Brad Smith - Chief Financial Officer Amar Sawhney - President, Chief Executive Officer and Chairman Jon Talamo - Chief Medical Officer Scott Corning - Vice President of Sales and Marketing Eric Ankerud - Executive Vice President of Regulatory, Quality and Compliance.

Ken Cacciatore - Cowen & Company Adnan Butt - RBC Capital Markets Hartaj Singh - BTIG.

Good morning, ladies and gentlemen. Thank you for standing by. And welcome to Ocular Therapeutix's 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..

Thanks Bridget. Good morning everyone. Thank you for joining us on our First Quarter 2016 Earnings and Corporate Update Conference Call. Earlier this morning, we issued a press release providing an update on the Company's product development programs and details of our financial results for the first quarter ended March 31, 2016.

These can be accessed on the Investor portion of our website at investors.ocutx.com. Leading the call today will be Dr. Amar Sawhney, our President, CEO and Chairman, who will provide a summary of our recent clinical and corporate developments, as well as provide an overview of the various key milestones expected through the remainder of the year.

Following Amar's remarks, I will provide an overview of the financial highlights for the first quarter of 2016 and then we will open the call for questions. Amar and I are also joined on the call today by Dr.

Jon Talamo, our Chief Medical Officer, Eric Ankerud, our Executive Vice President of Regulatory, Quality and Compliance, 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 Form 10-Q on file with the SEC, which was filed earlier this morning.

In addition, any forward-looking statements represent our views as of today only 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 Amar Sawhney..

Thank you, Brad. Good morning everyone and thank you for joining us on our call today. Before I review the recent progress we have made across our programs and provide an overview of our upcoming milestones, I just want to thank everyone who joined us for our first Investor Day last month.

It was a great venue to share our progress, future goals and vision for our company and we hope to continue the open conversation on this call today.

Importantly, we heard from several leading cataract, glaucoma and retinal specialists at our Investor Day about the potentials for our hydrogel-based sustained release drug product candidates, we changed our treatment that’s delivered to the eye of various ophthalmic conditions.

Currently, eye drops are often administered several times a day and even most injections are given monthly. With that approach, we hope – hold out the potential for one and done therapy for acute ophthalmic conditions and once in every several months therapy for the treatment of chronic diseases.

This represents the potential for a major change in the standard of care in the field of ophthalmology.

As we heard from leading physicians at our Investor Day event, as confirmed by our survey of over 200 ophthalmologist by Eye World Magazine, the biggest problem with the current standard of care eye drop regimens is not the level of efficacy, it’s that many patients either can’t or won’t take that.

In fact, this combination with patient compliance is motivating ophthalmologists to change the way they prescribe medication. Shifting away from complicated, daily eye drop regimens and exploring other methods of drug delivery, that puts control backend hand of the physician.

We also heard many examples of sub-optimal patients outcome through the non-compliance which is not only disappointing and discouraging to patients, but their physicians as well.

So if you can transfer the control to the physician for the entire course of therapy delivered in a secured fashion and in a significantly more convenient manner and with an improved safety profile due to the lack of preservatives and avoidance of the peak-end value of dosage associated with eye drop therapy. That would be really game-changing.

Our sustained release therapies and advanced clinical stage product pipeline has normal potential to replace the standard of care eye drop regimens and lead to improve patient compliance and improved safety profile, offer greater assurance of efficacy and potentially reduced disease progression.

Our goal is to make these innovative sustained release therapies available to patients and physicians as quickly as possible as there is clearly an unmet need right now.

We are working diligently to advance our sustained release product candidates across multiple indications and we expect a number of important milestones throughout the remainder of the year.

For our most advanced product candidate DEXTENZA, we are looking forward to the PDUFA action date of July 24 for the potential approval of DEXTENZA for post-surgical ocular pain. The target action date is based on a New Drug Application or NDA that was accepted by the FDA for filing in December.

