Biodesix, Inc. (BDSX)
NASDAQ: BDSX · Real-Time Price · USD
10.64
+0.68 (6.83%)
At close: Apr 24, 2026, 4:00 PM EDT
10.43
-0.21 (-1.97%)
After-hours: Apr 24, 2026, 7:03 PM EDT
← View all transcripts

Jefferies Global Healthcare Conference

Jun 6, 2024

Scott Hutton
CEO, Biodesix

Thank you, Izzy, and thank you to the Jefferies team for the opportunity to be here today. As Izzy said, my name is Scott Hutton. I'm the CEO of Biodesix. Biodesix is a blood-based, lung-focused diagnostic company. We're really excited to share significant growth and continued strong performance. In our most recent earnings call, we shared seven straight quarters of at least 50% growth in test volumes. We also shared industry-leading 79%, gross margins, and we've made tremendous progress on our path to profitability, and began sharing our adjusted EBITDA numbers and performance approximately a year ago, and you can continue to see the strong improvement year-over-year with a 48% improvement. We continue to play in an exceptionally large market with limited to no competition.

And again, that lung-focused diagnostic company focus with five, excuse me, five on-market test, all with Medicare coverage. So let's jump into it. Two sides of our business where we generate revenue and growth. I've referenced the lung side of the business, where our commercial team focuses on calling on the pulmonologist, and then we have a biopharmaceutical side of the business, where we provide services and support to biopharmaceutical companies, and we'll talk a little bit in greater detail on both. Biodesix has two locations, the company headquarters, both office and laboratory, just outside of Boulder, Colorado, and then a second office and laboratory located just outside of Kansas City. Both highly certified and regulated labs with ISO certifications that we think differentiates us from some of the competitors.

You may ask yourself, "Why lung?" Unfortunately, lung cancer remains the deadliest of all cancers. Even with smoking cessation programs and significant efforts and interest, we still have a situation where more individuals this year will die from lung cancer in the United States than the number two, three, and four cancers combined, being prostate, breast, and colorectal cancer. So big opportunity for us to positively impact patient care and treatment by helping with early detection and diagnosis. I mentioned our five tests, all with Medicare coverage. Pre-cancer diagnosis, we have the Nodify testing with both Nodify XL2 and Nodify CDT, and then post-cancer diagnosis, we have our treatment guidance portfolio that we call IQLung.

Here we have two genomic tests and one proteomic test, helping physicians understand what's both going on with the patient's cancer and their immune system, and we'll talk about each of these tests in greater detail. So we'll start pre-cancer diagnosis, where physicians have a tremendous challenge of identifying those patients with lung nodules, whether identified through incidental findings or a screening program, identifying those that they need to intervene on and/or have the highest likelihood of malignancy. The guidelines provide great clarity as to when you have a patient that presents with a high risk of lung cancer and a very low risk.

In those scenarios, they know with a high level of confidence on the high risk to intervene, whether that's biopsy or surgical resection, and then again, on the very low risk, having confidence that they can send a patient to CT surveillance and take a wait-and-watch approach, with those patients. Unfortunately, 80% of the patients that present reside in this, low to moderate risk category, where the physician's guidelines state, "Use your judgment." What judgment means to them is they can apply any one of those prior stated, options, whether it's biopsy, surgical resection, and/or taking a wait-and-watch approach. When we looked at the performance, in this, disease state, what we saw was historically 62% of patients, that had a biopsy conducted, had a biopsy, on a benign nodule.

Even more dire, one in three patients that had a surgical resection actually had a benign nodule. In lung cancer, that requires a lobectomy, so you're removing a significant portion of a patient's lung, driving down or decreasing pulmonary capacity. And then on the opposite extreme, nearly one in five patients historically sent to CT surveillance actually had a malignancy. So in those scenarios, you're hoping, first and foremost, that the patient remains compliant, that they return in a year and have a follow-on CT, at which time physician will notice disease progression and/or change. So when we looked at these statistics, we saw a significant opportunity to partner with physicians to give them more data, and allow that data to help drive some of their clinical decision-making. So we introduced the two Nodify tests, Nodify CDT and Nodify XL2.

You can see here in the slide how they fit into that, that guideline or that care continuum. So in the low to moderate risk category, a simple blood draw. We will, upon receipt in the laboratory, we'll run Nodify CDT first. This is a traditional rule-in test. Here, we're identifying those patients, that have a likely malignant nodule. In that scenario, where a patient is identified with a likely malignant nodule, we will destroy the Nodify XL2 sample and cancel the order for the test, because you've already identified a, a patient that you need to intervene on. When that does not come back as likely malignant, we then run that Nodify XL2 test, helping identify those patients that have a likely benign nodule, supporting a wait-and-watch approach, or CT surveillance on a twelve-month interval.

Again, you're helping physicians make data-driven decisions, so that they know when to intervene, when not to, and in the deadliest of all cancers, again, early detection and diagnosis is where we can make the most significant impact near term. So in that scenario, with a Nodify CDT, now we've led to a lung cancer diagnosis, whereas I mentioned earlier, we offer the IQLung treatment guidance testing strategy with two genomic tests and one proteomic test. When we look at performance and challenges in this space, I've already mentioned that lung cancer is the deadliest of all cancers, with an estimated 235,000 patients being diagnosed with lung cancer this year. Unfortunately, many of those are gonna be a late-stage diagnosis.

