Q2 2021 Impel Neuropharma Inc Earnings Call
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Ladies and gentlemen walk into the in call me a farm of second quarter 2021 earnings and corporate update conference call.
At this time all participants are in a listen only mode. After the speaker presentation. There will be a question and answer session to ask a question. During the session you will need to press star one on your telephone please.
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I would now like to hand, the conference over to your speaker today.
Impulse, Chief Financial Officer, Mr. John Leaman <unk>, Sir Please go ahead.
Thank you operator, and good morning, everyone. We are delighted that you could join US today for Impella Neuro farmers first quarterly earnings conference call during which we will review our second quarter 2021, and financial results as well as providing a general corporate update joining me from Minto. This morning is Adrian Adams impulse chairman of the board and Chief.
Decorative officer.
Before we begin I would like to remind everyone that we have a slide presentation to accompany our conference call. This morning, which can be viewed at our website at www dot empower N P. Dot com you're listening to this call on your telephone you may access a synchronized slide deck on our website, but she's been a link on our webcast page that says click here.
Listen.
If we can advance to slide two I'd ask everyone to review the forward looking statements and I would like to remind you that during this call. The company will be making forward looking statements that are subject to risks and uncertainties that may cause actual results to differ from the results discussed in the forward looking statements with that I will turn it over to Adrian.
Thank you John.
And good morning, everyone. We certainly appreciate the time you are giving to us this morning.
On this next slide slide number three you will find the agenda for this morning's call.
I will begin with a brief overview of our business on the potential value generating opportunities that lie ahead then.
We will review in a little more detail the commercial opportunity and potential future deaths in the rapidly growing dynamic acute treatment of migraine market, including an overview of our core prelaunch and launch activities and plans.
Following that I'll provide a summary of the market opportunity and outlined plans for another of our development assets <unk> five before turning the call back over to John to review, our second quarter financial results in more detail.
I will then conclude with a summary of recent and upcoming milestones before opening the call up fueled valued questions.
Turning now to slide number four.
On this slide I would like to highlight several points, which we believe illustrates an attractive investment opportunity with impelled Europe pharma.
Earlier this year.
The FDA accepted for review, our new drug application for <unk> for the acute treatment of migraine headaches without without aura in adults, a large and growing market opportunity.
<unk> 104 is dihydroergotamine visa light or D. A cheap.
Live it directly into the vascular rich upper nasal space using impella unique and proprietary pulse technology.
If approved <unk> 104 with market on the trade name <unk> in the United States.
The FDA has set a produce a target date of September six of 2021, which reflects a standard 10 month review time frame and is just three weeks away.
We are planning to launch <unk> early in October with a highly targeted go to market strategy, which will fully leverage existing knowledge experience and a deep support in use with DHA, among neurologists and headache specialists.
I will review this and I won't detail shortly.
In parallel while also advancing our second lead asset <unk> 105, which is being targeted for the acute treatment of agitation and aggression in autism another disease area with significant unmet need.
<unk> will fund also utilizes a unique impella pump technology targeting the upper nasal space.
To further illustrates our focused Potline progress you will see on our next slide slide number five the clinical come to US that we are currently evaluating we believe that the impella pump technology has the potential to unlock the therapeutic viability of a previously untapped treatment pathway the bus.
Asking the rich upper nasal space for a variety of serious medical conditions.
Although we are initially focused on CNS disease or strategic intent is to evaluate its broad utility potential in other therapeutic areas either through internal organic development or through value added corporate developments and licensing activities.
Please refer to our next slide slide number six.
Over the past year, we have kind of I'd say tremendous amounts of both qualitative and quantitative market research, including in depth discussions with key opinion leaders.
Broader health care providers and the patient community all within.
Better understanding what physicians and patients are looking for in terms of an ideal acute migraine treatment.
Patient reported outcomes were a critical part of our pivotal stopped 301 phase III study design on this study produced excellent results.
We are pleased that these study results were just published in the August 7th edition of Headache. The official journal of the American Headache Society. This is perfect timing given all planned October launch timeframe.
