5/11/2021

speaker
Operator

Good day and thank you for standing by. Welcome to the Biodesic's first quarter 2021 earnings conference call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you'll need to press star then 1 on your telephone keypad. Please be advised that today's conference may be recorded. If you require any further assistance, please press star then 0 to reach an operator. I'd now like to hand the conference over to your host today, Chris Brinzey, Investor Relations. Please go ahead.

speaker
Chris Brinzey

Thank you, Operator, and good afternoon, everyone. Thank you for joining us today for a discussion of Biodesic's first quarter 2021 business highlights and financial results. Leading the call today will be Scott Hutton, Chief Executive Officer. He will be joined by Robin Harper-Cowie, Chief Financial Officer. After the prepared remarks, we will open the call for Q&A. An audio recording and webcast replay for today's conference call will also be available online as detailed in the press release announcement for this call. Today we issued a press release announcing our business highlights financial results for the first quarter 2021. A copy of the release can be found on the investor relations page of the company website. Actual events or results may differ materially from those projected as a result of changing market trends, reduced demand, and the competitive nature of biodesics industry. Such forward-looking statements and their implications involve known and unknown risks, uncertainties, and other factors that may cause actual results or performance to differ materially from those projected. The forward-looking statements discussed on this call are subject to other risks and uncertainties, including those discussed in the risk factor section and elsewhere in the company's annual report on Form 10-K for the year ended December 31, 2020, filed with the Securities and Exchange Commission on March 16, 2021. Additional information concerning factors that could cause results to differ materially from our forward-looking statements are described in greater detail in the company's press release issued today. and in the company's filings with the SEC. I would now like to turn the call over to Scott Hutton, Chief Executive Officer. Scott?

