Sue Washer - Chief Executive Officer Larry Bullock - Chief Financial Officer

David Nierengarten - Wedbush Securities Mara Goldstein - Cantor Fitzgerald Steve Willey - Stifel

Thank you, Eric. Good afternoon and thank you all for joining us today.

Before we get started, I would like to remind everyone that during this conference call we will make forward-looking statements, including statements about our financial results, our future business strategies and operations, and our product development and regulatory progress. Actual results could differ materially from those discussed in the forward-looking statements due to a number of important factors, including uncertainty inherent in the regulatory process and other risks described in the Risk Factors section of our annual report on Form 10-K for the fiscal year ended June 30, 2015.

I would like to now turn the call over to Sue Washer, our President and Chief Executive Officer.

Thank you, Larry, and thank you everyone for joining us today. I will be providing a company update, including the progress of our current and pending clinical trials.

I will then turn the call over to Larry to discuss our fourth quarter and fiscal year 2015 financial results. Following Larry's comments, we will be happy to take your questions.

These past few months have been really transformative for AGTC and we are encouraged by the progress we have made and the recent milestones we have achieved. We continue to focus on employing a thorough rational approach to the selection of our product candidates and expanding our pipeline.

We also continue to execute on our goal to becoming a leader in ophthalmology gene therapy and developing life changing products for patients with severe eye diseases. Early in July 2015 we announced a key collaboration with Biogen to develop gene therapies in ophthalmology.

This partnership will enable us to expedite development of our lead programs and create additional commercial opportunities through the pursuit of additional therapeutic targets. Under the terms of the collaboration, we received an upfront payment of a 124 million from Biogen in August 2015.

Under the deal, AGTC is eligible to receive total upfront and milestone payments that could exceed $1 billion. We have already achieved the first collaboration milestone, a patient enrollment milestone under the XLRS clinical study which triggers an additional $5 million payment from Biogen.

We are continuing to expand our team and in June 2015 we made two key appointments, Mark Shearman joined our team as Chief Scientific Officer and is responsible for leading the company’s product candidate selection process, pre-clinical and translational research and long-term research and development planning as well as contributing to the overall strategic direction of the company. Rabia Ozden was appointed Vice President of Clinical Research and Development where she is responsible for leading the development pipeline product candidates and overseeing the company’s clinical research operation.

Both Mark and Rabia bring valuable experience to the team and we’re thrilled to have them onboard. To accommodate our ever growing team and to facilitate better collaboration with Biogen we have also announced the opening of a second AGTC office in Cambridge, Massachusetts.

I would now like to provide an update on our ongoing and planned clinical trials. AGTC has a robust product pipeline including five named ophthalmology development programs across four targets; one non-ophthalmology program and proof-of-concept data in multiple additional indications.

In addition to these programs under the Biogen collaboration we are also working on three early stage discovery programs, two ophthalmic and one non-ophthalmic condition for which Biogen has exclusive option rights. In May 2015 we announced new preclinical data further supporting the safety of our AAV vector gene therapies for the treatment of achromatopsia and XLRS as well as new safety data and AGTC’s proprietary manufacturing process.

This data were presented at the 18th Annual Meeting of American Society of Cell & Gene Therapy. We are on track with our Phase I clinical trial for the treatment of XLRS which is one of our partnered programs with Biogen.

We are currently dosing patients and anticipate initial clinical data by the end of 2015. For our second partnering program with Biogen the treatment of XLRP we expect to be starting pre-clinical toxicology and bio-distribution studies in 2016.

We have two achromatopsia programs both of which are being independently developed by AGTC. The first product is intended to address approximately 50% of the achromatopsia patient population and is expected to enter the clinic around year end 2015.

The second program follows closely behind and is expected to address approximately 25% of the patient population. I’ll now turn the call back over to Larry, who will briefly review our fourth quarter and full year financial year-end results.

Thank you, Sue. For the three months ended June 30, 2015 our total revenue increased by $589,000 to $713,000 as compared to the same period in 2014.

The increase was primarily driven by higher grant and sponsored research revenue boosted by the approval of our IND application for the XLRS product that was filled with the FDA in March 2015. Research and development expense for the three months ended June 30, 2015 increased by $1.9 million to $4.6 million as compared to the same period in 2014.

The increase was primarily the result of increased research and development activity relating to the company’s XLRS, achromatopsia, XLRP and other product candidates. In addition, employee-related costs were up year-over-year largely as a result of higher expenses associated with share-based compensation plans and also the hiring of additional employees to support further development of our company’s progress.

Our R&D headcount grew from 10 employees at June 30, 2014 to 25 employees as of June 30, 2015. General and administrative expense for the three months ended June 30, 2015 increased by $2.3 million to $4.2 million as compared to the same period in 2014.

The increase was primarily the result of higher legal and license fees that are associated with our business development activities. During the three months ended June 30, 2015 the company reported a net loss of $8 million, up from a loss of $4.5 million during the same period in 2014.

For the 12 months ended June 30, 2015 total revenue was $2.4 million an increase of $1.2 million compared to the same period in 2014. The increase was primarily driven by higher grant and sponsored research revenue resulting from increased research and development activities on grant funded projects and included revenue that were associated with clearing of our XLRS IND application by the FDA.

