Ocular Therapeutix Inc. Q1 2023 Earnings Call
Good day and thank you for standing by welcome to the ocular Therapeutics first quarter 2023 earnings conference call.
At this time all participants are in a listen only mode. After the speaker's presentation there'll be a question and answer session.
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Please be advised that today's conference is being recorded.
I would now like to hand, the conference over to your first speaker today, Donald <unk> Chief Financial Officer. Please go ahead.
Thank you Julia and good afternoon, everyone and thank you for joining us on our first quarter 2023 financial results and business update conference call.
This afternoon. After the close we issued a press release, providing an update on the company's product development programs and details of the company's financial results for the first quarter ended March 31 2023.
Press release can be accessed on the investors portion of our website.
Investors Ocu, TX dot com.
Leading the call today will be <unk>, our president and Chief Executive Officer, who will provide an update on our pipeline developments and the commercial progress DEXTENZA.
Speaking on the call today will be Dr. Robert.
Austin, our Chief Medical Officer, and Steve Myers, Our senior Vice President commercial.
Following their remarks, I will provide an overview of the financial highlights for the quarter before turning the call back over to Anthony for a summary and questions for.
For Q&A, we'll be joined by Chris White, our Chief business Officer, and Dr. Peter Kaiser our chief Medical advisor retina.
As a reminder, on today's call certain statements, we will be making maybe considered forward looking for the purposes of the private Securities Litigation Reform Act of 1095.
Particularly any statements regarding our regulatory and product development plans as well as our research activities are forward looking statements. These statements are subject to a variety of risks and uncertainties that may cause actual results to differ from those forecasted including those risks described in our Form 10-Q filed this afternoon with the SEC.
SEC and our most recent annual report on Form 10-K filed March six 2023.
I'll now turn the call over to Anthony.
Thanks, Paul and welcome everyone to the ocular therapeutics first quarter 2023 update.
We're very pleased with our progress in the quarter, both on the development of our pipeline and the commercial side of the business.
Importantly on the heels of an ARVO meeting last months have highlighted the emergence of pks is an exciting new potential option for the treatment of retinal diseases.
I thought it would be good idea to reintroduce <unk> PKI as many new investors, who have recently become interested in the space.
We started on our <unk> PKI program, because we believe there is a desperate need for novel MLA that enable new treatment paradigms for VEGF mediated retinal diseases like.
Like wet AMD diabetic macular edema, diabetic retinopathy and retinal vein occlusion.
Despite the emergence of antibiotic treatments that have the ability to quickly reduce fluid in the retina.
The problem is far from small and the constraints of current treatment paradigms.
And many patients with wet AMD remaining untreated.
Those who are lucky enough to get treatment real World studies have demonstrated the initial vision gains from treatment are not maintained.
As a result, VEGF mediated retinal diseases remain in a leading cause of blindness.
So why is there such a such and such a need despite seemingly effective therapy.
Believe it has to do with efficiencies inherent in those therapy deficiencies.
The efficiencies that <unk> PKI is designed to overcome.
Fundamentally VEGF mediated retinal diseases caused by cellular dysfunction that results in chronic disease.
Listing antibiotic treatments like Eylea or Lucentis and revised model are only effective in binding to pro angiogenic ligand and extra cellular space.
Additionally, existing treatment effect only specific lie against mainly VEGF R to P. J.
To demonstrate that the presence of all the isoforms of VEGF as well as PDGF play a role in the disease process through other types of receptors.
Most important of all current therapies are delivered as bolus injections into the guide this results in period, where drug levels are briefly thousands of holes above the IC 50, and then quickly fall below therapeutic levels.
Which may leave the retina unprotected and exposed to disease reactivation.
Because of the rapid elimination of these antibody therapies from the eye there is a need for frequent injections.
Jacksons lead to poor compliance or compliant leads to loss of vision.
To reduce the real world vision loss caused by the burden of frequent injections retina specialist have created a new paradigm of treatment called treat and extend.
Treat and extend is an involved process with the goal of establishing individualized dosing intervals for each patient.
It is analogous to a game of chicken with the disease process for the revenues by unprotected without therapeutic levels of medication in the provider trying to time, a reinjection as closely as possible to disease reactivation.
Treat and extend is also in perfect process, given the natural variability of the disease in a patient and the need for perfectly time business to be maintained which is difficult to achieve in the real world. However.
