– BylvayTM (odevixibat) approved in
– Commercialization underway with Bylvay, first prescriptions received in the
– German price listing expected in September –
– Company to host a conference call and webcast today at
“Bylvay is now approved in over 30 countries around the world and we are delighted that the first prescriptions for Bylvay have been received in the U.S.,” said
Recent and Upcoming Highlights
July 20, the Company received U.S.Food & Drug Administration (FDA) approval of Bylvay, the first drug approved for the treatment of pruritus in all subtypes of progressive familial intrahepatic cholestasis (PFIC). Upon approval, the FDA issued a rare pediatric disease Priority Review Voucher (PRV) for Bylvay. The Company plans to monetize the PRV as a source of non-dilutive capital.
Europe, the Company received European Commission (EC) authorization for Bylvay as the first drug approved for the treatment of all subtypes of PFIC, with the first launch in Germany.
- First Bylvay prescriptions generated and first patients enrolled in AlbireoAssistTM, a customized, in-house patient program with dedicated Care Coordinators who support patients treated with Bylvay in the
U.S.Albireo and Travere sales representatives and medical teams are meeting with the approximately 100 key HCPs at 60 centers in the U.S.to provide education on Bylvay. Value dossiers submitted to main insurers and meetings set up to obtain access for patients.
- The Company continues to enroll and dose patients in two global Phase 3 studies for Alagille syndrome (ALGS) and biliary atresia. The ASSERT Study is a pivotal trial of Bylvay in patients with ALGS. The BOLD Study is the first and only pivotal trial of an IBAT inhibitor in biliary atresia, which is the largest pediatric cholestatic liver disease. Both studies remain on track to report topline data with ASSERT in 2022 and BOLD in 2024.
- New data in nine accepted abstracts presented at
European Association for the Studyof the Liver (EASL) International Liver Congress, demonstrating Albireo’s leading position in the science of bile acid modulation with further evidence of efficacy and tolerability of Bylvay. Highlights from the Phase 3 PEDFIC studies showed further evidence of a sustained and durable effect with Bylvay, while also showing improvements in sleep, growth and hepatic parameters in patients with PFIC.
- Presented data at the 6th World Congress of Pediatric Gastroenterology, Hepatology, and Nutrition (WCPGHAN) Meeting. Data from the Phase 3 pivotal PEDFIC 1 study and the PEDFIC 2 long-term extension study of Bylvay showed long-term treatment was associated with clinically meaningful, positive effects on cholestasis, growth and sleep parameters in patients with PFIC.
- Clinical development continues for A3907, the first oral systemic apical sodium-dependent bile acid transporter (ASBT) inhibitor in clinical studies, being developed for adult cholestatic liver diseases such as primary sclerosing cholangitis (PSC) and primary biliary cholangitis (PBC). A Phase 1, first-in-human, double-blind, single and multiple ascending dose study in healthy adult subjects to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of an A3907 oral formulation is underway with data readout expected by end of year.
- Data presented at EASL on Phase 1 candidate, A3907, showing positive impacts on markers of cholestatic disease.
- The Company is completing IND-enabling studies for A2342, the first potent oral systemic sodium-taurocholate co-transporting peptide (NTCP) inhibitor for development in viral and cholestatic liver diseases.
- Presented a corporate overview at several investor conferences during the quarter, including the
William Blair Biotech Focus Conference2021, Piper Sandler’s Virtual EASL Takeaway Day, Jefferies Virtual Healthcare Conferenceand William Blair’s 41st Annual Growth Stock Conference.
Second Quarter 2021 Financial Results
- Revenues were
$2.4 millionfor the second quarter of 2021, compared to $1.9 millionfor the second quarter of 2020. The higher revenue was due to the estimated royalty revenue to be received from EA Pharma for elobixibat for the treatment of chronic constipation. The royalty revenue is passed on to HealthCare Royalty Partners.
- R&D expenses were
$20.9 millionfor the second quarter of 2021, compared to $18.4 millionfor the second quarter of 2020. The higher expenses were principally due to personnel expenses as the Company continues to increase our headcount and program activities. The increase in program activities related to Bylvay consisting of biliary atresia and Alagille syndrome, and A3907 were partially offset by Bylvay PFIC expenses, elobixibat and preclinical programs.
- G&A expenses were
$16.9 millionfor the second quarter of 2021, compared to $8.5 millionfor the second quarter of 2020. The increase is attributable to personnel and related expenses as the Company continued to increase headcount and commercialization readiness activities related to Bylvay.
- Net loss for the second quarter of 2021 was
$36.4 million, or $(1.90)per share, compared to $20.6 million, or $(1.38)per share for the second quarter of 2020.
- The Company had cash and cash equivalents of
$186.3 millionas of June 30, 2021compared to $217.1 millionat March 31, 2021. The company anticipates the 2021 operating cash burn will be between $130-$135 million. 2021 revenue from Bylvay is anticipated to be in the low single digit U.S.$ millions. The Company anticipates cash runway into 2023, excluding any proceeds from the planned sale of the PRV received on approval, which should be sufficient to launch Bylvay and expansion beyond PFIC.
To access the live conference call by phone, please dial 877-407-0792 (domestic) or 201-689-8263 (international) and provide the access code 13720893. Live audio webcast will be accessible from the Media & Investors page of Albireo’s website. To ensure a timely connection to the webcast, it is recommended that participants register at least 15 minutes prior to the scheduled start time. An archived version of the webcast will be available for replay on the Events & Presentations section of the Media & Investors page of Albireo’s website for 3 months following the event.
About Bylvay (odevixibat)
Bylvay is the first drug treatment approved in the
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 and expectations for commercializing Bylvay in the
Condensed Consolidated Balance Sheets
(in thousands, except share and per share data)
|Cash and cash equivalents||$||186,286||$||251,272|
|Prepaid expenses and other current assets||8,966||10,593|
|Total current assets||195,252||261,865|
|Property and equipment, net||868||478|
|Liabilities and Stockholders' Equity|
|Current portion of note payable, net of discount||1,992||—|
|Other current liabilities||1,250||948|
|Total current liabilities||26,993||25,282|
|Liability related to sale of future royalties||67,834||65,894|
|Note payable, net of discount||7,865||9,621|
|Other long-term liabilities||3,301||3,579|
|Additional paid-in capital||464,665||456,472|
|Accumulated other comprehensive loss||(4,379||)||(8,612||)|
|Total stockholders’ equity||113,504||181,231|
|Total liabilities and stockholders’ equity||$||219,497||$||285,607|
Condensed Consolidated Statements of Operations
(in thousands, except share and per share data)
|Three Months Ended
||Six Months Ended
|Research and development||20,894||18,397||40,837||34,527|
|General and administrative||16,940||8,474||32,213||16,627|
|Other operating (income) expense, net||(2,374||)||(6,744||)||4,154||72|
|Total operating expenses||35,460||20,127||77,204||51,226|
|Interest expense, net||(3,389||)||(2,388||)||(7,344||)||(4,326||)|
|Net loss per share attributable to holders of common stock:|
|Net loss per common share - basic and diluted||$||(1.90||)||$||(1.38||)||$||(4.18||)||$||(3.58||)|
|Weighted-average common shares used to compute basic and diluted net loss per common share||19,200,747||14,981,756||19,196,798||14,556,986|
Source: Albireo Pharma, Inc.