company have 22 drugs in development. Regulus is focused on the discovery,
development and commercialization of micro ribonucleic acid (RNA) therapeutics.
In January 2009, the Company completed the sale of Ibis Biosciences, Inc. to
Abbott Molecular Inc. (AMI). It was founded in 1989 and located in the North
San Diego County city of Carlsbad.
Indian Patent News
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Annual Income Statement
Financials in: USD
(mil)
Except for share
items (millions) and per share items (actual units)
|
|
31-Dec-2010 |
31-Dec-2009 |
31-Dec-2008 |
31-Dec-2007 |
31-Dec-2006 |
|
Period Length |
12 Months |
12 Months |
12 Months |
12 Months |
12 Months |
|
UpdateType/Date |
Updated Normal |
Updated Normal |
Restated Normal |
Restated Normal |
Restated Normal |
|
Filed Currency |
USD |
USD |
USD |
USD |
USD |
|
Exchange Rate
(Period Average) |
1 |
1 |
1 |
1 |
1 |
|
Auditor |
Ernst &
Young LLP |
Ernst &
Young LLP |
Ernst &
Young LLP |
Ernst &
Young LLP |
Ernst &
Young LLP |
|
Auditor Opinion |
Unqualified with
Explanation |
Unqualified with
Explanation |
Unqualified with
Explanation |
Unqualified with
Explanation |
Unqualified |
|
|
|
|
|
|
|
|
Net Sales |
108.5 |
121.6 |
107.2 |
58.3 |
14.9 |
|
Revenue |
108.5 |
121.6 |
107.2 |
58.3 |
14.9 |
|
Total Revenue |
108.5 |
121.6 |
107.2 |
58.3 |
14.9 |
|
|
|
|
|
|
|
|
Gross Profit |
108.5 |
121.6 |
107.2 |
58.3 |
14.9 |
|
|
|
|
|
|
|
|
Selling/General/Administrative Expense |
11.7 |
14.5 |
13.8 |
13.1 |
11.2 |
|
Total Selling/General/Administrative Expenses |
11.7 |
14.5 |
13.8 |
13.1 |
11.2 |
|
Research & Development |
145.2 |
134.6 |
106.4 |
78.2 |
69.4 |
|
Restructuring Charge |
- |
- |
- |
- |
-0.5 |
|
Other Unusual Expense (Income) |
- |
0.0 |
0.0 |
3.2 |
0.0 |
|
Unusual Expense (Income) |
- |
0.0 |
0.0 |
3.2 |
-0.5 |
|
Total Operating Expense |
156.8 |
149.1 |
120.3 |
94.5 |
80.1 |
|
|
|
|
|
|
|
|
Operating Income |
-48.4 |
-27.5 |
-13.1 |
-36.1 |
-65.2 |
|
|
|
|
|
|
|
|
Interest Expense -
Non-Operating |
-13.2 |
-12.7 |
-11.8 |
-12.9 |
-9.0 |
|
Interest Expense, Net Non-Operating |
-13.2 |
-12.7 |
-11.8 |
-12.9 |
-9.0 |
|
Investment Income -
Non-Operating |
0.4 |
8.4 |
10.4 |
15.0 |
8.2 |
|
Interest/Investment Income - Non-Operating |
0.4 |
8.4 |
10.4 |
15.0 |
8.2 |
|
Interest Income (Expense) - Net Non-Operating Total |
-12.8 |
-4.2 |
-1.5 |
2.1 |
-0.8 |
|
Income Before Tax |
-61.2 |
-31.8 |
-14.5 |
-34.1 |
-66.0 |
|
|
|
|
|
|
|
|
Total Income Tax |
0.1 |
3.2 |
0.0 |
0.0 |
0.0 |
|
Income After Tax |
-61.3 |
-35.0 |
-14.5 |
-34.1 |
-66.0 |
|
|
|
|
|
|
|
|
Minority Interest |
0.0 |
4.4 |
4.7 |
-101.5 |
23.0 |
|
Net Income Before Extraord Items |
-61.3 |
-30.6 |
-9.8 |
-135.6 |
-43.0 |
|
Discontinued Operations |
0.0 |
185.6 |
-8.4 |
-6.0 |
-2.9 |
|
Total Extraord Items |
0.0 |
185.6 |
-8.4 |
-6.0 |
-2.9 |
|
Net Income |
-61.3 |
155.1 |
-18.2 |
-141.6 |
-45.9 |
|
|
|
|
|
|
|
|
Income Available to Common Excl Extraord Items |
-61.3 |
-30.6 |
-9.8 |
-135.6 |
-43.0 |
|
|
|
|
|
|
|
|
Income Available to Common Incl Extraord Items |
-61.3 |
155.1 |
-18.2 |
-141.6 |
-45.9 |
|
|
|
|
|
|
|
|
Basic/Primary Weighted Average Shares |
99.1 |
98.1 |
94.6 |
83.7 |
74.3 |
|
Basic EPS Excl Extraord Items |
-0.62 |
-0.31 |
-0.10 |
-1.62 |
-0.58 |
|
Basic/Primary EPS Incl Extraord Items |
-0.62 |
1.58 |
-0.19 |
-1.69 |
-0.62 |
|
Dilution Adjustment |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
|
Diluted Net Income |
-61.3 |
155.1 |
-18.2 |
-141.6 |
-45.9 |
|
Diluted Weighted Average Shares |
99.1 |
98.1 |
94.6 |
83.7 |
74.3 |
|
Diluted EPS Excl Extraord Items |
-0.62 |
-0.31 |
-0.10 |
-1.62 |
-0.58 |
|
Diluted EPS Incl Extraord Items |
-0.62 |
1.58 |
-0.19 |
-1.69 |
-0.62 |
|
Dividends per Share - Common Stock Primary Issue |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
|
Gross Dividends - Common Stock |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
|
Interest Expense, Supplemental |
13.2 |
12.7 |
11.8 |
12.9 |
9.0 |
|
Depreciation, Supplemental |
4.8 |
3.9 |
2.9 |
2.7 |
3.9 |
|
Total Special Items |
- |
0.0 |
0.0 |
3.2 |
-0.5 |
|
Normalized Income Before Tax |
-61.2 |
-31.8 |
-14.5 |
-30.8 |
-66.6 |
|
|
|
|
|
|
|
|
Effect of Special Items on Income Taxes |
- |
0.0 |
0.0 |
0.0 |
0.0 |
|
Inc Tax Ex Impact of Sp Items |
0.1 |
3.2 |
0.0 |
0.0 |
0.0 |
|
Normalized Income After Tax |
-61.3 |
-35.0 |
-14.5 |
-30.8 |
-66.6 |
|
|
|
|
|
|
|
|
Normalized Inc. Avail to Com. |
-61.3 |
-30.6 |
-9.8 |
-132.4 |
-43.5 |
|
|
|
|
|
|
|
|
Basic Normalized EPS |
-0.62 |
-0.31 |
-0.10 |
-1.58 |
-0.59 |
|
Diluted Normalized EPS |
-0.62 |
-0.31 |
-0.10 |
-1.58 |
-0.59 |
|
Amort of Intangibles, Supplemental |
4.3 |
5.4 |
3.9 |
4.0 |
4.0 |
|
Rental Expenses |
4.3 |
4.6 |
3.8 |
3.4 |
3.2 |
|
Research & Development Exp, Supplemental |
145.2 |
134.6 |
106.4 |
78.2 |
69.4 |
|
Reported Operating Profit |
-48.4 |
-27.5 |
-13.1 |
-32.9 |
-65.2 |
|
Normalized EBIT |
-48.4 |
-27.5 |
-13.1 |
-32.9 |
-65.8 |
|
Normalized EBITDA |
-39.2 |
-18.2 |
-6.2 |
-26.3 |
-57.9 |
|
Current Tax - Domestic |
-0.1 |
2.9 |
- |
- |
- |
|
Current Tax - Local |
0.2 |
4.9 |
- |
- |
- |
|
Current Tax - Total |
0.1 |
7.8 |
- |
- |
- |
|
Deferred Tax - Domestic |
0.0 |
-1.0 |
- |
- |
- |
|
Deferred Tax - Local |
0.0 |
-3.6 |
- |
- |
- |
|
Deferred Tax - Total |
0.0 |
-4.6 |
- |
- |
- |
|
Income Tax - Total |
0.1 |
3.2 |
- |
- |
- |
|
Defined Contribution Expense - Domestic |
0.4 |
0.5 |
0.5 |
0.4 |
0.4 |
|
Total Pension Expense |
0.4 |
0.5 |
0.5 |
0.4 |
0.4 |
Annual Balance Sheet
Financials in: USD (mil)
|
|
31-Dec-2010 |
31-Dec-2009 |
31-Dec-2008 |
31-Dec-2007 |
31-Dec-2006 |
|
UpdateType/Date |
Updated Normal |
Updated Normal |
Restated Normal |
Reclassified
Normal |
Updated Normal |
|
Filed Currency |
USD |
USD |
USD |
USD |
USD |
|
Exchange Rate |
1 |
1 |
1 |
1 |
1 |
|
Auditor |
Ernst &
Young LLP |
Ernst &
Young LLP |
Ernst &
Young LLP |
Ernst &
Young LLP |
Ernst &
Young LLP |
|
Auditor Opinion |
Unqualified with
Explanation |
Unqualified with
Explanation |
Unqualified with
Explanation |
Unqualified with
Explanation |
Unqualified |
|
|
|
|
|
|
|
|
Cash & Equivalents |
70.1 |
105.3 |
217.9 |
138.6 |
114.5 |
|
Short Term Investments |
402.3 |
469.1 |
273.1 |
55.1 |
78.8 |
|
Cash and Short Term Investments |
472.4 |
574.3 |
491.0 |
193.7 |
193.3 |
|
Trade Accounts Receivable - Net |
1.2 |
10.9 |
4.1 |
4.9 |
2.4 |
|
Total Receivables, Net |
1.2 |
10.9 |
4.1 |
4.9 |
2.4 |
|
Inventories - Work In Progress |
- |
- |
- |
- |
0.0 |
|
Inventories - Raw Materials |
- |
- |
- |
- |
0.9 |
|
Total Inventory |
2.5 |
2.8 |
2.7 |
1.8 |
0.9 |
|
Discontinued Operations - Current Asset |
- |
0.0 |
15.5 |
6.4 |
- |
|
Other Current Assets |
7.1 |
8.1 |
5.1 |
3.2 |
9.6 |
|
Other Current Assets, Total |
7.1 |
8.1 |
20.5 |
9.5 |
9.6 |
|
Total Current Assets |
483.1 |
596.1 |
518.4 |
209.9 |
206.2 |
|
|
|
|
|
|
|
|
Buildings |
25.1 |
24.8 |
17.7 |
12.1 |
11.8 |
|
Land/Improvements |
10.1 |
0.0 |
- |
- |
- |
|
Machinery/Equipment |
41.2 |
38.9 |
32.1 |
24.3 |
24.3 |
|
Property/Plant/Equipment - Gross |
76.5 |
63.7 |
49.8 |
36.4 |
36.1 |
|
Accumulated Depreciation |
-40.8 |
-36.4 |
-32.4 |
-30.4 |
-28.9 |
|
Property/Plant/Equipment - Net |
35.7 |
27.3 |
17.4 |
6.0 |
7.2 |
|
Intangibles - Gross |
69.5 |
67.6 |
64.0 |
62.5 |
- |
|
Accumulated Intangible Amortization |
-41.4 |
-37.1 |
-30.9 |
-27.0 |
- |
|
Intangibles, Net |
28.1 |
30.5 |
33.1 |
35.5 |
38.3 |
|
Other Long Term Assets |
3.5 |
3.3 |
3.9 |
7.5 |
4.3 |
|
Other Long Term Assets, Total |
3.5 |
3.3 |
3.9 |
7.5 |
4.3 |
|
Total Assets |
550.5 |
657.2 |
572.8 |
258.9 |
255.9 |
|
|
|
|
|
|
|
|
Accounts Payable |
6.5 |
4.7 |
5.7 |
2.6 |
4.3 |
|
Accrued Expenses |
19.2 |
19.5 |
16.4 |
14.0 |
12.3 |
|
Notes Payable/Short Term Debt |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
|
Current Portion - Long Term Debt/Capital Leases |
5.6 |
4.3 |
2.1 |
7.2 |
7.5 |
|
Customer Advances |
74.5 |
75.7 |
92.7 |
31.5 |
1.0 |
|
Income Taxes Payable |
0.0 |
7.3 |
0.0 |
- |
- |
|
Other Current Liabilities |
- |
0.0 |
7.9 |
6.9 |
- |
|
Other Current liabilities, Total |
74.5 |
83.0 |
100.5 |
38.4 |
1.0 |
|
Total Current Liabilities |
105.9 |
111.4 |
124.7 |
62.2 |
25.1 |
|
|
|
|
|
|
|
|
Long Term Debt |
138.6 |
136.6 |
127.9 |
162.9 |
132.8 |
|
Capital Lease Obligations |
10.1 |
0.0 |
- |
- |
- |
|
Total Long Term Debt |
148.8 |
136.6 |
127.9 |
162.9 |
132.8 |
|
Total Debt |
154.4 |
140.8 |
130.0 |
170.1 |
140.3 |
|
|
|
|
|
|
|
|
Minority Interest |
0.0 |
10.3 |
37.2 |
9.4 |
29.3 |
|
Other Long Term Liabilities |
51.3 |
107.1 |
172.8 |
23.5 |
0.0 |
|
Other Liabilities, Total |
51.3 |
107.1 |
172.8 |
23.5 |
0.0 |
|
Total Liabilities |
305.9 |
365.5 |
462.6 |
258.0 |
187.3 |
|
|
|
|
|
|
|
|
Common Stock |
0.1 |
0.1 |
0.1 |
0.1 |
0.1 |
|
Common Stock |
0.1 |
0.1 |
0.1 |
0.1 |
0.1 |
|
Additional Paid-In Capital |
1,000.2 |
985.6 |
960.4 |
828.0 |
881.0 |
|
Retained Earnings (Accumulated Deficit) |
-756.7 |
-696.2 |
-851.2 |
-827.7 |
-816.8 |
|
Other Comprehensive Income |
0.9 |
2.2 |
1.0 |
0.5 |
4.3 |
|
Other Equity, Total |
0.9 |
2.2 |
1.0 |
0.5 |
4.3 |
|
Total Equity |
244.5 |
291.7 |
110.2 |
0.9 |
68.6 |
|
|
|
|
|
|
|
|
Total Liabilities & Shareholders’ Equity |
550.5 |
657.2 |
572.8 |
258.9 |
255.9 |
|
|
|
|
|
|
|
|
Shares Outstanding - Common Stock Primary
Issue |
99.4 |
98.9 |
97.2 |
87.2 |
82.3 |
|
Total Common Shares Outstanding |
99.4 |
98.9 |
97.2 |
87.2 |
82.3 |
|
Treasury Shares - Common Stock Primary Issue |
0.0 |
0.0 |
0.0 |
0.0 |
- |
|
Employees |
370 |
335 |
300 |
300 |
274 |
|
Number of Common Shareholders |
836 |
922 |
857 |
890 |
960 |
|
Accumulated Intangible Amort, Suppl. |
41.4 |
37.1 |
30.9 |
27.0 |
23.1 |
|
Deferred Revenue - Current |
74.5 |
75.7 |
92.7 |
31.5 |
1.0 |
|
Deferred Revenue - Long Term |
50.4 |
107.1 |
172.8 |
- |
- |
|
Total Long Term Debt, Supplemental |
189.8 |
254.8 |
- |
170.1 |
140.4 |
|
Long Term Debt Maturing within 1 Year |
10.4 |
9.1 |
- |
7.2 |
7.5 |
|
Long Term Debt Maturing in Year 2 |
7.4 |
14.3 |
- |
0.0 |
7.5 |
|
Long Term Debt Maturing in Year 3 |
5.7 |
5.8 |
- |
0.0 |
125.0 |
|
Long Term Debt Maturing in Year 4 |
164.9 |
4.3 |
- |
0.0 |
0.0 |
|
Long Term Debt Maturing in Year 5 |
0.2 |
166.8 |
- |
0.0 |
0.0 |
|
Long Term Debt Maturing in 2-3 Years |
13.1 |
20.0 |
- |
0.0 |
132.5 |
|
Long Term Debt Maturing in 4-5 Years |
165.1 |
171.2 |
- |
0.0 |
0.0 |
|
Long Term Debt Matur. in Year 6 & Beyond |
1.2 |
54.5 |
- |
162.9 |
0.4 |
|
Interest Costs |
- |
- |
- |
- |
-0.1 |
|
Total Capital Leases, Supplemental |
10.9 |
10.8 |
- |
- |
1.0 |
|
Capital Lease Payments Due in Year 1 |
6.0 |
4.8 |
- |
- |
0.9 |
|
Capital Lease Payments Due in Year 2 |
2.3 |
3.0 |
- |
- |
0.2 |
|
Capital Lease Payments Due in Year 3 |
2.3 |
3.0 |
- |
- |
0.0 |
|
Capital Lease Payments Due in Year 4 |
0.2 |
0.0 |
- |
- |
0.0 |
|
Capital Lease Payments Due in Year 5 |
0.2 |
0.0 |
- |
- |
0.0 |
|
Capital Lease Payments Due in 2-3 Years |
4.5 |
6.0 |
- |
- |
0.2 |
|
Capital Lease Payments Due in 4-5 Years |
0.4 |
0.0 |
- |
- |
0.0 |
|
Cap. Lease Pymts. Due in Year 6 & Beyond |
0.0 |
0.0 |
- |
- |
0.0 |
|
Total Operating Leases, Supplemental |
32.4 |
16.9 |
- |
20.4 |
22.7 |
|
Operating Lease Payments Due in Year 1 |
3.5 |
3.3 |
- |
2.9 |
2.9 |
|
Operating Lease Payments Due in Year 2 |
1.4 |
3.3 |
- |
2.9 |
2.8 |
|
Operating Lease Payments Due in Year 3 |
1.4 |
1.2 |
- |
2.4 |
2.7 |
|
Operating Lease Payments Due in Year 4 |
1.4 |
1.2 |
- |
1.9 |
2.3 |
|
Operating Lease Payments Due in Year 5 |
1.3 |
1.2 |
- |
1.5 |
1.9 |
|
Operating Lease Pymts. Due in 2-3 Years |
2.8 |
4.5 |
- |
5.2 |
5.5 |
|
Operating Lease Pymts. Due in 4-5 Years |
2.7 |
2.4 |
- |
3.4 |
4.2 |
|
Oper. Lse. Pymts. Due in Year 6 & Beyond |
23.3 |
6.7 |
- |
8.9 |
10.1 |
Annual Cash Flows
Financials in: USD (mil)
|
|
31-Dec-2010 |
31-Dec-2009 |
31-Dec-2008 |
