UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On May 3, 2023, Cerevel Therapeutics Holdings, Inc. (the "Company") issued a press release announcing financial results for the quarter ended March 31, 2023. A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information contained in this Current Report on Form 8-K and Exhibit 99.1 attached hereto is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
CEO Transition
On May 3, 2023, the Company announced that N. Anthony Coles will transition from his role as Chief Executive Officer (“CEO”) of the Company, effective as of June 12, 2023. Dr. Coles will continue to serve as the chairperson of the Company’s board of directors (the “Board”).
On May 3, 2023, the Company also announced that, in connection with Dr. Coles’ transition, the Board appointed Ronald Renaud to succeed Dr. Coles as President and CEO of the Company and serve as a member of the Board, effective as of June 12, 2023. In connection with Mr. Renaud’s appointment, the size of the Board will be increased from 11 to 12 members and Mr. Renaud will be appointed as a Class I director, with a term expiring at the 2024 annual meeting of stockholders, to fill the vacancy, effective as of June 12, 2023.
Prior to joining the Company, Mr. Renaud, 54, served as a Partner of Bain Capital Life Sciences from September 2022 until May 2023. From 2014 until its acquisition by Sanofi S.A. in September 2021, Mr. Renaud served as the chair and chief executive officer of Translate Bio, Inc. (Nasdaq: TBIO). From 2007 to 2014, Mr. Renaud worked at Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX), where he held positions of increasing responsibility, including chief financial officer, chief business officer and eventually president and chief executive officer, up until its acquisition by Merck & Co., Inc. (NYSE: MRK). Prior to joining Idenix, Mr. Renaud was a biotechnology equity research analyst at J.P. Morgan, Schwab Soundview and Bear Stearns. He also spent more than five years at Amgen, where he held positions in clinical research, investor relations and finance. Mr. Renaud currently serves on the board of directors of Jnana Therapeutics and Upstream Bio, and previously served on the board of directors of Atara Biotherapeutics from April 2020 to December 2022, Ikena Oncology from March 2018 to December 2022, Chimerix from December 2014 to November 2020 and Akebia Therapeutics from September 2014 to December 2018. Mr. Renaud earned a B.A. from St. Anselm College and an MBA from the Marshall School of Business at the University of Southern California. The Company believes that Mr. Renaud is qualified to serve on the Board because of his extensive experience serving as an executive officer and as a director within the life sciences industry.
Employment Agreement
On May 1, 2023, the Company entered into an employment agreement with Mr. Renaud (the “Employment Agreement”). Pursuant to the Employment Agreement, Mr. Renaud will be paid an annual base salary of $675,000 and have the opportunity to earn a target annual incentive plan award of 65% of his annual base salary (the “Target Bonus”). Mr. Renaud is also eligible to be granted annual long-term incentive awards in the form of stock options to purchase shares of the Company’s common stock (“Options”), restricted stock units (“RSUs”) and performance-based restricted stock units (“PSUs”). The Options shall have an aggregate grant date fair value of $5,250,000, the RSUs shall have an aggregate grant date fair value equal to $5,250,000 and the target number of PSUs shall equal $10,500,000 divided by the average of the closing prices for one share of the Company’s common stock for the twenty (20) consecutive trading days ending on (and including) the date Mr. Renaud commences employment (the “Grant Date”). The Options shall vest over four years, with 25% of the Options vesting on the first anniversary of the Grant Date and the remaining 75% vesting in thirty-six monthly installments thereafter. The RSUs shall vest in four equal annual installments beginning on the first anniversary of the Grant Date. The PSUs shall vest at the end of a four-year performance period following the Grant Date, with 50% of the PSUs eligible to vest based on absolute TSR performance measured at the end of the performance period (with a payout range of 0% to 250% of the target number of PSUs, or 50% to 275% of the target number of PSUs upon a Sale Event (as defined in the Employment Agreement)) and the remaining 50% eligible to vest based on relative TSR performance at the end of the performance period as compared against the constituent companies of the Nasdaq Biotech Index as of the Grant Date (with a payout range of 0% to 250% of the target number of PSUs). The PSUs will be subject to the terms and conditions of a Performance Restricted Stock Unit Award Agreement under the Company’s 2020 Equity Incentive Plan (the “PSU Award Agreement”). Mr. Renaud will also be eligible to participate in the employee benefits plans generally available to other senior executive officers of the Company.
