T2 Biosystems, Inc.
Q4 2020 Earnings Call Transcript

Published: 4 Mar 2021

[Operator:]

Greetings. Welcome to T2 Biosystems Fourth Quarter and Full Year 2020 Earnings Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. Please note, this conference is being recorded. It is now my pleasure to turn the call over to your host, Philip Taylor.

[Philip Taylor:]

Thank you, operator. I'd like to remind everyone that comments made by management today and answers to questions will include forward-looking statements. Those include statements related to T2 Biosystems' future financial and operating results and plans for developing and marketing new products.

[John Sperzel:]

Thank you all for joining us today. I want to start by thanking the team at T2 Biosystems for their resilience throughout the pandemic and for their unwavering commitment to our customers and the patients we serve. Last year, we made meaningful progress toward our mission to fundamentally change the way medicine is practiced through transformative diagnostics that improved the lives of patients around the world. We're aware of the many lives being saved by usage of our sepsis panels T2Bacteria, T2Canada and T2Resistance. This is a reminder of why T2 Biosystems exists. We believe our products can become the standard of care for the detection of sepsis-causing pathogens, improve patient outcomes, reduce the threat of antibiotic resistance, and drive long-term sustained growth. On today's call, I will highlight the company's strong fourth quarter and full year 2020 performance, show details on the progress within each of our 2020 priorities, and update our 2021 priorities to guide our continued success. I will then turn the call over to John Sprague, who will review our financial results and provide 2021 guidance before I make some closing remarks, and we open the call for questions-and-answers. During the fourth quarter, the T2 Biosystems' team generated total revenue of $7.8 million, including product revenue of $5.8 million, representing growth of 154% and 273%, respectively, compared to the prior year period. For the full year 2020, we generated total revenue of $18.1 million, including product revenue of $11.7 million, representing growth of 118% and 119%, respectively, compared to the prior year. Each of those financial accomplishments represented record highs for the company. As we look back at 2020, there are many factors that made the year extremely successful. We made broad changes across the organization. We added deep clinical and commercial experience as well as diversity to our Board of Directors. We strengthened our Senior Leadership Team, reduced operating costs across the company, scaled our manufacturing, advanced our product pipeline and significantly improved our balance sheet. Throughout the pandemic, we stay true to our mission and maintained our focus on sepsis.

[John Sprague:]

Thank you, John. Total revenue for the fourth quarter of 2020 was $7.8 million, an increase of 154% compared to the prior year period. Product revenue for the fourth quarter of 2020 was $5.8 million, an increase of 273% compared to the prior year period, driven by increased sales of T2Dx instruments and T2Bacteria, T2Canada and SARS-Cov-2 test panels. Research and contribution revenue for the fourth quarter of 2020 was $2 million, an increase of 30% compared to the prior year period, driven by increased BARDA contract activities. For the fourth quarter of 2020, product costs were $7.5 million, an increase of $3.9 million compared to the prior year period, driven by increased product sales. Research and development expenses were $4 million, a decrease of $200,000. Selling, general and administrative expenses are $4.6 million, a decrease of $3 million driven by lower headcount and spending. Net loss for the fourth quarter of 2020 was $9.9 million, $0.07 per share, compared to a net loss of $14 million, $0.29 per share prior year period.

[John Sperzel:]

We built considerable momentum during 2020 with strong demand for our products. We more than doubled both our total product sales and our US installed base of instruments compared to the prior year. We took actions to improve our overall cost structure, while simultaneously scaling our manufacturing and significantly improved our balance sheet. We advanced our new product pipeline, including the comprehensive sepsis panel and next generation instrument, both of which are largely funded by the US government. We're extremely excited about the future of T2 Biosystems and confident in our ability to lead the culture-independent molecular diagnostics sepsis testing market. We'll now open it up to questions. Operator?

[Operator:]

Thank you. We will now be conducting a question-and-answer session. Our first question comes from Puneet Souda with SVB Leerink. Please go ahead.

[Westley Dupray:]

Hey, guys. This is Westley Dupray on for Puneet this afternoon. Thanks for taking the questions. Just wanted to start on the guide, hoping to dig in a little bit more on the cadence of the revenues throughout the year. Can we still expect to see some type of COVID tailwind in the first half of the year? And just curious as well on the cadence of the research revenues, how much visibility is there into that I mean, $2 million in the fourth quarter of this year, put this up to $8 million clip rate that you have in the guide. So I'm just curious if you can give us a little more information on that.

