Ladies and gentlemen, thank you for standing by. Welcome to the Biodesix Fourth Quarter and Full Year 2021 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions] Please be advised that today's conference maybe recorded. [Operator Instructions] I would now like to turn the call over to your host, Chris Brinzey. You may begin.

Thank you, operator, and good morning, everyone. Thank you for joining us today for a discussion of Biodesix's fourth quarter and year-end 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 and financial results for the fourth quarter and year-end 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 the competitive nature of Biodesix’s 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 Factors section and elsewhere in the company's annual report on Form 10-K for the year ending December 31, 2021, filed with the Securities and Exchange Commission 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?

Thank you, Chris. As a reminder, Biodesix is a patient-centric lung disease diagnostic company with a mission to unite biopharma, physicians, and patients to transform the standard of care and improve outcomes with personalized diagnostics. 2021 was another unprecedented year, with multiple COVID waves throughout the year impacting access to physicians and shutting down hospitals. The Biodesix team would like to thank all healthcare professionals who have and continue to work tirelessly to help every patient. We all know how difficult and challenging that job is and how the pandemic has made it even more complex. Despite the headwinds and obstacles from COVID, we're pleased with the performance and results delivered by the Biodesix team. I believe our accomplishments and successes in 2021, speak volumes about our team, mission, vision, and culture, as well as the value our tests provides physicians and healthcare professionals who use the key critical test results and insights to positively impact their patients. Throughout the year, as we saw and experienced the ebbs and flows of the pandemic, the Biodesix team continued to lead and focus on strategic commercial execution. We continued to focus on expansion of our direct dedicated sales team, growing from 24 sales team members to 48 sales team members by year end. Increasing our commercial footprint is critical to our continued growth and development. These 48 sales team members sell our broad portfolio of five blood-based lung diagnostic tests. The testing portfolio begins with the Nodify XL2 and Nodify CDT tests, which are used for lung nodule management. Not only did we see and experience significant growth in the number of physicians ordering and using these tests, but we also shared data on Nodify XL2 in October from our prospective ORACLE Clinical utility study at the 2021 chest annual meeting. The…

Thank you, Scott. Fourth quarter total revenue of $7.2 million was in line with our expectations, as compared to $27.0 million for the fourth quarter of 2020. The $7.2 million represented an increase in revenue from our five core blood-based lung diagnostic tests, offset by an expected decrease driven entirely by the year-over-year change in COVID testing. As a reminder, the fourth quarter 2020 reflected significant COVID-19 diagnostic testing revenue, which we did not expect to be repeated in the fourth quarter of 2021. Total revenue for the full year ended December 31, 2021, was $54.5 million compared to $45.6 million for the full year ending 2020, an increase of 20%, driven primarily by the growth in core lung diagnostic tests and biopharma services. Our fourth quarter core lung diagnostic testing revenue was $5.4 million versus $3.7 million for the fourth quarter 2020, reflecting a 48% growth rate. For the full year 2021, core lung diagnostic testing revenue was $18.7 million versus $12.6 million, a 49% increase over 2020. In the fourth quarter 2021, biopharmaceutical partnership and services revenue was $1.4 million, compared to $1.9 million for the fourth quarter of 2020, a decrease of 29%. Biopharmaceutical services for the full year 2021 was $5.6 million versus $4.6 million, a 20% increase over 2020. As we have said, this business can fluctuate due to several factors, including contract timing, which can be long under normal circumstances, but in this instance, reflects the continued impact the pandemic has had on overall prospective clinical trial enrollment. Despite the ongoing nature of the pandemic, we've consistently projected that COVID testing would drop off for multiple reasons, including the changing COVID-19 infection rates and shifting towards convenient, rapid and personal at-home antigen testing. And we were right. COVID testing revenue was $0.4 million in…

Thank you, Robin. Many of you reached out to check on the Biodesix team in the aftermath of the greater than 6,000-acre Boulder County Marshall fire that erupted on December 30, 2020. Thank you for thinking of the Biodesix team. The Marshall fire was the most destructive wildfire in Colorado history, as it destroyed 1,084 homes and 10 businesses, while displacing countless other businesses and families. The Biodesix team was lucky as the Biodesix Boulder-based office and laboratory were not impacted, and all Biodesix team members were accounted for, with no team members having lost their home. Unfortunately, and sadly, the Biodesix team cannot say the same about our friends, neighbors, and communities. This was not the end to 2021 that we had hoped for, nor was it something that we could have ever imagined. Yet, I'm extremely proud of the Biodesix team, as all team members rallied to support and assistance to those in need, by opening their homes, volunteering, donating, assisting with fundraising, and providing COVID-19 testing for the first responders. While our community was still dealing with the Marshall fire's immediate impact, we began the year with yet another significant increase in COVID-19 infections, as the Omicron wave hit locally and nationally. In fact, in January, the seven-day average number of COVID cases increased 93% in two weeks. Like many other companies, our business was impacted by the Omicron variant in January and early February, mimicking the impact that Delta had in the third quarter of 2021. However, we are encouraged that as quickly as Omicron hit has rapidly subsided, which was reflected in the recovery we've seen since late February, and the continued improvements we’re seeing in March, mimicking the rebound we saw in the fourth quarter of 2020. Yesterday marked the two-year anniversary of when…

[Operator Instructions] Our first question comes from Brian Weinstein with William Blair.

Hey, guys. Good morning. Thanks for taking the questions. So, a few things here. First, in the script, you guys talked about significant growth in physicians that were using the core lung franchise, and we saw the growth rates there, but can you give us a little bit more in terms of details there? I know you guys have been reticent in the past to kind of break things out a little bit, but is there any kind of color that you can provide about docs or utilization stats that you saw in the year? And then how that - Robin, for you, how that translates into the buildup for your guide in ‘22?

Yes. Thanks, Brian. Good morning. Good to hear from you. It's a great question. One of the things we've stated in the past is we’ve got a number of metrics that we track on physician utilization. And we were very clear over the last 18 to 24 months that obviously with the pandemic, there were a lot of starts and stops. And so, we think that we stabilized. we're looking forward to disclosing and sharing some of those metrics as we progress through 2022. But we've also been clear that Omicron did impact physicians. The one thing we saw with Omicron that was a little bit different was people got sick, right? You saw it run through - I think we stated in the script, 93% increase in two weeks. We saw a number of physicians, healthcare providers, and their staff get sick. They returned to work quickly though. So, that disruption was minimal. It didn't extend through the quarter. So, we feel good that we're starting to learn how to recover and rebound. So, we're excited to share those metrics when we get a little more stability. What I can share, though, Brian, is, we've seen a record number of physicians ordering. Retention and reorder rates are extremely high and they continue to improve. And that's what we were looking for, because we think that's not only a strong indicator of what the physicians see in terms of our test results and how much they matter and impact them, but also it starts to show the stability that they've got in their practice.

Yes. And …

And I think - sorry, go ahead, Robin. Sorry.

So, from a model perspective, Brian, all of those are critical inputs for us for predicting out the model. And as Scott mentioned, when you take out the COVID waves and sort of those starts and stops, it helps us become much more predictive about what we expect to happen, excluding COVID abnormality.

Yep, understood. On the NGS test, obviously very early days, but any comments that you want to make about the message and how it's being received? And then, Robin, it back to you on how to think about that product in particular as far as the contribution that it could make towards that guidance range?

Yes. Thanks, Brian. We're really pleased. Early feedback and utilization has been strong, slightly better than we forecasted and anticipated. But as said, it really is early. We did the limited release at the end of the year, just introduced it a few weeks ago. We've got the entire sales team, all 48 sales professionals out presenting and representing that test and supporting its needs and interest. But we're really pleased. We're excited. It will take a little bit of time to kind of scale and ramp, but thus far, early indications and feedback is exceptionally positive.

Yes. From a modeling perspective, we take a fairly conservative approach. As with any new test launch, we wait to see the adoption, the number of tests per physician, number of physicians that begin using. And so, we expect a relatively modest contribution from NGS in 2022, with a stronger performance in ‘23 and contribution to the business really in ‘23.

Okay. And the last one for me is on the sales force. You doubled it in ’21. And I wasn't sure if the comments on the call were signaling - you talked about a similar pace. So, I didn't know if that meant adding in another 24 in - wraps in ‘22 or kind of six per quarter. And then as you're adding those reps and just as you think about your business in general, there was the shift towards the pulmonologist a couple of years ago. Now, you have some products that are geared a little bit more towards the oncologist setting - the oncology setting. So, can you talk about how the sales force splits their time there and in the comp plans that are sort of, each segment is sort of based on and what - well, yes, just basically how those reps are being evaluated this year. Thanks.

Yes. Thank you, Brian. Just as a reminder for everybody, we had approximately 24 sales team members at the time of IPO. We stated we would double that, which we did. So, we exited the year at 48. What we achieved last year was a steady rate of six sales professionals per quarter. Really that allows us to train, onboard, educate, inform, get them up and running. So, we like that cadence, but we want to be opportunistic about it. Obviously, there are a lot of things out there impacting the market. We want to make certain that when we bring somebody on, they’ve got clear line of sight to a path for growth, and we want them to be able to get towards profitability and paying for themselves as quick as possible. For us, it is also a balance of bringing on sales professionals that we can put into new dirt or territories where we haven't had somebody calling each and every day. We stated at the time of IPO, we had 24 sales reps. We had a number of sales reps covering multiple states. So, one of the other goals for us was, let's minimize overnights, decrease windshield time, not only make it a little more lean, take out some costs, but let's embed them. Let's make their territories a little bit smaller so that they truly can be that consultative sales professional that physicians look for as a trusted resource for them. So, we think we're doing exceptionally well. We have - we're not going to be as bold, Brian, to state, yes, we're going to honor that and do six per quarter and add another 24. We think that there's room for that, but again, we'll be mindful about when we bring on sales professionals this…

Yep. That's great. Thank you, guys.

Our next question comes from Kyle Mikson with Canaccord Genuity.

Thanks. Hey, guys. Thanks for taking the questions, and good to see the guidance for the year. Sounds like that includes the NGS test. So, that's good. And I understand some of the expectations to assume there. Could you just tell us if that assumes any like COVID testing right now? I know it's probably a small contribution. Just curious how you're kind of thinking about that for this year. And then, could you also kind of parse out some of the assumptions for like sales force access and maybe productivity of the new reps just relative to some of the recent quarters? Thanks.

Sure, Kyle. Thanks for being on the call. The guidance includes very, very little COVID revenue for the year. As we saw in the fourth quarter, COVID revenue dropped off significantly as expected, as the country really shifted more towards the point of care rapid antigen testing. Nothing in our experience really changes that assumption. From a rep productivity standpoint, as we mentioned, the reps are continuing to pay for themselves in about four to six months. So, right on or a little ahead of expectations. And rep access is good right now. That can be impacted as there are COVID spikes, as we've seen over the last year. I think what we've seen wave after wave is consistence, that when there's a major wave in any given area, rep access is limited. Patients going into the doctors are limited. Physicians and staff being sick impacts access. And so, it's really a sort of start and stop. But excluding delta in the third quarter, excluding Omicron in January, early February, rep productivity continues to improve, and we're very pleased with the progress of the sales organization.

Okay. Great to hear. Thanks, Robin. And shifting to the biopharma services business, noticed in the 10-K this morning it kind of indicates that you're experiencing some delays still. So, just want to understand if what you're kind of assuming in the near term here with some of those trials. And obviously the funding environment for some of these biotechs is pretty much non-existent right now. I know we're talking about pretty much larger companies that you're in conversations with. I'm just wondering, do these things hinder the pharma services revenue going forward, maybe in the near-term for ’22. I’d be curious to hear that. Thanks.

