Item 1.01 Entry into a Material Definitive Agreement.
Acquisition of Worldwide Rights in Proleukin® (aldesleukin)
On January 23, 2023, Iovance Biotherapeutics, Inc. (the "Company") and its newly
formed, wholly owned subsidiary, Iovance Biotherapeutics UK Ltd ("Purchaser"),
entered into an Option Agreement (the "Agreement") with Clinigen Holdings
Limited, Clinigen Healthcare Limited, and Clinigen, Inc. (collectively, the
"Sellers"), pursuant to which Purchaser will acquire the worldwide rights in
Proleukin® (aldesleukin) (the "Product"), as well as the manufacturing, supply,
commercialization and the generation of income from such rights and associated
operations from the Sellers (the "Acquisition").
Material terms of the Agreement include an upfront payment of £167.7 million (or
approximately $200 million), a £41.7 million (or approximately $50 million)
milestone payment upon first approval of lifileucel in advanced melanoma, and
deferred consideration based on double digit rates on global net sales (as
defined therein) payable from the Company to Sellers following the completion of
the transaction for the applicable deferred consideration term.
The Company is financing the Acquisition with existing cash. As of January 20,
2023, the Company's unaudited cash position is approximately $477.0 million,
which includes net proceeds from its at-the market (ATM) equity financing
facility of approximately $227.1 million raised during the fourth quarter of
2022 and early 2023.
Subject to the terms and conditions of the Agreement, the Sellers granted
Purchaser a call option to purchase (x) all issued and outstanding shares of
Clinigen SP Limited ("Target") (the "Shares"), (y) the business of the Target
and the Sellers comprising the manufacturing, supply, commercialization and the
generation of income from the Product rights and the undertaking of an active
role in the development, maintenance and exploitation of those rights (the
"Operations"), and (z) certain specified assets identified in the Agreement (the
"Assets" and, together with the Shares and the Operations, the "Business") and
Purchaser granted Sellers a put option to sell the Business.
The Agreement contains customary representations and warranties of a transaction
of this type by each of the parties. These representations and warranties were
made solely for the benefit of the parties to the Agreement and:
· should not be treated as categorical statements of fact, but rather as a way of
allocating the risk to one of the parties if those statements prove to be
inaccurate;
· may have been qualified by disclosures that were made to the other party in
connection with the negotiation of the Agreement;
· may apply contractual standards of "materiality" that are different from
"materiality" under applicable securities laws;
· were made only as of the date of the Merger Agreement or such other date or
dates as may be specified in the Agreement; and
· information concerning the subject matter of such representations and
warranties may change after the date of the Agreement, which subsequent
information may or may not be fully reflected in public disclosures.
The Agreement is subject to customary termination provisions, and the Company
would be required to pay to the Sellers a reverse termination fee (less certain
transaction fees and expenses incurred by the Company) upon certain events as
described in the Agreement.
The Company has provided the Sellers with a parent guarantee in favor of the
Sellers, which guarantees that Purchaser will promptly fulfill all its
obligations under the Agreement, subject to the conditions set forth in the
Agreement.
The Acquisition is expected to close in the first quarter of 2023, subject to
required regulatory approvals and clearances and other customary closing
conditions.
The foregoing description of the Agreement does not purport to be complete and
is qualified in its entirety by reference to the complete terms and conditions
of the Agreement, a copy of which will be filed by amendment on Form 8-K/A to
this Current Report or as an exhibit with the next periodic report.
In addition, the Company has agreed to non-binding terms related to a proposed
secured line of credit of up to $100.0 million from Quogue Capital LLC (the
"Line of Credit"). The Line of Credit provides for an interest rate equal to the
Secured Overnight Financing Rate (SOFR) plus 8.50% with a floor of 12.5%, a
5-year maturity, a facility fee equal to $3,000,000, first priority security
interest, and reimbursement for reasonable and documented fees and expenses.
There will be no conversion features, nor any equity related thereto. The Line
of Credit is non-binding, and it remains subject to the execution of a
definitive agreement with customary provisions and customary closing conditions.
Additional terms will be disclosed if and when the parties execute a definitive
agreement. Wayne Rothbaum, a director of the Company, is the sole owner and
managing member of Quogue Capital LLC. Mr. Rothbaum recused himself from the
Company's Board of Directors (the "Board") deliberations related to the Line of
Credit. All of disinterested directors present at the Board meeting reviewed the
terms with outside counsel and the Company's financial advisor, and the
disinterested directors and the Audit Committee of the Board will approve the
definitive agreement, subject to their final review and approval of a binding
agreement.
The foregoing description of the Line of Credit does not purport to be complete
and is qualified in its entirety by reference to the complete terms and
conditions of the Line of Credit, a copy of which will be filed by amendment on
Form 8-K/A to this Current Report or as an exhibit with the next periodic
report.
Item 8.01 Other Events.
On January 23, 2023, the Company issued a press release announcing the
Acquisition and announcing certain other corporate and clinical updates. A copy
of the press release is attached hereto as Exhibit 99.1 and incorporated herein
by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. Description
99.1 Press Release of Iovance Biotherapeutics, Inc., dated January 23,
2023.
104 Cover Page Interactive Data File (embedded within the Inline XBRL
document).
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