Q2 2022 Eyenovia Inc Earnings Call
Some of it.
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Ladies and gentlemen, greetings and welcome to the second quarter.
Earnings Conference call.
At this time all participants are in a listen only mode.
A question and answer session will follow the formal presentation.
If anyone should require operator assistance during the conference.
Please press star zero on your telephone keypad.
As a reminder, this conference is being recorded.
I will now turn the conference over to Eric ripped out of lifestyle Advisors. Please go ahead Sir.
Thanks, very much and good afternoon, and welcome to <unk> second quarter 2022 earnings call and audio webcast with me today are I know he is chairman Dr. Shaun <unk>, Chief Executive Officer, Michael Rowe, and Chief Financial Officer, John <unk>.
This afternoon I am I know via issued a press release announcing financial results for the three months ended 2022.
We encourage everyone to read today's press release as well as I know via the report on Form 10-K for the year ended December 31st 2021, which is why I said March 30th 22, and our most recently filed 10-Q, the company's press release and annual report are also available on <unk>.
Yes.
At Www Dot I know via Dotcom and.
In addition, this conference call is being webcast at the website and will be archived there for future reference.
Please note on today's call, we will be discussing investigational product.
To receive FDA approval. Please 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 are nobody is managing well be making forward.
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. These forward looking statements are subject to a number of risks which are described in more detail in our annual report on Form 10-K, and most recently filed 10-Q.
This conference call contains time sensitive information accurate or.
Only as of the date of this broadcast August 10 2022.
I know via undertakes no obligation to revise or update any forward looking statements about events or circumstances. After the date of let's call except be required by applicable securities law.
With that said I'd like to turn the call over to Dr. Shawn I and she loves chairman of <unk> Board of directors Sean.
Thank you, Eric and welcome everyone to our second quarter 2022 financial results Conference call.
I'll keep my comments very brief this morning before handing the call over to an obvious new CEO , Michael Rowe for a comprehensive update in June I announced that I would be stepping down from both the CEO and Chief Medical Officer, Ross and transitioning to chairman of the board, while also serving as a medical consultant to the company at that.
<unk> the Bard retained an executive search firm and conducted a broad search for the most qualified candidate.
We identified several potential candidates and conducted interviews at the end of the day. However, the board agreed that none were better match for the skill set we require right. Now then Michael Roth the appointment of Michael who previously served as our Chief operating officer ensures continuity while at the same <unk>.
Bringing significant diverse of Tommy industry operations and commercialization expertise to the CEO role.
This is a critical moment, given where we as a company stand today, we will be resubmitting, our mid Combi, new drug application in the fourth quarter, giving us line of sight to transitioning into a commercial stage company.
At the same time, we're about to wrap up our second phase III Presbyopia study vision, too, which will be one input of microlight NDA for what we estimate to be a multibillion dollar presbyopia market in the U S alone.
Michael was also instrumental in brokering, our collaborations with Bausch and Lomb the eye care business that was spun out of Bausch health in 2021 and Arctic vision.
Together these agreements provide us with potential sources of non dilutive funding in the form of development and regulatory milestones and if their respective products are approved sales royalties.
This could be significant over time, and we see opportunities for additional agreements in other territories.
Michael's track record here. The board of Directors has also voted to add Michael as a board member, where we will be well served by his experience with my transition to chairman I will be able to continue to work with the board and leadership team to help guide I know obvious towards its long term goals, while also remaining.
Involved in future innovation as we work to expand our technology across additional therapeutic areas and cement our place as the new standard of care in topical ophthalmic therapies with the <unk> device.
This is a very exciting time for <unk>.
And with Michael assuming the CEO role I believe we have a world class team in place to best position us for long term success.
This will benefit not only patients and physicians, but our shareholders as well.
Remaining on the topic of leadership last month, we announced that we added doctors Alice trauma and ramp a lanky as new directors to our board of directors.
Each brings decades of medical technology clinical development launch and commercialization experience much of its specific to ophthalmology.
This cross functional expertise rounds out what I believe to be a top quality board, especially at a time when we have these significant clinical and regulatory milestones rapidly approaching.