Pursuant to the terms of the Employment Agreement, in the event that Mr. Renaud is terminated without cause or resigns for good reason (in each case, as defined in the Employment Agreement), outside of a Sale Event Period (as defined in the Employment Agreement), then Mr. Renaud will be entitled to receive: (i) payment of his base salary for two (2) years following his date of
termination; (ii) the Target Bonus for the year of termination, prorated for the number of days during the year in which Mr. Renaud’s employment terminates that he was employed by the Company; and (iii) the Company’s contribution toward the coverage Mr. Renaud and his eligible dependents are eligible for under the Company’s health insurance policy for up to 18 months following the date of termination. In the event Mr. Renaud is terminated by the Company without cause or resigns for good reason, during a period of time that begins three (3) months prior to and ends twelve (12) months following the occurrence of the first event constituting a Sale Event (as defined in the Employment Agreement), Mr. Renaud will be eligible to receive: (i) an amount equal to two (2) times his base salary; (ii) the Target Bonus for the calendar year in which the date of termination occurs; (iii) the Company’s contribution toward the coverage Mr. Renaud and his eligible dependents are eligible for under the Company’s health insurance policy for up to 18 months following the date of termination; and (iv) all equity awards with conditions and restrictions relating to the attainment of performance goals payable in the Board’s discretion or to the extent provided in the award agreement and the full accelerated vesting of his then-unvested time-based equity awards.
Waiver
On April 27, 2023, the Company entered into a waiver (the “Waiver”) of the Amended and Restated Registration and Shareholder Rights Agreement, dated as of October 27, 2020, by and among the Company and the investors party thereto, to expand the size of the Board to 12 directors and permit Mr. Renaud to be appointed as a Class I director.
The foregoing summaries of the Employment Agreement, PSU Award Agreement and Waiver are qualified in their entirety by the actual terms of the Employment Agreement, PSU Award Agreement and Waiver, respectively, each of which will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the three months ending June 30, 2023.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No. |
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Description |
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99.1 |
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Press release issued by Cerevel Therapeutics Holdings, Inc. on May 3, 2023, furnished herewith. |
104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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CEREVEL THERAPEUTICS HOLDINGS, INC. |
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Date: |
May 3, 2023 |
By: |
/s/ Mark Bodenrader |
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Mark Bodenrader |
Exhibit 99.1
Cerevel Therapeutics Appoints Ron Renaud as President and Chief Executive Officer and Reports First Quarter 2023 Financial Results
Ron Renaud to succeed Tony Coles, M.D. as CEO, effective June 12, 2023; Dr. Coles will continue as chairperson of the board
Mr. Renaud brings more than 25 years of biotechnology leadership to Cerevel, including two prior CEO roles and strong financial and operational experience
Emraclidine Phase 2 schizophrenia data readout on track for 1H 2024
Darigabat Phase 2 epilepsy data readout expected mid-year 2024; panic disorder Phase 2 trial expected to initiate in Q2 2023
Cash, cash equivalents, and marketable securities of $863.0 million as of March 31, 2023, expected to support seven data readouts in 2024 and fund operations into 2025
Conference call today at 8:00 a.m. ET
CAMBRIDGE, Mass., May 3, 2023 – Cerevel Therapeutics, (Nasdaq: CERE), a company dedicated to unraveling the mysteries of the brain to treat neuroscience diseases, today announced the appointment of Ron Renaud as president and chief executive officer (CEO), and member of the company’s board of directors, effective June 12, 2023. Mr. Renaud will succeed Tony Coles, M.D., the current CEO and chairperson of the board of directors, who will continue in his role as chairperson. The company also reported financial results for the first quarter ended March 31, 2023 and provided key pipeline and business updates.
