myok-8k_20200227.htm
MyoKardia Inc false 0001552451 0001552451 2020-02-27 2020-02-27

 

 

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): February 27, 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 February 27, 2020, MyoKardia, Inc. announced its financial results for the fourth quarter ended December 31, 2019. 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 February 27, 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: February 27, 2020

 

 

MyoKardia, Inc.

 

 

 

 

 

 

By:

 

/s/ Taylor Harris

 

 

 

 

 

Taylor Harris

 

 

 

 

 

Chief Financial Officer (principal financial officer)

 

 

myok-ex991_32.htm

Exhibit 99.1

 

News Release

 

 

 

MyoKardia Reports Fourth Quarter and
Full Year 2019 Financial Results

 

Brisbane, Calif., Feb. 27, 2020 -- MyoKardia, Inc. (Nasdaq: MYOK), today reported financial results for the fourth quarter and full year ended December 31, 2019.

 

“MyoKardia achieved significant progress in 2019, advancing our pipeline and regaining global rights to our entire portfolio. There were important data readouts across our clinical programs, including one-year safety and efficacy data from our PIONEER-OLE study of mavacamten in obstructive HCM; encouraging results from our Phase 2 MAVERICK study in non-obstructive HCM pointing to mavacamten’s ability to favorably impact diastolic relaxation; positive interim data from our Phase 2a study of danicamtiv in patients enabling us to move forward in a genetic DCM population; and the initiation of our Phase 1 study of MYK-224 in HCM,” said Tassos Gianakakos, MyoKardia’s Chief Executive Officer. “These accomplishments position us for a transformational year as we look ahead to topline results from our pivotal Phase 3 EXPLORER study of mavacamten, which we expect to report in just a few months, moving us ever closer toward our goal of leadership in targeted cardiovascular therapeutic development.”

 

2020 Anticipated Milestones

Mavacamten

 

Present complete results from the Phase 2 MAVERICK-HCM clinical trial of mavacamten in patients with non-obstructive hypertrophic cardiomyopathy (HCM) at the upcoming American College of Cardiology/World Cardiology Congress joint meeting in March 2020

 

Announce topline data from the Phase 3 EXPLORER-HCM clinical trial of mavacamten for the treatment of obstructive HCM in the second quarter of 2020

 

o

Present complete results from the EXPLORER-HCM trial before year-end

 

Initiate a Phase 2 clinical trial of mavacamten in a targeted population of patients with heart failure with preserved ejection fraction (HFpEF) in the second quarter of 2020

 

Initiate VALOR-HCM, the Phase 3 study of mavacamten as a possible alternative to septal reduction therapy (SRT) in mid-2020

 

Begin late-stage study of mavacamten in non-obstructive HCM before year-end

 

o

Provide update from regulatory interactions in the first half of 2020

 

Danicamtiv (formerly MYK-491)

 

Present complete results from the Phase 2a study of danicamtiv in patients with stable heart failure

 

Initiate a Phase 2 study of danicamtiv in patients with genetic dilated cardiomyopathy (DCM) in the second quarter of 2020

 

MYK-224

 

Share results from the Phase 1 clinical trial of MYK-224 in healthy volunteers in the third quarter of 2020

 

Initiate a Phase 2 study of MYK-224 by year end

 

Recent Clinical Program Highlights

 

Mavacamten for Hypertrophic Cardiomyopathy

 

 

Presented 48-week Data from the PIONEER-OLE Study of Mavacamten: At the American Heart Association Scientific Sessions, 48-week data from the PIONEER open-label extension study of 12 patients with obstructive HCM were presented. Consistent with data reported at 12, 24 and 36 weeks, treatment with mavacamten was generally well-tolerated, and patients continue to experience sustained clinical benefit, including reductions in left ventricular outflow tract (LVOT) gradient, improvements in NYHA functional class and improvement of multiple biomarkers toward

Driven by the Heart

 

 

 

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

 

 


 

normal ranges. A reduction in septal wall thickness, a defining characteristic of HCM, as well as an improvement in patient reported quality of life, as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ), were also reported.

 

 

Reported Positive Topline Data from the Phase 2 MAVERICK-HCM Study: Mavacamten was generally well-tolerated in patients with non-obstructive HCM in the 16-week dose-ranging study. Meaningful reductions in biomarkers of cardiac stress were observed in patients treated across both mavacamten drug concentration cohorts, and clear signals of clinical benefit were seen in a subgroup of patients with elevated cardiac filling pressure at baseline and in a pre-specified group of patients at higher risk for morbidity and mortality.

