Albireo
ALBIREO PHARMA, INC. (Form: 10-Q, Received: 08/21/2017 06:07:21)

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

(Mark One)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended June 30, 2017

OR

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from            to            .

Commission File Number 001-33451

 

Albireo Pharma, Inc.

(Exact name of registrant as specified in its charter)

 

 

Delaware
(State or other jurisdiction of incorporation or organization)

 

90-0136863
(IRS Employer Identification No.)

 

 

 

10 Post Office Square, Suite 502 South, Boston, MA

(Address of principal executive offices)

 

02109
(Zip code)

 

Registrant’s telephone number, including area code: (857) 254-5555

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.     Yes       No  

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).    Yes       No  

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer

 

Accelerated filer

Non-accelerated filer

(Do not check if a smaller reporting company)

Smaller reporting company

 

 

 

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. 

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).   Yes    No

As of August 1, 2017, the registrant had 8,882,452 shares of common stock, $0.01 par value per share, outstanding.

 

 


Albireo Pharma, Inc.

 

 

 

Page

 

 

 

PART I — FINANCIAL INFORMATION

 

 

 

 

 

Cautionary Note Regarding Forward-Looking Statements

 

3

 

Item 1. Financial Statements

 

5

Condensed Consolidated Balance Sheets (unaudited) at June 30, 2017 and December 31, 2016

 

5

Condensed Consolidated Statements of Operations (unaudited) for the Three and Six Months Ended June 30, 2017 and 2016

 

6

Condensed Consolidated Statements of Comprehensive Income (Loss) (unaudited) for the Three and Six Months Ended June 30, 2017 and 2016

 

7

Condensed Consolidated Statements of Cash Flows (unaudited) for the Six Months Ended June 30, 2017 and 2016

 

8

Notes to Condensed Consolidated Financial Statements (unaudited)

 

9

 

 

 

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

19

 

 

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk

 

27

 

 

 

Item 4. Controls and Procedures

 

27

 

 

 

PART II — OTHER INFORMATION

 

 

 

 

 

Item 1A. Risk Factors

 

29

 

 

 

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

 

29

 

Item 6. Exhibits

 

29

 

 

 

Signatures

 

30

 

 

 

Exhibit Index

 

31

 

 

 

 

 

 

 

 

 

All brand names, trademarks or service marks appearing in this quarterly report are the property of their respective owners.  The Registrant’s use or display of another party’s trademark, service mark, trade dress or product in this quarterly report is not intended to, and does not, imply a relationship with, or endorsement or sponsorship of, the Registrant by such other party.

 

 

 

 

2


CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This quarterly report includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, which we refer to as the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, which we refer to as the Exchange Act, that relate to future events or to our future operations or financial performance.  Any forward-looking statement involves known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by such forward-looking statement. Forward-looking statements include statements, other than statements of historical fact, about, among other things:

 

the progress, scope, cost, duration or results of our development activities, nonclinical studies and clinical trials of A4250, elobixibat, A3384 or any of our other product candidates or programs, such as the target indication(s) for development or approval, the size, design, population, conduct, cost, objective or endpoints of any clinical trial, or the timing for initiation or completion of or availability of results from any clinical trial (including our planned Phase 3 clinical trial of A4250 in patients with progressive familial intrahepatic cholestasis, or PFIC), for submission or approval of any regulatory filing (including a new drug application in Japan for elobixibat), for meeting with regulatory authorities;

 

the potential benefits that may be derived from any of our product candidates;

 

the timing of and our ability to obtain and maintain regulatory approval of our existing product candidates, any product candidates that we may develop, and any related restrictions, limitations, or warnings in the label of any approved product candidates;

 

any payment that EA Pharma Co., Ltd. (EA Pharma) may make to us or any other action or decision that EA Pharma may make concerning elobixibat or our business relationship;

 

our future operations, financial position, revenues, costs, expenses, uses of cash, capital requirements or our need for additional financing; and

 

our strategies, prospects, plans, expectations or objectives.

Words such as, but not limited to, “believe,” “expect,” “anticipate,” “estimate,” “forecast,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “targets,” “likely,” “will,” “would,” “could,” “should,” “continue,” “scheduled” and similar expressions or phrases, or the negative of those expressions or phrases, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.  Although we believe that we have a reasonable basis for each forward-looking statement contained in this report, we caution you that these statements are based on our projections of the future that are subject to known and unknown risks and uncertainties and other important factors that may cause our actual results, level of activity, performance or achievements expressed or implied by any forward-looking statement to differ.  These risks, uncertainties and other factors include, among other things, our critical accounting policies and:

 

the clinical trial design, size, duration and endpoints for our planned Phase 3 clinical trial of A4250 in patients with PFIC, or that will be required to obtain marketing approval for A4250 to treat patients with PFIC or any other pediatric cholestatic liver disease or for A3384 to treat bile acid malabsorption, or BAM;

 

whether favorable findings from clinical trials of A4250 to date, including findings in indications other than PFIC, will be predictive of results from future clinical trials, including the trials comprising our planned Phase 3 PFIC program for A4250;

 

whether either or both of the U.S. Food and Drug Administration, or FDA, and European Medicines Agency, or EMA, will determine that the primary endpoint and duration of the planned double blind Phase 3 trial in patients with PFIC is sufficient, even if such 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 or otherwise;

 

the outcome and interpretation by regulatory authorities of the ongoing third-party study pooling and analyzing long-term PFIC patient data;

 

the timing for initiation or completion of, or for availability of data from, the trials comprising the planned Phase 3 PFIC program for A4250, and the outcomes of such trials;

 

whether we receive additional feedback from regulatory authorities on our planned Phase 3 PFIC program for A4250 prior to initiation;

 

delays or other challenges in the initiation of, or recruitment of patients for, the planned double blind Phase 3 trial of A4250;

3


 

whether our current cash resources will be sufficient to fund our planned Phase 3 clin ical program for A4250 in patients with PFIC to completion;

 

whether A4250 will meet the criteria to receive a pediatric priority review voucher from the FDA when applicable, and, if necessary, whether the pediatric priority review voucher program will be renewed beyond 2020;

 

the competitive environment and commercial opportunity for a potential treatment for PFIC and other orphan pediatric cholestatic liver diseases;

 

the conduct and results of clinical trials and nonclinical studies and assessments of A4250, elobixibat, A3384 or any of our other product candidates and programs, including the performance of third parties engaged to execute them and difficulties or delays in patient enrollment and data analysis;

 

the medical benefit that may be derived from A4250, elobixibat, A3384 or any of our other product candidates;

 

the extent to which our agreement with EA Pharma for elobixibat generates nondilutive income for us;

 

the timing and success of submission, acceptance and approval of regulatory filings, including in particular the new drug application submitted by EA Pharma in Japan for elobixibat for the treatment of chronic constipation, and any related restrictions, limitations or warnings in the label of any approved product candidates;

 

the significant control or influence that EA Pharma has over the development and commercialization of elobixibat in Japan and other licensed territories;

 

whether we elect to seek and, if so, our ability to establish a license or other partnering transaction with a third party for elobixibat in the United States or Europe;

 

whether findings from nonclinical studies and clinical trials of IBAT inhibitors will be predictive of future clinical success for a future product candidate of ours in the treatment of nonalcoholic steatohepatitis, or NASH;

 

the accuracy of our estimates regarding expenses, future revenues, uses of cash and capital requirements;

 

our ability to obtain additional financing on reasonable terms, or at all;

 

our ability to establish additional licensing, collaboration or similar arrangements on favorable terms and our ability to attract collaborators with development, regulatory and commercialization expertise;

 

the success of competing third-party products or product candidates;

 

our ability to successfully commercialize any approved product candidates, including their rate and degree of market acceptance;

 

our ability to expand and protect our intellectual property estate;

 

regulatory developments in the United States and other countries;

 

the performance of our third-party suppliers, manufacturers and contract research organizations and our ability to obtain alternative sources of raw materials; and

 

our ability to attract and retain key personnel.

