Opiant Pharmaceuticals, Inc.
Q1 2021 Earnings Call Transcript

Published: 11 May 2021

[Operator:]

Greetings. Welcome to the Opiant Pharmaceuticals’ First Quarter 2021 Financial Results Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. Please note, this conference is being recorded. I will now turn the conference over to your host, Ben Atkins. You may begin.

[Ben Atkins:]

Thank you, operator, and thank you all for joining us this afternoon. With me on today's call, our Chief Executive Officer, Dr. Roger Crystal; and Chief Financial Officer, David O'Toole. This afternoon, Opiant issued a press release announcing its financial results and providing a business update for the first three months ended March 31, 2021.

[Roger Crystal:]

Thanks, Ben, and a very warm welcome to you all. I will begin by offering a brief corporate update and then hand off to David O'Toole our Chief Financial Officer to provide an overview on the financial highlights. Our mission is to transform the therapeutic treatment of addictions and drug overdose and in so doing, help more patients and drive the future growth of our company. Our priority at OPNT003 Nasal Nalmefene for over fueled overdose. About 180 people are dying every day from an opiod overdose in the United states, higher than ever before. 80% of these deaths are due to illicit synthetic opioids, mainly fentanyl. New therapeutic ideas on needed to save more lives, and we believe Nalmefene has a potential to be particularly well suited to treat synthetic opiod overdose. I will discuss the growing opioid epidemic and what differentiates OPNT003. First, I would like to provide an update on the status of OPNT003 development program. In 2021, our focus is on execution and expanding on the robust data in support of OPNT003. I'm pleased to report that, we are making important progress. We have fully enrolled and are close to completing our complementary pharmacokinetic study. We look forward to reporting top-line data from this study in the next few months. In addition, we have dosed the first subjects in our head-to-head clinical pharmacodynamic study, comparing the effectiveness of OPNT003 Nasal Nalmefene with Nasal Naloxone. In this study, we modeled the respiratory depression using the synthetic FDA approves opioids, Remifentanil in healthy volunteers. We expect reports, top-line data in the fourth quarter.

[David O'Toole:]

Thank you, Roger. For the three months ended March 31, 2021, we recorded approximately $6.4 million in revenue, compared to approximately $4.3 million during the corresponding period of 2020. This includes $2.1 million in grant and contract revenue, which is an increase of approximately two million over the same period in 2020, and illustrates the significant development efforts made in this first quarter for OPNT003. We also recorded approximately $4.3 million of revenue from our license agreement with Emergent Bio Solutions or EBS for the sale of NARCAN, compared to approximately $4.2 million in the same period of 2020. First quarter 2021 sales of NARCAN were approximately $74.2 million, as reported by EBS.

[Operator:]

Thank you. We will now be conducting a question-and-answer session. Our first question comes from Brandon Folkes with Cantor Fitzgerald. Please go ahead.

[Brandon Folkes:]

Hi, thanks for taking my questions and congratulations on progress during the quarter. Three quick ones for me. Can you just provide any color for the OPNT003 trial enrollment? Either, I guess, hopefully, living with COVID or losses - any color there. Secondly, any thoughts on the recent sigma approval, market dynamics and obviously the differentiation of your products to that drug. And then lastly, given an increase of problems, let's say during the quarantine, does it change your view in terms of how could be about your ? Thank you.

[Roger Crystal:]

Thank you, Brandon. Thanks for the question. In terms of the OPNT003 trial enrollment, this is in healthy volunteers. Overall that remains the result of the - the enrollment itself has overall gone well so far. We had a momentary pause and think a couple of weeks because the pharmacokinetic study being conducted in a facility in San Antonio, Texas, where you recall like severe weather issues, which most power supplies. So that facilitate caused a small pause, but overall enrollments is going as planned. The question on the headline is, we welcome more innovation in the spaces of opioid overdose, and we said, all along, I write to on this, but there is a market is growing, more reversal agents are needed. There is a place to NARCAN that might be a place to - your product as well as a result. What we believe nevertheless is that, what we are doing with Nasal Nalmefene we don't believe it is sufficiently differentiated from the NARCAN Nasal Spray, competitive the differentiation we think we can provide with OPNT003 and we hope that we get the data to support this. The issues around disorder. Absolutely, this reiterates the agency through which we'd love to see this program be successful. Let's not forget that, even prior to COVID, actual deaths from alcohol used disorder in this country exceeded opioid overdose deaths. It is a complex disease. There are FDA approved drugs on the market, but we don't believe any of them are sufficiently comprehensive to address all patient’s needs in this space, which is why we also keen to kick off this Phase II study. However, we want to do it in a way that will allow us to complete the study in the most efficient manner, so that is the reason to not yet so kick it off. Thanks for the questions.

