Exelixis, Inc. (EXEL) Earnings Call Transcript & Summary

All right. Good morning, everybody. The meeting will now please come to order. I want to welcome all of you to the Annual Meeting of Stockholders of Exelixis. I am Michael Morrissey, President and CEO of Exelixis, and I will be presiding at this meeting. Also present at the meeting today are Stelios Papadopoulos, Chairman of the Exelixis Board; Charles Cohen, Chairman of the Exelixis Compensation Committee; Chris Senner, EVP and CFO; and Susan Hubbard, EVP of Public Affairs and Investor Relations. Jeffrey Hessekiel, EVP of Legal & General Counsel, will act as secretary of the meeting. Jennifer Drimmer Rokovich, SVP of Corporate Legal Affairs, has been appointed to act as inspector of election. Jodi Smith, a representative from Exelixis' independent public accounting firm, Ernst & Young, is also present at this meeting. During the question-and-answer period of the meeting, she will be available to answer questions concerning the corporation's financial statements. For this year, our annual meeting is once again being held virtually via live webcast in the interest of protecting the health and well-being of our stockholders and employees during the ongoing COVID-19 pandemic. Similar to 2020, we have designated the format of this meeting to ensure that our stockholders who attend virtually will be afforded the same rights and opportunity to participate as they would at an in-person meeting. Accordingly, as stockholders, you will be able to listen, submit your questions and vote your shares online during the meeting. This year, due to the number of questions we received through the voting portal in advance of the meeting, and to ensure we are able to respond to as many questions as possible while stockholders remain logged in to the meeting, we will host a question-and-answer session immediately after we announce the results of the voting. During the Q&A session, we will first provide responses to the various questions and comments related to Exelixis in advance of today's meeting and then turn to those that are submitted during the meeting itself. And in each case, we will only address questions and comments that are germane to the meeting and otherwise comply with the rules of conduct for this meeting. If we are not able to respond to your question or comment during the time allocated, please raise it separately after the meeting by contacting Exelixis' Investor Relations and Public Affairs team via the Exelixis website. Each of you has registered through the virtual meeting portal by using your 16-digit control number provided on your Notice of Internet Availability of Proxy Materials, your proxy card or your voting instruction form that accompanied your proxy materials. If there are any of you that have joined as guests, we welcome you to the meeting as well, but please be reminded that you will not be able to vote any shares or ask any questions during the meeting. Both the agenda and the rules of conduct for the annual meeting are available in the virtual meeting portal in the lower right-hand part of the screen. To conduct an orderly meeting, we kindly ask the participants to abide by these rules. As stated in the rules of conduct, the business of the meeting will follow the agenda provided and only proposals to be voted on will be those included in the Exelixis proxy statement. Should you desire to submit a question or comment during the meeting, please type it into the designated field in the virtual meeting portal located in the lower left-hand part of the screen. We ask that you restrict remarks to the items on the agenda. Thank you for your cooperation with these rules. A list of stockholders at the close of business on the record date, showing the number of shares held by each holder of record is available for your inspection, which any stockholder can access by clicking on the link at the bottom border of the virtual meeting portal. The secretary has delivered an affidavit of mailing, establishing that notice of this meeting was duly given. Copy of this notice of meeting and affidavit of mailing will be incorporated into the minutes of this meeting. All stockholders of record at the close of business on March 29, 2021, are entitled to vote at the annual meeting. All right. So our first order of business today at the meeting is to determine whether the shares represented at the meeting, either in person or by proxy, are sufficient to constitute a quorum for the purpose of transacting business. Mr. secretary, do you have a report?

Yes, I do. The stockholders' list shows that holders of 313,097,850 shares of common stocks of the corporation are entitled to vote at this meeting. We're informed by Ms. Drimmer that there are stockholders present or represented by proxies holding in the aggregate 266,189,898 shares of common stock or approximately 85.02% of all of the shares entitled to vote at this meeting.

