Q2 2021 Eyenovia Inc Earnings Call
Thank you for standing by this is the conference operator welcome to the I know the second quarter 2021 earnings call. As a reminder, all participants are in listen only mode and the conference is being recorded.
After the presentation, there will be an opportunity to ask questions to join the question queue. You May Press Star then one on your telephone keypad should you need assistance during the conference call you may signal, an operator by pressing star and zero.
I would like to now turn the conference over to Eric ribbon or Investor relation relations.
Go ahead please.
Thank you. Thank you good afternoon, everyone and welcome to Nokia second quarter 2021 earnings conference call and audio webcast.
With me today are cheap.
<unk> operating officer, Michael Rowe, and Chief Financial Officer, John Gandolfo, Doctor, Sean I answer that I know <unk>, Chief Executive Officer, and Chief Medical Officer has an unavoidable cost split which arose and is not able to join today's call.
Earlier. This afternoon I know via issued a press release announcing financial results for the three and six month period ended June 30 of 2021.
Encourage everyone to read today's press release as well as I know its quarterly report on Form 10-Q for the quarter ending June 30th 'twenty, 'twenty, one which will be filed with the SEC. The company's press release and quarterly report also will be available on <unk> website at <unk> Dot com.
In addition, this conference call is being webcast through the company's website and will be archived there for future reference.
Please note that on today's call, we will be discussing investigational products, which have yet to receive FDA approval.
Also note that certain information discussed on the call today is covered under the Safe Harbor provisions of the private Securities Litigation Reform Act, we caution listeners that during this call I know that management will be making forward looking statements actual results could differ materially from those stated or implied by these forward looking statements due to risks.
And uncertainties associated with the company's business.
Forward looking statements are subject to a number of risks, including risks related to fluctuations in our financial result volatility and uncertainty in the global economy and financial markets in light of the evolving.
COVID-19 pandemic, our ability to raise additional money to fund our operations for at least the next 12 months as a going concern R.
Our estimates regarding the potential market opportunity for our product candidates and potential revenue from licensing transactions reliance on third parties the ability of us and our partners at the time, we develop implement and maintain manufacturing commercialization and marketing capabilities and strategies for our product candidates risks.
Risks of our and our licensed clinical trials, including but not limited to the cost design.
She Asian, and enrollment, which could be adversely impacted by Covid, 19, and resulting social distancing.
<unk> progress and results of such trials.
So impact of Covid, 19, and related economic disruptions on our supply chain, including the availability and sufficient components and materials used in our product candidate.
The timing of the end of our licensees ability to submit applications for obtain and maintain relative regulatory approvals for our product candidate.
Changes in the legal regulatory and legislative.
In the markets in which we operate and the impact of these changes on our ability to obtain regulatory approval for our products.
Advantages of our product candidates the rate and degree of market acceptance and clinical utility of our product candidates.
Our ability to attract and retain key personnel intellectual property risks and others detailed in and qualified by the cautionary statements contained in our Adobe's press release and SEC filings, including its most recent annual report on Form 10-K and subsequent filings.
This conference call contains time sensitive information that is accurate only as of the date of this live broadcast August 11.2021.
<unk> undertakes no obligation to revise or update any forward looking statements to reflect events or circumstances. After the date of this conference call, except as may be required by applicable securities law with that I'd like to turn the call over to our Chief operating Officer, Michael Rowe Michael.
Thank you, Eric and welcome everyone to our second quarter 2021 earnings conference call.
The clear highlights since our last quarterly update is the positive data from our phase III vision, one study that we announced in May.
Did you Wanna evaluated the safety and efficacy of our proprietary pilocarpine solution micro line versus placebo with both being administered using our novel after Jeff dispenser.
Vision, one met its primary endpoint with a 7.7 fold higher rate.
Three or more like responders in Masonic distance corrected near visual acuity for the microwave 2% arm compared to placebo, which was statistically significant and enabled us to select the dose for a second registration trial called vision two.
In this study Michael I'd had a favorable safety profile.
Adverse events were all mild in nature and there were no serious adverse events headache of frequent issue with pilocarpine deliberate that's night drop well.
As seen in fewer than 3% of patients treated with micro ly.
