ALBO Albireo Pharma Inc.

25.33
-0.17  -1%
Previous Close 25.5
Open 25.48
52 Week Low 11.26
52 Week High 31.5
Market Cap $379,431,748
Shares 14,979,540
Float 13,173,790
Enterprise Value $231,463,270
Volume 102,182
Av. Daily Volume 83,414
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Upcoming Catalysts

Drug Stage Catalyst Date
Elobixibat
Nonalcoholic steatohepatitis (NASH)
Phase 2
Phase 2
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Odevixibat (A4250) - PEDFIC- 1
Progressive familial intrahepatic cholestasis (PFIC)
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
Odevixibat (A4250)
Biliary atresia
Phase 3
Phase 3
Phase 3 trial has been initiated.
Odevixibat
Alagille syndrome
Phase 3
Phase 3
Phase 3 trial to commence by the end of 2020.

Latest News

  1. BOSTON, June 10, 2020 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (NASDAQ:ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, today announced that it will host a Key Opinion Leader (KOL) call on clinical outcome assessments (COAs) on Tuesday, June 16th at 8:00 am Eastern Time.

    This call will feature a presentation by KOL Chad Gwaltney, Ph.D. who will discuss key considerations for the design and implementation of COAs, including patient-reported and observer-reported outcomes, in clinical trials. His presentation will review best practices for identifying key patient experiences and developing and testing COAs that will be used to evaluate efficacy in clinical development programs.

    As…

    BOSTON, June 10, 2020 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (NASDAQ:ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, today announced that it will host a Key Opinion Leader (KOL) call on clinical outcome assessments (COAs) on Tuesday, June 16th at 8:00 am Eastern Time.

    This call will feature a presentation by KOL Chad Gwaltney, Ph.D. who will discuss key considerations for the design and implementation of COAs, including patient-reported and observer-reported outcomes, in clinical trials. His presentation will review best practices for identifying key patient experiences and developing and testing COAs that will be used to evaluate efficacy in clinical development programs.

    As a key contributor to the development of the PRUCISION pruritus measurement tools used by Albireo in the Phase 3 studies, Dr. Gwaltney will discuss the creation of the careful design of PRUCISION to measure treatment benefits. He and the Albireo management team will also be available to answer questions at the conclusion of the event.

    Albireo Chief Medical Officer Patrick Horn, M.D., Ph.D. will provide an overview of the company's registrational Phase 3 clinical trial of odevixibat for the treatment of patients with progressive familial intrahepatic cholestasis (PFIC), a rare pediatric cholestatic liver disease. Albireo is developing odevixibat, a potent and selective inhibitor of the ileal bile acid transporter (IBAT), to treat patients with PFIC, biliary atresia and Alagille syndrome.

    Conference Call Details
    Tuesday, June 16th @ 8:00am Eastern Time
    Domestic:877-407-0792
    International:201-689-8263
    Conference ID:13702827
    Webcast:Click Here For Webcast

    Chad Gwaltney, Ph.D. is President and Principal Consultant at Gwaltney Consulting. Dr. Gwaltney develops innovative methods to measure patient-centered outcomes in clinical trials. His academic and industry research includes the design of electronic platforms for the collection of information in real-time in the patient's natural environment. He has published over 85 peer-reviewed articles and book chapters addressing patient-reported outcomes and how the patient's perspective can be examined to better understand medical product efficacy and safety. He has served on U.S. National Institutes of Health review committees and has co-authored industry best practice guidelines on the development and use of patient-reported outcomes. Dr. Gwaltney has also served as Head, Patient Experience, Hematology/Oncology, at Celgene and as a research faculty member in the Brown University School of Public Health.

