myok-10q_20200630.htm
false 2020 Q2 0001552451 --12-31 Large Accelerated Filer 2021-03 P9Y9M18D P3M18D 0001552451 2020-01-01 2020-06-30 xbrli:shares 0001552451 2020-07-31 iso4217:USD 0001552451 2020-06-30 0001552451 2019-12-31 iso4217:USD xbrli:shares 0001552451 2020-04-01 2020-06-30 0001552451 2019-04-01 2019-06-30 0001552451 2019-01-01 2019-06-30 0001552451 us-gaap:CommonStockMember 2019-12-31 0001552451 us-gaap:AdditionalPaidInCapitalMember 2019-12-31 0001552451 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2019-12-31 0001552451 us-gaap:RetainedEarningsMember 2019-12-31 0001552451 us-gaap:CommonStockMember 2020-01-01 2020-03-31 0001552451 us-gaap:AdditionalPaidInCapitalMember 2020-01-01 2020-03-31 0001552451 2020-01-01 2020-03-31 0001552451 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2020-01-01 2020-03-31 0001552451 us-gaap:RetainedEarningsMember 2020-01-01 2020-03-31 0001552451 us-gaap:CommonStockMember 2020-03-31 0001552451 us-gaap:AdditionalPaidInCapitalMember 2020-03-31 0001552451 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2020-03-31 0001552451 us-gaap:RetainedEarningsMember 2020-03-31 0001552451 2020-03-31 0001552451 us-gaap:CommonStockMember 2020-04-01 2020-06-30 0001552451 us-gaap:AdditionalPaidInCapitalMember 2020-04-01 2020-06-30 0001552451 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2020-04-01 2020-06-30 0001552451 us-gaap:RetainedEarningsMember 2020-04-01 2020-06-30 0001552451 us-gaap:CommonStockMember 2020-06-30 0001552451 us-gaap:AdditionalPaidInCapitalMember 2020-06-30 0001552451 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2020-06-30 0001552451 us-gaap:RetainedEarningsMember 2020-06-30 0001552451 us-gaap:CommonStockMember 2019-01-01 2019-03-31 0001552451 us-gaap:CommonStockMember 2018-12-31 0001552451 us-gaap:AdditionalPaidInCapitalMember 2018-12-31 0001552451 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2018-12-31 0001552451 us-gaap:RetainedEarningsMember 2018-12-31 0001552451 2018-12-31 0001552451 us-gaap:AdditionalPaidInCapitalMember 2019-01-01 2019-03-31 0001552451 2019-01-01 2019-03-31 0001552451 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2019-01-01 2019-03-31 0001552451 us-gaap:RetainedEarningsMember 2019-01-01 2019-03-31 0001552451 us-gaap:CommonStockMember 2019-03-31 0001552451 us-gaap:AdditionalPaidInCapitalMember 2019-03-31 0001552451 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2019-03-31 0001552451 us-gaap:RetainedEarningsMember 2019-03-31 0001552451 2019-03-31 0001552451 us-gaap:CommonStockMember 2019-04-01 2019-06-30 0001552451 us-gaap:AdditionalPaidInCapitalMember 2019-04-01 2019-06-30 0001552451 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2019-04-01 2019-06-30 0001552451 us-gaap:RetainedEarningsMember 2019-04-01 2019-06-30 0001552451 us-gaap:CommonStockMember 2019-06-30 0001552451 us-gaap:AdditionalPaidInCapitalMember 2019-06-30 0001552451 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2019-06-30 0001552451 us-gaap:RetainedEarningsMember 2019-06-30 0001552451 2019-06-30 0001552451 2020-05-01 2020-05-31 myok:Segment 0001552451 myok:TerminationAgreementMember myok:AventisIncMember myok:RoyaltyRightsMember 2019-07-31 0001552451 us-gaap:USTreasurySecuritiesMember 2020-06-30 0001552451 us-gaap:MoneyMarketFundsMember 2020-06-30 0001552451 us-gaap:MoneyMarketFundsMember us-gaap:FairValueMeasurementsRecurringMember us-gaap:FairValueInputsLevel1Member 2020-06-30 0001552451 us-gaap:USGovernmentAgenciesDebtSecuritiesMember 2020-06-30 0001552451 us-gaap:USGovernmentAgenciesDebtSecuritiesMember us-gaap:FairValueMeasurementsRecurringMember us-gaap:FairValueInputsLevel2Member 2020-06-30 0001552451 us-gaap:CorporateDebtSecuritiesMember 2020-06-30 0001552451 us-gaap:CorporateDebtSecuritiesMember us-gaap:FairValueMeasurementsRecurringMember us-gaap:FairValueInputsLevel2Member 2020-06-30 0001552451 us-gaap:FairValueMeasurementsRecurringMember us-gaap:FairValueInputsLevel1Member 2020-06-30 0001552451 us-gaap:FairValueMeasurementsRecurringMember us-gaap:FairValueInputsLevel2Member 2020-06-30 0001552451 us-gaap:MoneyMarketFundsMember 2019-12-31 0001552451 us-gaap:MoneyMarketFundsMember us-gaap:FairValueMeasurementsRecurringMember us-gaap:FairValueInputsLevel1Member 2019-12-31 0001552451 us-gaap:USGovernmentAgenciesDebtSecuritiesMember 2019-12-31 0001552451 