Announcement • Dec 10

Albireo Pharma, Inc. Submits for U.S. FDA and EMA Product Approval of Once-Daily Odevixibat for PFIC

Albireo Pharma, Inc. announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval of odevixibat for the treatment of patients with progressive familial intrahepatic cholestasis (PFIC). Odevixibat is a potent, once-daily, non-systemic ileal bile acid transport inhibitor (IBATi) being developed to treat rare pediatric cholestatic liver diseases, including PFIC, biliary atresia and Alagille syndrome. The EMA has validated the odevixibat MAA on the accelerated assessment timeline, which begins the formal review process. With FDA and EMA regulatory submissions complete, odevixibat has the potential to become the first approved drug treatment for patients with PFIC in the U.S and Europe. Odevixibat has previously received Fast Track, Rare Pediatric Disease and Orphan Drug Designations in the U.S. In addition to PFIC, odevixibat has Orphan Drug Designations for the treatment of Alagille Syndrome, biliary atresia and primary biliary cholangitis. The EMA has granted odevixibat accelerated assessment, Orphan Designation, as well as access to the PRIority MEdicines (PRIME) scheme for the treatment of PFIC. The EMA’s Pediatric Committee has agreed to Albireo’s odevixibat Pediatric Investigation Plans for PFIC and biliary atresia. With U.S. and EU regulatory submissions for odevixibat in PFIC completed, the Company anticipates potential regulatory approvals, issuance of a rare pediatric disease priority review voucher and launch in the second half of 2021. Phase 3 data was recently presented at the AASLD that showed a durable response to odevixibat in patients with PFIC. Full results from PEDFIC 1, the first and largest, global, Phase 3 study ever conducted in PFIC, confirm both U.S. and EU primary endpoints were met in the randomized, double-blind, placebo-controlled trial. Additionally, long-term data from PEDFIC 2, an open-label Phase 3 extension study, demonstrate continued and durable reductions in sBAs, improvements in pruritus assessments and encouraging markers of liver and growth function in patients treated up to 48 weeks. Across both studies, odevixibat was generally well tolerated, and treatment-emergent adverse events (TEAEs) were mostly mild or moderate. Collectively, these studies reaffirm odevixibat’s potential to be the first drug treatment approved for patients living with PFIC, a devastating disease which is currently treated with surgical options including liver transplantation. Odevixibat is also currently being evaluated in the ongoing PEDFIC 2 Phase 3 open-label trial in patients with PFIC, and the BOLD Phase 3 trial in patients with biliary atresia. The Phase 3 trial of odevixibat in Alagille syndrome will be the third pivotal trial of odevixibat. The Company also provides an Expanded Access Program for eligible patients with PFIC in the U.S., Canada, Australia and Europe. Progressive familial intrahepatic cholestasis (PFIC) is a rare disorder that causes progressive, life-threatening liver disease. Patients have impaired bile flow, or cholestasis, caused by genetic mutations. The resulting bile build-up in liver cells causes liver disease and symptoms. The most prominent and problematic ongoing manifestation of the disease is pruritus, or intense itching, which often results in a severely diminished quality of life. Other symptoms include jaundice, poor weight gain and slowed growth. In many cases, PFIC leads to cirrhosis and liver failure within the first 10 years of life, and nearly all people with PFIC require treatment before age 30. There are no drugs currently approved for PFIC, only surgical options that include partial external biliary diversion (PEBD) and liver transplantation. Biliary atresia is a rare pediatric liver disease with symptoms typically developing about two to eight weeks after birth. Damaged or absent bile ducts outside the liver result in bile and bile acids being trapped inside the liver, quickly resulting in cirrhosis, and even liver failure. Children have clay-colored or no color in their stools, jaundice among other things and a few patients are pruritic. Biliary atresia is the most common pediatric cholestatic liver disease and is the leading cause of liver transplants among children as there are no approved drug treatments. Alagille Syndrome (ALGS) is a rare multisystem genetic disorder that 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 ALGS present with chronic cholestasis, usually within the first three months of life, and up to 88% also present with severe, intractable pruritus. Currently, there are no approved drug treatments. Odevixibat is an investigational product candidate being developed to treat rare pediatric cholestatic liver diseases, including progressive familial intrahepatic cholestasis (PFIC), biliary atresia and Alagille syndrome. A potent, once-daily, non-systemic ileal bile acid transport inhibitor (IBATi), odevixibat acts locally in the small intestine. Odevixibat does not require refrigeration and can be taken as a capsule for older children, or opened and sprinkled onto food, which are factors of key importance for adherence in a pediatric patient population. Odevixibat is currently being evaluated in the ongoing PEDFIC 2 open-label trial (NCT03659916) and the BOLD Phase 3 trial in patients with biliary atresia (NCT04336722). Initiation of a pivotal Phase 3 trial of odevixibat for Alagille syndrome is also anticipated by the end of 2020.

