advm-10q_20160930.htm

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 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 September 30, 2016

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: 001-36579

 

Adverum Biotechnologies, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

 

 

Delaware

 

20-5258327

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

1035 O’Brien Drive,

Menlo Park, CA

(Address of principal executive offices)

94025

(Zip Code)

(650) 272-6269

(Registrant’s telephone number, including area code)

 

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, or a smaller reporting company. See definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):

 

 

 

 

 

 

 

 

Large accelerated filer

 

  

Accelerated filer

 

 

 

 

 

Non-accelerated filer

 

  (Do not check if a smaller reporting company)

  

Smaller reporting company

 

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 October 31, 2016 there were 41,718,515 shares of the registrant’s common stock, par value $0.0001 per share, outstanding.

 

 

 

 

 

 


 

Adverum Biotechnologies, Inc.

(Formerly Avalanche Biotechnologies, Inc.)

TABLE OF CONTENTS

 

 

 

Page

 

 

 

PART I—FINANCIAL INFORMATION

  

3

 

 

 

Item 1. Unaudited Condensed Consolidated Financial Statements

  

3

Condensed Consolidated Balance Sheets as of September 30, 2016 and December 31, 2015

  

3

Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and nine months ended September 30, 2016 and 2015

  

4

Condensed Consolidated Statements of Cash Flows for nine months ended September 30, 2016 and 2015

  

5

Notes to Condensed Consolidated Financial Statements

  

6

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

  

21

Item 3. Quantitative and Qualitative Disclosures About Market Risk

  

27

Item 4. Controls and Procedures

  

28

 

 

 

PART II—OTHER INFORMATION

  

29

 

 

 

Item 1. Legal Proceedings

  

29

Item 1A. Risk Factors

  

29

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

  

34

Item 3. Defaults Upon Senior Securities

  

35

Item 4. Mine Safety Disclosures

  

35

Item 5. Other Information

  

35

Item 6. Exhibits

  

35

 

 

 

SIGNATURES

  

36

 

 

 

EXHIBIT INDEX

  

37

 

 

 

 

2


 

PART I—FINANCIAL INFORMATION

Item 1.

Unaudited Condensed Consolidated Financial Statements

Adverum Biotechnologies, Inc.

(Formerly Avalanche Biotechnologies, Inc.)

Condensed Consolidated Balance Sheets

(Unaudited)

(In thousands except share and per share data)

 

 

September 30,

 

 

December 31,

 

 

2016

 

 

2015

 

 

(Unaudited)

 

 

 

 

 

Assets

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

Cash and cash equivalents

$

231,271

 

 

$

221,348

 

Marketable securities

 

 

 

 

37,732

 

Receivable from collaborative partner

 

1,785

 

 

 

449

 

Prepaid expenses and other current assets

 

2,840

 

 

 

1,463

 

Total current assets

 

235,896

 

 

 

260,992

 

Property and equipment, net

 

4,335

 

 

 

3,187

 

Intangible assets

 

16,200

 

 

 

 

Deposit and other long-term assets

 

140

 

 

 

140

 

Total assets

$

256,571

 

 

$

264,319

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

Accounts payable

$

3,067

 

 

$

605

 

Restructuring liabilities

 

25

 

 

 

1,013

 

Accrued expenses and other current liabilities

 

5,777

 

 

 

4,007

 

Deferred rent, current portion

 

89

 

 

 

66

 

Deferred revenue, current portion

 

1,691

 

 

 

883

 

Total current liabilities

 

10,649

 

 

 

6,574

 

Long-term liabilities:

 

 

 

 

 

 

 

Deferred rent, net of current portion

 

378

 

 

 

447

 

Deferred revenue, net of current portion

 

6,834

 

 

 

4,706

 

Deferred tax liability

 

2,025

 

 

 

 

Other noncurrent liabilities

 

455

 

 

 

 

Total liabilities

 

20,341

 

 

 

11,727

 

Commitments and contingencies (Note 8)

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

 

Preferred stock, $0.0001 par value, 5,000,000 shares authorized; no shares issued

   and outstanding

 

 

 

 

 

Common stock, $0.0001 par value, 300,000,000 shares authorized at September 30,

   2016 and December 31, 2015; 41,718,515 and 25,858,722 shares issued and

   outstanding at September 30, 2016 and December 31, 2015, respectively

 

4

 

 

 

3

 

Additional paid-in capital

 

411,766

 

 

 

336,768

 

Accumulated other comprehensive loss

 

(19

)

 

 

(11

)

Accumulated deficit

 

(175,521

)

 

 

(84,168

)

Total stockholders’ equity

 

236,230

 

 

 

252,592

 

Total liabilities and stockholders’ equity

$

256,571

 

 

$

264,319

 

 

See accompanying notes to condensed consolidated financial statements

 

 

 

3


 

Adverum Biotechnologies, Inc.

(Formerly Avalanche Biotechnologies, Inc.)

Condensed Consolidated Statements of Operations and Comprehensive Loss

(Unaudited)

(In thousands except per share data)

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

2016

 

 

2015

 

 

2016

 

 

2015

 

 

(Unaudited)

 

 

(Unaudited)

 

Collaboration revenue

$

395

 

 

$

953

 

 

$

967

 

 

$

1,359

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

8,362

 

 

 

7,523

 

 

 

23,772

 

 

 

18,270

 

General and administrative

 

6,146

 

 

 

7,631

 

 

 

19,578

 

 

 

16,733

 

Goodwill impairment charge

 

394

 

 

 

 

 

 

49,514

 

 

 

 

Total operating expenses

 

14,902

 

 

 

15,154

 

 

 

92,864

 

 

 

35,003

 

Operating loss

 

(14,507

)

 

 

(14,201

)

 

 

(91,897

)

 

 

(33,644

)

Other income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other income, net

 

206

 

 

 

117

 

 

 

544

 

 

 

285

 

Total other income, net

 

206

 

 

 

117

 

 

 

544

 

 

 

285

 

Net loss

$

(14,301

)

 

$

(14,084

)

 

$

(91,353

)

 

$

(33,359

)

Other comprehensive loss:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net unrealized (loss) gain on marketable securities

 

(6

)

 

 

2

 

 

 

 

 

 

12

 

Foreign currency translation adjustment

 

(23

)

 

 

(17

)

 

 

(13

)

 

 

(25

)

Comprehensive loss

$

(14,330

)

 

$

(14,099

)

 

$

(91,366

)

 

$

(33,372

)

Net loss per share attributable to common stockholders-basic

   and diluted

$

(0.35

)

 

$

(0.55

)

 

$

(2.66

)

 

$

(1.31

)

Weighted-average common shares outstanding-basic and

   diluted

 

41,416

 

 

 

25,685

 

 

 

34,382

 

 

 

25,378

 

 

See accompanying notes to condensed consolidated financial statements

 

 

 

4


 

Adverum Biotechnologies, Inc.

(Formerly Avalanche Biotechnologies, Inc.)