The data included in the NDA are from a Phase II clinical trial and two Phase III clinical trials conducted with DEXTENZA for the treatment of post-surgical ocular inflammation and pain. The market opportunity for DEXTENZA in the United States is estimated to be in excess of $3 billion, about one quarter of which is post-surgical.

Approximately, 5.3 million eye surgeries are performed each year including 3.8 million cataract surgeries.

Should the FDA grant marketing approval for DEXTENZA for the treatment of post-surgical ocular pain on the PDUFA action target date, we expect to apply this transitional pass-through payment status to gain reimbursement and launch this product in early 2017.

After payment status for while reimbursement for innovative new products used in the hospital or ambulatory surgery centers for a period of up to three years. We intend to launch DEXTENZA for post-surgical ocular pain in the United States through a direct sales force with sales representatives dedicated to DEXTENZA.

If approved by the FDA, we anticipate DEXTENZA would be the first and only sustained release steroid available to ophthalmologists that is also preservative-free and the first and only FDA approved drug to provide the complete course of therapy with a single placement in ophthalmology.

Our third Phase III clinical trial for DEXTENZA also has primary endpoints for post-surgical ocular inflammation and pain is currently ongoing with 395 patients out of a planned total of 436 patients enrolled as of May 3.

Patient enrollment has been progressing ahead of schedule and we expect top-line results from this study to be available in the fourth quarter of 2016. As a reminder, we made some modifications for the trial design as compared to the first two Phase III clinical trials.

These include, one-to-one randomization versus two-to-one randomization, exclusion of patients on high-dose systemic and end phase or non-steroidal anti-inflammatory drugs and providing more detailed physician training regarding the user rescue medications.

Assuming favorable results from the third trial later this year, and subject to potential approval of our NDA for post-surgical ocular pain in, we plan to submit an NDA supplement for DEXTENZA for post-surgical ocular inflammation.

Also this past year, we completed enrollment in second Phase III clinical trial of DEXTENZA for the treatment of allergic conjunctivitis. The primary endpoint of ocular itching was met in the first Phase III study in allergic conjunctivitis, which was reported late last year.

We demonstrated clinically meaningful reduction of ocular itching in the DEXTENZA treatment group versus a placebo group.

There was a statistically significant difference in the P value of less than 0.0001 in the mean scores between DEXTENZA treatment group and the placebo group for the ocular itching primary endpoint at all three time points at day 7 post insertion of the intracanalicular depot.

And according to the prior FDA guidance of needing two Phase III clinical trials for NDA approval, our second Phase III trial will evaluate the safety and efficacy of DEXTENZA versus the placebo vehicle intracanalicular depot using the ophthalmic research associates modified Conjunctival Allergen Challenge, Ora-CAC model as in the first study.

The primary endpoint that we evaluated is ocular itching at day 7 following the insertion of the intracanalicular depot. We expect top-line results from the second Phase III trial to be available in June.

Patients who have strong seasonal allergies would benefit from a sustained release therapy which could provide long-lasting relief throughout allergy season with a one-time administration. Steroids are used in about one-third of patients suffered from moderate to severe allergies and who do not respond adequately to antihistamine.

DEXTENZA offers the opportunity to move therapy from patient’s self-administered daily treatment to physician-controlled prophylaxis lasting a month or longer. Not only our chronical steroids such as Dexamethasone logarithmically more effective than antihistamine for the peaks and troughs associated with eye drops play a very significant role here.

Once the information cycle starts, it’s very hard to stop it. So if a patient misses a drop or the drug wears out overnight while they are sleeping they get the information cycle starting again.

If approved, DEXTENZA would potentially set a new standard by offering long-acting prophylactic ocular allergy medication with a one-time administered therapy.

With respect to reimbursement, we expect to apply for to CMS a J code for DEXTENZA for allergic conjunctivitis subject to favorable clinical trial results and the approval of the initial NDA for pain and an NDA supplement for allergic conjunctivitis.

