Good day and welcome to the Viking Therapeutics 2017 Fourth Quarter and Year-End Financial Results Conference Call. At this time, all participants are in listen-only mode. Following management's prepared remarks, we will hold a Q&A session. [Operator Instructions] As a reminder, this conference call is being recorded today, on March 7, 2018. I would now like to turn the conference over to Viking's Manager of Investor Relations, Stephanie Diaz. Please go ahead, Stephanie.

Hello and thank you all for participating in today's call. Joining me today is Brian Lian, Viking's President and CEO, and Michael Morneau, our Chief Financial Officer. Before we begin, I'd like to caution that comments made during this conference call, today, March 7, 2018, will contain forward-looking statements within the meaning of the Securities Act of 1933 concerning the current beliefs of the Company, which involve a number of assumptions, risks, and uncertainties. Actual results could differ from these statements and the Company undertakes no obligation to revise or update any statement made today. I encourage you to review all of the Company's filings with the Securities and Exchange Commission concerning these and other matters. I'll now turn the call over to Brian Lian for his initial comments. Brian?

Thanks, Stephanie, and thanks to everyone participating on the call and on the Webcast. Today I'll be providing an update on recent progress and developments related to our pipeline programs and operations. 2017 was a pivotal year for Viking. During the year, we announced positive clinical data for our lead program, VK5211 for hip fracture, advanced our Phase 2 clinical trial evaluating VK2809 for liver disease, and achieved several important milestones with our earlier-stage programs targeting glycogen storage disease and X-linked adrenoleukodystrophy. I'd like to begin today's call with a review of our fourth quarter and year-end financial results, after which I'll provide an update on our most recent corporate developments. I'll now turn the call over to Mike Morneau, Viking's Chief Financial Officer, to discuss our financial results. Mike?

Thanks Brian. In conjunction with my comments, I'd like to recommend that participants refer to Viking's 10-K filing with the Securities and Exchange Commission, which we expect to file later today, for additional details. I'll now go over our financial results for the fourth quarter of 2017. Our research and development expenses for the three months ended December 31, 2017 were $3 million, compared to $2.6 million for the same period in 2016. The increase was primarily due to increased activities related to our VK2809 clinical program. Our fourth quarter general and administrative expenses were $1.4 million, compared to $1.1 million for the same period in 2016. The increase was primarily due to increases in salaries and benefits-related expense. For the three months ended December 31, 2017, Viking reported a net loss of $4.1 million, or $0.14 per share, compared to a net loss of $3.6 million, or $0.18 per share, in the corresponding period in 2016. The increase in net loss for the fourth quarter of 2017 was primarily due to an increase in research and development expenses and general and administrative expenses noted previously. That concludes the fourth quarter financial review and I'll now go over the financial results for the year ended December 31, 2017. Our research and development expenses for the twelve months ended December 31, 2017 were $13.7 million, compared to $9 million for the same period in 2016. The increase in research and development expenses was primarily related to increases in expenses related to clinical trial activities for our VK5211 and VK2809 programs, our preclinical efforts for our VK0214 program, third party manufacturing of our clinical-stage drug candidates, as well as regulatory and other services provided by certain third-party consultants. Our general and administrative expenses for the twelve months ended December 31, 2017 were $5.3 million, compared to $4.8 million for the same period in 2016. This increase was primarily due to increases in salaries and benefits-related expense, offset by a decrease in non-cash stock compensation expense. For the twelve months ended December 31, 2017, Viking reported a net loss of $20.6 million, or $0.79 per share, compared to a net loss of $14.7 million, or $0.90 per share, in the comparable period in 2016. The increase in net loss for the full year 2017 was primarily due to the increase in research and development expenses and general and administrative expenses noted previously as well as a decrease in change in fair value of debt conversation feature liability. Our balance sheet at December 31, 2017 showed cash, cash equivalents and short-term investments totaling $20.6 million. In February 2018, Viking sold an aggregate of 12,650,000 shares of its common stock, resulting in gross proceeds of $63.3 million before deducting underwriting discounts and commissions and other offering expenses. As of February 28, 2018, Viking had 50,898,802 shares of common stock outstanding. This concludes my financial review. I'll now turn the call back over to Brian.

Thanks Mike. Since the Company's inception, we have worked diligently to advance our two lead programs, VK5211 and VK2809. During 2017 we completed and announced the results from a successful Phase 2 trial of VK5211 in patients recovering from hip fracture. We also made progress with our Phase 2 trial of VK2809 for non-alcoholic fatty liver disease and hypercholesterolemia. In addition to these two Phase 2 programs, in 2017 we generated positive data supporting the continued development of our earlier-stage orphan disease programs addressing glycogen storage disease and X-linked adrenoleukodystrophy. I'll now provide more detail for each program. VK5211 is Viking's lead program for muscle and bone disorders. It is an orally available non-steroidal selective androgen receptor modulator, or SARM, designed to selectively stimulate muscle and bone formation with reduced activity in peripheral tissues such as skin and prostate. Following hip fracture, many patients experience a loss of bone and muscle at accelerated rates, placing them at increased risk of further morbidity, re-fracture and prolonged disability. During the fourth quarter, we announced positive results from a 12-week Phase 2 clinical trial of VK5211 in patients who had recently suffered a hip fracture. Top line data showed that the trial achieved its primary endpoint, demonstrating statistically significant dose-dependent increases in lean body mass, less head, following treatment with VK5211 compared with placebo. The study also achieved important secondary endpoints, demonstrating statistically significant increases in appendicular lean body mass, which is muscle in the limbs, and total lean body mass for all doses of VK5211, compared to placebo. Importantly, VK5211 also demonstrated encouraging safety and tolerability in this study, with no drug-related serious adverse events reported. I'd like to take a minute to quickly review the key results from this study. The Phase 2 clinical trial was a randomized, double-blind, placebo-controlled, parallel…

[Operator Instructions] The first question comes from Jason McCarthy with Maxim Group. Please go ahead.

