Good afternoon, ladies and gentlemen. Thank you for standing by. And welcome to the Ocular Therapeutix Q2 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 Mr. George Migausky, Interim Chief Financial Officer of Ocular Therapeutix. Please go ahead, sir.

Thank you, Andrew. Good afternoon, everyone, and thank you for joining us on our second quarter 2017 financial results and business update conference call. Earlier this afternoon, we issued a press release providing an update on the company's product development programs and details of our financial results for the quarter ended June 30, 2017. The press release can be accessed on the investor portion of our website at investors.ocutx.com. Leading the call today will be Antony Mattessich, President and Chief Executive Officer, who will provide a summary of our recent corporate developments. And following his remarks, I'll provide an overview of the financial highlights for the second quarter of 2017 before we open the call for questions. For Q&A, we are also joined by Dr. Amar Sawhney, Executive Chairman, Dr. Dan Bollag, Senior Vice President, Regulatory Affairs, Pharmacovigilance and Quality; Eric Ankerud, Senior Advisor and Scott Corning, Vice President of Marketing and Commercial Operations. 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, 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 point in the future, we specifically disclaim any obligation to do so even if our views change. I'll now turn the call over to Antony.

Thanks, George, and good afternoon, everyone. This is my first afternoon to speak as CEO of Ocular so please forgive me if I take a different tone or provide less granularity than you're used to. I will go through a brief high-level status update later, but first, I want to take a few minutes to give a perspective on what brought me to Ocular and what my vision is for its future. For those of you who know Mundipharma, where I come from and its associated companies, you'll know that by any standards, it's a leading formulations company having developed products like OxyContin and Targin that have recorded multiple billions of dollars in sales. In running Mundipharma international for the last 7 years, and living in it for the last 13, I understand how to assess the value and potential of a formulation platform. I've spent a good deal of my life scouring the globe for new formulation technologies, diligencing their capabilities, bringing them to market and then commercializing them through their life cycles. I believe I understand the space as well as anyone. Quite simply, I believe hydrogel is a tremendous formulation platform, and that is why I moved myself and my family to Boston to be part of Ocular Therapeutix. Unlike most other depot formulation technologies, it has been in the human body in significant amounts in millions of patients to date. It's fully absorbable and has been used in many environments in the human body without significant known side effects to date. It appears to be versatile and programmable in its drug-release potential. It can be formulated both with small molecules as well as large proteins. In short, it is a well-suited platform for drug-eluting depots. So what needs to be done to validate the platform? Clearly,…

Thanks, Antony. Let me begin by summarizing our capitalization as of June 30, 2017. At that time, we had $66 million in cash, cash equivalents and marketable securities. We also have an available at-the-market program, ATM, under which shares of our common stock may be sold from time to time. We had approximately 29.1 million shares issued and outstanding at June 30, 2017. With respect to operations, during Q2 2017, our operating cash burn was $11.3 million during the quarter. As we announced last week, going forward, we expect to realize savings in operating expenses, including personnel costs, as a result of streamlining headcount by approximately 19% as part of an initiative to enhance operations and to reduce expenses. With these anticipated cost savings and based on our current plans and forecasted expenses, we believe that existing cash equivalents and marketable securities will fund operating expenses, debt service obligations and capital expenditures through the third quarter of 2018. This is, of course, subject to a number of assumptions about our clinical development programs and other aspects of our business. With respect to financial results for the second quarter ended June 30, 2017, we reported a net loss of $18.7 million or $0.64 per share, and this compares to a net loss of $11.4 million or $0.46 per share for the second quarter of 2016. Net loss for the second quarter of 2017 included $2.1 million in non-cash charges for stock-based compensation and depreciation compared to $1.7 million in similar non-cash charges for the comparable quarter in 2016. Research and development expenses totaled $8.1 million in the second quarter of 2017 compared to $7 million in the second quarter of 2016 as we continue to advance the clinical and preclinical development of our hydrogel platform technology and the portfolio of drug product candidates. Selling and marketing expenses for Q2 2017 were $6.8 million, and this primarily represented the costs of pre-commercial activities in preparation for the launch of DEXTENZA. And as I mentioned earlier, looking ahead and in conjunction with the reorganization implemented last week, the selling and marketing costs are expected to decrease significantly over the next several quarters. Revenues for the second quarter of 2017 totaled approximately $400,000 from sales of ReSure Sealant. And as has been noted in the past, we don't expect product sales - product revenues from the sales of ReSure to be material in 2017. That concludes my comments on our second quarter financial results. And so I'd now like to turn the call back over to the operator, and we can go ahead and take your questions.

Thank you. [Operator Instructions] And our first question comes from Dane Leone with BTIG. Your line is now open.

