cara-10q_20180630.htm

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 10-Q

 

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

FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2018

OR

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

COMMISSION FILE NUMBER 001-36279

CARA THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

 

Delaware

75-3175693

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer

Identification No.)

 

 

4 Stamford Plaza

107 Elm Street, 9th Floor

Stamford, Connecticut

06902

(Address of registrant’s principal executive offices)

(Zip Code)

 

Registrant’s telephone number, including area code: (203) 406-3700

 

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

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

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company.  See definition 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.

The number of outstanding shares of the registrant's common stock, par value $0.001 per share, as of August 1, 2018 was: 39,290,464.

 


CARA THERAPEUTICS, INC.

 

INDEX TO FORM 10-Q

FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2018

 

PART I –FINANCIAL INFORMATION

 

 

 

PAGE

NUMBER

 

 

 

Item 1.

Financial Statements (Unaudited):

 

 

 

 

 

Condensed Balance Sheets as of June 30, 2018 and December 31, 2017

1

 

 

 

 

Condensed Statements of Comprehensive Loss for the Three and Six Months Ended June 30, 2018 and 2017

2

 

 

 

 

Condensed Statements of Stockholders’ Equity for the Six Months Ended June 30, 2018 and 2017

3

 

 

 

 

Condensed Statements of Cash Flows for the Six Months Ended June 30, 2018 and 2017

4

 

 

 

 

Notes to Condensed Financial Statements

5

 

 

 

Item 2.

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

28

 

 

 

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

46

 

 

 

Item 4.

Controls and Procedures

47

 

 

 

 

PART II – OTHER INFORMATION

 

 

 

 

Item 1.

Legal Proceedings

48

 

 

 

Item 1A

Risk Factors

48

 

 

 

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

48

 

 

 

Item 3.

Defaults Upon Senior Securities

48

 

 

 

Item 4.

Mine Safety Disclosures

48

 

 

 

Item 5.

Other Information

48

 

 

 

Item 6.

Exhibits

49

 

 

 

 

SIGNATURES

50

 

 

 


 

PART I

FINANCIAL INFORMATION

Item 1.  Financial Statements.

CARA THERAPEUTICS, INC.

CONDENSED BALANCE SHEETS

(amounts in thousands, excluding share and per share data)

(unaudited)

 

 

 

June 30, 2018

 

 

December 31, 2017

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

17,802

 

 

$

9,388

 

Marketable securities

 

 

114,159

 

 

 

83,181

 

Income tax receivable

 

 

473

 

 

 

731

 

Other receivables

 

 

116

 

 

 

123

 

Prepaid expenses

 

 

5,615

 

 

 

1,635

 

Restricted cash, current

 

 

361

 

 

 

 

Total current assets

 

 

138,526

 

 

 

95,058

 

Property and equipment, net

 

 

959

 

 

 

1,177

 

Restricted cash

 

 

408

 

 

 

769

 

Total assets

 

$

139,893

 

 

$

97,004

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable and accrued expenses

 

$

12,553

 

 

$

8,506

 

Current portion of deferred revenue

 

 

22,270

 

 

 

 

Total current liabilities

 

 

34,823

 

 

 

8,506

 

 

 

 

 

 

 

 

 

 

Deferred revenue, non-current

 

 

30,299

 

 

 

 

Deferred lease obligation

 

 

1,695

 

 

 

1,718

 

Commitments and contingencies (Note 15)

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

 

 

Preferred stock; $0.001 par value; 5,000,000 shares authorized at June 30, 2018

   and December 31, 2017, zero shares issued and outstanding at June 30, 2018

   and December 31, 2017

 

 

 

 

 

 

Common stock; $0.001 par value; 100,000,000 shares authorized at

   June 30, 2018 and December 31, 2017, 34,059,214 shares and 32,662,255

   shares issued and outstanding at June 30, 2018 and December 31, 2017,

   respectively

 

 

34

 

 

 

33

 

Additional paid-in capital

 

 

327,401

 

 

 

307,158

 

Accumulated deficit

 

 

(254,302

)

 

 

(220,341

)

Accumulated other comprehensive loss

 

 

(57

)

 

 

(70

)

Total stockholders’ equity

 

 

73,076

 

 

 

86,780

 

Total liabilities and stockholders’ equity

 

$

139,893

 

 

$

97,004

 

 

See Notes to Condensed Financial Statements.

 

1


 

CARA THERAPEUTICS, INC.

