Q1 2022 Aerie Pharmaceuticals Inc Earnings Call
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Good afternoon. Thank you for standing by and welcome to the Aerie Pharmaceuticals first quarter 2022 earnings conference call at this time.
All participants are in a listen only mode.
Later, we will conduct a question and answer session and instructions will follow at that time.
Today's conference call will be recorded it is now my pleasure to turn the floor over to Hannes midst of lifestyle partners Arris Investor Relations firm. Please go ahead.
Thank you operator, good afternoon, and thank you for joining us with US today are Raj Kannan, Chief Executive Officer, Peter Lang, Chief Financial Officer, and Garry Sternberg Chief Medical Officer. Today's call is also being webcast live on our website investors dot area.
<unk> dot com and it will be available for replay as indicated in our press release now for forward looking statements and non-GAAP financial measures.
On this call we will make certain forward looking statements, including statements forecasts and observations regarding our future financial and operating performance, including our observations regarding ongoing operating expenses. These statements will include observations associated with our commercialization of Rhopressa and <unk> in the United States and our.
<unk> in Japan, Europe , and other regions of the World. It will also include plans and expectations regarding the success timing and cost of our clinical trials.
Additionally, we will discuss progress regarding maintaining requesting or obtaining approvals from regulatory agencies of our products and product candidates along with the associated business strategies regarding these products and product candidates. Finally, we will address our financial liquidity and other statements related to future events.
Including our financial outlook for 2022 these.
These statements are based on the beliefs and expectations of management as of today. Our actual results may differ materially from our expectations investors should carefully read the risks and uncertainties described in today's press release as well as the risk factors included in our filings with the SEC we assume.
No obligation to revise or update forward looking statements, whether as the result of new information future events or otherwise. Please note that we will file our Form 10-Q tomorrow.
In addition, during this call we will be discussing certain adjusted or non-GAAP financial measures for additional disclosures relating to these non-GAAP financial measures, including a reconciliation to the comparable GAAP measures. Please see today's press release, which is posted on the Investor Relations section of our website.
With that I will now turn the call over to Raj Kannan, the CEO of Aerie.
Thank you Han and good afternoon, everyone.
I am pleased to speak with you on the excellent progress we've made in advancing Aerie version two point, though and why we remain confident about our growth in 2022 and beyond.
During today's call.
I will provide you with a high level update on our first quarter commercial performance.
Our outlook for 2022, and an overview of our progress to date against the three strategic pillars outlined previously.
Then I'll ask Gary to provide you with an update on our late stage clinical portfolio.
In particular.
Getting prospects with <unk>.
And finally, Peter will review the first quarter 2020 group financials.
Before I close with a few remarks.
We made significant progress across several fronts in the first quarter for aerie.
We continued to execute well on our three strategic pillars in building Aerie version two point out.
We delivered strong year over year revenue growth in line with our expectations.
Our first in class glaucoma franchise comprise of the novel products <unk> and Rhopressa.
We achieved alignment with the FDA on the Phase III program for our lead product candidate <unk> 15, probably one two for dry eye disease.
We initiated a phase <unk> program supporting rock with Ham.
We continued to drive operational efficiencies to reduce net cash burn.
And we strengthened our senior leadership team with the addition of Dr. Gary Sternberg, Chief Medical Officer, and Peter Lang, Chief Financial Officer, who are with us on this call.
We believe these achievements taken together.
Aerie upwards exactly 2022 and beyond.
During our February call.
Produce the three strategic pillars for our long term success.
First driving sustainable growth of the commercial business.
Two making smart choices with our capital and advancing our pipeline.
And three reducing our net cash burn rate to maintain its amit.
Angel position.
These pillars are built on a foundation of attracting and retaining the right talent and leadership to support sustainable growth, which has been strengthened by the appointment of Gary and Peter.
Taking them one at a time sustainable growth of the commercial franchise.
We reiterate our full year guidance for rocket tenant brokers that sale of $130 million to $140 million, which represent a 16% to 25% net revenue growth over 2021.
I'll elaborate more on the commercial performance in a few minutes.
Making smart choices with our capital and advancing the pipeline.
We prioritize three program based on our assessment of likelihood of approval.
Potential value inflection in the near to mid term and the speed to market.
<unk> for dry eye.
<unk> for diabetic macular edema, or dnb and <unk> for wet age related macular degeneration or wet AMD.
<unk> two is scheduled to commence phase III trials in the second quarter of 2022.