These and other risks and uncertainties are described in greater detail under the caption “Risk Factors” in Item 1A of Part I of our Annual Report on Form 10-K for the fiscal year ended December 31, 2016, in Exhibit 99.3 to our Current Report on Form 8-K filed May 23, 2017 and in other filings that we make with the Securities and Exchange Commission, or SEC. As a result of the risks and uncertainties, the results or events indicated by the forward-looking statements may not occur. We caution you not to place undue reliance on any forward-looking statement.

In addition, any forward-looking statement in this quarterly report represents our views only as of the date of this quarterly report and should not be relied upon as representing our views as of any subsequent date. We anticipate that subsequent events and developments may cause our views to change. Although we may elect to update these forward-looking statements publicly at some point in the future, we specifically disclaim any obligation to do so, except as required by applicable law. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments we may make.

 


4


PART I — FINANCI AL INFORMATION

Item 1.  Financial Statements

Albireo Pharma, Inc.

Condensed Consolidated Balance Sheets

(in thousands, except share and per share data)

(unaudited)

 

 

 

June 30, 2017

 

 

December 31, 2016

 

ASSETS

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

62,598

 

 

$

29,931

 

Trade receivables

 

 

 

 

 

26

 

Prepaid expenses and other assets

 

 

471

 

 

 

560

 

Other receivables

 

 

663

 

 

 

344

 

Total current assets

 

 

63,732

 

 

 

30,861

 

Property and equipment, net

 

 

155

 

 

 

21

 

Intangible assets

 

 

150

 

 

 

150

 

Goodwill

 

 

18,110

 

 

 

18,110

 

Other noncurrent assets

 

 

529

 

 

 

518

 

Total assets

 

$

82,676

 

 

$

49,660

 

LIABILITIES AND STOCKHOLDERS' EQUITY

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Trade payables

 

$

1,329

 

 

$

972

 

Accrued expenses

 

 

3,825

 

 

 

7,548

 

Long-term debt, current portion

 

 

1,928

 

 

 

3,075

 

Warrant liability

 

 

 

 

 

844

 

Other liabilities

 

 

298

 

 

 

269

 

Total current liabilities

 

 

7,380

 

 

 

12,708

 

Long-term liabilities

 

 

43

 

 

 

 

Total liabilities

 

 

7,423

 

 

 

12,708

 

Stockholders' Equity:

 

 

 

 

 

 

 

 

Common stock, $0.01 par value per share — 30,000,000 authorized at June 30, 2017

   and 200,000,000 authorized at December 31, 2016; 8,859,141 and 6,292,644 issued

   and outstanding at June 30, 2017 and December 31, 2016, respectively

 

 

90

 

 

 

63

 

Additional paid in capital

 

 

112,549

 

 

 

61,338

 

Accumulated other comprehensive income

 

 

1,406

 

 

 

1,496

 

Accumulated deficit

 

 

(38,792

)

 

 

(25,945

)

Total stockholders’ equity

 

 

75,253

 

 

 

36,952

 

Total liabilities and stockholders’ equity

 

$

82,676

 

 

$

49,660

 

 

See accompanying notes to Condensed Consolidated Financial Statements.

5


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,

 

 

 

2017

 

 

2016

 

 

2017

 

 

2016

 

Revenue

 

$

1

 

 

$

7,973

 

 

$

2

 

 

$

8,097

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

2,962

 

 

 

2,713

 

 

 

5,774

 

 

 

4,310

 

General and administrative

 

 

3,713

 

 

 

3,028

 

 

 

6,925

 

 

 

4,334

 

Other (income) expense, net

 

 

(65

)

 

 

290

 

 

 

9

 

 

 

135

 

Total operating expenses

 

 

6,610

 

 

 

6,031

 

 

 

12,708

 

 

 

8,779

 

Operating income (loss)

 

 

(6,609

)

 

 

1,942

 

 

 

(12,706

)

 

 

(682

)

Interest expense, net

 

 

(152

)

 

 

(512

)

 

 

(401

)

 

 

(1,038

)

Non-operating income, net

 

 

585

 

 

 

709

 

 

 

260

 

 

 

620

 

Net income (loss) before income taxes

 

 

(6,176

)

 

 

2,139

 

 

 

(12,847

)

 

 

(1,100

)

Income tax

 

 

 

 

 

 

 

 

 

 

 

 

Net income (loss)

 

$

(6,176

)

 

$

2,139

 

 

$

(12,847

)

 

$

(1,100

)

Net income (loss) per share - basic

 

$

(0.86

)

 

$

7.42

 

 

$

(1.91

)

 

$

(3.97

)

Net income (loss) per share - diluted

 

$

(0.86

)

 

$

0.69

 

 

$

(1.91

)

 

$

(3.97

)

Weighted average shares outstanding - basic

 

 

7,171,610

 

 

 

288,427

 

 

 

6,734,555

 

 

 

277,120

 

Weighted average shares outstanding - diluted

 

 

7,171,610

 

 

 

3,101,115

 

 

 

6,734,555

 

 

 

277,120

 

 

See accompanying notes to Condensed Consolidated Financial Statements.

6


Albireo Pharma, Inc.

Condensed Consolidated Statements of Comprehensive Income (Loss)

(in thousands)

(unaudited)

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2017

 

 

2016

 

 

2017

 

 

2016

 

Net income (loss)

 

$

(6,176

)

 

$

2,139

 

 

$

(12,847

)

 

$

(1,100

)

Other comprehensive income (loss):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Foreign currency translation adjustment

 

 

389

 

 

 

380

 

 

 

(90

)

 

 

41

 

Total other comprehensive income (loss)

 

 

389

 

 

 

380

 

 

 

(90

)

 

 

41

 

Total comprehensive income (loss)

 

$

(5,787

)

 

$

2,519

 

 

$

(12,937

)

 

$

(1,059

)

 

See accompanying notes to Condensed Consolidated Financial Statements.

 

7


Albireo Pharma, Inc.

Condensed Consolidated Statements of Cash Flows

(in thousands)

(unaudited)

 

 

 

Six Months Ended June 30,

 

 

 

2017

 

 

2016

 

Cash flows from operating activities:

 

 

 

 

 

 

 

 

Net loss

 

$

(12,847

)

 

$

(1,100

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

 

 

Accretion of debt discount and amortization of issuance costs

 

 

301

 

 

 

557

 

Depreciation and amortization

 

 

13

 

 

 

7

 

Change in fair value of financial instruments

 

 

(251

)

 

 

(620

)

Stock-based compensation expense

 

 

2,051

 

 

 

55

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Trade receivables

 

 

27

 

 

 

1,248

 

Prepaid expenses and other current assets

 

 

94

 

 

 

298

 

Other receivables

 

 

(292

)

 

 

(130

)

Other noncurrent assets

 

 

(12

)

 

 

 

Trade payables

 

 

280

 

 

 

(815

)

Taxes payable

 

 

 

 

 

 

Accrued expenses

 

 

(3,864

)

 

 

2,115

 

Other liabilities and long-term liabilities

 

 

29

 

 

 

(23

)

Other noncurrent liabilities

 

 

43

 

 

 

 

 

Net cash provided by (used in) operating activities

 

 

(14,428

)

 

 

1,592

 

Cash flows from investing activities:

 

 

 

 

 

 

 

 

Purchase of property, plant and equipment

 

 

(146

)

 

 

(3

)

Net cash used in investing activities

 

 

(146

)

 

 

(3

)

Cash flows from financing activities:

 

 

 

 

 

 

 

 

Proceeds from issuance of Ordinary A shares

 

 

 

 

35

 

Proceeds from issuance of warrants, net of issuance costs

 

 

 

 

39

 

Proceeds from issuance of common stock, net of issuance costs

 

 

48,508

 

 

 

 

Exercise of stock options

 

 

62

 

 

 

 

 

Payments of principal on borrowings

 

 

(1,648

)

 

 

(709

)

Net cash provided by (used in) financing activities

 

 

46,922

 

 

 

(635

)

Effect of exchange rate changes on cash and cash equivalents

 

 

319

 

 

 

176

 

Net increase in cash and cash equivalents

 

 

32,667

 

 

 

1,130

 

Cash and cash equivalents—beginning of period

 

 

29,931

 

 

 

5,120

 

Cash and cash equivalents—end of period

 

$

62,598

 

 

$

6,250

 

Supplemental disclosures of cash flow information:

 

 

 

 

 

 

 

 

Cash paid for interest

 

$

136

 

 

$

283

 

Shares issued upon cashless exercise of Kreos warrants

 

 

617

 

 

 

 

 

See accompanying notes to Condensed Consolidated Financial Statements.

