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EX-32.2 - EX-32.2 - TREVENA INCtrvn-20180331ex32245ecf6.htm
EX-32.1 - EX-32.1 - TREVENA INCtrvn-20180331ex321e3b40b.htm
EX-31.2 - EX-31.2 - TREVENA INCtrvn-20180331ex312af5906.htm
EX-31.1 - EX-31.1 - TREVENA INCtrvn-20180331ex31153b940.htm
EX-10.2 - EX-10.2 - TREVENA INCtrvn-20180331ex1021af6a7.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, 2018

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 001-36193

 

Trevena, Inc.

 

(Exact Name of Registrant as Specified in Its Charter)

 

 

 

Delaware
(State or Other Jurisdiction of
Incorporation or Organization)

26-1469215
(I.R.S. Employer
Identification No.)

 

 

955 Chesterbrook Boulevard, Suite 200
Chesterbrook, PA
(Address of Principal Executive Offices)

19087
(Zip Code)

 

Registrant’s telephone number, including area code: (610) 354-8840

 

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

 

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

 

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

(Do not check if a smaller reporting company)

 

 

 

Emerging growth company 

 

 

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

 

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practical date.

 

 

 

Common Stock, $0.001 par value

Shares outstanding as of April 27, 2018: 67,968,713

 

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. 

 

 

 

 


 

TABLE OF CONTENTS

 

 

 

 

 

Page

Cautionary Note Regarding Forward-Looking Statements 

ii

 

 

 

 

PART I- FINANCIAL INFORMATION

 

Item 1. 

Financial Statements (Unaudited)

1

 

Balance Sheets

1

 

Statements of Operations and Comprehensive Loss

2

 

Statement of Stockholders’ Equity

3

 

Statements of Cash Flows

4

 

Notes to Unaudited Financial Statements

5

Item 2. 

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

13

Item 3. 

Quantitative and Qualitative Disclosures About Market Risk

20

Item 4. 

Controls and Procedures

21

 

PART II- OTHER INFORMATION

 

Item 1. 

Legal Proceedings

22

Item 1A. 

Risk Factors

22

Item 2. 

Unregistered Sales of Equity Securities and Use of Proceeds

22

Item 3. 

Defaults Upon Senior Securities

22

Item 4. 

Mine Safety Disclosures

22

Item 5. 

Other Information

22

Item 6. 

Exhibits

23

 

 

 

SIGNATURES 

25

 

 

 

i


 

Cautionary Note Regarding Forward-Looking Statements

 

This Quarterly Report on Form 10‑Q (this “Quarterly Report”) contains forward-looking statements that involve substantial risks and uncertainties. The forward-looking statements are contained principally in the section entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” but also are contained elsewhere in this Quarterly Report, as well as in sections such as “Risk Factors” that are incorporated by reference into this Quarterly Report from our most recent Annual Report on Form 10‑K (the “Annual Report”). In some cases, you can identify forward-looking statements by the words “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “objective,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue” and “ongoing,” or the negative of these terms, or other comparable terminology intended to identify statements about the future. These statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this Quarterly Report, we caution you that these statements are based on a combination of facts and factors currently known by us and our expectations of the future, about which we cannot be certain. Forward-looking statements include statements about:

 

·

our plans to develop and potentially commercialize our product candidates;

 

·

our ability to fund future operating expenses and capital expenditures with our current cash resources or to secure additional funding in the future;

 

·

our planned preclinical studies and clinical trials for our product candidates;

 

·

the timing and likelihood of obtaining and maintaining regulatory approvals for our product candidates;

 

·

the extent of clinical trials potentially required by the FDA for our product candidates;

 

·

the clinical utility and market acceptance of our product candidates, particularly in light of existing and future competition;

 

·

our sales, marketing, and manufacturing capabilities and strategy;

 

·

our intellectual property position; and

 

·

our ability to identify additional product candidates with significant commercial potential that are consistent with our commercial objectives.

 

You should refer to the “Risk Factors” section of the Annual Report for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. As a result of these factors, we cannot assure you that the forward-looking statements in this Quarterly Report will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

 

 

ii


 

PART I

ITEM 1. FINANCIAL STATEMENTS

TREVENA, INC.

Balance Sheets

(in thousands, except share and per share data)

 

 

 

 

 

 

 

 

    

March 31, 2018

    

December 31, 2017

 

 

 

(unaudited)

 

 

 

Assets

 

 

  

 

 

  

Current assets:

 

 

  

 

 

  

Cash and cash equivalents

 

$

18,146

 

$

16,557

Marketable securities

 

 

43,445

 

 

49,543

Prepaid expenses and other current assets

 

 

1,847

 

 

1,393

Total current assets

 

 

63,438

 

 

67,493

Restricted cash

 

 

1,413

 

 

1,413

Property and equipment, net

 

 

3,779

 

 

3,805

Intangible asset, net

 

 

11

 

 

11

Total assets

 

$

68,641

 

$

72,722

Liabilities and stockholders’ equity

 

 

  

 

 

  

Current liabilities:

 

 

  

 

 

  

Accounts payable

 

$

1,387

 

$

1,424

Accrued expenses and other current liabilities

 

 

1,519

 

 

4,303

Current portion of loans payable, net

 

 

12,460

 

 

12,425

Deferred rent

 

 

63

 

 

61

Total current liabilities

 

 

15,429

 

 

18,213

Loans payable, net

 

 

12,595

 

 

15,725

Capital leases, net of current portion

 

 

28

 

 

31

Deferred rent, net of current portion

 

 

2,992

 

 

3,006

Warrant liability

 

 

10

 

 

10

Other long term liabilities

 

 

1,270

 

 

1,104

Total liabilities

 

 

32,324

 

 

38,089

Commitments and contingencies (Note 6)

 

 

  

 

 

  

Stockholders’ equity:

 

 

  

 

 

  

Common stock—$0.001 par value; 100,000,000 shares authorized, 67,603,736 and 62,310,795 shares issued and outstanding at March 31, 2018 and December 31, 2017, respectively

 

 

68

 

 

62

Preferred stock—$0.001 par value; 5,000,000 shares authorized, none issued or outstanding at March 31, 2018 and December 31, 2017

 

 

 —

 

 

 —

Additional paid-in capital

 

 

402,806

 

 

392,103

Accumulated deficit

 

 

(366,511)

 

 

(357,490)

Accumulated other comprehensive loss

 

 

(46)

 

 

(42)

Total stockholders’ equity

 

 

36,317

 

 

34,633

Total liabilities and stockholders’ equity

 

$

68,641

 

$

72,722

 

See accompanying notes to financial statements.

