Earnings Labs

VivoSim Labs, Inc. (VIVS)

Q1 2016 Earnings Call· Mon, Aug 10, 2015

$1.40

-6.04%

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Transcript

Operator

Operator

Good afternoon and welcome to the Organovo Holdings Conference Call for the period ended June 30, 2015. The period represents the First Quarter of Organovo's 2016 First Fiscal Year, which will end on March 31, 2016. All participants will be in a listen-only mode. [Operator Instructions] After today’s presentation there will be an opportunity to ask questions. [Operator Instructions] Please note, this event is being recorded. I would now like to turn the conference call over to Mr. Barry Michaels, the Chief Financial Officer of Organovo Holdings. Please go ahead, sir.

Barry Michaels

Analyst

Good afternoon, everyone and thank you for joining us for the Organovo Holdings conference call for the fiscal 2016 first quarter ended June 30, 2015. With me today is Keith Murphy, Organovo’s President and Chief Executive Officer. Before we begin the substance of today’s call, I would like to make a brief introductory comment. Earlier this afternoon we issued a press release which outlines the topics we planned to discuss today. If anyone has not seen a copy of the press release, it is available on our corporate website at www.organovo.com. It is also available on the SEC's website. Additionally, I would like to remind our listeners that this conference call is open to the media and we are providing a simultaneous webcast of this call for the public. A replay of our discussion will be available later today. Details are in the press release. During this call, we will discuss some factors and matters that are likely to influence our business going forward. Any matters discussed today that are not historical facts particularly comments regarding our future plans, objectives and expected future performance constitute forward-looking statements. These forward-looking statements are subject to risks and uncertainties which could cause our actual results to differ materially from those suggested by our forward-looking statements. The factors that could cause our actual future results to differ materially from current expectations are identified and described in more detail in our filings with the SEC including our Annual Report on Form 10-K for the year ended March 31, 2015 and our fiscal 2016 Quarterly Report for the period ended June 30, 2015. We encourage all of our listeners to review all of our SEC filings. As a result of these risks and uncertainties, you should not place undue reliance on these forward-looking statements, which speak only as of the date of this conference call. We undertake no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date hereof. With that said it’s my pleasure to turn the call over to Mr. Murphy.

Keith Murphy

Analyst

Thank you, Barry. Good afternoon and thank you all for joining us today. Today we are happy to report an update on Organovo’s progress in the first quarter. I’ll make some general comments and then Barry will walk through financial results in detail. The topic to address would be our recent financing. On June 18th, Organovo raised $46 million in a confidentially marketed secondary offering with Jefferies and Piper Jaffray serving its joint book runners and Cantor Fitz’s shareholders co manager. The deal closed fully after three days. Organovo did two full days of marketing and the deal was a public offering overnight. The deal was two times oversubscribed at the offering price of $4.25, meaningly had a request over 18 million share, despite on the offering 9.4 million, resulting an institutional orders being only partially filled. The deal closed as expected three days after the announcement and the bankers exercised the full shoe. Organovo was extremely happy with the investor profile of the institutions participating in this deal. Our road show was a success with top Tier Healthcare and generalist institutional funds making up the schedule and the order book. 95% of the allocations went to institutional funds in blocks of 100s of 1,000s to millions of shares. Institutional funds with existing holdings increased physicians through the round, previous investors from our August 2013 secondary offering bought into the round and new institutional funds also made their first investment in Organovo. Our financing was successful in achieving all of our goals. We’ve brought in significant capital to fund new work that will be additive to the long term value of the business, including capacity expansion for liver and kidney tissues, investment in new tissue build outs for commercial uses and building powerful new drug discovery models. As mentioned, we…

Barry Michaels

Analyst

Thank you, Keith. While I will comment on the company’s financial results for the first quarter of fiscal 2016 ended June 30th, 2015. It’s not my intention to replace the full financial disclosure enclosed in the company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission earlier today. I encourage all shareholders to refer to that document for additional information. Allow me to first address our financial condition in terms of liquidity and capital resources. During the quarter ended June 30th, 2015, we’re raised net proceeds of approximately $43.2 million to the sale of 10.8 million shares of our common stock in an underwritten secondary offering. At the close of our first quarter, the company had cash and cash equivalents of $86 million and an accumulated deficit of 130.8 million with negative cash flows from operations of $6.3 million. This compares favorably with last year’s cash and cash equivalents balance of 44.9 million. Although as expected, negative cash flows from operations increased over last year’s value of $3.4 million as we invested an additional plant, equipment and staff in connection with our commercialization of our exVive3D Liver Tissue and expanded our development efforts in kidney and skin. Total current assets of $87 million and current liabilities of 5.2 million resulted in working capital of $81.8 million versus prior year total current assets of 45.7 million and current liabilities of $3.1 million which resulted in working capital of $42.6 million. Net cash used in investing activities was approximately 1.1 million and $200,000 for the quarters ended June 30th, 2015 and 2014 respectively. The majority of net cash used in investing activities to date has been for the purchases of laboratory equipment particularly noting that the company launches first commercial product and expanded its research capabilities in the back…

