Full Press Release Details
Sarepta Therapeutics Announces Second Quarter 2016 Financial Results and Recent Corporate Developments
CAMBRIDGE, Mass. (BUSINESS WIRE) July 19, 2016 Sarepta Therapeutics, Inc. (NASDAQ:SRPT), a developer of innovative RNA-targeted therapeutics,
today reported financial results for the three and six months ended June 30, 2016, and provided an update of recent corporate developments.
For the second quarter of 2016,
Sarepta reported a net loss of $62.3 million, or $1.35 per share, compared to a net loss of $41.9 million for the second quarter of 2015, or $1.01 per share. The incremental loss of $20.5 million was primarily the result of increased research and
development expenses.
Excluding $7.5 million of stock-based compensation expense and restructuring expenses, non-GAAP net loss for the second quarter of
2016 was $54.8 million, or $1.19 per share, compared to a non-GAAP net loss excluding $5.9 million of stock-based compensation expense of $35.9 million for the second quarter of 2015, or $0.87 per share.
No revenue was recognized for the three months ended June 30, 2016 and 2015.
Research and development expenses were $44.3 million for the second quarter of 2016, compared to $29.2 million for the second quarter of 2015, an increase of
$15.2 million. Non-GAAP research and development expenses (excluding $2.9 million of stock-based compensation and restructuring expenses) were $41.4 million for the second quarter of 2016, compared to $26.6 million (excluding $2.6 million of
stock-based compensation) for the second quarter of 2015, an increase of $14.8 million.
General and administrative expenses were $17.8 million for the second quarter of 2016, compared to $12.9 million
for the second quarter of 2015, an increase of $4.8 million. Non-GAAP general and administrative expenses (excluding $4.5 million of stock-based compensation and restructuring expenses) were $13.2 million for the second quarter of 2016, compared to
$9.6 million (excluding $3.4 million of stock-based compensation) for the second quarter of 2015, an increase of $3.7 million.
The Company had $134.7
million in cash, cash equivalents, short-term investments and restricted cash as of June 30, 2016 compared to $204.0 million as of December 31, 2015, a decrease of $69.3 million. The decrease was due to the use of cash to fund the
Company s ongoing operations and commercial launch activities.
Use of Non-GAAP Measures
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 expense adjustments, non-GAAP net loss, and non-GAAP basic and diluted net loss per share, which present operating results on a basis adjusted for stock-based
compensation and restructuring expenses.
Stock-based compensation expenses represent non-cash charges related to equity awards granted by Sarepta.
Although these are recurring charges to operations, management believes the measurement of these amounts can vary substantially from period to period and depend significantly on factors that are not a direct consequence of operating performance that
is within management s control. Therefore, management believes that excluding these charges from non-GAAP research and development expenses, non-GAAP general and administrative expenses, non-GAAP net loss and non-GAAP net loss per share
facilitates comparisons of the Company s operational performance in different periods.
Restructuring related expenses incurred related to the
consolidation of the Company s operations to Massachusetts have been excluded from non-GAAP research and development expenses, non-GAAP general and administrative expenses, non-GAAP
net loss and non-GAAP net loss per share as the Company believes that the adjustments for these items represent more closely the sustainability of the Company s operating performance and
understanding of its financial results.
The Company uses these non-GAAP measures as key performance measures for the purpose of evaluating operational
performance and cash requirements internally. The Company also believes these non-GAAP measures increase comparability of period-to-period results and are useful to investors as they provide a similar basis for evaluating the Company s
performance as is applied by management. These non-GAAP measures are not intended to be considered in isolation or 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 expense adjustments, non-GAAP net loss, and non-GAAP basic and diluted net loss per share may differ from similar measures reported by other companies, which may
limit comparability, and are not based on any comprehensive set of accounting rules or principles. All relevant non-GAAP measures are reconciled from their respective GAAP measures in the attached table Reconciliation of GAAP to Non-GAAP Net
Recent Corporate Developments
Duchenne Muscular Dystrophy Program
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 diseases. The Company is primarily focused on rapidly advancing the
development of its potentially disease-modifying DMD drug candidates, including its lead DMD product candidate, eteplirsen, designed to skip exon 51. Sarepta is also developing therapeutics for
the treatment of rare, infectious and other diseases. For more information, please visit us at www.sarepta.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the safe harbor provisions of the U.S. Private Securities
Litigation Reform Act of 1995. 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, intends, potential, possible and similar expressions are intended to identify forward-looking statements. Forward-looking statements include those regarding the
Company s business plans.
These forward-looking statements involve risks and uncertainties, many of which are beyond Sarepta s control.