1


 

TREVENA, INC.

Statements of Operations and Comprehensive Loss (Unaudited)

(in thousands, except share and per share data)

 

 

 

 

 

 

 

 

 

Three Months Ended

 

 

March 31, 

 

    

2018

    

2017

Revenue:

 

 

  

 

 

  

Revenue

 

$

 —

 

$

 —

Operating expenses:

 

 

  

 

 

  

General and administrative

 

 

5,072

 

 

4,879

Research and development

 

 

4,598

 

 

16,096

Restructuring charges

 

 

23

 

 

 —

Total operating expenses

 

 

9,693

 

 

20,975

Loss from operations

 

 

(9,693)

 

 

(20,975)

Other income (expense):

 

 

  

 

 

  

Change in fair value of warrant liability

 

 

 —

 

 

35

Net gain on asset disposals

 

 

223

 

 

 —

Miscellaneous income

 

 

928

 

 

628

Interest income

 

 

199

 

 

174

Interest expense

 

 

(678)

 

 

(576)

Total other income

 

 

672

 

 

261

Net loss attributable to common stockholders

 

$

(9,021)

 

$

(20,714)

Other comprehensive loss, net:

 

 

  

 

 

  

Unrealized loss on marketable securities

 

 

(4)

 

 

(51)

Other comprehensive loss

 

 

(4)

 

 

(51)

Comprehensive loss

 

$

(9,025)

 

$

(20,765)

Per share information:

 

 

  

 

 

  

Net loss per share of common stock, basic and diluted

 

$

(0.14)

 

$

(0.36)

Weighted average common shares outstanding, basic and diluted

 

 

64,562,236

 

 

56,894,672

 

See accompanying notes to financial statements.

2


 

TREVENA, INC.

Statement of Stockholders’ Equity (Unaudited)

For the period from January 1, 2018 to March 31, 2018

(in thousands, except share data)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stockholders' Equity

 

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

Common Stock

 

 

 

 

 

 

 

Other

 

 

 

 

 

Number

 

0.001

 

Additional

 

 

 

 

Comprehensive

 

Total

 

 

of

 

Par

 

Paid-in

 

Accumulated

 

Income

 

Stockholders'

 

    

Shares

    

Value

    

Capital

    

Deficit

    

(Loss)

    

Equity

Balance, January 1, 2018

 

62,310,795

 

$

62

 

$

392,103

 

$

(357,490)

 

$

(42)

 

$

34,633

Stock-based compensation expense

 

 —

 

 

 —

 

 

1,498

 

 

 —

 

 

 —

 

 

1,498

Exercise of stock options

 

88,048

 

 

 —

 

 

57

 

 

 —

 

 

 —

 

 

57

Issuance of common stock, net of issuance costs

 

5,204,893

 

 

 6

 

 

9,148

 

 

 —

 

 

 —

 

 

9,154

Unrealized loss on marketable securities

 

 —

 

 

 —

 

 

 —

 

 

 —

 

 

(4)

 

 

(4)

Net loss

 

 —

 

 

 —

 

 

 —

 

 

(9,021)

 

 

 —

 

 

(9,021)

Balance, March 31, 2018

 

67,603,736

 

$

68

 

$

402,806

 

$

(366,511)

 

$

(46)

 

$

36,317

 

See accompanying notes to financial statements.

3


 

TREVENA, INC.

Statements of Cash Flows (Unaudited)

(in thousands)

 

 

 

 

 

 

 

 

 

Three Months Ended

 

 

March 31, 

 

    

2018

    

2017

Operating activities:

 

 

 

 

 

 

Net loss

 

$

(9,021)

 

$

(20,714)

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

 

 

  

 

 

  

Depreciation and amortization

 

 

171

 

 

79

Stock-based compensation

 

 

1,498

 

 

1,795

Noncash interest expense on loans

 

 

237

 

 

274

Revaluation of warrant liability

 

 

 —

 

 

(35)

Amortization (accretion) of bond premium (discount) on marketable securities

 

 

(5)

 

 

182

Changes in operating assets and liabilities:

 

 

 

 

 

  

Prepaid expenses and other assets

 

 

(454)

 

 

(1,142)

Accounts payable, accrued expenses and other liabilities

 

 

(2,832)

 

 

(9,891)

Net cash used in operating activities

 

 

(10,406)

 

 

(29,452)

Investing activities:

 

 

  

 

 

  

Purchases of property and equipment

 

 

(144)

 

 

(116)

Maturities of marketable securities

 

 

16,500

 

 

21,958

Purchases of marketable securities

 

 

(10,402)

 

 

(15,108)

Net cash provided by investing activities

 

 

5,954

 

 

6,734

Financing activities:

 

 

  

 

 

  

Proceeds from exercise of common stock options

 

 

57

 

 

355

Proceeds from issuance of common stock, net

 

 

9,154

 

 

6,833

Capital lease payments

 

 

(3)

 

 

(2)

Proceeds from loans payable, net

 

 

 —

 

 

9,921

Repayments of loans payable, net

 

 

(3,167)

 

 

 —

Net cash provided by financing activities

 

 

6,041

 

 

17,107

Net increase (decrease) in cash and cash equivalents

 

 

1,589

 

 

(5,611)

Cash, cash equivalents and restricted cash—beginning of period

 

 

17,970

 

 

25,459

Cash, cash equivalents and restricted cash—end of period

 

$

19,559

 

$

19,848

Supplemental disclosure of cash flow information:

 

 

  

 

 

  

Cash paid for interest

 

$

464

 

$

304

Fair value of common stock warrants issued

 

$

 —

 

$

184

 

See accompanying notes to financial statements.

4


 

TREVENA, INC.

Notes to Unaudited Financial Statements

March 31, 2018

1. Organization and Description of the Business

Trevena, Inc., or the Company, was incorporated in Delaware as Parallax Therapeutics, Inc. on November 9, 2007. The Company began operations in December 2007, and its name was changed to Trevena, Inc. on January 3, 2008. The Company is a biopharmaceutical company developing innovative therapies based on breakthrough science to benefit patients and healthcare providers confronting serious medical conditions. The Company operates in one segment and has its principal office in Chesterbrook, Pennsylvania.

Since commencing operations in 2007, the Company has devoted substantially all of its financial resources and efforts to research and development, including preclinical studies and clinical trials. The Company has never been profitable and has not yet commenced commercial operations. In January 2018, the United States Food and Drug Administration, or FDA, accepted the new drug application, or NDA, submission for oliceridine, the Company's lead product candidate. The FDA also indicated that the Prescription Drug User Fee Act, or PDUFA, review date for the oliceridine NDA is November 2, 2018 and that it plans to hold an advisory committee meeting to discuss the NDA. If oliceridine ultimately receives regulatory approval, the Company plans to commercialize it in the United States, either on its own or with a commercial partner, for use in acute care settings such as hospitals and ambulatory surgery centers; outside the United States, the Company plans to commercialize oliceridine in certain countries with commercial partners.

