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Biodesix, Inc. (BDSX -0.80%)
Q4 2020 Earnings Call
Mar 16, 2021, 4:30 p.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:


Operator

Good afternoon, ladies and gentlemen, and welcome to the Biodesix fourth-quarter 2020 financial results conference call. At this time, all participants are in a listen-only mode. [Operator instructions] As a reminder, this conference is being recorded. I would now like to turn the conference over to Jeremy Feffer of LifeSci Advisors.

Jeremy Feffer -- Investor Relations

You may begin. Thank you, operator, and good afternoon, everyone. Thank you for joining us today for a discussion of Biodesix fourth-quarter and full-year 2020 financial and operating 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. For the benefit of those who may be listening to the replay or archived webcast, this call is being held and recorded on Tuesday, March 16, 2021.

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Today, we issued a press release announcing our financial results for the fourth quarter and full year 2020, including our recent business highlights. 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 Biodesix sector. 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 factors section and elsewhere in the company's annual report on Form 10-K for the quarter ended December 31, 2020, filed today. 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?

Scott Hutton -- Chief Executive Officer

Thank you, Jeremy, and thanks to everyone for joining Biodesix first earnings call since becoming a public company. By all accounts, 2020 was an incredible year for Biodesix. The challenges brought about by the global pandemic seemed to bring out the best in the Biodesix team. The company launched three new tests and services, including Nodify CDT and COVID ddPCR antibody and antigen testing services.

We initiated new clinical trials, expanded our pipeline, published new clinical data and formed new partnerships with biopharma companies and academic institutions. We also delivered record revenue of 45.6 million in 2020, which represented an 86% year-over-year growth. And we completed an IPO in October that raised approximately 64 million and provides the financial means to execute on our ambitious growth strategy. The funds from the IPO enabled us to begin a large commercial expansion to capitalize on the untapped nodule management market, invest in our technology and increase development of new tests that broaden our portfolio.

As this is Biodesix's first quarterly earnings call, we thought it would be helpful to spend a few minutes describing our company. Biodesix is a patient-centric mission-driven company. Our goal is to be the trusted partner that the world relies on for data-driven diagnostic solutions to improve patient outcomes while lowering healthcare costs. We do this by developing and offering tests that reduce the use of ineffective and unnecessary treatments and procedures.

In so doing, we partner and collaborate with physicians and biopharma companies to address those critical unmet needs. Our focus is solving complex diagnostic challenges in lung disease and for our biopharma partners. A U.S. market opportunity that we estimate is greater than $29 billion.

By combining multiple technologies with a holistic view of each patient's immune response, our diagnostic test provides physicians with greater insights to help personalize their patients' care and meaningfully improve disease detection, evaluation and treatment. Today, we're proud to offer six commercially available diagnostic tests for lung disease with best-in-class turnaround times. We continue to leverage our proprietary AI platform to develop additional test for our commercial pipeline and companion diagnostics for our biopharma partners. We believe there is a critical clinical need to help physicians reclassify risk of malignancy in patients presenting with suspicious lung nodules.

We offer the blood-based Nodify lung nodule risk assessment testing strategy to aid physicians in stratifying patients into two distinct nodule management treatment pathways, diagnostic procedures or imaging surveillance. Nodify lung testing consists of two blood-based proteomic test: the Nodify CDT test, which helps identify patients with lung nodules that are likely malignant or higher risk of cancer; and the Nodify XL2 test, which conversely helps identify those patients with lung nodules that are likely benign or lower risk of cancer. Currently, there are no other test addressing this need in the marketplace. There's an imminent need for a blood-based testing solution that measures tumor-specific mutations and the patient's immune profile to provide physicians with more comprehensive information to assure the overall prognosis of the patient and personalize every patient's treatment plan.

To that point, we offer the blood-based Biodesix lung reflex testing strategy, which consists of the GeneStrat, genomic tumor profiling test, and the VeriStrat proteomic immune profiling test for patients diagnosed with non-small cell lung cancer. With a 72-hour turnaround time, we're able to quickly provide critical diagnostic information to physicians to facilitate personalized treatment decisions for their patients. During 2020, we expanded our offering by launching the Nodify CDT test, COVID-19 ddPCR and antibody test and related services. To address patient needs, we expanded our mobile phlebotomy network, resulting from an increased use of telehealth services.

