Press Releases
Isis Reports Financial Results and Highlights for Second Quarter 2015
"So far this year we have completed transactions that advance every element of our business. These transactions support our continued strong financial performance. However, their strategic value now and in the future is even more important. Yesterday, we announced an expansion of our strategic relationship with
"In addition, our other collaborations continue to yield successes. We reported positive top line conclusions from the FOCUS FH study of KYNAMRO. We initiated the first clinical study on ISIS-HTTRx in patients with Huntington's disease in our
"Our continued strong financial performance so far this year has been driven by the successes across all areas of our business. We reported significant operating and net income for our second quarter and the first six months of this year due in large part to the more than
"Because of our strong financial performance in the first half of this year, we expect to substantially improve upon our year-end guidance. We are reducing our projected pro forma NOL by more than 40 percent to a pro forma NOL in the low
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
$41 million from Biogen including payments for advancing ISIS-SMNRx in late-stage clinical development, for advancing ISIS-BIIB4Rx into development and for validating two new undisclosed targets for neurological disorders; and$15 million from GSK for advancing the Phase 3 study of ISIS-TTRRx.
Isis' revenue in the first half of 2015 also included
Already in the third quarter of 2015, Isis has earned
Isis' revenue fluctuates based on the nature and timing of payments under agreements with its partners and consists primarily of revenue from the amortization of upfront fees, milestone payments and license fees.
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 volanesorsen. As such, Isis' pro forma operating expenses of
Net Income (Loss)
Isis reported net income of
Balance Sheet
As of
Business Highlights
"We believe that the second half of the year will be equally productive with a number of pipeline activities that should continue to provide value to Isis and its shareholders. From our lipid franchise, we plan to report data from our Phase 2 study on our novel Lp(a)-lowering drug. The importance of therapies to specifically reduce Lp(a) and the promise of Akcea's drug to do so was highlighted in a recent Lancet article and points to patients' need for a specific Lp(a) lowering medicine. We have numerous clinical trial initiations planned, including the Phase 3 study in cardiomyopathy being conducted by GSK and the Phase 3 study evaluating volanesorsen in patients with familial partial lipodystrophy. This second Phase 3 study for volanesorsen is designed to support bringing this important drug to the market for these patients who have an ultra-rare orphan disease and who are in need of effective new therapies. And of course, we expect to continue to add new drugs to our pipeline this year," concluded Ms. Parshall.
Corporate Highlights (2015 second quarter and subsequent activities)
- Isis licensed ISIS-FXIRx to Bayer to develop and commercialize ISIS-FXIRx for the prevention of thrombosis.
- Isis generated a
$100 million upfront payment from Bayer and is eligible to earn up to$275 million in additional payments, including 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.
- Isis generated a
- Isis and
AstraZeneca formed a multi-year collaboration to discover and develop novel antisense drugs primarily focused on treating cardiovascular, metabolic and kidney diseases.- In total, Isis has the potential to earn up to more than
$4 billion in license fees and milestone payments.- Isis will receive a
$65 million upfront payment fromAstraZeneca and is eligible to earn substantial development and regulatory milestone payments and license fees. Isis is eligible to earn a payment of$25-30 million under this collaboration next year upon identification of the first drug candidate to move into development. - Isis is also eligible to earn tiered double digit royalties on annual net sales for each of the programs.
- This transaction is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act.
- Isis will receive a
- In total, Isis has the potential to earn up to more than
- To date this year, Isis has generated nearly
$300 million in payments from its partners.
Drug Development Highlights (2015 second quarter and subsequent activities)
- Isis reported positive clinical results from KYNAMRO, ISIS-SMNRx and ISIS-TTRRx. These data exemplify the broad applicability and potential for antisense drugs to provide therapeutic benefit for many different diseases.
- Isis reported that the FOCUS FH study evaluating KYNAMRO in patients with severe heterozygous familial hypercholesterolemia met its primary endpoint with a statistically significant reduction of LDL-Cholesterol. Genzyme and Isis plan to report the full data from this study at an upcoming medical meeting.
- Isis presented positive results based on an
April 17, 2015 data analysis from the ongoing open-label Phase 2 clinical study of ISIS-SMNRx in infants with Type I spinal muscular atrophy. The data reported showed continued increases in median event-free survival and muscle function scores as well as achievement of developmental milestones. - Isis provided an update based on a
May 15, 2015 data analysis in children with spinal muscular atrophy who have completed the open-label, Phase 2 multiple-dose study of ISIS-SMNRx and are continuing to receive treatment in an open-label extension study. Consistent with earlier observations, increases in muscle function scores and additional motor function tests were observed in children treated with ISIS-SMNRx. - Dr.
Merrill Benson , an investigator of ISIS-TTRRx, reported positive data from an investigator-initiated study in patients with TTR amyloid-related cardiomyopathy. In this study, Dr. Benson observed apparent stabilization of cardiac disease after six months of treatment with ISIS-TTRRx with no progression of cardiac disease. Patients also experienced up to 88 percent reduction in TTR after nine months of dosing compared to baseline. - Isis reported positive results from an ongoing open-label extension study of ISIS-TTRRx in patients with familial amyloid polyneuropathy (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.
- Isis reported positive Phase 2 data for ISIS-GCCRRx in patients with type 2 diabetes. In this study after six weeks of treatment with ISIS-GCCRRx, patients achieved improvements in multiple measures of glucose control with trends toward improvements in insulin sensitivity.