 

CONDENSED STATEMENTS OF COMPREHENSIVE LOSS

(amounts in thousands, excluding share and per share data)

(unaudited)

 

 

 

Three Months Ended

 

 

Six Months Ended

 

 

 

June 30, 2018

 

 

June 30, 2017

 

 

June 30, 2018

 

 

June 30, 2017

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

License and milestone fees

 

$

2,874

 

 

$

 

 

$

2,874

 

 

$

530

 

Collaborative revenue

 

 

 

 

 

 

 

 

 

 

 

313

 

Clinical compound revenue

 

 

 

 

 

 

 

 

 

 

 

68

 

Total revenue

 

 

2,874

 

 

 

 

 

 

2,874

 

 

 

911

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

17,002

 

 

 

6,961

 

 

 

30,429

 

 

 

27,797

 

General and administrative

 

 

3,685

 

 

 

2,672

 

 

 

7,382

 

 

 

5,072

 

Total operating expenses

 

 

20,687

 

 

 

9,633

 

 

 

37,811

 

 

 

32,869

 

Operating loss

 

 

(17,813

)

 

 

(9,633

)

 

 

(34,937

)

 

 

(31,958

)

Other income

 

 

467

 

 

 

331

 

 

 

778

 

 

 

421

 

Loss before benefit from income taxes

 

 

(17,346

)

 

 

(9,302

)

 

 

(34,159

)

 

 

(31,537

)

Benefit from income taxes

 

 

152

 

 

 

2

 

 

 

198

 

 

 

33

 

Net loss

 

$

(17,194

)

 

$

(9,300

)

 

$

(33,961

)

 

$

(31,504

)

Net loss per share:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic and Diluted

 

$

(0.52

)

 

$

(0.29

)

 

$

(1.03

)

 

$

(1.06

)

Weighted average shares:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic and Diluted

 

 

33,315,809

 

 

 

32,239,877

 

 

 

33,000,487

 

 

 

29,783,424

 

Other comprehensive income (loss), net of tax of $0:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Change in unrealized gains (losses) on available-for-

   sale marketable securities

 

 

57

 

 

 

(37

)

 

 

13

 

 

 

(16

)

Total comprehensive loss

 

$

(17,137

)

 

$

(9,337

)

 

$

(33,948

)

 

$

(31,520

)

 

See Notes to Condensed Financial Statements.

2


 

CARA THERAPEUTICS, INC.

CONDENSED STATEMENTS OF STOCKHOLDERS’ EQUITY

(amounts in thousands except share and per share data)

(unaudited)

 

 

 

Common Stock

 

 

Additional

Paid-In

 

 

Accumulated

 

 

Accumulated

Other

Comprehensive

 

 

Total

Stockholders'

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Income (Loss)

 

 

Equity

 

Balance at December 31, 2016

 

 

27,296,863

 

 

$

27

 

 

$

212,866

 

 

$

(162,171

)

 

$

3

 

 

$

50,725

 

Sale of common stock in a follow-

   on public offering ($18.00 per

   share), net of underwriting

   discounts and commissions

   and offering expenses of $5,891

 

 

5,117,500

 

 

 

5

 

 

 

86,219

 

 

 

 

 

 

 

 

 

86,224

 

Stock-based compensation

   expense

 

 

 

 

 

 

 

 

2,426

 

 

 

 

 

 

 

 

 

2,426

 

Shares issued upon exercise

   of stock options

 

 

153,122

 

 

 

1

 

 

 

1,364

 

 

 

 

 

 

 

 

 

1,365

 

Cumulative effect adjustment

   upon adoption of ASU 2016-09

 

 

 

 

 

 

 

45

 

 

 

(45

)

 

 

 

 

 

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(31,504

)

 

 

 

 

 

(31,504

)

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(16

)

 

 

(16

)

Balance at June 30, 2017

 

 

32,567,485

 

 

$

33

 

 

$

302,920

 

 

$

(193,720

)

 

$

(13

)

 

$

109,220

 

 

 

 

Common Stock

 

 

Additional

Paid-In

 

 

Accumulated

 

 

Accumulated

Other

Comprehensive

 

 

Total

Stockholders'

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Income (Loss)

 

 

Equity

 

Balance at December 31, 2017

 

 

32,662,255

 

 

$

33

 

 

$

307,158

 

 

$

(220,341

)

 

$

(70

)

 

$

86,780

 

Sale of common stock under

   license agreement

 

 

1,174,827

 

 

 

1

 

 

 

14,555

 

 

 

 

 

 

 

 

 

14,556

 

Stock-based compensation

   expense

 

 

 

 

 

 

 

 

3,940

 

 

 

 

 

 

 

 

 

3,940

 

Shares issued upon exercise of

   stock options

 

 

222,132

 

 

 

 

 

 

1,748

 

 

 

 

 

 

 

 

 

1,748

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(33,961

)

 

 

 

 

 

(33,961

)

Other comprehensive income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

13

 

 

 

13

 

Balance at June 30, 2018

 

 

34,059,214

 

 

$

34

 

 

$

327,401

 

 

$

(254,302

)

 

$

(57

)

 

$

73,076

 

 

See Notes to Condensed Financial Statements.

3


 

CARA THERAPEUTICS, INC.

