Notes to the Unaudited Condensed Financial Statements
1. Organization
OncoMed Pharmaceuticals, Inc. (“OncoMed,” the “Company,” “us,” “we,” or “our”) is a clinical-stage biopharmaceutical company focused on discovering and developing novel therapeutics that address the fundamental biology driving cancer’s growth, resistance, recurrence and metastasis. The Company currently has three anti-cancer therapeutic candidates in active clinical development. The Company is also pursuing discovery of additional novel approaches to cancer treatment, including new immuno-oncology therapeutic candidates. The Company’s operations are based in Redwood City, California and it operates in one segment.
2. Summary of Significant Accounting Policies
Basis of Presentation
The Company’s financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) for interim reporting. These financial statements have been prepared on the same basis as the Company’s annual financial statements and, in the opinion of management, reflect all adjustments, consisting only of normal recurring adjustments that are necessary for a fair statement of the Company’s financial information. These interim results are not necessarily indicative of the results to be expected for the year ending December 31, 2018 or for any subsequent interim period.
The condensed balance sheet data as of December 31, 2017 was derived from the audited financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017. The accompanying condensed financial statements and related financial information should be read in conjunction with the audited financial statements and the related notes thereto contained in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2017, filed with the Securities and Exchange Commission (the “SEC”) on March 9, 2018.
There have been no material changes to our significant accounting policies as of and for the nine months ended September 30, 2018, except for the policy related to revenue recognition.
Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and judgments that affect the amounts reported in the financial statements and accompanying notes. On an ongoing basis, management evaluates its estimates, including, but not limited to, those related to revenue recognition, preclinical study and clinical trial accruals, fair value of assets and liabilities, restructuring charges, stock-based compensation and income taxes. Management bases its estimates on historical experience and on various other market-specific and relevant assumptions that management believes to be reasonable under the circumstances. Actual results may differ from those estimates.
Revenue Recognition
Effective January 1, 2018, the Company adopted Accounting Standards Codification, or ASC, Topic 606, Revenue from Contracts with Customers, using the modified retrospective transition method. Under this method, the Company recorded a cumulative adjustment to the opening balance of accumulated deficit and to deferred revenue. Under Topic 606, the Company recognizes revenue when it transfers control of promised goods or services to its customers in an amount that reflects the consideration which the Company expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of Topic 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once a contract is determined to be within the scope of Topic 606, the Company assesses the goods or services promised within the contract and determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.
The Company evaluated its existing contracts and only applied Topic 606 to those contracts that were not completed at January 1, 2018. As a result of this evaluation, the Company determined that only its collaboration with Celgene Corporation (“Celgene”) is
7
within the scope of Topic 606.
The
terms of this arrangement include payment to
the Company of a non-refundable upfront fee; potential development, regulatory and sales milestones; program opt-in payments; and royalties on net product sales. Each of these payments results in collaboration revenue, except for revenues from royalties on
net product sales, which would be classified as royalty revenues. In determining the appropriate amount of revenue to be recognized as it fulfills its obligations under its collaboration agreement with Celgene, the
Company
applies
the five-step model
. As
part of the accounting for this arrangement, the Company must develop assumptions that require judgment to determine the stand-alone selling price for each performance obligation identified in the contract. The Company also must develop assumptions that re
quire judgment in determining the measure of progress used to recognize revenue.
Milestone
Payments
At the inception of each arrangement that includes development, regulatory or commercial milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant reversal of cumulative revenue would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or partner, such as regulatory approvals, are not considered probable of being achieved until those approvals
are received
or the underlying activity has been completed
. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such development milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect collaboration revenues and earnings in the period of adjustment.
Customer Concentration
Customers whose revenue accounted for 10% or more of total revenues were as follows:
|
|
Three Months Ended September 30,
|
|
|
Nine Months Ended September 30,
|
|
|
|
2018
|
|
|
2017
|
|
|
2018
|
|
|
2017
|
|
Celgene Corporation ("Celgene")
|
|
100%
|
|
|
100%
|
|
|
100%
|
|
|
88%
|
|
Bayer Pharma AG ("Bayer")
|
|
—
|
|
|
—
|
|
|
—
|
|
|
11%
|
|
Net Income (Loss) per Common Share
Basic net income (loss) per common share is calculated by dividing the net income (loss) by the weighted-average number of common shares outstanding during the period, without consideration for common stock equivalents. Diluted net income (loss) per common share is computed by dividing the net income (loss) by the weighted-average number of common shares and common share equivalents outstanding for the period determined using the treasury-stock method. For purposes of this calculation, potentially dilutive securities consisting of stock options and restricted stock units are considered to be common stock equivalents. Common stock equivalents were excluded in the calculation of diluted net loss per common share because their effect would be anti-dilutive.
