Biodesix, Inc. (NASDAQ:BDSX) Q4 2023 Earnings Call Transcript

Biodesix, Inc. (NASDAQ:BDSX) Q4 2023 Earnings Call Transcript March 1, 2024

Biodesix, Inc. beats earnings expectations. Reported EPS is $-0.1, expectations were $-0.11.
BDSX isn’t one of the 30 most popular stocks among hedge funds at the end of the third quarter (see the details here).

Operator: Good day and thank you for standing by. Welcome to the Biodesix’s Fourth Quarter 2023 Earnings Conference Call. [Operator Instructions]. Please be advised that today’s conference is being recorded. I would now like to hand the conference over to Chris Brinzey, Investor Relations. Please go ahead.

Chris Brinzey: Thank you, operator, and good morning, everyone. Thank you for joining us today for a discussion of Biodesix’s fourth quarter and year-ended 2023 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-ended 2023. A copy of the release can be found on the Investor Relations page of the company’s 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 the diagnostics 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-ended December 31st, 2023, which was filed today with the Securities and Exchange Commission. 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.

This call will also include a discussion of non-GAAP financial measures which are adjusted to exclude certain specified items, a reconciliation to the most directly comparable GAAP financial measure is available in the press release we issued today. I would now like to turn the call over to Scott Hutton, Chief Executive Officer. Scott?

Scott Hutton: Thank you, Chris. Happy to share that, 2023 was a great year of execution at Biodesix. We’ve been focused on three goals, driving increased revenue through the adoption of our lung diagnostic test and our biopharma and diagnostic services, implementing operational efficiencies to improve gross margins and maintaining a strict cost discipline. In 2023, we delivered approximately 38,700 lung diagnostic tests, which represent 65% growth over 2022. We increased our gross margins over the course of the year to 77% and we improved our fourth quarter adjusted EBITDA by 55% over the comparable period. Our team and culture have never been stronger, and you see that strength reflected in our results. I want to express my sincere gratitude to our team for their hard work and dedication to improving the lives of patients and the healthcare professionals that serve them.

Our top priority remains the ongoing adoption of our five blood-based tests for patients with potentially cancerous lung nodules and those with lung cancer. This past quarter, we delivered approximately 10,900 test results, reflecting growth of 54% as compared to the approximately 7,100 test results delivered in the fourth quarter of 2022. This is the sixth straight quarter of at least 50% year-over-year growth, primarily driven by our notified CDT and XL2 lung testing volumes. Lung nodule management is by far the largest market we serve and will continue to be the largest driver of lung diagnostic test volume growth. Our industry-leading commercial team was responsible for driving this outstanding growth in 2023. We continued to invest and expand our organization throughout the year, finishing with approximately 50 fully trained representatives, with an additional 10 that came on board late in quarter four.

On average, our sales representatives began paying for themselves within two to three months. Therefore, we expect these new teammates to begin contributing in the first quarter of 2024. We also validated the benefit of adding associate sales consultants into existing territories, working alongside established team members to improve account retention and penetration, while building a bench for future expansion. As a result, 2024 will see an ongoing expansion that includes splitting existing territories into more manageable geographies as the business grows, with an increase in the number of territories holding both a sales consultant and an associate sales consultant that will accelerate adoption within those territories. In the second half of 2023, the publication of the primary endpoint for the Oracle Prospective Registry Study was published.

The data showed that use of the Nodify XL2 test resulted in a 74% reduction in costly and unnecessary biopsies and/or surgeries on patients with benign lung nodules. In addition to this data, an independent group of academic medical centers published a 73% reduction in unnecessary procedures, clearly demonstrating the clinical utility of Nodify in the real-world clinical setting. Peer-reviewed publications such as these are critical to help expand physician adoption of our test, as well as expanding payer coverage. In addition to the growth in volumes driven by our sales team, broadening reimbursement coverage remains an important part of our growth strategy. In July, the Nodify CDT test was awarded Advanced Diagnostic Laboratory Test or ADLT status by the Center for Medicare and Medicaid Services.

Receiving ADLT status is a major milestone for the Biodesix’s team, as this is reserved for innovative tests with Medicare coverage that provide clinical value and new diagnostic information that cannot be obtained from any other test or combination of tests. The ADLT status is a public recognition of unique clinical utility. Nodify CDT joins Nodify XL2 and VeriStrat in having received that important classification. In late fourth quarter, Geisinger Health Plan issued a positive coverage decision for Nodify lung testing, including both the Nodify CDT and Nodify XL2 blood-based proteomic tests. Geisinger Health Plan was the first commercial plan to cover Nodify CDT. The combined coverage of both Nodify CDT and Nodify XL2 testing recognizes the importance of these tests in assisting healthcare professionals in lung nodule management to help improve patient outcomes.

Moving on to our biopharmaceutical services business, we generated exceptional momentum in the second half of the year with more than 35% year-over-year growth in each of the last two quarters. We are encouraged with the strong growth this quarter and are pleased to see an increasing number of samples received from several different biopharma companies, running multiple clinical studies and an increasing number of incoming RFPs and opportunities. In addition, our team continues to deliver on test process automation and workflow optimization projects that have driven a steady increase in gross margins over the course of 2023, ending the fourth quarter with 77% gross margin, an increase of 11 points over fourth quarter of 2022. We’ve been exceptionally effective in providing our tests with industry-leading turnaround times and have made great strides in becoming even more efficient in the delivery of those tests.

Finally, our commitment to a cost-disciplined approach, while growing and expanding the business continues to deliver tangible results. Adjusted EBITDA in the fourth quarter improved 55% over the same period in 2022. We built a commercial and operational platform that will help facilitate long-term, consistent, sustainable growth, and I believe everyone is to appreciate the leverage that exists within the business model and our efforts to demonstrate the team’s significant progress and outstanding execution on our path to profitability. Before I turn the call over to Robin, I’d like to reiterate our commitment to transform the standard of care in lung cancer and improve patient outcomes with personalized diagnostics. Lung cancer is still the deadliest of all cancers as it claims more lives annually in the United States than the combined total of the next three deadliest cancers, breast, prostate and colon cancer.

Time is of the essence when it comes to diagnosing and treating these patients. By discovering, developing, and commercializing tests with demonstrated clinical utility and best-in-class turnaround times, we believe that our diagnostic tests play a critical role in these efforts to treat the right patients quickly and effectively. With that, let me turn it over to Robin to review the fourth quarter and year-end 2023 financial performance.

Robin Harper Cowie: Thanks, Scott. Fourth quarter total revenue was 14.7 million, a 53% increase over the prior year. Full-year revenue in 2023 was 49.1 million, a 49% increase over prior year excluding 2022 COVID revenue of 5.2 million, and a 28% increase over full-year revenue in 2022 including COVID revenue. As Scott mentioned, we delivered approximately 10,900 lung diagnostic test results in the fourth quarter versus approximately 7,100 test results for fourth quarter 2022 and approximately 38,700 lung diagnostic test results for full year 2023 versus 23,500 test results for the full year 2022, a 54% increase and 65% increase respectively. Test volume in the quarter was our sixth straight quarter of at least 50% year-over-year growth.

Lung diagnostic revenue in the fourth quarter was 12.8 million compared to 8.2 million for the fourth quarter of 2022, an increase of 55% over prior year. Lung diagnostic revenue for the full year 2023 was 45.1 million, a 54% increase over the full year 2022. As we’ve discussed in prior earnings calls, we continue to experience delays in some Medicare Advantage payments for our Medicare covered tests from certain payers. While we continue to work with the plans to resolve the administrative hurdles, the backlog continues to grow and ended the year at approximately $3 to $3.5 million, up from 2.5 to 3 million reported in our third quarter earnings call. We will continue to provide updates in our calls as we work towards a satisfactory resolution.

Biopharmaceutical services revenue was 1.9 million in the quarter compared to 1.35 million in the fourth quarter 2022 and 3.9 million for the full year 2023 compared to 3.7 million for the full year 2022, an increase of 38% and 6% over the respective prior year comparable periods. As a reminder, this business can fluctuate due to several factors including contract timing and project execution. And while we had a strong quarter, we did experience a delay in the receipt of samples for a large project resulting in approximately $600,000 in revenue pushing from the fourth quarter into the first half of 2024. Overall, we ended the year with $7.9 million contracted but not yet recognized as revenue. The decrease in contracted revenue from the third quarter is something we typically see as we complete contracts and record higher revenue totals like we did in the second half of the year.

However, it’s important to note that the number of incoming requests have continued to be strong in the first eight weeks of 2024 and we have a robust pipeline. Since the beginning of the year, we have signed new contracts and increased our total dollars under contract but not yet recognized to 9.1 million as of today. Gross margin percentage in the fourth quarter 2023 increased to 77% versus 66% in the prior year quarter and 76% in the third quarter of 2023. Current gross margin trends reflect the growth in our lung diagnostic testing and successful completion of projects to decrease costs and optimize testing workflows. The steady improvement across 2023 resulted in full year gross margins of 73% versus 63% for the full year 2022. We anticipate the ability to maintain margins in the mid-70s going forward.

