UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
Current Report
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
July 5, 2011 (June 20, 2011)
Date of Report (Date of earliest event reported)
MEDGENICS, INC.
(Exact name of registrant as specified in its charter)
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Delaware
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1-35112
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98-0217544
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(State or other jurisdiction of
incorporation or organization)
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(Commission File Number)
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(I.R.S. Employer
Identification No.)
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8000 Towers Crescent Drive, Suite 1300
Vienna, Virginia 22182
(Address of principal executive offices, zip code)
(646) 239-1690
(Registrant’s telephone number, including area code)
Not Applicable
(Former name or former address, if changed since last report)
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):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Item 5.02
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Departure of Directors or Certain Officers; Election of Directors;
Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
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On June 20, 2011, the Board of Directors of Medgenics, Inc. (the “Company”) appointed Clarence L. “Butch” Dellio, 65, as Chief Operating Officer of the Company, effective as of July 1, 2011. Upon the commencement of Mr. Dellio’s employment, Stephen Bellomo, who previously served as the Company’s Chief Operating Officer, will continue with the Company as Vice President of Product Development and Intellectual Property and Chief Operating Officer of Medgenics Medical (Israel) Limited, the Company’s wholly-owned operating subsidiary located in Israel.
Most recently, since 2008, Mr. Dellio has been a consultant to a variety of emerging biotechnology and medical technology companies, providing facilities, manufacturing, clinical and regulatory expertise to therapeutics and diagnostics companies, including to the Company since January 2011.
From 2004 to 2008 Mr. Dellio served as President and Chief Operating Officer of Neosil, Inc., a venture-backed dermatology company that subsequently merged with Peplin, Inc. From 1984 to 2004, he was Chief Operating Officer and Senior Vice President-Operations for XOMA Ltd., a publicly held biotechnology company focused on peptides and monoclonal antibodies. At XOMA he held a series of progressively responsible positions culminating in CFO and VP Manufacturing, where he led a staff of 70 in manufacturing, facilities, process development, quality assurance/quality control, purchasing and information technology. Previously Mr. Dellio was Vice President Manufacturing/New Product Development Manager at Becton-Dickinson & Company, a global medical technology company. During his 11 years at Becton-Dickinson he held various positions in multiple divisions, including Director of Planning, Division Controller, Strategic Business Unit Controller and Cost/Staff Accountant. Mr. Dellio earned his B.S. in Accounting from Bentley College and served in the U.S. Air Force.
In connection with his appointment, Mr. Dellio was issued options to purchase 40,000 shares of the Company’s common stock under the Company’s 2006 Stock Incentive Plan. Such options will vest in equal increments over three years, expire in 10 years and have an exercise price of $3.64 per share.
In connection with his appointment, the Company expects to enter into an employment agreement with Mr. Dellio. As of this time, the terms of Mr. Dellio’s employment agreement with the Company have not been finalized. Upon reaching an agreement on these terms, the Company will file an amendment to this Form 8-K to disclose such terms.
In addition, as previously reported in a Current Report on Form 8-K filed on June 8, 2011, the Company elected Isaac Blech to serve as a director of the Company on June 8, 2011. In connection with his election as a director, on June 30, 2011, the Company and Mr. Blech executed a Non-Executive Director Appointment Letter dated as of June 6, 2011 (the “Letter Agreement”) setting forth, among other things, Mr. Blech’s duties as a director. Pursuant to the Letter Agreement, Mr. Blech will be entitled to the same cash fees for his services as a director as the other non-executive directors pursuant to the director compensation plan previously adopted by the Board. These fees consist of a $5,000 annual retainer fee, as well as meeting fees that range between $750 and $2,000 per meeting based on location and type. The fees are fixed for a period of one year from the date of the Letter Agreement, following which they shall be subject to review. Pursuant to the Letter Agreement, Mr. Blech also agreed to maintain the confidentiality of all confidential business information, to disclose conflicts of interest to the Company and not to compete or solicit certain employees or other parties with which the Company does business for a period ending twelve months following the termination of his directorship.
