Cholestasis, Progressive Familial Intrahepatic 1

PARIS, France & BOSTON, MA, USA I January 09, 2023 I Ipsen (Euronext: IPN: ADR: IPSEY) and Albireo (Nasdaq: ALBO) today announced that they have entered into a definitive merger agreement under which Ipsen will acquire Albireo, a leading innovator in bile-acid modulators to treat pediatric and adult cholestatic liver diseases. The anticipated acquisition will enrich Ipsen’s Rare Disease portfolio and pipeline. The lead medicine in Albireo’s pipeline is Bylvay ® (odevixibat), a potent, once-daily, oral, non-systemic ileal bile acid transport inhibitor (IBATi). Bylvay was approved in 2021 in the U.S. for the treatment of pruritus in patients three months of age and older with progressive familial intrahepatic cholestasis (PFIC) 1 , and in the E.U. for the treatment of PFIC in patients aged six months or older. 2 Pruritus is one of the most prominent and problematic manifestations of the disease, 3 often resulting in severely diminished quality of life. 4 Bylvay has orphan exclusivity for the approved indications in PFIC in the U.S. and E.U. “We are excited about the potential of Albireo’s assets and scientific expertise, which we gain through this acquisition, and we believe this is a compelling growth opportunity for Ipsen.” said David Loew, Chief Executive Officer of Ipsen. “Our Rare Disease franchise is strengthened with Bylvay, which, in addition to being the first-approved treatment in PFIC, has two further indications being investigated in rare liver conditions that are underserved. Additionally, Bylvay and the clinical and preclinical novel bile acid transport inhibitors in Albireo’s portfolio complement our own pipeline in liver disease.” “Unwavering dedication to patients and commitment to science have always been the north star for Albireo. This focus has driven us to develop and gain approval for Bylvay as the first drug treatment for PFIC,” said Ron Cooper, President and Chief Executive Officer of Albireo. “Our talented team at Albireo have advanced the first Phase III studies in three different pediatric liver diseases while discovering two promising new clinical stage bile acid modulators. We believe that Ipsen is well positioned to apply its global R&D and commercial capabilities to make these medicines available to more cholestatic liver disease patients and accelerate the mission of providing hope for families. ” In addition to this lead indication, Albireo announced in December 2022 that supplementary regulatory filings have been made for Bylvay in the E.U. and the U.S. for Alagille syndrome (ALGS). ALGS is a rare, genetic disorder that can affect multiple organ systems, including the liver, with a paucity of bile ducts preventing bile flow from the liver to the small intestine. The most debilitating symptom of ALGS is severe pruritus. 5 In the Phase III ASSERT trial, treatment with Bylvay met both primary and secondary endpoints and was associated with statistically significant improvements in pruritus severity and reductions in serum bile acid levels compared to placebo, and was well tolerated. 6 Furthermore, Bylvay is in late-stage development for biliary atresia (BA). It is currently being investigated in the BOLD study, the first, prospective double-blind, Phase III clinical trial in BA, a rare, pediatric liver disease that can result in cirrhosis and liver failure and is the leading cause of liver transplantation among children. 7 Orphan drug designations have been granted in both ALGS and BA indications in the U.S. and E.U. As part of the transaction, Ipsen will also acquire Albireo’s clinical stage asset A3907, a novel oral systemic apical sodium-dependent bile acid transporter (ASBT) inhibitor currently in development for adult cholestatic liver disease, such as primary sclerosing cholangitis (PSC), which could complement Ipsen´s existing development programs. In addition to Bylvay and A3907, Albireo’s pipeline includes A2342, an oral systemic sodium-taurocholate co-transporting peptide (NTCP) inhibitor being evaluated for viral and cholestatic diseases, which is moving ahead in investigational new drug (IND)-enabling trials. Financial highlights The acquisition of Albireo will provide immediate incremental sales and strengthen Ipsen’s rare disease infrastructure. Albireo guided for total Bylvay revenues of $24 million for 2022. Given the level of ongoing R&D expenses, the transaction is expected to be dilutive to Ipsen’s core operating income until the end of 2024. This is in line with Ipsen’s medium-term outlook regarding its strategic focus on building a high-value and sustainable pipeline through external innovation. The Group will provide its annual guidance for 2023 in February. Transaction details Under the terms of the agreement and plan of merger, Ipsen, through a fully-owned subsidiary, will initiate a tender offer to acquire all outstanding shares of Albireo at a price of $42.00 per share in cash at the closing of the transaction, for an initial estimated aggregate consideration of $952 million plus one contingent value right (CVR) per share. Each CVR will entitle its holder to deferred cash payments of $10.00 per CVR payable upon the U.S. Food and Drug Administration (FDA) approval of Bylvay in the Biliary Atresia indication at the latest by 31 December 2027, allowing for a potential increase in the number of patients in the BOLD study. The $42.00 per-share cash consideration represents a premium of 104% compared to Albireo’s 1-month volume-weighted average price of $20.60 preceding announcement of the transaction. The transaction will be fully financed by Ipsen’s existing cash and lines of credit. The Board of Directors of Albireo has unanimously approved the transaction and recommended that the stockholders of Albireo tender their shares in the tender offer. The closing of the tender offer will be subject to customary conditions, including the tender of shares which represent at least a majority of the total number of Albireo’s outstanding shares, the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and the receipt of consents of, or filings with, any governmental body or pursuant to certain foreign antitrust laws and the expiration of any applicable waiting period and other customary conditions. Upon the successful completion of the tender offer, Ipsen would acquire all shares not acquired in the tender offer through a second-step merger for the same consideration that the tendering stockholders will receive in the tender offer. It is anticipated the transaction will close by end of Q1, 2023. Advisors Goldman Sachs is acting as exclusive financial advisor to Ipsen and Orrick Herrington & Sutcliffe LLP as legal counsel to Ipsen. Centerview Partners is serving as exclusive financial advisor to Albireo.  