Bay Street News

Albireo Reports Third Quarter 2018 Financial Results

Odevixibat selected as International Nonproprietary Name (INN) for A4250

A4250 granted Fast Track and additional Orphan Drug designations

A4250 Phase 3 trial progressing as planned, new natural history data presented at AASLD

Management to host conference call and webcast today at 8:30 a.m. EST

BOSTON, Nov. 13, 2018 (GLOBE NEWSWIRE) — Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, today announced financial results and corporate highlights for the third quarter ended September 30, 2018.

“With our Phase 3 clinical trial of A4250 for progressive familial intrahepatic cholestasis (PFIC) progressing according to our plan, we focused in Q3 on driving Phase 3 enrollment, deepening our understanding of cholestatic liver diseases and achieving key regulatory milestones on the way to bringing the first approved pharmacological treatment for PFIC and other cholestatic liver diseases to patients,” said Ron Cooper, President and Chief Executive Officer of Albireo.

Recent Highlights

A4250

Corporate

Financial Update for the Three and Nine Month Periods Ended September 30, 2018

Three Months Ended September 30, 2018 vs. 2017

Nine Months Ended September 30, 2018 vs. 2017

Financial Guidance
For the full year 2018, we anticipate total expenses, including R&D and G&A expenses, to be at the high end of the range of $45-$50 million. In terms of cash, we expect our current cash balance to be sufficient to meet our operating needs into 2021.

Conference Call
As previously announced, Albireo will host a conference call and webcast today, November 13, 2018, at 8:30 a.m. EST. To access the live conference call by phone, dial 877-407-0792 (domestic) or 201-689-8263 (international) and provide the access code 13683207. A live audio webcast will be accessible from the Media & Investors page of Albireo’s website, http://ir.albireopharma.com/. To ensure a timely connection to the webcast, it is recommended that users register at least 15 minutes prior to the scheduled start time. An archived version of the webcast will be available for replay in the Events & Presentations section of the Media & Investors page of Albireo’s website for at least 2 weeks following the event.

About Albireo 
Albireo Pharma is a clinical-stage biopharmaceutical company focused through its operating subsidiary on the development of novel bile acid modulators to treat orphan pediatric liver diseases, and other liver and gastrointestinal diseases and disorders. Albireo’s lead product candidate, A4250, is being developed to treat rare pediatric cholestatic liver diseases and is in Phase 3 development in its initial target indication, progressive familial intrahepatic cholestasis (PFIC). Albireo’s clinical pipeline also includes two Phase 2 product candidates. Albireo’s elobixibat, approved in Japan for the treatment of chronic constipation, is the first ileal bile acid transporter (IBAT) inhibitor approved anywhere in the world. Albireo was spun out from AstraZeneca in 2008. 

Albireo Pharma is located in Boston, Massachusetts, and its key operating subsidiary is located 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: the plans for, or progress, scope, cost, duration or results or timing for availability of results of, development of A4250 or any other Albireo product candidate or program, including regarding the Phase 3 clinical program for A4250 in patients with PFIC; the target indication(s) for development, the size, design, population, location, conduct, objective, duration or endpoints of any clinical trial, or the timing for initiation or completion of or reporting of results from any clinical trial, including the double-blind Phase 3 PFIC trial for A4250; the size of the PFIC population or any other disease population for indications that may be targeted by Albireo; the potential benefits or competitive position of A4250, or any other Albireo product candidate or program or the commercial opportunity in any target indication; the potential benefits of a rare pediatric disease designation, the potential benefits of a fast track designation, the pricing of A4250 if approved; the period for which Albireo’s cash resources will be sufficient to fund its operating requirements (runway); 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,” and 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: whether favorable findings from clinical trials of A4250 to date, including findings in indications other than PFIC, will be predictive of results from the trials comprising the Phase 3 PFIC program or any other clinical trials of A4250; whether either or both of the FDA and EMA will determine that the primary endpoint for their respective evaluations and treatment duration of the double-blind Phase 3 trial in patients with PFIC are sufficient, even if the primary endpoint is met with statistical significance, to support approval of A4250 in the United States or the European Union, to treat PFIC, a symptom of PFIC, a specific PFIC subtype(s) or otherwise; 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 A4250, including the trials comprising the Phase 3 PFIC program, and the outcomes of such trials; Albireo’s ability to obtain coverage, pricing or reimbursement for approved products in the United States or European Union; delays or other challenges in the recruitment of patients for, or the conduct of, the double-blind Phase 3 trial; and Albireo’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.

 
Albireo Pharma, Inc.
Condensed Consolidated Balance Sheets
(in thousands, except per share data)
(unaudited)
 
    September 30,   December 31,
    2018     2017  
ASSETS            
Current assets:            
Cash and cash equivalents   $ 173,602     $ 53,231  
Prepaid expenses and other assets     490       1,054  
Other receivables     2,304       726  
Total current assets     176,396       55,011  
Property and equipment, net     199       178  
Goodwill     17,260       17,260  
Other noncurrent assets     396       775  
Total assets   $ 194,251     $ 73,224  
LIABILITIES AND STOCKHOLDERS’ EQUITY            
Current liabilities:            
Trade payables   $ 3,481     $ 1,350  
Accrued expenses     5,278       6,105  
Other liabilities     327       474  
Total current liabilities     9,086       7,929  
Liability related to sale of future royalties     48,461        
Long-term liabilities     37       42  
Total liabilities     57,584       7,971  
Stockholders’ Equity:            
Common stock, $0.01 par value per share — 30,000,000 authorized at September 30, 2018 and December 31, 2017; 11,969,928 and 8,902,784 issued and outstanding at September 30, 2018 and December 31, 2017, respectively     120       89  
Additional paid in capital     213,005       114,522  
Accumulated other comprehensive income     4,150       1,001  
Accumulated deficit     (80,608)       (50,359)  
Total stockholders’ equity     136,667       65,253  
Total liabilities and stockholders’ equity   $ 194,251     $ 73,224  
                 

Albireo Pharma, Inc.
Condensed Consolidated Statement of Operations
(in thousands, except share and per share data)
(unaudited)
         
    Three Months Ended September 30,   Nine Months Ended September 30,
    2018     2017     2018     2017  
Revenue   $ 237     $     $ 12,169     $ 2  
Operating expenses:                        
Research and development     9,666       3,226       22,228       9,000  
General and administrative     3,850       3,709       12,216       10,634  
Other operating (income) expense, net     (614)       (401)       1,377       (392)  
Total operating expenses     12,902       6,534       35,821       19,242  
Operating loss     (12,665)       (6,534)       (23,652)       (19,240)  
Interest income (expense), net     (1,367)       23       (4,049)       (378)  
Other income (expense), net     7             (2,546)       260  
Net loss before income taxes     (14,025)       (6,511)       (30,247)       (19,358)  
Income tax                        
Net loss   $ (14,025)     $ (6,511)     $ (30,247)     $ (19,358)  
Net loss per share attributable to holders of common stock:                        
Net loss per share – basic and diluted   $ (1.17)     $ (0.73)     $ (2.60)     $ (2.60)  
Weighted average shares outstanding – basic and diluted     11,969,791       8,878,430       11,612,760       7,452,709  

Investor Contact:
Hans Vitzthum
LifeSci Advisors, LLC
212-915-2568

Media Contact:
Heather Anderson
6 Degrees
980-938-0260
handerson@6degreespr.com

Source: Albireo Pharma, Inc.