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MYOK - MyoKardia Inc News Story

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MyoKardia Reports Third Quarter 2020 Financial Results

Thu 5th November, 2020 9:13pm
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BRISBANE, Calif., Nov. 05, 2020 (GLOBE NEWSWIRE) -- MyoKardia, Inc. (Nasdaq:
MYOK) today reported financial results for the third quarter ended September
30, 2020.

Recent Clinical Program Highlights

Mavacamten for Hypertrophic Cardiomyopathy (HCM)
* EXPLORER-HCM Data Presented at the European Society of Cardiology 2020
Virtual Congress and Published in The Lancet: Results from MyoKardia’s Phase
3 clinical study of mavacamten for the potential treatment of symptomatic,
obstructive HCM demonstrated statistically significant improvements in patient
symptoms and cardiac function, as well as reductions in left ventricular
outflow tract (LVOT) obstruction. In addition to meeting the primary and all
secondary endpoints, mavacamten showed reductions in biomarkers of cardiac
wall stress and myocardial injury and was well tolerated, with a safety
profile similar to placebo. The benefits observed were consistent across
multiple prespecified subgroups.
Danicamtiv (formerly MYK-491) for Dilated Cardiomyopathy (DCM)
* Initiated Phase 2 Clinical Trial of Danicamtiv in Genetic DCM: Danicamtiv
binds directly to and activates myosin, the heart’s motor protein, to boost
the power of each contraction without impacting the ability of the heart to
relax and fill with oxygenated blood. MyoKardia’s Phase 2 study of
danicamtiv is enrolling patients with DCM with documented genetic variants of
MYH7 or titin. Pathogenic variants in single genes encoding proteins of the
sarcomere have been associated with the contractile dysfunction underlying
approximately 20-30 percent of dilated cardiomyopathies.
Recent Corporate Highlights
* Entered into Strategic Partnership with LianBio to Develop and Commercialize
Mavacamten in China: The partnership will initially pursue a registration
strategy for mavacamten in China for obstructive HCM, with plans for
additional indications to follow, in keeping with MyoKardia’s development
strategy.


* Bristol-Myers Squibb to Acquire MyoKardia for $13.1 Billion in Cash:
Bristol-Myers Squibb (BMS) and MyoKardia announced a definitive merger
agreement under which BMS will acquire MyoKardia for $13.1 billion, or $225.00
per share in cash. The transaction is expected to close during the fourth
quarter of 2020.
Third Quarter 2020 Financial Results
* Cash Position: Cash, cash equivalents and investments as of September 30,
2020 were $895.9 million, compared to $430.3 million as of December 31,
2019. The quarter end cash receipts include $40.0 million from LianBio related
to the strategic partnership to develop and commercialize mavacamten in
greater China. 


* R&D Expenses: Research and development expenses were $59.1 million in the
third quarter of 2020, up from $47.4 million for the same period in 2019. The
increase in R&D expenses was primarily driven by the payment of approximately
$10.0 million to Fulcrum Therapeutics, as well as increases in personnel,
facility and information technology expenses, offset by reductions in clinical
expenses due to completion of our EXPLORER clinical trial.


* G&A Expenses: General and administrative expenses were $26.3 million for
the third quarter of 2020, compared to $17.7 million for same period in
2019. The increase in G&A expense was primarily driven by increases in
personnel and professional fees.


* Net Loss: Net loss was $84.7 million ($1.60 loss per share) for the third
quarter of 2020, compared to a net loss of $141.8 million ($3.07 loss per
share) for the third quarter of 2019.
About MyoKardia
MyoKardia is a clinical-stage biopharmaceutical company discovering and
developing targeted therapies for the treatment of serious cardiovascular
diseases. The company is pioneering a precision medicine approach to its
discovery and development efforts by 1) understanding the biomechanical
underpinnings of disease; 2) targeting the proteins that modulate a given
condition; 3) identifying patient populations with shared disease
characteristics; and 4) applying learnings from research and clinical studies
to inform and guide pipeline growth and product advancement. MyoKardia’s
initial focus is on small molecule therapeutics aimed at the proteins of the
heart that modulate cardiac muscle contraction to address diseases driven by
excessive contraction, impaired relaxation, or insufficient contraction. Among
its discoveries are three clinical-stage therapeutics: mavacamten (formerly
MYK-461); danicamtiv (formerly MYK-491) and MYK-224.

MyoKardia’s mission is to change the world for people with serious
cardiovascular disease through bold and innovative science.

