Quotient Limited (NASDAQ:QTNT) Q1 2020 Results Earnings Conference Call August 5, 2019 8:00 AM ET
Chris Lindop - Chief Financial Officer
Franz Walt - Chief Executive Officer
Conference Call Participants
Brandon Couillard - Jefferies
Josh Jennings - Cowen and Company
Sung Ji Nam - BTIG
Greetings. Welcome to the Quotient Limited First Quarter Fiscal Year 2020 Financial Results Conference Call. At this time, all participants are in listen-only mode. A brief question-and-answer session will follow the formal presentation. Please note that this conference is being recorded.
I will now turn the conference over to Chris Lindop, Chief Financial Officer. Thank you. You may now begin.
Thank you, Melissa. And good morning, everyone and welcome to Quotient’s earnings conference call for our first fiscal qua year ended June 30, 2019. Joining me today is Franz Walt, Chief Executive Officer of Quotient. Today’s conference call is being broadcast live through an audio webcast and a replay of the conference call will be available later today at www.quotientbd.com.
During this call, Quotient will be making forward-looking statements, including guidance and projections as to future operating results. As such statements deal with future events, actual results may differ materially from those projected in the forward-looking statements. Additional information concerning factors that could cause actual results to differ materially from those in the forward-looking statements can be found in Quotient’s filings with the U.S. Securities and Exchange Commission as well as in this morning’s release. The forward-looking statements including guidance and projections provided during this call are valid only as of today’s date, August 5, 2019, and Quotient assumes no obligation to publicly update these forward-looking statements.
With that, I’d like to turn the call over to Quotient's Chief Executive Officer, Franz Walt.
Thank you very much, Chris. What a year we have had since successfully completing our first EU field trial for the initial blood grouping multiplex in microarray back in June of 2018. A series of important milestones and achievements since then accumulated in the approval of that [ph] microarray for the hypercare launch in the EU later in April of this year. The achievements of the last year are the foundation upon which we will build the future commercial success of MosaiQ.
With both of our state of the art manufacturing facility is up and running and approved by the relevant regulatory agencies and with the CE marking of the MosaiQ device itself, now it's all about the menu.
The CE approval of the initial IH microarray gives us the opportunity to place the MosaiQ platform in the hands of our customers to permit them to evaluate the technology working in their laboratories side-by-side with the existing technologies, even as our menu expansion program continues to move forward.
Remember, our competitive strategy is all about delivering the same tests that our customers are required to perform today on a more efficient, modern platform with the lowest available total cost of ownership, by delivering a comprehensively characterized blood product for every donation. This will involve the consolidation onto MosaiQ of the testing done today on multiple platforms and in some cases even manually.
So where are we? And what are we targeting in the next 9 months to 12 months with respect to the menu we expect to be available in the marketplace. While following the CE approval of the blood grouping or IH microarray in June, we submitted for the CE mark approval for the companion initial Serological Disease Screening microarray after its successful EU field trial. If past is prologue and, of course, there can be no guarantees, we may expect to have this available in Europe by early next calendar year.
Our menu expansion plans to lead us to our first US trial, which we have already begun. This involves the initial serological disease microarray with the expectation of making a 510(k) submission later this year. The submission will cover both the MosaiQ device and the initial serological disease testing menu.
When approved, this will create the opportunity to place devices for evaluation with US customers that are already aware of the potential of the MosaiQ platform and appeal to be very anxious to try it in their laboratories.
Its initial placements will be important as our menu expansion plans continue to unfold and as they will also conduct for research purposes, usability testing of our products in development.
Other important proof point for our ultimate menu for transfusion diagnostics, which are planned to be available later this year include V&V data or [indiscernible] the expanded IH microarray and the expanded SDS microarray. This will add detection of an additional nine clinically significant blood grouping antigens to our initial IH menu and an additional seven require infectious disease tests, with the tests for CMV and Syphilis which are working so well on the initial SDS microarray today.