us-gaap:USGovernmentAgenciesDebtSecuritiesMember us-gaap:FairValueMeasurementsRecurringMember us-gaap:FairValueInputsLevel2Member 2019-12-31 0001552451 us-gaap:CorporateDebtSecuritiesMember 2019-12-31 0001552451 us-gaap:CorporateDebtSecuritiesMember us-gaap:FairValueMeasurementsRecurringMember us-gaap:FairValueInputsLevel2Member 2019-12-31 0001552451 us-gaap:FairValueMeasurementsRecurringMember us-gaap:FairValueInputsLevel1Member 2019-12-31 0001552451 us-gaap:FairValueMeasurementsRecurringMember us-gaap:FairValueInputsLevel2Member 2019-12-31 0001552451 us-gaap:CashAndCashEquivalentsMember 2020-06-30 0001552451 us-gaap:ShortTermInvestmentsMember 2020-06-30 0001552451 us-gaap:CashAndCashEquivalentsMember 2019-12-31 0001552451 us-gaap:ShortTermInvestmentsMember 2019-12-31 0001552451 myok:LongTermInvestmentsMember 2019-12-31 0001552451 myok:CoporateBondsMember 2019-12-31 utr:sqft 0001552451 myok:CorporateHeadquartersMember 2018-09-30 0001552451 myok:CorporateHeadquartersMember 2020-01-01 2020-01-31 0001552451 myok:CorporateHeadquartersMember 2020-01-31 0001552451 us-gaap:LeaseholdImprovementsMember 2020-06-30 xbrli:pure 0001552451 myok:SubleasedPropertyMember 2020-06-30 0001552451 myok:SubleasedPropertyMember 2020-01-01 2020-06-30 0001552451 srt:MinimumMember 2020-01-01 2020-06-30 0001552451 srt:MaximumMember 2020-01-01 2020-06-30 0001552451 us-gaap:LeaseholdImprovementsMember 2020-01-01 2020-06-30 0001552451 us-gaap:MachineryAndEquipmentMember 2020-06-30 0001552451 us-gaap:MachineryAndEquipmentMember 2019-12-31 0001552451 us-gaap:FurnitureAndFixturesMember 2020-06-30 0001552451 us-gaap:FurnitureAndFixturesMember 2019-12-31 0001552451 us-gaap:SoftwareDevelopmentMember 2020-06-30 0001552451 us-gaap:SoftwareDevelopmentMember 2019-12-31 0001552451 us-gaap:LeaseholdImprovementsMember 2019-12-31 0001552451 us-gaap:ConstructionInProgressMember 2020-06-30 0001552451 us-gaap:ConstructionInProgressMember 2019-12-31 0001552451 myok:MultiTargetCollaborationAndLicenseAgreementMember myok:FulcrumTherapeuticsIncMember us-gaap:SubsequentEventMember 2020-07-01 2020-07-31 0001552451 myok:MultiTargetCollaborationAndLicenseAgreementMember myok:FulcrumTherapeuticsIncMember srt:MaximumMember us-gaap:SubsequentEventMember 2020-07-01 2020-07-31 0001552451 myok:FollowOnOfferingMember 2020-05-01 2020-05-31 0001552451 myok:FollowOnOfferingMember 2020-05-31 0001552451 us-gaap:OverAllotmentOptionMember 2020-05-01 2020-05-31 0001552451 myok:FollowOnOfferingMember 2020-01-01 2020-06-30 0001552451 srt:MaximumMember 2020-01-03 0001552451 myok:FollowOnOfferingMember 2019-03-01 2019-03-31 0001552451 myok:FollowOnOfferingMember 2019-03-31 0001552451 us-gaap:OverAllotmentOptionMember 2019-03-01 2019-03-31 0001552451 myok:FollowOnOfferingMember 2019-01-01 2019-06-30 0001552451 us-gaap:EmployeeStockOptionMember 2020-06-30 0001552451 us-gaap:EmployeeStockOptionMember 2019-12-31 0001552451 myok:TwoThousandFifteenStockOptionAndIncentivePlanMember 2020-06-30 0001552451 myok:TwoThousandFifteenStockOptionAndIncentivePlanMember 2019-12-31 0001552451 myok:TwoThousandFifteenEmployeeStockPurchasePlanMember 2020-06-30 0001552451 myok:TwoThousandFifteenEmployeeStockPurchasePlanMember 2019-12-31 0001552451 us-gaap:ResearchAndDevelopmentExpenseMember 2020-04-01 2020-06-30 0001552451 us-gaap:ResearchAndDevelopmentExpenseMember 2019-04-01 2019-06-30 0001552451 us-gaap:ResearchAndDevelopmentExpenseMember 2020-01-01 2020-06-30 0001552451 us-gaap:ResearchAndDevelopmentExpenseMember 2019-01-01 2019-06-30 0001552451 us-gaap:SellingGeneralAndAdministrativeExpensesMember 2020-04-01 2020-06-30 0001552451 us-gaap:SellingGeneralAndAdministrativeExpensesMember 2019-04-01 2019-06-30 0001552451 us-gaap:SellingGeneralAndAdministrativeExpensesMember 2020-01-01 2020-06-30 0001552451 us-gaap:SellingGeneralAndAdministrativeExpensesMember 2019-01-01 2019-06-30 0001552451 us-gaap:RestrictedStockUnitsRSUMember 2019-12-31 0001552451 us-gaap:RestrictedStockUnitsRSUMember 2020-01-01 2020-06-30 0001552451 us-gaap:RestrictedStockUnitsRSUMember 2020-06-30 0001552451 us-gaap:EmployeeStockOptionMember 2020-01-01 2020-06-30 0001552451 us-gaap:EmployeeStockOptionMember 2019-01-01 2019-06-30 0001552451 myok:TwoThousandFifteenEmployeeStockPurchasePlanMember 2020-01-01 2020-06-30 0001552451 myok:TwoThousandFifteenEmployeeStockPurchasePlanMember 2019-01-01 2019-06-30