We believe <unk> could have a very competitive profile.
In the dry eye market.
Dr <unk> could potentially replace the currently available steroid treatment for <unk> with a one every six months dosing intervals.
And <unk> all three four is on track.
IND submission later this year with the potential of a 12 month dosing interval with a best in class tyrosine kinase inhibitor exceeded them.
And third reducing our annual burn rate one of my ongoing priority is to continue driving greater efficiency in our ongoing operations.
<unk> cash and optimized capital allocation decisions.
Number one you will recall that we introduced a refreshed brand strategy for our commercial glaucoma franchise in February of 2022 with a focus on the lower is better team.
This has generated encouraging early feedback from the customer facing team, calling on targeted prescribers, who say the clarity on where to use rocket 10, aligns well with the medical need and the product profile.
Our goal is to drive powerful efficacy right from the start as a primary reason for brand choice.
We are doing that by calling attention to the fact that <unk> is highly effective in lowering IOP.
Potentially getting patients to the lowest risk of vision loss right from the start.
So why not start with the most powerful efficacy from the start or start with Rockwood Tan as our key message to prescribers.
Rhopressa on the other hand continues to be well positioned on its novel mechanism of action and why that matters.
Given the encouraging feedback from our customer facing team on what they hear from their customers.
We believe that the differentiated efficacy and good safety profile.
<unk> positioned with a clear reason to prescribe these products and.
And we believe that this refresh brand strategy could be the cornerstone to our commercial growth going forward.
And number two.
On the increased pull through opportunities available to us today.
Our broad formulary coverage, especially in the Medicare book of business paved the way for increased pull through opportunities to drive greater adoption for our brands.
In summary.
We're pleased with our first quarter commercial glaucoma franchise growth and we believe that the updated brand strategy with greater clarity and positioning and refreshed messaging.
And increased pull through opportunities on a broad formulary coverage could position area to achieve our revenue growth targets in 2022 and beyond and.
And importantly fund our journey to a bright future.
Before I move on I want to take a moment to thank the entire <unk> team for their performance dedication and commitment to the company's goals throughout the first quarter of 2022.
Let me now turn the call over to Gary Our Chief Medical Officer to continue building on the reasons for our excitement about the future for Aerie Gary.
Thanks Raj It is great to have joined and be part of the <unk> team.
I'm going to review the clinical pipeline and then briefly provide updates on ongoing global studies, our medical Affairs program and close with an update on some of our recent medical meeting presentation.
Our 15, five two or $5 12 is entering phase III development of a differentiated novel first in class product candidate for the treatment of the signs and symptoms of dry eye.
While there are a number of prescription and OTC products on the market for dry eye. We believe there is a significant unmet need for new therapies that can provide rapid onset of efficacy convenient dosing and importantly, consistent improvements across a range of signs and symptoms and quality of life endpoints.
As you know.
<unk> hundred 12 is a triple agonist, which acts as a coke thermal receptor modulator to stimulate the cold sensing receptors found on the nerve endings and innovate the cornea an island.
By stimulating these receptors 512 leads through natural tear production and a cooling sensation across the surface of the eye that may result in a reduction in dry eye symptoms.
As background I want to make two points about the results of our phase <unk> trial named comment one that we reported in September 2021.
First while our chosen primary endpoints were not achieved we showed statistically significant dose dependent improvements on multiple validated signed symptom and quality of life endpoints across multiple time points importantly, we generally saw the difference between the $5 12 in the vehicle responses increase over time.
Pointing to a potential sustained meaningful treatment effect in dry eye signs and symptoms.
We also reported a good tolerability profile with no systemic or serious adverse events attributed to $5 12.
In February during our conference call regarding the fourth quarter financial results. We reported that we had gained alignment with the FDA on our phase III endpoints and overall program, which will consist of two identical phase III Registrational efficacy studies on a 12 month long term safety study.
To mitigate the risk of variability from phase II to phase III results. Many aspects of the clinical trial design from the Phase <unk> study were kept consistent in the upcoming phase III comment too uncommon III studies.
The first of the phase III efficacy studies comet two will be a multicenter vehicle controlled double masked randomized study that will evaluate a single concentration of Ah <unk> at 0.00% to 3% compared to the 512 vehicles administered twice daily for 90 days.
<unk> is expected to enroll about 460 participants at approximately 20 sites in the United States.
