8/5/2025

speaker
Operator
Conference Operator

financial results. At this time, all participants are in a listen-only mode. Following the presentation, there will be a question and answer session. Please be advised that today's conference is being recorded. I would now like to hand the conference over to Alina Venezia, Head of Investor Relations for Experian Therapeutics. Please go ahead.

speaker
Alina Venezia
Head of Investor Relations

Thank you, Operator. Good morning, and welcome to Experian's second quarter 2025 earnings conference call. With us on today's call, are Sheldon Koenig, President and CEO, and Ben Halliday, CFO. Other members of the executive team will be available for Q&A following our prepared remarks. We issued a press release earlier this morning detailing the content of today's call. A copy can be found on the investor page of our website together with a copy of the presentation that we will also be referencing. I want to remind callers that the information discussed on today's call is covered under the Safe Harbor provision of the Private Securities Litigation Reform Act. I caution listeners that management will be making forward-looking statements. Actual results could differ materially from those stated or implied by our forward-looking statements due to the risks and uncertainties associated with the business. These forward-looking statements are qualified in their entirety by the cautionary statements contained in today's press release and in our SEC filing. The content of this conference call contains time-sensitive information that is only accurate as of the date of this live broadcast, August 5, 2025. We undertake no obligation to revise or update any forward-looking statements to reflect events or circumstances as to the date of the conference call and webcast. As a reminder, this conference call and webcast are being recorded and archived. We will begin the call with prepared remarks and then open the lines for your questions. I'll now turn the call over to you, Sheldon.

