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BOSTON, Nov. 08, 2022 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq: ALBO), a rare disease company developing novel bile acid modulators to treat rare pediatric and adult liver diseases, today provided a business update and reported financial results for the quarter ended September 30, 2022.
“I am pleased with this quarter’s growth in Total Bylvay PFIC patients and Bylvay sales. With the new native liver survival evidence presented at scientific congresses, our value proposition has strengthened. On top of that, we believe the recently announced positive ASSERT Phase 3 results will give us access to Alagille patients which are an additional and larger patient community than PFIC,” said Ron Cooper, President and Chief Executive Officer of Albireo. “We are expanding Bylvay’s reach even further as our Phase 3 BOLD study in biliary atresia is fully enrolled with topline results planned for 2024. Having completed a royalty monetization deal for Bylvay we strengthened our cash runway, providing enough resources to execute on our plans for Bylvay, A3907 and A2342.”
Bylvay Highlights
R&D Update:
Corporate News:
Third Quarter 2022 Financial Results
Conference Call
Albireo will host a conference call and live audio webcast today at 4:30 p.m. ET. To access the live conference call by phone, dial 1-855-327-6837 (domestic) or 1-631-891-4304 (international), and provide the access code 10020423. A live audio webcast will be accessible from the Investors page at 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 An archived version of the webcast will be available for replay on the Events & Presentations section of the Investors page of Albireo’s website for 3 months following the event.
About Bylvay (odevixibat)
Bylvay is the first drug approved in the U.S. for the treatment of pruritus in patients 3 months of age and older in all types of progressive familial intrahepatic cholestasis (PFIC). Limitation of Use: Bylvay may not be effective in PFIC type 2 patients with ABCB11 variants resulting in non-functional or complete absence of bile salt export pump protein (BSEP-3). The European Commission (EC) and UK Medicines and Healthcare products Regulatory Agency (MHRA) have also granted marketing authorization of Bylvay for the treatment of PFIC in patients aged 6 months or older. A potent, once-daily, non-systemic ileal bile acid transport inhibitor, Bylvay has minimal systemic exposure and acts locally in the small intestine. Bylvay can be taken as a capsule for patients that are able to swallow capsules, or opened and sprinkled onto food, which is a factor of key importance for adherence in a pediatric patient population. The most common adverse reactions for Bylvay are diarrhea, liver test abnormalities, vomiting, abdominal pain, and fat-soluble vitamin deficiency. The medicine can only be obtained with a prescription. For more information about using Bylvay, see the package leaflet or contact your doctor or pharmacist. For full prescribing information, visit www.bylvay.com.
In the U.S. and Europe, Bylvay has orphan exclusivity for its approved PFIC indications, and orphan designations for the treatment of ALGS, biliary atresia and primary biliary cholangitis. Bylvay is being evaluated in the ongoing PEDFIC 2 open-label trial in patients with PFIC, in the BOLD Phase 3 study for patients with biliary atresia and the ASSERT open-label trial for ALGS.