Forward-Looking Statements
This press release contains “forward-looking statements” relating to the
development and commercialization of MyoKardia’s product candidates,
MyoKardia’s collaboration agreement with LianBio, and the pending
acquisition of MyoKardia by Bristol Myers Squibb. Such forward-looking
statements are generally identified by terminology such as “may,”
“will,” “should,” “expects,” “plans,” “anticipates,”
“could,” “intends,” “target,” “projects,” “contemplates,”
“believes,” “estimates,” “predicts,” “potential” or
“continue” or the negative of these terms or other similar words. These
statements are only predictions, and such forward-looking statements are based
on current expectations and involve inherent risks and uncertainties,
including factors that could delay, divert or change any of them, and could
cause actual outcomes and results to differ materially from current
expectations. No forward-looking statement can be guaranteed. Among other
risks are (i)  the development and commercialization of MyoKardia’s product
candidates may be delayed or halted for a variety of reasons, (ii) MyoKardia
may not realize the anticipated benefits of its collaboration with LianBio,
(iii) there can be no guarantee that the acquisition of MyoKardia by Bristol
Myers Squibb will be completed, or if it is completed, that it will close
within the anticipated time period or that the expected benefits of the
acquisition will be realized, (iv) the outcome of any legal proceedings that
may be instituted against the parties and others related to the merger
agreement and (v) unanticipated difficulties or expenditures relating to the
proposed transaction, the response of business partners and competitors to the
announcement of the proposed transaction and/or potential difficulties in
employee retention as a result of the announcement and pendency of the
proposed transaction. Forward-looking statements in this report should be
evaluated together with the many uncertainties that affect MyoKardia’s
business, particularly those identified in the risk factors in MyoKardia’s
most recent Annual Report on Form 10-K for the year ended December 31, 2019
and subsequent quarterly reports filed on Form 10-Q with the SEC, as well as
other documents that may be filed by MyoKardia from time to time with the SEC.
Except to the extent required by applicable law, MyoKardia undertakes no
obligation to publicly update any forward-looking statement, whether as a
result of new information, future events or otherwise. The forward-looking
statements made in this communication relate only to events as of the date on
which the statements are made.

Additional Information about the Proposed Transaction and Where to Find It
This press release is neither an offer to purchase nor a solicitation of an
offer to sell shares, nor is it a substitute for the tender offer materials
that Bristol-Myers Squibb and its acquisition subsidiary filed with the SEC
upon commencement of the tender offer. Bristol-Myers Squibb and its
acquisition subsidiary have filed a tender offer statement on Schedule TO with
the SEC, and MyoKardia has filed a solicitation/recommendation statement on
Schedule 14D-9 with respect to the tender offer. THE TENDER OFFER STATEMENT
(INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL AND OTHER
OFFER DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT CONTAIN
IMPORTANT INFORMATION THAT SHOULD BE READ CAREFULLY AND CONSIDERED BY
MYOKARDIA’S STOCKHOLDERS BEFORE ANY DECISION IS MADE WITH RESPECT TO THE
TENDER OFFER.  Both the tender offer statement and the
solicitation/recommendation statement were mailed to MyoKardia’s
stockholders free of charge.  A free copy of the tender offer statement and
the solicitation/recommendation statement is also available to all
stockholders of MyoKardia by accessing www.myokardia.com or by contacting
MyoKardia’s Investor Relations contact at ir@myokardia.com.  In addition,
the tender offer statement and the solicitation/recommendation statement (and
all other documents filed with the SEC) are available at no charge on the
SEC’s website: www.sec.gov.

MYOKARDIA’S STOCKHOLDERS ARE ADVISED TO READ THE SCHEDULE TO AND THE
SCHEDULE 14D-9, AS EACH MAY BE AMENDED OR SUPPLEMENTED FROM TIME TO TIME, AND
ANY OTHER RELEVANT DOCUMENTS FILED WITH THE SEC BEFORE THEY MAKE ANY DECISION
WITH RESPECT TO THE TENDER OFFER, BECAUSE THEY CONTAIN IMPORTANT INFORMATION
ABOUT THE PROPOSED TRANSACTION AND THE PARTIES THERETO.

Contacts 
Michelle Corral 
Executive Director, Corporate Communications and Investor Relations 
MyoKardia, Inc. 
650-351-4690 
ir@myokardia.com

Hannah Deresiewicz (investors) 
Stern Investor Relations, Inc. 
212-362-1200 
hannah.deresiewicz@sternir.com

Julie Normant (media)
W2O
628-213-3754
jnormart@w2ogroup.com

MYOKARDIA, INC.

