Q2 2021 Oyster Point Pharma Inc Earnings Call
[music].
Yeah.
Good evening and welcome to Oyster point Pharma second quarter 2021 earnings Conference call. My name is Justin and I will be your operator today after their company's pool and rural months there'll be a question and answer session. At this time I would like to turn the call over to Mr. Daniel Lochner Oyster point pharma.
And as Chief Financial Officer. Please go ahead.
Good evening, everyone and welcome to the Oyster point Pharma second quarter earnings conference call for the 3 months ending June 32021.
This evening and we issued a press release containing our second quarter financial results and recent business highlights.
In addition, our earnings press release, and our form 10-Q that was filed with the SEC.
After the close of market today are available on our website under the Investor and news section at Www Dot Oyster point Rx Dot com.
Joining us on our call today, and our Doctor Geoffrey now President and Chief Executive Officer of Oyster point pharma and John and his Aramco Chief Commercial officer. Following Doctor now Mr. Smith's Aramco and my prepared remarks, we will open up the line for questions.
During our call today, and we will be making forward looking statements regarding future events and the future performance of Oyster point pharma forward. Looking statements include statements regarding oyster point possible or assumed future results of operations expenses and financial position business strategies, and plans research development and commercial plans or expectations.
Trends market sizing and competitive position our belief regarding our clinical trial outcome, including secondary end point analysis predictions regarding product approvals or the decision, making and the impact of COVID-19, and the industry environment and potential growth opportunities. Among other things. These statements are based upon information available and.
The company today, and Oyster point assumes no obligation to update there.
These statements as circumstances change future events and actual results could differ materially from those projected and the company's forward looking statements additional information concerning these factors could cause results to differ materially from our forward looking statements are described in greater detail on the company's filings with the SEC, including our quarterly report on form.
10-Q for the quarters ended June 32021, and March 31, and 2021 and our annual report on form 10-K for the year ended December 31.2020.
I will now turn the call over to Dr. Jeffrey now President and Chief Executive Officer of Oyster point pharma.
Thank you Dan Good evening, everyone and thank you for joining us on our call today to discuss our second quarter 2021 financial results and recent business highlights as.
As you know our <unk> target action date for OCR, 1 vertical and nasal spray for the treatment of the signs and symptoms of dry eye is October 17th 2021.
We are currently preparing the organization to support the launch of both <unk> nasal spray in the fourth quarter, if approved by the FDA and.
And you've seen and our Q2 earnings press release, we have initiated hiring of sales Representatives and July and we're extremely pleased with the sales talent, we have hired already from across the country.
To date, we have received more than 6000 applications from individuals interested in joining our sales organization and we are excited about the culture and the team that we're building here at Oyster point.
As you May recall, we have previously communicated that we plan to hire a 150 to 200 sales representatives, calling on both ophthalmology and optometry and we are on track to deliver this goal at the time of launch.
And once in place Oyster point, we will have 1 of the leading U S. Eyecare provider focused sales teams and the industry.
And what's your point sales representatives are already and the field communicating our dry eye disease state awareness campaign, and we look forward to completing hiring and the sales team as we approach on <unk>.
With regards to payer access our medical affairs and access teams have been providing preapproval information exchange to many of the key payers already and we are currently building our payer engagement calendars for the remainder of 2021 and into 2022.
Our goal is to focus on achieving broad payer coverage to ensure access for eye care providers and patients.
As we prepare for a potential launch there are a number of major ophthalmology meetings that are important for oyster point to attend and for the remainder of 2021, either virtually or live depending upon the environment in light of the current Covid pandemic, we have accepted presentations that the women and ophthalmology meeting and the European Society of cataract and where.
And for active surgeons meeting in Amsterdam.
And the 2021 American Academy of Optometry meeting will be held in Boston and November 3rd to the sick and Oyster point, we will have 3 accepted abstracts presented at this meeting.
And the 2021 American Academy of Ophthalmology meeting will be held in New Orleans and November 12th of the 15th and Oyster point has 3 accepted abstracts that were presented at this meeting as well.
And I want to commend our medical affairs team for their 100% abstract acceptance rate for these major ophthalmology and optometry meetings for the year of 2021.
In addition to our development of Oc <unk> nasal spray for dry eye disease, we filed and India in November to evaluate the potential of OCR <unk> for the treatment of stage, 1 and they retrofit keratopathy and announced that the first patient was enrolled in June 'twenty, 1.2020, 1 we expect enrollment to continue.
Through 2021 and into the first half of 2020..2 we believe that OCR <unk> unique mechanism of action of stimulating natural tear film by the trigeminal parasympathetic pathway as seen in preclinical and clinical studies may be beneficial for <unk>.
Patients with corneal epithelium, hyperplasia, and or pump take Keratopathy. This patient population is often under diagnosed and are misdiagnosed based on our clinical trial experience and we think that these patients represent a meaningful proportion of the population suffering from ocular surface disease.
Looking at our earlier stage pipeline Oyster point is moving ahead with plans to engage with the food and drug administration with pre IND meetings for our enriched tear film gene therapy platform. The first gene therapy targets that we will focus on is the identity associated virus vector that codes for the human nerve growth factor protein.
In our preclinical studies and we have shown the ability to transduce, the lacrimal gland and harness its protein producing machinery discrete nerve growth factor onto the ocular surface.