We've also expanded our COVID service offering by performing on-site rapid antigen testing for schools, athletics and employers to quickly identify presumptive positive cases, coupled with high-accuracy PCR testing for confirmation and validation of cases through our customizable Work Safe COVID-19 testing program. As a data-driven company, we're continuously adding to the body of evidence, demonstrating the value of our test. Over the last quarter or so, we published two-year outcomes data for our Nodify XL2 test, data from our patented blood collection device and presented new data on Nodify XL2 and CDT, VeriStrat, and our primary immune response test from our pipeline. These publications, posters and abstracts are providing more data to help support clinical adoption and reimbursement for our products.

We launched two new studies, including the ALTITUDE Clinical Utility Study, which is designed to further demonstrate the efficacy and performance of Nodify XL2 and Nodify CDT, in a first of its kind, rigorously designed, randomized controlled study. We're grateful to Dr. Gerard Silvestri of Medical University of South Carolina for acting as principal investigator, and we look forward to sharing data from this important study. The second study is the BEACON-Lung Clinical Study launched in partnership with ALCMI to prospectively evaluate the performance and utility of our primary immune response test in patients with advanced-stage lung cancer.

We also partnered with biopharma companies to provide research, clinical trial testing and new companion diagnostic discovery and validation. We recently announced one such partnership with HiberCell, a biotechnology company developing novel therapeutics for cancer relapse and metastasis with a focus on breast cancer. The partnership is for the development of a companion diagnostic to be used in future registrational breast cancer trials of its lead clinical asset Imprime PGG. This test, which will also emerge from our AI platform, will further strengthen our position as a leader in clinical proteomics by allowing for the selection of patients eligible for and likely to benefit from Imprime PGG therapy.

Now let me turn it over to Robin to discuss our financial results. Robin?

Robin Harper-Cowie -- Chief Financial Officer

Thank you, Scott. Our fourth-quarter revenue was 27.0 million compared to 8.3 million for the fourth quarter of 2019, an increase of 227% and an increase of 194% over the 9.2 million in revenue reported in the third quarter of 2020. For the year ended December 31, 2020, total revenue was 45.6 million as compared to 24.6 million for the prior-year 2019 and reflects an increase of 86%. Our revenue improvement was fueled by our successful entry into COVID-19 testing services, enabling us to diversify our portfolio during a period of expected downturn resulting from the global pandemic.

Our COVID-19 testing services revenue grew 287% to 21.4 million in the fourth quarter 2020, over 5.5 million for the third quarter of 2020, in total of 28.3 million for the year. While COVID-19 testing services played an important role in our revenue growth for the quarter and throughout the year, we are particularly pleased with the sequential quarter-over-quarter improvement in our lung diagnostic testing, which we believe is a leading indicator of overall recovery and built up demand for lung diagnostic testing that will benefit us in fiscal 2021. Our primary call point for lung diagnostic testing are pulmonologists, and they were particularly impacted by the pandemic by being pulled into ICUs and ERS to treat patients with COVID. Although we expect pulmonologists to continue to be impacted by the ebbs and flows of the effects of the pandemic, our fourth-quarter 2020 lung diagnostic revenue was 3.7 million, representing 22% growth over third quarter 2020 and a 20% decrease from 4.6 million from the fourth-quarter 2019 due to impacts of the pandemic.

Fourth-quarter 2020 biopharma services revenue were 1.9 million as compared to 0.6 million in the third quarter 2020, a 198% improvement and a decline of 48% from 3.7 million in the fourth quarter of 2019, which was primarily attributable to the impact of COVID-19 and the global slowdown in clinical trials due to the ongoing pandemic. As a result of our expanded offerings, direct costs and expenses for the fourth quarter of 2020 were 14.7 million as compared to 1.8 million for fourth-quarter 2019. For the full-year 2020, direct costs and expenses were 22.0 million as compared to 6.1 million for the full-year 2019. The increase in direct costs and expenses was primarily driven by costs associated with our entry into COVID-19 diagnostic testing services as well as the release of our Nodify CDT test, offset in part by decreases in costs related to our other lung diagnostic test costs.

Our COVID testing services provided strong revenue and gross profit, which helped offset the impact of the pandemic on our lung diagnostic and biopharma services. We don't expect COVID-19 testing services to be an ongoing core growth platform. However, our ability to quickly pivot to offering these valuable services enables us to generate additional gross profit dollars to invest in our core lung diagnostic testing and biopharma services. The gross margin percentage for COVID testing services are lower than for our other testing services, which suppressed our overall gross margin percentage for the year and the fourth quarter.

