-
Well capitalized with
$111 million in cash and other investments at quarter end, with an additional$120 million raised post-quarter end
“We are encouraged by the established body of clinical, biochemical and
safety data for eteplirsen, which we plan to present at the tentatively
scheduled Advisory Committee meeting in January,” said
Financial Results
For the third quarter of 2015, Sarepta reported a non-GAAP net loss of
On a GAAP basis, the net loss for the third quarter of 2015 was
Revenue for the third quarter of 2015 decreased by
Non-GAAP research and development expenses were
The Company had cash, cash equivalents, short-term investments and
restricted investments of
In addition to the GAAP financial measures set forth in this press release, the Company has included certain non-GAAP measurements: non-GAAP research and development expenses, non-GAAP general and administrative expenses, non-GAAP operating expenses, non-GAAP net loss, and non-GAAP basic and diluted net loss per share, which present operating results on a basis adjusted for certain items. The Company uses these non-GAAP measures as key performance measures for the purpose of evaluating performance internally. The Company also believes these non-GAAP measures provide the Company’s investors with useful information regarding the Company’s historical operating results. These non-GAAP measures are not intended to replace the presentation of the Company’s financial results in accordance with GAAP. Use of the terms non-GAAP research and development expenses, non-GAAP general and administrative expenses, non-GAAP operating expenses, non-GAAP net loss, and non-GAAP basic and diluted net loss per share may differ from similar measures reported by other companies. All relevant non-GAAP measures are reconciled from their respective GAAP measures in the attached table 'Reconciliation of GAAP to Non-GAAP Net Loss.'
Recent Corporate Developments
Duchenne Muscular Dystrophy Program
--
--Sarepta Therapeutics Announces Additional Long-Term
Efficacy and Safety Data from Phase IIb Program of Eteplirsen for the
Treatment of Duchenne Muscular Dystrophy
--
--Sarepta
Therapeutics Receives Rare Pediatric Disease Designation from
Corporate Updates
--Sarepta Therapeutics Announces Public Offering of Common Stock
--Sarepta
Therapeutics Announces Collaborative Research Agreement with Murdoch
University Researchers Steve Wilton and
--Sarepta
Therapeutics Appoints Jean-Paul Kress, M.D., to the Company’s Board of
Directors
--Sarepta Therapeutics Announces USPTO Decision in Patent
Interference Case with
--Sarepta
Therapeutics Announces Formation of
Conference Call
The Company will be hosting a conference call at 8:00 a.m. EST, to discuss these financial results and other corporate updates. The conference call may be accessed by dialing 866-436-9172 for domestic callers and 630-691-2760 for international callers. The passcode for the call is 41044861. Please specify to the operator that you would like to join the “Sarepta Third Quarter 2015 Earnings Call.” The conference call will be webcast live under the investor relations section of Sarepta’s website at www.sarepta.com and will be archived there following the call for 90 days. Please connect to Sarepta’s website several minutes prior to the start of the broadcast to ensure adequate time for any software download that may be necessary. An audio replay will be accessible through November 19, 2015 by calling 888-843-7419 or 630-652-3042 and entering access code 4104 4861#.
About Sarepta Therapeutics
Sarepta Therapeutics is a biopharmaceutical company focused on the discovery and development of unique RNA-targeted therapeutics for the treatment of rare, infectious, and other life-threatening diseases. The Company is primarily focused on rapidly advancing the development of its potentially disease-modifying Duchenne Muscular Dystrophy (DMD) drug candidates, including its lead DMD product candidate, eteplirsen, designed to skip exon 51. Sarepta is also developing therapeutics for the treatment of infectious diseases, such as drug-resistant and other rare human diseases. For more information, please visit us at www.sarepta.com.
Forward-Looking Statements
In order to provide Sarepta’s investors with an understanding of its current results and future prospects, this press release contains statements that are forward-looking. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “will,” “may,” “intends,” “prepares,” “looks,” “potential,” “possible” and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements relating to Sarepta’s future operations, financial performance, business plans, priorities and development of product candidates including: Sarepta being well capitalized; Sarepta’s plans to present the established body of clinical, biochemical and safety data for eteplirsen in the advisory committee meeting tentatively scheduled for January; Sarepta’s evolving understanding of exon-skipping based on the data from the eteplirsen program; and focus on advancing additional programs and making new therapies available to Duchenne patients.
These forward-looking statements involve risks and uncertainties,
many of which are beyond Sarepta’s control. Actual results could
materially differ from those stated or implied by these forward-looking
statements as a result of such risks and uncertainties. Known risk
factors include the following: the
Any of the foregoing risks could materially and adversely affect the Company’s business, results of operations and the trading price of Sarepta’s common stock. You should not place undue reliance on forward-looking statements. Sarepta does not undertake any obligation to publicly update its forward-looking statements based on events or circumstances after the date hereof, except to the extent required by applicable law or SEC rules.
Internet Posting of Information
We routinely post information that may be important to investors in the 'For Investors' section of our web site at www.sarepta.com. We encourage investors and potential investors to consult our website regularly for important information about us.