However, it is the best it can be done with the current treatments and is a testament to the inventiveness and patient centricity of the retina community.
We believe the world needs a treatment that works inside the cell binding to the receptor binding at the receptor level one.
One that covers all the isoforms of IGF in PDGF.
And most importantly, one that can be delivered at a steady state over a long period of time with minimal injections for patients and providers can move beyond the current treatment extend approach.
With <unk> PKI, we're developing a therapy designed to treat VEGF mediated retinal disease.
Like a chronic disease like the chronic disease that it is.
With a baseline maintenance therapy that stays above therapeutic levels to avoid disease reactivation.
Most importantly, as possible that vision gains may be maintained in the real world with easier compliance regiments of a long acting maintenance therapy.
And this new treatment paradigm, which we like to call. It treats and maintain the antibody therapies would be reserve to do what they do best removed extracellular fluid quickly and would be reserved in the occasional circumstances when fluid might breakthrough the maintenance therapy.
Much like our rescue Halo in the treatment of asthma.
<unk> is designed to have all of our properties above <unk>, the active ingredient and I'll take <unk>.
It's highly selective for the <unk> two receptor, which we believe to be the most important contributor to retinal disease and covers all of the different types of VEGF and PDGF receptors with negligible is going to do any other receptor.
As the PKI, it's mechanism of action is working inside the cell. Most importantly, it's potently potency and solubility profile lends itself to formulation with alluded our alluded technology, allowing for the development of formulations that can deliver continuous therapy for nine to 12 months from a single injection.
In designing <unk> PKI the challenge to our formulary supposed to develop a product that could deliver nine to 12 months of a continuous dose of exiting with a single implant.
Additionally challenged the team to deliver the implant through 25 gauge our narrow needle and required that a REIT treatment window be created by an effective dose of <unk> is still getting to the target tissues. After full buyer absorption of the initial implants.
This would ensure that the vitreous would never have more than one implant at any one time that the patient would have leeway in scheduling an important an appointment to be readouts.
And the data we observed in our clinical preclinical trial and in vitro trials the formulations for <unk> appear to be supportive of this target product profile.
It is worth saying something about our alluded technology, a hydrogel technology that underpins <unk> has been used in the human body 1992, and has demonstrated safety and effectiveness and over 5 million patients across five FDA approved devices since that time.
Our own approved product extend there is been used nearly 300000 I have since launched with reported adverse events and less than one in 10000 patients.
The only factor that regulate the buyer a resort of our alluded polymers, our temperature and ph of the aqueous environment.
Since the human vitreous does not vary significantly in temperature in ph and theres enough water and every retina saturate our polymer matrix.
We believe we can program the time to buy a resort. So the implant will be impact long enough to deliver the desired dose and duration of except nib and then be fully buyer resort when its time to re dose.
The added benefits of not creating an authentic microenvironment EZ elimination from the vitreous, leaving behind no harmful byproduct and Softgel properties give us added comfort regarding the safety profile.
This technology will potentially provide solutions not only for the durable therapies for wet AMD to decrease the injection burden, but also for other retinal indications, which need frequent injections.
Like the new therapies treating geographic atrophy.
However, no matter, how I deal the formulation of <unk> active ingredient <unk> perform in the clinic, which it has.
We put <unk> in a very challenging situation and its initial clinical trial in Australia by testing it as monotherapy in patients with uncontrolled disease in wet AMD.
You saw in that trial that <unk> was able to eliminate fluid as monotherapy in some patients in a dose dependent fashion something that no. Other teekay <unk> development program is done.
And a second trial, our current U S based trial.
We are valuing <unk> PKI to assess the durability benefits of continuous dosing in patients with control retina.
It does represent a dry state.
Interim data has shown that 73% of patients were maintained rescue free for up to 10 months and the injection burden was reduced by 92%.
These data are recently footwear recently presented as an encore presentation by Dr. Andrew <unk> at the 2023 ARVO meeting held in New Orleans.
We augmented the results from the ongoing clinical trial with pharmacokinetics data from two animal models.
The uptake of <unk> from our hydrogel implant in the choroid and RPE cells, we're exiting the intracellular Lee to observe VEGF receptor inhibiting effect.
