• Acquisition of Stemline estab­lishes Menarini’s presence in the U.S. bio­pharma­ceu­tical on­col­ogy mar­ket
• Menarini will sup­port fur­ther de­vel­op­ment of Stemline’s ELZONRIS® and enable global ex­pan­sion by leveraging its com­mer­cial infrastructure in Europe and other ex-U.S. geographies
• Total poten­tial con­sid­er­a­tion of $12.50 per share comprising $11.50 cash and $1.00 Contingent Value Right (CVR)

Florence, Italy and New York, NY (Press Release) – 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.

Source: Stemline Thera­peutics.