Q1 2020 Earnings Call
Ladies and gentlemen, thank you for standing by and welcome to the first quarter 2020, ocular Therapeutix earnings Conference call.
Operator: Ladies and gentlemen, thank you for standing by, and welcome to the first quarter 2020 Ocular Therapeutix earnings conference call. At this time, all participant lines are in listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during this session, you will need to press star, then 1 on your touchtone telephone. Please be advised that today's conference may be recorded. If you require any further assistance, please press star then zero to reach an operator. I'd now like to hand the conference over to your speaker today, Mr. Donald Notman, Chief Financial Officer. Please go ahead, sir.
At this time all participant lines are in listen only mode.
After the speakers presentation, there will be a question and answer session.
To ask the question. During this session you will need to press Star then one on your Touchtone telephone.
Please be advised today's conference maybe recorded.
If you require any further assistance. Please press star then zero to reach an operator.
I know what can the conference over to your speaker today, Mr. Dolls, Lattmann Chief Financial Officer. Please go ahead Sir.
Thank you operator, good morning, everyone and thank you for joining us on our first quarter 2020 financial results business update conference call. This morning before the open we issued a press release, providing an update on the company's product development.
Donald Notman: Thank you, Operator. Good morning, everyone, and thank you for joining us on our first quarter 2020 financial results and business update conference call. This morning before the open, we issued a press release providing an update on the company's product development programs and details of the company's financial results for the quarter ended March 31, 2020. The press release can be accessed on the Investors portion of our website at investors.ocutx.com. Leading the call today will be Antony Mattessich, our President and Chief Executive Officer, who will provide a summary of our corporate developments and an update on the Dextensa commercial launch. Also speaking on the call today will be Dr. Michael Goldstein, our Chief Medical Officer, who will give an update on our clinical developments and pipelines. Following Michael's remarks, I will provide an overview of the financial highlights for the quarter before turning the call back over to Antony for a summary and questions. As a reminder, on today's call, we will be making forward-looking statements regarding our regulatory and product development plans.
Programs and details of the Companys financial results for the quarter ended March 31 2020.
The press release can be accessed on the investors portion of our web site at investors that folks see you X dot com.
During the call today will be asking about such our president and Chief Executive Officer, who will provide a summary of our corporate developments at an update on the DEXTENZA commercial launch also speaking on the call today will be Dr., Michael Goldstein, Our Chief Medical Officer, who will give an update on our clinical development. Some pipeline. Following Michaels remarks, I will provide an overview of the financial.
For the quarter before turning the call back over to ask me for a summary and questions. As a reminder, on today's call we will be making forward looking statements regarding our regulatory and product development plan as well as or Richard research activities.
Donald Notman: , As well as our research activities. These statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted. A description of these risks can be found in our most recent Form 10-K on file with the SEC. I will now turn the call over to Antony. Thank you.
These statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted a description of these risks can be found in their most recent form 10-K on file with the FCC I will now turn the call over to Anthony.
Thank you know and welcome Dr. Therapeutics first socially distance quarterly earnings report.
Antony Mattessich: And welcome to Ocular Therapeutix's first socially distanced quarterly earnings report. Before I get started, I wanted to note how proud I am of our organizational response to the COVID-19 pandemic. The company has contributed to the fight against COVID-19 through donations of PPE to local healthcare providers, and many of our employees have given time to supply food to those most in need in the Bedford, Massachusetts area. Thank you for all of your efforts.
Oregon started I wanted to know how proud I am dark organizational response to the cobot Nike pandemic.
The company has contributed to the fight against covert 19 through donations of P.P.E.. So local health care providers in many of our employees have given time to supply food to those most in need in the Bedford, Massachusetts area. Thank you for all of your office.
Antony Mattessich: Despite the upheaval caused by the coronavirus, the outlook for ocular continues to brighten. It is good to take stock of the major value drivers and how their prospects have improved in the recent past. Due to favorable changes...
Yep Eagle caused by the Corona virus.
Outlook for ocular continues to bright.
It's good to take stock of the major value drivers and how their prospects have improved in the recent past due to favorable changes in the external business and regulatory environments as well as important developments in the portfolio.
Antony Mattessich: [inaudible] One of the great benefits of Ocular Therapeutix is that, being a small company with a limited budget, our technology allows us to advance many programs across several of the most valuable segments in ophthalmology. These segments are wet age-related macular degeneration, or wet AMD, glaucoma, dry eye disease, or DET, and Post-Surgical Inflammation and Pain. Let's start with the largest of these value drivers, wet AMD.
One of the great benefits of occupancy therapeutics that being a small company with a limited spend or technology allows us to advance many programs across several of the most valuable segments in ophthalmology.
These segments are wet age related macular degeneration, or what Andy glaucoma, dry eye disease or de <unk>.
Postsurgical inflammation and pain.
Let's start with the largest these value drivers wet AMD D.
Antony Mattessich: The global market for wet AMD is nearing $11 billion and growing annually at approximately 8%. A key driver in treatment selection for wet AMD is durability. The longer a treatment works to keep a patient without fluid on a single injection, the greater the attractiveness of the treatment. Current standard of care typically has patients needing re-injection every four to eight weeks.
Global market for wedding D. is nearing $11 billion annually at approximately 8%.
A key driver in the treatment selection for wet AMD is durability.
The longer treatment works keep a patient without fluid on a single injection the greater the attractiveness of the treatment.
Current standard of care typically has patients needing reinjection every 40 weeks.
Antony Mattessich: In the space of the last few quarters, OTX-TKI, our intravitreal tyrosine kinase eluting implant designed to deliver up to six months of therapy with a single injection, has received favorable results from the clinic and benefited from changes in the commercial landscape. In the clinic, our second higher dose cohort demonstrated for the first time that delivering a tyrosine kinase inhibitor into the eye using our delivery technology led to a strong clinical signal toward clinically meaningful reductions in retinal thickness in some patients. Mike Goldstein will share with you the latest data.
In the space for the last few quarters, Oh, Gx, Teekay high or Intravitreal tyrosine kinase eluding implant designed to deliver up to six months of therapy with a single injection has received a favorable has actually better results in the clinic.
And benefited from changes in the commercial landscape.
In the clinic, our second higher dose cohort has demonstrated for the first time that delivering a tyrosine kinase inhibitor into the eye using our delivery technology has led to a strong clinical signal toward clinically meaningful reductions and retinal thickness some patients.
Michael soon we'll share with you the latest data.
Antony Mattessich: Given the performance in the clinic, we believe that OTX-TKI has the potential to extend the durability of treatment for wet AMD. In the competitive landscape, as many of you are aware, the emergence of retinobasculitis with brolicizumab leaves the market for more durable treatments of wet AMD open to a product that can demonstrate superiority on this parameter. Moving on to Glaucoma, another large potential market for possibly the greatest unmet medical need, it's a product that ensures patient compliance. Recent FDA approval of inter-cancer...