The data showed that clinically representative formulations of <unk> PKI delivered sustained exit NIM concentration through 12 months, there were well above the IC 54, Veg F. R. Two and final monkey retina tissue and in Colorado retinal pigment epithelium tissue.
This excellent preclinical pharma pharmacokinetics data aligns with the pharmacodynamics data we have observed in our ongoing U S clinical trial.
Namely that the high proportion of rescue free subjects up to at least 10 months and suggest continuous veg F receptor inhibition, which in turn will support this new treatment paradigm treat to maintain and wet AMD care.
As a note we expect to release, our 12 month data for the U S. Best trial of <unk> for the treatment of wet AMD at the clinical trial at the Summit Conference on June 10.
We anticipate seeing a reactivation of disease in some patients, which we believe would indicate <unk> PKI continues to function as designed with exiting of concentration is beginning to fall below therapeutic levels as we approach and exceed one year of treatment.
We believe the next steps with <unk> <unk> will be to prepare to commence our first pivotal trial in wet AMD as early as three third quarter of this year and our first pivotal trial in diabetic retinopathy as early as the first quarter of 2024.
Our confidence in entering pivotal programs is based on the clinical program to date with nearly all of the boxes, one would require from a robust phase II program.
First and foremost we are a proof of concept as.
As monotherapy in uncontrolled redness in the Australia study and in control retina with anti VEGF antibody induction in the U S trial.
We were able to demonstrate a dose response in Australia and have settled on an optimal dose per day.
We have comparative data from a mass trial, comparing <unk> PKI to Eylea given every eight weekly.
We also have at least six to be we will have at least 60 patients dosed with <unk> PKI prior to the commencement of our first pivotal some of whom who have had follow up for nearly four years.
As we continue to evaluate funding alternatives, including collaborative partnerships and finalized trial protocol, we hope to be able to give concrete guidance on precise plans in the near future.
I would like to now hand, the call over to Robert who will explain our ongoing clinical trials.
We are with our planned pivotal clinical trials in wet AMD and diabetic retinopathy and our next steps for our Ots CIC in dry eye program.
He will then hand over the call to Steve Myers, Our senior Vice President of commercial who will recap our commercial business, which is currently experiencing exciting and market growth.
But I hope you don't mind me, giving a bigger picture overview of our leading technology and our <unk> PKI story.
It is increasingly clear, especially since ARVO, but longer acting antibodies are not going to solve the problems of the current therapy and the gene therapy approaches to VEGF mediated diseases are unlikely to replace current standard of care in any near term horizon.
We believe Teekay is really the most promising new therapies that will allow patients and providers to evolve beyond the imperfect and onerous treatment extend into a new area of treatment maintain enabled by Pan VEGF receptor inhibition intracellular therapies like <unk> AI.
Robin.
Thank you Anthony let me begin with an update on the back of the eye program <unk> T J.
Currently completing a multi center prospective masked randomized controlled phase <unk> clinical.
Clinical trial into 81, Scott checks evaluating its 600 microgram <unk> dose in a single implant containing oxytonic compared to October administered every eight weeks in controlled with AMD subjects previously treated with anti VEGF therapy.
The trial is designed to assess the safety.
And tolerability of <unk>, II and towards biological activity in subjects by measuring anatomical and functional changes.
To date, we have reported interim data at two time points seven months, and 10 months and have not observed any direct related or killer or systemic serious adverse events.
<unk> <unk> Teekay <unk> subjects importantly, the 7% to 3% of the Ot X P. J I take it stopped Jason who will give free it's months seven interim analysis.
<unk> Q3.
Patton highlighting what we believe is best in class durability.
Furthermore, we saw in the trial and 92% reduction in treatment burden for up to 10 months.
<unk> showed stable and sustain best corrected visual acuity and central subfield thickness comparable.
I never said.
<unk>.
Okay.
We believe the data highlights the potential of <unk> to become a differentiated product capable of providing a durable anti VEGF pretty sponsor that improves upon today's bomb that goes in.
In the management of the day Andy.
Continue to have productive dialogue with the FDA and recently completed a formal meeting with the agency that included a discussion of our data and clinical developments.
Got it.
Just on the feedback we believe we have two potential designs for the period.
Pivotal trials.
We'll share more about the trial design that we plan to use in future.