For the fourth quarter, gross margin was 46% versus 58% for the third quarter, and 52% for fiscal 2020 versus 75% for fiscal 2019. Research and development costs for the fourth-quarter 2020 was 3.1 million as compared to 2.5 million for the fourth-quarter 2019. Research and development costs for full-year 2020 were 10.8 million as compared to 10.5 million for full-year 2019. The overall increase in R&D was attributable to an increase in internal costs, primarily associated with variable compensation tied to fiscal 2020 performance measures, slightly offset by a decrease in external costs during the middle of the year due to the pandemic.

Sales, marketing and G&A expense for the fourth-quarter 2020 were 12.1 million as compared to 6.6 million for the fourth quarter of 2019. Sales, marketing, G&A expenses for full-year 2020 was 34.9 million as compared to 30.6 million for full-year 2019. The increase was a result of variable compensation tied to fiscal 2020 performance measures, offset by reductions in employee-related costs associated with COVID-19 pandemic restriction. After beginning the expansion of our commercial organization, launching multiple new clinical trials and investing in our pipeline, the net loss for the fourth quarter 2020 was 4.5 million as compared to a net loss of 6.5 million for the fourth quarter of 2019.

Net loss for the full-year 2020 was 31.4 million as compared to a net loss of 30.7 million for 2019. Included in our fourth quarter and full-year 2020 net loss were approximately 10.2 million in noncash charges, including onetime charges related to the IPO in October. These charges consist of the following: 4.4 million in accelerated amortization of convertible notes discount, 3.7 million in stock-based compensation primarily associated with our bonus to equity program, 1.3 million in change in value of outstanding warrants and 0.8 million in contingent consideration related to the integrated diagnostics acquisition. Finally, turning to the balance sheet.

We ended the quarter with 62 million in cash and cash equivalents. This increase in cash was a result of our successful IPO in October that raised approximately $64 million. 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 diagnostic testing activities and an expansion 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 revenue will be highest in the first quarter with decreasing revenues throughout the year. However, we will continue to provide COVID 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 expect that these costs, excluding direct costs, will decline as a percentage of revenue for the full-year 2021 as compared to the full-year 2020. Now, I'll turn the call back to Scott.

Scott Hutton -- Chief Executive Officer

Thanks, Robin. At Biodesix, we're dedicated to bringing tests to market that will positively and quickly impact the lives of patients. Our growth in 2021 will be driven by several factors. We're doubling the size of our direct and dedicated sales force calling on pulmonologists, which will better allow us to reach more physicians and provide them with personalized information to help direct the right patients on to biopsy or surgery and help many more avoid unnecessary interventions.

We will continue to enhance our clinical data set to support on-market and pipeline products with publications and at conferences across the year. We're continuing to invest in our blood-based risk of recurrence proteomic presurgery test to help identify those early stage lung cancer patients that are likely to recur, and in our blood-based primary immune response proteomic test to help guide immunotherapy treatment decisions and identify patients that are likely to be rapid progressors on immunotherapy. But we're not stopping with these two products. In February, we announced the publication describing the development of a new AI-based COVID-19 algorithm and the important data from a related study.

The AI-based algorithm designed to be easily incorporated into existing clinical decision support systems helps identify those patients who are likely to require intervention, such as treatment with ventilators and admission to intensive care units, or those patients who may develop acute respiratory distress syndrome, versus those who likely will not require intervention. This was developed utilizing our Diagnostic Cortex AI platform and reflects the versatility of the platform to develop valuable tests beyond our current portfolio. We's will continue to invest to bring this and other novel testing solutions to our research partners and, ultimately, to our clinical customers and plan to grow our pipeline in 2021. Finally, we continue to partner with academic institutions, diagnostic companies and biopharmaceutical companies to expand our technologies, provide research and clinical trial testing, and leverage our Diagnostic Cortex AI platform and sample and data biobanks to discover and develop new companion diagnostics.

