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): November 6, 2019

 


 

ALBIREO PHARMA, INC.

(Exact name of registrant as specified in its charter)

 

Delaware
(State or other jurisdiction of
incorporation)

 

001-33451
(Commission File
Number)

 

90-0136863
(IRS Employer
Identification No.)

 

10 Post Office Square, Suite 1000
Boston, Massachusetts
(Address of principal executive offices)

 

02109
(Zip Code)

 

(857) 254-5555

Registrant’s 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:

 

o                                    Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

o                                    Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

o                                    Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

o                                    Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading Symbol(s)

 

Name of each exchange on which
registered

 

Common Stock

 

ALBO

 

The Nasdaq Capital Market

 

 

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                                              o

 

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.  o

 

 

 


 

Item 2.02 Results of Operations and Financial Condition.

 

On November 6, 2019, Albireo Pharma, Inc. issued a press release announcing its financial results for the third quarter ended September 30, 2019 and providing a business update. 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 November 6, 2019

 

2


 

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: November 6, 2019

/s/ Ronald H.W. Cooper

 

Ronald H.W. Cooper

 

President and Chief Executive Officer

 

3


Exhibit 99.1

 

 

Albireo Reports Third Quarter 2019 Financial Results

and Provides Business Update

 

 Phase 3 PFIC trial randomization more than three-quarters complete.

  Topline results expected mid-2020.

  Pivotal trial in biliary atresia expected to be initiated in 2020. 

—  Management to host conference call and webcast today at 10 a.m. ET. —

 

BOSTON, MA — November 6, 2019 — Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, today provided a business update and reported financial results for the third quarter ended September 30, 2019.

 

“Randomization of patients in our Phase 3 trial of odevixibat in PFIC is nearing completion, and we remain on track to report topline results in mid-2020,” said Ron Cooper, President and Chief Executive Officer of Albireo. “Odevixibat is being developed for a range of cholestatic liver diseases, and Albireo is finalizing discussions with regulators for a pivotal program in biliary atresia, one of the most common rare pediatric liver diseases. We expect to initiate the world’s first pivotal trial in this indication during 2020.”

 

Recent Highlights

 

Odevixibat

 

·                  Over three-quarters of the patients needed to complete the PEDFIC 1 Phase 3 study in progressive familial intrahepatic cholestasis (PFIC) had been randomized as of end of October 2019. Additionally, the patients in screening or entering screening should be sufficient to meet the trial’s 60-patient target based on the screening success rate to date. PEDFIC 1 is enrolling both PFIC type 1 and type 2 patients that are 6 months to 18 years of age. The trial is studying both high- and low-dose odevixibat using the company’s planned commercial formulation. Patients randomized to odevixibat are treated with once-daily oral capsules or sprinkles, which do not require refrigeration. Albireo expects to report topline results in mid-2020, and continues to project a potential first regulatory approval and launch in 2021.

 

·                  Enrolled the first patients in the second cohort in PEDFIC 2, the long-term, open-label extension study of PEDFIC 1. The expanded cohort is expected to broaden the evidence base for odevixibat by including PFIC patients who do not meet eligibility criteria for PEDFIC 1, but have elevated serum bile acid levels and pruritus. This includes patients with all types of PFIC, and patients younger than 6 months or older than 18 years of age. Cohort 1 of PEDFIC 2 is composed of patients who have completed, and rolled over from, the PEDFIC 1 study. We now have patients who are approaching a year on odevixibat treatment.

 

·                  Presented data on odevixibat at the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition Annual Meeting in Chicago. The presentations included data regarding the clinical pharmacology of odevixibat, as well as information about the development of the proprietary patient- and observer-reported outcome (PRO and ObsRO) tools used in the PEDFIC program.

 


 

·                  Completing dialogue with the U.S. Food and Drug Administration (FDA) regarding key parameters for a planned pivotal clinical trial of odevixibat in biliary atresia, one of the most common rare pediatric liver diseases. Albireo plans to initiate this trial in 2020.

 

Elobixibat

 

·                  Randomized the first patients in the company’s Phase 2 multicenter, placebo-controlled clinical trial of elobixibat in non-alcoholic fatty liver disease (NAFLD)/nonalcoholic steatohepatitis (NASH). This trial, which has all 10 initial clinical trial sites active, is designed to randomize 46 patients with biopsy-confirmed NASH, or a diagnosis of suspected NAFLD or NASH based on metabolic syndrome definitions.

 

Corporate

 

·                  Strengthened the company’s leadership team with the appointment of Michelle Graham as Chief Human Resources Officer.

 

Third-Quarter Financial Results

 

·                  Revenues were $1.4 million for the third quarter of 2019, compared to $0.2 million for the third quarter of 2018. The year-over-year change was primarily the result of estimated royalty revenue received from EA Pharma for elobixibat for the treatment of chronic constipation.

 

·                  R&D expense was $12.0 million for the third quarter of 2019, compared to $9.7 million for the third quarter of 2018. The year-over-year change was primarily the result of personnel, and program expenses as we continue to increase our headcount, and program activities, respectively.

 

·                  G&A expense was $6.0 million for the third quarter of 2019, compared to $3.9 million for the third quarter of 2018. The year-over-year change was primarily the result of personnel and related expenses as we continue to increase our headcount.

 

·                  Net loss for the third quarter of 2019 was $21.9 million, or $(1.73) per share, compared to $14.0 million, or $(1.17) per share for the third quarter of 2018.