Just in time to be prepared to initiate the first two required pivotal trial in wet AMD as early as the third quarter of this year subject to obtaining the necessary financing.
Moving to <unk> for the treatment of diabetic retinopathy.
Continue to enroll subjects in our multi center prospective Matt regarding those randomized controlled phase <unk> trial into 81 subjects tables or anything it's 600 microgram <unk> dose in a single implant containing Oxford <unk>.
Compared to a sham injection procedure.
We believe the same attributes that make <unk>, a compelling product candidate for the treatment of wet AMD.
So we used all the office space injection and long term durability could establish RPX teekay is the first time that of care in the treatment of diabetic retinopathy.
Based on the feedback from the recent agency discussions we believe may have a potential pivotal design for David District, and apathy that is consistent.
Fda's guidance and subject to.
Top line data from our ongoing trial and obtaining the necessary funding. We believe that we will be well positioned to initiate phase III clinical trial for this program as early as Q1 two answer to antitrust.
We are also making excellent progress.
And another one of our late stage pipeline programs <unk> <unk>.
Gross intra tumoral implants, using our analytics technology being developed for the treatment of <unk>.
Patients with primary open angle glaucoma or ocular hypertension.
Ongoing phase III trial <unk> is currently enrolling and we believe we are on track to complete the trial on schedule.
<unk> CIC is a program that we believe represents a significant opportunity for ocular therapeutics.
There are many medications available to lower intraocular pressure or IOP.
Commodity remains a leading cause of blindness.
In part because the unwanted side effects improper technique or simply forgetting to take their daily three ops. We believe most patients fail to comply and may ultimately lose data vision.
<unk> is being developed to close the gap between clinical trials and real world outcomes by taking patient compliance.
The equation.
We are enrolling approximately 8% to six subjects in this prospective multi center randomized.
Randomized controlled U S based phase.
Phase II clinical trial.
The safety Tolerability and efficacy of <unk> for the reduction of IOP in subjects with primary open angle glaucoma or ocular hypertension.
Trial is designed to preserve the changes in diurnal IOP from baseline it.
Two six and throughout fees and total duration of IOP response over time against the risk.
We look forward to shading phase II top line clinical data in Q4 to answer to answer three assessing the efficacy and durability of <unk> IC and as importantly, the preservation Norland opinion that has that could indicate that the product candidate is suitable for it.
<unk>.
Regarding our ocular surface disease program, we remain committed to the development of our two dry eye program.
<unk>, a low dose inject generative chiller insert containing dexamethasone for the short term treatment of the signs and symptoms of dry eye disease.
<unk> CSI is cyclosporine in chicken Nuggets jewelry insert for the chronic treatment of patients with dry eye disease.
We initiated a small study in this quarter. So evaluate the performance of <unk> versus placebo in starts named the fastest fast dissolving pulp fluff and no <unk> at all.
Plan to use there is also the drive to important the selection of a more appropriate placebo comfort.
For use in future clinical trials for both the <unk> and the <unk> side that could potentially help derisk the pivotal programs moving forward.
I would now like to turn the call over to Steve for recognize shield update Steve.
Thank you Rob here on.
On the commercial front, we finished the quarter with DEXTENZA net product revenue sales to specialty distributors at $13 2 million representing growth of approximately 6% over the same period last year importantly.
Importantly in market billable units were up 25% versus the prior year period, which represented an increase of over 7200 units.
Measured against fourth quarter 2022 in market billable units in the first quarter of 2023 grew by over 2500 units or 8%.
Throughout the quarter weekly and monthly DEXTENZA in market sales continued to accelerate in fact in March DEXTENZA recorded the highest in market sales ever surpassing 13000 units in one month.
We anticipate that with the full sales team in place a revised pricing discounting strategy that was implemented in the third quarter of last year and our strong market access.
Extensive will continue its growth in 2023.
Looking at DEXTENZA Q1, net revenue are recorded net revenues were slightly down versus Q4.
The difference between DEXTENZA is recorded net sales in the growth of the extends us in market billable units is due to distributors stocking patterns not changes in gross to net.
The specialty distributors closed March with eight fewer days of product on hand compared to Q4.
However, with the continued strong in market unit volumes recorded in April we believe specialty distributors inventories have been rebuilt to meet end market demand of DEXTENZA.
Looking ahead I remain bullish for the remainder of the year, we have secured several national strategic account contracts over the past few quarters that are now in place and helping fuel our growth.
