Achillion Reports 2012 Fourth Quarter and Year-End Financial Results

Wed Feb 20, 2013 4:08pm EST

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- Conference call and webcast to be held today, February 20th, at 5:00 pm EST -

NEW HAVEN, Conn., Feb. 20, 2013 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN)
today reported financial results for the three and twelve months ended December 31, 2012.

For the three months ended December 31, 2012, the Company reported a net loss of $11.2 million,
compared to a net loss of $12.4 million in the three months ended December 31, 2011. For the full
year ended December 31, 2012, the Company's net loss was $47.1 million, compared to a net loss of
$44.2 million for the year ended December 31, 2011. Cash and cash equivalents and marketable
securities at December 31, 2012 were $77.4 million.

Recent HCV Pipeline Accomplishments

* Announced plans to initiate in the second quarter of 2013 a Phase 2 clinical trial evaluating 12
weeks of therapy consisting of sovaprevir and ACH-3102, with ribavirin, for the treatment of
genotype 1 treatment-naive HCV;
 
* Reported interim Phase 2 results indicating that six out of eight patients receiving 12 weeks of
therapy consisting of ACH-3102 and ribavirin for the treatment of genotype 1b, IL28B CC genotype,
HCV achieved rapid virologic response (RVR) and three out of three patients who completed
treatment also remained HCV RNA undetectable four weeks after completion of therapy (SVR4); and
 
* Achieved Phase 1 proof-of-concept with once daily ACH-2684, a second generation protease
inhibitor, in genotype 1 HCV patients, with and without cirrhosis.

Anticipated Clinical Milestones for 2013

ACH-3102: Phase 2 second-generation NS5A inhibitor

* Expand the Phase 2 clinical trial evaluating 12 weeks of therapy consisting of ACH-3102 and
ribavirin, for the treatment of genotype 1b treatment-naive HCV during the second quarter of 2013;
 
* Report SVR4 results following 12 weeks of therapy consisting of ACH-3102 and ribavirin for the
treatment of genotype 1b, IL28B CC genotype, HCV in the second quarter of 2013; and
 
* Provide RVR results from the Phase 2 trial of ACH-3102 and ribavirin for genotype 1b
treatment-naive HCV during the third quarter of 2013.

Combination of sovaprevir and ACH-3102 for the treatment of genotype 1 HCV

* Initiate dosing patients in a Phase 2 trial evaluating 12 weeks of sovaprevir and ACH-3102, with
ribavirin, for the treatment of genotype 1 HCV during the second quarter of 2013; and
 
* Report interim Phase 2 results from this first sovaprevir and ACH-3102 combination, including
RVR, during the third quarter of 2013.

Fourth Quarter 2012 Financial Results

The Company reported a net loss of $11.2 million for the three months ended December 31, 2012,
compared to a net loss of $12.4 million for the three months ended December 31, 2011. Research and
development expenses were $8.4 million in the fourth quarter of 2012, compared to $9.9 million for
the same period of 2011, the decrease primarily resulting from the timing of clinical trial
activities, offset by an increase in development group personnel. Revenue for the three months
ended December 31, 2012 totaled $118,000 compared to $62,000 in the three months ended December
31, 2011.

For the three months ended December 31, 2012, general and administrative expenses totaled $2.9
million, compared to $2.6 million in the same period in 2011, the increase primarily resulting
from higher business development and professional services fees.

Year-end 2012 Financial Results

For the year ended December 31, 2012, the Company reported a net loss of $47.1 million, compared
to a net loss of $44.2 million in 2011. For the year ended December 31, 2012, research and
development expenses totaled $39.0 million, compared to $35.4 million in 2011. The increase in
research and development expenses was primarily a result of increased personnel levels and
increased clinical trial costs associated with the development of sovaprevir and ACH-3102, offset
by decreased manufacturing expenses for ACH-2684.  

Total revenues were $2.6 million for the year ended December 31, 2012, compared to $247,000 for
the year ended December 31, 2011. The majority of revenue during 2012 was related to recognition
of $2.5 million of deferred revenue under the Company's former collaboration with Gilead Sciences,
Inc.

General and administrative expenses were $10.9 million for the year ended December 31, 2012,
compared to $9.2 million for the year ended December 31, 2011, the increase primarily resulting
from increased non-cash stock compensation combined with increased business development and
professional services fees.

2013 Financial Guidance

At December 31, 2012, Achillion had cash and cash equivalents and marketable securities of
approximately $77.4 million. The Company expects that research and development expenses during
2013 will be approximately $50 million and that net cash used in operating activities in 2013 will
approximate $55 million based on current operating plans, anticipated timelines and the estimated
cost of clinical trials and product development programs. The net loss per share is anticipated to
approximate $0.75 per share.

Conference Call

The Company will host a conference call and simultaneous webcast on Wednesday, February 20, 2013
at 5:00 p.m. Eastern time. To participate in the conference call, please dial (877) 266-0482 in
the U.S. or (631) 291-4567 for international callers. A live audio webcast of the call will be
accessible at www.achillion.com
http://www.globenewswire.com/newsroom/ctr?d=10022441&l=18&a=www.achillion.com&u=http%3A%2F%2Fwww.achillion.com
, under the News Center section of the website. Please connect to Achillion's website several
minutes prior to the start of the broadcast to ensure adequate time for any software download that
may be necessary.

A replay of the webcast will be available on www.achillion.com
http://www.globenewswire.com/newsroom/ctr?d=10022441&l=19&a=www.achillion.com&u=http%3A%2F%2Fwww.achillion.com
. Alternatively, a replay of the conference call will be available starting at 8:00 p.m. Eastern
time on February 20, 2013, through 11:59 p.m. Eastern time on February 27, 2013 by dialing (855)
859-2056 or (404) 537-3406. The replay passcode is 13062862.

