UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
_______________________
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(D) OF
PURSUANT TO SECTION 13 OR 15(D) OF
THE SECURITIES EXCHANGE ACT OF 1934
Date of report (Date of earliest event reported): October 21, 2019
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(Exact name of registrant as specified in its charter)
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(State or other jurisdiction of incorporation or organization) | (Commission File Number) | (I.R.S. Employer Identification No.) |
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(Address of Principal Executive Offices) (Zip Code)
Registrant's telephone number, including area code: (475 ) 230-2596
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below): | |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) | |
Securities registered pursuant to Section 12(b) of the Act:
Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). | |
Emerging Growth Company | |
Item 8.01. Other Events.
As previously disclosed, on October 15, 2019, Alexion Pharmaceuticals, Inc. (“Alexion”) and Achillion Pharmaceuticals, Inc. (“Achillion”) entered into an Agreement and Plan of Merger, pursuant to which, among other things, upon the terms and subject to the conditions thereof, a subsidiary of Alexion will merge with and into Achillion, with Achillion surviving as a wholly owned subsidiary of Alexion. On October 21, 2019, Alexion made available to employees of Achillion the presentation filed as Exhibit 99.1 to this Current Report on Form 8-K, which is incorporated herein by reference.
Forward Looking Statements
The information contained in this document is as of October 21, 2019. Alexion assumes no obligation to update forward-looking statements contained in this document as the result of new information or future events or developments.
This document contains forward-looking information related to Alexion, Achillion and the proposed acquisition of Achillion by Alexion 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 include, among other things, statements about the potential benefits of the proposed acquisition, the anticipated contractual contingent value right payment, earnings dilution and accretion, and growth, Alexion’s and Achillion’s plans, objectives, expectations and intentions, the financial condition, results of operations and business of Alexion and Achillion, Achillion’s product pipeline and portfolio assets, the ability to achieve certain milestones that trigger the contractual contingent value right payment, and the anticipated timing of closing of the proposed acquisition. Risks and uncertainties include, among other things, risks related to the fact that the proposed acquisition may not be completed due to Achillion’s or Alexion’s failure to satisfy or waive 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 whether Achillion’s stockholders will approve the Merger 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 regulatory approvals from various governmental entities (including any conditions, limitations or restrictions placed on these approvals and the risk that one or more governmental entities may deny approval); the risk that the businesses will not be integrated successfully; disruption from the transaction making it more difficult to maintain business and operational relationships; negative effects of the announcement or the consummation of the proposed acquisition on the market price of Alexion’s common stock, Alexion’s credit ratings and/or Alexion’s operating results; significant transaction costs or unexpected expenses; unknown liabilities; the risk of litigation and/or regulatory actions related to the proposed acquisition; other business effects, including the effects of industry, market, economic, political or regulatory conditions; future exchange and interest rates; changes in tax and other laws, regulations, rates and policies, including government-mandated price decreases of Alexion’s products; future business combinations or disposals; 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; the potential benefits of factor D inhibition as a treatment for complement-mediated diseases, including danicopan (ACH-4471) for paroxysmal nocturnal hemoglobinuria and C3glomerulopathy (C3G); the potential benefits of, and indications for, Achillion’s compounds that inhibit factor D, including danicopan and ACH-5228; the status of enrollment in Achillion’s ongoing clinical trials; Achillion’s expectations regarding the advancement of, and timeline for reporting results from, clinical trials of its product candidates (including danicopan and ACH-5228) as well as its ability to advance additional compounds; the possibility that results of clinical trials are not predictive of safety and efficacy results of products in broader patient populations; the possibility that
clinical trials of product candidates could be delayed or terminated prior to completion for a number of reasons; the possibility that interim results from a clinical trial are not predictive of the final results of that trial and the possibility that results of early clinical trials or preclinical studies will not be indicative of the results of later clinical trials; Achillion’s expectations regarding the timing of regulatory interactions and filings; the uncertainty that the milestones for the contractual contingent value right payment may not be achieved in the prescribed timeframe or at all; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from Alexion’s and Achillion’s clinical studies; the possibility that Achillion fails to satisfactorily address matters raised by the regulatory agencies; whether and when drug applications may be filed in any jurisdictions for any potential indication for any of Alexion’s or Achillion’s pipeline assets; whether and when any such applications may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether any such products will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of any such products; and competitive developments.