That Alan and Ram have agreed to join our board provides strong validation of our technology and I look forward to working with them and the entire board as we Shepherd the company through this new and exciting phase of growth.
At this point I'd like to pass the baton over to Michael.
Thank you Sean for the kind words and thanks for everyone for joining our call. This afternoon I'm excited for this next chapter and I know there is evolution and I'm eager to take on my new responsibilities in moving our company forward and sustain the positive momentum that we currently enjoy I would like to thank you and the board for the confidence that you were showing me through these appointments.
So let's begin first with an update on our on our investigational Mydriasis candidate mid coffee. We are very very close to completing all of the off the jet device validation studies required by the F. D. A when the economy was reclassified to a drug device combination.
We previously announced a three or four tests were completed successfully those included a microbial challenge study that demonstrated the ability the ability of the opted yet to keep microbes from entering the device.
The human factor study assessing the ability of users to follow cleaning instructions.
The electronic safety study the fourth test, which is real time drug stability is ongoing and nearly complete we expect results. Later this quarter. We did experience modest supply chain delays that have impacted most high technology manufacturers and those have now been resolved as a result, we now anticipate re somebody or resell.
Betty Army Kabi NDA in the fourth quarter of this year.
Reiterating the anticipated regulatory timeline, we are assuming a six month review period and are making plans for our precision launch if approved during the first half of next year and this launch timeline is unchanged from our prior guidance.
As we have said before we believe the time and effort invested in this off to jet the bice validation work today may benefit potentially streamline the review process for our other programs in the future both microbiome and microbiome.
To ensure that we are fully capable of meeting the ongoing and new clinical product supply requirements of our partners. We recently announced that our new manufacturing facility in Redwood City, California is now operational the capacity and capabilities that we gained from this new state of the art facility complement our existing contract manufacturing relationship.
Yes.
So it is strategically located near several of our Silicon Valley based suppliers and will be used primarily for off the drip manufacturing, finishing operations, including drug loading labeling and packaging prior to distributions.
We also announced the hiring of medical technology industry veteran Brendan Curran as senior Vice President of manufacturing operations. Brent has spent his career, helping companies transition from research and development entities into scaled commercial manufacturing organizations.
Over the past 20 years, he has led product and manufacturing optimization supported regulatory approvals and establish GMP compliant manufacturing solutions worldwide.
We believe brand brings to I know via the ideal skillset and get it done attitude that we need as we prepare to make the important transition to a commercial stage company.
Now, let's move to Microbot or.
Proprietary microdose array print pilocarpine therapy for the temporary improvement in near vision associated with Presbyopia. This is an addressable market representing over 18 million people in the United States alone between the ages of 40, and 55, who otherwise never wear glasses and have the resources for a cash pay product.
Our second phase III study vision to its progressing nicely as a reminder, vision. She was a double masked superiority trial evaluating 2% multi array print pilocarpine versus placebo, we are close to achieving full enrollment of subjects into the study and anticipate top line data. This quarter. This is slightly later than our original.
And says we as well as many other companies found it challenging to get people out of their workspace for the required office visits. This is a consequence of the high employment rates that we currently enjoy it but we are approaching our target enrollment of 139 and this gives us confidence in the current timeline.
Today. There is current currently one pharmacological treatment available on the market allergens viewing and while this is helping to create the market. We believe we can capture a significant share of this market by leveraging the potential benefits of our off the jet technology.
Among these is a low rate of headache envision one we saw a very low rate of headache, and brow ache, a common side effect of pilocarpine conventional pilocarpine eye drops can cause headache, and about 15% of patients with the optics that we saw this rate reduced to less than 3% and our vision one trial and so far we're seeing the same profile coming out of vision too.
In addition, micro line delivered through the afternoon Spencer is easier and neither to administer and is designed to be used on demand with far less ocular stresses caused by preservative than traditional eyedrops topical ophthalmic medications typically contain preservatives to help ensure the sterility of the product and two to increase the shelf life.
Over time this can lead to adverse events due to the toxicity from overexposure to these preservatives.