Since the Company’s inception, the Company has incurred losses and negative cash flows from operations. At March 31, 2018, the Company had an accumulated deficit of $366.5 million. The Company’s net loss was $9.0 million and $20.7 million for the three months ended March 31, 2018 and 2017, respectively. The Company expects its cash and cash equivalents of $18.1 million and marketable securities of $43.4 million as of March 31, 2018, together with interest thereon, as well as proceeds from the sale of shares of common stock under the Company’s at the market, or ATM, sales agreement with Cowen and Company, LLC, or Cowen, and from ex-U.S. licensing activities between March 31, 2018 and the date of this filing, to be sufficient to fund its operating expenses and capital expenditure requirements for at least twelve months following the date of this filing.

 

2. Summary of Significant Accounting Policies

Basis of Presentation

The accompanying financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America, or GAAP. Any reference in these notes to applicable guidance is meant to refer to the authoritative United States generally accepted accounting principles as found in the Accounting Standards Codification, or ASC, and Accounting Standards Update, or ASU, of the Financial Accounting Standards Board, or FASB. The Company’s functional currency is the U.S. dollar.

The financial statements include all normal and recurring adjustments that are considered necessary for the fair presentation of the Company’s balance sheet as of March 31, 2018, its results of operations and its comprehensive loss for the three months ended March 31, 2018 and 2017, its statement of stockholders’ equity for the period from January 1, 2018 to March 31, 2018, and its cash flows for the three months ended March 31, 2018 and 2017. The information included in this Quarterly Report on Form 10‑Q should be read in conjunction with the financial statements and accompanying notes included in the Company’s most recent Annual Report on Form 10‑K for the year ended December 31, 2017. Since the date of those financial statements, there have been no changes to the Company’s significant accounting policies. The financial data and other information disclosed in these notes related to the three ended March 31, 2018 and 2017 are not necessarily indicative of the results to be expected for the year ending December 31, 2018, any other interim periods, or any future year or period.

5


 

Recently Adopted Accounting Standards

In December 2017, the SEC staff issued Staff Accounting Bulletin No. 118, or SAB 118, which provides guidance on accounting for the tax effects of the Tax Act of 2017, of the Tax Act. SAB 118 was issued to address the application of U.S. GAAP in situations when a registrant does not have the necessary information available, prepared, or analyzed (including computations) in reasonable detail to complete the accounting for certain income tax effects of the Act and allows the Company to record provisional amounts during a measurement period not to extend beyond one year of the Tax Act enactment date. The Company was able to reasonably estimate certain effects of the Tax Act as of December 31, 2017 and has not changed the preliminary estimates as of March 31, 2018.

 

In May 2017, the FASB issued ASU No. 2017-09, Stock Compensation - Scope of Modification Accounting, which amends the scope of modification accounting for share-based payment arrangements. The amendment provides guidance about which changes to the terms or conditions of a share-based payment award require an entity to apply modification accounting.  The new standard is effective for fiscal years beginning after December 15, 2017. The adoption of this standard did not have an impact on the Company’s consolidated financial statements.

 

In August 2016, the FASB issued ASU 2016-15, Statement of Cash Flows (Topic 230), to clarify how certain cash receipts and payments should be presented in the statement of cash flows. The standard is effective for annual periods beginning after December 15, 2017 and interim periods within that reporting period. The adoption of this standard did not have an impact on the Company’s consolidated financial statements.

 

In May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers. ASU 2014-09 is a comprehensive new revenue recognition model requiring a company to recognize revenue to depict the transfer of goods or services to a customer in an amount reflecting the consideration it expects to receive in exchange for those goods or services. Additionally, in March 2016, the FASB issued ASU 2016-08, Revenue from Contracts with Customers, Principal versus Agent Considerations. ASU 2016-08 amends the principal versus agent guidance in ASU 2014-09 to clarify how an entity should identify the unit of accounting for the principal versus agent evaluation and how it should apply the control principal to certain types of arrangements. The effective date for both standards is January 1, 2018. The Company adopted these standards on January 1, 2018 and elected the modified retrospective transition method, meaning the cumulative effect of applying the new guidance, if any, was recognized at that date as an adjustment to the opening accumulated deficit balance. Since the Company does not have any open contracts with customers as of January 1, 2018 and did not enter into any new contracts with customers during the three months ended March 31, 2018, the adoption of this standard did not have an impact on the Company's financial statements.

 

Recent Accounting Standards Not Yet Adopted

In February 2018, the FASB issued ASU 2018-02, Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income, which provides the option to reclassify stranded tax effects within accumulated other comprehensive income to retained earnings.  This option would be available in each period in which the effect of the change in the U.S. federal corporate income tax rate in the Tax Cuts and Jobs Act (or a portion thereof) is recorded.  This is effective for the Company beginning after December 15, 2018, with early adoption permitted.  These amendments should be applied in the period of adoption or retrospectively to each period in which the effect of the change in the U.S federal corporate income tax rate in the Tax Cuts and Jobs Act is recognized. The Company is evaluating the effect this standard will have on its financial statements and related disclosures.

 

In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842), which requires lessees to record most leases on their balance sheets and disclose key information about leasing arrangements in an effort to increase transparency and comparability among organizations. The standard is effective for annual periods beginning after December 15, 2018 and interim periods within that reporting period. Early adoption is permitted. The Company is evaluating the effect this standard will have on its financial statements and related disclosures.

 

3. Fair Value of Financial Instruments

ASC Topic 820, Fair Value Measurement, establishes a fair value hierarchy for instruments measured at fair value that distinguishes between assumptions based on market data (observable inputs) and the Company’s own assumptions (unobservable inputs). Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from sources independent of the Company. Unobservable inputs are inputs

6


 

that 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.

ASC 820 identifies fair value as the exchange price, or exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As a basis for considering market participant assumptions in fair value measurements, ASC 820 establishes a three-tier fair value hierarchy that distinguishes among the following:

·

Level 1‑Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access.

·

Level 2‑Valuations based on quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active and models for which all significant inputs are observable, either directly or indirectly.

·

Level 3‑Valuations based on inputs that are unobservable and significant to the overall fair value measurement.

To the extent that the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement.

