Sarepta Therapeutics Announces Fourth Quarter and Full-Year 2012 Financial Results and Recent Corporate Developments

Sarepta Therapeutics Announces Fourth Quarter and Full-Year 2012 Financial 
Results and Recent Corporate Developments 
Upcoming Meetings With FDA Will Determine Fastest Path to Pursue
Eteplirsen Approval; Additional Drugs for Duchenne Muscular Dystrophy
(DMD) Continue to Progress Through Preclinical Development; 2013
Financial Guidance of $18-24 Million in Revenues; $85-115 Million in
Operating Loss; Cash Balance of $187 Million at Year-End 2012 
CAMBRIDGE, MA -- (Marketwire) -- 03/07/13 --  Sarepta Therapeutics,
Inc. (NASDAQ: SRPT), a developer of innovative RNA-based
therapeutics, today reported financial results for the three months
and full year ended December 31, 2012, and provided an update of
recent corporate developments. 
"Last year was a transformational year for Sarepta as we achieved
tremendous progress with our lead DMD product candidate, eteplirsen,
which demonstrated safety and efficacy that highlights its potential
to be a major advance in the treatment of this disease," said Chris
Garabedian, president and chief executive officer of Sarepta
Therapeutics. "We look forward to our upcoming meetings with the FDA
to discuss our eteplirsen data and to determine the fastest path
toward potential approval, along with our plans to supply the market
in the event of an early approval." 
Financial Results 
For the fourth quarter of 2012, Sarepta reported an operating loss of
$10.4 million, compared with an operating loss of $9.0 million in the
fourth quarter of 2011. The incremental loss is the result of a $6.3
million decrease in government contract revenues offset by a $4.9
million decrease in operating expenses. 
Revenue for the fourth quarter of 2012 was $7.3 million, down from
the $13.6 million in the fourth quarter of 2011. The $6.3 million
decrease was due to the August 2012 stop-work-order and subsequent
termination of the Ebola portion of the Ebola Marburg U.S. government
contract due to a lack of available U.S. government funding. The
Ebola termination did not impact the Marburg portion of the contract.
Revenues from the Marburg portion of the contract also decreased due
to the timing of activities throughout the normal progression of the
contract. These decreases were partially offset by revenue from the
intramuscular administration contract with the U.S. government for
the Marburg virus that started in August 2012. 
Research and development expenses were $12.8 million in the fourth
quarter of 2012, compared to $18.7 million in the fourth quarter of
2011, a decrease of $5.9 million. The decrease was primarily
attributable to termination of the Ebola portion of the government
contract, reduced spending on the Marburg portion of the government
contract due to the timing of activities and reduced spending
associated with DMD and other proprietary research. This decrease was
partially offset by increased spending related to the intramuscular
administration contract. 
General and administrative expenses in the fourth quarter of 2012
were $4.9 million, compared to $3.9 million in the fourth quarter of
2011, an increase of $1.0 million. The increase was the result of
additional personnel costs associated with key positions hired in the
second half of 2012. 
For the full year 2012, the operating loss was $29.7 million,
compared to an operating loss of $35.9 million for the prior year.
The $6.2 million improvement was the result of a $14.5 million
decrease in research and development expenses and a $1.4 million
decrease in general and administrative expenses partially offset by a
$9.7 million decrease in revenue from government contracts. 
Revenue for the full year 2012 decreased to $37.3 million from $47.0
million in 2011 primarily due to the Ebola stop-work-order, the
termination of the Ebola portion of the Ebola Marburg contract in the
second half of 2012 and the completion of the H1N1/influenza contract
with the U.S. government in June 2011. 
Research and development expenses were $52.4 million for 2012,
compared to $66.9 million for the prior year, a $14.5 million
decrease. The decrease was due primarily to reduced costs related to
the Ebola portion of the Ebola Marburg government contract, the
completion of the H1N1 contract in 2011 and a reduction in our
overall non-DMD proprietary research.  
General and administrative expenses for 2012 were $14.6 million,
compared to $16.0 million for 2011, a decrease of $1.4 million. The
decrease was primarily due to reduced professional service costs and
severance costs compared to the prior year. 
The net loss for the fourth quarter of 2012 was $62.1 million, or
$2.36 per share, compared to a net loss for the fourth quarter of
2011 of $1.4 million, or $0.06 per share. The net loss for the full
year 2012 was $121.3 million, or $5.14 per share, compared to a net
loss in 2011 of $2.3 million, or $0.11 per share. The increase in the
net loss for both the fourth quarter and the year was primarily due
to the change in the valuation of outstanding warrants to purchase
common stock described below. 
In connection with prior equity financings, Sarepta issued warrants
that are classified as current liabilities and are adjusted to fair
value on a quarterly basis with the change in fair value being
included in net loss. The amount included in net loss is a non-cash
item as Sarepta is not required to expend any cash to settle the
warrant liability. The warrant liability is primarily affected by
changes in Sarepta's stock price during each financial reporting
period which causes the warrant liability to fluctuate as the market
price of Sarepta's stock fluctuates. In the fourth quarter of 2012,
the increase in Sarepta's stock price resulted in the warrant
valuation increasing which resulted in other expense of $51.8
million. In the fourth quarter of 2011, the decrease in Sarepta's
stock price resulted in other income of $7.4 million. For the full
year 2012, the change in the warrant valuation resulted in other
expense of $91.9 million while in 2011, the decrease in the warrant