Brian, sounds like everything is going very well over there. Just a couple of questions, first for VK5211, you mentioned that the time to meet with the FDA will be in the second half of this year, can you just give us a sense of how long after that you might expect to potentially initiate a Phase 3 program, and maybe what you might think the size of that program would be? And for VK2809, can you give us a sense, and I'm not sure if you mentioned it earlier, where the enrollment is today? And if you could just review with us what the endpoint to that trial is in cholesterol and reducing liver fat, because we have seen some interesting data lately within this class of molecules showing significant reductions in liver fat?

So with the VK5211 program, we currently expect to request a meeting with the FDA that we would expect to occur likely later in the summer. And following that meeting, it's our intention to really seek a partner for further development of VK5211. At this point, we probably would not proceed further into a Phase 3 program. It's probably best handled by someone with a bone franchise or a musculoskeletal franchise who is a little bit larger than us, and so the timing of that is a little bit unknown, pending a licensing agreement. With VK2809, we are I think reasonably close to having that trial enrolled, but when we look at the calendar, it seems like it would be difficult to have the data available by the end of June. So, we decided to push it into the second half, and so I don't think I would interpret that as December but that's probably all the guidance that we're going to give on that now.

Okay, great. Thank you for taking the question.

The next question comes from Scott Henry with ROTH Capital. Please go ahead.

Just two, couple of pipeline questions, did you disclose what the current size of the enrollment is currently for VK2809?

So the trial is enrolling up to 60 patients with elevated LDL and non-alcoholic fatty liver disease.

Okay. It has taken a little longer than originally anticipated now, granted you have more resources as well. Can you just talk about why it took a little bit longer and how it's kind of evolved over that time?

Yes, we've discussed this previously. So, several factors sort of combined here. One of them is that we are requiring patients to have sort of a constellation of lipid abnormalities. They've got to have elevated LDL, they've got to have elevated triglycerides, they've got to have a minimum fat content in their liver. So, it's a little different than simply looking at one of those metrics. Secondly, we are enrolling people who have a minimal cardiovascular disease risk, and so we are excluding Type 2 diabetics, and that's a pretty significant portion of the NASH population. We don't expect that to be required in further studies, but this is required in this study. And then thirdly, and probably less importantly, there are a lot of other NASH trials ongoing, but that's probably not a major contributor to the challenges with enrollment. That said, it is enrolling and we are I think moving along with getting trial wrapped up.

Perfect. Thank you for that color. And then on GSD Ia with the Phase 1 trial starting in 2018, would you expect that data by year-end?

So it's a good question. I think we will have some initial data by the end of the year, and that would be a look at plasma triglycerides after 28 days. And so, we would expect that we should have some top line data on that metric at four weeks, yes.

Okay, great. And then just a couple of modeling questions, when we think about R&D for 2018, if we think about $14 million in 2017, I would expect a bump-up in 2018, any color on how we should think about R&D for the full year in 2018?

Yes, it is going to increase as the GSD study gets underway here and as the GLP talks work. It's underway for VK0214. So, I think when you look at total burn, we were typically below $1.5 million a month in 2017 and we'll probably be closer to $1.5 million to $2 million in burn per month in 2018, and that will be a combination of R&D and SG&A.

Okay, great. Thank you for taking the questions.

The next question comes from David Bautz with Zacks Investment Research. Please go ahead.

Thanks for the update and for taking the questions. In regards to partnering 5211, I'm wondering if you're seeing or if you anticipate seeing any interest in other indications besides hip fracture, and if so, if you could talk about what those indications might be?

It's a great question. And so, we did the study in hip fracture and showed this tremendous effect on muscle. I think maybe others have viewed those data as potentially interesting in a number of different indications. So, fracture definitely, and then replacement market, hip replacements and knee replacement. But the larger markets that seem to have come up, and some of the discussions include cachexia and sarcopenia, and I think they are all really interesting areas, they all face I think similar challenges with what the regulatory path might look like, but I think people see the data as important for a much broader array of indications than simply hip fracture.

Okay. And sorry if I missed this earlier, but did you mention what conference you are targeting for presentation of the 5211 data, and then is there going to be any additional follow-up data released from that study before that conference?

So we are planning to submit an abstract to ASBMR Conference. That's at the end of September. And we do not yet have the 24-week data. So, this trial, as you'll remember, had a 12-week treatment period and then a 12-week follow-up period. We're expecting to receive the 12-week follow-up data later this month. And so, we haven't yet received that, and we haven't decided whether or not we'll make the announcement there or include it in the abstract submission for the ASBMR Conference.

Okay. Thanks for taking the questions.

This concludes our question-and-answer session. I would like to turn the conference back over to Stephanie Diaz for any closing remarks.

Great, thank you, and thanks everyone for your participation and continued support of Viking Therapeutics. We look forward to updating you again in the coming months. Thank you.

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.