Chestnut Partners also provided advice to Albireo. Paul, Weiss, Rifkind, Wharton & Garrison and Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C are serving as legal counsel to Albireo. Conference call A conference call and webcast for investors and analysts will begin today at 3pm, Paris time. Participants can access the call and its details by registering here ; webcast details can be found here . A recording will be available on ipsen.com . About Bylvay ® (odevixibat) Bylvay (odevixibat) is a potent, non-systemic ileal bile acid transport inhibitor (IBATi). It is approved in the U.S. for the treatment of pruritus in patients three months of age and older with PFIC, 1 where it has orphan exclusivity. Bylvay is launched in the U.S., where it is supported by a program designed to assist with access to treatment and patient support. Bylvay is also approved in the E.U. for the treatment of PFIC in patients aged six months or older. 2 It has launched in over nine countries and has secured public reimbursement across several major markets including Germany, Italy, UK, France and Belgium. View full E.U. prescribing information here: Bylvay, INN-odevixibat (europa.eu) View full U.S. prescribing information here: label (fda.gov) A second potential indication for Bylvay in patients with ALGS has been submitted as a supplemental New Drug Application to the U.S. Food and Drug Administration (FDA) and a variation application to the European Medicines Agency (EMA) in December 2022. Bylvay is being investigated in biliary atresia, a severe and potentially fatal pediatric liver disease, in a pivotal Phase III clinical trial. About PFIC PFIC is a spectrum 8-11 of autosomal recessive genetic disorders in which cholestasis may lead to end-stage liver disease. 12 The estimated global incidence of PFIC is 1 in 100,000 live births. 12 Currently in the U.S., it is estimated that there are 500 PFIC patients who may be eligible for IBATi treatment. Subtypes PFIC1, PFIC2 and PFIC3 are the most common. 12 In addition, other rare forms of PFIC exist with varying degrees of cholestasis. 13 Patients with PFIC have impaired bile flow, or cholestasis, and the resulting bile build-up in liver cells causes liver disease and symptoms. The most debilitating symptom of PFIC is pruritus (itching), which may be so severe that it leads to skin mutilation, loss of sleep, irritability, poor attention and impaired school performance. 11 Up to 80% of PFIC patients suffer from severe pruritus, associated with abrasions, skin mutilation, hemorrhage or scarring. 14 About PEDFIC 1 and 2 The PEDFIC trials (NCT03566238 and NCT03659916) represented the largest trials ever completed in children with PFIC. PEDFIC 1 was a randomized, double-blind, placebo-controlled Phase III trial aiming to evaluate the efficacy and tolerability of Bylvay in reducing pruritus and serum bile acids (sBAs) in children with PFIC. All patients enrolled in PEDFIC-1 were eligible to participate in PEDFIC 2, a long-term, open-label extension phase. About Alagille syndrome ALGS is an inherited rare, genetic disorder that can affect multiple organ systems in the body including the liver, heart, skeleton, eyes and kidneys. Liver damage may result from having fewer than normal, narrowed or malformed bile ducts, which leads to toxic bile acid build-up, which in turn can cause scarring and progressive liver disease. 15 Approximately 95% of patients with the condition present with chronic cholestasis, usually within the first three months of life and as many as 88% also present with severe, intractable pruritus. 16,17 The estimated global incidence of ALGS is 3 in 100,000 live births. 18 Currently in the U.S., it is estimated that there are 1,300 patients who may be eligible for IBATi treatment. About ASSERT ASSERT (NCT04674761) is a double-blind, randomized, placebo-controlled trial designed to evaluate the safety and efficacy of Bylvay (odevixibat) for 24 weeks in patients with ALGS up to 17 years of age. The primary endpoint evaluates the impact of odevixibat on pruritus score compared to placebo. Key secondary endpoints measure changes in serum bile acid levels and safety and tolerability. Top-line results were presented at the American Association for the Study of Liver Disease (AASLD) Conference in November 2022, supporting the efficacy and safety of Bylvay in patients with ALGS: Improvement in pruritus scores and reduction in serum bile acid levels were statistically significant compared to placebo. Additionally, Bylvay led to significant sleep improvements over time. There were no trial discontinuations and all patients completed the initial 24 weeks treatment duration, with 96% rolled over into the open-label extension trial. Low rates of diarrhea were reported during the trial. About biliary atresia BA is a rare pediatric liver disease. Symptoms typically develop about two to eight weeks after birth and there are no approved pharmacological therapies. Damaged or absent bile ducts outside the liver result in bile and bile acids being trapped inside the liver, quickly resulting in cirrhosis and liver failure requiring liver transplantation. At the time of diagnosis, a hepatic portoenterostomy (HPE) called Kasai procedure is performed to create a conduit allowing biliary drainage. The rate of success in re-establishing bile flow is dependent on the age of the infant when the HPE is performed. Kasai procedure is not curative and most patients who have BA have progressive disease, with at least 80% requiring liver transplantation by age 20 years. 19 Of those who survive into the third decade after birth, almost all have portal hypertension or other complications of cirrhosis. 20 New therapies are therefore needed to delay or avoid the need for liver transplantation following Kasai procedure. 21 There are currently no approved pharmacological treatments for biliary atresia. There is an estimated incidence of 5/6 per 100,000 live births worldwide with BA 22 . Currently in the U.S., it is estimated that there are 750 patients who may be eligible for IBATi treatment. About BOLD BOLD ( NCT04336722 ) is a double-blind, randomized, placebo-controlled trial to evaluate the efficacy and safety of Bylvay (odevixibat) in children who have biliary atresia and have undergone a Kasai procedure before age three months. Children in the treatment arm receive Bylvay 120 μg/kg orally once daily for 24 months. The primary efficacy endpoint is improvement in the proportion of patients who are alive and have not undergone a liver transplant after two years of treatment compared to placebo, and secondary outcome measures include time to onset of any sentinel events, total bilirubin levels and sBA levels. About Albireo Albireo is a rare disease company focused on the development of novel bile acid modulators to treat pediatric and adult liver diseases. Albireo’s lead product, Bylvay, was approved by the U.S. FDA as the first drug for the treatment of pruritus in all types of progressive familial intrahepatic cholestasis (PFIC), and in Europe for the treatment of PFIC. Bylvay is also being developed to treat other rare pediatric cholestatic liver diseases with a completed Phase III trial in ALGS, an ongoing Phase III study in biliary atresia, as well as Open-label Extension (OLE) studies for PFIC and ALGS. The company has also completed a Phase I clinical trial