Sarepta Therapeutics, Inc. | ||||||||||||||||||||||||
Condensed Consolidated Statements of Operations | ||||||||||||||||||||||||
(in thousands, except per share amounts) | ||||||||||||||||||||||||
(unaudited) | ||||||||||||||||||||||||
Three months ended September 30, | Nine months ended September 30, | |||||||||||||||||||||||
2015 | 2014 | 2015 | 2014 | |||||||||||||||||||||
Revenues from grants and research contracts | $ | - | $ | 1,059 | $ | - | $ | 9,730 | ||||||||||||||||
Operating expenses: | ||||||||||||||||||||||||
Research and development | 36,673 | 21,852 | 105,018 | 63,399 | ||||||||||||||||||||
General and administrative | 15,090 | 12,882 | 50,714 | 35,398 | ||||||||||||||||||||
Operating loss | (51,763 | ) | (33,675 | ) | (155,732 | ) | (89,067 | ) | ||||||||||||||||
Other income (loss): | ||||||||||||||||||||||||
Interest (expense) income and other, net | (176 | ) | 193 | 383 | 473 | |||||||||||||||||||
Gain (loss) on change in warrant valuation | - | 4,256 | - | (2,779 | ) | |||||||||||||||||||
Net loss | $ | (51,939 | ) | $ | (29,226 | ) | $ | (155,349 | ) | $ | (91,373 | ) | ||||||||||||
Net loss per share - basic and diluted | $ | (1.25 | ) | $ | (0.71 | ) | $ | (3.75 | ) | $ | (2.31 | ) | ||||||||||||
Shares used in per share calculation | ||||||||||||||||||||||||
basic and diluted | 41,565 | 41,066 | 41,416 | 39,595 |
Sarepta Therapeutics, Inc. | ||||||||||||||||||||||||||
Reconciliation of GAAP to Non-GAAP Net Loss | ||||||||||||||||||||||||||
(in thousands, except per share amounts) | ||||||||||||||||||||||||||
(unaudited) | ||||||||||||||||||||||||||
Three months ended September 30, | Nine months ended September 30, | |||||||||||||||||||||||||
2015 | 2014 | 2015 | 2014 | |||||||||||||||||||||||
Net loss - GAAP | $ | (51,939 | ) | $ | (29,226 | ) | $ | (155,349 | ) | $ | (91,373 | ) | ||||||||||||||
Research and development: | ||||||||||||||||||||||||||
Stock-based compensation expense | 2,631 | 1,668 | 7,639 | 5,886 | ||||||||||||||||||||||
Restructuring Expense | - | - | - | 11 | ||||||||||||||||||||||
Total research and development non-GAAP adjustments 1 | 2,631 | 1,668 | 7,639 | 5,897 | ||||||||||||||||||||||
General and administrative: | ||||||||||||||||||||||||||
Stock-based compensation expense | 3,052 | 2,981 | 18,130 | 8,692 | ||||||||||||||||||||||
Total general and administrative non-GAAP adjustments 1 | 3,052 | 2,981 | 18,130 | 8,692 | ||||||||||||||||||||||
Other non-operating loss: | ||||||||||||||||||||||||||
(Gain) loss on change in warrant valuation non-GAAP adjustment | - | (4,256 | ) | - | 2,779 | |||||||||||||||||||||
Net loss - non-GAAP | $ | (46,256 | ) | $ | (28,833 | ) | $ | (129,580 | ) | $ | (74,005 | ) | ||||||||||||||
Non-GAAP net loss per share - basic and diluted | $ | (1.11 | ) | $ | (0.70 | ) | $ | (3.13 | ) | $ | (1.87 | ) | ||||||||||||||
Shares used in per share calculations - basic and diluted | 41,565 | 41,066 | 41,416 | 39,595 |
1 Non-GAAP operating expense adjustments are
comprised of total general and administrative non-GAAP adjustments and
total research and development non-GAAP adjustments. Total non-GAAP
operating expense adjustments were
Sarepta Therapeutics, Inc. | |||||||||||
Balance Sheet Highlights | |||||||||||
(in thousands) | |||||||||||
(unaudited) | |||||||||||
September 30, | December 31, | ||||||||||
2015 | 2014 | ||||||||||
Cash, cash equivalents and short-term investments | $ | 99,909 | $ | 210,344 | |||||||
Restricted investments | 11,478 | 782 | |||||||||
Total assets | 184,751 | 295,033 | |||||||||
Total liabilities | 61,515 | 47,380 | |||||||||
Total stockholders' equity | $ | 123,236 | $ | 247,653 |
View source version on businesswire.com: http://www.businesswire.com/news/home/20151105005470/en/
Source:
Media and Investors:
Sarepta Therapeutics, Inc.
Ian Estepan,
617-274-4052
iestepan@sarepta.com
or
W2O
Group
Ryan Flinn, 415-946-1059
Mobile: 510-207-7616
rflinn@w2ogroup.com
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