Good afternoon, and welcome to the Voyager Therapeutics' Fourth Quarter and Year-End 2018 Financial Results and Corporate Highlights Conference Call. At this time, all participants are in a listen-only mode. Following the formal remarks, we will open up the call for your questions. Please be advised that this call is being recorded at the Company's request. At this time, I'd like to turn the call over to Matt Osborne, Voyager's Vice President of Corporate Affairs, Communications and Investor Relations. Please proceed.

Thank you. Good afternoon, and welcome to the conference call. This afternoon, we issued a press release, which outlines the results and corporate highlights for the fourth quarter and year end of 2018 and provides our corporate goals and financial guidance for 2019. The release is available at voyagertherapeutics.com. Before we begin, just a reminder that the forward-looking statements included in this call represent the Company's view as of today, February 26th, 2019, Voyager disclaims any obligation to update these statements to reflect future events or circumstances, except as required by law. Please refer to today's press release as well as Voyager's filings with the SEC for information concerning risk factors that could cause actual results to differ materially from those expressed or implied by such statements. With that, I'll pass the call over to Andre.

Thank you, Matt, and good afternoon everyone. Welcome to our year-end call and review of corporate highlights. I'll start by summarizing for you our key developments since the start of 2018. Next, I'll discuss the two strategic collaborations we've entered into since the start of this year and how these deals support our strategic vision of becoming a leading fully integrated biopharmaceutical Company. I will then present our 2019 goals, before turning it over to Allison, who will outline our financial results and guidance. Voyager has had a tremendous 2018 and start of 2019. We took important steps in advancing our lead and pipeline programs. We've continued to invest in our product, discovery engine, vectorized antibody platform and novel capsids. We've expanded our manufacturing capabilities. We've significantly strengthened our management team, we've also entered into major new collaborations. I'll give you more detail on each of these developments and how they position us for success in 2019 and beyond. So first, for VY-AADC for Parkinson's disease, we initiated the randomized placebo-controlled Phase II RESTORE-1 trial. In December, we held a productive Type-B meeting with the FDA gaining clarity on their earlier feedback. We incorporate their guidance to conduct two adequate and well-controlled trials into the design of the RESTORE-1 trial and the planned RESTORE-2 trial. We started enrolling RESTORE-1 and we've recently held two well-attended investigator meetings. During 2018, we announced positive long-term results from the Phase 1b open-label dose escalating trial VY-AADC. In November, we shared data from all three cohorts with follow-up data from patients to three years post-treatment in Cohort 1, two years in Cohort 2, and 18 months in Cohort 3. We're encouraged with the long-term follow-up data as we believe it continues to demonstrate that VY-AADC can restore the brain's ability to make dopamine and…

Thanks. Andre. I'll spend the next few minutes reviewing the financials and guidance before we move to Q&A. Voyager reported a GAAP net loss of $22.5 million or $0.70 per share for the fourth quarter ended December 31, 2018 compared to a GAAP net loss of $11.8 million or $0.40 per share for the fourth quarter of 2017. GAAP net loss was $88.3 million or $2.75 per share for the full year ended December 31, 2018 compared to a GAAP net loss of $70.7 million or $2.64 per share for the same period in 2017. Collaboration revenues of $2.0 million for the fourth quarter of 2018 compared to collaboration revenues of $6.3 million for the fourth quarter of 2017. Collaboration revenues of $7.6 million for the full year ended 2018 compared to collaboration revenues of $10.1 million for the same period in 2017. Collaboration revenues reflect the recognition of payments for research and development services that we provided for various programs under the Sanofi Genzyme and AbbVie collaboration agreements, and can vary based on quarterly assessments of our efforts under the collaborations. The decrease in collaboration revenues for the fourth quarter and full year 2018 compared to the same periods in 2017 reflect the one-time recognition of amounts allocated to Sanofi Genzyme's rights in the Parkinson's program in the fourth quarter of 2017 and the January 1, 2018 adoption of the new revenue accounting standards which modified our recognition methodology. These decreases were partially offset by revenue from the collaboration agreement with AbbVie entered into in February 2018. R&D expenses of $16.9 million for the fourth quarter ended December 31, 2018 compared to $13.3 million for the fourth quarter of 2017. R&D expenses of $64.9 million for the year ended December 31, 2018 compared to $62.3 million for the same…

[Operator Instructions] Our first question comes from Dane Leone with Raymond James.

