myok-8k_20201105.htm
false 0001552451 0001552451 2020-11-05 2020-11-05

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): November 5, 2020

 

MYOKARDIA, INC.

(Exact name of registrant as specified in its charter)

 

 

Delaware

001-37609

44-5500552

(State or other jurisdiction

of incorporation)

(Commission

File Number)

(I.R.S. Employer

Identification No.)

1000 Sierra Point Parkway

Brisbane, CA 94005

(Address of principal executive offices, including zip code)

(650) 741-0900

(Registrant’s telephone number, including area code)

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

Trading symbol(s)

Name of each exchange on which registered

Common Stock, par value $0.0001

MYOK

Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. 

 

 

 


 

Item 2.02 Results of Operations and Financial Condition.

On November 5, 2020, MyoKardia, Inc. announced its financial results for the third quarter ended September 30, 2020. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information in Item 2.02 of this Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such a filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit No.

 

Description

 

 

 

99.1

 

Press Release issued by MyoKardia, Inc. on November 5, 2020, furnished herewith

104

 

Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

 

 

 


 

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Date: November 5, 2020

 

 

MyoKardia, Inc.

 

 

 

 

 

 

By:

 

/s/ Taylor Harris

 

 

 

 

 

Taylor Harris

 

 

 

 

 

Chief Financial Officer (principal financial officer)

 

 

myok-ex991_7.htm

Exhibit 99.1

 

News Release

 

 

 

 

MyoKardia Reports Third Quarter 2020 Financial Results

 

Acquisition of MyoKardia by Bristol-Myers Squibb Expected to Close During 4th Quarter of 2020

 

Brisbane, Calif., Nov. 5, 2020 -- 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 hypertrophic cardiomyopathy (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 Dilated Cardiomyopathy (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

Driven by the Heart

 

 

1000 Sierra Point Parkway, Brisbane, CA 94005 / +1 650 741 0900 / myokardia.com

 

 

 

 


 

 

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

 

 

 

 

 

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Document and Entity Information
Nov. 05, 2020
Cover [Abstract]  
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Entity Central Index Key 0001552451
Document Type 8-K
Document Period End Date Nov. 05, 2020
Entity Registrant Name MYOKARDIA, INC.
Entity Incorporation State Country Code DE
Entity File Number 001-37609
Entity Tax Identification Number 44-5500552
Entity Address, Address Line One 1000 Sierra Point Parkway
Entity Address, City or Town Brisbane
Entity Address, State or Province CA
Entity Address, Postal Zip Code 94005
City Area Code (650)
Local Phone Number 741-0900
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Pre Commencement Tender Offer false
Pre Commencement Issuer Tender Offer false
Security 12b Title Common Stock, par value $0.0001
Trading Symbol MYOK
Security Exchange Name NASDAQ
Entity Emerging Growth Company false