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Healthcare - Biotechnology - NASDAQ - US
$ 9.16
-7.66 %
$ 1.43 B
Market Cap
-8.4
P/E
EARNINGS CALL TRANSCRIPT
EARNINGS CALL TRANSCRIPT 2015 - Q3
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Executives

Brad Smith - CFO Amar Sawhney - Chairman, President & CEO Scott Corning - VP, Sales and Marketing Eric Ankerud - EVP, Clinical, Regulatory and Quality.

Analysts

Ken Cacciatore - Cowen and Company Andrew Baron - Morgan Stanley Hartaj Singh - BTIG.

Operator

Good afternoon, ladies and gentlemen. Thank you for standing by. And welcome to Ocular Therapeutix's Third Quarter 2015 Earnings Conference Call. At this time all participants are in a listen-only mode. Later we will conduct a question-and-answer session and instructions will follow at that time.

It is now my pleasure to turn the call over to Brad Smith, Chief Financial Officer of Ocular Therapeutix. Please go ahead, sir..

Brad Smith

Thanks Andrew, good afternoon and thank you for joining on our third quarter call. This afternoon we issued a press release providing up update on the Company's product development programs and details of our financial results for the third quarter ended September 30, 2015.

These can be accessed on the Investor portion of our Web site at investors.ocutx.com. Leading the call today will be Dr.

Amar Sawhney, our President, Chief Executive Officer and Chairman, who will provide a summary of the key clinical trial data results that were reported recently including top line efficacy results of our first phase pre-trial for DEXTENZA for the treatment of allergic conjunctivitis and interim top line efficacy results from our Phase 2b clinical trial evaluating our OTX-TP product candidate for the treatment of glaucoma and ocular hypertension.

Following Amar's remarks, I will provide an overview of the financial highlights for the third quarter of 2015 before opening the call up for questions. We are joined today by Eric Ankerud, our Executive Vice President of Clinical, Regulatory, and Quality and Scott Corning, our Vice President of Sales and Marketing.

As a reminder, during today's call we will be making certain forward-looking statements. Various remarks that we make during this call about the Company's future expectations, plans and prospects, constitute forward-looking statements for purposes of the Safe Harbor provisions under the Private Securities Litigation Reform Act of 1995.

Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors including those discussed in the Risk Factors section of our most recent quarterly report on 10-Q and filed with the SEC, which was filed earlier this afternoon.

In addition, any forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. While we may elect to update these forward-looking statements at some future point, we specifically disclaim any obligation to do so, even if our views change.

These forward-looking statements should not be relied upon as representing our views as of any date subsequent to today. I will now turn the call over to our Chairman, President and CEO, Amar Sawhney..

Amar Sawhney

Thank you Brad, good afternoon everyone and thank you joining us on our call today. For the past several months we’re highlighted by numerous clinical and corporate accomplishments.

Our clinical programs successfully advanced with an NDA submission in September to the Food and Drug Administration for our lead product candidate, DEXTENZA for a post-surgical ocular pain indication.

We reported top line efficacy results for our Phase 3, first phase 3 clinical trial for DEXTENZA for the treatment of allergic conjunctivitis and initial top line efficacy results from our Phase 2b clinical evaluating OTX-TP, our preservative pre sustained-release travoprost product candidate for the treatment of glaucoma and ocular hypertension.

Lastly, we expanded and strengthened our Board of Directors with the appointments of two highly respected individuals. We welcome Dr. Jeffrey Heier, a prominent Retina Specialist at Ophthalmic Consultants of Boston and a leading retinal clinical researcher of new treatments for diseases of the back of the eye.

And just yesterday we announced that James O’Shea, former Chief Operating Officer, President and Vice Chairman of Sepracor., has joined our Board bringing substantial experience in successfully managing commercial stage biotechnology companies. Jim led the successful launch of Lunesta and other products during his tenure at Sepracor.

I look forward to their valuable insights that they will contribute to our Board.

With several key data releases during the past several months let me review our objectives for our clinical study since Phase 2 results for our sustained delivery approach cannot be interpreted in the exact manner as a traditional biotechnology companies results which are frequently setup as dose escalation studies powered to report on defined primary and secondary end points.

