0001104659-21-147935.txt : 20211209 0001104659-21-147935.hdr.sgml : 20211209 20211209093208 ACCESSION NUMBER: 0001104659-21-147935 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20211203 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements of Certain Officers ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20211209 DATE AS OF CHANGE: 20211209 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ALBIREO PHARMA, INC. CENTRAL INDEX KEY: 0001322505 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-33451 FILM NUMBER: 211480495 BUSINESS ADDRESS: STREET 1: 10 POST OFFICE SQUARE STREET 2: SUITE 502 SOUTH CITY: BOSTON STATE: MA ZIP: 02109 BUSINESS PHONE: 857-415-4774 MAIL ADDRESS: STREET 1: 10 POST OFFICE SQUARE STREET 2: SUITE 502 SOUTH CITY: BOSTON STATE: MA ZIP: 02109 FORMER COMPANY: FORMER CONFORMED NAME: Biodel Inc DATE OF NAME CHANGE: 20050331 8-K 1 tm2134984d1_8k.htm FORM 8-K
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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): December 3, 2021

 

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.)

 

10 Post Office Square, Suite 1000
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 1.01  Entry into a Material Definitive Agreement.

 

Hi Marley Sublease

 

On December 6, 2021, Albireo Pharma, Inc. (“Albireo”) and Hi Marley, Inc. (“Hi Marley”), as subtenant, entered into a sublease agreement (the “Hi Marley Sublease”), pursuant to which Albireo agreed to sublease to Hi Marley 14,734 rentable square feet of office space located at 10 Post Office Square, Boston, Massachusetts, Albireo’s current principal executive offices (the “Hi Marley Subleased Premises”). The Hi Marley Sublease is subject and subordinate to that certain Office Lease Agreement by and between Albireo, as tenant, and NS Boston III PO Owner LLC, as landlord (the “NS Boston III”), dated February 7, 2017 (as amended, the “Albireo Lease”). Hi Marley agreed to use the Hi Marley Subleased Premises for general office use.

 

The term of the Hi Marley Sublease will commence on the latest to occur of (i) April 1, 2022; (ii) the date on which Albireo delivers possession of the Hi Marley Subleased Premises to Hi Marley in the required condition as set forth in the Hi Marley Sublease; and (iii) the date on which NS Boston III delivers its written consent to such sublease (such latest date, the “Hi Marley Commencement Date”) and will expire on October 31, 2026 (the “Hi Marley Sublease Term”), unless earlier terminated pursuant to the terms of the Hi Marley Sublease.

 

Following a one-month rent abatement period, Hi Marley will be obligated to make monthly rent payments in an amount beginning at approximately $68,759 and increasing by approximately 2% annually for the term of the Hi Marley Sublease. In addition, Hi Marley is responsible under the Hi Marley Sublease for specified costs and charges, including certain operating expenses, utilities, taxes and insurance.

 

In addition, the Hi Marley Sublease contains customary events of default that entitle Albireo, among other things, to terminate the Hi Marley Sublease and recover from Hi Marley the rent payments remaining to be paid by Hi Marley for the balance of the Hi Marley Sublease Term. The specified events of default include, among others, nonpayment of rent or other amounts due and payable by Hi Marley under the Hi Marley Sublease, an uncured breach of a covenant under the Hi Marley Sublease and certain bankruptcy and insolvency events.

 

Albireo Sublease

 

On December 7, 2021, Albireo and Institute For Healthcare Improvement (“IFHI”) entered into a sublease agreement (the “Albireo Sublease”), pursuant to which IFHI agreed to sublet to Albireo the approximately 26,962 rentable square feet of office space that IFHI currently leases at 53 State Street, Boston, Massachusetts, which Albireo plans to use as its principal executive offices (the “Albireo Subleased Premises”). The Albireo Sublease is subject and subordinate to that certain Office Lease Agreement by and between IFHI, as tenant, and 53 State Property, L.P., as landlord (“53 State Property”), dated June 29, 2017 (as amended, the “IFHI Lease”).

