Case 3:21-cv-01019-BAS-MSB Document 11 Filed 03/28/22 PageID.167 Page 1 of 61
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`David E. Bower (SBN 119546)
`MONTEVERDE & ASSOCIATES PC
`600 Corporate Pointe, Suite 1170
`Culver City, CA 90230
`Tel: (213) 446-6652
`Fax: (212) 202-7880
`dbower@monteverdelaw.com
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`Lead Counsel for Lead Plaintiffs and the Putative Class
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`UNITED STATES DISTRICT COURT
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`SOUTHERN DISTRICT OF CALIFORNIA
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` Case No. 3:21-cv-01019-BAS-MSB
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`FIRST AMENDED CLASS ACTION
`COMPLAINT
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`DEMAND FOR JURY TRIAL
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`KURT ZIEGLER and DANIEL BRADY,
`on Behalf of Themselves and All Others
`Similarly Situated,
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`Plaintiffs,
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`v.
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`GW PHARMACEUTICALS, PLC,
`JUSTIN GOVER, GEOFFREY GUY,
`CABOT BROWN, DAVID GRYSKA,
`CATHERINE MACKEY, JAMES
`NOBLE, ALICIA SECOR, and LORD
`WILLIAM WALDEGRAVE,
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`Defendants.
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`Lead Plaintiffs Kurt Ziegler and Daniel Brady (together, “Plaintiffs”), by their
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`undersigned attorneys, allege upon personal knowledge with respect to themselves,
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`and upon information and belief based upon, inter alia, the investigation of counsel
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`as to all other allegations herein, as follows:
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`FIRST AMENDED CLASS ACTION COMPLAINT
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`Case 3:21-cv-01019-BAS-MSB Document 11 Filed 03/28/22 PageID.168 Page 2 of 61
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`NATURE OF THE ACTION
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`This action is brought as a class action by Plaintiffs on behalf of
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`themselves and the other former public holders GW Pharmaceuticals, PLC (“GW” or
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`the “Company”) against GW and GW’s former executive officers and/or members of
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`its board of directors (collectively referred to as the “Board” or the “Individual
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`Defendants” and, together with GW, the “Defendants”) for their violations of Sections
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`14(a) and 20(a) of the Securities Exchange Act of 1934 (“Exchange Act”), 15 U.S.C.
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`§§ 78n(a), 78t(a), and SEC Rule 14a-9, 17 C.F.R. § 240.14a-9. Plaintiffs’ claims arise
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`in connection with the acquisition (the “Merger”) of GW by Jazz Pharmaceuticals,
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`PLC and its subsidiaries (“Jazz”).
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`2.
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`On February 3, 2021, GW entered into an agreement and plan of merger
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`pursuant to which Jazz acquired GW and the holders of GW American Depositary
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`Shares1 (“GW shareholders”) had their holdings extinguished in exchange for $200 in
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`cash and $20 in Jazz stock (0.120360 shares) for each GW ADS they owned (the
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`“Merger Consideration”). Despite knowing that the Merger Consideration grossly
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`undervalued the Company, Defendant Geoffrey W. Guy (founder, Executive
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`Chairman, and Chairman of the Board of his namesake GW) sought an exit from the
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`responsibility of running a public Company and wanted to free up time and money to
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`begin work on his latest project. So, when Jazz offered to acquire GW during the
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`pandemic in late 2020, it was perfect timing and he pounced on the opportunity to
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`cash out. Using his powerful influence over his handpicked Board, he authorized
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`nearly $100 million dollars in change in control payments for Company management
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`and steered GW towards a sale.
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`1 An American Depository Share ("ADS") represents an ownership interest in a
`foreign deposited security (much like a share of stock represents an ownership interest
`in a corporation) that has been deposited with a depository, such as a United States
`bank or trust company. ADSs are traded in the United States in much the same way
`as equity securities issued by domestic companies.
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`FIRST AMENDED CLASS ACTION COMPLAINT
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`Case 3:21-cv-01019-BAS-MSB Document 11 Filed 03/28/22 PageID.169 Page 3 of 61
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`3.