A further description of risks and uncertainties relating to Achillion can be found in Achillion’s Annual Report on Form 10-K for the fiscal year ended December 31, 2018, 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 http://www.achillion.com.
These forward-looking statements are based on numerous assumptions and assessments made by Alexion and Achillion 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. The factors described in the context of such forward-looking statements in this document could cause Alexion’s plans with respect to Achillion, actual results, performance or achievements, industry results and developments to differ materially from those expressed in or implied by such forward-looking statements. Although it is believed that the expectations reflected in the forward-looking statements in this document are reasonable, no assurance can be given that such expectations will prove to have been correct and persons reading this document are therefore cautioned not to place undue reliance on these forward-looking statements which speak only as at the date of this document.
Note to Investors and Security Holders
This document does not constitute a solicitation of any vote or approval. In connection with the proposed acquisition of Achillion by Alexion, Achillion intends to file with the SEC a proxy statement, as well as other relevant documents concerning the proposed transaction. INVESTORS AND SECURITY HOLDERS OF ACHILLION ARE URGED TO READ THE PROXY STATEMENT REGARDING THE PROPOSED TRANSACTION WHEN IT BECOMES AVAILABLE AND ANY OTHER RELEVANT DOCUMENTS FILED WITH THE SEC, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS TO THOSE DOCUMENTS, BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION. You may obtain these documents (when they become available) free of charge through the website maintained by the SEC at http://www.sec.gov. Copies of the documents filed with the SEC by Alexion will be available free of charge on Alexion’s internet website at http://www.alexion.com under the tab, “Investors” and under the heading “SEC Filings” or by contacting Alexion’s Investor Relations Department at investorrelations@alexion.com. Copies of the documents filed with the SEC by Achillion will be available free of charge on Achillion’s internet
website at http://www.achillion.com under the tab “Investors and News” and under the heading “SEC Filings” or by contacting Achillion’s Investor Relations Department through http://ir.achillion.com/contact-us.
Certain Information Regarding Participants
Alexion, Achillion and their respective directors and executive officers may be considered participants in the solicitation of proxies in connection with the proposed transaction. Information about the directors and executive officers of Alexion is set forth in its Annual Report on Form 10-K for the year ended December 31, 2018, which was filed with the SEC on February 6, 2019, and its proxy statement for its May 14, 2019 annual meeting of stockholders, which was filed with the SEC on March 26, 2019. Information about the directors and executive officers of Achillion is set forth in its Annual Report on Form 10-K for the year ended December 31, 2018, which was filed with the SEC on March 7, 2019, and its proxy statement for its May 30, 2019 annual meeting of stockholders, which was filed with the SEC on April 15, 2019. Other information regarding the participants in the proxy solicitations and a description of their direct and indirect interests, by security holdings or otherwise, will be contained in the proxy statement and other relevant materials to be filed with the SEC regarding the proposed transaction when they become available.
The following exhibits are filed herein:
Exhibit Number | Description | |
104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |
Signature
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Date: October 21, 2019 | ALEXION PHARMACEUTICALS, INC. |
By: /s/ Doug Barry | |
Name: Doug Barry | |
Title: Vice President, Corporate Law | |
RARE INSPIRATION. CHANGING LIVES. Confidential – For internal use only
