Q3 2020 Oyster Point Pharma Inc Earnings Call
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Good evening and welcome to Oyster point, former third quarter 2020 earnings Conference call. My name is Dylan and I'll be your operator today.
After the Companys formal remarks, there will be a question and answer session.
At this time I would like to turn the call over to Mr., Daniel Lochner Oyster point farmers Chief Financial Officer, Sir. Please go ahead.
Good evening, everyone and welcome to always your point on this third quarter earnings conference call for the three months ending September Thirtyth 2020.
Evening, we issued a press release containing our third quarter financial results and recent business highlights. In addition, given the company recently passed the one year anniversary of our initial public offering the company filed a shelf registration statement and establish an aftermarket offering to provide additional financial flexibility going for our.
The press release, and our form 10-Q and form S. Three that were filed with the FCC even are available on our website under the Investor and news section at Www Dot Oyster point Rx dotcom.
Joining us on our call today, our jocular Jeffrey now President and Chief Executive Officer of Whats Your current funnel and Johnson is wrinkle Chief commercial officer. Following Dr. now in my prepared remarks, we'll open up the line for questions.
This conference call contains forward looking statements regarding future events and the future performance of Oyster point Mark.
Oh and need changes in shermer scores importantly, we see this effect in both the study I and fellow I illustrating the bilateral treatment benefits scene with our nasal spray approach.
When looking at the symptom improvement data from our integrated efficacy analysis, we see a statistically significant improvement in both those groups versus vehicle, although we see a larger symptom benefit versus vehicle with the 1.2 milligram per Mil dose group in the clinic environment with that benefit and the higher dose group even more pronounced.
And the low humidity high airflow controlled adverse environment illustrative of an environment that many patients will experience.
In addition to these analyses of the integrated data. When we include the use of concomitant artificial tears as a covariate in our statistical models. The difference between treatment and placebo is even more pronounced in both groups. We believe this highlights the benefit we might expect I care provider to see with the real world use a O C.
Oh, one nasal spray base.
Based on integrated analysis.
And the totality of data from our development program. We believed that the data supports our decision to seek F. D. A approval of the 1.2 milligram per male dose of O C. O. One for the treatment of the signs and symptoms a dry eye disease and.
Are currently being treated with a therapeutic and over 7 million people diagnosed with dry eye disease have tried and abandoned the currently available options we.
We believe that OTO, one has a compelling therapeutic profile that if approved may address some of the unmet needs of this large addressable dry end market.
As we continue to build out our commercial organization with an experienced team in the second half of 2021, we are planning on fielding a sales force of between 150 to 200 reps, which would target close to 90% of the current prescriber base of therapeutic dry eye products.
We also believe that patient access to over one will be critical.
Access strategy includes competitive contracting for broad payer coverage comprehensive pharmacy distribution, along with patient support programs to enable broad patient access to oversee a one.
I will now turn the call back over to Dan Lochner, Oyster Point's, Chief Financial officer to discuss our third quarter financial results.
Thank you John I will now provide a brief overview oil points Pharmas record financial results additional detail about our through or financial results can be found in our form 10-Q that was filed with the SEC. This evening.
For the third quarter of 2020 point, former reported a net loss of $16.3 million or 63 cents per share compared to a net loss of $11.5 million or $8.10 per share for the same period in 2019.
As of September Thirtyth, 2020, cash and cash equivalents were $214.3 million compared to $139.1 million as of December 30, Onest 2019.
Total research and development expenses for the third per quarter for 2000 $28.2 million compared to $8.1 million for the same period in 2019.
Companys clinical and preclinical then was $2.2 million lower during the third quarter and 2020, primarily due to the completion of the onset to phase III clinical trial in May 2012.
We incurred higher CMC and other research and development expense of $1.3 million, primarily due to the advancement of OTO, one as well as costs associated with the IND submission plan in the fourth quarter of 2020.
Total general and administrative expenses for the third quarter of 2012 or $8.1 million compared to $3.8 million for the same period in 2019.
The increase was due to higher headcount and reflects an increase in payroll payroll related expenses, including stock based compensation of $2.1 million.
