UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): August 7, 2018
ALBIREO PHARMA, INC.
(Exact name of registrant as specified in its charter)
Delaware | 001-33451 | 90-0136863 | ||
(State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) | ||
10 Post Office Square, Suite 502 South Boston, Massachusetts |
02109 | |||
(Address of principal executive offices) | (Zip Code) |
(857) 254-5555
Registrants telephone number, including area code
Not applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 | Results of Operations and Financial Condition. |
On August 7, 2018, Albireo Pharma, Inc. issued a press release announcing its financial results for the second quarter ended June 30, 2018. The full text of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Current Report on Form 8-K (including Exhibit 99.1) shall not be deemed to be filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the Exchange Act), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
The following exhibit is furnished with this report:
Exhibit Number |
Description | |
99.1 | Press release dated August 7, 2018 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
ALBIREO PHARMA, INC. | ||||||
Date: August 7, 2018 | /s/ Ronald H.W. Cooper | |||||
Ronald H.W. Cooper | ||||||
President and Chief Executive Officer |
Exhibit 99.1
Albireo Reports Second Quarter 2018 Financial Results
A4250 Phase 3 trial in PFIC underway
A4250 granted rare pediatric disease designation, eligible to apply for priority review voucher
Management to host conference call and webcast today at 8:30 a.m. EDT
BOSTON Aug. 7, 2018 Albireo Pharma, Inc. (Nasdaq:ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, today announced financial results and corporate highlights for the second quarter ended June 30, 2018.
The first half of 2018 was defined for Albireo by initiation of our Phase 3 program for A4250 in progressive familial intrahepatic cholestasis (PFIC), said Ron Cooper, President and Chief Executive Officer of Albireo. Notably, A4250 also received rare pediatric disease designation from the FDA, making Albireo eligible to apply for a priority review voucher upon submission of a new drug application for A4250. At the same time, we secured U.S. and EU method of use patents for elobixibat in the treatment of NASH, shared important findings on cholestatic liver disease at two scientific meetings, continued to strengthen our understanding of the cholestatic liver disease population and made key board and management appointments for our company.
Recent Highlights
Advanced A4250 Program
| Enrolled the first patient in the PEDFIC-1 study, held successful E.U. and U.S. investigators meetings and continued activating trial sites. Twelve sites were initiated in seven countries as of the end of July. PEDFIC-1 is a randomized, double-blind, placebo-controlled Phase 3 clinical trial of A4250 in patients ages 6 months to 18 years with PFIC (subtype 1 or 2) who have elevated serum bile acid (sBA) levels and pruritus. Data generated from this study are expected to support potential drug approval applications for A4250 in the U.S. and European Union Topline data currently are expected in late 2019 or early 2020. |
| Reported data on a pharmacodynamic marker measured in the completed Phase 2 clinical trial of A4250 in children with cholestatic liver disease and pruritus at the European Association for the Study of the Liver (EASL) The International Liver Congress. Treatment with A4250 decreased lysophospholipase autotaxin (ATX) levels in most patients, and there was a statistically significant correlation with a reduction in serum bile acids (sBA) (r=0.60; p=0.003). Pruritus intensity at baseline was significantly correlated with baseline levels of ATX (r=0.67; p=0.001). |
| Presented data from two studies on cholestatic liver disease at the European Society for Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) Annual Meeting. |
| Data from a qualitative study supporting the development of Albireos proprietary Patient Reported Outcome (PRO) and Observer Reported Outcome (ObsRO) tools that are being used to measure pruritus in the PEDFIC-1 study illustrated the significant impact that pediatric cholestatic liver diseases, such as PFIC, have on quality of life. |
| Research from a systematic literature review of partial external biliary diversion (PEBD) surgery in patients with PFIC found that changes in sBA and bilirubin appear useful as biomarkers in predicting both early and long-term outcomes. sBA responder rate is the primary endpoint in Europe and a key secondary endpoint in the U.S. in the PEDFIC-1 study. |
| Participated in a PRIority MEdicines (PRIME) program kick-off meeting at the European Medicines Agency (EMA) that included the rapporteur. PRIME provides enhanced early dialogue with EMA to facilitate accelerated assessment of therapies considered to be priority medicines. |
| Received rare pediatric disease designation from the FDA for A4250 in PFIC, affirming Albireos eligibility to apply for a priority review voucher upon submission of a new drug application for A4250. A4250 has received orphan drug designation for PFIC in the U.S. and E.U. |
| Continued progress in commercialization planning for A4250 with completed qualitative, quantitative and pricing comparison market research on PFIC and other cholestatic liver diseases. |
Elobixibat