Given the performance in the clinic, we believe that OTI ex Teekay has the potential to extend the durability of treatment for wet AMD D.
On the competitive landscape as many of you are aware the emergence of retinal vasculitis Wipro says AMAP leads the market for more durable treatments of wet AMD D. Open for a product that can demonstrate superiority on this parameter.
Moving on to glaucoma, another large potential market for possibly the greatest unmet medical need it's a product that ensures patient compliance.
Recent FDA approval of inter camel deliveries across the Glenn most notably with the approval of Derisk Oh against the amount of Prost containing inter camera injection as paved the way for OTI FDIC, our travel Prostituting inter camera implant.
Antony Mattessich: Osteogastric Landins. Most notably, with the approval of Dorisca, Allergan's Bromatoprost-containing intracameral injection has paved the way for OTXPIC, our travoprost-eluting intracameral implant. We believe we can be a fast follower to Allergan's Dorista and can potentially offer some interesting safety and durability benefits. With a targeted product profile of six months of IOP lowering with a single insert that bio-erodes on its own and current data showing an efficacy signal beyond this time point in some subjects, and observed to have a favorable safety profile. We are very excited by what we have seen in the early results from this trial and believe OTX-TIC has the potential to become standard of care for the treatment of elevated IOP and for the treatment of ocular surface diseases such as allergic conjunctivitis and dry eye disease.
We believe we can be a fast followers elegans derisk. The thank you potentially offer some interesting safety and durability benefits.
With a target product profile of six months of Io p. lowering with a single insert that bio roads on its own and current data showing an efficacy signal beyond this time point in some subjects and observed a habit favorable safety profile, we're very excited.
He and the early results from this trial and believe OTI X T. I see has the potential to become standard of care for treatment of elevated I don't see.
Well, it's even if I could reserves diseases, such as allergic conjunctivitis and dry eye disease.
Antony Mattessich: We have seen positive developments in both our internal programs and in the regulatory environment. On the product side, we are excited by the results of our Phase 3C trial for Dextenza and allergic ductivitis. Mike will go into the details of that trial, but the big picture is that we believe it will enable us to file an SNDA application for Dextenza's first ocular surface disease indication, ocular itching associated with ulcerative conjunctivitis, and be the first indication in the ophthalmology office environment. Similarly, the environment looks to have positively changed in our effort to leverage the extensor in the largest segment of We were very pleased to see that the results of the STRIDE 3 trial for colotherapeutics met its primary endpoint, resulting in a high probability of a steroid being approved for dry eye conditions. Clearly, for ocular and extensa, it is good news that a steroid treatment will likely be indicated in DED.
We have seen positive developments in both our internal programs and in the regulatory environment.
On the product side, we're excited by the results of our phase three trial for DEXTENZA in allergic conjunctivitis.
Mike will go into the details of that trial, but the big picture is that we believe it will enable us to file an NDA application for Dextenzas first October surface disease indication ocular itching associated with allergic conjunctivitis.
We were very pleased to see that the results of its stride three trial for color Therapeutics met its primary endpoint, resulting in a high probability of a steroid being approved dry eye condition.
Clearly for ocular and extensive is good news at the steroids that a steroid treatment will be likely indicated in d., giving us greater confidence and clarity in our development pathway and indeed.
Antony Mattessich: , Dr. David D.. .. .. .. .. .. .. We believe the market will become a non-abusable, preservative-free, steroid-free option that includes the
The treatment of dry eye disease were excited by the potential of both extend the and our new product Oh do you see ESI.
Antony Mattessich: Finally, in the treatment of post-surgical inflammation and pain with Dextenza, we are making strides internally, and paradoxically, we believe the external post-COVID environment could be even more conducive to a product like Dextenza. On the sales side, we recorded $2.1 million in Dextenza net revenue for the first quarter. This sales performance represents an increase of 31% over the prior quarter and is even more notable because of the near total shutdown in cataract surgeries that began in the second half of March. To give you a sense of the volume change, we sold nearly 1,000 billable units to AFCs and hospitals in the first two weeks of March, reaching a runway for nearly $15 million in annual sales. But they sold only around 300 inserts in the following two weeks as ASCs and hospitals canceled cataract surgeries due to the coronavirus pandemic. The near total shutdown in cataract surgeries continued through April. We are beginning to see the ASC schedule reopen, so the temporary shutdown is frustrating, particularly because of the momentum we were seeing.
For these ocular surface indications.
We believe the market will become a non abusable preservative free steroid free option that includes the candle oculus and provide the hands free alternative to the Asian.
Finally in the treatment of Postsurgical inflammation and pain with DEXTENZA, we're making strides internally and paradoxically, we believe the external post kobin environment could be even more conducive to a product like December.
On the sale side, we reported 2.1 billion in DEXTENZA net revenue for the first quarter. The sales performance represents an increase of 31% over prior quarter and is even more notable because of the near total shutdown cataract surgeries to begin the second half of March.
If you a sensitive volume change we sold nearly 1000 builder units at season Hospital in the first two weeks of March reaching a runway for nearly $50 million national sales.
That's only around 300 inserts and the following two weeks it S season hospitals cancel cataract surgery due to the Corona wives pandemic.
The near total shutdown and cataract surgeries continued through April we are beginning CAMC schedule reopenings.
So the temporary shutdown, it's frustrating, particularly because of the momentum you were seeing we expect to come out of the shutdown better position them for.
Antony Mattessich: We expect to come out of the shutdown in a better position than before. We've had many conversations with anterior segment surgeons as they restart their surgeries in the post-COVID era and have been pleased to hear that their appreciation for the benefits of Dextenza has only grown. Clearly, in an environment where infection risk must be minimized, the hands-free option of replacing 70 steroid drops with a single physician-administered bioresorbable intercanellicular insert is even more compelling. In summary, Ocular Therapeutix is making tremendous progress in the development of its portfolio, but it is also being helped by changes in the competitive and regulatory environment. As we look at Ocular's prospects, even a few quarters prior, we see a very different outlook today, across the spectrum of wet AMD, glaucoma, DED, and prevention of post-surgical pain and inflammation. Our products have progressed substantially in the market and are even more attractive than before. With that, I will now turn the call over to Mike Goldstein.
We've had many conversations with venture segment surgeons, if they restart their surgeries in the post cobot here have been pleased to hear that their appreciation for the benefits of DEXTENZA has only grown clearly in an environment, where infection risk must be minimize the hands free option of replacing 70 steroid drops with a single physician administered bioresorbable interconnect to insert.
More compelling.
In summary, occupier therapeutics is making tremendous slides in the development of its portfolio.