The primary measure over the comet two study will be assessed by the anesthetized Schirmer test at day 14, which as you will recall was statistically significant in the phase <unk> study.
The key secondary outcome measure will be the sandy symptom questionnaire score at day 28, which was also statistically significant in the phase III study.
In addition, numerous other signs and symptoms and quality of life assessments will be performed throughout the 90 day study period.
We expect to enroll the first subject in the second quarter of 2022, and we expect the trial to yield topline results in the second half of 2023 now.
Now I would like to mention two other exciting pipeline programs <unk>.
<unk> hundred <unk> for diabetic macular edema, or DMA and AAR 14034 for wet age related macular degeneration or wet AMD.
Let's start with <unk> hundred five.
This was the first product candidate to use areas print delivery platform and the only buyer audible dexamethasone retinal implant to demonstrate six months of efficacy in treating macular edema.
These differentiated product features could enable reduce injection frequency and potential to position <unk> hundred five as a best in class molecule. We continue to evaluate options for phase III development of <unk> hundred five and our partnering discussions underway.
Second a 14034 is a pan VEGF receptor inhibitor intended to block all veg F receptor isoforms for the treatment of wet AMD.
14034 also uses Ares print platform and is targeted to achieve an injection dosing frequency of up to once every 12 months.
We expect to file an IND for <unk> 1403, or four by the end of 2022.
Moving to our glaucoma.
Well I would like to spend a few minutes on our global studies at medical Affairs initiatives.
These studies are intended to continue strengthening the product profile and supports the generation of meaningful clinical data to improve patient outcomes.
Starting with our global studies in February 2022, we reported that our partner and have initiated a second confirmatory phase III study with Rhopressa required for approval in Japan.
As you know Samsung is taking the lead on next steps and preparation for registration based on Santander disclosures, we expect to complete phase III studies in 2023.
Moving to medical Affairs.
Pleased to note that Aerie continues to have a strong scientific presence at major Congresses we.
We had recent strong showings at the American Glaucoma Society or Aes American.
The American society of cataract, and refractive surgery or <unk> Crs.
And most recently at the association for research in vision, and ophthalmology or ARVO.
All of the abstracts from these meetings are posted to our website once they're published at.
At Crs two weeks ago. They represented two abstracts related to a clinical study evaluating the use of Rhopressa and <unk> dystrophy and.
In detailing the clinical data from the phase <unk> study in dry eye in.
In addition in May 10 abstracts related to the glaucoma franchise were presented at ARVO.
These abstracts up to elaborate on the clinical utility of Rhopressa in glaucoma management, and the potential of Rhopressa and other ocular indications Adair.
Additionally, at ARVO, Erik presented aspects related to our <unk> two dry eye program as well as a preclinical abstract related to our novel Rockstars ocular anti inflammatory program.
We are gratified with the ophthalmology community is active interest in our pipeline.
Lastly, I am pleased to inform you that we have initiated a phase <unk> study with Rockwood 10 in the U S. While the multicenter open label Rockwood <unk> evaluation or more study.
The study was designed to further demonstrate the powerful efficacy of Rockwood <unk> as a single therapy relative to the use of Latanoprost alone.
<unk> plus additionally, one or two individual agents.
The first subject in this planned 180 subject 12 week dosing study was enrolled in March and we expect topline data to be available in the first half of 2023.
I'd now like to turn the call over to Peter.
Thanks, Gary as you expressed before I'm also excited to be part of the <unk> family.
Focus my comments on our financial results for the first quarter of 2022.
All numbers that I will review in this discussion will be approximate for easy sharing during the call.
For additional information regarding our first quarter results and prior period comparisons. Please refer to today's earnings release, and our Form 10-Q, which we will file tomorrow.
Combined Rhopressa and Rocco 10, net revenues in the first quarter of 2022 totaled $29 8 million, a 30% increase over the first quarter of 2021.
Total costs and expenses include cost of goods sold of $6 8 million.
<unk> $31 $5 million of selling general and administrative expenses and $25 two.
$2 million of research and development expenses.
Our cost of goods sold was essentially flat compared to the first quarter of 2021.
Our gross margins improved to 77, 3% from 78% in the prior year period, mainly driven by increased utilization during the quarter.
SG&A expenses reflect in investment in sales and marketing for our glaucoma franchise.
Overall, we expect SG&A to decrease for the remainder of 2022.
R&D expenses include continued investment in our clinical programs plus an $8 million milestone payment made in the first quarter of 2022 related to 512 <unk>.