For patients with stage, 2 and stage 3 neurotrophic keratopathy.
We look forward to continued progress and the start of IND, enabling studies and the second half of this year.
Also this past quarter, we entered into a collaboration agreement with adaptive phase therapeutics to develop what has the potential to be the first evergreen and anti microbial to enter the ophthalmic market.
Our focus will be bacterial infections of the ocular surface and ensure segment and we look forward to announcing our first disease day target and the latter half of this year or early part of 2022.
Lastly at our recent analyst day. This past July we shared preclinical data on <unk>, 1 and O C O 2 Sim pinnacle and anti viral activity against Sars Covid, 2 and variance of concern.
We have recently completed a number of in vivo studies and a non human primate study with Oc <unk> nasal spray and it's illustrated that within 24 hours of your exposure. These compounds have the potential to dramatically reduce viral entry and replication with no evidence of viral sub genomic RNA and the nasal cavity after.
48 hours.
We believe that a nasal spray approach could represent a meaningful preexposure and post exposure prophylaxis therapy as well as have the possibility of that changed the transmission dynamics and positively impact the coronavirus pandemic.
And the upcoming weeks, we plan to complete a second non human Primate study investigating both OCR <unk> and O C O 2 nasal spray respectively against the Delta variant of the Sars Covid 2 virus.
Our vision and focus on bringing innovative and transformative ophthalmic disease treatments to patients and building Oyster point pharma into a best in class Ophthalmology company remains our primary goal I would now like to turn the call over to Johnson, <unk> Oyster Point's Chief commercial officer to discuss our ongoing.
<unk> for the potential commercial launch of Oc <unk> nasal spray and dry eye disease and Q4 of 2021.
Thank you Jess the dry eye disease segment is a large market with over 17 million people diagnosed and the United States alone.
Only a small proportion of these patients approximately $2 million are currently being treated with a branded therapeutic.
Over 7 million people diagnosed dry eye disease have tried and abandoned the currently available options.
We believe that Oc <unk> nasal spray has a compelling therapeutic profile that if approved may address the unmet needs of patients with mild moderate and severe disease and dry eye disease, and the eye care practitioners, who provide for these patients.
This product has been developed with the patient and mind and it has the potential to provide a preservative free nasal spray that naturally spares the ocular surface from harmful harmful preservatives and common ocular side effects associated with topical eye drops.
From a commercial perspective launch preparations are underway and we are progressing on 3 key prelaunch initiatives that we outlined last quarter.
In early 2021, we introduced our dry eye disease awareness campaign.
The website for this program can be found at Www Dot dry island Dot com and that's spelled D. R Y E Y E L a and D dot com.
The goal of the disease State awareness campaign is to reframe the narrative around dry eye disease and to educate practitioners on the importance of chats on homeostasis and how tear film instability impacts dry eye disease.
Historically education has been primarily focused on later stage disease and inflammatory component of that disease, which in our opinion is a long term sequela of a disruption in tear film homeostasis.
Interest and traffic to dry island Dot Com has been high as we continued our efforts to educate the eye care community in quarter 2 of 2021.
The second phase and our launch preparation is in the area of market access and reimbursement our pre approval product dossier has been completed and we.
Started the dialogue with payers about OCR one's therapeutic profile and value proposition.
We will continue to meet with many of the key players in the upcoming quarter.
We've also done quite a lot of research with payers, including a number of advisory boards and we remain extremely focused on obtaining the best possible positioning and <unk> post approval.
The third stage is continuing to build out our sales team throughout the upcoming year as we previously mentioned we plan on hiring between 150 to 200, representatives, which would target greater than 90% of the current prescriber base of therapeutic dry eye disease products as of the end of Q2 'twenty 1 our regional sales directors.
As well as all the district managers have been hired.
In addition, the hiring of sales Representatives was initiated in July and this group of teammates has already been onboard and trained and are currently calling on eye care specialists with our disease state awareness education efforts.
The remaining sales positions have been posted and our goal is to have them hired on boarded trained and certified prior to our <unk> date.
Adjusted previously interest and Oyster point and sales positions have been very high with over 6000 applicants to date. This has allowed ourselves leadership to attract some great talent.
Upon their planned launch post FDA approval, our focus will be on broad eye care professional and patient education and marketing with a planned 4 targeted direct to patient campaign, so leveraging OCR ones novel, MLA and nasal spray route of administration.
Our sales and marketing efforts will be supported with a comprehensive patient support program.
As a potential first in class nasal spray to treat the signs and symptoms of dry eye disease, and <unk> product profile and may be compelling to both prescribers as well as patients.
I will now turn the call back over to Dan Lochner, Oyster Point's, Chief Financial officer to discuss our second quarter financial results.
Thank you John and I will now provide a brief overview of oyster point pharma and second quarter financial results additional details about our second quarter as well as our quarterly financial results can be found in our form 10-Q that was filed with the SEC.
For the second quarter of 2021, Oyster point pharma reported a net loss of $22 million or 85 cents per share compared to a net loss of $15.5 million or <unk> 66 per share from the same period and 22 point as of June 32021, cash and cash equivalents were on.
$154.8 million compared to $192.6 million as of December 31, 2020.
Total research and development expenses for the second quarter of 2021, or $6.7 million compared to $8.6 million from the same period and 2020.
Increase was primarily driven by lower CMC expenses incurred by the company and the second quarter of 2021 compared to the second quarter of 2002 point.
