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Life Sciences Company Settles Regulation FD Charges With SEC

On August 20, 2019, the US Securities and Exchange Commission (SEC) charged TherapeuticsMD Inc., a Boca Raton, Florida, headquartered life sciences company, with violations of Regulation FD for sharing material, non-public information with sell-side analysts about the company’s interactions with the US Food and Drug Administration (FDA). While neither admitting nor denying the SEC charges, the company settled by paying a fine of $200,000. The settlement demonstrates the importance of companies having an established Regulation FD policy and ensuring that employees are adequately trained in complying with such a policy.

IN DEPTH


Regulation FD prohibits public companies, or persons acting on their behalf, from selectively disclosing material, non-public information to certain persons outside the company. In the TherapeuticsMD matter, the SEC charged the company with two separate violations of Regulation FD for selectively disclosing details about a meeting between the company and the FDA regarding a drug candidate for which the company had previously filed a New Drug Application (NDA).

On June 14, 2017, the company met with the FDA to discuss safety concerns related to the drug candidate subject to the NDA; the company had previously publicly disclosed the FDA meeting. On June 15, the company sent emails to sell-side analysts describing the meeting as “very positive and productive,” had follow up calls with certain analysts to discuss the meeting, and, in a follow-up email to one analyst, indicated that the company was “pleasantly surprised at how accommodating” the FDA officials were. On June 16, the company’s stock price increased 19.4% on heavy volume. Market watch officials from the New York Stock Exchange (NYSE) contacted the company, but the executives with whom they spoke did not know of the emails sent to analysts the prior day, believed that market events could have caused the volatility in the company’s stock price, and told the NYSE officials that they were not aware of any material information affecting the stock.

On July 17, 2017, the company issued a press release and filed a Form 8-K prior to market open following receipt from the FDA of the June 14 meeting minutes, indicating that the company had been able to present “new information” to the FDA at the meeting to address safety concerns raised by the FDA and to “positively affect” the status of the NDA, but that the company did not have a clear path forward regarding the NDA. The company’s stock price fell approximately 16% in pre-market and early trading, prompting questions from sell-side analysts as to what the press release meant. At a pre-scheduled 7:30 am conference call with sell-side analysts, the company discussed the new information provided to the FDA during the meeting, which consisted of three previously published medical studies and one long-term National Institutes of Health study, the results of which had not yet been published. The three published studies were emailed to analysts along with a statement by the company’s chief medical officer indicating that, based on the findings in the studies, the drug candidate “posed no safety risk.” After the call, the sell-side analysts published notes conveying information about the studies provided to the FDA and the finding of no safety risks related to the drug candidate, leading to a rise in the company’s stock price, which finished down only 6.6% by market close.

The SEC found that the disclosures to the sell-side analysts on June 14 and July 17 were each instances of providing material, non-public information, and, because the company failed to simultaneously or promptly publicly disclose that information, that such disclosures constituted violations of Regulation FD. Furthermore, the SEC noted that the company did not have a policy in place with respect to Regulation FD disclosure. The company subsequently implemented such a policy, however, and this remedial action was considered in connection with the settlement.

The settlement offers some important lessons for companies.

  • While a company might conclude that neither a statement as to “the positive and productive” nature of a meeting with a regulatory agency nor granular information on specific studies or information provided to a regulatory agency warrants public disclosure, providing different information to the public and to sell-side analysts can potentially constitute a Reg FD violation.

  • It is important for companies not to share any material, non-public information, or information that may be construed as such, with sell-side analysts and others who do not have a “need to know.” Shared information is evaluated with the benefit of hindsight, and a seemingly innocuous statement might lead to significant movements in stock price, triggering the scrutiny of the SEC, the stock exchanges or other regulators.

  • While a company should always be vigilant of its communications, at critical inflection points such as FDA meetings, trial commencement and the public release of results—each of which spark interest in analysts and investors alike—there is an increased likelihood of Regulation FD violations occurring due to the tendency of such events to affect stock prices.

