stro-10q_20190331.htm

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 10-Q

 

(Mark One)

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

For the quarterly period ended March 31, 2019

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: 001-38662

 

SUTRO BIOPHARMA, INC.

(Exact Name of Registrant as Specified in its Charter)

 

 

Delaware

47-0926186

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer
Identification No.)

 

 

310 Utah Avenue, Suite 150

South San Francisco, California

94080

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code: (650) 392-8412

 

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 every Interactive Data File required to be submitted 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 such files).     Yes      No  

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

 

Large accelerated filer

 

  

Accelerated filer

 

Non-accelerated filer

 

  

Smaller reporting company

 

Emerging growth company

 

 

 

 

 

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. 

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

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

 

Title of each class

Trading Symbol

Name of each exchange on which registered

Common stock

STRO

Nasdaq Global Market

As of May 10, 2019, the registrant had 22,925,441 shares of common stock, $0.001 par value per share, outstanding.

 

 

 


Table of Contents

 

 

 

Page

PART I.

FINANCIAL INFORMATION

 

Item 1.

Financial Statements (Unaudited)

1

 

Condensed Balance Sheets

1

 

Condensed Statements of Operations

2

 

Condensed Statements of Comprehensive Loss

3

 

Condensed Statement of Stockholder’s Equity

4

 

Condensed Statements of Cash Flows

5

 

Notes to Unaudited Condensed Financial Statements

6

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

23

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

31

Item 4.

Controls and Procedures

31

PART II.

OTHER INFORMATION

 

Item 1.

Legal Proceedings

32

Item 1A.

Risk Factors

32

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

73

Item 3.

Defaults Upon Senior Securities

73

Item 4.

Mine Safety Disclosures

73

Item 5.

Other Information

73

Item 6.

Exhibits

74

Signatures

75

 

 

 

i


 

PART I—FINANCIAL INFORMATION

Item 1. Financial Statements.

Sutro Biopharma, Inc.

Condensed Balance Sheets

(In thousands, except share and per share amounts)

 

 

 

March 31,

 

 

December 31,

 

 

 

2019

 

 

2018

 

 

 

(Unaudited)

 

 

(See Note 2)

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

26,616

 

 

$

125,298

 

Marketable securities—current

 

 

143,953

 

 

 

79,194

 

Accounts receivable, net (including amounts from related parties of

   $1,188 and $959 as of March 31, 2019 and December 31, 2018,

   respectively)

 

 

3,338

 

 

 

2,489

 

Prepaid expenses and other current assets

 

 

2,628

 

 

 

2,965

 

Total current assets

 

 

176,535

 

 

 

209,946

 

Property and equipment, net

 

 

9,926

 

 

 

10,934

 

Marketable securities, non—current

 

 

13,747

 

 

 

-

 

Other long-term assets

 

 

2,235

 

 

 

2,244

 

Restricted cash

 

 

15

 

 

 

15

 

Total assets

 

$

202,458

 

 

$

223,139

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

3,395

 

 

$

3,061

 

Accrued compensation

 

 

2,502

 

 

 

6,217

 

Deferred revenue—current

 

 

19,024

 

 

 

21,574

 

Debt—current

 

 

5,766

 

 

 

4,724

 

Other current liabilities

 

 

443

 

 

 

847

 

Total current liabilities

 

 

31,130

 

 

 

36,423

 

Deferred revenue, non—current

 

 

31,520

 

 

 

44,599

 

Deferred rent

 

 

469

 

 

 

476

 

Debt—non-current

 

 

8,500

 

 

 

10,000

 

Other noncurrent liabilities

 

 

121

 

 

 

102

 

Total liabilities

 

 

71,740

 

 

 

91,600

 

Stockholders’ equity:

 

 

 

 

 

 

 

 

Common stock, $0.001 par value — 300,000,000 shares authorized

   as of March 31, 2019 and December 31, 2018; 22,925,441 and

   22,848,184 shares issued and outstanding as of March 31, 2019

   and December 31, 2018, respectively

 

 

23

 

 

 

23

 

Additional paid-in-capital

 

 

284,890

 

 

 

281,891

 

Accumulated other comprehensive gain (loss)

 

 

56

 

 

 

(47

)

Accumulated deficit

 

 

(154,251

)

 

 

(150,328

)

Total stockholders’ equity

 

 

130,718

 

 

 

131,539

 

Total liabilities and stockholders’ equity

 

$

202,458

 

 

$

223,139

 

 

See accompanying notes to unaudited interim condensed financial statements.

1


 

Sutro Biopharma, Inc.