Biotechs Industry Growth	-14.59%
Revenue growth rate	49.25%
Return on equity	-131.05%
Net Margin	-228.51%
Last Earnings Update	30 Sep 2022

Date	Revenue	Earnings	G+A Expenses	R&D Expenses
30 Sep 22	57	-131	80	87
30 Jun 22	51	-36	77	85
31 Mar 22	45	-33	72	83
31 Dec 21	41	-34	71	81
30 Sep 21	11	-48	65	81
30 Jun 21	9	-136	59	82
31 Mar 21	9	-120	51	79
31 Dec 20	8	-108	44	76
30 Sep 20	12	-90	35	70
30 Jun 20	11	-82	30	60
31 Mar 20	11	-78	27	53
31 Dec 19	10	-63	24	45
30 Sep 19	4	-71	23	41
30 Jun 19	3	-63	21	38
31 Mar 19	2	-61	20	34
31 Dec 18	13	-46	18	31
30 Sep 18	12	-35	17	26
30 Jun 18	12	-28	17	19
31 Mar 18	11	-19	17	16
31 Dec 17	0	-24	16	13
30 Sep 17	3	-31	16	10
30 Jun 17	3	-28	13	9
31 Mar 17	11	-20	12	9
31 Dec 16	11	-16	10	8
30 Sep 16	13	-5	8	8
30 Jun 16	13	-4	8	7
31 Mar 16	5	-8	5	6

Data	Last Updated (UTC time)
Company Analysis	2023/03/03 19:23
End of Day Share Price	2023/03/02 00:00
Earnings	2022/09/30
Annual Earnings	2021/12/31

Package	Data	Timeframe	Example US Source ^*
Company Financials	10 years	Income statement Cash flow statement Balance sheet	SEC Form 10-K SEC Form 10-Q
Analyst Consensus Estimates	+3 years	Forecast financials Analyst price targets	Analyst Research Reports Blue Matrix
Market Prices	30 years	Stock prices Dividends, Splits and Actions	ICE Market Data SEC Form S-1
Ownership	10 years	Top shareholders Insider trading	SEC Form 4 SEC Form 13D
Management	10 years	Leadership team Board of directors	SEC Form 10-K SEC Form DEF 14A
Key Developments	10 years	Company announcements	SEC Form 8-K

Analyst	Institution
Brian Skorney	Baird
null null	Guggenheim Securities, LLC
Seamus Fernandez	Guggenheim Securities, LLC

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Albireo Pharma Past Earnings Performance

Past criteria checks 0/6

Key information

Recent past performance updates

Third quarter 2022 earnings released: US$1.92 loss per share (vs US$2.96 profit in 3Q 2021)

Albireo Pharma, Inc. to Report Q3, 2022 Results on Nov 08, 2022

Second quarter 2022 earnings released: US$2.04 loss per share (vs US$1.90 loss in 2Q 2021)

Albireo Pharma, Inc. to Report Q2, 2022 Results on Aug 15, 2022

First quarter 2022 earnings released: US$2.19 loss per share (vs US$2.29 loss in 1Q 2021)

Albireo Pharma, Inc. to Report Q1, 2022 Results on May 16, 2022

Recent updates

Forecast to breakeven in 2025

Albireo Pharma, Inc. Announces U.S. Food and Drug Administration Accept Its Supplemental New Drug Application

Ipsen Biopharmaceuticals, Inc. entered into a definitive merger agreement to acquire Albireo Pharma, Inc. (NasdaqCM:ALBO) for approximately $910 million.

Albireo Pharma, Inc. Submits Bylvay(R) Alagille Syndrome Regulatory Filings to FDA and EMA

Albireo Pharma, Inc. Appoints Paul Streck as Chief Medical Officer and Craig Hopkinson to its Board of Directors

Third quarter 2022 earnings released: US$1.92 loss per share (vs US$2.96 profit in 3Q 2021)

Albireo Pharma, Inc. Presents New Data at the American Association for the Study of Liver Diseases

Albireo Pharma, Inc. Completes Phase 3 BOLD Study Enrollment of Bylvay(R) in Biliary Atresia

Albireo Pharma, Inc. to Present Late Breaking Bylvay (odevixibat) Data at AASLD 2022

Albireo Pharma, Inc. to Report Q3, 2022 Results on Nov 08, 2022

Albireo Pharma, Inc. Reports Positive Topline Data from Phase 3 Trial of Bylvay® (Odevixibat) in Alagille Syndrome

