IPN-60260

Ipsen completes acquisition of Albireo, expanding the scope of its Rare Disease portfolio Bringing medicines to patients with rare liver disease, a growth opportunity for Ipsen Lead asset Bylvay® (odevixibat) is the first approved treatment in progressive familial intrahepatic cholestasis, with two additional investigational indications in rare, pediatric liver diseases Acquisition adds novel bile-acid modulators and an innovative pipeline to the existing rare liver portfolio PARIS, FRANCE, 3March2023 – Ipsen (Euronext: IPN: ADR: IPSEY) today announced it has completed the acquisition of Albireo Pharma, Inc., a leading innovator in bile-acid modulators to treat rare liver conditions. The acquisition enriches Ipsen’s Rare Disease portfolio, with promising therapeutics for pediatric and adult rare cholestatic-liver diseases, innovative pipeline potential, as well as scientific and commercial capabilities. Pursuant to the transaction, Ipsen acquires all the issued and outstanding shares at a price of $42.00 per share in cash plus one non-transferable contingent value right (CVR) of $10.00 per share. “The acquisition of Albireo will greatly strengthen our portfolio in rare diseases,” said David Loew, Chief Executive Officer of Ipsen. “I am excited to welcome new colleagues to Ipsen, who led the innovation on the development of novel bile acid modulators, like Bylvay, to treat rare liver diseases in children and adults. With Ipsen’s global presence, together we will be able to bring the full potential of the approved medicines to patients around the world.” Lead medicine, Bylvay, is a potent once-daily ileal bile acid transport inhibitor (IBATi) that received regulatory approvals 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 In addition to the lead indication, Bylvay was accepted for Priority Review by the U.S. FDA for pediatric and adult Alagille syndrome (ALGS) in February 2023 with a Prescription Drug User Fee Act (PDUFA) action date of June 15, 2023. A variation seeking authorization for ALGS was also submitted to the EMA in 2022, which has been validated for review. In a third indication, the rare pediatric cholestatic liver disease, biliary atresia (BA), Bylvay is in late-stage development with the Phase III BOLD (Biliary atresia and the use of Odevixibat in treating Liver Disease) trial. This is the first, prospective, double-blind clinical trial in this patient population. Bylvay has orphan exclusivity for the approved indications in PFIC in the U.S. and E.U., and 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 has also acquired A3907 and A2342, two clinical-stage assets in Albireo’s pipeline. A3907 is a novel oral systemic apical sodium-dependent bile-acid transporter inhibitor currently in Phase II clinical development for primary sclerosing cholangitis (PSC).3 A2342 is an oral systemic sodium-taurocholate co-transporting peptide (NTCP) inhibitor being evaluated for viral and cholestatic diseases in a Phase I trial. As of 2 March 2023, close of business, Albireo’s common stock will cease to be traded on the NASDAQ Capital Market and will be subsequently deregistered. ENDS About Bylvay®(odevixibat) Bylvay 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 PFIC1, where it has orphan exclusivity. Bylvay was launched in the U.S. in 2021, 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, the U.K., 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) 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 PFIC PFIC is a spectrum4-7 of autosomal recessive genetic disorders in which cholestasis may lead to end-stage liver disease.8 The estimated global incidence of PFIC is 1 in 100,000 live births.8 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.8 In addition, other rare forms of PFIC exist with varying degrees of cholestasis.9 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.7 Up to 80% of PFIC patients suffer from severe pruritus, associated with abrasions, skin mutilation, hemorrhage or scarring.10 About ALGS 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.11 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.12,13 The estimated global incidence of ALGS is 3 in 100,000 live births.14 Currently in the U.S., it is estimated that there are 1,300 patients who may be eligible for IBATi treatment. About BA 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.15 Of those who survive into the third decade after birth, almost all have portal hypertension or other complications of cirrhosis.16 New therapies are therefore needed to delay or avoid the need for liver transplantation following Kasai procedure.17 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.18 Currently in the U.S., it is estimated that there are 750 patients who may be eligible for IBATi treatment. About Ipsen Ipsen is a global, mid-sized biopharmaceutical company focused on transformative medicines in Oncology, Rare Disease and Neuroscience. With total sales of €3.0bn in FY 2022, 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 For further information: Ipsen Contacts Investors Craig Marks Vice President, Investor Relations +44 (0)7584 349 193 Media Anna Gibbins Global Head of Franchise Communications, Rare Disease +44 (0)7717801900 Amy Wolf VP, Head of Corporate Brand Strategy & Communications +41 79 576 07 23 Ioana Piscociu Senior Manager Global Media Relations +33 6 69 09 12 96 Ipsen’s forward-looking statements The forward-looking statements, objectives and targets contained herein are based on Ipsen’s management strategy, current views and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated herein. All of the above risks could affect Ipsen’s future ability to achieve its financial targets, which were set assuming reasonable macroeconomic conditions based on the information available today. Use of the words ‘believes’, ‘anticipates’ and ‘expects’ and similar expressions are intended to identify forward-looking statements, including Ipsen’s expectations regarding future