NanoString Technologies, Inc.
Q2 2015 Earnings Call Transcript

Published: 5 Aug 2015

[Operator:]

Good day, ladies and gentlemen and welcome to the NanoString 2015 Second Quarter Financial Results Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time. [Operator Instructions] As a reminder this conference call is being recorded. I would now like to introduce your host for today's conference Ms. Leigh Salvo of Westwicke Partners, ma'am you may begin.

[Leigh Salvo:]

Thank you. On the call with me today is Brad Gray, NanoString President and CEO, and Jim Johnson, CFO. Earlier today NanoString released financial results for the second quarter ended June 30, 2015 and a copy of the press release can be found on the Company's Web site at nanonstring.com. During this call we will make a number of statements that are forward-looking including statements about financial projections, existing and future collaborations, future business growth, trends and related factors, prospects for expanding and penetrating addressable markets, interactions with third-party payors and the timing and outcome of any related reimbursement decisions, our strategic focus and objectives and the development status and anticipated success of recent and other planned product offerings. Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond our control including the risks and uncertainties described from time-to-time in our SEC filings. Our results may differ materially from those projected on today's call. We undertake no obligation to publically update any forward-looking statements. With that I would like to turn the call over to Brad.

[Brad Gray:]

Thanks, Leigh. Good afternoon and thank you for joining us today. The last several months have been pivotal for NanoString through the achievement of many milestones both large and small we believe that we've positioned the Company for long-term growth and leadership in the field of precision oncology. Let me provide a few highlights, we substantially expanded the market opportunity for our products in oncology research, through the launch of the nCounter SPRINT Profiler and the introduction of our unique RNA

[Jim Johnson:]

Thanks Brad. Total revenue for the second quarter of 2015 was $13.1 million up 20% versus the second quarter of last year. Total product and service revenue was 12.5 million up 22% year-over-year. Foreign exchange rate fluctuations reduced the growth in both total revenue and total product and service revenues by approximately 3 percentage points. Instrument revenue for the quarter was $4.4 million up 17% over second quarter 2014. System sales were strong outside North America generating over 60% of total instrument revenue, and particularly strong growth from our distributors. The quarter also included the sale of our first two SPRINT systems to d'Hebron Institute. Total consumable revenue including Prosigna was $7.4 million 23% higher than a year ago and above $100,000 per system on an annualized basis. Life Sciences consumables were $6.8 million of this total up 17% year-over-year. It is consistent with the guidance we provided last quarter of $1 million to $1.5 million of sequential growth over the first quarter. Within Life Sciences consumables we found recovery in our biopharma pull through and from customers in the Northeast after Q1 weather related issues were sighted. Also we continue to see the shift away from custom consumables panels, with panel sales representing over 40% of total Life Sciences consumables revenues for the quarter. Prosigna test kit revenue grew to 591,000 another step up from the previous quarter and we continue to see increasing momentum in the demand for Prosigna kits particularly outside the U.S. where our localized testing model clearly resonates. We recorded $568,000 of collaboration revenue for the quarter and most of this relates to our cell gene collaboration, with modest contributions from the new Merck collaboration beginning in June and a small exploratory research collaboration. Gross margin and product and service revenue for the quarter was comparable to the second quarter of last year at 53% and gross margin during the quarter benefited from increased panel volume and consumables which was generally offset by the impact of a higher promotion of instruments sales sold through distributors which generated lower margins than direct sales. R&D expense was $5.8 million compared to 5.3 million in the second quarter of last year. The increase largely reflects investment in the development of nCounter products and technology. SG&A expense was 12.8 million for the second quarter comparable to the 12.9 million reported a year ago. This flat trend reflects cost efficiencies resulting from the changes to our sales and marketing organization that occurred in the first quarter of this year. Stock-based compensation expense was $1.7 million for the second quarter of this year compared to 1.3 million a year ago. Consistent with our increased revenue and moderated operating expense growth we saw a decline in our net loss for the quarter. Our GAAP net loss was $12.4 million or $0.66 per share compared to GAAP net loss of 14.1 million or $0.78 per share in the second quarter of last year. During the quarter we raised approximately $12.5 million net of expenses through our ATM facility. We ended the quarter with $53 million of cash in investments. Now I’ll turn to financial guidance which we’re updating in light our new collaboration with Merck. We are raising our total revenue guidance to $60 million to $63 million for the year which includes $4.5 million of collaboration revenue. Previously we projected revenue in the range of 58 million to 61 million including 2.5 million of collaboration revenue. Although we expect to receive approximately $4 million of cash this year from the new Merck collaboration all of that would be recognized as revenue in 2015. Just like with our cell gene collaboration revenue recognition will lag the receipt of cash and so we’re raising our 2015 collaboration revenue guidance by just $2 million. There is no change to our guidance for total product and service revenue it remains at $55.5 million to $58.5 million including $2 million of Prosigna revenue. Overall for the full year we continue to expect consumable revenues to be at or above the $100,000 per system we've generated historically. In Q3, we expect a modest sequential increase in instrument revenue with a more meaningful step up in Q4, consistent with our historical seasonal patterns and as the funnel for the new SPRINT system begins to mature. We continue to expect that most of the impact from SPRINT sales in the current year will occur in the fourth quarter. For the full year we continue to expect gross margin on product and service revenue to be in the range of 53% to 55%, and as a reminder collaboration revenue is excluded from our calculation of gross margins. For operating expenses we continue to expect $77 million to $81 million for the year, including approximately $6 million to $7 million of stock-based compensation expense. Our anticipated GAAP operating loss for the year is now expected to be lower in the range of $41 million to $47 million previously we have guided to range of 43 million to 49 million. We continue to expect interest expense of approximately $4 million for the year bringing our revised GAAP net loss guidance to $45 million to $51 million. We still expect capital expenditures of $4 million to $5 million approximately half of which will be funded by our landlord at leasehold improvements. So, with that I'll turn it back over to Brad to wrap up.

