Full Press Release Details
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Therapeutics Announces Third Quarter
2013 Financial Results and Recent Corporate Developments
Ongoing discussions with FDA remain a priority to advance eteplirsen program in Duchenne muscular dystrophy;
Updated guidance lowers full-year operating loss to $80-90 million range;
Strong financial position with approximately $281 million in cash and other investments at quarter end
CAMBRIDGE, MA, November 12, 2013 Sarepta Therapeutics, Inc. (NASDAQ: SRPT), a developer of innovative RNA-based therapeutics, today
reported financial results for the three and nine months ended September 30, 2013, and provided an update of recent corporate developments.
look forward to continuing to work with the FDA to keep the eteplirsen program moving forward, said Chris Garabedian, president and chief executive officer of Sarepta. Our cash position is strong as we continue to scale up manufacturing
and advance our follow-on DMD drug candidates toward clinical development.
For the third quarter of 2013, Sarepta reported a non-GAAP net loss of $21.3 million, or $0.63 per share, compared to a non-GAAP net loss of $6.1 million for
the third quarter of 2012, or $0.27 per share. The incremental loss is primarily the result of a $3.4 million decrease in contract revenues as well as an $11.8 million increase in non-GAAP operating expenses, excluding the effects of stock-based
compensation and restructuring expenses.
On a GAAP basis, the net loss for the third quarter of 2013 was $42.0 million, or $1.24 per share (including
$3.5 million of stock-based compensation expense and restructuring expense), compared with a net loss of $49.6 million for the third quarter of 2012, or $2.17 per share (including $0.7 million of stock-based compensation expense). The decrease in
net loss is the result of a $25.6 million decrease in expense incurred due to the change in valuation of our outstanding warrants offset by a $3.4 million decrease in contract revenues and a $14.6 million increase in operating expenses.
Revenue for the third quarter of 2013 was $4.2 million, down from $7.6 million for the third quarter of 2012. The $3.4 million decrease was primarily due to
the August 2012 stop-work-order and subsequent termination for convenience of the Ebola portion of the Ebola-Marburg U.S. government contract due to a lack of available U.S. government funding. The termination of the Ebola portion did not impact the
Marburg portion of the contract. Revenues from the Marburg portion of the contract also decreased during the third quarter of 2013 due to the timing of activities throughout the normal progression of the contract. These decreases were partially
offset by revenue from the intramuscular administration (IM) contract with the U.S. government for the Marburg virus and two other research agreements.
Non-GAAP research and development expenses were $19.9 million for the third quarter of 2013, compared to $10.6 million for the third quarter of 2012, an
increase of $9.3 million. GAAP research and development expenses were $21.1 million for the third quarter of 2013 (including $1.2 million of stock-based compensation expense and restructuring expense), compared to $10.9 million for the third quarter
of 2012 (including $0.3 million of stock-based compensation expense), an increase of $10.2 million.
Non-GAAP general and administrative expenses were
$5.7 million for the third quarter of 2013, compared to $3.1 million for the third quarter of 2012, an increase of $2.6 million. GAAP general and administrative expenses were $8.0 million for the third quarter of 2013 (including $2.3 million of
stock-based compensation expense), compared to $3.6 million for the third quarter of 2012 (including $0.4 million of stock-based compensation expense), an increase of $4.4 million.
The increased operating expenses were primarily caused by corporate growth as the Company continues the development of its programs in Duchenne Muscular
The company had cash, cash equivalents and restricted investments related to our letters of credit of $281.4 million as of
September 30, 2013 compared to $187.7 million
as of December 31, 2012, an increase of $93.7 million. The increase in cash and cash equivalents was primarily due to $125 million in proceeds from the issuance of approximately
3.4 million shares of common stock under the At-the-Market (ATM) equity financing that was put in place in July 2013 and $18.9 million in proceeds from the exercise of warrants and stock options, offset by cash used to fund our ongoing
The warrant liability is primarily affected by changes in the company s stock price. In the third quarter of 2013, the appreciation in
the company s stock price caused the warrant valuation to increase, which resulted in a non-cash warrant valuation expense of $17.2 million. In the third quarter of 2012, the company s stock price increase resulted in a non-cash warrant
valuation expense of $42.7 million. All remaining warrants outstanding at September 30, 2013, if not exercised, will expire no later than August of 2014.
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
The conference call may be accessed by dialing 888.895.5271 for domestic callers and 847.619.6547 for international callers. The passcode for the call is
35957586. Please specify to the operator that you would like to join the Sarepta Third Quarter 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
available through November 26, 2013 by calling 888.843.7419 or 630.652.3042 and entering access code 35957586.
About Sarepta Therapeutics
Sarepta Therapeutics is focused on developing first-in-class RNA-based therapeutics to improve and save the lives of people affected by serious and
life-threatening rare and infectious diseases. Sarepta s diverse pipeline includes its lead program eteplirsen, for Duchenne muscular dystrophy, as well as potential treatments for some of the world s most lethal infectious diseases.
