Good afternoon, ladies and gentlemen. Thank you for standing by. And welcome to Ocular Therapeutix's Second 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 at Ocular Therapeutix. Please go ahead, sir.

Thank you and good afternoon, everyone. Welcome to Ocular Therapeutix's second quarter 2015 earnings and business update conference call. Earlier this afternoon we issued a press release providing details of the Company's financial results for the second quarter ended June 30, 2015 and recent company developments and near-term milestones. This press release is available on the Investor portion of our Web site at investors.ocu.com. Leading the call today will be Dr. Amar Sawhney, our President, Chairman and Chief Executive Officer, who will provide an update on the status of each of our clinical and pre-clinical development programs as well as anticipated milestones. Following Amar's remarks, I will provide an overview of the financial highlights for the second quarter of 2015 and our recently completed follow on financing before opening the call for questions. We are joined on the call today by Eric Ankerud, our Executive Vice President of Clinical, Regulatory, and Quality as well as 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 which was filed with the SEC, was filed earlier today. 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 point in the future, 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.

Thank you Brad, good afternoon everyone and thank you joining us today on our second quarter 2015 earnings call. Before I provide an update on recent company developments and expected milestones I want to take a moment to reinforce our vision at Ocular Therapeutix. I strongly believe that we have the ability to transform the way in which patients receive care for their ocular diseases by providing a one-time treatment for acute conditions and a less frequently administered therapy in the case of chronic diseases. Patients in front of the eye conditions are faced with difficult task of administering eye drops daily and compliance on safety concern are some of the major issues that could potentially be overcome with our product candidates. Patients with back of the eye conditions such as those suffering from wet age related macular degeneration or AMD, require intraviteral injections typically every one to two months. We hold out the prospects of sustain delivery of drugs for up to six months, potentially reducing the number of injections to twice a year. These could be major paradigm shift in the treatment regimen of patient's impacted by ophthalmic diseases. I will now provide an update on recent developments and expected milestones. During the second quarter we have made progress on our clinical programs and on the corporate development front. We finalized enrollment in pre clinical trials, including Phase 3 trials for DEXTENZA and allergic conjunctivitis, a Phase 2 be trial for OTX-TP our sustainably lease product candidate of glaucoma and exploratory Phase 2 trial for inflammatory dry eye also with DEXTENZA. In addition, this quarter was highlighted by our closing of a follow-on public offering which resulted in approximately $66 million in net proceeds to Ocular. I will let Brad provide more details on the financing later on…

Thanks Amar, with regard to our cash and investment position, as of June 30, 2015, we had $123.7 million in cash, cash equivalents and marketable securities. As Amar alluded to, we close the follow-on financing earlier June through an offering of 4.6 million shares including the underwriters' options. The company sold 3.2 million primary shares at a price $22 per share and received net proceeds of 66 million and two selling shareholders for venture capital investors who invested at an early stage of the company's development sold a portion of their holdings 1.4 million shares. We are pleased to have had Morgan Stanley, Cowen and our RBC Capital involved in our financing once again we added Nomura and BTIG as co-managers for the offering. Our balance sheet was considerably strengthened with our cash position nearly doubling with this recent offering. We believe that we have sufficient cash and cash equivalents to fund the company through the third quarter of 2017 and through several important clinical and commercial milestones with our product development programs. These expected milestones include submitting the NDA for DEXTENZA for the treatment of post-surgical ocular pain initiating and completing patient enrollment in a third Phase 3 clinical trial for DEXTENZA for post-surgical ocular inflammation and pain, advancing our DEXTENZA program for the treatment of allergic conjunctivitis, completing a Phase 2 exploratory clinical trial of DEXTENZA for the treatment of inflammatory dry eye disease reporting top line efficacy data and assessing the longer term strategy for this program. Completing a Phase 2B clinical trial of OTX-TP for the treatment of glaucoma and ocular hypertension and reporting top line efficacy data and then initiating Phase 3 clinical trials and advancing our sustained release hydrogel depot preclinical program for the intravitreal delivery of anti-VEGF drugs for the treatment of Wet…