    About Albireo

    Albireo Pharma is a clinical-stage biopharmaceutical company focused 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, odevixibat, is being developed to treat rare pediatric cholestatic liver diseases and is in Phase 3 development in progressive familial intrahepatic cholestasis (PFIC) and biliary atresia, with a third Phase 3 trial being planned in Alagille syndrome. Albireo's clinical pipeline also includes two Phase 2 product candidates. Elobixibat is in Phase 2 development in NAFLD and NASH. Approved in Japan for the treatment of chronic constipation, elobixibat 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, Mass., and its key operating subsidiary is located in Gothenburg, Sweden. The Boston Business Journal named Albireo one of the 2019 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: the plans for, or progress, scope, cost, initiation, duration, enrollment, results or timing for availability of results of, development of odevixibat, elobixibat or any other Albireo product candidate or program, including regarding expectations regarding the impact of COVID-19 on our business and our ability to adapt our approach as appropriate; the Phase 3 clinical program for odevixibat in patients with PFIC, the pivotal trial for odevixibat in biliary atresia, the planned pivotal trial for odevixibat in Alagille syndrome, the Phase 2 clinical trial for elobixibat in NAFLD/NASH, and another Phase 3 trial for elobixibat being conducted by EA Pharma in Japan; 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 Phase 3 PFIC trial for odevixibat, and the long-term open-label extension study, the pivotal trial for odevixibat in biliary atresia, the planned pivotal trial for odevixibat in Alagille syndrome, or the Phase 2 trial for elobixibat in NAFLD/NASH; the potential approval and commercialization of odevixibat; discussions with the FDA or EMA regarding our programs; the potential benefits or competitive position of odevixibat, elobixibat, or any other Albireo product candidate or program or the commercial opportunity in any target indication; the potential benefits of an orphan drug designation; 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: 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 odevixibat 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 odevixibat; 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 odevixibat 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 odevixibat, including the trials comprising the Phase 3 PFIC program, the pivotal program in biliary atresia or the planned pivotal program in Alagille syndrome, 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 or other pivotal trials; 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.

    Investor Contact: Hans Vitzthum, LifeSci Advisors, LLC, 617-430-7578

    Media Contact: Claire LaCagnina, 6 Degrees, 315-765-1462,

    Source: Albireo Pharma, Inc.

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  2. — Restructured HealthCare Royalty Partners elobixibat royalty monetization agreement nets additional $15M in non-dilutive capital — 

    — Initial draw down of $10M on debt facility of up to $80M with Hercules Capital —

    BOSTON , June 09, 2020 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (NASDAQ:ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, today announced it has agreed to terms with Hercules Capital, Inc. (NYSE:HTGC) on a debt facility to provide up to $80 million of new capital, and will receive $15M under a restructured royalty monetization agreement with HealthCare Royalty Partners (HCR) for elobixibat in the treatment of chronic constipation in Japan. Elobixibat, approved in Japan for…

    — Restructured HealthCare Royalty Partners elobixibat royalty monetization agreement nets additional $15M in non-dilutive capital — 

    — Initial draw down of $10M on debt facility of up to $80M with Hercules Capital —

    BOSTON , June 09, 2020 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (NASDAQ:ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, today announced it has agreed to terms with Hercules Capital, Inc. (NYSE:HTGC) on a debt facility to provide up to $80 million of new capital, and will receive $15M under a restructured royalty monetization agreement with HealthCare Royalty Partners (HCR) for elobixibat in the treatment of chronic constipation in Japan. Elobixibat, approved in Japan for the treatment of patients with chronic constipation, is the first ileal bile acid transporter (IBAT) inhibitor approved anywhere in the world.

    "These funding arrangements with new and existing partners provide the company additional flexibility and cash runway into the beginning of 2022, past the planned approval and commercial launch of odevixibat for the treatment of progressive familial intrahepatic cholestasis," said Ron Cooper, President and Chief Executive Officer of Albireo. "This strengthened financial foundation will also enable our continued growth as we deliver on additional odevixibat pivotal trials, NASH clinical development and pre-clinical programs."

    Under the updated terms of the agreement with HCR, the company will receive an additional $15 million on top of the $45 million royalty financing commitment HCR made in 2018 for royalty rights based on sales for elobixibat in the treatment of chronic constipation in Japan. In exchange, the company eliminated the cap on HCR's rights to receive royalties on sales in Japan and sales milestones for elobixibat in certain other territories that may become payable by the Company's partner, EA Pharma Co., Ltd.. Elobixibat is marketed and sold in Japan under the trade name GOOFICE.

    "HCR's additional investment reinforces our view that elobixibat's unique mechanism of action results in a differentiated product that provides a meaningful benefit to patients in Japan", said John Urquhart, Managing Director of HCR.

    Under the terms of the new agreement with Hercules Capital, Albireo may access up to $80 million of new capital, with an initial minimum of $10 million drawn down on a first available tranche of $15M, and additional tranches based on regulatory and other milestones.