Newly Adopted and Recent Accounting Pronouncements
Accounting Standard Update (“ASU”) No. 2014-09, Revenue from Contracts with Customers (Topic 606), which supersedes the revenue recognition requirements in ASC 605, Revenue Recognition.
Collaboration with Celgene
The Company adopted the accounting standard update on January 1, 2018 using the modified retrospective approach, for its collaboration agreement with Celgene. Therefore, comparative historical information will not be adjusted and will continue to be reported under ASC 605 with the impact of the transition reflected in the opening balance of accumulated deficit as of January 1, 2018. The Company is eligible to receive consideration under this agreement that includes non-refundable upfront payments; development, regulatory, and sales milestone payments; and program opt-in payments; and royalties on net product sales. The new revenue recognition standard differs from ASC 605 in many respects, such as in the accounting for variable consideration and the measurement of progress toward completion of performance obligations. The most significant impact of the standard relates to the Company’s method of revenue recognition for performance obligations that are delivered over time. Under the new standard, milestone payments are included in the transaction price as variable consideration, subject to a constraint, and are allocated to the performance obligations in the contract when recognized.
Through December 31, 2017, the Company also received payments from
8
Celgene to reimburse the costs of research and development services performed by the Company; these payments were historically recorded as other revenue. As the perfo
rmance of these research and development services was at the Company's discretion and is not reflective of a commitment or performance obligation pursuant to the Celgene agreement, the reimbursement paid to the Company has been excluded from the transactio
n price.
The Company’s deferred revenue associated with its Celgene collaboration agreement as of December 31, 2017 under Topic 605 was $143.8 million. As a result of adopting Topic 606, the Company recorded a $98.3 million reduction to its deferred revenue and opening accumulated deficit on January 1, 2018 as a result of the cumulative impact of the change in the recognition of the upfront and milestone payments using the input method (described further in
Note 5, “Collaborations”
) under Topic 606, rather than on a ratable basis which was applied in prior periods. Under Topic 606, the deferred revenue balance was $45.5 million as of January 1, 2018. The remaining performance obligation under the contract is estimated to be substantially complete by the third quarter of 2019.
Collaborations with Bayer and GlaxoSmithKline (“GSK”)
As the GSK collaboration was terminated in its entirety on October 28, 2017, this arrangement was outside the scope of Topic 606 as of the adoption date. For the Bayer collaboration, Bayer terminated all biologic therapeutic programs under the collaboration effective June 16, 2017, while the small molecule therapeutics program remained active. Refer to Note 5, “Collaborations,” for further details. The Company has determined that the small molecule therapeutic program remaining as of December 31, 2017 is immaterial in the context of the collaboration agreement relative to the biologics therapeutic programs that was terminated during 2017. The Company’s performance obligations under the small molecule therapeutic program with respect to Bayer were substantially complete at December 31, 2017, and any future receipts in the form of milestones or royalties are contingent upon the achievement of specified development, commercial and/or sales targets. The Company has concluded that there was no transition adjustment to be recognized on January 1, 2018 for these two agreements.
