Moderna, Inc. (MRNA) Earnings Call Transcript & Summary

Good morning, and welcome to 2021 Moderna Annual Stockholders Meeting. I would now like to introduce the first presenter, Noubar Afeyan.

Good morning. I'm Noubar Afeyan, Chairman of the Board of Moderna. Thank you for joining us this morning, and welcome to the Moderna 2021 Annual Stockholders' Meeting. Although our company has made significant strides in helping combat the pandemic, today's meeting will be held virtually again, and we appreciate your understanding of the precautions we've taken. Before I call the meeting to order, I'd like to introduce to you the members of the Board and the executives who are joining us today. I'm accompanied in person from our office in Cambridge by Stephane Bancel, our CEO as well as Director. The rest of the Board is joining us virtually today. They include Stephen Berenson; Sandra Horning; Bob Langer, Betsy Nabel; Francois Nader; Paul Sagan; and Liz Tallett. The officers of the company joining us in person and virtually today are Juan Andres, Marcello Damiani, Tracey Franklin, Lori Henderson, Stephen Hoge, Corinne Le Goff, David Meline and Tal Zaks. Ms. Henderson, Moderna's General Counsel and Corporate Secretary, will serve as the secretary of this meeting. Before proceeding, let me just say on behalf of the Moderna Board how impressed and how much gratitude we feel towards this leadership team and the whole company for the sacrifices and efforts put in during 2020, a crucial year for the company, for the biotech industry and for the world and being able to accomplish so much. I'd also like to introduce Pam Kelleher of Ernst & Young, Moderna's independent registered public accounting firm, who is available to respond to appropriate questions. The meeting will now officially come to order. We will proceed with the formal business of the meeting as set forth in your notice of annual meeting and proxy statement, which was sent to all shareholders of record as of the close of business on March 1, 2021. Following the presentation of the proposal and before the polling is closed, there will be an opportunity for shareholders to submit questions specific to those items. After the formal part of our meeting, I will ask Stephane to join me in addressing the questions we received from shareholders in advance of the meeting and to the extent time permits, we'll also address questions that are submitted by shareholders through the virtual meeting platform. The meeting will be conducted in accordance with the rules of conduct that you have access to on the meeting website. Will the Secretary please report at this time with respect to the mailing of the notice of the meeting and the stockholders list?

Thank you, Mr. Chairman. We have posted on the virtual platform a complete list of the stockholders of record of the company's common stock on March 1, 2021, the record date for this meeting. Shareholders of record on that date are entitled to vote at this meeting. A duplicate record of the list of stockholders has been on file with the secretary of the company for the last 10 days prior to the date of this meeting and has been available for inspection by any stockholder during that period at any time during normal business hours in accordance with Delaware law. I also have an affidavit certifying that on March 11, 2021, the company's annual report on Form 10-K, annual meeting notice, proxy statement and proxy card were deposited in the United States Mail to each of the stockholders of record at the close of business on March 1, 2021, designated to receive full set delivery.

At this time, I'd like to introduce Jennifer Borton. Ms. Borton has been appointed by the Board to act as inspector of election at this meeting. She's taken and subscribed the customary oath of office to execute her duties with strict impartiality. We will file this oath with the records of the meeting. Her function is to decide upon the qualification of voters, accept their votes and, when balloting on all matters is completed, to tally the final votes. Will the Secretary please report at this time with respect to the existence of a quorum?

I have been informed by the inspector of elections that proxies have been received for at least a majority of the shares of common stock outstanding on the record date. This constitutes a quorum of the meeting today, and we may now carry out the official business of the meeting.

Will the Secretary please review the voting procedures?

Voting today is by proxy and virtual ballots. It is not necessary for stockholders to vote by virtual ballot if they have already submitted their proxy cards unless they wish to change their votes. Virtual ballots are available for any stockholder who wishes to vote by virtual ballot or to change their vote. Stockholders who are logged in using their control number may change their vote by clicking on the vote link on the website. Your submission of a virtual ballot will revoke all prior proxies. Each share of common stock is entitled to one vote.

We will now proceed with the formal business of this meeting and the agenda that is accessible to you on the meeting website. There are 3 matters to be considered by the stockholders at this meeting: the election of directors; approval of a nonbinding advisory vote to approve the compensation of our executive officers; and the ratification of the independent registered public accounting firm, Ernst & Young LLP for the year ended December 31, 2021. The Secretary will now declare the polls open.

The virtual voting tab is now open for voting on all matters to be presented. The virtual voting tab will be closed to voting after we go through the matters to be voted on. Questions that are specific to these items may be submitted on the platform.

