Trevena, Inc.

looking statements within the meaning of federal securities law. These statements are subject to risks and uncertainties related to our business, including those covered in our filings with the SEC. We undertake no obligation to update these statements beyond today. I'll now turn the call over to Carrie.

Thank you, Barry. Good morning, everyone. Thank you for joining us today. For those of you who are new to us, a little background. Trevino was built from the ground up. based on Nobel Prize-winning science around GPCR selective agonists. With our innovative science, we've built a pipeline that is tackling some of the most urgent diseases in CNS. Let me provide a few highlights on what we accomplished in 2020. 2020 really was an unprecedented year for Trevena. With FDA's approval late last year of Alimbic, our novel IV analgesic for acute pain, We accomplished what very few companies our size do. We successfully took a drug candidate through the entire discovery, development, and commercialization process. We're in the early days of our launch, but what I can say, and Dr. Hammer will speak more to this, is that Alimbic's unique profile is compelling to physicians, especially as they evaluate Alimbic for their most challenging acute pain patients in both the inpatient hospital settings and in ambulatory surgery centers. Also, we've now published all the current Alembic GI and respiratory safety data versus IV morphine. The data is available in peer-reviewed journals, and this is important because hospital formulary committees will use this data as they review Alembic. Of course, this is a unique time to be launching a new product. We're hearing from our customers that in some areas they expect the impact of COVID-19 to extend into this year. We're also hearing that elective surgeries in certain regions of the country are starting to return to normal levels, and shortages for drugs like morphine continue in hospitals, which may create an opportunity for a new IV analgesic option like a limbic. But you'll hear from Bob that we're being very thoughtful in our approach to staffing and commercialization activities. We've made great progress on our pipeline assets in 2020 as well, and we have a number of key catalysts on the horizon. Let me start with TRV027, which is being studied in COVID patients by Imperial College, and they expect to complete their study in the first half of this year. They'll be reporting pipeline data soon after. Also on track for the first half of this year is our IND filing of TRV045, a novel S1P receptor modulator for the potential treatment of epilepsy and neuropathic chronic pain. And lastly, I'm pleased to announce that we've identified a novel oral form for TRV250, our new mechanism for acute migraine. We've already started IND enabling work for the oral because we believe this will be very useful for migraine patients and for other CNS areas that we'd like to explore. Mark will provide additional details on all of these exciting pipeline developments later on the call. As you can tell, it was an extremely productive year. We ended the year with $109.4 million in cash, which we expect will fund our operations for two years through year-end 2022. I'm proud of all that we accomplished last year, especially in light of the challenges that COVID-19 presented to our industry and our communities. And I'd like to thank our employees and our business partners for their amazing focus and resilience on delivering medicines that make a difference for patients. Now let me turn the call over to Bob to talk more about the Alimbic launch. Bob?

Thank you, Carrie. It is great to be here this morning to give you an update to the progress we've made with the commercial launch of Alimbic. Ever since FDA approval and DEA scheduling, the team has been hard at work to build out our launch capabilities and prepare for the field launch this quarter. I am thrilled that we've recently crossed the final milestone with our 40-person customer-facing team fully deployed as of late February. All of our new team members have prior experience in the hospital and ASC setting, and many also have experience in the acute pain space, so they are able to leverage prior relationships to facilitate early access with HCPs. Even though they've been out in the field less than a month, Our team is reporting that HCPs are interested in hearing more about Alimbic, the first new chemical entity in the IV opioid space in decades, and they are open to having more detailed discussions. We're deploying the customer-facing team across 550 target hospitals and about 500 target ASCs. We have a group of medical science liaisons in the field who are a critical asset in our health economic strategy. Recall we developed a health economic model that's included in our comprehensive product dossier, which quantifies the overall value that a limbic can deliver to the healthcare system. Prior to the launch of our field team, we had already received positive feedback on that model in discussions with formulary stakeholders. In hiring our MSLs, we focused on bringing individuals with a strong health economics background. And they'll play a critical role in translating our model into an economic value proposition for Alimbic. On the commercial side, we have a mix of regional sales managers and key account managers. This group brings an average of over 20 years of experience in pharma, along with extensive sales leadership and launch experience. They're leading our team of sales reps, all of whom bring deep experience in the acute care hospital and ambulatory surgery center settings. We are really pleased to have this level of expertise and talent supporting our launch of Alimbic and the introduction of Trevena to our customers. As we think through the unique challenges of launching a new product during COVID-19, our goal is to put the right resource in the right place at the right time. We're utilizing local and state-level data on hospital protocols and elective surgery trends, as well as real-time data from our partner, Cineos Health, to help inform our deployment strategy across a range of resources. In addition, we also deployed a separate cohort of telesales reps who will be focused on orthopedic surgeons in both hospitals and ambulatory surgery centers. We believe this additional promotional channel is an efficient way to drive awareness and adoption of a limbic in a key customer group. These telesales reps were previously engaged in the post-surgical pain space with orthopedic surgeons, and are very familiar with the outpatient setting of care. As a reminder, our initial core focus covers approximately 9 million complex patients, a significant market totaling an estimated $1.5 billion addressable market opportunity. Our strategy continues to be focused on replacing conventional IV opioids with a limbic in the right patients and surgeries, not on expanding the overall market. We've set a year-end target of 100 formulary wins. And as with any launch in the hospital space, these early months will be focused on laying a strong foundation on which to build momentum. Things like developing customer relationships, initiating formulary discussions, and facilitating customer education. We believe that employing a thoughtful and disciplined approach will pay off in the long run for us. And with this strong field team in place, we're in a great position to begin executing on our sales plans. As Kerry mentioned, we're very encouraged by the inbound interest we've already received from potential customers, and we're starting to see some exciting movement from our early leads. We're in the process of scheduling our first series of speaker programs, and those will begin rolling out in the next few weeks. We believe the opportunity for HCPs to hear from their colleagues about the differentiating features and appropriate patients for LINVIC will be an important driver of expanded awareness and initial trial. Many of our initial speakers have experience with a LNVIC via their participation in the Phase III Open Label Safety Study. With our reps in the field less than a month, I am pleased to report that we're in active formulary review discussions with a broad range of institutions and already have some early wins. On that note, I'd like to introduce Dr. Greg Hammer, a perioperative physician, anesthesiologist, and intensivist at Stanford. Dr. Hammer has clinical experience with a LNVIC and recently submitted it to his institution's formulary committee for review. We have asked Dr. Hammer to join us this morning to provide his clinical perspective on where he sees a limbic fitting into his practice and his experience with the formulary review process at Stanford. Before he begins, I'd like to remind everyone that a limbic is indicated in adults for the management of acute pain severe enough to require an IV opioid analgesic and for whom alternative treatments are not adequate, And I would encourage you to visit olympic.com for important safety information, including the boxed warning and the full prescribing information. With that, I'll turn the call over to Dr. Hammer. Dr. Hammer?