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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, 2022

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 4, 2022 the registrant had 36,870,380 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

6

 

Notes to Unaudited Condensed Consolidated Financial Statements

7

Item 2.

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

24

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

37

Item 4.

Controls and Procedures

38

PART II.

OTHER INFORMATION

 

Item 1.

Legal Proceedings

39

Item 1A.

Risk Factors

39

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

91

Item 3.

Defaults Upon Senior Securities

91

Item 4.

Mine Safety Disclosures

91

Item 5.

Other Information

91

Item 6.

Exhibits

92

Signatures

93

 

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 approved product and the success of our business depends, in part, on our ability to market and sell Livmarli profitably.
As a company we currently have limited marketing and sales experience. If we are unable to adequately maintain and scale our marketing and sales capabilities or enter into or maintain rights pursuant to 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 and further maintain such capabilities, market acceptance 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 rely completely on third parties to supply, manufacture and distribute drug supplies for Livmarli, including certain sole-source suppliers and manufacturers.
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 requires 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 for 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.
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 other product candidates, if approved, may be adversely affected.

 

ii


 

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,

 

 

 

2022

 

 

2021

 

 

 

(Unaudited)

 

 

(Note 2)

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

35,759

 

 

$

31,340

 

Short-term investments

 

 

149,588

 

 

 

125,201

 

Accounts receivable

 

 

16,337

 

 

 

3,267

 

Inventory

 

 

6,943

 

 

 

1,513

 

Prepaid expenses and other current assets

 

 

6,929

 

 

 

5,271

 

Total current assets

 

 

215,556

 

 

 

166,592

 

Restricted cash equivalents

 

 

100,000

 

 

 

100,000

 

Long-term investments

 

 

 

 

 

4,983

 

Property and equipment, net

 

 

795

 

 

 

981

 

Operating lease right-of-use assets

 

 

1,254

 

 

 

1,569

 

Intangible assets, net

 

 

45,032

 

 

 

18,740

 

Other assets

 

 

1,710

 

 

 

1,786

 

Total assets

 

$

364,347

 

 

$

294,651

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

10,548

 

 

$

9,166

 

Accrued expenses

 

 

38,311

 

 

 

30,723

 

Operating lease liabilities

 

 

775

 

 

 

711

 

Derivative liability

 

 

1,764

 

 

 

1,996

 

Total current liabilities

 

 

51,398

 

 

 

42,596

 

Revenue interest liability, net

 

 

138,017

 

 

 

129,923

 

Operating lease liabilities, noncurrent

 

 

1,311

 

 

 

1,903

 

Other liabilities

 

 

4,324

 

 

 

17

 

Total liabilities

 

 

195,050

 

 

 

174,439

 

Commitments and contingencies

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

Preferred stock, $0.0001 par value; 10,000,000 shares authorized,
   and
zero shares issued and outstanding as of September 30, 2022
   and December 31, 2021, respectively

 

 

 

 

 

 

Common stock, $0.0001 par value; 200,000,000 shares
   authorized;
36,836,024 shares issued and 36,813,754 shares outstanding,
   excluding
22,270 shares subject to repurchase as of September 30, 2022;
   and
30,705,060 shares issued and 30,582,596 shares outstanding,
   excluding
122,464 shares subject to repurchase as of December 31, 2021

 

 

4

 

 

 

3

 

Additional paid-in capital

 

 

526,099

 

 

 

377,403

 

Accumulated deficit

 

 

(356,393

)

 

 

(257,159

)

Accumulated other comprehensive loss

 

 

(413

)

 

 

(35

)

Total stockholders’ equity

 

 

169,297

 

 

 

120,212

 

Total liabilities and stockholders’ equity

 

$

364,347

 

 

$

294,651

 

 

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,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

Product sales, net

 

$

18,780

 

 

$

 

 

$

47,156

 

 

$

 

License revenue

 

 

 

 

 

5,000

 

 

 

2,000

 

 

 

16,000

 

Total revenue

 

 

18,780

 

 

 

5,000

 

 

 

49,156

 

 

 

16,000

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Cost of sales

 

 

2,932

 

 

 

 

 

 

7,880

 

 

 

 

Research and development

 

 

26,217

 

 

 

30,471

 

 

 

75,737

 

 

 

103,653

 

Selling, general and administrative

 

 

22,513

 

 

 

17,353

 

 

 

62,598

 

 

 

40,185

 

Total operating expenses

 

 

51,662

 

 

 

47,824

 

 

 

146,215

 

 

 

143,838

 

Loss from operations

 

 

(32,882

)

 

 

(42,824

)

 

 

(97,059

)

 

 

(127,838

)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

1,352

 

 

 

72

 

 

 

1,714

 

 

 

301

 

Interest expense

 

 

(3,971

)

 

 

(5,667

)

 

 

(11,620

)

 

 

(13,824

)

Change in fair value of derivative liability

 

 

 

 

 

1,355

 

 

 

232

 

 

 

417

 

Other (expense) income, net

 

 

(192

)

 

 

(35

)

 

 

953

 

 

 

(565

)

Net loss before income taxes

 

 

(35,693

)

 

 

