UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d)
of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): January 7, 2023
Mirum Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
Delaware | 001-38981 | 83-1281555 | ||
(State or other jurisdiction of incorporation) |
(Commission File Number) |
(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
N/A
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
Trading |
Name of each exchange on which registered | ||
Common stock, par value $0.0001 per share | MIRM | Nasdaq Global Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒
Item 2.02 | Results of Operations and Financial Condition. |
On January 9, 2023, Mirum Pharmaceuticals, Inc. (the “Company”) issued a press release announcing, among other things, the Company’s preliminary unaudited revenues for both the quarter and fiscal year ended December 31, 2022. The full text of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
Item 5.02 | Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers. |
(b)
On January 7, 2023, the Company and Ian Clements, Ph.D. entered into a Transition, Separation and Consulting Agreement, dated January 7, 2023 (the “Agreement”), pursuant to which Dr. Clements will resign as Chief Financial Officer of the Company.
Pursuant to the Agreement, Dr. Clements will continue his employment with the Company in the role of Chief Financial Officer from the effective date of the Agreement through May 15, 2023 unless such date is extended by mutual agreement or Dr. Clements’ employment is terminated earlier in accordance with the terms of the Agreement (the “Transition Period”). Following the end of the Transition Period and subject to the terms and conditions of the Agreement, Dr. Clements will serve as a consultant to the Company for a period of 12 months unless such consulting arrangement is terminated earlier in accordance with the Agreement (the “Consulting Period”).
During the Transition Period, Dr. Clements will be entitled to: (a) continued payments of his then-effective base salary in accordance with the Company’s standard payroll practices; (b) receipt of any earned cash incentive bonus payments at a target bonus percentage of 40% of his then-effective base salary, as determined by the Company’s board of directors or compensation committee based on the Company’s achievement of its performance goals for the fiscal year ended December 31, 2022; and (c) the right to participate in the Company’s standard benefits where permitted by such plans and programs. In addition, subject to the terms and conditions of the Agreement, Dr. Clements will be entitled to: (x) a severance consisting of regular payments of his then-effective base salary made in accordance with the Company’s standard payroll practices for a period of 12 months immediately following the termination of the Transition Period; (y) extension of the time period for him to exercise any vested equity awards that are stock options for a period of 12 months immediately following the termination of the Consulting Period, except in the case that the Company terminates Dr. Clements’ consultancy during the Consulting Period without cause (as defined in the Agreement), in which case the extension of the time period for Dr. Clements to exercise any vested equity awards that are stock options will be for a period of 12 months from the later of May 15, 2024 or the end of the Consulting Period; and (z) payment of his monthly health insurance premium under COBRA for the 12-month period immediately following the Transition Period (or, if earlier, the date that Dr. Clements becomes eligible to participate in a group health insurance plan of a subsequent employer or the date that Dr. Clements ceases to be eligible for COBRA continuation coverage). During the Consulting Period, Dr. Clements will provide mutually agreeable consulting services on an as needed basis in exchange for a mutually agreed hourly fee. During both the Transition Period and Consulting Period, Dr. Clements’ outstanding equity awards will continue to vest in accordance with their terms; provided, however, that if the Company terminates Dr. Clements’ consultancy during the Consulting Period without cause, all outstanding equity awards will immediately vest as to that portion of such equity awards that would have vested had Dr. Clements continued to remain a consultant of the Company for 12 months following the end of the Transition Period.
The terms of the Agreement amend and supersede any conflicting terms in any prior employment or severance arrangements between Dr. Clements and the Company.
The foregoing description of the Agreement does not purport to be complete and is subject to, and qualified in its entirety by, the final Agreement which is filed herewith as Exhibit 10.1 and incorporated by reference.
(e)
The information provided in Item 5.02(b) of this Current Report on Form 8-K is incorporated by reference into this Item 5.02(e).
Item 7.01 | Regulation FD Disclosure. |
On January 9, 2023, in connection with its participation in the J.P. Morgan Healthcare Conference, the Company posted a corporate slide presentation in the “Investors” portion of its website at www.mirumpharma.com. A copy of the presentation is furnished as Exhibit 99.2 to this Current Report on Form 8-K. The Company undertakes no obligation to update, supplement or amend the materials attached hereto as Exhibit 99.2.
The information in this Current Report on Form 8-K, including Exhibits 99.1 and 99.2 and excluding the disclosure set forth under Items 5.02(b) and (e), shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
Exhibit No. |
Description | |
10.1* | Transition, Separation and Consulting Agreement, dated January 7, 2023, by and between the Registrant and Ian Clements, Ph.D. | |
99.1 | Press Release dated January 9, 2023 | |
99.2 | Investor Presentation dated January 9, 2023 | |
104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
* | Schedules have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The registrant undertakes to furnish supplemental copies of any of the omitted schedules upon request by the Securities and Exchange Commission. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Mirum Pharmaceuticals, Inc. | ||||||
Date: January 9, 2023 | By: | /s/ Christopher Peetz | ||||
Christopher Peetz | ||||||
President and Chief Executive Officer |
Exhibit 10.1
January 7, 2023
Ian Clements, Ph.D.
Re: | Transition, Separation and Consulting Agreement |
Dear Ian:
This letter sets forth the substance of the transition, separation and consulting agreement (the Agreement) that Mirum Pharmaceuticals, Inc. (the Company) is offering to you.
1. Separation. Your last day of work with the Company and your employment termination date will be May 15, 2023 (the Separation Date), unless your employment terminates sooner pursuant to Section 3(c) below. The Separation Date may be extended upon mutual agreement between the Company and you. If termination occurs earlier or later than May 15, 2023, the actual date of termination shall become the Separation Date for purposes of this Agreement. As of the Separation Date, you hereby resign as Chief Financial Officer and from any other officer or director roles you may hold with the Company and its subsidiaries.
2. Accrued Salary and Paid Time Off. On or promptly following the Separation Date, the Company will pay you all accrued salary and all accrued and unused paid time off earned through the Separation Date, subject to standard payroll deductions and withholdings. You are entitled to this payment by law.
3. Transition Period.
a. Duties. Between now and the Separation Date (the Transition Period), you will remain in your current role and will continue to perform your regular duties, including signing and certifying as to the Companys 2022 Annual Report on Form 10-K as the principal financial and accounting officer of the Company. During the Transition Period, you also agree to transition your duties and responsibilities and perform other transition related tasks as requested by the Company. During the Transition Period, you will be allowed a reasonable amount of time to pursue outside professional opportunities and to conduct job search efforts, subject to your satisfying all reasonable Company work deadlines and performing all transition and other tasks as requested of you by the Company. You agree to perform your Transition Period services in good faith and to the best of your abilities. During the Transition Period, you must continue to comply with all of the Companys policies and procedures and with all of your statutory and contractual
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obligations to the Company, including, without limitation, your obligations under your Employee Confidential Information and Inventions Assignment Agreement (a copy of which is attached hereto as Exhibit A), which you acknowledge and agree are contractual commitments that remain binding upon you, both during and after the Transition Period.
b. Compensation/Benefits. During the Transition Period, your base salary of $442,000 per year will remain the same, and you will continue to be eligible for the Companys standard benefits, subject to the terms and conditions applicable to such plans and programs. During the Transition Period, you will remain eligible to receive your annual cash incentive bonus payment for 2022, with a target bonus percentage of 40%, as determined by the Companys Board of Directors and/or its Compensation Committee based on the Companys achievement of its performance goals for 2022. During the Transition Period, your outstanding equity awards (the Equity Awards) will continue to vest under the existing terms and conditions set forth in the Companys 2018 Equity Incentive Plan and 2019 Equity Incentive Plan (together, each as amended from time to time, the Equity Plans), as applicable, and your applicable grant documents (the Equity Documents).
c. Termination. Nothing in this Agreement alters your employment at will status. Accordingly, during the Transition Period you are entitled to resign your employment with or without cause or advance notice, and the Company may terminate your employment with or without Cause (as defined below) or advance notice. If you resign your employment prior to May 15, 2023 for any reason, or if the Company terminates your employment with Cause at any time, then you will no longer be eligible for participation in any Company benefit plans, and you will not be entitled to the severance benefits specified in Sections 4 through 6 below or the Consulting Agreement specified in Section 7 below.
d. Definition of Cause. For purposes of this Agreement, Cause for termination will mean any one or more of the following: (i) commission of any felony or any crime involving fraud, dishonesty or moral turpitude under the laws of the United States or any state thereof; (ii) attempted commission of, or participation in, a fraud or act of dishonesty against the Company; (iii) intentional, material violation of any contract or agreement between the employee and the Company or of any statutory duty owed to the Company (including violation of any provision or obligation under this Agreement); (iv) unauthorized use or disclosure of the Companys confidential information or trade secrets; or (v) your gross misconduct.