We will also follow through on the plan to place our novel molecular disease screening microarray in the hands of our research institute here in Europe. This will be the first test of this unique technology in the field. Once again, our value proposition will focus on state-of-the-art performance and results of today's required tests, while delivering significant efficiencies and economic advantages to automate that workflow and microarray multiplexing on a low cost disposable design to work with the existing MosaiQ platform.
Turning to our liquid reagent business, I'm very pleased to note that the recent FDA approval of 13 antisera for use with the OEM automation of one of our major customers. This cycle of innovation and regulatory submissions and approvals has underpinned the strong growth of this business in recent years, and most recent clearance gives me continued confidence in the long-term prospects for continued growth.
My thanks to the team that worked so hard on the clinical and regulatory aspect of this important milestone. Our experience in creating successful clinical dossiers that have already delivered 70 US biological license approvals will be invaluable as we continue the innovation and approval process for MosaiQ menu expansion and global market access.
So with that, let me hand over the call to Chris Lindop, our CFO. Chris, please.
Thanks, Franz. While I'm happy to report that the first quarter product sales were a record $8.2 million, an increase of 3.9% from last year's first quarter. Reported sales were slightly behind our original guidance range of $8.3 million to $8.8 million, but we still expect to achieve the same revenue and earnings figures for the full financial year that we previously indicated.
The increase in product sales is attributable to both OEM customers and to direct and distribution sales. OEM sales of $5.7 million grew 1.6% year-over-year and represented 70% of product sales, while direct and distributor sales of $2.4 million increased 9.7% year-over-year and represented 30% of product sales. Product sales from standing orders in the quarter were 68% versus 65% last year.
Gross profit on product sales were $3.6 million, down 5% compared with $3.8 million last year. In the quarter, gross margin was impacted by additional depreciation and other non-cash costs related to bringing online our new Allan-Robb campus. These incremental non-cash costs were $400,000 higher compared to the equivalent costs in the quarter ended June 30th 2018 and contributed therefore 490 basis points of headwind to gross margin on product sales, which were 44.1% in the quarter compared to 48.3% last year.
In the first quarter, the operating loss was $18.4 million compared with $18.5 million last year. Operating expenses reduced $300,000 from last year to $22 million with a $900,000 decrease in R&D expense to $11.7 million, a $300,000 increase in sales and marketing expense to $2.6 million and a $300,000 increase in general and administrative expenses to $7.8 million.
The increase in sales and marketing expenses attributable to the expansion of the MosaiQ Commercial Group in anticipation of the MosaiQ launch. The majority of the increase in general and administrative expenses reflects greater personnel-related costs as we move towards commercialization of MosaiQ.
Stock compensation expense was $1.2 million in the first quarter compared with $1.3 million in the prior year. In the first quarter, net other expense was $5.1 million compared with $6.6 million in the same quarter last year.
Net other expense consisted of interest expense of $6.1 million and a $1 million foreign exchange gain arising from the revaluation of monetary assets and liabilities, denominated in foreign currencies.
Quarterly interest expense included $4 million, which is due currently on our senior loan notes, which is paid biannually in April and October. Estimated future royalties due under the senior loan notes and amortization of deferred debt issuance costs are also included in quarterly interest expense.
Interest expense increased over the prior year as a result of an incremental borrowing during the last 12 months. Overall, our net loss for the quarter was $23.6 million or $0.36 per ordinary share.
Moving to the balance sheet, cash and other short term investments were $90.7 million on June 30th, while long-term debt was $148.1 million with an offsetting long-term cash reserve account of $8.7 million.
On May 15th of this year, we issued an additional $25 million of our senior secured notes, following receipt of the CE mark for our initial IH microarray. This debt issuance yielded net proceeds of $24.1 million after funding expenses of the offering which totaled $900,000 and required a $1.5 million addition to the offsetting long-term cash reserve account. On June 30th, accounts receivable totaled $4.7 million and inventory totaled $16.7 million. Capital expenditures totaled $1.1 million in the first quarter.
Now, moving to guidance. We are confirming previously provided guidance ranges for product revenues of $30 million to $31 million and an estimated operating loss of $77 million to $82 million. Estimated operating losses include approximately $18.5 million of non-cash expenses such as depreciation, amortization and stock compensation. Capital expenditures are still expected to be between $5 million and $10 million for the full fiscal year.