Condensed Statements of Operations

(Unaudited)

(In thousands, except share and per share amounts)

 

 

 

Three Months Ended

 

 

 

March 31,

 

 

 

2019

 

 

2018

 

 

 

(dollars in thousands)

 

Revenues (including amounts from related

   parties of $4,916 during the three months ended

   March 31, 2019, and $4,084 during the three

   months ended March 31, 2018)

 

$

8,629

 

 

$

5,793

 

Operating expenses

 

 

 

 

 

 

 

 

Research and development

 

 

15,180

 

 

 

13,082

 

General and administrative

 

 

7,715

 

 

 

4,414

 

Total operating expenses

 

 

22,895

 

 

 

17,496

 

Loss from operations

 

 

(14,266

)

 

 

(11,703

)

Interest income

 

 

1,176

 

 

 

40

 

Interest and other expense, net

 

 

(1,160

)

 

 

(383

)

Net loss

 

$

(14,250

)

 

$

(12,046

)

Net loss per share, attributable to common

   stockholders, basic and diluted

 

$

(0.62

)

 

$

(25.75

)

Weighted-average shares used in computing net loss per

   share attributable to common stockholders

 

 

22,865,075

 

 

 

467,719

 

 

See accompanying notes to unaudited interim condensed financial statements.

 

2


 

Sutro Biopharma, Inc.

Condensed Statements of Comprehensive Loss

(Unaudited)

(In thousands)

 

 

 

Three Months Ended

 

 

 

March 31,

 

 

 

2019

 

 

2018

 

Net loss

 

$

(14,250

)

 

$

(12,046

)

Other comprehensive income (net of tax):

 

 

 

 

 

 

 

 

Unrealized gain on available-for-sale securities

 

 

103

 

 

 

 

Comprehensive loss

 

$

(14,147

)

 

$

(12,046

)

 

See accompanying notes to unaudited interim condensed financial statements.

3


 

Sutro Biopharma, Inc.

Condensed Statements of Stockholders’ (Deficit) Equity

(Unaudited)

(In thousands, except share amounts)

 

For the three months ended March 31, 2019

 

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

Other

 

 

 

 

 

 

Total

 

 

 

Common Stock

 

 

Paid-In-

 

 

Comprehensive

 

 

Accumulated

 

 

Stockholders’

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Loss

 

 

Deficit

 

 

(Deficit) Equity

 

Balances at December 31, 2018

 

 

22,848,184

 

 

$

23

 

 

$

281,891

 

 

$

(47

)

 

$

(150,328

)

 

$

131,539

 

Exercise of common stock options and common

   stock warrants for cash

 

 

8,347

 

 

 

 

 

 

42

 

 

 

 

 

 

 

 

 

42

 

Issuance of common stock under Employee Stock

   Purchase Plan

 

 

68,910

 

 

 

 

 

 

671

 

 

 

 

 

 

 

 

 

671

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

2,286

 

 

 

 

 

 

 

 

 

2,286

 

Net unrealized loss on available-for- sale securities

 

 

 

 

 

 

 

 

 

 

 

103

 

 

 

 

 

 

103

 

Adoption of new accounting standards

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

10,327

 

 

 

10,327

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(14,250

)

 

 

(14,250

)

Balances at March 31, 2019

 

 

22,925,441

 

 

$

23

 

 

$

284,890

 

 

$

56

 

 

$

(154,251

)

 

$

130,718

 

 

For the three months ended March 31, 2018

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Note

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

 

 

Redeemable Convertible

 

 

 

 

 

 

 

 

 

 

Receivable

 

 

Additional

 

 

Other

 

 

 

 

 

 

Total

 

 

 

Preferred Stock

 

 

Common Stock

 

 

from

 

 

Paid-In-

 

 

Comprehensive

 

 

Accumulated

 

 

Stockholders’

 

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Stockholder

 

 

Capital

 

 

Loss

 

 

Deficit

 

 

(Deficit) Equity

 

Balances at December 31, 2017

 

 

173,750,421

 

 

$

102,505

 

 

 

465,330

 

 

$

 

 

$

(208

)

 

$

6,218

 

 

$

 

 

$

(115,011

)

 

$

(109,001

)

Exercise of common stock options and common

   stock warrants for cash

 

 

 

 

 

 

 

 

6,619

 

 

 

 

 

 

 

 

 

38

 

 

 

 

 

 

 

 

 

38

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

249

 

 

 

 

 

 

 

 

 

249

 

Vesting of early exercised shares

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

14

 

 

 

 

 

 

 

 

 

14

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(12,046

)

 

 

(12,046

)

Balances at March 31, 2018

 

 

173,750,421

 

 

$

102,505

 

 

 

471,949

 

 

$

 

 

$

(208

)

 

$

6,519

 

 

$

 

 

$

(127,057

)

 

$

(120,746

)

 

 

See accompanying notes to unaudited interim condensed financial statements.

4


 

Sutro Biopharma, Inc.