About HCV

The hepatitis C virus is the most common cause of viral hepatitis, which is an inflammation of the
liver. It is currently estimated that more than 170 million people are infected with HCV worldwide
including more than 5 million people in the United States, more than twice as widespread as HIV.
Three-fourths of the HCV patient population is undiagnosed; it is a silent epidemic and a major
global health threat. Chronic hepatitis, if left untreated, can lead to permanent liver damage
that can result in the development of liver cancer, liver failure or death. Few therapeutic
options currently exist for the treatment of HCV infection. The current standard of care is
limited by its specificity for certain types of HCV, significant side-effect profile, and
injectable route of administration.

About Achillion Pharmaceuticals

Achillion is an innovative pharmaceutical company dedicated to bringing important new treatments
to patients with infectious disease. Achillion's proven discovery and development teams have
advanced multiple product candidates with novel mechanisms of action. Achillion is focused on
solutions for the most challenging problems in infectious disease including HCV and resistant
bacterial infections. For more information on Achillion Pharmaceuticals, please visit
www.achillion.com
http://www.globenewswire.com/newsroom/ctr?d=10022441&l=23&a=www.achillion.com&u=http%3A%2F%2Fwww.achillion.com
 or call 1-203-624-7000.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other
important factors that could cause actual results to differ materially from those indicated by
such forward-looking statements, including statements with respect to: the potency, safety,
tolerability, effectiveness and other characteristics of Achillion's protease inhibitors and NS5A
inhibitors; Achillion's expectations regarding timing for the commencement, completion and
reporting of results of clinical trials of drug candidates in its protease inhibitor and NS5A
inhibitor programs; Achillion's ability to advance a potentially best-in-class all-oral,
interferon-free combination protease and NS5A inhibitor; and Achillion's estimates for research
and development expenses, net cash used in operations and net loss per share for the year ended
December 31, 2013. Among the factors that could cause actual results to differ materially from
those indicated by such forward-looking statements are risks relating to, among other things
Achillion's ability to: replicate in later clinical trials positive results found in earlier stage
clinical trials of sovaprevir, ACH-3102 and its other product candidates; advance the development
of its drug candidates under the timelines it anticipates in current and future clinical trials;
obtain necessary regulatory approvals; obtain patent protection for its drug candidates and the
freedom to operate under third party intellectual property; establish commercial manufacturing
arrangements; identify, enter into and maintain collaboration agreements with appropriate
third-parties; compete successfully with other companies that are seeking to develop improved
therapies for the treatment of HCV; manage expenses; and raise the substantial additional capital
needed to achieve its business objectives. These and other risks are described in the reports
filed by Achillion with the U.S. Securities and Exchange Commission, including its Annual Report
on Form 10-K for the fiscal year ended December 31, 2012 and its subsequent SEC filings.

In addition, any forward-looking statement in this press release represents Achillion's views only
as of the date of this press release and should not be relied upon as representing its views as of
any subsequent date. Achillion disclaims any obligation to update any forward-looking statement,
except as required by applicable law.

-- Financial Tables Attached --

 ACHILLION PHARMACEUTICALS INC. (ACHN)                                                                                       
 Statements of Operations                                                                                                    
 (Unaudited, in thousands, except per share amounts)                                                                         
                                                                                                                          
                                                          Three Months Ended                       Year Ended               
                                                          December 31,                             December 31,             
                                                                                                                          
                                                          2012                2011                2012        2011        
                                                                                                                          
 Revenue                                                  $ 118               $ 62                $ 2,607     $ 247       
                                                                                                                          
 Operating expenses:                                                                                                      
 Research and development                                 8,436               9,937               38,999      35,441      
 General and administrative                               2,936               2,572               10,901      9,153       
 Total operating expenses                                 11,372              12,509              49,900      44,594      
                                                                                                                          
 Loss from operations                                     (11,254)            (12,447)            (47,293)    (44,347)    
                                                                                                                          
 Other income (expense):                                                                                                  
 Interest income                                          66                  72                  234         186         
 Interest expense                                         (16)                (10)                (68)        (45)        
                                                                                                                          
 Net loss                                                 $ (11,204)          $ (12,385)          $ (47,127)  $ (44,206)  
                                                                                                                          
                                                                                                                          
 Net loss per share - basic and diluted                   $ (0.14)            $ (0.18)            $ (0.64)    $ (0.69)    
                                                                                                                          
 Weighted average shares outstanding - basic and diluted  79,523              69,755              73,965      64,248      
                                                                                                                          
                                                                                                                          
                                                                                                                                
 Balance Sheets                                                                                                             
 (Unaudited, in thousands)                                                                                                  
                                                                                                                          
                                                          December 31,        December 31,                                
                                                          2012                2011                                        
 Cash and cash equivalents and marketable securities      $ 77,418            $ 79,943                                    
 Working capital                                          58,731              46,148                                      
 Total assets                                             81,530              82,630                                      
 Long-term liabilities                                    347                 2,718                                       
 Total liabilities                                        9,483               11,662                                      
 Total stockholders' (deficit) equity                     72,047              70,968                                      


CONTACT: Company Contact:
         Glenn Schulman
         Achillion Pharmaceuticals, Inc.
         Tel. (203) 624-7000
         gschulman@achillion.com
         
         Investors:
         Mary Kay Fenton
         Achillion Pharmaceuticals, Inc.
         Tel. (203) 624-7000
         mfenton@achillion.com

         Media:
         Christin Culotta Miller
         Ogilvy PR
         Tel. (212) 880-5264
         christin.miller@ogilvy.com
                  
         Investors:
         Seth Lewis
         The Trout Group, LLC
         Tel. (646) 378-2952
         slewis@troutgroup.com