Impact of Adoption
The following table
summarizes
the impact of adopting Topic 606 on select unaudited condensed balance sheet and condensed statement of operations line items (in thousands, except per share data):
|
|
Balance at
December 31, 2017
|
|
|
Adjustment
|
|
|
Balance at
January 1, 2018
|
|
Condensed Balance Sheets:
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred revenue, current portion
|
|
$
|
82,193
|
|
|
$
|
(51,299
|
)
|
|
$
|
30,894
|
|
Deferred revenue, non-current portion
|
|
|
61,645
|
|
|
|
(47,023
|
)
|
|
|
14,622
|
|
Accumulated deficit
|
|
|
(452,007
|
)
|
|
|
98,322
|
|
|
|
(353,685
|
)
|
|
|
|
|
|
|
Three months ended September 30, 2018
|
|
|
|
As reported
under Topic 606
|
|
|
Adjustment
|
|
|
Balances without the adoption of Topic 606
|
|
Condensed Statements of Operations:
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration revenue
|
|
$
|
19,518
|
|
|
$
|
1,031
|
|
|
$
|
20,549
|
|
Income from operations
|
|
|
5,791
|
|
|
|
1,031
|
|
|
|
6,822
|
|
Net income
|
|
|
6,115
|
|
|
|
1,031
|
|
|
|
7,146
|
|
Net income per common shares, basic and diluted
|
|
$
|
0.16
|
|
|
$
|
0.03
|
|
|
$
|
0.19
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine months ended September 30, 2018
|
|
|
|
As reported
under Topic 606
|
|
|
Adjustment
|
|
|
Balances without the adoption of Topic 606
|
|
Condensed Statements of Operations:
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration revenue
|
|
$
|
34,237
|
|
|
$
|
27,410
|
|
|
$
|
61,647
|
|
Income (loss) from operations
|
|
|
(5,029
|
)
|
|
|
27,410
|
|
|
|
22,381
|
|
Net income (loss)
|
|
|
(3,435
|
)
|
|
|
27,410
|
|
|
|
23,975
|
|
Net income (loss) per common shares, basic and diluted
|
|
$
|
(0.09
|
)
|
|
$
|
0.71
|
|
|
$
|
0.62
|
|
9
Contract Balances
Upfront payments and fees may be required to be recorded as deferred revenue upon receipt or when due, and recognized in a future period when or as the Company performs its obligations under these arrangements. Amounts payable to the Company are recorded as accounts receivable when the Company’s right to consideration is unconditional.
As of September 30, 2018, the
Company’s
contract liabilities, which consisted of deferred revenue, decreased by a total of $132.6 million from December 31, 2017, of which $98.3 million was related to the cumulative adjustment to the opening balance of accumulated deficit upon the adoption of Topic 606 on January 1, 2018 and $34.2 million related to revenue recognized for the nine months ended September 30, 2018.
The remaining performance obligation under the Company’s collaboration agreement with Celgene is expected to be substantially complete by the third quarter of 2019.
Upon adoption of the standard as of January 1, 2018,
the Company had a $45.5 million contract liability. As of September 30, 2018, the Company had a $11.3 million contract liability. There were no changes in transaction price during the three and nine month periods ended September 30, 2018.
ASU No. 2016-02, Leases (Topic 842
)
In February 2016, the FASB issued ASU No. 2016-02,
Leases
. ASU No. 2016-02 amends a number of aspects of lease
accounting
, including requiring lessees to recognize almost all leases with a term greater than one year as a right-of-use asset and corresponding liability, measured at the present value of the
lease
payments. ASU 2016-02 notes that the guidance should be adopted using a modified retrospective approach. The guidance will become effective for the Company beginning in the first quarter of 2019 with early adoption permitted. While the Company is currently evaluating the impact of the adoption of this standard on its financial statements, the Company anticipates recognition of additional assets and corresponding liabilities related to leases on its Balance Sheet. In July 2018, the FASB issued ASU No. 2018-11,
Leases (Topic 842) Targeted Improvements
, which provides entities with an additional (and optional) transition method which would enable entities to initially apply the new leases standard at the adoption date and recognize a cumulative-effect adjustment to the opening balance of retained earnings/accumulated deficit. This optional transition method is in addition to the modified retrospective transition approach included in ASU 2016-02.
ASU No. 2018-07, Improvement to Nonemployees Share-based Payment Accounting (Topic 718
)
In June 2018, the FASB issued ASU No. 2018-07,
Stock Compensation
. ASU No. 2018-07 simplifies the accounting for share-based payments to nonemployees by aligning it with the accounting for share-based payments to employees, with certain exceptions. The guidance is effective for fiscal years beginning after December 15, 2019, and interim periods within fiscal years beginning after December 15, 2020. Early adoption is permitted, but not earlier than the Company’s adoption of Topic 606. The Company chose to adopt the guidance early, in the second quarter of 2018. The adoption of the standard did not have material impact on the Company’s financial statements.