Condensed Statements of Cash Flows

(Unaudited)

(In thousands)

 

 

 

Three Months Ended

 

 

 

March 31,

 

 

 

2019

 

 

2018

 

Operating activities

 

 

 

 

 

 

 

 

Net loss

 

$

(14,250

)

 

$

(12,046

)

Adjustments to reconcile net (loss) income to net cash provided by (used in)

   operating activities:

 

 

 

 

 

 

 

 

Depreciation and amortization

 

 

1,137

 

 

 

1,162

 

Accretion of discount on marketable securities

 

 

(600

)

 

 

 

Stock-based compensation

 

 

2,286

 

 

 

264

 

Reduction of the liability attributable to a research, development and

   commercialization agreement

 

 

(127

)

 

 

 

Accretion of debt discount

 

 

42

 

 

 

38

 

Revaluation of SutroVax option liability

 

 

14

 

 

 

 

Other

 

 

17

 

 

 

35

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Accounts receivable

 

 

(849

)

 

 

(2,531

)

Prepaid expenses and other assets

 

 

336

 

 

 

(130

)

Accounts payable

 

 

476

 

 

 

(189

)

Accrued compensation

 

 

(3,715

)

 

 

980

 

Other liabilities

 

 

397

 

 

 

44

 

Deferred rent

 

 

(7

)

 

 

21

 

Deferred revenue

 

 

(5,302

)

 

 

(2,658

)

Net cash used in operating activities

 

 

(20,145

)

 

 

(15,010

)

Investing activities

 

 

 

 

 

 

 

 

Purchases of marketable securities

 

 

(119,053

)

 

 

 

Maturities of marketable securities

 

 

37,750

 

 

 

 

Sales of marketable securities

 

 

3,500

 

 

 

 

Purchases of property and equipment

 

 

(276

)

 

 

(364

)

Net cash used in investing activities

 

 

(78,079

)

 

 

(364

)

Financing activities

 

 

 

 

 

 

 

 

Payment of deferred offering costs

 

 

 

 

 

(52

)

Payment of debt

 

 

(500

)

 

 

 

Proceeds from exercise of common stock options

 

 

42

 

 

 

38

 

Net cash used in by financing activities

 

 

(458

)

 

 

(14

)

Net decrease in cash, cash equivalents and restricted cash

 

 

(98,682

)

 

 

(15,388

)

Cash, cash equivalents and restricted cash at beginning of period

 

 

125,313

 

 

 

22,035

 

Cash, cash equivalents and restricted cash at end of period

 

$

26,631

 

 

$

6,647

 

Supplemental disclosure of cash flow information:

 

 

 

 

 

 

 

 

Cash paid for interest

 

$

330

 

 

$

300

 

Supplemental disclosure of non-cash investing and financing information:

 

 

 

 

 

 

 

 

Vesting of early exercised shares

 

$

 

 

$

14

 

Purchase of property and equipment included in accounts payable

 

 

63

 

 

 

5

 

Deferred initial public offering costs included in accounts payable

 

 

 

 

 

53

 

Embedded interest associated with program fees

 

$

860

 

 

$

 

 

See accompanying notes to unaudited interim condensed financial statements.

5


 

Sutro Biopharma, Inc.

Notes to Unaudited Interim Condensed Financial Statements

1. Organization and Principal Activities

Description of Business

Sutro Biopharma, Inc. (the “Company”) is a clinical stage drug discovery, development and manufacturing company focused on leveraging its integrated cell-free protein synthesis and site-specific conjugation platform, XpressCF+™, to create a broad variety of optimally designed, next-generation protein therapeutics for cancer and autoimmune disorders. The Company was incorporated on April 21, 2003, and was formerly known as Fundamental Applied Biology, Inc. The Company is headquartered in South San Francisco, California.

The Company operates in one business segment, the development of biopharmaceutical products.

 

Liquidity

The Company has incurred significant losses and has negative cash flows from operations. As of March 31, 2019, there was an accumulated deficit of $154.3 million. Management expects to continue to incur additional substantial losses in the foreseeable future as a result of the Company’s research and development activities and costs to operate as a public company.

As of March 31, 2019, the Company had unrestricted cash, cash equivalents and marketable securities of $184.3 million, which are available to fund future operations. The Company will need to raise additional capital to support the completion of its research and development activities and its operations.

The Company believes that its unrestricted cash, cash equivalents and marketable securities as of March 31, 2019 will be sufficient for the Company to continue as a going concern for at least one year from the issuance date of its unaudited interim condensed financial statements.

 

2. Summary of Significant Accounting Policies

Basis of Presentation and Use of Estimates

The accompanying condensed financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”). The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. The Company bases its estimates on historical experience and market-specific or other relevant assumptions that it believes are reasonable under the circumstances. The amounts of assets and liabilities reported in the Company’s balance sheets and the amount of expenses and income reported for each of the periods presented are affected by estimates and assumptions, which are used for, but are not limited to, determining research and development periods under multiple element arrangements, stock-based compensation expense, fair value of redeemable convertible preferred stock warrant liabilities (prior to closing of the Company’s IPO), income taxes and certain accrued liabilities. Actual results could differ from such estimates or assumptions.