The first item of business is the election of the Class III Directors to serve until the 2024 annual meeting and until their successors are duly elected and qualified or such director's earlier death, resignation or removal. Based on the recommendation of the Nominating and Governance Committee of the Board, the nominees for Class III Director are Bob Langer, Betsy Nabel and Liz Tallett. All 3 nominees are current members of our Board. And all 3 have consented to serve if elected. For proposal 1, the election of our Class III Directors requires a plurality vote of the shares of common stock entitled to vote. No other persons having been nominated in accordance with the company's amended and restated bylaws, the nominations are now closed. The Board of Directors unanimously recommends that stockholders vote in favor of this proposal. The second item of business today is the approval of a nonbinding advisory basis of the compensation of our named executive officers. As required by Section 14a-1 of the Exchange Act, the Board is providing the stockholders an opportunity to approve, on a nonbinding advisory basis, the compensation of our named executive officers as described in detail in the proxy. The Board unanimously recommends that stockholders vote for approval on a nonbinding advisory basis of the compensation of the company's named executive officers. The third item of business today is the ratification of the selection by the Audit Committee of the Board of Directors of Ernst & Young LLP as the independent registered public accounting firm of the company for the fiscal year ending December 31, 2021. For proposal 3, a majority of the votes properly cast is required in order to ratify the appointment of Ernst & Young. In the event that a majority of the votes properly cast do not ratify this appointment of Ernst & Young, we will review our future appointment of Ernst & Young. We will now proceed with the voting. Anyone who is voting by virtual ballot and have not already done so during the meeting, please click on the voting button on the virtual platform and mark your virtual ballot now. We will give everyone a moment to mark their virtual ballots. [Voting]

The inspector of elections will not accept virtual ballots, proxies or votes or any changes or ratifications submitted after the closing of the polls. The time is 8:09 am on April 28, 2021, and the polls for each matter to be voted on at this meeting are now closed for voting. No additional virtual ballots, proxies or votes and no changes or revocations will be accepted. May we have the preliminary results of the voting?

The preliminary report of the inspector of election covering the proposals presented at this meeting is as follows: regarding the first proposal, each of Bob Langer, Betsy Nabel and Liz Tallett has received the requisite number of votes in favor of his or her election and has been elected as a Class III Director; the second proposal to approve, on a nonbinding advisory basis, the compensation of our named executive officers has received the requisite number of votes in favor, and the compensation of the named executive officers is approved; the third proposal to ratify the selection of Ernst & Young LLP as the company's independent registered public accounting firm for the year ended December 31, 2021, has received the requisite number of votes in favor of their ratification. Their appointment is ratified. The final results of voting, including any virtual ballots and proxies recorded during the meeting, will be set forth in the report of the inspector of elections and will be included in the minutes of the meeting. We expect to report our final voting results on a current report on Form 8-K to be filed with the SEC within 4 business days.

I declare that all of the proposals presented at the meeting have been ratified or approved by the stockholders. There being no further business, the annual meeting is adjourned. Let me now ask Stephane Bancel, our Chief Executive Officer, to join me by making a few remarks and to assist in addressing the questions that we received from shareholders in advance of the meeting. To the extent time permits, we will also address those questions that are submitted by shareholders during this meeting. Before doing so, let me just say once more a direct note of appreciation to Stephane. Only a few months ago marked the 10th anniversary of when he joined this journey to build Moderna and to look back at those 10 years and to see where we are only motivates us. And I know him to think ahead over the next 10 years and to foresee what's possible in terms of the impact this company can have. Thank you, Stephane. Over to you.

Before we begin, please note that during the Q&A session, we will be making forward-looking statements as contemplated by the safe harbor provision of the Private Securities Litigation Reform Act of 1995. Please see the accompanying presentation on our SEC filings for important risk factors that could cause our actual performance and results to differ materially from those expressed or implied in these forward-looking statements. We undertake no obligation to update or revise the information provided during this presentation as a result of new information or future results or developments.