speaker
Sheldon Koenig
President and CEO

Thank you, Alina. Good morning, everyone, and thank you for joining us. We're thrilled to report a standout second quarter that delivered double-digit sequential growth, more than 42% year-over-year gains in U.S. net product sales, and our first quarter of operating income from ongoing business. These results reflect accelerating clinical adoption of Nexotol and Nexoset fueled by our sharpened commercial execution, strong payer alignment, and our ongoing targeted promotional strategy that's resonating with the statin intolerant community. Total revenue for the second quarter 2025 grew 12% year over year to $82.4 million. Looking at our strong U.S. performance, where we saw a return to sequential double-digit quarterly prescription and revenue growth, U.S. net product revenue grew 42% year-over-year to $40.3 million and grew 15% sequentially from the first quarter of 2025. Given our strong performance, we achieved operating income from ongoing business of approximately $15 million, giving us confidence that with continued global growth, we expect to transition to sustainable profitability beginning in the first quarter of 2026. As we shared on our last call, the endorsement of Nexlatal Nexlizet from leading cardiovascular professional societies was a powerful validation of our science, and it's already translated into action. Later this month, we look forward to the European Society of Cardiology updating their lipid management guidelines at the society's annual meeting, where we expect to be included in these updates. Turning to the progress we made on a number of our core marketing initiatives, including our campaign to reach patients who are statin intolerant, our tagline, can't take a statin, make Nexlozet happen, was well received, and this catchy phrase supported increased brand awareness among our target audience. In fact, during the second quarter alone, we had more than 650,000 visits to our new consumer statin intolerance website, and more than 600,000 click-throughs to our physician site, underscoring the impact of this successful campaign. We are implementing the right balance of in-person and digital outreach and are pleased to report that 23% or nearly one-quarter of our prescriptions were written by physicians with only digital touchpoints. In addition of prescriptions coming from new writers, 38% were driven by digital-only touchpoints. This highlights the importance of our digital omnichannel programs and underscores the impact they can continue to have. We remain committed to building on these successful programs and are confident in their continued contribution to our growth. Our expanded U.S. Field Reimbursement Manager support team made great strides in supporting our growing prescriber base by educating over 1,100 target prescribers on Nexlital and Nexlivet's favorable reimbursement landscape. This was evident by an increase in all targeted prescriber approval rates over 80%. Combined with further expanded payer coverage, reductions in prior authorization requirements, increased reimbursement support resources, and our appropriate balance of direct and digital marketing efforts, we believe we have significantly improved the access environment for patients and physicians alike. which resulted in a 10% increase in total retail prescription equivalents from this first quarter of 2025 and increased our total prescriber base to more than 28,000 healthcare practitioners. This momentum validates the growing confidence among clinicians and the expanding role of our therapies in addressing the unmet needs of statin-intolerant patients. Our consumer marketing program, featuring the Lipid Lurkers, tackles the challenge of high cholesterol, a silent but serious threat, by transforming it into mischievous characters that demand attention, which may be quietly lurking without their knowledge. Rather than relying on fear tactics, the lurkers personify LDL cholesterol's hidden dangers, making the risk tangible and manageable without intimidation. This fresh, compelling approach reshapes how patients perceive and address their cardiovascular risk. By blending engagement with patient empowerment, the campaign stood out in a crowded market, driving awareness and action for proactive cholesterol management with Nexlital and Nexlizet, the next step after StatNews. This campaign has won the prestigious MedAdNews Best Consumer Digital Campaign and is nominated for several more awards this year. Moving forward, we plan to launch a consumer television ad later in the year that will stream on connected TV such as Hulu and NBC Sports. These branded ads are expected to broaden awareness of statin intolerance and will feature our award-winning lipid lurkers. The combined strength of the statin intolerance and lipid lurkers campaign coupled with improving payer dynamics support AHRQ's continued growth now and into the future. Speaking of future growth, we remain committed to experience continued growth in cardiovascular risk reduction with our plans to develop a triple combination product. This therapy has the potential to be the most effective oral LDL cholesterol lowering option and to rival both existing injectables and emerging oral therapies. Development remains on track. In addition, our business development efforts are progressing nicely as we evaluate a number of potential opportunities to in-license or acquire synergistic products to leverage our existing commercial infrastructure. We look forward to updating you on progress here as it unfolds. Additionally, we reached important settlement agreements with three Nexotol, three generic manufacturers have agreed not to market a generic version of Nexotol in the United States prior to 2040. We continue to identify opportunities to strengthen our intellectual property position and look forward to updating you on our progress. Turning to our pipeline where our strategy is to expand into high-need, high-value indications that highlight the broader potential of our novel ACLY biology, we continue to make progress advancing IND-enabling studies to support our recently introduced program targeting primary sclerosing cholangitis, known as PSC. PSC is a rare progressive liver disease with no approved therapies and represents a major unmet need with an estimated $1 billion annual market opportunity. We look forward to completing these studies and to filing an IND and potentially initiating first in human studies in the second half of 2026. Throughout the second quarter, we and our international partners continue to make tremendous progress across a number of key geographies. Our European partner, Daiichi Sankyo Europe, continues to expand their reach of Nalemdo and Newstendi to benefit patients at the risk of cardiovascular disease who cannot manage their LDL cholesterol levels. Our royalty revenue from DSC increased 30% from the first quarter of 2025 to $13.6 million in the second quarter of 2025. We are also thrilled to report that DSC has surpassed the 500,000 patient mark For patients who have been treated with our therapies in Europe, half a million patients. This is a meaningful milestone that reinforces confidence in our ability to build a similarly sized market in the U.S. Throughout the first half of the year, we continue to advance multiple processes for the technology transfer for manufacturing of Nalemzo and Eustendi to DSE with the various working capital benefits expected in 2025. Our Japanese partner, Otsuka Pharmaceutical, submitted for approval of our pemphidoic acid products in Japan for LDL cholesterol lowering and remain on track for approval and national health insurance pricing in the second half of 2025. Upon this achievement, we expect to receive milestone payments of up to $120 million. The Japanese market is the world's third largest cardiovascular prevention market, and we believe the royalties on Japanese product sales will be a major revenue contributor over time. Building on our global progress, we expanded our international reach through a commercial partnership with HLS Therapeutics, giving them the exclusive rights to commercialize Nexlatal and Nexlozet in Canada. Our previously filed new drug submissions to Health Canada are on track for review, and we continue to expect market approval in the fourth quarter of 2025. Our partner in Israel, Neofarm Israel, remains on track for market approval of Nexotal and Nexoset in the first half of 2026. And CSL Sequeres, our partner in Australia and New Zealand, filed a marketing application in Australia for Nexotal and Nexoset in July 2025 and expects market approval in Q4 2026. The progress with these international partnerships is expected to deliver a consistent cadence of approvals and product launches over the coming months and year that will also provide a growing royalty stream and milestone payment, all of which support our strategic focus to drive revenue growth and profitability. With that overview of the business, let me turn the call over to Ben for a detailed review of our financial progress during the second quarter. Ben?

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