Takeda to acquire LSP portfolio company TiGenix



Takeda announces its intention to acquire TiGenix
 
Leuven (BELGIUM) - January 5, 2018, 7:30h CET - TiGenix NV ("TiGenix") (Euronext Brussels and NASDAQ: "TIG"), an advanced biopharmaceutical company focused on exploiting the anti-inflammatory properties of allogeneic, or donor-derived, stem cells to develop novel therapies for serious medical conditions, today confirms that Takeda Pharmaceutical Company Limited ("Takeda") has announced its intention to launch a voluntary conditional takeover bid on TiGenix. 
 
Takeda intends to acquire 100% of the securities with voting rights or giving access to voting rights of TiGenix not already owned by Takeda or affiliates at a price of EUR 1.78 per share in cash and an equivalent price in cash per American Depositary Share, warrant and convertible bond.
 
Takeda intends to launch the proposed takeover bid shortly after the approval of the bid prospectus and the response memorandum by the Belgian Financial Services and Markets Authority ("FSMA"). The bid will be subject to Takeda and its affiliates owning at least 85% of the securities of TiGenix with voting rights or giving access to voting rights on a fully diluted basis, as well as the following conditions precedent: the absence of a material adverse effect occurring after the date of this announcement, Cx601 obtaining European Medicines Agency approval and expiration of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 in the U.S. The European Medicines Agency approval for Cx601 is expected during the first half of 2018.
 
Consistent with its fiduciary duties and subject to review of the final bid prospectus, the bid is unanimously supported by TiGenix' board of directors, who will provide its formal response to the proposed takeover bid in a response memorandum which it will issue in due course in accordance with the applicable legal provisions. Takeda and TiGenix entered into an offer and support agreement confirming TiGenix' support and the terms and conditions of the bid set forth in the press release of Takeda. Cowen and Company, LLC served as financial advisor to TiGenix.
 
Gri-Cel S.A., holding 32,238,178 TiGenix shares, and its affiliate Grifols Worldwide Operations Ltd., holding 7,189,800 TiGenix shares held in the form of American Depositary Shares, have irrevocably confirmed that they will tender their shares and American Depositary Shares held in TiGenix into the potential public takeover bid.
 
For further information on the terms and conditions of the proposed takeover bid by Takeda, reference is made to the Takeda press release attached as Annex 1.
 
"We believe the intended takeover bid of Takeda is a positive step for TiGenix' security holders and reflects the true value of our dedication to patients over the last few years. We believe that TiGenix's expertise would help accelerate Takeda's ambition to develop novel stem cell therapies," said Eduardo Bravo, CEO of TiGenix. "Takeda is a patient centric company that offers the best capabilities and resources to ensure access to Cx601 to patients worldwide."
 
This press release does not constitute an offer or invitation for the sale or purchase of securities of TiGenix in any jurisdiction. Further announcements will be made in due course, if and when circumstances so require.
 
About TiGenix
TiGenix NV (Euronext Brussels and NASDAQ: TIG) is an advanced biopharmaceutical company developing novel therapies for serious medical conditions by exploiting the anti-inflammatory properties of allogeneic, or donor-derived, expanded stem cells.
 
TiGenix lead product, Cx601, has successfully completed a European Phase III clinical trial for the treatment of complex perianal fistulas - a severe, debilitating complication of Crohn's disease. Cx601 has been filed for regulatory approval in Europe and a global Phase III trial intended to support a future U.S. Biologic License Application (BLA) started in 2017. TiGenix has entered into a licensing agreement with Takeda, a global pharmaceutical company active in gastroenterology, under which Takeda acquired the exclusive right to develop and commercialize Cx601 for complex perianal fistulas outside the U.S. TiGenix' second adipose-derived product, Cx611, is undergoing a Phase Ib/IIa trial in severe sepsis - a major cause of mortality in the developed world. Finally, AlloCSC-01, targeting acute ischemic heart disease, has demonstrated positive results in a Phase I/II trial in acute myocardial infarction (AMI). TiGenix is headquartered in Leuven (Belgium) and has operations in Madrid (Spain) and Cambridge, MA (USA). For more information, please visit http://www.tigenix.com
 