[Brad Gray:]

Thanks Jim, in summary NanoString is at a key inflection point. We’ve delivered solid growth while achieving multiple critical milestones in rapid successions. Anyone of these milestones alone would be a major event for the company. After achieving them in a short burst over just a few months, we believe we're emerging as a truly different company poised not just to deliver growth quarter-after-quarter but year-after-year. We're proud of these recent achievements and optimistic about our future. I would now like to open up the lines for questions.

[Operator:]

Thank you. [Operator Instructions] And our first question comes from the line of Steve Beuchaw with Morgan Stanley. Your line is now open.

[Steve Beuchaw:]

The first question I wanted to or I'll ask two both about SPRINT. So, I wonder if you guys have looked at the evolution of the funnel, not just for SPRINT but for FLEX and MAX now that, that product has been on the market for several weeks and made any attempt to assess whether the SPRINT launch just have any -- having any impact on the traction with FLEX and MAX and then I'll go ahead and ask my follow-up because it's related and the follow-up is also on SPRINT, Brad you again made a comment that the launch of SPRINT can take the landscape of addressable labs to two to three times what it was with just Gen 2 or MAX, can you remind us how it is you get to that figure, what are the datapoints you're looking at? And thanks again for taking the questions guys.

[Brad Gray:]

So, the reaction to the new instrument line up has been very positive, what it's done is it's effectively changed the nature of the dialogue that our sales people are having in the field over the last three weeks. So, one from a dialogue and wherein the past one of the first concerns of a customer would be whether they could afford our technology to a dialogue where the conversation is about which of our several instruments is the right one for the customer. And we do believe that with this new product line with three different instruments targeted at three different segments we have an expanded offering that will grow our addressable market. So, in the first three weeks, we have not seen the availability of SPRINT have a major impact on traction for MAX and FLEX it is early days. We are working hard to make SPRINT sales incremental to our normal customer sales in the past, and as a result I think for Q3 we think for unit placements low to mid-single digit units, there's a reasonable start in Q3 and we're going to go it from there. Let me go to your next question then, why are we confident we're going to be able grow into this larger addressable market? Before we set out to develop the SPRINT system, we commissioned and executed conjoined market research and with that market research study attempted to do was understand the way that customers, researchers makes a trade-off between features like throughput or number of genes that our system could look at and cost and footprint. The major engineering input to our design process and through that conjoined market research what we discovered was there is a segment of individual researchers who we weren’t really retained with the traditional nCounter MAX and FLEX configurations who have lower throughput needs approximately half of what a whole app would need and who really want to get system that costs in the range of $150,000 or less. And believe it for that segment that we built the SPRINT, and then we quantified through our market research how many more customers were in that segment that we weren’t yet reaching compared to the ones we were it is two to three times as many researches. So it is really on that basis that we have estimated that we will increase our overall addressable number of placements to two to three times what it is today with the addition of SPRINT.