Condensed Consolidated Statements of Cash Flows

(Unaudited)

(In thousands)

 

 

Nine Months Ended September 30,

 

 

2016

 

 

2015

 

 

(Unaudited)

 

Cash flows from operating activities:

 

 

 

 

 

 

 

Net loss

$

(91,353

)

 

$

(33,359

)

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

 

 

 

 

 

 

 

Depreciation and amortization

 

1,116

 

 

 

506

 

Stock-based compensation expense

 

9,852

 

 

 

7,084

 

Non-cash research and development expense

 

24

 

 

 

 

Goodwill impairment charge

 

49,514

 

 

 

 

Amortization of premium on marketable securities

 

 

 

 

570

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

Receivable from collaborative partner

 

(532

)

 

 

 

Prepaid expenses and other current assets

 

(1,317

)

 

 

(542

)

Deposit and other long-term assets

 

 

 

 

(1

)

Accounts payable

 

817

 

 

 

283

 

Accrued expenses and other current liabilities

 

(46

)

 

 

388

 

Restructuring liabilities

 

(988

)

 

 

 

Deferred revenue

 

2,936

 

 

 

(1,359

)

Deferred rent

 

(47

)

 

 

218

 

Net cash used in operating activities

 

(30,024

)

 

 

(26,212

)

Cash flows from investing activities:

 

 

 

 

 

 

 

Purchases of marketable securities

 

 

 

 

(88,427

)

Maturities of marketable securities

 

37,738

 

 

 

19,600

 

Purchases of property and equipment

 

(1,488

)

 

 

(2,804

)

Cash acquired in business acquisition

 

3,449

 

 

 

 

Net cash provided by (used in) investing activities

 

39,699

 

 

 

(71,631

)

Cash flows from financing activities:

 

 

 

 

 

 

 

Proceeds from sales of common stock, net of offering cost

 

 

 

 

138,954

 

Proceeds from issuance of common stock pursuant to option exercises

 

633

 

 

 

181

 

Taxes paid related to net share settlement of restricted stock units

 

(493

)

 

 

 

Proceeds from employee stock purchase plan

 

113

 

 

 

 

Proceeds from financing arrangement

 

100

 

 

 

 

Net cash provided by financing activities

 

353

 

 

 

139,135

 

Effect of foreign currency exchange rate on cash and cash equivalents

 

(105

)

 

 

(20

)

Net increase in cash and cash equivalents

 

9,923

 

 

 

41,272

 

Cash and cash equivalents at beginning of period

 

221,348

 

 

 

159,404

 

Cash and cash equivalents at end of period

$

231,271

 

 

$

200,676

 

 

 

 

 

 

 

 

 

Supplemental schedule of noncash investing and financing information

 

 

 

 

 

 

 

Issuance of common stock and exchange of stock options for business acquisition

$

64,845

 

 

 

 

Fixed assets in accounts payable, accrued expenses and other current liabilities

$

771

 

 

$

182

 

 

See accompanying notes to condensed consolidated financial statements.

 

 

 

5


 

Adverum Biotechnologies, Inc.

(Formerly Avalanche Biotechnologies, Inc.)

September 30, 2016

Notes to Condensed Consolidated Financial Statements

(Unaudited)

 

1. Organization and Basis of Presentation

Adverum Biotechnologies, Inc. (the “Company”, “we” or “us”) was incorporated in Delaware on July 17, 2006 as Avalanche Biotechnologies, Inc. and changed its name to Adverum Biotechnologies, Inc. on May 11, 2016. The Company is headquartered in Menlo Park, California. The Company is a gene therapy company committed to discovering and developing novel medicines that can offer potentially life-changing therapeutic benefit to patients suffering from chronic or debilitating and rare diseases. Since the Company’s inception, it has devoted its efforts principally to performing research and development activities, including conducting preclinical studies, early clinical trials, filing patent applications, obtaining regulatory agreements, hiring personnel, and raising capital to support these activities.

The Company has not generated any revenue from the sale of products since its inception. The Company has experienced net losses since its inception and has an accumulated deficit of $175.5 million as of September 30, 2016. The Company expects to incur losses and have negative net cash flows from operating activities as it engages in further research and development activities. The Company believes that it has sufficient funds to continue operations for at least the next 36 months.

On May 11, 2016, the Company completed the acquisition of all the outstanding shares of Annapurna Therapeutics SAS, a French simplified joint stock company (“Annapurna”), in accordance with the terms of the acquisition agreement (the “Agreement”) dated as of January 29, 2016, as amended on April 6, 2016. As a result, Annapurna is now a wholly owned subsidiary of the Company.

Pursuant to the terms of the Agreement, the Company issued 14,087,246 shares of the Company’s common stock, par value $0.0001 per share, for all of the issued and outstanding capital stock of Annapurna. All outstanding options and other rights to purchase capital stock of Annapurna were converted into the Company’s options for common stock. Refer to Note 3 for more details.

 

Upon completion of the acquisition, the Company changed its name to “Adverum Biotechnologies, Inc.”. The Company’s shares of common stock listed on The NASDAQ Global Market, previously trading through the close of business on Wednesday, May 11, 2016 under the ticker symbol “AAVL,” commenced trading on The NASDAQ Global Market under the ticker symbol “ADVM” on Thursday, May 12, 2016.

Follow-on Offerings —In January 2015, the Company completed a public offering of 2,369,375 shares of its common stock, which included 359,918 shares the Company issued pursuant to the underwriters’ exercise of their option to purchase additional shares. The Company received net proceeds of approximately $130.6 million, after underwriting discounts, commissions and offering expenses.

In March 2015, (i) the Company received net proceeds of approximately $8.3 million, after discounts and other issuance costs, which resulted from the sale of 230,000 common shares, and (ii) the Company issued 230,000 common shares to a shareholder that exercised warrants prior to the initial public offering.

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (U.S. GAAP) and following the requirements of the Securities and Exchange Commission (SEC) for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by U.S. GAAP can be condensed or omitted. These condensed consolidated financial statements have been prepared on the same basis as the Company’s annual consolidated financial statements and, in the opinion of management, reflect all adjustments, consisting only of normal recurring adjustments, which are necessary for a fair statement of the Company’s consolidated financial information. The results of operations for the nine months ended September 30, 2016, are not necessarily indicative of the results to be expected for the full year or any other future period. The balance sheet as of December 31, 2015 has been derived from audited consolidated financial statements at that date but does not include all of the information required by U.S. GAAP for complete consolidated financial statements.

The accompanying condensed consolidated financial statements and related financial information should be read in conjunction with the audited consolidated financial statements and the related notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2015 filed with the SEC.

 

 

 

6


 

2. Summary of Significant Accounting Policies

The accounting policies followed in the preparation of the interim condensed consolidated financial statements are consistent in all material respects with those presented in Note 2 to the consolidated financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2015. The Company added the significant valuation accounting policies below as a result of the Annapurna acquisition in May 2016, and Editas revenue recognition policy related to the new license and collaboration agreement entered in August 2016.

 

Valuation of Long‑Lived Assets and Purchased Intangible Assets

The Company evaluates the carrying value of amortizable long‑lived assets, whenever events, or changes in business circumstances or the planned use of long‑lived assets indicate that their carrying amounts may not be fully recoverable or that their useful lives are no longer appropriate. If these facts and circumstances exist, the Company assesses for recovery by comparing the carrying values of long‑lived assets with their future undiscounted net cash flows. If the comparison indicates that impairment exists, long‑lived assets are written down to their respective fair value based on discounted cash flows. Significant management judgment is required in the forecast of future operating results that is used in the preparation of expected undiscounted cash flows. If management’s assumptions about future operating results were to change as a result of events or circumstances, the Company may be required to record an impairment loss on these assets. No impairment indicators were noted for the Company’s amortizable long-lived assets, fixed assets, in the periods presented.

The Company also evaluates the carrying value of intangible assets (not subject to amortization) related to in‑process research and development (“IPR&D”) assets, which are considered to be indefinite‑lived until the completion or abandonment of the associated research and development efforts. Accordingly, amortization of the IPR&D assets will not occur until the product reaches commercialization. During the period the assets are considered indefinite‑lived, they will be tested for impairment on an annual basis, as well as between annual tests if the Company become aware of any events occurring or changes in circumstances that would indicate that the fair values of the IPR&D assets are less than their carrying amounts. If and when development is complete, which generally occurs when regulatory approval to market the product is obtained, the associated IPR&D assets would be deemed definite‑lived and would then be amortized based on their estimated useful lives at that point in time based on respective patent terms. If the related project is terminated or abandoned, the Company may have an impairment related to the IPR&D asset, calculated as the excess of its carrying value over fair value. The Company estimated fair value of IPR&D assets acquired in Annapurna transaction at the acquisition closing date, May 11, 2016. No impairment indicators were noted and no impairment charge was recorded at September 30, 2016.