CONDENSED STATEMENTS OF CASH FLOWS

(amounts in thousands)

(unaudited)

 

 

 

Six Months Ended

 

 

 

June 30, 2018

 

 

June 30, 2017

 

Operating activities

 

 

 

 

 

 

 

 

Net loss

 

$

(33,961

)

 

$

(31,504

)

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

   operating activities:

 

 

 

 

 

 

 

 

Stock-based compensation expense

 

 

3,940

 

 

 

2,426

 

Depreciation and amortization

 

 

239

 

 

 

245

 

Amortization/accretion of available-for-sale marketable securities

 

 

(559

)

 

 

(163

)

Realized loss (gain) on sale of available-for-sale marketable securities

 

 

15

 

 

 

(3

)

Realized gain on sale of property and equipment

 

 

 

 

 

(13

)

Deferred rent costs

 

 

(23

)

 

 

(7

)

Deferred revenue

 

 

52,569

 

 

 

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Income tax receivable

 

 

258

 

 

 

292

 

Other receivables

 

 

7

 

 

 

(88

)

Prepaid expenses

 

 

(3,980

)

 

 

(405

)

Accounts payable and accrued expenses

 

 

4,047

 

 

 

(4,343

)

Net cash provided by (used in) operating activities

 

 

22,552

 

 

 

(33,563

)

Investing activities

 

 

 

 

 

 

 

 

Proceeds from maturities of available-for-sale marketable securities

 

 

56,700

 

 

 

35,906

 

Proceeds from sale of available-for-sale marketable securities

 

 

11,150

 

 

 

5,430

 

Purchases of available-for-sale marketable securities

 

 

(98,271

)

 

 

(98,021

)

Purchases of property and equipment

 

 

(21

)

 

 

(30

)

Proceeds from sale of property and equipment

 

 

 

 

 

13

 

Net cash used in investing activities

 

 

(30,442

)

 

 

(56,702

)

Financing activities

 

 

 

 

 

 

 

 

Proceeds from sale of common stock in a follow-on public offering

 

 

 

 

 

86,224

 

Proceeds from the sale of common stock under license agreement

 

 

14,556

 

 

 

 

Proceeds from the exercise of stock options

 

 

1,748

 

 

 

1,365

 

Net cash provided by financing activities

 

 

16,304

 

 

 

87,589

 

Net increase (decrease) in cash, cash equivalents and restricted cash

 

 

8,414

 

 

 

(2,676

)

Cash, cash equivalents and restricted cash at beginning of period

 

 

10,157

 

 

 

13,561

 

Cash, cash equivalents and restricted cash at end of period

 

$

18,571

 

 

$

10,885

 

 

See Notes to Condensed Financial Statements.

 

 

 

4


CARA THERAPEUTICS, INC.

 

NOTES TO CONDENSED FINANCIAL STATEMENTS

(amounts in thousands, except share and per share data)

(unaudited)

 

1.

Business

Cara Therapeutics, Inc., or the Company, is a clinical-stage biopharmaceutical corporation formed on July 2, 2004. The Company is focused on developing and commercializing new chemical entities designed to alleviate pruritus and pain by selectively targeting kappa opioid receptors. The Company’s primary activities to date have been organizing and staffing the Company, developing its product candidates, including conducting preclinical studies and clinical trials of CR845/difelikefalin-based product candidates and raising capital.

As of June 30, 2018, the Company had raised aggregate net proceeds of approximately $291,100 from several rounds of equity financing, including its initial public offering, or IPO, which closed in February 2014 and two follow-on public offerings of common stock, which closed in April 2017 and August 2015, and the issuance of convertible preferred stock and debt prior to the IPO. The Company had also received approximately $88,900 under its license agreements for CR845/difelikefalin, primarily with Vifor Fresenius Medical Care Renal Pharma Ltd., or VFMCRP, Maruishi Pharmaceutical Co. Ltd., or Maruishi, and Chong Kun Dang Pharmaceutical Corp., or CKDP, and an earlier product candidate for which development efforts ceased in 2007. Additionally, in May 2018, the Company received net proceeds of $14,556 from the issuance and sale of 1,174,827 shares of the Company’s common stock to Vifor (International) Ltd., or Vifor, in connection with the license agreement with VFMCRP (see Note 10, Collaborations and Licensing Agreements).

As of June 30, 2018, the Company had unrestricted cash and cash equivalents and marketable securities of $131,961 and an accumulated deficit of $254,302. The Company has incurred substantial net losses and negative cash flows from operating activities in nearly every fiscal period since inception and expects this trend to continue for the foreseeable future. The Company recognized net losses of $17,194 and $9,300 for the three months ended June 30, 2018 and 2017, respectively, and $33,961 and $31,504 for the six months ended June 30, 2018 and 2017, respectively, and had net cash provided by (used in) operating activities of $22,552 and $(33,563) for the six months ended June 30, 2018 and 2017, respectively.

 

In July 2018, the Company received net proceeds of approximately $92,026 from the issuance and sale of 5,175,000 shares of its common stock in a follow-on public offering, including the full exercise of the underwriters’ option to purchase 675,000 additional shares of its common stock (see Note 16, Subsequent Event).

The Company is subject to risks common to other life science companies including, but not limited to, uncertainty of product development and commercialization, lack of marketing and sales history, development by its competitors of new technological innovations, dependence on key personnel, market acceptance of products, product liability, protection of proprietary technology, ability to raise additional financing, and compliance with Food and Drug Administration, or FDA, and other government regulations.  If the Company does not successfully commercialize any of its product candidates, it will be unable to generate recurring product revenue or achieve profitability.  

2. Basis of Presentation

The unaudited interim condensed financial statements included herein have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission, or SEC. Accordingly, they do not include all information and disclosures necessary for a presentation of the Company’s financial position, results of operations and cash flows in conformity with generally accepted accounting principles in the United States of America, or GAAP. In the opinion of management, these unaudited interim financial statements reflect all adjustments, consisting primarily of normal recurring accruals, necessary for a fair presentation of results for the periods presented. Certain amounts in the prior year’s condensed financial statements have been reclassified to conform to the current-year presentation due to the adoption of certain accounting standards (see Note 2, Accounting Pronouncements Recently Adopted: ASU 2016-18, Statement of Cash Flows (Topic 230), Restricted Cash). The results of operations for interim periods are not necessarily indicative of the results for the full year. Certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted from this report, as is permitted by SEC rules and regulations; however, the Company believes that the disclosures are adequate to make the information presented not misleading. The condensed balance sheet data for the year ended December 31, 2017 were derived from audited financial statements, but do not include all disclosures required by GAAP. These unaudited interim condensed financial statements should be read in conjunction with the audited financial statements and accompanying notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017.  

5


CARA THERAPEUTICS, INC.

 

NOTES TO CONDENSED FINANCIAL STATEMENTS

(amounts in thousands, except share and per share data)

(unaudited)

 

Use of Estimates

The preparation of financial statements in conformity with GAAP requires the Company to make estimates and assumptions that affect the reported amounts of assets and liabilities, and disclosure of contingent assets and liabilities, as of the date of the financial statements as well as the reported amounts of revenues and expenses during the reporting period. Actual results could differ materially from the Company’s estimates and assumptions. Significant estimates include the fair value of marketable securities that are classified as level 2 of the fair value hierarchy, useful lives of fixed assets, the periods over which certain revenues will be recognized, including licensing and collaborative revenue recognized from non-refundable up-front and milestone payments, the determination of prepaid research and development, or R&D, clinical costs and accrued research projects, the amount of non-cash compensation costs related to share-based payments to employees and non-employees and the periods over which those costs are expensed and the likelihood of realization of deferred tax assets.

Significant Accounting Policies

There have been no material changes to the significant accounting policies previously disclosed in Note 2 to the Financial Statements in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017, except for the recent adoption of new accounting pronouncements as disclosed below.

Accounting Pronouncements Recently Adopted

Revenue Recognition

On January 1, 2018, the Company adopted Accounting Standards Update, or ASU, 2014-09, Revenue from Contracts with Customers (Topic 606), or ASC 606, as amended by ASU 2016-08, 2016-10, 2016-12 and 2016-20 using the full retrospective method. Under ASC 606, the Company recognizes revenue in an amount that reflects the consideration to which it expects to be entitled in exchange for the transfer of promised goods or services to customers. To determine revenue recognition for contracts with customers that are within the scope of ASC 606, the Company performs the following steps: (1) identifies the contract with the customer, (2) identifies the performance obligations in the contract, (3) determines the transaction price, (4) allocates the transaction price to the performance obligations in the contract, and (5) recognizes revenue when (or as) the entity satisfies a performance obligation. The Company has concluded that upon adoption of ASC 606, as amended, there was no impact on its results of operations, financial position or cash flows for any period presented from its only two revenue-related contracts, which were in effect at that time: the CKDP Agreement or the Maruishi Agreement (see Note 10, Collaboration and Licensing Agreements and Note 11, Revenue Recognition).

The Company has entered into agreements to license its intellectual property, or IP, related to CR845/difelikefalin to develop, manufacture and/or commercialize drug products. These agreements typically contain multiple performance obligations, including licenses of IP and R&D services. Payments to the Company under these agreements may include nonrefundable license fees, payments for research activities, payments based upon the achievement of certain milestones and royalties on any resulting net product sales.

The Company identifies agreements as contracts that create enforceable rights and obligations when the agreement is approved by the parties, identifies the rights of the parties and the payment terms, has commercial substance and it is probable that the Company will collect the consideration to which it will be entitled in exchange for the goods and services that will be transferred to the customer. The counterparty is considered to be a customer when it has contracted with the Company to obtain goods and services that are the output of the Company’s ordinary activities (i.e., development of pharmaceutical products) in exchange for consideration.

A performance obligation is a promise to transfer distinct goods or services to a customer. Performance obligations that are both capable of being distinct and distinct within the context of the contract are considered to be separate performance obligations. Performance obligations are capable of being distinct if the counterparty is able to benefit from the good or service on its own or together with other resources that are readily available to it. Performance obligations are distinct within the context of the contract when each performance obligation is separately identifiable from each other; i.e., the Company is not using the goods or services as inputs to produce or deliver the combined output or outputs specified by the customer; one or more of the goods or services does not significantly modify or customize one of the other goods or services in the contract; and goods or services are not highly interdependent or not highly interrelated. Performance obligations that are not distinct are accounted for as a single performance obligation over the period that goods or services are transferred to the customer. The determination of whether performance obligations in a contract are distinct may require significant judgment.

6


CARA THERAPEUTICS, INC.