But it is also being helped by changes in the competitive and regulatory environment.
As we look at Okcular prospects, even a few quarters. Prior we see a very different outlook today across the spectrum of way MD glaucoma di di and prevention of Postsurgical pain and inflammation.
Our products have progressed substantially in the market and even more and more attractive than before.
With what I will now that I will now turn the call over to Michael's thing.
Thanks Anthony.
Unknown Attendee: Thanks, Antony. Let me begin with an update on our back-of-the-eye program, OTX-TKI. OTX-TKI is a bioresorbable hydrogel implant containing axitinib, which has anti-angiogenic properties and is delivered by intravitreal injection. It is being developed to treat patients with wet, age-related macular degeneration and other retinal diseases such as diabetic macular edema, and Retinal Vanocluse. We continue to treat those subjects in a multi-center, open-label, phase one clinical trial in Australia that is designed to assess the safety and tolerability of OTX-TKI, as well as to assess preliminary biological activity by measuring anatomical and functional changes. As Antony mentioned, we recently reported encouraging interim data from the ongoing Phase 1 trial in March.
Let me begin with an update of our back will be I program for TX Teekay <unk>.
TX Teekay <unk>, the by Resorbable hydrogel implants, containing axitinib, which has anti anti angiogenic properties and it's delivered by Intravitreal injection.
It is being developed to treat patients with wet age related macular degeneration and other retinal diseases, such as diabetic macular edema.
And retinal vein occlusion.
We continue to those subjects in a multicenter open label Phase one clinical trial in Australia, but at the that is designed to assess the safety and Tolerability, Oh, TX Teekay <unk> as well to assess preliminary biological activity by measuring anatomical and functional changes.
As Anthony mentioned, we recently reported encouraging interim data from the ongoing phase one trial in March.
In April Robert Avery, a member of the data safety monitoring committee overseeing the phase one trial presented an interim.
Presented interim data on Otis Teekay at the annual difficult Society meeting.
Unknown Attendee: Robert Avery, a member of the Data Safety Monitoring Committee overseeing the Phase 1 trial, presented interim data on OTX-TKI at the annual BitBuckle Society meeting. These data included an update on the first two fully enrolled cohorts and demonstrated that OTX-TKI in both cohorts was generally observed to be well tolerated with a favorable safety profile with no ocular serious adverse events. Regarding biological activity, in this interim look at this small data set, there seems to be a dose response with greater clinical response in the higher dose cohort compared to the lower dose cohort. In the Higher Dose Cohort 2 OTX-TKI treated subjects showed a decrease in retinal fluid as measured by decreases in intraretinal and or subretinal fluid with the longest treated subjects with age-related wet, Immaculate Generation, now out to beyond 4.5 months.
These data included an update on the first two fully enrolled cohorts and demonstrated that OTI, Oh, TX Teekay <unk>, both cohorts with generally observed to be well tolerated with a favorable safety profile with no okcular serious adverse events.
Regarding biological activity in the interim look in this small dataset there seems to be a dose response with greater clinical response in the higher dose cohort compared with the lower dose cohort.
And the higher dose cohort two Oh T X T. I treated subjects showed a decrease in retinal fluid as measured by decreases in Tourette mall and or sub retinal fluid with the longest treated subjects with age related what.
Active generation now out to be on 4.5 month.
Additionally, some patients in cohort, one who had required frequent anti by Jeff dosing prior to enrollment in this study for shown to potentially not need rescue therapy for as long as 10 months after being treated with OTI ex Teekay <unk>.
Unknown Attendee: Additionally, some patients in Cohort 1 who had required frequent anti-VEGF dosing prior to enrollment in the study were shown to potentially not need rescue therapy for as long as 10 months after being treated with OTX-TKI. While the drug product profile is still emerging, we are pleased with the interim data that show intravitreal injection of a TKI can reduce intraretinal and or subretinal fluid. There are a number of questions that still need to be addressed as we continue to study the durability of the response, and we have recently amended the current protocol to allow for an even higher dose for the next cohort to be enrolled.
Well the drug product profile is still emerging we're pleased with the interim data that shows intravitreal injection of a T.K. I can reduce into retinal endorse sub retinal fluid.
There are number of questions that still needs to be addressed as we continue to study the durability of response and we have recently amended the current protocol to allow for an even higher dose for the Mexico her to be enrolled.
Moving to our glaucoma program OTI X T I see the virus or both travoprost containing hydrogels implant delivered via inter Campbell injection designed to deliver extended duration of IP reduction.
We continue to roll enrolled subjects with cry reopening glaucoma or ocular hypertension in a phase one perspective multicenter open label dose escalation clinical trial in the United States evaluate the safety biological activity durability, and Tolerability, a T X T I see.
Unknown Attendee: Moving to our glaucoma program, OTX-TIC is a bioresorbable trabefrost-containing hydrogel implant delivered via an intracameral injection designed to deliver extended duration of IOT reduction. We continue to enroll subjects with primary open-angle glaucoma or ocular hypertension in a Phase I prospective multicenter open-label dose escalation clinical trial in the United States to evaluate the safety, In February, we presented interim data at the Glaucoma 360 Conference that took place in San Francisco. Data from the first two fully enrolled cohorts, five subjects in Cohort 1 and four subjects in Cohort 2, showed decreased IOP in patients receiving OTX-TIC that was comparable to the current standard of care, topical triglycerides placed in the non-steady eye throughout the six-month period. The data also showed that the IOP remained consistently decreased for an extended duration of six to nine months in many subjects with a single implant. We also have seen one subject with well-controlled IOP for over 20 months with a single implant.
In February we presented interim data at the glaucoma Threesixty conference that took place in San Francisco.
Data from the first two fully enrolled cohorts five subjects in cohort one four subjects in cohort to show decreased I hope he in patients receiving OTI X T. I see there was comparable to current standard of care.
Topical travoprost placed in the non study I throughout the six month period.
The data also showed that the I hope you remain consistently decrease for an extended duration of six to nine months in many subjects with a single implant.
We also have seen one subject with well controlled I hope the for over 20 months for the single implant.
The hydro Biodegrade said approximately five to seven months and most subjects and we continue to observed that the product as well tolerated and has a favorable safety profile.
The safety perspective, we've seen no clinically meaningful changes and corneal endothelial cells as measured by slit lamp the chemistry direct imaging of the individual felt.
We have now complete enrollment in cohort to covert three same dose of travel process cohort, one, but more rapidly degrading hydrogel implants and are currently enrolling cohort for smaller implants with a lower dose.
Unknown Attendee: 5-7 months in most subjects.