Forward-looking information 
This communication may contain forward-looking statements and estimates with respect to the anticipated future performance of TiGenix and the market in which it operates and statements regarding the expected consummation of the tender offer, which involves a number of risks and uncertainties, including the satisfaction of closing conditions for the tender offer, the possibility that the transaction will not be completed, the impact of general economic, industry, market or political conditions, and the other risks and uncertainties discussed in TiGenix' public filings with the SEC, including the "Risk Factors" section of TiGenix' Form 20-F filed on April 6, 2017, as well as the tender offer documents to be filed by Takeda (the "Offeror") and the solicitation/recommendation statement to be filed by TiGenix. Certain of these statements, forecasts and estimates can be recognised by the use of words such as, without limitation, "believes", "anticipates", "expects", "intends", "plans", "seeks", "estimates", "may", "will" and "continue" and similar expressions. They include all matters that are not historical facts. Such statements, forecasts and estimates are based on various assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable when made but may or may not prove to be correct. Actual events are difficult to predict and may depend upon factors that are beyond TiGenix' control. Therefore, actual results, the financial condition, performance, timing or achievements of TiGenix, or industry results, may turn out to be materially different from any future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this communication. The Offeror and TiGenix disclaim any obligation to update any such forward-looking statement, forecast or estimates to reflect any change in TiGenix' expectations with regard thereto, or any change in events, conditions or circumstances on which any such statement, forecast or estimate is based, except to the extent required by Belgian law.
 
Disclaimer
This communication does not constitute an offer to purchase securities of TiGenix nor a solicitation by anyone in any jurisdiction in respect of such securities, any vote or approval. If the Offeror decides to proceed with an offer to purchase TiGenix' securities through a public tender offer, such offer will and can only be made on the basis of an approved offer document by the FSMA and tender offer documents filed with the U.S. Securities and Exchange Commission ("SEC"), which holders of TiGenix' securities should read as they will contain important information. This communication is not a substitute for such offer documents. Neither this communication nor any other information in respect of the matters contained herein may be supplied in any jurisdiction where a registration, qualification or any other obligation is in force or would be with regard to the content hereof or thereof. Any failure to comply with these restrictions may constitute a violation of the financial laws and regulations in such jurisdictions. The Offeror, TiGenix and their respective affiliates explicitly decline any liability for breach of these restrictions by any person.
 
Important Additional Information for U.S. Investors
The voluntary takeover bid described herein has not yet commenced. This communication is for informational purposes only and is neither a recommendation, an offer to purchase nor a solicitation of an offer to sell any securities of TiGenix. 
 
At the time the voluntary public takeover bid is commenced, shareholders of TiGenix are urged to read the offer documents which will be available at www.sec.gov. At the time the voluntary public takeover bid is commenced, it shall be comprised of two separate offers - (i) an offer for all securities with voting rights or giving access to voting rights, issued by TiGenix (except for ADSs) (the "Securities"), in accordance with the applicable law in Belgium, and (ii) an offer to holders of TiGenix' American Depositary Shares issued by Deutsche Bank Trust Company Americas acting as depositary ("ADSs"), and to holders of Securities who are resident in the U.S. in accordance with applicable U.S. law (the "U.S. Offer").
 
The U.S. Offer will only be made pursuant to an offer to purchase and related materials. At the time the U.S. Offer is commenced, the Offeror will file, or cause to be filed, a tender offer statement on Schedule TO with the SEC and thereafter, TiGenix will file a solicitation/recommendation statement on Schedule 14D-9, in each case with respect to the U.S. Offer.
 
Holders of TiGenix ADSs and Securities subject to the U.S. Offer who wish to participate in the U.S. Offer, are urged to carefully review the documents relating to the U.S. Offer that will be filed by the Offeror with the SEC since these documents will contain important information, including the terms and conditions of the U.S. Offer. Holders of TiGenix' ADSs and Securities subject to the U.S. Offer who wish to participate in the U.S. Offer, are also urged to read the related solicitation/recommendation statement on Schedule 14D-9 that will be filed with the SEC by TiGenix relating to the U.S. Offer. You may obtain a free copy of these documents after they have been filed with the SEC, and other documents filed by TiGenix and the Offeror with the SEC, at the SEC's website at www.sec.gov. In addition to the offer and certain other tender offer documents, as well as the solicitation/recommendation statement, TiGenix files reports and other information with the SEC. You may read and copy any reports or other information filed by TiGenix at the SEC Public Reference Room at 100 F Street, N.E., Washington, D.C. 20549. Please call the SEC at 1-800-SEC-0330 for further information on the Public Reference Room. TiGenix' filings at the SEC are also available to the public from commercial document-retrieval services and at the website maintained by the SEC at www.sec.gov.
 
YOU SHOULD READ THE FILINGS MADE BY THE OFFEROR AND TIGENIX WITH THE SEC CAREFULLY BEFORE MAKING A DECISION CONCERNING THE U.S. OFFER.
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Takeda to acquire LSP portfolio company TiGenix



Takeda announces its intention to acquire TiGenix
 
Leuven (BELGIUM) - January 5, 2018, 7:30h CET - TiGenix NV ("TiGenix") (Euronext Brussels and NASDAQ: "TIG"), an advanced biopharmaceutical company focused on exploiting the anti-inflammatory properties of allogeneic, or donor-derived, stem cells to develop novel therapies for serious medical conditions, today confirms that Takeda Pharmaceutical Company Limited ("Takeda") has announced its intention to launch a voluntary conditional takeover bid on TiGenix. 
 
Takeda intends to acquire 100% of the securities with voting rights or giving access to voting rights of TiGenix not already owned by Takeda or affiliates at a price of EUR 1.78 per share in cash and an equivalent price in cash per American Depositary Share, warrant and convertible bond.
 
Takeda intends to launch the proposed takeover bid shortly after the approval of the bid prospectus and the response memorandum by the Belgian Financial Services and Markets Authority ("FSMA"). The bid will be subject to Takeda and its affiliates owning at least 85% of the securities of TiGenix with voting rights or giving access to voting rights on a fully diluted basis, as well as the following conditions precedent: the absence of a material adverse effect occurring after the date of this announcement, Cx601 obtaining European Medicines Agency approval and expiration of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 in the U.S. The European Medicines Agency approval for Cx601 is expected during the first half of 2018.
 
Consistent with its fiduciary duties and subject to review of the final bid prospectus, the bid is unanimously supported by TiGenix' board of directors, who will provide its formal response to the proposed takeover bid in a response memorandum which it will issue in due course in accordance with the applicable legal provisions. Takeda and TiGenix entered into an offer and support agreement confirming TiGenix' support and the terms and conditions of the bid set forth in the press release of Takeda. Cowen and Company, LLC served as financial advisor to TiGenix.
 
Gri-Cel S.A., holding 32,238,178 TiGenix shares, and its affiliate Grifols Worldwide Operations Ltd., holding 7,189,800 TiGenix shares held in the form of American Depositary Shares, have irrevocably confirmed that they will tender their shares and American Depositary Shares held in TiGenix into the potential public takeover bid.
 
For further information on the terms and conditions of the proposed takeover bid by Takeda, reference is made to the Takeda press release attached as Annex 1.
 
"We believe the intended takeover bid of Takeda is a positive step for TiGenix' security holders and reflects the true value of our dedication to patients over the last few years. We believe that TiGenix's expertise would help accelerate Takeda's ambition to develop novel stem cell therapies," said Eduardo Bravo, CEO of TiGenix. "Takeda is a patient centric company that offers the best capabilities and resources to ensure access to Cx601 to patients worldwide."
 
This press release does not constitute an offer or invitation for the sale or purchase of securities of TiGenix in any jurisdiction. Further announcements will be made in due course, if and when circumstances so require.
 
About TiGenix
TiGenix NV (Euronext Brussels and NASDAQ: TIG) is an advanced biopharmaceutical company developing novel therapies for serious medical conditions by exploiting the anti-inflammatory properties of allogeneic, or donor-derived, expanded stem cells.
 
TiGenix lead product, Cx601, has successfully completed a European Phase III clinical trial for the treatment of complex perianal fistulas - a severe, debilitating complication of Crohn's disease. Cx601 has been filed for regulatory approval in Europe and a global Phase III trial intended to support a future U.S. Biologic License Application (BLA) started in 2017. TiGenix has entered into a licensing agreement with Takeda, a global pharmaceutical company active in gastroenterology, under which Takeda acquired the exclusive right to develop and commercialize Cx601 for complex perianal fistulas outside the U.S. TiGenix' second adipose-derived product, Cx611, is undergoing a Phase Ib/IIa trial in severe sepsis - a major cause of mortality in the developed world. Finally, AlloCSC-01, targeting acute ischemic heart disease, has demonstrated positive results in a Phase I/II trial in acute myocardial infarction (AMI). TiGenix is headquartered in Leuven (Belgium) and has operations in Madrid (Spain) and Cambridge, MA (USA). For more information, please visit http://www.tigenix.com
 
