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Albireo Pharma reported a net product revenue of $7 million for 2021, driven by its bile acid modulator Bylvay, which was launched in the U.S. and Europe. The company has strong cash reserves of $248.1 million, expected to fund operations into 2024. Notable highlights include the endorsement of Bylvay by NICE and ongoing Phase 3 studies for Alagille syndrome. Despite a net loss of $34 million for 2021, financial metrics show positive momentum with anticipated sales of $5-6 million for Q1 2022.
Albireo Pharma (Nasdaq: ALBO) will host a conference call and live audio webcast on March 1, 2022, at 10:00 a.m. ET to share a business update and review the financial results for Q4 and the year ended December 31, 2021. The company is known for developing novel bile acid modulators targeting rare liver diseases, with its lead product, Bylvay, set to treat pruritus linked to progressive familial intrahepatic cholestasis (PFIC). The conference call can be accessed via phone or a webcast available on Albireo's investor relations page.
Albireo Pharma announced that the National Institute for Health and Care Excellence (NICE) has recommended Bylvay (odevixibat) for treating all types of progressive familial intrahepatic cholestasis (PFIC)MHRA approval and marks the first successful clinical and economic benefit assessment of Bylvay in Europe. The treatment is expected to be funded within 90 days in England, Wales, and Northern Ireland, addressing a critical need for non-surgical options for PFIC patients.
Albireo Pharma (Nasdaq: ALBO) announced the publication of the PICTURE study, evaluating the impact of progressive familial intrahepatic cholestasis (PFIC) on caregivers. The study highlights significant burdens on caregivers' quality of life, including mental and physical health challenges. Key findings indicate that 82% of caregivers experienced relationship strain, and 86% reported sleep difficulties. Caregivers also faced high impairment in daily activities and work productivity. The study underscores the need for resources and support for PFIC families, aligning with Albireo’s commitment to improving treatment through Bylvay.
Albireo Pharma (Nasdaq: ALBO) has updated its guidance for Bylvay, expecting global net sales of $6-7M, exceeding prior estimates of $3-4M. The company's unaudited cash is at least $248M, ensuring sufficient funding through 2024. The BOLD Phase 3 study for biliary atresia has surpassed 50% enrollment, while the ASSERT Phase 3 study for Alagille syndrome is on track for topline data by year-end. Management highlights rapid Bylvay uptake and a robust cash position.
Albireo Pharma announced positive results from its Phase 1 trial of A3907, the first oral systemic ASBT inhibitor, revealing it was safe and well tolerated among participants. No serious adverse events occurred, and the drug demonstrated favorable pharmacokinetics and systemic exposure. The results indicate significant potential for treating liver diseases, showing target engagement signals with favorable outcomes. The company plans to initiate a Phase 2 study for adult liver disease in 2022, advancing its development of novel bile acid modulators.
Albireo Pharma (Nasdaq: ALBO) presented five posters on Bylvay (odevixibat) at the NASPGHAN meeting, highlighting significant correlations between reductions in serum bile acids and long-term improvements in pruritus and sleep among patients with progressive familial intrahepatic cholestasis (PFIC). Key findings indicated that Bylvay improves quality of life in pediatric patients, even those with prior biliary diversion surgery. The treatment demonstrated a favorable safety profile, with mild adverse events reported. Bylvay is the first approved treatment for pruritus in PFIC patients aged 3 months and older in the U.S.
Albireo Pharma (Nasdaq: ALBO) announced the departure of Chief Medical Officer Pat Horn at year-end, after nearly 3.5 years with the company. Jan Mattsson, co-founder and Chief Scientific Officer, will serve as interim head of R&D. Albireo has achieved significant milestones, including the launch of its first drug, Bylvay, and ongoing Phase 3 trials for Alagille syndrome and biliary atresia. The company aims for $1 billion in Bylvay sales by the end of the decade. Despite positive advancements, there are ongoing uncertainties regarding the commercialization of Bylvay and other product candidates.
Albireo Pharma has appointed Constantine Chinoporos as Chief Business Officer to enhance its corporate and business development strategy. Chinoporos brings 30 years of biopharmaceutical experience from companies like Boston Pharmaceuticals, Sanofi, and Eli Lilly. He will focus on a forward integration strategy to expedite growth opportunities, particularly with the recent global launch of Bylvay. Mr. Chinoporos will receive inducement grants of stock options and restricted stock units tied to his service. Bylvay is positioned as a potential billion-dollar product, enhancing Albireo's growth prospects.
Albireo Pharma (ALBO) announced encouraging data from the Phase 3 PEDFIC 1 and 2 studies, showing that Bylvay (odevixibat) significantly improves liver health and function in patients with progressive familial intrahepatic cholestasis (PFIC) over 128 weeks. Key results include a 40% response rate in serum bile acids and improved pruritus scores. Additionally, the company presented A2342 preclinical data indicating potential against Hepatitis B. A post-AASLD conference call is scheduled for November 16, 2021, to discuss these findings.
