Press Releases
Isis Reports Financial Results and Highlights for Third Quarter 2012
"We have had a very successful year. With a number of exciting events on the horizon, the remainder of 2012 promises to be equally eventful. Of course, the most notable events this year are associated with KYNAMRO™. We are pleased with the positive recommendation from the
"While KYNAMRO is the most notable of our successes, we have had many achievements across our pipeline. Most recently, we have completed key steps to move two of our severe and rare disease drugs toward commercial markets. We initiated the next clinical study in patients with spinal muscular atrophy for our drug, ISIS-SMNRx, which we partnered with
Potential Upcoming Key Milestones
- Report clinical data from multiple drugs in Isis' pipeline
- Initiate a Phase 2/3 study of ISIS-TTRRx in patients with familial amyloid polyneuropathy
- Receive marketing approval of KYNAMRO in
the United States andEurope - Earn a
$25 million milestone payment from Genzyme followingFDA marketing approval for KYNAMRO
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 compensation expense related to equity awards. Please refer to the reconciliation of pro forma and GAAP measures, which is provided later in this release.
Revenue
Revenue for the three and nine months ended
Operating Expenses
On a pro forma basis, operating expenses for the three and nine months ended
On a GAAP basis, Isis' operating expenses for the three and nine months ended
Early Retirement of Debt
In
Net Loss
Isis reported a net loss of
Balance Sheet
As of
Investment in
In
Business Highlights
"With a pipeline of more than two dozen drugs in development, we have multiple opportunities for pipeline news. A number of our drugs will complete first-in-man studies this year, and we will share that data with you as it becomes available. We also plan to advance several drugs into later-stage clinical studies. These are drugs, like our TTR drug, that could have rapid routes to the market in orphan patient populations who have limited treatment options. In addition, as we have done every year for the past several years, we plan to add three to five new drugs to our pipeline. In short, we are on track to end the year with many significant accomplishments that demonstrate the therapeutic potential of our drugs and the productivity of our technology."
"We encourage the advancement of antisense drugs and support innovation in antisense technology, in part through our satellite company strategy, which allows us to work with a consortium of smaller companies in areas outside of our core focus. Often, the investments we make in our satellite company partners are not monetary, but rather, we provide our satellite company partners access to our intellectual property, expertise in antisense technology and manufacturing support in exchange for company equity, milestone payments and future royalties as programs advance toward the market. Regulus is a great example of the value of this strategy," commented Ms. Parshall. "We co-founded Regulus based on our know-how and clinical advances with antisense drugs and applied this knowledge to the field of microRNAs. Last month Regulus completed an initial public offering, which we supported, bringing our ownership in Regulus to approximately seven million shares of Regulus' common stock, which is currently valued at
"In closing, 2012 has already been a very successful year, not just with our pipeline and with KYNAMRO, but also financially. A key goal for us this year was to refinance our existing debt on favorable terms. By taking advantage of the favorable market conditions and the considerable interest in Isis, we successfully completed a private placement of
Corporate and Drug Development Highlights
- KYNAMRO continues to advance in development and move closer to the market for patients with severe forms of familial hypercholesterolemia (FH; homozygous FH and severe heterozygous FH) through regulatory approval and with the FOCUS FH study.
- The
FDA 'sEndocrinologic and Metabolic Drugs Advisory Committee voted 9 to 6 that Genzyme had provided sufficient efficacy and safety data to support the marketing of KYNAMRO for the treatment of patients with homozygous FH. - Dr. Klaus Parhofer, a clinical investigator, presented an analysis of data from the KYNAMRO Phase 3 study in patients with severe heterozygous FH at the
European Society of Cardiology . These data highlighted the potential of KYNAMRO to reduce the need for apheresis by lowering LDL-C values below the thresholds for apheresis eligibility in patients with severe heterozygous FH. - Isis received European GMP certification of its manufacturing facility for production of drug substance to support KYNAMRO commercial launch.
- The
- Isis initiated a Phase 2 study on ISIS-FXIRx in patients undergoing total knee replacement surgery and a Phase 1b/2a study on ISIS-SMNRx in children with spinal muscular atrophy.
- Isis and GlaxoSmithKline amended the clinical development plan and financial terms relating to ISIS-TTRRx to support an accelerated development plan for the drug. As a result of the revised agreement, Isis will receive a
$2.5 million upfront payment and will receive$7.5 million upon initiation of the Phase 2/3 study for ISIS-TTRRx. Isis is also eligible to earn an additional$50 million in pre-licensing milestone payments to support the ISIS-TTRRx Phase 2/3 study. - Isis reported preliminary Phase 1 data on ISIS-STAT3Rx in patients with cancer and initiated a Phase 2 study evaluating ISIS-STAT3Rx in patients with advanced lymphoma.
- Isis and collaborators published a paper in Nature demonstrating that an antisense compound selectively and rapidly reduced target RNA in skeletal muscle and alleviated disease in animal models of muscular dystrophy type 1 (DM1).
- Isis and collaborators published two papers in the journal Cell demonstrating that single-stranded RNA-like antisense technology can activate the RNAi pathway and inhibit the expression of targeted genes.
- Isis benefits from its partners as they advance RNA-based technologies and products that incorporate Isis' technology resulting in financial benefits as these assets mature.
- Isis earned
$2.7 million from Alnylam as a result of Alnylam's licenses that included Isis' patents. - Regulus formed a strategic alliance with
AstraZeneca for the discovery, development and commercialization of microRNA therapeutics. - Regulus formed a strategic alliance with
Biogen Idec to identify microRNAs as biomarkers for multiple sclerosis. - Isis received a
$1.25 million payment from Pfizer triggered by Pfizer's decision to advance EXC 001 into a Phase 2 study.