events, including regulatory filings and determinations. Moreover, the targets described in this document were prepared without taking into account external-growth assumptions and potential future acquisitions, which may alter these parameters. These objectives are based on data and assumptions regarded as reasonable by Ipsen. These targets depend on conditions or facts likely to happen in the future, and not exclusively on historical data. Actual results may depart significantly from these targets given the occurrence of certain risks and uncertainties, notably the fact that a promising medicine in early development phase or clinical trial may end up never being launched on the market or reaching its commercial targets, notably for regulatory or competition reasons. Ipsen must face or might face competition from generic medicine that might translate into a loss of market share. Furthermore, the research and development process involves several stages each of which involves the substantial risk that Ipsen may fail to achieve its objectives and be forced to abandon its efforts with regards to a medicine in which it has invested significant sums. Therefore, Ipsen cannot be certain that favorable results obtained during preclinical trials will be confirmed subsequently during clinical trials, or that the results of clinical trials will be sufficient to demonstrate the safe and effective nature of the medicine concerned. There can be no guarantees a medicine will receive the necessary regulatory approvals or that the medicine will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Other risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and healthcare legislation; global trends toward healthcare cost containment; technological advances, new medicine and patents attained by competitors; challenges inherent in new-medicine development, including obtaining regulatory approval; Ipsen's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Ipsen’s patents and other protections for innovative medicines; and the exposure to litigation, including patent litigation, and/or regulatory actions. Ipsen also depends on third parties to develop and market some of its medicines which could potentially generate substantial royalties; these partners could behave in such ways which could cause damage to Ipsen’s activities and financial results. Ipsen cannot be certain that its partners will fulfil their obligations. It might be unable to obtain any benefit from those agreements. A default by any of Ipsen’s partners could generate lower revenues than expected. Such situations could have a negative impact on Ipsen’s business, financial position or performance. Ipsen expressly disclaims any obligation or undertaking to update or revise any forward-looking statements, targets or estimates contained in this press release to reflect any change in events, conditions, assumptions or circumstances on which any such statements are based, unless so required by applicable law. Ipsen’s business is subject to the risk factors outlined in its registration documents filed with the French Autorité des Marchés Financiers. The risks and uncertainties set out are not exhaustive and the reader is advised to refer to Ipsen’s latest Universal Registration Document, available on ipsen.com. label (fda.gov) Bylvay, INN-odevixibat (europa.eu) Safety and Tolerability of A3907 in Primary Sclerosing Cholangitis - Full Text View - ClinicalTrials.gov (last accessed 21 February 2023) Henkel S. World J Hepatol. 2019;11(5):450-463 Schatz B. Hepatol Commun. 2018;2(5):504-514 Aldrian D. J Clin Med. 2021;10(3):481 Folmer D E. Hepatology 2009;50(5):1597-1605 Davit-Spraul A. Orphanet J Rare Dis. 2009;4:1 Amirneni S World J Gastroenterol. 2020;26(47):7470- 7484 Baker A. Clin Res Hepatol Gastroenterol. 2019;43(1):20-36 U.S. Department of Health and Human Services. Alagille syndrome- about the disease. Genetic and rare diseases information center. Singh S P.Euroasian J Hepatogastroenterol. 2018;8(2):140-147 Feldman A G. Neoreviews 2013;14 (2): e63–e73 Leonard L. European Journal of Human Genetics. 2014; 22:435 Lykavieris P. Heptology. 2005;4 (2):366-371 Jain V. Hepatology. 2001;73 (1); 93-98 Efficacy and Safety of Odevixibat in Children with Biliary Atresia Who Have Undergone a Kasai HPE (BOLD) - Full Text View - ClinicalTrials.gov Hopkins P J Pediatr. 2017;187:253-257. doi: 10.1016/j.jpeds.2017.05.006. Epub 2017 Jun 1. Attachment Ipsen completes acquisition of Albireo - Press Release - 03-23

Bylvay (odevixibat)granted Priority Review by U.S. FDA ASSERT study demonstrated efficacy of Bylvay in pruritus, bile acids and sleep with a low drug-related diarrhea rate in Alagille patients Approval in second indication would more than double Bylvay market opportunity BOSTON, Feb. 14, 2023 (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 that the U.S. Food and Drug Administration (FDA) has accepted the Company’s supplemental New Drug Application (sNDA) and issued a Prescription Drug User Fee Act (PDUFA) action date of June 15, 2023 for a second Bylvay (odevixibat) indication for patients with Alagille syndrome (ALGS). As defined by the FDA, the Priority Review timeline is 6 months and the agency will direct overall attention and resources to the evaluation of applications for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications. With completed submissions for Bylvay in the U.S. and EU for use in patients with ALGS, the Company anticipates approvals in mid-2023. “After completing the regulatory submissions in record time and now with FDA Priority Review acceptance, we are one step closer to bringing Bylvay to market to treat patients with Alagille syndrome, providing hope for this rare disease community that deserves treatment options,” said Ron Cooper, President and Chief Executive Officer of Albireo. “With the Phase 3 randomized, placebo-controlled ASSERT data and Orphan Designation, we are planning for approval in Alagille syndrome in mid-2023, expanding