    "Hercules is pleased to be partnering with Albireo and supporting its clinical efforts which are focused on the development of novel treatments for orphan pediatric liver diseases, and other liver and gastrointestinal diseases and disorders. This structured debt investment represents a significant commitment from Hercules, and it is consistent with our goal of supporting innovative life sciences companies through all stages of development," said Kristen Kosofsky, Senior Managing Director at Hercules.

    About Albireo

    Albireo Pharma is a clinical-stage biopharmaceutical company focused 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, odevixibat, is being developed to treat rare pediatric cholestatic liver diseases and is in Phase 3 development in progressive familial intrahepatic cholestasis (PFIC) and biliary atresia, with a third Phase 3 trial being planned in Alagille syndrome. Albireo's clinical pipeline also includes two Phase 2 product candidates. Elobixibat is in Phase 2 development in NAFLD and NASH. Approved in Japan for the treatment of chronic constipation, elobixibat 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, Mass., and its key operating subsidiary is located in Gothenburg, Sweden. The Boston Business Journal named Albireo one of the 2019 Best Places to Work in Massachusetts. For more information on Albireo, please visit www.albireopharma.com.

    About HCR

    HealthCare Royalty Partners ("HCR") is a private investment firm that purchases royalties and uses debt-like structures to invest in commercial or near-commercial stage biopharmaceutical assets. HCR has $5.5 billion in cumulative capital commitments with offices in Stamford (CT), San Francisco, Boston and London. For more information, visit www.healthcareroyalty.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, initiation, duration, enrollment, results or timing for availability of results of, development of odevixibat, elobixibat or any other Albireo product candidate or program, including regarding expectations regarding the impact of COVID-19 on our business and our ability to adapt our approach as appropriate; the Phase 3 clinical program for odevixibat in patients with PFIC, the pivotal trial for odevixibat in biliary atresia, the planned pivotal trial for odevixibat in Alagille syndrome, the Phase 2 clinical trial for elobixibat in NAFLD/NASH, and another Phase 3 trial for elobixibat being conducted by EA Pharma in Japan; 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 Phase 3 PFIC trial for odevixibat, and the long-term open-label extension study, the pivotal trial for odevixibat in biliary atresia, the planned pivotal trial for odevixibat in Alagille syndrome, or the Phase 2 trial for elobixibat in NAFLD/NASH; the potential approval and commercialization of odevixibat; discussions with the FDA or EMA regarding our programs; the potential benefits or competitive position of odevixibat, elobixibat, or any other Albireo product candidate or program or the commercial opportunity in any target indication; the potential benefits of an orphan drug designation; 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: 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 odevixibat 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 odevixibat; 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 odevixibat 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 odevixibat, including the trials comprising the Phase 3 PFIC program, the pivotal program in biliary atresia or the planned pivotal program in Alagille syndrome, 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 or other pivotal trials; 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.

    Investor Contact: Hans Vitzthum, LifeSci Advisors, LLC, 617-430-7578

    Media Contact: Claire LaCagnina, 6 Degrees, 315-765-1462,

    Source: Albireo Pharma, Inc.

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  3. BOSTON, May 26, 2020 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (NASDAQ:ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, today announced that Ron Cooper, President and Chief Executive Officer, will present via webcast at the 2020 Jefferies Virtual Healthcare Conference on Tuesday, June 2, at 8:30 a.m. EDT.

    The live webcast of the presentation will be accessible from the Media & Investors page of Albireo's website, 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…

    BOSTON, May 26, 2020 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (NASDAQ:ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, today announced that Ron Cooper, President and Chief Executive Officer, will present via webcast at the 2020 Jefferies Virtual Healthcare Conference on Tuesday, June 2, at 8:30 a.m. EDT.

    The live webcast of the presentation will be accessible from the Media & Investors page of Albireo's website, 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 two weeks following the event.

    About Albireo
    Albireo Pharma is a clinical-stage biopharmaceutical company focused 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, odevixibat, is being developed to treat rare pediatric cholestatic liver diseases and is in Phase 3 development in progressive familial intrahepatic cholestasis (PFIC) and biliary atresia. Albireo's clinical pipeline also includes two Phase 2 product candidates. Elobixibat is in Phase 2 development in NAFLD and NASH. Approved in Japan for the treatment of chronic constipation, elobixibat 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, Mass., and its key operating subsidiary is located in Gothenburg, Sweden. The Boston Business Journal named Albireo one of the 2019 Best Places to Work in Massachusetts. For more information on Albireo, please visit www.albireopharma.com.