Unknown Attendee: and we continue to observe that the product is well tolerated and has a favorable safety profile. For example, from a safety perspective, we have seen no clinically meaningful changes in corneal endothelial cells as measured by split-lamp tachymetry and direct imaging of the endothelial cells. We have now completed enrollment in Cohort 2 and Cohort 3, the same dose of Travopress as Cohort 1, but a more rapidly degrading hydrogel implant, and are currently enrolling Cohort 4, a smaller implant with a lower dose. Enrollment has recently been slowed slightly by COVID-19, but we believe this will pick up as ophthalmic offices open back up for non-emergent patients.
Enrollment has recently been slowed slightly by Cobot 19, but we believe this will pick up as ophthalmic out.
LMIC offices open back up for non emergent patient.
Once this trial is complete we intend to advance the most promising formulations into phase two clinical trials.
In the area of ocular surface disease, which includes our work in allergic conjunctivitis and dry eye, We recently announced positive top line results for our phase three clinical trial for DEXTENZA in the treatment of locker inching associated with allergic conjunctivitis.
The phase three randomized double masked parallel our parallel arm placebo controlled clinical trial.
96 subjects and was conducted across six sites in the United States using or as modified conjunctival Allergen challenge model.
Unknown Attendee: Once this trial is complete, we intend to advance the most promising formulations into Phase 2 clinical trials. In the area of ocular surface diseases, which includes our work in allergic conjunctivitis and dry eye, we recently announced positive top-line results for our phase three clinical trial for dexbenza in the treatment of ocular itching associated with allergic conjunctivitis. The Phase III Randomized Double-Masked Parallel-Armed Placebo-Controlled Clinical Trial enrolled 96 subjects and was conducted across 6 sites in the United States using AURA's Modified Conjunctival Allergen Challenge model. The primary efficacy measure for this trial was ocular itching on day 8 at 3 minutes, 5 minutes, and 7 minutes post-challenge and included subjects with seasonal and perennial, Extensa-treated subjects demonstrated a statistically significant difference in ocular itching scores, p-value less than.0001 compared to vehicle-treated subjects at all three pre-specified time points.
Primary efficacy measure for this trial with ocular itching on day eight at three minutes five minutes and seven minutes coast challenge that included subjects with seasonal and perennial allergens.
Senza treated subjects demonstrated a statistically significant difference in OCC or itching scores.
Value less than quaint 001, compared to vehicle treated subjects at all three pre specified time points.
And assessment of the secondary endpoints of Arthur Itching at all of their visit a seven to eight in the morning. The afternoon at 10 minutes volume exposure in 14 and day 15 in the morning, an afternoon.
Also showed that extends the treated subjects had lower it seems scores that vehicle treated subjects.
Three minutes five minutes segments, and 10 minutes post CAC.
Value less than 0.05 for all 21 time points, except they seven at three minutes.
Extend those observed to have a favorable safety profile and be well tolerated with no serious adverse events observed ocular or non ocular.
No subjects required rescue medication and no subjects experienced elevated intraocular pressure.
Overall, the data highlights the compelling product profile targeting a large market that could potentially change the current standard of care.
Unknown Attendee: An assessment of the secondary endpoints of ocular itching at all of their visits, day 7, day 8 in the morning, day 8 in the afternoon at 10 minutes following exposure, day 14, and day 15 in the morning and afternoon, also showed that extensive treated subjects had lower itching scores than vehicle treated subjects. 3 minutes, 5 minutes, 7 minutes, and 10 minutes post-cac. Evaluate less than 0.05 for all 21 time points, except day 7 at 3 minutes.
The onetime long acting and three therapy for the treatment of large divide it.
Importantly, as Anthony say those comments. This sndk if approved would represent our first it off the syndication and expand significantly the versatility and potential for DEXTENZA.
In terms, what next steps we plan to complete a review of the full dataset from this phase three study discuss our findings and regulatory pathway with the FDA and target submission of an SMB by the end of this year.
The largest potential opportunity in the treatment of ocular surface disease. It is dry eye disease, we have two programs in dry disease OTN see it cfive isn't intercare molecular insert which includes the punctum and releases cyclists forward for approximately three month for patients with dry disease.
Unknown Attendee: Extendo is observed to have a favorable safety profile and be well tolerated with no serious adverse events observed ocular or non-ocular. No subjects required rescue medication, and no subjects experienced elevated intraocular pressure. Overall, the data highlights a compelling product profile targeting a large market that can potentially change the current standard of care with a one-time, log-acting, hands-free therapy for the treatment of allergic rectivitis. And importantly, as Antony stated in his comments, this SMDA, if approved, would represent our first in-office indication and significantly expand the versatility and potential of Dick Stenza. In terms of next steps, we plan to complete a review of the full data set from this Phase 3 study, discuss our findings and regulatory pathway with the FDA, and target submission of an SNDA by the end of this year.
And to extend the has potential benefit for patients with episodic dry eye disease.
For Otis Cfive, we've recently initiated a phase one open label single Center clinical trial in United States to evaluate the safety efficacy durability and Tolerability of Txts I.
We expect to dose the first subjects in the near future. We're very excited about the potential for this hands free option in helping dry eye disease patients receive the benefits of cycles for him but.
But with the potentially greater tolerability and more rapid clinical benefit.
It's a therapies currently on the market.
There continues to be significant interest in studying DEXTENZA in many areas of unmet need with over 70 investigator initiated trial request submitted including many seeking to evaluate to extend the in the treatment of dry eye disease patients. We currently have nine I two studies that are active including but one that has completed enrollment I.
Unknown Attendee: The largest potential opportunity in the treatment of ocular surface diseases is dry eye disease. We have two programs for dry eye disease. OTX-CFI is an intracanalicular insert that occludes the punctum and releases cyclosporine for approximately three months for patients with dry eye disease, and Dick Stenza has potential benefits for patients with episodic dry eye disease. For OTX-CSI, we recently initiated a phase one open-label, single-center clinical trial in the United States to evaluate the safety, efficacy, durability, and tolerability of We expect this to be the first subject in the near future. We're very excited about the potential for this hands-free option in helping dry eye disease patients receive the benefits of cyclosporine but with potentially greater tolerability and more rapid clinical benefit compared to therapies currently on the market. There continues to be significant interest in studying Dextenza in many areas of unmet need, with over 70 investigator-initiated trial requests submitted, including many seeking to evaluate Dextenza in the treatment of dry-eyed disease patients. We currently have 9 IIT studies that are active, including one that has completed enrollment.
I would now like to turn the call back over to Donald who will review, our fourth quarter and year end financial results.
Thanks, Michael gross product revenue net of discounts rebates and returns, which the company refers to as total product revenue was $2.6 million for the three months ended March 31, 2020 that product revenue of DEXTENZA and we're sure sealant in the first quarter were $2.1 million end point $5 million respectively.
Research and development expenses for the first quarter were 6.1 million.