Cash, Cash Equivalents and Marketable Securities

The following table presents fair value of the Company’s cash, cash equivalents, and marketable securities as of March 31, 2018 and December 31, 2017 (in thousands):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

March 31, 2018

 

    

Adjusted 

    

Unrealized

    

Unrealized

    

 

 

    

Cash and Cash

    

Restricted

    

Marketable

 

 

Cost

 

Gains

 

Loss

 

Fair Value

 

Equivalents

 

Cash

 

Securities

Cash

 

$

7,052

 

$

 —

 

$

 —

 

$

7,052

 

$

5,639

 

$

1,413

 

$

 —

Level 1 (1):

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

Money market funds

 

 

12,507

 

 

 —

 

 

 —

 

 

12,507

 

 

12,507

 

 

 —

 

 

 —

U.S. treasury securities

 

 

1,994

 

 

 —

 

 

(2)

 

 

1,992

 

 

 —

 

 

 —

 

 

1,992

Subtotal

 

 

14,501

 

 

 —

 

 

(2)

 

 

14,499

 

 

12,507

 

 

 —

 

 

1,992

Level 2 (2):

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

U.S. government agency securities

 

 

41,497

 

 

 —

 

 

(44)

 

 

41,453

 

 

 —

 

 

 —

 

 

41,453

Total

 

$

63,050

 

$

 —

 

$

(46)

 

$

63,004

 

$

18,146

 

$

1,413

 

$

43,445

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

December 31, 2017

 

 

Adjusted 

 

Unrealized

 

Unrealized

 

 

 

 

Cash and Cash

 

Restricted

 

Marketable

 

    

Cost

    

Gains

    

Losses

    

Fair Value

    

Equivalents

    

Cash

    

Securities

Cash

 

$

6,783

 

$

 —

 

$

 —

 

$

6,783

 

$

5,370

 

$

1,413

 

$

 —

Level 1 (1):

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

Money market funds

 

 

11,187

 

 

 —

 

 

 —

 

 

11,187

 

 

11,187

 

 

 —

 

 

 —

U.S. treasury securities

 

 

1,991

 

 

 —

 

 

 —

 

 

1,991

 

 

 —

 

 

 —

 

 

1,991

Subtotal

 

 

13,178

 

 

 —

 

 

 —

 

 

13,178

 

 

11,187

 

 

 —

 

 

1,991

Level 2 (2):

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

U.S. government agency securities

 

 

47,594

 

 

 —

 

 

(42)

 

 

47,552

 

 

 —

 

 

 —

 

 

47,552

Total

 

$

67,555

 

$

 —

 

$

(42)

 

$

67,513

 

$

16,557

 

$

1,413

 

$

49,543


(1)

The fair value of Level 1 securities is estimated based on quoted prices in active markets for identical assets or liabilities.

7


 

(2)

The fair value of Level 2 securities is estimated based on observable inputs other than quoted prices in active markets for identical assets and liabilities, quoted prices for identical or similar assets or liabilities in inactive markets, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.

The Company classifies investments available to fund current operations as current assets on its balance sheets. As of March 31, 2018, the Company did not hold any investment securities exceeding a one-year maturity.

Unrealized gains and losses on marketable securities are recorded as a separate component of accumulated other comprehensive income (loss) included in stockholders’ equity. Realized gains (losses) are included in interest income (expense) in the statement of operations and comprehensive income (loss) on a specific identification basis. The Company did not record any realized gains or losses during the three months ended March 31, 2018 and 2017. To date, the Company has not recorded any impairment charges on marketable securities related to other-than-temporary declines in market value.

The Company recognizes transfers between levels of the fair value hierarchy as of the end of the reporting period. There were no transfers between Level 2 and Level 3 during the three months ended March 31, 2018 or the year ended December 31, 2017.

4. Loans Payable

In September 2014, the Company entered into a loan and security agreement with Oxford Finance LLC and Pacific Western Bank (formerly Square 1Bank) (together, the lenders), pursuant to which the lenders agreed to lend the Company up to $35.0 million in a three-tranche series of term loans (Term Loans A, B, and C). Upon initially entering into the agreement, the Company borrowed $2.0 million under Term Loan A. In April 2015, the Company amended the agreement with the lenders to change the draw period for Term Loan B. In December 2015, the Company further amended the agreement with the lenders to, among other things, change the draw period for Term Loan C, modify the interest only period, and modify the maturity date of the loan. In December 2015, the Company borrowed the Term Loan B tranche of $16.5 million. The Company’s ability to draw an additional $16.5 million under Term Loan C was subject to the satisfaction of one or more specified triggers related to the results of the Company’s Phase 2b clinical trial of TRV027, which were announced in May 2016. Although those triggers were not attained, in December 2016, the Company and the lenders modified the terms and conditions under which the Company could exercise an option to draw $10.0 million of Term Loan C. In March 2017, the Company borrowed the Term Loan C tranche of $10.0 million.

Borrowings under Term Loans A and B accrue interest at a fixed rate of 6.50% per annum. Borrowings under Term Loan C accrue interest at a fixed rate of 6.98% per annum. The Company was required to make payments of interest only on borrowings under the loan agreement on a monthly basis through and including January 1, 2018. Payments of principal in equal monthly installments and accrued interest began January 1, 2018 and will continue to be due until the loan matures on March 1, 2020. Upon the last payment date of the amounts borrowed under the agreement, the Company will be required to pay a final payment fee equal to 6.6% of the aggregate amounts borrowed, which is recorded as interest expense over the term of the loans payable. In addition, if the Company repays Term Loan A, Term Loan B, or Term Loan C prior to the applicable maturity date, it will pay the lenders a prepayment fee of 1.0% of each of Term Loans A and B, and 2.0% of Term Loan C, if the prepayment occurs on or between April 1, 2018 and March 31, 2019, and 1.0% of Term Loan C, if the prepayment occurs on or after April 1, 2019.

The Company’s obligations under the loan and security agreement are secured by a first priority security interest in substantially all of the assets of the Company, including the Company’s cash, cash equivalents, and marketable securities but excluding the Company’s intellectual property (together, the collateral). The Company has agreed not to pledge or otherwise encumber its intellectual property, other than through grants of certain permitted non-exclusive or exclusive licenses or other conveyances of its intellectual property.

