Press Releases
Isis Reports Financial Results and Highlights for Second Quarter 2013
"We had a successful second quarter. We ended the quarter with a significantly improved financial position. We added a new partner,
"We ended the second quarter with more than
Upcoming Key Milestones
- Report clinical data on ISIS-APOCIIIRx as a monotherapy in patients with severely high triglycerides at the
European Society of Cardiology Congress . - Present the complete Phase 2 clinical data for ISIS-APOCIIIRx at the
American Heart Association . - Report data from two clinical studies evaluating ISIS-SMNRx in children and in infants with spinal muscular atrophy.
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 and six months ended
$25 million from Genzyme when theFDA approved the KYNAMRO™ NDA;$10 million whenAstraZeneca added a second development candidate, ISIS-ARRx, to its collaboration with Isis;$7.5 million from GlaxoSmithKline when Isis initiated the Phase 2/3 study of ISIS-TTRRx;$3.5 million fromBiogen Idec when Isis dosed the first infant in a Phase 2 study of ISIS-SMNRx; and$3.5 million when Xenon licensed a development candidate, XEN701, from Isis.
In comparison, Isis earned a
Operating Expenses
On a pro forma basis, Isis' operating expenses of
On a GAAP basis, Isis' operating expenses for the three and six months ended
Net Loss
Isis reported a net loss of
Balance Sheet
As of
Business Highlights
"Our innovative business strategy provides us with multiple opportunities to create and maintain value. We design our drug development activities to demonstrate the broad therapeutic profile of each drug. In this way, we strive to maximize the value of each drug. For example, ISIS-APOCIIIRx is an antisense drug we discovered and are developing to treat patients with severely high triglycerides. Because of our clinical experience with KYNAMRO, our strong internal development capabilities and the manageable size of the clinical program required for our initial indication, we believe we can successfully develop ISIS-APOCIIIRx on our own without a partner. Our recent successful stock offering provides us with the cash we need to develop ISIS-APOCIIIRx through Phase 3 development on our own. Already this year, we reported positive Phase 2 data from ISIS-APOCIIIRx in two separate Phase 2 studies in patients with high triglycerides. In these studies, we observed positive effects on apoC-III, triglycerides, overall lipid parameters and other measures of activity. These data show that ISIS-APOCIIIRx can be used as a monotherapy or in combination with other triglyceride-lowering drugs with the potential to positively impact the lives of patients with severely high triglycerides. We plan to report the third set of data later this month and initiate the Phase 3 program for ISIS-APOCIIIRx early next year after discussions with the
Drug Development Highlights
- Isis and its partners advanced antisense drugs in Isis' pipeline and reported positive clinical data from three programs.
- Isis advanced the Phase 2/3 study of ISIS-TTRRx, a drug to treat patients with familial amyloid polyneuropathy. As a result, Isis earned
$2 million from GlaxoSmithKline. - Isis reported Phase 2 data on ISIS-APOCIIIRx in patients with high to severely high triglycerides on stable fibrates. In this study, ISIS-APOCIIIRx treatment resulted in statistically significant reductions in triglycerides and apoC-III and a statistically significant increase in HDL.
- Isis reported Phase 2 data on ISIS-APOCIIIRx in patients with high triglycerides and type 2 diabetes at the American Diabetes Association Scientific Sessions. In this study, ISIS-APOCIIIRx treatment resulted in statistically significant reductions in triglycerides and apoC-III and a statistically significant increase in high-density lipoprotein (HDL). In this study treated patients also experienced improvements in glucose control and trends toward enhanced insulin sensitivity.
- Isis reported Phase 2 data on ISIS-CRPRx in patients with rheumatoid arthritis (RA). In this study, patients treated with ISIS-CRPRx achieved rapid, dose-dependent mean reductions of up to 67 percent in CRP, but failed to demonstrate improvements in signs and symptoms of RA that were sufficiently better than those achieved by patients in the placebo group to justify further development of ISIS-CRPRx for RA.
- Dr.
David Hong reported Phase 1 data on ISIS-STAT3Rx at theAmerican Society of Clinical Oncology . In this study, treatment with ISIS-STAT3Rx resulted in partial responses that were durable and prolonged in two out of three patients with diffuse large B-cell lymphoma who were refractory to prior chemotherapy treatments.
- Isis advanced the Phase 2/3 study of ISIS-TTRRx, a drug to treat patients with familial amyloid polyneuropathy. As a result, Isis earned
- Isis and its partners initiated clinical studies on three drugs in Isis' pipeline.
- Isis initiated a Phase 2 study of ISIS-SMNRx in infants with SMA and earned a
$3.5 million milestone payment fromBiogen Idec . AstraZeneca initiated a Phase 1b/2a study of ISIS-STAT3Rx in patients with advanced metastatic hepatocellular carcinoma.- Isis initiated a Phase 1 study of ISIS-APOARx, an antisense drug designed to reduce levels of Lp(a), an atherogenic lipoprotein.
- Isis initiated a Phase 2 study of ISIS-SMNRx in infants with SMA and earned a
- Isis and its partners continued to advance Isis' preclinical stage pipeline by adding three drugs into development.
AstraZeneca selected ISIS-ARRx as the second development candidate to advance into development under its collaboration with Isis. As a result, Isis earned a$10 million milestone payment fromAstraZeneca .- Xenon selected XEN701 as a development candidate and licensed XEN701 from Isis. As a result, Isis earned
$3.5 million from Xenon. - Isis added a new drug to its pipeline, ISIS-ANGTL3Rx, for the treatment of hyperlipidemia.