  • To the extent that a company does not already have a Regulation FD or communications policy in place, it should consider developing such a policy, including relevant disclosure controls, and provide training on the policy to all relevant employees.

  • Companies should expect to be contacted by the stock exchanges, FINRA or the SEC if there is unusual trading activity in the company’s stock, and should be prepared to respond to the question of whether the company is aware of any material information affecting the stock. Because all team members will not necessarily have access to the same information, a coordinated response is important, and appropriate internal inquiries should be made before answering.

  • Although not subject to Regulation FD, foreign private issuers should nevertheless comply with Regulation FD as a corporate governance matter and to avoid liability for potential selective disclosures under the anti-fraud provisions of the securities laws.

© 2020 McDermott Will & EmeryNational Law Review, Volume IX, Number 247

TRENDING LEGAL ANALYSIS


About this Author

Thomas P. Conaghan, Mcdermott Will Emery law Firm,  (M&A), joint ventures, strategic investments, spin-offs,
Partner

Thomas P. Conaghan is a partner in the law firm of McDermott Will & Emery and is based in the Firm’s Washington, D.C., office.  Tom represents both publicly held and closely held businesses, underwriters and other sources of capital, corporate boards and board committees and corporate executives.  He advises both U.S. and foreign-based public companies on issues relating to public and private offerings of securities, disclosure, periodic reporting, corporate governance, executive compensation, the rules of the New York Stock Exchange and the Nasdaq Stock Market and compliance with the...

202-756-8161
Partner

Gary Emmanuel is a partner in the law firm of McDermott Will & Emery and is based in the Firm’s New York office. He focuses his practice on corporate securities matters.

With over 15 years of experience, Gary represents both domestic and foreign companies that are navigating the process of capital raising including initial public offerings, registered direct offerings, follow-on offerings, private placements, PIPEs and bridge financings. Gary has worked extensively with biotechnology and other life science companies, both as company counsel and as underwriter’s counsel. 

He advises companies on issues relating to disclosure, periodic reporting, corporate governance, American Depositary Receipt (ADR) programs, and the rules of the NYSE MKT, NYSE and Nasdaq. He also counsels companies in a wide variety of corporate transactions including licensing, reverse mergers, acquisitions and joint ventures.

212 547 5541
Eric Orsic, corporate, securities, attorney, McDermott Will, law firm
Partner

Eric Orsic is a partner in the law firm of McDermott Will & Emery LLP and is based in the Firm’s Chicago office. Eric focuses his practice in the areas of mergers and acquisitions, and securities transactions and compliance.   Eric works with both public and privately-held companies to structure and negotiate business acquisitions/dispositions.  His public company transactional experience includes public equity and debt offerings, tender offers and going-private transactions.  Eric also serves as outside securities counsel to several public companies and advises on SEC compliance...

312-984-7617
Mark S. Selinger, McDermott Will Emery Law Firm, Corporate Attorney
Partner

Mark Selinger is a partner in the law firm of McDermott Will & Emery LLP and is based in the Firm’s New York office.  Mark focuses his practice on two areas:  the representation of private equity funds and family offices in all aspects of their business, including initial and follow-on investments, workouts and exit transactions; and the representation of public and private U.S. and Israeli technology companies, in public offering, private placement and merger and acquisition transactions.

In his representation of private equity ...

212-547-5438
Partner

Ze’-ev D. Eiger focuses his practice on securities and capital markets for both foreign and domestic companies. He represents issuers, investment banks/financial intermediaries, and investors in financing transactions, including initial public offerings, follow-on offerings and private placements of equity and debt securities. Ze’-ev has extensive experience working with a wide range of issuers, including biotechnology/health care companies, technology companies, startups, real estate investment trusts (REITs), business development companies (BDCs) and closed and open-end funds.

Ze...

212-547-5470