— Commercial preparations advancing, with topline PEDFIC 1 results expected mid-2020 —
— First sites initiated for second pivotal trial in biliary atresia —
— Management to host conference call and webcast today at
“Despite the unprecedented challenges of COVID-19, our fundamentals remain unchanged, and we continue to make significant progress across our development programs, while accelerating preparations for commercialization,” said
“COVID-19 has had a sweeping impact across the industry and society as a whole. We have successfully adapted our business operations, with the safety of our employees and the patient communities as our top priority. We are fortunate that our clinical trials in PFIC and NASH have completed enrollment this quarter, and we have sufficient clinical trial supply to support those programs. As of now, our prior guidance regarding our clinical trials remains unchanged.”
More information on the impact of COVID-19 on Albireo is available at albireopharma.com.
- With the PEDFIC 1 trial fully randomized, have accelerated preparations for commercialization. More than three-quarters of patients have completed the trial, and we continue to expect topline results mid-2020 and anticipate potential first regulatory approval H2 2021.
- We have initiated the first clinical trial sites for the BOLD pivotal study, Biliary Atresia and the Use of Odevixibat in Treating Liver Disease. Biliary atresia is a rare pediatric liver disease that is the leading cause of liver transplants among children, and for which there is no approved pharmacological therapy. Biliary atresia is the most common rare pediatric cholestatic liver disease and the largest market opportunity in that therapeutic category. The
U.S. Food and Drug Administration(FDA) and European Commissionhave granted orphan designations for odevixibat in the treatment of biliary atresia.
- Received FDA feedback and are finalizing pivotal trial design in Alagille syndrome. Anticipate initiating trial by the end of this year. The FDA and the
European Commissionhave granted orphan designations for odevixibat in the treatment of Alagille syndrome.
- Achieved full enrollment in elobixibat Phase 2 trial in NAFLD and NASH. Proof-of-concept study is the first study ever conducted in both NAFLD and NASH patients with an IBAT inhibitor. Expect topline data by mid 2020. Additionally, expect topline data from another Phase 2 trial being conducted through our partner EA Pharma in
Japanby the end of the year or early next year.
- Continued as planned IND-enabling studies of lead preclinical candidate with novel mechanism of action.
- Completed equity capital raise of net
First Quarter 2020 Financial Results
- Revenues were
$1.5 millionfor the first quarter of 2020, compared with $0.6 millionfor the first quarter of 2019. The higher revenue was due to the estimated royalty revenue 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
$16.1 millionfor the first quarter of 2020, compared with $8.3 millionfor the first quarter of 2019. The higher expenses were primarily due to program expenses for odevixibat and elobixibat, as well as personnel costs, as we continue to increase our program activities and headcount.
- G&A expenses were
$8.2 millionfor the first quarter of 2020, compared with $5.3 millionfor the first quarter of 2019. The increase was attributable to personnel and related expenses, as we continue to increase our headcount, and commercialization readiness expenses.
- Net loss for the first quarter of 2020 was
$31.5 million, or $(2.23)per share, compared with $16.7 million, or $(1.39)per share for the first quarter of 2019.
- The company had cash and cash equivalents at
March 31, 2020, of $150.5 million, which compares with $150.3 millionat March 31, 2019. During the first quarter of 2020, an additional $43.0 millionof net cash was raised through an underwritten public offering of our common stock. As a result, cash and cash equivalents are anticipated to be sufficient into the second half of 2021.
As previously announced, Albireo will host a conference call and webcast today, May 7, 2020, at
Albireo was spun out from AstraZeneca in 2008.
Odevixibat is a product candidate being developed to treat rare pediatric cholestatic liver diseases and is in Phase 3 development in both progressive familial intrahepatic cholestasis (PFIC) and biliary atresia. A highly potent and selective inhibitor of the ileal bile acid transporter (IBAT), odevixibat has minimal systemic exposure and acts locally in the small intestine.
The odevixibat PFIC program has received fast track, rare pediatric disease and orphan drug designations in
This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements, other than statements of historical fact, regarding, among other things: the plans for, or progress, scope, cost, initiation, duration, enrollment, results or timing for availability of results of, development of odevixibat, elobixibat or any other Albireo product candidate or program, including regarding expectations regarding the impact of COVID-19 on our business and our ability to adapt our approach as appropriate; the Phase 3 clinical program for odevixibat in patients with PFIC, the pivotal trial for odevixibat in biliary atresia, the planned pivotal trial for odevixibat in Alagille syndrome, the Phase 2 clinical trial for elobixibat in NAFLD/NASH, and another Phase 3 trial for elobixibat being conducted by EA Pharma in
Albireo Pharma, Inc.
Condensed Consolidated Balance Sheets
(in thousands, except share and per share data)
|Cash and cash equivalents||$||150,515||$||131,843|
|Prepaid expenses and other current assets||7,818||9,956|
|Total current assets||158,333||141,799|
|Property and equipment, net||554||597|
|Liabilities and Stockholders' Equity|
|Other current liabilities||798||653|
|Total current liabilities||15,147||18,924|
|Liability related to sale of future royalties||49,407||48,714|
|Other long-term liabilities||4,121||4,270|
|Additional paid-in capital||291,221||245,769|
|Accumulated other comprehensive income||12,739||6,452|
|Total stockholders’ equity||113,434||93,161|
|Total liabilities and stockholders’ equity||$||182,109||$||165,069|
Albireo Pharma, Inc.
Condensed Consolidated Statements of Operations
(in thousands, except share and per share data)
|Three Months Ended
|Research and development||16,130||8,329|
|General and administrative||8,153||5,293|
|Other operating expense, net||6,816||2,296|
|Total operating expenses||31,099||15,918|
|Interest expense, net||(1,938||)||(1,309||)|
|Net loss per share attributable to holders of common stock:|
|Net loss per common share - basic and diluted||$||(2.23||)||$||(1.39||)|
|Weighted-average shares outstanding:|
|Weighted-average common shares used to compute basic and diluted net loss per common share||14,132,217||12,001,125|
Source: Albireo Pharma, Inc.