UCB Media Room: UCB to acquire Zogenix

https://mb.cision.com/Public/18595/logo/86a99b25f755738d_org.jpg ** UCB to acquire Zogenix ------------------------------------------------------------ =C2=B7 Transaction broadens and builds upon UCB=E2=80=99s role as a leader = in, and our continued commitment to, addressing unmet needs of people livin= g with epilepsy, complementing existing medicines and expanding clinical de= velopment pipeline of epilepsy and rare disease therapies =C2=B7 Adds treatment option for specific, vulnerable patient populations w= ith FINTEPLA^=C2=AE (fenfluramine) C-IV oral solution - approved for seizur= es associated with Dravet syndrome, with potential in other significant sei= zure disorders including Lennox-Gastaut syndrome =C2=B7 Total transaction* value of up to approximately US$ 1.9 billion / = =E2=82=AC 1.7 billion. This consists of US$ 26.00 in cash per Zogenix share= plus a milestone-based contingent value right for a potential cash payment= of US$ 2.00 per share Brussels (Belgium) and Emeryville, CA (USA), 19 January 2022 - Regulated in= formation =E2=80=93 Inside information =E2=80=93 UCB (Euronext: UCB) and Zo= genix (NASDAQ: ZGNX) announced today that the companies have entered into a= definitive agreement under which UCB would acquire Zogenix, Inc., a global= biopharmaceutical company commercializing and developing therapies for rar= e diseases. Under the terms of the agreement, UCB will commence a tender of= fer to purchase all outstanding shares of Zogenix for a purchase price per = share of US$ 26.00 in cash at closing, plus a contingent value right (CVR) = for a potential cash payment of US$ 2.00 upon EU approval by December 31, 2= 023, of FINTEPLA^=C2=AE as an orphan medicine for treatment of Lennox-Gasta= ut syndrome (LGS). The upfront consideration represents a 72% premium to Zo= genix shares based on the 30-day volume weighted average closing stock pric= e of Zogenix prior to signing. The total transaction is valued at up to app= roximately US$ 1.9 billion / =E2=82=AC 1.7 billion. The board of directors of both companies have unanimously approved the tran= saction, the closing of which remains subject to the tender of shares repre= senting at least a majority of the total number of Zogenix=E2=80=99s outsta= nding shares, receipt of required antitrust clearances, and other customary= conditions.=C2=A0 The transaction will broaden and build upon UCB=E2=80=99s role as a leader = in, and our continued commitment to, addressing unmet needs of people livin= g with specific or rare forms of epilepsy, in particular, adding FINTEPLA^= =C2=AE to UCB=E2=80=99s existing product line. FINTEPLA^=C2=AE has been app= roved by the U.S. Food and Drug Administration (FDA)^1 and the European Med= icines Agency (EMA)^2 and is under regulatory review in Japan^3, for the tr= eatment of seizures associated with Dravet syndrome in patients two years o= f age and older. Zogenix is also pursuing indications for the use of FINTEP= LA^=C2=AE in the treatment of seizures associated with additional rare epil= epsies, Lennox-Gastaut syndrome (LGS) and CDKL5 Deficiency Disorder (CDD)^4= . Zogenix has submitted a Type II Variation Application to the EMA^5, and t= he U.S. FDA recently accepted for filing Zogenix=E2=80=99s supplemental New= Drug Application (sNDA)^6, granting Priority Review, for LGS. Beginning in= childhood, Dravet syndrome and Lennox-Gastaut syndrome are two of the most= devastating and life-long forms of epilepsy^ 7,8,9,10. =E2=80=9CThe proposed acquisition of Zogenix reinforces UCB=E2=80=99s susta= inable patient value strategy and continued commitment to addressing unmet = needs of people living with epilepsy with an increasing focus on those livi= ng with specific or rare forms of epilepsy, where few options exist. Comple= menting UCB=E2=80=99s existing therapeutic offerings, the Zogenix acquisiti= on provides UCB with an approved medicine for a life-threatening, rare infa= nt- and childhood-onset epilepsy marked by frequent and severe treatment-re= sistant seizures, that are particularly challenging to treat,=E2=80=9D said= Charl van Zyl, Executive Vice President, Neurology & Head of Europe/Intern= ational Markets, UCB. =E2=80=9CUtilizing our deep expertise, experience and= global capabilities, we plan to accelerate access for patients to the trea= tment. We look forward to welcoming the Zogenix team to UCB, benefiting fro= m their insights and working together to maximize the reach and impact of t= heir medicines for the benefit of as many people as possible.