We have conducted studies such as the one conducted in collaboration with Tufts University that we discussed last quarter, which have demonstrated that preserve drugs to leverage with the after Jeff Act more like unpreserved drugs reduce the ocular stress and potentially avoiding these long term adverse events.
We have compiled a significant body of market research among consumers patients and prescribers, indicating strong interest in the after jet over traditional eyedropper.
And our most recent research most recent research conducted in the last four weeks, 94% of prescribers agreed with the statement that the after jet will improve drug delivery process for patients taking up the almac medications.
So it's based on the doctor's belief that the optics, yet with improve the ability of patients to get the medication onto the Ark and address issues that patients have with Hadley I dropped bottles or vials, helping their head and dispensing too much medication.
Similarly, <unk> 93 per cent of consumers, who regularly use eye drops also felt that the offers that would give them more control or independents over I medication use.
The reasons behind this strong result were very much like those stated by the doctors the totality of research that we've conducted give us a great deal of conviction that the options that can be a significant differentiator for us potentially leading to strong consumer demand for our solutions relative to others on the market.
I would now like to turn the call over to our Chief Financial Officer, John Gandolfo to provide a financial update Jon. Thank.
Thank you Michael.
For the second quarter of 2022, we reported net loss of approximately $7 $2 million or 22 per share on approximately $33 6 million weighted average shares outstanding and this compares to a net loss of approximately $4.8 million of 19 cents per share for the second quarter of two.
<unk> thousand 21 on approximately $25 9 million weighted average shares outstanding.
Research and development expenses totaled approximately $3 6 million for the second quarter of 2022. This compares to approximately $3 7 million for the same period in 2021, a decrease of approximately two 7%.
For the second quarter of 2022 general and administrative expenses were approximately $3 5 million compared.
Compared with approximately $2 3 million for the second quarter of 2021, an increase of approximately 53, 8%.
Total operating expenses for the second quarter of 2022 were approximately $7 1 million compared to total operating expenses of $6 million for the same period in 2021. This represents an increase of approximately 19%.
At June 30 of 2022, the company's unrestricted and restricted cash balance was approximately $29.4 million, which includes $7 9 million of restricted cash.
Before we open the call to questions I will conclude with a brief update on our licensing program for fashion loan from micro <unk> in the U S and Canada and Arctic vision for all three of our drugs in China and South Korea.
This worth noting that while our original licensing agreement in October 2020 was with Bausch health Our U S. Licensee became Bash alone the eye care business that was formerly part of <unk> that was spun out as a separate company in early 2021, so for the sake of clarity our U S. Licensee is bashing alone.
And not by shell.
Micro <unk> as you may recall is a proprietary atropine formulation put a reduction of pediatric myopia progression. That's 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. This can result in retinal detachment myopic retinopathy and vision loss bifocal multifocal glasses or contact lenses are typically prescribed to myopic children.
Recall that as part of the agreement with passion.
Oversight and costs related to the ongoing phase III chaperone micra being clinical trial were transferred to our partner Chaperone is a 48 month U S. Based multicenter randomized double masked trial that is enrolling more than 400 children between three and 12 years of age the trial is comparing micro dose.
<unk> pinpoint a 1% versus placebo ophthalmic solution and enrollment is progressing as planned.
Our agreement with Arctic vision coverage, greater China, and South Korea, and while the original agreement that we announced in August 2020 was for micro peanut micro line Tayo.
So subsequently added Ms Combi as well so Arctic vision now licenses all three of our current programs.
<unk> for pediatric myopia in particular represents a significant opportunity in China. The Ministry of Education estimates that nearly 53% of all Chinese children suffered from myopia in 2020, and 13 million children are estimated to be at the highest risk our.
Our agreement with the RF Division provides for sales what royalties. In addition to development milestones, so if and when approved micra being could be for us.
Of non dilutive funds to our company.
Finally, we recently announced a large division has now.
And as Presbyopia study so that program is progressing nicely.
Data license agreements have generated approximately $16 million on license fees and we have the potential to earn an additional $60 million and net license and development milestones in Reimbursable expenses.
Next four years.
As noted upon commercialization if approved.
