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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, 2021

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 10, 2021 the registrant had 30,638,194 shares of common stock, $0.0001 par value per share, outstanding.

 

 

 


 

Table of Contents

 

SUMMARY OF RISKS ASSOCIATED WITH OUR BUSINESS

 

 

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 Statements of Stockholders’ Equity

4

 

Condensed Consolidated Statements of Cash Flows

5

 

Notes to Unaudited Condensed Consolidated Financial Statements

6

Item 2.

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

20

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

33

Item 4.

Controls and Procedures

33

PART II.

OTHER INFORMATION

 

Item 1.

Legal Proceedings

34

Item 1A.

Risk Factors

34

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

87

Item 3.

Defaults Upon Senior Securities

87

Item 4.

Mine Safety Disclosures

87

Item 5.

Other Information

87

Item 6.

Exhibits

88

Signatures

89

 

i


 

SUMMARY OF RISKS ASSOCIATED WITH OUR BUSINESS

 

An investment in shares of our common stock involves a high degree of risk. Below is a list of the more significant risks associated with our business. This summary does not address all of the risks that we face. Additional discussion of the risks listed in this summary, as well as other risks that we face, are set forth under Part I, Item 1A, “Risk Factors” in this Quarterly Report on Form 10-Q.

LIVMARLI (maralixibat) oral solution (“Livmarli”) is our only U.S. Food and Drug Administration-approved product and the success of our business depends, in part, on its successful commercialization.

 

As a company we currently have limited marketing and sales experience and we have never commercialized a product. If we are unable to adequately maintain and scale our marketing and sales capabilities or enter into agreements with third parties to market and sell our products, we may not be able to generate viable product revenues. Even if we adequately establish such capabilities, market acceptance or reimbursement of our products may be lower than expected.

 

Livmarli may fail to achieve the broad degree of physician and patient adoption and use necessary for commercial success.

 

We have a very limited operating history, and we have incurred significant losses since our inception and anticipate that we will continue to incur significant losses for the foreseeable future.

 

Our business depends, in part, on the success of our product candidates, each of which require significant clinical testing before we can seek regulatory approval and potentially launch commercial sales.

 

We have encountered and may continue to encounter delays and difficulties enrolling patients in our clinical trials, and as a result, our clinical development activities could be delayed or otherwise adversely affected.

 

Our product candidates are subject to extensive regulation and compliance, which is costly and time consuming, and such regulation may cause unanticipated delays or prevent the receipt of the required approvals to commercialize our product candidates.

 

Our clinical trials may fail to adequately demonstrate the safety and efficacy of our product candidates, which could prevent or delay regulatory approval and commercialization.

 

Clinical drug development involves a lengthy and expensive process with uncertain outcomes, and results of earlier studies and trials may not be predictive of future trial results.

 

Any delays in the commencement or completion, or termination or suspension, of our clinical trials could result in increased costs to us, delay or limit our ability to generate revenue and adversely affect our commercial prospects.

 

Our applications for marketing authorization with regulatory authorities may not be accepted or may require additional studies, regulatory actions, or manufacturing requirements to be completed before marketing authorization is granted.

 

Even if we obtain regulatory approval for our product candidates, our product candidates may not gain market acceptance among physicians, patients, tertiary care centers, transplant centers and others in the medical community.

 

We face significant competition from other biotechnology and pharmaceutical companies with products that may directly or indirectly compete with ours, and our operating results will suffer if we fail to compete effectively.

 

We will need substantial additional financing to continue our commercialization efforts for Livmarli, develop our product candidates and implement our operating plans. If we fail to obtain additional financing, we may be forced to delay, reduce or eliminate our product development programs or commercialization efforts.

 

We depend on intellectual property licensed from third parties and termination of any of these licenses could result in the loss of significant rights, which would harm our business.

 

ii


 

If we are unable to obtain and maintain sufficient intellectual property protection for Livmarli and our product candidates, or if the scope of the intellectual property protection is not sufficiently broad, our competitors could develop and commercialize products similar or identical to ours, and our ability to successfully commercialize Livmarli and our product candidates, if approved, may be adversely affected.