31-Dec-2007 |
31-Dec-2006 |
|
Period Length |
12 Months |
12 Months |
12 Months |
12 Months |
12 Months |
|
UpdateType/Date |
Updated Normal |
Updated Normal |
Reclassified
Normal |
Reclassified
Normal |
Updated Normal |
|
Filed Currency |
USD |
USD |
USD |
USD |
USD |
|
Exchange Rate
(Period Average) |
1 |
1 |
1 |
1 |
1 |
|
Auditor |
Ernst &
Young LLP |
Ernst &
Young LLP |
Ernst &
Young LLP |
Ernst &
Young LLP |
Ernst &
Young LLP |
|
Auditor Opinion |
Unqualified with
Explanation |
Unqualified with
Explanation |
Unqualified with
Explanation |
Unqualified with
Explanation |
Unqualified |
|
|
|
|
|
|
|
|
Net Income/Starting Line |
-61.3 |
150.7 |
-22.9 |
-40.1 |
-45.9 |
|
Depreciation |
4.8 |
3.9 |
2.9 |
2.7 |
3.9 |
|
Depreciation/Depletion |
4.8 |
3.9 |
2.9 |
2.7 |
3.9 |
|
Amortization of Intangibles |
4.3 |
5.4 |
3.9 |
4.0 |
4.0 |
|
Amortization |
4.3 |
5.4 |
3.9 |
4.0 |
4.0 |
|
Unusual Items |
2.2 |
-187.0 |
2.8 |
0.6 |
-22.9 |
|
Equity in Net Earnings (Loss) |
2.2 |
0.0 |
0.0 |
- |
- |
|
Other Non-Cash Items |
25.5 |
22.7 |
14.4 |
15.3 |
5.1 |
|
Non-Cash Items |
29.9 |
-164.3 |
17.3 |
15.9 |
-17.7 |
|
Accounts Receivable |
10.5 |
-6.8 |
1.2 |
-3.8 |
1.5 |
|
Inventories |
0.3 |
0.0 |
-1.3 |
-2.0 |
0.1 |
|
Prepaid Expenses |
- |
-1.0 |
-2.7 |
-0.5 |
-0.2 |
|
Other Assets |
-0.9 |
- |
- |
- |
- |
|
Accounts Payable |
1.3 |
-3.7 |
1.0 |
-0.8 |
1.2 |
|
Accrued Expenses |
1.4 |
-0.1 |
1.7 |
5.0 |
0.4 |
|
Taxes Payable |
-7.2 |
-10.0 |
0.0 |
0.0 |
- |
|
Other Liabilities |
-46.8 |
-82.7 |
211.0 |
55.7 |
-0.4 |
|
Changes in Working Capital |
-41.4 |
-104.1 |
210.9 |
53.6 |
2.6 |
|
Cash from Operating Activities |
-63.6 |
-108.4 |
212.0 |
36.1 |
-53.2 |
|
|
|
|
|
|
|
|
Purchase of Fixed Assets |
-13.2 |
-13.4 |
-13.7 |
-2.3 |
-1.0 |
|
Capital Expenditures |
-13.2 |
-13.4 |
-13.7 |
-2.3 |
-1.0 |
|
Acquisition of Business |
- |
0.0 |
0.0 |
-80.4 |
0.0 |
|
Sale of Fixed Assets |
10.3 |
0.0 |
0.0 |
- |
0.0 |
|
Sale/Maturity of Investment |
577.5 |
581.7 |
266.0 |
125.1 |
77.0 |
|
Investment, Net |
- |
- |
- |
- |
0.0 |
|
Purchase of Investments |
-530.4 |
-777.7 |
-483.1 |
-95.4 |
-107.0 |
|
Intangible, Net |
-4.3 |
-2.9 |
-3.4 |
-2.7 |
-1.5 |
|
Other Investing Cash Flow |
-16.2 |
0.0 |
0.0 |
- |
- |
|
Other Investing Cash Flow Items, Total |
36.9 |
-198.9 |
-220.6 |
-53.4 |
-31.6 |
|
Cash from Investing Activities |
23.7 |
-212.3 |
-234.2 |
-55.6 |
-32.6 |
|
|
|
|
|
|
|
|
Other Financing Cash Flow |
0.0 |
0.3 |
0.0 |
0.0 |
71.0 |
|
Financing Cash Flow Items |
0.0 |
0.3 |
0.0 |
0.0 |
71.0 |
|
Sale/Issuance of
Common |
0.0 |
185.0 |
90.1 |
10.0 |
0.0 |
|
Common Stock, Net |
4.4 |
198.2 |
102.8 |
21.4 |
0.0 |
|
Sale/Issuance of Common/Preferred |
- |
- |
- |
- |
86.4 |
|
Issuance (Retirement) of Stock, Net |
4.4 |
198.2 |
102.8 |
21.4 |
86.4 |
|
Long Term Debt Issued |
4.7 |
6.4 |
12.0 |
157.1 |
0.0 |
|
Long Term Debt
Reduction |
-4.4 |
-2.8 |
-7.2 |
-134.8 |
-7.9 |
|
Long Term Debt, Net |
0.3 |
3.6 |
4.8 |
22.3 |
-7.9 |
|
Issuance (Retirement) of Debt, Net |
0.3 |
3.6 |
4.8 |
22.3 |
-7.9 |
|
Cash from Financing Activities |
4.7 |
202.0 |
107.6 |
43.7 |
149.5 |
|
|
|
|
|
|
|
|
Net Change in Cash |
-35.2 |
-118.7 |
85.4 |
24.1 |
63.6 |
|
|
|
|
|
|
|
|
Net Cash - Beginning Balance |
105.3 |
224.0 |
138.6 |
114.5 |
50.9 |
|
Net Cash - Ending Balance |
70.1 |
105.3 |
224.0 |
138.6 |
114.5 |
|
Cash Interest Paid |
4.9 |
4.9 |
4.6 |
6.2 |
8.4 |
|
Cash Taxes Paid |
7.3 |
13.2 |
0.0 |
0.0 |
- |
Annual Income Statement
Financials in: USD (mil)
Except for share items (millions) and per share items (actual units)
|
|
31-Dec-2010 |
31-Dec-2009 |
31-Dec-2008 |
31-Dec-2007 |
31-Dec-2006 |
|
Period Length |
12 Months |
12 Months |
12 Months |
12 Months |
12 Months |
|
UpdateType/Date |
Updated Normal |
Updated Normal |
Restated Normal |
Restated Normal |
Restated Normal |
|
Filed Currency |
USD |
USD |
USD |
USD |
USD |
|
Exchange Rate
(Period Average) |
1 |
1 |
1 |
1 |
1 |
|
Auditor |
Ernst &
Young LLP |
Ernst &
Young LLP |
Ernst &
Young LLP |
Ernst &
Young LLP |
Ernst &
Young LLP |
|
Auditor Opinion |
Unqualified with
Explanation |
Unqualified with
Explanation |
Unqualified |
Unqualified |
Unqualified |
|
|
|
|
|
|
|
|
R&D Agreements |
102.9 |
108.1 |
98.9 |
22.3 |
5.4 |
|
Licensing Revenue |
5.6 |
13.5 |
8.3 |
36.0 |
9.4 |
|
Total Revenue |
108.5 |
121.6 |
107.2 |
58.3 |
14.9 |
|
|
|
|
|
|
|
|
Research & Development Expenses |
145.2 |
134.6 |
106.4 |
78.2 |
69.4 |
|
Selling, General and Administrative Exp. |
11.7 |
14.5 |
13.8 |
13.1 |
11.2 |
|
Restructuring activities |
- |
- |
- |
- |
-0.5 |
|
Loss on early retirement of debt |
- |
0.0 |
0.0 |
3.2 |
0.0 |
|
Total Operating Expense |
156.8 |
149.1 |
120.3 |
94.5 |
80.1 |
|
|
|
|
|
|
|
|
Equity in net loss of Regulus Therapeuti |
-2.2 |
0.0 |
0.0 |
- |
- |
|
Investment Income |
3.4 |
6.4 |
11.3 |
11.4 |
6.0 |
|
Interest expense |
-13.2 |
-12.7 |
-11.8 |
-12.9 |
-9.0 |
|
Gain (loss) on investments, net |
-0.7 |
2.1 |
-1.0 |
3.5 |
2.3 |
|
Net Income Before Taxes |
-61.2 |
-31.8 |
-14.5 |
-34.1 |
-66.0 |
|
|
|
|
|
|
|
|
Provision for Income Taxes |
0.1 |
3.2 |
0.0 |
0.0 |
0.0 |
|
Net Income After Taxes |
-61.3 |
-35.0 |
-14.5 |
-34.1 |
-66.0 |
|
|
|
|
|
|
|
|
Net loss attributable to noncontrolling |
0.0 |
4.4 |
4.7 |
0.6 |
0.0 |
|
Excess purchase price over carrying valu |
- |
0.0 |
0.0 |
-125.3 |
0.0 |
|
Net loss attributable to noncontrolling |
- |
0.0 |
0.0 |
23.2 |
23.0 |
|
Net Income Before Extra. Items |
-61.3 |
-30.6 |
-9.8 |
-135.6 |
-43.0 |
|
Gain on sale of Ibis Biosciences, Inc., |
0.0 |
185.7 |
0.0 |
0.0 |
- |
|
Loss from discontinued operations |
0.0 |
0.0 |
-8.4 |
-6.0 |
-2.9 |
|
Net Income |
-61.3 |
155.1 |
-18.2 |
-141.6 |
-45.9 |
|
|
|
|
|
|
|
|
Income Available to Com Excl ExtraOrd |
-61.3 |
-30.6 |
-9.8 |
-135.6 |
-43.0 |
|
|
|
|
|
|
|
|
Income Available to Com Incl ExtraOrd |
-61.3 |
155.1 |
-18.2 |
-141.6 |
-45.9 |
|
|
|
|
|
|
|
|
Basic Weighted Average Shares |
99.1 |
98.1 |
94.6 |
83.7 |
74.3 |
|
Basic EPS Excluding ExtraOrdinary Items |
-0.62 |
-0.31 |
-0.10 |
-1.62 |
-0.58 |
|
Basic EPS Including ExtraOrdinary Item |
-0.62 |
1.58 |
-0.19 |
-1.69 |
-0.62 |
|
Dilution Adjustment |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
|
Diluted Net Income |
-61.3 |
155.1 |
-18.2 |
-141.6 |
-45.9 |
|
Diluted Weighted Average Shares |
99.1 |
98.1 |
94.6 |
83.7 |
74.3 |
|
Diluted EPS Excluding ExtraOrd Items |
-0.62 |
-0.31 |
-0.10 |
-1.62 |
-0.58 |
|
Diluted EPS Including ExtraOrd Items |
-0.62 |
1.58 |
-0.19 |
-1.69 |
-0.62 |
|
DPS-Common Stock |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
|
Gross Dividends - Common Stock |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
|
Normalized Income Before Taxes |
-61.2 |
-31.8 |
-14.5 |
-30.8 |
-66.6 |
|
|
|
|
|
|
|
|
Inc Tax Ex Impact of Sp Items |
0.1 |
3.2 |
0.0 |
0.0 |
0.0 |
|
Normalized Income After Taxes |
-61.3 |
-35.0 |
-14.5 |
-30.8 |
-66.6 |
|
|
|
|
|
|
|
|
Normalized Inc. Avail to Com. |
-61.3 |
-30.6 |
-9.8 |
-132.4 |
-43.5 |
|
|
|
|
|
|
|
|
Basic Normalized EPS |
-0.62 |
-0.31 |
-0.10 |
-1.58 |
-0.59 |
|
Diluted Normalized EPS |
-0.62 |
-0.31 |
-0.10 |
-1.58 |
-0.59 |
|
Amort of Intangibles |
4.3 |
5.4 |
3.9 |
4.0 |
4.0 |
|
Depreciation |
4.8 |
3.9 |
2.9 |
2.7 |
3.9 |
|
Research & Development Exp |
145.2 |
134.6 |
106.4 |
78.2 |
69.4 |
|
Interest Expense |
13.2 |
12.7 |
11.8 |
12.9 |
9.0 |
|
Rental Expense |
4.3 |
4.6 |
3.8 |
3.4 |
3.2 |
|
Federal |
-0.1 |
2.9 |
- |
- |
- |
|
State |
0.2 |
4.9 |
- |
- |
- |
|
Current Tax - Total |
0.1 |
7.8 |
- |
- |
- |
|
Federal |
0.0 |
-1.0 |
- |
- |
- |
|
State |
0.0 |
-3.6 |
- |
- |
- |
|
Deferred Tax - Total |
0.0 |
-4.6 |
- |
- |
- |
|
Income Tax - Total |
0.1 |
3.2 |
- |
- |
- |
|
Loss from operations |
-48.4 |
-27.5 |
-13.1 |
-32.9 |
-65.2 |
|
401(k) Salary Deferral Plan |
0.4 |
0.5 |
0.5 |
0.4 |
0.4 |
|
Total Pension Expense |
0.4 |
0.5 |
0.5 |
0.4 |
0.4 |
Annual Balance Sheet
Financials in: USD (mil)
|
|
31-Dec-2010 |
31-Dec-2009 |
31-Dec-2008 |
31-Dec-2007 |
31-Dec-2006 |
|
UpdateType/Date |
Updated Normal |
Updated Normal |
Restated Normal |
Reclassified
Normal |
Updated Normal |
|
Filed Currency |
USD |
USD |
USD |
USD |
USD |
|
Exchange Rate |
1 |
1 |
1 |
1 |
1 |
|
Auditor |
Ernst &
Young LLP |
Ernst &
Young LLP |
Ernst &
Young LLP |
Ernst &
Young LLP |
Ernst &
Young LLP |
|
Auditor Opinion |
Unqualified with
Explanation |
Unqualified with
Explanation |
Unqualified |
Unqualified |
Unqualified |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
70.1 |
105.3 |
217.9 |
138.6 |
114.5 |
|
Short term investments |
402.3 |
469.1 |
273.1 |
55.1 |
78.8 |
|
Contracts receivable |
1.2 |
10.9 |
4.1 |
4.9 |
2.4 |
|
Raw Materials |
- |
- |
- |
- |
0.9 |
|
Work in Process |
- |
- |
- |
- |
0.0 |
|
Inventories |
2.5 |
2.8 |
2.7 |
1.8 |
- |
|
Assets held for sale |
- |
0.0 |
15.5 |
6.4 |
- |
|
Other current assets |
7.1 |
8.1 |
5.1 |
3.2 |
9.6 |
|
Total Current Assets |
483.1 |
596.1 |
518.4 |
209.9 |
206.2 |
|
|
|
|
|
|
|
|
Land |
10.1 |
0.0 |
- |
- |
- |
|
Equipment |
38.7 |
37.1 |
30.3 |
22.8 |
22.8 |
|
Leasehold Imprv. |
25.1 |
24.8 |
17.7 |
12.1 |
11.8 |
|
Furn./Fixtures |
2.6 |
1.8 |
1.8 |
1.5 |
1.5 |
|
Depreciation |
-40.8 |
-36.4 |
-32.4 |
-30.4 |
-28.9 |
|
Licenses, net |
- |
- |
- |
- |
21.4 |
|
Licenses, Gross |
36.2 |
36.1 |
36.0 |
35.9 |
- |
|
Accumulated Amortization |
-23.9 |
-21.6 |
-19.1 |
-16.8 |
- |
|
Patents Gross |
33.3 |
31.4 |
28.1 |
26.6 |
- |
|
Accumulated Amortization |
-17.5 |
-15.5 |
-11.8 |
-10.2 |
- |
|
Patents net |
- |
- |
- |
- |
16.8 |
|
Deposits and other assets |
3.5 |
3.3 |
3.9 |
7.5 |
4.3 |
|
Total Assets |
550.5 |
657.2 |
572.8 |
258.9 |
255.9 |
|
|
|
|
|
|
|
|
Accounts Payable |
6.5 |
4.7 |
5.7 |
2.6 |
4.3 |
|
Accrued compensation |
6.8 |
7.1 |
6.8 |
8.8 |
6.2 |
|
Income taxes payable |
0.0 |
7.3 |
0.0 |
- |
- |
|
Accrued liabilities |
12.4 |
12.3 |
9.6 |
5.2 |
6.1 |
|
Current portion of long term obligations |
5.6 |
4.3 |
2.1 |
7.2 |
7.5 |
|
Current portion of deferred contract rev |
74.5 |
75.7 |
92.7 |
31.5 |
1.0 |
|
Liabilities held for sale |
- |
0.0 |
7.9 |
6.9 |
- |
|
Total Current Liabilities |
105.9 |
111.4 |
124.7 |
62.2 |
25.1 |
|
|
|
|
|
|
|
|
25/8 percent convertible subordinated no |
132.9 |
125.1 |
118.0 |
162.5 |
0.0 |
|
5.5% Conv. Sub |
- |
- |
- |
- |
125.0 |
|
Long term obligations |
5.7 |
11.5 |
9.9 |
0.4 |
7.8 |
|
Long-term financing obligation |
10.1 |
0.0 |
- |
- |
- |
|
Capital Leases |
0.0 |
- |
- |
- |
- |
|
Total Long Term Debt |
148.8 |
136.6 |
127.9 |
162.9 |
132.8 |
|
|
|
|
|
|
|
|
Long term deferred contract revenue |
50.4 |
107.1 |
172.8 |
23.5 |
0.0 |
|
Noncontrolling interest in Ibis Bioscien |
- |
0.0 |
32.4 |
0.0 |
- |
|
Investment in Regulus Therapeutics Inc. |
0.9 |
0.0 |
- |
- |
- |
|
Noncontrolling interest in Regulus Thera |
0.0 |
10.3 |
4.7 |
9.4 |
0.0 |
|
Noncontrolling Int. in Symphony GenIsis |
- |
- |
- |
- |
29.3 |
|
Total Liabilities |
305.9 |
365.5 |
462.6 |
258.0 |
187.3 |
|
|
|
|
|
|
|
|
Common Stock |
0.1 |
0.1 |
0.1 |
0.1 |
0.1 |
|
Additional paid-in capital |
1,000.2 |
985.6 |
960.4 |
828.0 |
881.0 |
|
Accumulated other comprehensive income |
0.9 |
2.2 |
1.0 |
0.5 |
4.3 |
|
Accumulated deficit |
-756.7 |
-696.2 |
-851.2 |
-827.7 |
-816.8 |
|
Total Equity |
244.5 |
291.7 |
110.2 |
0.9 |
68.6 |
|
|
|
|
|
|
|
|
Total Liabilities & Shareholders' Equity |
550.5 |
657.2 |
572.8 |
258.9 |
255.9 |
|
|
|
|
|
|
|
|
S/O-Common Stock |
99.4 |
98.9 |
97.2 |
87.2 |
82.3 |
|
Total Common Shares Outstanding |
99.4 |
98.9 |
97.2 |
87.2 |
82.3 |
|
T/S-Common Stock |
0.0 |
0.0 |
0.0 |
0.0 |
- |
|
Deferred Revenue - Long Term |
50.4 |
107.1 |
172.8 |
- |
- |
|
Deferred Revenue - Current |
74.5 |
75.7 |
92.7 |
31.5 |
1.0 |
|
Accumulated Amortization |
41.4 |
37.1 |
30.9 |
27.0 |
23.1 |
|
Full-Time Employees |
370 |
335 |
300 |
300 |
274 |
|
Number of Common Shareholders |
