UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)

☒	QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended March 31, 2022

☐	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from to .

Commission File Number 001-33451

Albireo Pharma, Inc.

(Exact name of registrant as specified in its charter)

s
Delaware (State or other jurisdiction of incorporation or organization)		90-0136863 (IRS Employer Identification No.)

53 State Street, 19th Floor, Boston, MA (Address of principal executive offices)		02109 (Zip code)

Registrant’s telephone number, including area code: (857) 254-5555

Securities registered pursuant to Section 12(b) of the Act:


Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, par value $0.01 per share	ALBO	The Nasdaq Capital Market

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ◻

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ◻

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.


Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☒
		Emerging growth company	☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). ☐ Yes ☒ No

As of May 9, 2022, there were 19,576,319 shares of Common Stock, $0.01 par value per share, outstanding.

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Albireo Pharma, Inc.


		Page
Cautionary Note Regarding Forward-Looking Statements

PART I — FINANCIAL INFORMATION

Item 1. Financial Statements (unaudited)		6

Condensed Consolidated Balance Sheets at March 31, 2022 and December 31, 2021		6

Condensed Consolidated Statements of Operations for the Three Months Ended March 31, 2022 and 2021		7

Condensed Consolidated Statements of Comprehensive Loss for the Three Months Ended March 31, 2022 and 2021		8

Condensed Consolidated Statements of Stockholders’ Equity for the Three Months Ended March 31, 2022 and 2021		9

Condensed Consolidated Statements of Cash Flows for the Three Months Ended March 31, 2022 and 2021		10

Notes to Condensed Consolidated Financial Statements		11

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations		22

Item 3. Quantitative and Qualitative Disclosures About Market Risk		35

Item 4. Controls and Procedures		35

PART II — OTHER INFORMATION

Item 1. Legal Proceedings		36

Item 1A. Risk Factors		36

Item 6. Exhibits		37

Signatures		38

All brand names, trademarks or service marks appearing in this quarterly report are the property of their respective owners. The registrant’s use or display of another party’s trademark, service mark, trade dress or product in this quarterly report is not intended to, and does not, imply a relationship with, or endorsement or sponsorship of, the registrant by such other party.

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CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This quarterly report includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, which we refer to as the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, which we refer to as the Exchange Act, that relate to future events or to our future operating or financial performance. Any forward-looking statement involves known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by such forward-looking statement. Forward-looking statements include statements, other than statements of historical fact, about, among other things:

●

our commercialization plans and expectations for commercializing Bylvay™ (odevixibat) globally;

●

the progress, number, scope, cost, duration or results of our development activities, nonclinical studies and clinical trials of Bylvay, elobixibat, A3907, A2342 or any of our other product candidates or programs, such as the target indication(s) for development or approval, the size, design, population, conduct, cost, objective or endpoints of any clinical trial, or the timing for initiation or completion of or availability of results from any clinical trial (including BOLD, our pivotal clinical trial of Bylvay in patients with biliary atresia, or ASSERT, our pivotal trial of Bylvay in Alagille syndrome, or ALGS) for submission, review or approval of any regulatory filing, or for meeting with regulatory authorities;

●

the potential benefits that may be derived from any of our product candidates;

●

the timing of and our ability to obtain and maintain regulatory approval of our existing product candidates, any product candidates that we may develop, and any related restrictions, limitations, or warnings in the label of any approved product candidates;

●

any payment that EA Pharma Co., Ltd., or EA Pharma, may make to us or any other action or decision that EA Pharma may make concerning elobixibat or our business relationship;

●

the potential impacts of the COVID-19 pandemic on our business operations or financial condition;

●

our future operations, financial position, revenues, costs, expenses, uses of cash, capital requirements, our need for additional financing or the period for which our existing cash resources will be sufficient to meet our operating requirements; or

●

our strategies, prospects, plans, expectations, forecasts or objectives.