Mr. Renaud brings more than 25 years of experience in evaluating, building, and leading biotechnology companies, with deep expertise in executive leadership, finance, and operations. Mr. Renaud’s career underscores his commitment to delivering new treatment options to patients in need, cultivating strong company cultures, and advancing innovation in challenging disease areas. Under his leadership as CEO, Mr. Renaud led Translate Bio from an early-stage startup to a public company with a leading mRNA technology platform, substantially growing the size and value of the organization through innovative dealmaking and strategic growth opportunities. As the Idenix Pharmaceuticals CEO, he streamlined operations and established a promising portfolio of potential treatments for hepatitis C.
“I am delighted to welcome Ron to Cerevel as our next CEO, as I know that his leadership, experience, and expertise are ideally suited for this next phase of our journey to transform what is possible in neuroscience,” said Tony Coles, M.D. chairperson and chief executive officer of Cerevel Therapeutics. “In the four years since our founding, we have delivered positive data readouts that support Cerevel’s scientific thesis, built a world-class team, debuted as a public company, and raised more than $1.5 billion in capital through a series of innovative transactions. With strong business fundamentals in place and a robust pipeline of important programs advancing in the clinic, now is the right time for me to transition back to the role of chairperson, and I look forward to partnering with Ron as we write Cerevel’s next chapter.”
“I am thrilled to join Cerevel and lead this incredible organization into an exciting future, starting with the seven expected data readouts coming in 2024,” said Ron Renaud. “Cerevel has an impressive track record of success, and I look forward to all that is to come. The organization has the pipeline, the people, and the capital needed to make a meaningful difference for the millions of people living with diseases like schizophrenia, Parkinson’s, epilepsy, and panic disorder. I am privileged to take the baton from Tony, who has built one of the leading neuroscience companies in the industry, as I partner with him, the team, and the board to continue the work of unraveling the mysteries of the brain.”
“On behalf of the board, I would like to sincerely thank Tony for his tremendous leadership and the dedication he has displayed as CEO since assuming the role in 2019,” said Norbert Riedel, Ph.D., lead independent director of the Cerevel board of directors. “We have been incredibly fortunate to have a leader like Tony during this crucial growth period, as he shepherded the company through important pipeline advancements, positive data readouts, and significant capital formation.”
“The board is now delighted to welcome Ron to the CEO role,” continued Dr. Riedel, “as we continue the strong leadership that has been a hallmark of Cerevel since its inception. We look forward to all that Ron will bring to the organization as we advance our journey to become the premiere neuroscience company.”
About Ron Renaud
Ron Renaud has more than 25 years of experience evaluating, building and leading biotechnology companies. He led Translate Bio as chairman and chief executive officer from 2014 until the close of its acquisition by Sanofi in September 2021. During his tenure, he transformed the company from a start-up platform into a leading mRNA company, following the strategic acquisition of mRNA assets from Shire for $110 million in 2016. Building upon that investment, Mr. Renaud developed a strong corporate culture and a robust research and development organization, and ultimately generated significant returns for shareholders when the company was acquired by Sanofi for $3.2 billion.
Mr. Renaud was at Idenix Pharmaceuticals from 2007 through 2014, where he served as chief financial officer, chief business officer and finally, president and chief executive officer. At the start of his CEO tenure, the market capitalization of Idenix was $300 million, and through streamlining of operations, increasing employee engagement, and more focused research and development supported by significant capital raises, he led the company to an acquisition by Merck at a value of $3.85 billion.
From September 2022 to May 2023, Mr. Renaud served as a Partner of Bain Capital Life Sciences. Earlier in his career, he was a biotechnology equity research analyst at J.P. Morgan, Schwab Soundview and Bear Stearns. He also spent more than five years at Amgen, where he held positions in clinical research, investor relations and finance.
Mr. Renaud holds a bachelor’s degree from St. Anselm College and an MBA from the Marshall School of Business at the University of Southern California.
About Tony Coles, M.D.