8


Albireo Pharma, Inc.

Notes to Condensed Consolidated Financial Statements

(unaudited)

1.  Summary of significant accounting policies and basis of presentation

Organization and Share Exchange

Albireo Pharma, Inc. (Parent), together with its direct and indirect subsidiaries (the Company), is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel bile acid modulators to treat orphan pediatric liver diseases and other liver and gastrointestinal diseases and disorders. The Company’s clinical pipeline includes one Phase 3 product candidate, one Phase 2 product candidate and a third product candidate for which an application for regulatory approval has been filed in Japan.  A4250, the Company’s lead product candidate, is in development initially for the treatment of patients with progressive familial intrahepatic cholestasis (PFIC), a rare, life-threatening genetic disorder affecting young children.

Prior to November 3, 2016, Parent’s name was Biodel Inc. (Biodel).  On that date, Biodel effected a 1-for-30 reverse stock split of its common stock (Reverse Stock Split) and completed a share exchange transaction with Albireo Limited, a limited company domiciled in London, United Kingdom, in accordance with the terms of an Amended and Restated Share Exchange Agreement, dated as of July 13, 2016, by and among Biodel, Albireo Limited and the shareholders and noteholders of Albireo Limited (the Agreement). Pursuant to the Agreement, each holder of shares or notes convertible into shares of Albireo Limited received newly issued shares of Biodel common stock and Albireo Limited became a wholly owned subsidiary of Biodel (the Transaction). Following completion of the Transaction, the business of Albireo Limited became the business of Parent and Parent changed its name to Albireo Pharma, Inc.

For accounting purposes, the Transaction was treated as a “reverse acquisition” and Albireo Limited was considered the accounting acquirer. Accordingly, with respect to periods prior to completion of the Transaction, the accompanying Condensed Consolidated Financial Statements reflect the historical results of Albireo Limited and its direct and indirect subsidiaries and do not include the historical results of Biodel prior to completion of the Transaction. All share and per share information for periods prior to completion of the Transaction has been retroactively adjusted to reflect the exchange of shares in the Transaction based on an exchange ratio of 0.06999 and, where applicable, the Reverse Stock Split.

Basis of presentation

The accompanying unaudited Condensed Consolidated Financial Statements have been prepared in accordance with U.S. generally accepted accounting principles (GAAP) for interim financial information, the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements and should be read in conjunction with the audited consolidated financial statements and accompanying notes included in Parent’s Annual Report on Form 10-K for the fiscal year ended December 31, 2016.  In the opinion of management, all adjustments (including normal recurring accruals) considered necessary for fair presentation have been included in the Condensed Consolidated Financial Statements.  The results of operations for the three and six months ended June 30, 2017 are not necessarily indicative of the results that may be expected for the full fiscal year, any other interim period or any future fiscal year.

Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the Accounting Standards Codification (ASC) and Accounting Standards Update (ASU) of the Financial Accounting Standards Board (FASB).  Any reference in these Condensed Consolidated Financial Statements to common stock or options or warrants to purchase shares of common stock of the Company means the common stock or options or warrants to purchase shares of common stock of Parent. Any reference in these Condensed Consolidated Financial Statements to common stock means, for periods prior to November 3, 2016, Ordinary shares of Albireo Limited.  

The Company has reclassified certain amounts in the Condensed Consolidated Balance Sheet as of December 31, 2016 from Advances from licensees and from Warrant liability to Other liabilities to conform to the current year presentation.

Error corrections

 

In fiscal 2016, the Company under recognized stock-based compensation expense by $788,000. The understatement of stock-based compensation expense was attributable to the use of an incorrect service period, and related period of expense recognition, for certain stock option awards.  This understatement was identified during the first quarter of 2017 and the Company attempted to correct the prior period error at that time.  In seeking to correct the prior period understatement in the first quarter of 2017, the Company made clerical errors that resulted in the failure to recognize the additional $788,000 of stock-based compensation expense as intended, the

9


incorrect recognition of $788,000 of other comprehensive loss related to foreign currency translation adjustment, the understatement of cash used in operating activities by $788,000 and the incorrect reporting of the effect of foreign exchange changes on cash and cash equivalents as a decrease of $375,000 rather than as an incr ease of $413,000.

 

In the preparation of its unaudited interim financial statements for the second quarter of 2017, the Company detected the clerical errors made in the first quarter of 2017 and corrected the accounting. As a result, there is $788,000 of additional stock-based compensation expense included in general and administrative expenses for the three and six month periods ended June 30, 2017, as well as an additional $788,000 of other comprehensive income for the three months ended June 30, 2017.  The Company determined that the errors and subsequent corrections recorded for the second quarter ended June 30, 2017 are not material to its financial statements for any prior period and does not expect the corrections to be material to its financial statements for the year ending December 31, 2017.

Principles of consolidation

The accompanying Condensed Consolidated Financial Statements include the accounts of Parent and its direct or indirect wholly owned subsidiaries, Albireo Limited, Albireo AB, Elobix AB, Albireo, Inc and, for periods following completion of the Transaction, Biodel UK Limited. All intercompany balances and transactions have been eliminated in consolidation.

Foreign currency translation

Functional and presentation currency

Items included in the financial statements of each entity comprising the Company are measured using the currency of the primary economic environment in which the entity operates (the functional currency). The functional currency for Parent and Albireo, Inc. is the U.S. Dollar (USD), the functional currency for Albireo Limited, Elobix AB and Biodel UK Limited is the Euro, and the functional currency for Albireo AB is the Swedish Krona (SEK). The Company consolidates its financial statements in USD.

Transactions and balances

Foreign currency transactions in each entity comprising the Company are remeasured into the functional currency of the entity using the exchange rates prevailing at the respective transaction dates. Foreign exchange gains and losses resulting from the settlement of such transactions and from the translation at period-end exchange rates of monetary assets and liabilities denominated in foreign currencies are recognized within Other (income) expense, net in the Condensed Consolidated Statements of Operations.

The results and financial position of the Company and its subsidiaries that have a functional currency different from the presentation currency are translated into the presentation currency as follows:

 

a.

assets and liabilities presented are translated at the closing exchange rate as of June 30, 2017 and December 31, 2016;

 

b.

income and expenses for each statement of comprehensive income (loss) are translated at the average exchange rate for the applicable period;

 

c.

significant transactions use the closing exchange rate on the date of the transaction; and

 

d.

all resulting exchange differences arising from such translation are recognized directly in other comprehensive income (loss) and presented as a separate component of equity.

 

Use of estimates

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts of assets, liabilities, revenues and expenses reported in the financial statements and accompanying notes. Management must apply significant judgment in this process. On an ongoing basis, the Company evaluates its estimates and assumptions, including but not limited to accruals, deferred tax assets and warrant liability estimated at fair value.  Actual results could materially differ from these estimates.

 

Research and development expenses

Research and development costs are expensed as incurred and include primarily salaries, benefits and other staff-related costs; clinical trial and related clinical manufacturing costs; contract services and other outside costs.

The Company’s nonclinical studies and clinical trials are performed by third-party contract research organizations (CROs). Some of these expenses are billed monthly for services performed, while others are billed based upon milestones achieved. For

10


nonclinical studies, the significant factors used in estimating accruals include the percentage of work completed to date and contract milestones achieved. For clinical trial expenses, the significant factors used in est imating accruals include the number of patients enrolled and percentage of work completed to date or contract milestones achieved. The Company’s estimates are highly dependent upon the timeliness and accuracy of the data provided by the respective CROs reg arding the status of the contracted activity, with adjustments made when deemed necessary.