2020 was a transformative year for Biodesix and demonstrated the value that we're creating and delivering to our physicians and partners. By expanding our commercial organization and reach while continuing to bring new tests into our pipeline into market, we are well-positioned for rapid growth, but most importantly, we're positioned to quickly and positively impact the lives of patients. Lastly, I want to close with significant appreciation to all Biodesix teammates. Their efforts and contributions in 2020 made this one of our best years on record, which would not have been possible without their dedication and effort in working toward our mission.

Operator, we're now happy to open the lines for questions.

Questions & Answers:


Operator

Thank you. [Operator instructions] Our first question comes from the line of Sung Ji Nam with BTIG. Please proceed with your question.

Sung Ji Nam -- BTIG -- Analyst

Hi. Thanks for taking my question. Could you -- Robin or Scott, could you talk about ASP trends throughout last year and particularly for the fourth quarter, just given that you guys don't break out the test volumes. I'm just trying to get a sense of how to think about the ASP trend?

Robin Harper-Cowie -- Chief Financial Officer

Hi, Sung Ji. Yes, the ASP trends by product across the year were incredibly consistent. We've had no large swings in either direction for any of the products.

Sung Ji Nam -- BTIG -- Analyst

OK. Fantastic. And then just, you know, totally appreciate you guys not providing guidance, but was curious about, for your diagnostic lung cancer diagnostic business, how should we think about first quarter versus fourth quarter? You guys saw a sequential increase in the fourth quarter. And given we're almost at the end of the -- or middle of March here, just kind of curious if we can anticipate another sequential increase? Or just kind of what kind of, I guess, end market trends that you're seeing there.

Robin Harper-Cowie -- Chief Financial Officer

Sure. You're right. We're not providing full-year guidance at this time, but we are pleased with how the quarter is shaping up through February and into March. There were absolutely disruptions with the massive COVID spike toward the end of 2020 and into early '21.

And then storms and other disruptions in February due to that snowstorm that hit the South and Southeast. With those disruptions, we are pleased with the uptick and the rebound that we saw post the storm. And across the board, expect our 2021 first quarter to be pretty much in line with fourth-quarter 2020.

Sung Ji Nam -- BTIG -- Analyst

OK. That's helpful. And then lastly from me. Very excited to hear about the AI-based algorithm that you guys are developing for the COVID patients.

Was curious what the testing entails. Is it -- are you looking at -- are you looking at the immune profile of the patients? Kind of trying to get a better sense of what this is about. Thank you.

Scott Hutton -- Chief Executive Officer

Yes. Thank you, Sung Ji. So what we did is we collaborated with an academic institution to use 559 patients, 229 of which were hospitalized with COVID-19, and created an AI-based algorithm that highlighted multiple patient characteristics, vital signs and readily available laboratory test values. The machine learning algorithm was then accurately able to predict and highlight which patients would need to be admitted to the ICU.

So it truly is an AI-based algorithm assay, and we're continuing to work and collaborate with that not named academic institution on opportunities to expand this and commercialize it so it can be more readily available.

Sung Ji Nam -- BTIG -- Analyst

Great Thank so very much.

Scott Hutton -- Chief Executive Officer

Thank you.

Operator

Our next question comes from the line of Tejas Savant with Morgan Stanley. Please proceed with your question.

Tejas Savant -- Morgan Stanley -- Analyst

Hey, guys. Thanks for taking my question. I just following up there on the earlier question on trends year-to-date, Scott and Robin. Can you elaborate a little bit on sort of why the core lung business outside of biopharma services won't grow sequentially here in the first quarter? I know you mentioned sort of weather.

But is there any other sort of dynamic? Is it sort of sales force taking some time to ramp as you onboard these new reps or anything else that we need to be aware of when we think of sequential trends versus the 3.7 million you did in the fourth quarter for lung? And then related follow-up, over the medium term, I mean, can you just walk us through how you view the updated USPSTF lung cancer screening guidelines? And what you, collectively as an industry, can do to get adherence levels up to those the expanded guidelines?

Scott Hutton -- Chief Executive Officer

Yeah. Thank you, Tejas. Yeah, we continue to expand our sales force, and we're really pleased with the progress we've made. You highlighted in your question maybe why we aren't ramping faster.

As we exited 2020 and entered 2021, the COVID spike really did impact the ability of pulmonologists to treat patients. Many of them were called back to the frontlines, treating patients in emergency rooms and ICUs. So our sales recruitment efforts continued. We're really excited by the talent that we brought on board that's joined the Biodesix team.