access to Bylvay for more of the cholestatic liver community.” The sNDA submission is supported by results from the ASSERT Phase 3 study. Positive data from the Phase 3 ASSERT study recently presented at the 2022 AASLD The Liver Meeting demonstrated 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 across the two most prominent genetic types in Alagille syndrome, JAG1 and NOTCH2. Over 90% of patients were pruritus responders and 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. “As an advocate for Alagille families, it is great to know physicians may have another drug treatment option for the debilitating pruritus that affects so many Alagille patients,” said Roberta Smith, President, Alagille Syndrome Alliance. “I personally know the devastation of pruritus and the terrible impact to a child’s quality of life and ability to sleep and thrive; this FDA acceptance and priority review paves the way to alleviating that burden for more patients.” In Europe, the Company has also submitted Bylvay for a variation to the EMA seeking authorization for ALGS and this submission has been accepted and validated. Bylvay received orphan exclusivity for the treatment of PFIC and Orphan Drug Designations for the treatment of ALGS, biliary atresia and primary biliary cholangitis. A potent, once-daily, non-systemic ileal bile acid transport inhibitor (IBATi), Bylvay has minimal systemic exposure and acts locally in the small intestine. Bylvay is already 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), and in Europe for the treatment of all types of PFIC in patients aged 6 months or older. ASSERT Phase 3 Clinical Trial Data ASSERT is a gold standard, prospective intervention trial with 32 sites across North America, Europe, Middle East, and Asia Pacific. The double-blind, randomized, placebo-controlled trial was designed to evaluate the safety and efficacy of 120 µg /kg/day Bylvay for 24 weeks in relieving pruritus in patients with ALGS. Key secondary endpoints measure serum bile acid levels and safety and tolerability. The trial enrolled patients aged 0 to 17 years of age with a genetically confirmed diagnosis of ALGS. In the primary analysis, the study met the primary endpoint showing statistically significant reduction in pruritus as measured by the PRUCISION Observer-Reported Outcome scratching score (0-4 point scale), from baseline at month 6 (weeks 21 to 24), compared to the placebo arm (p=0.002). Over 90% of patients were pruritus responders during the study, as defined as at least a 1-point drop at any time point. The study also met the key secondary endpoint showing a statistically significant reduction in serum bile acid concentration from baseline to the average of weeks 20 and 24 (compared to the placebo arm p=0.001). Statistically significant improvements in multiple sleep parameters were observed as early as week 1-4 compared to patients on placebo with continued improvement through week 24. In the study, there were no patient discontinuations. Bylvay was well tolerated, with an overall adverse event incidence similar to placebo and a low incidence of drug-related diarrhea (11.4% vs. 5.9% placebo). ALGS & Expanded Access Program (EAP) Alagille syndrome, or ALGS, is a rare, multisystem genetic disorder that the Company estimates impacts 25,000 people globally. ALGS can affect the liver, heart, skeleton, eyes, central nervous system, kidneys and facial features. 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% also present with severe, intractable pruritus. Albireo continues to prioritize access and continued scientific research for patients living with rare cholestatic liver diseases, with the Expanded Access Program (EAP) for ALGS. Albireo has partnered with Tanner Pharma Group. Eligible patients with ALGS in Europe and the U.S., with no other options, may receive Bylvay on a free-of-charge (FOC) basis through our existing expanded access program, subject to authorization by the relevant country competent authority and meeting Albireo’s eligibility criteria. If you are a physician who would like to request ALGS EAP access for your patient, please send your enquiry to Tanner using odevixibat@tannerpharma.com, and you will receive a response within one working day with further information. About Bylvay (odevixibat)  The European Commission (EC) and UK Medicines and Healthcare products Regulatory Agency (MHRA) have granted marketing authorization of Bylvay for the treatment of progressive familial intrahepatic cholestasis (PFIC) in patients aged 6 months or older. Bylvay is also 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 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). 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 Europe and the U.S., 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 in Europe for the treatment of PFIC. Bylvay 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. 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 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; potential regulatory approval, potential timing for approval, and plans for potential commercialization of Bylvay in biliary atresia or ALGS or in additional countries, 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: uncertainties as to the timing of the transactions contemplated by Albireo’s merger agreement with Ipsen, and any effects of the announcement, pendency or completion of the announced merger, including the anticipated benefits therefrom; whether the regulatory filings made for Bylvay in patients with ALGS will be approved by the FDA and EMA and on the timelines we anticipate; whether the FDA and EMA will complete their respective reviews within target timelines, including the FDA’s PDUFA goal date; the risk that the sNDA will not be approved despite the FDA’s acceptance of the sNDA for review or that the variation application will not be approved despite the EMA’s acceptance and validation of the submission; 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