Hi. Thank you guys for taking the questions here, and congrats on the strong start to the year. A couple from me. Maybe on the AbbVie deal, I just want to ask the expansion of the strategic relationship was great, I'm just curious, can you give us a little bit of color of what you've actually kind of delivered in that relationship to date that kind of helped catalyze the expansion of the partnership?

Yes, thanks for the question, Dane. So we're almost exactly a year into the relationship with AbbVie on tau and it's been a very close working relationship. So it's both parties are contributing and at a high level, what we've done so far has been to select, clone, vectorize a number of different research test antibodies targeting tau. We've been evaluating this in various models looking at the distribution in pharmacology and starting to work in animal models using novel AAV capsids to be able to evaluate these. So, quite a bit of work done in a short amount of time working hand-in-hand with them and it was interesting for us to be able to leverage all of that to be able to work with AbbVie to be able to add a target that we think is very compelling. So I think from both perspective, short amount of time under the belt, but quite a bit of positive momentum and a lot of interest in applying it to another target.

Great. And if I could just follow up with 1/2 on the investigator meeting that you recently held. Few points of interest there from your commentary. One, just in terms of the feedback from your investigators that are now in the RESTORE program, you have -- there is a number of endpoints that thankfully have all seem correlated with the administration of VY-AADC, but the feedback from these investigators and clinical community that they've been expressing as you move toward the pivotal studies, what's your feeling of where they're really focused on out the real critical endpoints that they think are going to be more clinically impactful, whether it's the UPDRS or the reductions in levodopa load on a daily basis? I'm just kind of curious to hear the updated thoughts there, and then the second kind of part of that is where you're at with integrating some of the MRI guided technology and now approved V-TAG technology with investigators and what's been the reception? Thank you.

Yes, thanks for these questions, I'll ask Matt to start with addressing these.

Sure. Hi, Dane. Matt Osborne [Ph]. So a couple of different questions in there. So for the investigators, I'd break it down into with the RESTORE-1 trial, we are expanding to new clinical sites beyond the core group that have been involved with the program for a number of years. And so as we had initial discussions, I'd say what is most compelling to them and then when they see the totality of the data is it's very remarkable how strong the alignment is across all of the measures recalling that for this program one of the things that really stands out is that -- it's very elegant in terms of replacing the enzyme being able to see that you're actually getting enzyme activity in the part of the brain where it was not previously evident as a result of the Parkinson's, than over time seeing the reduction in the oral medication across levodopa, and then seeing that translate into both improvement around diary as well as patient and physician measures of quality of life. So seeing that, all heading into consistent direction and between the early cohorts at a lower dose and then increasing the dose and improving the delivery, seeing a dose-dependent response. That's what really gets them excited about the potential of the program. Then, when you shift into this being a potentially pivotal study and then really focusing on the regulatory aspect and the placebo-controlled plant [Ph], these conversations are very much around the ability to impact the primary endpoint which is the diary reported improvement in good on time at 12 months. That's the one that we've really focused on and in looking at optimizing the way we run the study and we guide the titration of the oral medications, that kind of land them…

Excellent. Thank you very much.

Our next question comes from Christopher Marai with Nomura.

Hello, this is Jackson Harvey on for Christopher Marai. I was just curious on the AbbVie collaboration with the vectorized antibodies, if you could just speak a little bit to how you see this fitting into the competitive landscape as more technologies for crossing the blood-brain barrier emerge. In particular, I'm thinking of the Denali's transferrin receptor program and even AbbVie's own dual targeted antibodies. Thank you.

Yes. Thanks for your question, Jackson. So it is something that's been a challenge for the sales [Ph] for many, many years. So it's a natural thing and a good thing that there is a number of approaches being attempted to get better penetrance of the -- through the blood-brain barrier. What we leverage here is our delivery capability with our novel capsids to be able to encode for an antibody or an antibody fragment sequence to be able to get the payload broadly distributed to the right, the sales across the CNS. So we will tell as we get to advance our efforts into animal models and eventually, we opened non-human primates, and eventually into the clinic to see how we fare, but the stability to get a significantly enhanced ability to get across to get delivery of a therapeutic payload across the CNS is something that we are seeing early in our efforts and is the basis for Fortis [Ph]. Now, the -- one of the advantages with the vectorizing in an antibody is that you can -- that's one of the payloads that you can incorporate, if we have success with our novel capsids and being able to achieve this, you can then have the number of permutations for other therapeutic payloads that you can deliver with that same vehicle. So these are things that we're going to look to instep, explore as well, but to start with the expert in antibody development in AbbVie and to work on two compelling targets we thought was -- just the right place to start.

