Sarepta Therapeutics, Inc. (SRPT) Earnings Call Transcript & Summary

June 3, 2021

NASDAQ US Health Care Biotechnology shareholder_meeting 22 min

Earnings Call Speaker Segments

Operator

operator
#1

Hello, and welcome to the Annual Meeting of Stockholders of Sarepta Therapeutics Inc. Please note that today's meeting is being recorded. [Operator Instructions] It is now my pleasure to turn today's meeting over to Dr. M. Kathleen Behrens. Dr. Behrens, the floor is yours.

M. Behrens

executive
#2

Thank you, Chris. Welcome to the 2021 Annual Meeting of Stockholders for Sarepta Therapeutics. It is now 9:00 a.m., and the meeting will please come to order. My name is Dr. M. Kathleen Behrens, and as chairwoman of the Board of Directors of Sarepta, I will be presiding over this meeting. Doug Ingram, President and Chief Executive Officer of Sarepta, will also preside over portions of the meeting. Ryan Brown Senior Vice President, General Counsel and Corporate Secretary, will record the proceedings. We would now like to take a moment to acknowledge the contributions of Dr. John C. Martin, former Sarepta Board member and renowned biotech leader, who passed away unexpectedly on March 30 of this year. Dr. Martin was an extraordinary person and adviser to Sarepta. Those who had the privilege of knowing him were bettered by his colleagueship and the lives of millions of patients across the globe were extended and improved through the therapies that he championed. His vision, wisdom and insight had a lasting impact, and we were fortunate to know and work with him, and to consider him part of the Sarepta community. A fierce advocate for patients and science, he dedicated his life to improving the lives of others. John joined Sarepta's Board in January of 2020, also serving and sharing his expertise as a member of the Board's Research and Development Committee. Dr. Martin brought decades of experience, including from his instrumental role in building one of the world's foremost biotechnology companies, Gilead Sciences. During his 20-year tenure as Chief Executive Officer of Gilead, he oversaw the growth of the company and development of its scientific portfolio into 24 marketed products, including treatments for HIV/AIDS and a cure for hepatitis C. Prior to Gilead, Dr. Martin held several leadership positions at Bristol Myers Squibb and Syntex Corporation. In addition to Sarepta, he served on the Board of Directors of the Scripps Research Institute and Kronos Bio. John's involvement within the industry extended to public health. He served on the Center for Disease Control, Health Resources and Services Administration Advisory Committee on HIV and STD prevention and treatment, and was a member of the Presidential Advisory Council on HIV/AIDS. In 2008, Dr. Martin was inducted into the National Academy of Engineering, and in 2019, he received the National Academy of Sciences Award for chemistry in service to society. Dr. Martin's legacy of leadership and his fierce commitment to advancing scientific discovery and innovation to benefit the lives of patients is second to none across the biopharmaceutical ecosystem. In the passing of Dr. John Martin, we have lost a giant, but its impact on the world endorse. We are grateful for his service to Sarepta and his family remains in our thoughts as they mourn his passing. Now I will turn to the order of business at today's meeting, which will follow the agenda that is attached in the documents section of the webcast. [Operator Instructions] We will conduct the business portion of our meeting, first, and answer questions at the end of the meeting. Though we may not be able to answer every question, we will do our best to provide a response to as many as possible. Joining me today are the following current members of the Sarepta Board of Directors. Doug Ingram, who will be speaking later; as well as Richard Barry; Dr. Mary Ann Gray; and Dr. Hans Wigzell; Dr. Claude Nicaise cannot be with us today due to a family emergency. I would now like to call your attention to the individuals who have agreed to stand for election as Class II directors to the Board of Directors at this meeting. Richard J. Barry, Dr. Claude Nicaise and myself, Dr. M. Kathleen Behrens, are standing for election to the Board of Directors. Also present today are the company's member of its Executive Committee, Doug Ingram, President and Chief Executive Officer; Ian Estepan, Executive Vice President, Chief Financial Officer; Diane Berry, Senior Vice President, Global Health Policy, Government and Patient Affairs; Bill Ciambrone, Executive Vice President, Technical Operations; Dallan Murray, Senior Vice President and Chief Commercial Officer; Ryan Brown, Senior Vice President, General Counsel and Corporate Secretary; Alison Nasisi, Interim Head of Human Resources; Gilmore O'Neill, Executive Vice President, R&D and Chief Medical Officer; and Louise Rodino-Klapac, Executive Vice President, Chief Scientific Officer. In addition, Brian McCurrie and Stacy Farees of KPMG, the company's independent registered public accountants, have joined us today. This morning, our program will proceed as follows. First, I will conduct the official business of the 2021 annual meeting as presented in the company's proxy statement filed with the Securities and Exchange Commission. This year is the following, are the 3 proposals for stockholders to vote on. First, the election of Class II directors; second, the advisory vote on named Executive Officer compensation; and third, the ratification of KPMG as the company's independent registered public accounting firm for fiscal 2021. The company has not received notice from any of its stockholders as required under its bylaws or any other matters to be considered at today's meeting, and therefore, no other proposals may be properly introduced by stockholders. After we complete the official business of the meeting, Mr. Ingram will address those attending today and open up the meeting with stockholders to a general question-and-answer session on the company's business. We have a quorum present, which allows us to proceed to the official business of this meeting. We also have an affidavit from Computershare, the company's Inspector of Elections, certifying that the notice of internet availability of proxy materials was mailed and deposited with United States Post Office commencing on April 20, 2021, to each shareholder of record as of April 9, 2021. Additional proxy materials, which included a proxy statement, proxy card, annual report and other material necessary to vote at this meeting were mailed to shareholders, who've requested to receive printed copies of the proxy materials. The Board of Directors has appointed Computershare to serve as Inspector of Elections. Jeffrey Seiders of Computershare will determine, first, the number of shares outstanding, second, the shares represented at the meeting, and third, the validity of the proxies and ballots. Mr. Seiders will also tabulate the votes for this annual meeting. I will now turn to the official business of this meeting. The first matter to be voted upon today is Proposal 1, the Election of Class II Directors. Nominations are now in order for Class II Directors on the Board of Sarepta for the 2-year term, expiring at the 2023 Annual General Meeting of Stockholders and until their successors are duly elected and qualified. The current Board of Directors favors the election of the following individuals: Richard J. Barry, Dr. Claude Nicaise, Dr. M. Kathleen Behrens. Do we have a nomination?