Unaudited Interim Condensed Financial Statements

The interim condensed balance sheet as of March 31, 2019, the condensed statements of operations and comprehensive loss for the three months ended March 31, 2019 and 2018, the condensed statements of stockholders’ (deficit) equity for the three months ended March 31, 2019 and 2018 and the condensed statements of cash flows for the three months ended March 31, 2019 and 2018, are unaudited. The unaudited interim condensed financial statements have been prepared on the same basis as the annual financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary to present fairly the Company’s financial position as of March 31, 2019, its results of operations and comprehensive loss for the three months ended March 31, 2019 and 2018, the changes in stockholders’ (deficit) equity for the three months ended March 31, 2019 and 2018 and cash flows for the three months ended March 31, 2019 and 2018. The financial data and the other financial information contained in these notes to the condensed financial statements related to the three-month periods are also unaudited. The results of operations for the three months ended March 31, 2019 are not necessarily indicative of the results to be expected for the year ending December 31, 2019 or for any other future annual or interim period. The condensed balance sheet as of December 31, 2018 included herein was derived from the audited financial statements as of that date. The condensed financial statements should be read in conjunction with the Company's audited financial statements included in the Annual Report on Form 10-K pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, for the year ended December 31, 2018.

6


 

Adoption of New Accounting Principles

Revenue Recognition

On January 1, 2019, the Company adopted Accounting Standards Update (ASU) No. 2014-09 (Topic 606), Revenue from Contracts with Customers (“ASC 606”). ASC 606 supersedes the guidance in ASC 605, Revenue Recognition. Under ASC 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the entity 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.

In the adoption of ASC 606, the Company used the practical expedients to analyze only those contracts that were still active contracts as of January 1, 2019 and evaluated those contracts based on the cumulative contract modifications through that date. The Company does not believe that the use of the practical expedients has or will have a material impact on its transition adjustment or its prospective accounting. The Company adopted ASC 606 on a modified retrospective basis under which it recognized the cumulative effect of adoption of $10.3 million as a transition adjustment to reduce opening accumulated deficit; therefore, the periods prior to the adoption date of ASC 606 have not been restated. If the Company had continued to use ASC 605 during 2019, revenue would have been $7.6 million in the three months ended March 31, 2019, as compared to the $8.6 million reported.

The impact of the adoption of Topic 606 on select unaudited condensed balance sheet as of January 1, 2019 was as follows (in thousands):

 

 

 

December 31, 2018

 

 

Adjustments Due to the Adoption of Topic 606

 

 

January 1, 2019

 

Condensed Balance Sheet Data

 

 

 

 

 

 

 

 

 

 

 

 

Accounts receivable, net

 

$

2,489

 

 

$

 

 

$

2,489

 

Total current assets

 

 

209,946

 

 

 

 

 

 

209,946

 

Deferred revenue, current

 

 

21,574

 

 

 

(2,124

)

 

 

19,450

 

Deferred revenue, non-current

 

 

44,599

 

 

 

(8,203

)

 

 

36,396

 

Total liabilities

 

 

91,600

 

 

 

(10,327

)

 

 

81,273

 

Accumulated deficit

 

 

(150,328

)

 

 

10,327

 

 

 

(140,001

)

The impact of the adoption of ASC 606 on select unaudited condensed balance sheet and condensed statement of operations line items as of and for the three months ended March 31, 2019 were as follows:

 

 

 

As of and for the three months ended March 31, 2019

(in thousands)

 

 

 

As reported

 

 

Adjustments

Increase / (Decrease)

 

 

Balances without the

Adoption of Topic 606

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Condensed Balance Sheet Data

 

 

 

 

 

 

 

 

 

 

 

 

Deferred revenue, current

 

 

19,024

 

 

 

(3,171

)

 

 

22,195

 

Deferred revenue, non-current

 

 

31,520

 

 

 

(7,309

)

 

 

38,829

 

Total liabilities

 

 

71,740

 

 

 

(10,480

)

 

 

82,220

 

Accumulated deficit

 

 

(154,251

)

 

 

10,480

 

 

 

(164,731

)

 

 

 

 

 

 

 

 

 

 

 

 

 

Condensed Statement of Operations data

 

 

 

 

 

 

 

 

 

 

 

 

Revenues

 

 

8,629

 

 

 

1,013

 

 

 

7,616

 

Interest and other expense, net

 

 

(1,160

)

 

 

860

 

 

 

(300

)

Net loss

 

 

(14,250

)

 

 

(153

)

 

 

(14,403

)

 

Nonemployee Share-Based Payment

In June 2018, the FASB issued ASU 2018-07 (Topic 718), Improvements to Nonemployee Share-Based Payment Accounting (“ASU 2018-07”). ASU 2018-07 simplifies the accounting for share-based payments to nonemployees by

7


 

aligning it with the accounting for share-based payments to employees, with certain exceptions. Some of the areas of simplification apply only to nonpublic entities. The Company adopted this guidance on January 1, 2019. The adoption of this guidance did not have a material impact on the Company’s financial statements.