IN THE ROOM - B L U E B E L L 2 | RARE INSPIRATION. CHANGING LIVES. John Orloff, MD Gianluca Pirozzi Camilo Garcia EVP SVP VP G l o b a l Hematology & R & D H R ROLE H e a d o f Nephrology L e a d R&D R&D TA Head T I M E W I T H 2 Y e a r s 2 Y e a r s ALEXION 3 W e e k s Confidential – For internal use only
IN THE ROOM – N E W H A V E N 3 | RARE INSPIRATION. CHANGING LIVES. Aradhana Sarin, MD Sharon Barr Rachael Alford EVP VP VP H e a d o f Chief Strategy G l o b a l and Business H e a d o f ROLE P r o d u c t O f f i c e r R e s e a r c h Development T I M E W I T H 2 Y e a r s 1 5 Y e a r s ALEXION 6 y e a r s Confidential – For internal use only
ALEXION TO ACQUIRE ACHILLION 4 | RARE INSPIRATION. CHANGING LIVES. Strategic Rationale ✓ Opportunity to diversify into additional complement-mediated diseases using oral therapies • Adds clinical-stage portfolio of oral small molecule Factor D inhibitors to Alexion pipeline ✓ Potential to enhance treatment for PNH patients • Opportunity to treat the small portion of PNH patients experiencing clinical extravascular hemolysis (EVH) ✓ Potential first-in-class treatment for C3 glomerulopathy • Severe kidney disease with no approved treatment ✓ Promising development platform • Significant opportunity for Factor D inhibition in other alternative pathway complement-mediated rare diseases • Small molecule chemistry expertise and library ✓ Aligned with Alexion BD strategy Confidential – For internal use only
ALEXION BY THE NUMBERS 5 | RARE INSPIRATION. CHANGING LIVES. 3000+ TALENTED COLLEAGUES AROUND THE GLOBE PRIX3 GALIEN AWARDS 20+ YEARS OF LEADERSHIP IN COMPLEMENT BIOLOGY APPROVED $4.75 4 DEVASTATING6 THERAPIES RARE DISEASES -4.8b SERVING PATIENTS IN Projected Revenues in 2019 50 (Per 2Q19 Earnings release COUNTRIES MADDOX July 24, 2019) LIVING WITH HPP Confidential – For internal use only
OUR 25+ YEAR JOURNEY 6 | RARE INSPIRATION. CHANGING LIVES. 1992 2015 2017 2018 Alexion founded in New Haven, CT STRENSIQ® (asfotase alfa) first approved Partnered with Halozyme Therapeutics and ULTOMIRIS® (ravulizumab-cwvz) first ® for the treatment of patients with HPP established license agreement for ENHANZE approved for the treatment of adult patients 1996 drug-delivery technology with PNH Alexion goes public with ticker ALXN 2015 2018 ® (sebelipase alfa) first approved 2019 KANUMA Opened global headquarters in Boston 2007 for the treatment of patients with LAL-D Established partnerships with Caelum Biosciences, Zealand Pharma and Affibody SOLIRIS® (eculizumab) first approved for the treatment of patients with PNH 2018 2016 Acquired Wilson Therapeutics, the company Opened Center of Excellence in New Haven 2019 that developed ALXN1840 (WTX101) for the SOLIRIS first approved for the treatment of 2011 treatment of Wilson Disease adult patients with NMOSD SOLIRIS first approved for the 2017 treatment of patients with aHUS SOLIRIS first approved for the treatment of patients with gMG 2019 2018 Announced Japanese license agreement with 2012 Acquired Syntimmune, the company that BridgeBio to develop and commercialize Eidos’ Acquired asfostase alfa, a potential 2017 began development of ALXN1830 (SYNT001) AG10 for transthyretin amyloidosis (ATTR) treatment for patients living with HPP for the treatment of rare IgG-mediated Partnered with Halozyme Therapeutics and diseases established license agreement for ENHANZE® 2015 drug-delivery technology 2019 ULTOMIRIS first approved for the treatment of Acquired Synageva and added to its 2018 adults and pediatric patients one month of age pipeline KANUMA, a potential treatment Established partnerships with Complement and older with aHUS to inhibit complement- for patients living with LAL-D Pharma and Dicerna mediated thrombotic microangiopathy (TMA) APPROVALS ACQUISITIONS PARTNERSHIPS Confidential – For internal use only
MANAGEMENT TEAM 7 | RARE INSPIRATION. CHANGING LIVES. Ludwig Hantson, PhD Ellen Chiniara, JD Paul Clancy Indrani Franchini, JD Brian Goff Chief Executive Officer EVP, General Counsel EVP, Chief Financial Officer EVP, Chief Compliance Officer EVP, Chief Commercial Officer Anne-Marie Law John Orloff, MD Aradhana Sarin, MD Rana Strellis EVP, Chief Patient & Employee EVP, Global Head of Research EVP, Chief Strategy and SVP, Global Communications Experience Officer & Development Business Officer & Culture Confidential – For internal use only