 

Revenue Recognition

Collaboration and License Revenue - Editas Collaboration, Option and License agreement

In August 2016, the Company entered into a collaboration, option and license agreement with Editas. Refer to Note 6 for details of the agreement.  Under the terms of the agreement, the Company received initial payments of $1.0 million that included $0.5 million for research services.  As the agreement provides for multiple deliverables, the Company accounts for this agreement as a multiple elements revenue arrangement.  At the inception of the agreement, identified deliverables include research services, manufacturing of viral vectors for research, participation in joint research committee and exclusivity during the option period. These deliverables did not appear to have a standalone value and were combined into one unit of accounting. Options for each indication to license the Company’s AAV vector are considered substantive options and do not include significant incremental discounts. Therefore, they are not considered as deliverables under the Agreement.

The Company allocated the $1.0 million received to a single unit of accounting identified in the arrangement.  The Company expects to recognize $1.0 million ratably over the associated period of performance, which is the maximum research period of three years.  As there is no discernible pattern of performance and/or objectively measurable performance measures do not exist, the Company will recognize revenue on a straight-line basis. During the three months ended September 30, 2016, the Company recognized $56,000 as collaboration revenue.

 

Recently-Issued Accounting Pronouncements In May 2014, the Financial Accounting Standards Board (FASB) issued Accounting Standard Update (ASU) No. 2014-09, Revenue from Contracts with Customers (Topic 606), which supersedes the revenue recognition requirements in Accounting Standard Codification (ASC) 605, Revenue Recognition. This ASU is based on the principle that revenue is recognized to depict the transfer of 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. The ASU also requires additional disclosure about the nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgments and assets recognized from costs incurred to obtain or fulfill a contract. Companies may adopt ASU 2014-09 using a full

 

7


 

retrospective approach or report the cumulative effect as of the date of adoption. In July 2015, the FASB voted to approve a one-year deferral of the effective date to December 15, 2017 for interim and annual reporting periods beginning after that date and permitted early adoption of the standard, but not before the original effective date of December 15, 2016. The FASB issued supplemental adoption guidance and clarification to ASU 2014-09 in March 2016, April 2016 and May 2016 within ASU 2016-08 Revenue From Contracts With Customers: Principal vs. Agent Considerations, ASU 2016-10 Revenue From Contracts with Customers: Identifying Performance Obligations and Licensing, and ASU 2016-12 Revenue from Contracts with Customers: Narrow-Scope Improvements and Practical Expedients, respectively. The Company is evaluating the application of this ASU and method of adoption, but has not yet determined the potential effect it may have on the Company’s consolidated financial statements.

In August 2014, the FASB issued ASU 2014-15, Presentation of Financial Statements—Going Concern (Subtopic 205-40): Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern, requiring management to evaluate whether events or conditions could impact an entity’s ability to continue as a going concern and to provide disclosures if necessary. Management will be required to perform the evaluation within one year after the date that the financial statements are issued. Disclosures will be required if conditions give rise to substantial doubt and the type of disclosure will be determined based on whether management’s plans will be able to alleviate the substantial doubt. The accounting standards update will be effective for the first annual period ending after December 15, 2016, and for annual periods and interim periods thereafter with early application permitted. The adoption of this ASU is not expected to impact the Company’s financial position or results of operations.

In February 2016, the FASB issued ASU No. 2016-2, Leases. ASU 2016-2 is aimed at making leasing activities more transparent and comparable, and requires substantially all leases be recognized by lessees on their balance sheet as a right-of-use asset and corresponding lease liability, including leases currently accounted for as operating leases. The new standard is effective for fiscal years and interim periods within those fiscal years beginning after December 15, 2018, with early adoption permitted. The Company has not yet determined the method of adoption and the potential effect the new standard will have on the Company’s consolidated financial statements.

In March 2016, the FASB issued ASU No. 2016-9, Compensation-Stock Compensation: Improvements to Employee Share-Based Payment Accounting. ASU 2016-9 simplifies several aspects of the accounting for share-based payment award transactions, including: (1) the income tax consequences, (2) classification of awards as either equity or liabilities, and (3) classification in the consolidated statement of cash flows. The new standard is effective for fiscal years and interim periods within those fiscal years beginning after December 15, 2016, with early adoption permitted. The Company has not yet determined the method of adoption and the potential effect the new standard will have on the Company’s consolidated financial statements.

 

The Company has reviewed other recent accounting pronouncements and concluded they are either not applicable to the business or no material effect is expected on the consolidated financial statements as a result of future adoption.

 

 

3. Acquisition of Annapurna

 

 

(a)

Purchase Price Allocation

 

On May 11, 2016, the Company completed the acquisition of all outstanding equity interests of Annapurna. Annapurna is a privately held French limited liability company and has two wholly-owned subsidiaries, Annapurna, Inc. in the U.S. and Annapurna Therapeutics Limited in Ireland. Annapurna is a biopharmaceutical company focused on discovering and developing novel gene therapy products for people living with severe rare diseases. The primary reasons for the acquisition were to expand the technology platforms within the Company’s research and development portfolio and to apply the Company’s resources and expertise in gene vectors development to advance Annapurna’s programs through development and clinical trials. Annapurna’s results of operations and fair value of assets acquired and liabilities assumed are included in the Company’s condensed consolidated financial statements from the date of acquisition.

 

The purchase price consideration was estimated to be $64.8 million, which was based on the Company’s common stock closing price on NASDAQ on the acquisition closing date of $4.14 per share. A total of 14,087,246 shares of the Company’s common stock were issued to shareholders of Annapurna in exchange for all common and preferred stock outstanding at the closing date. Annapurna stockholders did not receive any fractional shares of the Company’s common stock in connection with the acquisition. Instead of receiving any fractional shares, each Annapurna stockholder was paid an amount in cash (without interest) equal to such fraction amount multiplied by the average 10 business days sale price of the Company’s common stock on NASDAQ from the acquisition date. Annapurna Series O preferred shares issued to founders were canceled prior to the acquisition date and were not included in the purchase price consideration. Vesting of certain of Annapurna’s options and unvested common stock shares was accelerated at the closing date. The fair value of awards related to the accelerated vesting of options and shares of $0.9 million was excluded from the purchase price consideration and included in the Company’s operating expenses post acquisition. A portion of the purchase price has

 

8


 

been attributed to the exchange of Annapurna’s options and other rights to purchase capital stock outstanding at the acquisition closing date for corresponding common stock options of the Company at an exchange ratio of 9.54655.

The Company reserved 3,673,940 shares for the future exercise of the Company’s stock options. The total fair value of assumed Annapurna stock options and stock-based awards was estimated at $14.7 million on the acquisition date, using the Black-Scholes pricing model, assuming no dividends, expected volatilities of 80% and 89%, risk-free interest rates of 1.4% and 1.1%, and expected lives of six and ten years for employees and non-employees awards, respectively. Of the total fair value, $7.4 million has been attributed as pre-combination service and included as part of the total purchase price consideration. The post-combination attribution of $7.2 million will be recognized as compensation expense over the remaining requisite service period. The Company has included $1.1 million in stock-based compensation expense related to the vesting of exchanged stock options and day-one post combination compensation expenses related to the accelerated vesting of options and shares in its condensed consolidated statement of operations during the second quarter 2016.