ASU No. 2018-13, Fair Value Measurements (Topic 820
)
In August
2018, the FASB issued ASU 2018-13,
Fair Value Measurement
. ASU 2018-13 eliminates certain disclosure requirements for fair value measurements for all entities, requires public entities to disclose certain new information and modifies some disclosure requirements. This guidance will become effective
for the Company in the first quarter of 2020, with early adoption permitted.
The Company plans to adopt the guidance in the first quarter of 2020. The Company does not expect that the adoption of this standard will have a material impact on its financial statements.
3. Cash, Cash Equivalents and Investments
The fair value of securities at September 30, 2018 and December 31, 2017, was as follows (in thousands):
|
|
September 30, 2018
|
|
|
|
Amortized
|
|
|
Gross Unrealized
|
|
|
Fair
|
|
|
|
Cost
|
|
|
Gains
|
|
|
Losses
|
|
|
Value
|
|
Money market funds
|
|
$
|
169
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
169
|
|
U.S. treasury bills
|
|
|
62,512
|
|
|
|
—
|
|
|
|
(62
|
)
|
|
|
62,450
|
|
Total available-for-sale securities
|
|
$
|
62,681
|
|
|
$
|
—
|
|
|
$
|
(62
|
)
|
|
$
|
62,619
|
|
Classified as:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash equivalents
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
169
|
|
Short-term investments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
62,450
|
|
Total
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
62,619
|
|
10
As of September 30, 2018, the Company had a total of $70.9 million in cash, cash equivalents and short-term investments, which includes $8.4 million in cash and cash equivalents and $62.5 million in short-term invest
ments.
|
|
December 31, 2017
|
|
|
|
Amortized
|
|
|
Gross Unrealized
|
|
|
Fair
|
|
|
|
Cost
|
|
|
Gains
|
|
|
Losses
|
|
|
Value
|
|
Money market funds
|
|
$
|
99
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
99
|
|
U.S. treasury bills
|
|
|
89,525
|
|
|
|
289
|
|
|
|
—
|
|
|
|
89,814
|
|
Total available-for-sale securities
|
|
$
|
89,624
|
|
|
$
|
289
|
|
|
$
|
—
|
|
|
$
|
89,913
|
|
Classified as:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash equivalents
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
99
|
|
Short-term investments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
89,814
|
|
Total
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
89,913
|
|
As of December 31, 2017, the Company had a total of $103.1 million in cash, cash equivalents and short-term investments, which includes $13.3 million in cash and cash equivalents and $89.8 million in short-term investments.
All available-for-sale securities held as of September 30, 2018 and December 31, 2017 had contractual maturities of less than one year. There have been no significant realized gains or losses on available-for-sale securities for the periods presented.
4. Fair Value Measurements
The Company records its financial assets and liabilities at fair value. The accounting guidance for fair value provides a framework for measuring fair value, clarifies the definition of fair value, and expands disclosures regarding fair value measurements. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants at the reporting date. The Company applies the following hierarchy for disclosure of the inputs used to measure fair value, which prioritizes the inputs used into three broad levels as follows:
|
•
|
Level 1: Inputs which include quoted prices in active markets for identical assets and liabilities.
|
|
•
|
Level 2: Inputs other than Level 1 that are observable, either directly or indirectly, 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.
|
The Company’s financial assets and liabilities subject to fair value measurements on a recurring basis and the level of inputs used in such measurements were as follows (in thousands):
|
|
September 30, 2018
|
|
|
|
Level 1
|
|
|
Level 2
|
|
|
Level 3
|
|
|
Total
|
|
Assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Money market funds
|
|
$
|
169
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
169
|
|
U.S. treasury bills
|
|
|
—
|
|
|
|
62,450
|
|
|
|
—
|
|
|
|
62,450
|
|
Total
|
|
$
|
169
|
|
|
$
|
62,450
|
|
|
$
|
—
|
|
|
$
|
62,619
|
|
|
|
December 31, 2017
|
|
|
|
Level 1
|
|
|
Level 2
|
|
|
Level 3
|
|
|
Total
|
|
Assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Money market funds
|
|
$
|
99
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
99
|
|
U.S. treasury bills
|
|
|
—
|
|
|
|
89,814
|
|
|
|
—
|
|
|
|
89,814
|
|
Total
|
|
$
|
99
|
|
|
$
|
89,814
|
|
|
$
|
—
|
|
|
$
|
89,913
|
|
Where quoted prices are available in an active market, securities are classified as Level 1. The Company classifies money market funds as Level 1. When quoted market prices are not available for the specific security, then the Company estimates fair value by using benchmark yields, reported trades, broker/dealer quotes, and issuer spreads. The Company classifies U.S. Treasury securities as Level 2
.