- Isis earned
Regulus Therapeutics completed an initial public offering and is now traded on TheNASDAQ Global Market under the ticker RGLS. Isis purchased$3 million of Regulus' common stock at the offering price and remains a significant shareholder with approximately 17% ownership on a fully diluted basis.- Isis completed a successful offering of
$201.3 million of 2 ¾% Convertible Senior Notes. Isis used the proceeds of this offering to redeem the entire$162.5 million of 2 ⅝% Convertible Subordinated Notes.
Conference Call
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 25 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, in
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. |
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SELECTED FINANCIAL INFORMATION |
|||||||||
Condensed Consolidated Statements of Operations (In Thousands, Except Per Share Data) |
|||||||||
Three months ended, |
Nine months ended, |
||||||||
September 30, |
September 30, |
||||||||
2012 |
2011 |
2012 |
2011 |
||||||
Revenue: |
(unaudited) |
(unaudited) |
|||||||
Research and development revenue under collaborative agreements |
$11,127 |
$20,189 |
$80,085 |
$64,508 |
|||||
Licensing and royalty revenue |
474 |
524 |
2,091 |
2,175 |
|||||
Total revenue |
11,601 |
20,713 |
82,176 |
66,683 |
|||||
Expenses: |
|||||||||
Research and development |
36,551 |
39,924 |
115,700 |
110,178 |
|||||
General and administrative |
3,096 |
3,105 |
9,281 |
8,989 |
|||||
Total operating expenses |
39,647 |
43,029 |
124,981 |
119,167 |
|||||
Loss from operations |
(28,046) |
(22,316) |
(42,805) |
(52,484) |
|||||
Other income (expense): |
|||||||||
Equity in net loss of Regulus Therapeutics Inc. |
- |
(386) |
(1,139) |
(2,275) |
|||||
Investment income |
408 |
575 |
1,485 |
1,896 |
|||||
Interest expense |
(5,937) |
(4,773) |
(16,335) |
(11,624) |
|||||
Gain (loss) on investments, net |
- |
18 |
19 |
(267) |
|||||
Loss on early retirement of debt |
(4,770) |
- |
(4,770) |
- |
|||||
Loss before income tax benefit (expense) |
(38,345) |
(26,882) |
(63,545) |
(64,754) |
|||||
Income tax benefit (expense) |
706 |
- |
704 |
(11) |
|||||
Net loss |
$(37,639) |
$(26,882) |
$(62,841) |
$(64,765) |
|||||
Basic and diluted net loss per share |
$(0.37) |
$(0.27) |
$(0.63) |
$(0.65) |
|||||
Shares used in computing basic and diluted net loss per share |
100,680 |
99,687 |
100,351 |
99,620 |
Isis Pharmaceuticals, Inc. Reconciliation of GAAP to Pro Forma Basis: Condensed Consolidated Operating Expenses and Loss From Operations (In Thousands) |
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Three months ended, September 30, |
Nine months ended, September 30, |
|||||||||||||
2012 |
2011 |
2012 |
2011 |
|||||||||||
(unaudited) |
(unaudited) |
|||||||||||||
As reported operating expenses according to GAAP |
$39,647 |
$43,029 |
$124,981 |
$119,167 |
||||||||||
Excluding compensation expense related to equity awards |
(2,034) |
(2,364) |
(6,761) |
(7,596) |
||||||||||
Pro forma operating expenses |
$37,613 |
$40,665 |
$118,220 |
$111,571 |
||||||||||
As reported loss from operations according to GAAP |
$(28,046) |
$(22,316) |
$(42,805) |
$(52,484) |
||||||||||
Excluding compensation expense related to equity awards |
(2,034) |
(2,364) |
(6,761) |
(7,596) |
||||||||||
Pro forma loss from operations |
$(26,012) |
$(19,952) |
$(36,044) |
$(44,888) |
||||||||||
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 |
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(In Thousands) |
|||||
September 30, |
December 31, |
||||
2012 |
2011 |
||||
(unaudited) |
|||||
Assets: |
|||||
Cash, cash equivalents and short-term investments |
$343,573 |
$343,664 |
|||
Other current assets |
18,013 |
16,475 |
|||
Property, plant and equipment, net |
92,598 |
96,615 |
|||
Other assets |
31,497 |
28,140 |
|||
Total assets |
$485,681 |
$484,894 |
|||
Liabilities and stockholders' equity: |
|||||
Other current liabilities |
$28,174 |
$39,528 |
|||
Current portion of deferred contract revenue |
23,427 |
36,584 |
|||
2 3/4% convertible senior notes |
142,500 |
- |
|||
2 5/8% convertible subordinated notes |
- |
141,448 |
|||
Long-term obligations, less current portion |
78,779 |
74,002 |
|||
Investment in Regulus Therapeutics Inc. |
5,563 |
4,424 |
|||
Long-term deferred contract revenue |
36,961 |
17,474 |
|||
Stockholders' equity |
170,277 |
171,434 |
|||
Total liabilities and stockholders' equity |
$485,681 |
$484,894 |
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SOURCE
D. Wade Walke, Ph.D., Executive Director, Corporate Communications and Investor Relations, +1-760-603-2741, or Amy Blackley, Ph.D., Associate Director, Corporate Communications, +1-760-603-2772