836 |
922 |
857 |
890 |
960 |
|
Long Term Debt Maturing Within 1 Year |
10.4 |
9.1 |
- |
7.2 |
7.5 |
|
Long Term Debt Maturing Within 2 Years |
7.4 |
14.3 |
- |
0.0 |
7.5 |
|
Long Term Debt Maturing Within 3 Years |
5.7 |
5.8 |
- |
0.0 |
125.0 |
|
Long Term Debt Maturing Within 4 Years |
164.9 |
4.3 |
- |
0.0 |
0.0 |
|
Long Term Debt Maturing Within 4 Years |
0.2 |
166.8 |
- |
0.0 |
0.0 |
|
Long Term Debt Maturing Remaining Years |
1.2 |
54.5 |
- |
162.9 |
0.4 |
|
Total Long Term Debt, Supplemental |
189.8 |
254.8 |
- |
170.1 |
140.4 |
|
Capital Lease Maturing Within 1 Year |
6.0 |
4.8 |
- |
- |
0.9 |
|
Capital Lease Maturing Within 2 Years |
- |
- |
- |
- |
0.2 |
|
Capital Lease Maturing Within 3 Years |
4.5 |
6.0 |
- |
- |
0.0 |
|
Capital Lease Maturing Within 4 Years |
- |
- |
- |
- |
0.0 |
|
Capital Lease Maturing Within 5 Years |
0.4 |
0.0 |
- |
- |
0.0 |
|
Thereafter |
0.0 |
0.0 |
- |
- |
0.0 |
|
Representing Interest |
- |
- |
- |
- |
-0.1 |
|
Total Capital Leases |
10.9 |
10.8 |
- |
- |
1.0 |
|
Operating Lease Maturing Within 1 Year |
3.5 |
3.3 |
- |
2.9 |
2.9 |
|
Operating Lease Maturing Within 2 Years |
1.4 |
3.3 |
- |
2.9 |
2.8 |
|
Operating Lease Maturing Within 3 Years |
1.4 |
1.2 |
- |
2.4 |
2.7 |
|
Operating Lease Maturing Within 4 Years |
1.4 |
1.2 |
- |
1.9 |
2.3 |
|
Operating Lease Maturing Within 5 Years |
1.3 |
1.2 |
- |
1.5 |
1.9 |
|
Thereafter |
23.3 |
6.7 |
- |
8.9 |
10.1 |
|
Total Operating Leases |
32.4 |
16.9 |
- |
20.4 |
22.7 |
Annual Cash Flows
Financials in: USD (mil)
|
|
31-Dec-2010 |
31-Dec-2009 |
31-Dec-2008 |
31-Dec-2007 |
31-Dec-2006 |
|
Period Length |
12 Months |
12 Months |
12 Months |
12 Months |
12 Months |
|
UpdateType/Date |
Updated Normal |
Updated Normal |
Reclassified
Normal |
Reclassified
Normal |
Updated Normal |
|
Filed Currency |
USD |
USD |
USD |
USD |
USD |
|
Exchange Rate
(Period Average) |
1 |
1 |
1 |
1 |
1 |
|
Auditor |
Ernst &
Young LLP |
Ernst &
Young LLP |
Ernst &
Young LLP |
Ernst &
Young LLP |
Ernst &
Young LLP |
|
Auditor Opinion |
Unqualified with
Explanation |
Unqualified with
Explanation |
Unqualified |
Unqualified |
Unqualified |
|
|
|
|
|
|
|
|
Net Income |
-61.3 |
150.7 |
-22.9 |
-40.1 |
-45.9 |
|
Depreciation |
4.8 |
3.9 |
2.9 |
2.7 |
3.9 |
|
Amort. Patents |
2.0 |
3.0 |
1.6 |
1.6 |
1.6 |
|
Amort. Licenses |
2.4 |
2.3 |
2.3 |
2.3 |
2.3 |
|
Compensation |
- |
- |
- |
- |
0.0 |
|
Amortisation of Premium on Investment |
5.1 |
2.0 |
-0.2 |
-0.8 |
-0.6 |
|
Amortization of debt issuance costs |
0.5 |
0.5 |
0.5 |
0.6 |
- |
|
Amortization of 25/8 percent convertible |
7.8 |
7.1 |
6.5 |
5.6 |
- |
|
Share based compensation expense |
12.2 |
13.4 |
15.1 |
9.9 |
5.7 |
|
Equity in net loss of Regulus Therapeuti |
2.2 |
0.0 |
0.0 |
- |
- |
|
Loss attributed to noncontrolling intere |
0.0 |
0.0 |
-2.1 |
0.0 |
0.0 |
|
Gain from sale of Ibis Biosciences, Inc. |
0.0 |
-185.7 |
0.0 |
0.0 |
- |
|
Gain from derivative instruments issued |
0.0 |
0.0 |
-5.3 |
0.0 |
0.0 |
|
Gain from the sale of property, plant an |
-0.1 |
0.0 |
0.0 |
- |
- |
|
(Gain)/Loss on investments |
0.7 |
-2.1 |
1.0 |
-3.5 |
-2.3 |
|
Write-off Patents |
1.5 |
0.7 |
1.9 |
0.9 |
2.4 |
|
Excess tax benefits on share-based compe |
0.0 |
-0.3 |
0.0 |
0.0 |
- |
|
Loss attributed to noncontrolling |
- |
- |
- |
- |
0.0 |
|
Loss attributed to noncontrolling |
- |
- |
- |
- |
-23.0 |
|
Deferred Interest |
- |
- |
- |
- |
0.0 |
|
Loss on early retirement of debt |
- |
0.0 |
0.0 |
3.2 |
0.0 |
|
Noncash restructuring activities |
- |
- |
- |
- |
0.0 |
|
Variable Accounting of Warants |
- |
- |
- |
- |
0.0 |
|
Sale of Property, Plant and Equipment |
- |
- |
- |
- |
0.0 |
|
Contract Rcvbl. |
10.5 |
-6.8 |
1.2 |
-3.8 |
1.5 |
|
Inventory |
0.3 |
0.0 |
-1.3 |
-2.0 |
0.1 |
|
Other current and long-term assets |
-0.9 |
- |
- |
- |
- |
|
Accounts Payable |
1.3 |
-3.7 |
1.0 |
-0.8 |
1.2 |
|
Prepaids/Other |
- |
-1.0 |
-2.7 |
-0.5 |
-0.2 |
|
Accrued Payroll |
0.4 |
-4.4 |
-3.3 |
4.2 |
2.5 |
|
Income taxes payable |
-7.2 |
-10.0 |
0.0 |
0.0 |
- |
|
Accrued Liabilities |
1.0 |
4.3 |
4.9 |
0.7 |
-2.1 |
|
Deferred Revenues |
-46.8 |
-82.7 |
211.0 |
55.7 |
-0.4 |
|
Cash from Operating Activities |
-63.6 |
-108.4 |
212.0 |
36.1 |
-53.2 |
|
|
|
|
|
|
|
|
Purchase of ST Investment |
-530.1 |
-776.4 |
-483.1 |
-95.4 |
-107.0 |
|
Sale of Investment |
577.5 |
578.9 |
266.0 |
120.0 |
72.6 |
|
Capital Expenditures |
-13.2 |
-13.4 |
-13.7 |
-2.3 |
-1.0 |
|
Strategic investments in corporate sec. |
- |
- |
- |
- |
0.0 |
|
Sale of Property, Plant and Equipment |
0.2 |
0.0 |
0.0 |
- |
0.0 |
|
Proceeds from land sold to BioMed |
10.1 |
0.0 |
0.0 |
- |
- |
|
Reduction of cash due to deconsolidation |
-16.2 |
0.0 |
0.0 |
- |
- |
|
Acquisition of licenses and other assets |
-4.3 |
-2.9 |
-3.4 |
-2.7 |
-1.5 |
|
Purchases of strategic investments |
-0.3 |
-1.3 |
0.0 |
0.0 |
- |
|
Proceeds from the sale of strategic inve |
0.0 |
2.8 |
0.0 |
5.2 |
4.4 |
|
Acquisition of Symphony GenIsis, Inc. |
- |
0.0 |
0.0 |
-80.4 |
0.0 |
|
Cash from Investing Activities |
23.7 |
-212.3 |
-234.2 |
-55.6 |
-32.6 |
|
|
|
|
|
|
|
|
Net proceeds from issuance of equity |
4.4 |
13.2 |
12.7 |
11.4 |
- |
|
Proc.Iss.Pfr./Common |
- |
- |
- |
- |
86.4 |
|
Excess tax benefits on share-based compe |
0.0 |
0.3 |
0.0 |
0.0 |
- |
|
Proceeds from issuance of convertible pr |
0.0 |
0.0 |
5.0 |
0.0 |
0.0 |
|
Proceeds from equipment financing arrang |
4.7 |
6.4 |
7.0 |
0.0 |
0.0 |
|
Pymt. Capital Lease |
-4.4 |
-2.8 |
-7.2 |
-7.7 |
-7.9 |
|
Proceeds from stock purchase by Genzyme |
0.0 |
0.0 |
50.0 |
0.0 |
0.0 |
|
Proceeds from capital contributions to I |
0.0 |
175.0 |
40.0 |
0.0 |
0.0 |
|
Proceeds from capital contribution |
0.0 |
10.0 |
0.1 |
10.0 |
0.0 |
|
Proceeds from issuance of 25/8 percent c |
- |
0.0 |
0.0 |
157.1 |
0.0 |
|
Borrowing Proceeds |
- |
- |
- |
- |
0.0 |
|
Principal and redemption premium payment |
- |
0.0 |
0.0 |
-127.0 |
0.0 |
|
Proceeds from contribution to noncontrol |
- |
- |
- |
- |
71.0 |
|
Cash from Financing Activities |
4.7 |
202.0 |
107.6 |
43.7 |
149.5 |
|
|
|
|
|
|
|
|
Net Change in Cash |
-35.2 |
-118.7 |
85.4 |
24.1 |
63.6 |
|
|
|
|
|
|
|
|
Net Cash - Beginning Balance |
105.3 |
224.0 |
138.6 |
114.5 |
50.9 |
|
Net Cash - Ending Balance |
70.1 |
105.3 |
224.0 |
138.6 |
114.5 |
|
Cash Interest Paid |
4.9 |
4.9 |
4.6 |
6.2 |
8.4 |
|
Cash Taxes Paid |
7.3 |
13.2 |
0.0 |
0.0 |
- |
Financial Health
Financials in: USD (mil)
Except for share items (millions) and per share items (actual units)
|
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Ratio Comparisons
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Annual Ratios
Financials in: USD (mil)
Except for share items (millions) and per share items (actual units)
|
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Stock Report
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Stock History
|
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Annual Income Statement
Standardized
Financials in: USD (mil)
Except for share items (millions) and per share items (actual units)
|
|
31-Dec-2010 |
31-Dec-2009 |
31-Dec-2008 |
31-Dec-2007 |
31-Dec-2006 |
|
Period Length |
12 Months |
12 Months |
12 Months |
12 Months |
12 Months |
|
UpdateType/Date |
Updated Normal |
Updated Normal |
Restated Normal |
Restated Normal |
Restated Normal |
|
Filed Currency |
USD |
USD |
USD |
USD |
USD |
|
Exchange Rate
(Period Average) |
1 |
1 |
1 |
1 |
1 |
|
Auditor |
Ernst &
Young LLP |
Ernst &
Young LLP |
Ernst &
Young LLP |
Ernst & Young
LLP |
Ernst &
Young LLP |
|
Auditor Opinion |
Unqualified with
Explanation |
Unqualified with
Explanation |
Unqualified with
Explanation |
Unqualified with
Explanation |
Unqualified |
|
|
|
|
|
|
|
|
Net Sales |
108.5 |
121.6 |
107.2 |
58.3 |
14.9 |
|
Revenue |
108.5 |
121.6 |
107.2 |
58.3 |
14.9 |
|
Total Revenue |
108.5 |
121.6 |
107.2 |
58.3 |
14.9 |
|
|
|
|
|
|
|
|
Gross Profit |
108.5 |
121.6 |
107.2 |
58.3 |
14.9 |
|
|
|
|
|
|
|
|
Selling/General/Administrative Expense |
11.7 |
14.5 |
13.8 |
13.1 |
11.2 |
|
Total Selling/General/Administrative Expenses |
11.7 |
14.5 |
13.8 |
13.1 |
11.2 |
|
Research & Development |
145.2 |
134.6 |
106.4 |
78.2 |
69.4 |
|
Restructuring Charge |
- |
- |
- |
- |
-0.5 |
|
Other Unusual Expense (Income) |
- |
0.0 |
0.0 |
3.2 |
0.0 |
|
Unusual Expense (Income) |
- |
0.0 |
0.0 |
3.2 |
-0.5 |
|
Total Operating Expense |
156.8 |
149.1 |
120.3 |
94.5 |
80.1 |
|
|
|
|
|
|
|
|
Operating Income |
-48.4 |
-27.5 |
-13.1 |
-36.1 |
-65.2 |
|
|
|
|
|
|
|
|
Interest Expense -
Non-Operating |
-13.2 |
-12.7 |
-11.8 |
-12.9 |
-9.0 |
|
Interest Expense, Net Non-Operating |
-13.2 |
-12.7 |
-11.8 |
-12.9 |
-9.0 |
|
Investment Income -
Non-Operating |
0.4 |
8.4 |
10.4 |
15.0 |
8.2 |
|
Interest/Investment Income - Non-Operating |
0.4 |
8.4 |
10.4 |
15.0 |
8.2 |
|
Interest Income (Expense) - Net Non-Operating Total |
-12.8 |
-4.2 |
-1.5 |
2.1 |
-0.8 |
|
Income Before Tax |
-61.2 |
-31.8 |
-14.5 |
-34.1 |
-66.0 |
|
|
|
|
|
|
|
|
Total Income Tax |
0.1 |
3.2 |
0.0 |
0.0 |
0.0 |
|
Income After Tax |
-61.3 |
-35.0 |
-14.5 |
-34.1 |
-66.0 |
|
|
|
|
|
|
|
|
Minority Interest |
0.0 |
4.4 |
4.7 |
-101.5 |
23.0 |
|
Net Income Before Extraord Items |
-61.3 |
-30.6 |
-9.8 |
-135.6 |
-43.0 |
|
Discontinued Operations |
0.0 |
185.6 |
-8.4 |
-6.0 |
-2.9 |
|
Total Extraord Items |
0.0 |
185.6 |
-8.4 |
-6.0 |
-2.9 |
|
Net Income |
-61.3 |
155.1 |
-18.2 |
-141.6 |
-45.9 |
|
|
|
|
|
|
|
|
Income Available to Common Excl Extraord Items |
-61.3 |
-30.6 |
-9.8 |
-135.6 |
-43.0 |
|
|
|
|
|
|
|
|
Income Available to Common Incl Extraord Items |
-61.3 |
155.1 |
-18.2 |
-141.6 |
-45.9 |
|
|
|
|
|
|
|
|
Basic/Primary Weighted Average Shares |
99.1 |
98.1 |
94.6 |
83.7 |
74.3 |
|
Basic EPS Excl Extraord Items |
-0.62 |
-0.31 |
-0.10 |
-1.62 |
-0.58 |
|
Basic/Primary EPS Incl Extraord Items |
-0.62 |
1.58 |
-0.19 |
-1.69 |
-0.62 |
|
Dilution Adjustment |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
|
Diluted Net Income |
-61.3 |
155.1 |
-18.2 |
-141.6 |
-45.9 |
|
Diluted Weighted Average Shares |
99.1 |
98.1 |
94.6 |
83.7 |
74.3 |
|
Diluted EPS Excl Extraord Items |
-0.62 |
-0.31 |
-0.10 |
-1.62 |
-0.58 |
|
Diluted EPS Incl Extraord Items |
-0.62 |
1.58 |
-0.19 |
-1.69 |
-0.62 |
|
Dividends per Share - Common Stock Primary Issue |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
|
Gross Dividends - Common Stock |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
|
Interest Expense, Supplemental |
13.2 |
12.7 |
11.8 |
12.9 |
9.0 |
|
Depreciation, Supplemental |
4.8 |
3.9 |
2.9 |
2.7 |
3.9 |
|
Total Special Items |
- |
0.0 |
0.0 |
3.2 |
-0.5 |
|
Normalized Income Before Tax |
-61.2 |
-31.8 |
-14.5 |
-30.8 |
-66.6 |
|
|
|
|
|
|
|
|
Effect of Special Items on Income Taxes |
- |
0.0 |
0.0 |
0.0 |
0.0 |
|
Inc Tax Ex Impact of Sp Items |
0.1 |
3.2 |
0.0 |
0.0 |
0.0 |
|
Normalized Income After Tax |
-61.3 |
-35.0 |
-14.5 |
-30.8 |
-66.6 |
|
|
|
|
|
|
|
|
Normalized Inc. Avail to Com. |
-61.3 |
-30.6 |
-9.8 |
-132.4 |
-43.5 |
|
|
|
|
|
|
|
|
Basic Normalized EPS |
-0.62 |
-0.31 |
-0.10 |
-1.58 |
-0.59 |
|
Diluted Normalized EPS |
-0.62 |
-0.31 |
-0.10 |
-1.58 |
-0.59 |
|
Amort of Intangibles, Supplemental |
4.3 |
5.4 |
3.9 |
4.0 |
4.0 |
|
Rental Expenses |
4.3 |
4.6 |
3.8 |
3.4 |
3.2 |
|
Research & Development Exp, Supplemental |
145.2 |
134.6 |
106.4 |
78.2 |
69.4 |
|
Reported Operating Profit |
-48.4 |
-27.5 |
-13.1 |
-32.9 |
-65.2 |
|
Normalized EBIT |
-48.4 |
-27.5 |
-13.1 |
-32.9 |
-65.8 |
|
Normalized EBITDA |
-39.2 |
-18.2 |
-6.2 |
-26.3 |
-57.9 |
|
Current Tax - Domestic |
-0.1 |
2.9 |
- |
- |
- |
|
Current Tax - Local |
0.2 |
4.9 |
- |
- |
- |
|
Current Tax - Total |
0.1 |
7.8 |
- |
- |
- |
|
Deferred Tax - Domestic |
0.0 |
-1.0 |
- |
- |
- |
|
Deferred Tax - Local |
0.0 |
-3.6 |
- |
- |
- |
|
Deferred Tax - Total |
0.0 |
-4.6 |
- |
- |