4. Severance Payment. If you timely sign this Agreement, allow it to become effective, comply with your obligations under this Agreement, including without limitation satisfactorily transitioning your duties during the Transition Period, and, on or after the Separation Date, timely sign and return the Separation Date Release attached hereto as Exhibit B (collectively, the Severance Preconditions), and allow the Separation Date Release to become effective, then the Company will pay you, as severance, regular payments based on your base salary in effect as of the Separation Date, subject to standard payroll deductions and withholdings, for a period of twelve (12) months. Such payments shall be made on the Companys regularly-scheduled payroll dates commencing on the first payroll period that occurs at least one week after the Effective Date (as defined in the Separation Date Release). If a release revocation period spans two calendar years, then any payments that are contingent on the Severance Preconditions shall commence in the second of the two years.
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5. Equity Awards. Your rights to exercise or otherwise acquire any vested shares shall be governed and controlled by the applicable Equity Documents, as modified by Section 7 below. As an additional benefit under the Agreement, subject to satisfaction of the Severance Preconditions and provided that you comply with the terms of this Agreement through the end of the Consulting Period (as defined and set forth below), the Company will extend your time period to exercise any vested Equity Awards that are stock options for a period of twelve (12) months from the end of the Consulting Period (but in no event later than the final day of the original term of the stock option). However, in the event the Company terminates your consultancy during the Consulting Period pursuant to Section 7(g) below without Cause, the Company will extend your time period to exercise any vested Equity Awards that are stock options for a period of twelve (12) months from the later of May 15, 2024 or the end of the Consulting Period (but in no event later than the final day of the original term of the stock option). All terms, conditions and limitations applicable to the Equity Awards will continue to be governed by the applicable Equity Documents, subject to the provisions hereof. Note that due to this modification of the post-termination exercise period, by signing this Agreement any incentive stock options under Section 422 of the Internal Revenue Code that you hold will convert into non-qualified stock options upon this Agreement becoming effective, and by signing this Agreement, you acknowledge and agree to such change.
6. Health Insurance. Your participation in the Companys group health insurance plan will end on the last day of the month in which the Separation Date occurs (i.e. if the Separation Date occurs on March 25, 2023, your participation in the Companys group health insurance plan will end on March 31, 2023). To the extent provided under the Consolidated Omnibus Budget Reconciliation Act of 1985 (COBRA) or, if applicable, state insurance laws, and by the Companys current group health insurance policies, you will be eligible to continue your group health insurance benefits at your own expense following the Separation Date. Later, you may be able to convert to an individual policy through the provider of the Companys health insurance, if you wish. You will be provided with a separate notice describing your rights and obligations under COBRA. As an additional severance benefit under this Agreement, provided that you satisfy the Severance Preconditions set forth above and timely elect continued coverage under COBRA, then the Company shall pay directly to the carrier on your behalf the full amount of the COBRA premiums to continue your health insurance coverage (including coverage for eligible dependents, if applicable) through the period (the COBRA Premium Period) starting on the Separation Date and ending on the earliest to occur of: (i) twelve (12) months following the Separation Date; (ii) the date you become eligible for group health insurance coverage through a new employer; or (iii) the date you cease to be eligible for COBRA coverage for any reason. Upon the conclusion of the COBRA Premium Period, you will be responsible for the entire payment of premiums (or payment for the cost of coverage) required under COBRA for the duration of your eligible COBRA coverage period, if any. For purposes of this Section, (1) references to COBRA shall be deemed to refer also to analogous provisions of state law and (2) any applicable insurance premiums that are paid by the Company shall not include any amounts payable by you under an Internal Revenue Code Section 125 health care reimbursement plan, which amounts, if any, are your sole responsibility. In the event you become covered under another employers group health plan or otherwise cease to be eligible for COBRA during the COBRA Premium Period, you must immediately notify the Company in writing of such event.
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Notwithstanding the foregoing, if at any time the Company determines, in its sole discretion, that it cannot provide the COBRA premium benefits without potentially incurring financial costs or penalties under applicable law (including, without limitation, Section 2716 of the Public Health Service Act), then in lieu of paying COBRA premiums directly to the carrier on your behalf, the Company will instead pay you on the last day of each remaining month of the COBRA Premium Period a fully taxable cash payment equal to the value of your monthly COBRA premium for the first month of COBRA coverage, subject to applicable tax withholding (each such amount, a COBRA Severance Payment), such COBRA Severance Payment to be made without regard to your election of COBRA coverage or payment of COBRA premiums and without regard to your continued eligibility for COBRA coverage during the COBRA Premium Period. No further COBRA Severance Payments shall be made following the conclusion of the COBRA Premium Period.
7. Consulting Agreement. As part of this Agreement, and subject to your fulfillment of the Severance Preconditions, the Company agrees to engage you as a consultant, pursuant to the following terms and conditions (the Consulting Relationship):
a. Consulting Period. The Consulting Relationship will be deemed to have commenced on the Separation Date and will continue for twelve (12) months thereafter, unless terminated earlier pursuant to the terms below (the Consulting Period).
b. Consulting Services. You agree to provide consulting services at mutually agreeable times to the Company in any area of your expertise, including but not limited to general transition support on investor relations, corporate communications related matters and other assignments as requested by the Chief Executive Officer (the Consulting Services). You agree to make yourself available to the Company for Consulting Services for no more than an average of eight (8) hours per week for the duration of the Consulting Period. You agree to make yourself available to perform such Consulting Services throughout the Consulting Period, on an as needed basis. You agree to exercise the highest degree of professionalism and utilize your expertise and talents in performing these services. When providing such services, you shall abide by the Companys policies and procedures.
c. Independent Contractor Relationship. Your relationship with the Company during the Consulting Period will be that of an independent contractor, and nothing in this Agreement is intended to, or should be construed to, create a partnership, agency, joint venture or employment relationship after the Separation Date. Other than your COBRA rights, you will not be entitled to any of the benefits that the Company may make available to its employees, including but not limited to, group health or life insurance, profit-sharing or retirement benefits, and you acknowledge and agree that your relationship with the Company during the Consulting Period will not be subject to the Fair Labor Standards Act or other laws or regulations governing employment relationships.
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d. Consideration for Consulting Services. During the Consulting Period, you will be eligible for the following consideration:
(i) Consulting Fees. During the Consulting Period, you will receive cash compensation for your Consulting Services at a mutually agreed upon hourly rate (the Consulting Fees), which rate must be agreed to in writing before you perform any Consulting Services. You will submit detailed invoices of your Consulting Services on a monthly basis, and the Company will provide payment of any owed Consulting Fees within thirty (30) days after receipt of such invoices. The Company will not withhold from the Consulting Fees any amount for taxes, social security or other payroll deductions. The Company will report your Consulting Fees on an IRS Form 1099. You acknowledge that you will be entirely responsible for payment of any taxes that may be due with regard to the Consulting Fees, and you hereby indemnify, defend and save harmless the Company, and its officers and directors in their individual capacities, from any liability for any taxes, penalties or interest that may be assessed by any taxing authority with respect to the Consulting Fees (with the exception of the employers share of social security, if any). The Company encourages you to obtain professional advice from an advisor of your choice with respect to the tax treatment of, and any and all tax issues with respect to, the Consulting Fees.