Words such as, but not limited to, “believe,” “expect,” “anticipate,” “estimate,” “forecast,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “targets,” “likely,” “will,” “would,” “could,” “should,” “continue,” “scheduled” and similar expressions or phrases, or the negative of those expressions or phrases, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Although we believe that we have a reasonable basis for each forward-looking statement contained in this report, we caution you that these statements are based on our estimates or projections of the future that are subject to known and unknown risks and uncertainties and other important factors that may cause our actual results, level of activity, performance, experience or achievements to differ materially from those expressed or implied by any forward-looking statement. Actual results, level of activity, performance, experience or achievements may differ materially from those expressed or implied by any forward-looking statement as a result of various important factors, including our critical accounting policies and risks and uncertainties relating, among other things, to:

●

our ability to effectively commercialize Bylvay for its approved indications;

●

the design, size, duration and endpoints for, and results from BOLD, our pivotal trial of Bylvay in biliary atresia, and ASSERT, our pivotal trial of Bylvay in ALGS, or any other trials that will be required to obtain

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marketing approval for Bylvay to treat patients with PFIC, biliary atresia, ALGS or any other pediatric cholestatic liver disease or for A3907 and A2342 as potential treatments for adult liver and viral diseases;

●

whether favorable findings from clinical trials of Bylvay to date, including findings in our completed Phase 3 clinical trial in PFIC and findings in indications other than PFIC, will be predictive of results from future clinical trials, including our pivotal trial of Bylvay in biliary atresia and pivotal trial of Bylvay in ALGS;

●

the outcome and interpretation by regulatory authorities of an ongoing third-party study pooling and analyzing long-term PFIC patient data;

●

the timing for completion of, or for availability of data from, our pivotal trial of Bylvay in biliary atresia and our pivotal trial of Bylvay in ALGS, and the outcomes of such trials;

●

delays or other challenges in the recruitment of patients for the pivotal trial of Bylvay in biliary atresia and the pivotal trial of Bylvay in ALGS;

●

the COVID-19 pandemic, which may negatively impact the conduct of, and the timing of initiation, enrollment, completion and reporting with respect to, our clinical trials; negatively impact the supply of drug product for our clinical and preclinical programs; and/or result in other adverse impacts on our business;

●

the competitive environment and commercial opportunity for a treatment for PFIC and potentially other orphan pediatric cholestatic liver diseases;

●

the conduct and results of clinical trials and nonclinical studies and assessments of Bylvay, A3907, A2342 or any of our other product candidates and programs, including the performance of third parties engaged to execute them and difficulties or delays in patient enrollment and data analysis;

●

the medical benefit that may be derived from Bylvay, A3907, A2342 or any of our other product candidates;

●

the extent to which our agreement with EA Pharma for elobixibat generates nondilutive income for us;

●

the timing and success of submission, acceptance and approval of regulatory filings and any related restrictions, limitations or warnings in the label of any approved product candidates;

●

whether we are able to effectively commercialize Bylvay in patients with PFIC;

●

the significant control or influence that EA Pharma has over the commercialization of elobixibat in Japan, and through its sublicensee, in Thailand and the development and commercialization of elobixibat in EA Pharma’s other licensed territories;

●

whether we elect to seek and, if so, our ability to establish a license or other partnering transaction with a third party for elobixibat in the United States or Europe;

●

the accuracy of our estimates regarding expenses, costs, future revenues, uses of cash and capital requirements;

●

our ability to obtain additional financing on reasonable terms, or at all;

●

our ability to establish additional licensing, collaboration or similar arrangements on favorable terms and our ability to attract collaborators with development, regulatory and commercialization expertise;

●

the success of competing third-party products or product candidates;

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●

our ability to successfully commercialize any approved product candidates, including their rate and degree of market acceptance;

●

whether we are able to maintain compliance with the terms and conditions of our loan and security agreement with Hercules Capital, Inc.;

●

our ability to expand and protect our intellectual property estate;

●

regulatory developments in the United States and other countries;

●

the effectiveness of our internal control over financial reporting;

●

the performance of our third-party suppliers, manufacturers and contract research organizations and our ability to obtain alternative sources of raw materials;

●

our ability to attract and retain key personnel; and

●

our ability to comply with regulatory requirements relating to our business, and the costs of compliance with those requirements, including those on data privacy and security.

These and other risks and uncertainties are described in greater detail under the caption “Risk Factors” in Item 1A of Part I of our Annual Report on Form 10-K for the fiscal year ended December 31, 2021, in Item 1A of Part II of this quarterly report, and in other filings that we make with the Securities and Exchange Commission, or SEC. As a result of the risks and uncertainties, the results or events indicated by the forward-looking statements may not occur. We caution you not to place undue reliance on any forward-looking statement.

In addition, any forward-looking statement in this quarterly report represents our views only as of the filing date of this quarterly report and should not be relied upon as representing our views as of any subsequent date. We anticipate that subsequent events and developments may cause our views to change. Although we may elect to update these forward-looking statements publicly at some point in the future, we specifically disclaim any obligation to do so, except as required by applicable law. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments we may make.