 

Danicamtiv for Dilated Cardiomyopathy

 

 

Reported Positive Data from Phase 2a Study of Danicamtiv: An interim analysis of 26 patients with stable heart failure due to left ventricular systolic dysfunction in the ongoing Phase 2a clinical trial showed that danicamtiv demonstrated improvement in systolic function, including stroke volume increases of greater than 10 percent relative to baseline on a placebo-adjusted basis, without impacting diastolic function. Given the favorable safety profile observed to date, the Phase 2a study was extended to evaluate higher exposures of danicamtiv.

 

Fourth Quarter and Full Year 2019 Financial Results

 

Cash Position: Cash, cash equivalents and investments (short-term and long-term) as of December 31, 2019 were $430.3 million, compared to $394.8 million as of December 31, 2018. The change in MyoKardia’s cash position was primarily attributable to net proceeds from the March 2019 equity offering of $271.2 million, offset by expenditures related to operating activities of $241.8 million, which included an $80.0 million payment to Sanofi for the purchase of mavacamten and MYK-224 royalty rights.

 

Revenues: MyoKardia did not record revenue during the fourth quarter and year ended December 31, 2019. For the three and twelve months ended December 31, 2018, collaboration and license revenue from the company’s collaboration with Sanofi totaled $12.4 million and $33.6 million, respectively. MyoKardia fulfilled its research and development obligations under the collaboration agreement during the year ended December 31, 2018, and no further revenue will be recorded under the agreement.

 

R&D Expenses: Research and development expenses were $44.9 million for the fourth quarter of 2019, up from $19.0 million for the same period in 2018. R&D expenses totaled $146.2 million for the full year 2019, up from $68.8 million for the same period in 2018. The increase in R&D expenses was primarily driven by trial expenditures related to mavacamten, danicamtiv and MYK-224 clinical programs, a decrease in Sanofi reimbursement credits, increases in expenses related to discovery and preclinical programs, and increases in headcount and stock-based compensation expense.

 

SG&A Expenses: 

Selling, general and administrative expenses were $16.5 million for the three months ended December 31, 2019, compared to $11.3 million for the same period in 2018. For the year ended December 31, 2019, SG&A expenses were $61.7 million compared to $38.4 million in the same period in 2018. The increase in SG&A expenses was primarily due to increases in headcount and related costs as we build out the Company to prepare for the potential commercialization of mavacamten.

 

Net Loss: Net loss for the fourth quarter of 2019 was $58.8 million ($1.27 per share), compared to a net loss of $15.7 million ($0.39 per share) for the fourth quarter of 2018. For full year 2019, net loss was $276.2 million ($6.17 per share), of which $80.0 million ($1.79 per share) was related to the repurchase of royalty rights and $196.2 million ($4.38 per share) was related to loss from operations, compared to $67.7 million ($1.76 per share) during the same period of 2018.

 

Based on the company’s current cash position, MyoKardia estimates having sufficient funds to execute on current operating plans into mid-2021.  


 

Conference Call and Webcast

MyoKardia management will host a conference call and live audio webcast on Thursday, February 27, 2020, at 4:30 p.m. ET / 1:30 p.m. PT to discuss current operations and fourth quarter and year end 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 8698045. 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 90 days following the call.

 

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 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

 

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, and Section 21E of the Securities Exchange Act of 1934, as amended, which are usually identified by the use of words such as "anticipates," "believes," "estimates," "expects," "intends," "may," "plans," "projects," "seeks," "should," "will," and variations of such words or similar expressions. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Securities Exchange Act and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements, including statements regarding the clinical and therapeutic potential of mavacamten, danicamtiv and MYK-224, the availability of data from the Phase 3 EXPLORER-HCM clinical trial of mavacamten for the treatment of obstructive HCM, the Phase 2 MAVERICK-HCM study in patients with non-obstructive HCM and the Phase 2a study of danicamtiv in patients with stable heart failure and the Company’s expectation with respect to release of data from these studies, the Company’s ability to advance danicamtiv into a Phase 2 study in patients with genetic DCM, the commencement of a Phase 2 clinical trial of mavacamten in a targeted population of patients with HFpEF, the commencement of VALOR-HCM, the Phase 3 study of mavacamten as a possible alternative to SRT, the commencement of the late-stage study of mavacamten in non-obstructive HCM, the availability of data from the Phase 1 study of MYK-224 in healthy subjects and the commencement of a Phase 2 study of MYK-224, and the timing of these events as well as the Company’s projected cash runway, reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements ad will be affected by a variety of risks and factors that are beyond our control including, without limitation, risks associated with the development and regulation of our product candidates, as well as those set forth in our Annual Report on Form 10-K for the year ended December 31, 2019, and our other filings with the SEC. Except as required by law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

