Form 8-K - Current report

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

August 23, 2024

(Date of the earliest event reported)

Simulations Plus, Inc.

(Exact name of registrant as specified in its charter)


California	001-32046	95-4595609
(State or other jurisdiction of incorporation)	(Commission File Number)	(I.R.S. Employer Identification No.)

42505 10th Street West, Lancaster, California 93534-7059

(Address of principal executive offices) (Zip Code)

661-723-7723

Registrant's telephone number, including area code

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:


☐			Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐			Soliciting material pursuant to Rule 14z-12 under Exchange Act (17 CFR 240.14a-12)

☐			Pre-commencement communications pursuant to Rule 14d-2(b) under Exchange Act (17 CFR 240.14d-2(b))

☐			Pre-commencement communications pursuant to Rule 13e-4(c) under Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:


Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, par value $0.001 per share	SLP	The Nasdaq Stock Market LLC

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 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

On August 23, 2024, Simulations Plus, Inc., a California corporation (the “Company”), announced certain leadership changes in connection with the optimization of its business units.

Departure of Certain Officers

Effective August 30, 2024, Dr. Brett Howell, Ph.D., has departed the Company. Dr. Howell previously served as President, Quantitative Systems Pharmacology. In connection with Dr. Howell’s transition, he entered into a separation agreement consistent with his previously disclosed written employment agreement which, among other things, provides for the payment of twelve (12) months’ severance and related separation benefits and terminated his employment agreement.

Item 7.01 Regulation FD Disclosure

On August 23, 2024, the Company issued a press release announcing the leadership changes. The press release is furnished as Exhibit 99.1 to this Report.

In accordance with General Instructions B.2 of Form 8-K, the information set forth in Item 7.01 of this Report, including Exhibit 99.1, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liability 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, whether made before or after the date hereof, except as expressly set forth by specific reference in such filing to this Report.

CAUTION REGARDING FORWARD-LOOKING STATEMENTS

This Report, including the disclosures set forth herein and in Exhibit 99.1 attached hereto, contains certain forward-looking statements that involve substantial risks and uncertainties. When used herein, the terms “anticipates,” “expects,” “estimates,” “believes” and similar expressions, as they relate to us or our management, are intended to identify such forward-looking statements.

Forward-looking statements in this Report or reports hereafter furnished, including in other publicly available documents filed with the Securities and Exchange Commission (the “Commission”), to the Company’s stockholders and other publicly available statements issued or released by us involve known and unknown risks, uncertainties and other factors which could cause our actual results, performance (financial or operating) or achievements to differ from the future results, performance (financial or operating) or achievements expressed or implied by such forward-looking statements. Such future results are based upon management’s best estimates based upon current conditions and the most recent results of operations. These risks include, but are not limited to, the risks set forth herein and in such other documents filed with the Commission, each of which could adversely affect our business and the accuracy of the forward-looking statements contained herein. Our actual results, performance or achievements may differ materially from those expressed or implied by such forward-looking statements.

Item 9.01 Financial Statements and Exhibits

(d) Exhibits

99.1 Pres s Release , dated August 23, 2024

104 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 thereunto duly authorized.


			SIMULATIONS PLUS, INC.

Dated: August 23, 2024			By: /s/ Will Frederick
			Will Frederick
			Chief Financial Officer and Chief Operating Officer

Simulations Plus Optimizes Business Unit Structure to Support Future Growth Following Recent Strategic Acquisitions Announces leadership appointments for newly structured business units LANCASTER, CA, August 23, 2024 -- Simulations Plus, Inc. (Nasdaq: SLP) (“Simulations Plus”), a leading provider of biosimulation, simulation-enabled performance and intelligence solutions, and medical communications for the biopharma industry, today announced the optimization of its business unit and leadership structure to support future growth following the Company’s recent acquisitions. These actions will be effective August 30, 2024. “Over the past year, we made two key acquisitions, including the largest in our corporate history,” said Shawn O’Connor, Chief Executive Officer. “As a result, we have doubled our total addressable market, developed a one-of-a-kind platform, and significantly bolstered our talent pool. While integrating Pro- ficiency into our platform, we identified synergies and opportunities to reorganize our business units and leadership structure to better serve our clients and maximize our growth opportunities. Above all, our expanded team of top industry talent is united by the shared mission to create value for our customers by accelerating the development and delivery of drugs to patients. “In bringing Pro-ficiency on board, we focused on effective optimization of people and resources. As a result, we are forming two new and distinct business units — Adaptive Learning & Insights and Medical Communications — to enhance our customer engagement with both current and potential clients. We are also transitioning the Regulatory Strategies business unit into a new Regulatory Strategies Center of Excellence. This change is expected to enhance visibility within the sales organization and accelerate cross- selling opportunities driven by the increasing demand for biosimulation solutions. “Our suite of end-to-end and innovative offerings now spans the drug development continuum which we believe puts Simulations Plus in a unique competitive position to scale the business to drive growth and profitability. Looking forward, we are excited about the potential we see to create long-term value for all our stakeholders.” Simulations Plus announced the following leadership promotions and transitions: Steven Chang will be promoted to President, Quantitative Systems Pharmacology. Mr. Chang joined Simulations Plus in June 2023 with the acquisition of Immunetrics and served as its President and Chief Executive Officer since 2002. He is a successful technology entrepreneur with more than three decades of experience in identifying emerging market needs and combining state-of-the-art technologies and resources to meet those needs. Jenna Rouse will be promoted to President of the newly formed Adaptive Learning & Insights business unit. Ms. Rouse joined Simulations Plus with the acquisition of Pro-ficiency where, as Chief Markets Officer, Clinical, she spent five years driving the growth and engagement with the organization’s simulation-enabled training solutions for clinical trial optimization, competency development, and continuing medical education. Prior to joining Pro-ficiency, she spent 25 years in workforce development