Unknown Attendee

attendee
#3

I hereby nominate for election as Directors of the company to serve a term expiring on the date of the 2023 Annual General Meeting of Stockholders and until his or her successor is duly elected and qualified. Richard J. Barry, Dr. Claude Nicaise and Dr. M. Kathleen Behrens, who were named as Director nominees in the company's proxy statement for this Annual Meeting. May I have a second?

Unknown Attendee

attendee
#4

I second the motion.

M. Behrens

executive
#5

A motion to nominate the individuals listed in the proxy statement and announced at this meeting as directors of Sarepta for the 2-year term, expiring at the 2023 Annual General Meeting of Stockholders has been made and seconded. The second matter to be voted upon is Proposal 2. The advisory vote on 2020 named Executive Officer compensation. May I have a motion?

Unknown Attendee

attendee
#6

I hereby move to approve the advisory vote on 2020 named Executive Officer compensation. May I have a second?

Unknown Attendee

attendee
#7

I second the motion.

M. Behrens

executive
#8

A motion to approve the advisory vote on the 2020 named Executive Officer compensation has been made and seconded. The third matter to be voted upon at this meeting is Proposal 3, the ratification of the selection of KPMG as the independent registered public accounting firm for the company for 2021. May I have a motion?

Unknown Attendee

attendee
#9

I move that the selection of KPMG as the independent registered public accounting firm for the company for 2021 be ratified and approved. May I have a second?

Unknown Attendee

attendee
#10

I second the motion.

M. Behrens

executive
#11

A motion has been made and seconded to ratify and approve the selection of KPMG as the independent registered public accounting firm for the company for the fiscal year ended December 31, 2021. We will now proceed to vote on the motions for proposals 1 through 3 in the company's proxy statement, which are the proposals related to the election of Class II Directors, the advisory vote on named Executive Officer compensation and the ratification of the company's auditors for fiscal year 2021. Stockholders who sent in proxies or voted via telephone or internet, and do not wish to change their vote, do not need to take any further action. If you previously returned a proxy card and do not wish to change your vote, you do not need to vote again at this meeting. If you wish to vote at this meeting and have not yet done so, you may do so now by clicking on the cast-your-vote button on the web portal and following the instructions there. I'm now going to give us a minute or 2 for people to take time to vote. [Voting]

M. Behrens

executive
#12

We will now close the voting polls with respect to the 3 proposals in the proxy statement. Since the voting polls are now closed, I now move that the official business portion of this meeting be concluded. May I have a second?

Unknown Attendee

attendee
#13

I second the motion.

M. Behrens

executive
#14

Thank you very much. I will now turn the meeting over to Mr. Ingram.