Which included significant preapproval inventory costs as well as expenses related to the preparation of the NDA filing in December 2020.
Selling and general and administrative expenses for the second quarter of 2021 and were $15.3 million compared to $6.9 million from the same period of 2021.
The increase was driven by higher payroll related expenses, including stock based compensation expenses of $4.8 million due to additional head count as well as higher commercial and yet.
1.8 million and anticipation of the U S launch of OCR <unk> for reticle, and nasal spray different Peru, and the fourth quarter of 2021.
In addition, the company incurred higher other and general and administrative expenses of $1 million related to accounting legal facilities information technology and other office related costs. The company also incurred and an increase and medical affairs costs and the amount of point $8 million during the second quarter of 'twenty, 1 compared to this.
Second quarter of 2020.
With that overview of our financials I will now turn the call back to Jeff to finish our prepared remarks.
Thank you Dan before taking questions. We are also excited to announce and this is hot off the presses the signing of 2 agreements earlier today.
First as announced on our earnings release, we have entered into a credit agreement with already met royalty and credit opportunities to provide up to $125 million and aggregate funding, which will enable us to continue executing on our business plan and our go to market strategy in.
In addition, we also announced and issued a press release that Oyster point has entered into an exclusive license agreement with <unk> pharmaceuticals to develop and commercialize <unk> and <unk> nasal spray for patients with dry eye disease and greater China.
And what's your point looks forward to collaborating with both partners as we continue to execute on our preparation for commercialization.
That additional update I will now I will turn the call over to the operator to open up the line for questions.
Thank you as a reminder to ask a question Youll need to press star 1 on your telephone to withdraw your question press the pound key please standby, while we compile the Q&A roster. Once again that is star 1 if you would like to ask a question and our first question comes from safety and <unk> from Cowen and company. Your line is now open.
Okay.
Hi, Thanks for taking my questions on.
And on the progress so first given your.
And the recent exciting licensing agreement with teaching our C O on and as you can.
Maybe just your thoughts on the European opportunity and potentially a starting point on that the magnitude and E partnership.
Based on this last day or maybe if you aren't just on partnering what kind of partner you might get lucky and fly ash.
And getting back into some of these aren't commodity content from what has been the feedback from clinicians.
And maybe to talk about.
And I wish to point that potential approval and what kind of education.
Thanks, so much.
Yeah, Great Stacey and so.
I'll take the first part of the call. Thanks, a lot for the question.
And then I'll turn it over to allow John to add some additional color on the second part so I would say as with any partnership.
And like Oyster point, and you're really focused on I would say 2 main objectives, 1 is partnering with someone.
And we have the research and development capabilities and also the clinical development and regulatory capabilities and when we look at a partner like choosing and China, We see both and we're really excited about that type of a partnership. We're also interested and similar partners throughout the world and.
What I would also say that it is really important on the flip side is finding a partner who also has commercial capabilities and there are not many partners throughout the world that are going to have both those R&D capabilities as well as commercial capabilities and.
And as we look at Europe, we really are excited about and opportunity there.
Where we can treat patients who are in a more severe stage of the disease as you know and the United States and our development program, we really focus on a broad patient population and so we included mild moderate and severe patients the European market's a little bit different and the sense that the government there really <unk>.
The push for patients who have failed multiple over the counter or lubricating dropped therapies before they then go on to.
And to a prescription therapy and so we think that that opportunity. There is to really showcase OCR, 1 and that severe population and as we present data from our clinical trials throughout the course of this year will be really highlighting some of that data we have around that severe patient population, which we're excited about.
As for the Ophthalmology Congresses. This year, we began to go back to in person and ophthalmology conferences, I would say as a whole everyone's really excited to get back together and really be able to engage once again a lot of excitement just around the product that we're bringing to the.
And so the market.
Excited about the novel mechanism of action and excited about the route of administration and excited about the data that we've been able to share so far and so we've been sharing.
And at various medical conferences, and we will continue to do that as I stated in my prepared remarks through the American Academy of Optometry and the American Academy of Ophthalmology, we have a number of podium presentation. So we will be able to continue to talk about our data both on the podium as wells and posters as the year goes on.
And on and then maybe what I could do is allow John to also share some of his experience at the recent American society of cataract and refractive surgery.
Yeah, Thanks, Geoff and thanks <unk> for your question 1.
1 of the things that debt really.
And was great to hear at these Congresses is the awareness of the company the awareness of Oyster point a lot of these physicians have seen the presentation on the clinical trial results. They are aware of Oyster point and building. This world class eye care company and specifically what they really mentioned was they are quite excited about.
The ability to have patients treat dry eye with their own natural tears.
A lot of these physicians.
Prescribe a lot of different eyedrops for different conditions and the fact that we are taking an approach that we're sparing the ocular surface from additional chemical.
Chemicals, and we're actually using the ability of the body to produce natural tears, but something that they keep reiterating over and over and so the excitement is there and is building and I think the fact that you know.
And where we have the ability to work upstream and the dry eye disease cycle is something that they're excited about.
Thanks, so much.
And thank you and our next question comes from <unk> Rama from Jpmorgan. Your line is now open.
Hi, guys.
Thanks, so much for taking the question and also thanks for hosting analyst day.