IMPROVING PATIENT LIVES IN MORE THAN 50 COUNTRIES 8 | RARE INSPIRATION. CHANGING LIVES. REGIONS OF OPERATION United States International Japan Partners Confidential – For internal use only Major offices in Boston, New Haven, Dublin, Zurich and Tokyo
O U R V A L U E S 9 | RARE INSPIRATION. CHANGING LIVES. Our culture is rooted in integrity, inclusiveness, Serve Act with and our dedication to Patients Integrity joining and supporting the communities in which Empower Innovate for we live and work. People Solutions Confidential – For internal use only
THE MOST REWARDING COMPANY TO WORK FOR 10 | RARE INSPIRATION. CHANGING LIVES. WORLD CLASS LEADERSHIP AND INNOVATION CAPABILITY Leaders cultivate the climate for innovation and connect us to the experience of those we serve Alexion delivers world-class innovation to patients and caregivers to help them fully live their best lives PATIENT & EMPLOYEE EXPERIENCE We invest in and value By cultivating a deep understanding of the experience of both people who believe in the patients and employees, Alexion creates meaningful and importance of our purpose and fulfilling work, and a feeling of value, belonging and reward, understand what it takes for all employees to deliver on it. Confidential – For internal use only
SERVING THE COMMUNITIES WHERE WE LIVE AND WORK 11 | RARE INSPIRATION. CHANGING LIVES. 85+ PROJECTS 20+ COUNTRIES Our Global Day of Service is an annual opportunity for 8,500+ us to make a positive impact VOLUNTEER HOURS on the lives of the people in our local communities and each 1,700+ other EMPLOYEES Confidential – For internal use only
OUR KEY AREAS OF FOCUS 12 | RARE INSPIRATION. CHANGING LIVES. EXPAND ULTOMIRIS® (RAVULIZUMAB-CWVZ) 1. IN PNH PATIENTS AND PREPARE FOR AHUS VISION LAUNCHES ACCELERATE NEUROLOGY AS KEY 2. GROWTH DRIVER WITH gMG AND NMOSD 2025 4 GROWING, DURABLE EXECUTE AND EXPAND CLINICAL STAGE FRANCHISES PIPELINE 3. IN HEMATOLOGY & NEPHROLOGY 4. STRENGTHEN OUR PATIENT-CENTRIC CULTURE NEUROLOGY METABOLICS DELIVER TOP TIER BIOTECH FINANCIAL FcRn 5. PERFORMANCE Confidential – For internal use only
OUR MEDICINES 13 | RARE INSPIRATION. CHANGING LIVES. ULTOMIRIS® SOLIRIS® STRENSIQ® KANUMA® (RAVULIZUMAB-CWVZ) (ECULIZUMAB) (ASFOTASE ALFA) (SEBELIPASE ALFA) FOR FOR FOR FOR PNH PNH HPP LAL-D aHUS aHUS gMG NMOSD Confidential – For internal use only
2017 PIPELINE 14 | RARE INSPIRATION. CHANGING LIVES. 5 Development Preclinical Early Clinical Advanced Clinical Registration Programs Internal Complement ULTOMIRIS QW SC ALXN1210 IV PNH eculizumab gMG Programs Other Research ALXN1210 IV aHUS eculizumab NMOSD Hematology & Nephrology Metabolics Neurology FcRn TBD / Other Confidential – For internal use only
ACHILLION BOLSTERS ALEXION’S EARLY AND ADVANCED CLINICAL PIPELINES 15 | RARE INSPIRATION. CHANGING LIVES. 23 Development Preclinical Early Clinical Advanced Clinical Programs Planned Internal Complement ALXN1810 SC ALXN1840 (WTX101) ULTOMIRIS ALXN1210 QW SubQ Programs (ULTOMIRIS/PH20) Wilson Disease HSCT-TMA ABY-039 CAEL-101 Complement Pharma ULTOMIRISALXN1210 IVQW PNH SC Rare Autoimmune AL Amyloidosis ALXN1720 AG10 Dicerna ULTOMIRIS gMG (Anti-C5 Bi-specific) ATTR Cardiomyopathy1 Elamipretide Zealand ULTOMIRIS PPMS ULTOMIRIS NMOSD PMM Option to Co-Develop and Next-Gen Treatment ALXN1830 (SYNT001) Elamipretide Commercialize with Stealth ULTOMIRIS ALS for HPP SC (Healthy Volunteers) Barth Syndrome Biotherapeutics announced Oct 10th Next-Gen Factor D Elamipretide ALXN1830 (SYNT001) Elamipretide Inhibitors GA in AMD gMG LHON ACH-5228 ALXN1830 (SYNT001) Danicopan (ACH-4471) Subject to Achillion acquisition WAIHA PNH with Clinical EVH Hematology & Nephrology PNH approval and closure Danicopan (ACH-4471) Metabolics ACH-5228 C3G Neurology FcRn TBD / Other Italicized = plans to initiate Note: Caelum Biosciences deal is structured as an option to acquire 1Japan only Confidential – For internal use only