Revenue recognition

Revenue is generated from the receipt of upfront or license fees, milestone payments and payments for pharmaceutical ingredient or related procurement services that are made pursuant to out-licensing or related supply agreements.

Where an out-licensing arrangement of the Company involves the provision of multiple elements that may contain different remuneration arrangements such as upfront payments, milestone payments or product sales, the arrangement is assessed to determine whether separate delivery of the individual elements of such arrangement comprises more than one unit of accounting. The delivered elements are separated if (a) they have value to the licensee on a stand-alone basis, (b) there is objective and reliable evidence of the fair value of the undelivered element(s) and (c) if the arrangement includes a general right of return relative to the delivered element(s), delivery or performance of the undelivered element(s) is considered probable and is substantially in the control of the Company. Allocation of revenue to the different elements that require separate accounting is based on the separate selling prices determined for each component, and total consideration is then allocated pro rata across the components of the arrangement. If separate selling prices are not available, the Company will use its best estimate of such selling prices, consistent with the overall pricing strategy and relevant market factors.

The Company has determined that each element of its out-licensing agreements is a separate and distinct unit of accounting, and, as such, the fair value of each element has been subscribed and recognized as follows:

 

Nonrefundable upfront payments received from the Company’s out-licensing agreements relating to technical expertise and intellectual property are recognized in income if all rights relating to the intellectual property and all obligations resulting from them have been relinquished under the contract terms and the Company has no continuing material obligation to perform under the agreement. However, if rights to the intellectual property continue to exist or obligations resulting from them have yet to be fulfilled, the payments received would be deferred until all rights and obligations have been fulfilled.

 

Nonrefundable payments that are linked to the achievement of significant and substantive development or regulatory milestones in the research and development process are recognized as revenue upon the achievement of the specified milestone.

 

Revenue and costs associated with procurement services associated with pharmaceutical ingredients are recognized net in revenue when title and risk of loss of the pharmaceutical ingredients have passed to the licensee as the Company is not the primary obligor, and revenue and costs associated with related procurement services are recognized net in revenue when the Company is contractually bound.

As of June 30, 2017, the Company had a license agreement with EA Pharma Co., Ltd. (EA Pharma, formerly Ajinomoto Pharmaceuticals Co., Ltd.), entered into in 2012, to develop a select product candidate (elobixibat) for registration and subsequent commercialization in select markets. The Company satisfied its material performance obligations under the agreement in 2012, upon the delivery of technical expertise and intellectual property rights to EA Pharma.

Payments resulting from pharmaceutical ingredient or related procurement services are recognized as revenue as the activities are performed and are presented on a net basis. Revenue is recorded on a net basis because the Company acts as an agent, as it does not have discretion to change suppliers and does not perform any part of the services or manufacture of the subject pharmaceutical ingredients. The costs associated with these activities are netted against the related revenue in the Condensed Consolidated Statements of Operations.

For certain contingent payments under research and development arrangements, the Company recognizes revenue using the milestone method. Under the milestone method, a payment that is contingent upon the achievement of a substantive milestone is recognized in its entirety in the period in which the milestone is achieved. A milestone is an event: (i) that can be achieved based in whole or in part on either the Company’s performance or on the occurrence of a specific outcome resulting from the Company’s performance, (ii) for which there is substantive uncertainty at the date the arrangement is entered into that the event will be achieved and (iii) that would result in additional payments being due to the Company. The determination that a milestone is substantive requires estimation and judgment and is made at the inception of the arrangement. Milestones are considered substantive when the consideration earned from the achievement of the milestone is: (A) commensurate with either the Company’s performance to achieve the milestone or the enhancement of value of the item delivered as a result of a specific outcome resulting from the Company’s

11


performance to achieve the milestone, (B) related solely to past performance and (C) reasonable relative to all deliverables and payment terms in the arrangement. In making the determinati on as to whether a milestone is substantive or not, management of the Company considers all facts and circumstances relevant to the arrangement, including factors such as the scientific, regulatory, commercial and other risks that must be overcome to achie ve the milestone, the level of effort and investment required to achieve the milestone and whether any portion of the milestone consideration is related to future performance or deliverables. The Company has evaluated each milestone specified under its lic ense agreement with EA Pharma and determined the milestone to be substantive.

Under the terms of the license agreement with EA Pharma, the Company was eligible as of June 30, 2017 to receive up to approximately (a) €13.3 million ($15.2 million based on the Euro to USD exchange rate as of June 30, 2017) if specified regulatory events are achieved for elobixibat in Japan and (b) ¥3.5 billion ($31.1 million based on the Japanese Yen to USD exchange rate as of June 30, 2017) if specified sales milestones are achieved for elobixibat in EA Pharma’s licensed territory following regulatory approval in any country in EA Pharma’s licensed territory. The likelihood that the Company will achieve any particular milestone event with respect to elobixibat in any particular period, or at all, is uncertain, and the Company may not earn any future milestone payment with respect to elobixibat in any particular period, or ever. In addition, the Company is eligible to receive stepped royalties beginning in the high single digits on any future elobixibat product sales.  The Company will recognize royalty revenue in the period of sale of elobixibat, based on the underlying contract terms, provided that the reported sales are reliably measurable and the Company has no remaining performance obligations, assuming all other revenue recognition criteria are met.

Loss contingencies

Loss contingencies are recorded as liabilities when it is probable that a liability has occurred and the amount of loss is reasonably estimable. Disclosure is required when there is a reasonable possibility that an ultimate loss will be material. Contingent liabilities are often resolved over long periods of time. Estimating probable losses requires analysis that often depends on judgments about potential actions by third parties, such as regulators.

Recently adopted accounting pronouncements

In March 2016, the FASB issued ASU No. 2016-09, “ Compensation—Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting ,” which changes the accounting for stock-based payment transactions, including income tax consequences, classification of awards as either equity or liabilities, and classification in the statement of cash flows. The new standard is effective for fiscal years beginning after December 15, 2016 and for interim periods therein. The Company adopted this standard on a prospective basis as of January 1, 2017, which had no impact on deferred tax balances, the consolidated statement of cash flows or otherwise on the Company’s consolidated financial statements.  

Accounting pronouncements issued but not yet adopted

In May 2014, the FASB issued ASU No. 2014-09, “ Revenue from Contracts with Customers: (Topic 606) .” This ASU affects any entity that either enters into contracts with customers to transfer goods or services or enters into contracts for the transfer of nonfinancial assets unless those contracts are within the scope of other standards (e.g., insurance contracts or lease contracts). This ASU will supersede the revenue recognition requirements in ASC Topic 605, “ Revenue Recognition ,” and most industry-specific guidance. In addition, the existing requirements for the recognition of a gain or loss on the transfer of nonfinancial assets that are not in a contract with a customer (e.g., assets within the scope of ASC Topic 360, “ Property, Plant, and Equipment ,” and intangible assets within the scope of ASC Topic 350, “ Intangibles-Goodwill and Other ”) are amended to be consistent with the guidance on recognition and measurement (including the constraint on revenue) in this ASU. The core principle of the guidance is that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. In July 2015, the FASB deferred the effective date of ASU 2014-09. This ASU will be effective for the Company on January 1, 2018 (for the Company’s 2018 fiscal year).  The Company plans to adopt this standard effective January 1, 2018 using the modified retrospective approach, whereby the cumulative effect of applying the standard would be recognized at the date of initial application within retained earnings. The Company currently has one contract that generates revenue and will be impacted by the adoption of the new guidance. The Company is currently evaluating the impact this ASU will have on its consolidated financial statements.