- |
|
Income Tax - Total |
0.1 |
3.2 |
- |
- |
- |
|
Defined Contribution Expense - Domestic |
0.4 |
0.5 |
0.5 |
0.4 |
0.4 |
|
Total Pension Expense |
0.4 |
0.5 |
0.5 |
0.4 |
0.4 |
Interim Income Statement
Standardized
Financials in: USD (mil)
Except for share items (millions) and per share items (actual units)
|
|
30-Jun-2011 |
31-Mar-2011 |
31-Dec-2010 |
30-Sep-2010 |
30-Jun-2010 |
|
Period Length |
3 Months |
3 Months |
3 Months |
3 Months |
3 Months |
|
UpdateType/Date |
Updated Normal |
Updated Normal |
Updated Normal |
Updated Normal |
Updated Normal |
|
Filed Currency |
USD |
USD |
USD |
USD |
USD |
|
Exchange Rate
(Period Average) |
1 |
1 |
1 |
1 |
1 |
|
|
|
|
|
|
|
|
Net Sales |
24.8 |
21.1 |
26.4 |
28.6 |
23.5 |
|
Revenue |
24.8 |
21.1 |
26.4 |
28.6 |
23.5 |
|
Total Revenue |
24.8 |
21.1 |
26.4 |
28.6 |
23.5 |
|
|
|
|
|
|
|
|
Gross Profit |
24.8 |
21.1 |
26.4 |
28.6 |
23.5 |
|
|
|
|
|
|
|
|
Selling/General/Administrative Expense |
2.9 |
3.0 |
2.9 |
2.9 |
3.1 |
|
Total Selling/General/Administrative Expenses |
2.9 |
3.0 |
2.9 |
2.9 |
3.1 |
|
Research & Development |
36.0 |
34.2 |
39.3 |
34.7 |
39.1 |
|
Total Operating Expense |
38.9 |
37.3 |
42.3 |
37.6 |
42.2 |
|
|
|
|
|
|
|
|
Operating Income |
-14.1 |
-16.1 |
-15.9 |
-8.9 |
-18.7 |
|
|
|
|
|
|
|
|
Interest Expense -
Non-Operating |
-3.4 |
-3.4 |
-3.4 |
-3.3 |
-3.3 |
|
Interest Expense, Net Non-Operating |
-3.4 |
-3.4 |
-3.4 |
-3.3 |
-3.3 |
|
Investment Income -
Non-Operating |
-0.4 |
-0.5 |
5.4 |
-0.2 |
-3.2 |
|
Interest/Investment Income - Non-Operating |
-0.4 |
-0.5 |
5.4 |
-0.2 |
-3.2 |
|
Interest Income (Expense) - Net Non-Operating Total |
-3.8 |
-3.9 |
2.0 |
-3.5 |
-6.5 |
|
Income Before Tax |
-17.9 |
-20.0 |
-13.9 |
-12.5 |
-25.2 |
|
|
|
|
|
|
|
|
Total Income Tax |
0.0 |
0.0 |
0.1 |
0.0 |
0.0 |
|
Income After Tax |
-17.9 |
-20.0 |
-14.0 |
-12.5 |
-25.2 |
|
|
|
|
|
|
|
|
Minority Interest |
- |
- |
0.0 |
0.0 |
0.0 |
|
Net Income Before Extraord Items |
-17.9 |
-20.0 |
-14.0 |
-12.5 |
-25.2 |
|
Discontinued Operations |
- |
- |
0.0 |
0.0 |
0.0 |
|
Total Extraord Items |
- |
- |
0.0 |
0.0 |
0.0 |
|
Net Income |
-17.9 |
-20.0 |
-14.0 |
-12.5 |
-25.2 |
|
|
|
|
|
|
|
|
Income Available to Common Excl Extraord Items |
-17.9 |
-20.0 |
-14.0 |
-12.5 |
-25.2 |
|
|
|
|
|
|
|
|
Income Available to Common Incl Extraord Items |
-17.9 |
-20.0 |
-14.0 |
-12.5 |
-25.2 |
|
|
|
|
|
|
|
|
Basic/Primary Weighted Average Shares |
99.6 |
99.6 |
99.3 |
99.2 |
99.1 |
|
Basic EPS Excl Extraord Items |
-0.18 |
-0.20 |
-0.14 |
-0.13 |
-0.25 |
|
Basic/Primary EPS Incl Extraord Items |
-0.18 |
-0.20 |
-0.14 |
-0.13 |
-0.25 |
|
Dilution Adjustment |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
|
Diluted Net Income |
-17.9 |
-20.0 |
-14.0 |
-12.5 |
-25.2 |
|
Diluted Weighted Average Shares |
99.6 |
99.6 |
99.3 |
99.2 |
99.1 |
|
Diluted EPS Excl Extraord Items |
-0.18 |
-0.20 |
-0.14 |
-0.13 |
-0.25 |
|
Diluted EPS Incl Extraord Items |
-0.18 |
-0.20 |
-0.14 |
-0.13 |
-0.25 |
|
Dividends per Share - Common Stock Primary Issue |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
|
Gross Dividends - Common Stock |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
|
Interest Expense, Supplemental |
3.4 |
3.4 |
3.4 |
3.3 |
3.3 |
|
Depreciation, Supplemental |
1.5 |
1.8 |
- |
- |
1.5 |
|
Normalized Income Before Tax |
-17.9 |
-20.0 |
-13.9 |
-12.5 |
-25.2 |
|
|
|
|
|
|
|
|
Inc Tax Ex Impact of Sp Items |
0.0 |
0.0 |
0.1 |
0.0 |
0.0 |
|
Normalized Income After Tax |
-17.9 |
-20.0 |
-14.0 |
-12.5 |
-25.2 |
|
|
|
|
|
|
|
|
Normalized Inc. Avail to Com. |
-17.9 |
-20.0 |
-14.0 |
-12.5 |
-25.2 |
|
|
|
|
|
|
|
|
Basic Normalized EPS |
-0.18 |
-0.20 |
-0.14 |
-0.13 |
-0.25 |
|
Diluted Normalized EPS |
-0.18 |
-0.20 |
-0.14 |
-0.13 |
-0.25 |
|
Research & Development Exp, Supplemental |
36.0 |
34.2 |
39.3 |
34.7 |
39.1 |
|
Reported Operating Profit |
14.1 |
16.1 |
- |
8.9 |
18.7 |
|
Normalized EBIT |
-14.1 |
-16.1 |
-15.9 |
-8.9 |
-18.7 |
|
Normalized EBITDA |
-12.6 |
-14.3 |
-15.9 |
-8.9 |
-17.2 |
Annual Balance Sheet
Standardized
Financials in: USD (mil)
Except for share items (millions) and per share items (actual units)
|
|
31-Dec-2010 |
31-Dec-2009 |
31-Dec-2008 |
31-Dec-2007 |
31-Dec-2006 |
|
UpdateType/Date |
Updated Normal |
Updated Normal |
Restated Normal |
Reclassified
Normal |
Updated Normal |
|
Filed Currency |
USD |
USD |
USD |
USD |
USD |
|
Exchange Rate |
1 |
1 |
1 |
1 |
1 |
|
Auditor |
Ernst &
Young LLP |
Ernst &
Young LLP |
Ernst &
Young LLP |
Ernst &
Young LLP |
Ernst &
Young LLP |
|
Auditor Opinion |
Unqualified with
Explanation |
Unqualified with
Explanation |
Unqualified with
Explanation |
Unqualified with
Explanation |
Unqualified |
|
|
|
|
|
|
|
|
Cash & Equivalents |
70.1 |
105.3 |
217.9 |
138.6 |
114.5 |
|
Short Term Investments |
402.3 |
469.1 |
273.1 |
55.1 |
78.8 |
|
Cash and Short Term Investments |
472.4 |
574.3 |
491.0 |
193.7 |
193.3 |
|
Trade Accounts Receivable - Net |
1.2 |
10.9 |
4.1 |
4.9 |
2.4 |
|
Total Receivables, Net |
1.2 |
10.9 |
4.1 |
4.9 |
2.4 |
|
Inventories - Work In Progress |
- |
- |
- |
- |
0.0 |
|
Inventories - Raw Materials |
- |
- |
- |
- |
0.9 |
|
Total Inventory |
2.5 |
2.8 |
2.7 |
1.8 |
0.9 |
|
Discontinued Operations - Current Asset |
- |
0.0 |
15.5 |
6.4 |
- |
|
Other Current Assets |
7.1 |
8.1 |
5.1 |
3.2 |
9.6 |
|
Other Current Assets, Total |
7.1 |
8.1 |
20.5 |
9.5 |
9.6 |
|
Total Current Assets |
483.1 |
596.1 |
518.4 |
209.9 |
206.2 |
|
|
|
|
|
|
|
|
Buildings |
25.1 |
24.8 |
17.7 |
12.1 |
11.8 |
|
Land/Improvements |
10.1 |
0.0 |
- |
- |
- |
|
Machinery/Equipment |
41.2 |
38.9 |
32.1 |
24.3 |
24.3 |
|
Property/Plant/Equipment - Gross |
76.5 |
63.7 |
49.8 |
36.4 |
36.1 |
|
Accumulated Depreciation |
-40.8 |
-36.4 |
-32.4 |
-30.4 |
-28.9 |
|
Property/Plant/Equipment - Net |
35.7 |
27.3 |
17.4 |
6.0 |
7.2 |
|
Intangibles - Gross |
69.5 |
67.6 |
64.0 |
62.5 |
- |
|
Accumulated Intangible Amortization |
-41.4 |
-37.1 |
-30.9 |
-27.0 |
- |
|
Intangibles, Net |
28.1 |
30.5 |
33.1 |
35.5 |
38.3 |
|
Other Long Term Assets |
3.5 |
3.3 |
3.9 |
7.5 |
4.3 |
|
Other Long Term Assets, Total |
3.5 |
3.3 |
3.9 |
7.5 |
4.3 |
|
Total Assets |
550.5 |
657.2 |
572.8 |
258.9 |
255.9 |
|
|
|
|
|
|
|
|
Accounts Payable |
6.5 |
4.7 |
5.7 |
2.6 |
4.3 |
|
Accrued Expenses |
19.2 |
19.5 |
16.4 |
14.0 |
12.3 |
|
Notes Payable/Short Term Debt |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
|
Current Portion - Long Term Debt/Capital Leases |
5.6 |
4.3 |
2.1 |
7.2 |
7.5 |
|
Customer Advances |
74.5 |
75.7 |
92.7 |
31.5 |
1.0 |
|
Income Taxes Payable |
0.0 |
7.3 |
0.0 |
- |
- |
|
Other Current Liabilities |
- |
0.0 |
7.9 |
6.9 |
- |
|
Other Current liabilities, Total |
74.5 |
83.0 |
100.5 |
38.4 |
1.0 |
|
Total Current Liabilities |
105.9 |
111.4 |
124.7 |
62.2 |
25.1 |
|
|
|
|
|
|
|
|
Long Term Debt |
138.6 |
136.6 |
127.9 |
162.9 |
132.8 |
|
Capital Lease Obligations |
10.1 |
0.0 |
- |
- |
- |
|
Total Long Term Debt |
148.8 |
136.6 |
127.9 |
162.9 |
132.8 |
|
Total Debt |
154.4 |
140.8 |
130.0 |
170.1 |
140.3 |
|
|
|
|
|
|
|
|
Minority Interest |
0.0 |
10.3 |
37.2 |
9.4 |
29.3 |
|
Other Long Term Liabilities |
51.3 |
107.1 |
172.8 |
23.5 |
0.0 |
|
Other Liabilities, Total |
51.3 |
107.1 |
172.8 |
23.5 |
0.0 |
|
Total Liabilities |
305.9 |
365.5 |
462.6 |
258.0 |
187.3 |
|
|
|
|
|
|
|
|
Common Stock |
0.1 |
0.1 |
0.1 |
0.1 |
0.1 |
|
Common Stock |
0.1 |
0.1 |
0.1 |
0.1 |
0.1 |
|
Additional Paid-In Capital |
1,000.2 |
985.6 |
960.4 |
828.0 |
881.0 |
|
Retained Earnings (Accumulated Deficit) |
-756.7 |
-696.2 |
-851.2 |
-827.7 |
-816.8 |
|
Other Comprehensive Income |
0.9 |
2.2 |
1.0 |
0.5 |
4.3 |
|
Other Equity, Total |
0.9 |
2.2 |
1.0 |
0.5 |
4.3 |
|
Total Equity |
244.5 |
291.7 |
110.2 |
0.9 |
68.6 |
|
|
|
|
|
|
|
|
Total Liabilities & Shareholders’ Equity |
550.5 |
657.2 |
572.8 |
258.9 |
255.9 |
|
|
|
|
|
|
|
|
Shares Outstanding - Common Stock Primary
Issue |
99.4 |
98.9 |
97.2 |
87.2 |
82.3 |
|
Total Common Shares Outstanding |
99.4 |
98.9 |
97.2 |
87.2 |
82.3 |
|
Treasury Shares - Common Stock Primary Issue |
0.0 |
0.0 |
0.0 |
0.0 |
- |
|
Employees |
370 |
335 |
300 |
300 |
274 |
|
Number of Common Shareholders |
836 |
922 |
857 |
890 |
960 |
|
Accumulated Intangible Amort, Suppl. |
41.4 |
37.1 |
30.9 |
27.0 |
23.1 |
|
Deferred Revenue - Current |
74.5 |
75.7 |
92.7 |
31.5 |
1.0 |
|
Deferred Revenue - Long Term |
50.4 |
107.1 |
172.8 |
- |
- |
|
Total Long Term Debt, Supplemental |
189.8 |
254.8 |
- |
170.1 |
140.4 |
|
Long Term Debt Maturing within 1 Year |
10.4 |
9.1 |
- |
7.2 |
7.5 |
|
Long Term Debt Maturing in Year 2 |
7.4 |
14.3 |
- |
0.0 |
7.5 |
|
Long Term Debt Maturing in Year 3 |
5.7 |
5.8 |
- |
0.0 |
125.0 |
|
Long Term Debt Maturing in Year 4 |
164.9 |
4.3 |
- |
0.0 |
0.0 |
|
Long Term Debt Maturing in Year 5 |
0.2 |
166.8 |
- |
0.0 |
0.0 |
|
Long Term Debt Maturing in 2-3 Years |
13.1 |
20.0 |
- |
0.0 |
132.5 |
|
Long Term Debt Maturing in 4-5 Years |
165.1 |
171.2 |
- |
0.0 |
0.0 |
|
Long Term Debt Matur. in Year 6 & Beyond |
1.2 |
54.5 |
- |
162.9 |
0.4 |
|
Interest Costs |
- |
- |
- |
- |
-0.1 |
|
Total Capital Leases, Supplemental |
10.9 |
10.8 |
- |
- |
1.0 |
|
Capital Lease Payments Due in Year 1 |
6.0 |
4.8 |
- |
- |
0.9 |
|
Capital Lease Payments Due in Year 2 |
2.3 |
3.0 |
- |
- |
0.2 |
|
Capital Lease Payments Due in Year 3 |
2.3 |
3.0 |
- |
- |
0.0 |
|
Capital Lease Payments Due in Year 4 |
0.2 |
0.0 |
- |
- |
0.0 |
|
Capital Lease Payments Due in Year 5 |
0.2 |
0.0 |
- |
- |
0.0 |
|
Capital Lease Payments Due in 2-3 Years |
4.5 |
6.0 |
- |
- |
0.2 |
|
Capital Lease Payments Due in 4-5 Years |
0.4 |
0.0 |
- |
- |
0.0 |
|
Cap. Lease Pymts. Due in Year 6 & Beyond |
0.0 |
0.0 |
- |
- |
0.0 |
|
Total Operating Leases, Supplemental |
32.4 |
16.9 |
- |
20.4 |
22.7 |
|
Operating Lease Payments Due in Year 1 |
3.5 |
3.3 |
- |
2.9 |
2.9 |
|
Operating Lease Payments Due in Year 2 |
1.4 |
3.3 |
- |
2.9 |
2.8 |
|
Operating Lease Payments Due in Year 3 |
1.4 |
1.2 |
- |
2.4 |
2.7 |
|
Operating Lease Payments Due in Year 4 |
1.4 |
1.2 |
- |
1.9 |
2.3 |
|
Operating Lease Payments Due in Year 5 |
1.3 |
1.2 |
- |
1.5 |
1.9 |
|
Operating Lease Pymts. Due in 2-3 Years |
2.8 |
4.5 |
- |
5.2 |
5.5 |
|
Operating Lease Pymts. Due in 4-5 Years |
2.7 |
2.4 |
- |
3.4 |
4.2 |
|
Oper. Lse. Pymts. Due in Year 6 & Beyond |
23.3 |
6.7 |
- |
8.9 |
10.1 |
Interim Balance Sheet
Standardized
Financials in: USD (mil)
Except for share items (millions) and per share items (actual units)
|
|
30-Jun-2011 |
31-Mar-2011 |
31-Dec-2010 |
30-Sep-2010 |
30-Jun-2010 |
|
UpdateType/Date |
Updated Normal |
Updated Normal |
Updated Normal |
Updated Normal |
Updated Normal |
|
Filed Currency |
USD |
USD |
USD |
USD |
USD |
|
Exchange Rate |
1 |
1 |
1 |
1 |
1 |
|
|
|
|
|
|
|
|
Cash & Equivalents |
85.0 |
86.2 |
70.1 |
100.1 |
46.0 |
|
Short Term Investments |
310.2 |
340.6 |
402.3 |
397.8 |
478.2 |
|
Cash and Short Term Investments |
395.2 |
426.8 |
472.4 |
497.9 |
524.2 |
|
Trade Accounts Receivable - Net |
5.7 |
0.6 |
1.2 |
1.3 |
5.0 |
|
Total Receivables, Net |
5.7 |
0.6 |
1.2 |
1.3 |
5.0 |
|
Total Inventory |
2.2 |
2.6 |
2.5 |
2.0 |
2.8 |
|
Discontinued Operations - Current Asset |
- |
- |
- |
- |
0.0 |
|
Other Current Assets |
7.6 |
7.4 |
7.1 |
6.3 |
4.8 |
|
Other Current Assets, Total |
7.6 |
7.4 |
7.1 |
6.3 |
4.8 |
|
Total Current Assets |
410.7 |
437.4 |
483.1 |
507.6 |
536.9 |
|
|
|
|
|
|
|
|
Property/Plant/Equipment - Net |
88.0 |
37.7 |
35.7 |
35.5 |
36.1 |
|
Intangibles, Net |
27.6 |
27.5 |
28.1 |
29.1 |
29.6 |
|
LT Investments - Other |
- |
- |
- |
- |
0.6 |
|
Long Term Investments |
- |
- |
- |
- |
0.6 |
|
Other Long Term Assets |
3.3 |
3.4 |
3.5 |
3.7 |
3.2 |
|
Other Long Term Assets, Total |
3.3 |
3.4 |
3.5 |
3.7 |
3.2 |
|
Total Assets |
529.6 |
505.9 |
550.5 |
575.9 |
606.4 |
|
|
|
|
|
|
|
|
Accounts Payable |