Dr. Tony Coles joined Cerevel as chairperson in 2018, and in 2019 he took on the additional role of CEO. Before joining Cerevel, Dr. Coles was a founding investor, CEO and chairperson of the board of Yumanity Therapeutics, and had served as CEO, president, and chairperson of
the board of Onyx Pharmaceuticals until its acquisition by Amgen in 2013. Before joining Onyx, he was president, CEO, and a board member of NPS Pharmaceuticals, and had previously been senior vice president of commercial operations at Vertex Pharmaceuticals after holding executive positions earlier in his career at Bristol-Myers Squibb and Merck.
Dr. Coles currently serves on the board of directors of Regeneron Pharmaceuticals and is a member of the Board of Trustees of Johns Hopkins University. Among his other interests, he is a Trustee of The Metropolitan Museum of Art, member of the Council for the Smithsonian’s National Museum of African American History and Culture, and a member of the Board of Directors of the Council on Foreign Relations. In 2022, Dr. Coles was inducted into the American Academy of Arts & Sciences.
Dr. Coles earned his bachelor’s degree at Johns Hopkins University, his medical degree from Duke University, and his master’s degree in public health from Harvard University. He completed his cardiology and internal medicine training at Massachusetts General Hospital and was a research fellow at Harvard Medical School.
Pipeline Highlights
Leveraging its deep understanding of neurocircuitry and targeted receptor subtype selectivity, Cerevel is advancing its broad and diverse pipeline of novel neuroscience product candidates.
Below are the latest updates for Cerevel’s lead programs.
Emraclidine: an M4-selective positive allosteric modulator (PAM) in development for schizophrenia and Alzheimer’s disease psychosis.
Darigabat: an α2/3/5-selective GABAA receptor PAM currently under development for epilepsy and panic disorder.
Tavapadon: a D1/D5 partial agonist currently in Phase 3 for the treatment of Parkinson’s disease.
CVL-871: a D1/D5 partial agonist in development for treatment of dementia-related apathy.
In addition to these lead programs, Cerevel is advancing its early clinical pipeline and discovery programs, which include:
Financial Results for the First Quarter 2023
Conference Call Information
Cerevel will host a conference call and webcast today, May 3, at 8:00 a.m. ET to discuss its first quarter 2023 financial results and key pipeline and business updates. To access the call, please register at this link. Once registered, you will receive the dial-in information and a unique PIN number.
A live webcast of the call, along with supporting slides, will be available on the investors section of Cerevel’s website at investors.cerevel.com. Following the live webcast, an archived version of the call will be available on the website.
About Cerevel Therapeutics
Cerevel Therapeutics is dedicated to unraveling the mysteries of the brain to treat neuroscience diseases. The company is tackling diseases by combining its deep expertise in neurocircuitry with a focus on targeted receptor subtype selectivity and a differentiated approach to pharmacology. Cerevel Therapeutics has a diversified pipeline comprised of five clinical-stage investigational therapies and several preclinical compounds with the potential to treat a range of neuroscience diseases, including schizophrenia, Alzheimer’s disease psychosis, epilepsy, panic disorder, and Parkinson’s disease. Headquartered in Cambridge, Mass., Cerevel Therapeutics is advancing its current research and development programs while exploring new modalities through internal research efforts, external collaborations, or potential acquisitions. For more information, visit www.cerevel.com.
Special Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that are based on management’s beliefs and assumptions and on information currently available to management. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in
this press release include, but are not limited to, statements about: the potential attributes and benefits of our product candidates; the format, timing and objectives of our product development activities and clinical trials; the timing and outcome of regulatory interactions, including whether activities meet the criteria to serve as registrational; the ability to compete with other companies currently marketing or engaged in the development of treatments for relevant indications; the size and growth potential of the markets for product candidates and ability to serve those markets; the rate and degree of market acceptance of product candidates, if approved; and the sufficiency of our cash position. We cannot assure you that the forward-looking statements in this press release will prove to be accurate. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. Actual performance and results may differ materially from those projected or suggested in the forward-looking statements due to various risks and uncertainties, including, among others: clinical trial results may not be favorable; uncertainties inherent in the product development process (including with respect to the timing of results and whether such results will be predictive of future results); the impact of COVID-19, the post-COVID environment and other factors on the timing, progress and results of clinical trials; our ability to recruit and enroll suitable patients in our clinical trials; whether and when, if at all, our product candidates will receive approval from the FDA or other regulatory authorities, and for which, if any, indications; competition from other biotechnology companies; uncertainties regarding intellectual property protection; and other risks identified in our SEC filings, including those under the heading “Risk Factors” in our Annual Report on Form 10-K filed with the SEC on February 22, 2023 and our subsequent SEC filings. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. The forward-looking statements in this press release represent our views as of the date of this press release. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.
