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00:39 Thank you, operator and thank you all for joining us this afternoon. With me on today's call are Chief Executive Officer, Dr.

Roger Crystal; Chief Commercial Officer, Matt Ruth; and Chief Financial Officer, David O'Toole. This afternoon Opiant issued a press release announcing financial results and providing a business update for the 3 and 12 months ended December 31, 2021.

01:07 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 release and SEC filings, including in our annual report on Form 10-K for the year ended December 31, 2021 and subsequent filings.

This conference call also contains time-sensitive information that is accurate only as of the date of this live broadcast March 15, 2022. Opiant undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call.

02:15 Now, I'd like to turn the call over to Roger.

2:21 Thanks, Ben, and a very warm welcome to you all. Thanks for joining our conference call to discuss Opiant’s financial results and business highlights for the fourth quarter and full-year 2021.

We appreciate everyone's time and attention. 02:37 In 2021 we have 4 overarching goals.

One, advance OPNT003 nasal nalmefene towards NDA submission; two, establish leadership to potentially self-commercialize OPNT003 if approved; three, advance our pipeline; four, maintain a strong balance sheet in support of our development and commercial goals. I'm pleased to say that we have made significant progress in all 4 areas of focus.

03:09 Starting first with OPNT003, our investigative treatment for opioid overdose. In 2021, we reported multiple achievements around its advancement, this included the results of our complementary pharmacokinetic study and the initiation of 2 further studies, a multi dose study and a pharmacodynamic study, both requested by the FDA.

Moreover in November, the FDA granted OPNT003 Fast Track Designation. 03:41 This momentum has continued in early 2022.

In February, we reported positive top line results from our multi-dose study, in which OPNT003 demonstrated safety, tolerability and pharmacokinetic equivalent across multiple nasal doses. Importantly, these data are fully consistent with the rapid delivery of high plasma concentrations of nalmefene observed in our earlier single dose PK study, which we reported in July 2021.

04:12 I'm also pleased to announce that we have completed enrollment and reached our target of 46 subjects in the pharmacodynamic study. This study is comparing OPNT003 with nasal naloxone in reversing the respiratory depression produced by the synthetic opioids Remifentanil in healthy volunteers.

As a reminder, we designed this novel PD study at the request of and in consultation with the FDA. This is the first study ever conducted directly comparing the PD effects of nasal nalmefene and nasal naloxone in an experimental model of opioid-induced respiratory depression.

We are confident the data generated in this study will support the data generated in our pharmacokinetic studies and provide additional valuable information on the attributes OPNT003 relative to the current standard of care. 05:13 In this study, healthy volunteers were administered high concentrations of carbon dioxide to elevate respiration, and once this occurred were administered an infusion of the synthetic opioid Remifentanil.

Like other opioids Remifentanil suppresses carbon dioxide stimulated increases in respiration. The subjects then receive either nasal naloxone or nasal nalmefene.

The rate and extent of reversal was measured over time. Using a crossover design, subjects were dosed with either nasal naloxone or nasal nalmefene on days 1 and 5 of the study.

5:53 So, each subject received 1 dose of each opioid antagonist. The study was managed to strict safety criteria agreed with the FDA and Institutional Review Board.

As a reminder, as agreed to with the FDA, the study is powered to demonstrate non-inferiority between nalmefene and naloxone with the primary endpoint measuring the change in minutes ventilation at 5 minutes. Additional secondary endpoints cover a range of different time points.

06:25 As the study progressed there was a high rates of drop outs related to study conditions, including the wearing of a tight fitting mask for an extended period and the side effects produced by Remifentanil infusion, which includes nausea, emesis and dizziness. Unfortunately, the meant that the study took longer to complete than unanticipated.

With enrollment now complete, however, we are now diligently preparing our study data for analysis. Although we had initially hoped to have top line data by the end of Q1 given the completion of the clinical portion earlier this month, we now anticipate these results coming – these results in the coming quarter.

07:12 We believe this significant milestone complete all clinical studies required by the FDA. Earlier this year, we requested a pre-NDA meeting with the FDA, which is scheduled for later this month.