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

One of the key differences in the Phase 2B glaucoma study from Phase 2A is the patients now trying to be able to observe whether they still have plug or not, so I was just wondering I know you've mastered the study, is there any anecdotal kind of view you can on what's being observed in terms of ability for patients to at least know if the devices I don't not necessarily clearly the retention rate I know you can't give us, but maybe any feedback on the ease or difficulty in observing that? And then also maybe talk about some of the complexities with your back of the eye programs I would assume that some folks may want take a license but of course maybe you want to retain the program would be more attractive to any large suitor or if you're able to not like it out, so just kind of balance the ability to or the desire to move forward the partnership versus wanting to maybe retain your own rights of the program?

Sure, thanks Ken. So let me begin by answering your first question on the patients' ability to visualize and assess the presence of the drug product, while the study is massed and we don't know whether which of these groups things may fall-in everybody does get a plug and everybody does get a fluorescent plug which can be visualized using the little blue light that we provide to the patients. So, while we cannot comment upon how it's performing in one group or the other, what we do see is that some patients have been able to visualize that they have lost a plug and have asked for a replacement and in almost all cases, what patients findings are confirmed by the physicians finding. Now this has by far being the minority number of patients, however, what we do see is a good correlation between the physicians findings and the patients finding. So, it appears to be working and that when patients feel that they are missing a plug that is confirmed by the physician also. With regards to the second question, regarding the back-of-the-eye program, as you know we're pursuing a two pronged strategy, one is on the protein side and the second is on the TKI. We are able to in our discussions with the various potential partners, segments this out in that the small molecule work we intent to and they have actually expressed a willingness for us to be able to pursue that on our own, while we're pursuing protein based programs with the potential partners. Now the type of deal structures without going into too much of details, there are obviously a balance to be walked between on one hand gaining, non diluted type of financing and that having an interesting contribution to us, in terms of funding and other efforts. On the other hand we wanted to be able to retain enough commercial upside, so that as we grow to become not only just technology licensor but real company that is pursuing commercial development of products that we retain sufficient commercial upside. So, I think what you will see is us trying to strive that balance and to be able to do licensing deals on the protein front via keeping the small molecule efforts for our own development.

Thank you. And our next question comes from the line of Adnan Butt from RBC Capital Markets. Your line is now open.

First one on OTX-TP, so Amar just the Phase 2B, will it get the company sufficient data to be able to determine if OTX-TP should be take into Phase 3 or not? And if so, what exactly is the company looking for? And then please tell me if using the new plug that has a high retention rate, does that require any kind of bridging study or is the company free to use that in that Phase 3 glaucoma study?

So, with regards to what do we expect to learn from this Phase 2B trial, as we talked a little bit about in the earnings script is there are three things that we're mainly looking for or maybe for. The first is do we have an adequate level of effect, while this study is not statistically powered to be able to show the 1.5 millimeter non-inferiority relative to Timolol if we see an effect of IOP lowering that general range, I think we will feel that now we can statistically use that information and power the appropriate Phase 3 study. So that's one thing we're looking for. The second thing we looking for is, we've seen in the past work that we've done, IOP lowering at one month, two month and up to 75 days. We wanted to be able to see can we take it out to 90 days, so 90 days has been natural period in which people come back to see their ophthalmologist if they have glaucoma, which is not to say that is two months product is not viable product, a three month will be little bit more preferable, because it naturally fits in with the visit timings. And then ultimately, we've talked about this point already about the ability of the patient to visualize and replace because if you're developing a chronic therapy you want to be able to make sure that the patients are able to get a chronic therapy and the way we look at this is, we look at not only making the best and retain plug but also making a plug that patients can visualize themselves and ask for a replacement if they find it to be missing. So as they're assure to continue therapy. Finally safety is always something that we keep an eye on and we're pretty encouraged in that regard because till now with this type of drug product, we've not seen any hyperemia for example, which usually as you know in many whether it is prostaglandins drugs or ROCK inhibitors can be seen 35% to 40% of the time in patient -- and it is one of the factor that leads to non-compliance by the patients. So, by being able to eliminate that which is principally a peak dose related effect, we're able to create a product that could potentially have not only compliance enhancement but patient preference as a result of that so. We're excited about these different aspects on the glaucoma therapy.