Overall operating expense excluding direct costs and expenses was 18.2 million in the fourth quarter 2023 compared to 20.2 million for the same period of 2022 and 17.4 million in the third quarter of 2023. The decrease in operating expense versus the prior year quarter is primarily the result of a decrease in R&D expense and G&A partially offset by increased sales and marketing costs to support lung diagnostic sales growth to enhance product awareness and drive adoption. Total operating expenses excluding direct costs and expenses for the full year 2023 were 77.4 million versus 74.6 million in 2022. For the full year 2023, the slight increase as compared to the prior year period is related to increased sales and marketing expense partially offset by the realization of savings from our prioritization of projects that are expected to result in near-term revenue and the delay of longer-term projects.

Operating expense for the fourth quarter 2023 includes 1.1 million in non-cash stock compensation expense as compared to 2.1 million during the fourth quarter 2022. For the full year 2023, non-cash stock comp expense was 5.4 million compared to 6.0 million for the full year 2022. Net loss for the fourth quarter 2023 was 9.1 million compared to a 20.3 million net loss for the same period of 2022 and 10.9 million for third quarter 2023. Net loss for the full year ended 2023 was 52.1 million compared to a 65.4 million net loss for the full year 2022. The decrease in net loss for both the quarter and the full year was driven primarily by the increase in revenue, improvements in gross margins, and reduction in certain operating expenses including R&D expense as well as a reduction in non-cash stock-based compensation.

Fourth quarter and fiscal year 2023 included a gain of 0.1 million and loss of 1.3 million respectively from the change in fair value of warrant liabilities associated with our term loan facility with Perceptive Advisors. While fourth quarter and fiscal year 2022 included a one-time loss of approximately 4.0 million and 7.0 million respectively for the extinguishment of debt. To provide better clarity of progress on our path to profitability, during the third quarter we started reporting adjusted EBITDA which excludes certain non-cash items and COVID-19 testing revenue and direct costs and expenses. Adjusted EBITDA for the fourth quarter 2023 was a loss of 4.9 million compared to a loss of 10.8 million for the quarter 2022, a 55% improvement and 11% improvement over the third quarter 2023.

Adjusted EBITDA for the full year 2023 was a loss of 32.7 million compared to a loss of 43.2 million for full year 2022 and a 24% improvement. The improvement in adjusted EBITDA in both the fourth quarter and for the full year demonstrates our focus on actively managing our operating expenses, our success in improving gross margins and driving growth in top line revenue resulting in a decrease to our cash burn. We ended the year with 26.3 million in unrestricted cash and cash equivalents as compared to 19.8 million at the end of the third quarter, an increase of 6.5 million which included the addition of the remaining 12.2 million from the 27.5 million private placement announced in August and 10 million that was drawn from the second tranche of our 50 million term loan facility with Perceptive Advisors.

This was offset by our integrated diagnostics milestone payment of 3.5 million, an additional 3 million for one-time capex used to complete work on our new facility which is now fully operational and cash used to fund operations and working capital. I do want to remind you of a required shift in the display of the milestone payments to integrated diagnostics on our statement of cash flows. As I mentioned last quarter, payments made through the third quarter of 23 have been classified as cash outflows from financing activities in our statement of cash flows. However, beginning with a portion of the milestone payment made in the fourth quarter as well as all milestone payments to be made in 2024, these payments are now classified as cash outflows from operating activities due to the applicable US GAAP requirements.

For clarity, the dollar amounts are not changing, just where they are required to be captured on the statement of cash flows. Finally, turning to 2024 guidance, we plan to deliver 65 million to 68 million in total revenue driven primarily by growth in lung diagnostics with modest increases from our biopharma services offerings. This guidance does not include any expected revenues from the Medicare Advantage backlog. Now let me turn it back to Scott. Scott?

Scott Hutton: Thanks, Robin. We’ve again achieved impressive and high double-digit growth in the past quarter attributed to the exceptional performance of our consultative lung-focused commercial team who’ve been instrumental in fueling our success. We’ve improved our already strong gross margins and made substantial progress on our path to profitability. 2024 is a year of execution on our three goals, driving increased revenue by accelerating the adoption of our lung diagnostic tests and biopharma services, implementing operational efficiencies to improve gross margins, and maintaining a strict cost discipline. By aligning these three strategic efforts, we’re confident in our ability to sustain our aggressive growth trajectory, make progress on our path to profitability, and deliver value to the healthcare professionals, their patients, and all shareholders.

We are transforming the standard of care and are excited to be making such a significant impact. Finally, we’ve completed the move into our new 80,000 square foot, state-of-the-art corporate office and clinical laboratory in Louisville, Colorado. We believe this new facility provides another competitive advantage as it enables us to grow and expand in an efficient and effective manner. With that, I’ll turn the call over to the operator for questions.