Couple of weeks back I was reading my colleague, Chris Nathan's note from earlier today related to Kalla and it just seems like that launch is disappointing here and in dry eye and what are you learning from that launch you think that you can apply or do differently for OCI and <unk>. Thanks, so much.
Hey, Ana Paula and thanks, a lot for the questions and what I'll do here is have have John chime in.
On some of the learnings from the launch as well and and Dan can deliver some color there.
Yeah, Thanks and account for the question.
1 thing I wanted to.
Reiterate is that we have such a different mechanism of action that's very novel.
From a from a steroid perspective loteprednol has been prescribed for many different things, including you know dry eye in the past and and you know this is a <unk> product is a little pregnant and so there are some limitations with with the uptake that we've seen so far.
We feel with a very novel molecule, a very novel approach and even with our initial discussions with the payers.
And they feel that we have quite a lot of differentiation. They are very excited to have something new to add to the armamentarium and to offer something that is different from day anti inflammatories that are out there. So our positioning will be very different we treat.
With the potential approval, we chewed mild moderate and severe patients.
Right through the spectrum to the chronic patients. So I think we have quite a bit of differentiation and will also be investing.
Investing quite a bit in the launch and regards to field force as well as marketing and around our patient services offerings.
Yeah, and I would say the same thing just being sure. We're very focused on doing the best of our capabilities on market access and patient services really to be sure were and are positioned to avoid any areas along the patient journey, where patient abandonment could occur and so we're seeing a significant amount of time be ensure that.
And we're being quite diligent on all those parts and the journey.
So at the time of launch we can be and are positioned to really drive robust <unk>.
Yeah.
Yeah.
Thanks, so much for taking our question.
Thank you.
And our next question comes from Joe <unk>.
<unk> contains zero from Piper Sandler Your line is now open.
Perfect. Thanks, so much for taking my question here, maybe just 1 quick 1 from me you guys have been pretty transparent about the interactions with the FDA during the NDA review process and I think you've pre.
Obviously noted some CMC request just wondering if you could provide any updates there whether there had been any additional requests from the FDA and perhaps the nature of those requests and and the degree of confidence that a decision will be made on or before the October paducah. Thanks.
Hey, Thanks for the question Joe So we continue to engage with the agency.
As the review process goes along we continue to remain on track.
And our <unk> action date is October 17th our expectation would be sometime 30 days before if not sooner well, we would start in to having those labeling negotiations and so.
Things are moving ahead as planned.
With no additional surprises and so we continue to be available to engage or answer any questions and.
And.
On track according to that pretty fashion date and October currently.
Okay got it I think there had been some questions from you guys, whether there would be a pre approval inspection of the manufacturing facility there given some of the CMC request.
Are your expectations that there will or won't be a pre approval inspection thing.
Yeah, Yeah, so great question.
So and at the moment.
And the at least the feedback that we've received from the agency has been that their focus has been primarily catching up with facilities, especially those facilities, where they've not been out too and spectrum.
And so.
As you can imagine and number of facilities with new products coming to market that have never been visited by the agency. We are fortunate enough debt our facility.
Has been.
Visited by the agency within the last few years, so it'll be at the discretion of the agency as to whether they.
And they come out before the <unk> date or after the Paducah date, but we are manufacturing currently on the line.
And in a facility that is producing products that have entered the market. So we feel comfortable.
With that particular position, although the fda's not committing to whether they would be out.
Pre approval or post approval.
Okay I appreciate that very helpful. Thanks for taking my question.
Thank you and again, ladies and gentlemen, if you have a question that is star 1 Ken if you have a question that is star 1 and our next question comes from Patrick Dolezal from my side capital.
Your line is now open.
Hi, Thanks for taking the questions it sounds like you're not quite yet and labeling discussion and so this might be a bit preemptive, but to the extent possible can you just provide any further guidance on relate.
Related to the potential for signs and symptoms label versus and curious to your production and perhaps comment on how much 1 label versus another and might ultimately matter and the real world setting.
Yeah. Thanks, Patrick Great question, so yeah.
Yes, we have not begun and negotiation process, yet according to plan and schedule although.
And what I will say is in December of this year in fact, the day. After we filed the NDA FDA did put out a draft guidance around dry eye disease, which hadn't existed before so I think it's really important.
For folks as they look at our product as they look at other dry eye products out there to take a look at that guidance document.
And we we were provided from the agency guidance consistent with what's in that document before we filed the NDA. So we're very happy to see it put into print.
As you know our primary end point.
And on that too with the categorical change of 10 millimeters or more and Sherman score, which if you take a look at that guidance document youll see on.
On its own supports the.
Indication of signs and symptoms of dry eye disease, and then and our and our onset 2 trial. We also had meaningful improvements in symptoms and on top of that categorical change and the primary end point in the onset 1 study we had.
Not only the pre stated are pre specified primary and secondary endpoints of signs and symptoms, Matt, but we also had the <unk>.
Post hoc analysis of that categorical change so we feel that we're in a very strong position with the label, we think that we're going to have.
You know a real robust label among the labels that are out there I would I would point out debt.
There are other companies out there in the marketplace, we don't consider.
All signs and all symptoms being equal we think we have signs and symptoms that are clinically meaningful and relevant and so we're excited for where we'll land with the label and.
I think as as it pertains to the question that you asked with regards to.
What the real World will do with regards to our signs and a symptom label or something that's less than.
