Clovis Oncology, Inc. (NASDAQ:CLVS) Files An 8-K Unregistered Sales of Equity Securities
Item3.02
| Unregistered Sales of Equity Securities. |
The information set forth in Item 8.01 below is incorporated by
reference into this Item 3.02.
Clovis Oncology, Inc. (the Company) anticipates that the
Settlement Shares (as defined below) will be issued in a
transaction that is exempt from the registration requirements of
the Securities Act of 1933, as amended (the Securities Act), to
Section3(a)(10) of the Securities Act. The terms and conditions
of the issuance of the Settlement Shares are subject to approval
by the United States District Court for the District of Colorado,
to a hearing concerning the fairness of such terms and conditions
at which all persons to whom the Settlement Shares would be
issued, following the receipt of adequate notice, are permitted
to attend. The Settlement Shares are expected to be listed on
NASDAQ.
| Item8.01 | Other Events. |
On June18, 2017, the Company entered into a stipulation and
agreement of settlement that is intended to settle the previously
disclosed consolidated purported class action litigation
captioned Medina v. Clovis Oncology, Inc., et. al., No.
1:15-cv-02546 (the ClassAction) against the Company and certain
of its officers and underwriters pending in the United States
District Court for the District of Colorado (the Court). As
previously disclosed, the ClassAction, which was filed on behalf
of a putative class of purchasers of the Companys securities (the
Class), alleges that the Company and certain of its officers and
underwriters violated federal securities laws by making allegedly
false and misleading statements regarding the progress toward FDA
approval and the potential for market success of rociletinib. The
ClassAction is more fully described in the Companys Quarterly
Report on Form 10-Q for the period ended March31, 2017.
Under the terms of the proposed settlement, the Classwill receive
total consideration of approximately $142.0million, comprised of
$25.0million in cash and the issuance by the Company of a to be
determined number of shares of its common stock (the Settlement
Shares) equal to $117.0million divided by the volume weighted
average price of the Companys common stock over the 10 trading
days immediately preceding the date of the hearing set by the
Court to consider the final approval of the settlement. The cash
portion of the consideration is expected to be funded by the
Companys insurance carriers. Following such payment, the Company
will not receive any further significant contributions from its
insurance carriers for the reimbursement of legal expenses
expended on the finalization of the ClassAction settlement or any
amounts (including damages, settlement costs or legal fees)
related to the other pending litigations and inquiries relating
to the Companys regulatory update announcement in November 2015
that the FDA requested additional clinical data on the efficacy
and safety of rociletinib (other than certain damages or
settlement costs related to the pending derivative actions
described below).
In connection with the proposed settlement, the Company expects
to record a charge to earnings and a liability in the second
quarter of 2017 in the amount of approximately $142.0million and
a receivable of approximately $25.0million from the insurance
carriers. The Company will issue the Settlement Shares no later
than 5 business days after the date the judgment is entered by
the Court approving the settlement.
The proposed settlement contains no admission of wrongdoing. The
Company has always maintained and continues to believe that it
did not engage in any wrongdoing or otherwise commit any
violation of federal or state securities laws or other laws.
Upon the effectiveness of the proposed settlement, the Company
and its directors and officers as well as the other defendants
named in the Class Action will be released from the claims that
were asserted or could have been asserted in the Class Action by
Classmembers participating in the settlement. The proposed
settlement is subject to the confirmatory diligence by lead
counsel for the Class, the completion of final documentation,
preliminary and final Court approval, funding of the $25.0million
in cash by the Companys insurance carriers, the issuance of the
Settlement Shares and other customary closing conditions.
Further, the Company has the right to terminate the settlement if
Classmembers timely and validly requesting exclusion from the
Classmeet the conditions set forth in a confidential supplemental
agreement with the lead plaintiff. There can be no assurance that
the settlement will be finalized and approved and, even if
approved, whether the conditions to closing will be satisfied,
and the actual outcome of this matter may differ materially from
the terms of the settlement described herein.
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All other litigation described in the Companys Quarterly Report
on Form 10-Q for
the period ended March31, 2017, including, without limitation,
the Electrical Workers, Antipodean, Macalinao, McKenry, and Guo
complaints, remains pending and the Company continues to
vigorously defend against the allegations in those actions, but
there can be no assurance that the defenses will be successful.
In addition, on May10, 2017, John Solak, a purported shareholder
of the Company, filed a derivative complaint in the Delaware
Court of Chancery, alleging that the defendants breached their
fiduciary duties by adopting a compensation plan that
overcompensates the non-employee directors of the Company. The
Company intends to vigorously defend against the allegations in
the Solak complaint, but there can be no assurance that the
defense will be successful.
In addition, the
Company has received inquiries and requests for information from
governmental agencies, including the U.S. Securities and Exchange
Commission and the U.S. Department of Justice, relating to the
Companys regulatory update announcement in November 2015 that the
FDA requested additional clinical data on the efficacy and safety
of rociletinib. TheCompany is continuing to cooperate with these
agencieswith respect to their investigations. Theproposed
settlement does not resolve these inquiries and the Company
cannot predict their timing or outcome.
The
information in this report relating to the prospective resolution
of the putative class action consolidated complaint are
forward-looking statements reflecting the current beliefs and
expectations of management made to the safe harbor provisions of
the Private Securities Litigation Reform Act of 1995. These
statements involve substantial risks and uncertainties,
including, among others, risks and uncertainties associated with
obtaining court approval of the proposed settlement, the number
of plaintiffs who may opt-out of the proposed settlement, whether
any proposed settlement is appealed, and the outcome of the
ongoing inquiries from the U.S. Securities and Exchange
Commission and the U.S. Department of Justice. The Company
undertakes no obligation to update or revise any forward-looking
statements. For a further description of the risks and
uncertainties relating to the business of the Company in general,
see the Companys filings with the Securities and Exchange
Commission, including the Companys Annual Report on Form 10-K and
Quarterly Reports on Form 10-Q.
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About Clovis Oncology, Inc. (NASDAQ:CLVS)
Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing and commercializing anti-cancer agents in the United States, Europe and other international markets. The Company is developing approximately three product candidates: Rociletinib, Rucaparib and Lucitanib. Rociletinib is an oral epidermal growth factor receptor (EGFR), mutant-selective covalent inhibitor that is under review with the United States and European regulatory authorities for the treatment of non-small cell lung cancer (NSCLC) in patients with activating EGFR mutations, as well as the resistance mutation, T790M. Rucaparib is an oral inhibitor of poly (ADP-ribose) polymerase (PARP) that is in advanced clinical development for the treatment of ovarian cancer. Lucitanib is an oral inhibitor of the tyrosine kinase activity of vascular endothelial growth factor receptors 1-3 (VEGFR1-3) and platelet-derived growth factor receptors alpha and beta (PDGFR a/b).