3.1 |
4.7 |
6.5 |
3.4 |
5.4 |
|
Accrued Expenses |
15.3 |
11.2 |
19.2 |
15.1 |
17.6 |
|
Notes Payable/Short Term Debt |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
|
Current Portion - Long Term Debt/Capital Leases |
4.9 |
5.1 |
5.6 |
5.1 |
5.0 |
|
Customer Advances |
68.7 |
73.4 |
74.5 |
77.3 |
77.3 |
|
Income Taxes Payable |
- |
- |
0.0 |
0.0 |
0.0 |
|
Discontinued Operations - Current Liability |
- |
- |
- |
- |
0.0 |
|
Other Current liabilities, Total |
68.7 |
73.4 |
74.5 |
77.3 |
77.3 |
|
Total Current Liabilities |
92.0 |
94.4 |
105.9 |
100.9 |
105.2 |
|
|
|
|
|
|
|
|
Long Term Debt |
142.5 |
139.9 |
138.6 |
135.2 |
134.5 |
|
Capital Lease Obligations |
58.7 |
10.1 |
10.1 |
10.1 |
10.1 |
|
Total Long Term Debt |
201.3 |
150.0 |
148.8 |
145.3 |
144.7 |
|
Total Debt |
206.2 |
155.2 |
154.4 |
150.5 |
149.7 |
|
|
|
|
|
|
|
|
Minority Interest |
- |
- |
0.0 |
0.0 |
0.0 |
|
Other Long Term Liabilities |
24.1 |
33.8 |
51.3 |
75.9 |
94.2 |
|
Other Liabilities, Total |
24.1 |
33.8 |
51.3 |
75.9 |
94.2 |
|
Total Liabilities |
317.4 |
278.2 |
305.9 |
322.1 |
344.1 |
|
|
|
|
|
|
|
|
Common Stock |
0.1 |
0.1 |
0.1 |
0.1 |
0.1 |
|
Common Stock |
0.1 |
0.1 |
0.1 |
0.1 |
0.1 |
|
Additional Paid-In Capital |
1,006.3 |
1,003.6 |
1,000.2 |
995.1 |
991.4 |
|
Retained Earnings (Accumulated Deficit) |
-794.6 |
-776.7 |
-756.7 |
-742.7 |
-730.2 |
|
Other Comprehensive Income |
0.4 |
0.7 |
0.9 |
1.2 |
0.9 |
|
Other Equity, Total |
0.4 |
0.7 |
0.9 |
1.2 |
0.9 |
|
Total Equity |
212.2 |
227.7 |
244.5 |
253.7 |
262.2 |
|
|
|
|
|
|
|
|
Total Liabilities & Shareholders’ Equity |
529.6 |
505.9 |
550.5 |
575.9 |
606.4 |
|
|
|
|
|
|
|
|
Shares Outstanding - Common Stock Primary
Issue |
99.6 |
99.6 |
99.4 |
99.2 |
99.1 |
|
Total Common Shares Outstanding |
99.6 |
99.6 |
99.4 |
99.2 |
99.1 |
|
Treasury Shares - Common Stock Primary Issue |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
|
Deferred Revenue - Current |
68.7 |
73.4 |
74.5 |
77.3 |
77.3 |
|
Deferred Revenue - Long Term |
21.4 |
32.1 |
50.4 |
70.9 |
90.2 |
|
Total Long Term Debt, Supplemental |
175.3 |
175.3 |
189.8 |
177.4 |
5.0 |
|
Long Term Debt Maturing within 1 Year |
4.3 |
4.3 |
10.4 |
4.3 |
5.0 |
|
Long Term Debt Maturing in Year 2 |
85.5 |
4.3 |
6.5 |
4.3 |
- |
|
Long Term Debt Maturing in Year 3 |
85.5 |
4.3 |
6.5 |
4.3 |
- |
|
Long Term Debt Maturing in Year 4 |
0.0 |
81.3 |
82.6 |
82.3 |
- |
|
Long Term Debt Maturing in Year 5 |
0.0 |
81.3 |
82.6 |
82.3 |
- |
|
Long Term Debt Maturing in 2-3 Years |
171.0 |
8.5 |
13.1 |
8.5 |
- |
|
Long Term Debt Maturing in 4-5 Years |
0.0 |
162.5 |
165.1 |
164.6 |
- |
|
Long Term Debt Matur. in Year 6 & Beyond |
0.0 |
0.0 |
1.2 |
0.0 |
0.0 |
|
Total Capital Leases, Supplemental |
0.8 |
0.9 |
9.4 |
- |
- |
|
Capital Lease Payments Due in Year 1 |
0.1 |
0.2 |
- |
- |
- |
|
Capital Lease Payments Due in Year 2 |
0.2 |
0.2 |
- |
- |
- |
|
Capital Lease Payments Due in Year 3 |
0.2 |
0.2 |
- |
- |
- |
|
Capital Lease Payments Due in Year 4 |
0.2 |
0.2 |
- |
- |
- |
|
Capital Lease Payments Due in Year 5 |
0.2 |
0.2 |
- |
- |
- |
|
Capital Lease Payments Due in 2-3 Years |
0.4 |
0.4 |
- |
- |
- |
|
Capital Lease Payments Due in 4-5 Years |
0.3 |
0.3 |
- |
- |
- |
|
Cap. Lease Pymts. Due in Year 6 & Beyond |
0.0 |
0.0 |
- |
- |
- |
|
Total Operating Leases, Supplemental |
30.7 |
31.5 |
35.2 |
30.8 |
- |
|
Operating Lease Payments Due in Year 1 |
2.5 |
3.0 |
3.5 |
3.3 |
- |
|
Operating Lease Payments Due in Year 2 |
1.4 |
1.4 |
1.4 |
1.5 |
- |
|
Operating Lease Payments Due in Year 3 |
1.4 |
1.4 |
2.8 |
1.5 |
- |
|
Operating Lease Payments Due in Year 4 |
1.4 |
1.4 |
1.4 |
1.2 |
- |
|
Operating Lease Payments Due in Year 5 |
1.4 |
1.4 |
2.7 |
1.2 |
- |
|
Operating Lease Pymts. Due in 2-3 Years |
2.8 |
2.8 |
4.2 |
3.0 |
- |
|
Operating Lease Pymts. Due in 4-5 Years |
2.7 |
2.7 |
4.1 |
2.3 |
- |
|
Oper. Lse. Pymts. Due in Year 6 & Beyond |
22.7 |
23.0 |
23.4 |
22.2 |
- |
Annual Cash Flows
Standardized
Financials in: USD (mil)
Except for share items (millions) and per share items (actual units)
|
|
31-Dec-2010 |
31-Dec-2009 |
31-Dec-2008 |
31-Dec-2007 |
31-Dec-2006 |
|
Period Length |
12 Months |
12 Months |
12 Months |
12 Months |
12 Months |
|
UpdateType/Date |
Updated Normal |
Updated Normal |
Reclassified
Normal |
Reclassified
Normal |
Updated Normal |
|
Filed Currency |
USD |
USD |
USD |
USD |
USD |
|
Exchange Rate
(Period Average) |
1 |
1 |
1 |
1 |
1 |
|
Auditor |
Ernst &
Young LLP |
Ernst &
Young LLP |
Ernst &
Young LLP |
Ernst &
Young LLP |
Ernst &
Young LLP |
|
Auditor Opinion |
Unqualified with
Explanation |
Unqualified with
Explanation |
Unqualified with
Explanation |
Unqualified with
Explanation |
Unqualified |
|
|
|
|
|
|
|
|
Net Income/Starting Line |
-61.3 |
150.7 |
-22.9 |
-40.1 |
-45.9 |
|
Depreciation |
4.8 |
3.9 |
2.9 |
2.7 |
3.9 |
|
Depreciation/Depletion |
4.8 |
3.9 |
2.9 |
2.7 |
3.9 |
|
Amortization of Intangibles |
4.3 |
5.4 |
3.9 |
4.0 |
4.0 |
|
Amortization |
4.3 |
5.4 |
3.9 |
4.0 |
4.0 |
|
Unusual Items |
2.2 |
-187.0 |
2.8 |
0.6 |
-22.9 |
|
Equity in Net Earnings (Loss) |
2.2 |
0.0 |
0.0 |
- |
- |
|
Other Non-Cash Items |
25.5 |
22.7 |
14.4 |
15.3 |
5.1 |
|
Non-Cash Items |
29.9 |
-164.3 |
17.3 |
15.9 |
-17.7 |
|
Accounts Receivable |
10.5 |
-6.8 |
1.2 |
-3.8 |
1.5 |
|
Inventories |
0.3 |
0.0 |
-1.3 |
-2.0 |
0.1 |
|
Prepaid Expenses |
- |
-1.0 |
-2.7 |
-0.5 |
-0.2 |
|
Other Assets |
-0.9 |
- |
- |
- |
- |
|
Accounts Payable |
1.3 |
-3.7 |
1.0 |
-0.8 |
1.2 |
|
Accrued Expenses |
1.4 |
-0.1 |
1.7 |
5.0 |
0.4 |
|
Taxes Payable |
-7.2 |
-10.0 |
0.0 |
0.0 |
- |
|
Other Liabilities |
-46.8 |
-82.7 |
211.0 |
55.7 |
-0.4 |
|
Changes in Working Capital |
-41.4 |
-104.1 |
210.9 |
53.6 |
2.6 |
|
Cash from Operating Activities |
-63.6 |
-108.4 |
212.0 |
36.1 |
-53.2 |
|
|
|
|
|
|
|
|
Purchase of Fixed Assets |
-13.2 |
-13.4 |
-13.7 |
-2.3 |
-1.0 |
|
Capital Expenditures |
-13.2 |
-13.4 |
-13.7 |
-2.3 |
-1.0 |
|
Acquisition of Business |
- |
0.0 |
0.0 |
-80.4 |
0.0 |
|
Sale of Fixed Assets |
10.3 |
0.0 |
0.0 |
- |
0.0 |
|
Sale/Maturity of Investment |
577.5 |
581.7 |
266.0 |
125.1 |
77.0 |
|
Investment, Net |
- |
- |
- |
- |
0.0 |
|
Purchase of Investments |
-530.4 |
-777.7 |
-483.1 |
-95.4 |
-107.0 |
|
Intangible, Net |
-4.3 |
-2.9 |
-3.4 |
-2.7 |
-1.5 |
|
Other Investing Cash Flow |
-16.2 |
0.0 |
0.0 |
- |
- |
|
Other Investing Cash Flow Items, Total |
36.9 |
-198.9 |
-220.6 |
-53.4 |
-31.6 |
|
Cash from Investing Activities |
23.7 |
-212.3 |
-234.2 |
-55.6 |
-32.6 |
|
|
|
|
|
|
|
|
Other Financing Cash Flow |
0.0 |
0.3 |
0.0 |
0.0 |
71.0 |
|
Financing Cash Flow Items |
0.0 |
0.3 |
0.0 |
0.0 |
71.0 |
|
Sale/Issuance of
Common |
0.0 |
185.0 |
90.1 |
10.0 |
0.0 |
|
Common Stock, Net |
4.4 |
198.2 |
102.8 |
21.4 |
0.0 |
|
Sale/Issuance of Common/Preferred |
- |
- |
- |
- |
86.4 |
|
Issuance (Retirement) of Stock, Net |
4.4 |
198.2 |
102.8 |
21.4 |
86.4 |
|
Long Term Debt Issued |
4.7 |
6.4 |
12.0 |
157.1 |
0.0 |
|
Long Term Debt
Reduction |
-4.4 |
-2.8 |
-7.2 |
-134.8 |
-7.9 |
|
Long Term Debt, Net |
0.3 |
3.6 |
4.8 |
22.3 |
-7.9 |
|
Issuance (Retirement) of Debt, Net |
0.3 |
3.6 |
4.8 |
22.3 |
-7.9 |
|
Cash from Financing Activities |
4.7 |
202.0 |
107.6 |
43.7 |
149.5 |
|
|
|
|
|
|
|
|
Net Change in Cash |
-35.2 |
-118.7 |
85.4 |
24.1 |
63.6 |
|
|
|
|
|
|
|
|
Net Cash - Beginning Balance |
105.3 |
224.0 |
138.6 |
114.5 |
50.9 |
|
Net Cash - Ending Balance |
70.1 |
105.3 |
224.0 |
138.6 |
114.5 |
|
Cash Interest Paid |
4.9 |
4.9 |
4.6 |
6.2 |
8.4 |
|
Cash Taxes Paid |
7.3 |
13.2 |
0.0 |
0.0 |
- |
Interim Cash Flows
Standardized
Financials in: USD (mil)
Except for share items (millions) and per share items (actual units)
|
|
30-Jun-2011 |
31-Mar-2011 |
31-Dec-2010 |
30-Sep-2010 |
30-Jun-2010 |
|
Period Length |
6 Months |
3 Months |
12 Months |
9 Months |
6 Months |
|
UpdateType/Date |
Updated Normal |
Updated Normal |
Updated Normal |
Updated Normal |
Updated Normal |
|
Filed Currency |
USD |
USD |
USD |
USD |
USD |
|
Exchange Rate
(Period Average) |
1 |
1 |
1 |
1 |
1 |
|
|
|
|
|
|
|
|
Other Operating Cash Flow |
-66.0 |
-39.8 |
-63.6 |
-38.1 |
-16.7 |
|
Changes in Working Capital |
-66.0 |
-39.8 |
-63.6 |
-38.1 |
-16.7 |
|
Cash from Operating Activities |
-66.0 |
-39.8 |
-63.6 |
-38.1 |
-16.7 |
|
|
|
|
|
|
|
|
Purchase of Fixed Assets |
-6.0 |
-2.6 |
-13.2 |
-12.7 |
-11.9 |
|
Capital Expenditures |
-6.0 |
-2.6 |
-13.2 |
-12.7 |
-11.9 |
|
Sale of Fixed Assets |
0.0 |
0.0 |
10.3 |
10.1 |
10.1 |
|
Sale/Maturity of Investment |
298.2 |
170.3 |
577.5 |
483.5 |
302.3 |
|
Purchase of Investments |
-209.1 |
-110.5 |
-530.4 |
-430.3 |
-326.8 |
|
Intangible, Net |
-1.8 |
-0.5 |
-4.3 |
-3.4 |
-2.5 |
|
Other Investing Cash Flow |
0.0 |
0.0 |
-16.2 |
-16.2 |
-16.2 |
|
Other Investing Cash Flow Items, Total |
87.3 |
59.3 |
36.9 |
43.7 |
-33.1 |
|
Cash from Investing Activities |
81.4 |
56.7 |
23.7 |
30.9 |
-45.0 |
|
|
|
|
|
|
|
|
Other Financing Cash Flow |
- |
- |
0.0 |
0.0 |
0.0 |
|
Financing Cash Flow Items |
- |
- |
0.0 |
0.0 |
0.0 |
|
Sale/Issuance of
Common |
- |
- |
0.0 |
0.0 |
0.0 |
|
Common Stock, Net |
- |
0.7 |
4.4 |
0.0 |
0.0 |
|
Sale/Issuance of Common/Preferred |
0.9 |
- |
- |
2.0 |
1.3 |
|
Issuance (Retirement) of Stock, Net |
0.9 |
0.7 |
4.4 |
2.0 |
1.3 |
|
Long Term Debt Issued |
1.6 |
- |
4.7 |
3.1 |
3.1 |
|
Long Term Debt
Reduction |
-2.9 |
-1.4 |
-4.4 |
-3.1 |
-1.9 |
|
Long Term Debt, Net |
-1.2 |
-1.4 |
0.3 |
0.0 |
1.1 |
|
Issuance (Retirement) of Debt, Net |
-1.2 |
-1.4 |
0.3 |
0.0 |
1.1 |
|
Cash from Financing Activities |
-0.4 |
-0.7 |
4.7 |
2.0 |
2.4 |
|
|
|
|
|
|
|
|
Net Change in Cash |
15.0 |
16.1 |
-35.2 |
-5.1 |
-59.2 |
|
|
|
|
|
|
|
|
Net Cash - Beginning Balance |
70.1 |
70.1 |
105.3 |
105.3 |
105.3 |
|
Net Cash - Ending Balance |
85.0 |
86.2 |
70.1 |
100.1 |
46.0 |
|
Cash Interest Paid |
2.4 |
2.3 |
4.9 |
4.7 |
2.4 |
|
Cash Taxes Paid |
0.0 |
0.0 |
7.3 |
7.7 |
7.7 |
Annual Income Statement
As Reported
Financials in: USD (mil)
Except for share items (millions) and per share items (actual units)
|
|
31-Dec-2010 |
31-Dec-2009 |
31-Dec-2008 |
31-Dec-2007 |
31-Dec-2006 |
|
Period Length |
12 Months |
12 Months |
12 Months |
12 Months |
12 Months |
|
UpdateType/Date |
Updated Normal |
Updated Normal |
Restated Normal |
Restated Normal |
Restated Normal |
|
Filed Currency |
USD |
USD |
USD |
USD |
USD |
|
Exchange Rate
(Period Average) |
1 |
1 |
1 |
1 |
1 |
|
Auditor |
Ernst &
Young LLP |
Ernst &
Young LLP |
Ernst &
Young LLP |
Ernst &
Young LLP |
Ernst &
Young LLP |
|
Auditor Opinion |
Unqualified with
Explanation |
Unqualified with
Explanation |
Unqualified |
Unqualified |
Unqualified |
|
|
|
|
|
|
|
|
R&D Agreements |
102.9 |
108.1 |
98.9 |
22.3 |
5.4 |
|
Licensing Revenue |
5.6 |
13.5 |
8.3 |
36.0 |
9.4 |
|
Total Revenue |
108.5 |
121.6 |
107.2 |
58.3 |
14.9 |
|
|
|
|
|
|
|
|
Research & Development Expenses |
145.2 |
134.6 |
106.4 |
78.2 |
69.4 |
|
Selling, General and Administrative Exp. |
11.7 |
14.5 |
13.8 |
13.1 |
11.2 |
|
Restructuring activities |
- |
- |
- |
- |
-0.5 |
|
Loss on early retirement of debt |
- |
0.0 |
0.0 |
3.2 |
0.0 |
|
Total Operating Expense |
156.8 |
149.1 |
120.3 |
94.5 |
80.1 |
|
|
|
|
|
|
|
|
Equity in net loss of Regulus Therapeuti |
-2.2 |
0.0 |
0.0 |
- |
- |
|
Investment Income |
3.4 |
6.4 |
11.3 |
11.4 |
6.0 |
|
Interest expense |
-13.2 |
-12.7 |
-11.8 |
-12.9 |
-9.0 |
|
Gain (loss) on investments, net |
-0.7 |
2.1 |
-1.0 |
3.5 |
2.3 |
|
Net Income Before Taxes |
-61.2 |
-31.8 |
-14.5 |
-34.1 |
-66.0 |
|
|
|
|
|
|
|
|
Provision for Income Taxes |
0.1 |
3.2 |
0.0 |
0.0 |
0.0 |
|
Net Income After Taxes |
-61.3 |
-35.0 |
-14.5 |
-34.1 |
-66.0 |
|
|
|
|
|
|
|
|
Net loss attributable to noncontrolling |
0.0 |
4.4 |
4.7 |
0.6 |
0.0 |
|
Excess purchase price over carrying valu |
- |
0.0 |
0.0 |
-125.3 |
0.0 |
|
Net loss attributable to noncontrolling |