And then 1.1 could just point to the fact that the the 1 product.
With respect to us out there that has what we would all call say a limited label is currently doing $1.2 billion and sales versus the product with the signs and symptoms label, which as you know.
Not a.
Not necessarily at that level and so what I would say is you know.
From the H D P perspective, probably less important than.
And from that perspective.
<unk> investors and I think that the hep's and patients are really worried about.
And then of course additional payments would be potentially occurring as a development move forward and trying to theater, but we're still working on the development plan with <unk>. So we're we're not at the point of providing that guidance, but of course those additional payments.
Would be incorporated into the the numbers that you saw on the release today.
Great. Thanks for taking the questions.
And thank you for your question and I would thank you I will now turn the call back over to Doctor now for any closing remarks.
[noise], Thank you, operator, and and thanks for to everybody who's on the call for joining today and we look forward to everything that's happening at Oyster point farm and not only with the O C O 1 <unk>.
Radical nasal spray launch this year and the fourth quarter, if approved but also building out our pipeline expanding and extending our reach with our first collaboration and China with Chi-ching Pharmaceuticals, we continue to execute on creating oyster point into a world class Ophthalmology company, we're really excited about being and ball.
Austin and New Orleans, this fall with the American Academy of Optometry, and the American Academy of Ophthalmology meetings and.
And we potentially launch our first product into the U S marketplace, So and closing I want to thank everybody for joining us Tonight and for having a great evening.
This concludes today's conference call. Thank you could participate and you may now disconnect.
[music] [noise].
[music].
Good evening and welcome to Oyster point farmers second quarter 2021, and earnings Conference call. My name is Justin and I will be your operator today after their companies fall and remarks there'll be a question and answer session. At this time I would like to turn the call over to Mister Daniel Lochner Oyster point.
From his chief Financial Officer. Please go ahead.
And everyone and welcome to the Oyster point format second quarter earnings conference call for the 3 months and and June 30th 2021.
Evening, and we issued a press release containing our second quarter and extra salt and recent business highlight.
In addition, our earnings press release, and our form 10-Q that was filed with yet.
After the closed the market today are available on our website on or the investor and new section at Www Dot Oyster point Rx Dot com.
Joining up on a call today, and our Doctor Jeffrey now President and Chief Executive Officer, and Oyster point format, and Johnson and his ranco Chief commercial officer falling Doctor now Mr. Smith, Durango and my prepared remarks, we will open up the line per question.
During our call today, and we will be making forward looking statements regarding future and the future performance of Oyster point pharma forward. Looking statements include statements regarding oyster point possible or assume future results of operation and expenses and financial position business strategies, and plans research development and commercial plans or expectations.
[noise] trendy market size and competitive position or belief regarding our clinical trial outcome, including secondary on analysis predictions regarding product approvals are you decision, making the impact and COVID-19, and the industry environment and potential growth opportunities. Among other things. These statements are based upon the information available on.
The company today, and and what's your point and since no obligation to update these statements that circumstances change future events and the actual results could differ materially from those projected and the companies forward looking statements and additional information concerning and factors could cause results to differ materially from our forward looking statements are described in greater detail.
To access teams have been providing preapproval information exchange to many of the key payers already and we are currently building our payer engagement calendars for the remainder of 2021 and into 2022.
Our goal is to focus on achieving broad payer coverage to ensure access for eye care providers and patients.
As we prepare for a potential launch there are a number of major ophthalmology meetings that are important for oyster point to attend for the remainder of 2021, either virtually or live depending upon the environment in light of the current Covid pandemic, we have accepted presentations that the women and ophthalmology meeting and the European Society of cataract and <unk>.
Refractive surgeons meeting in Amsterdam.
The 2021 American Academy of Optometry meeting will be held in Boston in November 3rd to the sticks and Oyster point, we will have 3 accepted abstracts presented at this meeting.
2021 American Academy of Ophthalmology meeting will be held in New Orleans November 12 to the 15th and Oyster point has 3 accepted abstracts that were presented at this meeting as well.
I want to commend our medical affairs team for their 100% abstract acceptance rate for these major ophthalmology and optometry meetings for the year of 2021.
In addition to our development of Oc <unk> nasal spray for dry eye disease, we filed an IND and November to evaluate the potential of OCR <unk> for the treatment of stage, 1 neurotrophic Keratopathy and announced that the first patient was enrolled in June 21, 2021, we expect enrollment to continue through.
2021 and into the first half of 2022, we believe that OCR <unk> unique mechanism of action of stimulating natural tear film by the trigeminal parasympathetic pathway Athene and preclinical and clinical studies may be beneficial for patients with corneal epithelium hyperplasia, and our pump take care with Hopper.
Hi, we shared preclinical data on O C O 1 O C O 2.
<unk> and.
Anti viral activity against Sars, Kobe, 2 and variance of concern we.
We have recently completed a number of in vivo studies, and and nonhuman Primate study with O C O 1 nasal spray and it's illustrated that within 24 hours of exposure.
These compounds have the potential to dramatically reduce viral entry and replication with no evidence of viral sub genomic RNA and the nasal cavity after 48 hours.
We believe that a nasal spray approach could represent a meaningful preexposure and post exposure prophylaxis therapy as well as have the possibility that change the transmission dynamics and positively impact the coronavirus pinned on.