This compares very favorably with the up to 20% that has been observed with other pilocarpine eye drop formulations.
In a post study survey, 71% of study participants reported strong interest in using micro lives for near vision improvement should it be approved.
These patients said that they would expect to use the product three or four times per week on average we're very proud of these study results, which is why we are moving rapidly into vision to which I will discuss later.
Michael line, that's not the only drug being developed for Presbyopia. We believe however that micro line will offer the best combination of attributes that will leave it to be a treatment of choice first in the visual one study micro ly has been proven to work in the phase III rigorous F D. A registration study.
They're highly controlled and validated conditions.
Further vision, one produced efficacy outcomes under makes opic or low light conditions. Some other presbyopia treatments and development report faux topic treatment outcomes, such as bright ambient light conditions, which can significantly insulate the therapeutic effect due to the avid stimulation a bright light and higher contrast, both.
Which can increase visual acuity measurements.
This is an important distinction because in actual practice presbyopia is more likely to impact functional vision that lower light conditions, such as when trying to read a restaurant menus.
Another important distinction of micro line versus other therapeutics in development. It's micro lines is the only one being developed for on demand use.
In other words, there is no need for chronic dosing every day or even twice a day for a therapy to work.
Finally micro line, that's administered by our after Jack dispenser, which is far easier to use and more accurate than traditional eyedropper is and has been shown in multiple studies to achieve the same or better efficacy as an eye drop with better tolerability due to 80% less exposure to drug and preservatives.
Needless to say these results strongly support continued development of microwave and to that end. We are planning a second phase III study vision two that we expect to initiate by the end of the year.
<unk> two will be a registrational double masked placebo controlled superiority trial up 2% multi rate print pilocarpine versus placebo.
We aim to enroll about 100 subjects into the study.
And anticipate top line data in mid 'twenty 'twenty two.
With a positive outcome of vision two we plan on moving towards a new drug application or NDA later in the year.
The presbyopia market is significant and the U S alone. There are estimated to be 18 million people between the ages of 40, and 55, who suffer from presbyopia, who never had to wear glasses prior to having difficulty with near vision.
This translates into a multibillion dollar potential marketing opportunity.
Micro Ly is also intended as an on demand companion product to reading glasses for instances when readers is inconvenient or undesirable.
When you look at the clinical results, our plans for a bit vision too and the benefits of our after jet dispenser. We believe we can capture a significant share of the market should microbiome be approved.
Turning now to mid Combi, which is our unique fixed combination of two leading mydriatic medications or pupil dilation agents as.
As we announced last quarter. The FDA has confirmed our could do for date for October 28 of this year.
The combi as a diagnostic agent with meaningful potential benefits to both the practitioner and the patient.
But the practitioner theres the potential to increase patient throughput without increasing costs with big coffee doctors and staff can spend less time, putting different eye drops into patients, including those have helped minimize the sting of the current formulations.
On a daily basis, we believe that over an hour of exam room time. It can be reclaimed just by switching to this faster more comfortable option.
And for patients since there are no patrolling parts with the opt to jet and a recess nozzle mccombie is far less likely touched the surface of the eye as compared to a conventional eyedropper.
This results in a potential decrease in cross contamination and improve patient safety.
Thing that resonates loudly and the COVID-19 era.
Also as mentioned the product was reported to be very comfortable to use in our clinical studies.
All of these benefits, we hope will translate to more people being willing to undergo a comprehensive eye exam.
Market research suggests that millions of people fail to get a comprehensive eye exam every year due to the discomfort and other side effects of traditional mydriatic drops with.
With Combi may be able to address these issues and doctors may be able to further encourage people to take better care of themselves by having a comprehensive eye exam.
The market opportunity for <unk> is substantial.
There are an estimated 100 million office based comprehensive and diabetic eye exams and $4 million of <unk> surgical violations performed annually in the United States alone. We estimate this market to be approximately $250 million annually.
If approved we plan to target high volume practices, and the 10 largest U S metropolitan areas with just 10 sales professionals to be higher than initially.
To help maximize the sufficiency and create the opportunity for quick payback. Our Salesforce will initially address the top 20% of eye care practices in terms of total patient volume and expand from there.