 

The Albireo Sublease will become effective upon receipt of consent from 53 State Property (the “Landlord Consent”). The Albireo Sublease provides that the term of the Albireo Sublease for the Albireo Subleased Premises will commence upon the earlier of (a) March 1, 2022, and (b) Albireo’s use of the Albireo Subleased Premises for the permitted use as set forth in the Albireo Sublease (the “Albireo Commencement Date”); provided, that the Albireo Commencement Date will not occur prior to December 15, 2021, which is the date upon which IFHI agreed to deliver the Albireo Subleased Premises to Albireo. The term of the Albireo Sublease will expire on January 31, 2030 (the “Albireo Sublease Term”) unless earlier terminated pursuant to the terms of the Albireo Sublease.

 

Commencing six (6) months after the Albireo Commencement Date assuming the Albireo Commencement Date is no later than March 1, 2022, Albireo is obligated to pay IFHI monthly base rent in an amount beginning at approximately $123,576 and increasing by approximately 2% annually for the term of the Albireo Sublease. In addition, Albireo is responsible under the Albireo Sublease for specified costs and charges, including certain operating expenses, utilities, taxes and insurance.

 

The Albireo Sublease contains customary provisions allowing IFHI to terminate the Albireo Sublease upon the termination of the IFHI Lease. In addition, the Albireo Sublease contains customary events of default that entitle IFHI, among other things, to terminate the Albireo Sublease and recover from Albireo the rent payments remaining to be paid for the balance of the Albireo Sublease Term. The specified events of default include, among others, nonpayment of rent or other amounts due and payable by Albireo under the Albireo Sublease, an uncured breach of a covenant under the Albireo Sublease and certain bankruptcy and insolvency events.

 

 

 

 

The foregoing description of the Hi Marley Sublease and the Albireo Sublease does not purport to be complete and is qualified in its entirety by reference to the full text of the Hi Marley Sublease and the Albireo Sublease, which will be filed with Albireo’s Annual Report on Form 10-K for the year ending December 31, 2021.

 

Item 5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

 

On December 3, 2021, Patrick T. Horn, M.D., Ph.D, Albireo’s Chief Medical Officer, resigned effective as of December 31, 2021 to pursue other opportunities. Dr. Jan Mattsson, Albireo’s Chief Scientific Officer and a co-founder of Albireo, will assume the role of interim head of research and development, leading research and development of early and late-stage assets and programs. Dr. Horn’s departure was not the result of any disagreement regarding any matter relating to Albireo’s operations, policies or practices.

 

Item 7.01 Regulation FD Disclosure.

 

On December 9, 2021, Albireo issued a press release announcing the departure of Dr. Horn from Albireo. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

 

The information in this Item 7.01 is being furnished and 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 incorporated by reference into any registration statement or other filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit No.   Description
     
99.1   Press Release issued by Albireo Pharma, Inc. on December 9, 2021
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: December 9, 2021 /s/ Ronald H.W. Cooper
  Name: Ronald H.W. Cooper
  Title President and Chief Executive Officer

 

 

 EX-99.1 2 tm2134984d1_ex99-1.htm EXHIBIT 99.1

Exhibit 99.1

 

 

 

Albireo Announces Changes to R&D Organization

 

BOSTON, MA — December 9, 2021 — Albireo Pharma, Inc. (Nasdaq: ALBO), a rare liver disease company developing novel bile acid modulators, today announced the upcoming departure of Pat Horn, M.D., Ph.D., Chief Medical Officer, who will be leaving at the end of the year after almost three and a half years with the Company. Jan Mattsson, Ph.D., Chief Scientific Officer and co-founder of Albireo, will be taking over as the interim head of R&D, leading research and development of early and late-stage assets and programs. As one of the co-founders of the Company with deep experience in drug development and approvals, Dr. Mattsson is primed to lead the R&D organization with his institutional knowledge, vision for the pipeline and products, and ability to deliver against corporate objectives.