As discussed earlier, we expect to start a phase III clinical trials for <unk> hundred 12 in the second quarter with additional trials commencing in the second half of 2022.
Therefore, we expect an increase in R&D costs due to the end of the year.
Our first quarter of 2022 net loss was $35 9 million or <unk> 76 per diluted share.
Total stock based compensation expense was $4 6 million of which $2 million was included in cost of goods sold $3 1 million in SG&A and one $3 million in R&D.
When excluding stock based compensation expense, our total adjusted net loss was $31 3 million or <unk> 66 per diluted share.
Over the quarter the weighted average shares outstanding was 47 5 million as of March 31, 2022 shares outstanding were approximately $48 6 million.
For the first quarter of 2022, our net cash provided by operating activities was $61 9 million, which includes $90 million received from Janssen relating to the December 2021 and licensing agreement.
As of March 31, 2022, we had $199 2 million in cash cash equivalents and total investments.
As Raj mentioned, we are reiterating our previously provided 2022 financial guidance.
2022, net product revenues for the glaucoma franchise are expected to be between $1 30 and $140 million.
Yes.
Net cash used is expected to be about 15% below 2021.
We believe we are well positioned financially to fund our current business plan.
Now I would like to turn the call back to Raj for a few closing remarks before Q&A.
Thank you Peter.
To conclude I believe we are off to an excellent start in 2022 for aerie.
In 2022, we expect to deliver continued revenue growth in our glaucoma franchise.
We expect to advance <unk> two to the phase III Registrational studies as was outlined by Gary and we continue to make headway and expense reductions to strengthen our balance sheet.
We're excited about building Eric version, two point out and I believe we have the right products the right plan and the right talent to be successful in growing areas sustainably for the future.
Thank you all for taking the time to join US today I look forward to the year ahead with confidence and and updating you on our progress along the way.
Joining us for our Q&A will be Casey Kopczynski, our chief Innovation Officer, and head of research and external innovation and Jeff Calibrating, our principal accounting officer.
Operator over to you for Q&A.
Thank you.
To ask a question you will need to press star one on your telephone again that is star one to ask a question to withdraw your question and just breast Bankey. Please limit yourself to one question and one follow up.
And that while we compile the Q&A roster.
Your first question comes from the line of Louise Chen from Cantor. Your line is now open.
Hi, Thank you for taking my questions here. So first question I have for you is do you expect any of these macro headwinds like inflation supply chain issues to impact your business for the remainder of 2022.
And then the follow up question I have is what is your cash runway and what are the pushes and pulls in your cash balance. Thank you.
Hi, Louise.
Thanks for your question this is Raj.
In terms of the macro.
Right now in terms of inflation.
From a production standpoint, we are seeing some increases on our energy cost for example.
But at this time, we haven't seen any material impact, but we continue to monitor that and in the supply chain again at this time, we are monitoring all of those including our backups to make sure that we don't run into a supply chain problem, but it's kind of hard to predict.
What it's going to be as the year progresses, but at this time I can tell you that nothing has impacted anything materially.
From a business perspective.
In terms of the cash runway.
We did.
Didn't give guidance per quarter, but I can tell you that base.
Based on the cash balance that we had we basically had provided guidance in terms of our net cash burn which is around 15% less in 2021 around that $85 million to $86 million this year.
Given the revenue increase that we're going to see given the increasing.
The focus that we have in reducing our cash burn and the.
Potential.
Monetization that we could have an ex U S markets with our assets.
I have said this before that we have no plans to raise cash.
From a capital markets perspective.
We are very comfortable supporting our current operations and.
That's the best I can I can answer that question Louise.
They are providing you an actual cash guidance.
Thank you.
Your next question comes from the line of <unk> <unk> from Needham <unk> Company. Your line is now open.
Hi, good afternoon.
I guess my first question regarding Rhopressa and <unk>.
You really reiterated your.
Sales guidance of $130 million to $140 million.
Is that.
Based on just script growth or do you expect any improvement in net prices for the products and then secondly.
Figure also reiterated.
One of your pillars was reducing the cash burn rate.
Curious what is on currently on the table two.
To address that.
Especially on the SG&A side. Thank you.
Hi.
This is raj thanks for your questions.
<unk> continued to reaffirm that guidance on 130 $240 million and if you recall that represented about a 16% to 25% increase over 2021, and if you look at the first quarter 2022, we had a growth of about 30% over a similar period in 2021. So we continue to be confident and it is.