for A3907 to advance development in adult cholestatic liver disease, with IND-enabling studies progressing with A2342 for viral and cholestatic liver disease. Albireo was spun out from AstraZeneca in 2008 and is headquartered in Boston, Massachusetts, with its key operating subsidiary in Gothenburg, Sweden. For more information on Albireo, please visit www.albireopharma.com . About Ipsen Ipsen is a global, mid-sized biopharmaceutical company focused on transformative medicines in Oncology, Rare Disease and Neuroscience. With Specialty Care sales of €2.6bn in FY 2021, Ipsen sells medicines in over 100 countries. Alongside its external-innovation strategy, the Company’s research and development efforts are focused on its innovative and differentiated technological platforms located in the heart of leading biotechnological and life-science hubs: Paris-Saclay, France; Oxford, U.K.; Cambridge, U.S.; Shanghai, China. Ipsen has around 5,000 colleagues worldwide and is listed in Paris (Euronext: IPN) and in the U.S. through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information, visit ipsen.com About the Offer The tender offer for the outstanding shares of Albireo common stock referenced in this press release has not yet commenced. This press release is for informational purposes only and is not a recommendation, an offer to purchase or a solicitation of an offer to sell securities, nor is it a substitute for the tender offer materials that Ipsen Biopharmaceuticals, Inc. (Parent) and its acquisition subsidiary will file with the SEC, upon the commencement of the tender offer. At the time the tender offer is commenced, Parent and its acquisition subsidiary will file with the SEC a tender offer statement on Schedule TO and thereafter Albireo will file a Solicitation/Recommendation Statement on Schedule 14D-9 with the SEC with respect to the tender offer. Once filed, stockholders will be able to obtain a free copy of these materials and other documents filed by Parent and its acquisition subsidiary and Albireo with the SEC at the website maintained by the SEC at www.sec.gov . The tender offer materials (including an Offer to Purchase, a related Letter of Transmittal and certain other tender offer documents) may also be obtained (when available) for free by contacting the information agent for the tender offer. THE TENDER OFFER MATERIALS (INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL AND CERTAIN OTHER TENDER OFFER DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT ON SCHEDULE 14D-9 WILL CONTAIN IMPORTANT INFORMATION. ALBIREO’S STOCKHOLDERS ARE URGED TO READ THESE DOCUMENTS CAREFULLY WHEN THEY BECOME AVAILABLE (AS EACH MAY BE AMENDED OR SUPPLEMENTED FROM TIME TO TIME) BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION THAT HOLDERS OF ALBIREO’S SECURITIES SHOULD CONSIDER BEFORE MAKING ANY DECISION REGARDING TENDERING THEIR SECURITIES. Additional copies of the tender offer materials and the Solicitation/Recommendation Statement (when available) may be obtained for free by contacting Parent or Albireo. Copies of the documents filed with the SEC by Albireo will be available free of charge on Albireo’s internet website at www.albireopharma.com or by contacting Albireo’s Investor Relations Department at 857 254-5555. Additional Information In addition to the Offer to Purchase, the related Letter of Transmittal and certain other tender offer documents, as well as the Solicitation/Recommendation Statement, Albireo files annual, quarterly and current reports and other information with the SEC. You may read and copy any reports or other information filed by Albireo at the SEC public reference room at 100 F. Street, N.E., Washington D.C. 20549. Please call the Commission at 1-800-SEC-0330 for further information on the public reference room. Albireo’s filings with the SEC are available to the public from the website maintained by the SEC at www.sec.gov . SOURCE: Ipsen

Early, rapid, and sustained efficacy across wide range of patients with evidence of disease modificationLong-term preservation of native liver in PFIC, improvements in pruritus, bile acids, and increased growth over timeLate-breaking oral presentation demonstrates restoration of bile acid secretion in PFIC patients receives “Best of Liver Meeting” distinctionLate-breaking oral presentation of new positive Phase 3 ASSERT trial results in Alagille syndrome receives “Best of Liver Meeting” distinction BOSTON, Nov. 07, 2022 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq: ALBO), a rare disease company developing novel bile acid modulators to treat pediatric and adult liver diseases, presented new data at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting® 2022, being held November 4 – 8, 2022 in Washington, D.C. Across three oral presentations, including two late-breakers, and six posters, the Company provided evidence of early, rapid, and sustained efficacy with Bylvay (odevixibat) treatment in patients with progressive familial intrahepatic cholestasis (PFIC) and Alagille syndrome (ALGS). Two key oral presentations on the PEDFIC trials provided evidence of the disease modifying effects of Bylvay in patients with PFIC. The first underscored that a decrease in serum bile acids was strongly associated with native liver survival for up to three years in PFIC patients treated with Bylvay. A second late-breaking oral presentation showed that Bylvay restored bile acid secretion in PFIC patients with bile salt export pump deficiency. The late-breaking abstract was selected by AASLD for inclusion as a key presentation in “The Best of The Liver Meeting” in the Pediatric Hepatology category. “We are pleased to share long term data in PFIC, providing evidence that Bylvay could modify the course of disease, preserving patients’ native liver and improving families’ quality of life by alleviating disease burden,” said Jan Mattsson, Ph.D., Chief Scientific Officer and Head of R&D at Albireo. “Furthermore, showing early, rapid, and consistent improvements in pruritus and bile acid levels in patients with Alagille syndrome, through the ASSERT body of evidence, makes for a big year at this year’s AASLD congress. PFIC and Alagille syndrome are devastating childhood diseases and our goal at Albireo has always been to relieve the suffering of these young patients and their families.” “Patients with PFIC have long needed a disease modifying treatment,” said Dr. Richard Thompson, Professor of Molecular Hepatology at King’s College London, and principal investigator of the PEDFIC 1 and PEDFIC 2 trials. “Sadly, most children with PFIC end up having a liver transplant, with fewer than half of PFIC1 patients and less than a third of PFIC2 patients keeping their native liver through their eighteenth birthday. I am encouraged by long-term data that showed Bylvay reduced serum bile acids after six months, and helped patients preserve their native liver. This supports the importance of treating early with Bylvay so children can benefit from the protective effects we are seeing on the liver.” Along with results observed with Bylvay