Thank you, Lori. Thank you, Noubar, for the kind words. I'm lucky to have great support from a great team across the company and from the Board of Directors. Good morning, or good afternoon, everybody. Thank you to all our shareholders for joining us this morning. We received a significant number of questions in advance of the meeting on a broad area of topics, and we would like to address those questions first. If we have time after going through these responses, we'll take questions from those of you joining us online this morning. I hope that those of you who are interested in Moderna's progress over the last year have had the opportunity and taken the time to read my shareholder letter that we published in January. It was included in the annual report. Our proxy statement also provides more information on governance matters and our executive compensation, and we are committed to providing you updates as we progress as demonstrated recently by our Vaccine Day presentation 2 weeks ago. We hope you'll also join us next Thursday on May 6 when we announce our earnings for the first quarter of 2021. First, thank you to all of you who wrote with your congratulations, kind words and thanks. The entire Moderna team is proud of the role we have been able to play in fighting the pandemic, and we appreciate [indiscernible]. Our success would not have been possible without your support who shared our beliefs [indiscernible]. But we recognize that our work is not done, and we'll continue to work on producing as much vaccine as possible, while also staying ahead of the virus as new variants emerge to do what we can to get the pandemic under control. Before I jump into answering questions, I think it's worth noting that most of the questions we received were focused on 2 major areas. First, our COVID-19 vaccine, mRNA-1273, and then Moderna's long-term strategy and development for the rest of the platform. As I noted in my letter to shareholders, for 2021, we are focused on 4 strategic priorities. Priority number one, to maximize the impact of our COVID-19 vaccine access and value creation during the year. There were a number of questions on our COVID-19 vaccine, and I hope my answers will help illustrate how we aim to execute on this strategic priority. The next 3 strategic priorities all look beyond COVID-19, and I hope you will keep this in mind as they also help frame the responses to many of your other questions. Those 3 of our priorities are, priority number two for the company, accelerate the vaccine development to advance our infectious disease vaccine pipeline and bring new important vaccines to market. Priority number three, generate human proof-of-concept data in autoimmune disease, in cardiovascular diseases, in oncology and in rare genetic diseases. Priority number four, continue to expand the use of mRNA technology to maximize the potential impact we can have on patients. We are not done on mRNA technology or science. We are just getting started. A number of you asked questions about our COVID-19 vaccine. I encourage you to listen to the presentation we gave during Vaccine Day on April 14, and that is available for replay on our Investor Relations web page where we addressed a number of question that were submitted, particularly questions about our strategy for boosters and the life of protections provided by our mRNA-1273 vaccine. To summarize as what we said there briefly, we are actively working on 3 different booster strategies, including: number one, a booster strategy that utilizes our original mRNA-1273, the vaccine currently authorized and used in many countries around the world. Our booster priority number two is a booster that is specific to the B.351 variant of SARS-CoV-2 virus, which was first identified in South Africa, which we refer to as mRNA-1273.351. And our booster priority number three is a booster that combines our original mRNA-1273, the one currently used, and mRNA-1273.351, and we refer this third booster strategy, mRNA-1273.211. We announced preclinical data for mRNA-1273.351 and mRNA-1273.211 ahead of Vaccine Day and both were shown to increase neutralizing cycles in mass studies against the variant strains, a positive sign as we speak to stay ahead of the variants. Our Phase II clinical study to evaluate the pre-opportunity is ongoing, and we expect human data soon. We anticipate that there will be likely a need for booster against COVID-19 going forward. The number of doses we are capable of producing will depend in part of ideal dosage, and we are currently testing boosters at 50 micrograms and less. I encourage you to listen to our fourth quarter earnings call next week, where we explain how our investment in new manufacturing capabilities and dosage level could impact our ability to produce boosters in 2022 as well as our Vaccine Day update. If you recall, our current vaccine regimen requires 2 dose at 100 micrograms, a booster of only 50 micrograms could allow us to reach 4x as many individuals for boosters the original vaccination series. We also have announced data that was published in the New England Journal of Medicine demonstrated that antibodies persisted in vaccinated individuals up to 6 months after the second dose of mRNA-1273. Additionally, ahead of Vaccine Day, we announced data from our COVE study demonstrating that mRNA-1273 continues to confer a high level of protection 6 months after vaccination. The COVE study updated case count showed greater than 90% efficacy for mRNA-1273 6 months after vaccination and greater than 95% protection against serious case of COVID-19. We will continue to evaluate the efficacy of a vaccine over time as part of the COVE study and to share the data externally. We received several questions on when we think our vaccine might be available for adolescents and pediatric populations. As we disclosed at Vaccine Day, our clinical trials are ongoing. Our [COVE-teen] study for 12 to 17 years old is fully enrolled, and we are enrolling our KidCOVE study, which is testing the vaccine in children aged 6 months to 11 years old. A handful of shareholders asked whether we plan to supply our COVID-19 vaccine to COVAX and low-income countries with some question about providing specific countries with the vaccine. We continue to have discussions with COVAX provide a meaningful amount of vaccine to help combat the pandemic in low- and middle-income countries. Consistent with the access principles, we are not [indiscernible] this number and as you can find on our website, we are committed to providing vaccines to low-income [indiscernible]. Our