Since we already use drugs with known mechanism of action and known efficacy, our Phase II clinical trials are set up to evaluate appropriate clinical study design and a patient population parameters and to estimate the magnitude and duration of drug effect.

Once we determine these parameters, this allows me appropriate design of two statistically powered Phase 3 studies acquired to support NDA approval. Based on the information gleaned in the Phase 2 study, we select the appropriate end points and timing of these end points as well as refine certain population and inclusion criteria.

These modifications help latest future clinical studies enabling the potential for a higher degree of success. For example, we made several changes in trial design to optimize our third Phase 3 design for DEXTENZA for post-surgical ocular pain and inflammation.

These included a one-to-one randomization, was to one randomization, then exclusion of patients on high dose, systemic end phase and providing better physician training for the use of rescue medications, thus improving the likelihood of successfully achieving our endpoints.

Our third Phase 3 clinical trial for DEXTENZA for post-surgical ocular inflammation and pain began in October 2015. Patient enrollment is progressing at a rapid pace, with 66 patients enrolled in the study as of November 6th, 2015.

Assuming favorable results and potential approval of our NDA for post-surgical ocular pain expected in the second half of 2016, we plan to submit an NDA supplement for DEXTENZA also in the second half of 2016.

Execution of the study is consistent with our strategy to broaden the DEXTENZA label with a potential post-surgical inflammation indication and regards to the NDA, we expect to know what our PDUFA date is by the end of the fourth quarter of 2015.

Similarly, based on information from our Phase 2 study for DEXTENZA in allergic conjunctivitis, we conducted the first Phase 3 study in a patient population with more severe rating and use day seven to evaluate the primary endpoint compared to day 14 in the Phase 2 study.

We reported topline efficacy results for this first Phase 3 study in allergic conjunctivitis recently. The trial had two separate primary endpoints, ocular itching and conjunctival redness. Please note that the primary endpoints are evaluated separately by the FDA. An approval has not historically been predicated on the achievement of both endpoints.

Our trial consistent with trials other companies have conducted for products for the treatment of allergic conjunctivitis was designed with two separate primary endpoints, not co-primary endpoints. Only one endpoint must be met in our for the trial to be considered a success.

This Phase 3 trial of DEXTENZA for the treatment of allergic conjunctivitis was conducted by Ora, Inc. using the modified Ora-CAC or Conjunctival Allergen Challenge Model. This proprietary model was developed by Ora to assess the longer therapeutic effect of a one-time administered sustain release drug product.

Ora has conducted many of the clinical trials for ophthalmic drugs that have been approved by the FDA. As many of you know, DEXTENZA successfully met the primary endpoint of ocular itching associated with allergic conjunctivitis at all time points evaluated.

It was a statistically significant different with a p-value of less than 0.0001 and the main score is between DEXTENZA treatment group and the placebo group for ocular itching at all three time points measured on day seven post insertion of the drug product.

The differences in the scores for ocular itching between DEXTENZA group and the placebo group was greater than 0.5 units at all time points on day seven post insertion and was greater than one unit at a majority of the time points on day seven post insertion.

In this clinical trial, as well as other clinical trials completed today, DEXTENZA continues to exhibit a strong safety profile and has been very well tolerated. In terms of the second primary end point for conjunctival redness, although favorable trends are seen, DEXTENZA did not achieve statistical significance for this endpoint.

The primary endpoint for conjunctival redness has typically been included in Phase 3 trials for allergic conjunctivitis but historically the FDA has not required the achievement of both endpoints for approval.

In fact, most commercially available prescription medication for the treatment of allergic conjunctivitis, have an ocular itching indication only; which is the most important symptom of allergic conjunctivitis.

These commercially available products within itching only indication on the label include the current market leading once-a-day drops, such as Pataday, Lastacaft, and PAZEO. These products, though they attempted to achieve the two primary endpoints of itching and redness, succeeded only in itching and were approved.