The loan and security agreement includes affirmative and restrictive covenants, including: (a) financial reporting requirements; (b) limitations on the incurrence of indebtedness; (c) limitations on liens; (d) limitations on certain merger and acquisition transactions; (e) limitations on dispositions of certain assets; (f) limitations on fundamental corporate changes (including changes in control); (g) limitations on investments; (h) limitations on payments and distributions and (i) other covenants. The agreement also contains certain events of default, including for payment defaults, breaches of covenants, a material adverse change in the Company’s business, operations or condition

8


 

(financial or otherwise), a material impairment in the value of the collateral or in the prospect of repayment of the Company’s obligations to the lender, certain levies, attachments and other restraints on the Company’s business, insolvency, defaults under other agreements and misrepresentations. Upon an event of default, the lenders have the right to foreclose upon the available collateral, including the Company’s existing cash and cash equivalents and marketable securities.

In connection with entering into the agreement, the Company issued to the lenders and the placement agent warrants to purchase an aggregate of 7,678 shares of Trevena’s common stock, of which 5,728 shares remain outstanding as of March 31, 2018. These detachable warrant instruments have qualified for equity classification and have been allocated upon the relative fair value of the base instrument and the warrants, according to the guidance of ASC 470-20-25-2. These warrants are exercisable immediately and have an exercise price of $5.8610 per share. The warrants may be exercised on a cashless basis and will terminate on the earlier of September 19, 2024 or the closing of a merger or consolidation transaction in which the Company is not the surviving entity. In connection with the draw of Term Loan B, the Company issued to the lenders and the placement agent additional warrants to purchase an aggregate of 34,961 shares of Trevena common stock, all of which remain outstanding at March 31, 2018. These warrants have substantially the same terms as those noted above, have an exercise price of $10.6190 per share and an expiration date of December 23, 2025. In connection with draw of Term Loan C, the Company issued to the lenders and placement agent additional warrants to purchase an aggregate of 62,241 shares of our common stock, all of which remain outstanding at March 31, 2018. These warrants have substantially the same terms as those noted above, and have an exercise price of $3.6150 per share and an expiration date of March 31, 2027.

As of March 31, 2018, borrowings of $25.3 million attributable to Term Loans A, B, and C remain outstanding. Interest expense of $0.4 million and $0.3 million was recorded during the three months ended March 31, 2018 and 2017, respectively. The Company incurred lender and third party costs of $1.0 million related to the issuance of our term loans. Per ASU 2015‑3, Interest-Imputation of Interest, debt discount and debt issuance costs are to be presented as a contra-liability to the debt on the balance sheet. These costs will be amortized to interest expense over the life of the loans using the effective interest method. Immaterial amounts of debt discount and debt issuance cost were amortized to interest expense during the three months ended March 31, 2018 and 2017 respectively.

The following table summarizes how the issuance of Term Loans A, B, and C are reflected on the balance sheet at March 31, 2018 and December 31, 2017 (in thousands):

 

 

 

 

 

 

 

 

 

    

March 31, 

    

December 31, 

 

 

 

2018

 

2017

 

Gross proceeds

 

$

25,333

 

$

28,500

 

Debt discount and debt issuance costs

 

 

(278)

 

 

(350)

 

Carrying value

 

 

25,055

 

 

28,150

 

Current portion of loans payable, net

 

 

12,460

 

 

12,425

 

Loans payable, net

 

$

12,595

 

$

15,725

 

 

 

5. Stockholders’ Equity

Equity Offerings

On December 14, 2015, the Company entered into an at the market, or ATM, sales agreement with Cowen and Company, LLC, or Cowen, to offer and sell, from time to time at its sole discretion, shares of its common stock, par value $0.001 per share, having an aggregate offering price of up to $75.0 million through Cowen as its sales agent. Sales of the shares are deemed to be “at the market offerings”, as defined in Rule 415 under the Securities Act of 1933, as amended. The Company is required to pay Cowen a commission of up to three percent of the gross sales proceeds and has provided Cowen with customary indemnification rights. In the first quarter of 2018, the Company issued and sold 5,204,893 shares of common stock under this ATM facility at a weighted average price per share of $1.81. The net offering proceeds to the Company were approximately $9.2 million after deducting related expenses, including commissions. As of March 31, 2018, approximately $11.2 million of the $75.0 million remained available under the ATM facility.

9


 

Equity Incentive Plans

The Company utilizes equity incentive plans to grant various forms of stock options and restricted stock to eligible employees, directors and consultants to the Company. Under all of such plans, the amount, terms of grants and exercisability provisions are determined by the board of directors or its designee. The term of the options may be up to 10 years, and options are exercisable in cash or as otherwise determined by the board of directors. Vesting generally occurs over a period of not greater than 4 years. For performance-based stock awards, we recognize expense when achievement of the performance factor is probable, over the requisite service period.

The estimated grant-date fair value of the Company’s stock-based awards is amortized ratably over the awards’ service periods. Stock-based compensation expense recognized was as follows (in thousands):

 

 

 

 

 

 

 

 

 

 

Three Months Ended March 31, 

 

 

    

2018

    

2017

    

Research and development

 

$

358

 

$

707

 

General and administrative

 

 

1,140

 

 

1,088

 

Total stock-based compensation

 

$

1,498

 

$

1,795

 

 

 

 

 

 

 

 

 

 

 

 

Options Outstanding

 

    

 

    

 

 

    

Weighted 

 

 

 

 

 

 

 

Average 

 

 

 

 

Weighted 

 

Remaining 

 

 

 

 

Average 

 

Contractual 

 

 

Number of 

 

Exercise 

 

Term 

 

 

Shares

 

Price

 

(in years)

Balance, December 31, 2017

 

8,624,223

 

$

5.22

 

7.2

Granted

 

2,600,625

 

 

1.79

 

 

Exercised

 

(88,048)

 

 

0.65

 

 

Forfeited/Cancelled

 

(739,557)

 

 

5.14

 

 

Balance, March 31, 2018

 

10,397,243

 

$

4.40

 

8.01

Vested or expected to vest at March 31, 2018

 

10,397,243

 

$

4.40

 

8.01

Exercisable at March 31, 2018

 

4,186,575

 

$

5.49

 

6.23

 

The intrinsic value of the options exercisable as of March 31, 2018 was $0.3 million, based on the Company’s closing stock price of $1.64 per share and a weighted average exercise price of $5.49 per share. At March 31, 2018, there was $13.7 million of total unrecognized compensation expense related to unvested options that will be recognized over the weighted average remaining period of 2.38 years.

The Company uses the Black-Scholes option pricing model to estimate the fair value of stock options at the grant date. The Black-Scholes model requires the Company to make certain estimates and assumptions, including estimating the fair value of the Company’s common stock, assumptions related to the expected price volatility of the Company’s stock, the period during which the options will be outstanding, the rate of return on risk-free investments and the expected dividend yield for the Company’s common stock.