 

NOTES TO CONDENSED FINANCIAL STATEMENTS

(amounts in thousands, except share and per share data)

(unaudited)

 

The transaction price is the amount of consideration that the Company expects to be entitled to in exchange for transferring promised goods or services to the customer based on the contract terms at inception of a contract. There is a constraint on inclusion of variable consideration related to licenses of IP, such as milestone payments or sales-based royalty payments, in the transaction price if there is uncertainty at inception of the contract as to whether such consideration will be recognized in the future because it is probable that there will be a significant reversal of revenue in the future when the uncertainty is resolved. The determination of whether or not it is probable that a significant reversal of revenue will occur in the future depends on the likelihood and magnitude of the reversal.  Factors that could increase the likelihood or magnitude of a reversal of revenue include (a) the susceptibility of the amount of consideration to factors outside the entity’s influence, such as the outcome of clinical trials, the timing of initiation of clinical trials by the counterparty and the approval of drug product candidates by regulatory agencies, (b) situations in which the uncertainty is not expected to be resolved for a long period of time and (c) level of the Company’s experience in the field. When it becomes probable that events will occur, for which variable consideration was constrained at inception of the contract, the Company allocates the related consideration to the separate performance obligations in the same manner as described below.  

At inception of a contract, the Company allocates the transaction price to the distinct performance obligations based upon their relative standalone selling prices. Standalone selling price is the price at which an entity would sell a promised good or service separately to a customer. The best evidence of standalone selling price is an observable price of a good or service when sold separately by an entity in similar circumstances to similar customers. Since the Company typically does not have such evidence, it estimates standalone selling price so that the amount that is allocated to each performance obligation equals the amount that the Company expects to receive for transferring goods or services. The methods that the Company uses to make such estimates include (1) the adjusted market assessment approach, under which the Company forecasts and analyzes CR845/difelikefalin in the appropriate market, the phase of clinical development as well as considering recent similar license arrangements within the same phase of clinical development, therapeutic area, type of agreement, etc. and (2) the expected cost of satisfying the performance obligations plus a margin, or the expected cost plus a margin approach.

The Company recognizes revenue when, or as, it satisfies a performance obligation by transferring a promised good or service to a customer and the customer obtains control of the good or service. Revenue related to the grant of a license that is a distinct performance obligation and that is deemed to be functional IP is recognized at the point in time that the Company has the right to payment for the license, the customer has legal title to the license and can direct the use of the license (for example, to grant sublicenses), the customer has the significant risks and rewards of ownership of the license and the customer has accepted the asset (license) by signing the license agreement.

Recognition of revenue related to R&D services that are a distinct performance obligation or that are combined with granting of a license as a single performance obligation is deferred at inception of a contract and is recognized as those services are performed based on the costs incurred as a percentage of the estimated total costs to be incurred to complete the performance obligation.

Milestone payments are considered to be variable consideration and are not included in the transaction price at inception of the contract if it is uncertain that the milestone will be achieved. Rather, when it becomes probable that the milestone will be achieved and, therefore, there will not be a significant reversal of revenue in future periods, the respective amount to be earned is included in the transaction price, allocated to the distinct performance obligations based on their relative standalone selling price and recognized as revenue, as described above.  Sales milestones and sales-based royalty payments related to a license of IP are recognized as revenue when the respective sales occur.

Other Accounting Pronouncements Recently Adopted

As of January 1, 2018, the Company adopted ASU No. 2017-09, Compensation – Stock Compensation (Topic 718) - Scope of Modification Accounting, or ASU 2017-09, which clarifies that a change to the terms or conditions of a share-based payment award should be accounted for as a modification only if the fair value, vesting conditions or classification (as equity or liability) of the award changes as a result of the change in terms or conditions. Modification of a share-based payment award may result in the Company recognizing additional compensation expense. The Company generally has not modified, and does not expect to frequently modify, the fair value, vesting conditions or classification of its share-based payment awards.  The Company does not expect this guidance to have a material effect on its financial position, results of operations or cash flows. However, if and when modifications occur, their effect could be material to the Company’s financial position, results of operations or cash flows (see Note 13, Stock-based Compensation).  

7


CARA THERAPEUTICS, INC.

 

NOTES TO CONDENSED FINANCIAL STATEMENTS

(amounts in thousands, except share and per share data)

(unaudited)

 

As of January 1, 2018, the Company adopted ASU No. 2017-01, Business Combinations (Topic 805), Clarifying the Definition of a Business, or ASU 2017-01, that clarifies the definition of a business to assist entities with evaluating whether transactions should be accounted for as acquisitions (or disposals) of assets or businesses. ASU 2017-01 requires an entity to evaluate if substantially all of the fair value of the gross assets acquired or disposed of is concentrated in a single identifiable asset or a group of similar identifiable assets; if so, the set of transferred assets and activities is not a business. ASU 2017-01 also requires a business to include at least an input and one substantive process that together significantly contribute to the ability to create output and removes the evaluation of whether a market participant could replace missing elements. The adoption of ASU 2017-01 did not have a material effect on the Company’s financial position, results of operations or cash flows.