The company incurred higher commercial planning expenses of $1 million in anticipation of a us launch of OTO. One if approved in the fourth quarter of 2021.
Additionally, there was an increase in other general and administrative expenses of $1.2 million due to the expansion at Spansion of the organization and operating as a publicly traded company.
With that overview of our financials I will now turn the call over to the operator to open up the line for questions.
Okay.
Thank you.
As a reminder to ask a question you need to press star one on your telephone.
To address your question just press the pound key please.
Please send violently composite can a roster.
And our first question comes from line of Stacy clue.
Alan you may begin.
Hi, Thanks.
Thanks for taking my questions and congrats on the progress.
So my first question is about whether you've had any additional interactions with the FDA regarding the NDS submission and just attack. If there are any remaining gating items beyond steadily.
And assuming an acceptance of the filing can you walk us through some of the manufacturing maybe some of the other regulatory requirements and your level of preparedness their metabolic.
Yes, Thanks, a lot Stacy for the question.
We have had.
Over the summer a pre end year meeting with the updated primarily focused on.
CMC, we continue to be on track with all of the CMC requirements for meeting our end da timeline, including that stability pull which will occur towards the end of the quarter.
And so no gating items currently that we foresee at this point in time.
With filing of the NDA as we go into 2021.
We will be focused on working with our manufacturing organization to pull together validation batches.
To prepare for launch and so those those three sets of validation batches are which are pretty standard in the industry will allow us to go into the launch in very good shape with regards to supply so nothing out of the ordinary with regards to your typical commercial launch of the product.
Got it and then in your early payer conversations can you help us understand.
Hi, good pricing in terms of the competitive landscape can you remind us how you will be thinking about branded dry eye products as well as products like generic restasis.
Yes, sure I think you're going to turn that.
Question over to John says Renko.
Thank you Stacy and.
In regards to our initial payer conversations.
We will be pricing.
No one upon approval in the end of Q.
Q4 up 21 competitively with the existing branded products that are on the market at the time.
We feel that is competitive and also the payer feedback based on our initial look at our therapeutic product profile is that we have some good differentiation and if we remain at the level of the branded products.
They are very interested in adding who see a one to the payer mix.
And just a follow up on the generic restasis, how you're thinking about that in terms of us your line.
Yes in terms of the generic restasis.
We're all awaiting the generic entries.
Any day now and we do feel that the way payers manage this class.
There will be a step through the generic for any branded products. So the generic restasis would be a tier one and then the branded products would follow thereafter.
One interesting statistic over the many years that restasis has been on the market and alongside IR.
Over 7 million patients have already tried.
These two products and.
For reasons has different reasons have abandoned them. So there's a lot of patients that have already stepped through and can go directly onto something new I knew opera thats available for dry eye disease.
Got it that's really helpful. Thank so much and congrats.
Congrats on another good quarter.
Thanks Stacy.
And our next question comes line.
Upon the Rama from JP Morgan you may begin.
Hey, Good afternoon, guys. This is tax on the call and on behalf of our anytime hope all is well.
Just two quick ones for Mike.
Perhaps you can talk about some of that physician awareness activities that are ongoing at the company ahead of a potential launch for LTL line, particularly in a virtual environment, we're all living in and and I guess are there any medical conference is that you're targeting and how is the current messaging messaging resonating with.
Position so far.
And then I guess, one more question on launch perhaps maybe.
Maybe how are you all thinking about market market segmentation by patient type.
And thanks, so much.
Speech and a virtual fashion as much as we possibly can and I think that will continue is John builds his team out more on the commercial side as well as our medical affairs team continues to grow as we get closer to lunch. So.
Obviously.
Not the perfect environment that we don't like to be in where we would be at in person meetings, but I think.
These meetings have been fairly well attended.
There are new virtual conferences coming up all the time and so we've been able to get that message out and be able to share our data and then maybe John can talk a little bit more about some of the activities as it relates to.
Market and launch yeah.
Thanks.
So our main focus prelaunch in 2021 is gonna be to introduce some launch an extensive disease state education program that targets kind of the high care professional audience and it will focus really on the importance of tier film homeostasis in the role of natural Tears you know the.
Current options on the market tend to be.