Recently Issued Accounting Pronouncements

In August 2018, the FASB issued ASU 2018-13 (Topic 820), Fair Value Measurement: Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement, reducing certain disclosures concerning the fair value hierarchy. The guidance is effective for the Company in annual periods beginning after December 15, 2019, and interim periods within those annual periods. The Company does not expect the adoption of this guidance to have a material impact on the Company’s condensed financial statements.

In June 2016, the FASB issued ASU 2016-13 (Topic 326), Financial Instruments Credit Losses, which requires consideration of a broader range of reasonable and supportable information to developing credit loss estimates. The guidance is effective for the fiscal year beginning January 1, 2020, including interim periods within that fiscal year. The Company does not expect the adoption of this guidance to have a material impact on the Company’s condensed consolidated financial statements.

Leases

In February 2016, the FASB issued ASU 2016-02 (Topic 842), Leases (“ASC 842”). ASC 842 supersedes the lease recognition requirements in ASC 840, Leases. ASC 842 clarifies the definition of a lease and requires lessees to recognize right-of-use assets and lease liabilities for all leases, including those classified as operating leases under previous lease accounting guidance. For public entities, ASU 2016-02 is effective for fiscal years beginning after December 15, 2018. The guidance is effective for nonpublic business entities for fiscal years and interim periods beginning after December 15, 2019, with early adoption permitted. As a result of the Company having elected the extended transition period for complying with new or revised accounting standards pursuant to Section 107(b) of the JOBS Act, ASC842 will be effective for the Company from January 1, 2020. Originally, entities were required to adopt ASC 842 using a modified retrospective transition method. However, in July 2018, the FASB issued ASU 2018-11 (Topic 842), Leases: Targeted Improvements, which provides entities with an additional transition method. Under ASU 2018-11, entities have the option of initially applying ASC 842 at the adoption date, rather than at the beginning of the earliest period presented, and recognizing the cumulative effect of applying the new standard as an adjustment to beginning retained earnings in the year of adoption while continuing to present all prior periods under previous lease accounting guidance. The Company expects to elect this transition method at the adoption date of January 1, 2020. The Company is currently evaluating the impact of adopting this guidance on the Company’s financial statements. The Company currently expects that its operating lease commitments will be subject to the new standard and recognized as right-of-use assets and operating lease liabilities upon adoption of this standard, which will increase the total assets and total liabilities that it reports relative to such amounts prior to adoption.  

Cash, Cash Equivalents and Restricted Cash

The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the balance sheets that sum to the total of the same amounts shown in the statements of cash flows.

 

 

 

March 31,

 

 

 

2019

 

 

2018

 

 

 

(in thousands)

 

Cash and cash equivalents

 

$

26,616

 

 

$

6,632

 

Restricted cash

 

 

15

 

 

 

15

 

Total cash, cash equivalents, and restricted cash shown in the

   statements of cash flows

 

$

26,631

 

 

$

6,647

 

 

8


 

Fair Value Measurements

Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability, or an exit price, in the principal or most advantageous market for that asset or liability in an orderly transaction between market participants on the measurement date, and establishes a fair value hierarchy that requires an entity to maximize the use of observable inputs, where available, and minimizes the use of unobservable inputs when measuring fair value. The Company determined the fair value of financial assets and liabilities using the fair value hierarchy that describes three levels of inputs that may be used to measure fair value, as follows:

Level 1—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; and

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 carrying amounts of accounts receivable, prepaid expenses, accounts payable, accrued liabilities and accrued compensation and benefits approximate fair value due to the short-term nature of these items.

The fair value of the Company’s outstanding loan (See Note 6) is estimated using the net present value of the payments, discounted at an interest rate that is consistent with market interest rate, which is a Level 2 input. The estimated fair value of the Company’s outstanding loan approximates the carrying amount, as the loan bears a floating rate that approximates the market interest rate.

Revenue Recognition

The Company recognizes revenue when its customers obtain control of the promised goods or services, in an amount that reflects the consideration that the Company expects to receive in exchange for those goods or services.

Collaboration revenue

The Company derives revenue from collaboration arrangements, under which the Company may grant licenses to its collaboration partners to further develop and commercialize its proprietary product candidates. The Company may also perform research and development activities under the collaboration agreements. Consideration under these contracts generally includes a nonrefundable upfront payment, development, regulatory and commercial milestones and other contingent payments, and royalties based on net sales of approved products. Additionally, the collaborations may provide options for the customer to acquire from the Company’s materials and reagents, clinical product supply or additional research and development services under separate agreements.

The Company assesses which activities in the collaboration agreements are considered distinct performance obligations that should be accounted for separately. The Company develops assumptions that require judgement to determine whether the license to the Company’s intellectual property is distinct from the research and development services or participation in activities under the collaboration agreements.