Other revenue estimates include $1 million of product development revenue of which $300,000 has already been earned during the second quarter and a balance, which is contingent upon completion of regulatory submissions and achievement of regulatory approval for certain additional products under development. As such, the receipt of this portion of the milestone payments involves risks and uncertainties.
For a full - excuse me, for our fiscal second quarter, we expect product sales in the range of $6.3 million to $6.7 million compared with $6.2 million in the second quarter of fiscal 2019.
Now, let me turn the call back to Franz.
Thanks, Chris. Over the next 6 months to 9 months, our expected regulatory milestones includes the completion of our first US field trials for each of the initial SDS, the expanded IH and the expanded SDS microarray, followed by submission in both the EU and the US.
Our commercialization strategy, which commenced last month, includes 9 hypercare sites in 7 countries in Europe. This plan includes the ability to place devices with customers using the initial CE mark IH microarray, but also to share the results of our menu expansion efforts for research purpose as soon as our technical risk is resolved.
In this case, the test results will not become the test of record, but the customers will be able to experience that ease of use and all the benefits that MosaiQ will offer before initially committing to attend the process. This will permit us to generate large datasets of performance studies in advance of full commercialization and also to allow potential customers to become familiar with and confident about their MosaiQ platform. We expect this approach to accelerate the adoption curve once approved products are available. While the ultimate timing of availability in the market depends on the regulatory review process, we hope to have both, the expanded IH and SDS microarray in the European market by the second half of calendar year 2020.
Europe represents a 21 million donation market opportunity, each one of which will require 2 microarrays in order to cover the first two testing modalities, blood grouping and Serological Disease Screening. It represents an approximately $300 million addressable market.
Obviously, a very significant near term opportunity and a significant cost saving opportunity for the European customers that implement this technology. Based on multiple studies using potential customer data, we estimate potential cost savings to be as much as 20% to 25% of their current total cost of testing.
In addition, later this year, we expect to bring forward independently derived performance data, demonstrating the effectiveness of our innovative approach to molecular disease screening, generated in a independent clinical setting. This study, which is planned and commissioned will commence later this summer. The timing of the publication of the results of this work may be impacted by the publication cycle within the organization conducting a study.
Once again, we expect that the performance results will provide confidence as to the ultimate donor transfusion diagnostic test menu, as well as underpinning the opportunity for Mosaic in the broader and much larger clinical diagnostics market.
So in summary, nothing has really changed except that we have significantly de-risked the technical aspects of the MosaiQ platform, as I anticipated we would when I spoke to you at this time last year. We are commencing tangible hands on customer interactions and continuing to make good progress on our menu expansion initiatives, which is the key to our competitive strategy of systematic, competitive platform replacement.
As I have said to many of you in the past, this will be a flow of decisive transformation of our initial target market. The change won't necessarily be fast, but like a train leaving the station, when it begins, it will be very hard to stop it.
In our initial target market, the advantage which MosaiQ offers remain very compelling and include a single, unified, testing platform from blood grouping Serological Disease Screening and ultimately for molecular disease screening, simplifying testing workflows and consumable management.
Also walk away automation, which is responsive to current and future shortage of qualified laboratory technicians. And in addition, the ability to comprehensively characterize all donor and patient blood, allowing for the better matching of donor blood to patients and cost savings resulting from the elimination of the vast majority of routine manual testing for blood grouping and from the multiplexing of multiple tests in parallel using a single donor sample and improved throughput and productivity as a clear leader.
Importantly, many of these advantages which will be available initially in transfusion diagnostics will also be big advantage in the central laboratory whenever a diagnosis is required and a panel of tests using multiple testing modalities in a single automated testing event necessary.
With that, I'd like to thank all of our employees and partners for their tremendous contribution towards the continued success of Quotient.
I will now ask the operator to begin the Q&A session.
Thank you. [Operator Instructions] Our first question comes from the line of Brandon Couillard with Jefferies. Please proceed with your question.