 

0

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 

FORM 10-Q

 

(Mark One)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended June 30, 2020

or

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from                      to                     

Commission File Number: 001-37609

MYOKARDIA, INC.

(Exact name of registrant as specified in its charter)

 

 

Delaware

 

44-5500552

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

1000 Sierra Point Parkway

Brisbane, CA

(Address of principal executive offices)

94005

(Zip Code)

(650) 741-0900

(Registrant’s telephone number, including area code)

 

 

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

MYOK

NASDAQ Global Select Market

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes  No 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes  No 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer

 

  

Accelerated filer

 

Non-accelerated filer

 

  

  

Smaller reporting company

 

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.    

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes  No 

 

The number of outstanding shares of the registrant’s common stock on July 31, 2020 was 53,003,114 shares.

 

 

 

 


 

MYOKARDIA, INC.

TABLE OF CONTENTS

 

 

Page

PART I—FINANCIAL INFORMATION

 

3

Item 1. Unaudited Condensed Consolidated Financial Statements

 

3

Condensed Consolidated Balance Sheets as of June 30, 2020 and December 31, 2019

 

3

Condensed Consolidated Statements of Operations and Comprehensive Loss for the Six Months Ended June 30, 2020 and 2019

 

4

Condensed Consolidated Statements of Stockholders’ Equity for the Six Months Ended June 30, 2020 and 2019

 

5

Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2020 and 2019

 

6

Notes to Condensed Consolidated Financial Statements

 

7

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

17

Item 3. Quantitative and Qualitative Disclosures About Market Risk

 

24

Item 4. Controls and Procedures

 

24

PART II—OTHER INFORMATION

 

25

Item 1. Legal Proceedings

 

25

Item 1A. Risk Factors

 

25

Item 6. Exhibits

 

56

SIGNATURES

 

57

 

 

 

2


 

PART I—FINANCIAL INFORMATION

 

 

Item 1.

Unaudited Condensed Consolidated Financial Statements

MYOKARDIA, INC.