    Investor Contact: Hans Vitzthum, LifeSci Advisors, LLC, 617-430-7578
    Media Contact: Claire LaCagnina, 6 Degrees, 315-765-1462,

    Source: Albireo Pharma, Inc.

     

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  4. — Commercial preparations advancing, with topline PEDFIC 1 results expected mid-2020  —
    — First sites initiated for second pivotal trial in biliary atresia —
    — Management to host conference call and webcast today at 10:00 a.m. ET —

    BOSTON, May 07, 2020 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (NASDAQ:ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, today provided a business update and reported financial results for the first quarter ended March 31, 2020.

    "Despite the unprecedented challenges of COVID-19, our fundamentals remain unchanged, and we continue to make significant progress across our development programs, while accelerating preparations for commercialization," said Ron Cooper, President…

    — Commercial preparations advancing, with topline PEDFIC 1 results expected mid-2020  —
    — First sites initiated for second pivotal trial in biliary atresia —
    — Management to host conference call and webcast today at 10:00 a.m. ET —

    BOSTON, May 07, 2020 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (NASDAQ:ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, today provided a business update and reported financial results for the first quarter ended March 31, 2020.

    "Despite the unprecedented challenges of COVID-19, our fundamentals remain unchanged, and we continue to make significant progress across our development programs, while accelerating preparations for commercialization," said Ron Cooper, President and Chief Executive Officer of Albireo. "In PFIC, we are now months away from our Phase 3 data readout, and we are advancing our preparations in manufacturing, market development, market access, patient support and other areas. Meanwhile, we are advancing pivotal trials in biliary atresia and Alagille syndrome, and our NASH program is making excellent progress, with data readout from our Phase 2 trial also a few months away.

    "COVID-19 has had a sweeping impact across the industry and society as a whole. We have successfully adapted our business operations, with the safety of our employees and the patient communities as our top priority. We are fortunate that our clinical trials in PFIC and NASH have completed enrollment this quarter, and we have sufficient clinical trial supply to support those programs. As of now, our prior guidance regarding our clinical trials remains unchanged."

    More information on the impact of COVID-19 on Albireo is available at albireopharma.com.

    Recent Highlights

    Odevixibat

    • With the PEDFIC 1 trial fully randomized, have accelerated preparations for commercialization. More than three-quarters of patients have completed the trial, and we continue to expect topline results mid-2020 and anticipate potential first regulatory approval H2 2021.
       
    • We have initiated the first clinical trial sites for the BOLD pivotal study, Biliary Atresia and the Use of Odevixibat in Treating Liver Disease. Biliary atresia is a rare pediatric liver disease that is the leading cause of liver transplants among children, and for which there is no approved pharmacological therapy. Biliary atresia is the most common rare pediatric cholestatic liver disease and the largest market opportunity in that therapeutic category. The U.S. Food and Drug Administration (FDA) and European Commission have granted orphan designations for odevixibat in the treatment of biliary atresia.     

    • Received FDA feedback and are finalizing pivotal trial design in Alagille syndrome. Anticipate initiating trial by the end of this year. The FDA and the European Commission have granted orphan designations for odevixibat in the treatment of Alagille syndrome.

    Pipeline

    • Achieved full enrollment in elobixibat Phase 2 trial in NAFLD and NASH. Proof-of-concept study is the first study ever conducted in both NAFLD and NASH patients with an IBAT inhibitor. Expect topline data by mid 2020. Additionally, expect topline data from another Phase 2 trial being conducted through our partner EA Pharma in Japan by the end of the year or early next year.
       
    • Continued as planned IND-enabling studies of lead preclinical candidate with novel mechanism of action.       

    Corporate

    • Completed equity capital raise of net $43.0 million.

    First Quarter 2020 Financial Results

    • Revenues were $1.5 million for the first quarter of 2020, compared with $0.6 million for the first quarter of 2019. The higher revenue  was due to the estimated royalty revenue received from EA Pharma for elobixibat for the treatment of chronic constipation. The royalty revenue is passed on to HealthCare Royalty Partners.
       