=E2=80=9D =E2=80=9CWe are delighted to announce UCB=E2=80=99s proposed acquisition of= Zogenix, recognizing the value of our lead medicine, both for the importan= t role it has already begun to play for Dravet patients and their caregiver= s, and for its potential to help many others in the future,=E2=80=9D said S= tephen J. Farr, PhD, President and Chief Executive Officer of Zogenix. =E2= =80=9CWe are excited for the potential opportunities ahead of us, working t= ogether to accelerate our mission and progress to improve the care of patie= nts in need of new therapies. We believe this transaction is in the best in= terests of both patients and our shareholders.=E2=80=9D Strategic Benefits=C2=A0 =C2=B7 Builds on UCB=E2=80=99s continued epilepsy ambitions: Acquisition pr= ovides medicine that complements UCB=E2=80=99s existing symptomatic treatme= nts, bringing significant and differentiated value to patients suffering fr= om Dravet syndrome and, if approved, from seizures associated with Lennox-G= astaut syndrome and potentially other rare epilepsies. =C2=B7 Expands benefits for patients globally: UCB brings an established gl= obal footprint, together with deep research and development, commercial, me= dical, and regulatory expertise in epilepsy, which will be utilized to rapi= dly advance and optimize the availability of these new treatments and reach= additional patients.=C2=A0 =C2=B7 Enhances future epilepsy pipeline and strategic priorities in rare/o= rphan diseases: Zogenix=E2=80=99s pipeline will add to UCB=E2=80=99s short-= term and long-term epilepsy pipeline, as well as provide critical learnings= in rare/orphan disease health ecosystems. =C2=B7 Enhances UCB=E2=80=99s top-line growth: FINTEPLA^=C2=AE was launched= in the U.S. and Europe in 2020 and has significant potential for usage in = other seizure types. It is expected that the proposed acquisition, if compl= eted, will contribute to UCB=E2=80=99s revenue growth upon closing and will= be accretive to UCB=E2=80=99s earnings in 2023. Transaction Terms, Approvals and Time to Closing=C2=A0 Under the terms of the acquisition agreement, UCB, through a wholly-owned s= ubsidiary, Zinc Merger Sub, Inc., will initiate a tender offer to acquire a= ll outstanding shares of Zogenix for a purchase price of US$ 26.00 per shar= e in cash, plus one non-tradeable CVR. The CVR will entitle holders to an a= dditional cash payment of US$ 2.00 per share if a regulatory milestone rela= ted to approval of FINTEPLA^=C2=AE for treatment of seizures associated wit= h Lennox-Gastaut syndrome (LGS) is achieved by or before December 31, 2023.= The closing of the tender offer will be subject to certain conditions, inc= luding the tender of shares representing at least a majority of the total n= umber of Zogenix=E2=80=99s outstanding shares, receipt of required antitrus= t clearances, and other customary conditions. Upon the successful completio= n of the tender offer, UCB=E2=80=99s acquisition subsidiary will be merged = into Zogenix, and any remaining shares of common stock of Zogenix will be c= ancelled and converted into the right to receive the same consideration per= share offered in the tender offer. The transaction is expected to close by= the end of the second quarter of 2022. There can be no assurance any payme= nts will be made with respect to the CVR.