Douglas Ingram

executive
#15

Thank you, Kathy. I will make some brief comments regarding progress and performance. To remind you all, I will be making some forward-looking statements here, so please refer to our public filings for a discussion of the risks and uncertainties that are attendant with making statements and predictions about the future. Sarepta set out only a few years ago to become the leader in genetic medicine for rare disease using multiple modalities, RNA, gene therapy and gene editing, and we have made significant progress toward that goal. Looking to the last 1.5 years, we have hit the majority of our ambitious goals. By now, we have 3 RNA therapies approved in the United States, with 2020 sales growth of nearly 20% over 2019. 2021 Q1 sales growth of 24%. And compounded annual growth from our first sale in 2016 of 19% thus far. We are in a strong cash position, having robust sales and having monetized our priority review vouchers, so that we commence Q2 of this year with $1.75 billion in cash available to invest in our programs. In addition to our leadership role in RNA therapies, we set out in 2018, to become a leader in gene therapy and gene therapy manufacturing. With the announcement of our stellar results of our SRP-9001 study 103 cohort, we have proven the progress we have made in manufacturing. We have become world leaders in process development and analytical development for gene therapy, have hundreds of professionals employed in our technical operations function and have the capacity available to fully serve the Duchenne community at the launch of SRP-9001, which, if successful, will be the largest gene therapy launch in history. We have now nearly 30 gene therapy and gene editing constructs in various stages of research and development and have built a world-class, and I believe, first-in-class gene therapy center of excellence in Columbus, Ohio, and a gene editing innovation center in Durham, North Carolina. We've also made significant progress on our pipeline, with approximately 15 human clinical programs currently underway. With respect to our lead gene therapy, SRP-9001 for Duchenne muscular dystrophy, we published positive 1 year results for Study 101 last year in JAMA Neurology, and we reported sustained functional improvements at 2 years at last year's World Muscle Conference. We obtained key insight from part 1 of our Study 102 program in January of this year, which bolstered our confidence in the therapy and informed our upcoming study, and we recently announced a robust expression and highly differentiated safety from Study 103, our program using our commercial process material. With respect to our LGMD pipeline, over the last year, we announced positive 1 year, then 18-month, then 2-year patient results from our program studying SRP-9003, our gene therapy intended to treat LGMD type 2E. And with respect to our next-generation PMO technology, the PPMO, we recently announced positive clinical results from Part A of Momentum, our multi-ascending dose trial setting SRP-5051. Our PPMO construct intended to treat patients, who have Duchenne muscular dystrophy and exon 51 amenable mutations. Additionally, we have become the partner of choice in genetic medicine for the treatment of rare disease, having closed over 50 transactions in less than 4 years, including augmenting our pipeline, partnering to bring SRP-9001 to regions outside of the United States and collaborations intended to advance the impact on genetic medicine, including enhanced delivery methods and methods to empower redosing and the avoidance of preexisting neutralizing antibodies. Looking forward, we have numerous consequential milestones over the coming months and quarters. We will meet with the FDA in the middle of this year with the goal of shortly thereafter commencing our next and pivotal trial for SRP-9001, which we call Study 301. We will report the functional results from the first cohort of patients treated with SRP-9001 to Study 103 at a future medical meeting. We will meet with the FDA this year to determine the clinical and regulatory pathway for SRP-9003 and then commence our pivotal trial for that program. We will meet with the FDA regarding SRP-5051, and then commence Part B of the MOMENTUM Trial, which we will propose to be a pivotal trial for that program. And we will continue to drive the remainder of our pipeline, all with the goal of firmly establishing ourselves as the world's leader in the use of multiple genetic medicine modalities to treat rare disease. And in so doing, if successful to extend and improve the lives of those living with life ending and life limiting disease. And with that, let me turn the meeting back to our Chair, Dr. Behrens. Kathy?

M. Behrens

executive
#16

Thank you, Doug. At this time, we will take questions or comments from our stockholders. [Operator Instructions] Please note, we will attempt to answer as many questions as time allows, but only questions that are germane to the meeting will be addressed.

Unknown Attendee

attendee
#17

There appear to be no questions at this time.

M. Behrens

executive
#18

Doug, would you like to make just a brief comment or 2, and we'll see if any questions do come in?

Douglas Ingram

executive
#19

Sure. I just would say that, thanks, everyone, for joining us today. Those of who join us for our Annual Meeting. I think Sarepta has had a very productive last 1.5 years to 2 years. We have a lot to do in the coming quarters and months, and I look forward to the opportunity to share our progress across these next 3 quarters with the shareholders that are invested in Sarepta. So thank you.

M. Behrens

executive
#20

[Operator Instructions]

Unknown Attendee

attendee
#21

I believe there are no questions.

M. Behrens

executive
#22

Okay. Well, thank you. I'd now like to ask Mr. Seiders to summarize the tabulation of stockholder votes on the proposals raised at this annual meeting.

Unknown Attendee

attendee
#23

Thank you, Dr. Behrens. The preliminary tabulation results are as follows: Proposal 1, election of Directors. Our preliminary tabulation of votes received immediately prior to and at this meeting indicate that the Director nominees named in the proxy statement, Mr. Barry, Dr. Behrens and Dr. Nicaise have been elected to serve for the 2-year term expiring at the 2023 annual meeting of stockholders and until his or her successor is duly elected and qualified. Proposal 2, advisory vote on named Executive Officer compensation. Our preliminary tabulation of votes received immediately prior to and at this meeting indicate that the advisory vote on 2020 named Executive Officer compensation has been approved. Proposal 3, ratification of the selection of KPMG as our independent registered public accounting firm for 2021. Our preliminary tabulation of votes received immediately prior to and at this meeting indicate that the selection of KPMG LLP as the independent registered public accounting firm for the company for 2021 has been ratified and approved.

M. Behrens

executive
#24

Thank you, Mr. Seiders and thank you all for attending Sarepta's Annual Meeting of Stockholders. This meeting is now adjourned with respect to all matters. I would like to thank you for your investment and interest in Sarepta Therapeutics.

Operator

operator
#25

This concludes the meeting. You may now disconnect. And have a pleasant day.

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