in regulated industries, with over 15 years dedicated to professional development and adult learning in clinical trials. Murry Alper will be promoted to President of the newly formed Medical Communications business unit. Mr. Alper joined Simulations Plus with the acquisition of Pro-ficiency. Mr. Alper brings almost 30 years of experience in the life sciences industry, with experience at both major developers, as well as on the agency side. Mr. Alper founded Caravel Group in 2006 after a decade in marketing and sales roles at Bristol-Myers Squibb and Genentech. He has co-founded multiple medical communications agencies and was Managing Partner of Compass Group Partners upon its purchase by Pro-ficiency in June of 2023. Sandra Suarez-Sharp, Ph.D., will transition to President, Regulatory Strategies Center of Excellence. Dr. Suarez-Sharp joined Simulations Plus in 2020 and has been instrumental in facilitating the Company’s regulatory support to clients. Prior to joining Simulations Plus, Dr. Suarez-Sharp had a long and successful career at the Food and Drug Administration, including roles in biopharmaceutics, bioequivalence, and clinical pharmacology. In her new role, she is responsible for expanding the Regulatory Strategies Center of Excellence to accelerate cross-selling opportunities driven by the rapidly growing demand for biosimulation solutions. The Company also announced the following departures: Brett Howell, Ph.D., President, Quantitative Systems Pharmacology and Michael Raymer, President, Clinical Simulations & Medical Communications will be leaving Simulations Plus after assisting with the transition process. O’Connor concluded: “We are grateful for Dr. Howell’s leadership and contributions to the Company. Under his guidance, our QSP business has achieved remarkable milestones since the acquisition of DILIsym in 2017. In addition, Mr. Raymer played an instrumental role in the acquisition and initial integration of Pro-ficiency. We wish both of them all the best in their future endeavors.” About Simulations Plus With more than 25 years of experience serving clients globally, Simulations Plus stands as a premier provider in the Biopharma sector, offering advanced software and consulting services that enhance drug discovery, development, research, clinical trial operations, regulatory submissions, and commercialization. Our comprehensive biosimulation solutions integrate artificial intelligence/machine learning (AI/ML), physiologically based pharmacokinetics, physiologically based biopharmaceutics, quantitative systems pharmacology/toxicology, and population PK/PD modeling approaches. We also deliver simulation- enabled performance and intelligence solutions alongside medical communications support for clinical and commercial drug development. Our cutting-edge technology is licensed and utilized by leading pharmaceutical, biotechnology, and regulatory agencies worldwide. For more information, visit our website at www.simulations-plus.com. Follow us on LinkedIn | X | YouTube. Environmental, Social, and Governance We focus our Environmental, Social, and Governance (ESG) efforts where we can have the most positive impact. To learn more about our latest initiatives and priorities, please visit our website to read our 2023 ESG update. Forward-Looking Statements Except for historical information, the matters discussed in this press release are forward-looking statements

that involve risks and uncertainties. Words like “believe,” “expect,” and “anticipate” mean that these are our best estimates as of this writing, but there can be no assurances that expected or anticipated results or events will actually take place, so our actual future results could differ significantly from those statements. Factors that could cause or contribute to such differences include, but are not limited to: our ability to successfully integrate the Pro-ficiency business with our own, as well as expenses we may incur in connection therewith, the efficiency and effectiveness of our internal business restructuring and leadership changes, our ability to maintain our competitive advantages, acceptance of new software and improved versions of our existing software by our customers, the general economics of the pharmaceutical industry, our ability to finance growth, our ability to continue to attract and retain highly qualified technical staff, market conditions, macroeconomic factors, and a sustainable market. Further information on our risk factors is contained in our quarterly and annual reports and filed with the U.S. Securities and Exchange Commission. Investor Relations Contacts: Lisa Fortuna Financial Profiles 310-622-8251 slp@finprofiles.com Renee Bouche Simulations Plus Investor Relations 661-723-7723 renee.bouche@simulations-plus.com

Cover	Aug. 23, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Aug. 23, 2024
Entity Registrant Name	Simulations Plus, Inc.
Entity Central Index Key	0001023459
Entity Incorporation, State or Country Code	CA
Entity File Number	001-32046
Entity Tax Identification Number	95-4595609
Entity Address, Address Line One	42505 10th Street West
Entity Address, City or Town	Lancaster
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	93534-7059
City Area Code	661
Local Phone Number	723-7723
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, par value $0.001 per share
Trading Symbol	SLP
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false