Menarini Group, a privately held Italian pharmaceutical and
diagnostics company, and Stemline Therapeutics Inc., a
commercial-stage biopharmaceutical company focused on the
development and commercialization of novel oncology therapeutics,
(Nasdaq: STML) today announced a definitive agreement under which
Menarini Group will acquire Stemline in a transaction valued up to
$677 million.
Under the terms of the agreement, a wholly owned subsidiary of
the Menarini Group will commence a tender offer for all outstanding
shares of Stemline, whereby Stemline shareholders will be offered a
total potential consideration of $12.50 per share, consisting of an
upfront payment of $11.50 in cash and one non-tradeable Contingent
Value Right (CVR) that will entitle each holder to an additional
$1.00 in cash per share upon completion of the first sale of
ELZONRIS in any EU5 country after European Commission approval.
Stemline launched ELZONRIS for the treatment of blastic
plasmacytoid dendritic cell neoplasm (BPDCN) in adult and pediatric
patients, two years or older, following the approval by the United
States Food and Drug Administration in December 2018. ELZONRIS is a
novel targeted therapy directed to the interleukin-3 (IL-3)
receptor-α (CD123).
With the support of Menarini’s infrastructure, Stemline will
continue its efforts to develop additional applications of ELZONRIS
to serve the unmet needs of patients suffering from difficult to
treat diseases and cancers. Following its strong U.S. launch of
ELZONRIS, Stemline will benefit from Menarini’s experience in
bringing products to markets in Europe and emerging markets as it
prepares for a successful international launch upon receipt of
regulatory approval in ex-U.S. territories.
Elcin Barker Ergun, CEO of Menarini Group, commented, “Stemline
is an excellent fit for Menarini, enabling us to expand our
presence in the U.S. with an established biopharmaceutical company
focused on developing oncology therapeutics. Through this
acquisition, we will continue to strengthen our portfolio and
pipeline of oncology assets and deliver novel therapies around the
world. We look forward to uniting together with the Stemline team
to advance our shared mission of serving patients.”
Ivan Bergstein, M.D., Chairman, CEO and Founder of Stemline,
said, “Joining Menarini represents a unique opportunity for
Stemline to advance the commercialization of ELZONRIS across the
globe and to accelerate the development of our pipeline of oncology
assets. We have transitioned Stemline over the last several years
into an established commercial-stage operation with a novel
treatment, a growing pipeline and a strong foundation. We are
excited to be combining with a like-minded organization in
Menarini, in a transaction that will deliver immediate and
significant cash value to our shareholders, while also allowing our
shareholders to participate in the future upside of ELZONRIS’s
European launch. We look forward to working closely together on our
unified goal of helping and delivering hope to patients
worldwide.”
Transaction Terms
Under the terms of the agreement, a wholly owned subsidiary of
the Menarini Group will commence a tender offer for all outstanding
shares of Stemline, whereby Stemline shareholders will be offered a
total potential consideration of $12.50 per share, consisting of an
upfront payment of $11.50 per share in cash, along with one
non-tradeable Contingent Value Right (CVR).
Under the terms of the non-tradeable CVR, Stemline shareholders
will be paid an additional $1.00 per share upon completion of the
first sale for use or consumption by the general public of ELZONRIS
in BPDCN in any one of the following countries: United Kingdom,
France, Spain, Germany, or Italy after receiving approval by the
European Commission of a Marketing Authorization Application (MAA),
through the centralized procedure, on or before December 31, 2021.
There can be no assurance such approval or commercialization will
occur or that any contingent payment will be made.
Menarini will acquire any shares of Stemline not tendered into
the tender offer through a second-step merger for the same per
share consideration as will be payable in the tender offer. The
merger will be effected as soon as practicable after the closing of
the tender offer.
The transaction has been unanimously approved by the Boards of
Directors of both companies. Stemline’s Board of Directors
recommends to shareholders of Stemline that they tender their
shares into the tender offer. The transaction is expected to close
in the second quarter of 2020, subject to customary closing
conditions, including the tender of more than 50% of all shares of
Stemline outstanding at the expiration of the offer and receipt of
Hart-Scott-Rodino clearance. The terms and conditions of the tender
offer will be described in the tender offer documents, which will
be filed with the U.S. Securities and Exchange Commission.
Menarini expects to fund the acquisition through existing cash
resources.
Advisors
Goldman Sachs International is acting as exclusive financial
advisor and Fried, Frank, Harris, Shriver & Jacobson LLP is
acting as legal advisor to Menarini. PJT Partners and BofA
Securities are acting as financial advisors and Skadden, Arps,
Slate, Meagher & Flom LLP and Alston & Bird LLP are acting
as legal advisors to Stemline.
About ELZONRIS®
ELZONRIS® (tagraxofusp), a targeted therapy directed to CD123,
is approved by the U.S. Food and Drug Administration (FDA) and
commercially available in the U.S. for the treatment of adult and
pediatric patients, two years or older, with BPDCN. For full
prescribing information in the U.S., visit www.ELZONRIS.com. In
Europe, a marketing authorization application (MAA) is under review
by the European Medicines Agency (EMA).
About BPDCN
BPDCN, formerly blastic NK-cell lymphoma, is an aggressive
hematologic malignancy, often with cutaneous manifestations, with
historically poor outcomes. BPDCN typically presents in the bone
marrow and/or skin and may also involve lymph nodes and viscera.
The BPDCN cell of origin is the plasmacytoid dendritic cell (pDC)
precursor. The diagnosis of BPDCN is based on the immunophenotypic
diagnostic triad of CD123, CD4, and CD56, as well as other markers.
The World Health Organization (WHO) termed this disease “BPDCN” in
2008; previous names included blastic NK cell lymphoma and
agranular CD4+/CD56+ hematodermic neoplasm. For more information,
please visit the BPDCN disease awareness website at
www.bpdcninfo.com.
About Stemline
Stemline Therapeutics, Inc. is a commercial-stage
biopharmaceutical company focused on the development and
commercialization of novel oncology therapeutics. ELZONRIS®
(tagraxofusp), a targeted therapy directed to CD123, is
FDA-approved and commercially available in the U.S. for the
treatment of adult and pediatric patients, two years and older,
with BPDCN. It is the only FDA-approved therapy for BPDCN in the
U.S. In Europe, a marketing authorization application (MAA) is
under review by the European Medicines Agency (EMA). ELZONRIS is
also being evaluated in clinical trials in additional indications
including chronic myelomonocytic leukemia (CMML), myelofibrosis
(MF), acute myeloid leukemia (AML), and additional trials and
indications are planned. For more information, please visit the
company’s website at www.stemline.com.
About Menarini
The Menarini Group is a leading international pharmaceutical
company with a presence in over 100 countries, including a direct
presence in over 70 countries. Its global platform extends
throughout Europe, Central America, Africa, the Middle East and
Asia and generates over $4.2 billion in annual sales. For over 125
years, Menarini has been investing in the development and
commercial distribution of pharmaceuticals to serve patients and
physicians around the world with a full portfolio of products in
the cardiovascular, gastroenterology, metabolic, infectious
diseases and anti-inflammatory/analgesic therapeutic areas.
Menarini is also committed to oncology, with several new
investigational drugs in development for the treatment of a variety
of tumors.
Notice to Investors and Security Holders
The Offer referred to in this communication has not yet
commenced. The description contained in this communication is
neither an offer to purchase nor a solicitation of an offer to sell
any securities, nor is it a substitute for the tender offer
materials that wholly owned subsidiaries of the Menarini Group will
file with the Securities and Exchange Commission (the “SEC”). The
solicitation and offer to buy shares of Stemline common stock (the
“Shares”) will only be made pursuant to an offer to purchase and
related tender offer materials. At the time the Offer is commenced,
wholly owned subsidiaries of the Menarini Group will file a tender
offer statement on Schedule TO and thereafter Stemline will file a
solicitation/recommendation statement on Schedule 14D-9 with the
SEC with respect to the Offer. THE TENDER OFFER MATERIALS
(INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL
AND CERTAIN OTHER OFFER DOCUMENTS) AND THE
SOLICITATION/RECOMMENDATION STATEMENT ON SCHEDULE 14D-9 WILL
CONTAIN IMPORTANT INFORMATION. ANY HOLDERS OF SHARES ARE URGED TO
READ THESE DOCUMENTS CAREFULLY WHEN THEY BECOME AVAILABLE BECAUSE
THEY WILL CONTAIN IMPORTANT INFORMATION THAT HOLDERS SHOULD
CONSIDER BEFORE MAKING ANY DECISION REGARDING TENDERING THEIR
SHARES. The offer to purchase, the related letter of transmittal
and the solicitation/recommendation statement will be made
available for free at the SEC’s website at www.sec.gov. Additional
copies may be obtained for free by contacting Stemline. Copies of
the documents filed with the SEC by Stemline will be available free
of charge on Stemline’s internet website at
https://ir.stemline.com/financial-information or by contacting
Stemline’s investor relations contact at +1 (646) 502-2307. Copies
of the documents filed with the SEC by wholly owned subsidiaries of
the Menarini Group can be obtained, when filed, free of charge by
directing a request to the Information Agent for the Offer which
will be named in the tender offer materials.
In addition to the offer to purchase, the related letter of
transmittal and certain other tender offer documents to be filed by
wholly owned subsidiaries of the Menarini Group, as well as the
solicitation/recommendation statement to be filed by Stemline,
Stemline will also file quarterly and current reports with the SEC.
Stemline’s filings with the SEC are available to the public from
commercial document-retrieval services and at the website
maintained by the SEC at http://www.sec.gov.
Forward Looking Statements
The information contained in this communication is as of May 4,
2020. Stemline and the wholly owned subsidiaries of the Menarini
Group assume no obligation to update forward-looking statements
contained in this communication as the result of new information or
future events or developments, except as may be required by
law.
This communication contains forward-looking information related
to the Menarini Group, Stemline and the proposed acquisition of
Stemline that involves substantial risks and uncertainties that
could cause actual results to differ materially from those
expressed or implied by such statements. Forward-looking statements
in this document and the accompanying exhibits include, among other
things, statements about the potential benefits of the proposed
acquisition, the anticipated contingent value right payment,
Stemline’s plans, objectives, expectations and intentions, the
financial condition, results of operations and business of
Stemline, Stemline’s product pipeline and portfolio assets,
Stemline’s ability to achieve certain milestones that trigger the
contingent value right payment, the anticipated timing of closing
of the proposed acquisition and expected plans for financing the
proposed acquisition. Risks and uncertainties include, among other
things, risks related to the satisfaction or waiver of the
conditions to closing the proposed acquisition (including the
failure to obtain necessary regulatory approvals) in the
anticipated timeframe or at all, including uncertainties as to how
many of Stemline’s stockholders will tender their Shares in the
tender offer and the possibility that the acquisition does not
close; the possibility that competing offers may be made; risks
related to obtaining the requisite consents to the acquisition,
including, without limitation, the timing (including possible
delays) and receipt of clearance under the Hart-Scott-Antitrust
Improvements Act of 1976, as amended; disruption from the
transaction making it more difficult to maintain business and
operational relationships; significant transaction costs; the
uncertainties inherent in research and development, including the
ability to meet anticipated clinical endpoints, commencement and/or
completion dates for clinical trials, regulatory submission dates,
regulatory approval dates and/or launch dates, as well as the
possibility of unfavorable new clinical data and further analyses
of existing clinical data and, as such, the uncertainty that the
milestone for the CVR payment may not be achieved in the prescribed
timeframe or at all.
A further description of risks and uncertainties relating to
Stemline can be found in Stemline’s Annual Report on Form 10-K for
the fiscal year ended December 31, 2019, and in its subsequent
Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, all
of which are filed with the SEC and available at www.sec.gov and
https://ir.stemline.com/financial-information.
These forward-looking statements are based on numerous
assumptions and assessments made by the wholly owned subsidiaries
of the Menarini Group and Stemline in light of their respective
experiences and perceptions of historical trends, current
conditions, business strategies, operating environment, future
developments and other factors they believe are appropriate. By
their nature, forward-looking statements involve known and unknown
risks and uncertainties because they relate to events and depend on
circumstances that will occur in the future. Although it is
believed that the expectations reflected in the forward-looking
statements in this communication are reasonable, no assurance can
be given that such expectations will prove to have been correct and
persons reading this corporate release are therefore cautioned not
to place undue reliance on these forward-looking statements which
speak only as at the date of this corporate release.
Menarini Contacts
Media & Investor RelationsCharlie Chichester / Camilla
Scassellati-Sforzolini (Europe)Andrew Cole / Gloria Labbad
(U.S.)Sard Verbinnen & CoEmail: menarini-svc@sardverb.com
Stemline Contacts
Investor RelationsPeter McDonaldStemline Therapeutics,
Inc.646-502-2307 Email: pmcdonald@stemline.com
MediaAndy Brimmer / Scott BisangJoele Frank, Wilkinson Brimmer
Katcher212-355-4449
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