| Positive Phase 3 trial results from Albireo licensee EA Pharma Co, Ltd. were presented at Digestive Disease Week (DDW) during a Distinguished Abstract Plenary Session. Data from this study demonstrated that elobixibat, a first-in-class IBAT inhibitor, resolved constipation in the short term, and improved bowel function and patient quality of life with long-term use in patients with chronic constipation in Japan. Elobixibat was well tolerated, with the most common side effects being mild gastrointestinal disorders. The data were published in The Lancet Gastroenterology & Hepatology. |
| Granted a patent for a method of using elobixibat to treat NASH in both the U.S. and Europe. |
Corporate
| Elected Anne Klibanski, M.D., and Stephanie Okey, M.S., to Albireos Board of Directors |
| Added Patrick Horn, M.D. as Chief Medical Officer and Jason G. Duncan, J.D., as General Counsel and Secretary to the leadership team. |
| Presented at multiple investor conferences, including Jefferies 2018 Global Healthcare Conference and Deutsche Bank 43rd Annual Health Care Conference. |
| Selected for inclusion in the Russell 2000® Index as part of the annual reconstitution of the Russell stock indexes. |
Financial Update for the Three and Six-Month Periods Ended June 30, 2018
Three Months Ended June 30, 2018 vs. 2017
| Revenues were $730 thousand in the second quarter of 2018. |
| R&D expense was $6.4 million up 113% compared to $3.0 million in the second quarter of 2017. |
| G&A expense was $4.2 million, up 13.5%, compared to $3.7 million in the second quarter of 2017. |
| Net Loss was $14.6 million, or $(1.22) per share, compared to $6.2 million, or $(0.86) per share in the second quarter of 2017. |
| The Company had cash and cash equivalents at June 30, 2018, of approximately $183.2 million, compared to $53.2 million at December 31, 2017. |
Six Months Ended June 30, 2018 vs. 2017
| Revenues were $11.9 million in the six months ending June 30, 2018. |
| R&D expense was $12.6 million up 117% compared to $5.8 million in the six months ending June 30, 2017. |
| G&A expense was $8.4 million, up 21.7%, compared to $6.9 million in the same six months of 2017. |
| Net Loss was $16.2 million, or $(1.42) per share, compared to $12.8 million, or $(1.91) per share in the same six months of 2017. |
Conference Call
As previously announced, Albireo will host a conference call and webcast today, August 7, 2018, at 8:30 a.m. EDT. To access the live conference call by phone, dial 877-407-0792 (domestic) or 201-689-8263 (international) and provide the access code 13680985. A live audio webcast will be accessible from the Media & Investors page of Albireos website, http://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 Media & Investors page of Albireos website for at least two weeks following the event.
About Albireo
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. Albireos lead product candidate, A4250, is being developed to treat rare pediatric cholestatic liver diseases and is in Phase 3 development in its initial target indication, progressive familial intrahepatic cholestasis. Albireos clinical pipeline also includes two Phase 2 product candidates. Albireos elobixibat, approved in Japan for the treatment of chronic constipation, is the first ileal bile acid transporter (IBAT) inhibitor approved anywhere in the world. 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.
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, duration or results or timing for availability of results of, development of A4250 or any other Albireo product candidate or program, including regarding the Phase 3 clinical 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, including the double-blind Phase 3 PFIC trial for A4250; the size of the PFIC population or any other disease population for indications that may be targeted by Albireo; the potential benefits or competitive position of A4250, elobixibat or any other Albireo product candidate or program or the commercial opportunity in any target indication; the potential benefits of a rare pediatric disease designation, the pricing of A4250 if approved; any future payment that HealthCare Royalty Partners or EA Pharma may make to Albireo or any other action or decision that EA Pharma may make concerning elobixibat or its business relationship with Albireo; the period for which Albireos cash resources will be sufficient to fund its operating requirements (runway); or Albireos 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, uncertainties and other factors, including, but not limited to: whether favorable findings from clinical trials of A4250 to date, including findings in indications other than PFIC, will be predictive of results from the trials comprising the Phase 3 PFIC program or any other clinical trials of A4250; 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, even if the primary endpoint is met with statistical significance, to support approval of A4250 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 A4250, including the trials comprising the Phase 3 PFIC program, and the outcomes of such trials; Albireos 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, the double-blind Phase 3 trial; the significant control that EA Pharma has over the commercialization of elobixibat in Japan; and Albireos critical accounting policies. These and other risks and uncertainties that Albireo faces are described in greater detail under the heading Risk Factors in Albireos 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 Albireos 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.