In February 2016, the FASB issued ASU 2016-02, “ Leases (Topic 842) .” The new standard establishes a right-of-use (ROU) model that requires a lessee to record a ROU asset and a lease liability on the balance sheet for all leases with terms longer than 12 months. Leases will be classified as either finance or operating, with classification affecting the pattern of expense recognition in the income statement. The new standard is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. A modified retrospective transition approach is required for lessees for capital and operating leases existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements. The Company is currently evaluating the impact this ASU will have on its consolidated financial statements and currently does not plan to early adopt this standard.

12


In September 2016, the FASB issued ASU 2016-15, “ Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments (a consensus of the Emerging Issues Task Force) ,” which changes how certain cash receipts and cash payments are presented and classified in the statement of cash flows. The new standard is effective for fiscal years beginning after December 15, 2017 and for interim perio ds therein, with early adoption permitted. The Company is currently evaluating the impact this ASU will have on its consolidated financial statements.

2.  Fair value of financial instruments

In measuring fair value, the Company evaluates valuation techniques such as the market approach, the income approach and the cost approach. A three-level valuation hierarchy, which prioritizes the inputs to valuation techniques that are used to measure fair value, is based upon whether such inputs are observable or unobservable.

Observable inputs reflect market data obtained from independent sources, while unobservable inputs reflect market assumptions made by the reporting entity. The three-level hierarchy for the inputs to valuation techniques is briefly summarized as follows:

Level 1—Observable inputs such as quoted prices (unadjusted) for identical instruments in active markets;

Level 2—Observable inputs such as quoted prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets that are not active, or model-derived valuations whose significant inputs are observable for substantially the full term of the assets or liabilities; and

Level 3—Unobservable inputs that reflect the reporting entity’s estimate of assumptions that market participants would use in pricing the asset or liability.

The following tables present the fair values for the Company’s financial instruments as well as the input levels used to determine these fair values as of June 30, 2017 and December 31, 2016. The Company values its current assets, which include trade and other receivables, and liabilities, which include trade payables, at historical cost, which approximates fair value. The estimated fair value of the Loan Facility (see Note 7) was $1.9 million as of June 30, 2017.  The Company used the income approach to value the Loan Facility.

 

 

 

 

 

 

 

Total Carrying Value on the

Condensed Consolidated Balance Sheet

 

 

Fair Value Measurements

 

 

 

Fair Value

Level

 

 

June 30, 2017

 

 

December 31, 2016

 

 

June 30, 2017

 

 

December 31, 2016

 

 

 

 

 

 

 

(in thousands)

 

Financial Instruments Recorded at Fair Value on a

   Recurring Basis

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Warrant liability

 

 

3

 

 

$

 

 

$

844

 

 

$

 

 

$

844

 

 

On December 17, 2014, the Company (in particular, Albireo Limited) executed a convertible loan instrument, which provided 1,251,000 €1.00 ($1.12) unsecured convertible loan notes (2014 Convertible Loans), denominated in Euros, and was subsequently amended on October 1, 2015.  On October 1, 2015, the Company executed a convertible loan instrument which provided 5,000,000 $1.00 unsecured convertible loan notes (the 2015 Convertible Loans), denominated in USD.  The valuation methods used to value the 2014 Convertible Loans, the 2015 Convertible Loans and their respective associated derivative liabilities were the income approach and the Monte Carlo simulation analysis.  The fair value of the 2014 Convertible Loans increased by $25,000 and $17,000 for the three and six months ended June 30, 2016, respectively. The fair value of the 2015 Convertible Loans increased by $222,000 and $127,000 for the three and six months ended June 30, 2016, respectively.  Immediately prior to completion of the Transaction on November 3, 2016, the conversion rights for the 2014 Convertible Loans and the 2015 Convertible Loans were exercised.

There were no transfers from one Level to another Level during the periods reported.

Warrants

In connection with the Loan Facility, the Company issued to Kreos Capital IV (Expert Fund) Limited (Kreos Capital) detachable warrants with a right to acquire shares at €720,000 (the Warrants).  The Company recognized the Warrants at fair value at the time of execution of the Loan Facility and remeasured their fair value on a recurring basis thereafter. In connection with the Transaction, the Warrants were replaced with warrants to purchase 67,271 shares of the Company’s common stock at an exercise price of $11.78 per share (the Replacement Kreos Warrants).  The exchange was accounted for as a modification whereby the fair value of the Replacement Kreos Warrants was compared to the fair value of the Warrants immediately before the terms were modified, measured based on the market price of the common stock of the Company and other pertinent factors on the date of the modification.

13


On May 10, 2017, Kreos Capital notified the Company of its intent to exercise the Replacement Kreos Warrants on a “cashless” basis.  In conjunction with the exercise, the Company remeasured the fair value of the Replacement Kreos Warrants to be $618,000 immediately prior to the exercise.  The number of shares of the Company’s common stock issued in the cashless exercise, 29,831 shares, was determined by a formula specified in the warrant document. The existing liability of the fair value at date of exercise was reclassified to Additional paid in capital.

The fair value of the Replacement Kreos Warrants decreased by $584,000 and $226,000 for the three and six months ended June 30, 2017, respectively. The fair value of the Warrants decreased by $956,000 and $765,000 for the three and six months ended June 30, 2016, respectively.

See Note 7 for a further description of the Loan Facility, Warrants and Replacement Kreos Warrants.

 

 

3.  Commitments and contingencies

Operating lease commitments

Parent is a party to an Office Lease Agreement with SHIGO 10 PO Owner LLC for approximately 5,116 rentable square feet in the building located at 10 Post Office Square, Boston, Massachusetts, which serves as Parent’s executive offices.  The initial term of the lease is 62 months beginning on March 1, 2017.  Parent has the option to extend the lease one time for an additional 5-year period.  Following an initial two-month rent abatement period, Parent is obligated to make monthly rent payments in an amount beginning at $20,997 and escalating by approximately 2% annually for the term of the lease.  In addition, Parent is responsible under the lease for specified costs and charges, including certain operating expenses, utilities, taxes and insurance.

Albireo AB is a party to a 36-month building lease for approximately 5,113 square feet of office space in Gothenburg, Sweden. The current quarterly payment under the lease is SEK 318,197 ($35,907 based on the SEK to USD exchange rate as of June 30, 2017) and subject to change based on applicable taxes and otherwise to increase based on changes in the Swedish Consumer Price Index (CPI).  The current term of the lease expires in November 2019, but renews automatically thereafter for consecutive three-year terms unless notice of nonrenewal is given by either party at least nine months prior to the end of the then-current term, subject to Albireo AB’s right to terminate the lease at any time upon six months’ notice.

As of June 30, 2017, future minimum commitments under facility operating leases were $1,339,000.

Rent expense recognized under the Company’s operating leases was $185,000 and $54,000 for the six months ended June 30, 2017 and 2016, respectively.

Agreements with CROs

As of June 30, 2017, the Company had various agreements with CROs for the conduct of specified research and development activities and, based on the terms of the respective agreements, may be required to make future payments of up to $6.0 million upon the completion of contracted work.

Other Commitments

In connection with the spin-off of Albireo Limited from AstraZeneca in 2008 and associated transfer agreements, the Company became party to an assignment agreement between AstraZeneca and a named inventor on a patent related to elobixibat. In connection with this agreement, upon the initial launch of a pharmaceutical product that constitutes an IBAT inhibitor in specified countries, the inventor is entitled to a one-time “launch fee” payment of SEK 4.0 million ($473,000, based on the SEK to USD exchange rate as of June 30, 2017).

 

4.  Net income (loss) per share

Basic net income (loss) per share, or Basic EPS, is calculated by dividing the net income (loss) by the weighted average number of shares of common stock outstanding. Diluted net income (loss) per share, or Diluted EPS, is calculated by dividing the net income (loss) by the weighted-average number of shares of common stock plus, in the case of dilutive net income per share, dilutive common stock equivalents outstanding.