Together with our agreement with ever Sona, We believe we are well positioned to initiate a commercial launch soon after approval pending no disruptions due to COVID-19 on our supply chain.
Call them at Combi as a cash pay model and purchased directly by the Doctor's practice and this means no interaction with managed care plans pharmacy benefit managers, and others, who may control formulary placement and reimbursement.
In addition to the commercial benefits associated with the Combi approval. There's also the strategic importance of demonstrating that our op to jet technology can be reviewed and approved by the drug division of the F. D. A.
Technology underscores all of our projects and the approval would help derisk those projects as well.
Now I'd like to share some exciting news about thereafter jet digital health system, and our ongoing efforts to enable a remote therapeutic monitoring platform for all of our smart microarray print pharmacologic projects.
Earlier this year, we shared exciting compliance data from one of our phase III trials showing that subjects were on average 90% compliant using the objet dispenser.
This compares favorably to the 50% compliance rate typically reported for Eyedropper bottles.
Since the technology and the optics that has the potential to become the first smart delivery system for pharmacologic eye treatments with fully embedded digital health functions, we will be able to track therapeutic compliance or adherence almost 100%.
And now we're demonstration project from our ongoing phase III trial was well informative to that effect.
The Objet digital health system could be the first one enabled smart pharmacological therapy in digital health for chronic eye diseases. This will not only opened a new pathway for smarter more personalized eyecare, but may enable a new reimbursable paradigm for remote therapeutic monitoring.
The American Medical Association manages the procedure code set that physicians and other health professionals use who identified the services for which they bill.
These codes are commonly known as the C. P. T code set which stands for current procedural terminology and our standard billing lexicon for medical services.
During a recent meeting of its editorial panel new CPT codes for remote therapeutic monitoring were approved with five new codes that will become effective in January 2022.
Some will cover acquisition and review of compliance and adherence data for Pharmacotherapy and this may provide a pathway for providers and clinics to get reimbursed for such care.
We are closely monitoring the CMS and payer adoption, so promote therapeutic monitoring and other telehealth initiatives as we work to create and enable the first pipeline of smart <unk> therapeutics with our after jet remote therapeutic monitoring platform.
We look forward to a time in the near future when doctors will be able to deliver better smarter care that is covered under a potential remote therapeutic monitoring C. P T coat.
I would now like to turn the call over to our Chief Financial Officer, John Gandolfo to provide a brief update on our licensee agreements as well as the financial update John.
Thanks, Michael I'll.
I will start with a brief update on our licensing agreements with Bausch health and Arctic vision.
Call that we entered into agreements to further development of our investigational treatment for the reduction of pediatric myopia progression, which we call micro pain.
<unk> is a proprietary atropine formulation that has been shown in clinical studies to slow myopia progression by 60% or more there are currently no FDA approved drug therapies for this indication and if left untreated discount result in retinal detachment myopic retinopathy.
Ambition loss.
Our agreement with the Arctic fishing covers greater China, and Korea, while our agreement with Bausch covers the U S and Canada.
To date, we have received $16 million in upfront and milestone payments and we have the potential to earn up to $100 million in development milestones over the next four years as well as significant sales royalties and cost savings if ultimately approved.
Development is progressing as planned and we are continuing to evaluate potential licensing partners covering other key geographical territories.
We are also assessing pipeline expansion opportunities as we believe we can leverage the optic jet technology to address unmet needs in additional large ophthalmic indications as we indicated last quarter. Some examples include anti effective anti inflammatories dry eye and glaucoma each with.
Significant market opportunities interestingly as Michael noted above we have also seen recent news acquisition charges and payments to tell him monitoring or things like medication compliance could become routine in the near future, which is a perfect match with the capabilities of our <unk> dispenser this could be.
Especially important in a disease like glaucoma medication compliance with traditional lives operators is notoriously poor we.
We have nothing definitive to share on this front today, but we do look forward to keeping you apprised of our progress of course. The beauty here is that these development activities would be at least partly funded by outsourcing opportunities such as soon as just described.
Now I would like to review our financial results for the three months ended June 32021.
For the second quarter of 2021 we reported a net loss of approximately $4.9 million when 19 cents per share and this compares to a net loss of approximately $5 million with 25 per share for the second quarter of 2020.