objective as a company is to provide effective and affordable vaccines and therapeutics to all populations. We are continuing to ramp our production to make this vision a reality, and we have continued to partner with other manufacturers, building on the relationship we announced with Lonza only a year ago to ensure we can produce as much vaccine as possible. We also announced in October of last year that we will not enforce our intellectual property rights, while the pandemic is ongoing against others who are engaged in the production of COVID-19 vaccines, and we are willing to enter into licensing agreements for the post-pandemic period. We believe these efforts are the most effective means of deploying the Moderna technology to combat the pandemic around the world. We also received a question on whether the fact that we received U.S. government financial support for the development of our COVID-19 vaccine will be factored into pricing decisions for all COVID vaccines going forward. Actually, the U.S. government received the best price for our vaccine among any high-income country in recognition for the financial support we received from the U.S. government. We are very grateful for this support and the speed with which it allowed us to move forward last year in developing in the clinic our vaccine. As I noted a moment ago, we are committed to providing our vaccine to low- and middle-income countries at the lowest price through COVAX, and we hope to conclude the transaction with them soon. A handful of investors asked about our approach to reporting and monitoring of side effects from the vaccine. We are pleased with the safety and tolerability to date that we have seen on the vaccine with more than 100 million doses of vaccine administered around the world. We will continue to report any side effects to local regulators and health officials as required under authorizations for the vaccine. A number of shareholders asked about our plans to -- for combination vaccines. As we discussed at Vaccine Day, we are actively working on developing mRNA-based seasonal flu candidates. We were first expected to enter the clinic this year. We envision that, in the future, we would like to be able to combine a number of vaccines for respiratory diseases into a single shot. We believe that using mRNA technology can produce a much more effective flu vaccine and traditional technology due to our ability to develop a vaccine on a shorter time in response to data on [indiscernible] strains. We also continue to explore ways to increase the stability of a vaccine as demonstrated with our announcement regarding mRNA-1283, which is a COVID-19 vaccine that is designed for increased stability at refrigerator temperature. We are hopeful that this will allow us to reach more patients that may not be in areas with cold chain infrastructure. Looking beyond our COVID-19 vaccine, a number of you asked questions about the rest of our pipeline. And I'd like to address those questions now. As I noted previously, I would encourage you to read my letter to shareholders in the annual report and listen to our Vaccine Day presentation. I hope those procession will make clear that we have to deploy our mRNA technology to combat a broad number of diseases. We never set out to be a one-drug company, and success with our COVID-19 vaccine will also allow us to reinvest in a number of programs. We currently have 24 programs in development, and we have discussed them at length in several of our investor presentations. One of our key strategic objectives is to go big in infectious disease, including proceeding with 2 vaccines, which I outlined a moment ago, as well as continuing to advance our program for vaccine against CMV, cytomegalovirus, which is another one cause of congenital birth defect, and RSV which is the most harmful respiratory disease, particularly for the elderly and the pediatric population. We also have announced several tropical vaccine programs to help protect people around the world, including programs to develop vaccine against HIV, the Nipah virus and Zika. We believe that our success with the COVID-19 vaccine providers with both the financial resources and the technical know-how to aggressively pursue these other programs, and we have a strong appetite to invest in our pipeline. We believe that our 10 years of experience in this field gives us an advantage that cannot easily be replicated by others who may seek to enter the field of mRNA-based medicines. Beyond infectious disease, our first strategic objective is to generate human proof-of-concept data in oncology, cardiovascular diseases, rare genetic diseases and autoimmune disease. I encourage you to look at the pipeline section of our Investor Relations website for more detailed overview on these programs. We received a handful of questions asking for an update on our cancer vaccines. As any follower of Moderna will know, we have 2 cancer vaccine programs in the clinic, a personal cancer vaccine called PCV and a vaccine against neoantigen related to a common oncogene called KRAS. Both conducted in collaboration with Merck. The PCV program is in Phase I and also in Phase II clinical trials. The KRAS program is in Phase I. This program continues to progress. We received a few questions on Moderna's political engagement and contributions, and I would like to set the record straight and to remind our investors that as a company we do not engage in political giving, and we have no plans to do so. We also do not sponsor an employee pack. The last category of questions that I will cover before handing back to Noubar are questions related to our financial performance and capital allocation. Several shareholders ask how we expect the COVID-19 rollout to impact our financial and self-performance. While I obviously cannot comment on how the market will react to our performance, we did announce in the fourth quarter earnings call that we anticipate that we will be profitable this year if we are successful in rolling out our COVID-19 vaccine. Ahead of Vaccine Day, we announced we have delivered 132 million doses of the vaccine worldwide as of April 12, and we'll continue to ship most of this in the 2 weeks since that time. We also delivered 700 million to 1 billion doses of our vaccine in 2021. As I noted previously, we currently envision reinvesting the proceeds from these vaccine sales in the development of the rest of our pipeline rather than changing our approach to capital allocation. With that, let me hand it back to Noubar for a few additional questions. Noubar?

