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The Trevena Team Continues to Be Guided by an Unwavering Comm

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The Trevena Team Continues to Be Guided by an Unwavering Comm LETTER TO STOCKHOLDERS Dear Fellow Stockholders: The Trevena team continues to be guided by an unwavering commitment to patients, especially in the face of new challenges the COVID‐19 global pandemic has introduced for businesses around the world. I am proud that we have remained focused and committed to developing innovative new medicines to address critical areas of need for central nervous system disorders. We are fortunate to be developing four differentiated drug candidates that have the potential to harness new mechanisms of action to improve patients’ lives. We are optimistic and confident in the approval of oliceridine, our lead product for the management of moderate‐to‐severe acute pain in a hospital setting. In 2019, we successfully completed the healthy volunteer QT study and addressed the items identified in the FDA’s complete response letter. On February 10, 2020, we resubmitted our new drug application and quickly received acknowledgment from FDA that the resubmission was a complete response to their action letter. FDA has set a Prescription Drug User Fee Act goal date of August 7, 2020 and we continue to prepare for approval to ensure oliceridine will be available for patients and healthcare providers later this year. Ultimately, we believe that oliceridine, once approved, will be a valuable new IV analgesic in the acute pain treatment landscape. Our other pipeline assets also reached significant milestones in 2019. We initiated a proof‐of‐concept study evaluating TRV250 for the treatment of acute migraine and associated anxiety. We also initiated a proof‐of‐ concept study sponsored and funded by the National Institute on Drug Abuse to explore the use of TRV734 as a potential treatment option for opioid use disorder. Finally, we entered into a collaboration with the U.S. National Institutes of Health to evaluate the potential of TRV045, our novel S1P modulator, as a treatment for epilepsy. We also continue to explore the potential of TRV045 as a novel, non‐opioid treatment option for a wide array of chronic pain conditions. We remain excited and encouraged about the key milestones ahead, including the approval of oliceridine. We also look forward to building out our presence in the broader CNS space. In closing, I would like to thank our employees for their passion and dedication, and I would like to express my gratitude to you, our shareholders, for your continued support of Trevena. Sincerely yours, Carrie L. Bourdow President and Chief Executive Officer April 13, 2020 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2019 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-36193 Trevena, Inc. (Exact Name of Registrant as Specified in Its Charter) Delaware 26-1469215 (State or Other Jurisdiction of (I.R.S. Employer Incorporation or Organization) Identification No.) 955 Chesterbrook Blvd., Suite 110, Chesterbrook, PA 19087 (Address of Principal Executive Offices) (Zip Code) Registrant’s telephone number, including area code: (610) 354-8840 Securities registered pursuant to Section 12(b) of the Act: Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, par value $0.001 per share TRVN The Nasdaq Stock Market LLC Securities registered pursuant to Section 12(g) of the Act: None Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒ Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐ No ☒ Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐ Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐ Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.: Large accelerated filer ☐ Accelerated filer ☒ Non-accelerated filer ☐ Smaller reporting company ☒ Emerging growth company ☐ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐ Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒ The aggregate market value of the voting stock held by non-affiliates of the registrant, as of June 28, 2019, the last business day of the registrant’s most recently completed second fiscal quarter, was approximately $93.9 million. Such aggregate market value was computed by reference to the closing price of the Common Stock as reported on the Nasdaq Stock Market LLC on June 28, 2019. For purposes of making this calculation only, the registrant has defined affiliates as including only directors and executive officers and stockholders holding greater than 10% of the voting stock of the registrant as of June 28, 2019. The number of shares of the registrant’s Common Stock outstanding as of March 10, 2020 was 97,727,185. DOCUMENTS INCORPORATED BY REFERENCE Portions of the registrant’s definitive proxy statement for its 2020 annual meeting of stockholders to be filed pursuant to Regulation 14A with the Securities and Exchange Commission not later than 120 days after the registrant’s fiscal year ended December 31, 2019 are incorporated by reference into Part III of this Form 10-K. TABLE OF CONTENTS Page Cautionary Note Regarding Forward-Looking Statements PART I Item 1. Business ........................................................................... 4 Item 1A. Risk Factors ........................................................................ 31 Item 1B. Unresolved Staff Comments ........................................................... 65 Item 2. Properties .......................................................................... 65 Item 3. Legal Proceedings ................................................................... 65 Item 4. Mine Safety Disclosures .............................................................. 66 PART II Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities ........................................................ 66 Item 6. Selected Financial Data ............................................................... 66 Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations .. 66 Item 7A. Quantitative and Qualitative Disclosures About Market Risk ................................ 78 Item 8. Financial Statements and Supplementary Data ............................................ 79 Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure . 113 Item 9A. Controls and Procedures .............................................................. 113 Item 9B. Other Information ................................................................... 113 PART III Item 10. Directors, Executive Officers and Corporate Governance ................................... 114 Item 11. Executive Compensation .............................................................. 114 Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters ................................................................ 115 Item 13. Certain Relationships and Related Transactions, and Director Independence ................... 115 Item 14. Principal Accountant Fees and Services ................................................. 116 PART IV Item 15. Exhibits and Financial Statement Schedules .............................................. 117 SIGNATURES ............................................................................... 121 Cautionary Note Regarding Forward-Looking Statements This Annual Report on Form 10-K (this “Annual Report”) contains forward-looking statements that involve substantial risks and uncertainties. The forward-looking statements are contained principally in the sections entitled “Business,” “Risk Factors,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” but also are contained elsewhere in this 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.
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