Important Safety Information
About Albireo
Albireo Pharma is a rare disease company focused on the development of novel bile acid modulators to treat pediatric and adult liver diseases. Albireo’s lead product, Bylvay, was approved by the U.S. FDA as the first drug for the treatment of pruritus in all types of progressive familial intrahepatic cholestasis (PFIC), and in Europe for the treatment of PFIC. Bylvay is also being developed to treat other rare pediatric cholestatic liver diseases with a completed Phase 3 trial in Alagille syndrome (ALGS), an ongoing Phase 3 study in biliary atresia, as well as Open-label Extension (OLE) studies for PFIC and ALGS. The Company has also completed a Phase 1 clinical trial for A3907 to advance development in adult cholestatic liver disease, with IND-enabling studies progressing with A2342 for viral and cholestatic liver disease. Albireo was spun out from AstraZeneca in 2008 and is headquartered in Boston, Massachusetts, with its key operating subsidiary in Gothenburg, Sweden. For more information on Albireo, please visit www.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: Albireo’s expected cash runway; Albireo’s commercialization plans; the plans for, or progress, scope, cost, initiation, duration, enrollment, results or timing for availability of results of, development of Bylvay, A3907, A2342 or any other Albireo product candidate or program; the target indication(s) for development or approval; the timing for anticipated regulatory filings; discussions with the FDA or EMA regarding our programs; potential regulatory approval and plans for potential commercialization of Bylvay in biliary atresia or ALGS or in additional countries, or Albireo’s other product candidates; the impact of the Expanded Access Program; the potential benefits or competitive position of Bylvay or any other Albireo product candidate or program or the commercial opportunity in any target indication; future price listings and reimbursement approvals of Bylvay; 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 regulatory filings to be made for Bylvay in patients with ALGS will be made on the timelines we expect and be approved by the FDA and EMA; whether the FDA and EMA will complete their respective reviews within target timelines, once determined; whether the FDA and EMA will require additional information, whether we will be able to provide in a timely manner any additional information that the FDA and EMA request, and whether such additional information will be satisfactory to the FDA and EMA; there are no guarantees that Bylvay will be commercially successful; we may encounter issues, delays or other challenges in commercializing Bylvay; whether Bylvay receives adequate reimbursement from third-party payors; the degree to which Bylvay receives acceptance from patients and physicians for its approved indication; challenges associated with execution of our sales activities, which in each case could limit the potential of our product; challenges associated with supply and distribution activities, which in each case could limit our sales and the availability of our product; results achieved in Bylvay in the treatment of patients with PFIC or other approved indications may be different than observed in clinical trials, and may vary among patients; 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 Bylvay to date, including findings in PFIC, ALGS and other indications, will be predictive of results from other clinical trials of Bylvay; there is no guarantee that Bylvay will be approved in jurisdictions or for indications (such as biliary atresia or ALGS) beyond the jurisdictions in which or indications for which Bylvay is currently approved; there is no guarantee that our other product candidates will be approved; estimates of the addressable patient population for target indications may prove to be incorrect; 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 Bylvay, including BOLD, and the Phase 2 clinical trial of A3907, and the outcomes of such trials; Albireo’s ability to obtain coverage, pricing or reimbursement for approved products in the United States or Europe; delays or other challenges in the recruitment of patients for, or the conduct of, the Company’s clinical trials; any repurchase by the Company of Sagard’s interest in the royalty interest payments under our royalty monetization agreement with Sagard could materially impact our financial condition; and the Company’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 Contacts:
