Earnings Labs

Viking Therapeutics, Inc. (VKTX)

Q3 2017 Earnings Call· Wed, Nov 8, 2017

$32.79

-0.61%

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Transcript

Operator

Operator

Good afternoon and welcome to the Viking Therapeutics' 2017 Third Quarter Financial Results Conference Call. At this time, all participants are in a listen-only mode. Following management's prepared remarks, we will hold a Q&A session. [Operator Instructions] As a reminder, today's conference call is being recorded, today, November 8, 2017. I would now like to turn the conference over to Viking's Manager of Investor Relations, Stephanie Diaz. Please go ahead, Stephanie.

Stephanie Diaz

Analyst

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, November 8, 2017, 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 statements made today. I encourage you to review all 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?

Brian Lian

Analyst

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. During the third quarter Viking achieved a number of important milestones with our clinical programs VK5211 for hip fracture and VK2809 for liver disease, as well as our earlier stage programs targeting glycogen stores disease and X-linked adrenoleukodystrophy. I'd like to begin today's call with a review of our third quarter 2017 financial results after which I will 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?

Michael Morneau

Analyst

Thanks Brian. In conjunction with my comments, I'd like to recommend participants refer to Viking's 10-Q 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 third quarter of 2017. Our research and development expenses for the three months ended September 30, 2017, were $3.5 million compared to $2.1 million for the same period in 2016. This increase was primarily due to increased activities related to our clinical trials for our VK5211 and VK2809 programs, pre-clinical efforts for our VK0214 program as well as services provider by certain third-party consultants. Our third quarter general and administrative expenses were $1.2 million which was consistent with $1.2 million for the same period in 2016. For the three months ended September 30, 2017, Viking reported a net loss of $6.1 million or $0.22 per share compared to a net loss of $3.8 million or $0.20 per share in the corresponding period in 2016. The increase in net loss for the three months was primarily due to the increase in research and development expenses noted previously as well as an increase in expense related to the change in fair value of our debt conversion feature liability. That concludes the third quarter financial review. I'll now go over the financial results for the nine months ended September 30, 2017. Our research and development expenses for the nine months ended September 30, 2017, were $10.7 million compared to $6.4 million for the same period in 2016. The increase in research and development expenses was primarily related to increase in expenses related to our clinical trial activity for our VK5211 and VK2809 programs and pre-clinical efforts of our VK0214 program, third-party manufacturing of our clinical stage drug candidates as well as regulatory and other consulting services provided by certain third-party consultants. Our general and administrative expenses for the nine months ended September 30, 2017, were $3.9 million compared to $3.8 million for the same period in 2016. The slight increase was primarily due to increases in salaries and benefits offset by a decrease in non-cash stock-based compensation expense. For the nine months ended September 30, 2017, Viking reported a net loss of $16.5 million or $0.67 per share compared to a net loss of $11.1 million or $0.74 per share in the comparable period in 2016. The increase in net loss for the nine months ended September 30, 2017, was primarily due to the increase in research and development expenses noted previously. Our balance sheet at September 30, 2017, shows cash, cash equivalents, and investments totaling $9.8 million as compared to $13.2 million at December 31, 2016. As of October 31, 2017, Viking had 28,498,847 shares of common stock outstanding. This concludes my financial review. And I'll now turn the call back over for Brian.

Brian Lian

Analyst

Thanks Mike. This is a pivotal time for Viking. We are approaching the anticipated read out of Phase II data from our VK5211 program and patients recovering from hip fracture. We expect to report the results from this study before the end of the year. We are also continuing to enroll patients in our ongoing Phase II trial of VK2809 and plan to complete that study in the first half of 2018. During the third quarter we made progress not only with these two clinical programs, but also with the earlier stage programs which target two orphan disease indications. We continue to carefully manage our resources and took steps during the quarter to strengthen our balance sheet and provide improved financial flexibility. We also increased the size of our Board of Directors during the third quarter adding an important director whom we believe will provide valuable insight and guidance as we continue to grow and execute our strategic plan. I'll start with an update on our VK5211 program for patients recovering from hip fracture surgery. VK5211 is a potentially best-in-class orally available non-steroidal small molecule selective androgen receptive modulator or SARM. In prior studies administration of VK5211 has led to improvements in lean body mass or muscle and bone mineral density. 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. We believe VK5211's preliminary profile suggests it could benefit these patients by potentially stimulating the formation of new muscle and bone. And we are not alone in this assessment. During the third quarter, we hosted a Key Opinion Leader Event in New York, which highlighted current treatment options and the importance of preserving musculoskeletal health in elderly patients following hip fracture as…

Operator

Operator

Ladies and gentlemen, at this time we will begin the question-and-answer session. [Operator Instructions] Our first question today comes from Jason McCarthy from Maxim Group. Please go ahead with your question.

Jason McCarthy

Analyst

Hi, Brian. Thanks for taking the questions. There are couple questions just with the head fracture study, can you remind us what the expectation is around the increase in lean body mass and how the secondary endpoints, even though they're not powered just based on numbers of patients. What those endpoints, whether it's [indiscernible] bone mineral density could it mean if they trend positively for the outlook for VK5211? What are regulators looking for?

Brian Lian

Analyst

Thanks Jason for the questions. So, on the primary endpoint; we think if we can show a 2% to 3% difference from the control arm, the placebo arm according to all of our KOLs that would be a very meaningful improvement in lean body mass for these people. As far as the secondary endpoint and the exploratory endpoints, so we have a variety of endpoints in there that we know FDA is interested in. For example, six-minute walk test, we know drugs have been approved using that test. The short physical performance battery, we know that that is being used in Sarcopenia studies. So, we know the update is similar with those and we also have best of 36 for quality-of-life. And so, you're right to say that we are not powered on any of those, but I think if we were to show a numerical trend in support of the treatment arms for any of those endpoints, it would be very meaningful. And we don't necessarily think we have to hit all of them, but if you can see some trend I think that would be a very positive sign. And I'll add at the KOL event just last month, one of the speakers indicated that he didn't care what the secondary endpoints looked like if we showed an improvement in lean body mass he thought it would be a good idea to just proceed aggressively because he felt that the functional and quality of life metrics would follow if you can improve lean body mass. So, we're hopeful that we can hit them although.

