mirm-10q_20200930.htm

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 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 September 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: 001-38981

 

Mirum Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)

 

 

Delaware

83-1281555

( State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer

Identification No.)

950 Tower Lane, Suite 1050, Foster City, California

94404

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code: (650) 667-4085

 

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 per share

 

MIRM

 

The Nasdaq Global 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, a 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  

As of November 6, 2020 the registrant had 25,716,877 shares of common stock, $0.0001 par value per share, outstanding.

 

 

 

 


Table of Contents

 

 

 

Page

PART I.

FINANCIAL INFORMATION

 

Item 1.

Financial Statements (Unaudited)

1

 

Condensed Consolidated Balance Sheets

1

 

Condensed Consolidated Statements of Operations

2

 

Condensed Consolidated Statements of Comprehensive Loss

3

 

Condensed Consolidated Statement of Stockholders’ Equity for the Three and Nine Months Ended September 30, 2020

4

 

Condensed Consolidated Statement of Redeemable Convertible Preferred Stock, Redeemable Common Stock and Stockholders’ Equity (Deficit) for the Three and Nine Months Ended September 30, 2019

5

 

Condensed Consolidated Statements of Cash Flows

6

 

Notes to Unaudited Condensed Consolidated Financial Statements

7

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

18

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

25

Item 4.

Controls and Procedures

26

PART II.

OTHER INFORMATION

 

Item 1.

Legal Proceedings

27

Item 1A.

Risk Factors

27

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

76

Item 3.

Defaults Upon Senior Securities

76

Item 4.

Mine Safety Disclosures

76

Item 5.

Other Information

76

Item 6.

Exhibits

77

Signatures

78

 

 

 

i


 

PART I—FINANCIAL INFORMATION

Item 1. Financial Statements.

Mirum Pharmaceuticals, Inc.

Condensed Consolidated Balance Sheets

(In thousands, except share and per share data)

 

 

 

 

September 30,

 

 

December 31,

 

 

 

2020

 

 

2019

 

 

 

(Unaudited)

 

 

(Note 2)

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

48,778

 

 

$

11,970

 

Short-term investments

 

 

84,971

 

 

 

104,690

 

Prepaid expenses and other current assets

 

 

4,402

 

 

 

2,703

 

Total current assets

 

 

138,151

 

 

 

119,363

 

Long-term investments

 

 

 

 

 

23,292

 

Property and equipment, net

 

 

1,349

 

 

 

1,372

 

Operating lease right-of-use assets

 

 

2,029

 

 

 

2,361

 

Other assets

 

 

336

 

 

 

324

 

Total assets

 

$

141,865

 

 

$

146,712

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

5,177

 

 

$

3,351

 

Accrued expenses

 

 

12,999

 

 

 

9,328

 

Operating lease liabilities

 

 

616

 

 

 

397

 

Total current liabilities

 

 

18,792

 

 

 

13,076

 

Operating lease liabilities, noncurrent

 

 

2,788

 

 

 

3,251

 

Other liabilities

 

 

30

 

 

 

36

 

Total liabilities

 

 

21,610

 

 

 

16,363

 

Commitments and contingencies

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

 

 

Preferred stock, $0.0001 par value; 10,000,000 shares authorized

   as of September 30, 2020 and December 31, 2019, respectively; zero shares issued and

   outstanding as of September 30, 2020 and December 31, 2019, respectively; and

   liquidation value of $0 as of September 30, 2020 and December 31, 2019, respectively

 

 

 

 

 

Common stock, $0.0001 par value; 200,000,000 shares

   authorized as of September 30, 2020 and December 31, 2019, respectively;

   25,500,340 shares issued and 25,210,885 shares outstanding, excluding 289,455 shares

   subject to repurchase as of September 30, 2020; 22,989,987 shares issued

   and 22,600,338 shares outstanding, excluding 389,649 shares subject to

   repurchase as of December 31, 2019

 

 

3

 

 

 

2

 

Additional paid-in capital

 

 

256,048

 

 

 

200,119

 

Accumulated deficit

 

 

(135,968

)

 

 

(69,901

)

Accumulated other comprehensive income

 

 

172

 

 

 

129

 

Total stockholders’ equity

 

 

120,255

 

 

 

130,349

 

Total liabilities and stockholders’ equity

 

$

141,865

 

 

$

146,712

 

 

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

1


 

Mirum Pharmaceuticals, Inc.