- |
0.0 |
0.0 |
23.2 |
23.0 |
|
Net Income Before Extra. Items |
-61.3 |
-30.6 |
-9.8 |
-135.6 |
-43.0 |
|
Gain on sale of Ibis Biosciences, Inc., |
0.0 |
185.7 |
0.0 |
0.0 |
- |
|
Loss from discontinued operations |
0.0 |
0.0 |
-8.4 |
-6.0 |
-2.9 |
|
Net Income |
-61.3 |
155.1 |
-18.2 |
-141.6 |
-45.9 |
|
|
|
|
|
|
|
|
Income Available to Com Excl ExtraOrd |
-61.3 |
-30.6 |
-9.8 |
-135.6 |
-43.0 |
|
|
|
|
|
|
|
|
Income Available to Com Incl ExtraOrd |
-61.3 |
155.1 |
-18.2 |
-141.6 |
-45.9 |
|
|
|
|
|
|
|
|
Basic Weighted Average Shares |
99.1 |
98.1 |
94.6 |
83.7 |
74.3 |
|
Basic EPS Excluding ExtraOrdinary Items |
-0.62 |
-0.31 |
-0.10 |
-1.62 |
-0.58 |
|
Basic EPS Including ExtraOrdinary Item |
-0.62 |
1.58 |
-0.19 |
-1.69 |
-0.62 |
|
Dilution Adjustment |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
|
Diluted Net Income |
-61.3 |
155.1 |
-18.2 |
-141.6 |
-45.9 |
|
Diluted Weighted Average Shares |
99.1 |
98.1 |
94.6 |
83.7 |
74.3 |
|
Diluted EPS Excluding ExtraOrd Items |
-0.62 |
-0.31 |
-0.10 |
-1.62 |
-0.58 |
|
Diluted EPS Including ExtraOrd Items |
-0.62 |
1.58 |
-0.19 |
-1.69 |
-0.62 |
|
DPS-Common Stock |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
|
Gross Dividends - Common Stock |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
|
Normalized Income Before Taxes |
-61.2 |
-31.8 |
-14.5 |
-30.8 |
-66.6 |
|
|
|
|
|
|
|
|
Inc Tax Ex Impact of Sp Items |
0.1 |
3.2 |
0.0 |
0.0 |
0.0 |
|
Normalized Income After Taxes |
-61.3 |
-35.0 |
-14.5 |
-30.8 |
-66.6 |
|
|
|
|
|
|
|
|
Normalized Inc. Avail to Com. |
-61.3 |
-30.6 |
-9.8 |
-132.4 |
-43.5 |
|
|
|
|
|
|
|
|
Basic Normalized EPS |
-0.62 |
-0.31 |
-0.10 |
-1.58 |
-0.59 |
|
Diluted Normalized EPS |
-0.62 |
-0.31 |
-0.10 |
-1.58 |
-0.59 |
|
Amort of Intangibles |
4.3 |
5.4 |
3.9 |
4.0 |
4.0 |
|
Depreciation |
4.8 |
3.9 |
2.9 |
2.7 |
3.9 |
|
Research & Development Exp |
145.2 |
134.6 |
106.4 |
78.2 |
69.4 |
|
Interest Expense |
13.2 |
12.7 |
11.8 |
12.9 |
9.0 |
|
Rental Expense |
4.3 |
4.6 |
3.8 |
3.4 |
3.2 |
|
Federal |
-0.1 |
2.9 |
- |
- |
- |
|
State |
0.2 |
4.9 |
- |
- |
- |
|
Current Tax - Total |
0.1 |
7.8 |
- |
- |
- |
|
Federal |
0.0 |
-1.0 |
- |
- |
- |
|
State |
0.0 |
-3.6 |
- |
- |
- |
|
Deferred Tax - Total |
0.0 |
-4.6 |
- |
- |
- |
|
Income Tax - Total |
0.1 |
3.2 |
- |
- |
- |
|
Loss from operations |
-48.4 |
-27.5 |
-13.1 |
-32.9 |
-65.2 |
|
401(k) Salary Deferral Plan |
0.4 |
0.5 |
0.5 |
0.4 |
0.4 |
|
Total Pension Expense |
0.4 |
0.5 |
0.5 |
0.4 |
0.4 |
Interim Income Statement
As Reported
Financials in: USD (mil)
Except for share items (millions) and per share items (actual units)
|
|
30-Jun-2011 |
31-Mar-2011 |
31-Dec-2010 |
30-Sep-2010 |
30-Jun-2010 |
|
Period Length |
3 Months |
3 Months |
3 Months |
3 Months |
3 Months |
|
UpdateType/Date |
Updated Normal |
Updated Normal |
Updated Normal |
Updated Normal |
Updated Normal |
|
Filed Currency |
USD |
USD |
USD |
USD |
USD |
|
Exchange Rate
(Period Average) |
1 |
1 |
1 |
1 |
1 |
|
|
|
|
|
|
|
|
R&D Revenue |
24.3 |
20.0 |
25.4 |
27.8 |
21.1 |
|
Licensing & Royalty |
0.5 |
1.1 |
1.0 |
0.8 |
2.4 |
|
Total Revenue |
24.8 |
21.1 |
26.4 |
28.6 |
23.5 |
|
|
|
|
|
|
|
|
Research and development |
36.0 |
34.2 |
39.3 |
34.7 |
39.1 |
|
General & Administrative |
2.9 |
3.0 |
2.9 |
2.9 |
3.1 |
|
Total Operating Expense |
38.9 |
37.3 |
42.3 |
37.6 |
42.2 |
|
|
|
|
|
|
|
|
Equity in net loss of Regulus Therapeuti |
-1.0 |
-0.9 |
4.1 |
-0.9 |
-3.9 |
|
Investment Income |
0.6 |
0.7 |
0.8 |
0.8 |
0.9 |
|
Interest expense |
-3.4 |
-3.4 |
-3.4 |
-3.3 |
-3.3 |
|
Gain (loss) on investments, net |
0.0 |
-0.3 |
0.4 |
0.0 |
-0.1 |
|
Net Income Before Taxes |
-17.9 |
-20.0 |
-13.9 |
-12.5 |
-25.2 |
|
|
|
|
|
|
|
|
Provision for Income Taxes |
0.0 |
0.0 |
0.1 |
0.0 |
0.0 |
|
Net Income After Taxes |
-17.9 |
-20.0 |
-14.0 |
-12.5 |
-25.2 |
|
|
|
|
|
|
|
|
Net loss attributable to noncontrolling |
- |
- |
0.0 |
0.0 |
0.0 |
|
Net Income Before Extra. Items |
-17.9 |
-20.0 |
-14.0 |
-12.5 |
-25.2 |
|
Loss from discontinued operations |
- |
- |
0.0 |
0.0 |
0.0 |
|
Gain on sale of Ibis Biosciences, Inc., |
- |
- |
0.0 |
0.0 |
0.0 |
|
Net Income |
-17.9 |
-20.0 |
-14.0 |
-12.5 |
-25.2 |
|
|
|
|
|
|
|
|
Income Available to Com Excl ExtraOrd |
-17.9 |
-20.0 |
-14.0 |
-12.5 |
-25.2 |
|
|
|
|
|
|
|
|
Income Available to Com Incl ExtraOrd |
-17.9 |
-20.0 |
-14.0 |
-12.5 |
-25.2 |
|
|
|
|
|
|
|
|
Basic Weighted Average Shares |
99.6 |
99.6 |
99.3 |
99.2 |
99.1 |
|
Basic EPS Excluding ExtraOrdinary Items |
-0.18 |
-0.20 |
-0.14 |
-0.13 |
-0.25 |
|
Basic EPS Including ExtraOrdinary Item |
-0.18 |
-0.20 |
-0.14 |
-0.13 |
-0.25 |
|
Dilution Adjustment |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
|
Diluted Net Income |
-17.9 |
-20.0 |
-14.0 |
-12.5 |
-25.2 |
|
Diluted Weighted Average Shares |
99.6 |
99.6 |
99.3 |
99.2 |
99.1 |
|
Diluted EPS Excluding ExtraOrd Items |
-0.18 |
-0.20 |
-0.14 |
-0.13 |
-0.25 |
|
Diluted EPS Including ExtraOrd Items |
-0.18 |
-0.20 |
-0.14 |
-0.13 |
-0.25 |
|
DPS-Common Stock |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
|
Gross Dividends - Common Stock |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
|
Normalized Income Before Taxes |
-17.9 |
-20.0 |
-13.9 |
-12.5 |
-25.2 |
|
|
|
|
|
|
|
|
Inc Tax Ex Impact of Sp Items |
0.0 |
0.0 |
0.1 |
0.0 |
0.0 |
|
Normalized Income After Taxes |
-17.9 |
-20.0 |
-14.0 |
-12.5 |
-25.2 |
|
|
|
|
|
|
|
|
Normalized Inc. Avail to Com. |
-17.9 |
-20.0 |
-14.0 |
-12.5 |
-25.2 |
|
|
|
|
|
|
|
|
Basic Normalized EPS |
-0.18 |
-0.20 |
-0.14 |
-0.13 |
-0.25 |
|
Diluted Normalized EPS |
-0.18 |
-0.20 |
-0.14 |
-0.13 |
-0.25 |
|
Research & Development Exp |
36.0 |
34.2 |
39.3 |
34.7 |
39.1 |
|
Interest Expense |
3.4 |
3.4 |
3.4 |
3.3 |
3.3 |
|
Depreciation |
1.5 |
1.8 |
- |
- |
1.5 |
|
Loss from operations |
14.1 |
16.1 |
- |
8.9 |
18.7 |
Annual Balance Sheet
As Reported
Financials in: USD (mil)
Except for share items (millions) and per share items (actual units)
|
|
31-Dec-2010 |
31-Dec-2009 |
31-Dec-2008 |
31-Dec-2007 |
31-Dec-2006 |
|
UpdateType/Date |
Updated Normal |
Updated Normal |
Restated Normal |
Reclassified
Normal |
Updated Normal |
|
Filed Currency |
USD |
USD |
USD |
USD |
USD |
|
Exchange Rate |
1 |
1 |
1 |
1 |
1 |
|
Auditor |
Ernst &
Young LLP |
Ernst &
Young LLP |
Ernst &
Young LLP |
Ernst &
Young LLP |
Ernst &
Young LLP |
|
Auditor Opinion |
Unqualified with
Explanation |
Unqualified with
Explanation |
Unqualified |
Unqualified |
Unqualified |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
70.1 |
105.3 |
217.9 |
138.6 |
114.5 |
|
Short term investments |
402.3 |
469.1 |
273.1 |
55.1 |
78.8 |
|
Contracts receivable |
1.2 |
10.9 |
4.1 |
4.9 |
2.4 |
|
Raw Materials |
- |
- |
- |
- |
0.9 |
|
Work in Process |
- |
- |
- |
- |
0.0 |
|
Inventories |
2.5 |
2.8 |
2.7 |
1.8 |
- |
|
Assets held for sale |
- |
0.0 |
15.5 |
6.4 |
- |
|
Other current assets |
7.1 |
8.1 |
5.1 |
3.2 |
9.6 |
|
Total Current Assets |
483.1 |
596.1 |
518.4 |
209.9 |
206.2 |
|
|
|
|
|
|
|
|
Land |
10.1 |
0.0 |
- |
- |
- |
|
Equipment |
38.7 |
37.1 |
30.3 |
22.8 |
22.8 |
|
Leasehold Imprv. |
25.1 |
24.8 |
17.7 |
12.1 |
11.8 |
|
Furn./Fixtures |
2.6 |
1.8 |
1.8 |
1.5 |
1.5 |
|
Depreciation |
-40.8 |
-36.4 |
-32.4 |
-30.4 |
-28.9 |
|
Licenses, net |
- |
- |
- |
- |
21.4 |
|
Licenses, Gross |
36.2 |
36.1 |
36.0 |
35.9 |
- |
|
Accumulated Amortization |
-23.9 |
-21.6 |
-19.1 |
-16.8 |
- |
|
Patents Gross |
33.3 |
31.4 |
28.1 |
26.6 |
- |
|
Accumulated Amortization |
-17.5 |
-15.5 |
-11.8 |
-10.2 |
- |
|
Patents net |
- |
- |
- |
- |
16.8 |
|
Deposits and other assets |
3.5 |
3.3 |
3.9 |
7.5 |
4.3 |
|
Total Assets |
550.5 |
657.2 |
572.8 |
258.9 |
255.9 |
|
|
|
|
|
|
|
|
Accounts Payable |
6.5 |
4.7 |
5.7 |
2.6 |
4.3 |
|
Accrued compensation |
6.8 |
7.1 |
6.8 |
8.8 |
6.2 |
|
Income taxes payable |
0.0 |
7.3 |
0.0 |
- |
- |
|
Accrued liabilities |
12.4 |
12.3 |
9.6 |
5.2 |
6.1 |
|
Current portion of long term obligations |
5.6 |
4.3 |
2.1 |
7.2 |
7.5 |
|
Current portion of deferred contract rev |
74.5 |
75.7 |
92.7 |
31.5 |
1.0 |
|
Liabilities held for sale |
- |
0.0 |
7.9 |
6.9 |
- |
|
Total Current Liabilities |
105.9 |
111.4 |
124.7 |
62.2 |
25.1 |
|
|
|
|
|
|
|
|
25/8 percent convertible subordinated no |
132.9 |
125.1 |
118.0 |
162.5 |
0.0 |
|
5.5% Conv. Sub |
- |
- |
- |
- |
125.0 |
|
Long term obligations |
5.7 |
11.5 |
9.9 |
0.4 |
7.8 |
|
Long-term financing obligation |
10.1 |
0.0 |
- |
- |
- |
|
Capital Leases |
0.0 |
- |
- |
- |
- |
|
Total Long Term Debt |
148.8 |
136.6 |
127.9 |
162.9 |
132.8 |
|
|
|
|
|
|
|
|
Long term deferred contract revenue |
50.4 |
107.1 |
172.8 |
23.5 |
0.0 |
|
Noncontrolling interest in Ibis Bioscien |
- |
0.0 |
32.4 |
0.0 |
- |
|
Investment in Regulus Therapeutics Inc. |
0.9 |
0.0 |
- |
- |
- |
|
Noncontrolling interest in Regulus Thera |
0.0 |
10.3 |
4.7 |
9.4 |
0.0 |
|
Noncontrolling Int. in Symphony GenIsis |
- |
- |
- |
- |
29.3 |
|
Total Liabilities |
305.9 |
365.5 |
462.6 |
258.0 |
187.3 |
|
|
|
|
|
|
|
|
Common Stock |
0.1 |
0.1 |
0.1 |
0.1 |
0.1 |
|
Additional paid-in capital |
1,000.2 |
985.6 |
960.4 |
828.0 |
881.0 |
|
Accumulated other comprehensive income |
0.9 |
2.2 |
1.0 |
0.5 |
4.3 |
|
Accumulated deficit |
-756.7 |
-696.2 |
-851.2 |
-827.7 |
-816.8 |
|
Total Equity |
244.5 |
291.7 |
110.2 |
0.9 |
68.6 |
|
|
|
|
|
|
|
|
Total Liabilities & Shareholders' Equity |
550.5 |
657.2 |
572.8 |
258.9 |
255.9 |
|
|
|
|
|
|
|
|
S/O-Common Stock |
99.4 |
98.9 |
97.2 |
87.2 |
82.3 |
|
Total Common Shares Outstanding |
99.4 |
98.9 |
97.2 |
87.2 |
82.3 |
|
T/S-Common Stock |
0.0 |
0.0 |
0.0 |
0.0 |
- |
|
Deferred Revenue - Long Term |
50.4 |
107.1 |
172.8 |
- |
- |
|
Deferred Revenue - Current |
74.5 |
75.7 |
92.7 |
31.5 |
1.0 |
|
Accumulated Amortization |
41.4 |
37.1 |
30.9 |
27.0 |
23.1 |
|
Full-Time Employees |
370 |
335 |
300 |
300 |
274 |
|
Number of Common Shareholders |
836 |
922 |
857 |
890 |
960 |
|
Long Term Debt Maturing Within 1 Year |
10.4 |
9.1 |
- |
7.2 |
7.5 |
|
Long Term Debt Maturing Within 2 Years |
7.4 |
14.3 |
- |
0.0 |
7.5 |
|
Long Term Debt Maturing Within 3 Years |
5.7 |
5.8 |
- |
0.0 |
125.0 |
|
Long Term Debt Maturing Within 4 Years |
164.9 |
4.3 |
- |
0.0 |
0.0 |
|
Long Term Debt Maturing Within 4 Years |
0.2 |
166.8 |
- |
0.0 |
0.0 |
|
Long Term Debt Maturing Remaining Years |
1.2 |
54.5 |
- |
162.9 |
0.4 |
|
Total Long Term Debt, Supplemental |
189.8 |
254.8 |
- |
170.1 |
140.4 |
|
Capital Lease Maturing Within 1 Year |
6.0 |
4.8 |
- |
- |
0.9 |
|
Capital Lease Maturing Within 2 Years |
- |
- |
- |
- |
0.2 |
|
Capital Lease Maturing Within 3 Years |
4.5 |
6.0 |
- |
- |
0.0 |
|
Capital Lease Maturing Within 4 Years |
- |
- |
- |
- |
0.0 |
|
Capital Lease Maturing Within 5 Years |
0.4 |
0.0 |
- |
- |
0.0 |
|
Thereafter |
0.0 |
0.0 |
- |
- |
0.0 |
|
Representing Interest |
- |
- |
- |
- |
-0.1 |
|
Total Capital Leases |
10.9 |
10.8 |
- |
- |
1.0 |
|
Operating Lease Maturing Within 1 Year |
3.5 |
3.3 |
- |
2.9 |
2.9 |
|
Operating Lease Maturing Within 2 Years |
1.4 |
3.3 |
- |
2.9 |
2.8 |
|
Operating Lease Maturing Within 3 Years |
1.4 |
1.2 |
- |
2.4 |
2.7 |
|
Operating Lease Maturing Within 4 Years |
1.4 |
1.2 |
- |
1.9 |
2.3 |
|
Operating Lease Maturing Within 5 Years |
1.3 |
1.2 |
- |
1.5 |
1.9 |
|
Thereafter |
23.3 |
6.7 |
- |
8.9 |
10.1 |
|
Total Operating Leases |
32.4 |
16.9 |
- |
20.4 |
22.7 |
Interim Balance Sheet
As Reported
|
Financials in:
USD (mil) Except for share
items (millions) and per share items (actual units) |
|
|
30-Jun-2011 |
31-Mar-2011 |
31-Dec-2010 |
30-Sep-2010 |
30-Jun-2010 |
|
UpdateType/Date |
Updated Normal |
Updated Normal |
Updated Normal |
Updated Normal |
Updated Normal |
|
Filed Currency |
USD |
USD |
USD |
USD |
USD |
|
Exchange Rate |
1 |
1 |
1 |
1 |
1 |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