What the literature will show us is a late-stage diagnosis has a 10.5-month median survival. Unfortunately, majority of these patients are not gonna make it to their one-year anniversary of diagnosis. The way we translate that is time matters. And so, historical utilization and reliance on tissue testing could result in a delay of 26 days or nearly one month before you apply treatment. In this disease state, physicians really need those molecular data results to guide their treatment. So the faster they can get these test results, the better off they are. So with our tests, we have a turnaround time of less than three days for all of our tests. GeneStrat ddPCR and GeneStrat NGS, here we're providing genomic insights.

We offer the two tests really early stage, targeted markers, ALK, EGFR, ROS, RET. We focus on giving those within a three-day time frame, highlighting the opportunity to put them on the optimal treatment. Medicare states that NGS can be utilized, one branded NGS test per patient, per cancer diagnosis, per lifetime. So what we've suggested is wait and utilize the broader, our 52-gene panel here for us at a later stage when you've seen the cancer advance, metastasize, or recur. And then to complement that, we offer our proteomic blood test called VeriStrat. Here we're measuring a patient's immune status and really tracking a chronic inflammatory disease state. And that can be associated with a scenario where the patient's immune system has become compromised and or subverted.

When that occurs, what that guides physicians to do is change direction, apply a different treatment, approach these patients in a different means, again, because you know you have limited time. We have the five on-market tests that our commercial teams sell today, and we have three tests currently in our pipeline. We have disclosed that we do not plan on commercializing these tests in 2024 or 2025 at this point in time. We'll continue to offer these in a research use-only capacity that our biopharmaceutical partners will continue to utilize and reference. The three tests, Risk of Recurrence, Primary Immune Response, and Minimal Residual Disease test. A Risk of Recurrence, blood-based proteomic test.

Here we're able to identify those patients that will recur pre-surgical resection, so simple blood draw prior to the surgical resection, and we can identify who those patients are. That's a proteomic test. To complement that, we have our Primary Immune Response test. Here, we're able to identify those patients that will respond favorably to an immunotherapy regimen. And then on the contrary, those patients that will not respond to that prescribed immune therapy regimen. And then on the Minimal Residual Disease, to complement Risk of Recurrence, Minimal Residual Disease will be a post-surgical resection blood draw. Here, we'll be the first company with both a proteomic, genomic offering, pre-surgical resection, and post-surgical resection.

We believe that there's a lot to tell from that data, both what is going on with the cancer, and also how is the patient responding to that cancer. So again, more details to follow on this portion of our portfolio, but we feel confident as we've built out the commercial channel that we have the largest and strongest diagnostic-focused sales team calling on pulmonologists. We believe there's an opportunity to continue to drop and add product into their bag, allowing them to not only continue to be consultative, but to add significant value to those pulmonary healthcare professionals. Shifting gears, we've talked about the lung diagnostic side of the business.

Now we'll focus on the biopharmaceutical side of the business, where over time, we've partnered with 60 different biopharmaceutical companies, nine of the 12 largest, and we continue to offer great clinical insights, whether that's early discovery insights or validating and confirming different clinical trial endpoints throughout their trials. We are supporting them with a multitude of technologies and a multitude of assays. We offer our commercial and clinical portfolio, but we have a number of other assays that are for research use only. And as I already stated, that's also where the current pipeline products will reside. This portion of the business accounts for about 10% of our revenue. We've seen tremendous growth and recovery post-pandemic.

We're excited for the potential here, and we began sharing the dollars under contract, but not yet recognized about a year ago, really trying to highlight and demonstrate that this business is rebounding, it is continuing to grow, and we'll recognize that $9 million anywhere from one to three years, it varies. And so as our team is out continuing to build that book of business, we fully expect that to stay in, and if not stay in that area, continue to grow in size. So again, Biodesix's blood-based, lung-focused diagnostic company, massive market. We have a first-mover advantage with no competition for our two Nodify products.

Again, really proud to share seven straight quarters of greater than 50% growth, with industry-leading gross margins that we feel confident we can continue to maintain and keep in that mid- to upper-70% range. We will continue to provide the Adjusted EBITDA performance, and fully expect, by the end of this year that we'll give greater clarity in that path and timing to profitability, but that we can get there. And we recently closed a $55 million fundraise, and during that point in time, we said, use of proceeds were to continue to expand commercial channel, and that it was last fundraise to profitability. So we're excited to continue to perform and deliver on that expectation.

I am very fortunate to represent an accomplished successful diagnostics team that I'm biased, but I feel is the best in the industry. And again, I'm honored to represent them. It's the daily work that they do that differentiates us, and you can see a few members of that leadership team here. We recently moved into a new facility just outside of Boulder, Colorado. It's an 80,000 sq ft office and laboratory, state-of-the-art. It will accommodate growth and expansion for 10+ years. If you ever find yourself in Colorado, we're happy to host, give tours, and show you around the facility and introduce you to the team. With that, I'd like to thank you all for your time today.

It's a great opportunity to be here, and thank you to the Jefferies team for the invitation.

Powered by