treatment in PFIC patients, Albireo shared the first detailed results of the Phase 3 ASSERT trial in Alagille syndrome (ALGS) in a late-breaking oral presentation. The data showed that Bylvay provided early, rapid, clinically meaningful, and sustained improvements in pruritus, as well as significant reductions in bile acids and improvements in sleep quality in patients with ALGS. The ASSERT abstract was selected by AASLD for inclusion as a key presentation in “The Best of The Liver Meeting” in the Pediatric Hepatology category. Analyses of the ASSERT and PEDFIC trials and real-world data on Bylvay treatment, as well as data on the investigational therapy A3907, were highlighted in the following presentations at AASLD The Liver Meeting: Early, Rapid, Sustained Effects in Alagille Syndrome Oral, Late-Breaking Parallel Session Presentation (Abstract #5005; Publication #38786): Efficacy and Safety of Odevixibat in Patients with Alagille Syndrome: Top-Line Results from ASSERT, a Phase 3, Double-Blind, Randomized, Placebo-Controlled StudyPresenter: Dr. Nadia Ovchinsky, Children’s Hospital at Montefiore, Albert Einstein College of Medicine, Bronx, NY, USASession: Late-Breaking Oral Abstract Session 1; Monday, November 7, 2022, 9:15 AM EST Top-line, unblinded data from the ASSERT study demonstrated that Bylvay treatment led to significant and clinically meaningful improvements in pruritus, as well as reductions in bile acid levels and improvements in sleep parameters in patients with ALGS​. Over 90% of patients were pruritus responders and the treatment effects were early, rapid, and sustained. ​Bylvay was generally well tolerated; the overall incidence of treatment emergent adverse events (TEAEs) was similar to placebo​. No patients discontinued the study​ and 96% of patients rolled over into the open-label extension study​. Disease Modification in PFIC Oral Presentation (Abstract #865): Native Liver Survival in Odevixibat Serum Bile Acid Responders: Data from the PEDFIC Studies in Patients with Progressive Familial Intrahepatic CholestasisPresenter: Dr. Richard J. Thompson, Institute of Liver Studies, King’s College LondonSession: Genes to Cures: What’s New in Pediatric Liver Disease; Sunday, November 6, 2:10 PM EST Pooled data analysis showed that PFIC patients who responded to Bylvay remained liver transplant free for up to three years. A decrease in serum bile acids (sBAs) at six months of treatment was strongly associated with native liver survival (p=0.0050) for sBA responders vs non-responders. Oral, Late-Breaking Parallel Session Presentation (Abstract #5004; Publication #38801): Odevixibat Treatment in Responsive Patients with Bile Salt Export Pump Deficiency Restores Biliary Bile Acid Secretion, as Indicated by Serum Bile Acid CompositionPresenter: Dr. Mark Nomden, Department of Surgery and Pediatrics, University Medical Center Groningen, Groningen, the NetherlandsSession: Late-Breaking Oral Abstract Session 1; Monday, November 7, 2022, 10:00 AM EST The analysis found that responders not only had a decrease in sBA concentration, but also alternations in sBA composition, more like that of a healthy individual. Data indicated that Bylvay restored biliary bile acid secretion in treatment-responsive patients with BSEP deficiency. Durable Improvement Across Wide Range of PFIC Patients Poster (Abstract #37939): Long-term Efficacy and Safety of Odevixibat in Patients with Progressive Familial Intrahepatic Cholestasis: Results with 96 Weeks or More of TreatmentPresenter: Dr. Richard J. Thompson, Institute of Liver Studies, King’s College LondonSession: Poster Session IV; Monday, November 7, 1:00 PM – 2:00 PM EST Pooled data analysis showed Bylvay treatment for 96 weeks or more was associated with durable clinical benefits in patients with PFIC, with improvements over time in mean sBA and aminotransferase levels and growth. Mean levels of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) decreased over time, while mean total bilirubin levels were relatively unchanged. Mean height and weight Z scores also increased over time and Bylvay was generally well tolerated. Poster (Abstract #37254): Serum Bile Acid Levels, Pruritus Scores, and Growth Over Time in Odevixibat Responders: Pooled Data from the PEDFIC Studies in Patients with Progressive Familial Intrahepatic CholestasisPresenter: Dr. Lorenzo D'Antiga, Department of Paediatric Hepatology, Gastroenterology, and Transplantation, Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, ItalySession: Poster Session IV; Monday, November 7, 1:00 PM – 2:00 PM EST This analysis of pooled data examined treatment effects in 49 Bylvay responders who had a mean duration of exposure of 110 weeks and showed mean reductions in sBAs and pruritus were sustained over time, across PFIC types in general. Patients also had mean improvements in growth. Poster (Abstract #37273): Effect of Odevixibat in Patients with Progressive Familial Intrahepatic Cholestasis Type 2 with at Least 1 Severe Mutation (BSEP3 Compound Heterozygotes): Pooled Data from the PEDFIC 1 and PEDFIC 2 StudiesPresenter: Dr. Henkjan J. Verkade, Department of Paediatrics, University of Groningen, Beatrix Children’s Hospital/University Medical Centre Groningen, Groningen, the NetherlandsSession: Poster Session IV; Monday, November 7, 1:00 PM – 2:00 PM EST Partial external biliary diversion (PEBD) is not effective in PFIC2 patients with BSEP 3 mutations, but this pooled data analysis showed that treatment with Bylvay provided substantial reductions in sBAs and/or pruritus severity in most patients with BSEP2/BSEP3 mutations, demonstrating that Bylvay may provide an alternative to surgical intervention for these patients. Poster (Abstract #37608): Odevixibat Therapy in Patients with FIC1-Deficient Progressive Familial Intrahepatic Cholestasis and Diarrhea Following Liver Transplantation That Impacted Daily Activities: A Retrospective Case SeriesPresenter: Georg-Friedrich Vogel, Assistant Professor, Medical University of Innsbruck, Innsbruck, AustriaSession: Poster Session IV; Monday, November 7, 1:00 PM – 2:00 PM EST Chologenic diarrhea can be a frequent and severe symptom after liver transplant in patients with FIC1 deficiency. Real-world data in three PFIC1 patients indicated that treatment with Bylvay can improve diarrhea and quality of life in PFIC1 patients with severe diarrhea after transplant. Poster (Abstract #850): Odevixibat Treatment in Patients with Recurrent Episodic Cholestasis and Biallelic Mutations in ATP8B1: A Retrospective Case SeriesPresenter: Dr. Angelo Di Giorgio, Hospital Papa Giovanni XXIII, Bergamo, ItalySession: Poster Session IV; Monday, November 7, 1:00 PM – 2:00 PM EST Recurrent episodic cholestasis is a rare disease characterized by episodes of cholestasis followed by periods of remission. In a case series of six patients treated with Bylvay during a cholestasis episode, most patients experienced clinical improvement, including improvements in sBA levels, hepatic laboratory parameters, pruritus, sleep disturbances and impacts on daily life. Before starting