=C2=A0 Financing and Guidance The acquisition of Zogenix will be financed by a combination of available c= ash resources and a new term loan. The transaction is not subject to any fi= nancing condition. In addition to contributing to UCB=E2=80=99s revenue gro= wth after closing, the acquisition of Zogenix is expected to be accretive t= o UCB=E2=80=99s earnings from 2023 onwards. Advisors Lazard and Barclays are acting as financial advisors to UCB in relation to = the transaction. Covington & Burling LLP is acting as legal advisor to UCB = on this transaction. BofA Securities and SVB Leerink are acting as financial advisors to Zogenix= on this transaction. Latham & Watkins LLP is acting as legal advisor to Zo= genix on this transaction. UCB Conference call UCB hosts a Capital Markets Call 19th January 2022, at 08:30am EST / 13:30 = GMT / 14:30 CET. Please register via the UCB Investor Relations website: ww= w.ucb.com/investors (http://www.ucb.com/investors) About Dravet Syndrome Dravet syndrome is a rare, devastating and life-long form of epilepsy that = generally begins in infancy and is marked by frequent, treatment-resistant = seizures, significant developmental, motor, and behavioral impairments, and= an increased risk of sudden unexpected death in epilepsy (SUDEP). Affectin= g one in 15,700 live births in the U.S. and approximately one in 20,000 to = 40,000 live births in Europe, most patients follow a course of developmenta= l delay with cognitive, motor and behavioral deficits that persist into adu= lthood. Dravet syndrome severely impacts quality of life for patients, fami= lies, and caregivers due to the high physical, emotional, caregiving, and f= inancial burden associated with the disease^7,8,9. About FINTEPLA^=C2=AE (fenfluramine) C-IV FINTEPLA^=C2=AE (fenfluramine) oral solution is a prescription medication u= sed to treat seizures associated with Dravet syndrome in patients two years= of age and older ^11, 12. FINTEPLA possesses dual activities to inhibit se= izures: as a serotonergic agent, acting as a potent 5-HT releaser with agon= ist activity at 5-HT1D, 2A, and 2C receptors, and as a positive modulator o= f Sigma1R. FINTEPLA is approved in the U.S. and Europe, and under regulator= y review in Japan, for the treatment of seizures associated with Dravet syn= drome. The U.S. Food and Drug Administration (FDA) has accepted for filing = the company=E2=80=99s supplemental New Drug Application (sNDA) and granted = Priority Review for the use of FINTEPLA for the treatment of seizures assoc= iated with Lennox-Gastaut syndrome (LGS). In the United States, FINTEPLA is available only through a restricted distr= ibution program called the FINTEPLA REMS program. FINTEPLA is available in = Europe under a controlled access program requested by the European Medicine= s Agency to prevent off-label use for weight management and to confirm that= prescribing physicians have been informed of the need for periodic cardiac= monitoring in patients taking FINTEPLA. Further information is available a= t www.FinteplaREMS.com or by telephone at [phone].=C2=A0 Please see full Prescribing Information (https://www.zogenix.com/pi/Fintepl= a-prescribing-information.pdf) , including Boxed Warning, for additional im= portant information on FINTEPLA. About Lennox-Gastaut Syndrome Lennox-Gastaut syndrome (LGS) is a rare and devastating lifelong childhood-= onset epilepsy that can arise from multiple different causes. LGS is charac= terized by many different seizure types, including many that result in freq= uent falls and injuries. The intellectual and behavioral problems associate= d with LGS, as well as around-the-clock care requirements, add to the compl= exity of life with this disease^10. About Zogenix Zogenix is a global biopharmaceutical company committed to developing and c= ommercializing therapies with the potential to transform the lives of patie= nts and their families living with rare diseases. The company=E2=80=99s fir= st rare disease therapy, FINTEPLA^=C2=AE (fenfluramine) oral solution, has = been approved by the U.S. Food and Drug Administration (FDA) and the Europe= an Medicines Agency and is under regulatory review in Japan for the treatme= nt of seizures associated with Dravet syndrome, a rare, severe lifelong epi= lepsy. The U.S. FDA recently accepted for filing Zogenix=E2=80=99s suppleme= ntal New Drug Application (sNDA) and granted Priority Review for the use of= FINTEPLA for the treatment of seizures associated with an additional rare = epilepsy, Lennox-Gastaut syndrome (LGS). Zogenix is also initiating a study= of FINTEPLA in a genetic epilepsy called CDKL5 Deficiency Disorder (CDD) a= nd is collaborating with Tevard Biosciences to identify and develop potenti= al next-generation gene therapies for Dravet syndrome and other genetic epi= lepsies. The company has an additional late-stage development program, MT-1= 621, in a mitochondrial disease called TK2 deficiency^13.