 


Contacts

Michelle Corral

Senior 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.dereseiwicz@sternir.com

 

Julie Normart (Media)

W2O

628-213-3754

jnormart@w2ogroup.com

 

 

 

 

 

 


MYOKARDIA, INC.

Consolidated Balance Sheets

(In thousands, except share and per share amounts)

 

 

 

December 31,

 

 

 

2019

 

 

2018

 

Assets

 

 

 

 

 

 

 

 

Current assets

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

101,436

 

 

$

246,122

 

Short-term investments

 

 

314,691

 

 

 

68,564

 

Prepaid expenses and other current assets

 

 

7,709

 

 

 

4,760

 

Total current assets

 

 

423,836

 

 

 

319,446

 

Property and equipment, net

 

 

15,743

 

 

 

5,138

 

Operating lease right-of-use assets

 

 

417

 

 

 

 

Long-term investments

 

 

14,153

 

 

 

80,148

 

Restricted cash and other

 

 

1,945

 

 

 

2,521

 

Total assets

 

$

456,094

 

 

$

407,253

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

 

 

 

Accounts payable

 

$

6,237

 

 

$

2,946

 

Accrued liabilities

 

 

41,292

 

 

 

20,758

 

Prepayment from collaboration partner

 

 

 

 

 

12,973

 

Operating lease liabilities - current

 

 

383

 

 

 

 

Total current liabilities

 

 

47,912

 

 

 

36,677

 

Other long-term liabilities

 

 

1,908

 

 

 

9

 

Total liabilities

 

 

49,820

 

 

 

36,686

 

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 December 31, 2019 and 2018; 46,379,073 and 40,288,949 shares issued and outstanding at December 31, 2019 and 2018, respectively

 

 

5

 

 

 

4

 

Additional paid-in capital

 

 

884,486

 

 

 

573,183

 

Accumulated other comprehensive income (loss)

 

 

549

 

 

 

(67

)

Accumulated deficit

 

 

(478,766

)

 

 

(202,553

)

Total stockholders’ equity

 

 

406,274

 

 

 

370,567

 

Total liabilities and stockholders’ equity

 

$

456,094

 

 

$

407,253

 



MYOKARDIA, INC.

Consolidated Statements of Operations and Comprehensive Loss

(In thousands, except share and per share amounts)

 

 

 

Year Ended December 31,

 

 

 

2019

 

 

2018

 

 

2017

 

Collaboration and license revenue

 

$

 

 

$

33,558

 

 

$

11,442

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Repurchase of royalty rights

 

 

80,000

 

 

 

 

 

 

 

Research and development

 

 

146,171

 

 

 

68,774

 

 

 

48,136

 

Selling, general and administrative

 

 

61,663

 

 

 

38,435

 

 

 

21,973

 

Total operating expenses

 

 

287,834

 

 

 

107,209

 

 

 

70,109

 

Loss from operations

 

 

(287,834

)

 

 

(73,651

)

 

 

(58,667

)

Interest and other income, net

 

 

11,621

 

 

 

5,953

 

 

 

1,657

 

Net loss

 

 

(276,213

)

 

 

(67,698

)

 

 

(57,010

)

Other comprehensive income (loss)

 

 

616

 

 

 

125

 

 

 

(200

)

Comprehensive loss

 

$

(275,597

)

 

$

(67,573

)

 

$

(57,210

)

Net loss per share, basic and diluted

 

$

(6.17

)

 

$

(1.76

)

 

$

(1.74

)

Weighted average number of shares used to compute net loss per share, basic and diluted

 

 

44,765,496

 

 

 

38,386,906

 

 

 

32,832,514