Predominantly driven by prescription growth in fact, the <unk> 2022 growth was predominantly from transaction growth.
In terms of.
I think I didn't get the question Serge.
Sure.
Yes.
The third pillar of reducing your burn rate for 2022, and what options around the table to achieve that goal.
Yeah. So if you look at our first quarter.
Cash net cash burn obviously, the first quarter tends to be much higher.
So the cadence of spend so when you look at the one time milestone payment that we had to make for <unk> going into phase III, you have got bonus and some severance payments in there we're quite comfortable with the guidance that we've provided in terms of reducing our net cash burn from 2021.
Which is the guidance was around the $85 million to $87 million.
And net cash flow. This year. So we remain confident on that guidance search.
Your next question comes from the line of Annabel Sammy from Stifel. Your.
Your line is now open.
Hi, Thanks for taking my question congratulations on.
And you can start there I guess relative to everybody else, who sees a lot more seasonality but.
Maybe you can talk about.
He managed a little bit so you did describe could touch on how.
The lower is better as well.
It resonated with people.
How much of it is the marketing message is working versus just increased experience with the drug and are you starting to see initial additional prescribers.
More of that Youre going deeper into their practices. So maybe you can actually talk about the prescriber growth that you have.
The metrics shared about 10000 targets.
Weekly prescribers.
Et cetera et cetera. So do you have any metrics like that to help us understand whether the message is bringing on new prescribers.
Yeah, Hi, Annabel, Thank you for that message and thank you for the call.
Comment on our performance.
In terms of the marketing message I believe it's a little too early to indicate but that is what has driven prescription growth in <unk>, especially for the results that we provided recall that we rolled out that marketing message in early March the reps got trained ended February but I can't say, it's a combination of many things right. The initial deal.
The physicians are continuing to have the positive feedback that patients who remain on rocket tenant rhopressa.
I think these are all factors in why we see continued strong growth in our franchise.
When you look at other indicators, we have incrementally more number of prescribers in the first quarter of 2021 2020.
This is the fourth quarter of 2021, and we continue to expand both on the breadth of prescribers, both monthly and weekly so when you look at the overall target of ophthalmologists that we call on.
Is about the top 50% to 60% of the highest potential ophthalmologist, we continued to see an increasing breadth of prescription use and increasing depth. So.
Again from from.
A little too early but our message like I said in the press release.
And in my prepared remarks, the initial feedback from prescribers from our field force.
Has been quite encouraging.
Very distinct positioning for rocket Tan asking for price line of first switch business and positioning Rhopressa and.
In MLD perspective, and potentially as an adjunct but really asking for the business in Iraq with him and Thats, what we see.
In terms of at least the initial growth in 2021 'twenty two sorry.
Okay, if I can ask one more.
How should we think about sales progress.
I know that it's more of a stage rollout.
And now that you have the phase three.
I guess agreement on design for 11, five currently see any partnership progress.
In the near future.
The phase III design, a gating factor.
Yes. So we are we are having conversations were not.
At a point where I could.
Actually update the market.
And in meaningful way, but we are getting an interest.
And there are parties in the data room.
But at some point I hope to update the market because we remain excited about 11 O buy it as a proof of principle in terms of our print platform.
Getting a product with an extended dosing delivery versus the current standard of care with with the steroids.
In.
DMA.
And more importantly, I think you know this.
Potential potentially replace that rate. So we remain excited about that product and we continue to have.
Robust conversations with interested parties, who could develop it and take it to market.
Okay.
In terms of the EU rollout for the glaucoma franchise.
So right.
Right now I think we had said publicly annabel we're committed to supplying Phantom. So Lee I think at this point in time.
<unk>.
Two.
The launch.
In early 2023.
So I think we will update you if it happens earlier, but all all our efforts are to make sure that they have commercial supply.
The allowance to start strongly in.
Early 2023.
Okay. Thank you.
Thank you.
Your next question comes from the line of Steve <unk> from Cowen and company. Your line is now open.
Hi, good afternoon, thanks for taking our questions and congrats on the progress.
So our first one.
With this improved managed care experience.
Part of that sales force new strategy, increasing clinician awareness there is seamless access.
Bill any friction left over there.
So what has been kind of that experience so far.
As well as any commentary about that first line use of Rhopressa rocket hand that yet you spoke about in your prepared remarks. So that's the first question.