Keith Murphy

Analyst

Thank you, Barry. I’d like to now provide some final comments on other active areas for Organovo including kidney and our partnerships. In regard to our kidney tissue, I am happy to provide an update on our progress. We’ve remained on track to achieve our next milestone which is functional validation of the kidney by December of this year. We are also on track to launch the exVive3D Kidney Tissue by September of 2016. Due to learnings from our communications around the launch of our liver tissue in November 2014 and when commercial results could reasonably be shared after than event, we are electing going forward to refer to the September 2016 milestone as initiation of contracting rather than launch. Investor should expect us to announce that we have initiated contracting for the exVive3D Kidney Tissue on time in September of 2016 and as following that I’ll first look at the progress of the contracting in terms of contract bookings would be available four to eight months subsequent to that date. Investors will recall that with our liver launch, the first communication of results after the November initiation of contracting was in June of the following year. We continue to expect strong demand for kidney based on interactions with our toxicology customers during marketing of our exVive3D Liver Tissue. Regarding our partnership with L'Oreal, we continue to make good progress and expect to update on that overtime. In the case of our Merck relationship, work on both the toxicology aspect as well as the custom tissues for disease modeling is in progress and we will provide updates on those as well when we can. With that we thank you again for joining the call and can take your questions at this time.

Operator

Operator

We will now begin the question-and-answer session [Operator Instructions] And our first question will come from Brandon Couillard of Jefferies.

Brandon Couillard

Analyst

Hey, thanks, good afternoon.

Barry Michaels

Analyst

Hey Brandon, how are you doing?

Brandon Couillard

Analyst

Good. Keith or Barry I realize you are opting to give the total I guess backlog or contract aggregate amount for the liver product on an annual base, but anything you can tell us in terms of total number of liver contracts, average contract size, any cancellations relative to let’s say we’re two months ago?

Keith Murphy

Analyst

Yeah, you are correct and that we’re focusing on the revenue numbers for now as the key way to measure that business quarter-to-quarter in overtime. And we haven’t chosen to talk about it in terms of contract in part because the number of contracts or the dollar value of these contract can very quiet brightly as a quite a broad range. So talking about the numbers is a big less relevant. We do expect overtime as we said to give updates on the contract bookings or the backlog as you stated but we think it’s better to do that on an annual basis for now. And I think we do expect that the great majority obviously of any bookings number is going to recognized this revenue, there are cases where some portion of that may not be recognized due to final phase of some one of other contract not being completed. But generally, we do expect the great majority of that to be booked. I’ll turn it over to Barry for any other comment he would have on that.

Barry Michaels

Analyst

Yeah, Brandon, what confirm for you and this isn’t a change but our average contract size remains at or above a $150,000, so we are encouraged by that pricing really hasn’t been so much of an issue in terms of the value that we are providing and that continues to be supported.

Brandon Couillard

Analyst

Super. And then I appreciate the update on the kidney timelines. What hurdles exists if any two perhaps accelerating that project, is that even possibility with to do resources?

Keith Murphy

Analyst

Yeah, good question because it’s kind of two different parts of the answer. The first is that you can’t accelerate some of the work that has to be done because of the timeframe it takes to turnaround certain results. So in building the initial kidney tissue like for example demonstrating the functional validation, the timeline that we are moving forward now in terms of getting to in December and having those results in hand that support making the next step into full on development of that tissue i.e. finalizing a manufacturing process making it robust and getting it ready for the commercial launch. You can’t change the timeline to that just by adding resources because there is a series of critical path steps that you just have to wait for the answers from rate to bet around. So the timeline to that point is somewhat fixed and that’s why even with the new dollars that we’ve taken in, we are not able to advance the kidney launch date from that September 2016 timeframe – excuse me the initiation of contracting date in September 2016. However, what you can’t do is enable the business to progress much more quickly from that date forward with efforts from now until that time, meaning that resources really added after the finalization of the tissue which will come around that December timeframe after we have the functional validation. What we’ll do is we’ll finalize what the tissue looks like and then as I said move it towards manufacture ability and launch. Ones you have that final tissues is selected with all the components that go into in the manufacturing process locked down, you can start to generate date that demonstrate the broad utility of it like some of the things you’ve seen rolling out overtime for liver. So what additional resources do allow us to do is to focus on having headcount working on delivering that date package that’s going to be in the hands of the sales and marketing team at the time of launch which allows you to think that penetration are largely to drive penetration in a faster way. Is that clear, I walk through that well?