And the upcoming weeks, we plan to complete a second nonhuman primate study investigating both O C O 1 and O C O 2 nasal spray respectively against the Delta variant of the Sars Kobe to virus.
Our vision and focus on bringing innovative and transformative ophthalmic disease treatments to patients and building Oyster point pharma into a best in class Ophthalmology company remains our primary goal I would now like to turn the call over to John Schnitzer, Renco Oyster points, Chief commercial officer to discuss our ongoing.
Asian for the potential commercial launch of OS yoann nasal spray and dry eye disease and Q4 of 2021.
Thank you, Jeff the dry eye disease segment is a large market with over 17 million people diagnosed and the United States alone.
Only a small proportion of these patients approximately 2 million are currently being treated with a branded therapeutic.
Over 7 million people diagnosed or die of disease had tried and abandoned the currently available options.
And we believe that O C. L..1 nasal spray has a compelling therapeutic profile that is approved may address the unmet needs of patients with mild moderate and severe disease and dry eye disease, and the eyecare practitioners who provide for these patients.
This product has been developed with the patient and mind and it has the potential to provide a preservative free nasal spray and naturally spares the aqua surface from harmful harmful preservatives and comment ocular side effects associated with topical eyedrops.
From a commercial perspective launch preparations are underway and we are progressing on 3 key prelaunch initiatives that we outlined last quarter.
In early 2021, we introduced our dry eye disease awareness campaign.
The website for this program can be found at Www Dot dry islands Dot com and that's spelled D. R Y E Y E L. A N D dot com.
The goal of the disease state of awareness campaign is to reframe the narrative around dry eye disease and to educate practitioners on the importance of tshirts on homeostasis and how to hear from instability impacts dry eye disease.
Historically education has been primarily focused on later states disease anti inflammatory component of that disease, which and our opinion as a long term <unk> on the disruption and cheer on homeostasis.
Interest and traffic to dry island Dot Com has been high as we continued our efforts to educate the <unk> community and quarter 2 of 2021.
The second phase and our launch preparation is in the area of market access and reimbursements, our preapproval product Garcia has been completed and and we have started the dialogue repairs about ossia ones therapeutic profile and and value proposition we.
And we will continue to meet with many of the key players in your upcoming quarter.
We've also done quite a lot of research with payers, including a number of advisory boards and we remain extremely focused on obtaining the best possible positioning I have O C O 1 post approval.
The third stage is continuing to build out our sales team throughout the upcoming year as we previously mentioned we plan on hiring between 150 to 200, representatives, which would target greater and 90% of the current prescriber base of therapeutic dry eye disease products.
As of the end of Q2, 21 or regional sales directors as well as all the district managers have been hired.
In addition, the hiring of sales Representatives was initiated and July and this group of teammates has already been on board and trained and are currently calling and I care specialist with our disease state of awareness education efforts.
The remaining sales positions have been posted and our goal is to have them hired on board are trained and certified prior to our Paducah day.
Adjusted previously interest and Oyster point sales positions have been very high with over 6000 applicants to date. This is a lot ourselves leadership detract from great talent.
Upon or plan to launch posted FTA approval, our focus will be on broad I kept professional and patient and education and marketing with a plan for targeted direct to patient campaigns and leveraging ossia ones novel, MLA and nasal spray route of administration.
Our sales and marketing efforts will be supported with a comprehensive patient support program.
As a potential first and class nasal spray to treat the some signs and symptoms of dry eye disease, ossia ones product profile and may be compelling to both prescribers as well as patients.
I will now turn the call back over to Dan Lochner or supports Chief financial officer to discuss our second quarter financial results.
Thank you John I will now provide a brief overview of oyster point, Pharmasset and quarter financial results additional details about our second quarter as well as our quarterly financial results can be found and our farm. Thank you that was filed with Ya.
For the second quarter of 2021, and what's your point farmer reported and net loss of $22 million or 85 and for sure compared to a net loss of $15.5 million or 66 cents per share for the same current and 20 point as of June 30th 2021, cash and cash equivalents.
$154.8 million compared to $192.6 million as of December 31st 20 point.
Total research and development expenses for the second quarter of 2021 or $6.7 million compared to 8.6 million from the standard and 2020.
Kris was primarily driven by lower AMC expenses incurred by the company and the second quarter of 2021 compared to the second quarter of 2000 point.
Which included significant preapproval inventory costs as well as expenses related to the preparation on the NDA filing and December 2020.
And in general and and minutes for and that sentence for the second quarter of 2021, and we're $15.3 million compared to 6.9 million from the same period of 2021 and.
The increase was driven by higher payroll related expenses, including and stock based compensation and the $4.8 million due to additional head count as well as higher commercials and yet.
Of 1.8 million and anticipation of the U S launch a O C O 1 for radical and nasal spray different from and the fourth quarter of 2021.
In addition, the comforting current hire other and Harel administrative expenses on 1 million related to accounting legal facilities information technology and other office really cost the.
The company also encouraged and increase and medical affairs costs and the amount of $2.8 million during the second quarter of 21 compared to the second quarter of 2020.
Once that overview, our financials and will now turn the call back to just to finish on prepared remarks.
Thank you Dan.
Oh come on what's your conference's what has been the feedback from clinicians and maybe talk about some of the buzz before the potential approval or what kind of education is is is needed uhm. Thanks. So much.
Yeah, Great Stacey and so I'll I'll take the first part of a call on thanks, a lot for the question.