Condensed Consolidated Balance Sheets

(In thousands, except share and per share amounts)

(Unaudited)

 

 

 

June 30,

2020

 

 

December 31,

2019

 

Assets

 

 

 

 

 

 

 

 

Current assets

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

659,107

 

 

$

101,436

 

Short-term investments

 

 

258,946

 

 

 

314,691

 

Prepaid expenses and other current assets

 

 

7,075

 

 

 

7,709

 

Total current assets

 

 

925,128

 

 

 

423,836

 

Property and equipment, net

 

 

19,703

 

 

 

15,743

 

Operating lease right-of-use assets

 

 

51,189

 

 

 

417

 

Long-term investments

 

 

 

 

 

14,153

 

Restricted cash and other

 

 

2,706

 

 

 

1,945

 

Total assets

 

$

998,726

 

 

$

456,094

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

 

 

 

Accounts payable

 

$

3,349

 

 

$

6,237

 

Accrued liabilities

 

 

32,600

 

 

 

41,292

 

Operating lease liabilities - current

 

 

8,042

 

 

 

383

 

Total current liabilities

 

 

43,991

 

 

 

47,912

 

Operating lease liability

 

 

44,188

 

 

 

 

Other long-term liabilities

 

 

1,908

 

 

 

1,908

 

Total liabilities

 

 

90,087

 

 

 

49,820

 

Commitments and contingencies (Note 7)

 

 

 

 

 

 

 

 

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 June 30, 2020 and December 31, 2019; 52,965,033 and

   46,379,073 shares issued and outstanding at June 30, 2020

   and December 31, 2019, respectively

 

 

5

 

 

 

5

 

Additional paid-in capital

 

 

1,520,101

 

 

 

884,486

 

Accumulated other comprehensive income

 

 

752

 

 

 

549

 

Accumulated deficit

 

 

(612,219

)

 

 

(478,766

)

Total stockholders’ equity

 

 

908,639

 

 

 

406,274

 

Total liabilities and stockholders’ equity

 

$

998,726

 

 

$

456,094

 

 

 

 

 

 

 

 

 

 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

 

3


 

MYOKARDIA, INC.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(In thousands, except share and per share amounts)

(Unaudited)

 

 

 

Three Months Ended

June 30,

 

 

Six Months Ended

June 30,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

44,334

 

 

$

27,708

 

 

$

96,212

 

 

$

53,898

 

Selling, general and administrative

 

 

20,251

 

 

 

13,856

 

 

 

40,153

 

 

 

27,407

 

Total operating expenses

 

 

64,585

 

 

 

41,564

 

 

 

136,365

 

 

 

81,305

 

Loss from operations

 

 

(64,585

)

 

 

(41,564

)

 

 

(136,365

)

 

 

(81,305

)

Interest and other income, net

 

 

1,012

 

 

 

3,172

 

 

 

2,924

 

 

 

5,443

 

Loss before income taxes

 

 

(63,573

)

 

 

(38,392

)

 

 

(133,441

)

 

 

(75,862

)

Income tax expense (benefit)

 

 

12

 

 

 

(218

)

 

 

12

 

 

 

(218

)

Net loss

 

 

(63,585

)

 

 

(38,174

)

 

 

(133,453

)

 

 

(75,644

)

Other comprehensive income

 

 

81

 

 

 

201

 

 

 

203

 

 

 

564

 

Comprehensive loss

 

$

(63,504

)

 

$

(37,973

)

 

$

(133,250

)

 

$

(75,080

)

Net loss per share, basic and diluted

 

$

(1.27

)

 

$

(0.83

)

 

$

(2.77

)

 

$

(1.75

)

Weighted average number of shares used to compute net loss

   per share, basic and diluted

 

 

49,878,578

 

 

 

46,065,901

 

 

 

48,222,787

 

 

 

43,301,417

 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

4


 

MYOKARDIA, INC.

Condensed Consolidated Statements of Stockholders’ Equity

(In thousands, except share and per share amounts)

(Unaudited)

 

For the six months ended June 30,

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

Accumulated

other

 

 

 

 

 

 

Total

 

 

 

Common Stock

 

 

Paid-In

 

 

comprehensive

 

 

Accumulated

 

 

Stockholders’

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

income

 

 

Deficit

 

 

Equity

 

BALANCE—December 31, 2019

 

 

46,379,073

 

 

$

5

 

 

$

884,486

 

 

$

549

 

 

$

(478,766

)

 

$

406,274

 

Issuance of common stock upon the exercise of options

   and release of stock awards

 

 

233,113

 

 

 

 

 

 

1,820

 

 

 

 

 

 

 

 

 

1,820

 

Stock-based compensation

 

 

 

 

 

 

 

 

10,752

 

 

 

 

 

 

 

 

 

10,752

 

Unrealized gains

 

 

 

 

 

 

 

 

 

 

 

122

 

 

 

 

 

 

122

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(69,868

)

 

 

(69,868

)

BALANCE—March 31, 2020

 

 

46,612,186

 

 

$

5

 

 

$

897,058

 

 

$

671

 

 

$

(548,634

)

 

$

349,100

 

Issuance of common stock in connection with the

   follow-on offering, net of issuance costs of $28,909

 

 

6,037,500

 

 

 

 

 

 

605,028

 

 

 

 

 

 

 

 

 

605,028

 