Condensed Consolidated Statements of Operations

(Unaudited)

(In thousands, except share and per share data)

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

15,984

 

 

$

12,159

 

 

$

51,879

 

 

$

28,611

 

General and administrative

 

 

5,732

 

 

 

3,708

 

 

 

15,466

 

 

 

7,474

 

Total operating expenses

 

 

21,716

 

 

 

15,867

 

 

 

67,345

 

 

 

36,085

 

Loss from operations

 

 

(21,716

)

 

 

(15,867

)

 

 

(67,345

)

 

 

(36,085

)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

237

 

 

 

785

 

 

 

1,391

 

 

 

1,485

 

Other income (expense), net

 

 

(30

)

 

 

(5

)

 

 

(109

)

 

 

(1

)

Net loss before provision for income taxes

 

 

(21,509

)

 

 

(15,087

)

 

 

(66,063

)

 

 

(34,601

)

Provision for (benefit from) income taxes

 

 

(3

)

 

 

 

 

 

4

 

 

 

 

Net loss

 

$

(21,506

)

 

$

(15,087

)

 

$

(66,067

)

 

$

(34,601

)

Net loss per share, basic and diluted

 

$

(0.86

)

 

$

(0.84

)

 

$

(2.65

)

 

$

(4.47

)

Weighted-average shares of common stock outstanding, basic

   and diluted

 

 

25,132,916

 

 

 

17,996,065

 

 

 

24,965,178

 

 

 

7,745,241

 

 

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

2


 

Mirum Pharmaceuticals, Inc.

Condensed Consolidated Statements of Comprehensive Loss

(Unaudited)

(In thousands)

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Net loss

 

$

(21,506

)

 

$

(15,087

)

 

$

(66,067

)

 

$

(34,601

)

Other comprehensive gain (loss):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized gain (loss) on available-for-sale investments

 

 

(151

)

 

 

77

 

 

 

39

 

 

 

123

 

Cumulative translation adjustments

 

 

5

 

 

 

(7

)

 

 

4

 

 

 

(25

)

Comprehensive loss

 

$

(21,652

)

 

$

(15,017

)

 

$

(66,024

)

 

$

(34,503

)

 

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

 

 

3


 

Mirum Pharmaceuticals, Inc.

Condensed Consolidated Statement of Stockholders’ Equity

(Unaudited)

(In thousands, except share and per share data)

 

 

 

Preferred Stock

 

 

Common Stock

 

 

Additional

Paid-In

 

 

Accumulated

 

 

Accumulated

Other

Comprehensive

 

 

Total

Stockholders’

 

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Income (Loss)

 

 

Equity

 

Balance as of December 31, 2019

 

 

 

 

$

 

 

 

22,600,338

 

 

$

2

 

 

$

200,119

 

 

$

(69,901

)

 

$

129

 

 

$

130,349

 

Issuance of common stock in follow-on public

   offering, net of issuance costs of $3,342

 

 

 

 

 

 

 

 

2,400,000

 

 

 

1

 

 

 

44,658

 

 

 

 

 

 

 

 

 

44,659

 

Restricted common stock vested in the period

 

 

 

 

 

 

 

 

33,398

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2,573

 

 

 

 

 

 

 

 

 

2,573

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(21,310

)

 

 

 

 

 

(21,310

)

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(153

)

 

 

(153

)

Balance as of March 31, 2020

 

 

 

 

$

 

 

 

25,033,736

 

 

$

3

 

 

$

247,350

 

 

$

(91,211

)

 

$

(24

)

 

$

156,118

 

Issuance of common stock in connection with common stock option exercises

 

 

 

 

 

 

 

 

4,203

 

 

 

 

 

 

25

 

 

 

 

 

 

 

 

 

25

 

Restricted common stock vested in the period

 

 

 

 

 

 

 

 

33,398

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2,974

 

 

 

 

 

 

 

 

 

2,974

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(23,251

)

 

 

 

 

 

(23,251

)

Other comprehensive income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

342

 

 

 

342

 

Balance as of June 30, 2020

 

 

 

 

$

 

 

 

25,071,337

 

 

$

3

 

 

$

250,349

 

 

$

(114,462

)

 

$

318

 

 

$

136,208

 

Issuance of common stock in at-the-market offering, net of

    issuance costs of $138

 

 

 

 

 

 

 

 

98,708

 

 

 

 

 

 

2,244

 

 

 

 

 

 

 

 

 

2,244

 

Issuance of common stock in connection with common stock option exercises

 

 

 

 

 

 

 

 

7,442

 

 

 

 

 

 

27

 

 

 

 

 

 

 

 

 

27

 

Restricted common stock vested in the period

 

 

 

 

 

 

 

 

33,398

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

3,428

 

 

 

 

 

 

 

 

 

3,428

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(21,506

)

 

 

 

 

 

(21,506

)

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(146

)

 

 

(146

)

Balance as of September 30, 2020

 

 

 

 

$

 

 

 

25,210,885

 

 

$

3

 

 

$

256,048

 

 

$

(135,968

)

 

$

172

 

 

$

120,255

 

 

 

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

4


 

Mirum Pharmaceuticals, Inc.