As of January 1, 2018, the Company adopted ASU No. 2016-18, Statement of Cash Flows (Topic 230), Restricted Cash (a consensus of the Emerging Issues Task Force), or ASU 2016-18, which changes the presentation of the cash flow statement to include amounts generally described as restricted cash or restricted cash equivalents, together with cash and cash equivalents, when reconciling the beginning-of-period and end-of-period amounts shown on the statement of cash flows. ASU 2016-18 also requires additional disclosures concerning the nature of the restrictions on cash and cash equivalents and a reconciliation between amounts of cash, cash equivalents and restricted cash on the balance sheet and statement of cash flows for each period presented. Upon adoption, ASU 2016-18 was applied retrospectively to all periods presented. The Company historically presented changes in restricted cash as an investing activity in the statement of cash flows. Upon adoption of ASU 2016-18, such changes are reflected in the beginning and ending balances of cash, cash equivalents and restricted cash for all periods presented (see Note 6, Restricted Cash).

 

Accounting Pronouncements Not Yet Adopted

 

In June 2018, the FASB issued ASU No. 2018-07, Compensation—Stock Compensation (Topic 718), Improvements to Nonemployee Share-Based Payment Accounting, or ASU 2018-07, which expands the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from nonemployees. ASU 2018-07 applies to all share-based payment transactions in which a grantor acquires goods or services to be used or consumed in a grantor’s own operations by issuing share-based payment awards. Accordingly, under ASU 2018-07, the fair value of stock options granted to nonemployees will be measured only on the grant date, the amount of which will be recognized as compensation expense over the nonemployee’s service (vesting) period in the same period(s) and in the same manner as if the Company had paid cash for the goods or services instead of paying with or using share-based payment awards. On an award-by-award basis, the Company may elect to use the contractual term as the expected term when estimating the fair value of a nonemployee award to satisfy the measurement objective. Prior guidance under Subtopic 505-50 required the fair value of nonemployee stock options to be marked to market at each reporting period during the service period, which resulted in volatility of compensation expense during that period. ASU 2018-07 is effective for fiscal years beginning after December 15, 2018, including interim periods within that fiscal year. Early adoption is permitted, but no earlier than an entity’s adoption date of Topic 606. The Company will adopt ASU 2018-07 on January 1, 2019 on a modified retrospective basis through a cumulative-effect adjustment to equity by remeasuring, on that date, the fair value of all outstanding unvested stock options that had been granted to nonemployees. The Company expects that the adoption of ASU 2018-07 will not have a material effect on its results of operations, financial position or cash flows because grants of stock options to non-employees have been insignificant.  

 

In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842), or ASU 2016-02, which amends the current guidance for the accounting and disclosure of leases (ASC 840) for both lessees and lessors. The Company is currently identifying its contracts that contain leases. The primary effect of adoption will be the requirement to record right-of-use assets and corresponding lease obligations for those current operating leases. ASU 2016-02 is effective for interim and annual periods beginning after December 31, 2018 but may be adopted earlier. ASU 2016-02 requires modified retrospective adoption. However, the FASB issued ASU 2018-11, Leases (Topic 842): Targeted Improvements, or ASU 2018-11, which allows entities to elect to continue to apply the guidance in ASC 840, including its disclosure requirements, in the comparative periods presented in the year that they adopt the new leases guidance in ASC 842. Entities that elect this option would record the cumulative effect of adoption on the effective date rather than at the beginning of the earliest comparative period presented. The Company does not expect that ASU 2016-02 or ASU 2018-11 will have a material impact on its Condensed Statements of Comprehensive Loss or its Condensed Statements of Cash Flows, but it does expect that upon adoption, it will have a material impact on the assets and liabilities on the Condensed Balance Sheets.    

8


CARA THERAPEUTICS, INC.

 

NOTES TO CONDENSED FINANCIAL STATEMENTS

(amounts in thousands, except share and per share data)

(unaudited)

 

 

3. Available-for-Sale Marketable Securities

As of June 30, 2018 and December 31, 2017, the Company’s available-for-sale marketable securities consisted of money market funds and debt securities issued by the U.S. Treasury, U.S. government-sponsored entities and by investment grade institutions.

The following tables summarize the Company's available-for-sale marketable securities by major type of security as of June 30, 2018 and December 31, 2017:

As of June 30, 2018

 

 

 

 

 

 

 

Gross Unrealized

 

 

 

 

 

Type of Security

 

Amortized

Cost

 

 

Gains

 

 

Losses

 

 

Estimated

Fair Value

 

Money market funds

 

$

68,195

 

 

$

 

 

$

(57

)

 

$

68,138

 

U.S. Treasury securities

 

 

1,495

 

 

 

 

 

 

 

 

 

1,495

 

U.S. government agency obligations

 

 

1,096

 

 

 

 

 

 

 

 

 

1,096

 

Corporate bonds

 

 

6,735

 

 

 

 

 

 

(1

)

 

 

6,734

 

Commercial paper

 

 

36,695

 

 

 

3

 

 

 

(2

)

 

 

36,696

 

Total available-for-sale marketable securities

 

$

114,216

 

 

$

3

 

 

$

(60

)

 

$

114,159

 

 

As of December 31, 2017

 

 

 

 

 

 

 

Gross Unrealized

 

 

 

 

 

Type of Security

 

Amortized

Cost

 

 

Gains

 

 

Losses

 

 

Estimated

Fair Value

 

Money market funds

 

$

39,988

 

 

$

 

 

$

(37

)

 

$

39,951

 

U.S. government agency obligations

 

 

7,799

 

 

 

 

 

 

(5

)

 

 

7,794

 

Corporate bonds

 

 

15,919

 

 

 

 

 

 

(12

)

 

 

15,907

 

Commercial paper

 

 

19,545

 

 

 

 

 

 

(16

)

 

 

19,529

 

Total available-for-sale marketable securities

 

$

83,251

 

 

$

 

 

$

(70

)

 

$

83,181

 

 

All available-for-sale marketable securities are classified in the Company’s Condensed Balance Sheets as Marketable securities.