I know via can also earn significant sales royalties as well.
We are also continuing to assess potential pipeline expansion opportunities as we believe we can leverage the <unk> technology to address unmet needs in additional large ophthalmic indications.
Some examples include anti Infectives anti inflammatory dry eye and glaucoma, each with significant market opportunities.
Pipeline expansion was a significant consideration consideration as we were building out our new Redwood City, California facility.
So in conclusion, we continue to be pleased with our performance to date to summarize our key highlights today.
One we are continuing to rapidly advance our micros.
Our phase III Micra line Presbyopia program, we are enrolling patients in our phase III trial vision, two and expect topline data in the third quarter.
We are also actively preparing for the Resubmission never admit combi MBA in the fourth quarter of this year, which if approved would give us our first commercial product and validate our ROTC dispensing technology.
We executed on our planned CEO transition and added significant expertise to our board of directors ahead of these meaningful clinical and regulatory milestones.
Our new state of the our manufacturing facility in Redwood City, California is now operational and this provides additional capacity to complement our existing contract manufacturing relationships and our license agreements with Arctic vision Abashed alone by progressing well and continues to offer the opportunity for meaningful.
Development and regulatory milestones as well as line of sight to potential sales sales royalties, possibly within the next two years.
So that concludes our prepared remarks, we would now like to open up the call to questions operator.
Thank you Sir.
Ladies and gentlemen at this time, we will be conducting a question and answer session.
If you would like to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question queue. You May press star two if you'd like to remove your question from the queue.
For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.
Ladies and gentlemen, we will wait for a moment, while we poll for questions.
Yeah.
Our first question comes from the line of Matt Kaplan from Ladenburg Thalmann. Please go ahead.
Hi, yeah. Thanks.
Thanks for taking my questions and and Michael Congratulations on your new title.
Thank you Matt.
Just in terms of you mentioned a staged launch that was planned for.
Kathy can you can you give us a sense of how that what that means and how that would roll out and end and why a stage launch yeah.
Yes. So our plan is approval of the first half of next year, we'll be prepared within weeks after that approval.
To do the launch, but because it's a new technology and we want to make sure that people have and the doctors remember this is geared for doctors mid combi have an optimal experience with the product.
We're going to roll it out with large group practices that we can go and train them and learn everything we can that's almost like a beta launch or a beta test and get all the bugs out of that might be in the system. Because it is a new technology, a new way of doing things before going national So I think what youll see is that we are gear.
The up to address about a 10% of those offices with the current staffing and resources. We have now so we're not going to expand.
Any additional money to do that and once we have a bit of experience and have that under our belt.
I'll expand after that.
Okay.
Well, thank you and then.
With that with respect to Michael line and the vision to study as you.
Getting close to topline data there what should we be looking for in the data as it comes out in the near term.
While the primary endpoint of course, everybody will be looking at is the percentage of patients who have a three line gain in the active group versus the control group. So you'll be looking for a statistically significant result, there.
And then we want to see the adverse event profile, we've looked at the masked data in the trial. So far overall, where I said that the headache brow ache was less than 3% that's for everybody.
That's in there so.
You know, we're looking at the right profile, assuming we have the efficacy which would be part of that top line. Our plan is to set up our end of phase III meeting with the FDA, which takes about 60 days after that go meet with the FDA and coming out of that meeting are preparing to put together a N D E and simultaneous.
With that we will start doing our registration batches.
For the NDA to save a little time.
And how long does it take to complete the registration batches.
The registration batches take a full year. So the sooner we can start that the better the trigger for that is the successful vision to Oh, we'll go right into making those registration batches, because they're not an expensive and we just want to be as efficient as possible.
Okay great.
Thanks for taking my questions.
Thank you Matt.
Thank you.
Ladies and gentlemen, if you wish to ask a question. Please press star one on your telephone keypad.
Okay.
Next question comes from the line of Alex Matthews.
On Investor. Please go ahead.
Yes. Thank you for taking my question.
[noise], who wanted to find out.
When it's approved.
It would be available for over the counter purchase.
You know regular use for dispensing drugs I eye drops.