Research and development expense for the 12 months ended June 30, 2015 increased by $8 million as compared to $16.5 million compared to the same period in 2014. The increase was primarily the result of increased spending on the XLRS, achromatopsia, XLRP and other product candidates, combined with higher employee-related costs from additional employees hired to support further development of the company’s programs.

General and administrative expense for the 12 months ended June 30, 2015 increased by $5.2 million to $10.4 million as compared to the same period in 2014. This increase was primarily the result of higher employee-related costs, license fees and professional legal fees.

Also contributing to the increase in general and admin expense were higher insurance accounting and other expenses that are largely associated with operating as a publicly-traded company. During the fiscal year ended June 30, 2015, the company reported a net loss of $24.3 million, up from a loss of $15.9 million for the same period of 2014.

As of June 30, 2015, the Company's cash, cash equivalents and investments amounted to $85.3 million. This balance excludes the gross amount of $124 million that we received in August from the closing of the Biogen collaboration as Sue had described earlier.

I will now turn the call back to over Sue for closing remarks and questions.

Thank you, Larry. In summary, we have had an exciting and remarkable year.

The collaboration with Biogen, our new facilities in Cambridge, and our recent staff appointments are all strong indications of our plans to continue expanding our corporate footprint and becoming a leader in ophthalmology gene therapy. We look forward to achieving many more milestones towards the end of 2015 and into 2016.

Operator, you may now open the line for questions.

I had a question, obviously there has been a lot of discussion around the regulatory pathways for another company pursuing gene therapy for rare eye disease and I just would like to know if you've had any additional or incremental discussions with the FDA regarding your any of your programs? And then as a second part, just if you could remind us, is Biogen in-charge of the regulatory discussions for your Phase I or Phase II and beyond for the partnered programs?

Thanks.

So to address your first question, the most recent communications we've had with the FDA have been around the IND for the XLRS program, and so there has been no new developments there. And as we've stated publically we feel the approvable endpoints that we're measuring for XLRS are visual acuity and visual field with supportive endpoints in OCT and ERG, but obviously we're in Phase I/II trials and we're looking at a wide variety of endpoints in that Phase I/II study that will help us determine the endpoints that we'll use in our pivotal study.

And as far as the, who is in-charge of the development of the program and the regulatory interaction, AGTC is responsible for the full developments of XLRS products all the way through BLA approval in the United States. And for XLRP we're in charge with development of the product through the end of the Phase I/II human clinical trial.

Got you, and when you -- just maybe one quick follow-up, when you think about additional or incremental endpoints that you could have imagined including in the future, I mean, are we thinking about the structure of the retina, the retinoschisis in the XLRS patients, Photophobia and achromatopsia, is that something to also consider besides visual acuity and OCT?

So yes, so for XLRS specifically as I stated, we're looking at visual acuity, visual fields and then also OCT and ERG, but we're also measuring a wide variety of other endpoints during that Phase I/II trial. And as you rightly said for achromatopsia, we're looking at visual acuity, photophobia, and again we're looking at ERG, but a wide range of other endpoints that might be useful in the future.

I wanted to just ask if you wouldn't mind, as it relates to the Biogen collaboration and I am understanding that you have specific responsibilities and they do, but just how we should think about the work building throughout the next fiscal year for you and I am hoping maybe we can get a little color on that.

So as far as work building, right, if I understand your question correctly, we have always anticipated doing the work that’s described in the collaboration for XLRS and XLRP, so that has always been within our plan, as is the work on achromatopsia and wet AMD. So the build out as a Biogen collaboration is really the formalization of working on the three-additional discovery programs are in the collaboration.

So that's early research and development work.

Okay, all right, and so that's not really something that we're going see particularly visible through the next year I would imagine, would that be correct?

That would be correct.

Just I was just wondering I guess as we get maybe closer to year end in an interim XLRS update if there has been any, I guess further clarification with respect to maybe the number of patients that we might be expecting data from and I guess to which of some of these surrogate endpoints you may be able to provide some kind of read on.

So we haven’t changed our guidance on the number of patients, it will be between seven and nine patients worth of data that we will have by the end of the year. And as we've also previously guided, we will gather all of the data that we have on those seven to nine patients, on each of the endpoints that were discussed and provide top line results on those end points.

Okay. And is it safe to assume that maybe an AAO presentation.

We haven’t determined exactly when that would be.

Okay. And I know that there is also the natural history study that's enrolling in achromatopsia and I guess I 'm just wondering if we should maybe think about some initial data coming out of that either this year or next?

Yes. We are currently evaluating all the data from both natural history studies with an outside [indiscernible] and we do plan to release that data at an appropriate time.

Okay. And then maybe just a housekeeping question for Larry regarding, I guess the handling of the upfront payment from an accounting perspective and should we presume that -- I guess there is some fraction of that, that gets recognized in 1Q or next quarter and some fraction of that, that will sit on the balance sheet as deferred revenue or has that not been worked out yet?

That's a reasonable expectation, but we have not worked it out yet obviously and that's one of the things that we’ll be doing as part of our first quarter here. So, unfortunately I can't give you real definitive answer on that one David.

Okay. Thank you for the color.