Pending the outcome of this meeting we anticipate a mid-year NDA submission, which, if approved, could position OPNT003 for commercial launch in the US by early 2023. As we progress OPNT003, we continue to attract strong and experienced talent for key roles.

In November, we welcome Tania Thomas as our VP of Regulatory and Medical Affairs. Tania joined us after 15 years at Pfizer and GSK, having held senior positions leading regulatory affairs teams, both in the US and globally.

She has a demonstrated track record in supporting successful US and ex-US regulatory approvals. We look forward to Tania leading our efforts with the FDA to approve -- to obtain approval for OPNT003.

08:21 Now, turning to commercial pipeline and our balance sheet. Commercially, as we get closer to NDA submission, our preparations for the potential launch of OPNT003 are progressing well.

Matt Ruth, our Chief Commercial Officer will speak to that in a moment. In R&D, we continue to advance our pipeline and have several exciting milestones expected over the next 12 to 18 months.

We reported in January that we initiated enrollment in our 300 patients Phase 2 randomized double-blind placebo-controlled study evaluating OPNT002 nasal naltrexone for the treatment of alcohol use disorder or AUD. The study, which we are conducting in Europe has already reached 10% of our recruitment goals.

We anticipate data from this trial in the first half of 2023. 09:19 OPNT002 a potentially represent a major breakthrough for treating AUD as its rapid onset of action and short half-life are ideally suited for administration on an as needed basis without the need for prior abstinence.

As we also previously reported, we are progressing OPNT004 drinabant, a treatment for acute Cannabinoid overdose or ACO towards IND enabling studies, working in partnership with the National Center for Advancing Translational Sciences. As more and more states legalize both the medical and recreational use of cannabis and particularly edibles, which contain very large amounts of THC, there is an increased need for an effective treatment of ACO in the emergency room setting.

10:08 For example, a study recently published in JAMA reports Ontario saw 9 times more emergency department visits per month for cannabis poisoning in young children under the age of 10 after Canada legalized recreational cannabis in 2019. We hope to have a pre-IND meeting by the end of this year and have OPNT004 in clinical studies next year.

Lastly, we managed our balance sheet in 2021 beyond the high end of our [Technical Difficulty] which David will go into in more detail a little later. 10:47 Let me end my remarks by reminding you of what we do at Opiant and why.

Our mission is to develop medicines with the potential to treat addictions and drug overdose. America is facing a deadly opioid epidemic.

From September 2020 to September 2021 opioids accounted for roughly three quarters of the more than 104,000 deaths in the US from drug overdoses. Since the mid-2010s the opioid epidemic has transitioned to very potent and illicit synthetic opioids in particular fentanyl.

11:25 As we've discussed on previous calls, fentanyl and other emerging synthetic opioids are distinct from heroin and prescription opioids. Synthetics are highly lipophilic and enter the brain more quickly than other opioid.

They act with far greater potency and many of these compounds have long half-life relative to heroin and prescription opioids. These longer half-life increase the risk of renarcotization if a victim is rescued for the short-acting agent like naloxone.

In the few years since illicit synthetic opioids began to proliferate in the US, yearly drug overdose deaths have more than doubled, making this one of the most rapidly spreading epidemics in history. 12:10 The increase in deaths due to opioid overdose has given rise to concerns about the longer-term effectiveness of current overdose reversal treatment and led to calls for innovation in this space.

In a 2016 report, an FDA advisory committee indicated that higher or multiple dose of naloxone often when needed in the community setting to revive individuals when stronger opioid like Sentinel were involved. Since then, the CDC, the NIH and other public health agencies have issued similar warnings.

Opioid overdose is the leading cause of death among Americans aged 18 to 45. This is robing us, our lives and our future.

In February, a new government report concluded that overdose death cost the economy $1 trillion a year in health expenses. 13:03 Reduced productivity and other losses equivalent to nearly half of America's economic growth last year.

And this trajectory is getting worse. Recent estimates in the medical journal The Lancet suggested opioid overdose could kill up to an additional 1.2 million Americans by 2029.

Since Opiant's original development of the NARCAN Nasal Spray and its FDA approval in 2015, NARCAN Nasal Spray has helped lead the fight against opioid overdose. It has made it clear and extremely positive difference in communities across America.

