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.

Please note that certain information discussed on the call today is covered under the Safe Harbor Provision of the Private Securities Litigation Reform Act. We caution listeners that during this call, Opiant management will be making Forward-Looking Statements.

Actual results could differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with the Company's business. These forward-looking statements are qualified by the cautionary statements contained in Opiant's news releases and SEC filings, including in our annual report on Form 10-K for the year ended December 31, 2020, and subsequent filings.

This conference call also contains time-sensitive information that is accurate only as of the date of this live broadcast, May 11, 2021. Opiant undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call.

Now, with that, I would like to turn the call over to Roger.

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.

Other drug development activities are also on-track for an NDA filing using the 505(b)(2) regulatory pathway by year-end or early first quarter 2022 Further reflecting our progress, in March, we were awarded the third and final traunch of $1.8 million from the total grants of approximately $7.4 million from NIDA support the advancements of OPNT003. As a reminder, the development of OPNT003 is also supported by BARDA.

With that, I would like to provide some further context on how we arrived at this point in the evolving opioid crisis and in our development of OPNT003. About eight years ago, we saw an opportunity to help save lives from opioid overdose.

We develop develops NARCAN Nasal Spray, so any bystander could administer potentially lifesaving medicine to a victim. In 2018, the U.S.

Surgeon General, Jerome Adams encouraged people to NARCAN with them. I think that in some communities and finding someone unconscious, you would more likely need to administer NARCAN than carry out CTR.

When we developed the NARCAN Nasal Spray, depending the lock zone, overdoses were commonly linked to prescription opioids and heroin. Today, we face an entirely different class of opioid illicitly made synthetic opioids, particularly fentanyl.

In new data released by the CDC that is linked to illicit synthetic opioids and then particular fentanyl were up 55% to 53,877 during the 12-months ended September 2020. That is a figure compared to approximately 10,000 deaths in 2015, an illustration of how firmly fentanyl has become entrenched in America's illicit drug supply.

Fentanyl and synthetic opioids differ from opioids. First, they are more lipophilic.

Fentanyl for example, is more easily taken by fatty tissues including the brain. This enables it to cross into the brain more quickly and in greater quantity.

This combination is the use of a fast and intense high. However too much fentanyl entering the brain will also rapidly suppress breathing leading to overdose.

Depending on the circumstances surrounding the overdose this can take seconds to a few minutes. The second is the differentiation or the sustained effects of synthetic opioids like fentanyl.

Naloxone last between 30 to 90 minutes of fentanyl has a plasma half life of about seven hours. It is possible that Naloxone levels for fentanyl levels both more slowly, the victim can sink back into an overdose known as [indiscernible].

The potency and long plasma half life of certain synthetic opioids is challenging Naloxone. As we have discussed on previous calls, scientific literature reports from Ian Esteems and in December, the Public Health Advisory by the CDC, collectively confirm a multiple doses in the Naloxone are likely necessary to revive an overdose victim and the further doses could be needed to avoid a recurrence.

It is a medical insight, it has driven as opioid to explore alternative molecules to Naloxone. Based on its pharmacological characteristics and the compelling data from our pilot PK study OPNT003 Nasal Nalmefene could prove uniquely suited to treat synthetic opioids in three important ways.

First, Nalmefene has a higher affinity of the opioid receptors than Naloxone which makes OPNT003 more potent. Second, Nalmefene has a longer half life, which as I explained before, reduces the potential for re-marketization.

Third, we formulated OPNT003 for rapid absorption by incorporating Intervale into our formulation and using a simple nasal spray device. This is important due to the shorter window to save a life from a synthetic opioid, including Sentinel.

We believe OPNT003 have a significant potential to treat synthetic opioid overdoses and look forward to the availability of the confirmatory PK and PD data in months ahead. With that, I will now move to the rest of our pipeline.

We continue to progress IND-enabling work with the National Center for Advancing Translational Sciences to formulate OPNT004, drinabant human studies for acute cannabinoid overdose. We expect to complete this work in 2021.

Regarding OPNT002 Nasal Naloxone alcohol use disorder, because the starts of a Phase II due to the COVID-19 pandemic in Europe. The starts of the study remained on-track and we are assessing is the optimal time to proceed.

In March, we were pleased to welcome Seasoned Clinical Development Executive, Dr. Lorianne Masuoka to our Board of Directors.

Her extensive experience, success makes the debts and value of the development pipelines, several biotech companies will be incredibly valuable to Opiant, as we serve advance our mission to develop new medicines, the potential treatment of addictions and drug overdose. With that, I will now turn the call over to David to discuss the financials.

David.

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. Research and development expenses for the first quarter were approximately $4.1 million, as compared to approximately $1.4 million in 2020.

External development expense increased by $2.6 million, primarily due to increased activity on our lead product candidate OPNT003 Nasal Nalmefene for opioid overdose. We also had an increase of approximately a 100,000 in personnel and related expenses for this quarter versus the same quarter last year.

For the three months ended March 31, 2021, G&A expenses were approximately $2.6 million, essentially flat as compared to the same period in 2020. Sales and marketing expenses were approximately 1.1 million for pre commercial efforts related to OPNT003.

This compares to approximately 1.1 million in the first quarter of 2020. Keeping our sales and marketing expenses and general administrative cost constant this quarter versus the same quarter last year, demonstrate our continued efforts to control cost as we do our important clinical work for OPNT003.

Royalty expense for the three months ended March 31, 2021, was approximately one million, compared 0.9 million for the comparable period of 2020. Interest expense was 537,000 for three months ended March 31, 2021, compared to zero for the comparable period of 2020.

This interest expense is related to the convertible debt. Net loss for the three months ended March 31, 2021, was approximately 2.8 million or a loss of $0.66 for basic and diluted share.

This compares to a net loss of approximately 1.7 million or a loss of $0.40 for basic and diluted share for the comparable period of 2020. As of March 31, 2021, Opiant had 50.6 million in cash, cash equivalents and marketable securities.

The current balance does not include the full impact of the NIDA grant of approximately 7.4 million, or the BARDA contract of approximately 8.1 million. Overall, we remain in a strong financial position to support our ongoing drug development activities and clinical studies and to support pre-commercial efforts for our lead program OPNT003.

Last week, based on the mid-range of the full-year 2021 guidance for sales of NARCAN Nasal Spray, recently reaffirmed by [EPS] (Ph) of 315 million. We continue to expect full-year 2021 royalty revenue from the sale of NARCAN Nasal Spray of approximately 27.8 million.

We also continue to expect to end 2021 with cash, cash equivalents and marketable securities of approximately 40 million, which will not include any receipt of additional trances of the existing convertible debt facility. Thank you.

And with that, let me open up the call for questions. Operator.

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 [indiscernible]?

Thank you.

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 [indiscernible] 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.

Great. Thank you very much.

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.

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.

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.

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.

Great. Thank you.

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?

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.

Yes.

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

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?

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.

Okay. Alright, great.

Well I appreciate you taking the questions.

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.