Press Releases
Isis Reports Financial Results and Highlights for First Quarter 2012
"Already in 2012, we have had multiple important accomplishments. Our partners at Genzyme submitted the KYNAMRO™ new drug application (NDA) to the FDA. With this submission, we are one step closer to commercializing KYNAMRO for patients who are at great risk of dying from their cardiovascular disease. In addition, the European regulatory review is proceeding as planned, and Genzyme is actively preparing to launch KYNAMRO. The commercialization of KYNAMRO will be an important milestone for Isis. Not only does it represent the commercialization of the first systemic antisense drug, but it also represents the opportunity to significantly change our financial position by adding commercial revenue," said
Upcoming Key Milestones
- Present an analysis of Lp(a) data from the KYNAMRO Phase 3 program at the
European Atherosclerosis Society . - Earn a
$25 million milestone from Genzyme followingFDA acceptance for the NDA submission of KYNAMRO for patients with homozygous FH. - Initiate a clinical study of ISIS-TTRRx in patients with Familial Amyloid Polyneuropathy.
Financial Results
On a GAAP basis, Isis reported a loss from operations of
All pro forma amounts referred to in this press release exclude non-cash stock compensation. Please refer to the reconciliation of pro forma and GAAP measures, which is provided later in this release.
Revenue
Revenue for the three months ended
Operating Expenses
On a pro forma basis, operating expenses for the three months ended
On a GAAP basis, Isis' operating expenses for the three months ended
Net Loss
Isis reported a net loss of
Balance Sheet
As of
Business Highlights
"In 2012, we are looking forward to a watershed event for Isis: the commercial launch of KYNAMRO. KYNAMRO is an important drug for many reasons. It should be the first systemic antisense drug on the market and it will be Isis' first important commercial asset. Most importantly, it is a drug that has the potential to help seriously ill patients with severe FH in desperate need of a lifesaving therapy," continued Ms. Parshall. "We recently reported data from our long-term extension study in patients who have been treated with KYNAMRO for two years and longer. In these patients, we continue to see sustained and robust reductions of LDL-cholesterol and other key atherogenic lipids with a safety profile that supports our plan to treat patients who are at very high risk of a cardiovascular-related death. While our initial registration dossiers are filed in
"While KYNAMRO is our flagship drug, our pipeline goes well beyond KYNAMRO. With drugs in numerous therapeutic areas, we have many opportunities for both short- and long-term revenue growth. We have several drugs that may provide substantial commercial opportunities with product launches that could occur within the next five years. These include our TTR amyloidosis and Spinal Muscular Atrophy drugs from our severe and rare disease franchise, which, due to the significant unmet medical need and orphan patient populations, could warrant an accelerated path to market. We expect that, if successful, they could be available for patients within the next five years. In addition, we are implementing a staged development path for our triglyceride-lowering drug, ISIS-APOCIIIRx, that could bring this important new medicine to the market sooner for patients with extremely high and poorly controlled triglycerides who, as a result, are at severe risk of disease," continued Ms. Parshall.
"In addition to the potential near-term product opportunities in our pipeline, we have several drugs that could represent significant licensing opportunities in the next year or two. With robust Phase 2 data packages, we may be able to command lucrative licensing terms for these drugs. Among these near-term licensing opportunities is our anticoagulant drug targeting Factor XI and our CRP drug from our cardiovascular franchise. Both of these drugs have the potential to treat numerous diseases with significant market potential. In addition, we have several drugs from our metabolic franchise that could complete Phase 2 studies in the next two years and could also provide significant licensing opportunities. These drugs represent novel approaches to the treatment of type 2 diabetes, and are designed to provide long-term control in patients who cannot control their glucose levels with existing therapies. With type 2 diabetes being the most rapidly growing epidemic worldwide, we believe bringing forward novel medicines to add to the treatment paradigm for these patients is a wise investment," continued Ms. Parshall.
"In summary, we have begun another productive year in which we expect to report data on many of the drugs in our pipeline, initiate larger, longer studies for our Factor XI and TTR drugs, and continue to move promising new drugs into our pipeline. We look forward to KYNAMRO commercialization and bringing this important new medicine to patients in great need," concluded Ms. Parshall.
Corporate and Drug Development Highlights
- Genzyme submitted a new drug application for KYNAMRO in
the United States for homozygous FH patients. - Dr.
Raul Santos presented data from the long-term extension study of KYNAMRO at the International Symposium on Atherosclerosis. The data highlight the long-term safety and efficacy of KYNAMRO in patients who have been treated with KYNAMRO. - Isis initiated a Phase 2 study on ISIS-APOCIIIRx in patients with elevated triglycerides and a Phase 1 study on ISIS-STAT3Rx in patients with cancer.
- Isis reported data from a Phase 1 study of ISIS-TTRRx showing that ISIS-TTRRx produced statistically significant reductions in TTR protein.
- Isis formed a new strategic alliance with
Biogen Idec to develop and commercialize ISIS-SMNRx to treat Spinal Muscular Atrophy (SMA). Isis received a$29 million upfront payment and is eligible to receive up to an additional$270 million in a license fee and milestone payments, and double-digit royalties on sales of ISIS-SMNRx. - Isis received Orphan Drug Designation for ISIS-SMNRx in
Europe for the treatment of SMA. - OncoGenex reported preliminary positive Phase 1 data at the
American Society of Clinical Oncology showing that treatment with OGX-427 produced a trend toward increased tumor cell death in patients with bladder cancer and preliminary Phase 2 data showing that treatment with OGX-427 decreased prostate specific antigen in patients with metastatic prostate cancer. Xenon Pharmaceuticals selected a drug targeting the hepcidin-hemojuvelin pathway as a development candidate to treat anemia of inflammation, a common form of anemia.