Second is if you could discuss the broader glaucoma market dynamics.
With the introduction of generic comp again would there be any implications to managed care as we're seeing these really strong net pricing. Thank you.
Thank you Stacy for your comments and for your question.
I think when you look at our Medicare coverage, we have very strong formulary coverage for Rhopressa, and especially rocket patented.
Mid Seventy's and I think.
Rhopressa is in the mid nineties. So I think we have very good coverage in which to position ourselves port pull through opportunities, especially in the Medicare population, which as you know represents about 60% right. So in that we're very focused right now with our field force to pull through on that particular business.
And.
I think the first lined our label is quite broad so from a payer perspective, we did not see any pushback in terms of that positioning and physicians do like.
Hear that message in terms of a crystal clear positioning for Rockwood Pan, especially given that we're trying to talk about why not use the most efficacious product right from the start so we're continuing to see.
Improved positive perception of <unk> in first line and if that first line doesn't happen remember the biggest bulk of the business lines in patients who are on Latanoprost and then asking for the switch rate. So hopefully our our bet is that our messaging is right. Our strategy is right and that should continue to grow the rockwood.
Friction and grow the franchise overall.
In terms of the generic observation of Com began what we've seen to date is that it has a.
Basically taking share from the branded molecule it hasnt really impacted.
From a crossover perspective than any other brand. So the data so far only tells us that <unk> has gone generic but it hasnt really impacted any other brand, including the franchise and from a payer perspective I don't think.
This won't necessarily pause.
Reengagement on rebates.
We are on the high side in terms of our where our formulary coverages and hopefully that should be the right.
Level that we planned to maintain for the rest of the year I hope that answers to your questions.
Hey, guys. Thanks, a lot.
Your next question comes from the line of fund coins Brisbane Wise from Oppenheimer. Your line is open.
Hi, Thanks for taking the questions just a couple here so on the on the way in this side, it's pretty competitive field more and more in terms of clinical trials. So I was just wondering can you just help us understand.
Maybe the delivery platform and how it's validated and maybe the differentiation here with your product.
Thank you.
I assume youre talking about $11 five right from the print.
Technology platform, which is the product that we.
Have a phase II phase III ready.
Yes, Im also wondering on the wet AMD side, maybe what's differentiating and maybe duration wise, what youre trying to attain.
Great.
On the wet AMD site.
Certainly have animal studies that point to the confidence that we have in why we are aiming for a target product profile of up to 12 months I'll, let Casey.
Speak more to the print technology and what has been done to date.
And why we remain confident about that particular product in wet AMD Casey.
Thank you Raj.
Yes.
Great platform has really allowed us to.
Create formulations that are.
Distinct from the other competitors in this space.
That is those who are trying to deliver small molecule.
Products to the back of the eye.
We have proprietary polymers.
That we can use along with other polymers that have previously been using in the back.
To get optimal drug dilution rate profiles.
And that's what we've managed to accomplish with the.
Fortunately 34.
Small molecule anti digest implant.
As a profile of that.
Looks to be able to maintain drug evolution through about 12 months.
<unk> clinical studies.
And I can say that.
Our preclinical work for the <unk> 11 O five steroid implant.
Allowed us to accurately predict the duration of that implants and our.
Follow up human clinical trials.
So we feel.
Pretty confident that it is it is.
Is potentially achievable.
To get a once per year.
<unk> from the experts in it.
<unk> hundred 30 <unk> implant.
Okay. That's extremely helpful. And then in terms of the brand strategy, obviously, Ralph attempt first but I was just wondering any pushback or any feedback maybe.
Maybe from from Docs, maybe not being aware that reimbursement has come a long way on the Rockwood San Fran.
Yes.
It's rod.
Good question.
That is one of the focus in terms of messages for physicians that may have had a perception initially where they run into formulary issues.
That is why we're very very focused in making sure that we target those physicians, where we feel there for them.
<unk> plans that cover their patients is where we focus on a bunch of opportunity. So that is part of the messaging to make sure that they understand that <unk> is covered.
The label is broad and there is really nothing.
Not that they cannot.
That's fine.
Okay, and if I could just sneak a quick one here lastly, I was just wondering in terms of I know you guys aren't sharing the net price per bottle anymore, but if we just track scripts and volume and bottles that we see.
From our side is it fair to say that from the fourth quarter to the first quarter there might have been a little drop in the net price or.