Thank you, Stephane. Let me address a few more questions that were submitted in advance before we open it up to questions in the queue from shareholders listening today. A few questions we received relate to sales by some of our company inside of the Moderna stock and the speculations that fueled in the market behind the reason for those sales as well as our policies related to 10b5-1 plans. As I believe most of our investors appreciate, many of our investors, executives and directors have invested much of their time and capital in building Moderna over the last decade from a concept into a groundbreaking company. Like many biotech and other start-ups, much of the compensation that we paid to our executives and directors came in the form of stock rather than cash. And following our IPO late in 2018, a number of individuals began to put in place plans to monetize part of their stockholdings. These 10b5-1 plans require that decisions on stock sale be set well in advance and when the person transacting is not in position of any material nonpublic information of the company. Last August, we announced that no new sale plans could be entered by our executives or directors until we have clarity on the development of mRNA-1273 and indeed, we did not permit any trading plan to be entered or modified until late December after the FDA granted authorization for the vaccine. When we permitted our team to enter into 10b5-1 plans, once again, starting last December, we extended the cooling off period for when those plans could trigger beyond the several-week period already in place previously. We have robust stock ownership policies in place that apply to our officers and directors, which are described in the proxy, and we are committed to ensuring that our leadership team and our investors are aligned. A handful of investors asked questions about our executive compensation policies and our approach to compensation for our broader employee base. As I noted a moment ago, a key pillar of our compensation program is to ensure that our executive team and our broader employee population are aligned with investors. While we feel it is important to pay our team competitively to attract and retain the best arm possible, we believe in paying for performance, and so more of our compensation is weighted towards equity that vests over time. But all of our employees receive equity in the company as part of their compensation, and last year, our median employee made about $159,000. The Board also received a vast majority of its compensation in equity rather than cash, promoting their alignment with investors as well. Lastly, we received several questions on the topic of promoting ethnic diversity on our Board of Directors, particularly for underrepresented ethnic groups and among our senior management team. We've made significant strides in terms of gender diversity on the Board in the last few years. But we recognize that there's more work that can be done to increase diverse representation on the Board. I appreciate the spirit of the question. And while we do not have a firm time line in place on our recruitment efforts, please note that we'll take this feedback into account as we consider future director candidates. In terms of our workforce, we are making strides there as well, but we have more work to do. 35% of our employees are identified as racially or ethnically diverse as at the end of last year, up from 32% the prior year. With that, let me welcome our Head of Investor Relations, Lavina Talukdar, to help us with some of their questions -- some of the questions that we received from investors during the meeting. We'll stay on for a few more minutes to take those questions.

Thank you, Noubar. We have received a question this morning that was not addressed in the prepared Q&A remarks. The questioner asked, can you comment on the timing of deliveries of the Moderna COVID-19 vaccine to countries outside of the United States?

Thank you, Lavina, and thank you for your question. So we shipped our first product outside the U.S. to Canada in December 2020. That product was the first product that came out of our supply chain made outside the U.S. The drug substance was manufactured in Switzerland at Lonza, and the product was filled at ROVI in Spain, then was shipped to Canada. As we noted at Vaccine Day, the supply chain outside the U.S. is around 1/4 behind the supply chain in the U.S. in terms of its ramp-up. This is due to the fact that we had a plant in the U.S. before the pandemic started in Massachusetts, but we did not have a plant outside the U.S. It is actually quite remarkable that we were able to ship in just a few quarters, starting from scratch products already in December 2020, and I think it's a testimony to the work of our team and the work of our partners. And so we are on track to track roughly 1/4 behind the U.S. supply chain in the outside the U.S. supply chain.

Thank you.

That will complete the question-and-answer period. Thank you all for attending, and thank you for your continued support.

Thank you. The Moderna Annual Stockholders Meeting has now come to an end. Thank you for attending. You may now disconnect.