Condensed Consolidated Balance Sheets
(in thousands, except share and per share data)
(unaudited)
June 30, 2018 | December 31, 2017 | |||||||
ASSETS |
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Current assets: |
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Cash and cash equivalents |
$ | 183,228 | $ | 53,231 | ||||
Prepaid expenses and other assets |
610 | 1,054 | ||||||
Other receivables |
2,406 | 726 | ||||||
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Total current assets |
186,244 | 55,011 | ||||||
Property and equipment, net |
210 | 178 | ||||||
Goodwill |
17,260 | 17,260 | ||||||
Other noncurrent assets |
422 | 775 | ||||||
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Total assets |
$ | 204,136 | $ | 73,224 | ||||
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LIABILITIES AND STOCKHOLDERS EQUITY |
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Current liabilities: |
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Trade payables |
$ | 3,020 | $ | 1,350 | ||||
Accrued expenses |
4,353 | 6,105 | ||||||
Other liabilities |
541 | 474 | ||||||
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Total current liabilities |
7,914 | 7,929 | ||||||
Liability related to sale of future royalties |
46,736 | | ||||||
Long-term liabilities |
39 | 42 | ||||||
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Total liabilities |
54,689 | 7,971 | ||||||
Stockholders Equity: |
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Common stock, $0.01 par value per share 30,000,000 authorized at June 30, 2018 and December 31, 2017; 11,957,491 and 8,902,784 issued and outstanding at June 30, 2018 and December 31, 2017, respectively |
120 | 89 | ||||||
Additional paid in capital |
211,140 | 114,522 | ||||||
Accumulated other comprehensive income |
4,768 | 1,001 | ||||||
Accumulated deficit |
(66,581 | ) | (50,359 | ) | ||||
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Total stockholders equity |
149,447 | 65,253 | ||||||
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Total liabilities and stockholders equity |
$ | 204,136 | $ | 73,224 | ||||
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See accompanying notes to Condensed Consolidated Financial Statements.
Albireo Pharma, Inc.
Condensed Consolidated Statements of Operations
(in thousands, except share and per share data)
(unaudited)
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2018 | 2017 | 2018 | 2017 | |||||||||||||
Revenue |
$ | 730 | $ | 1 | $ | 11,932 | $ | 2 | ||||||||
Operating expenses: |
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Research and development |
6,411 | 2,962 | 12,562 | 5,774 | ||||||||||||
General and administrative |
4,238 | 3,713 | 8,366 | 6,925 | ||||||||||||
Other (income) expense, net |
(191 | ) | (65 | ) | 1,313 | 9 | ||||||||||
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Total operating expenses |
10,458 | 6,610 | 22,241 | 12,708 | ||||||||||||
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Operating loss |
(9,728 | ) | (6,609 | ) | (10,309 | ) | (12,706 | ) | ||||||||
Interest income (expense), net |
(1,666 | ) | (152 | ) | (2,682 | ) | (401 | ) | ||||||||
Non-operating income (expense), net |
(3,209 | ) | 585 | (3,231 | ) | 260 | ||||||||||
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Net loss before income taxes |
(14,603 | ) | (6,176 | ) | (16,222 | ) | (12,847 | ) | ||||||||
Income tax |
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Net loss |
$ | (14,603 | ) | $ | (6,176 | ) | $ | (16,222 | ) | $ | (12,847 | ) | ||||
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Net loss per share - basic and diluted |
$ | (1.22 | ) | $ | (0.86 | ) | $ | (1.42 | ) | $ | (1.91 | ) | ||||
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Weighted average shares outstanding - basic and diluted |
11,938,357 | 7,171,610 | 11,417,463 | 6,734,555 | ||||||||||||
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###
Investor Contact:
Hans Vitzthum
LifeSci Advisors, LLC
212-915-2568
Media Contact:
Heather Anderson
6 Degrees
980-938-0260
handerson@6degreespr.com
Source: Albireo Pharma, Inc.