Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today reported its financial results for the fourth quarter and full year ended December 31, 2020, and provided an overview of its 2020 and 2021 year-to-date operational highlights.

“2020 was a year of unprecedented achievement for Trevena. We secured U.S. approval of OLINVYK, laid the groundwork for a successful field launch, and partnered with leading institutions to significantly advance our pipeline — all while navigating the challenges that COVID-19 posed to our industry and our communities,” said Carrie Bourdow, President and Chief Executive Officer of Trevena, Inc. “We enter 2021 with focus and resilience, as we look to deliver a successful first year of launch for OLINVYK and achieve multiple milestone events across our pipeline.”

2020 and 2021 YTD Corporate Highlights:

OLINVYKâ„¢ (oliceridine) injection Milestones

• Obtained FDA approval and DEA scheduling.  In August 2020, the U.S. FDA approved OLINVYK in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. In October 2020, the U.S. DEA classified oliceridine as a Schedule II controlled substance.

  The Company is reiterating its commitment to the ethical promotion of OLINVYK. OLINVYK is a novel and differentiated alternative to existing IV analgesics. In those patients for whom an IV opioid is necessary to manage their acute pain, the Company’s goal is to replace conventional IV opioids, not to increase opioid usage.

• Launched commercial and field medical teams in February.  The Company today announced it has recently completed full deployment of its customer-facing team, including Medical Science Liaisons, Regional Sales Managers, Key Account Managers, and sales representatives. Multiple institutions and ambulatory surgery centers are in the process of reviewing OLINVYK for formulary inclusion. The Company has set a target of 100 formulary acceptances by year-end.
• Completed foundational launch activities.  Following DEA scheduling, the Company made OLINVYK commercially available across all three vial presentations (1 mg/1 mL and 2 mg/2 mL single-dose vials; 30 mg/30 mL single-patient-use vials for patient-controlled analgesia) and announced contracts in place with the three major wholesalers covering the majority of the acute care business.

  In January 2021, the Company completed a comprehensive product dossier for OLINVYK, including head-to-head data versus IV morphine and health economic models, for use by hospital formulary committees. The Company also finalized all J- and C-code submissions with the Centers for Medicare and Medicaid (CMS) and completed market access resources for customers to facilitate reimbursement of OLINVYK.

• Continued to expand body of published peer-reviewed literature.  In 2020, the Company announced four new publications of OLINVYK data, with the number of publications from the development program now totaling 24. These findings provide additional insight into the differentiated safety and tolerability profile of OLINVYK and are available to healthcare providers as they consider the use of OLINVYK in their patients.
• Supported development progress made by ex-U.S. partner.  In June 2020, the Company announced that Jiangsu Nhwa Pharmaceutical Co., its partner in China, was approved by the Chinese National Medical Products Administration (NMPA) to initiate clinical trials for OLINVYK. Jiangsu Nhwa holds an exclusive license agreement for the development and commercialization of OLINVYK in China.

Pipeline Milestones

• Announced new pipeline asset: TRV027 for COVID-19 patients.  In June 2020, the Company entered into a collaboration with Imperial College London (ICL) to investigate TRV027, a novel AT₁  receptor selective agonist, as a potential treatment for acute lung damage / abnormal clotting associated with COVID-19. TRV027’s mechanism of action received significant scientific interest, including a publication in  Circulation, highlighting its hypothesized reparative effects in the lungs and other major organs.

  ICL initiated a 60-person study with a primary objective of assessing the effect of TRV027 on abnormal clotting in COVID-19 patients. ICL expects the primary completion date to be in 1H 2021.

• Commenced partnership with NIH to evaluate TRV045 for epilepsy and chronic neuropathic pain; IND filing on track for 1H 2021.  In March 2020, the Company announced that the National Institutes of Health (NIH) had begun evaluating TRV045, a novel S1P receptor modulator in nonclinical animal models, as a potential treatment for epilepsy. In May 2020, NIH also began evaluating TRV045 in nonclinical animal models as a treatment for various pain conditions, including inflammatory and neuropathic pain. Data demonstrating efficacy in animal models of neuropathic pain and epilepsy were presented in December 2020 at the 59th Annual Meeting for the American College of Neuropsychopharmacology (ACNP).
• Identified novel oral dose formulation for delta receptor selective agonist, TRV250.  The Company today announced that following the pause of clinical activity in 2020 due to COVID-19, it advanced formulation work for TRV250 that has yielded a novel oral dose form. This differentiated formulation could extend the Company’s market exclusivity an additional five years to 2041. The Company has initiated IND-enabling activities with this oral dosage form, which it believes offers significant advantages for exploring multiple CNS disease states.

Financial Milestones

• Strengthened balance sheet.  The Company significantly bolstered its financial position in 2020, including a successful $57.5 million public offering of common stock following approval of OLINVYK, and receipt of a $3 million milestone payment from its partner in China in connection with this approval. The Company today reported $109.4 million in cash and cash equivalents as of December 31, 2020.  

Financial Results for Fourth Quarter and Full Year 2020

For the fourth quarter of 2020, the Company reported a net loss attributable to common stockholders of $11.9 million, or $0.08 per share, compared to $6.4 million, or $0.07 per share, for the fourth quarter of 2019.  For the full year ended December 31, 2020, net loss attributable to common stockholders was $29.4 million, or $0.23 per share, compared to $24.9 million, or $0.27 per share, for the year ended December 31, 2019. This increase is primarily due to activities in preparation for commercial launch of OLINVYK.

Cash and cash equivalents were $109.4 million as of December 31, 2020, which the Company believes will be sufficient to fund the Company’s operating expenses and capital expenditure requirements through the fourth quarter of 2022.