Subject to favorable results, and approval of the NDA for the pain indication post-surgery, we expect to file an NDA supplement for ocular itching associated with allergic conjunctivitis indication in the fourth quarter of 2016.

This means that DEXTENZA maybe approved for two additional indications in 2017, ocular itching associated with allergic conjunctivitis as well as post-surgical ocular inflammation. If we are able to achieve the broadening of DEXTENZA’s label, we would likely start to expand our sales team as the business scales.

We may also elect to enter into a co-promotional arrangement with a corporate partner to accelerate market penetration. We are also evaluating DEXTENZA for the treatment of dry eye disease. We recently conducted an exploratory Phase II trial with DEXTENZA for this indication.

The results are encouraging, while the study was not designed to show statistical significance, total corneal staining at day 30 following randomization decreased by a statistically significant degree from baseline in the DEXTENZA group compared to the placebo group.

Inferior staining also showed clinically significance differences in the change from baseline in the DEXTENZA treatment group, compared to the placebo. Corneal staining is a primary endpoint that has been used in recent Phase III dry eye clinical trials conducted by other ophthalmology companies for dry eye disease.

We plan to meet with the FDA in mid-2016 to discuss these results, as well as potential Phase III clinical trial design for dry eye-related indications. I will now turn to OTX-TP, our sustained-release travoprost drug product candidate for the treatment of glaucoma and ocular hypertension. Compliance is an even bigger issue in this patient population.

It has been reported that greater than 50% of patients are no longer compliance with their topical therapy after six months potentially resulting in disease progression. Unlike DEXTENZA OTX-TP is designed to last longer and release a steady rather than a tapering level of drug over time.

Therefore potentially replacing the burden of chronic daily glaucoma therapy with a once in three months drug depot results of preservative-free. We recently announced that we completed an end of Phase II review with the FDA.

Following this review by the FDA we plan to initiate our Phase III program in the third quarter of 2016 with two clinical trials that will include an OTX-TP treatment arm and a placebo-controlled comparator arm using a non-drug-eluting hydrogel-based intracanalicular depot.

The Phase III study design will not include a Timolol comparator or validation arm and will not have eye drops, placebo or active administered in either arm.

We are quite pleased with this as we believe that this trial design reflects and appropriate real-world clinical study design for OTX-TP, the primary efficacy endpoint will be superiority and the reduction of intraocular pressure from baseline with OTX-TP compared to placebo.

As with the first-line therapies, FDA would like OTX-TP to demonstrate clinically relevant IOP lowering in addition to the statistical improvement over placebo. OTX-TP has shown a clinically meaningful IOP lowering effect in clinical trials today and may offer an important advancement in the treatment of glaucoma.

Again, we expect to initiate the first of the two planned Phase III clinical trials in the third quarter of 2016. Lastly, we also continue to move forward on our sustained release protein-based anti-VEGF depots for the treatment of back of the eye diseases including wet age-related macular degeneration or AMD.

We are pursuing this in addition to a small molecule TKI or tyrosine-kinase inhibitor initiative. We continue to pursue potential partnerships with strategic partners.

To summarize the status of the back of the eye program, we have demonstrated the following, sustained release in vitro models out to four to six months in multiple protein-based anti-VEGF drugs provided by our collaborators. Sustained release in in-vivo model of Bevacizumab with strong pharmacodynamics effect through twelve weeks.

Sustained release in in-vivo model of a TKI with a strong pharmacodynamics and pharmacokinetic effects through six months. In-vivo tolerability of our hydrogel depots demonstrated through eight weeks as presented at RO or the recent ophthalmology conference earlier this month.

With that, I will now turn the call back over to Brad, who will review our first quarter 2016 financial results..

Thanks Amar. With regard to our cash and investment position, as of March 31, 2016, we had $95.5 million in cash, cash equivalents and marketable securities. Cash used in operating activities was $9.3 million for the first quarter of 2016 compared to $6.9 million for the first quarter of 2015.