And then I'll I'll turn it over to allow John to add some additional color on the second part so I would say as with any partnership a company like what's your point and you're really focused on and I would say 2 main objective. It's 1 is partnering with someone who has the research and development capabilities and.
And also the clinical development and regulatory capabilities and when we look at a partner like choosing and China, We see both and we're really excited about that type of a partnership. We're also interested and similar partners throughout the world and what I would also say that it is really important on the.
The flip side is finding a partner who also has commercial capabilities and there are not many partners throughout the world that are going to have both of those are and D capabilities as well as commercial capabilities and.
And as we look at Europe, we really are are excited about and opportunity there where we can treat patients who are in a more severe stages of disease as you know and the United States and our development program, we really focus on abroad patient population and so we included mild.
Moderate and severe patient European markets, a little bit different and the sense that the government, they're really tries to push for patients to a failed multiple over the counter or lubricating drop therapies before they then go on to a prescription therapy and so we think that that opportunity. There is to really showcase O C O 1 and that so.
Of your population and as we present data from our clinical trials throughout the course of this year will be really highlighting some of that data we have around that severe patient population, which we're we're excited about.
As for the Ophthalmology Congresses. This year, we began to go back to in person Ophthalmology conference. It I would say you know as a whole everyone's really excited to get back together and really be able to engage once again a lot of excitement just around the product that we're bringing to the.
So the market excited about the novel mechanism vacuum excited about the route of administration excited about the the data that we've been able to share so far and so we've been sharing.
At various medical conferences, and we will continue to do that as I stated and my prepared remarks through the American Academy of Optometry, and the American Academy of Ophthalmology and have a number of podium and presentation. So we'll be able to continue to talk about our data both on the podium as well as and posters as the year and goes on.
And then maybe what I could do is allow John to also share some of his experience at the recent American Society, a cataract and refractive surgery.
Yeah, Thanks, Jeff and thanks for Tasty for your question 1 of the things that that really and was great to hear at these congresses is the awareness of the company and when it's supposed to point a lot of these physicians have seen the presentations on the clinical trial results, they're aware of Oyster point building this world.
I care company and specifically what they really mentioned was there quite excited about the ability to have patients kind of treat dry with their own natural tears and.
A lot of these physicians you know the prescribe a lot of different hydrops for different conditions and the fact that we are taking and approach that we're sparing the ocular surface from additional chemicals, and we're actually using the ability of the body to produce natural tears, but something that they keep reiterating over and over so the excitement and Sarah and it's built.
And I think the fact that you know where we have the ability to work upstream and to dry eye disease cycle is something that they're excited about.
Thanks, so much.
[noise] and thank you and our next question comes from a new Cam Rama from J P. Morgan Your line is not open.
Hi, guys.
Thanks, So much for taking the question and also thanks for hosting analysts day, a couple of weeks back I was reading my colleague, Chris Mayer's note from earlier today and related to caller and it just seemed like that launch is disappointing here and and and dry I and what are you learning from that launch you'd think that you can apply or do differently.
Oh C O 1 thanks, so much.
Hey on a palm thanks, a lot for the questions and what I'll do here is have have John chime in on some of the learnings from the launch as well and and Dan can deliver some color there.
Yeah, Thanks and account for the question 1 thing I wanted to reiterate is that we have such a different mechanism of action. That's very novel you know from a from a steroid perspective loteprednol has been prescribed for many different things, including you know dry eye and the past and.
And and you know this is a catalog product is a little pet and also there are some limitations with with the uptake that we've seen so far we feel with a very novel molecule a very novel approach and even with our initial discussions with the pairs. They feel that we have quite a <unk>.
Lot of differentiation, they're very excited to have something new to add to the on on the Terry them and to offer something that is different from the anti inflammatories that are out there. So our positioning will be very different we retreat potential approval, he chewed mild moderate and severe patients right through the <unk>.
From to the the chronic patient so I think we have quite a bit of differentiation and we'll also be investing quite a bit in the launch in regards to field force as well as marketing and around our patient services offerings.
And I would say the same thing just being sure very focused on doing the best of our capabilities on market access and pizza and services really to be sure of her and a position to avoid any areas along the patient journey, where patient abandonment could occur and so we're seeing a significant amount of time being sure.
That were being quite diligent on all those parts and the journey. So at the time of launch we can be and a position to really drive robust T. R X.
[noise]. Thanks, so much for taking my question.
Thank you and.
And our next question comes from Joe.
<unk> contains zero from Piper Sandler Your line is now open.
Perfect. Thanks, so much for taking my question here and maybe just 1 quick 1 from me you guys have been pretty transparent about the interactions with the F. D. A during the NDA review process and and I think you'd previously noted some theater and see request just wondering if you could provide any updates there whether there have been any additional requests from the F.
D. A prep the nature of those requests and and the degree of confidence that a decision will be made on or before the October Purdue. Thanks.
[noise] and thanks for the question Joe So we continue to engage with the agency.
As the review process goes along we continue to remain on track again or Purdue faction date is October 17th or expectation would be sometime 30 days before if not sooner what we would start in 2 having those labeling negotiations and so.
Things are moving ahead as planned with no additional surprises and so we continue to be available to engage or or answer any questions and you know on track according to that pretty fast and date in October currently.