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`On March 15, 2021, to convince GW shareholders to vote in favor of the
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`unfair Merger, Defendants caused a materially false and misleading Definitive Proxy
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`Statement (as amended and supplemented, the “Proxy”), to be filed with the SEC and
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`disseminated to GW shareholders. As set forth below, the Proxy was materially false
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`and misleading with respect to GW’s operations and financial projections, the value
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`of GW shareholders’ stock, and the fairness of the Merger Consideration.
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`The Proxy provided a materially false and misleading valuation picture
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`of GW by disseminating unreasonably low financial projections for 2021-2035 (the
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`“December Projections”), which were used to frame the Merger Consideration as
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`“fair.” In reality, the Merger Consideration significantly undercompensated GW
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`shareholders and provided them with substantially less than the fair value of their
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`holdings.
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`The changes made to, and the numbers reflected in, the December
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`Projections are entirely unreasonable, disconnected from the reality of GW’s business
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`operations, contradicted by contemporaneous statements made by the Company and
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`its executive officers, and reflect just a fraction of the actual value of the Company.
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`6.
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`The December Projections were created solely for use by GW’s financial
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`advisors, Goldman Sachs & Co. LLC (“Goldman Sachs”) and Centerview Partners
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`LLC (“Centerview” and together with Goldman Sachs, the “Financial Advisors”), to
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`perform the valuation analyses underlying their fairness opinions—which were then
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`summarized in the Proxy to convince GW shareholders the Merger Consideration was
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`fair. Without the December Projections, which Defendants authorized Goldman Sachs
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`and Centerview to use despite knowing that the December Projections did not
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`accurately reflect the Company’s long-term financial prospects and value, the
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`Financial Advisors would have been unable to issue fairness opinions, Defendants
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`would have been unable to claim that the Merger Consideration provided shareholders
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`FIRST AMENDED CLASS ACTION COMPLAINT
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`with fair value for their holdings, and the Financial Advisors would have been forced
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`to forego the $72 million in fees they received.
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`As set forth below, (i) the pretextual stated changes purportedly
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`justifying the slashes to the December Projections, (ii) the statements in the Proxy
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`conveying that the December Projections and their underlying assumptions were
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`“reasonably prepared” and reflected the Company’s “best currently available
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`estimates,” and (iii) the present value per GW ADS ranges that were predicated on the
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`downward manipulated December Projections misled GW shareholders about the fair
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`value of their ADSs, causing them to vote in favor of the Merger and accept the unfair
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`Merger Consideration.
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`The Merger closed on May 5, 2021, and GW ADSs were surrendered via
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`the Merger in exchange for $200 in cash and 0.120360 Jazz ordinary shares per each
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`ADS. Notably, cash was provided in lieu of any fractional amount of Jazz stock
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`owned. Accordingly, only owners of at least 9 ADSs were allowed to keep at least 1
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`share of Jazz stock and maintain any continued ownership interest in the Company.
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`9.
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`For these reasons and as set forth in detail herein, Defendants violated
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`Sections 14(a) and 20(a) of the Exchange Act. Plaintiffs seek to recover damages
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`resulting from Defendants’ violations of the Exchange Act.
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`JURISDICTION AND VENUE
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`10. This Court has original jurisdiction over this action pursuant to Section
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`27 of the Exchange Act (15 U.S.C. § 78aa) and 28 U.S.C. § 1331 (federal question
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`jurisdiction) as Plaintiffs allege violations of Sections 14(a) and 20(a) of the Exchange
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`Act.
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`11. Personal jurisdiction exists over each Defendant either because the
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`Defendant conducted business in or maintained operations in this District, or is an
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`individual who is either present in this District for jurisdictional purposes or has
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`sufficient minimum contacts with this District as to render the exercise of jurisdiction
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`FIRST AMENDED CLASS ACTION COMPLAINT
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`over the Defendant by this Court permissible under traditional notions of fair play and
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`substantial justice.