In accordance with FDA guidance today, these endpoints itching and redness continued to be separately evaluated for labeling and approval. Subsequent studies such as environmental studies may sometime be used to support label extensions if [desired]. Itching is the primary reason patient suffering from allergic conjunctivitis, go to see the doctor.

Patients who have a strong seasonal allergies would benefit from a sustained-release therapy, which could provide long lasting relief throughout allergy season with a one-time therapy. DEXTENZA hit all the requirements for a successful clinical trial for itching in this Phase 3 trial.

Now, also in accordance with prior FDA guidance of meeting two clinical trials for approval, we will conduct a second Phase 3 study which we expect to initiate before the end of 2015.

Assuming favorable results and approval of the NDA the pain indication, we expect to file an NDA supplement for the allergic conjunctivitis indication in the second half of 2016. If approved, DEXTENZA would set a new standard in terms of duration of effect offering by far the longest acting ocular allergy medication.

We also recently reported topline efficacy results from a Phase 2b clinical trial for the company's OTX-TP product candidate for the treatment of glaucoma and ocular hypertension. As a reminder, this study was not powered for statistical significance.

Our objective for the study were to assess the ability of OTX-TP to deliver a clinically meaningful level of intraocular pressure or IOP lowering. To asses OTX-TP's performance parallel to Timolol to assess the duration of IOP lowering effects and to determine if patients can visualize the presence of our drug depot and get a replacement as needed.

We are pleased with the results, since we observed and average IOP lowering effect of approximately 5mm mercury with OTX-TP, which is clinically meaningful especially when considering it was achieved over a 90 duration with a single administration.

The IOP lowering effect of OTX-TP in the Phase 2b study, was also consistent for what we have observed in the Phase 2a study.

We have a drug depot that has shown the ability to lower IOP in a clinically meaningful manner with the potential to dramatically improve compliance which clinicians believe and the literature sports is a single biggest issue with current glaucoma therapies.

In the intent-to-treat or ITT population of the study, the comparator Timolol lowered IOP by an average of 1.9mm mercury, more than the OTX-TP. At day 60 the time point for the primary efficacy measure the IOP lowering effect of OTX-TP was 4.8mm of mercury compared with 6.4mm of mercury in the Timolol arm.

At day 90, the time point for the secondary efficacy measure the IOP lowering effect in the OTX-TP arm was 5.2mm of mercury compared with 7.3mm of mercury in the Timolol arm. It is important to understand the elements of the study that may have contributed to this difference.

And in adjusting for these, as an inclusion or exclusion criteria in a post-hoc analysis, the difference in the IOP lowering for the Timolol arm and the OTX-TP narrows considerably. If we look back to the Phase 2a study, we saw that the Timolol arm and the OTX-TP arm differ slightly, but not enough to have an overall impact on results.

In the Phase 2a study, we use a softer deeper product and in the Phase -- than in the Phase 2 study -- B study. We design a more rigid depot to improve retention, and this depot also used in the comparator arm.

Due to its improved design, the product fit into the punctum more tightly and we saw that it improved retention, but it may have also allowed Timolol to remain on the surface of the eye longer in the comparator arm. In fact, increase IOP lowering of topical glaucoma drops to the presence of a punctum plug has been documented in the literature.

I suggest reading the research authored by three separate authors Dr. [indiscernible] who have observed an additional IOP lowering effect of between 1.32 millimeters of mercury to 1.80 millimeters of mercury for Timolol when combined with a non-drug eluting punctum plug.

Second about 10% of the population were on more than one eye drop therapy, why? They were likely prostaglandin analog under responders and thus required an additional drug to control their elevated IOP prior to beginning the study [Audio Gap] compared with 6.2 millimeters of mercury in the Timolol representing a difference of 0.9 millimeters of mercury and a day 90 the time point for the secondary efficacy measure the IOP lowering effect in the OTX-TP arm was 5.7 millimeters of mercury compared with 7.2 in the Timolol arm representing a difference of 1.5 millimeters of mercury.

So what we see in this post-hoc analysis is that the IOP lowering effect of OTX-TP was closer to that observed in the Timolol arm and was within the 0.9 to 1.5 millimeters of mercury at the time points used for the efficacy measures.