(ii) Equity Awards. Because your service as an employee during the Transition Period and as a consultant during Consulting Period will be continuous, your separation of employment will not constitute a termination of service for purposes of your Equity Documents. Accordingly, vesting of your applicable Equity Awards will continue during the Consulting Period. In addition, in the event the Company terminates your consultancy during the Consulting Period pursuant to Section 7(g) below without Cause, there shall immediately vest that portion of your applicable Equity Awards that would have vested as if you had continued to remain a consultant of the Company for twelve (12) months from the Separation Date. All terms, conditions and limitations applicable to the Equity Awards will continue to be subject to the applicable Equity Documents, subject to the provisions hereof.
e. Limitations on Authority. You will have no responsibilities or authority as a consultant to the Company other than as provided above. You will have no authority to bind the Company to any contractual obligations, whether written, oral or implied, except with the authorization of the Companys Chief Executive Officer. Further, except as part of your Consulting Services, you agree not to represent or purport to represent the Company in any manner whatsoever to any third party (including but not limited to customers, potential customers, investors, business partners or vendors), unless authorized by the Companys Chief Executive Officer to do so.
f. Confidential Information and Inventions. You agree that, during the Consulting Period and thereafter, you will not use or disclose, other than in furtherance of the Consulting Services, any confidential or proprietary information or materials of the Company, including any confidential or proprietary information that you obtain or develop in the course of performing the Consulting Services. Any and all work product you create in the course of performing the Consulting Services will be the sole and exclusive property of the Company. You hereby assign to the Company all right, title, and interest in all inventions, techniques, processes, materials, and other intellectual property developed in the course of performing the Consulting
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Services. Notwithstanding the foregoing nondisclosure obligations, pursuant to 18 U.S.C. Section 1833(b), you will not be held criminally or civilly liable under any federal or state trade secret law for the disclosure of a trade secret that is made: (i) in confidence to a federal, state, or local government official, either directly or indirectly, or to an attorney, and solely for the purpose of reporting or investigating a suspected violation of law; or (ii) in a complaint or other document filed in a lawsuit or other proceeding, if such filing is made under seal.
g. Early Termination of Consulting Period. Without waiving any other rights or remedies, the Company has the immediate right to terminate the Consulting Relationship if the Company determines that you have breached this Agreement (including any breach of any of the representations, warranties or Consulting Service commitments made by you in this Agreement) or your continuing obligations owed to the Company (including, but not limited to, the Employee Confidential Information and Inventions Assignment Agreement). Additionally, you have the right to terminate the Consulting Relationship at any time and for any reason, upon thirty (30) days advance written notice to the Company.
h. Other Work Activities / Representations. Throughout the Consulting Period, you retain the right to engage in employment, consulting, or other work relationships in addition to your Consulting Services for the Company, so long as such activities do not present a conflict of interest with the Companys business, or interfere with your continuing obligations owed to the Company. In the event that it is unclear to you whether a particular activity would breach this commitment, you agree to contact the Companys Chief Executive Officer to seek clarification. You represent and warrant that you are self-employed in an independently established trade, occupation, or business, maintain and operate a business that is separate and independent from the Companys business, hold yourself out to the public as independently competent and available to provide applicable services similar to the Consulting Services, have obtained and/or expect to obtain clients or customers other than the Company for whom you will perform services, and will perform work for the Company that you understand is outside the usual course of the Companys business.
8. No Other Compensation or Benefits. You acknowledge and agree that you are not entitled to any severance or other benefits in connection with your employment separation, whether under that certain Amended Participation Agreement under the Severance Benefit Plan by and between you and the Company, dated March 12, 2019, as amended to date, your offer letter, dated February 11, 2019, as amended to date, or any other agreement between you and the Company, any Company policy, or otherwise, and to the extent you were eligible for any severance benefits, this Agreement hereby supersedes and extinguishes any such severance benefits. You further acknowledge that, except as expressly provided in this Agreement, you have not earned and will not receive from the Company any additional compensation (including base salary, bonus, incentive compensation, or equity), severance, or benefits before or after the Separation Date, with the exception of any vested right you may have under the express terms of a written ERISA-qualified benefit plan (e.g., 401(k) account) or any vested options or vested restricted stock units.
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9. Expense Reimbursements. You agree that, within thirty (30) days after the Separation Date, you will submit your final documented expense reimbursement statement reflecting all business expenses you incurred through the Separation Date, if any, for which you seek reimbursement. The Company will reimburse you for these expenses pursuant to its regular business practice.
10. Return of Company Property. By the Separation Date, or earlier if requested by the Company, you agree to return to the Company all Company documents (and all copies thereof) and other Company property which you have in your possession or control, including, but not limited to, Company files, notes, drawings, records, plans, forecasts, reports, studies, analyses, proposals, agreements, financial information, research and development information, sales and marketing information, customer lists, prospect information, pipeline reports, sales reports, operational and personnel information, specifications, code, software, databases, computer-recorded information, tangible property and equipment (including, but not limited to, computers, facsimile machines, mobile telephones, servers), credit cards, entry cards, identification badges and keys; and any materials of any kind which contain or embody any proprietary or confidential information of the Company (and all reproductions thereof in whole or in part). You agree that you will make a diligent search to locate any such documents, property and information by the close of business on the Separation Date. If you have used any personally owned computer, server, or e-mail system to receive, store, review, prepare or transmit any Company confidential or proprietary data, materials or information, within five (5) days after the Separation Date, you shall provide the Company with a computer-useable copy of such information and then permanently delete and expunge such Company confidential or proprietary information from those systems; and you agree to provide the Company access to your system as requested to verify that the necessary copying and/or deletion is done. Your timely compliance with this paragraph is a condition to your receipt of the consideration provided under this Agreement. Following your return of Company property pursuant to this Section, the Company may permit you to receive and/or use certain documents, equipment, and/or information reasonably necessary to perform the Consulting Services, all of which you shall return to the Company by the last day of the Consulting Period, or earlier upon the Companys request, without retaining any copies or embodiments (in whole or in part).
11. Confidentiality. The provisions of this Agreement will be held in strictest confidence by you and will not be publicized or disclosed by you in any manner whatsoever; provided, however, that: (a) you may disclose this Agreement in confidence to your immediate family and to your attorneys, accountants, tax preparers and financial advisors; (b) you may disclose this Agreement insofar as such disclosure may be necessary to enforce its terms or as otherwise required by law; and (c) you may make such statements and disclosures as set forth in the section of this Agreement entitled Protected Rights. In particular, and without limitation, you agree not to disclose the terms of this Agreement to any current or former Company employee or independent contractor.
12. Nondisparagement. You agree not to disparage the Company, its officers, directors, employees, shareholders, parents, subsidiaries, affiliates, and agents, in any manner likely to be harmful to its or their business, business reputation, or personal reputation; provided that you may respond accurately and fully to any question, inquiry, or request for information if required by legal process or in connection with a government investigation. In addition, nothing in this provision or this Agreement is intended to prohibit or restrain you in any manner from
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making disclosures that are protected under the whistleblower provisions of federal or state law or regulation or as set forth in the section of this Agreement entitled Protected Rights. You further acknowledge and agree that the obligations set forth in this section are not provided in exchange for a raise, bonus, or as a condition of continued employment, but rather in exchange for the materially modified terms and conditions of employment during the Transition Period, eligibility for a consulting relationship and severance benefits you were not otherwise eligible to receive, and other consideration provided by the Company in this Agreement.
13. No Voluntary Adverse Action. You agree that you will not voluntarily (except in response to legal compulsion or as permitted under the Protected Rights section below) assist any person in bringing or pursuing any proposed or pending litigation, arbitration, administrative claim or other formal proceeding against the Company, its parent or subsidiary entities, affiliates, officers, directors, employees or agents.
14. Cooperation. You agree to cooperate fully with the Company in connection with its actual or contemplated defense, prosecution, or investigation of any claims or demands by or against third parties, or other matters arising from events, acts, or failures to act that occurred during the period of your employment by the Company. Such cooperation includes, without limitation, making yourself available to the Company upon reasonable notice, without subpoena, to provide complete, truthful and accurate information in witness interviews, depositions, and trial testimony. The Company will reimburse you for reasonable out-of-pocket expenses you incur in connection with any such cooperation (excluding foregone wages) and will make reasonable efforts to accommodate your scheduling needs.
15. No Admissions. You understand and agree that the promises and payments in consideration of this Agreement shall not be construed to be an admission of any liability or obligation by the Company to you or to any other person, and that the Company makes no such admission.
16. Release of Claims. In exchange for the consideration provided to you under this Agreement to which you would not otherwise be entitled, you hereby generally and completely release the Company, and its affiliated, related, parent and subsidiary entities, and its and their current and former directors, officers, employees, shareholders, partners, agents, attorneys, predecessors, successors, insurers, affiliates, and assigns from any and all claims, liabilities, demands, causes of action, and obligations, both known and unknown, that arise out of or are in any way related to events, acts, conduct, or omissions occurring at any time prior to and including the date you sign this Agreement. This general release includes, but is not limited to: (i) all claims arising out of or in any way related to your employment with the Company, the decision to terminate that employment, or the termination of that employment; (ii) all claims related to your compensation or benefits from the Company, including salary, bonuses, commissions, vacation pay, expense reimbursements, severance pay, fringe benefits, stock, stock options, restricted stock units, or any other ownership, equity, or profits interests in the Company; (iii) all claims for breach of contract, wrongful termination, and breach of the implied covenant of good faith and fair dealing; (iv) all tort claims, including claims for fraud, defamation, emotional distress, and discharge in violation of public policy; and (v) all federal, state, and local statutory claims, including claims for discrimination, harassment, retaliation, attorneys fees, or other claims arising under the federal Civil Rights Act of 1964 (as amended), the federal Americans with Disabilities Act of 1990, the California Labor Code (as amended), the California Family Rights Act, the Age Discrimination in Employment Act (ADEA), and the California Fair Employment and Housing Act (as amended).
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a. Release Acknowledgements. You acknowledge that you have been advised, pursuant to California Government Code Section 12964.5(b)(4), that you have the right to consult an attorney regarding this Agreement and that you were given a reasonable time period of not less than five business days in which to do so. You further acknowledge and agree that, in the event you sign this Agreement prior to the end of the reasonable time period provided by the Company, your decision to accept such shortening of time is knowing and voluntary and is not induced by the Company through fraud, misrepresentation, or a threat to withdraw or alter the offer prior to the expiration of the reasonable time period, or by providing different terms to employees who sign such an agreement prior to the expiration of the time period. You further acknowledge and agree that the release of claims in this Agreement is not provided in exchange for a raise, bonus, or as a condition of continued employment, but rather in exchange for the materially modified terms and conditions of employment during the Transition Period, eligibility for a consulting relationship and severance benefits you were not otherwise eligible to receive, and other consideration provided by the Company in this Agreement.
b. ADEA Release. You acknowledge that you are knowingly and voluntarily waiving and releasing any rights you have under the ADEA, and that the consideration given for the waiver and releases you have given in this Agreement is in addition to anything of value to which you were already entitled. You further acknowledge that you have been advised, as required by the ADEA, that: (i) your waiver and release does not apply to any rights or claims that arise after the date you sign this Agreement; (ii) you should consult with an attorney prior to signing this Agreement (although you may choose voluntarily not to do so); (iii) you have twenty- one (21) days to consider this Agreement (although you may choose voluntarily to sign it sooner); (iv) you have seven (7) days following the date you sign this Agreement to revoke this Agreement (in a written revocation sent to the Company); and (v) this Agreement will not be effective until the date upon which the revocation period has expired, which will be the eighth day after you sign this Agreement provided that you do not revoke it (the Effective Date).
c. Section 1542 Waiver. In giving the release herein, which includes claims which may be unknown to you at present, you acknowledge that you have read and understand Section 1542 of the California Civil Code, which reads as follows:
A general release does not extend to claims that the creditor or releasing party does not know or suspect to exist in his or her favor at the time of executing the release and that, if known by him or her, would have materially affected his or her settlement with the debtor or released party.
You hereby expressly waive and relinquish all rights and benefits under that section and any law of any other jurisdiction of similar effect with respect to your release of claims herein, including but not limited to your release of unknown claims.
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d. Exceptions. Notwithstanding the foregoing, you are not releasing the Company hereby from any obligation to indemnify you pursuant to the Amended and Restated Certificate of Incorporation and Amended and Restated Bylaws of the Company, any valid fully executed indemnification agreement with the Company, applicable law, or applicable directors and officers liability insurance. Also, excluded from this Agreement are any claims that cannot be waived by law.
17. Protected Rights. You understand that nothing in this Agreement limits your ability to file a charge or complaint with the Equal Employment Opportunity Commission, the Department of Labor, the National Labor Relations Board, the Occupational Safety and Health Administration, the Securities and Exchange Commission or any other federal, state or local governmental agency or commission (Government Agencies). You further understand this Agreement does not limit your ability to communicate with any Government Agencies or otherwise participate in any investigation or proceeding that may be conducted by any Government Agency, including providing documents or other information, without notice to the Company. While this Agreement does not limit your right to receive an award for information provided to the Securities and Exchange Commission, you understand and agree that, to maximum extent permitted by law, you are otherwise waiving any and all rights you may have to individual relief based on any claims that you have released and any rights you have waived by signing this Agreement. Nothing in this Agreement prevents you from discussing or disclosing information about unlawful acts in the workplace, such as harassment or discrimination or any other conduct that you have reason to believe is unlawful.
18. Representations. You hereby represent that you have been paid all compensation owed and for all hours worked through the date you sign this Agreement, have received all the leave and leave benefits and protections for which you are eligible pursuant to the Family and Medical Leave Act, or otherwise, and have not suffered any on-the-job injury for which you have not already filed a workers compensation claim.
19. Miscellaneous. This Agreement, including its Exhibits, constitutes the complete, final and exclusive embodiment of the entire agreement between you and the Company with regard to its subject matter. It is entered into without reliance on any promise or representation, written or oral, other than those expressly contained herein, and it supersedes any other promises, warranties, representations or agreements relating to the subject matter hereof, including that certain Amended Participation Agreement under the Severance Benefit Plan by and between you and the Company, dated March 12, 2019, as amended to date, and your offer letter, dated February 11, 2019, as amended to date. Amounts payable under this Agreement are intended to be exempt from (and if not so exempt, compliant with) Section 409A of the Internal Revenue Code of 1986, as amended, and the regulations and guidance issued thereunder, and the terms of this Agreement shall be interpreted accordingly. Your right to receive any installment payments will be treated as a right to receive a series of separate payments and, accordingly, each installment payment shall at all times be considered a separate and distinct payment. This Agreement may not be modified or amended except in a writing signed by both you and a duly authorized officer of the Company. This Agreement will bind the heirs, personal representatives, successors and assigns of both you and the Company, and inure to the benefit of both you and the Company, their heirs, successors and assigns. If any provision of this Agreement is determined to be invalid or unenforceable, in
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whole or in part, this determination will not affect any other provision of this Agreement and the provision in question will be modified by the court so as to be rendered enforceable to the fullest extent permitted by law, consistent with the intent of the parties. This Agreement will be deemed to have been entered into and will be construed and enforced in accordance with the laws of the State of California without regard to conflict of laws principles. Any ambiguity in this Agreement shall not be construed against either party as the drafter. Any waiver of a breach of this Agreement shall be in writing and shall not be deemed to be a waiver of any successive breach. This Agreement may be executed in counterparts which shall be deemed to be part of one original, and facsimile and electronic image signatures (including .pdf or any electronic signature complying with the U.S. federal ESIGN Act of 2000, Uniform Electronic Transactions Act, or other applicable law) shall be equivalent to original signatures.
[Signature page to follow]
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If this Agreement is acceptable to you, please sign below and return the original to me. You have twenty-one (21) calendar days to decide whether you would like to accept this Agreement, and the Companys offer contained herein will automatically expire if you do not sign and return it within this timeframe.
We wish you the best in your future endeavors.
Sincerely, | ||
By: | /s/ Chris Peetz | |
Chris Peetz | ||
Chief Executive Officer |
I HAVE READ, UNDERSTAND AND AGREE FULLY TO THE FOREGOING AGREEMENT:
/s/ Ian Clements, Ph.D. |
Ian Clements, Ph.D. |
January 7, 2023 |
Date |
EXHIBIT A
EMPLOYEE CONFIDENTIAL INFORMATION AND INVENTIONS ASSIGNMENT AGREEMENT
Page 1
EXHIBIT B
SEPARATION DATE RELEASE
(to be signed and returned to the Company on or within twenty-one (21) days after the Separation Date)
In exchange for the severance benefits to be provided to me by Mirum Pharmaceuticals, Inc. (the Company) pursuant to that certain transition, separation and consulting letter agreement with the Company to which this Exhibit is attached (the Agreement), I hereby provide the following Separation Date Release (the Release). Capitalized terms used but not defined herein shall have the meanings ascribed to them in the Agreement.
I hereby represent that I have been paid all compensation owed and for all hours worked through the date I sign this Release, have received all the leave and leave benefits and protections for which I am eligible pursuant to the Family and Medical Leave Act, or otherwise, and have not suffered any on-the-job injury for which I have not already filed a workers compensation claim. I acknowledge that, other than the severance benefits to be provided to me pursuant to the Agreement upon satisfaction of the Severance Preconditions, I have not earned and will not receive from the Company any additional compensation (including base salary, bonus, incentive compensation, or equity), severance, or benefits, with the exception of any vested right I may have under the express terms of a written ERISA-qualified benefit plan (e.g., 401(k) account) or any vested options or vested restricted stock units.
I hereby generally and completely release the Company, and its affiliated, related, parent and subsidiary entities, and its and their current and former directors, officers, employees, shareholders, partners, agents, attorneys, predecessors, successors, insurers, affiliates, and assigns from any and all claims, liabilities, demands, causes of action, and obligations, both known and unknown, that arise out of or are in any way related to events, acts, conduct, or omissions occurring at any time prior to and including the date I sign this Release. This general release includes, but is not limited to: (a) all claims arising out of or in any way related to my employment with the Company or the termination of that employment; (b) all claims related to my compensation or benefits from the Company, including salary, bonuses, commissions, vacation pay, expense reimbursements, severance pay, fringe benefits, stock, stock options, restricted stock units, or any other ownership, equity, or profits interests in the Company; (c) all claims for breach of contract, wrongful termination, and breach of the implied covenant of good faith and fair dealing; (d) all tort claims, including claims for fraud, defamation, emotional distress, and discharge in violation of public policy; and (e) all federal, state, and local statutory claims, including claims for discrimination, harassment, retaliation, attorneys fees, or other claims arising under the federal Civil Rights Act of 1964 (as amended), the federal Americans with Disabilities Act of 1990, the California Labor Code (as amended), the California Family Rights Act, the Age Discrimination in Employment Act (ADEA), and the California Fair Employment and Housing Act (as amended).
I acknowledge that I have been advised, pursuant to California Government Code Section 12964.5(b)(4), that I have a right to consult an attorney regarding this Release and that I was given a reasonable time period of not less than five (5) business days in which to do so. I further acknowledge and agree that, in the event I sign this Release prior to the end of the reasonable time period, my decision to accept such shortening of time is knowing and voluntary and is not induced by the Company through fraud, misrepresentation, or a threat to withdraw or alter the offer prior to the expiration of the reasonable time period, or by providing different terms to employees who sign such an agreement prior to the expiration of the time period.
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I acknowledge that I am knowingly and voluntarily waiving and releasing any rights I have under the ADEA, and that the consideration given for the waiver and releases I have given in this Release is in addition to anything of value to which I was already entitled. I further acknowledge that I have been advised, as required by the ADEA, that: (a) my waiver and release does not apply to any rights or claims that arise after the date I sign this Release; (b) I should consult with an attorney prior to signing this Release (although I may choose voluntarily not to do so); (c) I have twenty-one (21) days to consider this Release (although I may choose voluntarily to sign it sooner); (d) I have seven (7) days following the date I sign this Release to revoke this Release (in a written revocation sent to the Company); and (e) this Release will not be effective until the date upon which the revocation period has expired, which will be the eighth day after I sign this Release provided that I do not revoke it (the Effective Date).
In giving the release herein, which includes claims which may be unknown to me at present, I acknowledge that I have read and understand Section 1542 of the California Civil Code, which reads as follows:
A general release does not extend to claims that the creditor or releasing party does not know or suspect to exist in his or her favor at the time of executing the release and that, if known by him or her, would have materially affected his or her settlement with the debtor or released party.
I hereby expressly waive and relinquish all rights and benefits under that section and any law of any other jurisdiction of similar effect with respect to my release of claims herein, including but not limited to my release of unknown claims.
Notwithstanding the foregoing, I am not releasing the Company hereby from any obligation to indemnify me pursuant to the Amended and Restated Certificate of Incorporation and Amended and Restated Bylaws of the Company, any valid fully executed indemnification agreement with the Company, applicable law, or applicable directors and officers liability insurance. Also, excluded from this Release are any claims that cannot be waived by law.
I understand that nothing in this Release limits my ability to file a charge or complaint with the Equal Employment Opportunity Commission, the Department of Labor, the National Labor Relations Board, the Occupational Safety and Health Administration, the Securities and Exchange Commission or any other federal, state or local governmental agency or commission (Government Agencies). I further understand this Release does not limit my ability to communicate with any Government Agencies or otherwise participate in any investigation or proceeding that may be conducted by any Government Agency, including providing documents or other information, without notice to the Company. While this Release does not limit my right to receive an award for information provided to the Securities and Exchange Commission, I understand and agree that, to maximum extent permitted by law, I am otherwise waiving any and all rights I may have to individual relief based on any claims that I have released and any rights I have waived by signing this Release. Further, I understand that nothing in this Release prevents me from discussing or disclosing information about unlawful acts in the workplace, such as harassment or discrimination or any other conduct that I have reason to believe is unlawful.
[Signature page to follow]
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This Release, together with the Agreement (and its exhibits) constitutes the entire agreement between me and the Company with respect to the subject matter hereof. I am not relying on any representation not contained herein or in the Agreement.
UNDERSTOOD, ACCEPTED, AND AGREED:
|
Ian Clements, Ph.D. |
|
Date |
Exhibit 99.1
Mirum Pharmaceuticals Announces Preliminary Unaudited LIVMARLI 2022 Net Revenue and Provides Corporate Updates
- $76 million in total revenue and $74 million net product sales anticipated for LIVMARLI for 2022, preliminary and unaudited
- sNDA for LIVMARLI in PFIC submission planned for first quarter 2023
- Multiple data analyses planned in 2023 advancing late-stage cholestasis programs
FOSTER CITY, Calif. January 9, 2023 - Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today provided a preview of the companys plans, estimated revenue and net product sales for Q4 and full year 2022 ahead of its presentation at the 41st Annual J.P. Morgan Healthcare Conference.
2022 was a year of strong commercial performance and continued pipeline execution. LIVMARLI revenue growth and the positive results from the progressive familial intrahepatic cholestasis (PFIC) Phase 3 study show the important impact of IBAT inhibition in transforming cholestatic liver disease, said Chris Peetz, president and chief executive officer. The year ahead holds continued growth of our commercial business with a clear path to 50% year-over-year growth in net sales in the United States in 2023, potential for label expansion into PFIC, and data events in primary sclerosing cholangitis, primary biliary cholangitis, and biliary atresia to further realize the potential of our programs.
Commercial Highlights Positioned for Global Growth
| $76 million total revenue, including $74 million anticipated in LIVMARLI net product sales for 2022; |
| Fourth quarter 2022 estimated product sales of $27 million includes an estimated $5 million of international sales through partner market supply orders, including inventory; |
| LIVMARLI ALGS launches planned in international markets throughout 2023; |
| As of December 31, 2022, Mirum had cash, cash equivalents, restricted cash equivalents and investments of approximately $252 million. |
The foregoing amounts relating to 2022 financial data are unaudited and preliminary and are subject to completion of financial closing procedures. Additional information and disclosure would be required for a more complete understanding of the companys financial position and results of operations as of December 31, 2022.
Pipeline & Regulatory Highlights
| LIVMARLI approved for cholestatic pruritus in patients with Alagille syndrome (ALGS) in Europe and Israel; |
| Supplemental new drug application submission to FDA for LIVMARLI in PFIC on track for first quarter 2023; |
| Volixibat VISTAS study in primary sclerosing cholangitis blinded interim analysis expected mid- 2023; |
| Volixibat VANTAGE study for primary biliary cholangitis interim analysis expected in second half 2023; |
| LIVMARLI EMBARK study for biliary atresia data expected in second half 2023. |
Mirum also announced the planned departure of chief financial officer, Dr. Ian Clements. Dr. Clements is expected to continue to serve as CFO until May 15, 2023 and will remain in an advisory position for a transitional period.
Ian has made invaluable contributions to the organization during his tenure and was instrumental in helping build Mirum into what it is today, said Mr. Peetz. On behalf of the Board of Directors and our entire team, I want to thank Ian for his successful leadership as CFO over the last four years and I wish him all the best in his next endeavor.
Dr. Clements commented, Im incredibly proud of the work weve done since I joined Mirum in 2019, transitioning from a private entity to an established public company. It has been an honor to work alongside such a dedicated and talented team. I look forward to a smooth transition and know Mirum is well positioned for the future.
Presentation at J.P. Morgan Healthcare Conference
Mirum will present at the J.P. Morgan Healthcare conference on Tuesday, January 10, 2023 from 1:30-2:10 p.m. PT/4:30-5:10 p.m. ET.
View the Investors and Media section of Mirums corporate website for webcast links and additional information.
About Alagille Syndrome
Alagille syndrome (ALGS) is a rare genetic disorder in which bile ducts are abnormally narrow, malformed and reduced in number, which leads to bile accumulation in the liver and ultimately progressive liver disease. The estimated incidence of ALGS is one in every 30,000 people. In patients with ALGS, multiple organ systems may be affected by the mutation, including the liver, heart, kidneys and central nervous system. The accumulation of bile acids prevents the liver from working properly to eliminate waste from the bloodstream and, according to recent reports, 60% to 75% of patients with ALGS have a liver transplant before reaching adulthood. Signs and symptoms arising from liver damage in ALGS may include jaundice (yellowing of the skin), xanthomas (disfiguring cholesterol deposits under the skin), and pruritus (itch). The pruritus experienced by patients with ALGS is among the most severe in any chronic liver disease and is present in most affected children by the third year of life.
About LIVMARLI® (maralixibat) oral solution
LIVMARLI® (maralixibat) oral solution is an orally administered, once-daily, ileal bile acid transporter (IBAT) inhibitor approved by the U.S. Food and Drug Administration for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) one year of age and older. LIVMARLI is also approved by the European Commission for the treatment of cholestatic pruritus in patients with ALGS two months and older. It is the only approved medication to treat cholestatic pruritus associated with Alagille syndrome. For more information for U.S. residents, please visit LIVMARLI.com.
LIVMARLI is currently being evaluated in late-stage clinical studies in other rare cholestatic liver diseases including progressive familial intrahepatic cholestasis (PFIC) and biliary atresia. LIVMARLI has received Breakthrough Therapy designation for ALGS and PFIC type 2 and orphan designation for ALGS, PFIC and biliary atresia. To learn more about ongoing clinical trials with LIVMARLI, please visit Mirums clinical trials section on the companys website.
IMPORTANT SAFETY INFORMATION
LIVMARLI can cause side effects, including:
Changes in liver tests. Changes in certain liver tests are common in patients with Alagille syndrome and can worsen during treatment with LIVMARLI. These changes may be a sign of liver injury and can be serious. Your healthcare provider should do blood tests before starting and during treatment to check your liver function. Tell your healthcare provider right away if you get any signs or symptoms of liver problems, including nausea or vomiting, skin or the white part of the eye turns yellow, dark or brown urine, pain on the right side of the stomach (abdomen) or loss of appetite.
Stomach and intestinal (gastrointestinal) problems. LIVMARLI can cause stomach and intestinal problems, including diarrhea, stomach pain, and vomiting during treatment. Tell your healthcare provider right away if you have any of these symptoms more often or more severely than normal for you.
A condition called Fat Soluble Vitamin (FSV) Deficiency caused by low levels of certain vitamins (vitamin A, D, E, and K) stored in body fat. FSV deficiency is common in patients with Alagille syndrome but may worsen during treatment. Your healthcare provider should do blood tests before starting and during treatment.
Other common side effects reported during treatment were bone fractures and gastrointestinal bleeding.
US Prescribing Information
EU SmPC
About Mirum Pharmaceuticals
Mirum Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to transforming the treatment of rare liver diseases. Mirums approved medication is LIVMARLI® (maralixibat) oral solution which is approved in the U.S. for the treatment of cholestatic pruritus in patients with Alagille syndrome one year of age and older, and in Europe for the same indication in patients two months of age and older.
Mirums late-stage pipeline includes two investigational treatments for debilitating liver diseases affecting children and adults. LIVMARLI, an oral ileal bile acid transporter (IBAT) inhibitor, is currently being evaluated in clinical trials for pediatric liver diseases and includes the EMBARK Phase 2b clinical trial for patients with biliary atresia. In addition, Mirum has an expanded access program open across multiple countries for eligible patients with ALGS and PFIC.
Mirums second investigational treatment, volixibat, an oral IBAT inhibitor, is being evaluated in two potentially registrational studies including the VISTAS Phase 2b clinical trial for adults with primary sclerosing cholangitis and the VANTAGE Phase 2b clinical trial for adults with primary biliary cholangitis.
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Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, the companys estimates regarding its revenue and net product sales for the fourth quarter and year ended December 31, 2022, the companys projected 50% year over year growth in net sales in the United States in 2023, commercialization plans for LIVMARLI in international markets, the timing of ongoing and planned clinical trials and the regulatory approval process, as well as the timing of data and interim analyses of ongoing clinical trials, and the planned departure of Dr. Clements. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as ahead, expect, will, would, plan, potential and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Mirums current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with Mirums business in general, the impact of macroeconomic and geopolitical events, including the COVID-19 pandemic and ongoing conflict between Ukraine and Russia, and the other risks described in Mirums filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on managements assumptions and estimates as of such date. Mirum undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
Contacts
Media Contact:
Erin Murphy
media@mirumpharma.com
Investor Contacts:
Ian Clements, Ph.D.
ir@mirumpharma.com
Sam Martin
Argot Partners
ir@mirumpharma.com
January 2023 Corporate Presentation Exhibit 99.2
Forward-Looking Statements This presentation contains "forward-looking" statements that are based on our management’s beliefs and assumptions and on information currently available to management. Forward-looking statements include all statements other than statements of historical fact contained in this presentation, including information concerning our business strategy, objectives and opportunities. Forward-looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause our actual results, performance or achievements to differ materially and adversely from those anticipated or implied by our forward-looking statements, including, but not limited to: our plans and expectations for commercializing LIVMARLI in the United States and rest of world; the costs of our commercialization plans and development programs, and the financial impact or revenues from any commercialization we undertake; estimates of the number of patients impacted by ALGS, PFIC or related diseases and who are appropriate for treatment with LIVMARLI at optimal clinical doses; the potential benefits of LIVMARLI and our product candidates; the potential benefits of our business model and expected growth; our ability to obtain necessary regulatory approvals for our product candidates and, if and when approved, market acceptance of our products; our dependence on third-party clinical research organizations, manufacturers, suppliers and distributors; the design, implementation, timelines and outcomes of our clinical trials; the impact of competitive products and therapies; our ability to obtain necessary additional capital; our ability to attract and retain key employees; our ability to manage the growth and complexity of our organization; our ability to maintain, protect and enhance our intellectual property; and our ability to continue to stay in compliance with applicable laws and regulations. You should refer to the section entitled “Risk Factors” set forth in our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and other filings we make with the Securities and Exchange Commission (SEC) from time to time for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. Neither we nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements. We undertake no obligation to update any forward-looking statements after the date of this presentation except as may be required by law. This presentation also contains estimates and other statistical data made by independent parties and by us relating to market size and growth and other data about our industry. These data involve a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. Projections, assumptions and estimates of the future performance of the markets in which we operate are necessarily subject to a high degree of uncertainty and risk. The trademarks included herein are the property of the owners thereof and are used for reference purposes only. We use our website (www.mirumpharma.com), LinkedIn page (www.linkedin.com/company/mirum-pharmaceuticals), and Twitter account (https://twitter.com/mirumpharma) as channels of distribution of information about our company, product candidates, planned announcements, attendance at upcoming conferences and other matters. Such information may be deemed material information and we may use these channels to comply with our disclosure obligations under Regulation FD. Therefore, investors should monitor our website, LinkedIn page, Twitter account in addition to following our SEC filings, press releases, public conference calls and webcasts.
LIVMARLI approved for cholestatic pruritus In Alagille Syndrome Robust Pipeline Strong Team and Balance Sheet Leading the Way in Rare Diseases Delivering remarkable treatments to patients in need worldwide
What Sets Mirum Apart 1 Cash, cash equivalents, restricted cash equivalents and investments; Estimate as of December 31, 2022, preliminary and unaudited and are subject to completion of financial closing procedures. Additional information and disclosure would be required for a more complete understanding of the company's financial position and results of operations as of December 31, 2022. Efficient business model generating topline growth with multiple near-term value catalysts $76 Million1 Anticipated total revenue 2022 Rare Disease Commercial Excellence 4 Late-Stage Indications Strategic Investment ~$252M1 Strong balance sheet Deliver on Financial Goals DELIVERING LIFE-CHANGING RARE DISEASE MEDICINES Several catalysts in 2023 Global LIVMARLI approvals to drive further topline growth Q4 net product sales $27 million, including $5 million international1 US business positioned for 50% year over year growth in 2023 International markets launching Commercial business cash flow positive Operating expenses expected to be stable into 2023
IBAT Inhibition Targets Bile Acids in Cholestasis Cholestatic Liver Disease Abbreviation: IBAT - Ileal Bile Acid Transporter IBATi Reduces Bile Acids IBATi Clinical Impacts Inhibits reuptake by IBAT Interrupts recirculation of bile acids Increases fecal bile acid excretion Serum bile acid reductions Improvements in pruritus, growth, QoL Transplant free survival improvement Settings of bile acid disruption Significant clinical burden Poor outcomes
Commercial-Stage with Pipeline of Growth Opportunities *Received U.S. FDA approval for cholestatic pruritus in patients with ALGS one year of age and older. European Commission has granted marketing authorization for LIVMARLI® (maralixibat) oral solution for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) two months of age and older. LIVMARLI launched, 4 additional indications under development in high-need orphan indications Alagille syndrome* Progressive Familial Intrahepatic Cholestasis Biliary Atresia LIVMARLI (maralixibat) Oral Solution FDA & EMA Approved Volixibat Phase 1 Approved Preclinical Phase 2b/Phase 3 EMBARK, H2 2023 data MARCH-PFIC, Primary and key secondary endpoints met Primary Sclerosing Cholangitis Primary Biliary Cholangitis VISTAS, interim data mid-2023 VANTAGE, interim data in H2 2023 Phase 1 Approved Preclinical Phase 2b/Phase 3
Long-term data set showing significant effects on pruritus and event-free survival LIVMARLI® (maralixibat) oral solution for ALGS
ALGS: A Debilitating Disease with Severe Cholestasis Kamath BM, et al. J Pediatr Gastroenterol Nutri. 2018, Kamath BM et al, Liver Transpl 2012, Vandriel SM, et al. EASL 2020 (oral presentation), Mirum market research and company estimates Genetic disease leading to severe cholestasis, unbearable pruritus and multi-system effects 4k-5.5k Children in the U.S. & EU 88% Affected by cholestatic pruritus; leading indication for liver transplant 6 in 10 Children progress to transplant or death by adulthood
LIVMARLI Worldwide ALGS Commercialization Approved in the United States and Europe 1 Estimate as of December 31, 2022, preliminary and unaudited Launch Q4 2021 2022 Estimate 2023 Continued US & International growth Multiple Drivers of Commercial Growth Total Net Product Sales US business positioned for 50% growth in 2023 Continued growth in new patient Rx European Launches throughout 2023 Broad global coverage with partners and distributors $74.0M1 Commercial business cash flow positive, patent coverage to 2040
LIVMARLI US Commercialization Strategy Awareness & Use Disease education, unmet need and LIVMARLI clinical data Mirum Access Plus Prescription to fill, reimbursement, exclusive specialty pharmacy Long-term Support Dedicated case management to support adherence, outcomes Comprehensive support from first engagement through initial prescription and continued use www.LIVMARLI.com
ICONIC: ALGS Pivotal Study Showing Significant Long-term Benefit Gonzales et al., Lancet 2021; 398: 1581–92 Highly significant, clinically meaningful and sustained improvements in pruritus from baseline *Denotes statistical significance, 95% CI excludes zero (compared with baseline, overall population). †The maralixibat, placebo, maralixibat group (n=16) received placebo during the randomised withdrawal period (purple-shaded area), whereas the maralixibat treatment group (n=13) continued to receive maralixibat. ** p<0.001 ** View data published in recent article in The Lancet
Significant Improvement in Event-Free Survival in Patients with ALGS Treated with LIVMARLI Compared to Untreated Cohort Hansen BE, et al. Presentation. AASLD 2021. CI: confidence interval; EFS: event-free survival; HR: hazard ratio; MRX: maralixibat; SAP: statistical analysis plan. *Cox regression models: Primary: Cox regression – effect of MRX vs. GALA log likelihood test adjusted for age, sex, bilirubin, and ALT (according to SAP) 6-year analysis demonstrates a 70% reduction for clinical outcomes vs natural history control from the GALA database EFS: liver transplantation, biliary diversion surgery, hepatic decompensation, or death AASLD 2021 Best of Liver Meeting View the AASLD presentation
LIVMARLI Well-Characterized Safety Profile LIVMARLI Prescribing Information Safety Data of LIVMARLI in ALGS Includes 5 Years of Follow-up from 3 Randomized Studies Events observed over 5% of patients Number of events per 100 person-years Diarrhea 41.6 Abdominal pain 38.6 Vomiting 19.8 Nausea 2.9 Fat-soluble vitamin deficiency 11.1 Transaminase increased 6.9 GI bleeding 3.8 Bone fractures 3.3
Phase 3 MARCH-PFIC Study: Highly statistically significant effects in All-PFIC LIVMARLI (maralixibat) for PFIC
PFIC: Progressive Diseases of Bile-Related Transporters Progressive Familial Intrahepatic Cholestasis (PFIC) Genetic disease of bile transporters, resulting in cholestasis Severe pruritus, common indication for surgery or liver transplant ~20% transplant-free survival at 18 years of age Incidence of 1:50,000 to 1:100,000 births FIC1 BSEP MDR3 PFIC1 PFIC2 PFIC3 Hepatocyte Canalicular membrane Cholesterol Bile acid PFIC sub-types impact different transporters. PFIC2 is the most common.
Positive Phase 3 Data Across Broad Spectrum of PFIC Subtypes Data are LS Mean with standard error bars. Effect size compared the difference between LIVMARLI and placebo, averaged over the last 3 time periods using a repeated measures mixed effect model. * LIVMARLI LS Mean = Placebo LS Mean; #LS Mean Delta with 95% CI; LIVMARLI (n=33) Placebo (n=31) Change from baseline in pruritus morning score (ItchRO[Obs]) Significant Pruritus Improvements in All-PFIC Patients (PFIC1, PFIC2, PFIC3, PFIC4, PFIC6) Proportion of pruritus score assessments < 1 point: 62% LIVMARLI vs 28% placebo (p<0.0001) Δ: -1.17 (-1.705, -0.642)# p < 0.0001*
Significant Improvements in Markers of Liver Disease Data are LS Mean with standard error bars. Effect size compared the difference between LIVMARLI and placebo, averaged over the last 3 time periods using a repeated measures mixed effect model. * LIVMARLI LS Mean = Placebo LS Mean; #LS Mean Delta with 95% CI; ## Data are mean with standard error bars 3 Serum Bile Acid Change from baseline in serum BA, µmol/L Significant Improvements in All-PFIC Patients (PFIC1, PFIC2, PFIC3, PFIC4, PFIC6) LIVMARLI (n=33) Placebo (n=31) Change from Baseline, (mg/dL)## Bilirubin Δ: -160 µmol/L (-220.84, -99.97)# p < 0.0001*
Summary of Treatment Emergent Adverse Events Diarrhea was predominantly mild with no severe events, and transient with a median duration of 5.5 days One patient had a treatment emergent adverse event of mild diarrhea that led to discontinuation Treatment Emergent Adverse Event (TEAE) LIVMARLI (n=47) Placebo (n=46) Any TEAE, n (%) 47 (100%) 43 (93.5%) Severe TEAE, n (%) 3 (6.4%) 3 (6.5%) Serious TEAE, n (%) 5 (10.6%) 3 (6.5%) TEAE leading to discontinuation, n (%) 1 (2.1%) 0 TEAE leading to death, n (%) 0 0 Most common TEAE diarrhea, n (%) 27 (57.4%) 9 (19.6%)
sBA Response Associated with Transplant-Free Survival Loomes K et al, Hepatology Communications 2022 *NAPPED criteria (van Wessel et al, 2021): sBA responders defined as having an average sBA of <102 μmol/L (if baseline sBA ≥102 μmol/L), OR a ≤-75% average percent change from baseline INDIGO Phase 2: 100% 5yr transplant free survival in sBA responders Time from enrollment (weeks) TFS (%) 100 60 40 20 80 10 30 50 70 90 0 52 208 260 312 104 156 Log-Rank p=0.0006 sBA Responders
Phase 2b in post-Kasai (HPE) Biliary Atresia: Data 2H 2023 LIVMARLI (maralixibat) for Biliary Atresia
Biliary Atresia: Severe Cholestasis Leading to Transplantation 1 0.5 to 0.8 per 10,000 live births, Sanchez-Valle et al , Advances in Pediatrics 2017; 2Shneider et al, J Pediatr. 2006; 3Harpavat et al, AASLD 2020 Leading cause of pediatric liver transplant, rapidly progressing cholestatic disease Elevated bilirubin and sBA highly correlated with poor outcomes Bilirubin 3mo post HPE <2 mg/dl 2-6mg/dl >6mg/dl 24mo Native Liver Survival (%) 84% 40% 16% sBA 6mo post HPE <40 umol/L >40 umol/L Transplant/Death (%) (144mo post HPE) 2.3% 32.3% Bilirubin2 sBA3 Annual incidence roughly 380-600 in US/EU1 Fatal without Kasai procedure (HPE), standard of care within the first months of life Bile accumulation in the liver leads to liver damage and transplantation No approved medications Substantial opportunity in biliary atresia
Enrolling EMBARK Study in Biliary Atresia Primary endpoint data expected in 2H 2023 Biliary Atresia patients ≤3 months age at HPE N~72 Open Label Long Term Extension 6mo Day 1 +18mo Primary Endpoint Change in total bilirubin Secondary Endpoints Change in serum bile acid Bilirubin normalization Biomarkers of liver injury Safety Transplant-free survival & key liver events 6mo changes in total bilirubin and sBA: a leading indicator of efficacy on key markers of disease progression Outcomes will be assessed in Open Label Long Term Extension
IBATi for Cholestasis in Adults Volixibat
VOLIXIBAT: Targeting Adult Cholestasis Highly active on bile pathway; 48-week safety data in prior studies ~29,000 cases in US No approved therapies Pruritus: Potential Registration Endpoint 130,000 Cases in US No approved therapies for pruritus Pruritus: Potential Registration Endpoint PSC Primary Sclerosing Cholangitis PBC Primary Biliary Cholangitis Volixibat Phase 2b Studies VANTAGE EVALUATING THE SAFETY AND EFFICACY OF VOLIXIBAT IN PATIENTS WITH ITCH CAUSED BY PBC Interim Analysis mid-2023 Interim Analysis 2H 2023
PSC & PBC: Immuno-inflammatory Rare Liver Disease Elevated Bile Acid Levels Drive Severe Symptom Burden and Progressive Liver Disease Bile Acid accumulation associated with: Severe symptomatic burden Inflammation and fibrosis of bile ducts and liver Progressive liver damage IBATi Proof of Mechanism: Reductions in pruritus and sBA in PSC & PBC VLX: Reductions in pruritus and sBA in ICP PSC: bile ducts inside and outside of the liver; IBD common VISTAS Phase 2b enrolling Bile Acid Overload Obstruction of bile flow via impairment intrahepatic and extrahepatic bile ducts PBC: bile ducts inside the liver Phase 2b enrolling
Volixibat Clinical Studies: PSC and PBC Blinded interim analysis Mid-year 2023: n~45, Dose Selection Confirmatory Analysis n~120 PSC PSC patients with moderate-to-severe pruritus N~120 VLX Open Label Extension PBC PBC patients with moderate-to-severe pruritus N~260 28wk Interim analysis H2 2023: n~60, Dose Selection VLX Open Label Extension Day 1 Up to 2yrs Confirmatory Phase n~200 Primary Endpoint Change in pruritus from BL 28wk Secondary Endpoints Safety & tolerability Markers of disease and QoL Long Term Assessments Changes in pruritus and QoL Markers of disease progression Safety 28wk Day 1 Up to 2yrs
Leading the way in rare liver disease Mirum
Opportunity to Significantly Expand in Pipeline Indications PATIENT POPULATION ALGS ALGS ALGS +PFIC +BA PFIC BA FDA and EMA approved Pediatric indications Pediatric indications + adult indications >20x increase +VOLIXIBAT (PSC, PBC)
Mirum: Multiple Near-Term Transformative Milestones in 2023 Potential ALGS partner market approvals* (Q4 ’22+) MARCH-PFIC Phase 3 Met primary and key secondary endpoints ALGS EU approval LIVMARLI VOLIXIBAT EMBARK (BA) Phase 2 data (H2 ’23) EU Commercial Launch (Q1 ‘23) PFIC FDA sNDA Filing (Q1 ‘23) VISTAS (PSC) interim analysis (mid ’23) VANTAGE (PBC) interim analysis (H2 ’23)
Recent Company Highlights Anticipated fourth quarter 2022 net product sales $27M and $76M in total revenue full year 20221 US business positioned to grow 50% year over year in 2023; international markets launching Continued stable operating expenses; Commercial business cash flow positive Cash, cash equivalents, restricted cash equivalents and investments of ~$252M1 1As of December 31, 2022; preliminary and unaudited and are subject to completion of financial closing procedures. Additional information and disclosure would be required for a more complete understanding of the company's financial position and results of operations as of December 31, 2022. Strong Financial Position and Continued Progress Executing on Our Strategy European Commission granted marketing authorization for LIVMARLI® (maralixibat) oral solution for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) two months of age and older Advancing global commercial expansion Launch ready in EU; First launch in Germany expected Q1 2023 Global Partner Markets and Distributor Partners: Approval of LIVMARLI for cholestatic pruritus in patients with ALGS in Israel Announced positive topline data from Phase 3 trial evaluating LIVMARLI in patients with PFIC; study met primary and secondary endpoint in All-PFIC cohort; sNDA submission planned Q1 2023 Continued data generation supporting LIVMARLI’s benefits on transplant-free survival, growth, QoL and safety Financial Highlights Track Record of Execution
LIVMARLI approved for cholestatic pruritus In Alagille Syndrome Robust Pipeline Strong Team and Balance Sheet Leading the Way in Rare Diseases Delivering remarkable treatments to patients in need worldwide
Thank you! ©2023 Mirum Pharmaceuticals, Inc. All rights reserved. All service marks, trademarks and tradenames appearing in this presentation are the property of their respective owners. Solely for convenience, the trademarks and tradenames referred to in this presentation appear without the ® and ™ symbols, but those references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights, or the right of the applicable licensor to these trademarks and tradenames. The information herein is for informational purposes only and represents the current view of Mirum Pharmaceuticals, Inc. as of the date of this presentation (or as of an earlier date if specifically noted).
LIVMARLI (maralixibat) oral solution Important Safety Information Important Safety Information LIVMARLI can cause serious side effects, including: Changes in liver tests: Changes in certain liver tests are common in patients with Alagille syndrome but may worsen during treatment with LIVMARLI. These changes may be a sign of liver injury and can be serious. Your health care provider should do blood tests before starting and during treatment to check your liver function. Stomach and intestinal (gastrointestinal) problems: LIVMARLI can cause stomach and intestinal problems, including diarrhea, stomach pain, and vomiting during treatment. Fat Soluble Vitamin Deficiency: This vitamin deficiency is common in patients with Alagille syndrome but may worsen during treatment.