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`12. Venue is proper in this District under Section 27 of the Exchange Act, 15
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`U.S.C. § 78aa, as well as pursuant to 28 U.S.C. § 1391, because: (i) the conduct at
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`issue took place and had an effect in this District; (ii) GW maintained its US
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`headquarters in this District and each of the Individual Defendants, Company officers
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`and/or directors, either reside in this District or have extensive contacts within this
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`District; (iii) a substantial portion of the Merger and wrongs complained of herein
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`occurred in this District; (iv) relevant documents pertaining to Plaintiffs’ claims are
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`stored (electronically and otherwise), and evidence exists, in this District; and (v)
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`Defendants have received substantial compensation in this District by doing business
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`here and engaging in numerous activities that had an effect in this District.
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`PARTIES
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`13. Plaintiff Kurt Ziegler was a holder of GW ADSs at all relevant times.
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`14. Plaintiff Daniel Brady was a holder of GW ADSs at all relevant times.
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`15. Defendant GW is a company that was incorporated in the United
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`Kingdom. The Company maintained its U.S. headquarters and an administrative office
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`in Carlsbad, California. The Company’s U.S. subsidiary, Greenwich Biosciences, Inc.
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`was also located in Carlsbad, California. Prior to the Merger, the Company’s ADSs
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`traded on the Nasdaq stock exchange under the ticker symbol “GWPH”.
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`16.
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`Individual Defendant Geoffrey W. Guy was GW’s Executive Chairman
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`and Chairman of GW’s Board. He founded the eponymous GW Pharmaceuticals in
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`1998 shortly after being removed from control of his first two companies in late 1997.
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`He spent the next several months securing a license from the UK Home Office to grow
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`and supply cannabis for the research and development of medicine and GW was off
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`to the races. Learning from the experience of his previous companies, Defendant Guy
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`surrounded himself at GW with those he could control. When Jazz made its initial
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`FIRST AMENDED CLASS ACTION COMPLAINT
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`Case 3:21-cv-01019-BAS-MSB Document 11 Filed 03/28/22 PageID.172 Page 6 of 61
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`offer in July 2020, Defendant Guy was ready to exit the Company, and so the
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`Company was sold.
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`Individual Defendant Justin Gover was both GW’s Chief Executive
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`Officer and a director on GW’s Board. He has known and worked for Defendant Guy
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`for nearly 30 years. He grew from being Defendant Guy’s assistant at their first
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`Company, Ethical Pharmaceuticals, to exiting his position as GW CEO in the Merger
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`with a $40 million payday. When GW went public in 2013, and Defendant Guy needed
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`someone he could trust to run the day-to-day operations of a US publicly traded
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`company, he advanced Defendant Gover from Managing Director to CEO.
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`18.
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`Individual Defendant Cabot Brown was a non-executive director of the
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`Company since its IPO. Defendant Brown has a close and longstanding relationship
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`with Defendant Guy that spans a quarter of a century. When GW went public in 2013,
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`and Defendant Guy needed someone he could trust to support him, he named
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`Defendant Brown to GW’s Board of Directors.
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`Individual Defendant David Gryska was, at all relevant times, a non-
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`executive director of the Company. Defendant Gryska is the least tenured member of
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`the Board and was appointed unilaterally by the existing Board (with no outside
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`shareholder approval) in September 2020 specifically for his experience in strategic
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`transactions.
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`Individual Defendant Catherine Mackey was, at all relevant times, a non-
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`executive director of the Company. Defendant Mackey was unilaterally appointed to
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`the GW Board in 2017 when the Company still operated as a foreign private issuer
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`and was not subject to US proxy rules and regulations.
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`Individual Defendant James Noble was, at all relevant times, a non-
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`executive director of the Company. Defendant Noble has a longstanding relationship
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`with Defendant Guy and was one of the three initial non-executive directors appointed
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`to the Board when GW went public in 2013.
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`FIRST AMENDED CLASS ACTION COMPLAINT
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`22.
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`Individual Defendant Alicia Secor was, at all relevant times, a non-
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`executive director of the Company. Defendant Secor was unilaterally appointed to the
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`GW Board in 2017 when the Company still operated as a foreign private issuer and
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`was not subject to US proxy rules and regulations.
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`23.