Bylvay treatment, all 6 patients had high sBAs and severe pruritus leading to sleep or mood disturbances and/or the inability to attend school, play sports or work. ASBTi A3907 for Cholestatic Liver Diseases The apical sodium-dependent bile acid transporter (ASBT) plays an important role in regulation of bile acid homeostasis by promoting the reuptake of bile acids in the ileum, bile ducts, and proximal tubuli of the kidney. A3907 is an investigational therapy that is designed to inhibit ASBT to potentially benefit people with cholestatic liver diseases. The study showed that A3097 improved the general condition and liver phenotype of mice with induced obstructive cholestasis by promoting urinary secretion of bile acids, demonstrating that A3907 may have therapeutic potential for patients with cholestatic liver diseases. Treatment with A3907 resulted in marked decreases in serum and bile levels of bile acids relative to vehicle. The A3907 study was selected among the four posters for the Cholestatic and Autoimmune Liver Diseases SIG (Special Interest Group) debrief. Poster (Abstract #37733): Systemic ASBT Inhibition with A3907 Stimulates Urinary Excretion of Bile Acids and Halts Liver Disease Progression in Bile-Duct–Obstructed MicePresenters: Drs. Peter Åkerblad and Erik Lindström, Albireo, Boston, MA, USASession: Poster Session III; Sunday, November 6, 1:00 PM – 2:00 PM EST About the Phase 3 PEDFIC & ASSERT Studies The PEDFIC trials represent the largest studies ever completed in children with PFIC, or progressive familial intrahepatic cholestasis, a rare genetic disorder that causes progressive, life-threatening liver disease. PEDFIC 1 was a randomized, double-blind, placebo-controlled Phase 3 trial that evaluated the efficacy and tolerability of Bylvay in reducing pruritus and serum bile acids (sBAs) in children with PFIC, and PEDFIC 2 is a long-term, open-label Phase 3 extension study. Patients with PFIC have impaired bile flow, or cholestasis, and the resulting bile build-up in liver cells causes liver disease and symptoms, such as intense itching, poor sleep, delayed growth, and diminished quality of life. The harmful impacts of the disease extend to parents and caregivers, as the 2022 multinational PICTURE study revealed that PFIC negatively affects caregivers’ quality of life, relationships, and career prospects. ASSERT is a gold standard, prospective intervention trial in Alagille syndrome, or ALGS, a rare, multisystem genetic disorder that can affect the liver, heart, skeleton, eyes, central nervous system, kidneys, and facial features. With 32 sites across North America, Europe, Middle East, and Asia Pacific, the double-blind, randomized, placebo-controlled ASSERT trial was designed to evaluate the safety and efficacy of 120 µg /kg/day Bylvay for 24 weeks in relieving pruritus in patients with Alagille syndrome (ALGS). Key secondary endpoints measure serum bile acid levels, safety, and tolerability. The Company estimates that ALGS impacts 25,000 people globally. In people with ALGS, liver damage is caused by a paucity of bile ducts preventing bile flow from the liver to the small intestine. Approximately 95% of patients with the condition present with chronic cholestasis, usually within the first three months of life, and as many as 88 percent also present with severe, intractable pruritus. About Bylvay (odevixibat)Bylvay is the first drug approved in the U.S. for the treatment of pruritus in patients 3 months of age and older in all types of progressive familial intrahepatic cholestasis (PFIC). Limitation of Use: Bylvay may not be effective in PFIC type 2 patients with ABCB11 variants resulting in non-functional or complete absence of bile salt export pump protein (BSEP-3). The European Commission (EC) and UK Medicines and Healthcare products Regulatory Agency (MHRA) have also granted marketing authorization of Bylvay for the treatment of PFIC in patients aged 6 months or older. A potent, once-daily, non-systemic ileal bile acid transport inhibitor, Bylvay has minimal systemic exposure and acts locally in the small intestine. Bylvay can be taken as a capsule for patients that are able to swallow capsules, or opened and sprinkled onto food, which is a factor of key importance for adherence in a pediatric patient population. The most common adverse reactions for Bylvay are diarrhea, liver test abnormalities, vomiting, abdominal pain, and fat-soluble vitamin deficiency. The medicine can only be obtained with a prescription. For more information about using Bylvay, see the package leaflet or contact your doctor or pharmacist. For full prescribing information, visit www.bylvay.com. In the U.S. and Europe, Bylvay has orphan exclusivity for its approved PFIC indications, and orphan designations for the treatment of ALGS, biliary atresia and primary biliary cholangitis. Bylvay is being evaluated in the ongoing PEDFIC 2 open-label trial in patients with PFIC, in the BOLD Phase 3 study for patients with biliary atresia and the ASSERT open-label trial for ALGS.Important Safety Information The most common adverse reactions for Bylvay are diarrhea, liver test abnormalities, vomiting, abdominal pain, and fat-soluble vitamin deficiency.Liver Test Abnormalities: Patients should obtain baseline liver tests and monitor during treatment. Dose reduction or treatment interruption may be required if abnormalities occur. For persistent or recurrent liver test abnormalities, consider treatment discontinuation.Diarrhea: Treat dehydration. Treatment interruption or discontinuation may be required for persistent diarrhea.Fat-Soluble Vitamin (FSV) Deficiency: Patient should obtain baseline vitamin levels and monitor during treatment. Supplement if deficiency is observed. If FSV deficiency persists or worsens despite FSV supplementation, discontinue treatment. About AlbireoAlbireo Pharma is a rare disease company focused on the development of novel bile acid modulators to treat pediatric and adult liver diseases. Albireo’s lead product, Bylvay, was approved by the U.S. FDA as the first drug for the treatment of pruritus in all types of progressive familial intrahepatic cholestasis (PFIC), and it is also being developed to treat other rare pediatric cholestatic liver diseases with a completed Phase 3 trial in Alagille syndrome (ALGS), an ongoing Phase 3 study in biliary atresia, as well as Open-label Extension (OLE) studies for PFIC and ALGS. In Europe, Bylvay is reimbursed for the treatment of PFIC in Germany, England, Wales & Northern Ireland, Scotland, Italy, and Belgium. The Company has also completed a Phase 1 clinical trial for A3907 to advance development in adult cholestatic liver disease, with IND-enabling studies progressing with A2342 for viral and cholestatic liver disease. Albireo was spun out from AstraZeneca in 2008 and is headquartered in Boston, Massachusetts, with its key operating subsidiary in Gothenburg, Sweden. For more information on Albireo, please visit www.albireopharma.com. Forward-Looking Statements This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements, other