It has fundamentally changed how we respond to overdose by engaging bystanders within our homes and communities. Yet the crisis today is different than it was when we developed NARCAN Nasal Spray.

13:54 The limitations when matched against far stronger and more lethal opioids are becoming more and more evident. To serve public health and to save lives, we must make progress on prevention and treatment of opioid overdose.

New medicines are needed as the potency of a listed drugs flooding America grows. As the overdose crisis heightened, our colleagues across Opiant are more determined than ever to be part of the next potentially game changing great breakthrough.

14:25 And with that, I'll turn over to Matt, our Chief Commercial Officer.

14:31 Thank you, Roger. As we get closer to NDA submission and FDA consideration of OPNT003, we are ahead of schedule in building our foundation for launch.

I'm very pleased with the response we received to hiring. We now have all of the elements for launch covered in our leadership team, including government affairs, trading distribution, marketing and market access.

14:58 As I mentioned on our last earnings call, we have the very experienced Mike Potestio, who will lead our field sales, recruiting and execution as we get closer to a potential commercial launch. We have our external agency partners in place and have established and begun executing a comprehensive strategy in preparation for commercialization of OPNT003.

We are building experience depth in critical, commercial and government affairs functions, and we'll continue to build as appropriate and necessary. 15:35 As we build and execute our strategy the call for action rings loud.

As we speak with and listen to those confronting the opioid epidemic and with the families tragically affected by overdose, it is clear that we must elevate the education, awareness, preparedness and importantly increase access to appropriate reversal agents. While nasal naloxone is a vital tool, we continue to hear strong enthusiasm for advancement in opioid overdose reversal agent options.

With the rise of Sentinel and synthetic, we hear strong support for a treatment option with a faster action, longer duration and is stronger to combat higher potency opioids. Data generated so far indicates OPNT003 exhibits these attributes.

16:35 When my team and I launched NARCAN, the first FDA approved nasal naloxone in 2016, we changed the game. NARCAN empowers medically untrained citizens and responders to administer potentially lifesaving emergency treatment.

Now, it is a great privilege to work for NARCAN’s original creator Opiant, which remains dedicated in its pursuit of even more effective treatment of opioid overdose in America. 17:06 In summary, we have the experienced team, we have the unique and relevant marketing -- market expertise and we are well advanced in establishing the conditions to successfully commercialize OPNT003 if approved.

And I hope to deliver a much needed new tool to fight the escalating severity of opioid overdose. 17:30 And with that, I'll turn it over to David, who will provide a summary of our financial performance.

17:38 Thank you, Matt. The details of our financial results are in the press release, so I'll focus now on a few highlights.

For the fourth quarter and full-year 2021, we reported revenues of $8 13.million and $48 million, respectively. Continued demand for NARCAN Nasal Spray in the last quarter of 2021 meant we exceeded our previously provided full-year 2021 royalty revenue guidance of approximately $38 million, with actual 2021 royalty revenue of approximately $41 million, a 49% increase over full-year 2020.

18:20 We also recorded approximately $7.1 million in grants and contract revenue compared to approximately $2.2 million for full-year 2020. This was due to funding received from the National Institute of Drug Abuse and Biomedical Advanced Research and Development Authority for the development of OPNT003.

18:43 Total operating expenses for the fourth quarter were $12.5 million compared to $11 million for the same period in 2020. Operating expenses were $42.6 million for the full-year 2021 compared to $31.9 million in 2020.

Full year increase was primarily due to our investments in R&D, which were approximately $16.8 million as compared to approximately $9.2 million in the comparable period in 2020. 19:18 Net income for the 3 months ended December 31, 2021 was approximately $0.8 million or income of $0.17 per basic share, and income of $0.11 per diluted share, compared to a net loss of approximately $0.7 million or a loss of $0.16 per basic share and diluted share for the comparable period of 2020.

For the full-year 2021 net income was approximately $3 million or income of $0.68 per basic share, and income of $0.51 per diluted share, compared to a net loss of approximately $1.9 million or a loss of $0.44 per basic and diluted share for full-year 2020. 20:06 As we have noted on prior calls, with opioid-related deaths increasing throughout the pandemic, NARCAN Nasal Spray sales have also been on the rise.