Total purchase price consideration was estimated as follows (in thousands):

 

Fair value of common shares issued

 

$

58,321

 

Fair value of the Company's common share options

   exchanged for Annapurna stock options and other awards

   attributable to pre-combination services

 

 

7,422

 

Less: value of common stock and options accelerated

   vesting at the closing date

 

 

(898

)

Total purchase price consideration

 

$

64,845

 

 

The transaction has been accounted for using the acquisition method based on ASC 805, Business Combinations, with Adverum identified as the acquirer, based on the existence of a controlling financial interest of the combined entities. Under the acquisition method, assets acquired and liabilities assumed were recorded at their estimated fair values as of May 11, 2016. Goodwill, as well as intangible assets that do not qualify for separate recognition, is measured as of the acquisition date as the excess of consideration transferred, which is also measured at fair value, and the net of the fair values of the assets acquired and the liabilities assumed as of the acquisition closing date. Acquisition costs were expensed as incurred and recorded as general and administrative expenses. The Company recorded zero and $2.5 million of acquisition costs for the three-months and nine-months ended September 30, 2016, respectively.

 

Valuing certain components of the acquisition, primarily intangible assets acquired, deferred taxes, uncertain tax positions and accrued liabilities required us to make significant estimates that may be adjusted in the future; consequently, the fair value of identifiable assets acquired and liabilities assumed are considered preliminary. Final determination of these estimates could result in an adjustment to the preliminary purchase price allocation, with an offsetting adjustment to goodwill. During the third quarter of 2016, as management continued its review of the valuation model, the Company recorded an adjustment to reduce the fair value of the acquired IPR&D asset by $450,000, to adjust the related deferred tax liability by $56,000, and to adjust recorded goodwill by $394,000. The adjusted preliminary allocation of total purchase price consideration is as follows (in thousands):

 

Cash

 

$

3,449

 

Prepaid expenses and other assets

 

 

865

 

Property and equipment

 

 

185

 

Acquired intangible assets

 

 

16,200

 

Goodwill

 

 

49,514

 

Accounts payable

 

 

(1,118

)

Accrued liabilities

 

 

(1,848

)

Other noncurrent liabilities

 

 

(377

)

Deferred tax liabilities

 

 

(2,025

)

Total purchase price allocation

 

$

64,845

 

 

The identifiable intangible assets acquired consist of IPR&D assets related to products in development, as summarized in the table below (in thousands):

 

IPR&D - Alpha-1 antitrypsin deficiency

 

$

11,700

 

IPR&D - Hereditary angioedema

 

 

4,500

 

Total acquired intangible assets

 

$

16,200

 

 

9


 

 

The fair value of each IPR&D asset is estimated using the income approach and calculated using cash flow projections adjusted for inherent risks regarding regulatory approval, promotion, and distribution, discounted at a rate of approximately 11.0%. The Company acquired two additional intangible assets relating to the Friedreich’s Ataxia (FA) and severe allergy programs, but the fair value of each of these assets was determined to be nominal and is not included in the total acquired intangible assets. All IPR&D intangible assets acquired are currently classified as indefinite-lived and are not currently being amortized. IPR&D asset becomes definite-lived upon the completion or abandonment of the associated research and development efforts, and will be amortized from that time over an estimated useful life based on respective patent terms. The fair value of each IPR&D asset will continue to be evaluated for impairment on an annual basis or more often if the Company identifies impairment indicators that would require earlier testing. Based on the preliminary fair values above, an amount of $49.5 million has been allocated to goodwill, which represents the excess of the purchase price over the fair values assigned to the net assets acquired. The full amount of the preliminary value of goodwill has been assigned to the entire Company, since management has determined that the Company has only one reporting unit. The goodwill is not deductible for tax purposes.

The amount of net loss of Annapurna included in the consolidated statements of operations from the acquisition date through the period ended September 30, 2016 was $1.2 million for the three months and $2.4 million for the nine months ended September 30, 2016. Annapurna did not generate any revenues prior or post acquisition.

The following table presents the unaudited pro forma results for the nine months ended September 30, 2016 and 2015. The pro forma financial information combines the results of operations of Adverum and Annapurna as though the businesses had been combined as of the beginning of fiscal 2015. The pro forma financial information is presented for informational purposes only, and is not indicative of the results of operations that would have been achieved in the current or any future periods.

 

 

 

Nine Months Ended

September 30,

 

 

 

2016

 

 

2015

 

Pro forma information

 

 

 

 

 

 

 

 

Collaboration revenue

 

$

967

 

 

$

1,359

 

Net loss

 

$

(95,167

)

 

$

(38,475

)

Basic and diluted loss per share

 

$

(2.31

)

 

$

(0.97

)

Weighted-average common shares outstanding - basic and

   diluted

 

 

41,118

 

 

 

39,465

 

 

Pro-forma adjustments included the following:

 

 

Actual acquisition-related transaction costs of $2.5 million for nine months ended September 2016 were excluded from the 2016 pro forma results above. As these expenses were incurred prior to the closing of the acquisition, they were not included in the 2015 pro forma results.

 

Stock-based compensation expense related to the accelerated vesting associated with the acquisition of $0.9 million was excluded from the 2016 pro forma results and was recorded in the nine months ended September 30, 2015.

 

Stock-based compensation expense related to options granted to executives upon the acquisition closing of $0.2 million and $0.3 million was included in the 2016 and 2015 pro forma results above.

 

Interest expense related to convertible notes and changes in fair value of preferred stock warrants of $0.5 million for the nine months ended September 30, 2015 and $1.0 million for the nine months ended September 30, 2016, were excluded form 2015 and 2016 pro-forma results above, as the convertible notes and warrants were settled prior to the acquisition closing.

 

Bonuses paid in connection with closing of the acquisition in May 2016 of $0.4 million were excluded from the 2016 pro forma results and were recorded in the nine months ended September 30, 2015.

The unaudited condensed pro forma information does not include any anticipated synergies that may be achievable subsequent to the date of acquisition.

 

 

 

10


 

 

b)

Impairment evaluation for intangible assets and goodwill

 

As the Company recorded goodwill and IPR&D intangible assets upon the acquisition of Annapurna, the Company is required to test goodwill and indefinite lived intangible assets for impairment on an annual basis or more frequently if indicators of impairment exist. The Company operates as one reporting unit and goodwill was recorded to this reporting unit.

 

During the second quarter of 2016, the Company noted a continuing decrease in its stock price that resulted in the market capitalization being less than the carrying value of the Company’s net assets as of June 30, 2016. As the operating losses are expected to increase significantly in the following years due to continuing pre-clinical and expected clinical trials, the Company concluded that it is more likely than not that the fair value of the Company’s one reporting unit is less than its carrying value and as a result performed a step one goodwill impairment analysis.

 

In performing the step one analysis, the Company determined the fair value of the reporting unit using a market-based approach. The Company multiplied the stock price of $3.16 on June 30, 2016 by the 41.3 million common shares outstanding and applied a control premium to estimate the common equity value on a controlling basis. As the fair value was less than the carrying value of the Company’s net assets, the Company proceeded to step two of the impairment analysis.

