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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Albireo Pharma Inc | NASDAQ:ALBO | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 44.15 | 44.10 | 44.33 | 0 | 01:00:00 |
“2020 was a tremendous year as we delivered on several key milestones, including announcement of positive results from our pivotal PEDFIC 1 Phase 3 study in PFIC patients, completion of regulatory filings in the U.S. and EU in record time, and initiation of two additional pivotal Phase 3 studies in Alagille syndrome and biliary atresia,” said Ron Cooper, President and Chief Executive Officer of Albireo. “We anticipate 2021 to be a similar year of significant accomplishments with the planned approval and commercialization of odevixibat in the U.S. and EU, issuance of our priority review voucher, enrollment advancing in our Phase 3 trials and fully characterizing our two new bile acid modulators with novel MOAs.”
Recent and Upcoming Highlights
Odevixibat
Early-Stage Pipeline
Corporate
Fourth Quarter 2020 Financial Results
Financial Results for the Year Ended December 31, 2020
Conference CallAlbireo will host a conference call and webcast today, February 25 at 10:00 a.m. ET. To access the live conference call by phone, dial 877-407-0792 (domestic) or 201-689-8263 (international), and provide the access code 13715566. Live audio webcast will be accessible from the Media & Investors page of Albireo’s website ir.albireopharma.com/. 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 An archived version of the webcast will be available for replay on the Events & Presentations section of the Media & Investors page of Albireo’s website for 3 months following the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 OdevixibatOdevixibat is an investigational product candidate being developed to treat rare pediatric cholestatic liver diseases, including PFIC, biliary atresia and ALGS. 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. The FDA has granted Priority Review and set a PDUFA goal date of July 20, 2021. In Europe, the EMA validated MAA. Odevixibat is the only IBATi granted accelerated assessment by the EMA.
Odevixibat also been granted 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. In addition to PFIC, odevixibat has Orphan Drug Designations for the treatment of Alagille syndrome, biliary atresia and primary biliary cholangitis. 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. The Company anticipates potential regulatory approvals, issuance of a rare pediatric disease priority review voucher and launch in the second half of 2021.
The MAA and NDA filings are supported by results from PEDFIC 1 and PEDFIC 2 Phase 3 studies. PEDFIC 1 was the first and largest, global, pivotal Phase 3 study conducted in PFIC, which evaluated the efficacy and tolerability of odevixibat in reducing pruritus and serum bile acids in a randomized, double-blind, placebo-controlled trial. In the PEDFIC 1 study, odevixibat met both primary endpoints and was well tolerated with very low incidence of diarrhea/frequent bowel movements (9.5% of odevixibat treated patients vs. 5.0% of placebo patients). ir.albireopharma.com/news-releases/news-release-details/albireo-phase-3-trial-meets-both-primary-endpoints-odevixibat. PEDFIC 2 is a long-term, open-label Phase 3 extension study. The Company also provides an Expanded Access Program (EAP) for eligible patients with PFIC in the U.S., Europe, Canada and Australia. Odevixibat is also currently being evaluated in the BOLD Phase 3 trial in patients with biliary atresia, and the global Phase 3 ASSERT trial for ALGS.
About AlbireoAlbireo Pharma is a clinical-stage biopharmaceutical company focused on the development of novel bile acid modulators to treat rare pediatric and adult liver diseases. Albireo’s lead product candidate, odevixibat, is being developed to treat rare pediatric cholestatic liver diseases with Phase 3 pivotal trials in PFIC, Alagille syndrome and biliary atresia. The Company completed IND-enabling studies for new preclinical candidate A3907 and plans to advance development in adult liver disease. Albireo was spun out from AstraZeneca in 2008 and is headquartered in Boston, Massachusetts, with its key operating subsidiary in Gothenburg, Sweden. The Boston Business Journal named Albireo one of the 2020 Best Places to Work in Massachusetts for the second consecutive year. For more information on Albireo, please visit albireopharma.com.
Forward-Looking Statements 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 or any other Albireo product candidate or program; including expectations regarding the impact of the COVID-19 pandemic on our business and our ability to adapt our plans and activities as appropriate; the pivotal trial for odevixibat in biliary atresia (BOLD), and the pivotal trial for odevixibat in Alagille syndrome (ASSERT); the target indication(s) for development or approval, the size, design, population, location, conduct, cost, objective, enrollment, duration or endpoints of any clinical trial, or the timing for initiation or completion of or availability or reporting of results from any clinical trial, including the long-term open-label extension study for odevixibat in PFIC, the pivotal trial for odevixibat in biliary atresia, the pivotal trial for odevixibat in Alagille syndrome; the potential approval and commercialization of odevixibat; the potential for odevixibat to become the first approved drug for PFIC patients; discussions with the FDA or EMA regarding our programs; the potential benefits or competitive position of odevixibat or any other Albireo product candidate or program or the commercial opportunity in any target indication; the potential effects of odevixibat of the treatment of PFIC patients and its potential to improve the current standard of care; the potential benefits of an orphan drug designation; the potential issuance of a rare pediatric disease priority review voucher; or Albireo’s plans, expectations or future operations, financial position, revenues, costs or expenses. Albireo often uses words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “planned,” “continue,” “guidance,” or the negative of these terms or other similar expressions to identify forward-looking statements. Actual results, performance or experience may differ materially from those expressed or implied by any forward-looking statement as a result of various risks, uncertainties and other factors, including, but not limited to: whether the NDA for odevixibat for the treatment of pruritus in patients with PFIC will be approved by the FDA and whether the MAA for odevixibat in PFIC will be approved by the EMA; whether the FDA or EMA will complete their respective reviews within the target timelines, including the FDA’s PDUFA goal date, as a potential result of the impact of the COVID-19 pandemic or otherwise; the risk that the NDA will not be approved despite the FDA’s acceptance of the NDA for review; whether the FDA will require additional information, whether we will be able to provide in a timely manner any additional information that the FDA requests, and whether such additional information will be satisfactory to the FDA; other potential negative impacts of the COVID-19 pandemic, including on manufacturing, supply, conduct or initiation of clinical trials, or other aspects of our business; whether favorable findings from clinical trials of odevixibat to date, including findings in indications other than PFIC, will be predictive of results from other clinical trials of odevixibat; whether either or both of the FDA and EMA will determine that the primary endpoint for their respective evaluations and treatment duration of the double-blind Phase 3 trial in patients with PFIC are sufficient to support approval of odevixibat in the United States or the European Union, to treat PFIC, a symptom of PFIC, a specific PFIC subtype(s) or otherwise; the outcome and interpretation by regulatory authorities of the ongoing third-party study pooling and analyzing of long-term PFIC patient data; the timing for initiation or completion of, or for availability of data from, clinical trials of odevixibat, including the pivotal program in biliary atresia or the pivotal program in Alagille syndrome, and the outcomes of such trials; Albireo’s ability to obtain coverage, pricing or reimbursement for approved products in the United States or European Union; delays or other challenges in the recruitment of patients for, or the conduct of, company’s clinical trials; and Albireo’s critical accounting policies. These and other risks and uncertainties that Albireo faces are described in greater detail under the heading “Risk Factors” in Albireo’s most recent Annual Report on Form 10-K or in subsequent filings that it makes with the Securities and Exchange Commission. As a result of risks and uncertainties that Albireo faces, the results or events indicated by any forward-looking statement may not occur. Albireo cautions you not to place undue reliance on any forward-looking statement. In addition, any forward-looking statement in this press release represents Albireo’s views only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. Albireo disclaims any obligation to update any forward-looking statement except as required by applicable law.
Media Contact:Colleen Alabiso, 857-356-3905, colleen.alabiso@albireopharma.comLisa Rivero, 617-947-0899, lisa.rivero@syneoshealth.com
Investor Contact:Hans Vitzthum, LifeSci Advisors, LLC., 617-430-7578
Albireo Pharma, Inc.Condensed Consolidated Balance Sheets(in thousands, except share and per share data)(unaudited)
December 31, | December 31, | |||||||
2020 | 2019 | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 251,272 | $ | 131,843 | ||||
Prepaid expenses and other current assets | 10,593 | 9,956 | ||||||
Total current assets | 261,865 | 141,799 | ||||||
Property and equipment, net | 478 | 597 | ||||||
Goodwill | 17,260 | 17,260 | ||||||
Other assets | 6,004 | 5,413 | ||||||
Total assets | $ | 285,607 | $ | 165,069 | ||||
Liabilities and Stockholders' Equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 5,283 | $ | 4,785 | ||||
Accrued expenses | 19,051 | 13,486 | ||||||
Other current liabilities | 948 | 653 | ||||||
Total current liabilities | 25,282 | 18,924 | ||||||
Liability related to sale of future royalties | 65,894 | 48,714 | ||||||
Note payable, net of discount | 9,621 | — | ||||||
Other long-term liabilities | 3,579 | 4,270 | ||||||
Total liabilities | 104,376 | 71,908 | ||||||
Stockholders’ Equity: | ||||||||
Preferred stock, $0.01 par value per share — 50,000,000 authorized at December 31, 2020 and December 31, 2019; 0 and 0 issued and outstanding at December 31, 2020 and December 31, 2019, respectively | — | — | ||||||
Common stock, $0.01 par value per share — 30,000,000 authorized at December 31, 2020 and December 31, 2019; 19,107,040 and 12,749,443 issued and outstanding at December 31, 2020 and December 31, 2019, respectively | 191 | 127 | ||||||
Additional paid-in capital | 456,472 | 245,769 | ||||||
Accumulated other comprehensive (loss) income | (8,612 | ) | 6,452 | |||||
Accumulated deficit | (266,820 | ) | (159,187 | ) | ||||
Total stockholders’ equity | 181,231 | 93,161 | ||||||
Total liabilities and stockholders’ equity | $ | 285,607 | $ | 165,069 | ||||
Albireo Pharma, Inc.Condensed Consolidated Statements of Operations(in thousands, except share and per share data)(unaudited)
Three Months Ended December 31, | Year Ended December 31, | |||||||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||||||
Revenue | $ | 2,716 | $ | 6,431 | $ | 8,308 | $ | 9,636 | ||||||||
Operating expenses: | ||||||||||||||||
Research and development | 20,050 | 14,216 | 76,777 | 45,575 | ||||||||||||
General and administrative | 14,158 | 6,175 | 42,448 | 22,963 | ||||||||||||
Other operating (income) expense, net | (10,090 | ) | (4,109 | ) | (14,646 | ) | 2,210 | |||||||||
Total operating expenses | 24,118 | 16,282 | 104,579 | 70,748 | ||||||||||||
Operating loss | (21,402 | ) | (9,851 | ) | (96,271 | ) | (61,112 | ) | ||||||||
Interest expense, net | (3,397 | ) | (1,362 | ) | (11,362 | ) | (5,296 | ) | ||||||||
Other non-operating income | — | 3,691 | — | 3,691 | ||||||||||||
Net loss | $ | (24,799 | ) | $ | (7,522 | ) | $ | (107,633 | ) | $ | (62,717 | ) | ||||
Net loss per common share - basic and diluted | $ | (1.30 | ) | $ | (0.57 | ) | $ | (6.73 | ) | $ | (5.04 | ) | ||||
Weighted-average common shares used to compute basic and diluted net loss per common share | 19,082,963 | 12,698,492 | 15,983,058 | 12,437,742 | ||||||||||||
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