We expect demand for community-based reversal agents to increase significantly in the coming years. However, on its most recent earnings call EBS provided 2022 NARCAN revenue guidance of $240 million to $310 million.

This is significantly less than the $434 million of net NARCAN sales reported by EBS in 2021 and apparently reflects the impact of at least 1 generic entrant and branded competitors into the nasal naloxone market. 20:54 In December of 2021 Teva Pharmaceuticals announced the launch of its generic nasal naloxone.

At the same time Sandoz through an agreement with EBS launched an authorized generic of NARCAN. In addition, during 2021 Hikma Pharmaceuticals launched KLOXXADOTM , an 8 milligram nasal naloxone.

We do not yet have data to determine the evolution of the nasal naloxone market. We will wait information from EBS when they reports Q1 NARCAN sales next quarter.

21:35 As a reminder, we receive tiered royalty payments on NARCAN net sales with rates ranging up to 12%. However, with the launch of a generic equivalent in December of 2021, the royalty amount will reduce to 2% on a country-by-country and quarter-by-quarter basis when the sales of NARCAN, including sales of the authorized generic are cumulatively less than 70% of what the net NARCAN sales were in the third quarter of 2021.

22:10 It is important to note that this will be calculated separately each quarter. This means, we could have some or all quarters in 2022 at the standard tiered rate.

However, we could also have some or all quarters at 2%. It will depend on NARCAN sales performance in a given quarter.

Royalty revenue from net NARCAN sales will continue in 2022. However, until we have further clarity around net NARCAN sales in the coming months, we are not currently in a position to provide royalty revenue guidance for the full-year 2022.

22:53 With that said, we start the year with approximately $53 million of cash and continue to prudently manage our capital resources, providing us with a strong financial foundation to support our planned commercial and R&D initiatives this year. We also have access to additional $30 million under the existing debt facility upon achievement of certain milestones.

23:21 To conclude, a generic entrant of nasal naloxone into the marketplace doesn't change the dynamic that exist where most opioid overdose relate to higher potency opioids. And the innovation and treatment of overdose will need to evolve, calling for the introduction of new products, such as our OPNT003 nasal nalmefene.

23:48 Thank you. And with that, let me open the call for questions.

24:27 Hi, thanks for taking my questions, and congratulations on all the progress. Maybe just 2 on 003 and maybe they are related, but I guess, firstly, will the pre-NDA meeting inform anything around the PD data?

Just any comment on the sequence of events there? Is it real that the PD data took a little longer for the reasons you mentioned, like the most efficient use of time to keep it at that date?

Or is this something that could inform that PD data before we see it? 25:02 And then, I know this is a tough one to answer, but how do you think about the label at this stage?

And I mean that in terms of, when we think about detailing this product, I agree with the attributes and the need for stronger agent against these like synthetic opioid. I guess, how direct do you think you can be in your marketing with the data generated to-date that this is a better product than what's on the market?

Thank you.

25:40 Thank you. Brandon.

So in terms of the pre-NDA meeting, we wanted to schedule that because we have a ton of existing data anyway, and we want the FDA to ideally allow us to proceed with a rolling review. And with the PD data even though they won't have it in hand when we have the meeting, again, they have already read the study design and statistical plan.

So really it's everything out above that and this is still important to bring to the table, so that we are in best place to submit an NDA in the timely manner. 26:18 And on the label.

One of the key attributes and advantages we believe of OPNT003 is the long half-life. And in fact that data is already in the existing Revex label that was -- when the nalmefene was approved as an injection, we are actually in a state that has a longer half-life, longer than even duration than naloxone.

So that data we are able to use from the existing label. In addition, we will be able to provide all the additional data we generate into the package insert, such as the existing well known data around the actual potency of nalmefene and the affinity, et cetera and the speed of absorption, which appears to be faster than naloxone as well.

27:16 Ultimately, the PD data, I think, it's going to be a key piece as well. And even though it's powered to non-inferiority if we are, for example, seeing the majority of patients, healthy volunteers having the breathing restored faster, so naloxone it will also very much apparent in the entirety of the data that we have supporting this product.

