11/9/2022

speaker
Operator
Conference Operator

Please stand by, the conference will begin momentarily. We thank you for your patience and ask that you please continue to stand by. Greetings and welcome to the Trevena Incorporated Third Quarter 2022 Earnings Call. During the presentation, all participants will be in a listen-only mode. Afterwards, we will conduct a question and answer session. If you have a question, please press the one followed by the four on your telephone. If at any time during the conference you need to reach an operator, please press star zero. As a reminder, this conference is being recorded Wednesday, November 9th, 2022. I would now like to turn the conference over to Barry Shin, Chief Financial Officer. Please go ahead.

speaker
Barry Shin
Chief Financial Officer

Great, thanks. Good morning and welcome everyone. With me today are Kerry Bordeaux, our President and CEO, Patty Drake, our chief commercial officer, and our chief medical officer, Mark Demitrak. As a reminder, Alindic was approved by the FDA and indicated in adults for the management of acute pain severe enough to require an IV opioid analgesic and for whom alternative treatments are inadequate. The important safety information, including the box warning and full prescribing information, are all available on alindic.com. We'll also be making forward-looking statements within the meeting 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 for an overview of our third quarter and recent business accomplishments. Carrie?

speaker
Kerry Bordeaux
President and CEO

Thank you, Barry. Good morning, everyone, and thanks for joining. Let me start the call this morning talking about Alembic, what we're seeing in the overall environment, how we're executing, and what our plans are moving forward. While the pace of formulary wins and customer engagement levels are noticeably increasing, the hospital market environment remains challenging. And I know you're hearing this from all hospital-focused companies. It's the staffing shortages, the tight margins, formulary delays. They're all a factor. Importantly, inpatient admissions are still not up to pre-pandemic levels. So what are we doing? Well, first, in August, we downsized our field and medical teams, brought the remainder of the field team in-house, and signed a contract with Vizient so that their PharmDs can help us educate hospital customers on Alimbic. And together, we're covering approximately 50% of the IV opioid volume. By doing this, we're managing our resources and our cash to be as effective and efficient as possible to help weather the aftermath of the pandemic. Second, we focused on new business areas like burn centers and ambulatory surgical centers. And we recently secured CMS pass-through status, which will help reinforce our value message with customers in the hospital outpatient setting of care. Our field activity levels have improved. Face-to-face customer meetings and speaker programs are back to pre-pandemic levels. And physicians are also starting to attend medical meetings live again. Alimbic is getting significant attention at these meetings and were frequently highlighted for special podium presentations. We saw this at the recent anesthesiology meeting. And in December, the Alimbic cognitive data versus IV morphine will be presented at another large meeting. So what's our plan going forward? Well, we'll continue to be focused on efficient management of our resources. We're being conservative in how we think about resource allocation until we see a more stable trajectory with the inpatient hospital market. We do believe that it is important to continue to highlight Alindic's unique profile with new data in areas that our customers care about, like respiratory depression and cognitive function. And now that we've completed the cognitive study versus IV morphine, Our plan is to approach FDA early next year about potential next steps for label expansion. With regard to our pipeline, we're very excited about TRV045, our novel S1P receptor modulator, and we're interested in two areas, non-opioid treatment of chronic pain and epilepsy, large markets where there is tremendous unmet medical need and an interest in new product mechanisms. This morning, we were pleased to report top-line Phase I data for TRV045. And based on this data, together with our extensive non-clinical work and studies with the NIH, we believe that TRV045 may be a first-in-class molecule with anti-seizure, anti-inflammatory, and analgesic effects. And TRV045 may have a potential disease-modifying effect on epilepsy. Planning is underway to initiate a focused proof-of-concept study early next year. We believe this study will be helpful to us and strategic partners in highlighting the promising potential of TRV-045. Let me now turn the call over to Patty and Mark to provide more details on Olympic and TRV-045. Patty?

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

-

-