valuation resulted in other income of $33.0 million. 
Sarepta had cash and cash equivalents of $187.7 million as of
December 31, 2012, an increase of $147.8 million from December 31,
2011. This increase was primarily due to the completion of public
stock offerings during the second half of 2012 which raised net
proceeds of $154.3 million and warrant exercises that raised an
additional $20.6 million. These sources of funds were partially
offset by $29.7 million of cash used for operations during the year. 
2013 Guidance 
For 2013, Sarepta anticipates that revenue will be in the $18 to $24
million range and that loss from operations will be in the $85 to
$115 million range. The revenue guidance is based on the assumption
that Sarepta will continue to receive funding from its current
government contracts for Marburg. If Sarepta does not continue to
receive this funding, its revenue guidance would change
significantly. Additionally, the operating loss guidance is largely
based on continuing development and scale up manufacturing for
eteplirsen and our follow-on DMD drugs. 
Recent Corporate Developments  
Duchenne Muscular Dystrophy (DMD) Program  
-- Announced updated data from Study 202, its open-label, Phase IIb
extension study of eteplirsen for the treatment of DMD. Patients
treated with eteplirsen for 62 weeks and evaluable on ambulatory
measures (modified Intent-to-Treat population) maintained a
statistically significant clinical benefit on the primary clinical
outcome measure, the 6-minute walk test (6MWT), compared to patients
who received placebo for 24 weeks followed by 38 weeks of eteplirsen
treatment. 
-- Announced a collaboration for the development of an additional
exon-skipping drug targeting exon 53, its fourth drug in development,
in support of Sarepta's broad-based program for the treatment of DMD.
Sarepta's collaboration is with University College London's (UCL)
scientist, Professor Francesco Muntoni, MD, the Dubowitz
Neuromuscular Centre, the Institute of Child Health and other
scientists from the EU and US. The EU Health Innovation-1 2012
Collaborative research grant will support certain IND-enabling
activities and clinical proof of concept studies for an exon
53-skipping therapeutic. 
Infectious Disease Programs  
-- Announced positive results from a non-human primate study of
AVI-7288, the Company's lead drug candidate for the treatment of
Marburg virus infection. The data showed that intramuscular
administration of AVI-7288 resulted in survival rates up to 100
percent in treated subjects, similar to efficacy observed in previous
studies that evaluated the drug when administered by intravenous
injection. 
-- Announced that the Company entered into a Clinical Trial Agreement
(CTA) with the National Institute of Allergy and Infectious Diseases
(NIAID), part of the National Institutes of Health (NIH), to conduct
a Phase I study with AVI-7100, the Company's lead drug candidate with
a novel mechanism of action and potentially broad-spectrum activity
against influenza viruses, including Tamiflu-resistant virus strains. 
Corporate Developments 
-- Priced an underwritten public offering in December 2012 of an
aggregate of 4,950,495 shares of its common stock at a price to the
public of $25.25 per share, raising $125 million. 
Conference Call  
Sarepta Therapeutics will hold a financial results and corporate
update conference call today at 8:00 a.m., Eastern Time (5:00 a.m.
Pacific Time). The conference call may be accessed by dialing
800.446.2782 for domestic callers and 847.413.3235 for international
callers. The passcode for the call is 34143150. Please specify to the
operator that you would like to join the "Sarepta Fourth Quarter and
Full-Year 2012 Earnings Call." The conference call will be webcast
live under the events section of Sarepta's website at
www.sareptatherapeutics.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 March 14, 2013 by calling 888.843.7419 or
630.652.3042 and entering access code 34143150.  
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 www.sareptatherapeutics.com. 
Forward-Looking Statements and Information  
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," "intends," "potential,"
"possible" and similar expressions are intended to identify
forward-looking statements. These forward-looking statements include
statements about the safety, efficacy, development and potential of
Sarepta's product candidates, the potential and timing for regulatory
review and approval of Sarepta's product candidates, Sarepta's
ability to manufacture product candidates and Sarepta's estimates
regarding its future revenue, operating loss and expenses and
expectations regarding future success, revenue and funding from
government and other sources.  
These forward-looking statements involve risks and uncertainties,
many of which are beyond Sarepta's control. Known risk factors
include, among others: clinical trials may not demonstrate safety and
efficacy of any of Sarepta's drug candidates and/or Sarepta's
antisense-based technology platform; development of any of Sarepta's
drug candidates may not result in funding from the U.S. government in
the anticipated amounts or on a timely basis, if at all; scale-up of
manufacturing may not be successful and any of Sarepta's drug
candidates may fail in development, may not receive required
regulatory approvals (including Subpart H accelerated approval), or
be delayed to a point where they do not become commercially viable.  
Any of the foregoing risks could materially and adversely affect
Sarepta's business, results of operations and the trading price of
Saretpa's common stock. For a detailed description of risks and
uncertainties Sarepta faces, you are encouraged to review the
official corporate documents filed with the Securities and Exchange
Commission. 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)                        
                  (in thousands, except per share amounts)                  
                                (unaudited)                                 
                                                                            