R&D HIRING TO DELIVER THE PORTFOLIO 16 | RARE INSPIRATION. CHANGING LIVES. +293 ~1200 R&D COLLEAGUES ADDED OR POSITIONS OFFERED YTD 2019 R&D COLLEAGUES AROUND THE GLOBE BY THE END OF 2020 PLAN TO HIRE UP TO …. +~175 from 2019 365 Yearend Headcount THIS YEAR IN TOTAL (pending budget approval) (+72 ADDITIONAL BY YEAREND) Confidential – For internal use only
ACQUISITION NEXT STEPS 17 | RARE INSPIRATION. CHANGING LIVES. • Alexion’s acquisition of Achillion is subject to: • The approval of Achillion shareholders • Satisfaction of other customary closing conditions • Approval from relevant regulatory agencies, including clearance under the Hart-Scott Rodino Antitrust Improvements Act • Pending these approvals, the transaction is expected to close in the first half of 2020 • Until this time, we will continue to operate as two independent companies; Achillion will continue to make all decisions for all aspects of its business until the closing • Details for integration planning will be worked out over the coming months; as such, we are not able to provide answers on all the questions that you have today • We are committed to have a Day 1 kickoff to share details with employees once the deal closes • We are focused on ensuring that continuity is maintained in the clinical trials that are ongoing • We are committed to the KOLs and patients that are involved in the danicopan and ACH-5228 trials • We welcome having a presence in Pennsylvania to support these programs Confidential – For internal use only
18 | RARE INSPIRATION. CHANGING LIVES. QUESTIONS? Confidential – For internal use only
ADDITIONAL INFORMATION ABOUT THE PROPOSED TRANSACTION AND WHERE TO FIND IT 19 | RARE INSPIRATION. CHANGING LIVES. • This document does not constitute a solicitation of any vote or approval. In connection with the proposed acquisition of Achillion by Alexion, Achillion intends to file with the SEC a proxy statement, as well as other relevant documents concerning the proposed transaction. INVESTORS AND SECURITY HOLDERS OF ACHILLION ARE URGED TO READ THE PROXY STATEMENT REGARDING THE PROPOSED TRANSACTION WHEN IT BECOMES AVAILABLE AND ANY OTHER RELEVANT DOCUMENTS FILED WITH THE SEC, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS TO THOSE DOCUMENTS, BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION. You may obtain these documents (when they become available) free of charge through the website maintained by the SEC at http://www.sec.gov. Copies of the documents filed with the SEC by Alexion will be available free of charge on Alexion’s internet website at http://www.alexion.com under the tab, “Investors” and under the heading “SEC Filings” or by contacting Alexion’s Investor Relations Department at investorrelations@alexion.com. Copies of the documents filed with the SEC by Achillion will be available free of charge on Achillion’s internet website at http://www.achillion.com under the tab “Investors and News” and under the heading “SEC Filings” or by contacting Achillion’s Investor Relations Department through http://ir.achillion.com/contact-us • Alexion, Achillion and their respective directors and executive officers may be considered participants in the solicitation of proxies in connection with the proposed transaction. Information about the directors and executive officers of Alexion is set forth in its Annual Report on Form 10-K for the year ended December 31, 2018, which was filed with the SEC on February 6, 2019, and its proxy statement for its May 14, 2019 annual meeting of stockholders, which was filed with the SEC on March 26, 2019. Information about the directors and executive officers of Achillion is set forth in its Annual Report on Form 10-K for the year ended December 31, 2018, which was filed with the SEC on March 7, 2019, and its proxy statement for its May 30, 2019 annual meeting of stockholders, which was filed with the SEC on April 15, 2019. Other information regarding the participants in the proxy solicitations and a description of their direct and indirect interests, by security holdings or otherwise, will be contained in the proxy statement and other relevant materials to be filed with the SEC regarding the proposed transaction when they become available Confidential – For internal use only