Issuance of common stock upon the exercise of options and

   release of stock awards

 

 

290,977

 

 

 

 

 

 

5,910

 

 

 

 

 

 

 

 

 

5,910

 

Issuance of common stock pursuant to employee stock

   purchase plan

 

 

24,370

 

 

 

 

 

 

1,229

 

 

 

 

 

 

 

 

 

1,229

 

Stock-based compensation

 

 

 

 

 

 

 

 

10,876

 

 

 

 

 

 

 

 

 

10,876

 

Unrealized gains, net of tax expense

 

 

 

 

 

 

 

 

 

 

 

81

 

 

 

 

 

 

81

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(63,585

)

 

 

(63,585

)

BALANCE—June 30, 2020

 

 

52,965,033

 

 

$

5

 

 

$

1,520,101

 

 

$

752

 

 

$

(612,219

)

 

$

908,639

 

 

For the six months ended June 30,

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

Accumulated

other

 

 

 

 

 

 

Total

 

 

 

Common Stock

 

 

Paid-In

 

 

comprehensive

 

 

Accumulated

 

 

Stockholders’

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

income/ (loss)

 

 

Deficit

 

 

Equity

 

BALANCE—December 31, 2018

 

 

40,288,949

 

 

$

4

 

 

$

573,183

 

 

$

(67

)

 

$

(202,553

)

 

$

370,567

 

Issuance of common stock in connection with the

   follow-on offering, net of issuance costs of $17,638

 

 

5,663,750

 

 

 

1

 

 

 

271,212

 

 

 

 

 

 

 

 

 

271,213

 

Issuance of common stock upon the exercise of options

   and release of stock awards

 

 

49,076

 

 

 

 

 

 

280

 

 

 

 

 

 

 

 

 

280

 

Vesting of early exercised stock options

 

 

 

 

 

 

 

 

8

 

 

 

 

 

 

 

 

 

8

 

Stock-based compensation

 

 

 

 

 

 

 

 

6,981

 

 

 

 

 

 

 

 

 

6,981

 

Unrealized gains

 

 

 

 

 

 

 

 

 

 

 

363

 

 

 

 

 

 

363

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(37,470

)

 

 

(37,470

)

BALANCE—March 31, 2019

 

 

46,001,775

 

 

$

5

 

 

$

851,664

 

 

$

296

 

 

$

(240,023

)

 

$

611,942

 

Issuance of common stock upon the exercise of options

   and release of stock awards

 

 

75,326

 

 

 

 

 

 

716

 

 

 

 

 

 

 

 

 

716

 

Issuance of common stock pursuant to employee stock

   purchase plan

 

 

20,958

 

 

 

 

 

 

855

 

 

 

 

 

 

 

 

 

855

 

Vesting of early exercised stock options

 

 

 

 

 

 

 

 

7

 

 

 

 

 

 

 

 

 

7

 

Stock-based compensation

 

 

 

 

 

 

 

 

8,638

 

 

 

 

 

 

 

 

 

8,638

 

Unrealized gains, net of tax expense

 

 

 

 

 

 

 

 

 

 

 

201

 

 

 

 

 

 

201

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(38,174

)

 

 

(38,174

)

BALANCE—June 30, 2019

 

 

46,098,059

 

 

$

5

 

 

$

861,880

 

 

$

497

 

 

$

(278,197

)

 

$

584,185

 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

5


 

MYOKARDIA, INC.

Condensed Consolidated Statements of Cash Flows

(In thousands)

(Unaudited)

 

 

 

 

Six Months Ended

June 30,

 

 

 

2020

 

 

2019

 

Cash flow from operating activities:

 

 

 

 

 

 

 

 

Net loss

 

$

(133,453

)

 

$

(75,644

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

 

 

Stock-based compensation expense

 

 

21,628

 

 

 

15,619

 

Depreciation

 

 

1,576

 

 

 

944

 

Amortization of discount on investments

 

 

(477

)

 

 

(656

)

Income tax benefit of unrealized gains on investments

 

 

 

 

 

(218

)

Loss on disposal of equipment

 

 

49

 

 

 

 

Change in operating assets and liabilities:

 

 

 

 

 

 

 

 

Prepaid expenses and other current assets

 

 

921

 

 

 

822

 

Operating lease right-of-use assets

 

 

1,817

 

 

 

1,279

 

Other long-term assets

 

 

(761

)

 

 

125

 

Accounts payable

 

 

(2,719

)

 

 

281

 

Accrued liabilities

 

 

(601

)

 

 

4,428

 

Prepayment from collaboration partner

 

 

 

 

 

(10,717

)

Operating lease liabilities

 

 

(742

)

 

 

(1,390

)

Net cash used in operating activities

 