85.0 |
86.2 |
70.1 |
100.1 |
46.0 |
|
ST Investments |
310.2 |
340.6 |
402.3 |
397.8 |
476.0 |
|
Contracts receivable |
5.7 |
0.6 |
1.2 |
1.3 |
5.0 |
|
Inventory |
2.2 |
2.6 |
2.5 |
2.0 |
2.8 |
|
Assets held for sale |
- |
- |
- |
- |
0.0 |
|
Equity securities current portion |
- |
- |
- |
- |
2.2 |
|
Other current assets |
7.6 |
7.4 |
7.1 |
6.3 |
4.8 |
|
Total Current Assets |
410.7 |
437.4 |
483.1 |
507.6 |
536.9 |
|
|
|
|
|
|
|
|
Property, Plant & Equipment, Net |
88.0 |
37.7 |
35.7 |
35.5 |
36.1 |
|
License, Net |
11.1 |
11.7 |
12.3 |
12.9 |
13.5 |
|
Patent Costs |
16.4 |
15.8 |
15.8 |
16.2 |
16.2 |
|
Deposits and other assets |
3.3 |
3.4 |
3.5 |
3.7 |
3.2 |
|
LT Investments |
- |
- |
- |
- |
0.6 |
|
Total Assets |
529.6 |
505.9 |
550.5 |
575.9 |
606.4 |
|
|
|
|
|
|
|
|
Accounts Payable |
3.1 |
4.7 |
6.5 |
3.4 |
5.4 |
|
Accrued Payroll |
4.4 |
3.1 |
6.8 |
4.8 |
4.3 |
|
Income taxes payable |
- |
- |
0.0 |
0.0 |
0.0 |
|
Accd.Liabilities |
10.9 |
8.1 |
12.4 |
10.3 |
13.3 |
|
Cur.Port.LTD/Lease |
4.9 |
5.1 |
5.6 |
5.1 |
5.0 |
|
Current portion of deferred contract rev |
68.7 |
73.4 |
74.5 |
77.3 |
77.3 |
|
Liabilities from discontinued operations |
- |
- |
- |
- |
0.0 |
|
Total Current Liabilities |
92.0 |
94.4 |
105.9 |
100.9 |
105.2 |
|
|
|
|
|
|
|
|
convertible subordinated notes |
137.1 |
135.0 |
132.9 |
130.9 |
128.9 |
|
Long-term financing obligation |
58.7 |
10.1 |
10.1 |
10.1 |
10.1 |
|
Long-term obligations, less current port |
5.5 |
4.9 |
5.7 |
4.3 |
5.6 |
|
Total Long Term Debt |
201.3 |
150.0 |
148.8 |
145.3 |
144.7 |
|
|
|
|
|
|
|
|
Long term deferred contract revenue |
21.4 |
32.1 |
50.4 |
70.9 |
90.2 |
|
Investment in Regulus Therapeutics Inc. |
2.8 |
1.7 |
0.9 |
5.0 |
4.1 |
|
Noncontrolling interest in Regulus Thera |
- |
- |
0.0 |
0.0 |
0.0 |
|
Noncontrolling interest in Ibis Bioscien |
- |
- |
- |
- |
0.0 |
|
Total Liabilities |
317.4 |
278.2 |
305.9 |
322.1 |
344.1 |
|
|
|
|
|
|
|
|
Common stock, $0.001 par value; 200,000, |
0.1 |
0.1 |
0.1 |
0.1 |
0.1 |
|
Paid In Capital |
1,006.3 |
1,003.6 |
1,000.2 |
995.1 |
991.4 |
|
Accumulated other comprehensive income |
0.4 |
0.7 |
0.9 |
1.2 |
0.9 |
|
Accumulated Deficit |
-794.6 |
-776.7 |
-756.7 |
-742.7 |
-730.2 |
|
Total Equity |
212.2 |
227.7 |
244.5 |
253.7 |
262.2 |
|
|
|
|
|
|
|
|
Total Liabilities & Shareholders' Equity |
529.6 |
505.9 |
550.5 |
575.9 |
606.4 |
|
|
|
|
|
|
|
|
S/O-Common Stock |
99.6 |
99.6 |
99.4 |
99.2 |
99.1 |
|
Total Common Shares Outstanding |
99.6 |
99.6 |
99.4 |
99.2 |
99.1 |
|
T/S-Common Stock |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
|
Long term deferred contract revenue |
21.4 |
32.1 |
50.4 |
70.9 |
90.2 |
|
Deferred Revenue |
68.7 |
73.4 |
74.5 |
77.3 |
77.3 |
|
Long Term Debt Maturing Within 1 Year |
4.3 |
4.3 |
10.4 |
4.3 |
5.0 |
|
Long Term Debt Maturing Within 3 Years |
171.0 |
8.5 |
13.1 |
8.5 |
- |
|
Long Term Debt Maturing Within 5 Years |
0.0 |
162.5 |
165.1 |
164.6 |
- |
|
Long Term Debt Due After 5 Years |
0.0 |
0.0 |
1.2 |
0.0 |
- |
|
Total Long Term Debt, Supplemental |
175.3 |
175.3 |
189.8 |
177.4 |
5.0 |
|
Capital Lease Due Within 1 Year |
0.1 |
0.2 |
- |
- |
- |
|
Capital Lease Due Within 1 - 3 Years |
0.4 |
0.4 |
- |
- |
- |
|
Capital Lease Due Within 3 - 5 Years |
0.3 |
0.3 |
- |
- |
- |
|
Capital Lease Due After 5 Years |
0.0 |
0.0 |
- |
- |
- |
|
Total Capital Leases |
0.8 |
0.9 |
9.4 |
- |
- |
|
Operating Lease Due Within 1 Year |
2.5 |
3.0 |
3.5 |
3.3 |
- |
|
Operating Lease Due Within 2 Years |
- |
- |
1.4 |
- |
- |
|
Operating Lease Due Within 1 - 3 Years |
2.8 |
2.8 |
2.8 |
3.0 |
- |
|
Operating Lease Due Within 4 Years |
- |
- |
1.4 |
- |
- |
|
Operating Lease Due Within 5 Years |
2.7 |
2.7 |
2.7 |
2.3 |
- |
|
Operating Lease Due After 5 Years |
22.7 |
23.0 |
23.4 |
22.2 |
- |
|
Total Operating Leases |
30.7 |
31.5 |
35.2 |
30.8 |
- |
Annual Cash Flows
As Reported
Financials in: USD (mil)
Except for share items (millions) and per share items (actual units)
|
|
31-Dec-2010 |
31-Dec-2009 |
31-Dec-2008 |
31-Dec-2007 |
31-Dec-2006 |
|
Period Length |
12 Months |
12 Months |
12 Months |
12 Months |
12 Months |
|
UpdateType/Date |
Updated Normal |
Updated Normal |
Reclassified
Normal |
Reclassified
Normal |
Updated Normal |
|
Filed Currency |
USD |
USD |
USD |
USD |
USD |
|
Exchange Rate
(Period Average) |
1 |
1 |
1 |
1 |
1 |
|
Auditor |
Ernst &
Young LLP |
Ernst &
Young LLP |
Ernst &
Young LLP |
Ernst &
Young LLP |
Ernst &
Young LLP |
|
Auditor Opinion |
Unqualified with
Explanation |
Unqualified with
Explanation |
Unqualified |
Unqualified |
Unqualified |
|
|
|
|
|
|
|
|
Net Income |
-61.3 |
150.7 |
-22.9 |
-40.1 |
-45.9 |
|
Depreciation |
4.8 |
3.9 |
2.9 |
2.7 |
3.9 |
|
Amort. Patents |
2.0 |
3.0 |
1.6 |
1.6 |
1.6 |
|
Amort. Licenses |
2.4 |
2.3 |
2.3 |
2.3 |
2.3 |
|
Compensation |
- |
- |
- |
- |
0.0 |
|
Amortisation of Premium on Investment |
5.1 |
2.0 |
-0.2 |
-0.8 |
-0.6 |
|
Amortization of debt issuance costs |
0.5 |
0.5 |
0.5 |
0.6 |
- |
|
Amortization of 25/8 percent convertible |
7.8 |
7.1 |
6.5 |
5.6 |
- |
|
Share based compensation expense |
12.2 |
13.4 |
15.1 |
9.9 |
5.7 |
|
Equity in net loss of Regulus Therapeuti |
2.2 |
0.0 |
0.0 |
- |
- |
|
Loss attributed to noncontrolling intere |
0.0 |
0.0 |
-2.1 |
0.0 |
0.0 |
|
Gain from sale of Ibis Biosciences, Inc. |
0.0 |
-185.7 |
0.0 |
0.0 |
- |
|
Gain from derivative instruments issued |
0.0 |
0.0 |
-5.3 |
0.0 |
0.0 |
|
Gain from the sale of property, plant an |
-0.1 |
0.0 |
0.0 |
- |
- |
|
(Gain)/Loss on investments |
0.7 |
-2.1 |
1.0 |
-3.5 |
-2.3 |
|
Write-off Patents |
1.5 |
0.7 |
1.9 |
0.9 |
2.4 |
|
Excess tax benefits on share-based compe |
0.0 |
-0.3 |
0.0 |
0.0 |
- |
|
Loss attributed to noncontrolling |
- |
- |
- |
- |
0.0 |
|
Loss attributed to noncontrolling |
- |
- |
- |
- |
-23.0 |
|
Deferred Interest |
- |
- |
- |
- |
0.0 |
|
Loss on early retirement of debt |
- |
0.0 |
0.0 |
3.2 |
0.0 |
|
Noncash restructuring activities |
- |
- |
- |
- |
0.0 |
|
Variable Accounting of Warants |
- |
- |
- |
- |
0.0 |
|
Sale of Property, Plant and Equipment |
- |
- |
- |
- |
0.0 |
|
Contract Rcvbl. |
10.5 |
-6.8 |
1.2 |
-3.8 |
1.5 |
|
Inventory |
0.3 |
0.0 |
-1.3 |
-2.0 |
0.1 |
|
Other current and long-term assets |
-0.9 |
- |
- |
- |
- |
|
Accounts Payable |
1.3 |
-3.7 |
1.0 |
-0.8 |
1.2 |
|
Prepaids/Other |
- |
-1.0 |
-2.7 |
-0.5 |
-0.2 |
|
Accrued Payroll |
0.4 |
-4.4 |
-3.3 |
4.2 |
2.5 |
|
Income taxes payable |
-7.2 |
-10.0 |
0.0 |
0.0 |
- |
|
Accrued Liabilities |
1.0 |
4.3 |
4.9 |
0.7 |
-2.1 |
|
Deferred Revenues |
-46.8 |
-82.7 |
211.0 |
55.7 |
-0.4 |
|
Cash from Operating Activities |
-63.6 |
-108.4 |
212.0 |
36.1 |
-53.2 |
|
|
|
|
|
|
|
|
Purchase of ST Investment |
-530.1 |
-776.4 |
-483.1 |
-95.4 |
-107.0 |
|
Sale of Investment |
577.5 |
578.9 |
266.0 |
120.0 |
72.6 |
|
Capital Expenditures |
-13.2 |
-13.4 |
-13.7 |
-2.3 |
-1.0 |
|
Strategic investments in corporate sec. |
- |
- |
- |
- |
0.0 |
|
Sale of Property, Plant and Equipment |
0.2 |
0.0 |
0.0 |
- |
0.0 |
|
Proceeds from land sold to BioMed |
10.1 |
0.0 |
0.0 |
- |
- |
|
Reduction of cash due to deconsolidation |
-16.2 |
0.0 |
0.0 |
- |
- |
|
Acquisition of licenses and other assets |
-4.3 |
-2.9 |
-3.4 |
-2.7 |
-1.5 |
|
Purchases of strategic investments |
-0.3 |
-1.3 |
0.0 |
0.0 |
- |
|
Proceeds from the sale of strategic inve |
0.0 |
2.8 |
0.0 |
5.2 |
4.4 |
|
Acquisition of Symphony GenIsis, Inc. |
- |
0.0 |
0.0 |
-80.4 |
0.0 |
|
Cash from Investing Activities |
23.7 |
-212.3 |
-234.2 |
-55.6 |
-32.6 |
|
|
|
|
|
|
|
|
Net proceeds from issuance of equity |
4.4 |
13.2 |
12.7 |
11.4 |
- |
|
Proc.Iss.Pfr./Common |
- |
- |
- |
- |
86.4 |
|
Excess tax benefits on share-based compe |
0.0 |
0.3 |
0.0 |
0.0 |
- |
|
Proceeds from issuance of convertible pr |
0.0 |
0.0 |
5.0 |
0.0 |
0.0 |
|
Proceeds from equipment financing arrang |
4.7 |
6.4 |
7.0 |
0.0 |
0.0 |
|
Pymt. Capital Lease |
-4.4 |
-2.8 |
-7.2 |
-7.7 |
-7.9 |
|
Proceeds from stock purchase by Genzyme |
0.0 |
0.0 |
50.0 |
0.0 |
0.0 |
|
Proceeds from capital contributions to I |
0.0 |
175.0 |
40.0 |
0.0 |
0.0 |
|
Proceeds from capital contribution |
0.0 |
10.0 |
0.1 |
10.0 |
0.0 |
|
Proceeds from issuance of 25/8 percent c |
- |
0.0 |
0.0 |
157.1 |
0.0 |
|
Borrowing Proceeds |
- |
- |
- |
- |
0.0 |
|
Principal and redemption premium payment |
- |
0.0 |
0.0 |
-127.0 |
0.0 |
|
Proceeds from contribution to noncontrol |
- |
- |
- |
- |
71.0 |
|
Cash from Financing Activities |
4.7 |
202.0 |
107.6 |
43.7 |
149.5 |
|
|
|
|
|
|
|
|
Net Change in Cash |
-35.2 |
-118.7 |
85.4 |
24.1 |
63.6 |
|
|
|
|
|
|
|
|
Net Cash - Beginning Balance |
105.3 |
224.0 |
138.6 |
114.5 |
50.9 |
|
Net Cash - Ending Balance |
70.1 |
105.3 |
224.0 |
138.6 |
114.5 |
|
Cash Interest Paid |
4.9 |
4.9 |
4.6 |
6.2 |
8.4 |
|
Cash Taxes Paid |
7.3 |
13.2 |
0.0 |
0.0 |
- |
Interim Cash Flows
As Reported
Financials in: USD
(mil)
Except for share
items (millions) and per share items (actual units)
|
|
30-Jun-2011 |
31-Mar-2011 |
31-Dec-2010 |
30-Sep-2010 |
30-Jun-2010 |
|
Period Length |
6 Months |
3 Months |
12 Months |
9 Months |
6 Months |
|
UpdateType/Date |
Updated Normal |
Updated Normal |
Updated Normal |
Updated Normal |
Updated Normal |
|
Filed Currency |
USD |
USD |
USD |
USD |
USD |
|
Exchange Rate
(Period Average) |
1 |
1 |
1 |
1 |
1 |
|
|
|
|
|
|
|
|
Net cash used in operating activities |
-66.0 |
-39.8 |
-63.6 |
-38.1 |
-16.7 |
|
Cash from Operating Activities |
-66.0 |
-39.8 |
-63.6 |
-38.1 |
-16.7 |
|
|
|
|
|
|
|
|
Purchase of ST Investment |
-208.7 |
-110.2 |
-530.1 |
-429.6 |
-326.2 |
|
Sale of Investment |
298.2 |
170.3 |
577.5 |
483.5 |
302.3 |
|
Capital Expenditures |
-6.0 |
-2.6 |
-13.2 |
-12.7 |
-11.9 |
|
Proceeds from the sale of property, plan |
- |
- |
0.2 |
- |
- |
|
Proceeds from land sold to BioMed |
0.0 |
0.0 |
10.1 |
10.1 |
10.1 |
|
Reduction of cash due to deconsolidation |
0.0 |
0.0 |
-16.2 |
-16.2 |
-16.2 |
|
Proceeds from the sale of strategic inve |
- |
- |
- |
0.0 |
0.0 |
|
Acquisition of Licenses |
-1.8 |
-0.5 |
-4.3 |
-3.4 |
-2.5 |
|
Purchases of strategic investments |
-0.4 |
-0.4 |
-0.3 |
-0.7 |
-0.7 |
|
Sale of Strategic Investments |
- |
- |
0.0 |
- |
- |
|
Cash from Investing Activities |
81.4 |
56.7 |
23.7 |
30.9 |
-45.0 |
|
|
|
|
|
|
|
|
Net proceeds from issuance of equity |
- |
0.7 |
4.4 |
- |
- |
|
Sale/Issuance of Common/Preferred |
0.9 |
- |
- |
2.0 |
1.3 |
|
Excess tax benefits on share-based compe |
- |
- |
0.0 |
0.0 |
0.0 |
|
Proceeds from issuance of convertible pr |
- |
- |
0.0 |
- |
- |
|
Proceeds from equipment financing arrang |
1.6 |
- |
4.7 |
3.1 |
3.1 |
|
Principal payments on debt and capital l |
-2.9 |
-1.4 |
-4.4 |
-3.1 |
-1.9 |
|
Proceeds from stock purchase by Genzyme |
- |
- |
0.0 |
- |
0.0 |
|
Proceeds from capital contributions to I |
- |
- |
0.0 |
0.0 |
0.0 |
|
Proceeds from Alnylam capital co |
- |
- |
0.0 |
0.0 |
0.0 |
|
Cash from Financing Activities |
-0.4 |
-0.7 |
4.7 |
2.0 |
2.4 |
|
|
|
|
|
|
|
|
Net Change in Cash |
15.0 |
16.1 |
-35.2 |
-5.1 |
-59.2 |
|
|
|
|
|
|
|
|
Net Cash - Beginning Balance |
70.1 |
70.1 |
105.3 |
105.3 |
105.3 |
|
Net Cash - Ending Balance |
85.0 |
86.2 |
70.1 |
100.1 |
46.0 |
|
Cash Interest Paid |
2.4 |
2.3 |
4.9 |
4.7 |
2.4 |
|
Cash Taxes Paid |
0.0 |
0.0 |
7.3 |
7.7 |
7.7 |
Business Segments
Financials in: As Reported (mil)
|
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Business Segments
Financials in: As Reported (mil)
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Standard
& Poors
|
United
States of America Long-Term Rating Lowered To 'AA+' Due To Political Risks,
Rising Debt Burden; Outlook Negative |
|
Publication
date: 05-Aug-2011 20:13:14 EST |
We have lowered our long-term sovereign
credit rating on the United States of America to 'AA+' from 'AAA' and affirmed
the 'A-1+' short-term rating.
