Press Releases
Isis Reports Financial Results and Highlights for First Quarter 2015
"Our successes in the first quarter enabled us to end the first quarter of 2015 in a strong financial position. We are continuing this momentum into the second quarter. Yesterday we achieved an important strategic objective for Isis when we licensed ISIS-FXIRx to Bayer. Bayer is the optimal partner to develop and commercialize ISIS-FXIRx. Our goals for the ISIS-FXIRx program were to maximize the value we derive from this program both in the near-term and in the long-term. We wanted a partner committed to investing to maximize the commercial value of the drug, and we wanted to retain substantial participation in the commercial value created. This partnership meets all of these goals. As a leader in the antithrombotic market, Bayer has the expertise, resources and commitment to broadly develop ISIS-FXIRx. They plan to conduct a robust development plan that represents a commitment to make a substantial investment in ISIS-FXIRx. Bayer's development plan combines near-term indications, which have the potential for early market entrance in patients with limited therapeutic options, with long-term indications in patients who are underserved by current antithrombotic treatments. In short, a development plan designed to take advantage of the profile of ISIS-FXIRx and maximize its value. We are also pleased with the financial aspects of the transaction, which provide significant value upfront as well as a substantial royalty that enables us to participate in the long-term commercial success of ISIS-FXIRx," said
"Subsequent to the first quarter, we licensed ISIS-FXIRx to Bayer for a substantial upfront payment and significant milestone and other payments of up to
Financial Results
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 months ended
$31 million from Biogen including the following:$10 million for initiating investigational new drug supporting studies for ISIS-BIIB4Rx;$9 million for advancing CHERISH, the Phase 3 study for ISIS-SMNRx in infants with SMA;$7 million for advancing the Phase 2 open-label extension study for ISIS-SMNRx in children with SMA; and$5 million for validating an undisclosed target to treat a neurological disorder.
$15 million from GSK for advancing the Phase 3 study of ISIS-TTRRx.
Isis' revenue in the first quarter of 2015 also included
Isis' revenue fluctuates based on the nature and timing of payments under agreements with Isis' partners, including license fees, milestone-related payments and other payments.
Operating Expenses
Isis is conducting more later-stage clinical trials in 2015 than it did in 2014, including the continuation of its Phase 3 programs for ISIS-TTRRx, ISIS-SMNRx and ISIS-APOCIIIRx. As such, Isis' pro forma operating expenses of
Income Tax Benefit
Isis recognized a net tax benefit of
Net Loss
Isis reported a net loss of
Balance Sheet
As of
Business Highlights
"Bayer is the second new partner we added this year. Earlier in the year, we added Janssen as our partner in the discovery and development of antisense drugs to treat autoimmune disorders of the GI tract. Our Janssen collaboration expands our technology to a new area, the oral administration of antisense drugs for the local treatment of autoimmune diseases in the gastrointestinal tract," continued Ms. Parshall.
"We have a pipeline of novel antisense drugs that could provide significant value in the near-term with six drugs in Phase 3 development including, ISIS-SMNRx, ISIS-TTRRx and ISIS-APOCIIIRx. Enrollment for both of the Phase 3 studies of ISIS-SMNRx is on track, and we plan to share data on these studies in the 2016/2017 timeframe. We are pleased that Biogen is expanding the Phase 3 program for ISIS-SMNRx by conducting two additional studies of ISIS-SMNRx including a study evaluating ISIS-SMNRx, in newborns screened at birth and shown to have SMA, but who are presymptomatic. We presented positive data on ISIS-TTRRx in patients with FAP at the
Drug Development Highlights (2015 first quarter and subsequent activities)
- Isis and its partners reported positive data on six drugs in Isis' pipeline, including:
- Isis reported positive results from an ongoing open-label extension study of ISIS-TTRRx in patients with FAP. In the open-label study after thirteen weeks of treatment with ISIS-TTRRx, TTR protein was reduced up to 92 percent with a median reduction of 78 percent in patients with FAP compared to their baseline TTR levels at entry into the Phase 3 study.
AstraZeneca reported clinical and preclinical data on ISIS-STAT3-2.5Rx demonstrating evidence of antitumor activity in patients with cancer including advanced/metastatic hepatocellular carcinoma and diffuse large B cell lymphoma. Additionally,AstraZeneca reported that, in preclinical studies, co-treatment of ISIS-STAT3-2.5Rx and MEDI4736, an immune checkpoint inhibitor, showed significantly greater antitumor activity than when either drug was administered alone.AstraZeneca plans to initiate two clinical studies evaluating ISIS-STAT3-2.5Rx in combination with MEDI4736 this year.- Isis reported top-line Phase 2 data on ISIS-PTP1BRx demonstrating that patients with type 2 diabetes experienced statistically significant mean reductions in body weight and HbA1c (0.7 percentage point) at 36 weeks.
- Regulus reported clinical data on RG-101 showing that patients with hepatitis C virus achieved sustained viral suppression after only a single dose of RG-101, and that some patients remained below the level of detection for hepatitis C virus 20 weeks after a single dose.
- Isis reported Phase 1 results showing that ISIS-ANGPTL3Rx produced significant reductions of up to 93 percent in ANGPTL3, up to 63 percent in triglycerides and up to 46 percent in total cholesterol in healthy volunteers.
- Isis reported Phase 1 results showing that ISIS-PKKRx produced significant, dose-dependent reductions of PKK of up to 95 percent in healthy volunteers.
Corporate Highlights (2015 first quarter and subsequent activities)
- Isis licensed ISIS-FXIRx to
Bayer HealthCare to develop and commercialize ISIS-FXIRx for the prevention of thrombosis.- Isis is eligible to receive up to
$375 million in payments, including a$100 million upfront payment and a$55 million milestone payment upon advancement of the program following completion of the planned Phase 2 study. - Isis is eligible to receive tiered royalties in the low to high 20 percent range on gross margins of ISIS-FXIRx.