 

(112,762

)

 

 

(65,127

)

Cash flow from investing activities:

 

 

 

 

 

 

 

 

Purchases of investments

 

 

(116,897

)

 

 

(41,593

)

Sales of investments

 

 

4,000

 

 

 

4,000

 

Maturities of investments

 

 

183,475

 

 

 

29,000

 

Purchases of property and equipment

 

 

(14,019

)

 

 

(1,693

)

Net cash provided by (used in) investing activities

 

 

56,559

 

 

 

(10,286

)

Cash flow from financing activities:

 

 

 

 

 

 

 

 

Proceeds from issuance of common stock in follow-on offerings,

   net of issuance and financing costs

 

 

605,202

 

 

 

271,224

 

Proceeds from exercise of stock options and employee stock purchase plan

 

 

8,701

 

 

 

1,837

 

Net cash provided by financing activities

 

 

613,903

 

 

 

273,061

 

Net increase in cash, cash equivalents and restricted cash

 

 

557,700

 

 

 

197,648

 

Cash, cash equivalents and restricted cash, beginning of period

 

 

103,630

 

 

 

248,265

 

Cash, cash equivalents and restricted cash, end of period

 

$

661,330

 

 

$

445,913

 

Non-cash investing and financing activities:

 

 

 

 

 

 

 

 

Unpaid portion of property and equipment purchases included in

   period-end accounts payable and accrued liabilities

 

$

1,322

 

 

$

17

 

Vesting of early exercised options and restricted stock

 

$

 

 

$

15

 

Unpaid financing-related costs

 

$

174

 

 

$

11

 

Non-cash exercise of stock options

 

$

258

 

 

$

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

 

 

 

6


 

MYOKARDIA, INC.

Notes to Unaudited Condensed Consolidated Financial Statements

 

 

1. Organization

MyoKardia, Inc. (the Company) is a clinical-stage biopharmaceutical company pioneering a precision medicine approach to discover, develop and commercialize targeted therapies for the treatment of serious and neglected rare cardiovascular diseases. The Company was incorporated in 2012 in Delaware and its corporate headquarters are in Brisbane, California. The Company’s initial focus is on the treatment of cardiomyopathies, a group of diseases of the heart muscle. MyoKardia’s pipeline includes: mavacamten and MYK-224, which are being studied for the treatment of hypertrophic cardiomyopathy; LUS-1, being studied for the treatment of diseases of diastolic dysfunction; and danicamtiv (formerly MYK-491) and ACT-1, being studied for the treatment of diseases of systolic dysfunction.   

 

Liquidity

 

The Company has incurred significant operating losses since inception and has an accumulated deficit of $612.2 million as of June 30, 2020. The Company has relied on its ability to fund its operations through private and public equity financings and to a lesser extent, through a license and collaboration arrangement with a collaboration partner, Sanofi S.A. (Sanofi) via its subsidiary, Aventis Inc. The collaboration agreement ended on December 31, 2018 and the Company had no revenues relating to its Sanofi collaboration after December 31, 2018, nor has it received reimbursements of research and development expenses after June 30, 2019. In May 2020, the Company completed a follow-on offering and received proceeds totaling approximately $605.0 million from the offering, net of underwriting discounts and commissions and offering expenses. The Company has not yet received regulatory approval to commercialize or sell any product and does not have customers. Management expects operating losses and negative operating cash flows to continue for the foreseeable future.  The Company’s ultimate success depends on the outcome of its research and development activities and anticipates the need to raise additional capital to fully implement its business plan.  The Company intends to raise such capital through the issuance of additional equity, debt and/or strategic alliances with partner companies. There is no assurance that such financing will be available or that such strategic alliances will be executed on terms acceptable to the Company, or at all.   

As of June 30, 2020, the Company had $918.1 million of cash, cash equivalents and investments, which management believes will be sufficient to meet the Company’s anticipated operating and capital expenditure requirements for the twelve months following the date of issuance of these financial statements.  Management’s belief with respect to its ability to fund operations is based on estimates that are subject to risks and uncertainties. If actual results are different from management’s estimates, the Company may need to seek additional funding. In addition, the Company is closely monitoring ongoing developments in connection with the COVID-19 pandemic, which may negatively impact its financial and operating results.

The Company will continue to assess its operating expenses and cash and cash equivalents and, if circumstances warrant, the Company will make appropriate adjustments to its operating plan.

 

 

2. Basis of Presentation and Summary of Significant Accounting Policies

Basis of Presentation

The accompanying condensed consolidated financial statements are unaudited, include the Company’s accounts and those of its wholly-owned subsidiaries MyoKardia Australia Pty Ltd and MyoKardia Netherlands B.V., and have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”).