14


The following table sets forth the computation of Basic EPS and Diluted EPS (in thousands, except for share and per share da ta):  

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2017

 

 

2016

 

 

2017

 

 

2016

 

Basic EPS:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Numerator

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net income (loss)

 

$

(6,176

)

 

$

2,139

 

 

$

(12,847

)

 

$

(1,100

)

Net income (loss)

 

$

(6,176

)

 

$

2,139

 

 

$

(12,847

)

 

$

(1,100

)

Denominator

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average number of shares

 

 

7,171,610

 

 

 

288,427

 

 

 

6,734,555

 

 

 

277,120

 

Number of shares used for Basic

   EPS computation

 

 

7,171,610

 

 

 

288,427

 

 

 

6,734,555

 

 

 

277,120

 

Basic EPS

 

$

(0.86

)

 

$

7.42

 

 

$

(1.91

)

 

$

(3.97

)

Diluted EPS:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Numerator

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net income (loss)

 

$

(6,176

)

 

$

2,139

 

 

$

(12,847

)

 

$

(1,100

)

Net income (loss)

 

$

(6,176

)

 

$

2,139

 

 

$

(12,847

)

 

$

(1,100

)

Denominator

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average number of shares

 

 

7,171,610

 

 

 

288,427

 

 

 

6,734,555

 

 

 

277,120

 

Conversion of convertible preferred

   shares

 

 

 

 

 

2,754,386

 

 

 

 

 

 

 

Weighted average effect of dilutive

   securities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Warrants to purchase common stock

 

 

 

 

 

58,302

 

 

 

 

 

 

 

Number of shares used for Diluted

   EPS computation

 

 

7,171,610

 

 

 

3,101,115

 

 

 

6,734,555

 

 

 

277,120

 

Diluted EPS

 

$

(0.86

)

 

$

0.69

 

 

$

(1.91

)

 

$

(3.97

)

 

As described in Note 1, “Organization and Share Exchange,” the share and per share information as of and for the period ended June 30, 2016 has been retroactively adjusted to reflect the exchange of shares in the Transaction based on an exchange ratio of 0.06999 and does not include the historical results of Biodel.

The following outstanding common stock equivalents were excluded from the computation of Diluted EPS for the three months ended June 30, 2017 and 2016 and the six months ended June 30, 2017 and 2016 because including them would have been anti-dilutive:

 

 

 

For the Three Months Ended June 30,

 

 

For the Six Months Ended June 30,

 

 

 

2017

 

 

2016

 

 

2017

 

 

2016

 

Convertible preference shares

   (on an as-converted basis)

 

 

 

 

 

 

 

 

 

 

 

2,754,386

 

Warrants to purchase convertible preference

   shares (on an as-converted basis)

 

 

 

 

 

56,637

 

 

 

 

 

 

53,549

 

Options to purchase common stock

 

 

767,662

 

 

 

151,370

 

 

 

767,662

 

 

 

76,517

 

 

5.  Income taxes

The Company did not record a tax provision or benefit for either the three or six months ended June 30, 2017 or June 30, 2016.  The Company has continued to maintain a full valuation allowance against its net deferred tax assets.  The Company has had an overall net operating loss position since its inception.  The Company had approximately $53.3 million in valuation allowances recorded against its deferred tax assets as of both June 30, 2017 and December 31, 2016.  

 

The Company’s 2015 federal tax return, in respect of its predecessor (Biodel), is under examination.

15


6 .  Stock-based Compensation

On November 3, 2016, the Albireo Pharma, Inc. 2016 Equity Incentive Plan (the 2016 Equity Plan) was approved by the Company’s stockholders.  The 2016 Equity Plan replaced Biodel’s 2010 Stock Incentive Plan, as amended (the 2010 Plan), in connection with completion of the Transaction.  The 2016 Equity Plan authorized the issuance of up to 635,000 shares, plus up to 249,059 shares issued if awards outstanding under the 2010 Plan were cancelled, forfeited or expired on or after the Transaction.  All stock options outstanding under the 2010 Plan remain in full force and effect pursuant to their terms and the terms of the 2010 Plan.  The 2016 Equity Plan is structured to comply with the requirements imposed by Section 162 (m) of the Internal Revenue Code of 1986, as amended, and related regulations.

Prior to completion of the Transaction, Albireo Limited adopted a share option plan on March 18, 2016, providing for the grant of share options to employees, consultants, officers and directors of Albireo Limited or its subsidiaries (the Pre-Transaction Plan). The Pre-Transaction Plan was amended by Albireo Limited on April 18, 2016. Pursuant to the terms of the Pre-Transaction Plan and prior to completion of the Transaction, Albireo Limited issued or granted options to purchase 246,666 Ordinary A shares. These options were classified as a liability on the basis that they were granted in a currency other than the functional currency of the employing entity of the recipients and were subject to revaluation until exercised or forfeited. The options were replaced with options to purchase shares of the Company’s common stock in conjunction with the Transaction. The replacement was accounted for as a modification whereby the fair value of the replacement awards was compared to the fair value of the original award immediately before the terms were modified, measured based on the market price of the common stock of Biodel and other pertinent factors on the date of the modification. The options were then classified as equity awards with the liability reclassified to Additional paid in capital.

The Company’s employment agreements with certain of its executives provide that, upon a change of control as defined, all of the then outstanding unvested options and any other rights to purchase Company shares will become fully vested and exercisable and any vesting-like restrictions will lapse in full, unless earlier vesting is provided for in the applicable program under which such option or other right to purchase Company shares was granted or under applicable law. The Transaction was not a change of control under the employment agreements.

The Company recognized stock-based compensation expense for employees of $1,439,000 and $55,000 for the three months ended June 30, 2017 and 2016, respectively, and $2,051,000 and $55,000 for the six months ended June 30, 2017 and 2016, respectively.   

A summary of the outstanding stock options as of June 30, 2017 is as follows:

 

 

 

Stock Options Outstanding

 

 

 

Number of

Shares

 

 

Weighted

Average

Exercise

Price Per

Share

 

 

Weighted

Average

Remaining

Contractual

Term (Years)

 

 

Aggregate

Intrinsic

Value (in

thousands)

 

Outstanding—December 31, 2016

 

 

694,869

 

 

$

26.71

 

 

 

7.35

 

 

$

6,435

 

Granted

 

 

249,900

 

 

$

19.21

 

 

 

 

 

$

 

Expirations

 

 

(48,680

)

 

$

175.10

 

 

 

 

 

$

 

Exercises

 

 

(6,666

)

 

$

9.00

 

 

 

 

 

$

 

Outstanding—June 30, 2017

 

 

889,423

 

 

$

16.62

 

 

 

8.59

 

 

$

9,951

 

Exercisable—June 30, 2017

 

 

277,292

 

 

$

21.55

 

 

 

7.00

 

 

$

6,325

 

Vested or expected to vest at—June 30, 2017

 

 

870,001

 

 

$

16.96

 

 

 

8.59

 

 

$

9,570

 

 

Aggregate intrinsic value represents the difference between the estimated fair value of the underlying common stock and the exercise price of outstanding, in-the-money options.

Options to purchase 19,422 shares of common stock are performance based and vest upon the date the Company files a drug approval application for its product candidate A4250 for any orphan indication, if such filing occurs prior to a specified date. This unvested performance-based option is excluded from the vested or expected to vest balance as of June 30, 2017.

As of June 30, 2017, the total unrecognized compensation expense related to unvested options was $7.4 million, which the Company expects to recognize over a weighted average vesting period of 2.4 years.

In determining the estimated fair value of the stock-based awards, the Company uses the Black-Scholes option pricing model and assumptions discussed below. Each of these inputs is subjective and generally requires significant judgment to determine.