These adjustments are exactly the kind of information we were looking for in our phase 2 studies which will aid in the design of our phase 3 study. OTX-TP offers a preservative pre sustained-release therapy that has the potential to significantly improve patient compliance.

With the six months of being put topical on prostaglandin analog drops approximately 50% of patients are no longer compliant and they are at risk for a decline in the visual field and overall worsening of their condition. Glaucoma is the second leading cause of blindness and a major cause is lack of patient compliance.

Importantly OTX-TP does not contain any preservatives and as a result hyperemia or eye redness was not observed in the OTX-TP patients. Hyperemia is a common side effect of the currently marketed medications containing preservatives and prostaglandin analogs.

Let’s turn the enhanced retention rates that result from the design modifications of our drug depot. We successfully increased retention rates at day 60 to 91% to 91% up from 71% as seen in the phase 2A study. At day 75 retention increased to 88% from 51% and at day 90 retention was 48% up from 37%. As the depot goes out to day 90, it began softening.

When this occurs [indiscernible] may become harder to visualize because it may go deeper into the nasolacrimal duct and thus not be easily visualized. For purposes of the study if the deeper was not visualized it was counted as not retained.

However, it is important to note that we still saw significant IOP lowering effect with OTX-TP maintained out today 90 in the trial. One objective of the Phase 2B trial was to assist in the design of our Phase 3 clinical trial and indeed this has provided us with valuable information.

After examining the results of the post-hoc analysis we will likely continue to focus on a 90 day product.

We will be interacting with the FDA and expect to have a meeting in the first quarter of 2016 on potential clinical study design for our Phase 3 trials of OTX-TP which may minimize or eliminate the possible enhanced timilol effect associated with the occlusion of the punctum in the placebo arm and exclude patients on more than one glaucoma medication.

We have some clinical study designs in mind that are more in-line with how the product is likely to be used and compared in the real world, but would like FDA feedback on these designs before providing definitive guidance.

The main corporate findings from the non-significant risk or depot only studies on our product design and conduct some short term studies to examine the effect of placebo plug. It is possible that this would move the start data for Phase 3 program into the latter half of 2016 which represents approximately a six month delay in the program.

We will very confident on our hydrogel base sustain release platform. We’ve an NDA filed with the FDA for post surgical ocular pain, have completed a successful Phase 3 study for allergic conjunctivitis and have observed highly encouraging results in the platform for glaucoma.

For young company we’ve accomplished a great deal including commercializing the first and only seen ophthalmic use resource [indiscernible] as I just mentioned in advancing several late-stage programs.

We also conducted an exploratory Phase 2 Clinical trial with DEXTENZA for the treatment of inflammatory dry eye disease and expect top line results by year end 2015. As a reminder this trial is not powered for statistical significance.

The study is designed to evaluate a number of different signs and symptoms in an effort to inform us as to which of these measures would be suitable for future clinical study designs using DEXTENZA or other molecules in a sustained release product.

We continue to make substantial progress with our sustained anti-VEGF drug depots for the treatment of the back of the eye diseases including Wet AMD. We’re pursuing this in addition to a small molecule, Tyrosine Kinase Inhibitor initiative.

We continue to pursue potential partnerships with strategic partners and are encouraged by the progress of these discussions. Our enthusiasm about these programs remain unwavering. I will now turn the call to Brad Smith, our CFO, who will review the third quarter financial results..

Brad Smith

Thanks, Amar. With regard to our cash and investment position, as of September 30th, 2015, we had a 113.6 million in cash, cash equivalents and marketable securities. Cash use and operating activities was 9.7 million in the third quarter of 2015, it was 25.1 million year-to-date through September.

We expect cash use in operations to be in a range of 36 million to 37 million for the full-year 2015 and expect capital expenditures to be in a 3 million to 4 million range for the year.

Furthermore, we expect existing cash and investments to fund the company's operating activities, capital expenditures and debt service through at least the third quarter of 2017. And at the end of September, we had 15 million in outstanding debt.

