Q1 2021 Opiant Pharmaceuticals Inc Earnings Call
Greetings and welcome to the Opiate 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. If anyone should require operator assistance. During the conference. Please press star zero on your telephone.
Keypad. Please note. This conference is being recorded I will now turn the call over to your host Ben Atkins you may begin.
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 and Chief Financial Officer, David There too.
This afternoon, <unk> issued a press release announcing financial results and providing a business update.
The three months ended March 31st 2021.
Please note that certain information discussed on the call today is covered under the safe Harbor provision for the private Securities Litigation Reform Act.
We caution listeners that during this call <unk> management will be making forward looking statements.
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 <unk> news releases and SEC filings, including in our annual report on form 10-K for the year ended December 31st 2020 and subsequent filings.
This call also contains time sensitive information.
You're right I didn't really as of the date of this live broadcast May 11 2021.
And at times it takes 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'd like to turn the call over to Roger.
Thanks, Ben and a very warm welcome to you all.
I'll begin by offering a brief corporate update.
Then hand off to David O'toole, Chief Financial Officer to provide an overview for the financial highlights.
Our mission is to transform the therapeutic treatment of addiction and drug overdose.
So doing help more patients and drive the future growth of our company.
Our priority is O P N T 003, nasal nalmefene for opioid overdose.
About 180 people are dying every day from an opioid overdose in the United States higher than ever before.
80% of these deaths due to elicit synthetic opioids, mainly fentanyl.
We used therapeutic ideas are needed to save more lives and we believe nalmefene has the potential to be particularly well suited to treat synthetic opioid overdose.
I will discuss the growing opioid epidemic on what differentiates Oh pmt's areas anyway right.
Yeah.
First I'd like to provide an update on the status of our P. N T zero day its redevelopment program.
In 2021, our focus is on execution and expanding on the robust body of data in support for OPM Ts areas area three.
I'm pleased to report that we are making important progress.
We have fully enrolled.
There are close to completing our confirmatory pharmacokinetic study.
We look forward to reporting topline data from this study in the next few months.
In addition, we have.
That was the first subjects in a head to head clinical Pharmacodynamics study.
Jeremy the effectiveness.
P&C is there was there were three nasal nalmefene with nasal naloxone.
In this study, we muddle of respiratory depression, using the synthetic F. D. A approved opioid revenue fentanyl in healthy volunteers.
We expect to report top line data in the fourth quarter.
For the drug development activities are also on track for an NDA filing using the 505 P. Two regulatory pathway by year end or early first quarter 2022.
Further reflecting our progress in March we were awarded the third and final tranche of $1.8 million from the total grant of approximately $7.4 million from neither support the advancements of OPM T. There is a very three.
As a reminder, the developments of OCA in CS areas area. Three is also supported by BARDA.
With that I'd like to provide some further context on how we arrived at this point in the evolving opioid crisis and in our development of opiates easier day right right.
About eight years ago, we saw an opportunity to help save lives from opioid overdose.
We developed narcan nasal spray, so any bystander could administer potentially lifesaving medicines to a victim.
In 2018, the U S surgeon General Jerome Adams encouraged people to carry Narcan wisdom, I think that in some communities when finding someone unconscious you would more likely need to administer narcan than Carryout C. P. R.
When we developed the narcan nasal spray.
The lockdown overdoses with commonly linked to prescription opioids and heroin.
Today, we face an entirely different class of opioid.
This is Lee made synthetic opioids, particularly fentanyl.
And new data released by the C D C.
Yes.
So your implicit for synthetic opioids, and then particular Sentinel were up 55 per cent to 53877. During the 12 months ended September 2020.
That figure compares to approximately 10000 deaths in 2015, an illustration of how firm the Sentinel has become entrenched and Americas illicit drug supply.
Fentanyl uncertainty synthetic opioids differ from opiates.
First they are more or less for silica.
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 gives the user a fast and intense high.
I have a too much for fentanyl entering the brain will also rapidly suppressed breathing, leaving leading to overdose.
Depending on the circumstances surrounding the overdose. This can take seconds to a few minutes.
The second differentiation or the sustained effects of synthetic opioids like fentanyl.
The law zone loss between 30 to 90 minutes of Fentanyl has a plasma half life of about seven hours.
It is possible that as naloxone levels for both defense and low levels for a more slowly the victim can sink back into an overdose known as re Narcotize Asian.
Most of 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 S teams and in December public Health advisory by the C. C. D. C. Collectively confirm multiple doses of naloxone are likely necessary to revive an overdose victim and that's further doses could be needed to.