16


The fair value of stock optio n awards granted during the three and six months ended June 30, 2017, was estimated with the following assumptions:  

 

 

 

Three Months Ended June 30, 2017

 

 

Six Months Ended June 30, 2017

 

Price per share of common stock

 

$17.05-$23.82

 

 

$17.05-$23.82

 

Expected term (in years)

 

5.2-6.7

 

 

5.2-6.7

 

Risk-free interest rate

 

1.9-2.1%

 

 

1.9-2.1%

 

Expected volatility

 

69.5-76.7

 

 

69.5-78.4

 

  Dividend rate

 

 

0%

 

 

 

0%

 

 

7.  Long-term debt

 

 

 

June 30, 2017

 

 

December 31,

2016

 

 

 

(in thousands)

 

Long-term debt, including current portion:

 

 

 

 

 

 

 

 

Loan Facility

 

$

1,928

 

 

$

3,075

 

Total debt

 

 

1,928

 

 

 

3,075

 

Less: current portion

 

 

(1,928

)

 

 

(3,075

)

Long-term debt

 

$

 

 

$

 

 

Loan Facility

The Company (in particular, Albireo Limited) executed a loan agreement (Loan Facility) with Kreos Capital IV (UK) Limited (Kreos UK) in December 2014, at which time the Company borrowed €6.0 million ($7.3 million). The Loan Facility has a term of 36 months with principal and interest payable monthly, with an annual interest rate of 11.5%.  In addition, the Company is required to make an end-of-loan payment equal to 1.25% of the amounts lent by Kreos UK.  The principal amount outstanding as of June 30, 2017 was $1.4 million (€1.3 million).  The outstanding amount is due and payable in average monthly installments of €253,000 ($289,000, based on the Euro to USD exchange rate as of June 30, 2017) and an end of loan payment of €670,000 ($765,000, based on the Euro to USD exchange rate as of June 30, 2017) due and payable on December 1, 2017.  

The Company is accreting the debt discount of $114,000 remaining as of June 30, 2017 over the remaining six months of the loan term. Interest expense included $130,000 and $239,000 of discount accretion for the three months ended June 30, 2017 and 2016, respectively, and $301,000 and $472,000 of discount accretion for the six months ended June 30, 2017 and 2016, respectively.

The Company has the option to redeem all outstanding amounts. Upon the occurrence of a sale or a change of control, the Company shall redeem the principal, accrued interest and other fees, and remaining interest payments calculated until the end of the term, discounted by 5%.

Parent’s subsidiary, Albireo Limited, has pledged its shares in its subsidiary, Albireo AB, and has granted a debenture (incorporating fixed and floating charges) over its assets by way of security for the obligations it owes under the Loan Facility.

The Loan Facility is guaranteed by Parent and two of Parent’s indirect subsidiaries, Elobix AB and Albireo AB, as the principal obligors that have severally agreed to indemnify and keep indemnified Kreos UK in full and on demand from and against all and any losses, costs, claims, liabilities, damages, demands and expenses suffered or incurred by Kreos UK arising out of, or in connection with, any failure of the Company to perform or discharge any of its obligations or liabilities.

In addition, Parent, Elobix AB and Albireo AB have agreed to pledge the following:

 

Parent shares in Albireo Limited

 

Albireo AB shares in Elobix AB

 

Albireo AB bank accounts

 

Albireo AB A4250 patents

17


 

Elobix elobixibat patents

 

Elobix bank accounts

Although the bank accounts of Albireo AB and Elobix AB were pledged, Albireo AB and Elobix AB are not restricted from using the cash for working capital requirements.

The Company also pledged its present and future rights to fees, royalties and other payments due and payable any time under its license agreement with EA Pharma to Kreos UK in support of the Loan Facility.

On February 4, 2016, the Company (in particular, Albireo Limited) entered a Deed of Variation related to the Loan Facility. Under the terms of the Deed of Variation, the timing of principal payments was changed such that €512,000 ($585,000, based on the Euro to USD exchange rate as of June 30, 2017) of the payments was deferred to become payable at the end of the loan term.  The total principal due under the Loan Facility remained unchanged. In addition, there were no changes to the maturity date or the stated interest rate.  The Company accounted for the amendment to the Loan Facility prospectively in accordance with ASC 470-50, Modifications and Extinguishments , as there were no concessions granted to the Company by the lender and the difference in cash flows between the original and amended loans did not change by more than 10% per lender. As a result of the modification, the transaction costs incurred in connection with the amendment were expensed when incurred and the effective interest rate calculation was updated, resulting in an effective interest rate of 39.3%.

8.  Derivatives

The following disclosures summarize the fair value of derivative instruments not designated as hedging instruments in the Condensed Consolidated Balance Sheet as of June 30, 2017 and the effects of changes in fair value related to those derivative instruments on the Condensed Consolidated Statements of Operations for the six months ended June 30, 2017 (in thousands):

 

Derivative Instruments Not Designated as

Hedging Instruments

 

Balance Sheet Location

 

June 30, 2017

 

 

December 31, 2016

 

Warrants liability

 

Current liabilities

 

 

 

 

 

844

 

 

Effect of Derivative Instruments Not

 

Location of Gains

 

Six Months Ended June 30,

 

Designated as Hedging Instruments

 

(Losses) Recognized

 

2017

 

 

2016

 

Derivative liabilities

 

Non-operating expense, net

 

$

 

 

$

(145

)

Warrants liability

 

Non-operating income, net

 

 

251

 

 

 

765

 

 

Effect of Derivative Instruments Not

 

Location of Gains

 

Three Months Ended June 30,

 

Designated as Hedging Instruments

 

(Losses) Recognized

 

2017

 

 

2016

 

Derivative liabilities

 

Non-operating expense, net

 

$

 

 

$

(247

)

Warrants liability

 

Non-operating income, net

 

 

609

 

 

 

956

 

 

The derivative liabilities related to the conversion feature embedded in the 2014 Convertible Loans and 2015 Convertible Loans have been separately recognized at their respective fair values. The Company determined that embedded features met the definition of a derivative and were required to be recorded at fair value at issuance and remeasured for each reporting period thereafter.  Immediately prior to completion of the Transaction on November 3, 2016, the conversion rights for the 2014 Convertible Loans and the 2015 Convertible Loans were exercised.

9.  Financings

May 2017 Underwritten Public Offering

On May 30, 2017, the Company completed an underwritten public offering of 2,530,000 shares of its common stock, which included the full exercise of the underwriter's option to purchase 330,000 shares to cover overallotments, at a price to the public of $20.50 per share. The Company received net proceeds from this offering of $48.5 million, after deducting underwriting discounts, commissions and offering expenses.

 

 

18


Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

You should read the following discussion and analysis of our financial condition and results of operations together with our condensed consolidated financial statements and the related notes included elsewhere in this quarterly report and our audited financial statements and Management’s Discussion and Analysis of Financial Condition and Results of Operations included in our Annual Report on Form 10-K for the year ended December 31, 2016, filed with the SEC. In addition to historical information, the following discussion contains forward-looking statements that involve risks, uncertainties and assumptions. Our actual results, performance or experience could differ materially from what is indicated by any forward-looking statement due to various important factors, risks and uncertainties, including, but not limited to, those set forth under “Cautionary Note Regarding Forward-Looking Statements” included elsewhere in this quarterly report or under “Risk Factors” in Item 1A of Part I of our Annual Report on Form 10-K for the year ended December 31, 2016 or other filings that we make with the SEC.

Overview

Prior to November 3, 2016, we were a specialty biopharmaceutical company known as Biodel Inc. that historically had been focused on the development and commercialization of innovative treatments for diabetes. On November 3, 2016, we completed a share exchange transaction, or the Transaction, pursuant to an Amended and Restated Share Exchange Agreement dated July 13, 2016 that we entered into with Albireo Limited and the shareholders and noteholders of Albireo Limited.  Upon the completion of the Transaction, we changed our name to “Albireo Pharma, Inc.,” the business of Albireo Limited became our business and we became a biopharmaceutical company focused on the development and commercialization of novel bile acid modulators to treat orphan pediatric liver diseases and gastrointestinal disorders where improper flow or absorption of bile causes serious medical conditions for which there is high unmet need.  The initial target indication for our lead product candidate, A4250, is progressive familial intrahepatic cholestasis, or PFIC, a rare, life-threatening genetic disorder affecting young children for which there is currently no approved drug treatment. We have completed a Phase 2 clinical trial in children with chronic cholestasis and we plan to initiate a Phase 3 clinical trial in patients with PFIC by the end of 2017. In addition to PFIC, we plan to consider conducting future clinical development of A4250 as a treatment for other pediatric cholestatic liver diseases and disorders. Our clinical-stage product candidates in addition to A4250 include elobixibat, for which our licensee has submitted a new drug application for approval in Japan to treat chronic constipation, and A3384, which is in development to treat bile acid malabsorption.  We also have a preclinical program in nonalcoholic steatohepatitis, or NASH.