# # #
Media Contact:
Anna Robinson
Cerevel Therapeutics
anna.robinson@cerevel.com
Investor Contact:
Matthew Calistri
Cerevel Therapeutics
matthew.calistri@cerevel.com
TABLE 1 |
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CEREVEL THERAPEUTICS HOLDINGS, INC. |
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
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(unaudited, in thousands, except share amounts and per share amounts) |
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For the Three Months Ended |
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2023 |
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2022 |
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Operating expenses: |
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Research and development |
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$ |
78,181 |
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$ |
55,023 |
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General and administrative |
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21,370 |
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17,507 |
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Total operating expenses |
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99,551 |
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72,530 |
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Loss from operations |
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(99,551 |
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(72,530 |
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Interest income (expense), net |
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6,440 |
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295 |
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Other income (expense), net |
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(11,090 |
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3,941 |
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Loss before income taxes |
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(104,201 |
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(68,294 |
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Income tax benefit (provision), net |
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(85 |
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— |
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Net loss |
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$ |
(104,286 |
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$ |
(68,294 |
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Net loss per share, basic and diluted |
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$ |
(0.67 |
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$ |
(0.46 |
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Weighted-average shares used in calculating net loss per share, basic and diluted |
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156,648,365 |
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147,984,926 |
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TABLE 2 |
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CEREVEL THERAPEUTICS HOLDINGS, INC. |
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CONDENSED CONSOLIDATED BALANCE SHEETS |
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(unaudited, in thousands) |
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As of |
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March 31, |
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December 31, |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
153,816 |
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$ |
136,521 |
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Marketable securities |
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673,171 |
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755,509 |
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Prepaid expenses and other current assets |
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13,795 |
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13,621 |
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Total current assets |
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840,782 |
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905,651 |
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Marketable securities |
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36,048 |
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58,126 |
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Property and equipment, net |
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27,006 |
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27,467 |
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Operating lease assets |
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21,434 |
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21,820 |
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Restricted cash |
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1,867 |
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1,867 |
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Other long-term assets |
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3,208 |
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2,891 |
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Total assets |
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$ |
930,345 |
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$ |
1,017,822 |
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LIABILITIES AND STOCKHOLDERS’ EQUITY |
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Current liabilities |
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$ |
62,957 |
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$ |
72,564 |
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Operating lease liabilities, net of current portion |
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30,381 |
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31,190 |
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2027 convertible senior notes, net |
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335,962 |
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335,482 |
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Financing liabilities |
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69,336 |
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57,348 |
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Total stockholders’ equity |
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431,709 |
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521,238 |
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Total liabilities and stockholders’ equity |
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$ |
930,345 |
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$ |
1,017,822 |
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TABLE 3 |
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CEREVEL THERAPEUTICS HOLDINGS, INC. |
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CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS |
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(unaudited, in thousands) |
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For the Three Months Ended |
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2023 |
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2022 |
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Net cash flows used in operating activities |
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$ |
(94,923 |
) |
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$ |
(67,648 |
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Net cash flows provided by (used in) investing activities |
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110,783 |
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(38,542 |
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Net cash flows provided by financing activities |
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1,435 |
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2,603 |
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Net increase (decrease) in cash, cash equivalents and restricted cash |
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17,295 |
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(103,587 |
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Cash, cash equivalents and restricted cash, beginning of the period |
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138,388 |
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197,218 |
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Cash, cash equivalents and restricted cash, end of the period |
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$ |
155,683 |
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$ |
93,631 |
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Note:
Cash, cash equivalents and restricted cash balances include restricted cash of $1.9 million as of March 31, 2023 and March 31, 2022.