For the second quarter of 2021, the company reported license fee revenues from our Arctic fishing license agreement of $2 million and a corresponding cost of revenue representing payments to send you an $800000.
Research and development expenses totaled approximately $3.6 million for the second quarter of 2021, and this compares to approximately $2.9 million for the same period in 2020, an increase of approximately 24%.
For the second quarter of 2021 G&A expenses were approximately $2.4 million compared with approximately $2.1 million for the second quarter of 2020, an increase of approximately 14, 3%.
Total operating expenses for the second quarter of 2021 for approximately $6 million compared to total operating expenses of $5 million for the same period in 2020.
This represents an increase of approximately 20%.
I would like to note that operating expenses included approximately 637000 of noncash stock compensation expense.
As of June 30th 2021 the company's cash balance was approximately $27.2 million and this figure includes approximately $7.5 million and initial net proceeds from the $25 million credit facility with Silicon Valley Bank that we received in May of this year, we believe.
Our current cash resources in the initial SBB loan proceeds.
Provides the company with sufficient cash into the end of the third quarter of 2022.
Our current cash resources include inclusive of best Phebe are sufficient to bring out Mcafee midrise product through the NDA process and commercial launch complete our presbyopia clinical program for micro line and complete the preparation of our pilot manufacturing facility.
In closing we are very pleased with our performance during the second quarter and subsequent period to summarize the key highlights today.
Results from our ambition one presbyopia study were positive and we are rapidly advancing our phase III Presbyopia program, we anticipate initiating a second phase III trial fishing too by the end of the year with topline data expected in mid 2022.
We look forward to October 28th Paducah date pertaining to our <unk> Combi NDA, which if approved gives us our first commercial product and validates our optic jet dispensing technology.
Our licensing agreements with the Arctic vision about Bausch health are progressing well and continue to offer the pretense show for meaningful development and regulatory milestones, which represents nine non dilutive funding that if realized we can use to expand and advance our pipeline of novel therapeutic Pudic.
Leveraging our map technology.
We believe we are well positioned to achieve multiple commercial regulatory and development catalysts. This year.
And next for the benefits of patients and shareholders alike.
That concludes our prepared remarks, we would now like to turn open the call to questions operator.
We will now begin the question and answer session to join the question queue. You May Press Star then one on your telephone keypad, you will hear atone acknowledging your request if you're using a speaker phone. Please pick up your handset before pressing any Keith to withdraw your question. Please press Star then two.
We'll pause for a moment as callers join the queue.
The first question comes from Tim Chiang Northland Capital go ahead. Please.
Hi, Thanks, Michael.
Michael could you talk a little bit about you know some of the learnings coming out of the Crs conference.
That recently happened you know obviously.
Again did show some additional data on their presbyopia product.
I think what the incidence of headache was around 14%. So obviously.
Do you have a product here.
That has a much a much more favorable side effect profile. So I think thats a positive but could you provide I don't know.
Just some commentary.
Post that conference.
Yeah, Hi, Tim and thanks for the question I I think the thing that was most striking to me was the increase in interest of presbyopia therapies enough drug therapies to treat <unk>.
B O P and in just the last year I'm, just seeing how really the interest has exploded how the interest by prescribers by practitioners.
They're thinking about including these therapies are into their practice and seen it as a potential opportunity to bring in patients who the otherwise never would have seen because they just go to the drugstore.
To get their readers so everybody's very much excited about it in terms of the studies and I'm glad that Allergan was able to share their data and when we're in a position to file our NDA I'm looking forward to being able to do the same what I did notice is that each of these studies are somewhat different from each other so it's very hard to make a cross.
Study comparison between the results are for example, Allergan and we did our studies in Ms Opic or dark light conditions, where some of the other people did there isn't bright light, which is much easier to get a positive answer.
You know the different age groups that are included the different amounts of presbyopia that people have a between the different studies we.
We did take a look at our data and try to see well if we included patients similar to.
To what you saw on the Allergan study you know what.
It's not a scientific way to do things because it's post hoc and it's not a lot of people, but basically the results. We saw in terms of ethics efficacy were very much the same as what Allergan did so I think in the end. The important thing is that I see a number of products that could end up getting approved.