The foregoing description of the Letter Agreement is qualified in its entirety by reference to the Letter Agreement, a copy of which is filed as Exhibit 10.1 to this Form 8-K and incorporated by reference herein.
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Item 7.01
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Regulation FD Disclosure.
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Attached hereto as Exhibit 99.1 is a copy of the Company’s press release dated July 5, 2011, which contains information regarding the appointment of Mr. Dellio as the Company’s Chief Operating Officer.
The information furnished in this report under this Item 7.01, including the Exhibit attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
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(d)
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Exhibits. The following exhibits are filed or furnished herewith:
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Exhibit No.
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Description
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10.1
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Non-Executive Director Appointment Letter, dated as of June 6, 2011, for Isaac Blech.
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99.1
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Medgenics, Inc. Press Release dated July 5, 2011 (furnished pursuant to Item 7.01).
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SIGNATURES
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.
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MEDGENICS, INC.
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By:
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/s/ Phyllis K. Bellin
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Name: Phyllis K. Bellin
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Title: Director of Finance and Administration
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Date: July 5, 2011
July 5, 2011
MEDGENICS NAMES CLARENCE “BUTCH” DELLIO AS CHIEF OPERATING OFFICER
Experienced Biotech Executive Provides Strategic Management and Manufacturing Expertise
MISGAV, Israel and San Francisco (July 5, 2011) – Medgenics, Inc. (NYSE Amex: MDGN and AIM: MEDU, MEDG)
today announced that Clarence “Butch” Dellio has been named to the position of Chief Operating Officer. Mr. Dellio will be based in the Company’s new U.S. headquarters located in San Francisco, California. Former Chief Operating Officer, Stephen Bellomo, will continue with the Company as Vice President of Product Development and Intellectual Property and Chief Operating Officer of Medgenics Medical (Israel) Limited, the Company’s wholly-owned operating subsidiary located in Israel.
Most recently Mr. Dellio has been a consultant to a variety of emerging biotechnology and medical technology companies, providing facilities, manufacturing, clinical and regulatory expertise to therapeutics and diagnostics companies.
From 2004 to 2008 Mr. Dellio served as President and Chief Operating Officer of Neosil, Inc., a venture-backed dermatology company that subsequently merged with Peplin, Inc. From 1984 to 2004, he was Chief Operating Officer and Senior Vice President-Operations for XOMA Ltd., a publicly held biotechnology company focused on peptides and monoclonal antibodies. At XOMA he held a series of progressively responsible positions culminating in CFO and VP Manufacturing, where he led a staff of 70 in manufacturing, facilities, process development, QA/QC, purchasing and information technology. Previously Mr. Dellio was Vice President Manufacturing/New Product Development Manager at Becton-Dickinson & Company, a global medical technology company. During his 11 years at Becton-Dickinson he held various positions in multiple divisions, including Director of Planning, Division Controller, Strategic Business Unit Controller and Cost/Staff Accountant. Mr. Dellio earned his B.S. in Accounting from Bentley College and served in the U.S. Air Force.
“Butch is a successful, results-orientated executive with impressive credentials. He is known for rapidly scaling-up companies and for attracting and building quality management teams,” stated Andrew L. Pearlman, Ph.D., President and CEO of Medgenics. “In April 2011 we completed our U.S. initial public offering as part of our strategy to establish a U.S. presence, and Butch’s appointment is an important step in executing that strategy. His experience with clinical and manufacturing processes will be valuable to Medgenics as we expand our autologous, tissue-based technology platform into the U.S.”
Commenting on his appointment, Mr. Dellio said, “I am delighted to be joining Medgenics at this important juncture in its development. The Biopump is an exciting technology that has the potential to change the treatment paradigm in a number of chronic diseases. I look forward to working with the Medgenics team to build the Company’s U.S. presence and to advancing this breakthrough technology toward commercialization.”