We expect cash used in operations to be between $45 million and $48 million for 2016 and we expect that capital expenditures will be in a range of $6 million to $7 million. This is of course subject to a number of assumptions about our clinical development programs, the commercialization of DEXTENZA and other aspects of our business.

The spending is expected to be driven by our Phase III DEXTENZA programs, the treatment of post-surgical pain and inflammation and allergic conjunctivitis as well as our Phase III OTX-TP program for the treatment of glaucoma with the first of two trials expected to start in the third quarter of 2016.

In addition, as well, our clinical development efforts on our dry eye program and our preclinical development of back of the eye program. We will also be driven by our investment in the initial potential commercialization of DEXTENZA with the level of spending subject to the outcome of our PDUFA date for post-surgical ocular pain.

The expected investment of $6 million to $7 million in capital expenditures is primarily for the consolidation of our two facilities at the one location in close proximity to our existing facility and the associated build-out of manufacturing space, clean room and general office space and the purchase of new equipment to outfit this new facility.

We expect existing cash, cash equivalents and marketable securities to fund the company's operating activities, capital expenditures and debt service requirements through the third quarter of 2017. We have $15.6 million outstanding debt as of March 31, 2016 with no principal payments due until the early part of 2017.

For the first quarter ended March 31, 2016, we reported a net loss of $10.8 million or a loss of $0.44 per share. This compares to a net loss of $7.6 million or $0.35 per share loss for the first quarter of 2015.

The net loss for the first quarter of 2016 includes $1.3 million in non-cash charges for stock-based compensation compared to $900,000 in non-cash charges for stock-based comp for the comparable quarter in 2015.

Revenues for the first quarter of 2016 totaled approximately $0.5 million including collaboration revenue from our feasibility agreement with partners and revenue from the sales of ReSure Sealant.

As previously stated, we don't expect product revenues from the sales of ReSure to be material in 2016 as we continued to defer the deployment of the sales force until we launch our initial sustained release drug delivery product.

Total operating expenses during the first quarter of 2016 were $11 million, compared to $7.5 million for the first quarter of 2015 primarily reflecting an increase in our investment in product development and the advancement of our programs to the later-stage clinical trial.

Research and development expenses totaled $7.1 million for the first quarter of 2016 compared to $4.7 million in the first quarter of 2015.

We increased our investment in R&D in the first quarter of 2016 as we advanced the third Phase III clinical trial for DEXTENZA in the treatment of post-surgical inflammation and pain, advanced DEXTENZA for the treatment of allergic conjunctivitis and through the completion of enrollment in our second Phase III trial, advanced OTX-TP for the treatment of glaucoma through the final stages of our Phase 2b clinical trial, and advanced our other clinical and preclinical development programs.

As of March 31, 2016, we had approximately 24.8 million shares of common stock outstanding. This concludes my comments on the first quarter 2016 financial results. We will now turn the call back over to – for Q&A to the operator..

Thank you. [Operator Instructions] And our first question comes from the line of Ken Cacciatore with Cowen & Company. Your line is open. .

Hey good morning guys. Just a quick question on DEXTENZA and the interactions with the agency, would you just consider all of that at this point normal back and forth. So maybe a little bit of context as we approach the PDUFA date.

And then on the sales force and how we should be modeling or thinking about approaching the market, just in terms of the size and what should be expectations for this launch. Do you find the clinician bases given need to be up and educated or would you expect that this is something that we should think as more rapidly adopted? Thank you. .

Our interactions with the FDA during the review of the NDA have been ongoing and collaborative. The information request from the agency have been routine and typical for NDA review and we continued to remain on schedule for the PDUFA date at the end of July. .

Great..

Scott Corning will give us some inputs on the sales related question..