They continue to go through training and onboarding. We think they're ready to go. And as we work through the pandemic and start to return to some sense of normalcy, we're fully expecting pulmonologists to begin spending more time with traditional patients. Obviously, when you think of vaccinations and approaching herd immunity, that will have a positive impact also.

And then on the second question, Tejas, we're really excited with the USPSTF announcement. This definitely was something we anticipated as the draft recommendations went out about six to nine months ago. And we applaud USPSTF for making those changes to improve access to screening care for more Americans. However, in the United States, we still don't have a good track record of adhering to screening guidelines.

While these new recommendations are definitely going to increase and positively impact the number of nodules found, we definitely think it's going to take some time for true adherence. Right now, as best we can tell, we've got low-single-digit adherence to screening protocols for lung cancer. So it's definitely going to change the numbers of early detected nodules, but since this is already a large addressable market, and most pulmonologists can't get to all the patients they already have, we're going to continue to focus on the near term, ensuring that those pulmonologists recovering from the impact of COVID are able to get to all the patients possible.

Tejas Savant -- Morgan Stanley -- Analyst

Got it. That's helpful, Scott. And then, Robin, I think you alluded to this in terms of your comments on the outlook. How exactly should we think of the cadence for opex here in '21? Is the 15 million that you saw in the fourth quarter essentially a fair run rate to use in terms of the opex ramp ahead of you through the year-end?

Robin Harper-Cowie -- Chief Financial Officer

Opex will absolutely ramp up. We are doubling our -- the size of the sales organization, which also requires additional investments for customer care, marketing, in-house laboratory. So we will expect that the largest portion of our increase in operating expense goes to the expansion of the commercial organization. However, we also expect increases in our research and development spending.

We announced that at the end of the year, the launching of ALTITUDE and BEACON. So we have both of those studies now ongoing throughout the whole of 2021 versus just getting started in the fourth quarter. And we are also continuing to invest in new products and new studies to add to our pipeline in addition to peer and ROR, which we've talked extensively about.

Tejas Savant -- Morgan Stanley -- Analyst

Got it. OK. And then on COVID testing dynamics here, I mean, obviously, at a sort of U.S.wide level, there's been a pretty significant step down here relative to the fourth quarter. But on the other hand, your sort of COVID testing volume dynamics are not always in lockstep given that you have these contracts with very specific entities.

I know you highlighted Purdue and Chicago public schools. Can you help us, Scott, think through the degree to which sort of those specific contracts or perhaps others that you haven't publicly disclosed help insulate you, or not, perhaps, in terms of the broader sort of downtick here in testing volumes?

Scott Hutton -- Chief Executive Officer

Yeah. Great question. Thanks, Tejas. Mainly, those programs have been based upon large academic institutions or school systems.

So we know that by the end of May, most schools will be out, and children and young adults will be home for the summer. But it definitely provides additional opportunity as they return to school in the fall. And so we do continue to prioritize and focus on COVID testing opportunities with academic institutions, sports teams, sports leagues, large businesses. I think to your point, we see that as reproducible revenue.

And something else that we've done is really continue to pivot throughout the pandemic. And what I mean by that is, when we started, we initially offered the ddPCR testing, then we transitioned to antibody testing. And then through multiple partnerships, we began to support and provide services for antigen testing. And so with our Biodesix Work Safe program, we really are one of the few companies that are offering any of the testing solutions someone may request.

And then we're customizing our programs to support them. So we've really seen a significant change. Where now, we're seeing a number of -- especially on the academic front, a number of institutions that prefer rapid antigen testing upfront, followed by confirmatory testing with PCR. And now we're having conversations on a broader scale about antibody testing and neutralizing antibody testing as we think about vaccinations and the question still remains on how viable are vaccinations for the longer period of time, especially as people being vaccinated now, start to reemerge and potentially expose themselves to new variants in the fall.

Tejas Savant -- Morgan Stanley -- Analyst

Got it. That's helpful. And then one final one for me on ALTITUDE and the pipeline. Any update on early enrollment trends in the study in light of the pandemic? And can we look forward to any sort of interim readouts at all later this year? Or is that all sort of '22 and '23? And then on the pipeline, I believe there were -- I think you mentioned this in your prepared remarks, Scott.

But are those products, some of the newer tests around risk of recurrence, etc., are those products that we could see launched commercially in the back half of '21?

