Albireo Reports Q3 Financial Results and Business Update
– Bylvay™ (odevixibat) approved in the
– ASSERT & BOLD Phase 3 studies enrolling, on track for topline data readouts –
– 12 abstracts accepted at AASLD & NASPGHAN scientific congresses –
– A3907 Phase 1 topline data expected in Q4’21, A2342 composition of matter allowed –
– Elobixibat royalty revenue of
– Company to host a conference call and webcast today at
“With Bylvay now available, the positive responses from prescribers, patients and payors have translated to early sales,” said
Recent and Upcoming Highlights
- Bylvay was approved by the
U.S.Food & Drug Administration (FDA) on July 20, 2021as the first drug for the treatment of pruritus in all types of progressive familial intrahepatic cholestasis (PFIC). Bylvay was available days after approval and the U.S.commercial launch is underway with prescriptions and sales being generated.
Europe, Bylvay was authorized for the treatment of PFIC by the European Commission(EC) and UK Medicines and Healthcare Products Regulatory Agency(MHRA). Bylvay is currently available in Germanyand is expected to become available for sale in additional European countries following country price listings and reimbursement approvals.
- Albireo completed an exclusive distribution and supply agreement with
Swixx BioPharma AGin Central and Eastern Europe. This follows agreements with Medison Pharma, Ltd.in Israel, GEN İlaç in Turkey, Genpharm Services in Saudi Arabiaand other Gulf countries and Jadeite Medicines Inc.in Japan, all of which are expected to drive availability of Bylvay in key markets globally.
- The Company had five abstracts from the PEDFIC 1 and PEDFIC 2 studies of Bylvay accepted at the American Association for the Study of Liver Diseases (AASLD)
The Liver Meeting® to be held November 12– 15, 2021. The data being presented show evidence of long-term safety and efficacy; evidence of disease modification; improvements in hepatic health, growth and sleep that reduce the disease burden as well as improvement in serum bile acids and improvement in pruritus symptoms for all types of PFIC. These data further contribute to the largest body of prospective data collected in patients with PFIC.
- Five abstracts were accepted at the 2021
North American Society for Pediatric Gastroenterology, Hepatology & Nutrition (NASPGHAN) Annual Meeting to be held December 12– 18, 2021. Highlighted PFIC data from the Phase 3 PEDFIC 1 and PEDFIC 2 studies of Bylvay showed correlations in serum bile acid reductions and long-term improvements in pruritus and sleep; treatment with Bylvay had considerable impact on quality of life of patients and their caregivers as well as efficacy and safety of Bylvay in PFIC patients with prior partial external biliary diversion. There will also be a poster presentation on the ASSERT study design for Alagille syndrome.
- The Company continues to enroll and dose patients in the Phase 3 ASSERT Study, a pivotal trial of Bylvay in patients with Alagille syndrome and remains on track to report topline data in 2022.
- The Phase 3 BOLD Study, which is the first and only pivotal trial of an ileal bile acid transporter (IBAT) inhibitor in biliary atresia, remains on track to report topline data in 2024. Biliary atresia is the largest pediatric cholestatic liver disease.
- The Bylvay Phase 2 study in Alagille syndrome, biliary atresia and PFIC patients was published in the Clinics and Research in Hepatology and Gastroenterology October issue. Study results from the open-label, multi-center study in pediatric patients with cholestatic liver disease showed Bylvay was well tolerated, reduced serum bile acids and improved pruritus and sleep. Data also showed reduced pruritus correlated significantly with reduced serum bile acids. No serious adverse events were treatment related; most adverse events were transient. No diarrhea was reported during the treatment period.
Pipeline: Next Generation Bile Acid Modulators
- Clinical development continues for A3907, the first oral systemic apical sodium-dependent bile acid transporter (ASBT) inhibitor being developed for adult cholestatic liver diseases. 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.
- Two posters on A2342 will be presented at AASLD The Liver Meeting®, with data showing inhibition of hepatitis B viral entry and replication in preclinical models as well as effects in serum bile acids in organic anion transporting polypeptide (OATP) KO mice and in cynomolgus monkeys, a species expressing human-like OATPs, indicating target engagement. IND-enabling studies for A2342 are currently being completed for the first potent oral systemic sodium-taurocholate co-transporting peptide (NTCP) inhibitor for development in viral and cholestatic liver diseases, demonstrating Albireo’s leading position in the science of bile acid modulation.
- A2342 composition of matter patent allowed in the
U.S., with expiration in 2040 upon grant.
- In October, the Company entered into an exclusive licensing agreement with
Jadeite Medicines, Inc.for the development and commercialization of Bylvay in Japanfor PFIC, ALGS and biliary atresia. Under the terms of the agreement, Jadeite Medicines, a biopharmaceutical platform company focused on developing innovative pharmaceutical products, will be responsible for clinical development, regulatory approval and commercialization of Bylvay in Japan, where there is significant market opportunity. In addition to an upfront payment of $15 million, Albireo is entitled to receive up to $120 millionin milestone payments and double-digit royalties.
September 7, the Company entered into a definitive agreement to sell the rare pediatric disease Priority Review Voucher (PRV). The PRV was granted to Albireo in July 2021under an FDA provision that encourages the development of treatments for rare pediatric diseases. The non-dilutive capital from the sale further strengthens the Company’s financial position.