[John Sperzel:]

Sure. I'll take that. This is John Sperzel. We anticipated our COVID testing being 70%, one half of the year and 30% second half of the year. And we expect to ramp our sepsis testing in the second half of the year as we transition those new instruments that we sold in 2020 from COVID testing to sepsis testing. In terms of the BARDA revenue, that's pretty much in line with where the contract is at this point. Obviously, there's $10.5 million in funding for option one that we announced in October of 2020. There is - that's expected to run through the third quarter of 2021. And then obviously, we're hopeful to get option two funded by BARDA as well.

[Westley Dupray:]

Great. And then I guess as a quick follow-up, of the 30 and 30 plus instruments that you're expecting to contract throughout the year, are you still actively pursuing the COVID opportunity with new accounts or existing accounts? And I guess of the 30 plus, if you still are pursuing COVID, how much of that can we expect to be sepsis straightaway?

[John Sperzel:]

We continue to sell our instrument and test both for sepsis and COVID. As I mentioned in the opening remarks, we're primarily focused on sepsis testing, but to the extent we can continue to penetrate the microbiology labs of US hospitals, on the back of COVID, we will continue to do that. We obviously see the demand lightening up for COVID testing across the country. And we anticipate that at some point impacting the hospital testing as well.

[Westley Dupray:]

Great. And then just last one on the commercial salesforce. Can we expect any expansion here? I guess like what's the plan heading throughout the year? And then, if many new reps are coming on Board, how can we expect that or how can we expect the trajectory of the sales effort to move throughout the year? Thank you.

[John Sperzel:]

We manage the business in the second half of 2020 with a leader, our Senior Director of Sales as well as two Regional Account Managers. As I had mentioned previously, we had a lot of inbound interests stronger in Q3 than it was in Q4 for our instruments and our COVID tests. And we didn't feel it made sense to build too early in the second half of the year, as we got into Q4, we started to rebuild the sales team. The plan is to have 10 Regional Account Managers by the end of this quarter. I believe we have 7 in place already. So we're well on our way to get that done. And we've actually started the training for those 7. It's actually ongoing today.

[Westley Dupray:]

Great. Thanks, John.

[Operator:]

Next question, Max Masucci with Canaccord Genuity. Please go ahead.

[Max Masucci:]

Hey, guys thanks for taking the questions. So you know, we're more than, you know, we're three months into the first quarter. Just curious what you're seeing in terms of demand trends, if we could just go a little bit deeper, just for COVID-19 testing in the hospital lab channel? And then, if we could just talk about even directionally, you've seen any noticeable changes from that $265,000 annuity per analyzer for instruments that are running your COVID-19 panel? Anything that you've observed so far in 2021 that would be helpful. Thanks.

[John Sperzel:]

We haven't seen much change in the utilization on our COVID test across the whole business, it's somewhat dependent on whether we're the primary supplier of COVID test to a hospital or whether we might be the secondary or even the tertiary supplier of COVID test, obviously, where we're second or third, we're more impacted if that hospitals testing declines. If we're the primary, then it really kind of depends. And if you look at our installed base of instruments that we sold in the second half of the year, it's 50% of the time we're the primary supplier, and the other half of the time we're either secondary or tertiary. When we think about demand for COVID testing in 2021, I think it's important to remember, that we're only selling our test to US hospitals. Ours, obviously is a PCR test. So it's used to detect acute infections for people within the hospital. And because of that, we're not really affected by the back-to-work, back-to-school, back-to-sports sort of back-to-normal testing that's going on. So the demand for our test is much more likely to mirror COVID-related hospital admissions, which are expected to decrease throughout 2021. And we're seeing some of that already. And then on the other side, which is probably more of a tailwind, is an increase in elective surgeries, which are expected to increase throughout 2021. And then, I guess the last thing I would say on that, Max is, our decision to launch the COVID test, as I mentioned earlier, was intended to lay a foundation for long-term growth of our sepsis products. So we anticipated this, it was always part of our game plan. The idea was to get a bigger footprint in these microbiology labs, and at some point in 2021, start to transition that. We're able to actually start that process earlier than we thought given what's happening with COVID testing across the country.

