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SEC Filings

8-K
MYOKARDIA INC filed this Form 8-K on 05/09/2019
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Revenue: In the first quarter of 2019, MyoKardia recorded no revenue from collaborations, compared with $5.3 million during the same period in 2018.  As of December 31, 2018, MyoKardia had fulfilled all of its performance obligations to Sanofi, and no further revenue will be recorded from the Sanofi collaboration agreement.  

 

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R&D Expenses: Research and development expenses were $26.2 million in the first quarter 2019, net of reimbursement credits from Sanofi of $9.9 million, up from $16.6 million (net of Sanofi credits of $2.8 million) for the same period in 2018. The increase in R&D expenses for the first quarter of 2019 was primarily driven by an increase in clinical expenses related to the advancement of mavacamten and MYK-491 into later-stage trials, increases in personnel expenses and stock compensation due to higher headcount, and increases in research and preclinical activities.

 

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G&A Expenses: General and administrative expenses were $13.6 million for the three months ended March 31, 2019, compared to $7.3 million for the same period in 2018.  The change in G&A expense was primarily driven by an increase in personnel expenses and stock compensation due to higher headcount and an increase in accounting and consulting fees.

 

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Net Loss: Net loss was $37.5 million ($0.93 loss per share) for the first quarter of 2019, compared to a net loss of $17.8 million ($0.50 loss per share) for the first quarter of 2019.

 

Financial Guidance

Based on its current operating plans, MyoKardia anticipates that current cash, cash equivalents and investments are sufficient to fund operations into the second half of 2021.

 

Conference Call and Webcast

MyoKardia management will host a conference call and live audio webcast on Thursday, May 9, 2019, at 4:30 p.m. ET / 1:30 p.m. PT to discuss current operations and first quarter 2019 financial results.  The call may be accessed by phone by calling 844-494-0193 from the U.S. and Canada or 508-637-5584 internationally and using the conference ID 9189629. The webcast may be accessed live on the Investor Relations section of the Company's website at http://investors.myokardia.com. A replay of the webcast will be available on the MyoKardia website for approximately 90 days following the call.

 

About MyoKardia

MyoKardia is a clinical-stage biopharmaceutical company pioneering a precision medicine approach to discover, develop and commercialize targeted therapies for the treatment of serious cardiovascular diseases. MyoKardia’s initial focus is on the development of small molecule therapeutics aimed at the cardiac muscle proteins that modulate cardiac muscle contraction and underlie diseases of systolic and diastolic dysfunction. Based on an in-depth understanding of disease biology, MyoKardia applies a precision medicine approach to develop its therapeutic candidates for patient populations with shared characteristics, such as causal genetic mutations or disease subtypes. MyoKardia’s most advanced product candidate is mavacamten (formerly MYK-461), a novel, oral, allosteric modulator of cardiac myosin intended to reduce hypercontractility. Mavacamten has advanced into a pivotal Phase 3 clinical trial, known as EXPLORER-HCM, in patients with symptomatic, obstructive hypertrophic cardiomyopathy (HCM). MyoKardia is also developing mavacamten in a second indication, non-obstructive HCM, in the Phase 2 MAVERICK-HCM clinical trial. MYK-491, MyoKardia’s second product candidate, is designed to increase cardiac output among patients with systolic heart dysfunction by increasing the overall extent of the heart’s cardiac contractility. MyoKardia is currently evaluating MYK-491 in a Phase 1b/2a study in stable heart failure patients.

 

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

 

Forward-Looking Statements

Statements we make in this press release may include statements which are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended,