T2 Biosystems Inc (TTOO) 2020 Q4 法說會逐字稿

Greetings. Welcome to T2 Biosystems Fourth Quarter and Full Year 2020 Earnings Conference Call. (Operator Instructions) Please note, this conference is being recorded.

It is now my pleasure to turn the call over to your host, 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. Forward-looking statements are based on estimates and assumptions as of today and are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied by these statements, including the risks and uncertainties described in T2 Biosystems' annual report on Form 10-K filed with the SEC on March 16, 2020, and other filings the company makes with the SEC from time to time.

The company undertakes no obligation to publicly update or revise any forward-looking statements except as required by law.

With that, I would like to turn the call over to President and CEO, John Sperzel. John?

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 improve the lives of patients around the world.

We are aware of the many lives being saved by usage of our sepsis panels, T2Bacteria, T2Candida 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, share 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 stayed true to our mission and maintained our focus on sepsis. The human and economic toll related to sepsis is staggering. Sepsis is the #1 cost of hospitalization and claims the lives of nearly 270,000 Americans each year. In 2020, the U.S. Department of Health and Human Services estimated that the cost of sepsis care for patients in hospitals and skilled nursing facilities was more than $62 billion.

The current standard of care for patients at risk of sepsis relies on empiric, probability-based protocols to administer antibiotics or antifungals despite the fact that such protocols are only optimal in 30% to 50% of cases. This is no better than a coin toss and is the antithesis of precision medicine.

To further complicate matters, nearly all diagnostic products used to detect sepsis-causing pathogens rely on positive blood cultures as their clinical specimen. Positive culture -- blood cultures are notoriously insensitive, may require multiple samples and can take 1 to 5 days to achieve the growth necessary to run post-culture molecular diagnostic tests.

We are steadfast in our commitment to drive adoption of our technology and ensure it is a critical part of the sepsis standard of care. The rapid detection of sepsis-causing pathogens is critical for patients as each hour of delayed treatment can increase mortality rate by up to 8%. Our aim is to change the current standard of care by enabling targeted therapy faster within 3 to 5 hours of the first blood draw. T2 Biosystems has the only FDA-cleared products able to detect sepsis-causing pathogens directly from whole blood that is culture-independent in just 3 to 5 hours. As a sepsis survivor, I can personally attest to the value of rapid detection and appropriate treatment of sepsis-causing pathogens.

In early 2020, we set 3 corporate priorities intended to strengthen our business: accelerating our sales, improving our operations and advancing our pipeline. As we enter 2021, we will continue to focus on these 3 corporate priorities building on our progress from last year.

Starting with our first priority, accelerating our sales. While 2020 product revenue was bolstered by sales of our T2SARS-CoV-2 tests, which represented 27% of total revenue, we are a sepsis-focused company. It is important to remember that our decision to develop and launch a COVID-19 test was a strategic decision intended to lay a foundation for the long-term growth of our sepsis products. We saw a clinical link between critically ill hospitalized COVID-19 patients and the risk of sepsis. We believe the hospital microbiology labs, the users of our sepsis products, would need a high-quality molecular diagnostic test for COVID-19.

Finally, we believed we could significantly increase our installed base of T2Dx Instruments within the microbiology labs of U.S. hospitals. We sold 57 T2Dx Instruments during 2020, including 47 in the second half to U.S. hospital microbiology labs, which more than doubled our U.S. installed base.

Total 2020 product revenue in the United States increased by 284% compared to the prior year. While the 47 new instruments are currently being used for COVID-19 testing at an annualized run rate of $265,000 exiting the fourth quarter of 2020, we will begin to transition these accounts to sepsis testing during 2021, in line with our expectation that COVID-19 testing in U.S. hospitals will decline throughout the year. Because this was our game plan from day 1, we prescreened these new customers during the initial sales process to ensure they were sepsis targets and to obtain commitments to evaluate our sepsis products when COVID pressures eased.

Simply stated, everything we have done with COVID-19 was strategically designed to facilitate adoption of our T2Dx Instrument and our sepsis panels. Our sepsis test utilization continued to increase throughout 2020 for both T2 Biosystems and T2Candida, our panels for bacterial infections and fungal infections, respectively. In 2020, the annualized sepsis test utilization among our legacy U.S. instrument installed base increased by 72% from $50,000 at the beginning of 2020 to approximately $86,000 exiting the fourth quarter.

For 2021, we have set 3 commercial priorities or key performance indicators: one, to transition instruments sold in the second half of 2020 from COVID-19 to sepsis testing; two, to increase sepsis test utilization in our legacy installed base; and three, to expand our T2Dx Instrument installed base.

Transitioning instruments that were sold into U.S. hospitals during 2020 from COVID-19 to sepsis testing is a critical part of our strategy and the top commercial objective for 2021. Our commercial team has already initiated conversations with new customers related to sepsis management, which is ahead of schedule.

Driving further adoption of our platform and transitioning accounts from COVID-19 to sepsis testing requires the right commercial strategy and the right team. During 2020, we named a Chief Commercial Officer as well as heads of U.S. sales and customer operations. In 2021, we added heads of marketing and service and expect to complete the rebuild of our U.S. sales team by the end of March.

Our regional account managers made the comprehensive effort that is required to sell sepsis technology into U.S. hospitals. A sale generally requires selling to the whole hospital, including decision-makers on a hospital sepsis committee, which typically includes representatives from the executive leadership, laboratory and clinical departments.

We are pleased to announce that we recently hired Dr. Aparna Ahuja as Chief Medical Officer. As a laboratory medicine expert, she has extensive relationships in the laboratory community and brings significant diagnostic experience from her prior senior leadership roles at Becton Dickinson. Dr. Ahuja will lead our medical and clinical affairs teams to raise the visibility of T2 Biosystems and increase awareness of the medical value of our products through generating critical and health economic data, creation of clinical education programs and focusing on educating clinicians on the use of T2 Biosystems products. She will also lead the development of a scientific advisory board and develop and maintain collaborative relationships with key opinion leaders as well as professional associations. We're confident that her leadership will help raise T2 Biosystems' visibility within the laboratory community.

Moving to our second priority, improving our operations. Early in 2020, we implemented cost savings initiatives across the business, which resulted in reductions in our cost structure, head count and real estate footprint. We are making progress with a number of initiatives aimed at improving product gross margins through reductions in cost of goods. We also saw significant increases in unit volume during 2020, which had a favorable impact on overhead absorption. And we scaled our manufacturing fourfold to meet increased demand.

To maintain uninterrupted supply of our products to customers throughout the pandemic, we formed strategic partnerships with key suppliers, which we believe will be beneficial in the future.

Finally, we strengthened the balance sheet by raising $85.3 million through the sale of common stock, and we renegotiated the terms of our credit facility with CRG. In 2021, we will continue to prioritize improvement in product gross margins.

Moving to our third priority, advancing our pipeline. We made significant progress on our new product pipeline during 2020. In March, we made the decision to develop a test to detect SARS-CoV-2, the virus that is responsible for COVID-19 infections. While this product was not on our radar screen when we started the year, our team developed and launched a high-quality molecular diagnostic test, the T2SARS-CoV-2 Panel, under FDA emergency use authorization guidelines in less than 3 months. We subsequently determined that the T2SARS-CoV-2 Panel is capable of detecting SARS-CoV-2 virus variance, including those identified in the United Kingdom, South Africa and Brazil, along with 99.99% of all currently identified variants based on sequence alignments and in silico analysis.

We continue to prioritize programs under the milestone-based product development contract awarded by the U.S. government or BARDA in late 2019. As a reminder, total funding available under the BARDA contract is up to $69 million, and we're focused on developing 3 new products: a next-generation instrument, a comprehensive sepsis panel and a biothreat panel.

Our next-generation instrument is designed to be fully automated and random access like our current T2Dx Instrument yet will provide faster turnaround times at a lower cost per reportable result. The instrument is also being designed to detect an increased number of pathogens from a single whole blood sample.

The comprehensive sepsis panel is designed to cover up to 99% of all blood-borne infections and detect more than 250 species, in addition to all blood-borne antibiotic resistance threats identified by CDC, in a single test. The test is designed to use a whole blood sample and have a turnaround time of less than 3 hours. We believe this comprehensive sepsis panel has the potential to totally disrupt the traditional blood culture workflow and become the new standard of care.

The biothreat panel is designed to be the first highly sensitive, direct-from-blood panel to detect multiple biothreat pathogens from a single patient sample.

The BARDA contract includes a base phase and 6 options. We completed the base phase during the third quarter of 2020 and met all milestones. This progress led BARDA to exercise option 1 of the contract in October 2020 valued at $10.5 million in funding. We continue to meet the milestones of the contract and are operating ahead of schedule and under budget.

Now I'll turn the call over to John Sprague to detail the fourth quarter financials.

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, Candida 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 product contracting 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 were $4.6 million, a decrease of $3 million driven by lower head count 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 for the prior year period. Total cash, cash equivalents, marketable securities and restricted cash were $52.7 million as of December 31, 2020.

2021 financial outlook. We expect full year 2021 total revenues of $24 million to $26 million, including product revenues of $16 million to $18 million and research and contribution revenues of $8 million. We expect to close at least 30 T2Dx Instrument contracts in 2021, aligning with our focus to transition new accounts from COVID-19 to sepsis testing, increase sepsis test utilization in the current installed base and to add strategic new customer contracts.

Thank you, and back to John Sperzel for closing remarks.

We built considerable momentum during 2020 with strong demand for our products. We more than doubled both our total product sales and our U.S. 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 U.S. government.

We're extremely excited about the future of T2 Biosystems and confident in our ability to lead the culture-independent molecular diagnostic sepsis testing market.

We'll now open it up to questions. Operator?

(Operator Instructions) Our first question comes from Puneet Souda with SVB Leerink.

This is Westley Dupray on for Puneet this afternoon. 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 puts us at the $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.

Sure. I'll take that. This is John Sperzel. We anticipate our COVID testing being 70% front half of the year, 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 1 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 2 funded by BARDA as well.

Great. And then I guess as a quick follow-up, are you -- 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 that 30 plus, if you still are pursuing COVID, how much of that can we expect to be sepsis right away?

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 U.S. 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.

Great. And then just last one on the commercial sales force. 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 efforts to move throughout the year?

We managed the business in the second half of 2020 with a leader, a senior director of sales as well as 2 regional account managers. As I had mentioned previously, we had a lot of inbound interest, 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.

Next question, Max Masucci with Canaccord Genuity.

So we're more than -- we're 3 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, if 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.

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 even 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 hospital's 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 U.S. 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.

Great. And then that 70-30 split between first half, second half, I would imagine that's for COVID testing sales. But how should we be thinking about pacing of instrument placements even just first half versus second half?

I think about instrument -- the instruments similar to the COVID testing, maybe 30% in 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 instrument sales in the second half. That's why I think about that 30-70 weighing on instruments, too.

Sepsis, on the other hand, is going to ramp as we get into the second half of the year for the reasons I just mentioned earlier.

Okay. Great. And then just it's global pandemic, so each country, each region will have their own level of success with vaccine rollout. So 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.

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 specialists 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 U.S. 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 U.S., 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 Werfen Group, who was our previous distributor in Spain and Portugal, we renewed that agreement longer term, and we also added the U.K. And if you're familiar with the Werfen 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.

Next question, Mark Massaro with BTIG.

I guess I wanted to ask about the placement guidance for at least 30. So 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?

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 U.S. 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.

Okay. And then I think the commentary around the 70-30 mix, just to clarify, I believe that was just for COVID testing. But I don't think I heard you quantify the total pie of COVID testing versus sepsis testing in 2021. Is there any way to provide greater clarity?

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.

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

Sure. So that program, we obviously started it in, I think, the fourth quarter of 2019. It runs through 2024. There are 7 pieces to it. As I mentioned before, there's a base phase and 6 options. We're getting close to the midpoint of option 1, which was the $10.5 million in funding we announced. There is a very substantial statement of work for each one of those programs that has specific milestones throughout the, call it, 6- to 9-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.

Next question comes from Ben Haynor with Alliance Global Partners.

First for me, just kind of recognizing that you've got the conversions to do. First off, where do you kind of see the T2 sepsis utilization run rate exiting this year, if you can share kind of what your thinking is there?

So Ben, here's how we're thinking about that. We started the year with 41 instruments in the U.S. They were all running sepsis panels. We added 47 instruments in the U.S. in the back half of the year. And let's just assume at the end of the year, they were 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 2 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 a good objective for the company -- I don't think that we'll get there yet in 2021, is that our sepsis accounts should consume approximately $200,000 in tests annually. That is still our long-term goal.

Okay. That's fair, and I understand the bifurcation there. And I was just hoping that you could kind of walk us through what that conversion process looks like as an individual account. Your salespeople are going in there, holding hands. How long do you expect that takes on average? Just any more color on how you see that process playing out would be very helpful.

So first, it's 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 data set already. Under Aparna'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 targets.

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

It's a mix. It's a mix.

Okay. All right.

We sold 47 instruments. On average, accounts have 1.3 instruments. So some people have more than one, and that can create some capacity early on in the year, which is great.

Got it. And then maybe a point of clarification on the 30-plus instruments. I assume that's just U.S. Is that correct? Or does that also include international placements, let's say?

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

But the 30 number includes that worldwide then?

That's the number, yes.

Okay. Got it. And then just I guess finally for me, any expectation that we'll hear more on T2Lyme and then a potential partner there or the development and commercialization of that test here this year?

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 a better Lyme diagnostic test, 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's a possibility that funding exists to advance Lyme diagnostics in general. And we'll pursue that if it becomes available.

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

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.

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