Acceleron Pharma Inc.
Feb 26, 2014

Acceleron Pharma Reports Fourth Quarter and Year Ended 2013 Financial Results

Strong financial position and positive clinical data from several phase 2 clinical trials
Initiation of a phase 3 clinical trial in beta-thalassemia expected by the end of 2014 or early 2015

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Acceleron Pharma Inc. (NASDAQ:XLRN), a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of novel protein therapeutics for cancer and rare diseases, today provided a corporate update and reported financial results for the fourth quarter and year ended December 31, 2013.

"We are excited by the encouraging interim phase 2 data for both sotatercept and ACE-536 in patients with beta-thalassemia, and we are looking forward to reporting new data from ongoing phase 2 studies in patients with myelodysplastic syndromes, end-stage renal disease and renal cell carcinoma in the first half of 2014," said John Knopf, Ph.D., Chief Executive Officer of Acceleron. "Our three clinical candidates continue to advance across nearly a dozen Phase 2 studies and we plan to bring a new candidate, designed to increase muscle mass and strength, into clinical development in the second half of this year. Our goal to initiate the Company's first phase 3 clinical trial in beta-thalassemia by the end of the year or the first quarter of next year will be an exciting milestone for us and the beta-thalassemia community."

Recent Highlights

Sotatercept

ACE-536

Dalantercept

Other business highlights

Financial Results

Upcoming Milestones

Conference Call and Webcast Information

The company will host a conference call and live audio webcast to report its fourth quarter and year ended financial results for 2014 and provide a corporate update on February 26, 2014, at 9:00 AM EST. To participate by teleconference, please dial (877) 312-5848 (domestic) or (253) 237-1155 (international) and refer to the "Acceleron Q4 Earnings Call." To access the live webcast, please select "Events & Presentations" in the Investors & Media section on the Company's website (www.acceleronpharma.com). To ensure a timely connection, it is recommended that users register at least 15 minutes prior to the scheduled webcast.

A replay of the webcast will be archived on the Company's website and accessible approximately two hours after the event.

About Acceleron

Acceleron is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of novel protein therapeutics for cancer and rare diseases. The company is a leader in understanding the biology of the Transforming Growth Factor-Beta (TGF-β) protein superfamily, a large and diverse group of molecules that are key regulators in the growth and repair of tissues throughout the human body, and in targeting these pathways to develop important new medicines. Acceleron has built a highly productive R&D platform that has generated innovative clinical and preclinical protein therapeutic candidates with novel mechanisms of action. These protein therapeutic candidates have the potential to significantly improve clinical outcomes for patients with cancer and rare diseases.

For more information, please visit www.acceleronpharma.com.

 

ACCELERON PHARMA INC.

CONDENSED CONSOLIDATED BALANCE SHEET (UNAUDITED)

(Amounts in thousands)

 
   

December 31,
2013

   

December 31,
2012

 
Cash and cash equivalents $ 113,163 $ 39,611
Other assets 10,569 9,601  
Total assets $ 123,732 $ 49,212  
 
Deferred revenue $ 7,651 $ 34,600
Notes payable, net of discount 16,868 20,193
Warrants to purchase common stock 30,753 5,229
Other liabilities 10,649 11,553  
Total liabilities 65,921 71,575
Redeemable convertible preferred stock 268,610
Stockholders' equity (deficit) 57,811 (290,973 )

Total liabilities, redeemable convertible preferred stock and Stockholders'

equity (deficit)

$ 123,732 $ 49,212  
 
 

ACCELERON PHARMA INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)

(Amounts in thousands except per share data)

   
Three Months Ended December 31, Year Ended December 31,
2013   2012 2013   2012
 
Collaboration revenue $ 11,521 $ 3,985 $ 57,230 $ 15,254
 
Costs and expenses:
Research and development 10,216 9,673 36,051 35,319
General and administrative   4,756     2,506     14,227     8,824  
 
Total costs and expenses 14,972 12,179 50,278 44,143
 
(Loss) income from operations (3,451 ) (8,194 ) 6,952 (28,889 )
 
Other expense, net   (14,659 )   (2,185 )   (28,850 )   (3,693 )
 
Net loss $ (18,110 ) $ (10,379 ) $ (21,898 ) $ (32,582 )
 

Accretion of dividends, interest, redemption

value and issuance costs on redeemable

convertible preferred stock

(6,744 ) (19,870 ) (27,061 )

Gain on extinguishment of redeemable

convertible preferred stock

          2,765      
 

Net loss applicable to common stockholders -

basic and diluted

$ (18,110 ) $ ( 17,123 ) $ (39,003 ) $ (59,643 )
 
 

Net loss per share applicable to common

stockholders:

Basic and diluted $ (0.64 ) $ (7.10 ) $ (4.15 ) $ (24.84 )
 

Weighted average number of common shares

used in computing net loss per share

applicable to common stockholders:

Basic and diluted 28,123 2,416 9,407 2,401
 

Cautionary Note on Forward-Looking Statements

This press release includes forward-looking statements about the Company's strategy, future plans and prospects, including statements regarding the development of the Company's compounds, including sotatercept, ACE-536, dalantercept, or ACE-083 and the Company's TGF-β superfamily program generally, the timeline for clinical development and regulatory approval of the Company's compounds, the expected timing for the reporting of data from ongoing trials, and the structure of the Company's planned or pending clinical trials. The words "anticipate," "appear," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement. Applicable risks and uncertainties include the risks that the Company's cash position will be insufficient to fund operations through the first half of 2017, that preclinical testing of the Company's compounds and preliminary data from clinical trials may not be predictive of the results or success of ongoing or later clinical trials, that data may not be available when we expect it to be, that the Company or its collaboration partner, Celgene, will be unable to successfully complete the clinical development of its compounds, that the development of the Company's compounds will take longer or cost more than planned, that the Company may be delayed in initiating or completing any clinical trials, and that the Company's compounds will not receive regulatory approval or become commercially successful products. Other risks and uncertainties include those identified under the heading "Risk Factors" included in the Company's Registration Statement on Form S-1 which was declared effective by the Securities and Exchange Commission (SEC) on January 22, 2014, and other filings that the Company may make with the SEC in the future. The forward-looking statements contained in this press release reflect the Company's current views with respect to future events, and the Company does not undertake and specifically disclaims any obligation to update any forward-looking statements.

Acceleron Pharma Inc.
Kevin F. McLaughlin, 617-649-9204
Senior Vice President and Chief Financial Officer
or
Media:
Suda Communications LLC
Maureen L. Suda, 585-387-9248

Source: Acceleron Pharma Inc.

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