Colleen Alabiso, 857-356-3905, colleen.alabiso@albireopharma.com
Lance Buckley, 917-439-2241, lbuckley@lippetaylor.com
Investor Contact:
Hans Vitzthum, LifeSci Advisors, LLC., 617-430-7578
| Albireo Pharma, Inc. | ||||||||
| Condensed Consolidated Balance Sheets | ||||||||
| (in thousands, except share data) | ||||||||
| September 30, | December 31, | |||||||
| 2022 | 2021 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 222,476 | $ | 248,107 | ||||
| Accounts receivable, net | 2,029 | 3,272 | ||||||
| Inventory | 3,149 | 194 | ||||||
| Prepaid expenses | 8,516 | 5,261 | ||||||
| Other current assets | 2,666 | 12,096 | ||||||
| Total current assets | 238,836 | 268,930 | ||||||
| Restricted cash | 50,000 | — | ||||||
| Property and equipment, net | 1,303 | 668 | ||||||
| Goodwill | 17,260 | 17,260 | ||||||
| Other assets | 13,823 | 15,193 | ||||||
| Total assets | $ | 321,222 | $ | 302,051 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 6,950 | $ | 6,516 | ||||
| Accrued expenses | 25,365 | 35,951 | ||||||
| Other current liabilities | 5,504 | 2,880 | ||||||
| Total current liabilities | 37,819 | 45,347 | ||||||
| Liability related to sale of future royalties | 62,053 | 60,132 | ||||||
| Revenue interest liability, net | 111,644 | — | ||||||
| Note payable, net of discount | — | 10,004 | ||||||
| Other long-term liabilities | 9,635 | 10,960 | ||||||
| Total liabilities | 221,151 | 126,443 | ||||||
| Stockholders’ Equity: | ||||||||
| Preferred stock, $0.01 par value per share — 50,000,000 shares authorized at September 30, 2022 and December 31, 2021; 0 and 0 shares issued and outstanding at June 30, 2022 and December 31, 2021, respectively | — | — | ||||||
| Common stock, $0.01 par value per share — 60,000,000 shares authorized at September 30, 2022 and December 31, 2021; 20,700,458 and 20,692,698 shares issued and outstanding at September 30, 2022, respectively, and 19,304,312 and 19,296,552 shares issued and outstanding at December 31, 2021, respectively | 207 | 193 | ||||||
| Additional paid-in capital | 512,915 | 475,390 | ||||||
| Accumulated other comprehensive income | 8,212 | 1,105 | ||||||
| Accumulated deficit | (421,033 | ) | (300,850 | ) | ||||
| Treasury stock at cost, 7,760 shares at September 30, 2022 and December 31 2021, respectively | (230 | ) | (230 | ) | ||||
| Total stockholders’ equity | 100,071 | 175,608 | ||||||
| Total liabilities and stockholders’ equity | $ | 321,222 | $ | 302,051 | ||||
| Albireo Pharma, Inc. | ||||||||||||||||
| Condensed Consolidated Statements of Operations | ||||||||||||||||
| (in thousands, except share and per share data) | ||||||||||||||||
| (Unaudited) | ||||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Revenue: | ||||||||||||||||
| Product revenue, net | $ | 7,543 | $ | 1,060 | $ | 18,090 | $ | 1,060 | ||||||||
| Royalty revenue | 2,289 | 2,604 | 6,780 | 6,998 | ||||||||||||
| Total revenue | 9,832 | 3,664 | 24,870 | 8,058 | ||||||||||||
| Cost and operating expenses: | ||||||||||||||||
| Cost of product revenue | 612 | 431 | 1,622 | 431 | ||||||||||||
| Research and development | 23,312 | 21,083 | 68,103 | 61,920 | ||||||||||||
| Selling, general and administrative | 20,564 | 17,612 | 59,019 | 49,825 | ||||||||||||
| Other operating expense, net | 1 | 3,719 | 7,544 | 7,873 | ||||||||||||
| Total cost and operating expenses | 44,489 | 42,845 | 136,288 | 120,049 | ||||||||||||
| Operating loss | (34,657 | ) | (39,181 | ) | (111,418 | ) | (111,991 | ) | ||||||||
| Other (loss) income: | ||||||||||||||||
| Gain from sale of priority review voucher, net of transaction costs | — | 103,387 | — | 103,387 | ||||||||||||
| Loss on extinguishment of note payable, net of discount | (613 | ) | - | (613 | ) | |||||||||||
| Interest expense, net | (2,530 | ) | (3,331 | ) | (8,152 | ) | (10,675 | ) | ||||||||
| Net (loss) income before income taxes | (37,800 | ) | 60,875 | (120,183 | ) | (19,279 | ) | |||||||||
| Provision for income taxes | — | 3,789 | 3,789 | |||||||||||||
| Net (loss) income | $ | (37,800 | ) | $ | 57,086 | $ | (120,183 | ) | $ | (23,068 | ) | |||||
| Net (loss) income per share attributable to holders of common stock: | ||||||||||||||||
| Basic | $ | (1.92 | ) | $ | 2.96 | $ | (6.15 | ) | $ | (1.20 | ) | |||||
| Diluted | $ | (1.92 | ) | $ | 2.90 | $ | (6.15 | ) | $ | (1.20 | ) | |||||
| Weighted-average common shares outstanding: | ||||||||||||||||
| Basic | 19,655,350 | 19,258,905 | 19,541,044 | 19,197,536 | ||||||||||||
| Diluted | 19,655,350 | 19,651,243 | 19,541,044 | 19,197,536 | ||||||||||||