[Operator:]

Thank you. Our next question comes from the line of Tycho Peterson with JPMorgan. Your line is now open.

[Tejas Savant:]

This is actually Tejas on for Tycho, Brad how are you? So my first question is actually on the consumable pull through that you expect to see on SPRINT and I know it’s still very early, but just from a modelling perspective when you speak about the 100,000 in pull through for nCounter, does that include the SPRINT ramp in the back half of the year as well or is that independent of that number?

[Brad Gray:]

It’s including the SPRINT ramp in the back half of the year, Tejas. So with SPRINT placement just beginning with the few in Q3 and more in Q4 we do not expect SPRINT to contribute meaningfully to consumable pull through during the current year. Our experience when we instruments is that typically the first consumable order comes in the quarter subsequent to the instrument placement. So for instruments placed in Q3 we have our first orders in Q4 and for instruments placed in Q4 we have our first consumable order in -- not until the New Year. So we don’t expect consumable pull through in 2015 to be meaningfully impacted by the SPRINT launch. In terms of...

[Tejas Savant:]

Got it.

[Brad Gray:]

In terms of long-term you maybe want it for modelling purposes what we would say about the long-term pull through of SPRINT it is early days still, clearly we’re targeting a segment who by definition have fewer samples to process and less budget to spend than a core lab does. So we do expect it to be meaningfully less than a typical MAX or FLEX customer has been, but it’s too early for us to provide specific quantitative guidance on that.

[Tejas Savant:]

And then last quarter I know you’ve spoken about this lead generation program that you have put in place for driving SPRINT placement. Can you share with us the expense of that you can in terms of touch points, how many of these are new to NanoString customers who couldn’t potential afford an nCounter and how many of these are existing users who are potentially looking for a different used case?

[Brad Gray:]

Sure. So, we started preparing for the SPRINT launch late last year with a new lead generation program and the objective was to go back to customers who really haven’t been able to afford an nCounter in the past or because they were individual researchers who never really engaged with a company because that was not the customer segment that we targeted. So the lead generation and I’d say the initial funnel development is primarily focused on a; customers who were we know had been interested in the past in an nCounter who likes the technology who likes the capabilities but whose budgets were not sufficient for them to purchase so we began reengaging with those customers again in the first half of this year. And the second group was individual researchers who we had never really had a substantial coordinated outreach to in the past and what we did was through a substantial internal effort we combed through the literature and cancer research and genomic research to look for individual researchers who were publishing papers and applying for grants that focused on the kind of gene expression work that has been the core use of nCounter in the past and we began to target marketing at those individuals. Even in advance of having announced the availability of SPRINT and so, what we are doing today is converting that initial engagement into more of a sales dialogue and the typical sales cycle for capital equipment in this price range is between three and six months so, it will take some time to convert that interest into unit placements but we think we've done a very good job of laying the groundwork.

[Tejas Savant:]

And then just one final one here from me on Prosigna, given that you have the guidelines piece of this now, mostly in place, are you slightly more optimistic of your Prosigna contributions in the back half of this year and has there been any change in the tenure of your conversations with peers post NCCN inclusion?

[Brad Gray:]

So, I'd say absolutely, I'd say the risk in the back half of our guidance has been reduced substantially by some of the progress in the first half of the year, that being said, it's still very early days and things like MolDx guidelines and NCCN guidelines are mostly going to have a 2016 impact, that the implementation of the MolDx policy for instance could take -- could still take months and therefore not be completed and effective until very late in the year so, that doesn't have a meaningful necessarily impact in 2015. And NCCN guidelines really are allowing us to kind of go back and reengage with payors, give them an update about the acknowledge of the prognostic power of Prosigna and again it will take time before those dialogues yield revised medical policies and then those revised medical policies will take time before they yield to sales. So, all of these dynamics are all very positive they're in line with our expectations overall but they're really setting the stage for growth 2016 rather than impacting the second half of 2015.