10


 

The per-share weighted-average grant date fair value of the options granted to employees and directors during the three months ended March 31, 2018 and 2017 was estimated at $1.19 and $3.35 per share, respectively, on the date of grant using the Black-Scholes option pricing model with the following weighted-average assumptions:

 

 

 

 

 

 

 

 

 

Three Months Ended

 

 

 

 

March 31, 

 

 

 

    

2018

    

2017

    

 

Expected term of options (in years)

 

5.8

 

6.3

 

 

Risk-free interest rate

 

2.7

%  

2.1

%  

 

Expected volatility

 

76.0

%  

75.7

%  

 

Dividend yield

 

 0

%  

 0

%  

 


Shares Available for Future Grant

At March 31, 2018, the Company has the following shares available to be granted under its equity incentive plans:

 

 

 

 

 

 

    

 

    

Inducement 

 

 

2013 Plan

 

Plan

Available at December 31, 2017

 

991,613

 

293,000

Authorized

 

2,492,431

 

 —

Granted

 

(2,505,625)

 

(95,000)

Forfeited/Cancelled

 

687,057

 

52,500

Available at March 31, 2018

 

1,665,476

 

250,500

 

Shares Reserved for Future Issuance

At March 31, 2018, the Company has reserved the following shares of common stock for issuance:

 

 

 

Stock options outstanding under 2013 Plan

    

10,147,743

Shares available for future grant under 2013 Plan

 

1,665,476

Stock options outstanding under Inducement Plan

 

249,500

Shares available for future grant under Inducement Plan

 

250,500

Employee stock purchase plan

 

225,806

Warrants outstanding

 

123,091

Total shares of common stock reserved for future issuance

 

12,662,116

 

 

6. Commitments and Contingencies

Legal Proceedings

The Company is not involved in any legal proceeding that it expects to have a material effect on its business, financial condition, results of operations and cash flows.

11


 

7. Net Loss Per Common Share

The following table sets forth the computation of basic and diluted net loss per share for the periods indicated (in thousands, except share and per share data):

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

 

 

March 31, 

 

 

    

2018

    

2017

    

Basic and diluted net loss per common share calculation:

 

 

  

 

 

  

 

Net loss

 

$

(9,021)

 

$

(20,714)

 

Net loss attributable to common stockholders

 

$

(9,021)

 

$

(20,714)

 

Weighted average common shares outstanding

 

 

64,562,236

 

 

56,894,672

 

Net loss per share of common stock - basic and diluted

 

$

(0.14)

 

$

(0.36)

 

 

The following outstanding securities at March 31, 2018 and 2017 have been excluded from the computation of diluted weighted shares outstanding, as they would have been anti-dilutive:

 

 

 

 

 

 

 

 

March 31, 

 

 

    

2018

    

2017

 

Options outstanding

 

10,397,243

 

8,461,435

 

Warrants

 

123,091

 

123,091

 

Total

 

10,520,334

 

8,584,526

 

 

 

8. Other Comprehensive Loss

The following table presents changes in the components of accumulated other comprehensive loss (in thousands):

 

 

 

 

Balance, December 31, 2017

    

$

(42)

Net unrealized loss on marketable securities

 

 

(4)

Balance, March 31, 2018

 

$

(46)

 

There were no reclassifications out of accumulated other comprehensive loss during the three months ended March 31, 2018 and 2017. There was no tax effect during the three months ended March 31, 2018 and 2017.

9. Restructuring Charges

 

On October 11, 2017, upon the approval of the Company's Board of Directors, the Company announced a restructuring and reduction in force of approximately 30% of the Company's workforce, or 21 employees. As part of this restructuring, the Company also halted its investment in early stage research. The Company incurred pre-tax restructuring charges of $1.8 million during the year ended December 31, 2017, primarily related to severance and personnel related costs in addition to lease termination payments. As of December 31, 2017, the Company’s restructuring liability totaled $1.1 million. During the three months ended March 31, 2018, the Company made severance payments totaling $0.7 million. As of March 31, 2018, the Company’s restructuring liability totals $0.4 million, which has been recorded within accrued expenses on the Company’s balance sheet.

 

10. Subsequent Events

In April 2018 and May 2018, the Company announced that it had entered into exclusive licensing agreements for the development and commercialization of oliceridine in South Korea and China, respectively. Under the license in South Korea with Pharmbio Korea Inc., the Company received an upfront payment of $3.0 million, and will receive a commercial milestone, if approved in South Korea, and tiered royalties on product sales in South Korea ranging from high single digits to 20%. Under the license in China with Jiangsu Nhwa Pharmaceutical Co. Ltd., the Company will receive an upfront payment of $2.5 million, milestone payments of $3.0 million upon regulatory approval of oliceridine in each of the United States and China, up to $6.0 million of commercialization milestones, and a ten percent royalty on all net product sales in China.  

12


 

ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following discussion and analysis of our financial condition and result of operations should be read in conjunction with our unaudited financial statement and related notes that appear in Item 1 of this Quarterly Report on Form 10‑Q and with our audited financial statements and related notes for the year ended December 31, 2017, which are included in our Annual Report on Form 10‑K filed with the Securities and Exchange Commission, or SEC, on March 7, 2018. Unless the context otherwise requires, we use the terms “Trevena,” “company,” “we,” “us” and “our” to refer to Trevena, Inc.

Overview

Using our proprietary product platform, we have identified and are developing the following product candidates:

·

Oliceridine injection:  We are developing oliceridine, a G protein biased ligand of the μ opioid receptor, for the management of moderate-to-severe acute pain where intravenous, or IV, administration is preferred.  In February 2017, we announced positive top-line results from our Phase 3 APOLLO-1 and APOLLO-2 pivotal efficacy studies of oliceridine in moderate-to-severe acute pain following bunionectomy and abdominoplasty, respectively. In both studies, all dose regimens achieved their primary endpoint of statistically greater analgesic efficacy than placebo, as measured by responder rate.  In July 2017, we announced that we had completed enrollment in the Phase 3 open-label ATHENA safety study to support the new drug application, or NDA, for oliceridine.  In the study, 768 patients were administered oliceridine to manage pain associated with a wide range of procedures and diagnoses. In January 2018, we announced that the United States Food and Drug Administration, or FDA, had accepted the NDA we submitted for oliceridine.  The FDA also indicated that the Prescription Drug User Fee Act, or PDUFA, review date for the oliceridine NDA is November 2, 2018 and that it plans to hold an advisory committee meeting to discuss the NDA. If oliceridine ultimately receives regulatory approval, we plan to commercialize it in the United States, either on our own or with a commercial partner, for use in acute care settings such as hospitals and ambulatory surgery centers; outside the United States, we plan to commercialize oliceridine in certain countries with a commercial partner and we recently announced license agreements with partners in South Korea and China. 