(47,099

)

 

 

(105,780

)

 

 

(141,509

)

Provision (benefit) for income taxes

 

 

13

 

 

 

9

 

 

 

(6,546

)

 

 

25

 

Net loss

 

$

(35,706

)

 

$

(47,108

)

 

$

(99,234

)

 

$

(141,534

)

Net loss per share, basic and diluted

 

$

(1.02

)

 

$

(1.55

)

 

$

(3.03

)

 

$

(4.68

)

Weighted-average shares of common stock outstanding, basic

 

 

34,927,790

 

 

 

30,367,727

 

 

 

32,809,365

 

 

 

30,250,127

 

Weighted-average shares of common stock outstanding, diluted

 

 

34,927,790

 

 

 

30,367,727

 

 

 

32,825,314

 

 

 

30,250,127

 

 

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,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Net loss

 

$

(35,706

)

 

$

(47,108

)

 

$

(99,234

)

 

$

(141,534

)

Other comprehensive loss:

 

 

 

 

 

 

 

 

 

 

 

 

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

 

 

(191

)

 

 

7

 

 

 

(305

)

 

 

(83

)

Cumulative translation adjustments

 

 

(20

)

 

 

 

 

 

(73

)

 

 

(6

)

Comprehensive loss

 

$

(35,917

)

 

$

(47,101

)

 

$

(99,612

)

 

$

(141,623

)

 

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)

 

 

 

Common Stock

 

 

Additional
Paid-In

 

 

Accumulated

 

 

Accumulated
Other
Comprehensive

 

 

Total
Stockholders’

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Loss

 

 

Equity

 

Balance as of December 31, 2021

 

 

30,582,596

 

 

$

3

 

 

$

377,403

 

 

$

(257,159

)

 

$

(35

)

 

$

120,212

 

Issuance of common stock in connection with
   equity award plans

 

 

100,951

 

 

 

 

 

 

1,477

 

 

 

 

 

 

 

 

 

1,477

 

Issuance of common stock in at-the-market offerings,
   net of issuance costs of $
601

 

 

995,897

 

 

 

 

 

 

17,384

 

 

 

 

 

 

 

 

 

17,384

 

Restricted common stock vested in the period

 

 

33,398

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation

 

 

 

 

 

 

 

6,561

 

 

 

 

 

 

 

 

 

6,561

 

Net loss

 

 

 

 

 

 

 

 

 

 

(36,606

)

 

 

 

 

 

(36,606

)

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

 

(96

)

 

 

(96

)

Balance as of March 31, 2022

 

 

31,712,842

 

 

$

3

 

 

$

402,825

 

 

$

(293,765

)

 

$

(131

)

 

$

108,932

 

Issuance of common stock in connection with asset acquisition

 

 

609,305

 

 

 

 

 

 

15,585

 

 

 

 

 

 

 

 

 

15,585

 

Issuance of common stock in connection with
   equity award plans

 

 

92,593

 

 

 

 

 

 

1,408

 

 

 

 

 

 

 

 

 

1,408

 

Issuance of common stock in at-the-market offerings,
   net of issuance costs of $
184

 

 

165,018

 

 

 

 

 

 

3,905

 

 

 

 

 

 

 

 

 

3,905

 

Restricted common stock vested in the period

 

 

33,398

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of common stock in connection with employee stock purchase plan

 

 

76,099

 

 

 

 

 

 

1,032

 

 

 

 

 

 

 

 

 

1,032

 

Stock-based compensation

 

 

 

 

 

 

 

 

6,818

 

 

 

 

 

 

 

 

 

6,818

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(26,922

)

 

 

 

 

 

(26,922

)

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(71

)

 

 

(71

)

Balance as of June 30, 2022

 

 

32,689,255

 

 

$

3

 

 

$

431,573

 

 

$

(320,687

)

 

$

(202

)

 

$

110,687

 

Issuance of common stock in connection with
   equity award plans

 

 

91,101

 

 

 

 

 

 

1,378

 

 

 

 

 

 

 

 

 

1,378

 

Issuance of common stock in public offerings,
   net of issuance costs of $
5,922

 

 

4,000,000

 

 

 

1

 

 

 

86,077

 

 

 

 

 

 

 

 

 

86,078

 

Restricted common stock vested in the period

 

 

33,398

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation

 

 

 

 

 

 

 

 

7,071

 

 

 

 

 

 

 

 

 

7,071

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(35,706

)

 

 

 

 

 

(35,706

)

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(211

)

 

 

(211

)

Balance as of September 30, 2022

 

 

36,813,754

 

 

$

4

 

 

$

526,099

 

 

$

(356,393

)

 

$

(413

)

 

$

169,297

 

 

 

 

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

4


 

Mirum Pharmaceuticals, Inc.

Condensed Consolidated Statements of Stockholders’ Equity

(Unaudited)

(In thousands, except share and per share data)

 

 

 

 

Common Stock

 

 

Additional
Paid-In

 

 

Accumulated

 

 

Accumulated
Other
Comprehensive

 

 

Total
Stockholders’

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Income (Loss)

 

 

Equity

 

Balance as of December 31, 2020