[Operator:]

Thank you. Our next question comes from the line of Jeff Elliott with Robert W. Baird. Your line is now open.

[Jeff Elliott:]

I guess my first question is really a follow-up to the last question, is really -- you're following the NCCN guideline update in your conversations with payors, what is your sense did payors get the wording in that guideline update that they needed in order to move forward?

[Brad Gray:]

I think it's early days till to know the answer to that Jeff. I think the guideline update does provide some payors what they were looking for which is an acknowledgement by the experts in the field who have reviewed the literature, that our test does what it says it does, which is to identify low risk patients who may be spared the need for arsenic chemotherapy because without chemotherapy their outcomes are going to be good. So definitely I would expect there would be a subset of payors for whom that is sufficient, I am sure there will be other payors, who are looking for even stronger wording than they got in this round of guidelines. And the good thing about the guidelines is that they're updated from time-to-time and we have continued to generate strong evidence since the submission to the NCCN guidelines in June of 2014 that we hope will improve our position overtime.

[Jeff Elliott:]

And then I think during the prepared comments, you mentioned in the collaboration line there was another smaller research collaboration that contributed revenue, can you share any more color on what that is, is that on a biopharma collaboration, or what is that?

[Jim Johnson:]

Yes hi, Jeff, this is Jim, it's basically a like a pilot study, it's related to the Phase 2 study where they are using our assay to evaluate whether it has the ability to help select patients for a subsequent study which would be a Phase 3 study and then that is since it would, if it is successful it would transition most likely to a companion diagnostic collaboration.

[Brad Gray:]

It's a research pilot study with a biopharmaceutical company so I could be clear.

[Jeff Elliott:]

So, your guidance doesn’t assume that that kind of flips over to a larger collaboration this year, does it?

[Brad Gray:]

No.

[Operator:]

Thank you. Our next question comes from the line of Dan Leonard with Leerink Partners. Your line is now open.

[Mike Schmidt:]

This is Mike Schmidt calling filling in for Dan Leonard. Can you elaborate on the feedback you’re receiving about RNA

[Brad Gray:]

Sure. So, the question was what has been the feedback to the RNA

[Operator:]

Thank you. [Operator Instructions] Our next question comes from the line of Dane Leone with BTIG. Your line is now open.

[Dane Leone:]

So in terms of the mentioned the MolDx covering North Carolina or [indiscernible] all that Prosigna testing, just to kind of couch expectations for the out years or 2016-2017, when you think about the Prosigna program there is kind of two variables, one is a hurdle for people to be allowed to use it i.e. insurance coverage and another is that the motivation to use it. You made progress on both fronts, but I guess the question is to really see a ramp in utilization, what you feel to be the hurdle I mean if we go back in history of third-party complex test sales you really do need very clear pricing for the test. So I guess one question would be, when do you think you will get clarity in terms of pricing specific reimbursement for the test itself? The second is where do you think you are at in the timeline of convincing people to use it?

[Brad Gray:]

Yes, so I agreed with the kind of framework that you described Dane, that there are a few issues reimbursement being a gating item and then demand being of course important for generating prescription with the test. Really before you get through the reimbursement hurdle as a kit manufacturer it’s nearly impossible to generate demand. So we think the MolDx decision for Medicare which is the largest group of patients out there and our intended use population will be substantially improved with the MolDx decision. So to kind of quantify that when we look at our intended use population today we think that post MolDx, if you think of MolDx that is effectively providing national coverage decision for Medicare something like 55% of our intended use population will be covered and that would be meaningfully increased. I mean you could say to the physician the majority of your patients will have coverage which is much better than it is today. And in terms of the pricing that is coming with the MolDx we would expect pricing to be established around the same time that the coverage policy would become effective. We have provided information to MolDx to help support them in that effort of doing the gap fill and we would expect to probably have clarity on pricing from the minute that the policy is effective. So there be a -- we won’t expect a pricing overhang or a pricing uncertainty I should say. On demand I think what we hope and expect is that once reimbursement is available the commercial organizations of the laboratories that are providing the test like LAD4, like Quest, like genom PIX, like Avra that they will be motivated in the way they aren't today to promote the use of Prosigna to their existing customers. And when you think about those national labs, they all are very-very -- they touched a large number of patients. And a large number of physicians, so they do have we believe the capability to drive market share once they are properly motivated. So, we see reimbursement as a key gating event to begin generating demand, but it will take time as you point out and that would be a dynamic that we'll talk more about as we get closer into giving 2016 guidance.