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At
About
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 26 drugs to treat a wide variety of diseases with an emphasis on cardiovascular, metabolic, severe and rare diseases, and cancer. Isis' partner, Genzyme, plans to commercialize Isis' lead product, KYNAMRO, 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.
Forward Looking Statements
This press release includes forward-looking statements regarding
In this press release, unless the context requires otherwise, "Isis," "Company," "we," "our," and "us" refers to
Isis Pharmaceuticals® is a registered trademark of
ISIS PHARMACEUTICALS, INC. SELECTED FINANCIAL INFORMATION Condensed Consolidated Statements of Operations (In Thousands, Except Per Share Data) |
||||||||
Three months ended, |
||||||||
March 31, |
||||||||
2012 |
2011 |
|||||||
Revenue: |
(unaudited) |
|||||||
Research and development revenue |
||||||||
under collaborative agreements |
$21,818 |
$20,014 |
||||||
Licensing and royalty revenue |
1,417 |
1,133 |
||||||
Total revenue |
23,235 |
21,147 |
||||||
Expenses: |
||||||||
Research and development |
38,714 |
34,245 |
||||||
General and administrative |
2,976 |
3,010 |
||||||
Total operating expenses |
41,690 |
37,255 |
||||||
Loss from operations |
(18,455) |
(16,108) |
||||||
Other income (expense): |
||||||||
Equity in net loss of Regulus Therapeutics Inc. |
(976) |
(856) |
||||||
Investment income |
600 |
705 |
||||||
Interest expense |
(5,179) |
(3,415) |
||||||
Gain (loss) on investments, net |
17 |
(318) |
||||||
Loss before income tax expense |
$(23,993) |
$(19,992) |
||||||
Income tax expense |
(2) |
(2) |
||||||
Net loss |
$(23,995) |
$(19,994) |
||||||
Basic and diluted net loss |
$(0.24) |
$(0.20) |
||||||
Shares used in computing basic and diluted net loss per share |
100,157 |
99,569 |
||||||
Isis Pharmaceuticals, Inc. Reconciliation of GAAP to Pro Forma Basis: Condensed Consolidated Operating Expenses and Loss From Operations (In Thousands) |
||||||
Three months ended, March 31, |
||||||
2012 |
2011 |
|||||
(unaudited) |
||||||
As reported operating expenses according to GAAP |
$41,690 |
$37,255 |
||||
Excluding compensation expense related to equity awards |
(2,267) |
(2,732) |
||||
Pro forma operating expenses |
$39,423 |
$34,523 |
||||
As reported loss from operations according to GAAP |
$(18,455) |
$(16,108) |
||||
Excluding compensation expense related to equity awards |
(2,267) |
(2,732) |
||||
Pro forma loss from operations |
$(16,188) |
$(13,376) |
||||
Reconciliation of GAAP to Pro Forma Basis
As illustrated in the Selected Financial Information in this press release, pro forma operating expenses and pro forma loss from operations were adjusted from GAAP to exclude compensation expense related to equity awards, which are non-cash. Isis has regularly reported non-GAAP measures for operating expenses and loss from operations as pro forma results. These measures are provided as supplementary information and are not a substitute for financial measures calculated in accordance with GAAP. Isis reports these pro forma results to better enable financial statement users to assess and compare its historical performance and project its future operating results and cash flows. Further, the presentation of Isis' pro forma results is consistent with how Isis' management internally evaluates the performance of its operations.
Isis Pharmaceuticals, Inc. Condensed Consolidated Balance Sheets |
|||||
(In Thousands) |
|||||
March 31, |
December 31, |
||||
2012 |
2011 |
||||
(unaudited) |
|||||
Assets: |
|||||
Cash, cash equivalents and short-term investments |
$333,944 |
$343,664 |
|||
Other current assets |
13,669 |
16,475 |
|||
Property, plant and equipment, net |
95,132 |
96,615 |
|||
Other assets |
28,062 |
28,140 |
|||
Total assets |
$470,807 |
$484,894 |
|||
Liabilities and stockholders' equity: |
|||||
Other current liabilities |
$27,387 |
$39,528 |
|||
Current portion of deferred contract revenue |
34,320 |
36,584 |
|||
2 5/8% convertible subordinated notes |
143,717 |
141,448 |
|||
Long-term obligations, less current portion |
73,642 |
74,002 |
|||
Investment in Regulus Therapeutics Inc. |
5,400 |
4,424 |
|||
Long-term deferred contract revenue |
35,469 |
17,474 |
|||
Stockholders' equity |
150,872 |
171,434 |
|||
Total liabilities and stockholders' equity |
$470,807 |
$484,894 |
|||
SOURCE
Kristina Lemonidis, Director, Corporate Communications, +1-760-603-2490, or Amy Blackley, Ph.D. Assistant Director, Corporate Communications, +1-760-603-2772, both of Isis Pharmaceuticals