Corporate Highlights
- Isis successfully completed a public offering of common stock raising
$173.2 million in net proceeds. Isis plans to use the proceeds from this offering to pursue Phase 3 development of ISIS-APOCIIIRx, retain additional drugs longer in development and advance the rest of its pipeline. - Isis added
Breaux Castleman , a senior executive with extensive business experience, to its Board of Directors. - Isis received
$6 million fromAstraZeneca related to the continuation of the research collaboration between Isis andAstraZeneca to discover and develop novel antisense drugs to treat cancer. - Isis formed a new alliance with
Roche to discover and develop antisense drugs to treat Huntington's disease.- Isis received a
$30 million upfront payment and is eligible to receive up to$362 million in a license fee, pre-licensing and post-licensing milestone payments, including up to$80 million in commercial milestones. - In addition, Isis is eligible to receive up to
$136.5 million in milestone payments for each additional drug successfully developed plus up to$50 million in commercial milestones if a drug usingRoche's proprietary brain shuttle technology is successfully commercialized. - Isis is also eligible to receive tiered royalties on sales of drugs arising from the alliance.
- Isis received a
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 28 drugs to treat a wide variety of diseases with an emphasis on cardiovascular, metabolic, severe and rare diseases, 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® 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, |
Six months ended, |
||||||||
June 30, |
June 30, |
||||||||
2013 |
2012 |
2013 |
2012 |
||||||
Revenue: |
(unaudited) |
(unaudited) |
|||||||
Research and development revenue under collaborative agreements |
$37,615 |
$47,140 |
$79,535 |
$68,957 |
|||||
Licensing and royalty revenue |
477 |
200 |
1,916 |
1,618 |
|||||
Total revenue |
38,092 |
47,340 |
81,451 |
70,575 |
|||||
Expenses: |
|||||||||
Research and development |
42,631 |
40,435 |
80,944 |
79,149 |
|||||
General and administrative |
3,389 |
3,209 |
6,811 |
6,185 |
|||||
Total operating expenses |
46,020 |
43,644 |
87,755 |
85,334 |
|||||
Income (loss) from operations |
(7,928) |
3,696 |
(6,304) |
(14,759) |
|||||
Other income (expense): |
|||||||||
Equity in net loss of Regulus Therapeutics Inc. |
- |
(163) |
- |
(1,139) |
|||||
Investment income |
589 |
477 |
967 |
1,077 |
|||||
Interest expense |
(4,808) |
(5,219) |
(9,603) |
(10,398) |
|||||
Gain on investments, net |
840 |
2 |
1,898 |
19 |
|||||
Loss before income tax benefit (expense) |
(11,307) |
(1,207) |
(13,042) |
(25,200) |
|||||
Income tax benefit (expense) |
1,181 |
- |
1,244 |
(2) |
|||||
Net loss |
$(10,126) |
$(1,207) |
$(11,798) |
$(25,202) |
|||||
Basic and diluted net loss per share |
$(0.09) |
$(0.01) |
$(0.11) |
$(0.25) |
|||||
Shares used in computing basic and diluted net loss per share |
108,539 |
100,213 |
105,225 |
100,185 |
Isis Pharmaceuticals, Inc. Reconciliation of GAAP to Pro Forma Basis: Condensed Consolidated Operating Expenses and (Income) Loss From Operations (In Thousands)
|
||||||||||
Three months ended, June 30, |
Six months ended, June 30, |
|||||||||
2013 |
2012 |
2013 |
2012 |
|||||||
(unaudited) |
(unaudited) |
|||||||||
As reported operating expenses according to GAAP |
$46,020 |
$43,644 |
$87,755 |
$85,334 |
||||||
Excluding compensation expense related to equity awards |
(2,636) |
(2,460) |
(5,505) |
(4,727) |
||||||
Pro forma operating expenses |
$43,384 |
$41,184 |
$82,250 |
$80,607 |
||||||
As reported income (loss) from operations according to GAAP |
$(7,928) |
$3,696 |
$(6,304) |
$(14,759) |
||||||
Excluding compensation expense related to equity awards |
(2,636) |
(2,460) |
(5,505) |
(4,727) |
||||||
Pro forma income (loss) from operations |
$(5,292) |
$6,156 |
$(799) |
$(10,032) |
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 income (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 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)
|
|||||
June 30, |
December 31, |
||||
2013 |
2012 |
||||
(unaudited) |
|||||
Assets: |
|||||
Cash, cash equivalents and short-term investments |
$590,752 |
$374,446 |
|||
Investment in Regulus Therapeutics Inc. |
62,190 |
33,622 |
|||
Other current assets |
16,119 |
15,370 |
|||
Property, plant and equipment, net |
88,312 |
91,084 |
|||
Other assets |
31,278 |
31,164 |
|||
Total assets
|
$788,651 |
$545,686 |
|||
Liabilities and stockholders' equity: |
|||||
Other current liabilities |
$46,586 |
$38,397 |
|||
Current portion of deferred contract revenue |
40,409 |
35,925 |
|||
2 3/4% convertible senior notes |
147,099 |
143,990 |
|||
Long-term obligations, less current portion |
78,292 |
77,952 |
|||
Long-term deferred contract revenue |
75,184 |
66,656 |
|||
Stockholders' equity |
401,081 |
182,766 |
|||
Total liabilities and stockholders' equity |
$788,651 |
$545,686 |
|||
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