speaker
Scott Hutton

Thank you, Chris, and welcome everyone to Biodesic's first quarter 2021 earnings conference call. We were pleased with our operating and financial performance in the first quarter and believe we're off to a solid start in 2021. Beginning with a high-level overview of our financial performance, we reported record revenue of $28.9 million in the quarter, which represented year-over-year and sequential quarterly increases of 466% and 7% respectively. Robin will go into more detail, but this comes on the heels of another record quarter from our COVID-19 testing services revenue, which grew 8% over the fourth quarter of 2020. As many of you know, our COVID-19 offering was developed in response to the public health emergency and has been driven by the need for quality, rapid testing that could be delivered quickly and reliably. We were compelled to respond to the pandemic and our COVID-19 testing services quickly became a strong source of revenue growth for Biodesics. While the overall rate of testing in the U.S. is tapering off due to the availability of vaccines and readily available retail at-home testing options, we continue to work to support communities both locally and across the country by expanding our WorkSafe COVID-19 testing program. Biodesics continues to perform on-site rapid antigen testing for schools, athletics, and employers to quickly identify potential cases that are then reflexed to our highly accurate PCR testing for confirmation and validation. Over the last year, we nimbly addressed the evolving challenges of the pandemic and are proud that we continue to do so. Recently, we announced a partnership with Genscript Biotech to conduct performance verification in our laboratory and commercialize its CPAS SARS-CoV-2 neutralization antibody test. This is the first and only surrogate neutralizing antibody test with FDA EUA authorization. The current vaccines are highly effective at generating antibodies against the viral spike protein when administered as recommended. However, Despite significant research and clinical advances made to combat the SARS-CoV-2 virus, the emergence of new variants and community outbreaks are of continued concern. Neutralizing antibodies may specifically block the interaction between the receptor binding protein on SARS-CoV-2 and the host cell's membrane receptor protein, thereby preventing infection of the cell by the virus. In essence, the test has the potential to identify individuals who may have antibodies capable of preventing the virus from infecting the cells. We believe that the CPAS test could be important in understanding long-term protective immunity to SARS-CoV-2. This test is currently available for research and biopharma services work, and announcements about the commercial launch of the test in our WorkSafe program will be forthcoming. In many respects, our role in the global pandemic has increased the public's awareness of Biodesics and who we are, a trusted partner that the world can rely on for data-driven diagnostic solutions that improve patient outcomes, lower healthcare costs, and deliver results quickly with the goal of improving patient outcomes. Biodesics remains focused on our core business, which includes solving complex diagnostic challenges in lung disease and for our biopharma partners. This focus represents a large US target addressable market that we estimate is greater than $29 billion. We utilize multiple technologies, including genomics, transcriptomics, proteomics, and radiomics, and leverage our proprietary AI-based diagnostic cortex platform to discover innovative diagnostic tests for clinical use. The company has six diagnostic tests commercially available, each of which intends to solve complex diagnostic challenges in lung disease and provide best-in-class turnaround times while reducing cost by eliminating unnecessary tests and procedures. Our Notify XL2 and Notify CDT tests are used to assess the risk of lung cancer for patients presenting with lung nodules and to help physicians identify the most appropriate treatment pathway. Our Genistrat and Veristrat tests are ordered by physicians following diagnosis of lung cancer to measure the presence of mutations in the tumor in addition to the state of the patient's immune system to establish the patient's prognosis and help personalize treatment decisions. In our lung diagnostic testing, we were pleased to see our first quarter revenue increase both year over year as well as sequentially above the fourth quarter of 2020. This business does, however, continue to be adversely impacted by the global pandemic as pulmonologists have redirected time and efforts to treat patients with COVID, and they have limited clinic volumes. However, this quarter, we did begin to see a shift that suggests pulmonologists are beginning to see more non-COVID-19 patients and expect this to continue throughout the course of the year, barring additional spikes and changes in the pandemic. As we focus on the recovery and our growth expectations, we continue to invest in our sales infrastructure and remain on track to double the size of our direct and dedicated sales force in 2021. The expanded sales force will better allow us to reach more physicians and provide them with a portfolio of tests to provide personalized information on their patients. This information will aid the physician in making educated decisions to direct the right patient onto biopsy or surgery and help many more avoid unnecessary interventions and guide treatment decisions. One of the most exciting recent developments is our new liquid biopsy next-generation sequencing test. The test was shown in a recent publication to have an unprecedented 72-hour turnaround time, which is significantly faster than the 7 to 14 days it takes for other NGS tests on market. Time to treatment for patients with cancer is critical, and we strive to provide reliable blood-based tests as quickly as possible to support our physicians and their patients. The NGS test will complement the Genistrat DDPCR test and Veristrat proteomic test currently offered, with the expanded coverage of broader molecular markers. The 52-gene NGS test will be intended for use in patients diagnosed with advanced, late-stage, or recurrent cancer, while the targeted ala carte Genistrat DDPCR test measuring six genes individually can be used for identification of the select mutations in all stages of disease and for treatment guidance, recurrence monitoring, and detection of the development of resistance mutations over time. Over the last year, we've cut the turnaround time of Genistrat and Veristrat in half, from 72 hours to 36 hours, furthering our commitment to provide high-quality test results as quickly as possible. The NGS test has been available for research and clinical trial use since 2018, and we plan to launch the test for commercial use in the first half of 2022. We'll provide more details in the months leading up to commercialization. We also continue to support the use of our diagnostic test by adding to the body of evidence demonstrating their utility and value. This remains a key component to our business and drives both clinical adoption and reimbursement. In April, we announced three abstracts from multiple clinical studies on our primary immune response and varistrat test, which were presented at the 2021 Association for Cancer Research Annual Meeting. These abstracts reflect our commitment to continual research and address the utility of physicians utilizing blood-based proteomic testing as an approach to support their treatment decisions with the ultimate goal to improve patient outcomes. We also partner with academic institutions, biopharma, technology, and diagnostic companies to provide research, clinical trial testing, and new companion diagnostic discovery and validation services. With significant ongoing partnership and research activities at Biodethics, we will continue to strengthen and broaden our position in the market, executing a deliberate patent strategy. We recently announced the issuance of two new patents that enhance our ability to develop blood-based immunotherapy and pipeline testing strategies. Patents have historically driven the biotechnology industry forward, but conversely have become more difficult than ever to obtain. Our recent issuances across diverse technology fields is good news in light of the increasingly fast-paced diagnostic sector. These developments further improve Biodesic's ability to develop and commercialize rapid and accurate diagnostic testing to support physician treatment decisions and strategies for their patients. Now let me turn the call over to Robin to discuss the first quarter financial performance.

speaker
Chris

Thank you, Scott. Our first quarter revenue was $28.9 million compared to $5.1 million for the first quarter of 2020, representing an increase of 466% and an increase of 7% over the $27.0 million reported in the fourth quarter of 2020. Both year over year and quarter over quarter revenue improvement continues to be fueled by our successful entry into COVID-19 testing services, which has enabled us to diversify our portfolio during a period of expected downturn resulting from the global pandemic. Our COVID-19 testing services revenue was $23.2 million in the first quarter of 2021. Since this business began in the second quarter of 2020, there is no meaningful year-over-year comparison. However, sequentially, our COVID-19 testing revenue grew 8% over the fourth quarter of 2020. The increase in revenue was driven by volumes from existing and new customers and we continue to expect meaningful contribution during the second quarter of 2021. While COVID-19 testing services played an important role in our overall revenue growth during the quarter, we are particularly pleased with the improved trends in lung diagnostic testing. Our lung diagnostic revenue was 4.0 million in the first quarter of 2021, compared to 3.6 million for the first quarter of 2020, representing an increase of 10% and an increase of 8% over the 3.7 million reported in the fourth quarter of 2020. As you know, our primary call point in lung diagnostic testing is the pulmonologist, who have been particularly impacted by the pandemic as they have been pulled into ICUs and ERs to treat patients with COVID-19. Although we expect pulmonologists to continue to be impacted by any ebbs and flows in COVID-19 case volumes, we are encouraged with the progress this quarter, and particularly the bounce back in volumes we saw in the month of March. Overall, We believe the recent volume trends represent a leading indicator of the recovery from the pandemic. As the vaccine rollout continues and more pulmonologists return to their normal workflow seeing patients, we would anticipate an increased need for lung diagnostics that we believe will benefit our testing business throughout the course of 2021. Of course, potentially offset by the spikes of the virus in hotspots around the country. Turning to biopharma services, first quarter 2021 revenue was $1.7 million compared to $1.5 million for the first quarter 2020, an increase of 12%. Biopharma service revenue declined 12% sequentially from $1.9 million in the fourth quarter of 2020. As we have said, this particular business can fluctuate quarter to quarter due to a number of factors, including contract timing and the impact of COVID-19, which has resulted in a global slowdown of clinical trials. However, we expect full year 2021 revenue results will represent growth over fiscal 2020. Overall, biopharma services remain a significant long-term opportunity for biodesics as clinical trials begin to ramp back up. Moving down the P&L, direct costs and expenses for the first quarter of 2021 were $18.2 million as compared to $1.6 million for the first quarter of 2020 and $14.7 million for the fourth quarter of 2020. The increase in direct costs and expenses was primarily driven by costs associated with our entry into COVID-19 testing, as well as the release of our Notify CDT test in March of 2020. Overall, our COVID-19 testing continues to provide strong revenue and gross profit dollars that offsets the impact of the pandemic, and perhaps more importantly, enables us to invest in our core lung diagnostic testing and biopharma services. Gross margin percentage in the first quarter 2021 was 37% versus 69% for the first quarter 2020 and 46% for the fourth quarter 2020. The decrease in gross margin percentage for all periods presented is driven primarily from our entry into COVID-19 testing, as those margins are lower overall than the margins for our long diagnostic testing. While the COVID-19 testing services gross margin percentage is lower than that of our other tests, It does provide strong revenue and gross profit dollars contributing to the business. We continue to see strong margins in our lung diagnostic business consistent with pre-pandemic levels and expect that to continue during the recovery from the pandemic. Operating expenses, excluding direct cost and expenses, for the first quarter of 2021 were $16.2 million compared to $11.9 million for the first quarter of 2020, an increase of 36% and 8% compared to $15.0 million for the fourth quarter of 2020. The increase in operating expense in the first quarter of 2021, as compared to the first quarter of 2020, was driven primarily by higher selling, marketing, and G&A expenses, including investments in the expansion of our sales force, which increased to $11.9 million compared to $8.1 million in the first quarter of 2020. The increase in selling, marketing, and G&A is attributable to an increase in variable compensation associated with stock-based compensation from our first quarter 2021 option grants, our bonus to equity incentive program, an increase in headcount, and public company costs. Our first quarter 2021 operating expenses increased by approximately 1.2 million compared to the fourth quarter 2020, which was primarily attributable to the change in fair value of contingent consideration. Research and development costs for the first quarter 2021 were 3.3 million as compared to 2.9 million for the first quarter 2020 and 3.1 million for the fourth quarter 2020. The overall increase in R&D was attributable to an increase in internal costs primarily associated with increase in headcount as we scale R&D and add new products to our pipeline following our IPO. After beginning the expansion of our commercial organization, launching multiple new clinical trials, and investing in our pipeline, the net loss for the first quarter 2021 was $7.0 million as compared to a net loss of $9.7 million for the first quarter of 2020 and $4.5 million for the fourth quarter 2020. Included in our first quarter net loss were non-cash stock-based compensation charges of approximately $1.8 million and $728,000 in non-recurring costs associated with the loss on extinguishment of our 2018 term loan. Finally, turning to the balance sheet, we ended the quarter with $55.3 million in cash and cash equivalents, a reduction of approximately $6.8 million in primarily as a result of an increase in working capital partially offset by cash provided by financing activities of approximately $5 million. During the quarter, we enhanced our financial flexibility through a new $30 million term loan and extinguished the outstanding borrowings of $25.9 million under the company's prior term loan, with the remaining proceeds of approximately $4 million available to enhance existing liquidity for general corporate purposes. The transaction will provide Biodesics with additional operational and financial flexibility, including an interest-only period through February 2024, as we achieved the trailing 12-month revenue milestone of $65 million as of March 31, 2021. In addition, the net proceeds, along with the benefit of extending our interest and principal payments, will enable Biodesics to continue the growth of our commercial organization and expansion of our clinical pipeline. Looking forward, Due to the rapidly evolving nature of the pandemic, testing strategies, vaccinations, and the resulting impact on healthcare in the U.S., we are not providing revenue or earnings guidance at this time. We do, however, expect year-over-year revenue growth with our gross margin percentage in the first half of the year suppressed by the strength of our COVID-19 testing activities and an improvement in our gross margin percentage occurring in the latter half of 2021 as the expansion of our sales force gains further momentum and generates growth in our lung diagnostic testing. We expect that COVID-19 testing revenue will be highest in the first quarter, with decreasing revenues throughout the year, subject to our ability to enter into further testing services such as the CPAS COVID-19 Neutralization Antibody Detection Test. However, we will continue to provide COVID-19 testing services to our healthcare, schools, and other employer group partners, and expect to evolve our offering as the country continues to move forward and we learn to live with COVID-19. While we expect to increase our overall operating costs during 2021 due to the execution of our growth strategy and investments in bringing new products to market, we are maintaining a disciplined focus on costs and are continuing to evolve our offering with the future launch of the CPAS total neutralization antibody detection test and our new NGS test. Now I will turn the call back to Scott.

speaker
Scott Hutton

Thanks, Robin. So before opening the call up for questions, let me do a quick summary. Our liquidity position remains strong and provides us with the financial flexibility to achieve our business growth objectives. We were thrilled with our financial performance in the quarter, and most encouragingly, we're seeing early signs of pulmonologists returning to pre-COVID-19 levels. Barring another wave, we expect this trend will drive our core lung business for the remainder of 2021. We continue to enhance our clinical data set to support both on-market and pipeline products and are thrilled to have announced two new tests, the CPAS SARS-CoV-2 neutralization antibody test and our new 72-hour turnaround time liquid biopsy next-generation sequencing test. The latter expands our comprehensive portfolio of products focused on solving complex diagnostic challenges in lung disease. We're also making progress expanding our sales force. A doubling of our sales force over the course of this year, calling on pulmonologists, will allow us to reach more physicians and better leverage improving trends in our growing product portfolio. Lastly, I want to close with a thank you to all Biodesics teammates whose efforts, dedication, and daily contributions make it possible to achieve our ambitious mission. With that, I'll turn the call over for questions.

speaker
Robin

Thank you. As a reminder, if you would like to ask a question, please press star 1. To withdraw your question, please press the pound key. Please stand by while we complete the survey roster. Our first question comes from the line of TJ Savit with Morgan Stanley. Your nine is open. Please go ahead.

speaker
spk01

Hey, Scott, Robin, good evening. Maybe I'll start off here with one question in the 52 gene liquid biopsy panel. Scott, can you give us a sense of what remains to be done between now and commercialization in the first half of next year? Are there plans to add sort of additional markers like TMB and MSI to the panel prelaunch? And then as a follow-up, how do you see this panel fitting into the relatively crowded landscape with larger incumbents who already have reimbursement in place, and also vis-a-vis your own sort of Genestrat and Beristrat workflow?

speaker
Scott Hutton

Yeah, thanks, Tejas. Great question. As you might recall, you know, we've stated that Genistrat is complementary to the other NGS tests that are currently on the market, and we expect the same with our own NGS test. A reminder for everybody and refresher that Genistrat is a small, actionable offering of guideline-recommended targeted mutations, and the NGS test is going to be a broader panel for additional targeted and rare mutations. We believe this combination of two tests allows physicians to utilize at all stages of lung cancer and through the full patient journey, including both diagnosis, prognosis, and even later lines of treatment selection. On the first part of the question, in terms of our development timeline, obviously we're working towards commercialization and regulatory submission. And so with that, many things in our product development timeline are consistent with prior product launches. So just really ensuring that we're ready as a business to scale and ramp the test. I'll turn it over to Robin. She may want to comment on reimbursement and our plans there.

speaker
Chris

I can also comment on the MSI and TMB portion of it. So right now, the current clinical data that we've seen on MSI and TMB is predominantly in tissue. However, as that starts to move and evolve into the liquid space, we will absolutely look to add those. From a reimbursement perspective, yes, it is definitely a crowded landscape, but I also think there's benefits there too. This is not something that will be brand new for payers. There's an established set of criteria. And so it's going in and discussing with them how the test works and providing the statistics for the test. So yes, while it's crowded, it also provides some benefits as well.

speaker
spk01

Got it. Very helpful. And then one on COVID testing. I know, I think, Robin, you mentioned in your prepared remarks that you do expect sort of a sequential decline through the rest of the year here. Is there anything beyond that in terms of color that you can share? I mean, obviously, 23 million is sort of the high watermark, but Do you expect to be in the single-digit sort of COVID contribution range by the fourth quarter here, or you just don't have that kind of visibility yet? And then secondly, in terms of the neutralizing antibody detection launch in mid-21, can you help us think through how significant of a contributor that could be? You know, obviously you'll have to set wide guardrails around it because it's not live yet, but any color there would be helpful.

speaker
Chris

Sure. I think with everything in the pandemic, it's really hard to predict how this will evolve and change. I think the one thing we absolutely can predict is that it will continue to change. And I think that's one of the things that we excel at is evolving our offering, changing and adding services, adding the neutralizing antibodies. So With the visibility we have now, yes, we continue to think that the COVID testing will decrease, but do anticipate that there is demand that recurs into the fall, particularly around schools, travel, events, things like that. And so while we are still anticipating the decline, we are not in any way giving up on COVID testing. There's still a huge need and are continuing to pursue opportunities As for the neutralizing antibody test, that one really is a big question mark right now because we're all still trying to figure out where and how it fits. I think the utility there, at least from a personal standpoint, seems pretty clear to me, but what the country will recommend and how it gets integrated into understanding personalized immunization schedules is still yet to be determined. But in the webinar we hosted a few days ago, we presented some early data from a study we've been conducting over the last several months where we have seen individuals who are immunized maintain very high neutralizing antibody levels for a long period of time, up to, I think we're at six or seven months now, and not seeing any decreases. And we've seen individuals that start to decrease very rapidly as early as three to four months. and have their neutralizing antibodies drop off very quickly. So it just goes to show that with this, as well as every other piece of healthcare, everything really is very personalized. And we think a test could help there.

speaker
spk01

Got it. Got it. Helpful. And then one final one for me on the base business. I know you mentioned sort of seeing a pickup here in March, but Are you willing to sort of quantify where exactly patient volumes stand today among your pulmonologist community relative to pre-pandemic levels? Is it sort of 80% back to normal, or is it sort of even higher than that perhaps? And can you also share the trajectory? I mean, Jan versus Feb, how things looked versus March and into April here?

speaker
Chris

We're pleased with the state of the recovery and seeing improvement over time. January was an interesting month with the massive spike. February, an interesting month with the massive snowstorm. And are pleased with how we're seeing recovery in March and April. It's hard to state, to compare really pre-pandemic to current, mostly because we had really just launched XL2. and then launched CDT in March, literally days before we sent everybody home. So it's a little difficult to compare the two.

speaker
spk01

Got it. Fair enough. Thank you. Thank you, Teja.

speaker
Robin

Thank you. And our next question comes from the line of Brian Weinstein with William Blair. Your line is open. Please go ahead.