The Company classifies its marketable debt securities based on their contractual maturity dates. As of June 30, 2018, the Company’s marketable debt securities mature at various dates through January 2019. The amortized cost and fair values of marketable debt securities by contractual maturity were as follows. The table does not include money market funds that are classified as available-for-sale marketable securities.

 

 

 

As of June 30, 2018

 

 

As of December 31, 2017

 

Contractual maturity

 

Amortized

Cost

 

 

Fair

Value

 

 

Amortized

Cost

 

 

Fair

Value

 

Less than one year

 

$

46,021

 

 

$

46,021

 

 

$

43,263

 

 

$

43,230

 

 

During the six months ended June 30, 2018, the Company sold shares of a money market fund, that is classified as an available-for-sale marketable security, with a total fair value of $11,150. The cost of the money market fund shares that were sold was determined by specific identification. The sales of the shares of the money market fund resulted in a realized loss of $15.

9


CARA THERAPEUTICS, INC.

 

NOTES TO CONDENSED FINANCIAL STATEMENTS

(amounts in thousands, except share and per share data)

(unaudited)

 

The following tables show the fair value of the Company's available-for-sale marketable securities that have unrealized losses and that are deemed to be only temporarily impaired, aggregated by investment category and length of time that the individual investments have been in a continuous unrealized loss position.

As of June 30, 2018

 

 

 

Less than 12 Months

 

 

12 Months or Greater

 

 

Total

 

 

 

Fair

Value

 

 

Gross

Unrealized

Losses

 

 

Fair

Value

 

 

Gross

Unrealized

Losses

 

 

Fair

Value

 

 

Gross

Unrealized

Losses

 

Money market funds

 

$

68,138

 

 

$

(57

)

 

$

 

 

$

 

 

$

68,138

 

 

$

(57

)

Corporate bonds

 

 

5,334

 

 

 

(1

)

 

 

 

 

 

 

 

 

5,334

 

 

 

(1

)

Commercial paper

 

 

12,672

 

 

 

(2

)

 

 

 

 

 

 

 

 

12,672

 

 

 

(2

)

Total

 

$

86,143

 

 

$

(60

)

 

$

 

 

$

 

 

$

86,143

 

 

$

(60

)

 

As of December 31, 2017

 

 

 

Less than 12 Months

 

 

12 Months or Greater

 

 

Total

 

 

 

Fair

Value

 

 

Gross

Unrealized

Losses

 

 

Fair

Value

 

 

Gross

Unrealized

Losses

 

 

Fair

Value

 

 

Gross

Unrealized

Losses

 

Money market funds

 

$

39,951

 

 

$

(37

)

 

$

 

 

$

 

 

$

39,951

 

 

$

(37

)

U.S. government agency obligations

 

 

7,794

 

 

 

(5

)

 

 

 

 

 

 

 

 

7,794

 

 

 

(5

)

Corporate bonds

 

 

15,907

 

 

 

(12

)

 

 

 

 

 

 

 

 

15,907

 

 

 

(12

)

Commercial paper

 

 

19,031

 

 

 

(16

)

 

 

 

 

 

 

 

 

19,031

 

 

 

(16

)

Total

 

$

82,683

 

 

$

(70

)

 

$

 

 

$

 

 

$

82,683

 

 

$

(70

)

 

As of June 30, 2018 and December 31, 2017, the Company held a total of 11 out of 26 positions and 30 out of 31 positions, respectively, that were in an unrealized loss position, none of which had been in an unrealized loss position for 12 months or greater. Based on the Company’s review of these securities, the Company believes that the cost basis of its available-for-sale marketable securities is recoverable and that, therefore, it had no other-than-temporary impairments on these securities as of June 30, 2018 and December 31, 2017. The Company does not intend to sell these debt securities before maturity and the Company believes it is not more likely than not that it will be required to sell these securities before the recovery of their amortized cost basis, which may be maturity.  

10


CARA THERAPEUTICS, INC.

 

NOTES TO CONDENSED FINANCIAL STATEMENTS

(amounts in thousands, except share and per share data)

(unaudited)

 

4. Accumulated Other Comprehensive Income (Loss)

The following table summarizes the changes in accumulated other comprehensive income (loss), or AOCI, net of tax, from unrealized gains (losses) on available-for-sale marketable securities, the Company's only component of AOCI, for the six months ended June 30, 2018 and June 30, 2017.