Jason McCarthy

Analyst

Right. And I remember at the KOL event, which is a great event. Some of the doctors there were talking about using VK5211 not just for hip fracture, but for knee replacement and hip replacements. Can you just talk a little bit about the potential of using a [indiscernible] like this across multiple indication?

Brian Lian

Analyst

Yes. So one thing that was really interesting during one of the presentations was the comments that when you get older in life, your deterioration in health and physical status is not necessarily tied directly to age, but it's tied to major events, major illnesses if you get an infection, if you get pneumonia, if you're hospitalized for something you never quite come back to your pre-functional or you're pre-illness or pre-injury status regardless of what that is once you get older. And so, his comment was that if you can take something that would help you following one of these major traumatic events later in life. That might preserve function and just preserve your overall health much better than if you were simply destruction in the hospital. So those were just sort of the generic comments about when it might be used outside of the hip fracture setting. And getting into specifics around other fractures, we feel that there are - I mean probably, we would be interested in looking at other [indiscernible] as well as the replacement market. We think that both knee and hip replacement. Those patients lose muscle and bone pretty rapidly as well. So those would be ideal candidates for that sort of therapy. So, we think there are broader indications, but the first will be hip for us.

Jason McCarthy

Analyst

Okay, just one brief question on 0214, you show great preclinical data and you had mentioned you're finishing up some other pre-clinical work. Can you give us a sense of what the Company is making in terms of moving into the clinic in 2018, maybe when we could see IND filed?

Brian Lian

Analyst

Yes. So, we haven't initiated the GLP study there yet. We're planning those and one of the questions is how long should those studies be and how long should the initial human study be? But we think we could be in a position to file an IND for that program in the second half of 2018.

Jason McCarthy

Analyst

Okay, thank you Brian.

Brian Lian

Analyst

Thanks a lot.

Operator

Operator

Our next question comes from David Bautz from Zacks. Please go ahead with your question.

David Bautz

Analyst · your question.

Hey, good afternoon. Question about VK2809 study, you've previously mentioned there's a lot of competition for patients, a lot of NASH that is going on. I was wondering if you think this is simply a lack of patients I want to participate in clinical trials or do you think it's more indicative of a fact maybe that NASH market isn't quite as big of people think it is?

Brian Lian

Analyst · your question.

Yes, it's an interesting question. I think the NASH market is probably actually bigger than people think it is, just coming from AASLD. There's just - every year the market seems to be larger than people believe and that the fact that more and more transplants are taking place due to problems resulting from NASH. I think the market is real, but one of the issues for us in particular VK2809 is that we're doing two studies and one so patient have to be meet the enrollment criteria for both the hypercholesterolemia and the fatty liver study, and that that tend to exclude more than we had initially expected, but that you had later that onto the competition for patients that you mentioned I think both of those make good studies in the setting and challenging but I think we're making good progress.

David Bautz

Analyst · your question.

Okay, now for the orphan indications. Do either of those have patient advocacy groups that you could potentially partner with or even to get funding from to run those trials?

Brian Lian

Analyst · your question.

Yes, they both do actually. So last month was the Annual Meeting - it was in September, the Annual Meeting of the Glycogen Storage Disease Association and then next Friday is the Annual Meeting of ALD connect, which is a big X-ALD, the patient advocacy group and we were at the GSD meeting and will be at the X-ALD meeting. So, I think we have a good relationship with the patient advocacy groups and that should go a long way toward building enthusiasm and participation and in both of those studies.

David Bautz

Analyst · your question.

Okay, they potentially be - went through for a patient recruitment?

Brian Lian

Analyst · your question.

Yes.

David Bautz

Analyst · your question.

Great, thanks for taking the questions.

Brian Lian

Analyst · your question.

Thanks David.

Operator

Operator

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

Scott Henry

Analyst · your question.

Thank you and good afternoon. Just one question on clarification as we look to the SARM data for VK5211, and I believe the last patient was out in late September and typically if we get six weeks for topline readout, we would be think about the back half of November? Is there anything unique that make push this data perhaps further into early December or late December? Just trying to get a sense of when to look for that top line data? Thank you.

Brian Lian

Analyst · your question.

Yes, it's a great question and I think you had a very fair question. One of the issues - not an issue, one of the things with the study, it's an international study. We have a central reader on our decks to scans and transferring data from some of those international sites. It's not as straightforward as you might think it is. But I mean it's all moving forward and there are no major glitches or anything like that. I think your timing is not wildly inappropriate. We hope to have a data as soon as possible, but we guide into the fourth quarter and probably can't give much better perception than the fourth quarter right now.

Scott Henry

Analyst · your question.

Okay, fair enough. Thank you for the color and thank you for taking the question.

Brian Lian

Analyst · your question.

Yes, thanks Scott.

Operator

Operator

And ladies and gentlemen, we have reached the end of today's question-and-answer session. At this point, I'd like to turn the conference call back over to management for any closing remarks.

Stephanie Diaz

Analyst

Thank you again for your participation and continued support of Viking Therapeutics. We look forward to updating you again in the coming months. That concludes our call for today. Thanks.

Operator

Operator

Ladies and gentlemen, that does conclude today's conference call. We do thank you for attending. You may now disconnect your lines.