At the inception of each agreement, the Company determines the arrangement transaction price, which includes variable consideration, based on the assessment of the probability of achievement of future milestones and contingent payments and other potential consideration.

For arrangements that include multiple performance obligations, the Company allocates the transaction price to the identified performance obligations based on the standalone selling price (“SSP”) of each distinct performance obligation. In instances where SSP is not directly observable, the Company develops assumptions that require judgment to determine the SSP for each performance obligation identified in the contract. These key assumptions may include full-time equivalent (“FTE”) personnel effort, estimated costs, discount rates and probabilities of clinical development and regulatory success.

Upfront Payments: For collaboration arrangements that include a nonrefundable upfront payment, if the license fee and research and development services cannot be accounted for as separate performance obligations, the transaction price is deferred and recognized as revenue over the expected period of performance using a cost-based input methodology. The Company uses judgement to assess the pattern of delivery of the performance obligation.  In addition, amounts paid in advance of services being rendered may result in an associated financing component to the upfront payment.  Accordingly, the interest on such borrowing cost component will be recorded as interest expense and revenue, based on an appropriate borrowing rate applied to the value of services to be performed by the Company over the estimated service performance period.

9


 

License Grants: For collaboration arrangements that include a grant of a license to the Company’s intellectual property, the Company considers whether the license grant is distinct from the other performance obligations included in the arrangement. For licenses that are distinct, the Company recognizes revenues from nonrefundable, upfront payments and other consideration allocated to the license when the license term has begun and the Company has provided all necessary information regarding the underlying intellectual property to the customer, which generally occurs at or near the inception of the arrangement.

Milestone and Contingent Payments: At the inception of the arrangement and at each reporting date thereafter, the Company assesses whether it should include any milestone and contingent payments or other forms of variable consideration in the transaction price using the most likely amount method. If it is probable that a significant reversal of cumulative revenue would not occur upon resolution of the uncertainty, the associated milestone value is included in the transaction price. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of each such milestone and any related constraint and, if necessary, adjusts its estimate of the overall transaction price. Since milestone and contingent payments may become payable to the Company upon the initiation of a clinical study or filing for or receipt of regulatory approval, the Company reviews the relevant facts and circumstances to determine when the Company should update the transaction price, which may occur before the triggering event. When the Company updates the transaction price for milestone and contingent payments, the Company allocates the changes in the total transaction price to each performance obligation in the agreement on the same basis as the initial allocation. Any such adjustments are recorded on a cumulative catch-up basis in the period of adjustment, which may result in recognizing revenue for previously satisfied performance obligations in such period. The Company’s collaborators generally pay milestones and contingent payments subsequent to achievement of the triggering event.

Research and development services: For amounts allocated to the Company’s research and development obligations in a collaboration arrangement, the Company recognizes revenue over time using a cost-based input methodology, representing the transfer of goods or services as activities are performed over the term of the agreement.

Materials Sales: The Company provides materials and reagents, clinical materials and services to certain of its collaborators under separate agreements. The consideration for such services is generally based on FTE personnel effort used to manufacture those materials reimbursed at an agreed upon rate in addition to agreed-upon pricing for the provided materials. The amounts billed are recognized as revenue as the performance obligations are met by the Company.  

The Company’s revenue recognition policies under ASC 605 are described in the Annual Report on Form 10-K for the year ended December 31, 2018.

 

3. Fair Value Measurements

The following table sets forth the fair value of the Company’s financial assets and liabilities measured on a recurring basis by level within the fair value hierarchy:

 

 

 

March 31, 2019

 

 

 

Total

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

 

(in thousands)

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

26,721

 

 

$

26,721

 

 

$

 

 

$

 

Commercial paper

 

 

55,085

 

 

 

 

 

 

55,085

 

 

 

 

Corporate debt securities

 

 

38,998

 

 

 

 

 

 

38,998

 

 

 

 

Asset-backed securities

 

 

30,862

 

 

 

 

 

 

30,862

 

 

 

 

U.S. government agency securities

 

 

32,755

 

 

 

 

 

 

32,755

 

 

 

 

Total

 

$

184,421

 

 

$

26,721

 

 

$

157,700

 

 

 

 

 

10


 

 

 

December 31, 2018

 

 

 

Total

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

 

(in thousands)

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

116,202

 

 

$

116,202

 

 

$

 

 

$

 

Commercial paper

 

 

26,625

 

 

 

 

 

 

26,625

 

 

 

 

Corporate debt securities

 

 

11,774

 

 

 

 

 

 

11,774

 

 

 

 

Asset-backed securities

 

 

16,899

 

 

 

 

 

 

16,899

 

 

 

 

U.S. government agency securities

 

 

23,896

 

 

 

 

 

 

23,896

 

 

 

 

Total

 

$

195,396

 

 

$

116,202

 

 

$

79,194

 

 

$

 

 

Where applicable, the Company uses quoted market prices in active markets for identical assets to determine fair value. This pricing methodology applies to Level 1 investments, which are composed of money market funds.