than statements of historical fact, regarding, among other things: Albireo’s expected cash runway; Albireo’s commercialization plans; the plans for, or progress, scope, cost, initiation, duration, enrollment, results or timing for availability of results of, development of Bylvay, A3907, A2342 or any other Albireo product candidate or program; the target indication(s) for development or approval; ;discussions with the FDA or EMA regarding our programs; potential regulatory approval and plans for potential commercialization of Bylvay in biliary atresia or ALGS or Albireo’s other product candidates; the potential benefits or competitive position of Bylvay or any other Albireo product candidate or program or the commercial opportunity in any target indication; or Albireo’s plans, expectations or future operations, financial position, revenues, costs or expenses. Albireo often uses words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “planned,” “continue,” “guidance,” or the negative of these terms or other similar expressions to identify forward-looking statements. Actual results, performance or experience may differ materially from those expressed or implied by any forward-looking statement as a result of various risks, uncertainties and other factors, including, but not limited to: whether the regulatory filings to be made for Bylvay in patients with ALGS will be made on the timelines we expect and be approved by the FDA and EMA; whether the FDA and EMA will complete their respective reviews within target timelines, once determined; whether the FDA and EMA will require additional information, whether we will be able to provide in a timely manner any additional information that the FDA and EMA request, and whether such additional information will be satisfactory to the FDA and EMA; there are no guarantees that Bylvay will be commercially successful; we may encounter issues, delays or other challenges in commercializing Bylvay; whether Bylvay receives adequate reimbursement from third-party payors; the degree to which Bylvay receives acceptance from patients and physicians for its approved indication; challenges associated with execution of our sales activities, which in each case could limit the potential of our product; challenges associated with supply and distribution activities, which in each case could limit our sales and the availability of our product; results achieved in Bylvay in the treatment of patients with PFIC or other approved indications may be different than observed in clinical trials, and may vary among patients; potential negative impacts of the COVID-19 pandemic, including on manufacturing, supply, conduct or initiation of clinical trials, or other aspects of our business; whether favorable findings from clinical trials of Bylvay to date, including findings in PFIC, ALGS and other indications, 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 (such as biliary atresia or ALGS) beyond the jurisdictions in which or indications for which Bylvay is currently approved; there is no guarantee that our other product candidates will be approved; estimates of the addressable patient population for target indications may prove to be incorrect; the outcome and interpretation by regulatory authorities of the ongoing third-party study pooling and analyzing of long-term PFIC patient data; the timing for initiation or completion of, or for availability of data from, clinical trials of Bylvay, including BOLD, and the Phase 2 clinical trial of A3907, and the outcomes of such trials; Albireo’s ability to obtain coverage, pricing or reimbursement for approved products in the United States or Europe; delays or other challenges in the recruitment of patients for, or the conduct of, the Company’s clinical trials; and the Company’s critical accounting policies. These and other risks and uncertainties that Albireo faces are described in greater detail under the heading “Risk Factors” in Albireo’s most recent Annual Report on Form 10-K or in subsequent filings that it makes with the Securities and Exchange Commission. As a result of risks and uncertainties that Albireo faces, the results or events indicated by any forward-looking statement may not occur. Albireo cautions you not to place undue reliance on any forward-looking statement. In addition, any forward-looking statement in this press release represents Albireo’s views only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. Albireo disclaims any obligation to update any forward-looking statement except as required by applicable law. Media Contacts: Colleen Alabiso, 857-356-3905, colleen.alabiso@albireopharma.com Lance Buckley, 917-439-2241, lbuckley@lippetaylor.com Investor Contact: Hans Vitzthum, LifeSci Advisors, LLC., 617-430-7578

– New data presented at the North American Society for Pediatric Gastroenterology, Hepatology & Nutrition meeting (NASPGHAN) – Earlier treatment with Bylvay (odevixibat) provided greater efficacy in children with PFIC – Direct link between level of pruritus relief, liver function, and sleep-related outcomes – Bylvay improved bile acids, sleep, growth, and quality of life even in patients with low pruritus BOSTON, Oct. 13, 2022 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq: ALBO), a rare disease company developing novel bile acid modulators to treat pediatric and adult liver diseases, today announced the presentation of new data at the NASPGHAN Annual Meeting being held in Orlando, Florida from October 12-15, 2022. A new analysis of pooled data from the landmark Phase 3 PEDFIC 1 and PEDFIC 2 trials demonstrates that Bylvay (odevixibat) reduces serum bile acids and pruritus in children with progressive familial intrahepatic cholestasis (PFIC) who have varying levels of baseline hepatic impairment. Importantly, the analysis shows that significantly more patients with mild hepatic impairment at baseline had a serum bile acid response, suggesting children may benefit from earlier treatment with Bylvay. Additional data analyses presented at the meeting show that Bylvay reduced pruritus in patients regardless of their baseline pruritus scores. Further, pruritus reductions were associated with improvements in serum bile acids, hepatic parameters, growth, and disease aspects related to sleep, with greater reductions in pruritus associated, in general, with greater improvements across these additional measures. “These new data provide important evidence that treating children with Bylvay earlier in their disease course could result in greater efficacy,” said Jan Mattsson, Ph.D., Chief Scientific Officer and Head of R&D at Albireo. “Furthermore, the data we are presenting reinforce the medicine’s efficacy in patients with mild pruritus, suggesting patients’ benefit from beginning treatment at the first sign of itching.” “If a physician is trying to determine when to start treatment with Bylvay, this new data suggest the earlier the better,” said Dr. Lorenzo D’Antiga, Department of Paediatric Hepatology, Gastroenterology, and Transplantation, Azienda Ospedaliera Papa Giovanni XXIII, Bergamo. “We