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Q&A Session

Operator: [Operator Instructions]. Our first question will come from the line of Andrew Brackmann with William Blair.

Andrew Brackmann: Scott, Robin, good morning. Thanks for taking the question. I have a few. Maybe to start here on revenue guidance for the year, it’s nice to see that solid growth outlook that you did talked about. You may be helped parse out some of the build there. I guess I’m just looking for things related to sort of rep ads, utilization increases, new accounts, revenue per test, any color there might be appreciated. Thanks.

Scott Hutton: Good morning, Andrew. Thanks for the question. We talked a lot about Salesforce expansion and growth. As you just heard, we exited the year right at about 50 sales reps contributing. We’re going to continue to grow and expand that Salesforce. What we do know from a past performance and obviously a modeling perspective, we’ve seen our sales professionals come on and start to pay for themselves in about three months. The one thing we’re mindful of is as we continue to expand into territories where we haven’t had representation prior, that ramp may be a little bit slower. Then as we look at promoting associate sales consultants into open territories, which we’ve done, we had five that we promoted towards the end of the year, which really demonstrates that our plan and approach is working.

We still know that those are going to be junior young sales professionals. We’ve really looked at this trying to improve forecast accuracy, ensure that we put them in a position to succeed. What we’ve seen from a sales rep productivity number really is we can get them into that $750,000 to $1 million per rep in a pretty reasonable timeframe. One of the things we’ve disclosed in the past is we have seen some sales professionals get north of $1.5 million per rep, but we cut their territory. We were never really striving to see could we get them to $2 million. We wanted to make certain that we could cut territories and then demonstrate that they could grow again. We just wrapped up our national sales meeting, Andrew, and share this with you. We have a back-to-back top sales rep of the year.

What makes that most remarkable is two years ago she won with an associate sales consultant. At the end of the year, we split her territory, promoted the sales consultant into one half of that territory. They both finished in the top five. What we’ve really proven out is we can go deep. I use the word consultative. I think the more we put our sales professionals in healthcare professional offices, they’re going to find that we are consultative. We bring tremendous value. The clinical value of our test isn’t really questioned. Again, we haven’t seen where we can cap out on that sales rep productivity number just yet. We factored all of the past performance into modeling really what we think in that guide range is achievable for us this year.

Is that helpful?

Andrew Brackmann: Very helpful. Thanks for all that color. I guess related to the outlook here, you’re making really nice progress on the margin front and sort of reducing operational burn. Can you maybe just sort of talk about how we should think about further reductions in that burn metric this year and the sort of leverage that you expect in the model throughout 2024?

Scott Hutton: Andrew, you’ve actually been out here and you’ve seen the facility. The new facility really should empower us to continue to make some improvements. We’ve focused over the last three to four years on workflow and operational efficiencies. Obviously, we’ve made those and achieved those. One of the things most may not appreciate is that old facility was really constructed for one product in the laboratory. And so we ran out of space. We were limited in what we were able to do. Moving into the new facility gives us the ability to move forward with growth and expansion in mind. We think that we’re set up to continue to improve that. We’re also mindful that we believe we’ve got industry-leading gross margins. We’re aware maybe two other diagnostic companies that are in the ballpark may be slightly better. We also want to be realistic. We’re still forecasting for modest improvements there to take us into that mid and keep us in that mid-70s range.

Robin Harper Cowie: From an operation expense standpoint, it remains one of our top goals and focus for 2024, maintaining that strict cost discipline, being very efficient and effective with our cash to keep driving down our overall burn and make continued progress on our path to profitability.

Andrew Brackmann: That’s great. And then maybe if I could, just a bigger picture question here. It’s been a couple of years since USPSTF updated their screening guidelines. We should hopefully get some sort of update on the development of quality measures there for screening later this year. I think it’s safe to say there’s going to be a lot of tailwinds in nodule identification over the next couple of years. For Biodesix in particular, aside from continuing to invest in that commercial team, can you talk about some of the things that are in your control to really ensure that you’re going to be that go-to solution for nodule management as all these tailwinds play out here over the next few years? Thanks.

Scott Hutton: It’s a really insightful question, Andrew. Thank you. Yeah, I think you’re right. We’re all eager to see what USPSTF change in screening guidelines does and what that impact is. Obviously, everybody’s got their fingers crossed that it improved those numbers and that we see more early detection and diagnosis. Because we’re dealing with the deadliest of all cancers, we know right now that the first thing that will improve outcomes is that early detection and diagnosis. So, we’ll eagerly sit back and wait for that. We also know and we’ve seen what the HEDIS measures did in breast cancer. And so, right now, we’re anticipating HEDIS measures for lung cancer to go into effect in the third and fourth quarter of this year.