- This transaction is subject to clearances under the Hart-Scott Rodino Antitrust Improvements Act.
- Isis is eligible to receive up to
- Isis formed an alliance with Janssen to discover and develop antisense drugs to treat autoimmune disorders of the GI tract.
- Isis received
$35 million in upfront payments and is eligible to receive nearly$800 million in development, regulatory and sales milestone payments and license fees for the programs under this alliance. - Isis will also receive tiered royalties that on average are double digits on sales of drugs successfully commercialized.
- Isis received
- Isis formed a wholly owned subsidiary, Akcea Therapeutics, to develop and commercialize its lipid drugs, ISIS-APOCIIIRx, ISIS-APO(a)Rx, ISIS-ANGPTL3Rx and the follow on drugs for these programs.
- Isis and Alnylam formed a new agreement that includes a cross-license of intellectual property, providing each company rights to certain of each other's technology advances.
- The new agreement also provides each company with exclusive RNA therapeutic license rights for two programs.
- Isis generated more than
$195 million in payments from partners, including the following:$100 million from Bayer$42 million from Biogen$35 million from Janssen$17 million from GSK
Conference Call
At
ABOUT
Isis is exploiting its leadership position in RNA-targeted technology to discover and develop novel drugs for its product pipeline and for its partners. Isis' broad pipeline consists of 38 drugs to treat a wide variety of diseases with an emphasis on cardiovascular, metabolic, severe and rare diseases, including neurological disorders, and cancer. Isis' partner, Genzyme, is commercializing Isis' lead product, KYNAMRO®, in
FORWARD-LOOKING STATEMENT
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, INC. SELECTED FINANCIAL INFORMATION |
|||||
Condensed Consolidated Statements of Operations (In Thousands, Except Per Share Data) |
|||||
Three months ended, |
|||||
March 31, |
|||||
2015 |
2014 |
||||
Revenue: |
(unaudited) |
||||
Research and development revenue |
|||||
under collaborative agreements |
$61,892 |
$19,550 |
|||
Licensing and royalty revenue |
691 |
8,611 |
|||
Total revenue |
62,583 |
28,161 |
|||
Expenses: |
|||||
Research, development and patent expenses |
64,447 |
53,448 |
|||
General and administrative |
7,466 |
4,380 |
|||
Total operating expenses |
71,913 |
57,828 |
|||
Income (loss) from operations |
(9,330) |
(29,667) |
|||
Other income (expense): |
|||||
Investment income |
845 |
657 |
|||
Interest expense |
(9,021) |
(4,943) |
|||
Gain on investments, net |
- |
397 |
|||
Loss before income tax benefit |
$(17,506) |
$(33,556) |
|||
Income tax benefit |
789 |
2,276 |
|||
Net loss |
$(16,717) |
$(31,280) |
|||
Basic and diluted net loss per share |
$(0.14) |
$(0.27) |
|||
Shares used in computing basic and diluted net loss per share |
118,948 |
117,128 |
Isis Pharmaceuticals, Inc. Reconciliation of GAAP to Pro Forma Basis: Condensed Consolidated Operating Expenses, and (Income) Loss From Operations (In Thousands) |
|||||
Three months ended, |
|||||
2015 |
2014 |
||||
(unaudited) |
|||||
As reported operating expenses according to GAAP |
$71,913 |
$57,828 |
|||
Excluding compensation expense related to equity awards |
(13,305) |
(7,069) |
|||
Pro forma operating expenses |
$58,608 |
$50,759 |
|||
As reported income (loss) from operations according to GAAP |
$(9,330) |
$(29,667) |
|||
Excluding compensation expense related to equity awards |
(13,305) |
(7,069) |
|||
Pro forma income (loss) from operations |
$3,975 |
$(22,598) |
|||
As reported net loss according to GAAP |
$(16,717) |
$(31,280) |
|||
Excluding compensation expense related to equity awards |
(13,305) |
(7,069) |
|||
Pro forma net loss |
$(3,412) |
$(24,211) |
Reconciliation of GAAP to Pro Forma Basis
As illustrated in the Selected Financial Information in this press release, pro forma operating expenses, pro forma income (loss) from operations, and proforma net income (loss) 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 results 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, |
||||
2015 |
2014 |
||||
(unaudited) |
|||||
Assets: |
|||||
Cash, cash equivalents and short-term investments |
$695,054 |
$728,832 |
|||
Investment in Regulus Therapeutics Inc. |
93,446 |
81,881 |
|||
Other current assets |
46,927 |
25,884 |
|||
Property, plant and equipment, net |
89,047 |
88,958 |
|||
Other assets |
30,959 |
30,254 |
|||
Total assets |
$955,433 |
$955,809 |
|||
Liabilities and stockholders' equity: |
|||||
Other current liabilities |
$47,702 |
$63,619 |
|||
Current portion of deferred contract revenue |
52,586 |
51,713 |
|||
1% convertible senior notes |
332,274 |
327,486 |
|||
2 3/4% convertible senior notes |
48,579 |
48,014 |
|||
Long-term obligations, less current portion |
79,358 |
79,400 |
|||
Long-term deferred contract revenue |
119,083 |
127,797 |
|||
Stockholders' equity |
275,851 |
257,780 |
|||
Total liabilities and stockholders' equity |
$955,433 |
$955,809 |
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SOURCE
D. Wade Walke, Ph.D., Vice President, Corporate Communications and Investor Relations, 760-603-2741, Amy Blackley, Ph.D., Associate Director, Corporate Communications,760-603-2772