GeneDx Holdings Corp.

Thank you for standing by, and welcome to the GeneDx Third Quarter 2024 Earnings Conference Call. At this time, all participants are in a listen-only mode. And after the speaker's presentation, we will have a question-and-answer session. Keep in mind that this call is being recorded. If you would like to ask a question, please press star-one-one on your telephone, and you will hear an automated message advising your hand is raised. I would now like to turn the call over to Sabrina Dunbar, Investor Relations. Please go ahead.

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 Feeley, Chief Financial Officer. Earlier today, GDX released financial results for the third quarter ended September 30, 2024. 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, October 29th, and we are 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 third quarter 2024 earnings release and slides available at ir.gndx.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 Katherine.

Thanks, Sabrina, and thank you all for joining us. The third quarter was an exceptionally strong quarter for GDX. We delivered over $76 million in revenues, expanded gross margins to 64%, and achieved our 10th consecutive quarter of cash burn reduction. Our organizational focus and discipline continued to fuel our growth, and we achieved profitability in the third quarter. This milestone is an important one in the industry. We've demonstrated that you can prioritize patient care and do it while running a successful business. And as we walk through the door of profitability, we're entering a new phase of growth for GeneDx. one in which we hold a sustainable and durable market leading position in exome and genome testing and translate our leadership to serve all patients who can benefit from genomic insights. On the back of a strong Q3, we're raising our revenue guidance for the full year 2024 to between $284 million to $290 million. We're bullish on our ability to keep expanding our footprint to the pediatric outpatient setting and begin extending our reach into new clinical settings in the years to come. Our work is just getting started. Today, we enjoy 80% of the US exome market share. Historically, our dominance was anchored in volumes from expert genetics providers, but beginning in 2023, we shifted our commercial focus to pediatric neurologists who represented the next rung of clinicians primed for a more comprehensive approach to genetic testing. While these pediatric neurologists have significantly expanded adoption and fueled growth over the last 12 months, there remains an ample multi-year growth opportunity ahead as we remain approximately 12% penetrated amongst these specialists. As we look at the path in front of us, there are many untapped growth catalysts yet to be unlocked. We see expanded clinical indications for exome and genome, entry into the general pediatrician market, and the development of additional patient access channels as opportunities to cultivate new arenas for our market leadership. We're proud to share that as of Q3, we've officially sequenced over 700,000 clinical exomes and genomes, completing over 100,000 of those sequences in the last six months alone. This acceleration is a testament to growing utilization of our exome and genome testing while creating a flywheel effect for our business. With every test we complete, we deepen our understanding of disease gene correlations to inform more definitive diagnoses for more patients. We unlock improved operational efficiency and lower costs, and we further differentiate our products from those of our competitors. This acceleration in volume also demonstrates our ability to scale our data engine and positions us to be a key strategic partner for biopharma. We're leveraging our growing data asset to deliver value to biopharma companies big and small while supporting our own commercial initiative, as evidenced by our Epilepsy Partnership Program, which improves access to testing for children with epilepsy while delivering valuable insights to biopharma looking to inform their drug development efforts with new targets and find patients to enroll in active clinical trials. In the NICU, we're seeing a steady increase in rapid whole genome volume quarter over quarter, as we set the stage for a broader push in 2025. We announced in Q2 that we've taken steps to solidify our position in this growing market with product improvements and a partnership with Epic Aura. Recent product releases are already providing an uplift in this segment, and we're proving that our product and technology approach is effective. Regarding Epic, we're well on our way to implementing our partnership, which will seamlessly integrate GDX exome and genome testing into the workflows at many of the largest health systems across the country. We expect to begin receiving orders through ORA in the first half of 2025, with revenue ramping in the second half of the year. Our experience in the NICU has demonstrated time and again the power of a genetic diagnosis to change the course of a baby's life. We also know there's an opportunity to intervene even earlier. We believe in a world where every newborn's genome can be sequenced at birth, And we're confident GeneDx will lead this opportunity to revolutionize the traditional approach to newborn screening by adding genomic sequencing. Today's traditional newborn screening protocols test for about 60 conditions. But with the addition of genomic sequencing, newborn screening can be enhanced to screen for more than 450 actionable conditions. For some of these families, actionability can be as simple as changing their baby's diet, And for others, it can mean enrolling in a clinical trial or treating the condition with an FDA-approved therapy. We are approaching the genomic newborn screening opportunity with never-before-seen scale. In the short timeframe we've invested in the space, we've sequenced more than 15,000 newborns, which is more than any other lab in the United States. We began work with the Guardian study merely two years ago, and the findings of that research were published last week in the Journal of the American Medical Association, a leading peer-reviewed publication. An analysis of Guardian participants found a nearly 4% positivity rate with genomic newborn screening. Dramatically, 92% of newborns with true positive results would have been assumed healthy and sent home using today's traditional newborn screening. In an absence of proactive genomic screening for these conditions, we're subjecting families to a multi-year diagnostic odyssey and funneling a pipeline of sick kids directly into our healthcare system. In the meantime, we have an incredible opportunity to serve an ever-growing number of patients and their families who are symptomatic today with our industry-leading exome and genome testing. Our focus and financial discipline, combined with the proven clinical utility of our testing, are setting us up for the next phase of sustainable growth, and we're excited by the opportunities ahead. And with that, I'll turn it over to Kevin.