We've also achieved exceptional market access coverage for DEXTENZA, including 100% coverage in Medicare part D over 90% coverage in Medicare advantage and over 70% coverage on the commercial payer side.
Additionally, in Q1 2023, we launched a commercial assurance program to provide assistance with patient out of pocket costs and the early feedback has provided us more confidence to expand into the commercial patient population.
Based on these dynamics, we remain confident reiterating our DEXTENZA net product revenue guidance for the full year 2023 to be between 55 and $60 million.
Representing potential growth of approximately 10% to 20% over 2022.
With that let me turn the call back to Donal to discuss our financial results.
Thank you Steve total net revenue, which includes both growth to extend that product revenue net of discounts rebates and returns, which the company refers to as net product revenue and collaboration revenue was $13 4 million for the first quarter of 2023 slightly ahead of first quarter of 2022.
Revenues of $13 2 million and slightly behind fourth quarter net revenue of $14 1 million.
DEXTENZA net product revenue grew from $12 5 million to $13 $2 million over the comparable period in 2022, while collaboration revenue declined $3 7 million $2 2 million.
Research and development expenses for the quarter of 2023 for the first quarter of 2023 were $14 $7 million.
Versus $13 1 million for the same period in 2022, driven primarily by an increase in expenses associated with clinical and preclinical programs selling.
Selling and marketing expenses in the first quarter of 2023.
$10 8 million as compared to $9 1 million for the same quarter of 2022.
Reflecting primarily an increase in field force personnel.
General and administrative expenses were $9 1 million for the first quarter of 2023 versus $7 $6 million in the comparable quarter of 2022, primarily due to an increase in personnel related costs, including stock based compensation and professional fees.
The company reported a net loss for the first quarter of 2023 of $33 million or a loss of 39 per share on both a basic and diluted basis compared to a net loss of $12 5 million or a net loss of <unk> 16 per share on a basic basis and a loss of 22.
Per share.
A good basis for the comparable period in 2022.
Net loss in the first quarter of 2023 included a $6 $6 million noncash.
Noncash items attributable to a change in the fair value of the derivative liability associated with the company's convertible notes increasing total other expenses as the price of the Companys common stock increased during the quarter.
Noncash charges for stock based compensation and depreciation and amortization were $5 1 million in the first quarter of 2023.
First is $4 8 million for the comparable quarter in 2022.
As of March 31, 2023, the company had $79 million in cash and cash equivalents.
$102 3 million as of December 31, 2022.
Based on current plans and related estimates of anticipated cash inflows from the extensive and anticipated cash outflows from operating expenses, but excluding any expenses related to our planned pivotal clinical trials for <unk>. The company believes that its existing cash and cash equivalents.
Sufficient to enable the company to fund planned operating expenses debt.
Service obligations and capital expenditure requirements to the middle of 2024.
As of May 4th 2023.
<unk> 77 5 million shares outstanding.
This concludes my comments on our first quarter and I would like to turn the call back to Anthony for some final thoughts.
Yeah.
Thanks Tal.
For opening the call up for questions. Let me do a quick summary.
<unk> continues to progress well and we are pleased with ongoing FDA communication regarding our potential pivotal program for both wet AMD and diabetic retinopathy.
Enrollment continues to go well in the phase II trial of <unk> CIC in glaucoma, and we plan to provide top line data in Q4 2023.
<unk> had a strong start in 2023 with volumes in the first quarter running over 20% above the first quarter of last year and leaves us confident in our ability to meet our 2023 guidance of $55 million to $60 million in net sales.
And we have a solid balance sheet with $79 million in cash that currently supports our ambitious plans and other planned pivotal programs into the middle of 2024.
With that I'll turn the call over to the operator for questions.
Thank you at this time, we will conduct a question and answer session.
As a reminder to ask a question you will need to press star one on your telephone and wait for your name to be announced.
Withdraw your question. Please press star one one again.
Please standby, while we compile the Q&A roster.
Yeah.
Hmm.
Our first question comes from the line of John <unk> of JMP. Your line is now open.
Hey, good afternoon, and thanks for taking the questions.
A couple on the 12 month data and then a follow up on the pivotal trial if I can.
Just wondering if you could give us a little bit more granularity on what you expect to see in the 12 months update us exiting that business.