    • R&D expenses were $16.1 million for the first quarter of 2020, compared with $8.3 million for the first quarter of 2019. The higher expenses were primarily due to program expenses for odevixibat and elobixibat, as well as personnel costs, as we continue to increase our program activities and headcount.
       
    • G&A expenses were $8.2 million for the first quarter of 2020, compared with $5.3 million for the first quarter of 2019. The increase was attributable to personnel and related expenses, as we continue to increase our headcount, and commercialization readiness expenses.
       
    • Net loss for the first quarter of 2020 was $31.5 million, or $(2.23) per share, compared with $16.7 million, or $(1.39) per share for the first quarter of 2019.
       
    • The company had cash and cash equivalents at March 31, 2020, of $150.5 million, which compares with $150.3 million at March 31, 2019. During the first quarter of 2020, an additional $43.0 million of net cash was raised through an underwritten public offering of our common stock. As a result, cash and cash equivalents are anticipated to be sufficient into the second half of 2021.

    Conference Call
    As previously announced, Albireo will host a conference call and webcast today, May 7, 2020, at 10:00 a.m. ET. To access the live conference call by phone, dial 877-407-0792 (domestic) or 201-689-8263  (international), and provide the access code 13699920. 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 participants register at least 15 minutes prior to the scheduled start time. An archived version of the webcast will be available for replay on the Events & Presentations section of the Media & Investors page of Albireo's website for 3 months following the event.

    About Albireo 
    Albireo Pharma is a clinical-stage biopharmaceutical company focused 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, odevixibat, is being developed to treat rare pediatric cholestatic liver diseases, and is in Phase 3 clinical trials in both progressive familial intrahepatic cholestasis (PFIC) and biliary atresia. Albireo's clinical pipeline also includes two Phase 2 product candidates. Elobixibat is in Phase 2 development in NAFLD and NASH. Approved in Japan for the treatment of chronic constipation, elobixibat 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, Mass., and its key operating subsidiary is located in Gothenburg, Sweden. The Boston Business Journal named Albireo one of the 2019 Best Places to Work in Massachusetts. For more information on Albireo, please visit www.albireopharma.com.

    About Odevixibat
    Odevixibat is a product candidate being developed to treat rare pediatric cholestatic liver diseases and is in Phase 3 development in both progressive familial intrahepatic cholestasis (PFIC) and biliary atresia. A highly potent and selective inhibitor of the ileal bile acid transporter (IBAT), odevixibat has minimal systemic exposure and acts locally in the small intestine.

    The odevixibat PFIC program has received fast track, rare pediatric disease and orphan drug designations in the United States. In addition, the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to odevixibat for the treatment of Alagille syndrome, biliary atresia and primary biliary cholangitis. The European Medicines Agency (EMA) has granted odevixibat orphan designation, as well as access to the PRIority MEdicines (PRIME) scheme for the treatment of PFIC. Its Pediatric Committee has agreed to Albireo's odevixibat Pediatric Investigation Plan for PFIC. EMA also has granted orphan designation to odevixibat for the treatment of Alagille syndrome, biliary atresia and primary biliary cholangitis.

    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, initiation, duration, enrollment, results or timing for availability of results of, development of odevixibat, elobixibat or any other Albireo product candidate or program, including regarding expectations regarding the impact of COVID-19 on our business and our ability to adapt our approach as appropriate; the Phase 3 clinical program for odevixibat in patients with PFIC, the pivotal trial for odevixibat in biliary atresia, the planned pivotal trial for odevixibat in Alagille syndrome, the Phase 2 clinical trial for elobixibat in NAFLD/NASH, and another Phase 3 trial for elobixibat being conducted by EA Pharma in Japan; 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 Phase 3 PFIC trial for odevixibat, and the long-term open-label extension study, the pivotal trial for odevixibat in biliary atresia, the planned pivotal trial for odevixibat in Alagille syndrome, or the Phase 2 trial for elobixibat in NAFLD/NASH; the potential approval and commercialization of odevixibat; discussions with the FDA or EMA regarding our programs; the potential benefits or competitive position of odevixibat, elobixibat, or any other Albireo product candidate or program or the commercial opportunity in any target indication; the potential benefits of an orphan drug designation; 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: 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 odevixibat 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 odevixibat; 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 odevixibat 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 odevixibat, including the trials comprising the Phase 3 PFIC program, the pivotal program in biliary atresia or the planned pivotal program in Alagille syndrome, 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 or other pivotal trials; 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.