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PART I — FINANCIAL INFORMATION

Item 1. Financial Statements

Albireo Pharma, Inc.

Condensed Consolidated Balance Sheets

(in thousands, except share data)

(unaudited)


	March 31,		December 31,
	2022		2021
Assets
Current assets:
Cash and cash equivalents	$	216,655	$	248,107
Accounts receivable, net		1,275		3,272
Inventory		1,821		194
Prepaid expenses		6,486		5,261
Other current assets		2,490		12,096
Total current assets		228,727		268,930
Property and equipment, net		837		668
Goodwill		17,260		17,260
Other assets		14,437		15,193
Total assets	$	261,261	$	302,051
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable	$	6,369	$	6,516
Accrued expenses		21,103		35,951
Other current liabilities		4,035		2,880
Total current liabilities		31,507		45,347
Liability related to sale of future royalties		60,899		60,132
Note payable, net of discount		10,080		10,004
Other long-term liabilities		10,589		10,960
Total liabilities		113,075		126,443
Stockholders’ Equity:
Preferred stock, $0.01 par value per share — 50,000,000 shares authorized at March 31, 2022 and December 31, 2021; 0 and 0 shares issued and outstanding at March 31, 2022 and December 31, 2021, respectively		—		—
Common stock, $0.01 par value per share — 60,000,000 shares authorized at March 31, 2022 and December 31, 2021; 19,527,920 and 19,520,160 shares issued and outstanding at March 31, 2022, respectively, and 19,304,312 and 19,296,552 shares issued and outstanding at December 31, 2021, respectively		195		193
Additional paid-in capital		483,276		475,390
Accumulated other comprehensive income		8,229		1,105
Accumulated deficit		(343,284)		(300,850)
Treasury stock at cost, 7,760 shares at March 31, 2022 and December 31 2021, respectively		(230)		(230)
Total stockholders’ equity		148,186		175,608
Total liabilities and stockholders’ equity	$	261,261	$	302,051

See accompanying notes to Condensed Consolidated Financial Statements.

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Albireo Pharma, Inc.

Condensed Consolidated Statements of Operations

(in thousands, except share and per share data)

(unaudited)


	Three Months Ended March 31,
	2022		2021
Revenue:
Product revenue, net	$	4,656	$	—
Royalty revenue		2,176		1,966
Total revenue		6,832		1,966
Cost and operating expenses:
Cost of product revenue		234		—
Research and development		21,903		19,943
Selling, general and administrative		16,855		15,273
Other operating expense, net		7,398		6,528
Total cost and operating expenses		46,390		41,744
Operating loss		(39,558)		(39,778)
Other loss:
Interest expense, net		(2,876)		(3,955)
Net loss	$	(42,434)	$	(43,733)
Net loss per share attributable to holders of common stock:
Net loss per common share - basic and diluted	$	(2.19)	$	(2.29)
Weighted-average common shares used to compute basic and diluted net loss per common share		19,379,586		19,131,557

See accompanying notes to Condensed Consolidated Financial Statements.

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Albireo Pharma, Inc.

Condensed Consolidated Statements of Comprehensive Loss

(in thousands)

(unaudited)


	Three Months Ended March 31,
	2022		2021
Net loss	$	(42,434)	$	(43,733)
Other comprehensive income:
Foreign currency translation adjustment		7,124		6,954
Total other comprehensive income		7,124		6,954
Total comprehensive loss	$	(35,310)	$	(36,779)

See accompanying notes to Condensed Consolidated Financial Statements.

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Albireo Pharma, Inc.

Condensed Consolidated Statements of Stockholders’ Equity

(in thousands, except share data)

(unaudited)


						Accumulated
				Additional		Other				Treasury Stock			Total
	Common Stock			Paid-In		Comprehensive		Accumulated		At Cost			Stockholders’
	Shares	Amount		Capital		Income		Deficit		Shares	Amount		Equity
Balance--December 31, 2021	19,304,312	$	193	$	475,390	$	1,105	$	(300,850)	(7,760)	$	(230)	$	175,608
Stock-based compensation expense	—		—		3,508		—		—	—		—		3,508
Exercise of options and vesting of RSUs	223,683		2		4,378		—		—	—		—		4,380
Other comprehensive income	—		—		—		7,124		—	—		—		7,124
Net loss	—		—		—		—		(42,434)	—

SEC Form 10-Q filed by Albireo Pharma Inc.