The third quarter ended September 2015, we reported a net loss of a 11.5 million or a loss of $0.47 per share. This compares to a net loss of 7.3 million or a loss of $0.48 per share for the third quarter of 2014.

The net loss for the third quarter of 2015 included 1.2 million a non-cash charges for stock based compensation, compared to 600,000 in similar charges for this comparable quarter in 2014. Revenues for the third quarter of 2015 totaled $400,000 including revenue from the sales of our ReSure Sealant and collaboration revenue.

As previously stated, we don’t expect product revenues from the sales of ReSure to be material in 2016 as we are differing the hiring of a direct salesforce until we launch our initial sustain release drug delivery product.

Total operating expenses during the third quarter 2015 were a 11.6 million which compares to 6.9 million for the third quarter of 2014.

We increase our investment in R&D in the third quarter of 2015 as we advanced OTX-TP for the treatment of glaucoma and ocular hypertension through the Phase 2b clinical trial against DEXTENZA for the treatment of allergic conjunctivitis through the first Phase 3 clinical trial and advanced our exploratory Phase 2 clinical trial at DEXTENZA for the treatment of inflammatory dry eye disease.

We also made investments in our preclinical programs for the treatment of wet AMD and other back-of-the-eye diseases. Research & Development expenses totaled 8.3 million in the third quarter of 2015, compared to 4.5 million in the third quarter of 2014. At the end of September, we had approximately 24.7 million shares outstanding.

This concludes my comments on the third quarter 2015 financial results. We will now turn it back over to Andrew for Q&A.

Operator?.

Operator

[Operator Instructions] And our first question or comment comes from the line of Ken Cacciatore with Cowen and Company. Your line is now open..

Ken Cacciatore

Hey, guys. Thanks for the additional details as you did more analysis. Can you just flush out a little bit more for us the decision from the 75 to the 90 days? I think just the explanation was that even though it may not have appeared that it was being retained that you think that the plug was.

Can you just talk about kind of what you’re seeing in IOP lowering in those patients that the drug doesn’t seem right, the plug doesn’t seem retained but you were still seeing fairly decent IOP lowering.

Is that these kind of the real simple explanation?.

Brad Smith

Two things, Ken. Thank you for the question. I think that we had even at the time that we announced the results earlier, we had seen the IOP lowering at 90 days was consistent and good compared to other time points, so meeting that five kind of unit threshold.

The thing that we learned with the additional analysis was that when we looked at this post-hoc analysis where we took away some of the patients who were about 10% of the patients who were on more than one medication for IOP lowering.0 And this is when you start out looking at the inclusion criteria you want to start out broad in Phase 2 and then narrow it to a Phase 3.

So, we took all comers up to two drops of IOP lowering drops. So, but however you think about why somebody would be on the second drop relative to having a first drop of prostaglandin is because there would be under responders to prostaglandin. And since our drug is a prostaglandin, to some extent that is probably not the right population to include.

So we looked at the cohort where these 10 patients were excluded and what we found was that the gap narrowed a fair amount between us and Timolol. So, that gave us that 0.7'ish units that we would have gotten by say moving the product from a 90 day to a 75 day product by maybe having a little bit more drug being released.

So, we don’t really feel that that is required and given that by an exclusion criteria modification which is relatively simple to do and really wouldn’t affect the enrolment all that much or the population that is addressable by this product all that much. We would be able to attain that differential that we were looking for.

So that was the rationale behind saying I think this product has been seen to lower IOP out to 90 days and if you look at the patient population of patients on one drop, you should be able to get closer to the Timolol differential..

Ken Cacciatore

Okay..

Brad Smith

Now, ideally we would like to see a little bit more differential narrowing and that’s what we would like to evaluate the role of the placebo plug in the Timolol arm..

Ken Cacciatore

Okay. And then, you’re talking about working on a placebo plug or a plug that maybe I would think dissolves more rapidly or maybe is not as tightly fitting on the placebo yet still kind of mask the placebo.

Is there still a chance that you may run a straight placebo arm that has no Timolol component on it, just a plug with no Timolol or is that out of the question, is that still up for debate as you go to FDA?.