Anything there that might be.
<unk>.
It might happen again in the future.
I think we have always said that we would maintain our net price per bottle. The only reason we did not give any guidance on that as you know is that it tends to vary and it can be quite uncertain, but that being said I think the.
From a Trs perspective.
The slight dip that we saw which is round about 1%.
From <unk> perspective for the franchise.
Potentially reflected in our opinion the ad.
Annual deductibles.
Deductibles rate that's the one.
The presence of resource. So we continue to remain constant growth rate that we saw and even from a revenue perspective, given that our guidance of 16 to 25 and our <unk>.
At 30 <unk>.
Okay.
Confident about the guidance.
Here for 2022.
That makes a lot of sense as Anabelle mentioned, the lack of seasonality here is pretty nice compared to other companies. So that's it for me. Thank you.
Okay. Thank you.
Your next question comes from the line of <unk> from Citigroup. Your line is open.
Great Hi, this is carly on for Yigal. Thanks, So much for taking my question. Firstly I just wanted to ask if you're comfortable with the current size of the sales force you have now or is that something you think can be.
<unk> optimized as well Matthew.
Yes.
Refreshed marketing strategy.
Hi, Carly great Great question, and we continued to monitor two things right. One is the breadth of the target calls from each rep and how many cars they make in a day.
Sales effectiveness.
We also monitor how are we competitive in.
Targeted prescriber base.
To drive adoption and utilization and both with regard to this time.
Right.
Political in the share of voice.
System.
In terms of driving the fourth quarter Tennant Rhopressa.
Okay perfect. That's helpful. And then we just had.
One quick clarification question on the dry eye Registrational program will you wait for comment too to read out in the second half of next year before you start the second phase III that would be required for approval or do you expect to start.
Phase III this year as well.
So we plan to start all three studies comet two permits III and comment for which is the safety study is required safety study from the FDA perspective, all key studies this year.
They are slightly staggered and what we've publicly said that we are definitely on track and getting comet two off the ground with the first patient enrollment this quarter.
Okay perfect. Thanks, so much for taking the question.
Thanks Carlin.
Your next question comes line of Jason <unk> from Bank of America. Your line is now open.
Kerry on the line for Jason Thanks for taking my question.
To the first.
Was curious to get your thoughts on.
Balance sheet to recent phase III data for <unk> three in dry eye.
And your thoughts on that program as a potential competitor and then second curious.
Curious about the extent of Covid still impacting the.
Marketing efforts for rock Tenn Rhopressa.
Thanks.
Okay, Hi, Barry if I didn't get the.
First question totally I got the second question in terms of the impact on us.
Our franchise.
I can answer the second question and maybe if you could repeat the first question I can address that as well, but let me answer the second one that I heard clearly.
The Covid impact, we see actually an improving trend from the first quarter towards the end of the quarter, we actually saw improving trends in terms of access that's probably occurring industrywide in terms of the access to physicians face.
<unk> face to face in person details.
We continue to believe our critical along with the other channels that we have in engaging with our customers.
But more importantly, I think in 2021.
I think we did a pretty nice job in continuing to grow our franchise in spite E.
Difficulties that we had in senior positions. So it hasnt impacted us as much as what I tend to see how much that affected other products.
We tend to remain confident that hopefully as the markets return back to normal.
We'll continue to see an increased growth in adoption and utilization of our franchise.
Could you. Please repeat that first question on phase III on dry eye that you asked.
Okay sure and thanks for that yeah, sorry, if I'm breaking up a little bit.
So it was related to <unk> recent phase III data for <unk> three in dry eye.
Just curious on your thoughts on that and that program as a potential competitor.
Yep.
I think Gary are you on the line of Casey are you on the line so could you address.
Novo three phase III program data that we saw.
Yes. This is Gary I'll address that so without speaking directly to a competitor obviously the data is the data we're very comfortable with the target product profile of <unk> $5 two program and I'll just point out a few points of differentiation.
Our dry eye program compared to others first we have a very unique mechanism of action trip I made which is the cold sensing receptor. The mechanism of action itself leads to increased hearing on the cooling sensation on the IDE. So it's on target for mechanism of action of dry eye relief dry eye as well we ran a large phase <unk> study of <unk> three.
<unk> hundred 69 patients and although we didn't hit our primary endpoint. When you look at all of the signs and symptoms that were hit the significance.