=C2=A0 About UCB UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company = focused on the discovery and development of innovative medicines and soluti= ons to transform the lives of people living with severe diseases of the imm= une system or of the central nervous system. With more than 8,000 people in= approximately 40 countries, the company generated revenue of =E2=82=AC5.3 = billion in 2020. UCB is listed on Euronext Brussels (symbol: UCB). Follow u= s on Twitter: @UCB_news. For further information =E2=80=93=C2=A0 UCB Investor Relations Antje Witte T [phone] | [e-mail] Media/Corporate Communications=C2=A0 Laurent Schots T [phone] | [e-mail] Nick Francis T [phone] | [e-mail] Erica Puntel (U.S. Media) T [phone] | [e-mail] Zogenix [e-mail]=C2=A0 Investors Brian Ritchie Managing Director, LifeSci Advisors LLC T [phone] | [e-mail] Media=C2=A0 Trish McCall, Porter Novelli=C2=A0 T [phone] | [e-mail]=C2=A0 Important Information About the Tender Offer The tender offer described in this press release has not yet commenced. Thi= s press release is for informational purposes only and is neither an offer = to purchase nor a solicitation of an offer to sell any shares of the common= stock of Zogenix, Inc. (=E2=80=9CZogenix=E2=80=9D) or any other securities= , nor is it a substitute for the tender offer materials described herein. A= t the time the planned tender offer is commenced, a tender offer statement = on Schedule (TO), including an offer to purchase, a letter of transmittal a= nd related documents, will be filed by UCB S.A. (=E2=80=9CUCB=E2=80=9D) and= Zinc Merger Sub, Inc., a wholly-owned subsidiary of UCB, with the Securiti= es and Exchange Commission (the =E2=80=9CSEC=E2=80=9D), and a solicitation/= recommendation statement on Schedule 14D-9 will be filed by Zogenix with th= e SEC. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ BOTH THE TENDER OFFER MATE= RIALS CAREFULLY (INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF TRANSM= ITTAL AND CERTAIN OTHER TENDER OFFER DOCUMENTS) AND THE SOLICITATION/RECOMM= ENDATION STATEMENT ON SCHEDULE 14D-9 REGARDING THE OFFER, AS THEY MAY BE AM= ENDED FROM TIME TO TIME, WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTA= IN IMPORTANT INFORMATION THAT INVESTORS AND SECURITY HOLDERS SHOULD CONSIDE= R BEFORE MAKING ANY DECISION REGARDING TENDERING THEIR SECURITIES. Investors and security holders may obtain a free copy of the Offer to Purch= ase, the related Letter of Transmittal, certain other tender offer document= s and the Solicitation/Recommendation Statement (when available) and other = documents filed with the SEC at the website maintained by the SEC at www.se= c.gov or by directing such requests to the Information Agent for the Offer,= which will be named in the tender offer statement. In addition, Zogenix fi= les annual, quarterly and current reports and other information with the SE= C, which is available to the public from commercial document-retrieval serv= ices and at the SEC=E2=80=99s website at www.sec.gov. Copies of the documen= ts filed with the SEC by UCB in connection with the Offer may be obtained a= t no charge on UCB=E2=80=99s internet website at www.ucb.com or by contacti= ng UCB at All=C3=A9e de la Recherche, 60 1070 Brussels, Belgium, or Tel: +3= 2 2 559 99 99. Copies of the documents filed with the SEC by Zogenix may be= obtained at no charge on Zogenix=E2=80=99s internet website at www.zogenix= .com or by contacting Zogenix at 5959 Horton St Fl 5, Emeryville, Californi= a, 94608, USA, or Tel: [phone]. =C2=A0 Forward-Looking Statement of UCB, S.A.