2/23/2026

speaker
Operator
Conference Operator

Good day, and thank you for standing by. Welcome to the GeneDx Fourth Quarter 2025 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Sabrina Dunbar, Investor Relations. Please go ahead.

speaker
Sabrina Dunbar
Investor Relations

Thank you, Operator, and thank you to everyone for joining us today. On the call, we have Catherine Stuland, President and Chief Executive Officer, and Kevin Feely, Chief Financial Officer. Earlier today, GDX released financial results for the fourth quarter, ended December 31, 2025. Before we begin, please take note of our cautionary statements. We may make forward-looking statements on today's call, including about our business plans, guidance, and outlook. Forward-looking statements inherently involve risks and uncertainties and only reflect our view as of today, February 23rd, and we're under no obligation to update. When discussing our results, we refer to non-GAAP measures, which exclude certain items from reported results. Please refer to our fourth quarter 2025 earnings release and slides available. at ir.gbx.com for definitions and reconciliations of non-GAAP measures and additional information regarding our results, including a discussion of factors that could cause actual results to materially differ from forward-looking statements. And with that, I'll turn the call over to Catherine.

speaker
Catherine Stuland
President & Chief Executive Officer

Thank you, Sabrina, and good morning, everyone. The fourth quarter was a strong finish to a transformative year for GDX. We reported quarterly revenues of $121 million, bringing full-year revenues to $428 million, underpinned by 54% exome and genome revenue growth. We continue to balance high growth and profitability in service of a massive unmet need, delivering accurate genetic diagnosis to the millions of patients and families seeking and waiting for it. Today, we reaffirm our full year 2026 guidance, and we'll talk you through the elements of this growth that give us such confidence in our near and long-term targets. 2026 is going to be a breakout year for GeneDx. We're operating in an enormous and largely untapped market with a 25-year head start. We've cemented our position as the clear leader in rare by diagnosing more patients with exome and genome than anyone else in the world, and we have the number one genetic test the largest and most diverse rare disease data set, and the leading technology and team. Our leadership position was further reinforced by our recent FDA breakthrough device designation, which positions GEN-Dx to become the first FDA authorized comprehensive genomic solution in this category, a meaningful long-term differentiator, particularly as we enter mainstream medicine. The clinical case, the economic case, and the policy case for exome and genome are converging. And GeneDx, alongside our patients, is shifting the power of genomics from promise to practice. Patients are the center of everything we do at GeneDx. Every test, every data point, and every partnership comes together to create a network effect in service of faster answers, deeper understanding, and expanded access to precision care. We're opening new markets. like general pediatrics to reach patients at the earliest moment possible. Rare disease affects one in 10 Americans, and it still takes an average of five years for a patient with a rare disease to receive an accurate diagnosis. The current standard of care often allows years of disease progression at a time when we can offer an accurate diagnosis in a matter of hours. There's a huge opportunity here that looks similar to where cancer diagnostics was 15 years ago. And GDX is best positioned to serve this massive unmet need. Diagnosing rare disease is fundamentally a scale problem. In cancer, the key genes are well characterized, but in rare disease, most patients carry genetic changes that have never been seen before. Novel variants aren't the exception, they're the norm. To diagnose these patients, you need to find others who show the same genetic change and the same symptoms. That means the size and diversity of your reference data set is everything. The larger your data set, the more matches you make and the more diagnoses you deliver. No one does this at the scale we do, and that's because of GeneDx Infinity. Infinity is the world's largest and most diverse rare disease data set composed of more than 2.5 million rare genetic tests, over 1 million exomes and genomes, and over 8 million phenotypic data points. More than 60% of the exomes and genomes in INFINITY have parental data, which is critical for interpretation. And over 50% are from patients of non-European descent, which improves their diagnostic capabilities across real-world populations. While incredibly vast, INFINITY is also deep, structured, and expertly annotated to enable fast and accurate diagnoses at scale and across clinical indications. As we test more patients, The power of infinity compounds. With over a dozen exome and genome products currently on the market, GNDX is still chosen 80% of the time by the most discerning specialists. And we've held that share through multiple competitive cycles. Infinity was built specifically for rare disease, patient by patient, year by year in the clinic. It would take decades to replicate what we have today. And by then, we'll be decades further ahead. AI models are only as good as the data they're trained on, and GeneDx Infinity is the richest resource available. Our clinical experts and leading AI tools leverage Infinity to surface insights hidden within complex clinical and genomic data, and we are constantly innovating to amplify this impact. For example, our proprietary AI gene ranker, Multiscore, analyzes billions of internal and external data points to identify the most likely genes causing a patient's symptoms, improving our scale, efficiency, and turnaround time. AI is an enabler for us, and our team will remain at the forefront of leveraging this technology to improve outcomes for patients. We are currently operating in six massive untapped markets, each of which will contribute to our accelerated growth in 2026. And we're nearly tripling what was already the largest sales force in rare disease to capture the wide open space ahead of us. We have multiple levers for growth. Namely, one, activating new clinicians in our existing call points. Two, driving higher utilization among clinicians already ordering from us. And three, introducing our industry-leading testing to new markets. Even with geneticists, our most established market, we have 80% clinician penetration but still have room to grow by shifting more testing from single gene and panel approaches to exome and genome. Among pediatric specialists, we've reached about 30% of clinicians and only 15% of eligible patients, giving us two clear ways to grow, establishing more doctors and increasing how often they order. In our four newer US markets, prenatal, NICU, adult specialists, and general pediatricians, There are over a million addressable patients, and we've barely scratched the surface with clinician adoption still in the single digits. Our first mover position, focused sales strategy, best-in-class products, geneticist endorsements, and experienced market access teams best position us to build these new markets and take dominant share early. With that in mind, I want to walk you through our building blocks of growth. each contributing to a stacking effect of revenue and volume that will compound over time. Our foundational markets, geneticists and pediatric specialists, delivered most of our growth in Q4, and there's still significant runway ahead. These markets drove nearly all of our growth in 2025 and have strong momentum entering 2026. We will continue to layer on new indications and call points to these specialist markets, And we've expanded our dedicated sales team from approximately 50 reps in 2025 to 75 in 2026 to drive continued adoption. On top of that foundation, we're ramping in key expansion markets, the largest of which is general pediatricians. We're hearing positive feedback on our one-minute ordering experience, which is set to launch this summer. And in combination with a dedicated 50-person sales force, We're well positioned to begin seeing volumes really pick up in Q4. The NICU remains another key element of our expansion strategy. We know what good looks like here based on our experience with leading institutions like Seattle Children's and the recommendations outlined in the 2025 Seek First study. This market takes longer to convert, but once it does, it's incredibly sticky and profitable. We have a team of 10 routes dedicated to the NICU and expect to see steady growth in 2026. We recently stepped into prenatal diagnostics with an exome and genome test intended for patients with abnormal ultrasounds. We're targeting maternal fetal medicine specialists with a small team of about 10 new reps to begin driving utilization to help clinicians deliver answers in these critical moments for families. Additionally, we began leveraging our specialist sales force to sell into adult neurologists diagnosing patients with pediatric onset conditions that were missed as children. Lastly, we continue building an international strategy centered around software and interpretation as a service, and we have five reps executing in key geography. We also see three key future markets on the horizon, genomic newborn screening, new channels like telemedicine, and leveraging our data set for biopharma in service of patients in precision medicine, and are laying the groundwork to unlock each. As you can see, our growth is not dependent on any single market or a single bet. It's layered, it's compounding, and it's anchored in a strong and fast-growing core. By introducing our services to mainstream clinicians, we're seizing a massive growth opportunity, and as the leader in RARE, we're setting the standard for what exome and genome testing should be. Accurate, fast, accessible, simple to order, and easy to understand, and we will continue to raise the bar. With that, I'll pass it over to Kevin.

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