For accounting purposes, the Transaction was treated as a “reverse acquisition” and Albireo Limited was considered the accounting acquirer. Accordingly, with respect to periods prior to completion of the Transaction, this discussion and analysis reflects the historical results of Albireo Limited and its direct and indirect subsidiaries and does not include the historical results of Biodel prior to completion of the Transaction.

Biodel was incorporated in December 2003 and commenced active operations in January 2004.  Albireo Limited’s business began when Albireo Limited was spun out of AstraZeneca AB in 2008.

Since inception, we have incurred significant operating losses. As of June 30, 2017, we had an accumulated deficit of $38.8 million.  We expect to continue to incur significant expenses and increasing operating losses for at least the next few years as we continue our development of, and seek marketing approvals for, our product candidates, prepare for and begin the commercialization of any approved products, and add infrastructure and personnel to support our product development efforts and operations as a public company in the United States.

As a clinical-stage company, our revenues, expenses and results of operations are likely to fluctuate significantly from quarter to quarter and year to year. Accordingly, we believe that period-to-period comparisons of our results of operations should not be relied upon as indicative of our future performance.

As of June 30, 2017, we had $62.6 million in cash and cash equivalents.

Financial Operations Overview

The following discussion sets forth certain components of our consolidated statements of operations as well as factors that impact those items.

Revenue

We generate revenue primarily from the receipt of upfront or license fees, milestone payments and payment for pharmaceutical ingredient or related procurement services that are made pursuant to license agreements or related supply agreements. License agreements with commercial partners generally include nonrefundable upfront fees and milestone payments, the receipt of which is

19


dependent upon the achievement of specified development, regulatory or commercial milestone events, as well as royalties on product sales of licensed products, if and when such product sales occur, and payments for pharmaceutical ingredient or related procurement services. For these agreements, management applies judgment in the allocation of total agreement consideration to the separately identifiable components on a reliable basis that reasonably reflects the selling prices that might be expected to be achieved in stand-alone transactions.

Operating Expenses

Research and Development Expenses

Research and development expenses consist primarily of personnel costs (including salaries, benefits and stock-based compensation) for employees in research and development functions, costs associated with nonclinical and clinical development services, including clinical trials and related manufacturing costs, third-party contract research organizations, or CROs, and related services and other outside costs, including fees for third-party professional services such as consultants. Our nonclinical studies and clinical studies are performed by CROs. We expect to continue to focus our research and development efforts on nonclinical studies and clinical trials of our product candidates. As a result, we expect our research and development expenses to continue to increase for the foreseeable future.

Our direct research and development expenses are tracked on a program-by-program basis and consist primarily of external costs such as fees paid to CROs and others in connection with our nonclinical and clinical development activities and related manufacturing. We do not allocate employee costs or facility expenses, including depreciation or other indirect costs, to specific product development programs because these costs are deployed across multiple product development programs and, as such, are not separately classified.

Successful development of our current and potential future product candidates is highly uncertain. Completion dates and costs for our programs can vary significantly by product candidate and are difficult to predict. As a result, we cannot estimate with any degree of certainty the costs we will incur in connection with development of any of our product candidates. We anticipate we will make determinations as to which programs and product candidates to pursue and how much funding to direct to each program and product candidate on an ongoing basis in response to the results of ongoing and future clinical trials, our ability to enter into licensing, collaboration and similar arrangements with respect to current or potential future product candidates, the success of research and development programs and our assessments of commercial potential.

General and Administrative Expenses

General and administrative expenses consist primarily of personnel costs (including salaries, benefits and stock-based compensation) for our executive, finance and other administrative employees. In addition, general and administrative expenses include fees for third-party professional services, including consulting, information technology, legal and accounting services and other corporate expenses and allocated overhead.

Critical Accounting Policies and Estimates

Our management’s discussion and analysis of financial condition and results of operations is based on our unaudited condensed consolidated financial statements, which have been prepared in accordance with United States generally accepted accounting principles for interim financial information. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses. We base our estimates and assumptions on historical experience and on various assumptions that we believe are reasonable under the circumstances, and we evaluate them on an ongoing basis. These estimates and assumptions form the basis for making judgments about the carrying values of assets and liabilities and the recording of revenues and expenses that are not readily apparent from other sources. Actual results and experiences may differ materially from these estimates and judgments. In addition, our reported financial condition and results of operations could vary if new accounting standards are enacted that are applicable to our business.

Our significant accounting policies are described in Note 1 to our audited consolidated financial statements included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2016 and in Note 1 to our condensed consolidated financial statements included in this quarterly report.  We believe that our accounting policies relating to revenue recognition, research and development expenses, stock-based compensation and fair value of financial instruments are the most critical to understanding and evaluating our reported financial results. We have identified these policies as critical because they are both important to the presentation of our financial condition and results of operations and require us to make judgments and estimates on matters that are inherently uncertain and may change in future periods. These policies are described under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations — Critical Accounting Policies and Estimates” in our Annual Report on Form 10-K for the year ended December 31, 2016.

20


Result s of Operations

Three Months Ended June 30, 2017 and June 30, 2016

Revenue

 

 

 

Three Months Ended June 30,

 

 

Change

 

 

 

2017

 

 

2016

 

 

$

 

 

 

(in thousands)

 

Revenue

 

$

1

 

 

$

7,973

 

 

$

(7,972

)

 

Revenue was $1,000 for the three months ended June 30, 2017 compared with $8.0 million for the three months ended June 30, 2016, a decrease of $8.0 million.  The decrease for the 2017 period was attributable to a nonrefundable one-time payment of $8.0 million received from EA Pharma in April 2016 in connection with a renegotiated payment stream linked to know-how and intellectual property that we delivered upon inception of the license agreement in 2012. The renegotiated payment stream was implemented via an amendment to the license agreement that did not change the contingent nature of the remaining deliverables or the parties’ respective obligations under the agreement.

Research and development expenses

 

 

 

Three Months Ended June 30,

 

 

Change

 

 

 

2017

 

 

2016

 

 

$

 

 

 

(in thousands)

 

Research and development expenses

 

$

2,962

 

 

$

2,713

 

 

$

249

 

 

Research and development expenses were $3.0 million for the three months ended June 30, 2017 compared with $2.7 million for the three months ended June 30, 2016, an increase of $249,000.  The increase in research and development expenses was principally due to increases for the 2017 period in costs related to A4250, mainly in connection with preparatory activities in the 2017 period for a planned Phase 3 clinical trial in patients with PFIC and nonclinical carcinogenicity studies, and nonclinical development activities associated with A3384 and our preclinical NASH program, partially offset by reductions for the 2017 period in other project costs attributable to patent expenses.

The following table summarizes our principal product development programs and the out-of-pocket third-party expenses incurred with respect to each clinical-stage product candidate and our preclinical programs for the three months ended June 30, 2017 and 2016.

 

 

 

Three Months Ended June 30,

 

 

Change

 

 

 

2017

 

 

2016

 

 

$

 

 

 

(in thousands)

 

Direct third-party project costs:

 

 

 

 

 

 

 

 

 

 

 

 

A4250

 

$

1,872

 

 

$

1,413

 

 

$

459

 

Elobixibat

 

 

(7

)

 

 

11

 

 

 

(18

)

A3384

 

 

62

 

 

 

 

 

 

62

 

Preclinical

 

 

61

 

 

 

4

 

 

 

57

 

Total

 

$

1,988

 

 

$

1,428

 

 

$

560

 

Other project costs (1) :