There were no transfers between Level 1 and Level 2 during the periods presented.
11
5. Collaborations
Summary of Collaboration Related Revenue
The Company has recognized the following revenues from its collaboration agreements during the three and nine months ended September 30, 2018 and 2017 (in thousands):
|
|
Three Months Ended September 30,
|
|
|
Nine Months Ended September 30,
|
|
|
|
2018
|
|
|
2017
|
|
|
2018
|
|
|
2017
|
|
Celgene:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Recognition of upfront payments
|
|
$
|
19,518
|
|
|
$
|
5,013
|
|
|
$
|
34,237
|
|
|
$
|
15,039
|
|
Other revenue
|
|
|
—
|
|
|
|
93
|
|
|
|
—
|
|
|
|
311
|
|
Celgene total
|
|
|
19,518
|
|
|
|
5,106
|
|
|
|
34,237
|
|
|
|
15,350
|
|
Bayer:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Recognition of upfront payments
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
278
|
|
Other revenue
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
1,734
|
|
Bayer total
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
2,012
|
|
GSK:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Recognition of upfront payments
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
150
|
|
Other revenue
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
3
|
|
GSK total
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
153
|
|
Total collaboration related revenue
|
|
$
|
19,518
|
|
|
$
|
5,106
|
|
|
$
|
34,237
|
|
|
$
|
17,515
|
|
Adoption of ASU No. 2014-09
On January 1, 2018, the Company adopted ASU No. 2014-09 using the modified retrospective method. Results for reporting periods beginning after January 1, 2018 are presented under Topic 606, while prior period amounts are not adjusted and continue to be reported in accordance with Topic 605.
Celgene Strategic Alliance
In December 2013, the Company entered into a collaboration agreement with Celgene pursuant to which the Company and Celgene are collaborating on research and development programs directed to the discovery and development of novel biologic therapeutics. In September 2018, Celgene informed the Company of Celgene’s decision not to exercise its option to license the navicixizumab program due to strategic product portfolio considerations. The Company and Celgene have formalized the termination of the collaboration agreement with respect to the navicixizumab program, and as a result, effective January 23, 2019, the Company will retain worldwide rights to navicixizumab. In October 2018, Celgene notified the Company of its decision not to exercise its option to license rosmantuzumab (anti-RSPO3, OMP-131R10) and terminated the companies’ collaboration agreement with respect to rosmantuzumab, effective February 12, 2019. The Company will retain worldwide rights to rosmantuzumab upon termination. The etigilimab (anti-TIGIT, OMP-313M32) program is the only program remaining under the collaboration. As of September 30, 2018, the Company is not eligible to receive any milestone payments under its collaboration with Celgene prior to the point that Celgene exercises its remaining option. The Company is eligible to receive up to approximately $35.0 million of contingent consideration if Celgene exercises its options for the etigilimab program. Following Celgene’s exercise of its option for the etigilimab program, Celgene will have exclusive development and commercialization rights worldwide, with the Company eligible to receive milestones and tiered royalties equal to a percentage of net product sales worldwide in the high-single digits to the mid-teens. If Celgene successfully develops and commercializes product candidates in the etigilimab program, the Company could receive additional contingent consideration of up to $402.5 million for the achievement of post-option exercise development, regulatory events and sales milestones. As all contingent consideration is based solely on the performance of Celgene, the Company would recognize the contingent payments upon receipt immediately as collaboration revenue if the Company had no further performance obligations under the agreement with Celgene.
The Company assessed its collaboration agreement with Celgene in accordance with Topic 606 and concluded that Celgene is a customer. The Company determined that its performance obligation
under the arrangement with Celgene is research and development services.
As part of the promised research and development services, the Company may provide the resultant data to Celgene
to assist Celgene in determining whether or not to exercise its options
. Under the arrangement, Celgene has options to further develop and commercialize biologic therapeutics in each program under the collaboration, which may be exercised during time periods specified in the agreement. Upon Celgene’s exercise of its option for certain programs, the Company may, at its discretion, gain co-development and co-commercialization rights and corresponding obligations. The Company determined that the exclusive
12
option(s) provided to Celgene is not a material right under Topic 606 and thus it is not a performance obligation. Based on its assessment, the Company has identified the research and development services as the only per
formance obligation at the inception of the collaboration agreement.
