Press Releases
Isis Reports Financial Results and Highlights for First Quarter 2014
"In the first quarter we have accomplished a number of significant milestones, setting the stage for a year of continuing growth. We reported positive clinical data on both ISIS-SMNRx and ISIS-APOCIIIRx, and are on track to initiate Phase 3 programs for both of these drugs this year. These Phase 3 studies will add to our Phase 3 study already ongoing for ISIS-TTRRx, which we began dosing over a year ago and is progressing according to plan. We started our first clinical study on ISIS-ANGPTL3Rx and added new drugs to the pipeline, including ISIS-HTTRx to treat Huntington's Disease. The continued growth and maturation of our pipeline means that we will have numerous pipeline events throughout the year, including in the middle of the year, reporting Phase 2 data from ISIS-GCGRRx and ISIS-FXIRx," said
"We started 2014 in a strong financial position and remain on track to meet our 2014 guidance. As our pipeline of partnered drugs mature, we have many opportunities to earn significant revenue from our partners. In the first quarter of 2014, we have earned more than
Upcoming Key Milestones
- Report Phase 2 clinical data on ISIS-FXIRx in patients undergoing total knee replacement
- Report Phase 2 clinical data on ISIS-GCGRRx in patients with type 2 diabetes
- Initiate Phase 3 clinical studies on ISIS-SMNRx and ISIS-APOCIIIRx
- Initiate Phase 1 clinical studies on ISIS-ARRx, ISIS-PKKRx and ISIS-DMPKRx
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
Operating Expenses
On a pro forma basis, Isis' operating expenses for the three 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 continue to successfully execute this strategy by establishing strategic partnerships that provide us with significant value not only when we begin a partnership, but also as our partnered drugs advance. Already this year, we have had numerous accomplishments with our partners that have led to the broadening and maturing of our pipeline. In less than a year, we have discovered and initiated development on a drug to treat Huntington's disease with our partners at Roche. Once we have completed the necessary studies to support clinical development, we will begin evaluating this drug in humans. Together with
Corporate and Drug Development Highlights
- Isis reported positive Phase 2 data on ISIS-APOCIIIRx in patients with high to extremely high triglyceride levels and as a single agent as well as in combination with fibrates.
- Isis presented final Phase 2 data on ISIS-APOCIIIRx in combination with fibrates in patients with high triglycerides. In this study, patients achieved statistically significant reductions in triglycerides, apoC-III protein and statistically significant increases in HDL-C on top of improvements achieved with each patient's existing therapeutic regimen of triglyceride lowering drugs. These data were presented at the
American College of Cardiology meeting. - Isis presented final Phase 2 data on ISIS-APOCIIIRx in patients with type 2 diabetes and high triglycerides. In this study, patients with diabetes experienced statistically significant improvements in glucose control with trends toward enhanced insulin sensitivity. These data were presented at the Arteriosclerosis, Thrombosis and Vascular Biology meeting.
- Isis presented final Phase 2 data on ISIS-APOCIIIRx in patients with familial chylomicronemia. In this study, patients with extremely high triglycerides experienced substantial reductions of triglycerides that correlated with substantial reductions in triglyceride-rich chylomicrons. These data were presented at the
National Lipid Association meeting. - Isis received European Orphan Drug Designation for ISIS-APOCIIIRx for the treatment of patients with familial chylomicronemia syndrome.
- Isis presented final Phase 2 data on ISIS-APOCIIIRx in combination with fibrates in patients with high triglycerides. In this study, patients achieved statistically significant reductions in triglycerides, apoC-III protein and statistically significant increases in HDL-C on top of improvements achieved with each patient's existing therapeutic regimen of triglyceride lowering drugs. These data were presented at the
- Isis reported positive clinical results for ISIS-SMNRx in children and infants with SMA. These data were presented at the
American Academy of Neurology meeting.- Isis presented results from both of the ongoing multiple-dose Phase 2 studies of ISIS-SMNRx in infants and children with SMA, which were consistent with earlier reported data. In the ongoing studies, Isis reported increases in muscle function scores in infants and children treated with multiple-doses of ISIS-SMNRx.
- Isis reported results from an assay that measures SMN protein levels in the cerebral spinal fluid. Isis observed dose-dependent increases in SMN protein levels which were more than two-fold greater than baseline levels at the highest dose in children treated with ISIS-SMNRx from both the single- and multiple-dose studies.