                                                                            
                               Three Months Ended      Twelve Months Ended  
                                  December 31,            December 31,      
                             ----------------------  ---------------------- 
                                2012        2011        2012        2011    
                             ----------  ----------  ----------  ---------- 
Revenues, from grants and                                                   
 research contracts                                                         
                             $    7,336  $   13,585  $   37,329  $   46,990 
Operating expenses:                                                         
  Research and development       12,834      18,701      52,402      66,862 
  General and administrative      4,868       3,884      14,630      16,055 
                                                                            
                             ----------  ----------  ----------  ---------- 
Operating loss                  (10,366)     (9,000)    (29,703)    (35,927)
                                                                            
Other income (loss):                                                        
  Interest income, and                                                      
   other, net                        83         147         354         587 
Gain (loss) on change in                                                    
 warrant valuation              (51,784)      7,443     (91,938)     33,022 
                             ----------  ----------  ----------  ---------- 
Net income (loss)                                                           
                                                                            
                             $  (62,067) $   (1,410) $ (121,287) $   (2,318)
                             ==========  ==========  ==========  ========== 
Net income (loss) per share                                                 
 -- basic and diluted*                                                      
                             $    (2.36) $    (0.06) $    (5.14) $    (0.11)
                             ==========  ==========  ==========  ========== 
Shares used in per share                                                    
 calculations -- basic and                                                  
 diluted*                        26,313      22,624      23,602      21,599 
                             ==========  ==========  ==========  ========== 
                                                                            
* All net income (loss) per share and shares used in the per share          
calculations have been adjusted to reflect a one for six reverse stock split
that was approved by the shareholders and the Board of Directors and        
effected in July 2012.                                                      
                                                                            
                                                                            
                                                                            
                                                                            
                          BALANCE SHEET HIGHLIGHTS                          
                               (in thousands)                               
                                                  December 31,  December 31,
                                                      2012          2011    
                                                  ------------  ------------
Cash and cash equivalents                         $    187,661  $     39,904
Total current assets                                   193,908        45,184
Total assets                                           204,993        54,368
Total current liabilities                               78,886        20,601
Total shareholders' equity                        $    123,679  $     31,017

  
Sarepta Investor Contact:
Erin Cox
425.354.5140
ecox@sareptatherapeutics.com 
Media Contact:
Jim Baker
857.242.3710
jbaker@sareptatherapeutics.com 
 
 
Press spacebar to pause and continue. Press esc to stop.