MyoKardia Reports Third Quarter 2020 Financial Results
Recent Clinical Program Highlights
Mavacamten for Hypertrophic Cardiomyopathy (HCM)
- EXPLORER-HCM Data Presented at the
European Society of Cardiology2020 Virtual Congressand 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 Partnershipwith LianBio to Develop and Commercialize Mavacamten in China: The partnership will initially pursue a registration strategy for mavacamten in Chinafor obstructive HCM, with plans for additional indications to follow, in keeping with MyoKardia’s development strategy.
- Bristol-Myers Squibb to Acquire
MyoKardiafor $13.1 Billion in Cash: Bristol-Myers Squibb (BMS) and MyoKardiaannounced a definitive merger agreement under which BMS will acquire MyoKardiafor $13.1 billion, or $225.00per 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 millionas of December 31, 2019. The quarter end cash receipts include $40.0 millionfrom LianBio related to the strategic partnership to develop and commercialize mavacamten in greater China.
- R&D Expenses: Research and development expenses were
$59.1 millionin the third quarter of 2020, up from $47.4 millionfor the same period in 2019. The increase in R&D expenses was primarily driven by the payment of approximately $10.0 millionto 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( $1.60loss per share) for the third quarter of 2020, compared to a net loss of $141.8 million( $3.07loss per share) for the third quarter of 2019.
MyoKardia’s mission is to change the world for people with serious cardiovascular disease through bold and innovative science.
This press release contains “forward-looking statements” relating to the development and commercialization of MyoKardia’s product candidates, MyoKardia’s collaboration agreement with LianBio, and the pending acquisition of
Additional Information about the Proposed Transaction and Where to Find It
This press release is neither an offer to purchase nor a solicitation of an offer to sell shares, nor is it a substitute for the tender offer materials that Bristol-Myers Squibb and its acquisition subsidiary filed with the
MYOKARDIA’S STOCKHOLDERS ARE ADVISED TO READ THE SCHEDULE TO AND THE SCHEDULE 14D-9, AS EACH MAY BE AMENDED OR SUPPLEMENTED FROM TIME TO TIME, AND ANY OTHER RELEVANT DOCUMENTS FILED WITH THE SEC BEFORE THEY MAKE ANY DECISION WITH RESPECT TO THE TENDER OFFER, BECAUSE THEY CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION AND THE PARTIES THERETO.
Executive Director, Corporate Communications and Investor Relations
Stern Investor Relations, Inc.
Condensed Consolidated Balance Sheets
(In thousands, except share and per share amounts)
|Cash and cash equivalents||$||675,541||$||101,436|
|Consideration due from related party||35,000||—|
|Prepaid expenses and other current assets||12,865||7,709|
|Total current assets||943,744||423,836|
|Property and equipment, net||19,982||15,743|
|Operating lease right-of-use assets||50,433||417|
|Related party warrant derivative asset||18,765||—|
|Restricted cash and other||2,737||1,945|
|Liabilities and stockholders’ equity|
|Operating lease liabilities - current||7,891||383|
|Total current liabilities||52,488||47,912|
|Operating lease liability||43,717||—|
|Related party liability||93,765||—|
|Other long-term liabilities||713||1,908|
|Commitments and contingencies|
|Additional paid-in capital||1,541,679||884,486|
|Accumulated other comprehensive income||257||549|
|Total stockholders’ equity||844,978||406,274|
|Total liabilities and stockholders’ equity||$||1,035,661||$||456,094|
Condensed Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts)
|Three Months Ended
||Nine Months Ended
|Research and development||$||59,074||$||47,372||$||155,286||$||101,270|
|Selling, general and administrative||26,329||17,746||66,482||45,153|
|Repurchase of royalty rights||—||80,000||—||80,000|
|Total operating expenses||85,403||145,118||221,768||226,423|
|Loss from operations||(85,403||)||(145,118||)||(221,768||)||(226,423||)|
|Interest and other income, net||668||3,332||3,592||8,775|
|Loss before income taxes||(84,735||)||(141,786||)||(218,176||)||(217,648||)|
|Income tax expense (benefit)||9||16||21||(202||)|
|Other comprehensive (loss) income||(495||)||(44||)||(292||)||520|
|Net loss per share, basic and diluted||$||(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|
Source: MyoKardia, Inc.