And.
Also do you expect the approval within six months or it's going to take six months for approval.
Now, let's yeah, Alex first of all thank you for being an investor.
We appreciate that the the after jet is not something that you can fill with with other products, it's not like a connect an eyedropper and squeeze it into the outage it and use it it actually is a primary container, which means it has to be developed with the drug that is intended to us from the beginning and that's why we.
Have to do these registration studies, so, but but but with that we are talking actively with other companies to see if they would like to put their products in our technology and there is substantial interest in one of our strategies is to partner or license the tech.
<unk> to these other companies so that we can see things in areas like dry eye or glaucoma.
Other people might have very good drugs, but they don't have very good ways of heavier spend stand if they married with us they could have the best of both worlds.
For your second question once we file.
The refile the NDA for mid Kaabi the clock for approval is six months at that point.
Did I answer your question.
Yes.
Thank you very much.
Thank you.
Yeah.
Ladies and gentlemen.
Next question comes from the line of Glenn Yeah.
Doc partners. Please go ahead.
Thank you and.
Sean Congratulations on having not so after yourself within.
Incredible success there so you succeeded.
All around my question from Michael is pretty simply on the beauty lines from Allergan. They they struggled with a lot of commercials and then the commercials.
Stop but what did you learn from seeing the launch and from talking to Optometrists are ophthalmologists in terms of.
The pluses and minuses of the product what you might have learned that you could do better when you launch the product in the next year.
Well, thank you Landon and I'm going to correct. Your last name Yafei. Thank you for calling.
And for your support the first thing we learned is that Theres a tremendous interest in a pharmacological option for presbyopia I think when when Allergan went out the gate with with a direct to consumer campaign, everybody was talking about it everybody was asking their doctors about it so we've learned that the car.
Onset of having a pharmaceutical option for.
For treating presbyopia is very very high so that's absolutely a positive.
What we've also learned is that what we bring to the table in terms of having a better delivery system for people and one that addresses the side effect of brow Ache and headache is also a very big positive because that's the thing that people probably like the least about their products. So those.
Who are the the two positives the third thing that I think we've learned is how important it is to give doctors a heads up of what's coming out and who the right patients are for this product.
For example, I have heard things like from other doctors, who say they have 70 year old patients who are coming into the office asking for it and these products are really not designed for people like that we've been very careful with what we've said which is always been this is a product designed for people between 40, and 55 more or less freshly.
<unk> be opex, and that's really where they work best So I think what we've learned is really to set the right expectation, who the right patient is and what they can get out of this which is good functional vision what most people between 40 and 55, we're looking for is they'd like to be able to look at their cell phone.
Out having to grab their glasses is that kind of function, they're not looking their teachers, they're not trying to grad grade term papers are without the glasses on so it's really setting the expectation of what youre going to get and I think our product frankly offers the best the best answer for all of those three things.
And you mentioned that there were 18 million presbyopia in the age range who will.
We'll have money not yeah, let money in a naive to glass wearing I'm wondering what your expectations are for the revenue per patient per year. So we could kind of arrive at a potential market size in the U S.
Our market research has said that people.
With the Objurgate, specifically on average a patient would probably fill that.
Three times a year.
So and we had previously discussed that our price would be somewhere around $100 a cartridge.
So that would give you an estimate of the revenue per patient.
Thanks, so much.
Thank you Lynn.
Okay.
Thank you.
Ladies and gentlemen, we have reached the end of the question and answer session and now I would like to turn the conference silver jewelry.
Mr. Michael Rowe, Chief Executive Officer for closing comments.
Thank you and thank you everybody that concludes today's call. We hope we were successful in conveying the significant progress that we continue to make with the <unk> technology and across our key clinical programs. We remain on track to resubmit the mid Kabi NDA in the fourth quarter of this year and micro lines Presbyopia program is progressing with <unk>.
Any clear and distinct advantages over therapies currently available or in development put simply we believe we have potential line of sight to two commercial products in the near future. Thank you again for joining us.
Thank you the conference of I Novo has now concluded. Thank you for your participation you may now disconnect your lines.
Okay.
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