Versus $11.3 million for the comparable period in 2019, and primarily reflects a decrease in personnel and non allocated costs do the organizational restructuring announced in November 2019.
Selling and marketing expenses for the quarter were $7.1 million is.
To $3.3 million for the same quarter in 2019. This increase relates almost entirely to support of the commercial launch sticks data driven primarily by the addition of that field force, including key account managers field reimbursement managers and medical science liaison.
Finally general and administrative expenses were $5.2 million for the first quarter of 2020.
Donald Notman: Thanks, Michael. Gross product revenue net of discounts, rebates, and returns, which the company refers to as total net product revenue, was $2.6 million for the three months ended March 31, 2020. Net product revenue of Dextensa and Reshure sealant in the first quarter were $2.1 million and $0.5 million, respectively. Research and development expenses for the first quarter were $6.1 million, versus $11.3 million for the comparable period in 2019 and primarily reflected a decrease in personnel and unallocated costs due to organizational restructuring announced in November of 2019. Selling and marketing expenses for the third quarter were $7.1 million as compared to $3.3 million for the same quarter of 2019. This increase relates almost entirely to support for the commercial launch of Extensa, driven primarily by the addition of the field force, including key account managers, field reimbursement managers, and medical science liaisons.
This is 5.4 million in the comparable quarter of 2019 decreasing expenses for the first quarter stemmed primarily from decreased professional costs.
With respect to financial results for the first quarter, we reported a net loss of $21.5 million.
Loss of 41 cents per share on a basic and diluted basis.
This compares to net loss of $17.1 million or a loss of 41 cents per share on a basic and 45 cents per share on a diluted basis for the same period in 2019.
Net loss for the first quarter included $2.4 million noncash charges for stock based compensation and depreciation compared to 2.5 billion dollar for the same quarter in 2018.
In addition, the net loss for the quarter included a non cash charge of $3.4 billion lazy the change in the fair value of the derivative liability associated with our convertible notes.
As of May 1st 2020.
We had approximately 53.4 million shares outstanding.
As of March 31, 2020, the company had $48.2 million in cash cash equivalents versus 54.4 million at the end of 2019.
These cash amounts exclude restricted cash of $1.8 million in both periods.
Donald Notman: Finally, general and administrative expenses were $5.2 million for the first quarter of 2020 versus $5.4 million in the comparable quarter of 2019. The decrease in expenses for the first quarter stem primarily from decreased professional fees. With respect to financial results for the first quarter, we reported a net loss of $21.5 million, or a loss of 41 cents per share on a basic and diluted basis. This compares to a net loss of $17.1 million, or a loss of $0.41 per share on a basic and $0.45 per share on a diluted basis, for the same period in 2019. The net loss for the first quarter included $2.4 million in non-cash charges for stock-based compensation and depreciation, compared to $2.5 million for the same quarter in 2019. In addition, the net loss for the quarter included a non-cash charge of $3.4 million related to the change in the fair value of the derivative liability associated with our convertible note.
Cash balance benefited during the first quarter from $12.7 million and net proceeds generated from the sale of common stock under the company's 2019 sales agreement under which the company may offer and sell its common stock having aggregate proceeds of up to 50 million from time to time.
[music].
For the period from March 31 to make 620 20. The company is sold additional common stock under the sales agreement generating net proceeds of $1.7 million approximately $1.3 million a common stock remains nail to be so sold under this facility.
Based on the current plans that included related estimates they anticipated cash inflows from DEXTENZA, then or shirts joint product sales and.
Cash outflows from operating expenses the company believes that existing cash and cash equivalent as at March 31, 2020, together with the second quarter net proceeds through March through May six from sales of common stock pursuant to the sales agreement highlighted previously.
Well enabled the company to unplanned operating expenses.
Service obligations and capital expenditure requirements into the first quarter of 2021.
Donald Notman: As of May 1, 2020, the company had approximately 53.4 million shares outstanding. Additionally, as of March 31, 2020, the company had $48.2 million in cash equivalents versus $54.4 million at the end of 2019. These cash amounts exclude restricted cash of $1.8 million in both periods.
This cash guidance is subject to various assumptions, including those related to the severity and duration of the Kobe 19 pandemic, an expected rebounding cataract surgeries beginning in the third quarter and other assumptions related to revenues and expenses associated with commercialization DEXTENZA.
Variable expense reductions and the pace of research and clinical development programs as well as other aspects of the company's business.
Donald Notman: Cash Balance benefited during the first quarter from $12.7 million in net proceeds generated from the sale of common stock under the company's 2019 sales agreement, under which the company may offer and sell its common stock for aggregate proceeds of up to $50 million from time to time. For the period from March 31 to May 6, 2020, the company sold additional common stock under the sales agreement, generating net proceeds of $1.7 million. Approximately $1.3 million of common stock remains available to be sold under this facility. Based on the current plans and related estimates of anticipated cash inflows from Dextens and reassured sealant product sales, and Cash Out Flow from Operating Expenses. The company believes that existing cash and cash equivalents, as of March 31, 2020, together with the second quarter net proceeds through May 6 from sales of common stock pursuant to the sales agreement highlighted previously, will enable the company to fund planned operating expenses, debt service obligations, and capital expenditure requirements into the first quarter of 2021.
This concludes my comments first quarter financial results.
I'd like to turn the call back to Anthony for some summary thoughts.
Thanks Donald.
So before opening the call up for questions. Let me do a quick summary, the performance of OTI X T. I in the clinic continued to support a product profile that could set a new standard of care for durability, the greatest area of unmet need and treatment of wet AMD D.
The performance of OTI X T I see in the clinic continues to support a product profile the could set the standard of care for patient compliance.
The greatest area of unmet need in the treatment of Oklahoma.
Our positive if they phase III trial in allergic conjunctivitis paves the way for ocular Therapeutix first indication in the treatment of Inoculates services.
What we believe treatment through the inner Kendall the killer rid of administration could set a new standard of care.
Finally, as cataract surgeries to begin to return to normal we anticipate that extended this features and benefits in the prevention of Postsurgical inflammation and pain will be enhanced by the fact that extend this truly a hands free alternative that replaces the need for 70 steroid drops and decreases the risk of infection from issues related to patient compliance with this comp.
Okay to dosing regimen.
Due to developments in our pipeline as well as changes in that regulatory competitive and postcode environments. We believe the future has never been brighter for ocular therapeutix with that I will turn color questions.
Donald Notman: This cash guidance is subject to various assumptions, including those related to the severity and duration of the COVID-19 pandemic, an expected rebound in cataract surgeries beginning in the third quarter, and other assumptions related to revenues and expenses associated with the commercialization of Dextensa, variable expense reductions, and the pace of research and clinical development programs, as well as other aspects of the company's business. This concludes my comments on the first quarter financial results, and I would like to turn the call back to Antony for some summary thoughts.