But in the end I believe that doctors are going to prescribe based on what the patient match used for that product what do they want something they can use on demand or use it once a day or if they want someone if someone wants to use it twice a day, it's really going to come down to matching the patient with the product, which you know I doctors are very used to doing.
I hope that helps thank you.
No that helps thanks Michael.
It's Tim.
Our next call comes from Matt Kaplan Ladenburg Thalmann.
Go ahead please.
Hi, Yeah, thanks for taking the questions Michael and John.
Just wanted to can you give us a quick update in terms of where you are with respect to the comedy I guess with the Paducah date al quickly approaching in October.
How are your commercial plans coming along and.
And any thoughts on pricing at this point.
Yeah, Thanks, Matt well, we're still going for a date of October 28th we've got nothing to.
Make us think that's going to be any different things are going along we hope to get some labeling from the FDA in the next four or five or six weeks.
Which will really indicate that things are happening quickly in terms of commercial progress.
We're preparing we have a new head of sales and marketing.
He is going to be hiring his salespeople are within the next Oh six weeks when the start hiring those people and putting them into place. Our plans are still to only go with 10 people on the largest population areas. We are working to collect our prospects ahead of time, so that we have places to go.
And we're not making cold calls are coming out the door ever Sona, our partner on the distribution, meaning they're the ones that are going to be doing the ecommerce taking any orders in fulfilling the orders were in close contact with them. So that's moving along well I would say everything is progressing.
Way that we would hope in and no hiccups in terms of pricing, we're operating on a price at launch of about.
Somewhere between a 100 and 120, a cartridge and you'd get about 75 patients out of the beach cartridge. So that's coming out to about a dollar twenty-five $4.35 per patient. We've now been testing this price with potential customers. They find it to be very very reasonable.
And at that price with a cost of goods of about $18 a cartridge. It's a very nice margin for us.
Hum what else can I tell you.
No that's that's great.
And that's the same pricing basically that there are spending today for the eyedropper bottles on.
Dilation.
So basically they get a oh, well, we believe to be a superior product for the same pricing.
Same price point okay.
And since there's no need to.
Oh, the secure reimbursement and coverage that way how should we think about kind of the trajectory of the other.
The launch once once it's out there.
Yeah, I think it's unlike a normal quote unquote normal pharmaceutical product, where you have to wait for patients to come in.
This is limited by how fast we can go and train the offices, because we do want to physically go and train people and make sure. They have a great experience with the product.
So I would look at this as in our assumptions or our plan is to be able to get to about 10% of the offices converted within the first year.
Okay.
That's great. Thanks, and then just switching switching gears.
There's two micron line and your second phase three of the vision two study.
Any any learnings on vision, one that you're applying to to division to like your you know you had very successful results from the first study anything that you're modifying in the second.
I think vision two it's going to look very much like vision, one except we don't need to have the 1%. So we know which dose we're going with John do you want to add anything to that.
No I think that's a it's basically a pretty accurate and I think that's currently the plan is going to look similar.
Except where we're only going to have the windows it.
Okay, Great and then last question you are in your prepared remarks, John you you spoke about potential.
Expansion using the Aki jet delivery technology into other products.
What how should we think about the timing on potential additional products either.
Licensing or organically internally developed.
So I would say that we have multiple discussions ongoing.
It's tough to handicap, the exact timing of things.
I think because we have multiple ongoing I think that I'd like to see a scant one in place by the end of this year I'm not sure that timing will work out, but we feel pretty confident that we'll be able to move.
Move forward with different collaborations.
Great well, thanks for detailing and good luck going into Europe would you state in October.
Thank you, Matt and thanks, Matt.
Once again.
If you have a question. Please press Star then one hour.
Our next question comes from Lin Yahtzee.
Start off so dot partners. Please go ahead.
Thank you very much Michael I was gonna have several questions I'm trying to square the circle between the current valuation of the company and the market opportunity. So I'll just throw out a couple of questions then.
Please ask them how do you like the first is that at the a S. T. R. S conference that Tim.
With referencing one of the things that impressed me.
Was the group of people you've assembled in terms of sales and marketing customer interaction.