Getting.
Bob resort in the eye.
Is that going to manifest it was just going to be seeing fluid.
Pick back up or is there some other manifestation.
And then at ARVO you mentioned the average resorption was about nine months of the hydrogel, but wondering what kind of variability you saw in the patients.
Within that nine months average.
Okay.
Well I mean, what we expect to see at 12 months is that the division should start to come back in some patients.
We saw him in the trials to date and is exactly what we anticipated that the the hydrogel goes away in a very tight window.
About eight months and that there is a release of drug after that.
As in the retina for a couple of months.
And some patients clears a little faster than others.
So what we expect to see as the disease coming back we.
We enrolled patients in this trial that had a demonstrated need for anti VEGF therapy.
That therapy starts to wane that you would expect the disease process to come back.
We expect that to vary quite a bit in terms of individuals individual.
We would expect to see some of that back and that would be reassuring that would show that the pharmacodynamics actually are representative of the pharmacokinetics.
Okay.
Can you tell us a little bit more about why two different pivotal trial designs and when you say one could start in third quarter, how you decide which to move forward and that is it going to be too differently designed pivotal trials or a subsequent trial identical to the first one you start just trying to understand that dynamic a little bit better when we have.
A lot of options.
Even with the new guidance and the feedback from the FDA that there are a lot of paths that we could take.
We have a very active data room now in discussions with strategics will essentially determine which path we take.
So unfortunately, we don't really have the ability to kind of definitively say at this moment.
Which protocol, we would we would choose to go down.
Protocol our protocol.
But we hope to have that in the very near future. Its actually its a very exciting time of a lot of possibilities.
Is that the data rooms are extremely active.
Okay. Thanks, a lot for Robyn.
From the end of it.
Yes, I mean.
The really good description by VR now John I, just wanted to ask to answer your question whether.
<unk> would be the same or not yes, it would be the similar design too.
Similar design.
Going forward, but Anthony explained we are just going to make that decision that move forward, but ultimately.
They need to be.
They're going to be similar at that time.
Okay. Thank you I'll jump back in the queue.
Thanks, John .
Yes.
One moment for our next question.
Yes.
Thank you. Our next question comes from the line of Joe Catanzaro of Piper Sandler. Your line is now open.
Hey, guys. Thanks for taking my questions. Maybe just one quick one for me on the potential pivotal design for the wet AMD.
Studies I think I recall previously there were maybe some speculation that.
Pivotal design could maybe include two active arms two different doses exploring maybe two different formulations I'm wondering if that is still a possibility between these two potential designs or have you sort of formally committed to moving forward solely with the current formulation.
And the quick answer to that is yes.
One of the pivotal trial designed to actually would use both formulations.
And there's another that would only use one formulation. So we have the ability to go either direction.
Okay got it I think that's all I had so thanks for taking my question. Thanks, Jeff.
One moment for our next question.
Thank you. Our next question comes from the line of Tara Bancroft of Cowen. Your line is now open.
Hi, Thanks for taking the question so I understand youre not disclosing specific details, but I was wondering if you can discuss.
Hypothetically, what you would consider the most favorable pivotal design like perhaps elaborating on the pros and cons of two things.
Lucentis as the comparator arm and maybe the possibility of using a superiority endpoint. Thanks.
That's a great question, one that I'm not sure I can be suckered into answering at the moment.
There certainly are instead, there's lots of options available and <unk> is also a potential comparator, if you're thinking about a superiority trial.
But yes, it's all.
It's all to play for there is not it is a non inferiority design that looks very interesting and there are superiority designs, but also.
Good potential, but I don't think we can say anything more other than that until we actually settle on tappan zee.
Okay. Thanks.
One moment for our next question.
Yes.
Thank you. Our next question comes from Colin <unk> of Baird. Your line is now open.
Great. Thanks, Good afternoon, and thanks for taking our question. So just to clarify on the two wet AMD trials that you are considering it.
It sounds like one might include two formulations. One may include one is there anything else that youre willing to share in terms of how youre thinking about the two different trial designs.
I don't think at this point it would be wise to do that but.
I appreciate the question and would love to be a more fulsome in our response, but until we get some sort of actually nailed down I think its not why its if anything tomorrow.