[Brandon Folkes:]

Great. Thank you very much.

[Operator:]

Next question comes from Carl Byrnes with Northland Securities. Please go ahead.

[Carl Byrnes:]

Thanks and congratulations on progress. With respect to OPNT004, drinabant, do you have a targeted IND filing date and what would be your expectation of first-in-humans after the NDA was made valid? Thanks. And I have a follow-up as well.

[Roger Crystal:]

We will provide more details on the timing of the actual first-in-humans and filing that IND once we completed this reformulation. But in general, upon the successful reformulation, in a few months, it was targeted to have filing that data in few months initiate the clinical study. So aiming for a 2022 proof-of-concept clinical study in humans.

[Carl Byrnes:]

Great. That is helpful. And then this is probably a question for David. How much remains available on the 8.1 million BARDA award, which if memory serves was largely earmarked to fund, NDA submission and related NDA submission costs. Thanks.

[David O’Toole:]

Carl, thank you for the question and thanks for attending. I don't have the exact number, but I would say the majority of it is still available. And if you recall, we were just granted an additional 3.5 million in December. And almost all of that will be used in the next, I would say, eight-months to nine-months. As you said, most of that was back-end loaded for reimbursement of expenses through the NDA filing.

[Carl Byrnes:]

Great. Thank you.

[Operator:]

Our next question comes from David Bautz with Zacks Small Cap Research. Please go ahead.

[David Bautz:]

Hey, good afternoon, everybody. So, I got a few questions on the PD study. First one, so you are using a three milligram dose of Nalmefene in that study, so is that going to be the doses commercialized and then also, how was that dose decided on? Second, is the study powered to show a statistically significant difference between Nalmefene and Naloxone and the primary outcome? And then lastly, will you be testing how long Nasal Nalmefene is active versus Nasal Naloxone?

[Roger Crystal:]

So, the dose selection arose from a combination as an initial PK work we did on Nasal Nalmefene in the pilot study, that that was very directional in citing the dose alongside the interaction with the FDA to their preliminary support on this dose going into the study. If this study is of the power statistically significant outcomes, and in consultation with the progress, that decisions of the CRA - CRA, we are using the study as well. And your question was around, will we also be evaluating you said that long half life? Was that is the question.

[David Bautz:]

Yes.

[Roger Crystal:]

That is also part of the study design exactly trying and determine whether there is a difference in those two outcomes.

[David Bautz:]

Okay, and for the alcohol use disorder study? Is there anything in particular that you are looking for or what you want to see before you want to get the study underway I mean, I'm assuming it is delayed because of COVID and all that, and when are you looking for vaccination rates or what are you looking for before you want to get that study up and going?

[Roger Crystal:]

There is no one specific aspect, COVID is main driver. And when we look at their return potential, not just Europe, overall, I should add, the majority of the locations are in Eastern Europe where exactly so vaccination rates are far lower than here in the U.S. or most in Europe, where that is a serious consideration is vaccination rates, alongside the overall rates of COVID-19 is getting not just a view of what things are like to say. But the key figures can we see the study suites completion to be confident that they won't be as soon as they might impact matters without factor.

[David Bautz:]

Okay. Alright, great. Well I appreciate you taking the questions.

[Operator:]

Okay, I would like to turn the floor over to Roger Crystal for closing remarks.

[Roger Crystal:]

Thank you, operator. Thank you for joining us today and for your interest in Opiant. We had an extremely busy start at 2021 and we look forward to an exciting remainder of the year. During which we exculpate investors on a series of important clinical and regulatory milestones. Enjoy the rest of your day and please stay healthy. Thank you.

[Operator:]

This concludes today's teleconference. You may disconnect your lines at this time. And thank you for your participation.