All across the board and to the FDA interaction. So I just thought it might be a value to go through the number of years of experience.
And prior associations that you've all had together are working at some of the top companies.
Second thing I was wondering is with mid Combi, you talk about it being a $250 million U S opportunity could that drug.
Tensely without the jet B.
At a breakeven or profitable.
Level, two I know the AR exiting its first fear in the market and you know if if that's the case given again that it's not a large sales force with significant detailing it could end up justifying the current market cap a pre micro line and micro pine.
And then on micro align them with.
With the Allergan data that we saw.
And perhaps it might be on the Allergan Abbvie have talked about this being a 500 million to a billion dollar market.
It seems like with the Allergan study they had a very large placebo effect, which I thought was odd in terms of patients who are not on active drug and the clinical study I think it was 10% we're actually getting three lines of improvement and I thought that was odd given that these are preserved.
L P a patients and it would be tough to generate that unless you were seeing near 2040, and then maybe went to a meeting of the eye drop. So I was wondering if you could talk about your understanding if I'm right about that with the high placebo effect and.
And to the extent that that could skew the data.
That they were able to show in terms of the net benefit and how you're positioned with the patients that you have in your study are where you may not get as high a placebo effect, but you may show a greater net difference. Thank you so much.
Wow. Thank you why they've been taking notes furiously through that let me start with the last question about the Allergan results and I think you know the thing I would probably look at is the entry criteria. So they had patients in their study that could have had.
At 2040, and we had patients in our study where the best you could have coming into our study is 2050 and I would guess if you have patients coming in at 2040 are it could be possible on any given day are they may be able to read something.
Without any help so you might find a larger placebo rate.
Just due to that but I think that what they are looking at and I don't want to talk for Allergan happy, but theyre looking at the delta between their.
Active group and the placebo group, which I think was 20 percentage points.
And that's what they would point to and as I said you know we don't have enough of the patients. The match theirs. For example, we don't have anybody with 24 D. In our study.
But just kind of looking sort of kind of we see our results that you know, we're very happy with compared to their results.
And that's the best I can say about that so I hope at the end you know they get approved I'd love to see them get approved and openness Mark It up I think it's a lot bigger than 500 million to 1 billion.
And that will only help us when we eventually get to the market.
Question about the money I think I'd like to turn that over to John.
John do you want to take that or do you want to be talking about people go ahead John.
Now I can talk about certainly talk about it. So the question basically was did we think at the end of one year that it will be providing positive contribution market margin to the company.
I think the first year is difficult to do that because usually you start off with a controlled launch.
I would say I think by the fourth quarter. If you look at it on a quarterly basis, we could be at a point where.
And our internal Manav, we've seen this we think that med combi will be contributing.
You know positive contribution meaning that.
You know the revenue less cost of goods sold and direct sales and marketing expenses will be positive.
At that point in time, I don't think it will cover the first 12 months, because I think I'll start off the day.
And I know, you'll start off in a loss position but.
The fourth quarter's out one year out yes.
One way to look at it is that if you think about it as 2023, we definitely show or a show on our internal model that that's.
And that year, it's definitely generating a positive contribution margin for the company.
Yeah.
Okay. So Mike I don't know if you went back to the last piece.
I'll answer the next one what about the people in Atlanta I appreciate the the kudos they are a fantastic team.
We have people here with many many years of experience not just in drugs, but specifically in ophthalmology and optometry and for people who are involved in eye care. They understand that eye care is different and people tend to stay in it for a very long time.
And people don't know the nuances in our team and very proud to have them here come.
Come from backgrounds, and much larger eye care companies and now have mainly come here because they want to be able to bring their learnings and their relationships and their expertise and be part of something they see that's going to hopefully create a revolution in eyecare. So thank you again for that and for.
Anybody from I know who might be listening in we.
We all appreciate you know when we're when we're recognized for that so thank you win yep. Thank you.
Operator.
This concludes the question and answer session I would like to turn the conference back over to Mr. Rowe for any closing remarks.
Thank you and thank you everybody. This concludes today's call. Thank you for joining us and have a good and safe rest of your day Bye bye.
Thank you everyone.
This concludes today's conference call you may disconnect. Your lines. Thank you for participating and have a pleasant day.
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