[Max Masucci:]

Great, and then that 70

[John Sperzel:]

I think about instruments, the instruments similar to the COVID testing, maybe 30%, the first half, 70% in the back half. And the reason I say that is, our sales team is going to spend a significant amount of effort converting those 47 instruments to sepsis. We're not going to get them all done this year, we don't believe, but a big part of their effort is going to be that conversion and driving test utilization of sepsis. And it will shift a little bit more as we get well into that into driving new instruments sales in the second half. That's why I think about that 30

[Max Masucci:]

Okay, great. And then just, you know, global pandemic, so each country, each region will have their own level of success with vaccine rollout. So you know how are you thinking about international opportunity? That's the question number one. And then number two, can you just give us an idea of the types of backgrounds for the new sales professionals that you're hiring? And that's it for me. Thanks, guys.

[John Sperzel:]

I'm going to take the sales team first and their backgrounds and then I'll get to international. We're hiring experienced diagnostic folks from notable diagnostic companies. And, in particular, we're making sure that the people have had success selling into the hospital environment, it's much different than selling in the primary care or to the retail environment, because it requires a system wide sale, it requires somebody that can act as a point guard or a quarterback to go into an account, identify the key decision-makers, the key influencers, and bring them together, as well as bring in our support team, whether it's the medical science, liaisons or our clinical application specialist to support that process. And we've had really good success doing that I'm really happy with the caliber of sales reps that we're bringing into the company. And I personally interview every single one of them. On the international front, we said going into 2020, that 80% of our effort would be focused on the US market commercially. And that's exactly what we did. And that's why you see the outstanding results in terms of sales growth from prior year, instrument sales, doubling the installed base, so that those results reflect our effort and our focus. We said on the international side of things that we would be opportunistic with the time that we invested there, that we would continue to support our distributors in the region, many of which were doing a terrific job, obviously, many of which were affected by COVID and the shutdowns that impacted Europe even before they impacted the US. And that we would also look for a pan-European partner, if we could find one, or one that got us closer to a pan-European distribution strategy. And I'm really happy to say that the who was our previous distributor, in Spain and Portugal, we renewed that agreement, a longer-term. And we also added the UK. And if you're familiar with the Wellcome Group, they are an outstanding very large partner that has a presence not just in the United States with companies that are part of their portfolio, but a very, very strong distribution arm in many parts of Europe.

[Max Masucci:]

Great. Thanks, John.

[John Sperzel:]

Thank you, Max.

[Operator:]

Next question, Mark Massaro with BTIG. Please go ahead.

[Mark Massaro:]

Hey, guys. Thanks for taking the questions. I guess I wanted to ask about the placement guidance for at least 30. So, you know, John that is the lowest level since 2017. So I guess I'm trying to understand how you came up with the number 30 given that in 2019, pre-pandemic, you placed 45?

[John Sperzel:]

Well, as I mentioned, Mark, we said at least and we're also focused on the conversion of 47 new instruments from COVID testing to sepsis testing. So I understand what the company did in the past. But the company never had 47 new customers that they were trying to convert to sepsis testing. And I will say that the past experience in winning customers for sepsis have been prolonged, one of the biggest obstacles in that process was getting a piece of real estate, a footprint in the microbiology lab and getting the support of the people that are responsible for the microbiology lab. So we're going to start that process in a really good place, because all 47 of those instruments are sitting in microbiology labs in US hospitals, all 47 of them were purchased with capital. And also those customers bought a service contract. So they've made an investment in our technology platform. And they've also made a verbal commitment to evaluate our sepsis panels when they have the bandwidth. So we feel really good about all that. But we also know it's going to take some bandwidth of our sales team. If that process goes faster, and we're more successful with it, then, hopefully we can move the instrument number throughout the year. But we have to stay focused on that conversion process as we start the year.

[Mark Massaro:]

Okay, thanks for that. And then, you know, I think the commentary around the 70

[John Sperzel:]

We didn't break that out, Mark, but I think that the COVID testing will be 70% front loaded, 30% in the second half. The sepsis testing is likely to be 30% front half, 70% second half and that's just because of growth in the instruments I mentioned, are going to likely be 30% first half, 70% second half, because of the emphasis on that conversion process in the early part of the year compared to new instrument sales.

[Mark Massaro:]

Okay, thank you. And my last question, can you just give us greater clarity around the milestones associated with the development of the next-gen T2Dx instrument?

[John Sperzel:]

Sure. So that program, we obviously started it in, I think the fourth quarter of 2019, it runs through 2024. There are seven pieces to it. As I mentioned before, there's a base phase and six options, we're getting close to the midpoint of option one, which was the $10.5 million in funding, we announced. There was a very substantial Statement of Work for each one of those programs that has specific milestones throughout the, call it, six-month to nine-month phase. So we generally are not public with those, we'll announce when we complete the option. And we'll announce when we get the next funding, as we get closer to the commercialization and initiating the clinical trial, for example, is within that window, those obviously would be material events that we would announce as well.