As a reminder, ladies and gentlemen, if you'd like to ask a question at this time. Please press the star and the number one key on your Touchtone telephone.
To withdraw your question, Chris the bounty.
My first question comes from the line of Joe patents are with Piper Sandler. Your line is now open.
Hey, guys that thanks, Thanks for taking my questions, maybe first the too on the on DEXTENZA. So we don't procedures have been impacted but just wondering how the process of getting DEXTENZA onto a formulary is that if these has an impact has been impacted.
Antony Mattessich: Thanks, Donald. So before opening the call up for questions, let me do a quick summary. The performance of OTX-PKI in the clinic continues to support a product profile that could set a new standard of care for durability, the greatest area of unmet need in the treatment of wet AMD. Similarly, the performance of OTX-TIC in the clinic continues to support a product profile that could set the standard of care for patient compliance. The Greatest Area of Unmet Need in the Treatment of Glaucoma. Our positive phase 3C trial in allergic necrosis pays the way for Ocular Therapeutix's first indication in the treatment of an ocular service disease where we believe treatment through the intercanalicular route of administration could set a new standard of care.
Our PMT committee meeting still happening happening virtually is that a process that's still going on and then I know, it's early but for AMC that that may have reopened do you see their initial volumes being higher than their historical volumes to maybe make up for some of the loss procedures. They they've lost over the last two months or so.
Thanks for the questions Joe.
It's really too hard to say at the moment due to answer your you're actually both question. What the first question is easy to answer and that.
The add Cesar still the administrative staffs are still working.
So we've been able to have a number of very good conversations with with people while at the surgeries are close in some ways, we get more attention from them now than when we get when they're they're in full flow.
Antony Mattessich: Finally, as cataract surgeries begin to return to normal, we anticipate that Dextenza's features and benefits in the prevention of post-surgical inflammation and pain will be enhanced by the fact that Dextenza is truly a hands-free alternative that replaces the need for 70 steroid drops and decreases the risk of infection from issues related to patient compliance with this complicated dosing regimen. Due to developments in our pipeline, as well as changes in the regulatory, competitive, and post-COVID environments, we believe the future has never been brighter for ocular therapeutics. With that, I will turn the call over to questions.
That's not the case across the board some places have furloughed employees, so that they are truly shutdown.
In terms of looking at our market share in the agencies that have reopened.
That number now is so it's so small in terms of actually getting the throughput through that we don't we don't have any useful data demonstrate what our share of counteract is on the other side of the co. Good.
Endemic.
Okay got it thanks, and then maybe one on OTN Teekay I guess, how should we think about data flow we've seen others in the extended bed, Jeff space provide updates every maybe three month three to six months as they get additional.
Operator: As a reminder, ladies and gentlemen, if you'd like to ask a question at this time, please press the star, then the number one key on your touchtone telephone. To withdraw your question, press the pound key. Our first question comes from the line of Joe Catanzaro with Piper Sandler. Your line is now open.
A follow ups. How are you guys thinking about this moving forward and I guess could be expect another update this year. Thanks.
Mike you want how that one.
Sure. So yeah, we will provide an update when we have something meaningful to say I'm. So were followed continuing to follow the patients in the first two cohorts.
And we are gearing up to enroll a third higher dose cohort.
We.
Joseph Michael Catanzaro: Hey guys, thanks for taking my questions. Maybe the first two on Dextensa. So we know procedures have been impacted, but just wondering how the process of getting Dextensa onto formularies at ASDs has been impacted. You know, are P&T committee meetings still happening virtually? Is that a process that's still going on? And then, I know it's early, but for ASDs that may have reopened, do you see their initial volumes being higher than their historical volumes to maybe make up for some of the lost procedures they've lost over the last two months or so?
We currently do plan to provide an update later in the air probably targeting around the a show timeframe.
Okay got it.
So much for for taking my questions.
You're welcome.
He's in to extend that up in clothes.
Or maybe the number of scheduled cataract surgeries that you're aware of potentially isn't it.
Antony Mattessich: Thanks for the questions, Joe. It's really too hard to say at the moment to answer your actually both questions. Well, the first question is easy to answer in that the ASCs are still, and the administrative staff is still working. So we've been able to have a number of very good conversations.
That that have been postponed and I'll.
Yeah, I mean, we're we're not giving any guidance going forward of course until we started to see how the flow moves through the the the F.C.S. What we are seeing is that there's a significant reopening of the S.C.'s in terms of scheduling of the surgery. I think the next question. We have is is whether they get the patients to actually show up to be able to get.
Antony Mattessich: [inaudible] In terms of looking at our market share in the ASCs that have reopened, that number is now so small in terms of actually getting the throughput through that we don't have any useful data to demonstrate what our share of cataract surgeries is on the other side of the COVID pandemic.
Throughput numbers that they they have.
We're seeing roughly say 20 to 30 per cent of volume returning in May we would expect that to bump up to 50, 60% in June and then by July.
Joseph Michael Catanzaro: Okay, I got it. Thanks.
Being back to somewhat normal levels, but this is all supposition at this point.
Joseph Michael Catanzaro: And then maybe one on OTX TKI. I guess, how should we think about data flow? You know, we've seen others in the extended VEGF space provide updates every maybe three months, three to six months as they get additional follow-ups. How are you guys thinking about this moving forward? And I guess, you know, could we expect another update this year? Thanks.
It's still so early in the cycle very very difficult to to game exactly how we how those four open up.
In terms of metrics I mean, there's one metric that we're reporting and we will continue to report and ended the only metric that really is substantially indicative of how the sales target how the sales progression is going and that sales available units into the A.S.C.'s in hospitals.
Antony Mattessich: Mike, you want to handle that one?
Unknown Attendee: Sure, so yeah, we will provide an update when we have something meaningful to say. So we're continuing to follow the patients in the first two cohorts, and we are gearing up to enroll a third higher dose cohort. We currently do plan to provide an update later in the year, probably targeting around the AAO timeframe.
This is a relatively expensive drugs for the season hospitals, they do not hold inventory so when they buy drugs from when when they buy an insert from the three P.L. distributors. They use that very short order of time, so that gives a true indication of what's happening in the marketplace and as we said we were averaging about five.
Joseph Michael Catanzaro: Okay, I got it. Well, thanks so much for taking my questions.
Stacey Koo: Our next question comes from Stacey Koo with Cowan and Company. Your line is now open. Good morning. Thanks for taking my questions. So we'll follow up kind of on your expectations moving forward, maybe more details or any metrics, such as the number of clinics using Dextenza that have been closed, or maybe the number of scheduled cataract surgeries that you're aware of potentially using Dextenza that have been postponed. And we'll have a follow-up.