Brad Smith

So, if I understand your question correctly, the question is would you consider having a placebo only arm and do a kind of a comparison to a placebo group?.

Ken Cacciatore

Yes..

Brad Smith

Is that what you’re asking?.

Ken Cacciatore

Yes..

Brad Smith

So, and we are ruling out any options. Certainly that is one of the options, but it’s not the preferred option from our standpoint.

Our preferred options would be to look at more of a real world situation where we are directly comparing our depot to Timolol drops the way they are used in the real world or there are some additional clinical study designs that I don’t want to speculate on at this point in time that may involve a different type of analysis.

Since we have to have some conversations with the agency, I wouldn’t speculate on that, but the comparison to placebo while theoretically is a possibility, is a less preferred option because enrolment of such studies can prove to be difficult.

We like to enroll our studies robustly as we just are demonstrating with our Phase 3 on in pain and inflammation that is ongoing. We would think that with patients are not put on a particular therapy for extended periods of time it may be harder to enroll that study. So, while we’re not taking it off the table, it is a less preferred option..

Ken Cacciatore

Great thank you..

Operator

And our next question or comment comes from the line of Andrew Baron with Morgan Stanley. Your line is now open..

Andrew Baron

Hi, thanks for taking the question, guys. One of the concerns that we had, I think was the amount of drop used for with TP was less than what you would normally see with Timolol just based on the amount in other clinical trials, not your trial per se.

So I am just trying to understand one of the things I thought you are going to try to do is get more drugs into the plug. This new 90 day plug, the reformulation which is former and has a higher retention rate.

Is there a possibility that you can get more drugs into that plug?.

Amar Sawhney

So Andy I don’t think now we had speculated that we wouldn’t necessarily expect to see much higher. We would – when we talked about the 75 day plug we talked about being able to put maybe a 10-15% more drug into it to be able to get a slightly more enhanced effect.

Our feeling is right now that that trade-off is probably not required given that we can get that differential simply by our inclusion criteria adjustment wherein if the under responders to prostaglandins are taken out the you would probably be able to achieve that differential narrowing. So that’s not required.

Now there is an additional portion to be understood in the double dummy design when we conducted this prior study we used a double dummy design which not only involves putting up placebo plug thus bolstering the effect of the Timolol drop and also involves administering placebo drops to the OTX-TP patients thus washing out the prostaglandin analog that is eluting out slowly.

So by, we again think that this doesn’t necessarily reflect real world type of situations so if we can come up with a clinical study design that eliminates both these double dummies and still is able to mask the evaluator.

Then you should be able to theoretically not allow Timolol to have such a high effect and potentially by not washing the drug out in the OTX-TP arm maybe the effect is enhanced. So these are some things that would be nice to study in some short-term type of one month type of studies.

If that effect is seen then that gives us guidance and more confidence that this differential will be under control..

Andrew Baron

What do you think if you design a trial that were would you expect that a label of the FDA or grant would exclude Timolol, I mean not prostaglandins hyper responders and if so what portion of the patient population does that represent?.

Amar Sawhney

So we are not talking about Prostaglandin hyper responder, we’re talking about removing under responders 10% of that population was observed to be there in our current clinical trials so we don’t think that this is a large population. It is basically 10% of patients in the first line of administration of prostaglandin maybe on more than one drop.

So we would be only be potentially about 10% of the population..

Andrew Baron

Okay. Thanks I appreciate the color..

Operator

And our next question or comment comes from the line of Adnan Butt with RBC Capital Markets. Your line is now open..

Unidentified Analyst

Hi guys this is for Arshad Haider here for Adnan.

Thanks for the question on OTX-TP can you elaborate on some of the work that needs to be done before starting the phase 3?.

Amar Sawhney

Yes so the work that may need to be done primarily consists of being able to have a discussion with the FTA on the clinical study design options. So we are asking for a meeting to be able to discuss two or three of the clinical study design options that we have on the table with them.