 

The second step of the analysis includes allocating the calculated fair value (determined in the step one analysis) of the reporting unit to its assets and liabilities to determine an implied fair value of goodwill. The implied fair value of goodwill was determined in the same manner as the amount of goodwill recognized in an acquisition. That is, the estimated fair value of the reporting unit was allocated to all of the assets and liabilities as if the Company had been acquired and the estimated fair value was the purchase price paid. As part of this assessment the Company considered the preliminary valuation of Annapurna net assets acquired, excluding goodwill, as their fair value from May 11, 2016, the acquisition closing date, to June 30, 2016 did not change. The Company also noted that the fair value of current assets and liabilities approximates their carrying value due to their short-term nature, the Company’s cash and cash equivalent balance is higher than the fair value estimated in the step one analysis, and the fair value of fixed assets approximates their recorded value as most of the Company’s fixed assets are acquired in the last couple of years. Based on this analysis, the implied fair value of the goodwill was zero. Accordingly, the Company recorded a goodwill impairment charge of $49.1 million in the condensed consolidated statements of operations and comprehensive loss for the six month period ended June 30, 2016. During the third quarter of 2016, the Company recorded changes in acquired intangible assets, deferred tax liability, and goodwill as discussed above. This resulted in the additional goodwill impairment charge of $0.4 million recorded in the three months ended September 30, 2016. Total goodwill impairment charge was $49.5 million for the nine months ended September 30, 2016.

 

As the Annapurna purchase price allocation is preliminary and the amount of goodwill might change during the measurement period, the recorded impairment charge reflects the Company’s best estimate as of September 30, 2016.

 

The Company did not impair recorded IPR&D intangible assets, as there were no impairment indicators as of September 30, 2016.

 

 

4. Cash Equivalents and Marketable Securities

The Company did not hold any marketable securities as of September 30, 2016, all investments of $225.7 million were held in money market funds and are treated as cash equivalents.

The following is a summary of the cash equivalents and marketable securities as of December 31, 2015:

 

 

 

December 31, 2015

 

 

 

Amortized

Cost Basis

 

 

Unrealized

Gains

 

 

Unrealized

Loses

 

 

Estimated

Fair Value

 

Money market funds

 

$

208,588

 

 

$

 

 

$

 

 

$

208,588

 

Certificates of deposit

 

 

1,680

 

 

 

 

 

 

 

 

 

1,680

 

U.S. treasury securities

 

 

15,046

 

 

 

 

 

 

(4

)

 

 

15,042

 

U.S. government agency securities

 

 

21,012

 

 

 

 

 

 

(2

)

 

 

21,010

 

 

 

 

246,326

 

 

 

 

 

 

(6

)

 

 

246,320

 

Less: Cash equivalents

 

 

(208,588

)

 

 

 

 

 

 

 

 

(208,588

)

Total marketable securities

 

$

37,738

 

 

$

 

 

$

(6

)

 

$

37,732

 

 

 

11


 

As of December 31, 2015, the contractual maturities of the Company’s marketable securities were less than one year. The Company has not sold any securities prior to their maturities and so does not consider any losses on these investments to be other-than-temporarily impaired. There were no sales of available-for-sale securities in any of the periods presented.

 

 

5. Fair Value Measurements and Fair Value of Financial Instruments

The authoritative guidance on fair value measurements establishes a three-tier fair value hierarchy for disclosure of fair value measurements as follows:

Level 1: Quoted prices in active markets for identical assets or liabilities.

Level 2: Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.

Level 3: Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires management to make judgments and consider factors specific to the asset or liability.

The fair value of Level 1 securities are determined using quoted prices in active markets for identical assets. Level 1 securities consist of highly liquid money market funds. Financial assets and liabilities are considered Level 2 when their fair values are determined using inputs that are observable in the market or can be derived principally from or corroborated by observable market data such as pricing for similar securities, recently executed transactions, cash flow models with yield curves, and benchmark securities. In addition, Level 2 financial instruments are valued using comparisons to like-kind financial instruments and models that use readily observable market data as their basis. U.S. Treasury securities, U.S. government agency securities and certificate of deposit are valued primarily using market prices of comparable securities, bid/ask quotes, interest rate yields and prepayment spreads and are included in Level 2.

There were no transfers within the hierarchy during the nine months ended September 30, 2016 and the year ended December 31, 2015. As of September 30, 2016, the Company has no Level 3 assets and one Level 3 liability.  As of December 31, 2015, the Company had no Level 3 assets or liabilities.

The following table summarizes, for assets recorded at fair value on a recurring basis, the respective fair value and the classification by level of input within the fair value hierarchy as described above (in thousands):

 

 

 

 

 

 

 

Quoted Prices

 

 

Significant Other

 

 

Significant

 

 

 

Total

 

 

In Active

Markets

 

 

Observable

Inputs

 

 

Unobservable

Inputs

 

 

 

Carrying Value

 

 

(Level 1)

 

 

(Level 2)

 

 

(Level 3)

 

September 30, 2016

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds - cash equivalent

 

$

225,735

 

 

$

225,735

 

 

$

 

 

$

 

Total cash equivalents

 

$

225,735

 

 

$

225,735

 

 

$

 

 

$

 

Other noncurrent liability:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Financing arrangement

 

$

74

 

 

$

 

 

$

 

 

$

74

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

December 31, 2015

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds - cash equivalent

 

$

208,588

 

 

$

208,588

 

 

$

 

 

$

 

Certificates of deposit

 

 

1,680

 

 

 

 

 

 

1,680

 

 

 

 

U.S. treasury securities

 

 

15,042

 

 

 

 

 

 

15,042

 

 

 

 

U.S. government agency securities

 

 

21,010

 

 

 

 

 

 

21,010

 

 

 

 

Total cash equivalents and

   marketable securities

 

$

246,320

 

 

$

208,588

 

 

$

37,732

 

 

$

 

 

In August 2016, the Company entered into a financing arrangement with an independent third party for a total amount of $0.3 million. Under the terms of the financing arrangement, the Company may be required to repay up to $1.4 million, depending on the

 

12


 

achievement of certain development and commercialization milestones.  The Company elected the fair value option to account for this financing arrangement.  The fair value of the financing arrangement was determined based on the expected value approach and is classified as Level 3 within the fair value hierarchy.  The key unobservable inputs in the valuation model include timing of milestones, probability of achievement of development and commercial milestones and a discount factor.

The following table presents quantitative information about the inputs and valuation methodologies used for the fair value measurements classified in Level 3 at the fair value hierarchy at September 30, 2016:

 

 

 

Fair Value  at

 

 

 

 

Significant

 

 

 

 

 

 

September 30, 2016

 

 

Valuation

 

Unobservable

 

Weighted Average

 

 

 

(in thousands)

 

 

Methodology

 

Input

 

(range, if applicable)

 

Financing arrangement

 

$

74

 

 

Expected value approach

 

Milestone dates

 

2017 to 2023

 

 

 

 

 

 

 

 

 

Discount rate

 

 

5.50

%

 

 

 

 

 

 

 

 

Percent probability of milestone achievements

 

18.2% to 80.0%

 

 

Non-financial assets such as intangible assets, property, plant, and equipment are evaluated for impairment and adjusted to their fair value using Level 3 inputs, only when impairment is recognized. Fair values are considered Level 3 when management makes significant assumptions in developing a discounted cash flow model based upon a number of considerations including projections of revenues, earnings and a discount rate. In addition, in evaluating the fair value of goodwill impairment, further corroboration is obtained using our market capitalization.

 

 

6. Significant Agreements

Regeneron

In May 2014, the Company entered into a research collaboration and license agreement with Regeneron to discover, develop and commercialize novel gene therapy products for the treatment of ophthalmologic diseases. The collaboration covers up to eight distinct therapeutic targets (collaboration targets). The Company and Regeneron will collaborate during the initial research period of three years that can be extended by Regeneron for up to an additional five years. During the research period, Regeneron has the option to obtain an exclusive worldwide license for a collaboration target’s further development by giving written notice to the Company and paying $2.0 million per target. If Regeneron exercises its option, it will be responsible for all further development and commercialization of the target. The Company is then eligible to receive contingent payments of up to $80.0 million upon achievement of certain development and regulatory milestones for product candidates directed toward each collaboration target, for a combined total of up to $640.0 million in potential milestone payments for product candidates directed toward all eight collaboration targets, plus a royalty in the low- to mid-single-digits on worldwide net sales of collaboration products.