Scott Hutton -- Chief Executive Officer

Great question, Tejas. I'll take ALTITUDE first. So you're correct, we have kicked off ALTITUDE. We're pleased with early enrollment and participation.

Just as a refresher and reminder, the goal here is to enroll a total of 2,000 patients. We're expecting full enrollment to be complete toward the second half of 2023. So with that, we're anticipating our first interim analysis sometime around mid-2022. So about a year from now.

But we are pleased with the progress thus far in ALTITUDE. When you think of the pipeline products with risk recurrence and primary immune response, we're anticipating commercial launch for both in 2023. We are committed to continuing to validate those products. And so we're hopeful that in the 2022 time frame, we'll be able to publish and present additional information on the continued validation of both.

And then as a reminder, both are available today in research use only capacity and in partnership with biopharmaceutical interest.

Tejas Savant -- Morgan Stanley -- Analyst

Perfect. Thanks so much, Scott. Appreciate the time.

Scott Hutton -- Chief Executive Officer

Thank you, Tejas.

Operator

Our next question comes from the line of Brian Weinstein with William Blair. Please proceed with your question.

Andrew Brackmann -- William Blair & Company -- Analyst

Hi. Good afternoon. This is Andrew on today. Thanks for taking my question.

Maybe to start out, a question on your expectations for drivers of growth this year in sort of that core lung franchise. Maybe can you talk a little bit about what you're seeing in terms of sort of your reps' access to the customers right now, as well as just sort of the general awareness that these customers have with that Nodify franchise at this stage and what might be changing from a commercialization standpoint, aside from adding new reps this year, which might help on that awareness campaign? Thanks.

Scott Hutton -- Chief Executive Officer

Yeah. Thanks, Andrew. Appreciate that. Just as a refresher, at the time of IPO, we had 24 sales reps.

Our goal is to double the size of that sales force this year. So we'll have approximately 48 sales reps by the end of 2021. So to your point, first and foremost, continued focus on commercial expansion. As I referenced earlier, we have brought on a number of sales professionals who are already out representing the company.

The more feet we have on the street, obviously, that aids in increasing awareness. Most importantly, continued data development and publishing on data also starts to drive increased awareness. When we think about the drivers for kind of return to success as we progress through 2021, what will strengthen is availability of pulmonologists, and we really start there. First and foremost, we need pulmonologist customers to remain healthy.

The good news is as they become vaccinated, that is less of a concern as it once was. Secondarily, the patient population that we're dealing with here is on the older side. So obviously, those patients getting and receiving vaccines and feeling comfortable returning back into clinics where they might be exposed, that's something that, obviously, is being addressed as we speak. And then really just working out of flu and cold season.

So we do feel that as we progress through the year, our pulmonologists will be fully engaged, able to dedicate a majority of their time back to treating those patients that they need to treat because of the risk of cancer. Hopefully, we'll continue to keep any potential spikes of the COVID virus to a minimum, again, allowing pulmonologists to focus.

Andrew Brackmann -- William Blair & Company -- Analyst

Got it. Thanks for that. Very helpful. And then maybe one other one that's a little bit broader here.

As we think about sort of the shifts in your markets over the last year due to COVID, can you maybe talk a little bit about how you're viewing the evolution of diagnostic solutions like yours and sort of the changing use case that we've seen play out over the last year? And I guess related to that, what are some of the things that you're going to position the business to sort of play into those larger macro trends? Thanks.

Scott Hutton -- Chief Executive Officer

Yes. Great question, Andrew. Obviously, I think more people in America and in the world are aware of diagnostic testing than ever before. Unfortunately, there was a great expense there to get increased awareness.

But you start to really appreciate what happened with COVID, where you see ddPCR testing to antigen -- to antibody testing to antigen testing, and you really see an evolution quite rapidly and an awareness of the general public. I think more and more individuals are aware of the impact that testing can have in early detection and diagnosis. So for us, we also look at the use case and think of it differently because COVID has encouraged us to actually go away from healthcare professionals. It's closer to a direct-to-consumer model at this point in time as we continue to partner with academic institutions, schools, sports leagues, et cetera.

We think that's going to continue to evolve, and it's critically important for us. We also think that the -- and believe that the hybrid approach we've taken in offering our customizable work program -- Work Safe program that is, to offer all of the different testing and services is a key differentiator. What we've learned and what we've been able to do as a team at Biodesix really speaks volumes about what we think we're going to be able do when we we have 100% focus back on lung disease, which is our No. 1 focus.