We believe that these data reinforce the potential for digestion to be a differentiated well tolerated treatment that subject to approval by the FDA has the potential to deliver rapid and reliable symptom relief for patients with acute migraine and.
In fact, the explorer to date, so short improved and sustained patient reported pain freedom and pain relief rates compared to existing standard of care.
Turning now to slide number seven I would like to illustrate the strong growth that has been seen in the acute migraine market.
At the end of 2020, there were 27 million prescriptions written in this market and impressive growth of 15% year over year.
This robust growth has continued into 2021 and it is important to note that much of this growth is being driven by non triptan therapies and in large part by the neurologists and headache specialist communities.
It is also worth noting that despite the strong growth on the shift away from trip tons there.
Still a lot of turnover and therapies as patients and physicians continue to search for more effective and better tolerated therapy.
This is the opportunity for desktop.
I would now like to summarize our plan go to launch market strategy as shown on our next slide slide number eight.
We will adopt a disciplined commercialization approach and with initial sales force size of 60 experienced sales professionals, we will pursue a highly concentrated prescriber base of around eight terrorism physicians, but are responsible for approximately 35% of market prescriptions.
These positions will comprise of 4000 neurologists.
<unk> thousand high prescribing primary care physicians importantly, our target neurologists account for nearly 90% to 95% of all prescriptions that are written for acute migraine amongst the new Rhonda just community.
These target urologists are important not just because of the strong influence on growth, but also because of the historical and current experience in support of DHT.
But that is recognized as being the gold standard efficacy product for acute migraine treatment.
As we make progress during our initial launch phase we do plan to further invest into this opportunity by doubling the size of our sales force and increasing our reach to nearly 45% of the marketplace.
You will see on our next slide slide number nine that all commercial strategy also includes promoting swift and accelerated payer adoption too early introduction of infill and true dessa.
Five payer organizations. This work has been ongoing just part of our prelaunch efforts and utilizes our experienced medical affairs and market access professionals.
We recognize the importance of developing strong market access and the post trip some failure space.
We've set a goal of approximately 70% of commercial lives covered by the middle of 2022.
In summary, we are progressing well with our prelaunch efforts and our confidence and our disciplined and targeted approach to building share in this large and rapidly growing market.
As we move to our next slide slide number 10, I would like to underscore the broad clinical possibilities that we see with our pulp technology platform on.
On the cusp of the imminent FDA decision with traditional we believe that the pump technology has the potential to deliver numerous additional therapeutics.
The next in line is <unk> 105.
<unk> 105 is comprised of a powder formulation of Olanzapine, which is the most commonly used treatment for acute agitation and aggression, but its use is currently limited to intramuscular injection.
We believe that <unk> has the potential to significantly reduce emergency room visits for patients with autism spectrum disorder.
We can cover this as being a major unmet need as there are.
At least 220000 emergency room visits a year, a large majority of which relate to patients that cannot be controlled in the home setting. Therefore, there is a significant market opportunity to bring a more humane approach to de escalating ingestion agitation and aggression episodes and the <unk>.
This patient population.
As we illustrated on next slide slide number 11 by targeting the upper nasal space in the studies, we've conducted <unk> 105 achieve rapid IV like absorption, which may provide an effective convenient noninvasive future alternative for treating acute agitation and aggression.
And the home community or hospital setting.
These phase one study results of <unk> 105 in healthy adults were published in the journal of clinical Psychiatry last year.
The findings demonstrated that <unk> five reached peak plasma levels approximately twice as fast as intramuscular Olanzapine currently marketed Zyprexa and 10 times faster than orally disintegrating tablets.
An ideal desired medication for acute agitation and aggression in autism. According to a 2005 expert consensus is easy to administer non dramatically administered.
Provides rapid tranquilized nation without excessive sedation.
As a swift onset of action with sufficient duration to prevent holding time late recurrence and as low risk for adverse events and drug interactions.