- Isis' collaborators presented preclinical data on an antisense drug targeting hepatitis B virus (HBV) demonstrating that antisense targeting of HBV produced dose-dependent reductions in HBV. Isis initiated a Phase 1 clinical trial on ISIS-HBVRx, an antisense drug to treat patients with HBV.
- Isis initiated a Phase 1 study of ISIS-ANGPTL3Rx, an antisense drug to treat patients with hyperlipidemia.
- 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 received a positive opinion on European Orphan Drug Designation in the EU for ISIS-TTRRx to treat patients with TTR amyloidosis.
- In 2014 to date, Isis received more than
$31 million in payments from its partners, including$11.9 million fromBiogen Idec related to the development of ISIS-SMNRx,$7.7 million from Alnylam related to Alnylam's alliance with Genzyme and$9 million from GSK related to the development of ISIS-TTRRx and ISIS-HBVRx. - Isis added
Joseph Loscalzo , M.D., Ph.D. to its Board of Directors.
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. |
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SELECTED FINANCIAL INFORMATION |
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Condensed Consolidated Statements of Operations |
|||||
(In Thousands, Except Per Share Data) |
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Three months ended, |
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March 31, |
|||||
2014 |
2013 |
||||
Revenue: |
(unaudited) |
||||
Research and development revenue |
|||||
under collaborative agreements |
$19,550 |
$41,671 |
|||
Licensing and royalty revenue |
8,611 |
1,689 |
|||
Total revenue |
28,161 |
43,360 |
|||
Expenses: |
|||||
Research, development and patent expenses |
53,448 |
38,312 |
|||
General and administrative |
4,380 |
3,423 |
|||
Total operating expenses |
57,828 |
41,735 |
|||
Income (loss) from operations |
(29,667) |
1,625 |
|||
Other income (expense): |
|||||
Investment income |
657 |
376 |
|||
Interest expense |
(4,943) |
(4,795) |
|||
Gain on investments, net |
397 |
1,058 |
|||
Loss before income tax benefit |
$(33,556) |
$(1,736) |
|||
Income tax benefit |
2,276 |
64 |
|||
Net loss |
$(31,280) |
$(1,672) |
|||
Basic and diluted net loss per share |
$(0.27) |
$(0.02) |
|||
Shares used in computing basic and diluted net loss per share |
117,128 |
101,875 |
Isis Pharmaceuticals, Inc. Reconciliation of GAAP to Pro Forma Basis: Condensed Consolidated Operating Expenses, (Income) Loss From Operations, and Net Income (Loss) (In Thousands) |
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Three months ended, March 31, |
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2014 |
2013 |
|||||||||
(unaudited) |
||||||||||
As reported operating expenses according to GAAP |
$57,828 |
$41,735 |
||||||||
Excluding compensation expense related to equity awards |
(7,069) |
(2,869) |
||||||||
Pro forma operating expenses |
$50,759 |
$38,866 |
||||||||
As reported income (loss) from operations according to GAAP |
$(29,667) |
$1,625 |
||||||||
Excluding compensation expense related to equity awards |
(7,069) |
(2,869) |
||||||||
Pro forma income (loss) from operations |
$(22,598) |
$4,494 |
||||||||
As reported net loss according to GAAP |
$(31,280) |
$(1,672) |
||||||||
Excluding compensation expense related to equity awards |
(7,069) |
(2,869) |
||||||||
Pro forma net income (loss) |
$(24,211) |
$1,197 |
||||||||
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 |
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(In Thousands) |
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March 31, |
December 31, |
||||
2014 |
2013 |
||||
(unaudited) |
|||||
Assets: |
|||||
Cash, cash equivalents and short-term investments |
$631,293 |
$656,761 |
|||
Investment in Regulus Therapeutics Inc. |
63,586 |
52,096 |
|||
Other current assets |
27,174 |
26,653 |
|||
Property, plant and equipment, net |
86,641 |
86,198 |
|||
Other assets |
25,922 |
25,448 |
|||
Total assets |
$834,616 |
$847,156 |
|||
Liabilities and stockholders' equity: |
|||||
Other current liabilities |
$46,408 |
$49,677 |
|||
Current portion of deferred contract revenue |
54,428 |
48,135 |
|||
2 3/4% convertible senior notes |
152,005 |
150,334 |
|||
Long-term obligations, less current portion |
76,918 |
77,830 |
|||
Long-term deferred contract revenue |
130,755 |
142,790 |
|||
Stockholders' equity |
374,102 |
378,390 |
|||
Total liabilities and stockholders' equity |
$834,616 |
$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