Known risk factors include, among others: data collected by the Company may not satisfy the FDA s requirements or support approval of our eteplirsen NDA, on an expedited timeframe or at all, and the FDA may further delay its approval decision,
make additional requests relating to the eteplirsen NDA, provide a complete response letter or otherwise decline to provide marketing approval for eteplirsen; we may not be able to comply with any other FDA requests relating to the eteplirsen NDA or
with respect to our ongoing or planned clinical trials, in a timely manner or at all; the FDA may further delay its decision on the eteplirsen NDA or may not provide marketing approval for eteplirsen for other reasons; we may not be able to complete
clinical trials required by the FDA for approval of our products or any submissions made in connection with our pipeline of product candidates; the results of our ongoing research and development efforts and clinical trials for our product
candidates including eteplirsen and our technologies may not be positive or consistent with prior results or demonstrate a safe treatment benefit or support an NDA filing, positive advisory committee recommendation or marketing approval by the FDA
or other regulatory authority; we may not be able to execute on our business plans including meeting our expected or planned regulatory milestones and timelines, clinical development plans and bringing our product candidates to market, including the
planned commercialization of eteplirsen, for various reasons, including factors outside of the Company s control, including possible limitations of Company financial and other resources,
manufacturing limitations that may not be anticipated or resolved for in a timely manner or at all, and regulatory, court or agency decisions, such as decisions by the United States Patent and Trademark Office with respect to patents that cover our
product candidates; and those risks identified under the heading Risk Factors in Sarepta s most recent Annual Report on Form 10-K for the year ended December 31, 2015 or most recent Quarterly Report on Form 10-Q filed with
the Securities and Exchange Commission (SEC) as well as other SEC filings made by Sarepta which you are encouraged to review.
Any of the foregoing
risks could materially and adversely affect Sarepta s business, results of operations and the trading price of Sarepta s common stock. For a detailed description of risks and uncertainties Sarepta faces, you are encouraged to review the
Company s filings with the SEC. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. Sarepta does not undertake any obligation to publicly update its forward-looking
statements based on events or circumstances after the date hereof.
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)
| Three months ended June 30, | Six months ended June 30, | |||||||||||||||
| 2016 | 2015 | 2016 | 2015 | |||||||||||||
| Revenues from grants and research contracts | $ | $ | $ | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 44,348 | 29,180 | 83,174 | 68,345 | ||||||||||||
| General and administrative | 17,752 | 12,927 | 38,628 | 35,624 | ||||||||||||
| Operating loss | (62,100 | ) | (42,107 | ) | (121,802 | ) | (103,969 | ) | ||||||||
| Other income (loss): | ||||||||||||||||
| Interest (expense) income and other, net | (201 | ) | 256 | (269 | ) | 559 | ||||||||||
| Net loss | $ | (62,301 | ) | $ | (41,851 | ) | $ | (122,071 | ) | $ | (103,410 | ) | ||||
| Net loss per share - basic and diluted | $ | (1.35 | ) | $ | (1.01 | ) | $ | (2.66 | ) | $ | (2.50 | ) | ||||
| Shares used in per share calculation basic and diluted | 46,157 | 41,357 | 45,927 | 41,341 |
Sarepta Therapeutics, Inc.
Reconciliation of GAAP to Non-GAAP Net Loss
(in thousands, except per share amounts)
| Three months ended June 30, | Six months ended June 30, | |||||||||||||||
| 2016 | 2015 | 2016 | 2015 | |||||||||||||
| Net loss - GAAP | $ | (62,301 | ) | $ | (41,851 | ) | $ | (122,071 | ) | $ | (103,410 | ) | ||||
| Research and development: | ||||||||||||||||
| Stock-based compensation expense | 2,404 | 2,562 | 4,853 | 5,008 | ||||||||||||
| Restructuring expense | 511 | 1,013 | ||||||||||||||
| Total research and development non-GAAP adjustments 1 | 2,915 | 2,562 | 5,866 | 5,008 | ||||||||||||
| General and administrative: | ||||||||||||||||
| Stock-based compensation expense | 4,426 | 3,368 | 8,667 | 15,078 | ||||||||||||
| Restructuring expense | 115 | 146 | ||||||||||||||
| Total general and administrative non-GAAP adjustments 1 | 4,541 | 3,368 | 8,813 | 15,078 | ||||||||||||
| Net loss - non-GAAP | $ | (54,845 | ) | $ | (35,921 | ) | $ | (107,392 | ) | $ | (83,324 | ) | ||||
| Non-GAAP net loss per share - basic and diluted | $ | (1.19 | ) | $ | (0.87 | ) | $ | (2.34 | ) | $ | (2.02 | ) | ||||
| Shares used in per share calculations - basic and diluted | 46,157 | 41,357 | 45,927 | 41,341 |
Sarepta Therapeutics, Inc.
Balance Sheet Highlights
| June 30, | December 31, | |||||||
| 2016 | 2015 | |||||||
| Cash, cash equivalents and short-term investments | $ | 123,215 | $ | 192,491 | ||||
| Restricted investments | 11,478 | 11,478 | ||||||
| Total assets | 204,068 | 273,782 | ||||||
| Total liabilities | 82,609 | 83,435 | ||||||
| Total stockholders equity | $ | 121,459 | $ | 190,347 |
Source: Sarepta Therapeutics, Inc.
Media and Investors:
Sarepta Therapeutics, Inc.
Ian Estepan, 617-274-4052
Brian Reid, 212-257-6725