 

·                  The company had cash and cash equivalents at September 30, 2019, of $142.7 million, which compares to $163.9 million at December 31, 2018.

 

Financial Guidance

 

For the full year 2019, the company anticipates total expenses, including R&D and G&A expenses, to be in the range of $70M-$75M. Albireo continues to anticipate that its current cash balance will be sufficient to meet its operating needs into 2021.

 


 

Conference Call

 

As previously announced, Albireo will host a conference call and webcast today, November 6, 2019, at 10 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 13694376. A live audio webcast will be accessible from the Media & Investors page of Albireo’s website, http://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 Albireo

 

Albireo Pharma is a clinical-stage biopharmaceutical company focused on the development of novel bile acid modulators to treat orphan pediatric liver diseases, and other liver and gastrointestinal diseases and disorders. Albireo’s lead product candidate, odevixibat, 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 (PFIC). Albireo’s clinical pipeline also includes two Phase 2 product candidates. Elobixibat is in Phase 2 development in NAFLD and NASH. Approved in Japan for the treatment of chronic constipation, elobixibat 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, Mass., and its key operating subsidiary is located in Gothenburg, Sweden. The Boston Business Journal named Albireo one of the 2019 Best Places to Work in Massachusetts. 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 odevixibat, elobixibat or any other Albireo product candidate or program, including regarding the Phase 3 clinical program for odevixibat in patients with PFIC; the planned pivotal trial for odevixibat in biliary atresia, the Phase 2 clinical trial for elobixibat in NAFLD/NASH, the target indication(s) for development, the size, design, population, location, conduct, objective, enrollment, 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 odevixibat, and the long-term open-label extension study, the planned pivotal trial for odevixibat in biliary atresia or the Phase 2 trial for elobixibat in NAFLD/NASH; the potential approval and commercialization of odevixibat; discussions with the FDA regarding our programs; the potential benefits or competitive position of odevixibat, elobixibat, or any other Albireo product candidate or program or the commercial opportunity in any target indication; the potential benefits of an orphan drug designation; the pricing of odevixibat if approved; the period for which Albireo’s cash resources will be sufficient to fund its operating requirements (runway); 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, uncertainties and other factors, including, but not limited to: whether favorable findings from clinical trials of odevixibat 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 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, even if the primary endpoint is met with statistical significance, 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 trials comprising the Phase 3 PFIC program, and the outcomes of such trials; Albireo’s completion of discussions with the FDA regarding the planned pivotal trial for odevixibat in biliary atresia; 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, the double-blind Phase 3 trial; 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.

 

Investor Contact: Hans Vitzthum, LifeSci Advisors, LLC., 212-915-2568

Media Contact: Heather Anderson, 6 Degrees, 980-938-0260, handerson@6degreespr.com

 


 

Albireo Pharma, Inc.

 

Condensed Consolidated Balance Sheets

 

(in thousands, except share and per share data)

 

(unaudited)

 

 

 

September 30,
2019

 

December 31,
2018

 

Assets

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

142,666

 

$

163,885

 

Prepaid expenses and other current assets

 

5,353

 

3,765

 

Total current assets

 

148,019

 

167,650

 

Property and equipment, net

 

633

 

187

 

Goodwill

 

17,260

 

17,260

 

Other assets

 

5,578

 

369

 

Total assets

 

$

171,490

 

$

185,466

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

 

$

3,185

 

$

4,352

 

Accrued expenses

 

8,459

 

8,165

 

Other current liabilities

 

683

 

308

 

Total current liabilities

 

12,327

 

12,825

 

Liability related to sale of future royalties

 

53,073

 

49,969

 

Other long-term liabilities

 

4,418

 

35

 

Total liabilities

 

69,818

 

62,829

 

Stockholders’ Equity:

 

 

 

 

 

Common stock, $0.01 par value per share — 30,000,000 authorized at September 30, 2019 and December 31, 2018; 12,685,326 and 11,969,928 issued and outstanding at September 30, 2019 and December 31, 2018

 

126

 

120

 

Additional paid in capital

 

242,638

 

214,694

 

Accumulated other comprehensive income

 

10,573

 

4,293

 

Accumulated deficit

 

(151,665

)

(96,470

)

Total stockholders’ equity

 

101,672

 

122,637

 

Total liabilities and stockholders’ equity

 

$

171,490

 

$

185,466

 

 


 

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,

 

 

 

2019

 

2018

 

2019

 

2018

 

Revenue

 

$

1,385

 

$

237

 

$

3,205

 

$

12,169

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

11,996

 

9,666

 

31,359

 

22,228

 

General and administrative

 

6,010

 

3,850

 

16,788

 

12,216

 

Other operating expense (income), net

 

4,015

 

(614

)

6,319

 

1,377

 

Total operating expenses

 

22,021

 

12,902

 

54,466

 

35,821

 

Operating loss

 

(20,636

)

(12,665

)

(51,261

)

(23,652

)

Interest expense, net

 

(1,274

)

(1,367

)

(3,934

)

(4,049

)

Non-operating income (expense), net

 

 

7

 

 

(2,546

)

Net loss

 

$

(21,910

)

$

(14,025

)

$

(55,195

)

$

(30,247

)

Net loss per common share - basic and diluted

 

$

(1.73

)

$

(1.17

)

$

(4.47

)

$

(2.60

)

Weighted-average common shares used to compute basic and diluted net loss per common share

 

12,685,000

 

11,969,791

 

12,349,870

 

11,612,760