Prior to recognizing revenue, the Company estimates the transaction price, including variable consideration that is subject to a constraint. Amounts of variable consideration are included in the transaction price to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. Variable consideration includes payments based upon the achievement of specified milestones, and royalty payments based on product sales derived from the collaboration. Under the collaboration agreement, the Company determined that the non-refundable upfront cash payment of $155.0 million and stock premium of $1.7 million received in December 2013 constitute consideration to be included in the transaction price. The Company also included in the transaction price the $70.0 million demcizumab (anti-DLL4, OMP-21M18) safety milestone that was achieved in December 2015 and the two designation milestone payments of $2.5 million each for the designation of rosmantuzumab and etigilimab as clinical candidates in 2014 and 2015, respectively. The total consideration received of $231.7 million constitutes the transaction price at the transition date for Topic 606. Through December 31, 2017, the Company also received a total of $2.5 million in the aggregate from Celgene to reimburse the costs of research and development services performed by the Company; these reimbursements have historically been recorded as other revenue. As the performance of these research and development services was at the Company's discretion and is not a commitment or performance obligation pursuant to the Celgene collaboration agreement, the reimbursement paid to the Company has been excluded from the transaction price. None of the remaining development and regulatory milestone amounts have been included in the transaction price, as all milestone amounts were fully constrained as of January 1, 2018 and September 30, 2018. As part of the Company’s evaluation of the constraint, the Company considered numerous factors, including that receipt of the milestone amounts is outside the control of the Company and contingent upon success in future clinical trials. Any consideration related to sales milestones and royalties on net product sales will be recognized at the later of when the related sales occur or the performance obligation to which some or all of the sales milestone or royalty has been allocated is satisfied (in whole or in part) and therefore have also been excluded from the transaction price. The Company will re-evaluate the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur.
Following the adoption of Topic 606, the Company recognizes collaboration revenue by measuring the progress toward complete satisfaction of the performance obligation using an input measure. The Company concluded the method that best correlates with progress of the services provided to Celgene is the input method, based on actual costs incurred to date compared to the overall total expected costs to satisfy the performance obligation. The Company will evaluate the estimate of expected costs to satisfy the performance obligation each reporting period and make adjustments for any significant changes. Under Topic 606, collaboration revenue under the Company’s collaboration agreement with Celgene was $34.2 million for the nine months ended September 30, 2018 and deferred revenue balance was $11.3 million as of September 30, 2018. The performance obligation under the contract is estimated to be substantially complete by the third quarter of 2019.
The
impact of adopting Topic 606 on the accounting treatment of the Company’s collaboration agreement with Celgene primarily relates to the change in the timing of revenue recognition of the transaction price. The Company’s deferred revenue associated with its Celgene collaboration agreement as of December 31, 2017 under Topic 605 was $143.8 million. Upon adoption of the standard as of January 1, 2018, the Company recognized a cumulative catch up adjustment of $98.3 million, which was recorded as a decrease to the opening balance of accumulated deficit, and a corresponding decrease in the deferred revenue balance from the Company’s collaboration with Celgene.
Bayer Strategic Alliance
In June 2010, the Company entered into a strategic alliance with Bayer to discover, develop and commercialize novel anti-CSC biologic and small molecule therapeutics targeting the Wnt signaling pathway. Effective June 16, 2017, Bayer terminated all biologic therapeutic programs under its collaboration with the Company. The Company is no longer eligible to receive any payments under its collaboration with Bayer with respect to biologic therapeutic candidates. With respect to the Wnt pathway small molecule program, the Company remains eligible to receive up to $27.0 million in development milestone payments for each small molecule candidate as well as contingent consideration payments for each small molecule candidate of up to $15.0 million for the achievement of certain regulatory events and up to $70.0 million upon the achievement of specified future product sales. As all such contingent consideration is based solely on the performance of Bayer, the Company would recognize the contingent payments upon receipt immediately as collaboration revenue.
