Press Releases
Isis Reports Financial Results and Highlights for Second Quarter 2014
"Our strong financial position demonstrates the value our unique business strategy creates as our pipeline continues to advance. We have initiated the Phase 3 program for ISIS-SMNRx to treat patients with spinal muscular atrophy. Our Phase 3 clinical study of ISIS-TTRRx in patients with the polyneuropathy form of transthyretin amyloidosis is enrolling well and patients who have completed the controlled portion of the study can continue to receive treatment in our open-label extension study. Also this year, we plan to initiate the Phase 3 program for ISIS-APOCIIIRx to treat patients with severely elevated triglyceride levels with the first study starting very shortly," said
"We ended the second quarter with pro forma net operating income of
Upcoming Key Milestones
- Initiate an additional Phase 3 clinical study on ISIS-SMNRx.
- Initiate a Phase 3 clinical program on ISIS-APOCIIIRx.
- Report the full data analysis of the Phase 2 study of ISIS-FXIRx at an upcoming medical meeting.
- Report data from Phase 2 studies of ISIS-SMNRx in both children and infants with SMA at an upcoming medical meeting.
- Report Phase 2 data from ISIS-GCCRRx and ISIS-PTP1BRx in patients with type 2 diabetes.
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
Isis also earned
$24.5 million fromBiogen Idec related to advancing ISIS-SMNRx, initiating a Phase 1 study for ISIS-DMPKRx, and validating an undisclosed target to treat a neurological disorder;$15 million fromAstraZeneca related to initiating a Phase 1 clinical study of ISIS-ARRx; and$2 million from GSK related to advancing ISIS-TTRRx.
Operating Expenses
On a pro forma 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
"We have had a successful start to the year. We reported positive Phase 2 data from five of the drugs in our pipeline. These data highlight the potential of our antisense technology to create drugs to treat a wide range of diseases, including type 2 diabetes, high triglycerides and orphan diseases, like SMA and FCS, where there are no therapeutic options. We advanced two partnered drugs into clinical development for which we earned
Corporate and Drug Development Highlights
- Isis reported positive clinical results from five drugs in later-stage development. These data exemplify the broad applicability and potential for antisense drugs to provide therapeutic benefit to many different diseases.
- Isis reported positive Phase 2 data on ISIS-APOCIIIRx in patients with high to extremely high triglyceride levels as a single agent and in combination with fibrates. In these studies, patients experienced substantial reductions of triglyceride and apoC-III levels with significant increases in HDL-cholesterol. These Phase 2 data were presented at the Arteriosclerosis, Thrombosis and Vascular Biology and the
National Lipid Association meetings. - Isis presented positive results from both of the ongoing multiple-dose open label Phase 2 studies of ISIS-SMNRx in infants and children with SMA, which were consistent with earlier reported data. In these studies, Isis reported increases in muscle function scores in infants and children treated with ISIS-SMNRx. These Phase 2 data were presented at the
American Academy of Neurology meeting. - Isis reported positive Phase 2 data for ISIS-GCGRRx in patients with type 2 diabetes. In this study, patients with type 2 diabetes uncontrolled on stable metformin therapy experienced up to a 2.25 percentage point mean reduction in HbA1c levels after 13 weeks of dosing. These Phase 2 data were presented at the American Diabetes Association Scientific Sessions.
- Isis reported positive top-line Phase 2 clinical results for ISIS-FXIRx in patients undergoing total knee replacement. In this study, ISIS-FXIRx-treated patients experienced a dose-dependent decrease in venous thromboembolism and numerically fewer bleeding events compared to patients treated with enoxaparin.
- Isis reported Phase 2 results showing that ISIS-CRPRx produced statistically significant mean reductions of CRP protein of 65% with reductions as great as 84% in patients with atrial fibrillation (AF). In addition, two patients who had elevated levels of CRP (>5 mg/L) experienced a reduction of CRP that was associated with a decline to zero in overall AF burden while on treatment.
- Isis reported positive Phase 2 data on ISIS-APOCIIIRx in patients with high to extremely high triglyceride levels as a single agent and in combination with fibrates. In these studies, patients experienced substantial reductions of triglyceride and apoC-III levels with significant increases in HDL-cholesterol. These Phase 2 data were presented at the Arteriosclerosis, Thrombosis and Vascular Biology and the
- Isis continued to advance its pipeline of drugs.
- Isis initiated a Phase 3 study, ENDEAR, of ISIS-SMNRx in infants with SMA and will earn an
$18 million milestone payment upon dosing of the first infant. This is the first of several planned studies in a broad and comprehensive late-stage clinical development program for ISIS-SMNRx. - Isis initiated a Phase 2 study of ISIS-APO(a)Rx in patients with high levels of lipoprotein(a), an independent risk factor for cardiovascular disease.
- Isis initiated a Phase 1 study of ISIS-PKKRx, an antisense drug to treat patients with hereditary angioedemia, and a Phase 1 study of ISIS-DMPKRx, an antisense drug to treat patients with myotonic dystrophy type 1.
- AstraZeneca initiated a Phase 1 study of ISIS-ARRx, an antisense drug discovered by Isis to treat patients with cancer.
- Isis added a new drug, ISIS-HTTRx, to its pipeline. ISIS-HTTRx is part of Isis' alliance with
Roche and is in development to treat patients with Huntington's Disease.