- The Company presented a corporate overview at several investor conferences during the quarter, including the 2021
Wedbush PacGrow Healthcare Virtual Conference, the 2021 Virtual Wells Fargo Healthcare Conference, the H.C. Wainwright 23rd Annual Global Investment Conferenceand the Baird 2021 Global Healthcare Conference.
Third Quarter 2021 Financial Results
- Bylvay net revenue was
$1.1 millionfor the third quarter of 2021. Bylvay was approved during this quarter, therefore revenue is from a partial quarter and there was no product revenue for the third quarter of 2020.
- Royalty revenue was
$2.6 millionfor the third quarter of 2021, compared with $2.1 millionfor the third quarter of 2020, an increase of $0.5 million. The increase relates to estimated royalty revenue to be received from EA Pharma for elobixibat for the treatment of chronic constipation which is passed on to HealthCare Royalty partners.
- Cost of product revenue was
$0.4 millionfor the third quarter of 2021. Following Bylvay approval certain manufacturing and quality headcount costs are now included in cost of product revenue. There were no material costs, as materials related to current product sold was expensed prior to approval. Bylvay was approved during this quarter, therefore there was no cost of product revenue for the third quarter of 2020.
- R&D expenses were
$21.1 millionfor the third quarter of 2021 compared with $22.2 millionfor the third quarter of 2020, a decrease of $1.1 million. The decrease in R&D expenses for the 2021 period were principally due to the completion of the PEDFIC1 study and the completion of the elobixibat Phase 2 trial in NASH in the third quarter 2020 offset by increases in expenses related to the Bylvay Phase 3 studies and early assets.
- Selling, general and administrative expenses were
$17.6 millionfor the third quarter of 2021 compared with $11.7 millionfor the third quarter of 2020, an increase of $5.9 million. The increase is attributable to personnel and related expenses as we continue to increase our headcount, and commercial expenses to launch Bylvay.
- Net income for the third quarter of 2021 was
$57.1 millioncompared to a net loss of $30.7 millionfor the third quarter of 2020 driven by the onetime sale of the PRV sales. Earnings per share for the third quarter of 2021 were $2.90on a fully diluted basis, compared to ( $1.96) for the third quarter of 2020.
- The Company had cash and cash equivalents of
$262.6 millionas of September 30, 2021, compared to $186.3 millionat June 30, 2021. The 2021 operating cash burn guidance has been $130-$135 millionand it’s expected to be closer to $130 million. During the third quarter of 2021, an additional $103.4 millionof net proceeds were received from the completed sale of the Priority Review Voucher. An additional $15 millioncash upfront fee from the recently announced Japanlicensing agreement due to be received in the fourth quarter of 2021. As a result, cash and cash equivalents are anticipated to be sufficient to fully fund the launches of Bylvay and the next stages of the early asset portfolio. 2021 revenue from Bylvay is anticipated to be $3-4 million.
To access the live conference call by phone, please dial 877-407-0792 (domestic) or 201-689-8263 (international) and provide the access code 13723976. Live audio webcast will be accessible from the Media & Investors page of Albireo’s website. To ensure a timely connection to the webcast, it is recommended that participants register at least 15 minutes prior to the scheduled start time. An archived version of the webcast will be available for replay on the Events & Presentations section of the Media & Investors page of Albireo’s website for 3 months following the event.
Albireo will host a post-AASLD conference call and live audio webcast on
About Bylvay (odevixibat)
Bylvay is the first drug approved in the
This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements, other than statements of historical fact, regarding, among other things: Albireo’s commercialization plans and expectations for commercializing Bylvay in the
Condensed Consolidated Balance Sheets
(in thousands, except share and per share data)
|Cash and cash equivalents||$||262,612||$||251,272|
|Accounts receivable, net||1,307||—|
|Prepaid expenses and other current assets||7,779||10,593|
|Total current assets||271,894||261,865|
|Property and equipment, net||775||478|
|Liabilities and Stockholders' Equity|
|Other current liabilities||5,043||948|
|Total current liabilities||33,149||25,282|
|Liability related to sale of future royalties||68,513||65,894|
|Note payable, net of discount||9,929||9,621|
|Other long-term liabilities||3,138||3,579|
|Additional paid-in capital||472,363||456,472|
|Accumulated other comprehensive loss||(722||)||(8,612||)|
|Total stockholders’ equity||181,716||181,231|
|Total liabilities and stockholders’ equity||$||296,445||$||285,607|
Condensed Consolidated Statements of Operations
(in thousands, except share and per share data)
|Three Months Ended
||Nine Months Ended
|Product revenue, net||$||1,060||$||—||$||1,060||$||—|
|Cost of product revenue||431||—||431||—|
|Research and development||21,083||22,200||61,920||56,727|
|Selling, general and administrative||17,612||11,663||49,825||28,290|
|Other operating expense (income), net||3,719||(4,628||)||7,873||(4,556||)|
|Total operating expenses||42,414||29,235||119,618||80,461|
|Other income (loss):|
|Gain from sale of priority review voucher, net of transaction costs||103,387||—||103,387||—|
|Interest expense, net||(3,331||)||(3,639||)||(10,675||)||(7,965||)|
|Net income (loss) before income taxes||60,875||(30,743||)||(19,279||)||(82,834||)|
|Provision for income taxes||3,789||—||3,789||—|
|Net income (loss)||$||57,086||$||(30,743||)||$||(23,068||)||$||(82,834||)|
|Net income (loss) per share attributable to holders of common stock:|
|Weighted-average common shares outstanding:|
Source: Albireo Pharma, Inc.