The condensed consolidated balance sheet at December 31, 2019, presented herein, has been derived from the audited consolidated financial statements as of that date but does not include all of the information and footnotes required by U.S. GAAP for complete financial statements. The results of operations for the interim periods are not necessarily indicative of the results of operations to be expected for the full fiscal year or any interim period and should be read in conjunction with the audited financial statements for the year ended December 31, 2019 and the notes thereto, which are included in the Company’s Annual Report on Form 10-K as of and for the year ended December 31, 2019. The significant accounting policies used in preparation of these condensed consolidated financial statements for the periods shown are consistent with those discussed in notes to the consolidated financial statements in the Company’s 2019 Annual Report on Form 10-K and are updated below as necessary.

7


 

The Company currently operates in one business segment, which is the identification, development and commercialization of therapies for the treatment of serious and neglected rare cardiovascular diseases and has a single reporting unit and operating segment. These interim statements, in the opinion of management, reflect all normal recurring adjustments necessary for the fair statement of the Company’s financial position and results of operations for the interim periods ended June 30, 2020 and 2019, respectively.

Reconciliation of Cash, Cash Equivalents, and Restricted Cash as Reported in Consolidated Statements of Cash Flows

Cash as reported in the consolidated statements of cash flows includes the aggregate amounts of cash, cash equivalents and restricted cash as presented on the consolidated balance sheets. Restricted cash at June 30, 2020 and December 31, 2019 represents cash balances held as security in connection with the Company’s facility lease agreements. The following table provides a reconciliation of cash, cash equivalents and restricted cash within the consolidated balance sheets to the total shown in the consolidated statements of cash flows (in thousands):

 

 

 

June 30,

2020

 

 

December 31,

2019

 

Cash and cash equivalents

 

$

659,107

 

 

$

101,436

 

Restricted cash included in prepaid expenses and other current assets

 

 

366

 

 

 

337

 

Restricted cash included in restricted cash and other

 

 

1,857

 

 

 

1,857

 

Total cash, cash equivalents and restricted cash shown in the consolidated statements

   of cash flows

 

$

661,330

 

 

$

103,630

 

Use of Estimates

 

The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities and the reported amounts of revenues and expenses in the consolidated financial statements and the accompanying notes. On an ongoing basis, management evaluates its estimates, including those related to clinical trials accrued liabilities, income tax valuation allowance and stock-based compensation. Management bases its estimates on historical experience and on various other market-specific and relevant assumptions that management believes to be reasonable under the circumstances. Actual results could differ from those estimates.

Recently Adopted Accounting Pronouncements

In November 2018, the Financial Accounting Standards Board (FASB) issued ASU 2018-18 (Topic 808), Clarifying the Interaction Between Topic 808 and Topic 606, which provides guidance on how to assess whether certain transactions between collaborative arrangement participants should be accounted for within the revenue recognition standard. The ASU also provides more comparability in the presentation of revenue for certain transactions between collaborative arrangement participants. It accomplishes this by allowing organizations to only present units of account in collaborative arrangements that are within the scope of the revenue recognition standard together with revenue accounted for under the revenue recognition standard. The parts of the collaborative arrangement that are not in the scope of the revenue recognition standard should be presented separately from revenue accounted for under the revenue recognition standard. The Company adopted this amendment in the first quarter of 2020 and the adoption did not have a material impact to the Company’s financial statements.

In August 2018, the FASB issued ASU 2018-13 (Topic 820), Fair Value Measurement, which modifies the disclosure requirements in Topic 820 by removing requirements for disclosing (i) amounts of and reasons for transfers between the Level 1 and Level 2 hierarchies, (ii) the policy for timing of transfers between levels and (iii) the valuation processes for Level 3 fair value measurements. The ASU 2018-13 amendment also adds requirements for disclosure of changes in unrealized gains and losses for the period relating to Level 3 fair value measurements and other factors considered in the valuation of Level 3 investments. The Company adopted this amendment in the first quarter of 2020 and the adoption did not have a material impact to the Company’s financial statements.

In June 2016, the FASB issued ASU No. 2016-13 (Topic 326), Financial Instruments –Measurement of Credit Losses on Financial Instruments, which requires measurement and recognition of expected credit losses for financial assets by requiring an allowance to be recorded as an offset to the amortized cost of such assets. For available-for-sale debt securities, expected credit losses should be estimated when the fair value of the debt securities is below their associated amortized costs. The Company adopted this amendment in the first quarter of 2020 and the adoption did not have a material impact to the Company’s financial statements. 

 

8


 

3. Sanofi License and Collaboration Agreement

Sanofi (Aventis Inc.)