If quoted prices in active markets for identical assets are not available, then the Company uses quoted prices for similar assets or inputs other than quoted prices that are observable, either directly or indirectly. These investments are included in Level 2 and consist of commercial paper, corporate debt securities, asset-backed securities and U.S. government agency securities. These assets are valued using market prices when available, adjusting for accretion of the purchase price to face value at maturity.

A financial instrument’s categorization within the valuation hierarchy is based upon 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.

In certain cases where there is limited activity or less transparency around inputs to valuation, securities are classified as Level 3 within the valuation hierarchy. Level 3 liabilities that were measured at estimated fair value on a recurring basis consisted of the redeemable convertible preferred stock warrant liability (prior to closing of the Company’s IPO).

Upon closing of the IPO on October 1, 2018, all of the outstanding redeemable convertible preferred stock warrants either expired or were converted into common stock warrants, which resulted in the reclassification of the redeemable convertible preferred stock warrant liability to other income and additional paid-in-capital.  

4. Cash Equivalents and Marketable Securities

Cash equivalents and marketable securities consisted of the following:

 

 

 

March 31, 2019

 

 

 

Amortized

Cost Basis

 

 

Unrealized

Gains

 

 

Fair

Value

 

 

 

(in thousands)

 

Money market funds

 

$

26,721

 

 

$

 

 

$

26,721

 

Commercial paper

 

 

55,085

 

 

 

 

 

 

55,085

 

Corporate debt securities

 

 

38,977

 

 

 

21

 

 

 

38,998

 

Asset-based securities

 

 

30,842

 

 

 

20

 

 

 

30,862

 

U.S. government agencies

 

 

32,740

 

 

 

15

 

 

 

32,755

 

Total

 

 

184,365

 

 

 

56

 

 

 

184,421

 

Less amounts classified as cash equivalents

 

 

(26,721

)

 

 

 

 

 

(26,721

)

Total marketable securities

 

$

157,644

 

 

$

56

 

 

$

157,700

 

 

11


 

 

 

December 31, 2018

 

 

 

Amortized

Cost Basis

 

 

Unrealized

Losses

 

 

Fair

Value

 

 

 

(in thousands)

 

Money market funds

 

$

116,202

 

 

$

 

 

$

116,202

 

Commercial paper

 

 

26,625

 

 

 

 

 

 

26,625

 

Corporate debt securities

 

 

11,795

 

 

 

(21

)

 

 

11,774

 

Asset-based securities

 

 

16,920

 

 

 

(21

)

 

 

16,899

 

U.S. government agencies

 

 

23,901

 

 

 

(5

)

 

 

23,896

 

Total

 

 

195,443

 

 

 

(47

)

 

 

195,396

 

Less amounts classified as cash equivalents

 

 

(116,202

)

 

 

 

 

 

(116,202

)

Total marketable securities

 

$

79,241

 

 

$

(47

)

 

$

79,194

 

 

As of March 31, 2019, $13.7 million of marketable securities had maturities of more than one year and are classified as long-term assets.  As of December 31, 2018, no marketable securities had maturities of more than one year.

 

5. Collaboration and License Agreements and Supply Agreements

The Company has entered into collaboration and license agreements with various pharmaceutical and biotechnology companies. As described in Note 2, on January 1, 2019, the Company adopted ASC 606, Revenue from Contracts with Customers, which supersedes the guidance in ASC 605, Revenue Recognition. The Company recognized revenue under ASC 606 for the three months ended March 31, 2019 and under ASC 605 for the three months ended March 31, 2018. In accordance with the collaboration agreements, the Company recognized revenue as follows:

 

 

 

Three Months Ended

March 31,

 

 

 

2019

 

 

2018

 

 

 

(dollars in thousands)

 

Celgene Corporation (“Celgene”) (1)

 

$

1,575

 

 

$

4,084

 

Merck Sharp & Dohme Corporation (“Merck”)—related party

 

 

4,635

 

 

 

-

 

Merck KGaA, Darmstadt, Germany (operating in the United

   States and Canada under the name “EMD Serono”)

 

 

2,138

 

 

 

1,709

 

SutroVax—related party

 

 

281

 

 

 

-

 

Total revenue

 

$

8,629

 

 

$

5,793

 

 

 

(1)

Celgene was a related party during the three months ended March 31, 2018 as it held more than 10% of the Company’s common stock for the periods presented until the IPO closed on October 1, 2018.

The following table presents the changes in the Company’s deferred revenue balance from collaboration agreements during the three months ended March 31, 2019:

 

 

 

Three Months Ended

March 31, 2019

 

 

 

(in thousands)

 

Deferred revenue—December 31, 2018

 

$

66,173

 

Transition adjustment related to adoption of ASC 606

 

 

(10,327

)

Recognition of revenue in current period

 

 

(5,302

)

Deferred revenue—March 31, 2019

 

$

50,544

 

 

The Company’s balance of deferred revenue contains the transaction price from collaboration agreements allocated to performance obligations which are partially unsatisfied. The Company expects to recognize approximately $19.0 million of deferred revenue over the next twelve months.