Amar in the prior call, the company talked about a plug with a high retention, if that were to be use for the Phase 3, would you need a bridging study or can that be taken direct….

No, you would not need a bridging study because those studies, we are already doing non-significant risk studies with kind of blank plus they have micro particles in them but they don't have an active drug agent in them, and we are studying those in separate clinical trials and the information from those trials will be provided to the FDA along with the Phase 2B trials to be able to file and proceed for our Phase 3 trials. So those are basically the hydrogel delivery system and we continue to kind of improve the prospects of how those are designed and developed for the maximum retention, ability to replace, visualize and incursion.

Okay and if I can get a question on the anti-VEGF depot program, would you expect any differences in timelines with development for a biologic versus a small molecule?

Good question, I think so let’s look at for the biologic, on one hand there is a lot of history of usage, and lot of clinical data and awareness that the partners might bring to the table. On the other hand formulating those is more technically challenging, requires kind of aseptic processing et cetera and customized manufacturing, something that we are starting to invest in and that's what you see in the capital investment this year. So faster in some regards, slower in other regards, small molecules if we pick molecules that have already had some level of history of usage in oncology drug for example, some of these are renal cell carcinoma drugs. That helps. But what really helps is that the manufacturing for these depots is simpler because these would be terminally sterilized, the small molecule drugs for example are stable to radiation and sterilization, so the manufacturing becomes a lot more facile and we can react and move much faster with that. So I think net-net our feeling is that we should be able to move with the TKI agents once we have selected the appropriate agent and we are selecting the agents based on potency, different target kind of effects, solubility, the IP situation, all of these things kind of go into the selection of a particular TKI agent and we've narrowed it down to a few candidates and we should be in a position to kind of pick one and move with it very soon.

Thank you. Our next question comes from the line of Hartaj Singh, from BTIG. Your line is now open.

Just one question on the filing for DEXTENZA in pain. Amar just with the Phase 3 that you've run the two, there were co-primary endpoints. I'm just trying to visualize that when you file this and I'm trying to see it in my head, how will the actual filing be done. Will you be able to separate out the co-primary endpoints and just be able to submit pain? Which I assume that was the pre-NDA discussion and then when assuming you have a positive readout for information then how will that fit in as sNDA into the previous NDA? And then lastly, because they were co-primary is there any potential that the FDA might want to go to an add-comm with this simply because you know it's a little bit different from normally what they're used with NDAs or just any thoughts on that.

We did have a pre-NDA meeting with FDA in regard to our planned filing for the ocular pain indication and so the NDA right now is being structured for pain only labeling. It includes the data from both of our Phase 3 trials in support of that indication. With the expectation as we stated for a third Phase 3 study with the same endpoints of information and pain to support an NDA supplement to gain the inflammatory labeling pending the approval of the initial NDA for ocular pain.

So you'd actually -- I assume is, if the timing works out right than you'd actually go ahead, you'd probably get a 10 month review at which point you'll have the readout for information and that'll be able to kind of get submitted while you're getting the approval for pain.

The 10 month review is what are anticipating for the NDA for ocular pain. The third Phase 3 study will be in progress and the timing of completion for that study is line with a supplement following that initial NDA approval for ocular pain.

And then just one last, just a housekeeping question, you know with the increase, a slight increase in burn into go into this year, would you expect and not looking for any guidance going to 2016 or '17 but just kind of in a broad perspective would you see that with the increased clinical activities that you're having in pre-clinical activities that there'll be some con- concomitant kind of growth in just expenditures going into 2016.