Forward-looking information 
This communication may contain forward-looking statements and estimates with respect to the anticipated future performance of TiGenix and the market in which it operates and statements regarding the expected consummation of the tender offer, which involves a number of risks and uncertainties, including the satisfaction of closing conditions for the tender offer, the possibility that the transaction will not be completed, the impact of general economic, industry, market or political conditions, and the other risks and uncertainties discussed in TiGenix' public filings with the SEC, including the "Risk Factors" section of TiGenix' Form 20-F filed on April 6, 2017, as well as the tender offer documents to be filed by Takeda (the "Offeror") and the solicitation/recommendation statement to be filed by TiGenix. Certain of these statements, forecasts and estimates can be recognised by the use of words such as, without limitation, "believes", "anticipates", "expects", "intends", "plans", "seeks", "estimates", "may", "will" and "continue" and similar expressions. They include all matters that are not historical facts. Such statements, forecasts and estimates are based on various assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable when made but may or may not prove to be correct. Actual events are difficult to predict and may depend upon factors that are beyond TiGenix' control. Therefore, actual results, the financial condition, performance, timing or achievements of TiGenix, or industry results, may turn out to be materially different from any future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this communication. The Offeror and TiGenix disclaim any obligation to update any such forward-looking statement, forecast or estimates to reflect any change in TiGenix' expectations with regard thereto, or any change in events, conditions or circumstances on which any such statement, forecast or estimate is based, except to the extent required by Belgian law.
 
Disclaimer
This communication does not constitute an offer to purchase securities of TiGenix nor a solicitation by anyone in any jurisdiction in respect of such securities, any vote or approval. If the Offeror decides to proceed with an offer to purchase TiGenix' securities through a public tender offer, such offer will and can only be made on the basis of an approved offer document by the FSMA and tender offer documents filed with the U.S. Securities and Exchange Commission ("SEC"), which holders of TiGenix' securities should read as they will contain important information. This communication is not a substitute for such offer documents. Neither this communication nor any other information in respect of the matters contained herein may be supplied in any jurisdiction where a registration, qualification or any other obligation is in force or would be with regard to the content hereof or thereof. Any failure to comply with these restrictions may constitute a violation of the financial laws and regulations in such jurisdictions. The Offeror, TiGenix and their respective affiliates explicitly decline any liability for breach of these restrictions by any person.
 
Important Additional Information for U.S. Investors
The voluntary takeover bid described herein has not yet commenced. This communication is for informational purposes only and is neither a recommendation, an offer to purchase nor a solicitation of an offer to sell any securities of TiGenix. 
 
At the time the voluntary public takeover bid is commenced, shareholders of TiGenix are urged to read the offer documents which will be available at www.sec.gov. At the time the voluntary public takeover bid is commenced, it shall be comprised of two separate offers - (i) an offer for all securities with voting rights or giving access to voting rights, issued by TiGenix (except for ADSs) (the "Securities"), in accordance with the applicable law in Belgium, and (ii) an offer to holders of TiGenix' American Depositary Shares issued by Deutsche Bank Trust Company Americas acting as depositary ("ADSs"), and to holders of Securities who are resident in the U.S. in accordance with applicable U.S. law (the "U.S. Offer").
 
The U.S. Offer will only be made pursuant to an offer to purchase and related materials. At the time the U.S. Offer is commenced, the Offeror will file, or cause to be filed, a tender offer statement on Schedule TO with the SEC and thereafter, TiGenix will file a solicitation/recommendation statement on Schedule 14D-9, in each case with respect to the U.S. Offer.
 
Holders of TiGenix ADSs and Securities subject to the U.S. Offer who wish to participate in the U.S. Offer, are urged to carefully review the documents relating to the U.S. Offer that will be filed by the Offeror with the SEC since these documents will contain important information, including the terms and conditions of the U.S. Offer. Holders of TiGenix' ADSs and Securities subject to the U.S. Offer who wish to participate in the U.S. Offer, are also urged to read the related solicitation/recommendation statement on Schedule 14D-9 that will be filed with the SEC by TiGenix relating to the U.S. Offer. You may obtain a free copy of these documents after they have been filed with the SEC, and other documents filed by TiGenix and the Offeror with the SEC, at the SEC's website at www.sec.gov. In addition to the offer and certain other tender offer documents, as well as the solicitation/recommendation statement, TiGenix files reports and other information with the SEC. You may read and copy any reports or other information filed by TiGenix at the SEC Public Reference Room at 100 F Street, N.E., Washington, D.C. 20549. Please call the SEC at 1-800-SEC-0330 for further information on the Public Reference Room. TiGenix' filings at the SEC are also available to the public from commercial document-retrieval services and at the website maintained by the SEC at www.sec.gov.
 
YOU SHOULD READ THE FILINGS MADE BY THE OFFEROR AND TIGENIX WITH THE SEC CAREFULLY BEFORE MAKING A DECISION CONCERNING THE U.S. OFFER.
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