Yes, in terms of the sales force, we are in the process of hiring sales management personnel and then we will move to sizing up with representatives starting with probably ten in the span of time after the PDUFA date leading up to when we anticipate pass-through payment status approval which is January of 2017 and shortly thereafter, scale up to 20 and then 40 and assess our needs beyond that in the out months of 2017 depending on uptake and then you said, you asked about expectations for launch.

We expect to be training and really learning more about our training process detailing the surgeons and seeing what is in entailed in a call but what we know is that, surgeons and optometrists alike are accustomed to the insertion of punctal plugs.

So in terms of the actual procedure, there shouldn’t be any burden there, but we do want to be present for initial insertions to make absolutely sure that we are successful from the start. .

Great. Thank you. .

And maybe, Dr. Talamo will comment briefly also..

I can.

We are making concerted effort to educate the ophthalmic community about DEXTENZA and its potential future role, we just emerged from the – as you may know from the Annual American Society of Cataract and Refractive Surgery Meeting in New Orleans where there are probably about 5000 ophthalmologists and we had close to half dozen podium presentations related to DEXTENZA, as well as, a present – and a similar number for ReSure, total of almost 20 presentations at the meeting overall, and as well as a presence at continual medical education events and industry M.D.

collaborative summit such us the ophthalmology innovation summit which also occurred last week. There seems to be a good awareness in the community about what DEXTENZA is. How it will be used and a lot of excitement. .

Great. Thank you. .

Our next question is from Adnan Butt with RBC Capital Markets. Your line is open..

Thanks. Just a couple here. Good morning everybody.

In terms of the pass-through reimbursement, could you clarify one more time if there is a floor pricing tied to it?.

What? Can you repeat that Adnan?.

Yes, sure, I just want to know, if there is a minimum, if there was any pricing criteria with – in regards to – in regards to the pass-through code for the hospital outpatient surgery indications?.

Hey, Adnan, it’s Scott.

In effect, there is a limit where you have to be at a percentage quote not insignificant to the reimbursement of the overall procedure and it’s pegged off of the hospital rate of reimbursement for cataract surgery in this case or ophthalmic surgery in general, but if you use the cataract surgery case, and you are talking approximately $1650, you need to be somewhere in the neighborhood of 20% of that 20% to 25% of that to qualify.

And so that puts us in a particular range of pricing. But what we understand is once you have pass-through payment status, you are not necessarily at risk of losing it should there be a reason or a desire to be any less than what we come out with. .

Okay, and if I recall correctly, first you will hear back on the status, is in September or September the first time post-approval that you’d able to file?.

Yes, the latter, it’s correct. So, if all goes as anticipated, the PDUFA date as you know, is in the late July and then that is timed nicely with the quarterly gates that you have to apply for pass-through payment status.

So that would mainly would apply in September to hope to get it in January thereby maximizing the three year period that pass-through payment status would be in effect. .

Okay, thanks, and then, in regards to the PDUFA date coming up, if I recall correctly, in the last quarter the FDA had a question or two about manufacturing.

Are those issues resolved? Or are they in the process of getting resolved?.

This is Eric Ankerud. Those issues are in the process of being resolved. We have completed a commercial quantity build in satisfaction of FDA’s request and are continuing to have dialogue with FDA in that regard and we expect those issues to be closed out very soon. .

Okay, and then, just a last question. I think, I heard on the call, Amar say that the company could consider a potential co-promote with a partner.

Was that in regards to DEXTENZA? Under what scenarios would you – would that be early in the launch? Later in the launch or all the different scenarios are under consideration at this time? What would drive you building your own sales force versus partnering?.

So, to be clear, we will be building our own sales force, the question is, do we, in addition, add on a co-promote partner.

The reason to kind of add on the co-promote partner is purely that of region frequency of coverage, just to be able to have much more muscle going into the launch so as to maximize during this pass-through duration our access of DEXTENZA to as many physicians as possible. So it’s purely driven by that.