Some of the other work we are going to be incorporating the learning from our non significant risk studies such as adding a particular shape dissolving tip to the plugs so that they can be easier to insert so that is work that has already been completed so it’s not – but remains to be done, but will be just be a feature that is incorporated into it..

.:.

Amar Sawhney

Okay thank you..

Operator

[Operator Instructions] And our next question or comment comes from the line of Hartaj Singh with BTIG. Your line is now open..

Hartaj Singh

Thanks for the question. Just had a couple. As you’re going forward at the end of this year.

Next year around this time you’ll have another approved product DEXTENZA assuming FDA approval of a post surgical pain is a good chance that you’ll also be getting ready or might not or might already have submitted an sNDA for inflammation and then maybe even the allergic conjunctivitis.

What are some of the things can you just kind of walk us through on a higher level strategically speaking and then operationally, the thing that you’re doing over the next 6 to 12 months kind of prepare the company to stay also still a research and development organization but also have to prove products with three maybe even four different labels and indications? Thank you..

Amar Sawhney

Sure that’s an excellent question. So obviously we need to start maturing as an organization in both operationally as well as commercially to be able to stand and readiness to begin initial commercialization towards the end of 2016 and then prepare for full commercial launch in 2017.

So there are several activities that are underway in that regard some of these for example are in building up manufacturing capacity, preparing for the FDA audits that would be happening. So readying the quality organization for that expanding the manufacturing capacity in organization, some automation might be introduced.

There are those types of things that we’re doing on the operational side. On the commercial side as you saw we just added Jim O’Shea as Board Member who has an extensive commercialization history and within the organization we’ve also just hired our first medical director to start bolstering some of the activities and outreach to clinicians.

We’re starting to add to the commercial organization and we will adding some folks on the head of sales for example as well as starting to talk to a number of contractor sales organizations and picking one to be able to provide us with the contract sales force that would be needed.

So several steps need to be taken and are being taken also on the reimbursement side of things in readiness for getting pass through payment initially and getting eventually a [j-core] for allergic conjunctivitis.

So, it is important that the product DEXTENZA has a payment mechanism both for use and surgery as well as in office and the allergic conjunctivitis indication would obviously be a office based indication while the post surgical indications are surgery based indications.

So, putting payment mechanisms in place for that and having appropriately imbursement strategies in place is also something that we’re actively working towards..

Hartaj Singh

Got them all.

And then , just one follow up to that is there, do you kind of, I know this might be thinking too far ahead but in 2016 do you kind of foresee maybe a kind of analysis briefing on the commercial opportunities for 2, 3, 4 products and just kind of walking through people what for example the office space indications, what it’s like, what are the doctors, kind of how you could see reimbursements are rolling out or something like that or would you well rather wait to get a approval before doing something like that?.

Amar Sawhney

Well, the progress on the NDA with the FDA seems to be quite rapid, they have been very communicative and we’ve had lot of back and forth with them.

So, we’re feeling that seems to be progressing so we might have an Analyst Day in Q1 of next year where we sit down and review both the commercial opportunities of the product that we’re currently developing as well as take a deeper look at other things that might be there in the pipeline that we currently are working on and at the clinical stage that we haven’t discussed.

We will talk about..

Hartaj Singh

Great, thank you, looking forward to it..

Operator

And at this time I’m showing no further questions, so with that said, I would like to turn the call back over to CEO, President and Chairman, Dr. Amar Sawhney for closing remarks..

Amar Sawhney

Thank you. I want to thank everyone for taking the time to join us on the call today. We hope to see you later this week at the American Academy of Ophthalmology Meeting in Los Vegas. We’ll have oral and poster presentations highlighting DEXTENZA and the ReSure® Sealant.

We will also be hosting an investor event, if you’re interested in attending please contact Kimberly [indiscernible] our contact details are in our third quarter 2015 earnings press release.

We’re pleased for the productivity of our research and clinical teams, we’re dedicated to developing sustained release ophthalmic therapies by the proprietary sale hydrogel then offer our promising variety of therapies with potentially greater compliance and better patient outcomes. On behalf of the Ocular team, thank you for all your support.

You may now disconnect..

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