 

“Our company has made significant progress, going from a small clinical stage team to a fully integrated commercial organization with the launch of BylvayTM (odevixibat), while pursuing two additional Bylvay indications and advancing two promising, novel early assets. Over the last three years, Pat has been an important leader as we progressed our development programs and brought our first product to market. I thank him for his guidance and contributions in providing hope for the families we serve,” said Ron Cooper, President and Chief Executive Officer of Albireo.

 

Over his time with the Company, Dr. Horn completed the PEDFIC 1 Phase 3 study and the ongoing open-label extension PEDFIC 2 study, both of which contributed to the large body of positive evidence supporting U.S. and European approvals and the subsequent launch of Bylvay. Simultaneously, Dr. Horn and his team initiated two Phase 3 pivotal studies with ASSERT (Alagille syndrome) and BOLD (biliary atresia), both of which are the largest gold standard trials, which will help pave the way toward the Company’s aspiration to reach $1 billion dollars of Bylvay sales by the end of the decade. Dr. Horn also partnered with Dr. Mattsson and his team in progressing the Company’s earlier stage assets A3907 and A2342 for adult cholestatic liver diseases and Hepatitis B & D, respectively.

 

About Albireo

Albireo Pharma is a rare disease company focused on the development of novel bile acid modulators to treat rare 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 it is also being developed to treat other rare pediatric cholestatic liver diseases with Phase 3 trials in Alagille syndrome and biliary atresia, as well as an Open-label Extension (OLE) study for PFIC. In Europe, Bylvay has been approved for the treatment of PFIC and has been submitted for pricing and reimbursement approval. The Company is progressing a Phase 1 clinical trial for A3907 to advance development in adult cholestatic liver disease, with IND-enabling studies moving ahead 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. The Boston Business Journal named Albireo one of the 2019 and 2020 Best Places to Work in Massachusetts. 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 and expectations for commercializing Bylvay in the U.S. and Europe; 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 pivotal trial for Bylvay in biliary atresia (BOLD); the pivotal trial for Bylvay in Alagille syndrome (ASSERT); the Phase 1 trial for A3907; the IND-enabling studies for A2342; the target indication(s) for development or approval; the size, design, population, location, conduct, cost, objective, enrollment, duration or endpoints of any clinical trial, or the timing for initiation or completion of or availability or reporting of results from any clinical trial, including the long-term open-label extension study for Bylvay in PFIC, the BOLD and ASSERT trials, Phase 1 trial for A3907 and the IND-enabling studies for A2342; potential regulatory approval by and discussions with the FDA or EMA regarding our programs; expectations that the Company’s distribution and supply agreements will drive availability of Bylvay in key markets globally, and potential revenue that may be generated by such agreements; potential regulatory approval and plans for potential commercialization of Bylvay in countries outside of the U.S. and Europe, including Japan; the potential benefits or competitive position of Bylvay or any other Albireo product candidate or program or the commercial opportunity in any target indication; the potential effects of Bylvay of the treatment of PFIC patients and its potential to improve the current standard of care; 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 launching or 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; other 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 Bylyay is currently approved; there is no guarantee that our other products 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 1 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

Investor Contact: Hans Vitzthum, LifeSci Advisors, LLC., 857-272-6177

 

 

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Cover
Dec. 03, 2021
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date Dec. 03, 2021
Entity File Number 001-33451
Entity Registrant Name ALBIREO PHARMA, INC.
Entity Central Index Key 0001322505
Entity Tax Identification Number 90-0136863
Entity Incorporation, State or Country Code DE
Entity Address, Address Line One 10 Post Office Square
Entity Address, Address Line Two Suite 1000
Entity Address, City or Town Boston
Entity Address, State or Province MA
Entity Address, Postal Zip Code 02109
City Area Code 857
Local Phone Number 254-5555
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common Stock
Trading Symbol ALBO
Security Exchange Name NASDAQ
Entity Emerging Growth Company false
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