Great, thank you and congratulations on your recent progress.

Thank you.

Our next question comes from Jim Birchenough with Wells Fargo Securities. Q – Unidentified Analyst: Hi, thanks for taking the questions. This is Yanan on for Jim. So I wanted to just start with a few questions on the Parkinson's disease program and then I have a follow-up on the Huntington's disease program. So for the Parkinson's disease program, would you be able to provide any incremental update on enrollment in RESTORE-1? And also would you report putamen coverage and AADC enzyme activity data, the biomarker data before -- at sometime before the clinical data readout? And also is there any possibility for some sort of an interim analysis for RESTORE-1 and/or RESTORE-2. Thank you.

Yes, thanks for your questions, Yanan, on the PD program. So we are yet to formally start the active celebration with our partner, Neurocrine on this, waiting for HSR clearance. So we will work closely with our new partner to share further updates about the enrollment status with the study, but as we were mentioning and commenting on earlier, we just held at the start of this year a pair of investigator meeting where we got the whole community of investigators to get reenergized about where we stand with the program and coordinate it among themselves between the referring site and surgical site. So there's a lot of momentum that's very fresh with this and with now with the resources of our partner we expect we'll be able to really do great progress with the continued enrollment of the program. So, we will provide updates as appropriate once we have that alignment with Neurocrine. As to the interim analysis, we considered this in the development of the optimal studies here, but as this will serve as one of two pivotal trials, we determine that there is too much of a statistical hit to take an interim look. So we will look to have a readout to that 12 month the primary endpoint. But again, we will work with Neurocrine to be able to provide periodic updates on the progress on all fronts on our lead program. Q – Unidentified Analyst: Great, and that's very helpful. And on the Huntington's disease program, just wondering, would you be able to compare your candidate with competitors AAV, miRNA candidate for example in terms of the miRNA scaffold differences as well as whether the ability to silence inside the nucleus might be important. Thank you.

Yes, thanks, Yanan. I'll start here, and Dinah could not participate, she's presenting actually at the -- an HD conference as we speak, I'll ask Matt to also chime in here. So, Matt why don't you start and I will complete the response.

Yes, I think as you are aware, it's difficult to compare data across different constructs, different trials, particularly in Huntington's where there isn't a gold standard animal model in large mammals, the different companies, different products are being tested in different models, different species, different time points, different methods. With that being said, we're very excited about the data that we shared at ESGCT this past fall, where we saw -- as a result of our further optimization on the dosing and the delivery, a very strong knock down across the three different places that we measured. If we saw on average 68% in the caudate, 67% of the putamen, and then 32% in cortical neurons, that data, we think is a very strong profile and excited to move that forward on track for later -- filing an IND held later this year. In terms of the second part of your question, in terms of differentiation within the cellularity [Ph], I think again we wouldn't want to comment on our competitors' constructs but we're highly confident that we've got a strong profile with what we've seen with very robust preclinical modeling up to this point. Q – Unidentified Analyst: Got it. Thank you Andre for the helpful answers.

Thanks Yanan.

Our next question comes from Laura Christianson with Cowen.

Hi, thanks for taking my question. I'm just curious about how the activation of sites is going for RESTORE-1. I know you're targeting 24, but how many have been activated thus far? And do the centers that have not yet been activated have eligible patients in queue waiting to enroll? And if you have any guidance for how long you think enrollment will take, that would be helpful.