Fair enough and then on diabetic retinopathy have you discussed with the FDA what the bar for success would be or do you have any internal hurdle on what you'd like to show can move into pivotal and diabetic retinopathy.
Diabetic retinopathy is far clearer I can defer to Ravi.
Where we are with diabetic retinopathy.
Yes.
Type C meeting Colby, we hit a discussion on the diabetic retinopathy design as well that will be <unk>.
Design.
Agreed by the agency designed to propose to them it would be.
PKI verses.
One injection.
Anything.
The.
Per our understanding sham injection is not a good comparator, but any injection would be except that that's why that design is clear.
The injection of PKI baseline versus an injection on the concentrate and the pull of up four.
Last month.
The equity of design and we are ready.
Ready to move forward as soon as the <unk>.
Behave.
Anthony was pointing at partnering.
<unk>.
Okay. Great. That's helpful. Thank you and just one quick follow up on the ongoing study in diabetic retinopathy, how much follow up would we expect to see in the initial readout from that study.
I don't think the.
The lowest hub long.
Initial <unk> dock is going to be top line that's why.
Just going to keep it keep it for now, but we do follow up the patients.
And.
And even more for that same period.
Okay, great. Thanks for taking our questions.
Thanks, Tom.
One moment for our next question.
Yeah.
Yes.
Thank you. Our next question comes from <unk>, Chen H C Wainwright.
Your line is now open.
Alright. Thank you for taking my questions could you give us a rough estimate of the cost to complete the phase III trial in wet AMD and the phase III trial and Dr.
Insurance is varies widely depends on the design of the pivotal.
That is.
Yes.
That's really dependent upon whether we're going to go after a non inferiority design our superiority design.
But we're looking at ranges.
Essentially $70 million for two pivotal.
And Dr or.
Superiority in wet AMD to $300 million for a two pivotal and a non inferiority.
Kind of wet finger in the air at the moment, but thats those are the numbers that we've quoted in the past.
Thanks and regarding the.
Phase II trial in glaucoma could you talk about your expectations for the top line readout in the fourth quarter.
Robert do you want to handle that.
Sure.
<unk>.
Like just mentioned if that trial is currently enrolling and rolling ball and our expectation is to share the top line data.
In the fourth quarter of this year.
That data of course wood.
While the IOP readings as required by the FDA and also durability information.
In addition, we're going to have the data on.
B.
On the corneal health.
Endothelial cell com comps in that.
In that top line.
Okay. Thanks, and last question is when can we expect to see the results from a small study of <unk>.
Yes, we have.
Recently initiated that trial and the we have not guided any timeline to share the topline data yet.
In future we are going to.
Sure.
As should be expected.
Thank you.
Thank you.
As a reminder to ask a question you will need to press star one one on your telephone.
Yeah.
Yeah.
Our next question comes from the line of Caroline Palmer lack of <unk> capital markets. Your line is now open.
Hi, Thanks for taking the question.
So on the expense side, you mentioned that Theres revised pricing and the discounting strategy that you've implemented.
In the third quarter I'm, just wondering if you could elaborate more on that and particularly how.
Got it.
As affecting your gross to net.
And then just a follow up on the business side just wondering if also.
Do you have any guidance on operational.
1023.
I'll stop there thanks.
No all of the further.
While on top line.
There has been no change in the gross to net from the fourth quarter of last year and for the first quarter of this year.
The what.
Growth in end market sales is.
Okay.
The decrement in net sales is due entirely to shareholders stockholder.
<unk>.
Distributor stockholding.
I will transfer on to Steve for the changes in our discount.
Thanks Anthony.
Last year from January until June .
Customers were purchase DEXTENZA the acquisition cost was higher than the reimbursement and following the close of a quarter the customers, we're getting a rebate.
They didn't like the cost economics of that in July we changed our pricing strategy.
The customer would get a discount at the time of purchase.
So we provide a discounted acquisition costs that they've got below that they've got that equaled reimbursement in July starting in July of last year. It took about three months for our customers.
Acquainted with this but since then.
We've seen tremendous growth in both Q4, and Q1 and customers now get a discount at the time of purchase and then they also get rebates at the end of the quarter, that's determined by their aggregate purchases throughout the quarter.
Got it that's helpful. Thanks.
Thank you.
Thank you for your participation. This concludes our Q&A and today's conference call you may now disconnect.
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