=C2=A0 This news release of UCB, S.A., Brussels, Belgium (the =E2=80=9Ccompany=E2= =80=9D) includes statements that are not statements of historical fact, or = =E2=80=9Cforward-looking statements,=E2=80=9D including with respect to the= company=E2=80=99s proposed acquisition of Zogenix. Such forward-looking st= atements include, but are not limited to, the ability of the company and Zo= genix to complete the transactions contemplated by the merger agreement, in= cluding the parties=E2=80=99 ability to satisfy the conditions to the consu= mmation of the offer contemplated thereby and the other conditions set fort= h in the merger agreement, statements about the expected timetable for comp= leting the transaction, the company=E2=80=99s and Zogenix=E2=80=99s beliefs= and expectations and statements about the benefits sought to be achieved i= n the company=E2=80=99s proposed acquisition of Zogenix, the potential effe= cts of the acquisition on both the company and Zogenix, the possibility of = any termination of the merger agreement, as well as the expected benefits a= nd success of Zogenix=E2=80=99s product candidates. These statements are ba= sed upon the current beliefs and expectations of the company=E2=80=99s mana= gement and are subject to significant risks and uncertainties. There can be= no guarantees that the conditions to the closing of the proposed transacti= on will be satisfied on the expected timetable or at all or that pipeline p= roducts will receive the necessary regulatory approvals or that they will p= rove to be commercially successful. If underlying assumptions prove inaccur= ate or risks or uncertainties materialize, actual results may differ materi= ally from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, uncertainties as to= the timing of the offer and the subsequent merger; uncertainties as to how= many of Zogenix=E2=80=99s shares will be tendered in the offer by Zogenix= =E2=80=99s stockholders; the risk that competing offers or acquisition prop= osals will be made; the possibility that various conditions to the consumma= tion of the offer and the merger may not be satisfied or waived; the effect= s of disruption from the transactions contemplated by the merger agreement = and the impact of the announcement and pendency of the transactions on Zoge= nix=E2=80=99s business; the risk that stockholder litigation in connection = with the offer or the merger may result in significant costs of defense, in= demnification and liability; the risks related to non-achievement of the CV= R milestones and that holders of the CVRs will not receive payments in resp= ect of the CVRs; the global spread and impact of COVID-19, changes in gener= al economic, business and competitive conditions, the inability to obtain n= ecessary regulatory approvals or to obtain them on acceptable terms or with= in expected timing, costs associated with research and development, changes= in the prospects for products in the pipeline or under development by UCB,= effects of future judicial decisions or governmental investigations, safet= y, quality, data integrity or manufacturing issues; potential or actual dat= a security and data privacy breaches, or disruptions of our information tec= hnology systems, product liability claims, challenges to patent protection = for products or product candidates, competition from other products includi= ng biosimilars, changes in laws or regulations, exchange rate fluctuations,= changes or uncertainties in tax laws or the administration of such laws, a= nd hiring and retention of its employees. UCB expressly disclaims any obligation to publicly update any forward-looki= ng statement, whether as a result of new information, future events or othe= rwise, except to the extent required by law. Forward-Looking Statement of Zogenix, Inc.=C2=A0 Zogenix cautions you that statements included in this press release that ar= e not a description of historical facts are forward-looking statements. Wor= ds such as =E2=80=9Cbelieves,=E2=80=9D =E2=80=9Canticipates,=E2=80=9D =E2= =80=9Cplans,=E2=80=9D =E2=80=9Cexpects,=E2=80=9D =E2=80=9Cindicates,=E2=80= =9D =E2=80=9Cwill,=E2=80=9D =E2=80=9Cintends,=E2=80=9D =E2=80=9Cpotential,= =E2=80=9D =E2=80=9Csuggests,=E2=80=9D =E2=80=9Cassuming,=E2=80=9D =E2=80=9C= designed,=E2=80=9D and similar expressions are intended to identify forward= -looking statements. These statements include: the ability of Zogenix and U= CB to complete the transactions contemplated by the merger agreement, inclu= ding the parties=E2=80=99 ability to satisfy the conditions to the consumma= tion of the offer contemplated thereby and the other conditions set forth i= n the merger agreement, statements about the expected timetable for complet= ing the transaction, Zogenix=E2=80=99s