Yes. Thank you, Kyle. That recent Omicron spike definitely had a little bit of an impact in biopharmaceutical services. We experienced a temporary slowdown in retrospective studies when it comes to sample delivery, access to those samples. And then on the prospective study side, there definitely was an impact. And then we're monitoring closely those contracts we have in place and the partners we're working with. As you can imagine, any sort of clinical study that's occurring in Eastern Europe right now, we've got some questions and concerns about access to those samples and compliance for those patients. So, I think it's easy to say that historically, the biopharma services business has been a little bit lumpy based upon timing of contracts. You may have noticed that we stated that we've got more contracts in place, larger samples committed to. We think that's one of the paths forward to kind of minimize the lumpiness and smooth that out. And so, we're going to continue to go out and hunt and farm and bring in as many samples as possible, hoping that we can normalize that over time. When it comes to trends, the biggest concern is still (COVID, right? The pandemic around the world does have the ability to impact those studies. It's really complex and difficult to actually forecast and anticipate that impact. we're spending more time than ever really looking at where are those samples coming from? Can we get ahead of it? What can we do to help? But as you can imagine, as you see a spike in COVID around the world, it definitely shuts down some of those communities. It keeps patients away and there is a delay there. We feel good about the long-term viability. The conversations we're having with biopharmaceutical companies, academic institutions, research institutions, if anything, what we've noticed is that we're coming out of a pandemic where we told patients to stay away, especially those that were immunocompromised. There's a lot coming out in the literature now on the number and the percentage increase of cancers that maybe were missed, and or now have a delayed diagnosis. Sadly, and unfortunately, we all know that one of the best things we can do is detect and diagnose cancer early or sooner, because it gives us a higher likelihood of a positive outcome. Those delayed cancer diagnoses could be extremely problematic. And so, what we've seen is healthcare professionals, academic institutions, biopharmaceutical companies, really highlighting that and focusing on that and trying to pull it forward. So, I'm hopeful and confident that no matter what happens with the pandemic in the coming quarters, that we'll change our approach and we'll continue to prioritize those high risk and cancer patients to make sure that they're compliant in their back end. If we're able to do that, we should see samples coming in at a consistent rate. Is that helpful, Kyle?

Yes, Scott. That was great. Thanks for all that. That was perfect. I'll ask just a last question. I heard your goals, I guess, for 2022, just given the recent financings and the capital position now. I just kind of wanted to ask though what the company's priorities were for this year in order to drive shareholder value, like more from a kind of investment perspective to shareholders obviously. And just curious how you could - what's a near term sort of priority for you, objective for you that you think could really - you could execute on and really demonstrate some value to your shareholders. Thanks.

Yes, it's a great question. We feel very fortunate to be in the position we're in with the number of reimbursed tests that we have, right? To be able to launch Nodify XL2 with Medicare coverage in place, put us in a great position. So, with that being said, the on-market tests we have continue to drive those. that's who we are at our core. We're excited to come out of the pandemic and get back to hopefully some pre-pandemic normalcy and leverage those reimbursed tests. You may have also heard and noticed that even though the NGS test is early days, we have begun receiving Medicare payment. So, for us to have the tests that we have that are available to physicians, with the clinical data that we have supporting those tests, we think the number one priority continues to be growth, topline growth, grow the business, continue to leverage the increased number of feet on the street with our broadened sales force. And if we can do that, then we can get towards profitability. You may have noticed that we’ve referenced some measures. Without going into great detail, some measures we've put in place. And so, we're going to continue to push on our pipeline, PIR and ROR, but as you'll recall, we said we were going to launch those in 2023. So, you're not going to see a revenue impact from those tests in the next two years. And so, if anything, we want to be mindful that each and every dollar, each and every Biodesix teammate, is focused on driving topline growth and generating revenue with our reimbursed core lung diagnostic tests.

Great. Thanks, Scott. I really appreciate that. Thanks, guys.

Our next question comes from Tejas Savant with Morgan Stanley.

Hello. This is Yuko on for Tejas. Thank you for taking our questions. For the GeneStrat NGS test, what are your expectations for commercial versus Medicare volume, the mix there? And then, how should we think about revenue per test in the early phases of the ramp and then over the longer run?