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`Individual Defendant William Waldegrave was, at all relevant times, a
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`non-executive director of the Company. Defendant Waldegrave was unilaterally
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`appointed to the GW Board in 2017 when the Company still operated as a foreign
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`private issuer and was not subject to US proxy rules and regulations.
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`24. The Individual Defendants referred to in ¶¶ 16-23 are collectively
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`referred to herein as the “Individual Defendants” and/or the “Board”, and together
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`with GW they are referred to herein as the “Defendants”.
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`RELEVANT NON-PARTIES
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`Jazz, a public limited company incorporated in the Republic of Ireland,
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`is a global biopharmaceutical company dedicated to developing and commercializing
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`medicines, with a focus in neuroscience, including sleep and movement disorders, and
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`in oncology, including hematologic malignancies and solid tumors. The Company’s
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`corporate headquarters are located in Dublin, Ireland, with U.S. operations located in
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`Palo Alto, California and Philadelphia, Pennsylvania. Jazz ordinary shares are listed
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`on Nasdaq stock exchange under the ticker symbol “JAZZ”.
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`26. Goldman Sachs & Co. LLC (“Goldman Sachs”) is a well-known
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`investment bank, with a history of serving as GW’s investment banker, and was hired
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`as a financial advisor to the GW Board for the purposes of completing the Merger.
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`For acting as financial advisor to the GW Board, Goldman Sachs was paid $36 million
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`wholly contingent upon GW executing a merger agreement and/or the consummation
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`of the Merger. Specifically, $1.5 million of the $36 million was payable upon the
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`announcement of the Merger and the remaining $34.5 million was contingent on GW
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`shareholders approving the Merger and the consummation of the Merger. Notably,
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`FIRST AMENDED CLASS ACTION COMPLAINT
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`Case 3:21-cv-01019-BAS-MSB Document 11 Filed 03/28/22 PageID.174 Page 8 of 61
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`after GW’s announcement of its blockbuster development plans for its drug product
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`Sativex/nabiximols and GW’s strong Second Quarter 2020 financial results, Goldman
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`Sachs issued a price target for GW of $271 per ADS—but that was before being paid
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`$36 million to provide a fairness opinion of $220 per GW ADS. Finally, at the time
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`of the Merger, Goldman Sachs was a lender to Jazz under its 2018 revolving credit
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`facility. To finance the merger Jazz entered into new debt arrangements, which
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`involved re-financing its existing credit facility. Accordingly, Goldman was set to
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`profit from both sides of the Merger, and was therefore doubly incentivized to push
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`through a deal.
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`27. Centerview Partners LLC (“Centerview”) is a well-known investment
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`bank that served as a financial advisor to the GW Board for the purposes of completing
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`the Merger. For acting as financial advisor to the GW Board, Centerview was paid
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`$36 million wholly contingent upon GW executing a merger agreement and/or the
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`consummation of the Merger. Specifically, $1.5 million of the $36 million was
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`payable upon execution of the merger agreement and the remaining $34.5 million was
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`contingent on GW shareholders approving the Merger and the consummation of the
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`Merger.
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`SUBSTANTIVE ALLEGATIONS
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`I.
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`Background of the Company and the Merger
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`Founding of GW
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`28. Defendant Geoffrey W. Guy founded the eponymous GW in 1998 as a
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`biopharmaceutical
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`focused
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`discovering,
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`developing,
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`and
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`commercializing novel therapeutics from proprietary cannabinoid products in a broad
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`range of disease areas.
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`29. GW was the third biopharmaceutical company founded by Defendant
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`Guy and the second biopharmaceutical company he took public.
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`FIRST AMENDED CLASS ACTION COMPLAINT
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`30.
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`In 1997, the year before GW was founded, Defendant Guy agreed to step
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`down as Chairman of his private company PhytoPharma to allow his public Company,
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`Ethical Pharmaceuticals (“Ethical”), to be able to sell at least some of its controlling
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`position in PhytoPharma. That summer, in anticipation of Ethical’s secondary listing
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`on the London Stock Exchange (Ethical was already trading on the Nasdaq), Ethical
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`took on new outside directors that were more well-known to the UK market. Shortly
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`after the new board members joined Ethical, Defendant Guy faced a coup and was
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`pushed out of both of the companies he founded.
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`31. Defendant Guy learned from his mistakes in allowing outsiders to control
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`his companies. With GW, Defendant Guy made concerted efforts to not repeat those
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`mistakes and to become the man in control of the Board and not the man the Board
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`controlled. When an outside Board became necessary to list GW shares for trade on
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`the Nasdaq as ADSs, Defendant Guy handpicked each member of the Board to stock
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`it with directors beholden to him that would do and vote as instructed.2 Take
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`Defendants Gover and Brown for example.
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`32. Defendant Guy met Defendant Gover in China when the latter was just
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`21 years old. Defendant Guy told Defendant Gover that if he was ever back in London,
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`that Defendant Gover should come work for Defendant Guy. When Defendant Gover
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`returned to London, Defendant Guy hired him as his executive assistant at Ethical
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`following the Nasdaq Listing. The two have known each other for so long that
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`Defendant Guy refers to Defendant Gover as his right-hand man and has said that the
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`2 In fact, none of the Individual Defendants’ initial selection to the Board came via
`open election from the full body of GW shareholders. Defendants Guy, Gover, Brown,
`and Noble were all appointed as directors prior to the initial offering. Defendants
`Mackey, Secor, and Waldegrave were all appointed to the Board in 2017 and ratified
`when GW was still a foreign private issuer that was exempt from compliance with US
`proxy and voting rules and procedures. Finally, Defendant Gryska was only appointed
`in September 2020 specifically for his experience with strategic alternatives and never
`stood for election as a director.
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`FIRST AMENDED CLASS ACTION COMPLAINT
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`two share a very special relationship to the point that it is almost telepathic. So
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`naturally, when GW was going public in 2013—and Defendant Guy, as Chairman
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`would take a step back from control of the day-to-day operations—Defendant Guy
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`elevated his right-hand man from Managing Director to Chief Executive Officer.
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`33. Similarly, Defendant Brown met Defendant Guy in the early 1990s when
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`Defendant Brown helped Defendant Guy enormously in taking Ethical public on the
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`Nasdaq. The two gelled instantly and developed a close relationship. Defendant Guy
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`appreciated that Defendant Brown acknowledged straight away and deferred to
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`Defendant Guy’s understanding of his company. Defendant Guy has even referred to
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`himself and Defendant Brown as fellow musketeers. So naturally, when Defendant
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`Guy needed to bring in outside directors to take his namesake GW public (particularly
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`those with close relationships that would defer to his decision-making), Defendant
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`Guy selected Defendant Brown.
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`GW’s Business and Its Products
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`34. GW was the world’s first pharmaceutical company to commercialize a
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`plant-derived cannabinoid prescription drug and, leading up to the Merger, the
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`Company was the leading player in the medical field for cannabis products. GW has
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`two primary products with current sales, either domestically or internationally, and in
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`the final stages of U.S. Food and Drug Administration (“FDA”) approval: Epidiolex
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`(also known as Epidyolex) and Sativex (also known as nabiximols). GW also has a
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`deep pipeline of additional cannabinoid product candidates and novel compounds in
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`various FDA trial phases and development.
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`35. Epidiolex is a pharmaceutical formulation comprising highly purified
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`plant-derived cannabidiol, or CBD, for which GW retains global commercial rights.
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`GW initially launched Epidiolex in the U.S. in November 2018 for the treatment of
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`seizures associated with Lennox-Gastaut syndrome (“LGS”) and Dravet syndrome for
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`patients two years of age and older. In July 2020, the FDA expanded the approval of
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`Epidiolex, adding a new indication of seizures associated with Tuberous Sclerosis
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`Complex (“TSC”). The FDA also approved the expansion of all existing indications,
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`LGS, Dravet syndrome, and TSC, to patients one year of age and older. LGS and
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`Dravet syndrome are severe childhood-onset, drug-resistant epilepsy syndromes. TSC
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`is a rare genetic disorder that causes non-malignant tumors to form in many different
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`organs and affects approximately 50,000 individuals in the United States and one
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`million worldwide. In the months leading up to the Merger, GW was actively pursuing
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`increasing the scope of Epidiolex both in existing sales to European and other
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`international countries and in growing indications to drastically expand the drug’s
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`addressable market.
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`36. Sativex, the world’s first plant-derived cannabinoid prescription drug, is
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`a complex botanical medicine formulated from extracts of the cannabis plant that
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`contains the principal cannabinoids THC and CBD. The primary focus of Sativex is
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`the treatment of spasticity:
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`Sativex is approved in 25 countries for the treatment of spasticity due to multiple
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`sclerosis (“MS”)—with demonstrated efficacy in multiple positive pivotal trials
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`conducted in Europe.
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`37.
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`In the United States, Sativex (under the name nabiximols) is in Phase III
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`of FDA trials for the treatment of spasticity due to MS, which would have enabled
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`GW to submit a new drug application (“NDA”) with the FDA, potentially as early as
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`the fourth quarter of 2021. MS is the most prevalent inflammatory neurological
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`disease of young adults affecting approximately 1 million people in the United States
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`and over 2 million worldwide, with diagnoses growing at ~2% per year. 80% of MS
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`patients experience spasticity, with 60% experiencing pain. The domestic MS market
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`would provide huge potential for Sativex/nabiximols, where the existing treatments
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`focus almost exclusively on reducing relapses and delaying disease progression, rather
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`than focusing on relieving specific symptoms, such as spasticity.
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`38. However, GW recognized far greater indications for Sativex/nabiximols
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`than MS spasticity. GW had plans, both short and long term, to unlock Sativex’s
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`“blockbuster” revenue potential, including indications for: spinal cord injury (250-
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`500k new cases per year, 80% spasticity, 80% pain); cerebral palsy (over 17 million
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`people worldwide, 70% spasticity); stroke (over 7 million people, 30-80% spasticity,
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`60% pain); traumatic brain injury (over 10 million people, 17-20% spasticity); and
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`post-traumatic stress disorder (“PTSD”) (estimated annualized population prevalence
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`is 1.8% for men and 5.2% for women).
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`39. GW also had a diverse and promising development pipeline for other
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`drug candidates, some of which were already showing strong results in Phase 1 or
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`Phase 2 clinical trials or studies.
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`Events Leading Up to the Merger
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`40.
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`In February 2020, Remuneration Committee of GW’s Board met in the
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`normal course of its business with the Company’s independent compensation
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`Case 3:21-cv-01019-BAS-MSB Document 11 Filed 03/28/22 PageID.179 Page 13 of 61
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`consultant, Anderson Pay Advisors (“Anderson”), to consider the ordinary salary
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`increases to be awarded to Executive Directors and Executive Officers. After
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`assessing and awarding the bonus pool based on the achievement of 2019 calendar
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`year objectives, the Remuneration Committee approved the bonus objectives to be
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`achieved by the Executive Directors during 2020 and agreed to the terms of the 2020
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`equity grants for the Long Term Incentive Plan (“LTIP”) awards to the Directors and
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`Executive Officers.
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`41. On May 11, 2020, GW announced its stellar financial results for the First
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`Quarter 2021, including record revenues of $120.6 million (up 207% year-over-year)
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`that exceeded expectations. Defendant Gover celebrated these results:3
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`In the first quarter of 2020, we have seen continued strength of the
`Epidiolex brand in both the U.S. and Europe and remain confident
`about prospects for growth in the remainder of the year. Having been
`granted priority review by the FDA for our proposed label expansion
`to include TSC, our US commercial team is actively preparing for the
`launch of this indication in August. In this current environment caused
`by COVID-19, we have been able to support the epilepsy community
`remotely and maintain production of Epidiolex, while taking necessary
`steps to maintain the wellbeing of our employees. Looking ahead, GW
`is well placed to emerge strongly from the COVID-19 crisis with
`significant growth prospects for Epidiolex in the US and Europe,
`important pipeline clinical trials ready to execute, a strong balance
`sheet, and an unparalleled leading position in cannabinoid science.
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`42. On the earnings call that followed later that day, Defendant Gover
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`explained how GW was uniquely situated to keep growing during the pandemic:
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`We have not had any interruptions in ensuring that our medicines are
`available to those who rely on them for their daily health and we
`continue to make progress across all areas of the business. We at GW
`control our own manufacture and supply chain, which has proven to be
`very beneficial. This control has not only enabled GW to ensure
`manufacturing continuity, but it has, in fact, allowed us to increase
`Epidiolex production in recent weeks. I will ask Chris to provide more
`detail on the specific actions his team have taken regarding production
`as well as his thoughts on the progress of Epidiolex commercialization
`in Europe later in the call.
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`3 Unless otherwise indicated, all emphasis has been added.
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`Our commercial teams continue to actively interact with clinicians,
`albeit virtually. We are fortunate that going into this COVID-19
`situation, Epidiolex brand awareness was very high among both
`patients and physicians. Our specialty pharmacy model, which features
`direct home delivery for the vast majority of our patients has been in
`place since launch and continues to work well.
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`***
`As you have heard, Epidiolex continues to demonstrate strong
`receptivity in both the U.S. and in Europe. And even in the COVID-19
`environment, we see major growth opportunities in 2020, particularly
`as we expand the products used to include the seizures associated with
`TSC, significantly broadening its overall utility in epilepsy.
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`We continue to believe that Epidiolex has a long commercial life ahead.
`With the addition of another patent last week, we now have 10 patents
`listed in the orange book, and we expect the addition of further LGS,
`DS and TSC patents this year. These patents expire in 2035 and provide
`real confidence in the durability of the brand. In addition to the use
`patents granted and under review, we continue to progress the
`composition patent application process. And while our clinical trials are
`on hold until the current restrictions are sufficiently eased, this is a
`temporary situation, and we continue to expect important pipeline
`progress in 2020. At the forefront of that list is nabiximols, an exciting
`late-stage program for GW in the U.S., for which we expect extended
`exclusivity. We strongly believe that now is the ideal time for this
`product to emerge into the U.S. and believe that it can meet patient
`needs across multiple indications in the coming years. Indeed, we are
`now planning a virtual deep dive for investors and analysts on this
`product, so please look out for further details of this event in the coming
`weeks. I do believe that GW is as well positioned as any company to
`withstand the impact of the COVID-19 situation and to emerge from
`this crisis with real momentum for both Epidiolex and the pipeline.
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`43. And GW’s Chief Medical Officer provided details regarding the
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`Company’s strong pipeline of products both in the near and long term:
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`Regarding our Epidiolex program, I am pleased to report that the FDA
`has accepted our sNDA for the use of Epidiolex to treat seizures
`associated with tuberous sclerosis complex. The FDA has granted
`priority review, which highlights the unmet need for new treatment
`options for patients with TSC, and the PDUFA date has been set for
`July 31, 2020. In Europe, we also submitted a type 2 variation
`application to the European Medicines Agency and recently received
`notice that this filing also has been accepted for their review. If
`approved, Epidiolex will be shown to be effective in treating seizures
`associated with Lennox-Gastaut syndrome, the Dravet syndrome and
`tuberous sclerosis complex, thus confirming the broad antiseizure
`effects of this medicine.
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`***
`As we emerge from COVID-19, I'm excited at the extensive clinical
`program planned for this year. Indeed, by the end of this year, we expect
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`Case 3:21-cv-01019-BAS-MSB Document 11 Filed 03/28/22 PageID.181 Page 15 of 61
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`to be conducting 7 Phase II and 4 Phase III trials as well as 1 Phase IV
`study. We will also be conducting 6 Phase I trials on new pipeline
`products and formulations. Further trials are also in the planning for
`2021.
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`As we look ahead in the next wave of cannabinoid products, it is clear
`that nabiximols is our top priority. Nabiximols offers a near-term route
`to market in the U.S. and is a product for which extensive safety and
`efficacy data already exist and which is already manufactured at
`commercial scale. It i