This is the goal with <unk> five and we are planning to initiate a phase II proof of concept study in the fourth quarter of this year.
With that I'll now turn the call over to John to review, our financial results for the quarter John.
Thank you Adrian on this next slide Slide number 12, you will see our financial results for the second quarter of 2021.
Research and development expenses for the second quarter of 2021 were $6.1 million, which compares with $6.8 million for the second quarter of 2020.
The decrease in R&D spending was due primarily to a decrease in clinical costs post the completion of the phase III trial.
General and administrative expenses for the second quarter of 2021 were $8.9 million, which compares with $6.1 million for the second quarter of 2020.
The increase in G&A was due primarily to the ramp up in expenses for the commercial and marketing activity preparations for the trajectory of launch.
Please now refer to slide 13.
For the second quarter of 2021, <unk> reported a net loss of $15.5 million compared to a net loss of $13.1 million for the same period in 2020.
Net loss per share was $1.10 for the second quarter of 2021 and $35.88 for the second quarter of 2020.
As of June 32021, the company had cash and cash equivalents of $69 million. This cash balance coupled with the debt financing we announced on July 2nd provide the company with a cash runway through the end of 2022.
I would now like to hand, the call back to Adrian who will summarize before opening the call for questions Adrian.
Thank you John.
Final slide slide number 14, I would like to conclude by highlighting our recently achieved an upcoming milestones. This is an exciting and potentially transformative time for inbound.
Tremendous progress so far in 2021, and look forward subject to FDA approval to successfully launching <unk> into the rapidly growing acute migraine market and to initiating a phase II proof of concept study with <unk> 105.
We would now like to open up the call fuel value questions. Operator can you. Please give the instructions.
Thank you and ladies and gentlemen, if you have a question at this time since your profit sorry, Dan.
Our next telephone coupon.
Keith first question.
Our first question comes from the line of Ken Cacciatore Cowen <unk> Company. Your line is open.
Hey, good morning, guys. Thanks for the call just a couple of questions Adrian and wondering if you can give a little bit of nuance on the FDA interaction zipcar in labeling or any color you can provide there. That's my first question and then second question really it's been a fantastic launch for both neuro Tech and <unk>.
The really good success with managed care and what appears to be very solid.
Net value pricing per prescription I was wondering if you could talk about how you feel you'll be able to do is that setting a nice example, or a nice platform in terms of both managed care and pricing.
As we think about <unk> and then lastly, I was wondering if you could comment on views of failure rates between Triptans and <unk> just looks like a massive opportunity a lot of churn still in prescriptions and so I was hoping you could frame the.
The failure rates. Thanks, so much.
Alright. Thank you. Thank you Kevin for the question.
Sure.
The question that's on.
Many minds in relation to higher things are tracking with the with.
With the FDA and.
And clearly I think I cant comment on the specifics with the with.
With the FDA I would say that since our file is accepted for review in January we've had.
A number of information requests as is normal course of business.
With the FDA, we've responded to all of those questions promptly.
And clearly.
And we are looking forward to the <unk> three weeks.
Three weeks time.
In addition, during the call I did make reference to our commercial preparations for.
The early October October timeframe.
We have staff.
The disciplined buildout of our commercial organization we've hired.
Head of sales, we've hired regional balances on during the course of <unk>.
<unk> we are.
Recruiting our 60 person 60 person sales force. So as you well know with the FDA you don't know right up until the end.
I would said all the questions that we've had we've responded in a prompt and timely yet timely way.
On the on the second point on the on Med Tech and your Bellevue I think youre quite right. So we've actually been pleased with the.
With the success that they've had in the.
The marketplace as you'll have seen from our presentation.
That success is manifest in terms of a very high proportion.
Of the market growth that is being driven by non <unk>.
Non triptan therapies.
And clearly I think we're delighted with our growth.
Just to pick up on one of <unk>.
Your last question Alec.
One of the things, but we have noted within.
The marketplace to your point is that there is a tremendous turnover in therapies.
Our estimates are that there are in excess of 50% of patients who are put on.