 

 

 

Total

Accumulated

Other

Comprehensive

Income (Loss)

 

Balance, December 31, 2017

 

$

(70

)

Other comprehensive loss before reclassifications

 

 

(2

)

Amount reclassified from accumulated

   other comprehensive loss

 

 

15

 

Net current period other comprehensive income

 

 

13

 

Balance, June 30, 2018

 

$

(57

)

 

 

 

 

 

Balance, December 31, 2016

 

$

3

 

Other comprehensive loss before reclassifications

 

 

(13

)

Amount reclassified from accumulated other

   comprehensive loss

 

 

(3

)

Net current period other comprehensive loss

 

 

(16

)

Balance, June 30, 2017

 

$

(13

)

 

The reclassifications out of AOCI and into net loss were as follows:

 

 

 

Three Months Ended

June 30,

 

 

Six Months Ended

June 30,

 

 

Affected Line

Item in the

Statements of

Component of AOCI

 

2018

 

 

2017

 

 

2018

 

 

2017

 

 

Operations

Unrealized gains (losses) on

   available-for-sale marketable

   securities

 

$

 

 

$

 

 

$

(15

)

 

$

3

 

 

Other income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Benefit from income taxes

 

 

$

 

 

$

 

 

$

(15

)

 

$

3

 

 

 

 

The amounts reclassified out of AOCI into net loss were determined by specific identification.

5. Fair Value Measurements

As of June 30, 2018 and December 31, 2017, the Company’s financial instruments consisted of cash and cash equivalents, available-for-sale marketable securities, restricted cash, accounts payable and accrued liabilities. The fair values of cash and cash equivalents, restricted cash, accounts payable and accrued liabilities approximate their carrying values due to the short-term nature of these financial instruments. Available-for-sale marketable securities are reported on the Company’s Condensed Balance Sheets as Marketable Securities at their fair values, based upon pricing of securities with the same or similar investment characteristics as provided by third-party pricing services, as described below.

11


CARA THERAPEUTICS, INC.

 

NOTES TO CONDENSED FINANCIAL STATEMENTS

(amounts in thousands, except share and per share data)

(unaudited)

 

Current accounting guidance defines fair value, establishes a framework for measuring fair value in accordance with ASC section 820, and requires certain disclosures about fair value measurements. The valuation techniques included in the guidance are based on observable and unobservable inputs. Observable inputs reflect readily obtainable data from independent sources, while unobservable inputs reflect the Company’s assumptions about the inputs that market participants would use in pricing the asset or liability and are developed based on the best information available in the circumstances.

The Company classifies its investments in a fair value hierarchy that is intended to increase consistency and comparability in fair value measurements and related disclosures. The fair value hierarchy is divided into three levels based on the source of inputs as follows:

 

Level 1 – Observable inputs – quoted prices in active markets for identical assets and liabilities.

 

Level 2 – Observable inputs other than the quoted prices in active markets for identical assets and liabilities – such as quoted prices for similar instruments, quoted prices for identical or similar instruments in inactive markets, or other inputs that are observable or can be corroborated by observable market data.

 

Level 3 – Unobservable inputs – includes amounts derived from valuation models where one or more significant inputs are unobservable and require the Company to develop relevant assumptions.

Valuation Techniques - Level 2 Inputs

The Company estimates the fair values of its financial instruments categorized as level 2 in the fair value hierarchy, including U.S. Treasury securities, U.S. government agency obligations, corporate bonds, commercial paper and money market funds with similar underlying investments, by taking into consideration valuations obtained from third-party pricing services. The pricing services use industry standard valuation models, including both income- and market-based approaches, for which all significant inputs are observable, either directly or indirectly, to estimate fair value. These inputs include reported trades of and broker/dealer quotes on the same or similar securities, benchmark yields, issuer credit spreads, benchmark securities, and other observable inputs. The Company obtains a single price for each financial instrument and does not adjust the prices obtained from the pricing service.

The Company validates the prices provided by its third-party pricing services by reviewing their pricing methods, obtaining market values from other pricing sources and comparing them to the share prices presented by the third-party pricing services. After completing its validation procedures, the Company did not adjust or override any fair value measurements provided by its third-party pricing services as of June 30, 2018 or December 31, 2017.

The following tables summarize the Company’s financial assets measured at fair value on a recurring basis as of June 30, 2018 and December 31, 2017.

Fair value measurement as of June 30, 2018:

 

Financial assets

 

 

 

 

 

Quoted prices in

 

 

Significant other

 

 

Significant

 

 

 

 

 

 

 

active markets for

 

 

observable

 

 

unobservable

 

 

 

 

 

 

 

identical assets

 

 

inputs

 

 

inputs

 

Type of Instrument

 

Total

 

 

(Level 1)

 

 

(Level 2)

 

 

(Level 3)

 

Cash and cash equivalents:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Money market fund and checking accounts

 

$

17,802

 

 

$

17,802

 

 

$

 

 

$

 

Available-for-sale marketable securities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

 

68,138

 

 

 

 

 

 

68,138

 

 

 

 

U.S. Treasury securities

 

 

1,495

 

 

 

 

 

 

1,495

 

 

 

 

U.S. government agency obligations

 

 

1,096

 

 

 

 

 

 

1,096

 

 

 

 

Corporate bonds

 

 

6,734

 

 

 

 

 

 

6,734

 

 

 

 

Commercial paper

 

 

36,696