·

TRV250:  We are developing TRV250, a G protein biased ligand targeting the δ-receptor, as a compound with a potential first-in-class, non-narcotic mechanism for the treatment of migraine. TRV250 also may have utility in a range of other central nervous system, or CNS, indications. Because TRV250 selectively targets the δ-receptor, we believe it will not have the addiction liability of conventional opioids or other μ-opioid related adverse effects like those seen with morphine or oxycodone. In the second quarter of 2017, we began a Phase I study of TRV250 in the United Kingdom in healthy volunteers; in the first quarter of 2018, we completed dosing in this study and are awaiting final top-line results.

We also have identified and have completed the initial Phase 1 studies for TRV734, an orally administered new chemical entity expected to be used for first-line treatment of moderate-to-severe acute and chronic pain. We intend to continue to focus our efforts for TRV734 on securing a development and commercialization partner for this asset. We also are evaluating a set of novel S1P modulators that may offer a new, non-narcotic approach to managing chronic pain. We expect to complete characterization of the lead compounds in 2018 to determine if any merit IND-enabling studies to support Phase 1 clinical trials. 

Since our incorporation in late 2007, our operations have included organizing and staffing our company, business planning, raising capital, and discovering and developing our product candidates. We have financed our operations primarily through private placements and public offerings of our equity securities and debt borrowings. As of March 31, 2018, we had an accumulated deficit of $366.5 million. Our net loss was $9.0 million and $20.7 million for the three months ended March 31, 2018 and 2017, respectively. Our ability to become and remain profitable depends on our ability to generate revenue or sales. We do not expect to generate significant revenue or sales unless and until we or a collaborator obtain marketing approval for and commercialize oliceridine, TRV250 or TRV734.

13


 

In September 2014, we announced we had entered into a senior secured tranched term loan credit facility with Oxford Finance LLC and Pacific Western Bank (formerly Square 1 Bank), of which $25.3 million remains outstanding as of March 31, 2018. As of January 1, 2018, we began making monthly payments of both principal and interest, which will be required until the loan maturity of March 1, 2020.

We expect to incur significant expenses and operating losses for the foreseeable future as we continue the development and clinical trials of, seek regulatory approval for, and prepare for commercialization of our product candidates and repay our outstanding loan obligations. If we obtain regulatory approval for oliceridine, we expect to incur significant expenses associated with the launch of this product. We will need to obtain substantial additional funding in connection with our continuing operations. We will seek to fund our operations through the sale of equity, debt financings or other sources, including potential collaborations. However, we may be unable to raise additional funds or enter into such other agreements when needed on favorable terms, or at all. If we fail to raise capital or enter into such other arrangements as, and when, needed, we may have to significantly delay, scale back or discontinue our operations, development programs, and/or any future commercialization efforts.

Senior Secured Tranched Term Loan Credit Facility

In September 2014, we entered into a loan and security agreement with Oxford Finance LLC and Pacific Western Bank, or the lenders, pursuant to which they agreed to lend us up to $35 million in a three-tranche series of term loans (Term Loans A, B, and C). Upon initially entering into the agreement, we borrowed $2 million under Term Loan A. On April 13, 2015, we amended the agreement with the lenders to change the draw period for Term Loan B. On December 23, 2015, we further amended the agreement with the lenders to, among other things, change the draw period for Term Loan C, modify the interest only period, and modify the maturity date of the loan. In December 2015, we borrowed the Term Loan B tranche of $16.5 million. Our ability to draw an additional $16.5 million under Term Loan C was subject to the satisfaction of one or more specified triggers related to the results of our Phase 2b clinical trial of TRV027. Although those triggers were not attained, in December 2016, we and the lenders modified the terms and conditions under which we could exercise an option to draw $10 million of Term Loan C.  In March 2017, we borrowed the Term Loan C tranche of $10.0 million.

 

Borrowings under Terms Loans A and B accrue interest at a fixed rate of 6.50% per annum. Borrowings under Term Loan C accrue interest at a fixed rate of 6.98% per annum. We were required to make payments of interest only on borrowings under the loan agreement on a monthly basis through and including January 1, 2018; payments of principal in equal monthly installments and accrued interest began on January 1, 2018 and will continue until the loan matures on March 1, 2020. Upon the last payment date of the amounts borrowed under the agreement, we will be required to pay a final payment fee equal to 6.6% of the aggregate amounts borrowed. In addition, if we repay Term Loan A, Term Loan B, or Term Loan C prior to the applicable maturity date, we will pay the lenders a prepayment fee of 1.0% of each of Term Loans A and B, and 2.0% of Term Loan C, if the prepayment occurs on or between April 1, 2018 and March 31, 2019, and 1.0% of Term Loan C, if the prepayment occurs on or after April 1, 2019.

 

Our obligations are secured by a first priority security interest in substantially all of our assets, including our cash and cash equivalents and marketable securities, but excluding our intellectual property (together, the collateral). In addition, we have agreed not to pledge or otherwise encumber our intellectual property, with specified exceptions. Upon an event of default, the lenders have the right to foreclose upon the available collateral, including our existing cash and cash equivalents and marketable securities.

 

In connection with entering into the original agreement, we issued to the lenders and placement agent warrants to purchase an aggregate of 7,678 shares of our common stock, of which 5,728 shares remain outstanding as of March 31, 2018. These warrants are exercisable immediately and have an exercise price of $5.8610 per share. The warrants may be exercised on a cashless basis and will terminate on the earlier of September 19, 2024 or the closing of a merger or consolidation transaction in which we are not the surviving entity. In connection with the draw of Term Loan B, we issued to the lenders and placement agent additional warrants to purchase an aggregate of 34,961 shares of our common stock, all of which remain outstanding as of March 31, 2018. These warrants have substantially the same terms as those noted above, and have an exercise price of $10.6190 per share and an expiration date of December 23, 2025. In connection with the draw of Term Loan C, we issued to the lenders and placement agent additional warrants to purchase an aggregate of 62,241 shares of our common stock, all of which remain outstanding as of March 31, 2018. These warrants have substantially the same terms as those noted above, and have an exercise price of $3.6150 per share and an expiration date of March 31, 2027. These detachable warrant instruments have qualified for equity classification and

14


 

have been allocated upon the relative fair value of the base instrument and the warrants, according to the guidance of ASC 470-20-25-2.

 

Critical Accounting Policies and Significant Judgments and Estimates

The preparation of our consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of our financial statements, as well as the reported revenues and expenses during the reported periods. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

A summary of our significant accounting policies appears in the notes to our audited consolidated financial statements for the year ended December 31, 2017 included in our annual report on Form 10‑K. However, we believe that the following accounting policies are important to understanding and evaluating our reported financial results, and we have accordingly included them in this discussion.