Hundred inserts per week at me early part of a March when the A.C. started to shut down that that of course, you know made that that number come down, but that's an area that we hope to get back to very soon the the 500 per week and then we hope to be able to to be able to to to accelerate that well.
Beyond that number as we get what we believe will be a greater share of the total cataract volume because of the the the benefits at the product has both in terms of the the time that we've used where where the the product is or the the S.C.'s have not been doing surgery. So in other words being able to get on formulary some habit.
Antony Mattessich: Bye. Yeah, I mean, we're not giving any guidance going forward, of course, until we start to see how the flow moves through the ASCs. What we are seeing is that there is a significant reopening of the ASCs in terms of scheduling of the surgeries. I think the next question we have is whether they get the patients to actually show up to be able to get the throughput numbers that they have. We're seeing roughly, say, 20 to 30 percent of volume returning in May. We would expect that to bump up to 50, 60 percent in June and then by July to be back to somewhat normal levels, but this is all speculation at this point. Still so early in the cycle; very difficult to game exactly how those will open up. In terms of metrics, I mean, there's one metric that we're reporting.
<unk> with with the A.S.C.'s that that helped put us into protocols.
And also because of the the benefits of a hands free solution that keeps patients hands out of their eyes on 70 different opportunities over a month.
Okay. Thank you and then just to follow up question I <unk> <unk> <unk> <unk> <unk> <unk> <unk>.
Antony Mattessich: In terms of metrics,
Antony Mattessich: This is a relatively expensive drug for ASCs in hospitals because they do not hold inventory.
<unk> comment.
Antony Mattessich: So when they buy the drugs from, when they buy an insert from the 3PL distributors, they use that within a very short order of time. So that gives a true indication of what's happening in the marketplace. And as we said, we were averaging about 500 inserts per week in the early part of March. When the ASD started to shut down, that, of course, made that number come down, but that's an area that we hope to get back to very soon, the 500 per week, and then we hope to be able to accelerate that well beyond that number as we get what we believe will be a greater share of the total cataract volume because of the benefits that the product has both in terms of the time that we've used where the ASCs have not been 70 different opportunities in a month.
Donald Trump Kiki <unk>.
You might want to handle that.
Sure. So so yeah, I think you do to sort of or on targets clocks of intravitreal implant, so or injections that that issues.
With inflammation.
Either of the you know in the vitreous or of the retina. So so that's obviously a key thing we're we're looking for and and today, we haven't had any patients who have.
Needed steroid treatment in any of the patients treated so far so you know so far from from the 12 patients that we have been following.
It seems to be extremely safe and well tolerated.
Thank you.
Thank you.
Hi next question comes from Jonathan well done with Jane P. Securities Caroline is open.
Hey, the morning congressional of progress in mind for taking the question.
Just a couple from me first for allergic conjunctivitis can you discuss how you envisioned extends it being used in the real world setting.
There's something you think patients we use proactively early in an allergy season or something.
Stacey Koo: Okay, thank you. And then just a follow-up question on OTXTKI. Given what you've observed with the other competitive entrants, considering inflammation, maybe you could comment on what you guys are focused on in terms of safety for intraperitoneal implants.
When drops may not be working and any comments I kind of your commercialization strategy.
Yeah.
<unk> the given the price differences that we would see in the marketplace between a generic steroid drops and a insert of DEXTENZA religion divided you would expect we would be used in in a refractory population and that we would be step edited by by pairs.
Antony Mattessich: Mike, do you want to handle that?
Unknown Attendee: Sure. So, yeah, I think you sort of were on target.
Unknown Attendee: Lots of intravitreal implants have had, or injections have had issues with information from the Retina. So that's obviously a key thing we're looking for.
So what we see the usage of is that this is first of all it it it gets us into the the ophthalmologist office, which is usually important to us and secondly, it's the first October surface indication, we have where where there's a tremendous opportunity.
Unknown Attendee: And to date, we haven't had any patients who have Needed steroid treatment in any of the patients we've treated so far. So, so far, from the 12 patients that we have been following, it seems to be extremely safe and well tolerated.
Jonathan Patrick Wolleben: Our next question comes from Jonathan Wolleben with J&P Securities. Your line is now open. Hey, good morning. Congratulations on the progress and thanks for taking the questions. Just a couple from me.
Multiple areas within within the October surface area.
But looking at the type of patient who's likely to get reimbursed are typically patients who would have failed on drops and you can fail and drops in a number of ways you can either failing drops because they simply don't work from advocacy standpoint, you can also feel and drops because you're unable to take them or unable to tolerate the the the preservatives that are instead right drop.
Jonathan Patrick Wolleben: for Allergic Conjunctivitis.
Jonathan Patrick Wolleben: Yeah.
Antony Mattessich: With allergic conjunctivitis, given the price differences that we would see in the marketplace between generic steroid drops and an insert of Dextenza for allergic conjunctivitis, you would expect that we would be used in a refractory population and that we would be step-edit by payers. So what we see in usage is that this is, first of all, it gets us into the ophthalmologist's office, which is hugely important to us, and secondly, it's the first ocular surface indication we have where there's a tremendous opportunity in multiple areas within the ocular surface area. But looking at the type of patient who's likely to get reimbursed, are typically patients who would have failed on drops. And you can fail on drops in a number of ways; you can either fail on drops because
Or have some issue with dexterity or or the the ability to to adequately dose yourself with with an eye drops that's actually a really significant population and within a c., we certainly would expect to capture that population.
But we would also expect.
Being in the office environment and being in October service disease area that other October service diseases in this patient type.
Antony Mattessich: or have some issue with dexterity or the ability to adequately dose yourself with an eye drop. That's actually a really significant population, and within AC, we certainly would expect to capture that population. But we would also expect, being in the office environment and being in the ocular service disease area, that other ocular service diseases in this patient type would also be motivating for both the physician and the payer to support a product like Dextensa in that environment. So AC is a great opportunity in and of itself, but the real opportunity is that it opens the door to much, much wider opportunities in the ocular surface disease space and in the refractory population of people who cannot take drops.
Also be a motivating for both the physician and the pair to to support a product like DEXTENZA in that environment.
So a c. is a great opportunity it enough itself, but actually it's the real opportunities that it opens the door to much much wider opportunities in the October service disease base in in the refractory population of people who cannot take drops.
That's helpful and just one on that would fix your side can you discuss beyond safety, what kind of measurements you'd be looking for two just determine how this is working in the kind of what what time points, we'd be measure. Thanks.
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Yeah sure. So check C.S.I. is a new program, it's a cyclist or and Intercarrier luckier and insert that's designed to at least like was born for approximately three mugs.
Jonathan Patrick Wolleben: That's helpful. And just one on OCX-TSI, can you discuss it beyond...
Jonathan Patrick Wolleben: Transcripts provided by Transcription Outsourcing, LLC.