Good morning, Yuko. The mix for GeneStrat NGS is the same as we've experienced with our other lung-based tests. Some Medicare accounts for about 60% of the patients. So, that is - and remains consistent. With the revenue mix for Medicare versus commercial, that drives a good strong portion of the ASP. We're billing using the existing greater than 50 gene NGS panel code, and the Medicare rate for that is about $2,900.

Great. That was super helpful. And then just a quick separate follow-up question. How should we think about OpEx cadence in ’22?

We expect OpEx in ‘22 to grow over 2021 as we’re continuing to expand our commercial organization and drive strong topline revenue growth for our lung diagnostics and biopharma business. But as we mentioned earlier, we have pulled on several levers to delay investments in certain long-term projects that do not impact revenue near term. So, we are watching OpEx growth very, very closely and trying to be very intentional with each dollar spent.

Great. Thank you very much.

[Operator instructions]. Our next question comes from Sung Ji Nam with BTIG.

Hi, thanks for taking the questions. Just have a couple. Could you give us a sense of the - in terms of the target clinicians and hospitals, the percentage of community hospitals versus academic that are - you are currently targeting or plan on targeting with the new NGS test?

Yes. Hi, Sung Ji. Thanks for the question. We've not disclosed, but the way we look at it is, our sales team members go in and really try to find in their community where they live, whether it's academic or community-based position, where the - really, we want it go as early as possible, right? So, where are the lung nodules being assessed? Where are they being referred to? And we really want to go there. We want to go as early as possible. We think that's where there's the greatest utility for the Nodify testing portfolio, right? Again, in early detection and diagnosis with both the rule and rule out tests. Then as we follow that lung cancer continuum of care, once a patient is diagnosed with lung cancer, similarly, follow those referral patterns. That's where you start to see a shift, and you'll see a lot of referrals out of community into academics. And so, we really call on both and all. We are not looking at prioritizing one over another. This is more about positively impacting patients treatment and lives. And so, the earlier we can get them into kind of a testing regime and get them referred on to the best and optimal physician, that works best for us also. Is that helpful, Sung Ji?

Yes. Absolutely. Thank you so much. And then in terms of the ORACLE Study, the Registry Study I believe, will be completed sometime this year. And could you talk about, what are some of the potential implications once that data is available in terms of from your commercial standpoint?

Yes, it's a great question. You don't want to speculate too much on what the potentials are, but there still is an opportunity to get guideline inclusion. And so, we think that the best way that you can do that is with data. And so, we're hopeful that as we continue to invest in ORACLE and we're able to share and publish those results, that there's an opportunity for physicians, especially from a guideline perspective, to consider kind of the, if, how, and when blood-based diagnostics play a critical role there. So, I think that's one. We've never discussed what a guideline inclusion could mean to forecast. We don't factor that in. Obviously, we want to be opportunistic for the if and when that presents. I would say that's probably the biggest opportunity at hand, but most importantly, for our sales professionals and team members, when they're out representing the portfolio of product, data is key, right? And so, our ability to highlight and demonstrate that in a real-world environment and real-world utilization that our tests perform at a similar rate to what they performed in the validation studies, we think that's critically important. We don't want to stand behind tests that show any sort of degradation in performance. And so, for us, I think that's the biggest. I think the - was it chest of last year in October, when we were able show nearly a 70% reduction in invasive procedures that weren't necessary. We think that's meaningful. It matters, and we've seen that data be requested. We've got a lot of sales professionals out there talking about it. So, we're really excited. I think you’re spot on on the timing. we're looking forward to submitting kind of the full data package for ORACLE here and hope to share news on a publication that might occur in 2022.

I would also add to that, that ORACLE is important for reimbursement as well. Payers don't want to pay for things that don't impact care. And so, this data really shows not only are we impacting outcomes, but impacting physician decision-making and helping to reduce unnecessary procedures. And so, we think it would be beneficial for reimbursement as well once the full publication is out.

Fantastic. Thank you so much.

And I’m not showing any further questions at this time. So, this does conclude today's presentation. We thank you for your participation. You may all disconnect, and have a wonderful day.