And then on our biopharmaceutical partnership, we're going to bring new unique approaches that we didn't have prior to the pandemic. Is that helpful, Andrew?

Andrew Brackmann -- William Blair & Company -- Analyst

That's great. Thanks, guys.

Scott Hutton -- Chief Executive Officer

Thank you.

Operator

Our next question comes from the line of Max Masucci with Canaccord. Please proceed with your question.

Max Masucci -- Canaccord Genuity -- Analyst

Hey. Thanks for taking the question, and congrats on a great year. First, in terms of just the directional commentary for Q1 and the expectation that Q1 will be roughly in line with Q4, is this a comment geared more toward total company revenues, or just for the core lung disease diagnostics business?

Robin Harper-Cowie -- Chief Financial Officer

It's for everything. It's for all segments, should be roughly in line.

Max Masucci -- Canaccord Genuity -- Analyst

OK, great. And then on the COVID testing side of the business, you're working with more than one rapid test provider. So the revenues that you generate from facilitating these rapid testing programs shouldn't necessarily be dependent on your relationship with any one singular test provider. Is that the right way of thinking about it?

Scott Hutton -- Chief Executive Officer

Yeah. Thanks, Max. Yeah, that's correct. We've taken kind of a technology-agnostic approach.

And in some of these instances, we've had partnership opportunities present because there are institutions that have gained access to rapid point-of-care testing, but don't have the means by which they can implement it and support it. And then nor do they have access to high-quality, accurate PCR testing that can be utilized in a confirmatory fashion.

Max Masucci -- Canaccord Genuity -- Analyst

OK. Great. And then one final question on the lung cancer diagnostics business. How -- is there any way we can think about the pace of new doctor adds in Q4, maybe versus Q3 or Q2? Has the pace of new doc adds ticked up in recent months there? Or if we could just get your general thoughts on how that might play out here as the vaccine rolls out, that would be great.

Thanks.

Scott Hutton -- Chief Executive Officer

Yeah. Thank you, Max. Yeah, definitely, across the lung cancer continuum of care, we have seen broader adoption and interest. The one thing that we're aware of is cancer can't wait even when you're in the midst of a pandemic.

And so we saw really good interest as pulmonologists and thoracic surgeons and medical oncologists were collaborating to highlight those patients that they needed to pull into the clinic. What they really did was start collaborating and highlighting what are the best means by which we can find these patients without bringing them into the clinic. And so, for us, building off of Andrew's question earlier too, we've expanded our utilization in our network of mobile phlebotomists, and we've integrated and collaborated on the telehealth and telemedicine front. And so we really have been able to partner with new, different and a broader group of physicians to highlight those patients that are diagnosed, hopefully, early with cancer so that they could begin treatment as soon as possible.

We're pleased with that, and then you add in conjunction, the expansion of footprint. And yes, we do expect that to continue throughout the year. And then again, as vaccines take hold and we get closer to herd immunity in the United States, we fully expect that patient comfort in returning back into clinics and visiting with physicians will increase and that physicians will begin to catch up this latent pool of patients that potentially were foregoing treatment. And again, with cancer, we need to catch up as quick as possible.

Is that helpful, Max?

Max Masucci -- Canaccord Genuity -- Analyst

Great. That's perfect. Thanks for taking the questions.

Operator

There are no further questions in the queue. I'd like to hand the call back over to the CEO for closing remarks.

Scott Hutton -- Chief Executive Officer

Great. Thank you, guys, for your questions and your time. As I stated earlier, we are really excited about what we achieved as a team in 2020. I used the phrase that it was a transformative year, but among the Biodesix team, we are looking at 2021 to be equally as rewarding and promising.

And we'll look forward to giving you updates as we continue through the year. Thank you all for your time.

Duration: 43 minutes

Call participants:

Jeremy Feffer -- Investor Relations

Scott Hutton -- Chief Executive Officer

Robin Harper-Cowie -- Chief Financial Officer

Sung Ji Nam -- BTIG -- Analyst

Tejas Savant -- Morgan Stanley -- Analyst

Andrew Brackmann -- William Blair & Company -- Analyst

Max Masucci -- Canaccord Genuity -- Analyst

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