Stock-Based Compensation

We have applied the fair value recognition provisions of Financial Accounting Standards Board Accounting Standards Codification Topic 718, Compensation — Stock Compensation, or ASC 718, to account for stock-based compensation for employees. We recognize compensation costs related to stock options granted to employees based on the estimated fair value of the awards on the date of grant.

 

We have equity incentive plans under which various types of equity-based awards including, but not limited to, incentive stock options, non-qualified stock options, and restricted stock awards, may be granted to employees, non-employee directors, and non-employee consultants. We also have an inducement plan under which various types of equity-based awards, including non-qualified stock options and restricted stock awards, may be granted to new employees.

 

For stock options granted to employees and directors, we recognize compensation expense for all stock-based awards based on the estimated grant-date fair values. For restricted stock awards to employees, the fair value is based on the closing price of the Company's common stock on the date of grant. The value of the portion of the award that is ultimately expected to vest is recognized as expense ratably over the requisite service period. The fair value of stock options is determined using the Black-Scholes option pricing model. We utilize a dividend yield of zero based on the fact that we have never paid cash dividends and have no current intention of paying cash dividends. In connection with the early adoption of ASU 2016-9 in the quarter ended December 31, 2016, we elected an accounting policy to record forfeitures as they occur.

 

See Note 5, included in Part 1, Item 1 of this quarterly report on Form 10‑Q, for a discussion of the assumptions used by the Company in determining the grant date fair value of options granted under the Black‑Scholes option pricing model, as well as a summary of the stock option activity under the Company’s stock‑based compensation plan for all years presented.

 

Recent Accounting Pronouncements

See Note 2, Summary of Significant Accounting Policies, in the notes to our unaudited financial statements for the three months ended March 31, 2018, included in Part 1, Item 1 of this quarterly report on Form 10‑Q for information on recent accounting pronouncements.

JOBS Act

The Jumpstart Our Business Startups Act of 2012, or the JOBS Act, contains provisions that, among other things, reduce reporting requirements for an “emerging growth company.” As an emerging growth company, we have elected to not take advantage of the extended transition period afforded by the JOBS Act for the implementation of new or revised accounting standards and, as a result, will comply with new or revised accounting standards on the relevant dates on which adoption of such standards is required for non-emerging growth companies.

15


 

Results of Operations

Comparison of the Three Months Ended March 31, 2018 and 2017 (in thousands)

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

 

 

 

 

March 31, 

 

 

 

 

    

2018

    

2017

    

Change

 

 

 

  

 

 

  

 

 

  

Revenue

 

$

 —

 

$

 —

 

$

 —

Operating expenses:

 

 

  

 

 

  

 

 

  

General and administrative

 

 

5,072

 

 

4,879

 

 

193

Research and development

 

 

4,598

 

 

16,096

 

 

(11,498)

Restructuring

 

 

23

 

 

 —

 

 

23

Total operating expenses

 

 

9,693

 

 

20,975

 

 

(11,282)

Loss from operations

 

 

(9,693)

 

 

(20,975)

 

 

11,282

Other income (expense):

 

 

  

 

 

  

 

 

  

Change in fair value of warrant liability

 

 

 —

 

 

35

 

 

(35)

Net gain on asset disposals

 

 

223

 

 

 —

 

 

223

Miscellaneous income

 

 

928

 

 

628

 

 

300

Interest income

 

 

199

 

 

174

 

 

25

Interest expense

 

 

(678)

 

 

(576)

 

 

(102)

Total other income

 

 

672

 

 

261

 

 

411

Net loss attributable to common stockholders

 

$

(9,021)

 

$

(20,714)

 

$

11,693

 

Revenue

To date, we have derived revenue principally from research grants and collaboration arrangements.

General and administrative expense

General and administrative expenses consist principally of salaries and related costs for personnel in our executive, finance, commercial, and other administrative areas, including stock‑based compensation and travel expenses. Other general and administrative expenses include professional fees for legal, market research, consulting, and accounting services.

General and administrative expenses increased by $0.2 million, or 4%, for the three months ended March 31, 2018, as compared to the same period in 2017, primarily as a result of increased headcount and associated salary and stock-based compensation expense, and increased rent and related expenditures associated with the relocation of our corporate headquarters to Chesterbrook, Pennsylvania in July 2017. These increases were partially offset by a decrease in market research expenditures associated with oliceridine Phase 3 data released in the first quarter of 2017.

Research and development expense

Research and development expenses consist primarily of costs incurred for research and the development of our product candidates. In addition, research and development expenses include salaries and related costs for our research and development personnel and stock-based compensation expense and travel expenses for such individuals.

Research and development costs are expensed as incurred and are tracked by discovery program and subsequently by product candidate once a product candidate has been selected for development. We record costs for some development activities, such as clinical trials, based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations or information provided to us by our vendors.

In October 2017, we announced a restructuring and reduction in force of 21 employees, primarily in the research and development area, as well as other cost saving initiatives.

16


 

Research and development expenses decreased by $11.5 million, or 71%, for the three months ended March 31, 2018, as compared to the same period in 2017. The following table summarizes our research and development expenses (in thousands):

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

 

 

March 31, 

 

 

    

2018

    

2017

 

Personnel-related costs

 

$

2,277

 

$

3,696

 

Oliceridine

 

 

1,373

 

 

10,756

 

TRV027

 

 

27

 

 

92

 

TRV250

 

 

468

 

 

443

 

Other research and development

 

 

453

 

 

1,109

 

 

 

$

4,598

 

$

16,096

 

 

The decrease in research and development expenses was primarily attributable to the completion of the oliceridine Phase 3 clinical program in 2017, and to a decrease in expenditures resulting from the October 2017 restructuring and reduction in force and associated decrease in research and laboratory-related costs.

Liquidity and Capital Resources

Since inception, we have financed our operations primarily through private placements and public offerings of our equity securities, debt borrowings and payments received under collaboration agreements. At March 31, 2018, we had an accumulated deficit of $366.5 million, working capital of $48.0 million, cash and cash equivalents of $18.1 million, restricted cash of $1.4 million, and marketable securities of $43.4 million.

Cash Flows

The following table summarizes our cash flows for the three months ended March 31, 2018 and 2017 (in thousands):

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

 

 

March 31, 

 

 

    

2018

    

2017

 

Net cash (used in) provided by:

 

 

  

 

 

  

 

Operating activities

 

$

(10,406)

 

$