 

iii


 

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,

 

 

 

2021

 

 

2020

 

 

 

(Unaudited)

 

 

(Note 2)

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

55,844

 

 

$

142,086

 

Other Receivable

 

 

400

 

 

 

 

Short-term investments

 

 

134,190

 

 

 

89,734

 

Prepaid expenses and other current assets

 

 

6,371

 

 

 

4,530

 

Total current assets

 

 

196,805

 

 

 

236,350

 

Investments

 

 

14,997

 

 

 

 

Property and equipment, net

 

 

1,060

 

 

 

1,293

 

Operating lease right-of-use assets

 

 

1,664

 

 

 

1,949

 

Intangible assets, net

 

 

19,000

 

 

 

 

Other assets

 

 

1,641

 

 

 

1,272

 

Total assets

 

$

235,167

 

 

$

240,864

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

5,003

 

 

$

3,151

 

Accrued expenses

 

 

43,847

 

 

 

13,411

 

Operating lease liabilities

 

 

690

 

 

 

636

 

Derivative liability

 

 

847

 

 

 

1,264

 

Total current liabilities

 

 

50,387

 

 

 

18,462

 

Revenue interest liability, net

 

 

126,277

 

 

 

47,651

 

Operating lease liabilities, noncurrent

 

 

2,088

 

 

 

2,627

 

Other liabilities

 

 

19

 

 

 

29

 

Total liabilities

 

 

178,771

 

 

 

68,769

 

Commitments and contingencies

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

Preferred stock, $0.0001 par value; 10,000,000 shares authorized
   as of September 30, 2021 and December 31, 2020, respectively;
   and
zero shares issued and outstanding as of September 30, 2021
   and December 31, 2020, respectively

 

 

 

 

 

 

Common stock, $0.0001 par value; 200,000,000 shares
   authorized as of September 30, 2021 and December 31, 2020, respectively;
  
30,562,167 shares issued and 30,406,303 shares outstanding,
   excluding
155,864 shares subject to repurchase as of September 30, 2021;
   and
30,032,600 shares issued and 29,776,544 shares outstanding,
   excluding
256,056 shares subject to repurchase as of December 31, 2020

 

 

3

 

 

 

3

 

Additional paid-in capital

 

 

371,104

 

 

 

345,180

 

Accumulated deficit

 

 

(314,705

)

 

 

(173,171

)

Accumulated other comprehensive (loss) income

 

 

(6

)

 

 

83

 

Total stockholders’ equity

 

 

56,396

 

 

 

172,095

 

Total liabilities and stockholders’ equity

 

$

235,167

 

 

$

240,864

 

 

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,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

License revenue

 

$

5,000

 

 

$

 

 

$

16,000

 

 

$

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

30,471

 

 

 

15,984

 

 

 

103,653

 

 

 

51,879

 

General and administrative

 

 

17,353

 

 

 

5,732

 

 

 

40,185

 

 

 

15,466

 

Total operating expenses

 

 

47,824

 

 

 

21,716

 

 

 

143,838

 

 

 

67,345

 

Loss from operations

 

 

(42,824

)

 

 

(21,716

)

 

 

(127,838

)

 

 

(67,345

)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

72

 

 

 

237

 

 

 

301

 

 

 

1,391

 

Interest expense

 

 

(5,667

)

 

 

 

 

 

(13,824

)

 

 

 

Change in fair value of derivative liability

 

 

1,355

 

 

 

 

 

 

417

 

 

 

 

Other expense, net

 

 

(35

)

 

 

(30

)

 

 

(565

)

 

 

(109

)

Net loss before provision for income taxes

 

 

(47,099

)

 

 

(21,509

)

 

 

(141,509

)

 

 

(66,063

)

Provision for (benefit from) income taxes

 

 

9

 

 

 

(3

)

 

 

25

 

 

 

4

 

Net loss

 

$

(47,108

)

 

$

(21,506

)

 

$

(141,534

)

 

$

(66,067

)

Net loss per share, basic and diluted

 

$

(1.55

)

 

$

(0.86

)

 

$

(4.68

)

 

$

(2.65

)

