Merck & Co., Inc.

Welcome to the Merck and Company Q3 Sales and Earnings Conference Call. At this time, all participants are in a listen-only mode until the question and answer session of today's conference. At that time, to ask a question, press star 1 on your phone and record your name at the prompt. This call is being recorded. If you have any objections, you may disconnect at this time. I will now turn the call over to Mr. Peter Dannenbaum, Vice President, Investor Relations. Sir, you may begin.

Thank you, Julie, and good morning, everyone. Welcome to Merck's third quarter 2023 conference call. Speaking on today's call will be Rob Davis, Chairman and Chief Executive Officer, Caroline Litchfield, Chief Financial Officer, and Dr. Dean Lee, President of Merck Research Labs. Before we get started, I'd like to point out a few items. You will see that we have items in our GAAP results, such as acquisition-related charges, restructuring costs, and certain other items. You should note that we have excluded these from our non-GAAP results and provide a reconciliation in our press release. I would like to remind you that some of the statements that we make today may be considered forward-looking statements within the meaning of the safe harbor provision of the U.S. Private Securities Litigation Reform Act of 1995. Such statements are made based on the current beliefs of Merck's management and are subject to significant risks and uncertainties. If our underlying assumptions prove inaccurate or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Our SEC filings, including Item 1A and the 2022 10-K, identify certain risk factors and cautionary statements that could cause the company's actual results to differ materially from those projected in any of our forward-looking statements made this morning. Merck undertakes no obligation to publicly update any forward-looking statements. During today's call, a slide presentation will accompany our speaker's prepared remarks. These slides, along with the earnings release, today's prepared remarks, and our SEC filings are all posted to the investor relations section of Merck's website. With that, I'd like to turn the call over to Rob.

Thanks, Peter. Good morning and thank you for joining today's call. We continue to bring forward innovation that can save and improve the lives of patients and animals around the world. We're advancing our broad pipeline and executing in support of our key growth drivers, enabling strong progress for our business and providing tangible benefits to patients. To that end, I want to acknowledge the efforts of our talented global team. Their passion and commitment to our science-led strategy are fundamental to our continued success. Scientific innovation is truly the foundation of our strategy, and it drives everything we do. We're pushing the boundaries of science through the significant investments we're making across our deep pipeline, augmented by strategic business development. I'm pleased by the continued progress with these programs and our growing diversity across new therapeutic areas and modalities. Along these lines, we're particularly excited by our recently announced clinical and commercial collaboration with Daiichi Sankyo for three potentially first-in-class antibody drug conjugates. The scientists at Daiichi Sankyo are proven innovators in this space, having developed proprietary ADC technology that has resulted in an approved product, which is being rapidly adopted for patients with certain cancers. We're privileged to begin working alongside them to advance this important science and achieve both companies' objectives of addressing the significant unmet patient need in oncology. Based on our strong conviction in these programs and the profound benefit they may bring to patients, we believe each has multi-billion dollar commercial revenue potential for Merck on a non-risk adjusted basis approaching the mid 2030s. We're also applying our clinical expertise to accelerate the development of other potentially transformative treatments that we've added through strategic business development, such as Certadacept for pulmonary arterial hypertension and NK7240, our TL1A inhibitor for ulcerative colitis and Crohn's disease. This is complemented by our strong commercial execution capabilities, which we expect to amplify the impact of these life-changing medicines and enable the creation of sustainable value for patients and shareholders over the long term. Turning to this quarter's performance, we delivered robust growth driven by demand for our innovative portfolio. We're confident that we will close out 2023 with continued strong performance, which is reflected in the updated full year outlook that Caroline will speak to in a few minutes. Moving to our research organization, as I mentioned, we're making remarkable progress across multiple therapeutic areas in our promising late phase pipeline. In oncology, Dean will speak to the significant success we're having in broadly leveraging the foundational position that we've achieved with Katruta. This includes the continued advancements we're making in the treatment of early stage cancers. We're very excited by the recent FDA approval of a Katruta regimen for the neoadjuvant and adjuvant treatment of certain patients with resectable non-small cell lung cancer based on the Keynote 671 trial results, which notably demonstrated an improvement in overall survival compared to a placebo and chemotherapy regimen. In addition, we presented numerous important data sets at last week's European Society for Medical Oncology meeting across a wide range of molecules, tumor types, and indications. Our progress across a broad set of programs reinforces our confidence in the sustainability of our oncology leadership well into the next decade. We're also making exciting progress in our cardiometabolic pipelines. Most significantly, the FDA-accepted proprietary review are filing for Cetatercept based on the unprecedented results of this stellar trial, and we look forward to the potential approval and launch in early 2024. We remain confident that Cetatercept has the potential to change the treatment paradigm for patients suffering with pulmonary arterial hypertension. We also initiated Phase III clinical trials for our oral PCSK9 candidate, MK0616. We believe MK0616 has the potential to provide significant benefit to patients with elevated cholesterol and impact cardiovascular disease on a global scale. We're very pleased with our progress and what we've achieved this quarter as we continue to focus on advancing and expanding Merck's pipeline. And I want to thank Dean and his team for their unwavering commitment to addressing unmet patient needs. In summary, We continue to move with urgency to deliver on our purpose, pursuing transformative science to save and improve lives around the world. We're executing scientifically, commercially, and operationally on the significant opportunities now in front of us, while also making the disciplined investments needed to sustain strong growth well into the future. With the efforts of our global team, we've increased confidence that we will deliver value to patients, shareholders, and to all of our stakeholders. With that, I'll turn the call over to Caroline.