Hi. Thanks, guys. Thank you for taking the questions and congrats, Antony, on taking the helm. So maybe to start, just I know you're staying away from creating a definitive timeline for the resub on DEXTENZA, but could you maybe flesh out a little bit what you think needs to be done to actually get the NDA resubmission? I think a number of us are just trying to understand what submitting a number of validation batches means in the context of what was said previously. And then, I guess it seemed like you were maybe implying more needs to be done than just a validation batch on that new part and the machine that was cutting up the insert, so anything there? And maybe I have one more follow-up question. Thank you.

Yes. I mean, the number of validation batches in particular is really a matter of discussion with the FDA, and it's not entirely clear at the moment how many those will be. I guess, the question about what needs to be done in terms of a full timeline in time and events, we're not going to go into with any granularity about what precisely needs to be done. As I mentioned in my comments, we're unhappy about the CRL, but we're at least happy to have some time to be able to optimize the process we have going forward. So I'm sorry if I can't be very specific about what these elements are. I'll turn it over to Dan Bollag after I sort of prevaricate for a little while, but we are trying not to be too granular at this point. That won't be our moniker going forward, but I really want to understand, and as I said in great detail, what it looks like and metabolize it myself before I start committing too many things in the public forum. So Dan?

Thanks, Antony. Yes, this is Dan Bollag. Maybe I'll just add a little bit as well. I understand, of course, the great interest in getting clarity on the details of how it will be moving forward, but I don't think we are in a good position to give those details right now. We're certainly looking into a number of process modifications that will help reduce the level of the particulates and to control those as well. So that's very important ongoing work. Overall, my intention is then to engage with the FDA and gain agreement with them about a resubmission plan, and I think once we have a sense of that, we'll have much better feeling for the timing and we'll be able to inform you. But today, it's just a bit too early to get into much more detail.

Okay. Can I just ask one clarifying question on that? And this is - maybe I asked the first question quarterly [ph]. But I think people are trying to - and of course, you guys are in a tough position versus what was said previously versus what you're saying now. But I think what us on the call are trying to understand is, is the issue with the particulate matter now more global or across a number of different processes versus what was previously communicated as being an issue with one part and one machine? I don't know if that's clear in terms of what I'm trying to ask?

I think the understanding is that it's - the particulate matter came from the cutting process, if that's what you are asking. I think that's still the presumption. So I mentioned in my comments, we're doing a fairly thorough root-cause analysis to sort of see - to confirm the suspicions that it was from the cutter itself. Does that answer the question?

Okay. So it's still - okay, yes, I think we're getting there. So what you're saying is you're still doing the analysis to fully understand whether the particulate matter was coming from the cutter specifically, or there might be other parts of the production process that was adding particulate matter, is that what you're saying?

I think it's a proper way to paraphrase it. But I think the obvious thing is to say it's from the cutter. And rather than just sort of accept the obvious, I think it's very important to deconstruct the entire process and see where a particulate could be getting in at any part of it. I fully expect that we'll reconfirm what the assumptions are, but it's a good opportunity to step back and sort of deconstruct the entire thing.

Okay, understood. Thank you.

And our next question comes from Yi Chen from H.C. Wainwright. Your line is now open.

Hi. Thank you for taking my question. I think - if I recall correctly, I think in your prepared remarks, you mentioned that the OTX-TP first phase pre-trial is not powered to show statistics significance. Is that correct?

No. We said that the Phase II trial was not powered to show statistical significance, just to inform the protocol in the Phase III.

Okay. So what is the power of the Phase III currently ongoing?

It's powered at a 90% confidence to be able to demonstrate a difference versus placebo.

Okay. Got it. And how confident are you currently about this Phase III trial to show statistical significance? And you plan to initiate a second Phase III trial while not having any interim readout from the ongoing first Phase III, is that correct?

Yes. The initiation of the trial for the Phase IIIb will start before the top line readout of the Phase IIIa, which is very normal for Phase III trials, not to wait for the readout of one before you start another.

Got it. And from your perspective or from FDA's perspective, what is considered a meaningful reduction in the intraocular pressure?

I'll let Dan handle that.

Clinically meaningful, well, I think that it's - there have been studies conducted in the past. My understanding is that somewhere in the order of 5 millimetres of IOP reduction is often considered something that would be clinically meaningful. I don't - I'm not aware that we have a specific target that we've agreed to with the agency. And so, I do believe that the trial results will be reviewed at the time based on how the trial was conducted and the relevant comparisons.

Okay. Got it. Thank you.

I'm showing no further questions at this time. I will now turn the call back to CEO, Antony Mattessich, for closing remarks.