Yes, thanks, Laura for the question, I'll ask Matt Osborne to --

Sure. Hi, Laura. So we're not going to give specific numbers on activation I think, as you're aware, clinicaltrials.gov is a bit of a lagging indicator in terms of activation, but we've made very strong progress this year and the number of 24 again it depends on how you count in terms of the number of neurology site and surgical sites. So we have targeted nine surgery sites and a total of 19 treating neurology sites. Some of those are the same and in some cases, the treating neurology sites are separate. We're also -- as a result of our FDA discussions at the end of last year as we look at refining this and now working with our Neurocrine, exploring whether or not to add additional sites for a larger sized study, that would also support a second pivotal study and also thinking toward the future of having a strong delivery base to support commercialization. So we expect to be activating sites really for the next couple of years across this program to make sure that we can drive the strong enrollment of the correct number of -- type of patients. The second part of your question around even for those sites that are not yet activated, they certainly have to comply with IRB standards that they cannot be consenting or having super detailed discussions with patients ahead of IRB approval, but they know these patients quite well and they have ideas in mind, even coming into the investigator workshops kind of refining among their different potential patients who would be ideal for this study. So that translates into strong momentum as sites activate, and one of the things that we're working with the sites on and we look forward to welcoming Neurocrine into the collaboration is how to even more broadly increase that awareness, so that adding onto our Michael J. Fox Foundation partnership increasing awareness of this trial, we feel will really raise the ability to bring in the right patients into the study. As we've described in the past of course, we want to go fast, but not at the expense of losing the signal that will result from having the right patients measured appropriately. And so we're very comfortable with the progress we're making there.

I'll just add. In terms of the guidance, we've just last month in January provided a guidance that we expect RESTORE-1 should take us 15 months to 21 months to fully enroll, so that with the progress we've made in the weeks [Ph] since we've made that guidance we feel very good about the progress and being on track to be able to achieve that.

Perfect, that's great. And then just one more, I'm curious what would make you decide to hold on Q1 asset rather than partner, you had mentioned wanting to add more programs beyond just the SOD1 that you would advance independently. How do you think about how to separate programs into one of those kind of three pathways that you outlined earlier.

Yes. So at the moment, as we have done the revamping of the portfolio and added a lot of financial resources, capable partners, as I noted the focus will be on adding additional wholly owned assets to the portfolio. So we have our discovery engine, we have ALS, SOD1 and we have additional programs coming out of there, potentially from the outside that will look to be able -- with our added resources now to be able to advance forward. So, but as we move forward, we'll continue to have that big picture that we have this ability to bring capable partners to the table and the mix again gives us the stability to both finance the effort, keep important stake in big important indications and then have our own wholly owned assets. So they'll continue to be an assessment given our circumstances, but for the near-term, we will look to add potentially in asset to the wholly retained part of the strategy.

Great. Thanks for taking my questions.

Thank you.

Our last question comes from Jeff Hung, Morgan Stanley.

Thanks for taking the questions. For the SOD1 program, can you remind us what magnitude of knock down, you think you need to see in humans for a clinically meaningful slowing of disease?

Hi, Jeff, it's Matt Osborne. I think it's a difficult one to answer given that there hasn't been strong efficacy seen in humans yet, if we extrapolate from the animal models, we're certainly very comfortable that when you get above 50%, it translates well into rescue, I would remind you again we released some data in ESGCT this past fall that with our delivery directly into the spinal cord, we're seeing an average of 70% in the cervical region, 50% in the thoracic region, both of which are critical to retaining respiratory function. And so again, until it's actually demonstrated in humans, no one can know for sure, but we're feeling very strong about that data going into the clinic.

Okay. Thanks and then I guess for ADC, given the co-promote option in the US, how are you thinking about the potential size of sales force you would need in that scenario versus previously?

I think it's very early in terms that we need to sit down with Neurocrine and kind of discuss where both companies are going to be at that point. One of the major advantages to Voyager from this collaboration is that we would have had to invest in building out that infrastructure, well ahead of time in doing this on our own probably even before we had all of the data available, so that we could be fully prepared to have a strong launch with Neurocrine's strong infrastructure that they already have in a highly successful launch of INGREZZA, we fully expect to kind of build on that and optimize it for Parkinson's, but again they have other products that are going to be in the Parkinson's ahead of VY-AADC what that then looks like for Voyager. It's a couple of years away, but would not expect it to be a large sales force, just because it's a pretty targeted call on the movement disorder centers but perhaps a secondary in the community neurology. But most of that -- most of these most advanced patients end up in the movement disorder centers which are larger academic areas.

Okay, thank you.

Ladies and gentlemen, this does conclude the Q&A portion of today's conference. I'd like to turn the call back to Andre for closing remarks.

Thank you, operator. And that does conclude our call. So thank you everyone for attending, for your questions, look forward to updating everyone on our progress throughout the year.

Ladies and gentlemen, this does conclude today's presentation. You may now disconnect and have a wonderful day.+