We have also removed both the short- and long-term ratings
from CreditWatch negative.
The downgrade reflects our opinion
that the fiscal consolidation plan that Congress and the Administration
recently agreed to falls short of what, in our view, would be necessary to
stabilize the government's medium-term debt dynamics.
More broadly, the downgrade
reflects our view that the effectiveness, stability, and predictability of
American policymaking and political institutions have weakened at a time of
ongoing fiscal and economic challenges to a degree more than we envisioned when
we assigned a negative outlook to the rating on April 18, 2011.
Since then, we have changed our
view of the difficulties in bridging the gulf between the political parties
over fiscal policy, which makes us pessimistic about the capacity of Congress
and the Administration to be able to leverage their agreement this week into a
broader fiscal consolidation plan that stabilizes the government's debt
dynamics any time soon.
The outlook on the long-term rating
is negative. We could lower the long-term rating to 'AA' within the next two
years if we see that less reduction in spending than agreed to, higher interest
rates, or new fiscal pressures during the period result in a higher general
government debt trajectory than we currently assume in our base case.
TORONTO (Standard &
Poor's) Aug. 5, 2011--Standard & Poor's Ratings Services said today that it
lowered its long-term sovereign credit rating on the United States of America
to 'AA+' from 'AAA'. Standard & Poor's also said that the outlook on the
long-term rating is negative. At the same time, Standard & Poor's affirmed
its 'A-1+' short-term rating on the U.S. In addition, Standard & Poor's
removed both ratings from CreditWatch, where they were placed on July 14, 2011,
with negative implications.
The
transfer and convertibility (T&C) assessment of the U.S.--our assessment of
the likelihood of official interference in the ability of U.S.-based public-
and private-sector issuers to secure foreign exchange for
debt service--remains
'AAA'.
We lowered our long-term
rating on the U.S. because we believe that the prolonged controversy over
raising the statutory debt ceiling and the related fiscal policy debate
indicate that further near-term progress containing the growth in public
spending, especially on entitlements, or on reaching an agreement on raising
revenues is less likely than we previously assumed and will remain a
contentious and fitful process. We also believe that the fiscal consolidation
plan that Congress and the Administration agreed to this week falls short of
the amount that we believe is necessary to stabilize the general government
debt burden by the middle of the decade.
Our lowering of the
rating was prompted by our view on the rising public debt burden and our
perception of greater policymaking uncertainty, consistent with our criteria
(see "Sovereign Government Rating
Methodology and Assumptions ," June 30, 2011,
especially Paragraphs 36-41). Nevertheless, we view the U.S. federal
government's other economic, external, and monetary credit attributes, which
form the basis for the sovereign rating, as broadly unchanged.
We have taken the ratings
off CreditWatch because the Aug. 2 passage of the Budget Control Act Amendment
of 2011 has removed any perceived immediate threat of payment default posed by
delays to raising the government's debt ceiling. In addition, we believe that
the act provides sufficient clarity to allow us to evaluate the likely course
of U.S. fiscal policy for the next few years.
The
political brinksmanship of recent months highlights what we see as America's
governance and policymaking becoming less stable, less effective, and less
predictable than what we previously believed. The statutory debt ceiling and
the threat of default have become political bargaining chips in the debate over
fiscal policy. Despite this year's wide-ranging debate, in our view, the
differences between political parties have proven to be extraordinarily
difficult to bridge, and, as we see it, the resulting agreement fell well short
of the comprehensive fiscal consolidation program that some proponents had
envisaged until quite recently. Republicans and Democrats have only been able
to agree to relatively modest savings on discretionary spending while
delegating to the Select Committee decisions on more comprehensive measures. It
appears that for now, new revenues have dropped down on the menu of policy
options. In addition, the plan envisions only minor policy changes on Medicare
and little change in other entitlements,
the containment of which
we and most other independent observers regard as key to long-term fiscal
sustainability.
Our opinion is that
elected officials remain wary of tackling the structural issues required to
effectively address the rising U.S. public debt burden in a manner consistent
with a 'AAA' rating and with 'AAA' rated sovereign peers (see Sovereign Government Rating
Methodology and Assumptions," June 30, 2011, especially
Paragraphs 36-41). In our view, the difficulty in framing a consensus on fiscal
policy weakens the government's ability to manage public finances and diverts
attention from the debate over how to achieve more balanced and dynamic
economic growth in an era of fiscal stringency and private-sector deleveraging
(ibid). A new political consensus might (or might not) emerge after the 2012
elections, but we believe that by then, the government debt burden will likely
be higher, the needed medium-term fiscal adjustment potentially greater, and
the inflection point on the U.S. population's demographics and other
age-related spending drivers closer at hand (see "Global Aging 2011: In The
U.S., Going Gray Will Likely Cost Even More Green, Now,"
June 21, 2011).
Standard & Poor's
takes no position on the mix of spending and revenue measures that Congress and
the Administration might conclude is appropriate for putting the U.S.'s
finances on a sustainable footing.
The act calls for as much
as $2.4 trillion of reductions in expenditure growth over the 10 years through
2021. These cuts will be implemented in two steps: the $917 billion agreed to
initially, followed by an additional $1.5 trillion that the newly formed
Congressional Joint Select Committee on Deficit Reduction is supposed to
recommend by November 2011. The act contains no measures to raise taxes or
otherwise enhance revenues, though the committee could recommend them.
The act further provides
that if Congress does not enact the committee's recommendations, cuts of $1.2
trillion will be implemented over the same time period. The reductions would mainly
affect outlays for civilian discretionary spending, defense, and Medicare. We
understand that this fall-back mechanism is designed to encourage Congress to
embrace a more balanced mix of expenditure savings, as the committee might
recommend.
We note that in a letter
to Congress on Aug. 1, 2011, the Congressional Budget Office (CBO) estimated
total budgetary savings under the act to be at least $2.1 trillion over the
next 10 years relative to its baseline assumptions. In updating our own fiscal
projections, with certain modifications outlined below, we have relied on the
CBO's latest "Alternate Fiscal Scenario" of June 2011, updated to
include the CBO assumptions contained in its Aug. 1 letter to Congress. In
general, the CBO's "Alternate Fiscal Scenario" assumes a continuation
of recent Congressional action overriding existing law.
We view the act's
measures as a step toward fiscal consolidation. However, this is within the
framework of a legislative mechanism that leaves open the details of what is finally
agreed to until the end of 2011, and Congress and the Administration could
modify any agreement in the future. Even assuming that at least $2.1 trillion
of the spending reductions the act envisages are implemented, we maintain our
view that the U.S. net general government debt burden (all levels of government
combined, excluding liquid financial assets) will likely continue to grow.
Under our revised base case fiscal scenario--which we consider to be consistent
with a 'AA+' long-term rating and a negative outlook--we now project that net
general government debt would rise from an estimated 74% of GDP by the end of
2011 to 79% in 2015 and 85% by 2021. Even the projected 2015 ratio of sovereign
indebtedness is high in relation to those of peer credits and, as noted, would
continue to rise under the act's revised policy settings.
Compared with previous
projections, our revised base case scenario now assumes that the 2001 and 2003
tax cuts, due to expire by the end of 2012, remain in place. We have changed
our assumption on this because the majority of Republicans in Congress continue
to resist any measure that would raise revenues, a position we believe Congress
reinforced by passing the act. Key macroeconomic assumptions in the base case
scenario include trend real GDP growth of 3% and consumer price inflation near
2% annually over the decade.
Our revised upside
scenario--which, other things being equal, we view as consistent with the
outlook on the 'AA+' long-term rating being revised to stable--retains these
same macroeconomic assumptions. In addition, it incorporates $950 billion of
new revenues on the assumption that the 2001 and 2003 tax cuts for high earners
lapse from 2013 onwards, as the Administration is advocating. In this scenario,
we project that the net general government debt would rise from an estimated
74% of GDP by the end of 2011 to 77% in 2015 and to 78% by 2021.
Our revised downside
scenario--which, other things being equal, we view as being consistent with a
possible further downgrade to a 'AA' long-term rating--features less-favorable
macroeconomic assumptions, as outlined below and also assumes that the second
round of spending cuts (at least $1.2 trillion) that the act calls for does not
occur. This scenario also assumes somewhat higher nominal interest rates for
U.S. Treasuries. We still believe that the role of the U.S. dollar as the key
reserve currency confers a government funding advantage, one that could change
only slowly over time, and that Fed policy might lean toward continued loose
monetary policy at a time of fiscal tightening. Nonetheless, it is possible
that interest rates could rise if investors re-price relative risks. As a
result, our alternate scenario factors in a 50 basis point (bp)-75 bp rise in
10-year bond yields relative to the base and upside cases from 2013 onwards. In
this scenario, we project the net public debt burden would rise from 74% of GDP
in 2011 to 90% in 2015 and to 101% by 2021.
Our revised scenarios
also take into account the significant negative revisions to historical GDP
data that the Bureau of Economic Analysis announced on July 29. From our
perspective, the effect of these revisions underscores two related points when
evaluating the likely debt trajectory of the U.S. government. First, the revisions
show that the recent recession was deeper than previously assumed, so the GDP
this year is lower than previously thought in both nominal and real terms.
Consequently, the debt burden is slightly higher. Second, the revised data
highlight the sub-par path of the current economic recovery when compared with
rebounds following previous post-war recessions. We believe the sluggish pace
of the current economic recovery could be consistent with the experiences of
countries that have had financial crises in which the slow process of debt
deleveraging in the private sector leads to a persistent drag on demand. As a
result, our downside case scenario assumes relatively modest real trend GDP
growth of 2.5% and inflation of near 1.5% annually going forward.
When comparing the U.S.
to sovereigns with 'AAA' long-term ratings that we view as relevant
peers--Canada, France, Germany, and the U.K.--we also observe, based on our
base case scenarios for each, that the trajectory of the U.S.'s net public debt
is diverging from the others. Including the U.S., we estimate that these five
sovereigns will have net general government debt to GDP ratios this year
ranging from 34% (Canada) to 80% (the U.K.), with the U.S. debt burden at 74%.
By 2015, we project that their net public debt to GDP ratios will range between
30% (lowest, Canada) and 83% (highest, France), with the U.S. debt burden at
79%. However, in contrast with the U.S., we project that the net public debt
burdens of these other sovereigns will begin to decline, either before or by
2015.
Standard & Poor's
transfer T&C assessment of the U.S. remains 'AAA'. Our T&C assessment
reflects our view of the likelihood of the sovereign restricting other public
and private issuers' access to foreign exchange needed to meet debt service.
Although in our view the credit standing of the U.S. government has
deteriorated modestly, we see little indication that official interference of
this kind is entering onto the policy agenda of either Congress or the
Administration. Consequently, we continue to view this risk as being highly
remote.
The outlook on the
long-term rating is negative. As our downside alternate fiscal scenario
illustrates, a higher public debt trajectory than we currently assume could
lead us to lower the long-term rating again. On the other hand, as our upside
scenario highlights, if the recommendations of the Congressional Joint Select
Committee on Deficit Reduction--independently or coupled with other
initiatives, such as the lapsing of the 2001 and 2003 tax cuts for high
earners--lead to fiscal consolidation measures beyond the minimum mandated, and
we believe they are likely to slow the deterioration of the government's debt
dynamics, the long-term rating could stabilize at 'AA+'.
On Monday,
we will issue separate releases concerning affected ratings in the funds,
government-related entities, financial institutions, insurance, public finance,
and structured finance sectors.
FOREIGN EXCHANGE RATES
|
Currency |
Unit
|
Indian Rupees |
|
US Dollar |
1 |
Rs.49.07 |
|
UK Pound |
1 |
Rs.76.65 |
|
Euro |
1 |
Rs.66.17 |
RATING EXPLANATIONS
|
RATING |
STATUS |
PROPOSED CREDIT LINE |
|
|
>86 |
Aaa |
Possesses an extremely sound financial base with the strongest capability
for timely payment of interest and principal sums |
Unlimited |
|
71-85 |
Aa |
Possesses adequate working capital. No caution needed for credit
transaction. It has above average (strong) capability for payment of interest
and principal sums |
Large |
|
56-70 |
A |
Financial & operational base are regarded healthy. General
unfavourable factors will not cause fatal effect. Satisfactory capability for
payment of interest and principal sums |
Fairly Large |
|
41-55 |
Ba |
Overall operation is considered normal. Capable to meet normal
commitments. |
Satisfactory |
|
26-40 |
B |
Capability to overcome financial difficulties seems comparatively
below average. |
Small |
|
11-25 |
Ca |
Adverse factors are apparent. Repayment of interest and principal sums
in default or expected to be in default upon maturity |
Limited with
full security |
|
<10 |
C |
Absolute credit risk exists. Caution needed to be exercised |
Credit not
recommended |
|
---- |
NB |
New Business |
---- |
This score serves as a reference to assess SCs credit risk
and to set the amount of credit to be extended. It is calculated from a
composite of weighted scores obtained from each of the major sections of this report.
The assessed factors and their relative weights (as indicated through %) are as
follows:
Financial
condition (40%) Ownership
background (20%) Payment
record (10%)
Credit history
(10%) Market trend
(10%) Operational
size (10%)
This report is issued at your request without any risk
and responsibility on the part of MIRA INFORM PRIVATE LIMITED (MIPL) or its
officials.