- Isis published clinical data from its novel lipid drugs, volanesorsen and ISIS-APO(a)Rx, in the
New England Journal of Medicine and The Lancet , respectively, two prestigious medical journals. These data highlight the significant interest from the medical community in Isis' lipid drugs and the significance of the clinical data from these programs. - Volanesorsen was granted orphan drug designation from the US FDA for the treatment of patients with familial chylomicronemia syndrome.
- Isis continued to advance its pipeline of drugs.
- Isis initiated a Phase 1/2 study of ISIS-HTTRx in patients with Huntington's disease (HD). ISIS-HTTRx has been granted orphan drug designation by the
European Medicines Agency for the treatment of patients with HD. - Isis initiated a Phase 2 study to evaluate the safety and activity of ISIS-FGFR4Rx in patients who are obese.
- Isis initiated a Phase 1/2 study of ISIS-HTTRx in patients with Huntington's disease (HD). ISIS-HTTRx has been granted orphan drug designation by the
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, |
Six months ended, |
|||||||
June 30, |
June 30, |
|||||||
2015 |
2014 |
2015 |
2014 |
|||||
Revenue: |
(unaudited) |
(unaudited) |
||||||
Research and development revenue under collaborative agreements |
$119,658 |
$56,628 |
181,551 |
$76,177 |
||||
Licensing and royalty revenue |
770 |
448 |
1,461 |
9,060 |
||||
Total revenue |
120,428 |
57,076 |
183,012 |
85,237 |
||||
Expenses: |
||||||||
Research, development and patent expenses |
68,007 |
59,264 |
132,454 |
112,712 |
||||
General and administrative |
7,775 |
4,462 |
15,241 |
8,842 |
||||
Total operating expenses |
75,782 |
63,726 |
147,695 |
121,554 |
||||
Income (loss) from operations |
44,646 |
(6,650) |
35,317 |
(36,317) |
||||
Other income (expense): |
||||||||
Investment income |
917 |
671 |
1,761 |
1,328 |
||||
Interest expense |
(9,127) |
(4,961) |
(18,148) |
(9,904) |
||||
Gain (loss) on investments, net |
1 |
(260) |
1 |
137 |
||||
Income (loss) before income tax benefit |
36,437 |
(11,200) |
18,931 |
(44,756) |
||||
Income tax benefit (expense) |
(789) |
(881) |
- |
1,395 |
||||
Net income (loss) |
35,648 |
$(12,081) |
18,931 |
$(43,361) |
||||
Basic net income (loss) per share |
$0.30 |
$(0.10) |
$0.16 |
$(0.37) |
||||
Diluted net income (loss) per share |
$0.29 |
$(0.10) |
$0.15 |
$(0.37) |
||||
Shares used in computing basic net income (loss) per share |
119,742 |
117,588 |
119,348 |
117,359 |
||||
Shares used in computing diluted net income (loss) per share |
127,779 |
117,588 |
124,061 |
117,359 |
||||
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, |
|||||||||||
2015 |
2014 |
2015 |
2014 |
|||||||||
(unaudited) |
(unaudited) |
|||||||||||
As reported operating expenses according to GAAP |
$75,782 |
$63,726 |
$147,695 |
$121,554 |
||||||||
Excluding compensation expense related to equity awards |
(13,605) |
(7,708) |
(26,910) |
(14,777) |
||||||||
Pro forma operating expenses |
$62,177 |
$56,018 |
$120,785 |
$106,777 |
||||||||
As reported income (loss) from operations according to GAAP |
$44,646 |
$(6,650) |
$35,317 |
$(36,317) |
||||||||
Excluding compensation expense related to equity awards |
(13,605) |
(7,708) |
(26,910) |
(14,777) |
||||||||
Pro forma income (loss) from operations |
$58,251 |
$1,058 |
$62,227 |
$(21,540) |
||||||||
As reported net income (loss) according to GAAP |
$35,648 |
$(12,081) |
$18,931 |
$(43,361) |
||||||||
Excluding compensation expense related to equity awards |
(13,605) |
(7,708) |
(26,910) |
(14,777) |
||||||||
Pro forma net income (loss) |
$49,253 |
$(4,373) |
$45,841 |
$(28,584) |
||||||||
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 pro forma 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) |
|||||
June 30, |
December 31, |
||||
2015 |
2014 |
||||
(unaudited) |
|||||
Assets: |
|||||
Cash, cash equivalents and short-term investments |
$754,934 |
$728,832 |
|||
Investment in Regulus Therapeutics Inc. |
60,604 |
81,881 |
|||
Other current assets |
39,914 |
25,884 |
|||
Property, plant and equipment, net |
89,692 |
88,958 |
|||
Other assets |
31,114 |
30,254 |
|||
Total assets |
$976,258 |
$955,809 |
|||
Liabilities and stockholders' equity: |
|||||
Other current liabilities |
$43,847 |
$63,619 |
|||
Current portion of deferred contract revenue |
58,285 |
51,713 |
|||
1% convertible senior notes |
337,158 |
327,486 |
|||
2 3/4% convertible senior notes |
49,160 |
48,014 |
|||
Long-term obligations, less current portion |
79,360 |
79,400 |
|||
Long-term deferred contract revenue |
108,128 |
127,797 |
|||
Stockholders' equity |
300,320 |
257,780 |
|||
Total liabilities and stockholders' equity |
$976,258 |
$955,809 |
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SOURCE
D. Wade Walke, Ph.D., Vice President, Corporate Communications and Investor Relations, 760-603-2741; Amy Williford, Ph.D., Associate Director, Corporate Communications, 760-603-2772