Agreement Overview, Termination and Repurchase of Royalty Rights

Until December 31, 2018 the Company had an exclusive license and collaboration agreement (Collaboration Agreement) with Aventis Inc., a wholly-owned subsidiary of Sanofi S.A. (Sanofi). On December 31, 2018, Sanofi notified the Company of its intent to terminate the collaboration, specifically, Sanofi elected not to continue with the mavacamten, MYK-224 and danicamtiv programs.  As a result, cost sharing and Sanofi’s reimbursement of the Company’s research and development costs for mavacamten and MYK-224 ended in the first half of 2019.  At that time Sanofi had continuing rights to royalties in the event of commercialization of the mavacamten and MYK-224 programs. In July 2019, the Company repurchased those rights from Sanofi for $80.0 million.  Neither the Company nor Sanofi have any material continuing rights or obligations under the Collaboration Agreement.

 

4. Fair Value Measurements

Fair value accounting is applied for all financial assets and liabilities, including short-term and long-term investments and non-financial assets and liabilities that are recognized or disclosed at fair value in the consolidated financial statements on a recurring basis (at least annually). The carrying amount of the Company’s financial instruments, including accounts payable and accrued liabilities and other current liabilities approximate fair value due to their short-term maturities.

Marketable securities are stated at their estimated fair values. The counterparties to the agreements relating to the Company’s investment securities consist of the U.S. Treasury, governmental agencies, various major corporations and financial institutions with reputable credit and therefore bear minimal credit risk. The carrying amounts for financial instruments consist of cash and cash equivalents, accounts payable and accrued liabilities and approximate fair value due to their short maturities.

The Company assesses its available-for-sale debt securities under the available-for-sale debt security impairment model in ASC 326 as of each reporting date in order to determine if a portion of any decline in fair value below amortized cost basis has resulted from a credit loss. The Company records credit losses in the consolidated statements of operations and comprehensive loss as credit loss expense within other expense, net, which is limited to the difference between the fair value and the amortized cost of the security.

Accrued interest related to the Company's available-for-sale debt securities is presented within other current assets on the Company's condensed consolidated balance sheets. The Company has elected the practical expedient available to exclude accrued interest from both the fair value and the amortized cost basis of available-for-sale debt securities for the purposes of identifying and measuring any impairment. The Company writes off accrued interest once it has determined that the asset is not realizable. Any write offs of accrued interest receivable are recorded by reversing interest income, recognizing credit loss expense, or a combination of both. To date, the Company has not written off any accrued interest receivables associated with its marketable securities.

The accounting guidance for fair value provides a framework for measuring fair value, clarifies the definition of fair value and expands disclosures regarding fair value measurements. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (exit price) in an orderly transaction between market participants at the reporting date. The accounting guidance establishes a three-tiered hierarchy, which prioritizes the inputs used in the valuation methodologies in measuring fair value as follows:

Level 1—Inputs are unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date.

Level 2—Inputs other than quoted market prices included in Level 1 are either directly or indirectly observable for the asset or liability through correlation with market data at the measurement date and for the duration of the instrument’s anticipated life.

Level 3—Inputs reflect management’s best estimate of what market participants would use in pricing the asset or liability at the measurement date. Consideration is given to the risk inherent in the valuation technique and the risk inherent in the inputs to the model.

9


 

The following table sets forth the Company’s financial instruments that were measured at fair value on a recurring basis by level within the fair value hierarchy (in thousands):

 

 

 

Fair Value Measurements at June 30, 2020

 

 

 

Total

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

Assets

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

660,289

 

 

$

660,289

 

 

$

 

 

$

 

U.S. government agency obligations

 

 

186,165

 

 

 

 

 

 

186,165

 

 

 

 

Corporate securities

 

 

72,781

 

 

 

 

 

 

72,781

 

 

 

 

Total

 

$

919,235

 

 

$

660,289

 

 

$

258,946

 

 

$

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Fair Value Measurements at December 31, 2019

 

 

 

Total

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

Assets

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

100,441

 

 

$

100,441

 

 

$

 

 

$

 

U.S. government agency obligations

 

 

134,055

 

 

 

 

 

 

134,055

 

 

 

 

Corporate securities

 

 

194,789

 

 

 

 

 

 

194,789

 

 

 

 

Total

 

$

429,285

 

 

$

100,441

 

 

$

328,844

 

 

$

 

The following table is a summary of amortized cost, unrealized gain and loss, and fair value of the Company’s marketable securities by contractual maturities (in thousands):

 

 

Fair Value Measurements at June 30, 2020

 

 

 

Amortized Cost

 

 

Unrealized Gain

 

 

Unrealized Loss

 

 

Fair Value

 

Cash equivalents (due within 90 days)

 

$