Thank you. Because the holders of a majority of the shares entitled to vote at this meeting are present in person or represented by proxy, I declare this meeting to be duly convened for purposes of transacting such business as may properly come before it. The next order of business is a description of the matters to be voted on at today's meeting. The first proposal before the stockholders of the corporation is the election of 11 directors to serve until the next annual meeting of stockholders in 2022. The Board of Directors has nominated and recommends the election of the following persons as directors of Exelixis; Charles Cohen, Ph.D., Carl Feldbaum, Esq., Maria Freire, Ph.D.; Alan Garber, M.D., Ph.D.; Vincent T. Marcehsi, M.D., Ph.D.; Michael M. Morrissey, Ph.D.; Stelios Papadopoulos, Ph.D.; George Poste, DVM, Ph.D., FRS; Julie Anne Smith; Lance Willsey, M.D.; and Jack Wyszomierski. No other nominations have been received in accordance with Exelixis' Bylaws, the Board of Directors recommends a vote for each of the named nominees. The second proposal is to ratify the selection of Ernst & Young LLP as Exelixis' independent registered public accounting firm for the fiscal year ending December 31, 2021. The Board of Directors recommends a vote in favor of proposal 2. The third proposal is to approve on an advisory basis the compensation of Exelixis' named executive officers as disclosed in the 2021 proxy statements. The Board of Directors recommends a vote in favor of proxy 3 (sic) [ proposal 3 ]. So now we'll vote, it is 9:07 a.m. Pacific Time, and the polls are now open for voting. Any stockholder that has yet -- that has not yet voted or wishes to change their vote, may do so by clicking on the Voting button in the virtual meeting portal and following the instructions there. Stockholders, who have sent in proxies or voted already by telephone, Internet or postal mail, and do not wish to change their vote, do not need to take any further action. [Voting]

It is now 9:08, and I hereby declare the polls closed. The inspector of election will now proceed to count the votes. All right. Will the secretary please report the preliminary results of the voting?

We have been informed by the inspector of election that the votes have been counted and that the nominees for election to the Board of Directors have been duly elected. Ernst & Young has been ratified as Exelixis' independent registered public accounting firm for the current fiscal year and the compensation of Exelixis' named executive officers as disclosed in the 2021 proxy statement has been approved.

All right. Thank you. We will -- now we would like to move to stockholder questions and comments. Please again note that we will only read and respond to those questions and comments that are germane to the meeting and otherwise comply with rules of conduct for this meeting.

Good morning, everyone.

Susan, you want to go ahead?

Yes, sure. Good morning, everyone. This is Susan Hubbard, EVP of Public Affairs and Investor Relations. As Dr. Morrissey previously mentioned, we did receive a number of questions through the portal, and we have grouped them based on themes. So if you don't hear your question verbatim, please note that we've captured it in the themes. Mike, the first question for you is, will Exelixis be doing a stock buyback program or issuing any dividends in the near term?

Thank you, Susan. Great question. While we haven't instituted a stock buyback program or issued dividends to date, we regularly assess the various potential vehicles and options to increase or return value to shareholders over the long term. Since we became cash flow positive, we have been reinvesting that cash back into the business to build our diverse pipeline of preclinical and clinical candidates and invest in maximizing the commercial value of the cabozantinib franchise with both cabo and XL092.

Great. Thank you, Mike. And the second question is, other than dividends or stock buybacks, are there any other plans for Exelixis' cash war chest, such as an acquisition?

Thank you, Susan. As we've discussed previously, we have a very active and cross-functional business development team who are focused on identifying promising assets that could benefit from our clinical development, regulatory and commercial expertise in oncology. We continue to have productive discussions about potential additions to the Exelixis pipeline. We are looking broadly at a variety of oncology assets with the aim of identifying agents with promising preclinical and clinical data, along with a market potential that could lead to commercial success. We have in the past, and we will continue to maintain a high degree of discipline and do not seek to overpay for assets that are relatively early stage with limited clinical data available. So we plan, as we have in the past, to be patient, waiting to find the right assets at the right price, at the right time.

Thanks, Mike. The third question is, why have earnings dropped despite sales revenues being so high? How is the increased revenue being spent? And when can we expect it to be reflected in the bottom line?

Thank you, Susan. As you've seen over the last 3 years, we've worked very hard to successfully generate free cash and as a result, have built a strong cash position. We've talked about investments in cabo in our pipeline. And our focus remains on driving long-term revenue growth, which requires spending more in order to advance the XL092 to full development plan across various combinations and tumor types, and into the initial wave of pivotal trials, which could start as early as this year. We're also executing on our late-stage clinical development program for cabo to drive near-term revenue growth, and build a diversified pipeline of compounds behind that. So we definitely see the advantages of being profitable and generating free cash. Therefore, we'll continue to be disciplined about how we invest that cash and spend that money in the future. And while we expect to revenue -- to see accelerated revenue growth in 2021, the degree of profitability we anticipate will wax and wane as we continue to invest in growing our product portfolio through internal efforts and through business development activities.

Thanks, Mike. The fourth question is, are there plans to invest in immune cell engagers such as technology from Affimed, ImmunityBio or Agenus, working with Dana-Farber on the iNKT cell therapy.

Thanks. That's a great question. And obviously, we don't want to provide detailed guidance on future potential technology investments or BD opportunities or transactions. We have, as I mentioned, the very active BD programs aimed at identifying promising agents that could benefit from our development and commercial expertise, and we'll continue to have productive discussions about potential additions to the Exelixis pipeline. We're taking, as we have in the past and will continue in the future, a multipronged approach as we move into biologics. The multiple collaborations that we've entered in recently, support that approach and we're really excited about our ability to gain access to a really wide variety and a wide network of companies that are focused on biological building blocks as an important element of our strategy, as you've seen with Invenra where we have access to novel monoclonal antibodies and bispecifics, binders, if you will and as in the case with Adagene, important technology to enhance them. Our deals from last year with Catalent and NBE, we have access to novel ADC, antibody drug conjugate linker and payload technologies and certainly the in-licensing of XB002 from Iconic gave us a preclinically validated program that recently entered Phase I evaluation. So we're super excited about the impact potentially all these different technologies and collaborations could have in our pipeline. And ultimately, we want to be able to pair the best mechanism of action or modality for the appropriate disease setting, tumor type, if you will, so we can deliver, hopefully, really important benefits to patients.

Thank you, Mike. And the next question is, can executive compensation be more tied to stockholder return? For example, using stock price as part of performance conditions given the price movement since 2018.

Thank you, great question. So over the last 3 years, the Exelixis Board and executive leadership team have moved to modify executive stock compensation policies to more directly correlate to shareholder value. For a complete description of our executive compensation policies, please see our 2021 proxy statement. Taking the feedback we received from stockholders during our annual outreach program, we first began granting executives performance-based restricted stock units, or PSUs, in 2018. This pay-per-performance philosophy has remained a cornerstone of our executive compensation program in both 2019 and 2020, where 100% of the equity program was comprised of PSUs tied to the achievement of critical developments and regulatory milestones. Under this program, PSUs held by executives will only vest if the company achieves the corporate goals and objectives approved by the Compensation Committee as outlined in our annual proxy statement.

Thank you, Mike. And the next question is, when does the patent expire for XL092? I don't see a sense of urgency with operations with regards to clinical trials, too many trials are behind in progress.

Thank you. So again, XL092 is our next-gen VEGFR-targeting TKI designed to have a similar target profile of the cabozantinib, but with a shorter pharmacokinetic half- life making it easier to dose adjust and keep patients on their medication. We have a number of patent applications that cover various aspects of the XL092 compound, which if issued, will expire beginning in 2039. Our goal is to evaluate XL092 in new doublet and triplet combinations and other novel therapeutic regimens across a variety of tumor types. We initiated Phase I clinical development for XL092 in early 2019, and the compound could enter late-stage pivotal trials as early as this year. As we move forward in 2022 and beyond, we anticipate gradually ramping down our investment in the development of cabozantinib, while ramping up the development and investments in XL092. In terms of our clinical development activities for cabo and XL092, our pivotal cabozantinib studies have enrolled ahead of schedule despite the challenges faced with COVID-19 in 2020 and XL092 is rapidly advancing through Phase I and Phase Ib development in parallel as a single agent and in combination with various immune checkpoint inhibitors.

Thank you, Mike. The next question is, what can management do in terms of discussing catalysts to generate more interest in the stock or other actions that may increase shareholder value generally?

Thank you. So our entire organization from the executive leadership team and down is focused on executing on key R&D, regulatory, commercial and corporate goals and milestones that we've outlined at the beginning of the year. And that was also the case in 2020. So we believe we have the potential to unlock significant long-term shareholder value should we continue to be successful in achieving those milestones. We regularly present at investor conferences, all of which are webcasts, and I encourage you to listen in to those different -- either fireside chats or meetings. In addition, our executive team all participates in our quarterly earnings calls, where we not only speak about the activities for the quarter, but lay out key milestones ahead.

Thank you, Mike. And there are no further questions at this time. I will turn it back to you for closing.

Fantastic. So I want to thank you all for joining us today at the Exelixis 2021 Annual Stockholders' Meeting. The meeting is now concluded, and we appreciate your continued interest and support in Exelixis. Thank you.