Void of recurrence.
It just is medical insight. This is driven assets open to explore alternative molecule to naloxone.
Based on its pharmacological characteristics and the compelling data from a pilot PK study.
I N T 003, nasal nalmefene could prove uniquely suited street synthetic opioids in three important ways.
Yes.
First nalmefene has a higher affinity of the opioid receptors done naloxone, which makes oh pmt's areas. There are three more potent.
Second Nalmefene has a longer half life, which as I explained before reduces the potential for re narcotization.
Third we formulated O P N T zero three for rapid absorption by incorporating <unk> 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 opioids, including Sentinel.
We believe Opn T series L. Three has significant potential to treat synthetic opioid overdoses and look forward to the availability of the consummated a PK and PD data in months ahead.
With that I'll now move to the rest of our pipeline.
We continue to progress our I N D, enabling work with the National Center for advancing translational sciences to formulate opn's, he's very very for Duane event.
Human studies for acute cannabinoid overdose.
We expect to complete this work in 2021.
Regarding O P. N T. There is there to nasal naltrexone for alcohol use disorder.
For the start of our planned phase III study due to the COVID-19 pandemic in Europe.
So this study remains on pause and we are assessing the optimal time to proceed.
In March we were pleased to welcome seasons clinical development executive Dr Lorie, and master broker to our board of directors.
Her extensive experience successfully expanding the depth and value of the development pipelines of several biotech companies will be incredibly valuable to open as we further advance our mission to develop new medicines for the potential treatment of addiction and drug overdose.
With that I will now turn the call over to David.
Discuss the finances David.
Thank you Roger.
For the three months ended March 31, 2021 re recorded approximately $6 4 million in revenue compared to approximately $4 3 million during the corresponding period of 'twenty 'twenty.
This includes $2 1 million in grant and current contract revenue, which is an increase of approximately 2 million over the same period in 2020.
And illustrates the significant development efforts made in this first quarter for <unk> 003.
We also recorded approximately $4 3 million of revenue from our license agreement with emergent bio solutions or E. P. S for the sale of Narcan compared to approximately $4 2 million in the same period of 'twenty 'twenty.
First quarter 'twenty three.
2021 sales of Narcan, where 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 <unk> P. M. P 003 names.
Nasal nalmefene for opioid overdose.
We also had an increase of approximately 100000 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 1.11 million for pre commercial efforts related to O. P. N T zero zero free this compares to approximately $1 1 million in the first quarter of 'twenty 'twenty.
Keeping our sales and marketing expenses and general administrative costs as cost constant this quarter versus the same quarter last year.
Straights, our continued effort to control cost as we do our important clinical work for O P. N T 003.
Royalty expense for the three months ended March 31, 2021 was approximately $1 million compared to <unk> 9 million for the comparable period of 2020.
Interest expense was 537000 for the three months ended March 31, 2021 compared to zero for the comparable period of 'twenty 'twenty.
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 66 cents per basic and diluted share.
This compares to a net loss of approximately $1 7 million or a loss of 40 cents per basic and diluted share for the comparable period of 2020.
As of March 31, 2021, O P and had 56 million in cash cash equivalents in marketable securities.
The current balance does not include the full impact of the night, a 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 Opn T 003.
Lastly, based on the mid range of the full year 2021 guidance for sales of Narcan nasal spray.
Suddenly reaffirmed by E. P. S 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 markets marketable securities of approximately $40 million, which will not include any receipt of additional tranches of the existing convertible debt facility.
Thank you and with that let me open up the call for questions operator.
Thank you we will now be conducting a question and answer session.
If you would like to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question queue. You May Press Star two if you would like to remove your question from the queue.
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Our first question comes from Brandon Folkes with Cantor Fitzgerald. Please go ahead.
Hi, Thanks for taking my question and congratulations on all the progress during the quarter and three quick ones for me maybe can you just provide any color as yours are three trial enrollment.
I guess.
Hopefully living with COVID-19 and lots of cash.
Just any color there.
Maybe just standard or is there any.
Any thoughts on the recent hikma approval and market dynamics in I would say to for.
For inflation of your product to that right and then lastly, yes.
Given the increase.
Oklahoma problems, that's like during the day.
Quarantine does that change your view in terms of how quickly you want to expedite and alcohol product. Thank you.
Okay.
Thank you Brandon and thanks for the questions.
In terms of the 003 trial enrollment.
This is in healthy volunteers, sorry for all that remains unresolved then.
The enrollment.
Enrollment itself is overall gone well so far we had a momentary pause I think a couple of weeks because of the pharmacokinetics study.
Being conducted in a facility in San Antonio, Texas, where you recall day.
Severe weather issues, which are power supply to the facility. So that for example cause day small pause, but overall the enrollment is going as planned the cash.
On the Hikma approval headline as we welcome more innovation in the space of opioid overdose.
And we said all along that I remain to invest that every day.
Market is growing more reversal agents are needed there is a place for narcan.
Might be a price for hikma products as well as a result, we believe nevertheless is that okay.
So what we're doing with nasal nalmefene, we don't believe it's sufficiently differentiated from the narcan nasal spray compared to the differentiation. We think we can provide with 003 and we hope that we get the data support this.
The.
Issues around au day alcohol use disorder, absolutely. This just reiterate the urgency through which we'd love to see this program be successful.
Let's not forget that even prior to COVID-19.
Actual deaths from alcohol use disorder in this country exceeded opioid overdose deaths. It is a complex disease. There are S. T a.
Approved drugs on the market. We don't believe any of them are sufficiently comprehensive to address all patient needs in this space, which is why we also.
Keen to.
Kick off this phase two study however, we want to do it in a way that will allow us to complete the study and the most efficient manner. So that's the reason to not yet still kick it off thank you for the questions.
Great. Thank you very much.
Next question comes from Carl Byrnes with Northland Securities. Please go ahead.
Thanks, and congratulations on the progress with respect to all O for journeyman do you have a target I N E filing date.
And what would be your expectation first in humans after the N D. A.
Was made valid thanks, and I have a follow up as well.
So if there's areas are for Trinidad, yes, we will provide more.
Details on the timing of the actual first in humans in filing that IND day. Once we successfully completed the re formulation.
But I.
In general upon the successful reformulation I envisage a few months it will take between that and finding that.
Getting the data finding value in day, and then a few months to actually initiate the clinical study so aiming for a 2022.
Proof of concept clinical study in humans.
Great. That's 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.
I don't have the exact number but I would say the majority of it is still available.
You recall, we were just granted an additional $3 5 million in in December.
And almost all of that will be used in the next.
I would say eight to nine months.
As you said most of that was backend loaded.
For reimbursement of expenses through the NDA filing.
Great. Thank you.
Once again, if you would like to ask a question. Please press star one on your telephone keypad. Our next question comes from David bouts with Zacks small cap research. Please go ahead.
Hey, good afternoon, everybody. So I've got a few questions on the PD study.
The first one so you're using a three milligram dose of Nalmefene in that study. So is that going to be the dose that is commercialized and then also how is 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 a nasal nalmefene is active versus nasal naloxone.
Thank you David So there's the dose selection arose from a combination of some initial PK work, we did on nasal nalmefene for the pilot study.
That was very directional insights from this dose alongside of the interaction with the FDA to get the preliminary support on this dose going into the study.
This study is going.
Be powered for statistically significant outcomes.
And that's been in consultation with the perfect.
Statisticians the CRA CRA.
CRA, we're using this study as well.
And your question you is around where we also.
Evaluation that you said the long half life is that was that the.
Question, Yes, yes, yes, yes.
That's also part of the study design exactly as to try and determine whether there's a difference in those two outcomes.
Okay and for the alcohol use disorder study is there anything in particular that you're looking for or what you want to see before you want to get the study underway I mean, I'm, assuming it's delayed because of COVID-19 and all that I mean are you looking for vaccination rates or you know what are you looking for before you want to get that study up and going.
There's no specific.
There's no one specific aspects of COVID-19 is.
Main driver.
And when we look at low rates in particular, not just Europe I rule out 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 western Europe.
That is a taken a consideration.
Asian rates alongside the overall rates.
19, so it's getting not just for.
Our view of what things are like today, but the key thing is can we see the study through to completion and be confident that there won't be a says that might impact matters. So thats also a factor.
Okay, Alright, great well I appreciate you taking the questions.
Once again, if you would like to ask a question. Please press star one on your telephone keypad.
Okay.
Okay.
Okay, I would like to turn the floor over to Roger Crystal for closing remarks.
Thank you operator, thank you for joining us today and for your interest in O P N. We.
We had an extremely busy start to 2021, and we look forward to an exciting remainder of the year during which we expect to update investors on a series of important clinical and regulatory milestones.
Enjoy the rest of your day and please stay healthy thank you.
This concludes today's teleconference. You may disconnect your lines at this time and thank you for your participation.
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