There have been no material changes to the Company’s collaboration agreements in the three months ended March 31, 2019, except as described below.

12


 

Celgene Agreement

In September 2014, the Company signed a Collaboration and License Agreement with Celgene to discover and develop bispecific antibodies and/or antibody-drug conjugates (“ADCs”), focused primarily on the field of immuno-oncology, using the Company’s proprietary integrated cell-free protein synthesis platform, XpressCF™.

Upon signing the Celgene Agreement, the Company received an upfront, nonrefundable payment totaling $83.1 million.   

In March 2015, the Company received a $15.0 million contingent payment (“March 2015 payment”) from Celgene that provided Celgene a right to access certain of the Company’s technology for use in conjunction with certain Celgene intellectual property. In June 2016, the Company received a $25.0 million milestone (“June 2016 payment”) upon completion of certain preclinical activities. Additionally, in June 2016, the Company earned a $10.0 million substantive milestone for certain manufacturing accomplishments.

In August 2017, the Company entered into an amended and restated collaboration and license agreement with Celgene to refocus the collaboration on four programs that are advancing through preclinical development, including an ADC program targeting B cell maturation antigen (“BCMA ADC”).

In August 2017, the Company received an option fee payment of $12.5 million. In September 2017, the Company earned a $10.0 million milestone for certain manufacturing accomplishments, which payment was received from Celgene in October 2017. In December 2018, the Company earned a $10.0 million milestone for certain manufacturing accomplishments, which payment was received from Celgene in the same month.

The Company has received and will be eligible to receive financial support for research and development services assigned to the Company by Celgene, based on an agreed-upon level of FTE personnel effort and related reimbursement rate, which will be recognized as revenue as the related reimbursable activities approved by Celgene and the Company are performed by the Company.

Under the terms of the Celgene Agreement, the Company is entitled to earn development and regulatory contingent payments for each of the four programs under the collaboration, and royalties on sales of any commercial products that may result from the Celgene Agreement.  For licensed products for which Celgene holds worldwide rights, the Company is eligible to receive contingent development and regulatory payments and tiered royalties. Additionally, for licensed products for which Celgene holds ex-U.S. rights, the Company will also be eligible to receive contingent development and regulatory payments and tiered royalties. The contingent payments under the Celgene Agreement are not considered to be substantive milestones because the receipt of such payments is based solely on the performance of Celgene.

Celgene may terminate the Celgene Agreement at any time with 120 days’ prior written notice. Either the Company or Celgene has the right to terminate the Celgene Agreement based on the other party’s uncured material breach, challenge of the validity and enforceability of intellectual property, or bankruptcy.

In accounting for this arrangement under ASC 606, applying the practical expedients, the Celgene Agreement was treated as a single arrangement that had been modified in 2017.  

Given the modification of the Celgene Agreement in 2017, the Company determined that the remaining deferred revenue balance of $8.2 million as of the date of the modification, related to certain prior Celgene payments to the Company, together with the $12.5 million option fee payment received in August 2017, would comprise the transaction price of $20.7 million to be allocated on a relative basis among the Company’s performance obligations based on the Company’s best estimate of each SSP or fair value. The Company identified the three  performance obligations relating to the Celgene Agreement as: (1) access by Celgene to worldwide development and commercialization rights on the first collaboration program to achieve investigational new drug (“IND”) clearance; (2) the Company’s estimated future services on the collaboration Joint Steering Committee (“JSC”); and (3) Celgene’s use of certain technology and the option to acquire worldwide development and commercialization rights to a second collaboration program.

Based on its estimated SSP, relative to the total estimated SSP values of all identified performance obligations, the portion of the transaction price allocated to the first performance obligation was $8.2 million, which performance obligation was satisfied as of the modification date of the Celgene Agreement, as the BCMA ADC program was the most advanced of the four collaboration programs and estimated by the Company to be the one for which Celgene would first achieve IND clearance and gain worldwide development and commercialization rights. The second and third performance obligations identified above were unsatisfied as of the modification date of the Celgene Agreement.  The Company determined the portion of the transaction price to be allocated to the JSC performance obligation was $0.2 million. Revenue related to such performance obligation will be recognized by the Company over the estimated period during which it will perform its JSC services.  The Company determined that the portion of the transaction price to be allocated to the third performance obligation, which provided Celgene with an option to acquire worldwide development and commercialization rights to a

13


 

second collaboration program, was $12.3 million.  Revenue related to such performance obligation will be recognized over the period from August 2017 through September 2020, the estimated term of the use of the technology.  

Upon the adoption of ASC 606 on January 1, 2019, the Company recorded a $4.5 million a