Reserved and used for more kind of a moderate to severe dry ice segments. They target Kennedy inflammatory component.
We also want to educate on you know the.
Roll of natural tier film and the loss of homeostasis when you do suffer from dry eyes.
And in regards to your question about the segmentation.
One of the things we looked at when we.
When we design they three pivotal trial is that we wanted to address a broad audience a dry eye patient. So in terms of the inclusion criteria. We included a broad set of patients ranging from mild moderate right through to severe the most severe of patients because of that and the results of the phase three trial.
<unk> when we do commercialized we plan to really address the huge unmet need of a broader audience right from the mild through to the severe patients.
Great. Thank you so much for taking my question.
Thank you Jeff.
Thank you and once again, that's star one for questions.
Our next question will come from the line Patrick the level from lifestyle capital it.
You may begin.
Thanks have a line this is valentina on for Patrick and Thanks for taking my question. Congrats on the continued progress.
Kitchen us so given the historic success at the keys. He campaigned in the marketing of dry I product how much emphasis do you guys plan to place on D E V.
Versus yourself fourth and DTC something you would roll out immediately of birth is.
Maybe waiting for some pbms to come on board and then.
An additional question on your account to carry Titus can you just describe the rationale here for us and maybe characterize the market opportunity in this indication as well thanks.
Sure Miss So I will turn it over to John to address the first part of the question.
Yeah. Thanks, Jeff.
In regards to.
The DTC program in the D. C. C efforts were looking at kind of the three pillars of our commercialization strategy equally so the sales force will be an important component of course patient access and payer access to the to the drug will be important and then of course educating the consumer the patient and the <unk>.
Prescriber. So in terms of ordering of that we will probably reserve our investment in direct to consumer after we get a lot of the pears to uhm to list Ossia. One after approval and then we do plan to invest quite substantially because we have seen historically.
<unk> that this is a very promotional sensitive market and then D. T. C is applied we've seen growth of the prescription dry market to be into double digit area. So it's an important component the timing will be everything from my perspective, our initial efforts will be really to make sure that pair uptake is is quick and then.
We get broad coverage.
And we're going to definitely target or feel for so from that perspective as well.
Great and so I'm dealing with the second part of the question with Neurotrophic Keratitis. This is a disease bye bye recent estimates affects approximately 11 out of 10000 patients in the United States that we know that the.
Ology is probably shooting very low and we've heard estimates as high as half of patients with diabetes in the United States May have some form of neurotrophic keratitis, we're really focused on the stage one in stage, two neurotrophic keratitis patient and really.
The the concept behind both C. O. One is that we do feel that ossia, one contains or it has a mechanism of action, which allows for us to stimulate the natural tier film, which contains a number of helpful components to the ocular surface, which could include things like growth factors.
Including nerve growth factor.
Whole host of different proteins lipids and.
Will allow for the patient to actually stimulate their own natural tier film. So one of the treatments. That's available today for these patients as autologous serum tears, which is obviously.
Very close in its make up to the natural to your film, although not perfect and with many of these patients they are experiencing a corneal.
Carneal hypoesthesia, so they're not feeling their corneal surface that feedback loop that currently would exist in a healthy patient.
That tells the brain, we need to stimulate the lachrymal gland to lubricate the ocular surface is often.
Third and so the unique mechanism of action of Ossia, one by being able to stimulate the lachrymal glands. The micro me in Glens mogul that sells through the nasal passage allows that patient to stimulate good healthy to your film that forms that barrier onto the ocular surface and oftentimes when there's a but.
Diseased cornea, we do know that there is a feedback mechanism that occurs that increases transcription of messenger RNA in the locker mill gland of various helpful proteins and so what we want to do is really harness the lachrymal glands healing potential for the cornea and really still.
<unk> those proteins to be secreted onto the ocular surface, what's interesting about this indication.
Is this is the first of a number of indications that we do think ossia, one will be applicable for and because this does not take any additional sales force.
This is another <unk>.
Disease state that just adds to the dry I.
Population directly without us having to invest in any other.
<unk> and so we'll begin this phase two study this year and hopefully from that data will move on to phase III development very shortly.
Great. Thank you for the color.
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