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Initiation of A4250 Phase 3 trial planned for 2H 2017
JNDA filing for elobixibat by licensee EA Pharma
Consummation of business combination to become NASDAQ listed
Conference call today at 8:30 a.m. ET
BOSTON, March 14, 2017 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (NASDAQ:ALBO), an orphan pediatric liver disease company developing novel bile acid modulators, today announced financial results for the year ended December 31, 2016.
Albireo reported a net loss of $16.3 million for the year ended December 31, 2016, compared with a net loss of $6.8 million for 2015. As of December 31, 2016, cash and cash equivalents totaled $29.9 million.
“2016 was a transformative year for Albireo, as we generated promising Phase 2 data for our lead product candidate, A4250, in children with cholestatic liver disease and successfully became a publicly traded company listed on NASDAQ,” said Ron Cooper, President and Chief Executive Officer of Albireo. “As we begin 2017, we are engaging with the FDA and EMA to finalize the design for our planned Phase 3 trial of A4250 in children with progressive familial intrahepatic cholestasis, a rare and highly debilitating genetic liver disorder, which we expect to begin in the second half of the year.”
Recent Highlights and Corporate Update
Financial Results for the Year Ended December 31, 2016
Cash Position: Cash and cash equivalents totaled $29.9 million at December 31, 2016.
Revenue: For the year ended December 31, 2016, revenue totaled $11.4 million compared with $5.1 million for 2015, an increase of $6.3 million. The increase was primarily due to an increase of $6.7 million in payments received in 2016 under the license agreement with EA Pharma Co., Ltd., including an $8.0 million payment in connection with a renegotiated payment stream and a $3.6 million milestone payment, partially offset by a decrease in payments for procurement services for licensees.
R&D Expenses: For the year ended December 31, 2016, research and development expenses totaled $8.1 million compared with $5.6 million for 2015, an increase of $2.5 million. The increase was driven by an increase of $1.7 million in preclinical and clinical trial costs, primarily for A4250.
G&A Expenses: For the year ended December 31, 2016, general and administrative expenses totaled $15.8 million compared with $4.5 million for 2015, an increase of $11.3 million. The increase was principally attributable to professional fees incurred in connection with the negotiation and completion of the Transaction on November 3, 2016, severance, lease termination and other one-time costs associated with the Transaction, higher compensation and related personnel costs due to the hiring of additional executive-level personnel, and costs associated with being a public company.
Interest expense, net: For the year ended December 31, 2016, interest expense, net totaled $1.4 million compared with $1.7 million for 2015, a decrease of $350,000. The decrease was attributable to lower interest on convertible loan notes due to their conversion into equity in connection with completion of the Transaction on November 3, 2016.
Non-operating expense: For the year ended December 31, 2016, non-operating expense totaled $2.7 million compared with $320,000 for 2015, an increase of $2.4 million. The increase was principally attributable to fair value adjustments for the 2016 period to derivative liabilities associated with convertible loan notes that were converted into equity in connection with completion of the Transaction on November 3, 2016, as well as mark-to-market adjustments on warrants.
Based on current operating plans, Albireo expects that its current cash resources will be sufficient to meet its operating requirements at least through mid 2018. This cash guidance assumes receipt of a contingent milestone payment under Albireo’s license agreement with EA Pharma.
As previously announced, Albireo will be hosting a conference call and webcast today, March 14, 2017, at 8:30 a.m. Eastern Time. To access the live conference call by phone, dial 877-407-0792 (domestic) or 201-689-8263 (international) and provide the access code 13654743.
The live audio webcast will be accessible from the Investors page of Albireo’s website, www.ir.albireopharma.com. To ensure a timely connection to the webcast, it is recommended that users 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 Investors page of Albireo's website for at least two weeks following the call.
Albireo Pharma is a clinical-stage biopharmaceutical company focused through its operating subsidiary on the development of novel bile acid modulators to treat orphan pediatric liver diseases and other liver and gastrointestinal diseases and disorders. Albireo’s clinical pipeline includes two Phase 2 product candidates and one Phase 3 product candidate. Albireo was spun out from AstraZeneca in 2008.
Albireo Pharma is located in Boston, Massachusetts, and its key operating subsidiary is located in Gothenburg, Sweden. For more information on Albireo, please visit www.albireopharma.com.
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: the progress or scope of development of A4250, elobixibat or any other Albireo product candidate or program, including regarding a planned Phase 3 clinical trial of A4250 in patients with PFIC, the timing for initiation of such planned Phase 3 clinical trial of A4250 or the timing for meeting with the European Medicines Agency regarding the planned Phase 3 program for A4250 in patients with PFIC, the target indication(s) for development, the size, design, population, location, conduct, objective, duration or endpoints of any clinical trial or the timing for initiation or completion of or reporting of results from any clinical trial; EA Pharma’s plans with regard to the development or commercialization of elobixibat; the competitive position of any Albireo product candidate or the commercial opportunity in any target indication; any milestone or other payments that EA Pharma may make to Albireo; the sufficiency of Albireo’s cash resources; 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,” and 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 and uncertainties, including, but not limited to, risks and uncertainties relating to: the conduct and results of Albireo’s ongoing clinical trial of A4250 in children with chronic cholestasis; whether such ongoing clinical trial of A4250 will be sufficient to support advancement of A4250 into a planned Phase 3 clinical trial in patients with PFIC in the United States and Europe; the outcomes of meetings with the FDA and EMA regarding Albireo’s planned Phase 3 clinical trial in patients with PFIC; the outcome of the ongoing long-term safety clinical trial of elobixibat in Japan; the discretion that EA Pharma has in the development and potential commercialization of elobixibat in Japan; and the timing and success of acceptance and approval of the new drug application submitted by EA Pharma with the Japanese Pharmaceuticals and Medical Devices Agency for elobixibat for the treatment of chronic constipation in Japan. 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 and in other 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.
|Albireo Pharma, Inc.|
|Unaudited Condensed Consolidated Balance Sheets|
|(in thousands, except share and per share data)|
|December 31,||December 31,|
|Cash and cash equivalents||$||29,931||$||5,120|
|Other current assets||909||548|
|Total current assets||30,866||6,940|
|Other noncurrent assets||518||—|
|LIABILITIES, CONVERTIBLE PREFERENCE SHARES AND STOCKHOLDERS’ EQUITY/DEFICIT|
|Long term debt||—||4,866|
|Other long term liabilities||10||2,047|
|Stockholders' equity (deficit)||37,006||(8,741)|
|Total liabilities, convertible preference shares and stockholders’ equity/deficit||$||49,665||$||6,974|
|Albireo Pharma, Inc.|
|Unaudited Consolidated Statements of Operations|
|(in thousands, except share and per share data)|
|Year Ended December 31,|
|Research and development||8,077||5,634|
|General and administrative||15,752||4,462|
|Other (income) expense, net||(205)||(271)|
|Total operating expenses||23,624||9,825|
|Interest expense, net||(1,372)||(1,722)|
|Net loss before income taxes||(16,299)||(6,768)|
|Net loss per share attributable to holders of common stock:|
|Weighted-average shares outstanding:|
Source: Albireo Pharma, Inc.
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