Albireo to Showcase New Data at AASLD The Liver Meeting® 2022

No longer forecast to breakeven

Albireo Pharma, Inc. Announces Enabled Reimbursed Access to Bylvay for the Treatment of All Types of Progressive Familial Intrahepatic Cholestasis Patients in Italy

Albireo Pharma, Inc. Announces New Committee Member Appointments

Second quarter 2022 earnings released: US$2.04 loss per share (vs US$1.90 loss in 2Q 2021)

No longer forecast to breakeven

Albireo Pharma, Inc. Announces the Appointments of Habib Dable and Susan Alesina to its Board of Directors

Albireo Pharma, Inc. to Report Q2, 2022 Results on Aug 15, 2022

Albireo Pharma, Inc. Announces Lancet Gastroenterology & Hepatology Published the Results of the Pivotal PEDFIC 1 Trial

Albireo Pharma, Inc.(NasdaqCM:ALBO) dropped from Russell Microcap Value Index

Albireo Presents New Bylvay® (odevixibat) Data at Annual ESPGHAN Congress

Albireo Pharma, Inc. Announces Presentation of New Data in Pediatric and Adult Liver Diseases

Albireo Pharma, Inc. Provides Sales Guidance for the Year 2022

First quarter 2022 earnings released: US$2.19 loss per share (vs US$2.29 loss in 1Q 2021)

Albireo Pharma, Inc. to Report Q1, 2022 Results on May 16, 2022

Insufficient new directors

Albireo Pharma, Inc., Annual General Meeting, Jun 16, 2022

Albireo Completes Enrollment in Pivotal Phase 3 ASSERT Study of BylvayTM (odevixibat) in Alagille Syndrome

Full year 2021 earnings: EPS in line with analyst expectations despite revenue beat

Albireo Pharma, Inc. Announces Publication of the PICTURE Study Highlighting the Caregiver Impact of PFIC, a Rare and Devastating Children’s Liver Disease

Forecast to breakeven in 2024

Albireo Announces Positive Topline Data from Phase 1 Study of A3907

Albireo Pharma, Inc. Presenting New Bylvay™ (Odevixibat) Data at NASPGHAN 2021

Third quarter 2021 earnings released: EPS US$2.96 (vs US$1.96 loss in 3Q 2020)

Albireo Pharma, Inc. Receives UK MHRA Approval of Bylvay® (odevixibat)

Second quarter 2021 earnings released: US$1.90 loss per share (vs US$1.38 loss in 2Q 2020)

Albireo Pharma, Inc. Announces European Commission Authorization of Bylvay (Odevixibat), the First Drug Approved for the Treatment of All Subtypes of Progressive Familial Intrahepatic Cholestasis

Albireo Pharma, Inc. Announces Expanded Phase 3 Data on Bylvay™ (odevixibat) and A3907 at Upcoming Easl International Liver Congress

Albireo Pharma, Inc Presents Clinical Data from Its Phase 3 Pedfic 1 Study and an Interim Data Cut of the Pedfic 2 Long-Term Extension Study of Its Lead Product Candidate, Bylvay

Albireo Receives Positive CHMP Opinion for Bylvay™ (odevixibat) for Treatment of Progressive Familial Intrahepatic Cholestasis (PFIC)

Albireo Pharma, Inc. Announces the Presentation of New Data from its Phase 3 PEDFIC 1 Study and PEDFIC 2 Long-Term Extension Study of its Lead Product Candidate, Bylvay

First quarter 2021 earnings released: US$2.29 loss per share (vs US$2.23 loss in 1Q 2020)

New 90-day low: €27.62

Full year 2020 earnings released: US$6.73 loss per share (vs US$5.04 loss in FY 2019)

Revenue beats expectations

Albireo Pharma, Inc. to Report Q4, 2020 Results on Feb 25, 2021

New 90-day high: €34.76

Albireo Announces U.S. Fda Acceptance of New Drug Application for Odevixibat

Albireo Pharma, Inc. Initiates Global Phase 3 Clinical Trial of Odevixibat in Alagille Syndrome

New 90-day high: €33.98

Albireo Pharma, Inc. Submits for U.S. FDA and EMA Product Approval of Once-Daily Odevixibat for PFIC

Albireo Pharma, Inc. Announce New Phase 3 Data at AASLD Show Durable Response to Odevixibat in a Rare Pediatric Liver Disease

Third quarter 2020 earnings released: US$1.96 loss per share

Revenue beats expectations

Albireo Pharma, Inc.’s Odevixibat PFIC Phase 3 Results Accepted for AASLD Late-Breakers

Albireo Pharma, Inc. to Report Q3, 2019 Results on Nov 06, 2019

Albireo Pharma, Inc. has completed a Follow-on Equity Offering in the amount of $160 million.

Albireo Pharma, Inc. to Report Q2, 2020 Results on Aug 06, 2020

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