- Isis initiated a Phase 3 study, ENDEAR, of ISIS-SMNRx in infants with SMA and will earn an
- Isis and its partners were recognized by the drug development community for Isis' innovative and collaborative alliances and Isis' commitment to developing drugs to treat patients with serious, unmet medical needs.
- Isis and Genzyme received the 2014 Partners in Progress Corporate Award from the
National Organization for Rare Disorders (NORD) for the development and approval of KYNAMRO, a drug selected for being a very important orphan therapy to reach the market inthe United States . This award honors companies that have brought important and innovative treatments to market for patients with rare disorders. - Isis' and
Biogen Idec's innovative collaboration was voted breakthrough alliance of 2014 by Thomson Reuters Recap. Frank Bennett , Ph.D., Isis' senior vice president, research, was a recipient of the Commitment to a Cure Award by theALS Association for his and Isis' research and commitment to develop a treatment for amyotrophic lateral sclerosis (ALS).
- Isis and Genzyme received the 2014 Partners in Progress Corporate Award from the
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 32 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, |
Six months ended, |
|||||||
June 30, |
June 30, |
|||||||
2014 |
2013 |
2014 |
2013 |
|||||
Revenue: |
(unaudited) |
(unaudited) |
||||||
Research and development revenue under collaborative agreements |
$56,628 |
$37,615 |
$76,177 |
$79,285 |
||||
Licensing and royalty revenue |
448 |
477 |
9,060 |
2,166 |
||||
Total revenue |
57,076 |
38,092 |
85,237 |
81,451 |
||||
Expenses: |
||||||||
Research, development and patent expenses |
59,264 |
42,631 |
112,712 |
80,944 |
||||
General and administrative |
4,462 |
3,389 |
8,842 |
6,811 |
||||
Total operating expenses |
63,726 |
46,020 |
121,554 |
87,755 |
||||
Loss from operations |
(6,650) |
(7,928) |
(36,317) |
(6,304) |
||||
Other income (expense): |
||||||||
Investment income |
671 |
589 |
1,328 |
967 |
||||
Interest expense |
(4,961) |
(4,808) |
(9,904) |
(9,603) |
||||
Gain (loss) on investments, net |
(260) |
840 |
137 |
1,898 |
||||
Loss before income tax benefit |
(11,200) |
(11,307) |
(44,756) |
(13,042) |
||||
Income tax benefit (expense) |
(881) |
1,181 |
1,395 |
1,244 |
||||
Net loss |
$(12,081) |
$(10,126) |
$(43,361) |
$(11,798) |
||||
Basic and diluted net loss per share |
$(0.10) |
$(0.09) |
$(0.37) |
$(0.11) |
||||
Shares used in computing basic and diluted net loss per share |
117,588 |
108,539 |
117,359 |
105,225 |
Isis Pharmaceuticals, Inc. Reconciliation of GAAP to Pro Forma Basis: Condensed Consolidated Operating Expenses, (Income) Loss From Operations, and Net Loss (In Thousands) |
||||||||||||
Three months ended, June 30, |
Six months ended, June 30, |
|||||||||||
2014 |
2013 |
2014 |
2013 |
|||||||||
(unaudited) |
(unaudited) |
|||||||||||
As reported operating expenses according to GAAP |
$63,726 |
$46,020 |
$121,554 |
$87,755 |
||||||||
Excluding compensation expense related to equity awards |
(7,708) |
(2,636) |
(14,777) |
(5,505) |
||||||||
Pro forma operating expenses |
$56,018 |
$43,384 |
$106,777 |
$82,250 |
||||||||
As reported loss from operations according to GAAP |
$(6,650) |
$(7,928) |
$(36,317) |
$(6,304) |
||||||||
Excluding compensation expense related to equity awards |
(7,708) |
(2,636) |
(14,777) |
(5,505) |
||||||||
Pro forma income (loss) from operations |
$1,058 |
$(5,292) |
$(21,540) |
$(799) |
||||||||
As reported net loss according to GAAP |
$(12,081) |
$(10,126) |
$(43,361) |
$(11,798) |
||||||||
Excluding compensation expense related to equity awards |
(7,708) |
(2,636) |
(14,777) |
(5,505) |
||||||||
Pro forma net loss |
$(4,373) |
$(7,490) |
$(28,584) |
$(6,293) |
||||||||
Reconciliation of GAAP to Pro Forma Basis
As illustrated in the Selected Financial Information in this press release, pro forma operating expenses, pro forma loss from operations, and proforma net 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) |
|||||
June 30, |
December 31, |
||||
2014 |
2013 |
||||
(unaudited) |
|||||
Assets: |
|||||
Cash, cash equivalents and short-term investments |
$590,835 |
$656,761 |
|||
Investment in Regulus Therapeutics Inc. |
56,678 |
52,096 |
|||
Other current assets |
58,284 |
26,653 |
|||
Property, plant and equipment, net |
86,321 |
86,198 |
|||
Other assets |
25,659 |
25,448 |
|||
Total assets |
$817,777 |
$847,156 |
|||
Liabilities and stockholders' equity: |
|||||
Other current liabilities |
$49,256 |
$49,677 |
|||
Current portion of deferred contract revenue |
51,560 |
48,135 |
|||
2 3/4% convertible senior notes |
153,700 |
150,334 |
|||
Long-term obligations, less current portion |
76,014 |
77,830 |
|||
Long-term deferred contract revenue |
120,387 |
142,790 |
|||
Stockholders' equity |
366,860 |
378,390 |
|||
Total liabilities and stockholders' equity |
$817,777 |
$847,156 |
|||
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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