Weighted-average shares of common stock outstanding, basic and diluted

 

 

30,367,727

 

 

 

25,132,916

 

 

 

30,250,127

 

 

 

24,965,178

 

 

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,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Net loss

 

$

(47,108

)

 

$

(21,506

)

 

$

(141,534

)

 

$

(66,067

)

Other comprehensive gain (loss):

 

 

 

 

 

 

 

 

 

 

 

 

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

 

 

7

 

 

 

(151

)

 

 

(83

)

 

 

39

 

Cumulative translation adjustments

 

 

 

 

 

5

 

 

 

(6

)

 

 

4

 

Comprehensive loss

 

$

(47,101

)

 

$

(21,652

)

 

$

(141,623

)

 

$

(66,024

)

 

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

3


 

Mirum Pharmaceuticals, Inc.

Condensed Consolidated Statements 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, 2020

 

 

 

 

 

 

 

 

29,776,544

 

 

$

3

 

 

$

345,180

 

 

$

(173,171

)

 

$

83

 

 

$

172,095

 

Issuance of common stock in connection with
   common stock option exercises

 

 

 

 

 

 

 

 

12,535

 

 

 

 

 

 

80

 

 

 

 

 

 

 

 

 

80

 

Issuance of common stock in public offering,
   net of issuance costs of $
476

 

 

 

 

 

 

 

 

375,654

 

 

 

 

 

 

7,038

 

 

 

 

 

 

 

 

 

7,038

 

Restricted common stock vested in the period

 

 

 

 

 

 

 

 

33,396

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation

 

 

 

 

 

 

 

   —

 

 

 

 

 

 

5,285

 

 

 

 

 

 

 

 

 

5,285

 

Net loss

 

 

 

 

 

 

 

   —

 

 

 

 

 

 

 

 

 

(50,532

)

 

 

 

 

 

(50,532

)

Other comprehensive loss

 

 

 

 

 

 

 

   —

 

 

 

 

 

 

 

 

 

 

 

 

(83

)

 

 

(83

)

Balance as of March 31, 2021

 

 

 

 

 

 

 

 

30,198,129

 

 

$

3

 

 

$

357,583

 

 

$

(223,703

)

 

$

 

 

$

133,883

 

Issuance of common stock in connection with
   common stock option exercises

 

 

 

 

 

 

 

 

41,668

 

 

 

 

 

 

295

 

 

 

 

 

 

 

 

 

295

 

Restricted common stock vested in the period

 

 

 

 

 

 

 

 

33,400

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of shares in connection with ESPP

 

 

 

 

 

 

 

 

43,976

 

 

 

 

 

 

643

 

 

 

 

 

 

 

 

 

643

 

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4,823

 

 

 

 

 

 

 

 

 

4,823

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(43,894

)

 

 

 

 

 

(43,894

)

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(13

)

 

 

(13

)

 Balance as of June 30, 2021

 

$

-

 

 

$

-

 

 

$

30,317,173

 

 

$

3

 

 

$

363,344

 

 

$

(267,597

)

 

$

(13

)

 

$

95,737

 

Issuance of common stock in connection with
   common stock option exercises

 

 

 

 

 

 

 

 

55,734

 

 

 

 

 

 

345

 

 

 

 

 

 

 

 

 

345

 

Restricted common stock vested in the period

 

 

 

 

 

 

 

 

33,396

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

7,415

 

 

 

 

 

 

 

 

 

7,415

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(47,108

)

 

 

 

 

 

(47,108

)

Other comprehensive gain

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

7

 

 

 

7

 

Balance as of September 30, 2021

 

 

 

 

$

 

 

 

30,406,303

 

 

$

3

 

 

$

371,104

 

 

$

(314,705

)

 

$

(6

)

 

$

56,396

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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 Statements of Cash Flows

(Unaudited)

(In thousands)

 

 

 

Nine Months Ended September 30,

 

 

 

2021

 

 

2020

 

Operating activities

 

 

 

 

 

 

Net loss

 

$

(141,534

)

 

$

(66,067

)

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

 

 

 

 

 

 

Stock-based compensation