We do yes. So you know, certainly gave the guidance of this year of 35 million to 37 million in operating cash burn plus CapEx, but yes, with just with four major clinical stage development programs next year we’re anticipating a Phase 3 glaucoma programs which will be expensive. We do anticipate an increase and when we give guidance, we believe we're funded through the third quarter 2017 it takes into consideration Hartaj.

[Operator Instructions] Our next question comes from the line of Ian Somaiya from Nomura. Your line is now open.

It's Mathew on for Ian. Just a couple of questions if I may, first, I want to come back to something Amar you mentioned, you've said they're continuing to work to improve and maximize the retention of the plugs for the glaucoma study and I was just wondering if you might be able to expand on that if there is anything different or changed in your sort of expectations hurdle rates versus sort of the last time you've touched on this? And then secondly as you gear up for the fourth quarter NDA filing, can you maybe talk little bit about any sort of pre-commercialization activities there as you're undertaking now or there you've got time for the early part of 2016 and if you have any discussions with payers what the time of those has been? And finally I was hoping you might be able maybe give some sort of directional guidance on when we will get any additional visibility into the TKI program?

Sure, so let's first talk about sort of the retention rates. As we had mentioned that with some of our later product candidates, which have been going through the placebo vehicle plug that have been going through the non-significant risk studies we have seen retention rates over three month duration quite high as 92%. So what we've changed in those to be able to achieve those types of rates are looking at the stiffness of the plugs, the swelling of the plugs, the size of the plugs those types of things are changed. So we have some key learning that have come from that. Now what we're trying to optimize is to be able to make sure that the plugs are not only well retained but in a chronic therapy would need to have them be removed at the end of three months and then new plugs reinserted. While the plug are designed, these systems are designed to be absorbable what we want to make sure that they are delivery drug for the duration and the absorption is a longer duration than that so they would need to be removed and then other ones inserted, so we're looking at different compositions of hydrogel. This is all well within our learning and our capability. This is standard stuff that we do but that progress is made along with and in parallel with the drug delivery work that has been done in the Phase 2B trial. So when those two pieces of information come together, we're allowed, we pick a candidate that has the best patient experience is the best way to describe it that would be entering the Phase 3 and also have the drug delivery capabilities, so that's the progress that we have made today over there. On the pre-commercial…

This is Scott Corning. Right now regarding pre-commercial activities we’re busy namely in the planning stages of course we got the name for the products several months ago, so we're now working on branding activities and campaign ideas as well as working on our marketing and sales staffing plans, putting people in place to prepare for commercialization of the products as early as third quarter of next year. And then also looking at MSL deployment which we could do prior to launch, if we so chose to do, and also working constantly on our publication plan our KOL engagement and also ensuring a strong congress presence. So there is a lot of activity going on right now and that will only increases as time moves on. Regarding reimbursement, we are looking at the scenarios that could come to fruition with the products so we're working closely with reimbursement consultants to gain a better understanding about this specific situation as it relates the product, of course our goal is to get the product reimbursed and we're working towards doing that in part of our strategy in terms of having an extended level multiple indications for DEXTENZA would only increase chance of doing so, lot of activity on that front as well.

And I'm showing no further question. I'll now turn the call over to Amar Sawhney for closing remarks.

Well, I want to thank everyone for taking the time to join us on the call today. We continue to deliver and advance our multiple programs including DEXTENZA, sustained-release dexamethasone, the post operative ocular inflammation and pain allergic conjunctivitis and inflammatory dry eye disease, OTX-TP, sustained-release travoprost of glaucoma and ocular hypertension and our pre clinical anti-VEGF agents of back-of-the-eye diseases. We look forward to several important value creating milestones during the second half of 2015, we also look forward to seeing many of you at the Morgan Stanley Healthcare Conference and at the Citi Biotech Conference this September. As always I want to thank our employees, advisors and Board Members who have been devoting their time, energy and passion to advance the Ocular Therapeutix's pipeline and vision. On behalf of the entire Ocular team, thank you for all your support. You may now disconnect.

Ladies and gentlemen, thank you for participating in today's conference. This does conclude the program. You may all disconnect. Everyone have a great day.