In connection with his appointment, Mr. Dellio was issued options to purchase 40,000 shares of Medgenics common stock under the Company’s 2006 Stock Incentive Plan. Such options will vest in equal increments over four years, expire in 10 years and have an exercise price of $3.64 per share. Further details of Mr. Dellio
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s employment are set out in the related Form 8-K, a copy of which will be available on the Company
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s website: www.medgenics.com.
Mr. Dellio is not being appointed to the Board of Medgenics, Inc. and therefore no further disclosure is required under the AIM Rules.
About Medgenics
Medgenics is developing and commercializing Biopump, a proprietary tissue-based platform technology for the sustained production and delivery of therapeutic proteins using the patient’s own skin biopsy for the treatment of a range of chronic diseases including anemia, hepatitis C and hemophilia. Medgenics believes this approach has multiple benefits compared with current treatments, which include regular and costly injections of therapeutic proteins.
Medgenics has three long-acting protein therapy products in development based on this technology:
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EPODURE (now completing a Phase I/II dose-ranging trial) to produce and deliver erythropoietin for many months from a single administration, has demonstrated elevation and stabilization of hemoglobin levels in anemic patients for 6 to more than 24 months;
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INFRADURE (to commence a Phase I/II trial in Israel in 2011) to produce a sustained therapeutic dose of interferon-alpha for use in the treatment of hepatitis C;
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HEMODURE is a sustained Factor VIII therapy for the prophylactic treatment of hemophilia, now in development.
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Medgenics intends to develop its innovative products and bring them to market via strategic partnerships with major pharmaceutical and/or medical device companies. Since October 2009, HEMODURE has been the focus of cooperation between Medgenics and a major healthcare company, a market leader in hemophilia.
In addition to treatments for anemia, hepatitis C and hemophilia, Medgenics plans to develop and/or out-license a pipeline of future Biopump products targeting the large and rapidly growing global protein therapy market, which is forecast to reach $132 billion in 2013. Other potential applications for Biopumps include multiple sclerosis, arthritis, pediatric growth hormone deficiency, obesity and diabetes.
Forward-looking Statements
This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995, which include all statements other than statements of historical fact, including (without limitation) those regarding the Company's financial position, its development and business strategy, its product candidates and the plans and objectives of management for future operations. The Company intends that such forward-looking statements be subject to the safe harbors created by such laws. Forward-looking statements are sometimes identified by their use of the terms and phrases such as "estimate," "project," "intend," "forecast," "anticipate," "plan," "planning, "expect," "believe," "will," "will likely," "should," "could," "would," "may" or the negative of such terms and other comparable terminology. All such forward-looking statements are based on current expectations and are subject to risks and uncertainties. Should any of these risks or uncertainties materialize, or should any of the Company's assumptions prove incorrect, actual results may differ materially from those included within these forward-looking statements. Accordingly, no undue reliance should be placed on these forward-looking statements, which speak only as of the date made. The Company expressly disclaims any obligation or undertaking to disseminate any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. As a result of these factors, the events described in the forward-looking statements contained in this release may not occur.
For further information, contact:
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Medgenics, Inc.
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Phone: +972 4 902 8900
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Dr. Andrew L. Pearlman
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Lippert/Heilshorn & Associates, Inc.
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Phone: 212-838-3777
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Anne Marie Fields
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afields@lhai.com
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De Facto Financial
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Phone: +44 207 556 1064
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Mike Wort
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Anna Dunphy
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Religare Capital Markets (Nomad)
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Phone: +44 207 444 0800
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James Pinner
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Derek Crowhurst
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SVS Securities plc (Joint Broker)
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Phone: +44 207 638 5600
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Alex Mattey
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Ian Callaway
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Nomura Code Securities (Joint Broker)
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Phone: +44 207 776 1219
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Jonathan Senior
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