So that's what makes us so exciting.

27:43 Thanks. That’s great and very helpful.

And maybe just one more if I may for David. So, Dave, just to clarify.

So the royalty will drop to 2% if sales in the quarter dropped below 70% of 3Q 2021. So I guess it’s 70% of that $133 million.

And then, does that include the authorized generic? And then, do you get a royalty on the authorized generic?

28:16 Thanks, Brandon. Thanks for the question also.

Point of clarification, and you did point it out that the third quarter was $133 million in total NARCAN sales. However, this is on a country-by-country basis.

And the $133 million is not all US sales, it includes also Canada. And that information is not publicly available.

But since there is not a generic in Canada, all of the revenue from Canada is not subject to the generic reduction clause at this point in time. So there is a bifurcation that needs to be done on a country-by-country basis.

29:03 And then, you are correct on the 70% and the total revenue that we will be measuring for that will be the branded product NARCAN plus the authorized generic. And so, that has to dip -- that total has to dip below 70% of the sales of NARCAN in the third quarter on a country-by-country basis.

And that's -- I am emphasizing that, because it's an important thing to consider.

29:38 That's very helpful. Thank you, David.

And just so I’m 100% clear hear. The 2, yes, I'm just giving you a 2%, I guess, illustrative purpose here.

Is that on the country-by-country basis NARCAN sales, branded NARCAN and authorized generic or just branded NARCAN?

29:56 On both of them. NARCAN sales plus authorized generic.

30:01 Thank you. I appreciate the color.

Thank you, Ronger.

30:13 Hi, this is Carl Byrnes from Northland Capital Markets. First, thanks for taking the question and congratulations on the progress.

My first question is for Matt. And Matt, I'm wondering how you envision the sales force count or target for the launch of 003?

And will you be looking at extending offers to candidates subject to approval, obviously, prior approval? And then what might you add with respect to like field managers and medical specialist liaisons?

And then I have a follow-up question. Thanks.

Carl, I'll jump in and then I’ll let Matt continue that. It’s Roger here.

Yeah, just to say, I mean our commercial plans is we're not going to provide significant detail around numbers at this point. I need to say that the Matt is obviously higher than initial commercial team who are doing tremendous work in the pre-launch world, if you like.

And then given our view of where we see the market opportunity at the moment, the balance between the public interest sector and the retail, again, we're going to be hiring shortly after towards approval and at approval in particular. But this is not like building out a huge sales force like most drugs out there and a lot of it is in and around government affairs activities.

And I think that's where Matt has tremendous experience. But Matt, anything you want to add to that.

31:42 No, I think you covered most all of them. I will just add that, when I built the Adapt sales force or market team to address this market, we had a tremendous amount of learnings, because it is such a unique marketplace and market space with different customer basis.

So I plan on using the same intelligence that we learned way back when. The good news is, we probably won't make some of the mistakes that we made at Adapt early on as I've learned from those.

32:16 Great. Thanks.

That's very helpful. And then, if I can have a follow-up question and this is transitioning back over to NARCAN.

Maybe we can talk just a little bit about the dynamics and the difference in the dynamics in the retail space where you do have a generic and you have an authorized generic, which is the EBS Sandoz products, on which we obviously collect royalties on. And I believe retail is roughly 35 or so percent of the market versus the public sector, where, as I understand it, there is not a launch of the authorized generic and also potential sort of encumbrances for things that may encumbered rather from using a generic in that space, I mean given that 65 or so percent of the market.

Anything that you can help with respective to dynamics would be great. Thanks.

33:09 Matt, I'll let you talk about how you see the retail in particular. I think -- I mean, I think call the overriding point for us is that, this is a product we think has clear clinical differentiation and that in our mind will drive choice and absolutely will people still prefer to use naloxone based products, but we are highly confident that with the data we have, plus essentially the data we continue to generate.

So this is what will drive choice, bearing in mind that both sectors has good retail and then in the public interest sector there is good funding and reimbursement available. 33:54 Matt, you want to expand on that.

33:56 Yeah, that's right. I think you hit all the key elements.