The Company evaluated the agreement under Topic 606, and determined that the small molecule therapeutic program remaining as of December 31, 2017 is immaterial in the context of the
collaboration
agreement relative to the biologics therapeutic programs that was terminated during 2017. Further, the Company’s performance obligations under the small molecule therapeutic program were
13
substantially complete at December 31, 2017, and any future receipts in the form of milestones or royalties are contingent upon t
he achievement of specified development, commercial and/or sales targets by Bayer.
GSK Strategic Alliance
Effective October 28, 2017, GSK terminated its collaboration agreement with the Company in its entirety.
As a result of such termination, the Company is no longer eligible to receive any payments under the collaboration agreement with GSK and the Company has no remaining performance obligations. As the GSK collaboration was terminated in its entirety on October 28, 2017, this arrangement is outside the scope of Topic 606 as of the adoption date.
6. Stockholder’s Equity
Equity Incentive Plans
As of September 30, 2018, a total of 7,537,838 shares of common stock have been authorized under the 2013 Equity Incentive Award Plan (the “2013 Plan”), including the additional 1,500,000 shares of common stock that became available on January 1, 2018 for future issuance under the 2013 Plan as a result of an annual automatic increase provision in the 2013 Plan. As of September 30, 2018, a total of 5,422,638 shares are subject to options and restricted stock units (“RSUs”) outstanding under the 2013 Plan. There are 989,854 shares subject to options outstanding under the 2004 Stock Incentive Plan (the “2004 Plan”) as of September 30, 2018, which will become available for issuance under the 2013 Plan to the extent the options are forfeited or lapse unexercised without issuance of such shares under the 2004 Plan.
The following table summarizes the Company’s stock option and RSU award activity under the 2004 Plan and 2013 Plan including grants to nonemployees during the nine months ended September 30, 2018 (in thousands):
|
|
Shares Available
|
|
|
|
|
|
|
|
for Grant
|
|
|
Options and
|
|
|
|
of Options and
|
|
|
Awards
|
|
|
|
Awards
|
|
|
Outstanding
|
|
Balance at December 31, 2017
|
|
|
606
|
|
|
|
6,097
|
|
Additional shares authorized
|
|
|
1,500
|
|
|
|
—
|
|
RSUs awarded
|
|
|
(70
|
)
|
|
|
70
|
|
Options granted
|
|
|
(1,744
|
)
|
|
|
1,744
|
|
RSUs vested
|
|
|
—
|
|
|
|
(268
|
)
|
Options forfeited
|
|
|
1,089
|
|
|
|
(1,089
|
)
|
RSUs forfeited
|
|
|
142
|
|
|
|
(142
|
)
|
Balance at September 30, 2018
|
|
|
1,523
|
|
|
|
6,412
|
|
The weighted-average grant date estimated fair value of options granted during the nine months ended September 30, 2018 was $2.32 per share.
Employee Stock Purchase Plan
As of September 30, 2018, a total of 1,893,620 shares of common stock have been authorized and 1,510,518 shares of common stock are available for future issuance under the Company’s Employee Stock Purchase Plan (the “ESPP”). This authorized number includes the additional 350,000 shares of common stock that became available for future issuance under the ESPP as of January 1, 2018 as a result of an annual automatic increase provision in the ESPP. The ESPP allows eligible employees to purchase shares of the Company’s common stock at a discount through payroll deductions of up to 15% of their eligible compensation, subject to any plan limitations. The ESPP provides for six-month offering periods, and at the end of each offering period, employees are able to purchase shares at 85% of the lower of the fair market value of the Company’s common stock on the first trading day of the offering period or on the last trading day of the offering period.
During the nine months ended September 30, 2018, the Company issued 45,352 shares under the ESPP.
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Stock-Based Compe
nsation
Employee stock-based compensation expense was calculated based on awards expected to vest and has been reduced for estimated forfeitures. Forfeitures are estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures are expected to differ from those estimates.
Stock-based compensation expense recognized was as follows (in thousands):
|
|
Three Months Ended September 30,
|
|
|
Nine Months Ended September 30,
|
|
|
|
2018
|
|
|
2017
|
|
|
2018
|
|
|
2017
|
|
Research and development
|
|
$
|
954
|
|
|
$
|
970
|
|
|
$
|
2,881
|
|
|
$
|
3,739
|
|
General and administrative
|
|
|
638
|
|
|
|
983
|
|
|
|
2,821
|
|
|
|
3,533
|
|
Restructuring charges
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
6
|
|
Total
|
|
$
|
1,592
|
|
|
$
|
1,953
|
|
|
$
|
5,702
|
|
|
$
|
7,278
|
|
As of September 30, 2018, the Company had $7.3 million, $1.7 million and $19,000 of unrecognized stock-based compensation expense related to stock options, RSUs and ESPP shares, respectively, which are expected to be recognized over an estimated weighted-average period of 2.8 years, 0.9 years and 0.4 years, respectively.