For any two collaboration targets, the Company has an option to share up to 35% of the worldwide product candidate development costs and profits. If the Company exercises this option, the Company will not be eligible for milestone and royalty payments discussed above but rather the Company will share development costs and profits with Regeneron.

The agreement will expire with respect to each collaboration target upon the earlier of the (a) expiration of the research term if the option right has not been triggered by the end of the research term or (b) expiration of the option right if the option right has not been exercised by Regeneron. If the option right has been exercised, the agreement in connection with each collaboration target will expire upon expiration of all payment obligations by Regeneron. In addition, the agreement, or Regeneron’s rights to any target development under the agreement, may terminate early under the following situations:

 

 

Regeneron may terminate the agreement for convenience at any time on a target by target basis or in totality upon a 30-day notice.

 

 

Each party can terminate the agreement if another party commits a material breach or material default in performance of its obligations and such breach or default is not cured within 60 days.

 

 

The agreement is automatically terminated upon initiation of any bankruptcy proceedings, reorganization or dissolution of either party.

 

 

The Company can terminate the agreement upon 30-day notice if Regeneron challenges the validity, scope or enforceability of any Company patent.

 

 

13


 

University of California

In May 2010, the Company entered into a license agreement, as amended, with the Regents of the University of California (Regents) for exclusive rights in the U.S. to certain patents owned by the Regents. Under the terms of the agreement, the Company paid an upfront license fee of $100,000 and agreed to reimburse the Regents for patent-related expenses. The Company is obligated to pay the Regents royalties on net sales, if any, as well as an annual maintenance fee of $50,000 beginning in the calendar year after the first commercial sale of a licensed product and milestone payments related to the achievement of certain clinical and regulatory goals totaling up to $900,000 for the first indication and $500,000 for each additional indication for up to two additional indications. Through September 30, 2016, none of these goals had been achieved, and no milestones were payable.

 

Cornell University

 

In August 2014, as amended in December 2015, Annapurna entered into a master service agreement with Cornell University for assistance in regulatory affairs, overall project management and parameter development. Per the amended agreement, Annapurna will pay Cornell $13.3 million ratably over 4 years for these services, as services will be performed.

 

In December 2015, Annapurna Therapeutics Limited entered into three licensing agreements with Cornell University, pursuant to which Annapurna will advance its ANN-001, ANN-002 and ANN-004 programs, which were each based on gene-therapy programs initiated at the Department of Genetic Medicine at Weill Cornell. Under Adverum these programs will be ADVM-043, ADVM-053 and our program targeting severe allergy, respectively.

 

A1AT Deficiency License Agreement: Under this agreement, Annapurna Therapeutics Limited holds an exclusive license to certain technology related to alpha-1 antitrypsin (“A1AT”) deficiency and rights to an Investigational New Drug (“IND”) application to initiate clinical studies of gene therapy for A1AT.

 

HAE License Agreement: Under this agreement, Annapurna Therapeutics Limited holds an exclusive license to certain technology related to hereditary angioedema (“HAE”) and a non-exclusive license to certain other intellectual property related to the HAE program.

 

Allergy License Agreement: Under this agreement, Annapurna Therapeutics Limited holds an exclusive license to certain patents related to allergens and a non-exclusive license to certain other technology related to allergens.

 

The Company may terminate any of these license agreements for convenience upon ninety days written notice.

 

Across these three license agreements, Cornell University is entitled to receive aggregate annual maintenance fees ranging from $30,000 to $300,000 per year, up to $16.0 million in aggregate milestone payments and royalties on sales in the low single-digits, subject to adjustments and minimum thresholds. In addition, under a master services agreement with Cornell University, Annapurna will utilize the university to scale production of gene therapies by manufacturing processes that the institution has already used to produce Good Manufacturing Practice (GMP) material for other gene-therapy trials. The Company accrued $1.1 million as of September 30, 2016 and recorded research and development expenses of $0.8 million for the three months ended September 30, 2016 and $1.3 million (post Annapurna’s acquisition) for the period from May 11, 2016 through September 30, 2016, related to Cornell agreements. No milestone payments were probable to achieve and none were recorded as of September 30, 2016.

 

Dr. Crystal, Chairman of Genetic Medicine, the Bruce Webster Professor of Internal Medicine and a Professor of Genetic Medicine and of Medicine at Weill Cornell, served as a consultant to Annapurna since inception and continues to provide services to the Company for the annual compensation of $0.3 million. Dr. Crystal also owns common shares of the Company and he does not have significant influence on the Company’s operations.

 

REGENXBIO

 

A1AT Deficiency/Allergy License Agreement: In October 2015, Annapurna Therapeutics Limited entered into an exclusive worldwide license to certain intellectual property in order to make, have made, use, import, sell and offer for sale certain licensed products for the treatment of A1AT deficiency. Additionally under this agreement, the Company has an option to be granted an exclusive worldwide license to certain intellectual property related to the treatment of severe allergies. Under this license agreement, REGENXBIO is eligible to receive annual maintenance fees, up to approximately $20.0 million in combined milestone payments and royalties in the mid-to-high single digits.

 

 

14


 

Friedreich’s Ataxia License Agreement: In April 2014, Annapurna entered into an exclusive worldwide license to certain intellectual property related to the Friedreich’s Ataxia (“FA”) program to make, have made, use, import, sell and offer for sale licensed products using AAVrh10 for FA where the vector is administered by any route except directly to the central nervous system (FA Systemic).  Under the terms of this license agreement, Annapurna also has an option to obtain a non-exclusive worldwide license to make, have made, use, import, sell and offer for sale licensed products using a single vector for each of FA where the vector is administered directly to the central nervous system and FA Systemic. Under this license agreement, REGENXBIO is eligible to receive annual maintenance fees, up to $13.85 million in combined milestone fees and royalties in the mid-to-high single digits.

 

The Company accrued $75,000 as of September 30, 2016 and recorded expenses of $49,000 (post Annapurna’s acquisition) for the period May 11, 2016 through September 30, 2016, related to REGENXBIO agreements. No milestone payments were probable to achieve and none were recorded as of September 30, 2016.

 

Inserm Transfert

 

In July 2014, Annapurna entered into an agreement with Inserm Transfert whereby Annapurna holds an exclusive license to certain patents to develop, make, have made, use, import, offer for sale and sell or otherwise distribute products for the treatment of Friedreich’s ataxia and a non-exclusive license to certain other intellectual property related to the FA program. The Agreement was amended in October 2015 to increase the scope of the intellectual property under the licenses.  Under this agreement, Inserm Transfert is entitled to receive certain de minimis license payments,  certain development milestone payments  of up to approximately  €2.0 million in the aggregate and royalties on sales in the low single-digits, subject to adjustments. The Company accrued $140,000 relating to Inserm as of September 30, 2016 and recorded research and development expenses of $140,000 for the three months ended September 30, 2016 and for the period from May 11, 2016 through September 30, 2016, related to this agreement. No milestone payments were probable to achieve and none were recorded as of September 30, 2016.

 

Editas Medicine, Inc.

In August 2016, the Company entered into a collaboration, option and license agreement with Editas Medicine, Inc. (“Editas”) pursuant to which the Company and Editas will collaborate on certain studies using adeno-associated viral (AAV) vectors in connection with Editas’ genome editing technology and the Company will grant to Editas an exclusive option to obtain certain exclusive rights to use the Company’s proprietary vectors in up to five ophthalmic indications. The Company received a $1.0 million non-refundable upfront payment, with $0.5 million of such payment to be credited against Editas’ obligation to fund research and development costs. Under the terms of the agreement, both the Company and Editas will be subject to exclusivity obligations.