[noise], Okay got it I think there had been some questions from you guys and whether there would be a pre approval inspection of the manufacturing facility given some of the themes you request Ah your expectations at their will or won't be a pre approval inspection thing.
Yeah, Yeah. So a great question so at the moment.
At least the feedback that we've received from the agency.
And that their focus has been primarily catching up with facilities, especially with those facilities, where they have not been out too and spectrum.
And so.
There are as you can imagine and number of facilities with new products coming to market that have never been visited by the agency. We are fortunate enough that our facility has been visited by the agency within the last few years, so it'll be at the discretion of the agency as to whether they.
They come out before the Paducah day or after the Paducah day, but we are manufacturing currently on the line and and a facility that is producing products that have entered the market. So we feel comfortable.
With that particular.
Position, although the fda's not committing to whether they would be out preapproval or post approval.
Okay I appreciate that very helpful. Thanks for taking my question.
Thank you and again, ladies and gentlemen, and if you have a question that is star 1 day and if you have a question that is star 1 and our next question comes from Patrick <unk> from my side capital.
Your line is not open.
Hi, Thanks for taking my questions. It sounds like you're not quite yet and and wavelength discussion on so this might be a bit pre-emptive, but to the extent possible can you just provided and a further guidance on related to the potential for signs and symptoms label versus and crickets chirp production and perhaps comments on how much 1 way and.
Versus another and my ultimately matter and the real world and setting.
Yeah. Thanks, Patrick Great question so.
Yeah, where we have not big on the negotiation process yet according to plan schedule and although what I will say is in December of this year in fact, the day. After we filed the NDA F. D. A did put out draft guidance around dry eye disease, which had and <unk>.
And just did before so I think it's really important for folks as they look at our product cause they look at other dry-eyed products out there to take a look at that guidance document.
And we we were provided from the agency guidance consistent with what's on that document before we filed the NDA. So we're we're very happy to see it put into print as you know, our our primary and point and onset too with the categorical.
Change of 10 millimeters or more and shermer score, which if you take a look at that guidance document and you'll see on its own supports the [noise].
Indication of signs and symptoms of dry eye disease, and then and our and.
On set to trial, we also had meaningful improvements and symptoms and on top of that categorical change and the primary endpoint and.
And the on that 1 study we had you know not only the priest dated or Prespecified primary and secondary and point of signs and symptoms, Matt, but we also had the post hoc analysis of that categorical changed. So we feel that were and a very strong position with the label, we think that we're going to have.
You know real robust label among the labels that are out there I would I would point out that you know.
There are other companies out there and the marketplace, we don't consider.
All signs and all symptoms being equal we think we have signs and symptoms that are clinically meaningful and relevant and so we're excited for where will land with the label and.
No I think as as it pertains to the question that you asked with regards to.
What the real World will do with regards to Ah signs and the symptom label or something that's less and signs and symptoms.
1.1 could just point to the fact that the the 1 product.
With Restasis out there that has what we would all call and say a limited label is currently doing $1.2 billion and sales versus the product with the signs and symptoms label, which is.
You know not not necessarily at that level and so what I would say is.
From the H C. P perspective, probably less important than from the perspective of investors and I think that the H G. PS and patience are really worried about less and the label and more about what's the product profile and so as it pretty.
And to our product I think you're gonna find the product that patients are going to like it's a product that works very rapidly it's able to give them that quick relief and also has chronic benefits when used twice daily overtime. So and are clinical trials retreat at a very broad population of patients.
State and before I think it's the only product with these characteristics and it's going to be in the marketplace. And then you add on this this novel relative administration. So we're super excited to launch this product. Our sales teams are excited to launch the product and so we're looking forward to heading into that to do today and having approval.
Super helpful. Thanks, and 1 more if I may just pretending to the jewelry and agreements Ah just to the extent that and you can provide further details on the potential of timing and size of these development and sales base milestones that would be helpful. You know as to whether there's a line of sight on the relative near term. Thanks.
Yeah sure well as we as we noted and the agreements the upfront payment of $17.5 million will be paid out in the near term and then I'll turn the question over to Dan and he can provide some additional color on the agreement itself.
Absolutely and then I would say in addition to that with F approval of O C O 1 and the United States. We would received an additional 5 million and that would be what we intend to receive and the current calendar year and then of course a dish.
Channel payments would be potentially occurring as a development move Ford and the kind of theater, but we're still working on the development plan with <unk>. So we're we're not at the point of providing that guidance, but of course, those additional payments would be.
Incorporated into the the numbers that you saw on the release today.
Great. Thanks for taking the questions.
And thank you for your question and I. Thank you I will now turn the call back over to Doctor now for any closing remarks.
[noise], Thank you, operator, and and thanks for to everybody who's on the call for joining today and we look forward to everything that's happening at Oyster point farm and not only with the O C O 1.
Varenicline nasal spray launch this year and the fourth quarter, if approved but also building out our pipeline expanding and extending our reach with our first collaboration and China with GJ Pharmaceuticals, we continue to execute on creating oyster point into a world class Ophthalmology company, we're really excited about being and boy.
Austin and New Orleans, this fall with the American Academy of Optometry, and the American Academy of Ophthalmology meetings.
And we potentially launch our first product into the us marketplace, So and closing I want to thank everybody for joining us Tonight and for having a great evening.
This concludes today's conference call. Thank you could participate and you may now disconnect.