Brandon Couillard

Analyst

Yeah, that’s helpful. And just on the commercial organization comment, can you give us a sense of how you see the I guess what were your hiring plans kind of the next 12 months over the balance of the year, how many reps you think you need to support the liver project and kind of the spend or cash burn if you will that’s associated that we should anticipate over the coming periods?

Barry Michaels

Analyst

Yeah sure, this is Barry, Brandon. It’s not just reps that are relevant to the sale here because this is such a technical sale particularly in these early days, it’s not as though we have a commoditized product, right, where it’s feed on the street exactly. So given the nature of that our funnel of leads coming in for our both service as well as product, revenue opportunities come from a verity of sources including our business development folks and frankly many of them come in from our technical folks particularly as they attend conferences jointly with customers and so on as discussions begin there. As Keith as pointed out many times, from the first discussion until closing a contract that is driving down the contract and getting a signature on an agreement if you would is often in the five to six months’ timeframe from those initial discussion. So it’s not just sales reps, it is in fact a broaden base from that and many opportunities that are funneling in. We had – in recent months you know we’ve had four people in total within a commercial organization. We’re looking to build that over the – out over the next year by adding a couple more reps within the area. But remember our initial focus is primarily to the top 25 large pharma companies. And so you are talking about a target base, a focus base that really is only a handful of companies per rep. And so something that we believe that they can cover and support in conjunction with the technical support that our research and product development people can give on that. In terms of cash burn, what we’ve indicated you know, I think as you know historically and most recently as we close the year, we were burning about $25 million annually and what we have guided and we’ve not changed any guidance on that. Our expectation is that will be at roughly $30 million or so as we build up our infrastructure here to support to activities both for commercialization as well as our increased development and research activities.

Brandon Couillard

Analyst

Super, thank you.

Barry Michaels

Analyst

Thanks, Brandon.

Operator

Operator

The next question comes from Caroline Corner of Cantor Fitzgerald.

Caroline Corner

Analyst

Hi guys, thanks for the update, I appreciate it. First of all just looking at your revenue line, your last update at the end of June was that you had 1.94 million booked in contracts and you had just under 300,000 already booked to the top line at that point. So by my mouth that mean there was 1.6 or so millions but over the next six to nine months from the last update, your revenues have come in at for product revenues at 200,000. Can you talk a little bit about, should be expect the bullish of the rest of that 1.6 million that should be coming in the next six to nine months given that timeline for contracts that you have talked about? Should we expect the bullish of that to becoming next quarter or can you talk us through how we should be thinking about that?

Barry Michaels

Analyst

Yeah, I don’t want to focus just on the exact timing of these things because it depends of the nature of the studies as they go forward the phases on these sometimes have positive for go, no go decisions because they are multi-deliverable contracts in certain cases, right, so you may do as an example, you may do a Phase I, you produced the results from that the customers studies also results and makes a decision and whether to continue studying that particular compound that they give us or not. And so sometimes there are pauses that occur. And each of these is really separate distinct or unique if you would to not just the company or the customer that we have but in the case that you have more than one project that you are working on for that customer there maybe differences for each of these because of the nature of the product that you are working on and so on. So I don’t want to guide just because I think it would be irresponsible to do so in terms of the what the timing of that is. I think the general guidance that you took away from that – and again remember, this isn’t just product but it’s product and service. And at this point in time, primarily service that they were gearing from this. And so that is why the backlog that occurs if you would what that bookings number that was reported and this takes a period of time to work through these. I think the relevant range to four to six months for the average agreement that’s out there.

Caroline Corner

Analyst

Okay, thanks, that’s helpful. And then turning to the kidney product, we’re expecting now initiating of contracting next September you having functional validation done December what has to happen between December and September that you can begin initiating the contracts?