[Dane Leone:]

And so, in terms of the model, who will be doing the direct education to clinical oncologists in terms of ordering the test yet?

[Brad Gray:]

NanoString has a modestly sized commercial organization that can in a very focused way provide that education and then we will be relying on the laboratory test providers to help us with that -- and that will be from both the commercial labs and of course the cancer centres and hospital systems who've also adopted the test.

[Dane Leone:]

In terms of the collaboration revenues can you just help us with the phasing of that, there was a step function to hit that for I think you guided to about $4 million for the year now, is the step that function for that in the third quarter or the fourth quarter versus what you just pointed obviously?

[Brad Gray:]

So yes the guidance was 4.5 million through the year. I think that it's hard to predict the breakdown between Q3 and Q4 it has -- it's entirely tied to the amount of work that's done in each quarter and so I think it's safe to say that with the new Merck collaboration it is still ramping and I would say it's reasonable to assume more of that revenue in the fourth quarter that in third quarter for that reason, but it's a really low key calculation that you have to do for accounting purposes so, we tend to focus more on the big picture which is $4 million of cash and it may vary from quarter-to-quarter in terms of how much is the quarter's revenue but it's very difficult to make definitive predictions about it.

[Dane Leone:]

So, the best guess is that we should be modelling a little the bulk of it probably in the fourth quarter and maybe a modest step up into the third quarter?

[Brad Gray:]

Yes I think that I mean I can make any definitive guidance, but I think there's logic that would say more work being done in fourth quarter than in third quarter.

[Dane Leone:]

And then on the outlook for the biopharma revenue, are we looking for kind of the normal sequential ramp in the back half of Q-on-Q or do you think there's a additional catch up from the weak 1Q that we would see in the back half or are we kind of caught up there?

[Brad Gray:]

Yes I think we believe we're more or less caught up at this stage biopharma consumable revenue contribution in the second quarter was about 30% of our total Life Sciences consumable revenue that's virtually identical to what it had been in the second quarter of 2014, so I think we're back towards being normalized and I don't think I have any specific guidance to provide about the sequential growth through the course of the year, other than to point out that last year was extraordinary. You may recall that in the fourth quarter of last year, biopharma contributed 50% or more of our overall consumable revenue and I do not think that we can guide to that pattern it won’t repeat itself every year. So, I think the big picture here is overall we expect consumable revenue to be at or above our $100,000 annualized pull through benchmark through both Q3 and Q4.

[Dane Leone:]

Okay. And then I guess the last one from me, so the instrument guidance that you gave is more or so weighted I guess for the fourth quarter versus the third quarter as you build the funnel with a couple of systems of FLEX but presumably you get a bit more placements in the fourth quarter?

[Brad Gray:]

Yes, the fourth quarter is always our strongest instrument quarter for reasons of the way the end of year budget flush tends to work on the capital equipment budget side. So even absent the SPRINT launch we expect a strong fourth quarter. And then of course the dynamic of the SPRINT launch are that the funnel is building and we would hope to see sequential growth from Q3 to Q4.

[Operator:]

Thank you. And I am showing no further questions at this time. I would like to turn the conference back over to Mr. Brad Gray for any closing comments.

[Brad Gray:]

Thank you all for joining our call today. And before we finish I’d like to invite you to join our first ever Investor Day which will be held in New York on the morning of Friday, September 11th. Please contact us for details and I look forward to seeing many of you there.

[Operator:]

Ladies and gentlemen, thank you for participating in today’s conference. This does conclude today’s program. You may all disconnect. Everyone have a great day.