[Mark Massaro:]

Okay, thank you.

[John Sperzel:]

Thank you, Mark.

[Operator:]

Next question comes from Ben Haynor with Alliance Global Partners. Please go ahead.

[Ben Haynor:]

Good afternoon, gentlemen. Thanks for taking the question. First, for me, just to kind of estimate I mean you got the conversions to do. You know, first off, you know, where do you kind of see the T2 sets of utilization run rates exiting this year, if you can, you know share kind of what your thinking is there?

[John Sperzel:]

So, Ben here's how we're thinking about that. We started the year with 41 instruments in the US, they were all running sepsis panels. We added 47 instruments in the US in the back half of the year and let's just assume at the end of the year, they're all running COVID tests. And so it starts to get convoluted, if we just talk about full number of instruments and utilization. So we're going to sort of bifurcate those two things, we're going to continue to track increasing utilization in that legacy installed base call it those 41 instruments and then we're going to track very closely the transition from COVID testing to sepsis testing in those new instruments. And then, of course, we'll track any additional new instruments that we sell in 2021. So we're going to do that separately, that makes it pretty difficult for me to sit here today and say, here's the number at the end of the year for sepsis, because we have to run through that process. What I can tell you is, we still believe strongly that a good baseline and then a good objective for the company, I don't think that we'll get there yet in 2021 is that, our sepsis account should consume approximately $200,000 in test annually. That is still our long-term goal.

[Ben Haynor:]

Okay, that's fair I mean I understand the bifurcation there. And I was hoping that you could kind of walk us through, you know what that conversion process looks like as an individual account. You know, your sales people are going in there, holding hands, you know how long do you expect that that takes on average, you know, just any more color on how you see that process playing out will be very helpful.

[John Sperzel:]

So first just going to start with data. Having the right clinical and economic data is going to be a really important part of that sales process, because that's what clinicians and laboratorians make their decisions based on. We have a pretty substantial dataset already. Under our partner's leadership, we're going to improve the way we present that to customers. And we're going to continue to build on that as well. But this is about sales execution and blocking and tackling. That's why having the right team to go out and do that is a really critical part of that process. We're going to start with the new accounts that we sold instruments to under COVID. As soon as they have bandwidth to start the transition to sepsis, they will be our initial target.

[Ben Haynor:]

And do you expect those to be the kind of the 50% where you're not the primary supplier for COVID testing?

[John Sperzel:]

It's a mix -

[Ben Haynor:]

The transition first.

[John Sperzel:]

It's a mix. We sold 47 instruments, on average accounts have 1.3 instruments. So some people have more than 1 and that can create some capacity early on in the year, which is great.

[Ben Haynor:]

Yeah, that's and then maybe a point of clarification on the 30 plus instruments. I assume that's just US. Is that correct? Or does that also include international placements?

[John Sperzel:]

It's going to be predominantly US. Again, we're going to be opportunistic on international.

[Ben Haynor:]

The 30 number includes that's worldwide then?

[John Sperzel:]

That's the number. Yes.

[Ben Haynor:]

Okay, got it. And then just, I guess finally for me, with the expectation that that will gear more on T2Lyme and, you know, potential partner there or you know, the development and commercialization of that past year, this year?

[John Sperzel:]

What I can say about T2Lyme, as we've discussed in the past is, we've developed a really great test, it's super sensitive, it's shown very promising performance. I think there's a significant market need for better Lyme diagnostic tests. And we're considering options on how we move that forward. The only thing I'll remind is that, our priority is sepsis. And we're not going to exhaust resources on Lyme at the expense of sepsis. If you look at what is being discussed and funding that's being applied, I think there is a possibility that that funding exists to advance Lyme diagnostics in general. And we'll pursue that if it becomes available.

[Ben Haynor:]

Okay, got it. Thanks for taking the question, gentlemen.

[Operator:]

Thank you. I would like to turn the floor over to John Sperzel for closing remarks.

[John Sperzel:]

Thank you very much for joining our Q4 and full year 2020 earnings call. We look forward to providing you updates throughout the year. Have a great night.

[Operator:]

This concludes today's teleconference. You may disconnect your lines at this time and thank you for your participation.