7. Income Taxes
For the nine months ended September 30, 2018, the Company recorded an income tax benefit of $0.4 million in the condensed statement of operations as a result of a lapse of statute of limitations on uncertain tax positions and accrued state minimum taxes, treated as a discrete item. The Company’s deferred tax assets continue to be fully offset by a valuation allowance.
In the fourth quarter of 2017, the period in which the Tax Cuts and Jobs Act (“Tax Act”) was enacted, the Company calculated its best estimate of the impact of the Tax Act in accordance with its understanding of the Tax Act. As a result, the Company recorded $1.1 million as income tax benefit in the fourth quarter of 2017 and
a corresponding receivable for the expected alternative minimum tax credit refund
. The Tax Act also included changes to the Internal Revenue Code, such as a tax rate decrease which resulted in a reduction of $51.7 million in the Company’s deferred tax assets, and a corresponding decrease of the same amount in the valuation allowance against these deferred tax assets, as substantially all of the Company’s deferred tax assets, net of deferred tax liabilities, are subject to a full valuation allowance.
The adjustment to deferred taxes continues to be a provisional amount and a reasonable estimate at September 30, 2018. The Company does not expect any impact on recorded deferred tax balances as the remeasurement of net deferred tax assets will be offset by a change in valuation allowance. The Company is analyzing certain aspects of the Tax Act which could potentially affect the remeasurement of the net deferred tax assets as of September 30, 2018.
8. Net Income (Loss) per Common Share
The following is a computation of basic and diluted net income (loss) per share (in thousands, except per share amounts):
|
|
Three Months Ended September 30,
|
|
|
Nine Months Ended September 30,
|
|
|
|
2018
|
|
|
2017
|
|
|
2018
|
|
|
2017
|
|
Net income (loss)
|
|
$
|
6,115
|
|
|
$
|
(10,692
|
)
|
|
$
|
(3,435
|
)
|
|
$
|
(48,525
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average common stock outstanding
|
|
|
38,508
|
|
|
|
37,663
|
|
|
|
38,381
|
|
|
|
37,521
|
|
Net income (loss) per share, basic
|
|
$
|
0.16
|
|
|
$
|
(0.28
|
)
|
|
$
|
(0.09
|
)
|
|
$
|
(1.29
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average common stock outstanding
|
|
|
38,508
|
|
|
|
37,663
|
|
|
|
38,381
|
|
|
|
37,521
|
|
Add: Common equivalent shares outstanding
|
|
|
5
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
Weighted-average common stock outstanding
and dilutive shares
|
|
|
38,513
|
|
|
|
37,663
|
|
|
|
38,381
|
|
|
|
37,521
|
|
Net income (loss) per share, diluted
|
|
$
|
0.16
|
|
|
$
|
(0.28
|
)
|
|
$
|
(0.09
|
)
|
|
$
|
(1.29
|
)
|
15
The following outstanding common stock equivalents were excluded from the computation of diluted net income (loss) per common share for the periods presented because including them would have been anti-dilutive (in t
housands):
|
|
Three Months Ended September 30,
|
|
|
Nine Months Ended September 30,
|
|
|
|
2018
|
|
|
2017
|
|
|
2018
|
|
|
2017
|
|
Options to purchase common stock
|
|
|
5,753
|
|
|
|
4,987
|
|
|
|
5,873
|
|
|
|
4,987
|
|
RSUs
|
|
|
540
|
|
|
|
667
|
|
|
|
540
|
|
|
|
667
|
|
|
|
|
6,293
|
|
|
|
5,654
|
|
|
|
6,413
|
|
|
|
5,654
|
|
9. Subsequent Events
In October 2018, the Company signed an agreement to sublease a specified portion of the Company’s office facility located in Redwood City, California. The sublease has a term of 24 months and will expire in 2020. The aggregate sublease proceeds for the term of the lease are approximately $1.8 million.
16