Exelixis, Inc.

Good day, ladies and gentlemen, and welcome to the XLX's second quarter 2024 financial results conference call. My name is Tawanda, and I'll be your operator for today. As a reminder, this call is being recorded for replay purposes. I would now like to turn the call over to your host for today, Ms. Susan Hubbard, Executive Vice President of Public Affairs and Investor Relations. You may begin.

Thank you, Tawanda, and thank you all for joining us for the Exalexis Second Quarter 2024 Financial Results Conference Call. Joining me on today's call are Mike Morrissey, our President and CEO, Chris Senner, our Chief Financial Officer, PJ Haley, our Executive Vice President of Commercial, Amy Peterson, our Chief Medical Officer, and Dana Aftab, our Chief Scientific Officer, who together will review our progress for the second quarter 2024 and the June 30th, 2024. During the call today, we will refer to financial measures not calculated according to generally accepted accounting principles. Please refer to today's press release, which is posted on our website, for an explanation of our reasons for using such non-GAAP measures, as well as tables deriving these measures from our GAAP results. During the course of this presentation, we will be making forward-looking statements regarding future events and the future performance of the company. This includes statements about possible developments regarding discovery, product development, regulatory, commercial, financial, and strategic matters. Actual events or results could, of course, differ materially. We refer you to the documents we file from time to time with the FCC, which under the heading Risk Factors, identify important factors that could cause actual results to differ materially from those expressed by the company verbally and in writing today, including about limitations, risks, and uncertainties related to product commercial success, market competition, regulatory review, and approval processes, conducting clinical trials, compliance with applicable regulatory requirements, our dependence on collaboration partners, and the level of cost associated with discovery, product development, business development, and commercialization activities. And with that, I will turn the call over to Mike.

All right. Thank you, Susan, and thanks to everyone for joining us on the call today. X-Elect has had a very busy and productive second quarter across literally all components of our business. especially in commercial, regulatory, and development, and we're thrilled with our momentum that's driving us into the second half of 2024. We continue to execute on key priorities for important future value drivers in discovery, development, and commercial, and remain steadfast in our focus to improve the standard of care for patients with cancer. We have a lot to cover today, so let's jump right into it with key highlights for the quarter, including first, Strong financial performance with top and bottom line growth driven by the strength of the Cabo Zantanib franchise globally. Momentum in the Cabo Zantanib business continued in the second quarter of 2024 with growth in demand and revenue, both quarter over quarter and year over year. Cabo Medics maintained its status as the leading TKI for RCC in the U.S. With second quarter of 2024, Cabo franchise net product revenue is growing 16%, quarter over quarter compared to first quarter 2024, and 7% year over year compared to second quarter 2023. Global Cabo San Antonio franchise net product revenues generated by Exalexis and its partners grew to $618 million in the second quarter 2024. The $150 million commercial milestone we earned from Ipsen in the second quarter is emblematic of the continued strength of the Cabo franchise on a worldwide basis. The robust net product revenue and total revenue for the quarter, along with continued expense discipline, drove our net income growth as well. As Chris will highlight later in the call, we had a very good second quarter and look forward to continuing the momentum in the second half of the year. Second, building off the strength of Cabo's leadership position in RCC, we're excited about the opportunity for new indications like net to drive future CABO growth and believe it could be another area where Exalexis has the potential to grow into a market leader. Our CABO SNDA submission based on the cabinet data was accepted with standard review and it produced a date in early April 2025. Exale's top priority is to advance the net indication from a clinical and regulatory perspective and launch as soon as possible pending approval. As you'll hear from Amy, The plan phase three of ZANSA and NET underscores our commitment to establish a leadership position in this underserved population and provides another therapeutic opportunity to improve standard of care for patients with NET. T.J. will also highlight recent market research, which helps frames our excitement for this indication. Third, we continue to advance our industry-leading pipeline with a focus on generating differentiating clinical data that will improve standard of care for patients with cancer. Our success in building the CABO franchise provides a roadmap to maximize clinical and commercial success for molecules in our pipeline. Advancing potential new CABO indications and expediting ZANSA clinical development with both existing and new pivotal trials remains our top focus. We continuously evaluate our pipeline to ensure we are disciplined in our investments and that they align with emerging data and the evolving treatment landscape. In that context, we've decided to discontinue XP002 as it is unlikely to improve upon the tissue factor targeting ADCs already approved or in the clinic. We believe there are higher value and therefore higher priority opportunities with ZANSA and NET and potentially other GU indications that drive us to reallocate resources to support these activities. The Cabo lens sets a high bar for clinical differentiation and ultimate commercial success, and we're mindful that investments in programs that are unlikely to improve standard of care does little to create value for patients or shareholders. We're optimistic in our progress with XL309, XB010, and new candidates in our pipeline, which we expect to advance quickly. Fourth, the strong financial performance this quarter and our continued financial and pipeline discipline allows us to be both strategic and opportunistic in capital deployment. While we expect business development and clinical collaboration discussions to continue throughout 2024, Our strong financial performance this quarter, with record levels of net product revenues and total revenues, allows us to pursue another $500 million share repurchase program on top of the billion dollars of shares we've bought over the last 15 months. Finally, there's nothing new to report on the Cabo and the litigation. As in the past, we will not speak to any specifics today, and it's a statement of the obvious that the upcoming and a ruling remains a critical milestone for the company and the Cabo's antediluvian franchise. Exalexis will continue to vigorously protect our intellectual property rights with respect to Cabo and our other differentiated molecules we pursue on behalf of patients with cancer. So with that, please see our press release issued an hour ago for our second quarter 2024 financial results and an extensive list of key corporate milestones achieved in the quarter. And I'll now turn the call over to Chris.