speaker
Brian Weinstein

So sticking to the core business here for a second here, obviously there's a backlog of patients that are going to be coming through that are going to need to have some sort of workup that is done, which would mean that your notify franchise seems like it's in a very good position to be able to kind of leverage the capabilities that it has and make the workflow more efficient. So can you talk about the sales and marketing activities that you guys are undertaking to amplify that message to your customers and any early read where you have Salesforce back in place, how that message might be being received.

speaker
Scott Hutton

Yeah, thanks, Brian. Great question. As you recall, post-IPO, we stated that our 2021 goal was to double the size of our direct and dedicated Salesforce service. going from 24 sales reps to 48 sales reps. First and foremost, we continue with that plan and are progressing nicely. We're very encouraged with the quality of teammates that we've added and their ability to onboard rather quickly. To your other point about the recovery, yes, pulmonologists are seeing less and less COVID patients and are returning back to what one could described as kind of a normal business cadence. There is this described backlog of patients, which makes a ton of sense knowing that we've not seen patients the way we would have prior to the pandemic. The real question is vaccination schedules, comfort of those patients to come into clinics, right? We started with our biggest concern being the physician ensuring the physicians were protected, not just physicians, but their healthcare staff. Now that they've all been vaccinated, ensuring that this patient population is vaccinated is key and critical. That is one of the rate limiters. Our dialogue with pulmonologists is that they are seeing patients return to in-person. We know that also benefits us. As much as we may never return to a pre-pandemic environment, because of COVID, being able to meet face-to-face, a physician consulting a patient not through telemedicine still has a place. And so our sales reps are there. They're conducting in-person sales calls. Yet at the same time, we do monitor the virus. We monitor spikes. And we still collaborate with pulmonologists to ensure that we're welcome coming into their clinic and that we're mindful of any potential exposures they may have had.

speaker
Brian Weinstein

Okay, thank you. And then on the liquid biopsy NGS test, you talked about the unprecedented 72-hour turnaround time versus the 7 to 14 days. Can you give us any insight into what you have done to allow that to take place, recognizing that some of it is probably trade secret, but just generally speaking, what is it about the way that you guys are operating that allows you to show that turnaround time? And then a follow-up question on that is, This product's been available for research and clinical trials, I think you said, since 2018. So why is now the right time to launch it? Is that tied to the improvements in turnaround time? Thank you.

speaker
Scott Hutton

Yeah, thank you, Brian. Great question. You know, I'll start with turnaround time for Genistrat. We've discussed how opportunistic we've been at Biodesics and how we really have evolved during the pandemic. One of the benefits... of proceeding with COVID testing and utilizing and leveraging our DDPCR platform is that we've been able to expand our laboratory. We also are running 24-7. That allows us to decrease that turnaround time. And you may recall Genistrat has improved by 50% during the pandemic. So we went from 72 hours down to 36 hours with Genistrat. That really is leveraging the additional resources team and laboratory capacity that we have. Related to the NGS product, you highlighted a 72-hour turnaround time on an NGS product is unprecedented. You're correct. Some of that is trade secrets, and you were also correct. We did introduce that for biopharma research in 2018, and many of those partnerships and collaborations gave us additional experience and opportunity to optimize that offering. So we're really excited about that. We think it matters. We know that we're dealing with patients that have cancer. And patients that have cancer, the one thing that they don't always have an abundance of is time. And so our ability to return those actionable insights as quick as possible will make a difference. Thank you for the answers, guys. Thanks, Brian.

speaker
Robin

Thank you. A reminder, if you wish to ask a question at this time, please press star, then 1. Our next question comes from the line of Sungji Nam with BTIG. Your line is open. Please go ahead.

speaker
Sungjie

Hi. Thanks for taking the questions. So just on the liquid biopsy and extracequencing assay, could you talk about your go-to-market strategy there? Do you anticipate leveraging the existing sales force and the sales channels and also with the REO users? you know, since 2018, or could they be kind of some of the early adopters of this platform?

speaker
Scott Hutton

Hi, Sungjie. Thanks for the question. I'll go in reverse order. When it comes to our biopharma partners, unfortunately, we haven't disclosed who those partners are at this time. But, yes, it's safe to say that those partnerships, those collaborations, and those relationships do provide great insights for us, and we're able to apply that to our commercialization strategy. We've not yet disclosed our commercialization strategy. Because we've announced that we'll launch this mid-2022, we plan on developing that plan and rolling that out as we progress through the year. So much more information to come there. But the good news is, is because of our existing Salesforce footprint, relationships, and experiences, selling Genistrat, this really is an opportunity for them to continue to leverage the relationships that they have, build on the awareness of Genistrat and Veristrat to ensure that we can provide the treatment guidance that others strive to.