Hey. Thanks, good morning.
Good morning, Brandon.
Franz, it sounds like you've added one extra hypercare site to the 8 you initially - planned initially. Can you sort of speak to the level of interest in the program, your ability to service those sites and sort of the pacing of instrument placements at the other 8 counts kind of over the next few months?
Yeah, I mean, the term hypercare, I think, says it already. It's not a normal care where you have a service and attention to the customer, but hypercare means almost 24/7 you're reachable, the support to customer in testing this new technology. And given the resources we have, we think about that we have the capacity to do this for about 8 customers.
But then when it came to giving the hypercare sites away, first of all, they were gone within a few days. There was one additional customer who didn't take no for an answer and after long forwards and backwards, we said, okay, we take the risk. We take 9 instead of 8 and we make it happen, that it is a hypercare and we have an immediate and top support for the customers.
And if we see over time that maybe less support is needed, maybe we can add on one more. We wanted to play it safe. And with the 9 of it is now planned, we should be on - just a little bit stretched, but we should be able to do this properly.
And the first one is already up and running completed all the radio - all the testing and we got positive comments. I mean, what resonated well with me is, first of all, setting everything up to only 2 days. The customer said, normally with alternative platforms, it takes around 7 days to get everything up and running and trained. They were also impressed with the built-in quality assurance concept and with that the confidence they have in the testing results.
And I think all the compliments we got for the professionalism of our team. I mean, the team was really eager and couldn't hold their horses any more, but finally, finally go out and see a real customer and place this technology. So I think our team did a great job as well. So far, so good, and the others are getting ready. In the next six months 9 months, we will have the nine hypercare sites up and running.
Also, what came in, in addition, Brandon, if I may just add this in, we thought it would be actually great for us not only to test and give - to play around and become confident the initial IH microarray, but maybe also elevate the product which are in the pipeline, and the customer also wanted to have access to the latest available products.
So this gives us a unique opportunity to test work in progress and incorporate potential findings already and we wouldn't have, as a small organization, the capacity to generate these large datasets just on our own. So, I think it's a win-win situation for us. If that answers your question.
That’s great. It's very helpful. How many of those hypercare sites have technology out clauses, and then, if we just look at the broader competitive landscape using an introduction, you know, the [indiscernible] there's a new version of the PK7400 out there. Has this changed the competitive landscape at all or locked up any potential customers for an extended period in front of kind of the MosaiQ launch in your view?
I will give it a shot, and Chris, if I leave something out or you have some complementary information, please feel free to chime in. So I cannot talk to how many of these 9 sites have updated clauses, as I don't know by heart.
What I know though, all the customers where we would expect tenders over the next 12 months have either postponed their tenders or they have actually the right to upgrade to better technology. So it's a variation of it.
There - right now, actually no tenders taking place. Many of them have been postponed because the new technology is around and I think that's really to our advantage. So we will be happy if there are no tenders for the next couple of months that just helps us.
Then, I think the second question was a couple of new products from their competitors. Of course, I will resist the temptation to talk about competition, but if you remember, the value proposition of our technology is that we are able to do in a high throughput fashion, testing across several modalities and nothing has changed there on the competitive landscape. There is still no technology inside who can do testing across modalities.
Of course, every manufacturer comes once in a while for facelift, doing a little bit more of the same bit faster on a smaller footprint, but does not change anything on our original plan. And also, when we put our business plans together, we knew already the timing of our launch. And, we also knew when the competitors are coming with all the other products, so that's all already factored in. So from - without talking about competition, the original concept of MosaiQ, high-throughput multiplex microarray, cross modality, nobody else has that.
And the only thing I would add to that is I believe that the immunity [ph] in its most recent version is available - has been available in Europe for a couple of years. So our whole competitive strategy is completely informed by that awareness and it is definitely, a niche product for infectious disease testing.
Thank, Chris. Just one follow up. Sort of help us with the timeline of which we should expect in terms of VMD data for the expanded IH microarray and is the start of the US field trials still just kind of a function of aligning schedules and calendars here over the next few weeks?