I think part of it is we do want to see how – some of the parameters of – how much time it takes to kind of get people an account active and trained and educated about the reimbursement process et cetera. So, those are some of the variables that we need to learn at – certainly we have in our discussions.

There is a fair amount of interest from most of the relevant parties to do that. We are examining what the economic terms will be. Obviously, we want to make sure that we are able to book in revenue and those types of things that are important for us.

And so, if the economics appear reasonable, and then we would like to do that, sooner or than later, but probably, wait until post-approval to do that. So, that’s kind of the current thinking subject to evolution and changes as we further our discussions, yes. .

And just to be clear that would be in – this is Brad, there would be no licensing rights where we are not talking about a licensing arrangement, we are talking about a short-term, co-promotional arrangement expires after a number of several years..

Okay, very helpful. Thanks. .

[Operator Instructions] Our next question comes from the line of Hartaj Singh with BTIG. Your line is open. .

Hi, thank you for letting me – taking the questions. I apologize, I am little under the weather. so for the voice.

Just actually a very quick question, one is on, just the operating kind of expenditures progression going forward, as you are kind of closing out the trial for – in both cataract surgery, allergic conjunctivitis you are getting right to launch DEXTENZA scaling up there.

Just, what are your thoughts, and just –maybe just kind of walk us through over the next four quarters, how do you see kind of various line items or operating expenses are progressing? And then, just another question is, on pass-through status, is there a possibility that you can’t meet the September deadline that what would be the next sort of deadline that you would be able to hit for filing? Thank you.

.

Scott, why don’t you start with the pass-through..

Yes, regarding pass-through, pass-through unlike the J code is on quarterly cycle and so, should we not have the opportunity to apply in September for January approval, we’d be looking at January for March, April approval. And so, we would effectively lose a quarter and then have two and three quarters a year’s lapse. .

Thanks, Scott. Hartaj, Brad. Just in response to your question about operating expenses, over the course of the next three to four quarters, yes, we will be winding down on the – and if completed enrollment in the second Phase III allergy trial, we have additional work to do there and of course data management closing out everything on that trial.

We will be anticipating starting the first Phase III trial for our OTX-TP product for glaucoma in the third quarter. And that’s going to be likely about a 555 patient trial. So that’s going to be an expense going on the order of $10 million.

And then, we would likely be starting three to six months later the second Phase III trial for that program as well. So while we are winding down certain trials, and we will also be winding down the third Phase III trial for post-surgical inflammation of pain later this year as we are getting close to full enrollment there.

We are well over 90% enrolled. Again, that will be even more than offset. So we will see an increase in R&D spend as a result of starting up our Phase III glaucoma program. We are also going to continue to make investments in the back of the eye program on top of that.

And then on dry eye, we will see – anticipating advancing that program subject to the meeting with the FDA that we have. On the sales and marketing line, we certainly will be increasing as Scott gave some indications here starting with a 10 sales representatives and growing in the 1st of 2017.

We are also already ramping up in terms of bringing on market access reimbursement folks as well as couple of MSLs and then some sales leadership. So, we will be - without getting into the specific numbers I think that gives you probably a sense in terms of the order of magnitude on sales and marketing.

We also will be adding a couple of additional people on the marketing team to support the product launch as well. And then, G&A, we continue – we expect to continue to see some modest increases there, primarily as we just grow the organization of the support for all of the operations that are ongoing. .

Got it. That’s very helpful. Thanks a lot, Brad..

I am not showing any further questions. I will now turn the call over – back over to Mr. Sawhney for closing remarks..

I want to thank everyone for taking the time to join us on the call today. We continue to position our company to be the leader at the forefront of transforming ophthalmic care providing solutions to overcome many of the major issues facing patients and physicians with the way drugs are currently delivered to the eye.

We hope to have a meaningful impact on patients’ lives and how physicians administer care and we are proud to be leading this transformation. We look forward to updating you during the months ahead. On behalf of the entire Ocular team, thank you for all of your support. You may now disconnect..