These treatments.
Tend to either switch away from our drop off therapy.
And.
So what is clear from all of the work that we've done is that the turnover.
And the market is being driven by.
By a desire for enhanced efficacy and enhanced tolerable.
Tolerability.
Clearly, we feel that illustrates the potential for <unk> given the profile of the products is manifest in the stop 301.301 study.
I'll ask John to comment in a moment topic you also ask questions in relation to price in the managed care.
Market access environment.
Clearly.
All of you is but.
A successful product launches dictated not just by what.
What you do at launch, but what you do ahead of launch we have been doing a tremendous amount of.
Information exchange with the.
The top players in the market access space.
We want to have a goal of.
Of around about 70% of commercial lives being covered by the middle of next year, which is.
Roughly what was achieved by some of the newer chief concern not timeframe, we're looking forward actually to exceeding exceeding bounce on the.
Clearly, there's a value proposition, but we have had in the <unk>.
<unk> pads with the with all the interactions we've had to date.
Allowing us to crystallize, our overall pricing strategy with the parts and indeed, a pricing strategy that will give us the flexibility from a discount perspective to offer compelling rebate strategy, but John maybe I'll ask you to comment on that a bit further.
Sure and I think you know as we.
Obviously, you stated as we've looked at the pricing on basically a four pack of prescriptions for true data, we've looked at a range of different pricing that range being somewhere between 600 to let's say 854, the four pack and I think as we've taken a look at the pricing. We believe that we will probably be towards the upper end.
That range as we look at pricing and I would just add that one of our major focus is getting access through the payers and I think Adrian and the team that he's brought on which he has done this several different times I think are making great progress in that.
Great. Thanks, so much real exciting time, so I'll go back in the queue.
Thank you very much Ken for your questions.
Yeah.
And our next question comes from the line of Abbvie Hickman with Guggenheim Securities. Your line is open.
Yes.
Hey, guys. Thanks for taking my questions. So if you go to the approval next month can you talk about what kind of launch metrics you will disclose on future earnings and what you consider the most important sort of launch factors early in the launch and then given your targeted strategy. How quickly do you think you could start to take make a dent in the <unk> Rx numbers. Thanks.
Yes, I think Eddie Thank you very much for your questions on income.
Clearly is just to emphasize I think we are adopting a very.
Targeted disciplined approach too.
To the market.
Just to reiterate targeting those eight parasol and kind of talk.
Target positions made up of predominantly neurologist.
Headache specialists I only repeat that form because.
Clearly, we do believe one key measure.
Our success given the belief we have in this targeted approach is the market share evolution of prescription emulation in that targets the target audience. So the metrics that we're going to be falling in addition to the kind of top line prescription growth from an <unk> perspective is indeed market share evolution.
And that target group, we believe passionately.
But given the.
Strong supports an experienced by the neurologists community or already.
Very very supportive, but the utility.
<unk> in the treatment of.
Of acute migraine.
Measuring the uptake and.
By them.
As Barry.
Very important so so clearly those are going to be very important met.
<unk>.
Clearly over quarter, one of launch in quarter two quarter three as we are evolving to into next year, we want to make sure that we have a very strong start to.
Two the prescription prescription journey that is one of the reasons obviously.
We are investing in prelaunch efforts with the <unk>.
Our market access team with the top Payor.
Population. So so thats, how we will be measuring our success over the over the point and Oh, the first number of number of quarters.
Clearly I think one of the questions.
If you have touched on as well.
Obviously, it's a very competitive.
And we want to make sure that that we have a strong.
Strong uptake and we are putting in place a lot of programs to ensure that patients can get access to our treatment.
Very quickly during the initial launch phase in the fourth quarter.
This year on <unk>.
The early part of <unk>.
Part of next year. So we are putting in place a number of quick start programs, which will ensure that patients while we're building up our market.
Footprint in the market access area that patients can get rapid access to til.
The treatment.
But John do you want to add into those points.