Maybe I go quickly through the timeline. So from a research development perspective, the expanded IH and the expanded SDS, we continue to do this second half this year. We will move to field trials in Europe and in the US for the expanded IH in the second half '19. I'm always talking about calendar years.
For the EU and US as well for the expanded SDS, that's early 2020, also calendar year. And then, we will have a US field trial for the initial Serological Disease Screening microarray, that has already commenced last month. So that's already ongoing.
Then regulatory filing US, Europe expanded IH early 2020, calendar year 2020 with expanded SDS later in the first half of 2020. Then on top of that, it's not really a regulatory milestone, but we also expect later this year the results of the molecular disease screening research study proving that multiplexing is a technology lending itself for PCR testing as well. So I think these are the key catalysts you will see coming around. Did I leave any out, Chris?
No, no, but to that question, the next thing up will be VMD for our expanded IH. So just stay tuned.
Pretty good, thank you.
Thank you. Our next question comes from line of Josh Jennings with Cowen and Company. Please proceed with your question.
Hi, thanks. And congratulations on the continued progress. I was - wanted to just ask about the CE mark approval process for expanded IH and SDS and expanded SDS. With your work with a notified body for the initial IH menu approval, I mean, can you leverage some of that work on future submissions and should be thinking a potential streamline process or should be thinking standard timelines as those submissions come through?
I think the advantage is that the notified body is already now familiar with the technology, but still for our planning, we are conservative. We are planning or we factored in six to nine months approval time. It might be faster than that now as the first one went through, but then, if you go for an expanded menu, it's also more things to have to verify and to validate both the amount of paper - the paper amount will be much larger.
So to answer your question, yes, the notified body should know already a lot, but the menu is also significantly increasing, which gives them also more work to verify. It's difficult for me to tell. I think with the planning assumption six to nine months, we should be on the safe side.
Thanks. And thinking about the US and the initial field trials with the SDS menu. How many sites are you using for that field trial? Will they be the same sites for the expanded IH menu and expanded SD menu field trials as well?
Yes. Three sites and they will not be the same sites. So you can think of six sites getting exposure to the technology.
Great. And then - and just thinking about future submissions, are there differences between the SDS submissions in the US and the expanded IH menu. I believe, the SDS submission is 510(k) pathway, but I just wanted to - just hear that confirmed and then maybe just the timeline as you expect for once you submit...
You're absolutely right. You're absolutely right. They are different submissions. So for the IH expanded, that's a BLA. A BLA takes more time. In our planning, we factored in up to 18 months to get the BLA approval. The initial SDS is the only microarray which is only a 510(k). That's also the reason why we pulled forward the SDS field trials, sDS1, initial SDS field trial. So we can go for an 510(k) submission for the instrument and for the first microarray faster and we can - and then get a faster approval. So here for the, 510(k)s which is the instrument in the initial SDS, we factored in up to six months.
So - and then, if we have an FDA approval earlier than in the original plan, we can also start earlier discussing with customers, which we can't do, at least not the same content right now, and give it to them to test it out and become familiar and get their feedback as well.
Yeah, more hypercare. Hypercare is not only for the customers to feel confident, but it's also for us to get additional people working on the technology and giving us input much more than we could do just on our own.
Excellent. And so just in the US we should expect another hypercare type launch and any thoughts on any details there in terms of number of potential initial centers and with a lag time between the SDS approval and instrument approval, an expanded IH menu be about a year?
Yes, I think if we - it will be about a year late and like in Europe, for the real commercial success, we need the expanded IH and initial SDS. And that alone - in many of the presentations we showed, how the menu grow will allow the customers reduce complexity. So that alone, the expanded IH and initial SDS is already a valid business case in itself. Remember, the slides with the green line around it.
And then, of course, if we follow up with an expanded SDS that will be a fantastic upside. And if we - and the cherry of the top would be the MDS, and all the results we have so far on them, these are extremely promising, very good results. So we are confident that we will have a comprehensive menu.