Condensed Consolidated Balance Sheets
(In thousands, except share and per share amounts)
(Unaudited)

                                                                                                                                                                                                                                  September 30, 2020           December 31, 2019        
 Assets                                                                                                                                                                                                                                                                                 
 Current assets                                                                                                                                                                                                                                                                         
 Cash and cash equivalents                                                                                                                                                                                                        $           675,541          $          101,436       
 Short-term investments                                                                                                                                                                                                                       220,338                     314,691       
 Consideration due from related party                                                                                                                                                                                                         35,000                      —             
 Prepaid expenses and other current assets                                                                                                                                                                                                    12,865                      7,709         
 Total current assets                                                                                                                                                                                                                         943,744                     423,836       
 Property and equipment, net                                                                                                                                                                                                                  19,982                      15,743        
 Operating lease right-of-use assets                                                                                                                                                                                                          50,433                      417           
 Long-term investments                                                                                                                                                                                                                        —                           14,153        
 Related party warrant derivative asset                                                                                                                                                                                                       18,765                      —             
 Restricted cash and other                                                                                                                                                                                                                    2,737                       1,945         
 Total assets                                                                                                                                                                                                                     $           1,035,661        $          456,094       
 Liabilities and stockholders’ equity                                                                                                                                                                                                                                                   
 Current liabilities                                                                                                                                                                                                                                                                    
 Accounts payable                                                                                                                                                                                                                 $           4,554            $          6,237         
 Accrued liabilities                                                                                                                                                                                                                          40,043                      41,292        
 Operating lease liabilities - current                                                                                                                                                                                                        7,891                       383           
 Total current liabilities                                                                                                                                                                                                                    52,488                      47,912        
 Operating lease liability                                                                                                                                                                                                                    43,717                      —             
 Related party liability                                                                                                                                                                                                                      93,765                      —             
 Other long-term liabilities                                                                                                                                                                                                                  713                         1,908         
 Total liabilities                                                                                                                                                                                                                            190,683                     49,820        
 Commitments and contingencies                                                                                                                                                                                                                                                          
 Stockholders’ equity                                                                                                                                                                                                                                                                   
 Preferred stock, $0.0001 par value; 5,000,000 shares authorized; none issued and outstanding                                                                                                                                                 —                           —             
 Common stock, $0.0001 par value, 150,000,000 shares authorized at September 30, 2020 and December 31, 2019; 53,308,689 and 46,379,073 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively                5                           5             
 Additional paid-in capital                                                                                                                                                                                                                   1,541,679                   884,486       
 Accumulated other comprehensive income                                                                                                                                                                                                       257                         549           
 Accumulated deficit                                                                                                                                                                                                                          (696,963    )               (478,766   )  
 Total stockholders’ equity                                                                                                                                                                                                                   844,978                     406,274       
 Total liabilities and stockholders’ equity                                                                                                                                                                                       $           1,035,661        $          456,094       
                                                                                                                                                                                                                                                                                        

MYOKARDIA, INC.

Condensed Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts)
(Unaudited)

                                                                                            Three Months Ended September 30,                             Nine Months Ended September 30,                            
                                                                                            2020                                2019                     2020                                2019                   
 Operating expenses:                                                                                                                                                                                                
 Research and development                                                                   $       59,074                      $       47,372           $       155,286                     $       101,270        
 Selling, general and administrative                                                                26,329                              17,746                   66,482                              45,153         
 Repurchase of royalty rights                                                                       —                                   80,000                   —                                   80,000         
 Total operating expenses                                                                           85,403                              145,118                  221,768                             226,423        
 Loss from operations                                                                               (85,403     )                       (145,118    )            (221,768    )                       (226,423    )  
 Interest and other income, net                                                                     668                                 3,332                    3,592                               8,775          
 Loss before income taxes                                                                           (84,735     )                       (141,786    )            (218,176    )                       (217,648    )  
 Income tax expense (benefit)                                                                       9                                   16                       21                                  (202        )  
 Net loss                                                                                           (84,744     )                       (141,802    )            (218,197    )                       (217,446    )  
 Other comprehensive (loss) income                                                                  (495        )                       (44         )            (292        )                       520            
 Comprehensive loss                                                                         $       (85,239     )               $       (141,846    )    $       (218,489    )               $       (216,926    )  
 Net loss per share, basic and diluted                                                      $       (1.60       )               $       (3.07       )    $       (4.38       )               $       (4.91       )  
 Weighted average number of shares used to compute net loss per share, basic and diluted            53,101,453                          46,133,068               49,860,879                          44,255,657     
                                                                                                                                                                                                                    

(https://www.globenewswire.com/NewsRoom/AttachmentNg/f2c7a5a7-d19b-4226-80bb-31c050a253fa)



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