and UCB=E2=80=99s beliefs and expect= ations and statements about the benefits sought to be achieved in the trans= action, the potential effects of the acquisition on both Zogenix and UCB, t= he possibility of any termination of the merger agreement, as well as the e= xpected benefits and success of Zogenix=E2=80=99s product candidates. These= statements are based on Zogenix=E2=80=99s current beliefs and expectations= . The inclusion of forward-looking statements should not be regarded as a r= epresentation by Zogenix that any of its plans will be achieved. Actual res= ults may differ from those set forth in this release due to uncertainties a= s to the timing of the offer and the subsequent merger; uncertainties as to= how many of Zogenix=E2=80=99s shares will be tendered in the offer by Zoge= nix=E2=80=99s stockholders; the possibility that various conditions to the = consummation of the offer and the merger may not be satisfied or waived; th= e effects of disruption from the transactions contemplated by the merger ag= reement and the impact of the announcement and pendency of the transactions= on Zogenix=E2=80=99s business; the risk that stockholder litigation in con= nection with the offer or the merger may result in significant costs of def= ense, indemnification and liability; the risks related to non-achievement o= f the CVR milestones and that holders of the CVRs will not receive payments= in respect of the CVRs; the global spread and impact of COVID-19; changes = in general economic, business and competitive conditions; and the potential= inability to obtain necessary regulatory approvals or to obtain them on ac= ceptable terms or within expected timing. You are cautioned not to place un= due reliance on these forward-looking statements, which speak only as of th= e date hereof, and Zogenix undertakes no obligation to revise or update thi= s press release to reflect events or circumstances after the date hereof. A= ll forward-looking statements are qualified in their entirety by this cauti= onary statement. This caution is made under the safe harbor provisions of S= ection 21E of the Private Securities Litigation Reform Act of 1995. Footnote: [*Total transaction value fully diluted]. References: 1. FDA News Release. FDA Approves New Therapy for Dravet Syndrome. June 25,= 2020. 2. Meeting highlights from the Committee for Medicinal Products for Human U= se (CHMP) 12-15 October 2020. 3. Zogenix Press Release. Zogenix Submits New Drug Application for FINTEPLA= =C2=AE (Fenfluramine) in Japan for the Treatment of Epileptic Seizures Asso= ciated with Dravet Syndrome. 21st December 2021. 4. Zogenix Pipeline Presentation. November 2021. 5. Zogenix Press Release. Zogenix Submits Type II Variation Application to = the European Medicines Agency (EMA) to Expand the Use of FINTEPLA=C2=AE (Fe= nfluramine) for the Treatment of Seizures Associated with Lennox-Gastaut Sy= ndrome. 20th December 2021. 6. Zogenix Press Release. Zogenix Announces U.S. FDA Acceptance for Priorit= y Review of Supplemental New Drug Application for FINTEPLA=C2=AE (Fenfluram= ine) for the Treatment of Seizures Associated with Lennox-Gastaut Syndrome = (LGS). 1st December 2021. 7. Dravet C. The Core Dravet Syndrome Phenotype. Epilepsia. 2011 Apr;52 Sup= pl 2:3-9. 2. 8. Dravet C. Dravet syndrome history. Dev Med Child Neurol. 2011 Apr;53 Sup= pl 2:1-6. 9. Wu YW, Sullivan J, McDaniel SS, et al. Incidence of Dravet Syndrome in t= he US Population. Pediatrics. 2015 Nov;136(5):e1310-1315. 10. National Institute of Neurological Disorders and Stroke. Lennox-Gastaut= Syndrome Information Page. Last Accessed Jan 2022. 11. Fintepla Summary of Product Characteristics. January 2022. 12. Fintepla U.S. Prescribing Information. January 2022. 13. Zogenix Presentation. MT-1621 Virtual Investor Event. November 2021. GenericFile Final Press Release - Approved for PR Newswire 19 01 2022 (https://mb.cisio= n.com/Public/18595/3488454/9b587c16d8fabda1.pdf) ______________________ If you would rather not receive future communications from UCB SA, please g= o to https://eu.vocuspr.com/OptOut.aspx?2973226x20421x93771x1x6868579x24000= x6&Email=3Dregnews%40symexglobal.com. UCB SA, All=C3=A9e de la Recherche, 60 ., Brussels, . B - 1070 Belgium