Actually, my last question just on the tender schedule for the rest of the year in Europe, I believe, some tenders open up later in the year, maybe, October or beyond. Can you just refresh us just as you're within this hypercare launch, how you expect tenders to potentially roll through and how Quotient will or will not participate in them? Thanks for taking all the questions and congrats again
Yes, I think maybe just - and sure, everybody has the same reference, basic information. We had 250 contacts before the product was launched, individuals, professionals, and doctors over a 125 different accounts. There where 75 opportunities identified. And you know - that with every 5 to 7 years. That's where all the opportunities on the horizon and across 20 different countries.
Out of them, we identified hypercare sites, which are relevant for the tenders, yeah? So, I mean, we also teamed up with customers who have a tender coming up near or mid-term. And then from September, October onwards, we expect around 15 tenders.
Now, this is just what they told us. I mean, it's up to the liberty of the customers to postpone it again or to make another change, we don't know, but based on what we know no tenders right now will be September or October or later and then about 15 or around the corner for the following twelve months. And as I said before, the more they postpone, the later they become available, the better for us because our menu will progress in the meantime.
Great. Thank you.
And maybe just to add on for us, a big thing was after getting the CE mark also for the first microarray, we could, for the very first time, show it to customers. And so, MosaiQ had its debut at the ISBT in Basel that was 22nd to 25th of June. And we got a lot of traffic at ISBT.
There were like 2,400 attendees and 45 [ph] customer demos. And there were really fantastic quotes. I remember one was saying it's proof that the microwave technology works. It's no longer just a [indiscernible] dream.
So a very good response from customers, and now we can actually talk with them openly. We don't have to show. Only for input to development behind the curtain, the instrument is publicly visible. So big thing for us.
Thank you. Our next question comes from line of Sung Ji Nam with BTIG. Please proceed with your question.
Sung Ji Nam
Hi. Thanks for taking the question. Just a few clarification questions. So the hypercare sites in Europe, are they also - are some of them your field trial sites? I'm trying to figure out the overlap. Is there a full overlap essentially?
No. No overlap, but they have been selected in terms of what I mentioned before. Do they have any tenders coming up short or mid term? So they are all relevant tender sites.
And high quality sites.
Sung Ji Nam
Okay. And then, for the molecular essay, will there be an initial menu - an initial group of testing as well? Or will it be a pretty comprehensive list of...
It's most likely -- most likely, there will be an initial and then an expanded. They are five to eight tests which should be on there. And I think we will see how it -- it's too early to tell. But at least the five tests will be on it, and maybe we do then an expanded. But five tests is much better than just one test as it possible today. And the advantage of our technology is that, you don't have to do any polling.
I mean, for those on the phone not so familiar with the MDS process, for cost reasons because it's such an expensive technology normally to today that pools 16 to 20 samples from 16 to 20 different patients, donors rounded, and they do a testing. And if something turns positive, they have to go back and read through all the testing to find out which person was positive. It can also be multiple.
So in our case, because the microarray will be available for IH, SDS and MDS for every single patient, no pooling is necessarily. So you completely get around these additional cumbersome work step. The technology is of course, for us it doesn't matter whether there are one test, five tests, eight tests. It's the same price.
Sung Ji Nam
Great , and then Chris, could you give us an update of your cash burn expectation for the remainder of the year?
No change, right around $5 million in operating cash burn per month and that ties in with what we did in the first quarter, if you adjust for the non-cash portion of our expenses and $5 million to $10 million of CapEx the course of the year. And then, obviously, that service - and that service is running just now about $4 million a quarter, the cash part - the part that gets paid finally.
Sung Ji Nam
Great. Thank you so much.
Thank you. Ladies and gentlemen, that concludes our question and answer session. I'll turn the floor back to Mr. Walt for any final comments.
Thank you very much. And thank you, everybody for joining us on this call today. So Quotient, the effort continues to make considerable progress on MosaiQ, and we look forward to its initial commercial launch next year and in the mean time, thank you very much and all the best. Take care. Bye-bye.
Thank you. This concludes today's teleconference. You may disconnect your lines. Thank you for your participation.