Condensed Consolidated Statement of Redeemable Convertible Preferred Stock, Redeemable Common Stock and Stockholders’ Equity (Deficit)

(Unaudited)

(In thousands, except share and per share data)

 

 

 

Series A Redeemable Convertible

Preferred Stock

 

 

Redeemable

Common Stock

 

 

 

Preferred Stock

 

 

Common Stock

 

 

Additional

Paid-In

 

 

Accumulated

 

 

Accumulated

Other

Comprehensive

 

 

Total

Stockholders’ Equity

 

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Income

 

 

(Deficit)

 

Balance as of December 31, 2018

 

 

59,908,284

 

 

$

59,849

 

 

 

1,859,151

 

 

$

6,990

 

 

 

 

 

 

$

 

 

 

636,719

 

 

$

1

 

 

$

34

 

 

$

(17,348

)

 

$

 

 

$

(17,313

)

Restricted common stock vested in the period

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

35,156

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

218

 

 

 

 

 

 

 

 

 

218

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(5,957

)

 

 

 

 

 

(5,957

)

Balance as of March 31, 2019

 

 

59,908,284

 

 

$

59,849

 

 

 

1,859,151

 

 

$

6,990

 

 

 

 

 

 

$

 

 

 

671,875

 

 

$

1

 

 

$

252

 

 

$

(23,305

)

 

$

 

 

$

(23,052

)

Restricted common stock vested in the period

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

33,398

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of Series A redeemable convertible

   preferred stock at $1.00259507 per share,

   net of issuance costs of $23

 

 

59,844,699

 

 

 

59,977

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1,641

 

 

 

 

 

 

 

 

 

1,641

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(13,557

)

 

 

 

 

 

(13,557

)

Other comprehensive income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

28

 

 

 

28

 

Balance as of June 30, 2019

 

 

119,752,983

 

 

$

119,826

 

 

 

1,859,151

 

 

$

6,990

 

 

 

 

 

 

$

 

 

 

705,273

 

 

$

1

 

 

$

1,893

 

 

$

(36,862

)

 

$

28

 

 

$

(34,940

)

Restricted common stock vested in the period

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

33,398

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2,144

 

 

 

 

 

 

 

 

 

2,144

 

Conversion of Series A redeemable

   convertible preferred stock into common

   stock on initial public offering

 

 

(119,752,983

)

 

 

(119,826

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

14,969,118

 

 

 

1

 

 

 

119,825

 

 

 

 

 

 

 

 

 

119,826

 

Reclassification of redeemable common

   stock into common stock on initial

   public offering

 

 

 

 

 

 

 

 

(1,859,151

)

 

 

(6,990

)

 

 

 

 

 

 

 

 

 

1,859,151

 

 

 

 

 

 

6,990

 

 

 

 

 

 

 

 

 

6,990

 

Issuance of common stock in initial public

   offering, net of issuance costs of $7,800

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

5,000,000

 

 

 

 

 

 

67,200

 

 

 

 

 

 

 

 

 

67,200

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(15,087

)

 

 

 

 

 

(15,087

)

Other comprehensive income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

70

 

 

 

70

 

Balance as of September 30, 2019

 

 

 

 

$

 

 

 

 

 

$

 

 

 

 

 

 

$

 

 

 

22,566,940

 

 

$

2

 

 

$

198,052

 

 

$

(51,949

)

 

$

98

 

 

$

146,203

 

 

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

 

5


 

Mirum Pharmaceuticals, Inc.

Condensed Consolidated Statement of Cash Flows

(Unaudited)

(In thousands)

 

 

 

Nine Months Ended September 30,

 

 

 

2020

 

 

2019

 

Operating activities

 

 

 

 

 

 

 

 

Net loss

 

$

(66,067

)

 

$

(34,601

)

Reconciliation of net loss to net cash used in operating activities:

 

 

 

 

 

 

 

 

Stock-based compensation

 

 

8,975

 

 

 

4,003

 

Depreciation and amortization

 

 

220

 

 

 

80

 

Amortization of operating lease right-of-use assets

 

 

238

 

 

 

124

 

Net amortization (accretion) on investments

 

 

32

 

 

 

(199

)

Change in operating assets and liabilities: