ALBIREO PHARMA, INC. (Form: 8-K, Received: 08/10/2022 08:38:08)

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): August 8, 2022

ALBIREO PHARMA, INC.

(Exact name of registrant as specified in its charter)

Delaware
(State or other jurisdiction of
incorporation)

001-33451
(Commission File
Number)

90-0136863
(IRS Employer
Identification No.)

53 State Street, 19th Floor
Boston, Massachusetts
(Address of principal executive offices)

02109
(Zip Code)

(857) 254-5555

Registrant’s telephone number, including area code

Not applicable

(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 Symbol(s)		Name of each exchange on which registered
Common Stock		ALBO		The Nasdaq Capital 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 5.02

Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

Appointment of New Directors

On August 8, 2022, the Board of Directors (the “Board”) of Albireo Pharma, Inc. (the “Company”) elected Susan Alesina to the Board as a Class I director, for a term to continue until the 2023 annual meeting of the Company’s stockholders and thereafter until Ms. Alesina’s successor has been elected and qualified or until her earlier death, resignation or removal. On the same day, the Board elected Habib Dable to the Board as a Class II director, for a term to continue until the 2024 annual meeting of the Company’s stockholders and thereafter until Mr. Dable’s successor has been elected and qualified or until his earlier death, resignation or removal. Ms. Alesina and Mr. Dable have not yet been appointed to serve on any committee of the Board.

Ms. Alesina, age 59, has served as Vice President, National Business Development and Alliances, at Boston Children’s Hospital since September 2015. In this role, she leads efforts to identify and develop strategic partnerships with national health systems and hospital providers to improve access for pediatric patients with rare and complex conditions. From 2014 to 2015, Ms. Alesina served as the Global Head of Business Partners Communications at Millipore Sigma, a leading supplier of technologies and services to the global life science industry, where she was responsible for articulating the strategy of various business sectors to internal and external stakeholders. Prior to that, Ms. Alesina served as a business consultant for pharmaceutical companies as well as had various leadership roles in corporate planning and communications at Sunovion Pharmaceuticals Inc. (“Sunovion”). During her tenure at Sunovion, Ms. Alesina supported the launch of products including Lunesta® and Latuda®. Ms. Alesina was a board member of the Thompson Island Outward Bound Education Center, St. Mark’s School of Southborough, MA, and the Boston Chapter of the Healthcare Businesswomen’s Association where she also served as the president. Ms. Alesina currently serves on the board of the HBS Healthcare Alumni Association. Ms. Alesina holds a Bachelor’s degree from the University of North Carolina at Chapel Hill, where she was a Morehead-Cain Scholar, and an M.B.A. from Harvard Business School. The Board has concluded that Ms. Alesina’s qualifications to serve on the Board include her extensive experience in strategic planning and analysis, and business development and communications across the healthcare and life sciences industries.

Mr. Dable, age 53, has been an Independent Director at Blueprint Medicines Corporation (Nasdaq: BPMC), a global precision therapy company developing therapies for people with cancer and blood disorders, since June 2022, and a part-time Venture Partner at RA Ventures since April 2022. He previously served as Chief Executive Officer and President and a member of the board of directors of Acceleron Pharma Inc., a biopharmaceutical company targeting leading-edge therapies for patients with serious and rare diseases, from December 2016 until its sale to Merck Sharp & Dohme Corp. in November 2021. Prior to joining Acceleron Pharma Inc., Mr. Dable spent 22 years at Bayer AG (OTCMKTS: BAYRY), a German multinational pharmaceutical and biotechnology company with core competencies in the life science fields of health care and nutrition. During his tenure at Bayer AG, Mr. Dable held positions of increasing responsibility, including President of U.S. Pharmaceuticals, Executive Vice President, Global Head Specialty Medicine, and led the launch of various brands, including EYLEA®, Stivarga®, and Xofigo®. Mr. Dable previously served on the board of directors and was a member of the compensation and transaction committees of Tempest Therapeutics, Inc. (formerly known as Millendo Therapeutics, Inc.) (Nasdaq: TPST), a clinical-stage oncology company advancing small molecules that combine both tumor-targeted and immune-mediated mechanisms with the potential to treat a wide range of tumors, from September 2018 until Millendo Therapeutics, Inc. merged with TempestTx, Inc. and was renamed Tempest Therapeutics, Inc. in June 2021. Mr. Dable also served on the Board of Directors of the Biotechnology Innovation Organization (BIO). Mr. Dable earned both Bachelor’s and Master’s degrees in Business Administration from the University of New Brunswick and completed an executive program from Stanford University’s Graduate School of Business. The Board has concluded that Mr. Dable’s qualifications to serve on the Board include his extensive executive leadership experience and industry knowledge across the healthcare and life sciences industries.

Pursuant to the Company’s Nonemployee Director Compensation Policy, as amended (the “Director Compensation Policy”), on August 8, 2022, each of Ms. Alesina and Mr. Dable was granted a nonqualified stock option to purchase 16,000 shares of the Company’s common stock, par value $0.01 per share (“Common Stock”), at an exercise price of $25.86 per share, the closing price of the Company’s Common Stock on the grant date. Ms. Alesina and Mr. Dable will each be eligible to receive the same compensation for their service on the Board as other nonemployee directors under the Director Compensation Policy, which includes (i) cash fees of $40,000 per year for their service on the Board, (ii) a nonqualified stock option to purchase the lesser of (a) 8,000 shares of the Company’s Common Stock and (b) the number of shares of Common Stock having an aggregate grant date fair value of $300,000 (rounded down to the nearest whole share) (the “Annual Director Grant Fair Value Cap”), each year on the fifth business day after the Company’s annual meeting of stockholders, and (iii) the reimbursement of business expenses in connection with their service on the Board. The Director Compensation Policy is further described in the definitive proxy statement relating to the Company’s 2022 annual meeting of stockholders filed on April 21, 2022. Subsequently, on June 15, 2022, the Board amended the Director Compensation Policy to include the Annual Grant Fair Value Cap. A copy of the Director Compensation Policy is attached hereto as Exhibit 10.1 and is incorporated by reference herein.

Also in connection with the election of Ms. Alesina and Mr. Dable to the Board, each of them entered into an indemnification agreement with the Company in the form the Company has entered into with its other nonemployee directors, which form was filed as Exhibit 10.8 to the Company’s Current Report on Form 8-K on November 4, 2016, and is incorporated herein by reference.

There are no arrangements or understandings between Ms. Alesina and any other person pursuant to which Ms. Alesina was selected as a director. There are no transactions to which the Company is a participant and in which Ms. Alesina has a material interest that are required to be disclosed under Item 404(a) of Regulation S-K.

There are no arrangements or understandings between Mr. Dable and any other person pursuant to which Mr. Dable was selected as a director. There are no transactions to which the Company is a participant and in which Mr. Dable has a material interest that are required to be disclosed under Item 404(a) of Regulation S-K.

Item 7.01

Regulation FD Disclosure

A copy of the press release announcing the election of Ms. Alesina and Mr. Dable to the Board is attached hereto as Exhibit 99.1 and incorporated herein by reference.

Item 9.01

Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.		Description
10.1		Nonemployee Director Compensation Policy, as amended
99.1		Press Release dated August 8, 2022
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

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.

	ALBIREO PHARMA, INC.

Date: August 10, 2022	/s/ Ronald H.W. Cooper
	Ronald H.W. Cooper
	President and Chief Executive Officer

Exhibit 10.1

ALBIREO PHARMA, INC.

NONEMPLOYEE DIRECTOR COMPENSATION POLICY

(Adopted January 23, 2017, Last modified June 15, 2022)

The Board of Directors of Albireo Pharma, Inc. (the “Company”) has approved the following Nonemployee Director Compensation Policy (this “Policy”) to provide an inducement to obtain and retain the services of qualified persons to serve as members of the Company’s Board of Directors. The Policy establishes compensation to be paid to nonemployee directors of the Company.

Applicable Persons

This Policy shall apply to each director of the Company who is not an employee of, or compensated consultant to, the Company or any Affiliate (each, an “Outside Director”). “Affiliate” shall mean an entity which is a direct or indirect parent or subsidiary of the Company, as determined pursuant to Section 424 of the Internal Revenue Code of 1986, as amended.

Compensation

A. Equity Grants

1. Annual Stock Option Grants

Each Outside Director shall be granted, automatically and without any action on the part of the Board of Directors, under the Company’s 2018 Equity Incentive Plan, as amended, or a successor plan (the “Equity Plan”), a nonqualified stock option to purchase the lesser of (i) 8,000 shares of the Company’s common stock, par value $0.01 per share (“Common Stock”), and (ii) the number of shares of Common Stock having an aggregate grant date fair value of $300,000 (rounded down to the nearest whole share), each year on the fifth (5^th) business day after the Company’s annual meeting of stockholders (the “Annual Stock Options”); provided, however, that if there has been no annual meeting of stockholders held by the first business day of the third fiscal quarter, each Outside Director shall be granted, automatically and without any action on the part of the Board of Directors, such Annual Stock Option on the first business day of the third fiscal quarter of such year.

2. Initial Stock Option Grants for Newly Appointed or Elected Directors

Each new Outside Director shall be granted, automatically and without any action on the part of the Board of Directors, under the Equity Plan, a nonqualified stock option to purchase 16,000 shares of Common Stock on the date that the Outside Director is first appointed or elected to the Board of Directors (the “Initial Stock Options” and, together with the Annual Stock Options, the “Outside Director Stock Options”).

3. Terms of Outside Director Stock Options

Unless otherwise specified by the Board of Directors or the Compensation Committee at the time of grant, each Outside Director Stock Option shall: (i) vest, in the case of (A) an Annual Stock Option, on the earlier of (a) one year from the date of the grant or (b) the day prior to the annual meeting for the next fiscal year that begins following the date of grant, subject to the Outside Director’s continued service on the Board of Directors on the vesting date, and (B) an Initial Stock Option, in equal annual installments over three years from the date of grant; provided that each Initial Stock Option shall in any case be fully vested on the day prior to the annual meeting for the third fiscal year that begins following the date of grant, subject to the Outside Director’s continued service on the Board of Directors on the applicable vesting dates; (ii) terminate 10 years from the date of grant, (iii) become fully vested immediately prior to a Change of Control (as defined in the Equity Plan, as amended from time to time), and (iv) be granted under the Company’s standard form of agreement unless on or prior to the date of grant the Board of Directors or the Compensation Committee shall determine that other terms or conditions shall be applicable.

B. Cash Fees

1. Annual Cash Fees

The following annual cash fees shall be paid to the Outside Directors serving on the Board of Directors and the Audit Committee, Compensation Committee and Nominating and Governance Committee, as applicable.

Board of Directors or Committee of Board of Directors	Annual Retainer Amount for Chair		Annual Retainer Amount for Other Members
Board of Directors	$	75,000	$	40,000
Audit Committee	$	20,000	$	10,000
Compensation Committee	$	15,000	$	7,500
Nominating and Governance Committee	$	10,000	$	5,000

2. Payment Terms for All Cash Fees

Cash fees payable to Outside Directors shall be paid quarterly in arrears as soon as practicable following the last business day of each fiscal quarter.

Following an Outside Director’s first election or appointment to the Board of Directors, such Outside Director shall receive his or her cash compensation prorated during the first fiscal quarter in which he or she was initially appointed or elected for the number of days during which he or she provides service. If an Outside Director dies, resigns or is removed during any quarter, he or she shall be entitled to a cash payment on a prorated basis through his or her last day of service that shall be paid as soon as practicable following the last business day of the fiscal quarter.

Expenses

Upon presentation of documentation of such expenses reasonably satisfactory to the Company, each Outside Director shall be reimbursed for his or her reasonable out-of-pocket business expenses incurred in connection with attending meetings of the Board of Directors and Committees thereof or in connection with other business related to the Board of Directors. Each Outside Director shall abide by the Company’s travel and other expense policies applicable to Company personnel.

Amendments

The Compensation Committee or the Board of Directors shall review this Policy from time to time to assess whether any amendments in the type and amount of compensation provided herein should be adjusted in order to fulfill the objectives of this Policy.

Exhibit 99.1

Albireo Appoints New Members to Board of Directors

– Habib Dable, Former President and CEO of Acceleron Pharma, and Susan Alesina, Vice President, National Business Development and Alliances at Boston Children’s Hospital, bring significant global drug development, financial and commercial operations expertise to Albireo

BOSTON, MA — Aug 10, 2022 — Albireo Pharma, Inc. (Nasdaq: ALBO), a rare liver disease company developing novel bile acid modulators to treat pediatric and adult liver diseases, today announced the appointments of Habib Dable and Susan Alesina to its Board of Directors — two experienced, strategic leaders with vast pharmaceutical and biotech expertise in business development, operations and commercialization. These additions mark an exciting time for Albireo as it continues to deliver on its clinical, regulatory, and commercialization milestones for Bylvay^® (odevixibat) and advance additional investigational compounds for adult liver and viral diseases.

“I am pleased to welcome Susan and Habib, two highly respected and experienced leaders, as independent directors to the Albireo Board,” said David Chiswell, Ph.D., Chairman of Albireo’s Board of Directors. “Habib offers extensive global operations and commercial experience spanning pharmaceutical and biotechnology drug classes and therapeutic areas that will be critical in the next phase of the Company’s growth. Susan’s expertise in strategic planning and business development will be important as we develop and expand our pipeline, as well as her insights and experience in championing access for pediatric patients with rare diseases as we continue to keep our Patient First mission at the forefront of our business.”

Mr. Dable is a versatile, patient-focused executive with approximately 28 years in “Big Pharma” and “Emerging Biotech” environments, currently an Independent Director at Blueprint Medicines Corporation and part-time Venture Partner at RA Ventures. Most recently, Mr. Dable was President & CEO of Acceleron Pharma Inc., a biopharmaceutical company targeting leading-edge therapies for patients with serious and rare diseases until its sale to Merck in 2021 for $11.5B. Prior to joining Acceleron in 2016, Mr. Dable spent 22 years at Bayer AG. During his tenure at Bayer, Mr. Dable held positions of increasing responsibility, including President of U.S. Pharmaceuticals, Executive Vice President, Global Head Specialty Medicine. Mr. Dable led the launch of various blockbuster brands, including EYLEA^®, Stivarga^®, and Xofigo^®. Mr. Dable is a previous member of the Board of Directors for BIO (Biotechnology Innovation Organization) and a prior Independent Board Director for Millendo Therapeutics. Mr. Dable holds a Master’s and Bachelor’s degree in business administration from the University of New Brunswick and completed an executive program from Stanford University’s Graduate School of Business.

“I am excited to contribute to the progress of this innovative company. I truly believe that Albireo has the opportunity to deliver life-changing treatments to patients suffering from liver diseases around the world and look forward to supporting the advancement of its compelling scientific pipeline,” said Habib Dable.

Ms. Alesina has more than 25 years of management experience in pharmaceutical, biotech, and medical device organizations. Throughout her career, she held senior roles in strategic planning and analysis, business development, and communications. She currently serves as Vice President, National Business Development and Alliances at Boston Children’s Hospital, where she leads efforts to identify and develop strategic partnerships with national health systems and hospital providers to improve access for pediatric patients with rare and complex conditions. Previously, she was Global Head of Business Partners Communications at Millipore Sigma and, prior to that, served as a business consultant for pharmaceutical companies as well as had various leadership roles in corporate planning and communications at Sunovion Pharmaceuticals Inc. During her tenure at Sunovion, Ms. Alesina supported the launch of blockbuster products including Lunesta^® and Latuda^®. Ms. Alesina is a past board member of the Thompson Island Outward Bound Education Center, St. Mark’s School of Southborough, MA, and the Boston Chapter of the Healthcare Businesswomen’s Association, where she was also the president. She is currently a board member for the HBS Healthcare Alumni Association. Ms. Alesina holds a Bachelor’s degree from the University of North Carolina at Chapel Hill, where she was a Morehead-Cain Scholar, and an M.B.A. from Harvard Business School.

“I am delighted to be joining Albireo’s board as I share the Company’s commitment to supporting patients and families with rare and complex conditions,” said Susan Alesina. “I look forward to bringing my experience in strategic planning, business development, and communications to contribute to the ongoing success of the Company.”

About Bylvay (odevixibat)

Bylvay is the first drug approved in the U.S. for the treatment of pruritus in patients 3 months of age and older in all types of progressive familial intrahepatic cholestasis (PFIC). Limitation of Use: Bylvay may not be effective in PFIC type 2 patients with ABCB11 variants resulting in non-functional or complete absence of bile salt export pump protein (BSEP-3). The European Commission (EC) and UK Medicines and Healthcare Products Regulatory Agency (MHRA) have also granted marketing authorization of Bylvay for the treatment of PFIC in patients aged 6 months or older. Bylvay is available in Germany and the UK and will be available for sale in other European countries following pricing and reimbursement approval. A potent, once-daily, non-systemic ileal bile acid transporter inhibitor (IBATi), Bylvay has minimal systemic exposure and acts locally in the small intestine. Bylvay can be taken as a capsule for patients that are able to swallow capsules, or opened and sprinkled onto food, which is a factor of key importance for adherence in a pediatric patient population. The most common adverse reactions for Bylvay are diarrhea, liver test abnormalities, vomiting, abdominal pain, and fat-soluble vitamin deficiency. The medicine can only be obtained with a prescription. For more information about using Bylvay, see the package leaflet or contact your doctor or pharmacist. For full prescribing information, visit www.bylvay.com.

In the U.S. and Europe, Bylvay has orphan exclusivity for its approved PFIC indications, and orphan designations for the treatment of ALGS, biliary atresia and primary biliary cholangitis. Bylvay is being evaluated in the ongoing PEDFIC 2 open-label trial in patients with PFIC, in the BOLD Phase 3 study for patients with biliary atresia and the ASSERT Phase 3 study for ALGS.

Important Safety Information

The most common adverse reactions for Bylvay are diarrhea, liver test abnormalities, vomiting, abdominal pain, and fat-soluble vitamin deficiency.

Liver Test Abnormalities: Patients should obtain baseline liver tests and monitor during treatment. Dose reduction or treatment interruption may be required if abnormalities occur. For persistent or recurrent liver test abnormalities, consider treatment discontinuation.

Diarrhea: Treat dehydration. Treatment interruption or discontinuation may be required for persistent diarrhea.

Fat-Soluble Vitamin (FSV) Deficiency: Patient should obtain baseline vitamin levels and monitor during treatment. Supplement if deficiency is observed. If FSV deficiency persists or worsens despite FSV supplementation, discontinue treatment.

About Albireo

Albireo Pharma is a rare disease company focused on the development of novel bile acid modulators to treat pediatric and adult liver diseases. Albireo’s lead product, Bylvay, was approved by the U.S. FDA as the first drug for the treatment of pruritus in all types of progressive familial intrahepatic cholestasis (PFIC), and in Europe, Bylvay has been approved for the treatment of PFIC. Bylvay is also being developed to treat other rare pediatric cholestatic liver diseases with global Phase 3 trials in Alagille syndrome (ALGS) and biliary atresia, as well as Open-label Extension (OLE) studies for PFIC and ALGS. The Company has also completed a Phase 1 clinical trial for A3907 to advance development in adult cholestatic liver disease, with IND-enabling studies progressing with A2342 for viral and cholestatic liver disease. Albireo was spun out from AstraZeneca in 2008 and is headquartered in Boston, Massachusetts, with its key operating subsidiary in Gothenburg, Sweden. For more information on Albireo, please visit www.albireopharma.com.

Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements, other than statements of historical fact, regarding, among other things: Albireo’s commercialization plans; the plans for, or progress, scope, cost, initiation, duration, enrollment, results or timing for availability of results of, development of Bylvay, A3907, A2342 or any other Albireo product candidate or program; the target indication(s) for development or approval; potential regulatory approval and plans for potential commercialization of Bylvay in additional countries; the potential benefits or competitive position of Bylvay or any other Albireo product candidate or program or the commercial opportunity in any target indication; or Albireo’s plans, expectations or future operations, financial position, revenues, costs or expenses. Albireo often uses words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “planned,” “continue,” “guidance,” or the negative of these terms or other similar expressions to identify forward-looking statements. Actual results, performance or experience may differ materially from those expressed or implied by any forward-looking statement as a result of various risks, uncertainties and other factors, including, but not limited to: there are no guarantees that Bylvay will be commercially successful; we may encounter issues, delays or other challenges in commercializing Bylvay; whether Bylvay receives adequate reimbursement from third-party payors; the degree to which Bylvay receives acceptance from patients and physicians for its approved indication; challenges associated with execution of our sales activities, which in each case could limit the potential of our product; challenges associated with supply and distribution activities, which in each case could limit our sales and the availability of our product; results achieved in Bylvay in the treatment of patients with PFIC may be different than observed in clinical trials, and may vary among patients; potential negative impacts of the COVID-19 pandemic, including on manufacturing, supply, conduct or initiation of clinical trials, or other aspects of our business; whether favorable findings from clinical trials of Bylvay to date, including findings in indications other than PFIC, will be predictive of results from other clinical trials of Bylvay; there is no guarantee that Bylvay will be approved in jurisdictions or for indications beyond the jurisdictions in which or indications for which Bylvay is currently approved; there is no guarantee that our other product candidates will be approved; estimates of the addressable patient population for target indications may prove to be incorrect; the outcome and interpretation by regulatory authorities of the ongoing third-party study pooling and analyzing of long-term PFIC patient data; the timing for initiation or completion of, or for availability of data from, clinical trials of Bylvay, including BOLD and ASSERT and the Phase 2 clinical trial of A3907, and the outcomes of such trials; Albireo’s ability to obtain coverage, pricing or reimbursement for approved products in the United States or Europe; delays or other challenges in the recruitment of patients for, or the conduct of, the Company’s clinical trials; and the Company’s critical accounting policies. These and other risks and uncertainties that Albireo faces are described in greater detail under the heading “Risk Factors” in Albireo’s most recent Annual Report on Form 10-K or in subsequent filings that it makes with the Securities and Exchange Commission. As a result of risks and uncertainties that Albireo faces, the results or events indicated by any forward-looking statement may not occur. Albireo cautions you not to place undue reliance on any forward-looking statement. In addition, any forward-looking statement in this press release represents Albireo’s views only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. Albireo disclaims any obligation to update any forward-looking statement except as required by applicable law.

Media Contact:

Colleen Alabiso, 857-356-3905, colleen.alabiso@albireopharma.com

Lance Buckley, 917-439-2241, lbuckley@lippetaylor.com

Investor Contact:

Hans Vitzthum, LifeSci Advisors, LLC., 617-430-757