Keith Murphy

Analyst

Hey Caroline, this is Keith, I’ll answer that, it’s a good question. So really the best way to think about it is to say that we would be moving from the research phase or the development phase of R&D meaning that at the end of December ones we have that dataset showing that we got the functional validation on that tissue that would basically mean that we achieved the desire characteristics for the toxic compounds that we want to test in the early days showing that the kidney performs like the normal human liver when exposed to those compounds, that would tell us that our research phase is done at least to the point of having something ready for the move towards initiation of contracting saying that this kidney tissue has achieved the goals we set for it as a commercial tissue. What then have to happen is reading it for commercialization. So there is a wide number of activities that take place but they could be summed up by saying that you are moving in into a manufacturing high volume setting from a research setting. So we have what is effectively a process development activity, we can it tech transfer here where the team takes it from the research team make sure it’s going to be manufacture puts it in through a manufacturing process, locks down the manufacturing process demonstrates the reproducibility and reliability of that manufacturing process. In addition there are things like quality standards have to be set for both the incoming cells that we are going to make that tissue from and the final tissue so that we know that we have something that’s ready to be used in a customer setting after we manufacture it, when we have those qualities, tests prepared, the assays that will used to measure how a drug effects it will be made more robust and locked down as well. So wide set of things that really have to do with the fact that you are going to be making it ready for broader set of uses and a higher volume set of uses.

Caroline Corner

Analyst

Okay, thanks. And then given that the product then will be ready for sale in September. We thought before about how the liver customers have other options available to them or is the kidney toxic studies, so kidney itself don’t plate, it’s a big unmet market need more urgently unmet then perhaps the liver product, but given that also the top 25 pharma companies in our customer base the ones that are doing live toxic studies are also doing kidney toxic studies, why wouldn’t we expect the sales of the kidney product to go faster out of the gate than the liver product?

Keith Murphy

Analyst

Yeah, that’s a good question. I would agree with you that we do expect to see them go faster. We are going to have as you said the customer relationships that are well established by that point and we do see this is a real benefit of the kidney tissue that we don’t have to build a separate sales force to launch it. We’ll have a well-established sales team who knows their customers. They have already been having preliminary discussions with these customers about the receptivity the kidney and that’s been very positive as we’ve stressed that, there is strong demand. And so well it’s hard to predict what that different trajectory. We do agree that it should be a faster uptick. If you notice I did say that our ability to report some date off of that initiation of contracting could be as early as fourth months. Realistically the window is four to eight months. But it could go a bit faster than the liver did and we do expect that it would.

Caroline Corner

Analyst

Okay.

Barry Michaels

Analyst

The other comment I would make Caroline is that I don’t think it’s unreasonable to believe that the kidney product and success in the hands of a customer who choose initially not to use our liver toxic product might choose to use at once they see the effectiveness of the kidney product. And so the difference between having some alternative versus no substitute or alternative for what we are doing, we may see it a too long if you would from the kidney across over and toeing along additional ramp up in sales within the liver product as well. One think that I think would be helpful to mention just as the – just in building awareness of the longer term kidney market. It’s – just for a moment remember that this is – this initial kidney tissue is a specific sub-tissue within a kidney, it’s proximal tubular tissue. So the liver represents the broad tissue meaning the activity in our exVive3D Liver Tissue represents the normal activity of the whole liver. In kidney, there are multiple architectural structures and we are building one of them with this first tissue. Next-gen kidney tissues will focus on different areas that can have an impact in other ways for customers. But one thing to think about with the kidney is that something that means that we can build up on overtime is that this is a proximal tubular structure which is the most important thing for predicting the toxicology results of a lot of different drugs because that’s big area, but we have the ability to maybe even get to bigger and better results than we predicted with the kidney overtime if we can introduce these additional tissues of full set of kidney structures that can be really impactful. So the second-gen kidney tissues have the potential to be really breakthrough and even though we predicted a premium pricing like $250,000 medium potential contract for the kidney versus 150 for liver. In the future it could even be higher if we can show additional kidney functions for some of the other areas preliminary line in that front.

Caroline Corner

Analyst

You are still expecting that $250,000 press point out of the gate for kidney though?

Keith Murphy

Analyst

It’s a projection that’s for why the aero bands around but yes we still believe that we should gather a premium over the current liver.

Caroline Corner

Analyst

Thank you. Thanks.

Keith Murphy

Analyst

Thank you.

Operator

Operator

At this time, we will conclude our question-and-answer session. I would like to turn the conference back over to management for any closing remarks.

Keith Murphy

Analyst

So we want to thank you all for your attendance today. We can remind you that there is information in the press release to access this call in recorded fashion. Thank you for your time and you can disconnect now and wish you well. Thank you.

Operator

Operator

The conference is now concluded. Thank you for attending today’s presentation. You may now disconnect.