should consider treating patients at an early stage of the disease to preserve their native liver and provide relief from the incessant itching associated with the condition. When we see babies stop scratching and sleeping better, we see quality of life improvements for them and their parents.” PFIC is a rare genetic disorder that causes progressive, life-threatening liver disease. Patients with PFIC have impaired bile flow, or cholestasis, and the resulting bile build-up in liver cells causes liver disease and symptoms, such as intense itching, poor sleep, delayed growth, and diminished quality of life. The harmful impacts of the disease extend to parents and caregivers, as the 2022 multinational PICTURE study revealed that PFIC negatively affects caregivers’ quality of life, relationships, and career prospects. New Analyses of the PEDFIC 1 and PEDFIC 2 Trials The global PEDFIC trials represent the largest studies ever completed in children with PFIC. New pooled data analyses from PEDFIC 1, a randomized, double-blind, placebo-controlled Phase 3 trial that evaluated the efficacy and tolerability of Bylvay in reducing pruritus and serum bile acids (sBAs) in children with PFIC, and PEDFIC 2, a long-term, open-label Phase 3 extension study, are being shared at NASPGHAN in an oral presentation and two poster presentations. An additional poster presents data showing that Bylvay may be mixed in liquids to give to the youngest patients: Benefit to Treating Earlier with Bylvay Oral Presentation: Hepatic Impairment Classifications at Baseline in Responders to Odevixibat Therapy in Children with Progressive Familial Intrahepatic Cholestasis Lead Author: Dr. Lorenzo D’Antiga, Department of Paediatric Hepatology, Gastroenterology, and Transplantation, Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, Italy Session Title: Concurrent Session V – Potent P’s in Hepatology: A daily double Date & Time: Saturday, October 15, 2:00pm – 3:30pm ET Pooled data analysis showed that treatment with Bylvay is associated with improvements in serum bile acids and pruritus and suggests greater efficacy when treatment with Bylvay occurs earlier in the disease. Significantly more patients with mild hepatic impairment at baseline, according to Child-Pugh scores, had a serum bile acid response than patients with more severe hepatic impairment at baseline. Among patients with mild and moderate hepatic impairment at baseline, 45% and 24% were Bylvay responders, respectively (p value=0.039). No patients had Child-Pugh scores of severe hepatic impairment at baseline. Across baseline hepatic impairment levels, pruritus response rates were comparable and Bylvay was generally well tolerated. Direct Link Between Sustained Level of Pruritus Reduction and Magnitude of Improvement in Other Disease Parameters Poster Abstract #301: Outcomes with Odevixibat in Patients with Progressive Familial Intrahepatic Cholestasis by Level of Pruritus Reduction: Pooled Analysis from the PEDFIC Trials Lead Author: Dr. Ekkehard Sturm, Pediatric Gastroenterology and Hepatology, University Children’s Hospital Tübingen, Tübingen, Germany Session Title: Poster Session II Date & Time: Friday, October 14, 12:00pm – 2:30pm ET An analysis of pooled data from 77 patients treated with Bylvay showed that pruritus reductions were associated with improvements in serum bile acids, hepatic parameters, growth, and disease aspects related to sleep and, in general, patients who had larger-magnitude pruritus reductions had larger-magnitude improvements in other outcomes. The median percentage change from baseline to weeks 70–72 in serum bile acid level was –12% in patients who had pruritus reductions of <1, –54% in patients who had reductions of ≥1 to <2, –94% in patients who had reductions of ≥2 to <3,–96% in patients who had reductions of ≥3 to <4, and –94% in patients who achieved a pruritus score of 0 or 1. Bylvay was generally well tolerated regardless of the level of pruritus reduction. Evidence of Bylvay Efficacy in Patients with Lower Baseline Pruritus Severity Poster Abstract #547: Outcomes in Patients with Progressive Familial Intrahepatic Cholestasis Treated with Odevixibat who had Medium or Lower Pruritus Severity at Baseline: Pooled Analysis from the PEDFIC 1 and PEDFIC 2 Studies Lead Author: Dr. Kathleen M. Loomes, Children’s Hospital of Philadelphia, Philadelphia, PA, USA Session Title: Poster Session III Date & Time: Saturday, October 15, 12:00pm – 2:30pm ET A pooled data analysis of 16 patients who had medium or lower pruritus severity at baseline showed that treatment with Bylvay was associated with improvement in serum bile acids, pruritus, hepatic parameters, growth, sleep, and quality of life (QoL), suggesting even patients with lower baseline pruritus severity may benefit from Bylvay treatment. Treatment with Bylvay led to a serum bile acid response in 31% of patients; improvements in mean percentage of days needing help falling asleep, falling from baseline of 41% to 18%; needing soothing falling from 37% to 19%; and sleeping with a caregiver falling from 36% to 16%; but not in percentage of days with scratching associated with bleeding, which was 9% at baseline and 30% at weeks 61-72. Bylvay was generally well tolerated. Stability of Bylvay Mixed in Liquid for Pediatric Dosing Poster Abstract #70:Stability of Odevixibat Oral Capsule Contents in Liquids Lead Author: Dr. Prince Korah, Albireo, Boston, MA, USA Session Title: Poster Session I Date & Time: Thursday, October 13, 5:00pm – 7:00pm ET An in vitro study showed that when Bylvay is mixed in a range of liquids often used to administer medicines to young infants, it is stable and provides children with an adequate dose. As the symptoms of PFIC often begin in infancy, when a child is not yet eating solid food, it is important that parents have an option to mix Bylvay in a liquid to give to their young children. Albireo will also host a product theater featuring an expert perspective on treating PFIC patients with Bylvay: Product Theater: Relief Made Possible with Bylvay® (odevixibat) Expert: Dr. Saeed Mohammad, Monroe Carell Jr. Children’s Hospital at Vanderbilt, Nashville, TN, USA Date & Time: Friday, October 14, 1:45pm -2:15pm ET Location: Promenade in front of Exhibit Hall About Bylvay (odevixibat)   Bylvay is the first drug approved in the U.S. for the treatment of pruritus in patients 3 months of age and older in all types of progressive familial intrahepatic cholestasis (PFIC). Limitation of Use: Bylvay may not be effective in PFIC type 2 patients with ABCB11 variants resulting in non-functional or complete absence of bile salt export pump protein (BSEP-3). The European Commission (EC) and UK Medicines and Healthcare Products Regulatory Agency (MHRA) have also granted marketing authorization of Bylvay for the treatment of PFIC in patients aged 6 months or older. A potent, once-daily, non-systemic ileal bile acid transport inhibitor, Bylvay has minimal systemic exposure and acts locally in the small intestine. Bylvay can be taken as a capsule for patients that are able to swallow capsules, or opened and sprinkled onto food, which is a factor of key importance for adherence in a pediatric patient population. The most common adverse reactions for Bylvay are diarrhea, liver test abnormalities, vomiting, abdominal pain, and fat-soluble vitamin deficiency. The medicine can only be obtained with a prescription. For more information about using Bylvay, see the package leaflet or contact your doctor or pharmacist. For full prescribing information, visit .  