We are very comfortable to be able to hit signs and symptoms multiple signs and symptoms, including the anesthetized farmers test, which was highly statistically significant in the phase <unk> study as well as staining and readiness that pit significance at day 84, as well as three symptoms of Sandy score, but drawing this score.
And the discomfort score that hit significance the sandy score from <unk> 14 in the drawing some discomfort score at day 84 as well. So we're very comfortable that our drug is not only based on our mechanistic action, but based on the large phase <unk> data that we have kind of hit on multiple signs and symptoms as well. We also ran <unk>.
Quality of life metrics, seven measures, including reading driving well opening and others <unk>.
Significance at day 14, and increased for the remainder of this study and this was a common finding in this study on both signs and symptoms and quality of life that the delta between our drug and the vehicle increased over time, giving us confidence that this is something that can be maintained over the long period of time.
<unk> of chronic dry eye finally, our inclusion criteria for phase III will be very very similar virtually identical to the phase <unk> data.
<unk> study all of this gives us confidence that we will be well differentiated in the dry eye market from other competitors, whether it be the personal loan product or others.
Yes.
Got it thank you.
Your next question comes from the line of Oren <unk> from H C. Wainwright. Your line is now open.
Thanks.
Couple to.
To get back to the notion of where Rockwell attendance fitting and lines of therapy and your efforts to.
Get first line, if possible, but switch patients from the obvious latanoprost bucket.
If that fails.
Can you just talk about.
I guess.
The volume of patients that are on polypharmacy or combination therapy already and I remember before this.
Launched one of the sort of obvious pitches was that <unk> got patients on two sometimes three times, even four sets of eyedrops paying co pays on all of them and that even with.
Tier three co pay perhaps for Rockwell Tan you'd come out ahead paying one co pay and get the same or better efficacy, maybe it even better tolerability and I don't think we've heard that talked about a long time. So I'm wondering if you could speak to that and then I have a follow up on comment too. Thanks.
Hi, Thank you for that question.
You are correct I think.
The way the market is split up and it's quite dynamic at any given point in time, hopefully by 45% to 50%.
Okay.
On a project and then about a half of these patients.
Multiple therapies.
Some tunes from three and some even for Aten and yet the initial message was always about the convenient and among postpaid with.
With resonated quite well, but we believe that the message that resonates well with physicians is on efficacy and reason why.
We switched our messaging from the convenience one co pay which is still a relevant message, but it's a secondary metric now the primary message is really driven towards efficacy, which is the primary driver of brand choice.
So what we're saying is if youre choosing even latanoprost has chosen not just because it's generic but it also in the physician's mind, it's a very efficacious product and so we are saying there is really nothing that surpasses Rockwell <unk> efficacy.
Why not start with the most efficacious agents that you have that could potentially reduce the progression towards vision loss, which aligns very nicely with the medical reason why.
Prescribed pharmacological agent for patients with <unk>.
Primary.
Angled glaucoma.
Okay.
And then I can comment to did I hear you correctly that you're saying the primary end point is going to be just emphasize anesthetized schirmer and that.
Sandy symptom end point is going to be a key secondary.
If so is that sufficient to get a sign and symptom label and would comment to be the same ordering or flip flopping endpoints, what what's the approach here and what kind of label are you trying to get thanks.
Yes so.
Let me just maybe comment on.
The label and then Gary maybe you could jump in on.
Comet two points.
So the label is for both signs and symptoms for.
For patients who have dry eye disease.
So that is the label that we aim to target with our.
Current clinical designs and then comment too.
In particular and also commentary.
We decided to go with one endpoint because thats all that was needed for an approval perspective, but we remain confident as Gary said in his previous comments.
We should be able to get both sides and a strong results on symptoms and be a very differentiated product.
Gary do you want to.
Adam anything that I may have missed.
So I'll just reiterate that our primary endpoint is anesthetized Schirmer test bank at day 14, that's our only primary.
Our first secondary endpoint is the Sandy symptom score at day 28 focused once we if we hit our primary that's enough for approval as Roger indicated and then we would move to our secondary endpoints on symptoms and the target is to get signs and symptoms not only in the in the label, but in the clinical trial section.
It can be promoted based on improvement.
Thanks.
Okay and is that something that actually one gets in the indication statements.
So our signs and symptoms pardon me if that's a dumb question.
That's correct.
It comes in the label.
Okay.
Thank you.
Yes.
Yeah.
Thank you for your participation. This afternoon. This concludes today's call.
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