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Sarepta Therapeutics Announces Fourth Quarter and Full-Year 2016 Financial Results and Recent Corporate Developments
02/28/17 4:05 PM EST
“2016 was a transformative year, with the
Financial Results
For the fourth quarter of 2016, Sarepta reported a net loss of
For the year ended
Net revenues
The Company commenced shipments of EXONDYS 51 to customers at the end of
the third quarter of 2016 following the accelerated approval by the
Operating expenses
Research and development expenses were
Research and development expenses were
Selling, general and administrative expenses were
Selling, general and administrative expenses for the year ended
Cash, cash equivalents and restricted cash and investments
The Company had
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 selling, 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 and other items.
1. Stock-based compensation 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 selling, 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.
2. Restructuring expenses
Restructuring expenses have been excluded from non-GAAP research and development expenses, non-GAAP selling, 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 financial results.
3. Other items
Management evaluates other items of expense and income on an individual basis. It takes into consideration quantitative and qualitative characteristics of each item, including (a) nature, (b) whether the items relates to the Company’s ongoing business operations, and (c) whether the Company expects the items to continue on a regular basis. These other items include the up-front and options payments related to existing collaboration and option agreements.
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 selling, 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 Loss."
Recent Corporate Developments
-Sarepta Therapeutics Agrees to Sale of Priority Review Voucher for
-Sarepta Therapeutics Enters into Research Agreement and Option
Agreement with Nationwide Children’s
-Sarepta Therapeutics Enters into License Agreement with Nationwide
Children’s
-Sarepta Therapeutics Announces EMA Validation of Eteplirsen Authorization Application for Treatment of Duchenne Muscular Dystrophy Amenable to Exon Skipping 51
About Sarepta Therapeutics
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 and projections, business plans, priorities and development of product candidates including: Sarepta’s plans for 2017, including executing a successful launch of EXONDYS 51 in the US, reaching more patients through global expansion and rapidly advancing Sarepta’s pipeline through internal and external development efforts, and Sarepta’s belief that it is well positioned for potential growth and towards its goal to help all boys with Duchenne muscular dystrophy.
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: we may not be able to meet expectations
with respect to EXONDYS 51 sales or attain profitability and positive
cash-flow from operations; we may not be able to comply with
all FDA post-approval commitments and requirements with respect to
EXONDYS 51 in a timely manner or at all; we may not be able to complete
clinical trials required by the FDA for approval of our product
candidates; the results of our ongoing research and development efforts
and clinical trials for our product candidates may not be positive or
consistent with prior results or demonstrate a safe treatment benefit;
we may not be able to execute on our business plans, including meeting
our expected or planned regulatory milestones and timelines, clinical
development plans, bringing EXONDYS 51 to markets outside
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 |
Twelve Months Ended |
||||||||||||||||||||||
2016 | 2015 | 2016 | 2015 | ||||||||||||||||||||
Revenues: | |||||||||||||||||||||||
Product, net | $ | 5,421 | $ | — | $ | 5,421 | $ |
— |
|||||||||||||||
Revenue from research contracts and other grants | — | 1,253 | — | 1,253 | |||||||||||||||||||
Total revenues | 5,421 | 1,253 | 5,421 | 1,253 | |||||||||||||||||||
Cost and expenses: | |||||||||||||||||||||||
Cost of sales | 130 | — | 130 | — | |||||||||||||||||||
Research and development | 70,749 | 41,376 | 188,272 | 146,394 | |||||||||||||||||||
Selling, general and administrative | 22,937 | 24,329 | 83,749 | 75,043 | |||||||||||||||||||
Total cost and expenses | 93,816 | 65,705 | 272,151 | 221,437 | |||||||||||||||||||
Operating loss | (88,395 | ) | (64,452 | ) | (266,730 | ) | (220,184 | ) | |||||||||||||||
Interest (expense) income and other, net | (57 | ) | (229 | ) | (535 | ) | 154 | ||||||||||||||||
Net loss | $ | (88,452 | ) | $ | (64,681 | ) | $ | (267,265 | ) | $ | (220,030 | ) | |||||||||||
Net loss per share — basic and diluted | $ | (1.62 | ) | $ | (1.44 | ) | $ | (5.49 | ) | $ | (5.20 | ) | |||||||||||
Weighted average number of shares of common stock outstanding for computing basic and diluted net loss per share | 54,619 | 44,882 | 48,697 | 42,290 |
Sarepta Therapeutics, Inc. | ||||||||||||||||||||||||
Reconciliation of GAAP to Non-GAAP Net Loss | ||||||||||||||||||||||||
(in thousands, except per share amounts) | ||||||||||||||||||||||||
(unaudited) | ||||||||||||||||||||||||
Three Months Ended |
Twelve Months Ended |
|||||||||||||||||||||||
2016 | 2015 | 2016 | 2015 | |||||||||||||||||||||
Net loss - GAAP | $ | (88,452 | ) | $ | (64,681 | ) | $ | (267,265 | ) | $ | (220,030 | ) | ||||||||||||
Research and development: | ||||||||||||||||||||||||
Up-front license and milestone payments | 40,785 | — | 40,785 | — | ||||||||||||||||||||
Stock-based compensation expense | 1,972 | 2,764 | 9,499 | 10,403 | ||||||||||||||||||||
Restructuring expense | 230 | — | 2,013 | — | ||||||||||||||||||||
Total research and development non-GAAP adjustments | 42,987 | 2,764 | 52,297 | 10,403 | ||||||||||||||||||||
Selling, general and administrative: | ||||||||||||||||||||||||
Stock-based compensation expense | 4,897 | 3,584 | 20,463 | 21,714 | ||||||||||||||||||||
Restructuring expense | 1,909 | — | 2,549 | — | ||||||||||||||||||||
Total selling, general and administrative non-GAAP adjustments | 6,806 | 3,584 | 23,012 | 21,714 | ||||||||||||||||||||
Net loss - non-GAAP | $ | (38,659 | ) | $ | (58,333 | ) | $ | (191,956 | ) | $ | (187,913 | ) | ||||||||||||
Non-GAAP net loss per share - basic and diluted | $ | (0.71 | ) | $ | (1.30 | ) | $ | (3.94 | ) | $ | (4.44 | ) | ||||||||||||
Weighted average number of shares of common stock outstanding for computing basic and diluted net loss per share | 54,619 | 44,882 | 48,697 | 42,290 |
Sarepta Therapeutics, Inc. | ||||||||||
Balance Sheet Highlights | ||||||||||
(in thousands) | ||||||||||
(unaudited) | ||||||||||
As of |
As of |
|||||||||
Cash, cash equivalents and short-term investments | $ | 317,845 | $ | 192,491 | ||||||
Restricted cash and investments | 11,479 | 11,478 | ||||||||
Total assets | 424,104 | 273,782 | ||||||||
Total liabilities | 87,413 | 83,435 | ||||||||
Total stockholders' equity | $ | 336,691 | $ | 190,347 |
View source version on businesswire.com: http://www.businesswire.com/news/home/20170228006776/en/
Source:
Media and Investors:
Sarepta Therapeutics, Inc.
Ian Estepan,
617-274-4052
iestepan@sarepta.com
or
W2O
Group
Brian Reid, 212-257-6725
breid@w2ogroup.com
This section of our website may contain dated or archived information which should not be considered current and may no longer be accurate. For current information, you are encouraged to review our most recent official corporate documents on file with the U.S. Securities and Exchange Commission.