Unknown Attendee: Sure, Mike. You want to handle that? Yeah, sure.
So you get the advantage of overly so have the medication, which we know works based on to update approvals in the space and you also get the advantage of punk occlusion, which we also know work. So that you know standard of care and are better sort of try patients.
Unknown Attendee: OCHx-TSI is a new program. It's a cyclosporine intercanellicular insert that's designed to release cyclosporine for approximately three months. So you get the advantage of a release of the medication, which we know works based on two FDA approvals in the space, and you also get the advantage of punctal occlusion, which we also know works as its standard of care in our management of dry eye patients. So, I'm super excited about this program.
So super excited about this program as we mentioned it to.
The study that's been initiated as a phase one study in patients with dry disease.
Unknown Attendee: As we mentioned, the study has been initiated. It is a phase one study in patients with dry disease. As you mentioned, phase one studies are primarily focused on safety, and we will focus there. We know that cyclosporine works well, and we know the hydrogel intercanalicular insert has been well tolerated in many, many patients.
As you mentioned phase one studies are primarily focused on on safety and and we will focus there we know that cyclists boring works well and we know the hydrogen l.
Will the killer inserted spend well tolerated in many many patients so no concerns there, but something way to follow.
Unknown Attendee: So, no concerns there, but something we need to follow. From an esophageal perspective, we will look at signs and symptoms of dry disease. So those would include Patient Recorded Outcomes using some of the standard metrics like the OSDI and looking at dry eye symptoms with a visual analog scale. We'll also look for signs of dry eye as measured by the physician, which would include things that you'd expect to see in dry eye studies like corneal fluorescein staining. We are following the patients for four months, and we'll be following both the signs and symptoms over that interval. And then the plan would then be, once phase one is completed, to transition to a larger phase two study later this year.
I'm from it it'd be perspective, we will follow signs and symptoms the hub drive to see.
So those would include.
Piszel recorded outcomes using some of the standard metrics like the.
Oh, S.T.I. and looking at at dry I symptoms with the visual analog scale. We'll also look for signs of dry as measured by the position, which would include you know things that you'd expect to see in in dry eye studies like corneal, forcing staining.
We were following the patience for four months and we'll be following both the signs and symptoms over that interval and then the clan would then be once the phase was completed to transition to a larger phase to study later this year.
Antony Mattessich: I think it's also important to think about both Dextenza in episodic dry eye disease and CSI in chronic disease, that punctal occlusion is a standard treatment for the treatment of dry eyes. And from a marketing standpoint, it's so much easier to actually get physicians to understand to do something they're already doing, which is occluding the punctum, but then getting the benefits of a drug release of a steady state drug release without a preservative by also occluding the punctum. So it's a tremendous opportunity for us to be able to go with the flow of the market rather than have to teach practitioners to do something different than what they've done in the past. It also has the benefit of having a procedure code attached to it that is not part of another procedure. So 356P would apply to both of those products. And over time, we would expect to make 356T a Category 1. Procedure Code that clearly would not be dependent upon another procedure happening at the same time because it would be independent in the ocular surface space and in the ophthalmologist's surgery.
I think it's important also to to.
Thinking about both extends in in a in episodic dry disease and and C.S.I. in in a chronic disease.
And that punk till exclusion is a standard treatment for the treatment of dry.
And in from a marketing standpoint, it's so much easier to actually get positions to understand to to do something they're already doing which is including the punk them, but then getting the benefits of a drug release of a steady state drug released with without a a preservative by also including the punk them.
So it is a it's it's a tremendous opportunity for us to be able to go with the flow of the market rather than to be able to do rather than to have to teach practitioners to do something different than than what they've done in the past.
It also has the benefit of having a a a procedure code attached to it that is <unk> that is not part of another procedure. So three 560 would apply to both of those products and overtime you would expect to make three 560 a category one.
Procedure code that clearly would not be dependent upon another procedure happening at the same time, because it would be independent in in the outdoor surface space and in the the the Osama ophthalmologist surgery.
Antony Mattessich: That's very helpful. Thanks again for taking the questions.
That's very helpful Thanksgiving for taking the questions.
Thank you.
Operator: Thank you.
That's their mind or ladies and gentlemen, if he would like to ask a question at this time that is star then one.
Yi Chen: As a reminder, ladies and gentlemen, if you would like to ask a question at this time, that is star, then 1. Our next question comes from the line of Yi Chen with HC Wainwright. Your line is now open.
Hi next question comes from a line of each one with H.T. Wainwright Caroline how often.
Unknown Attendee: Hi, this is Bhubalan dialing in for Yi Chen, and thanks for taking my question. So, I'm curious whether COVID-19 will have any impact on your SNDA submission for allergic conjunctivitis.
Hi, This is <unk> oh dialing for each one and bankrupt taking my question, but I'm curious whether floated 19 didn't have any impact on U.S.N.D. it's submission.
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I know it would yeah. The date is the data is complete the F.D.A. is is still a working through the <unk>.
Antony Mattessich: No, it wouldn't. The data is complete. The FDA is still working through the COVID pandemic. So we're very much on track to be able to get that SNDA filed and are very hopeful that the FDA will have a relatively short turnaround time.
Pandemic. So we're we're very much on track to be able to get that S.N.D.A. files, and then are very hopeful that the F.D.A., we'll have a relatively short turnaround time.
Okay.
Antony Mattessich: Okay, that's very helpful. And with respect to your TTI trial, will COVID-19 have any impact on...
My husband and the difficulty of T.K.I. trial. When you go in 19 of any back on that.
To date, it's had no effect on that.
Okay, and we don't expect it to.
Okay.
Antony Mattessich: Today, this had no effect, and we don't expect it to.
And final question again about probably 19, so do you expect any delay in initiation of new clinical trials, which is the dry ice candidates you decode 19.
Antony Mattessich: Do you expect any delay in the initiation of new clinical trials, such as dry eye studies, due to COVID-19?
We have not experience. They a delay is as Mike referenced earlier R.T.I.C. face for cohort as a it is somewhat slower enrolling than the other cohorts Ben.
Antony Mattessich: We have not experienced a delay; as Mike referenced earlier, our TIC Phase 4 cohort is somewhat slower to roll out than the other cohorts have been, but we have not experienced any delays anywhere else, and we don't expect any delays in the start of the CSI trial.
But we we have not experiencing you'd lays anywhere else and we we don't expect any delays in the the the started the C.S.I. trial.
Okay. That's it thank you for much.
Unknown Attendee: Okay, that's it. Thank you so much. Thank you.
Thank you.
I'm showing no further questions and he would this time.
Operator: I'm showing no further questions in queue at this time. Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.
Ladies and gentlemen, misconstrued today's conference call. Thank you for participating.
Connect.
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