In the U.S. and Europe, Bylvay has orphan exclusivity for its approved PFIC indications, and orphan designations for the treatment of ALGS, biliary atresia and primary biliary cholangitis. Bylvay is being evaluated in the ongoing PEDFIC 2 open-label trial in patients with PFIC, in the BOLD Phase 3 study for patients with biliary atresia and the ASSERT open-label trial for ALGS.   Important Safety Information   The most common adverse reactions for Bylvay are diarrhea, liver test abnormalities, vomiting, abdominal pain, and fat-soluble vitamin deficiency.   Liver Test Abnormalities: Patients should obtain baseline liver tests and monitor during treatment. Dose reduction or treatment interruption may be required if abnormalities occur. For persistent or recurrent liver test abnormalities, consider treatment discontinuation.   Diarrhea: Treat dehydration. Treatment interruption or discontinuation may be required for persistent diarrhea.   Fat-Soluble Vitamin (FSV) Deficiency: Patient should obtain baseline vitamin levels and monitor during treatment. Supplement if deficiency is observed. If FSV deficiency persists or worsens despite FSV supplementation, discontinue treatment.   About Albireo   Albireo Pharma is a rare disease company focused on the development of novel bile acid modulators to treat pediatric and adult liver diseases. Albireo’s lead product, Bylvay, was approved by the U.S. FDA as the first drug for the treatment of pruritus in all types of progressive familial intrahepatic cholestasis (PFIC), and it is also being developed to treat other rare pediatric cholestatic liver diseases with a completed Phase 3 trial in Alagille syndrome (ALGS), an ongoing Phase 3 study in biliary atresia, as well as Open-label Extension (OLE) studies for PFIC and ALGS. In Europe, Bylvay is reimbursed for the treatment of PFIC in Germany, England, Wales & Northern Ireland, Scotland, Italy, and Belgium. The Company has also completed a Phase 1 clinical trial for A3907 to advance development in adult cholestatic liver disease, with IND-enabling studies progressing with A2342 for viral and cholestatic liver disease. Albireo was spun out from AstraZeneca in 2008 and is headquartered in Boston, Massachusetts, with its key operating subsidiary in Gothenburg, Sweden. For more information on Albireo, please visit .   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 expected cash runway; Albireo’s commercialization plans; the plans for, or progress, scope, cost, initiation, duration, enrollment, results or timing for availability of results of, development of Bylvay, A3907, A2342 or any other Albireo product candidate or program; the target indication(s) for development or approval; the timing for anticipated regulatory filings; discussions with the FDA or EMA regarding our programs; potential regulatory approval and plans for potential commercialization of Bylvay in biliary atresia or ALGS or Albireo’s other product candidates; the impact of the Expanded Access Program; the potential benefits or competitive position of Bylvay or any other Albireo product candidate or program or the commercial opportunity in any target indication; or Albireo’s plans, expectations or future operations, financial position, revenues, costs or expenses. Albireo often uses words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “planned,” “continue,” “guidance,” or the negative of these terms or other similar expressions to identify forward-looking statements. Actual results, performance or experience may differ materially from those expressed or implied by any forward-looking statement as a result of various risks, uncertainties and other factors, including, but not limited to: whether the regulatory filings to be made for Bylvay in patients with ALGS will be made on the timelines we expect and be approved by the FDA and EMA; whether the FDA and EMA will complete their respective reviews within target timelines, once determined; whether the FDA and EMA will require additional information, whether we will be able to provide in a timely manner any additional information that the FDA and EMA request, and whether such additional information will be satisfactory to the FDA and EMA; there are no guarantees that Bylvay will be commercially successful; we may encounter issues, delays or other challenges in commercializing Bylvay; whether Bylvay receives adequate reimbursement from third-party payors; the degree to which Bylvay receives acceptance from patients and physicians for its approved indication; challenges associated with execution of our sales activities, which in each case could limit the potential of our product; challenges associated with supply and distribution activities, which in each case could limit our sales and the availability of our product; results achieved in Bylvay in the treatment of patients with PFIC or other approved indications may be different than observed in clinical trials, and may vary among patients; potential negative impacts of the COVID-19 pandemic, including on manufacturing, supply, conduct or initiation of clinical trials, or other aspects of our business; whether favorable findings from clinical trials of Bylvay to date, including findings in PFIC, ALGS and other indications, 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 (such as biliary atresia or ALGS) beyond the jurisdictions in which or indications for which Bylvay is currently approved; there is no guarantee that our other product candidates will be approved; estimates of the addressable patient population for target indications may prove to be incorrect; the outcome and interpretation by regulatory authorities of the ongoing third-party study pooling and analyzing of long-term PFIC patient data; the timing for initiation or completion of, or for availability of data from, clinical trials of Bylvay, including BOLD, and the Phase 2 clinical trial of A3907, and the outcomes of such trials; Albireo’s ability to obtain coverage, pricing or reimbursement for approved products in the United States or Europe; delays or other challenges in the recruitment of patients for, or the conduct of, the Company’s clinical trials; any repurchase by the Company of Sagard’s interest in the royalty interest payments under our royalty monetization agreement with Sagard could materially impact our financial condition; 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 Contacts: Colleen Alabiso, 857-356-3905, colleen.alabiso@albireopharma.com Lance Buckley, 917-439-2241, lbuckley@lippetaylor.com Investor Contact: Hans Vitzthum, LifeSci Advisors, LLC., 617-430-7578