    Investor Contact: Hans Vitzthum, LifeSci Advisors, LLC., 212-915-2568                                       
    Media Contact: Heather Anderson, 6 Degrees, 980-938-0260,  


    Albireo Pharma, Inc.

    Condensed Consolidated Balance Sheets

    (in thousands, except share and per share data)

    (unaudited)

        March 31,    December 31,  
        2020     2019    
    Assets              
    Current assets:              
    Cash and cash equivalents   $ 150,515     $ 131,843    
    Prepaid expenses and other current assets     7,818       9,956    
    Total current assets     158,333       141,799    
    Property and equipment, net     554       597    
    Goodwill     17,260       17,260    
    Other assets     5,962       5,413    
    Total assets   $ 182,109     $ 165,069    
    Liabilities and Stockholders' Equity              
    Current liabilities:              
    Accounts payable   $ 6,788     $ 4,785    
    Accrued expenses     7,561       13,486    
    Other current liabilities     798       653    
    Total current liabilities     15,147       18,924    
    Liability related to sale of future royalties     49,407       48,714    
    Other long-term liabilities     4,121       4,270    
    Total liabilities     68,675       71,908    
    Stockholders' Equity:              
    Common stock, $0.01 par value per share — 30,000,000 authorized at March 31, 2020 and December 31, 2019; 14,977,855 and 12,749,443 issued and outstanding at March 31, 2020 and December 31, 2019, respectively     149       127    
    Additional paid-in capital     291,221       245,769    
    Accumulated other comprehensive income     12,739       6,452    
    Accumulated deficit     (190,675 )     (159,187 )  
    Total stockholders' equity     113,434       93,161    
    Total liabilities and stockholders' equity   $ 182,109     $ 165,069    
                   


    Albireo Pharma, Inc.

    Condensed Consolidated Statements of Operations

    (in thousands, except share and per share data)

    (unaudited)

      Three Months Ended March 31, 
      2020     2019  
    Revenue $ 1,549     $ 570  
    Operating expenses:          
    Research and development   16,130       8,329  
    General and administrative   8,153       5,293  
    Other operating expense, net   6,816       2,296  
    Total operating expenses   31,099       15,918  
    Operating loss   (29,550 )     (15,348 )
    Interest expense, net   (1,938 )     (1,309 )
    Net loss $ (31,488 )   $ (16,657 )
    Net loss per share attributable to holders of common stock:          
    Net loss per common share - basic and diluted $ (2.23 )   $ (1.39 )
    Weighted-average shares outstanding:          
    Weighted-average common shares used to compute basic and diluted net loss per common share   14,132,217       12,001,125  

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  5. BOSTON, April 30, 2020 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (NASDAQ:ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, today announced that management will host a conference call and live audio webcast at 10:00 a.m. ET on May 7, 2020, to provide a business update and review the company's financial results for the first quarter ended March 31, 2019.

    To access the live conference call by phone, please dial 877-407-0792 (domestic) or 201-689-8263 (international), and provide the access code 13699920. 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…

    BOSTON, April 30, 2020 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (NASDAQ:ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, today announced that management will host a conference call and live audio webcast at 10:00 a.m. ET on May 7, 2020, to provide a business update and review the company's financial results for the first quarter ended March 31, 2019.

    To access the live conference call by phone, please dial 877-407-0792 (domestic) or 201-689-8263 (international), and provide the access code 13699920. 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 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 3 months following the event.

    About Albireo 
    Albireo Pharma is a clinical-stage biopharmaceutical company focused 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, odevixibat, 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. Elobixibat is in Phase 2 development in NAFLD and NASH. Approved in Japan for the treatment of chronic constipation, elobixibat 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, Mass., and its key operating subsidiary is located in Gothenburg, Sweden. The Boston Business Journal named Albireo one of the 2019 Best Places to Work in Massachusetts. For more information on Albireo, please visit www.albireopharma.com.

    Investor Contact: Hans Vitzthum, LifeSci Advisors, LLC., 212-915-2568                                       
    Media Contact: Heather Anderson, 6 Degrees, 980-938-0260,  

    Source: Albireo Pharma, Inc.

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