 

Editas may exercise the option, with respect to a designated initial Indication, until the first anniversary of the effective date of the agreement.  With respect to the four other Indications, Editas may exercise the option until the third anniversary of the effective date, provided that the option will expire on the second anniversary of the effective date if Editas has not exercised the option with respect to the initial Indication or any other Indication by such date.  Upon each exercise of the option, Editas will pay the Company a $1.0 million fee per Indication.  If Editas elects to develop a product using certain of the Company’s proprietary vectors, the Company will be eligible to receive up to a mid-teen million dollar amount in development and commercialization milestone payments for such product, and tiered royalties between the mid-single digits and low teens on net sales of such product, subject to certain adjustments.

Unless early terminated, the agreement will be in effect until the later of the expiration of the option exercise period or the expiration of the royalty term of the last product.  At any time after the option is first exercised, Editas may terminate the Agreement for convenience in its entirety or on an indication-by indication or country-by-country basis, upon prior written notice to the Company.  The Company may also terminate the agreement if Editas challenges the Company’s patents relating to its proprietary vectors and does not withdraw such challenge within a defined period of time.  In addition, either party may terminate the agreement with written notice upon a bankruptcy of the other party or upon an uncured material breach by the other party.

 

 

 

15


 

7. Property and Equipment, Net

Property and equipment, net consists of the following (in thousands):

 

 

 

September 30, 2016

 

 

December 31, 2015

 

Computer equipment and software

 

$

274

 

 

$

234

 

Laboratory equipment

 

 

4,052

 

 

 

3,041

 

Furniture and fixtures

 

 

552

 

 

 

552

 

Leasehold improvements

 

 

1,518

 

 

 

351

 

Construction in progress

 

 

46

 

 

 

 

Total property and equipment

 

 

6,442

 

 

 

4,178

 

Less accumulated depreciation and amortization

 

 

(2,107

)

 

 

(991

)

Property and equipment, net

 

$

4,335

 

 

$

3,187

 

 

Depreciation and amortization expense related to property and equipment for the three months ended September 30, 2016 and 2015 was $453,000 and $241,000, respectively.  Depreciation and amortization expense related to property and equipment for the nine months ended September 30, 2016 and 2015 was $1.1 million and $506,000, respectively.

 

 

8. Accrued Expenses and Other Current Liabilities

Accrued expenses and other current liabilities consist of the following (in thousands):

 

 

September 30, 2016

 

 

December 31, 2015

 

Employees’ compensation expenses

 

$

2,364

 

 

$

2,047

 

Accrued professional services

 

 

941

 

 

 

1,177

 

Accrued preclinical costs

 

 

1,992

 

 

 

642

 

Accrued clinical and process development costs

 

 

430

 

 

 

101

 

Other

 

 

50

 

 

 

40

 

Total accrued expenses and other current liabilities

 

$

5,777

 

 

$

4,007

 

 

 

9. Other non-current liabilities

 

Due to the innovative nature of Annapurna’s product candidate development programs, Annapurna has benefited from certain sources of financial assistance from Banque Publique d’Investissement (“BPI France”). BPI France provides financial assistance and support to emerging French enterprises to facilitate the development and commercialization of innovative technologies. The funds received by the Company are intended to finance its research and development efforts and the recruitment of specific personnel. The Company has received such funding in the form of conditional advances.

 

In August 2015, BPI France granted Annapurna a €750,000 interest free conditional advance, of which €500,000 was drawn down as of December 31, 2015. The remaining €250,000 advance was not and is not expected to be drawn down on. Payments are scheduled in equal quarterly amounts of €25,000 from September 30, 2017 to June 30, 2022. This payment schedule will be modified if the Company will receive revenue from license or product sales before advances are paid in full. The Company calculated 7% imputed interest expense on these advances that was recorded as a discount at the issuance date. The discount is amortized as an interest expense over the life of the advances. As of September 30, 2016 the carrying value, which approximates the fair value, of the conditional advance was $381,000 and is recorded in other noncurrent liabilities and the Company recorded $11,000 interest expense from the acquisition closing date to September 30, 2016.

 

In July 2016, the Company entered into a sponsored research agreement with The Alpha-1 Project, Inc. (TAP) in which TAP will fund the Company’s A1AT research activities of up to $300,000. The Company may repay up to 4.5 times the received amount if and when certain product approval and sales milestones are achieved. During the third quarter, the Company received $100,000 and issued the common stock warrant for 10,000 shares exercisable anytime during five years from the issuance date at an exercise price of $4.33 per share. Warrants were valued at $26,000 at the issuance date and recorded as equity. Financing arrangement was recorded at estimated fair value of $74,000 in other noncurrent liabilities as of September 30, 2016. Refer to Note 5 for valuation details of this financing arrangement.

 

 

 

 

16


 

10. Commitments and Contingencies

Collaborations and License Agreements

 

In August 2014, as amended December 2015, Annapurna entered into a master service agreement with Cornell University for assistance in regulatory affairs, overall project management and parameter development. Per the amended agreement, Annapurna will pay Cornell $13.3 million ratably over 4 years for these services.

 

The Company is a party to various agreements, principally relating to licensed technology that requires payment of annual maintenance fees and future payments relating to milestones or royalties on future sales of specified products. Refer to Note 6 for further details. The Company expenses the annual maintenance fees on a straight-line basis and accrues the aggregate balances until invoiced or paid. Through September 30, 2016, none of the goals had been achieved under the license agreements and no cash milestones were accrued or payable. Since the achievement of these milestones is not fixed and determinable, such commitments have not been included in the Company’s condensed consolidated balance sheets.

Guarantees and Indemnifications

In the normal course of business, the Company enters into contracts and agreements that contain a variety of representations and warranties and provide for indemnification for certain liabilities. The exposure under these agreements is unknown because it involves claims that may be made against the Company in the future but have not yet been made. To date, the Company has not paid any claims or been required to defend any action related to its indemnification obligations. However, the Company may record charges in the future as a result of these indemnification obligations. The Company also has indemnification obligations to its directors and executive officers for specified events or occurrences, subject to some limits, while they are serving at the Company’s request in such capacities. There have been no claims to date and the Company believes the fair value of these indemnification agreements is minimal. Accordingly, the Company has not recorded any liabilities for these agreements as of September 30, 2016.

Legal Proceedings

From time to time, the Company may become involved in litigation and other legal actions. The Company estimates the range of liability related to any pending litigation where the amount and range of loss can be estimated. The Company records its best estimate of a loss when the loss is considered probable. Where a liability is probable and there is a range of estimated loss with no best estimate in the range, the Company records a charge equal to at least the minimum estimated liability for a loss contingency when both of the following conditions are met: (i) information available prior to issuance of the financial statements indicates that it is probable that a liability had been incurred at the date of the financial statements and (ii) the range of loss can be reasonably estimated.

In July 2015, three securities class action lawsuits were filed against the Company and certain of its officers in the United States District Court for the Northern District of California, each on behalf of a purported class of persons and entities who purchased or otherwise acquired its publicly traded securities between July 31, 2014 and June 15, 2015. The lawsuits assert claims under the Securities Exchange Act of 1934 (Exchange Act) and the Securities Act of 1933, as amended (Securities Act) and allege that the defendants made materially false and misleading statements and omitted allegedly material information related to, among other things, the Phase 2a clinical trial for AVA-101 and the prospects of AVA-101. The complaints seek unspecified damages, attorneys’ fees and other costs. An amended consolidated complaint was filed in February 2016. On November 3, 2016, the Court granted the Company’s motion to dismiss the consolidated complaint.  It set a deadline of December 2, 2016 for plaintiffs to file an amended consolidated complaint.