I don't Adrian I think I would just reinforce that you know as Adrian laid out earlier. This 4000 neurologists and headache specialists is our target market, that's where we're looking to drive scripts and I think you know monitoring how we're doing in that space is really going to be key to the success as we launched.
The product.
Yeah, that'd be just one final point so again, thank you for your questions.
The reason that we believe it's really important to monitor success in this target group of neurologists and headache specialists in particular I think.
So they've got to annualize.
Ned referenced area that we've been very pleased with the success.
<unk> you Brad.
To date, despite that success, there's been a lot of turnover in the market.
It is also worth noting that if one looks at all of the prescriptions.
<unk> been written.
Since launch.
On the Aerotech and <unk>.
Excess of 80% to 85% of those prescriptions have come from round about five to five and a half thousand prescribing physicians with a strong predominant predominance amongst the neurologist community that is the essence of our targeting truck and how we intend to grow this product moving forward.
Great. Thank you. So much that can you also just talk a little bit about the pipeline opportunities like a little bit more about what youre thinking about what kind of the trials.
Yes.
Indication and sort of what metrics are looking out there than what that program could look like if these proof of concepts.
Yes, I'll ask John to just comment on the topline of them John.
Yeah. So Andy I think we're looking at an initial phase II proof of concept trial as we've indicated we plan on doing that in the fourth quarter of this year.
That would be patients typically patients who have aggression in.
<unk> they have a stimulus and so in the rate environment, we can test basically our product versus the placebo and we can use basically bipolar schizophrenia scales to basically take a look at.
The improvement in aggression that happens with or without our products I think that will be the first step we plan on having results in the second excuse me the fourth quarter of 2022 with that and then basically the plan would be post those results to move into basically the phase III program going forward, but we'll start with the <unk>.
Concept.
And as Adrian has pointed out you know atypical anti Psychotics I've always worked in ASD.
Giving a much more convenient and I would actually say you know not a shot but the ability to utilize it through the nose and I think caregivers and parents probably like that in this population. So next steps as we said fourth quarter of this year, we will initiate the trial and we'll have results in the second half of 2022.
Thanks, guys I appreciate it.
Thank you.
Your next question comes from the line of Larry <unk>.
Bush Securities Your line is open.
Hey, good morning, guys. Thanks for taking my question I think some of my questions have already been answered, but I guess, maybe one on drug device combinations either inherently a tougher review process, but you have the advantage of being a relatively known quantity here. So I guess in terms of the Pfizer view I'm. Just wondering if you can offer any commentary around maybe it would've been.
The primary endpoints of concerns from regulators towards the NDA submission. Thank you.
Thank you Lauren.
That's a very important question we've asked that.
Quite a number of number of times.
And again I think one of the reasons that we have a confidence in this areas but.
But all the way through development.
With <unk>, we've used the same the.
The same product the same device and until it we've been doing that in consultation and discussion with the with the FDA.
In addition, I think if one looks at the drug component <unk>.
Sourcing that drug from <unk> and vigilant there an FDA approved.
Manufacture the manufacturing for well.
Well over 2025 years and have a good inspection history with the.
With the FDA. So so all of those particular components I think that consistency through development.
Professionalism, I think something which we.
We believe significantly lowers the.
The risk that has been seen with other drug device come.
<unk> combinations.
And I guess a lot of points out of it over the course of the last number of months as we've been.
<unk>.
Answering questions from the FDA in relation to both from a clinical and a.
CMC drug device perspective, we've answered all of those questions.
Promptly.
And clearly and.
I would consider all of our interactions. So far has been normal course of business. So that's how I would respond to.
Thanks very much.
Thank you and I'm showing no questions in the queue at this time I'll hand, the call back to Mr. Adrian Adams for further remarks.
Yes.
Okay. Thank you very much and I would like to thank you all for joining US. This morning, and we look forward to updating you on our continued progress on corporate milestones.
Going forward. Thank you so much for your time this morning.
Ladies and gentlemen. This concludes today's conference. Thank you for participating you may now disconnect have a good day.
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