Sarepta aims to build a leading, independent biotech company dedicated to translating its RNA-based science into transformational therapeutics for patients who face significant unmet medical needs. For more information, please visit us at
Forward-Looking Statements and Information
This press release contains forward-looking statements. These forward-looking statements generally can be identified by use of words such as believes
or belief, anticipates, plans, expects, will, intends, potential, possible, advance and similar expressions. These forward-looking statements
include statements about the development of eteplirsen and its efficacy, potency and utility as a potential treatment for DMD, the potential for the use of dystrophin to predict significant clinical benefit, the clinical significance of our 6mwt
results to date, the timing of clinical studies and the timing and potential for regulatory submissions and meetings.
Each forward-looking
statement contained in this press release is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others:
subsequent clinical trials may fail to demonstrate the safety and efficacy of eteplirsen or replicate results; treatment of patients with DMD using eteplirsen may not lead to significant clinical benefit; any of Sarepta s drug candidates,
including eteplirsen, may fail in development, may not receive required regulatory approvals (including Subpart H accelerated approval), or may not become commercially viable due to delays or other reasons; and those identified under the heading
Risk Factors in Sarepta s Annual Report on Form 10-K for the full year ended December 31, 2012 and as updated by our 2013 third quarter 10-Q, and filed with the Securities and Exchange Commission (SEC).
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.
Sarepta Therapeutics, Inc.
(A Development-Stage Company)
Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)
(in thousands, except per share amounts)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2013 | 2012 | 2013 | 2012 | |||||||||||||
| Revenues from grants and research contracts | $ | 4,168 | $ | 7,574 | $ | 11,593 | $ | 29,993 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 21,087 | 10,914 | 47,833 | 39,568 | ||||||||||||
| General and administrative | 8,014 | 3,565 | 21,195 | 9,761 | ||||||||||||
| Operating loss | (24,933 | ) | (6,905 | ) | (57,435 | ) | (19,336 | ) | ||||||||
| Other non-operating income (loss): | ||||||||||||||||
| Interest income and other, net | 63 | 67 | 281 | 270 | ||||||||||||
| Loss on change in warrant valuation | (17,160 | ) | (42,716 | ) | (46,011 | ) | (40,154 | ) | ||||||||
| Net loss | $ | (42,030 | ) | $ | (49,554 | ) | $ | (103,165 | ) | $ | (59,220 | ) | ||||
| Net loss per share basic and diluted | $ | (1.24 | ) | $ | (2.17 | ) | $ | (3.17 | ) | $ | (2.61 | ) | ||||
| Shares used in per share calculations basic and diluted | 33,943 | 22,824 | 32,588 | 22,691 |
Sarepta Therapeutics, Inc.
(A Development-Stage Company)
Reconciliation of GAAP to non-GAAP net loss
(in thousands, except per share amounts)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2013 | 2012 | 2013 | 2012 | |||||||||||||
| Net loss GAAP | $ | (42,030 | ) | $ | (49,554 | ) | $ | (103,165 | ) | $ | (59,220 | ) | ||||
| Research and development: | ||||||||||||||||
| Stock-based compensation expense | 1,155 | 271 | 2,409 | 783 | ||||||||||||
| Restructuring expense | 54 | 397 | 16 | |||||||||||||
| Total research and development non-GAAP adjustments 2 | 1,209 | 271 | 2,806 | 799 | ||||||||||||
| General and administrative: | ||||||||||||||||
| Stock-based compensation expense | 2,332 | 421 | 5,067 | 1,057 | ||||||||||||
| Restructuring expense | 329 | 37 | ||||||||||||||
| Total general and administrative non-GAAP adjustments 2 | 2,332 | 421 | 5,396 | 1,094 | ||||||||||||
| Other non-operating loss: | ||||||||||||||||
| Loss on change in warrant valuation non-GAAP adjustment | 17,160 | 42,716 | 46,011 | 40,154 | ||||||||||||
| Net loss non-GAAP 1 | $ | (21,329 | ) | $ | (6,146 | ) | $ | (48,952 | ) | $ | (17,173 | ) | ||||
| Non-GAAP net loss per share basic and diluted | $ | (0.63 | ) | $ | (0.27 | ) | $ | (1.50 | ) | $ | (0.76 | ) | ||||
| Shares used in per share calculations basic and diluted | 33,943 | 22,824 | 32,588 | 22,691 |
Sarepta Therapeutics, Inc.
(A Development-Stage Company)
Balance Sheet Highlights
| September,30 2013 | December 31, 2012 | |||||||
| Cash and cash equivalents | $ | 273,644 | $ | 187,661 | ||||
| Restricted investments | 7,807 | |||||||
| Total assets | 304,479 | 204,993 | ||||||
| Total liabilities | 57,495 | 81,314 | ||||||
| Total stockholders equity | $ | 246,984 | $ | 123,679 |