In December 2015, a securities class action lawsuit was filed against the Company, its board of directors, underwriters of its January 13, 2015, follow-on public stock offering, and two of its institutional stockholders, in the Superior Court of the State of California for the County of San Mateo. The complaint alleges that, in connection with the Company’s follow-on stock offering, the defendants violated the Securities Act in essentially the same manner alleged by the consolidated federal action: by allegedly making materially false and misleading statements and by allegedly omitting material information related to the Phase 2a clinical trial for AVA-101 and the prospects of AVA-101. The complaint seeks unspecified compensatory and rescissory damages, attorneys’ fees and other costs. The plaintiff has dismissed the two institutional stockholder defendants. In August 2016, the Court denied the Company’s motion to stay without prejudice, denied the Company’s demurrer, and dismissed with leave to amend certain claims against the underwriter defendants.

 

The Company believes that the claims in the asserted actions are without merit and intends to defend the lawsuits vigorously. The Company expects to incur costs associated with defending the actions. While the Company has various insurance policies related to the risks associated with its business, including directors’ and officers’ liability insurance policies, there is no assurance that the Company will be successful in its defense of the actions, that its insurance coverage, which contains a self-insured retention, will be

 

17


 

sufficient, or that its insurance carriers will cover all claims or litigation costs. Due to the inherent uncertainties of litigation, the Company cannot reasonably predict at this time the timing or outcomes of these matters or estimate the amount of losses, or range of losses, if any, or their effect, if any, on its condensed consolidated financial statements.

 

 

11. Stock Option Plans

The Company’s  2014 Equity Incentive Award Plan (2014 Plan) permits the issuance of stock options (options), restricted stock units (RSUs) and other types of awards to employees, directors, and consultants.

As of September 30, 2016, a total of 13,162,656 shares of common stock were authorized for issuance and 3,033,936 shares were available for future grants under the 2014 Plan.

In July 2014, the Company’s board of directors and its stockholders approved the establishment of the 2014 Employee Stock Purchase Plan (2014 ESPP). During the nine months ended September 30, 2016, 52,002 shares were issued under the 2014 ESPP and no shares were issued in the same period for 2015. A total of 675,383 shares of common stock have been reserved for issuance under the 2014 ESPP and 623,381 were available for issuance under the 2014 ESPP as of September 30, 2016.

The following table summarizes option activity under our stock plans and related information:

 

 

 

 

 

 

 

 

 

 

Weighted-

 

 

 

 

 

 

Number

 

 

Weighted-

 

 

Average Remaining

 

 

Aggregate

 

 

of Options

 

 

Average Exercise

 

 

Contractual Life

 

 

Intrinsic Value (a)

 

 

(in thousands))

 

 

Price

 

 

(In years)

 

 

(in thousands)

 

Balance at January 1, 2016

 

5,494

 

 

$

8.75

 

 

 

 

 

 

 

 

 

Options granted

 

5,010

 

 

$

1.27

 

 

 

 

 

 

 

 

 

Options exercised

 

(1,474

)

 

$

0.45

 

 

 

 

 

 

 

 

 

Options cancelled

 

(1,349

)

 

$

12.02

 

 

 

 

 

 

 

 

 

Balance at September 30, 2016

 

7,681

 

 

$

4.90

 

 

 

8.3

 

 

$

17,866

 

Vested and expected to vest as of September 30, 2016

 

7,557

 

 

$

4.85

 

 

 

8.3

 

 

$

17,838

 

Exercisable as of September 30, 2016

 

3,806

 

 

$

3.89

 

 

 

7.4

 

 

$

12,136

 

 

(a)

The aggregate intrinsic value is calculated as the difference between the option exercise price and the closing price of common stock of $4.11 per share as of September 30, 2016.

Options granted number includes the Company’s stock options for 3,673,940 common stock shares issued in exchange for Annapurna stock options at $0.21 exercise price per share. The weighted-average fair values of options granted and exchanged during the nine months ended September 30, 2016 and 2015 were $1.27 and $23.92, respectively. The total intrinsic value of options exercised during the nine months ended September 30, 2016 and 2015 were $7.1 million and $11.2 million, respectively.

The Company has recorded aggregate stock-based compensation expense related to the issuance of stock option awards to employees and nonemployees in the condensed consolidated statement of operations and comprehensive loss as follows (in thousands):

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

September 30,

 

 

September 30,

 

 

2016

 

 

2015

 

 

2016

 

 

2015

 

Research and development

$

1,608

 

 

$

2,044

 

 

$

5,748

 

 

$

1,883

 

General and administrative

 

1,334

 

 

 

3,708

 

 

 

4,104

 

 

 

5,201

 

Total share-based compensation

$

2,942

 

 

$

5,752

 

 

$

9,852

 

 

$

7,084

 

 

Stock-based compensation expense included additional charges of 0.5 million and $1.5 million, recorded in general and administrative expense, and zero and $1.4 million, recorded in research and development expense, related to stock modifications in connection with separation agreements for four Company’s executive officers for the three and nine-months ended September 30, 2016, respectively.

Restricted Stock Units

Restricted stock units, or RSUs, are share awards that entitle the holder to receive freely tradable shares of our common stock upon vesting. The fair value of RSUs is based upon the closing sales price of our common stock on the grant date. RSUs granted to employees generally vest over a two-to-four year period.

 

18


 

The following table summarizes the RSUs activity under our stock plans and related information:

 

 

 

 

 

 

 

Weighted-Average

 

 

 

Number of

 

 

Grant-Date

 

 

 

Units

(in thousands)

 

 

Fair Value

(in dollars)

 

Outstanding at December 31, 2015

 

 

632

 

 

$

13.07

 

Granted

 

 

1,159

 

 

$

4.59

 

Vested and released

 

 

(375

)

 

$

12.45

 

Forfeited

 

 

(493

)

 

$

7.11

 

Outstanding at September 30, 2016

 

 

923

 

 

$

5.81

 

 

The total fair value of RSUs that vested for the nine months ended September 30, 2016 and 2015 was $4.0 million and $0.1 million, respectively. As of September 30, 2016, there was $3.9 million of unrecognized compensation cost related to unvested RSUs that the Company expects to recognize over a weighted-average period of 3.2 years.

Stock Options Granted to Employees

The fair value of each option issued to employees was estimated at the date of grant using the Black-Scholes valuation model with the following weighted-average assumptions:

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

September 30,

 

 

September 30,

 

 

2016

 

 

2015

 

 

2016

 

 

2015

 

Option grants:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Expected volatility

 

81

%

 

 

75

%

 

 

81

%

 

 

77

%

Expected term (in years)

 

6.0

 

 

 

6.1

 

 

 

5.9

 

 

 

6.1

 

Expected dividend yield

 

 

 

 

 

 

 

 

 

 

 

Risk-free interest rate

 

1.4

%

 

 

1.8

%

 

 

1.3

%

 

 

1.7

%

 

As of September 30, 2016, there was $12.6 million of unrecognized stock-based compensation expense related to employees’ awards that the Company expects to recognize over a weighted-average period of 3.1 years.

Stock Options Granted to Non-Employees

Stock-based compensation related to stock options granted to non-employees is measured and recognized as the stock options are earned. The Company believes that the estimated fair value of the stock options is more readily measurable than the fair value of the services rendered. The following weighted-average assumptions were used in estimating non-employees’ stock-based compensation expenses:

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

September 30,

 

 

September 30,

 

 

2016

 

 

2015

 

 

2016

 

 

2015

 

Option grants:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Expected volatility

 

84

%

 

 

71

%

 

 

83

%

 

 

74

%

Expected term (in years)

 

8.0

 

 

 

2.5

 

 

 

7.5

 

 

 

4.1

 

Expected dividend yield