If we get clear differentiation from a label perspective, our objective and our strategy will be to ensure that access is widely available and obviously that it's affordable. And then we'll detail physicians as necessary and by the means necessary to inform them of OPNT003.

34:29 Great. Thanks.

34:51 Hey, good afternoon, everyone. Matt, I have a question about the sale of naloxone in the public health sector.

I guess, I don't really understand the dynamics of that? And then what is going to be the most difficult aspect that kind of breaking into that market with 003?

35:20 Matt, you take that, Matt.

35:24 Yeah. So, in regards to the sale of naloxone in the public interest.

If you could just add a little more clarity in terms of the question that you're looking to learn from?

35:38 So, basically what I'm wondering is, is this something where the EMS units or whatever order they have it on autopilot in order like that so many units per month and it keep refilling every month like that?

35:55 Sure. Okay.

So I think I understand the question now. So, without going through a long process of the distribution flow, basically every state first and foremost is very different, how they order, but for departments of health, for law enforcement, community-based organizations, those types are typically ordered by individuals in the State Department of Health and then product is then funneled out.

Now it's complicated because every state is very different in how they interact. EMS is typically done traditionally through distributors.

There are couple of distributors that supply EMS across the country, which is pretty clean cut, pretty traditional distribution model. 36:42 And then I think your follow-up question was, how we intend to interact and engage those?

And if that's correct the advantages that I've done this before, and had to build out the market with the Adapt team, we've gotten a couple of those folks from the Adapt team on the Opiant Pharmaceuticals team right now. So we know where to go, we know how to access the different market channels and that's effectively what we plan to do.

37:17 Okay. Thanks.

That's helpful. And then, Roger, I had kind of a -- I guess a technical question about the PD trial.

So you're looking at the reversal of respiratory depression. I'm just curious if you can quantify how low these individuals breathing rates get.

So what kind of differences are you going to be looking at there?

37:42 Yeah, I mean it's hard to give you a number at this stage. We have not made that public.

Only to say that in the PD study we are confident we will achieve non-inferiority, but this is a – it’s like an experimental science kind of study that FDA wanted to see. And we can't fully -- in a full scale overdose.

So I think we'll be in a position where we can potentially show meaningful differences which is great, but if anything, what’s going to be really interesting is, in the field once first responders get to use this in a true overdose, a fentanyl overdose, not a remifentanil overdose, that's where I think even more data will generate post approval to show the true differences at that point as well. So headline is, we will – the PD study will generate the data we need for FDA approval and for decent differentiation, which we can build on post-approval.

38:52 Okay, great. I appreciate the answers and for taking the question.

39:07 Thanks again. I was just wondering what your expectations were in terms of grant funding and timing of grant funding, given that the BARDA grant largely funds the NDA submission, that's going to be obviously tied to the timing of the NDA costs associated with preparation of the NDA submission?

And then as a -- another item on cash, you ended with $53 million in cash and $30 million in royalty. So, on a pro forma basis is it safe to assume that your cash balances are really kind of effectively pro forma for the royalties $30 million or in excess of $60.

Thanks.

39:48 Carl, thanks again for the additional question. On the government funding the NIDA grant has been completely funded and we have received all of those funds already as of December 31.

Of the $10.3 million in BARDA funding and that includes the additional $2.2 million that we got, we had already build BARDA $5.7 million. And so that leaves another $4.6 million for this year, including the filing fees.

So that will -- the majority of that would probably be done -- would be built this year, the way I see that. 40:35 And then, your second question, again, was what, Carl, I’m sorry.

40:40 Yes. So you had $53 million in --

40:43 Yeah. I got it.

So we do receive the third -- the fourth quarter royalty in 2022, the fourth quarter royalty in 2022. It's a large number, as you indicated.

As you know, we pay out about 26% of that to our certain investors that invested in the company early on. And so we end up with somewhere around 70% to 75% of that number.

And so, the answer to your question on a pro forma, just looking at the 2 numbers together, yes, that would be the case.

41:27 Excellent. Thanks again.

41:45 Thank you, operator. Thank you for joining us today and for your interest in Opiant.

Enjoy the rest of your day. And please stay healthy.