speaker
Sungjie

Great. That's super helpful. And then just on the CPAS neutralizing antibody, could you talk about also kind of the go-to-market strategy there? You know, are you targeting largely the biopharmaceutical companies that have you know, these vaccines under development, or, you know, developing the vaccines or have developed the vaccines. And also, if you could talk about T cell profiling and other types of, you know, characterization, right, in terms of patient response and monitoring to the, you know, to the pathogens, as well as to the vaccines, and just kind of curious, in terms of, you know, how this test might fit into the kind of the whole ecosystem.

speaker
Scott Hutton

Yeah, great question, Sungji. Thank you. Because we just had the webinar and just announced that we'll be commercializing this test this summer, as you can imagine, we're getting a lot of input, a lot of inquiries, and numerous conversations are occurring as we speak. For us, this really has been about being a one-stop shop. As you recall, early in the pandemic, we announced that we had partnered with BioRad to launch the DDPCR test. Then shortly thereafter, we announced our collaboration with Bio-Rad to introduce our first antibody test. And then we continued to pivot where we provided support, surveillance, and monitoring for antigen testing that would then reflex to high-quality DDPCR testing. We really have viewed ourselves as a comprehensive COVID solution provider. a one-stop shop, if you will. So adding this into the portfolio, we think, positions us exceptionally well to continue to provide those personalized insights that individual institutions may have. And so with that, our approach has been consistent. Anyone that we've provided testing solutions and support to thus far, we've reached out to them to introduce the neutralizing antibody test. We've begun answering questions and really formulating a plan by which this may provide meaningful insights to them, whether it's a return-to-work strategy, whether it's travel or international travel, or then building upon some of our sports and athletic and educational services that we've offered, just really ensuring that they have the ability to utilize any one of these tests to set them up for success, whatever that means to them or however they define that. So much more to come with that in the coming weeks and months. And then when we do make that commercially available, we will disclose that and we'll start providing greater insights into the feedback we're receiving. But if you had an opportunity to participate in that webinar, some really good dialogue, numerous participants across biopharma industry and research, and so for your other question, Yes, we have continued to reach out to biopharma companies to include the vaccine companies, and we think that we can provide critical insights here that as we progress through 2021 and prepare ourselves for flu and cold season and the question that Robin presented is how long does a vaccine work or last, we'll be able to provide those insights on an individual basis, which we believe is meaningful.

speaker
Chris

As for the rest of your question, with the T cell and B cell, we are looking at those as options, looking to better understand, continuing to research, like many others, understanding the virus, the impact on the immune system, and how we respond as individuals. The CPAS test is FDA EUA authorized, and so was a great option for us to partner with Genscript to bring that forward quickly. And as you know, as the pandemic evolves and as the testing evolves, we'll evaluate if it makes sense to add others as well.

speaker
Sungjie

Great. And then just lastly from me, I was wondering if you might be able to break out, you know, great to see recovery in the base business, but, you know, I was wondering if we might get some insight into the oncology channels versus the pulmonology, so Veristrat and Genistrat. versus the Notify product lines, if you're seeing growth across the board, if you're seeing recovery across the board, or if it's mostly on the Notify side. Thank you.

speaker
Scott Hutton

Thanks, Sanjeev. Good question. We see it being very consistent and similar. Obviously, we've highlighted that pulmonologists were significantly impacted as they were pulled into ICUs and ERs early in the pandemic. and then whenever there was a spike or resurgence, they continued to be pulled back in. When they were pulled in, though, the one thing that also occurred is potential patients were told to stay home, right, stay safe and distance yourself. And so our experience across the multiple medical specialties that we call on and consult with is we are seeing kind of a similar recovery and return, and we're pleased with that. And I think for all of us, it's exciting to see that we're making progress, we're coming out of this, and there is some sense of normalcy on the horizon.

speaker
Sungjie

Great. Thank you so much.

speaker
Scott Hutton

Thank you, Sungji.

speaker
Robin

Thank you. And showing no further questions, this concludes the question and answer session and today's conference call. Thank you for participating. You may now disconnect. Everyone, have a great day.

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

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