MEDG Medgenics(Regs)

Medgenics, Inc. (NYSE MKT: MDGN and AIM: MEDU, MEDG) (the “Company”), the developer of a novel technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, today reported financial results for the three months ended March 31, 2013 and the filing with the U.S. Securities and Exchange Commission (“SEC”) of the Company’s Quarterly Report on Form 10-Q. The Form 10-Q includes unaudited interim consolidated financial statements containing the information presented below, as well as additional information regarding the Company. The Form 10-Q is available at www.sec.gov and at www.medgenics.com.

Highlights of the First Quarter and recent weeks:

• Raised gross proceeds of approximately $32 million in a public offering of common stock and warrants
• Appointed Joseph J. Grano, Jr., former Chairman and CEO of UBS Financial Services, to the Company’s Board of Directors
• Received a Notice of Allowance from the U.S. Patent Office for claims that expand the patent protection for the Company’s Biopump™ platform technology for additional therapeutic proteins
• Reported interim results from the Company’s ongoing Phase IIa study of EPODURE™ to treat anemia in dialysis patients

Management Commentary

“During the first quarter we achieved important milestones that strengthened our position in key areas and advanced our strategic and clinical goals,” stated Andrew L. Pearlman, Ph.D., President and Chief Executive Officer of Medgenics. “We raised gross proceeds of approximately $32 million to strengthen our financial foundation, reported interim clinical results from our Phase IIa anemia trial in patients with end-stage renal disease, fortified our intellectual property and enhanced our Board of Directors with the appointment of Joseph J. Grano, Jr.

“We look forward to advancing our clinical studies in both Israel and the U.S. and to achieving a number of value-creating milestones throughout the remainder of 2013,” concluded Dr. Pearlman.

First Quarter Financial Results

Gross research and development (“R&D”) expense for the first quarter of 2013 increased to $2.03 million from $1.59 million for same period in 2012 due to an increase in R&D personnel. Net R&D expense for the 2013 first quarter was $2.03 million compared with net R&D expense of $0.57 million for the prior year’s first quarter, when grants of $1.02 million were received from the Israel Office of the Chief Scientist.

General and administrative expense for the first quarter of 2013 was $2.55 million compared with $1.36 million for the first quarter of 2012, primarily due to increased stock-based compensation granted to directors and consultants.

Financial income for the first quarter of 2013 increased to $0.92 million from $0.02 million for the same period in 2012, mainly as a result of changes in valuation of the warrant liability.

For the quarter ended March 31, 2013, the Company reported a net loss of $3.68 million or $0.29 diluted loss per share, compared with a net loss of $2.71 million or $0.28 per share in the comparable 2012 period.

As of March 31, 2013, Medgenics had cash and cash equivalents of $32.46 million, compared with $6.43 million as of December 31, 2012. For the three months ended March 31, 2013, the Company used $2.80 million in net cash to fund operating activities, compared with $2.36 million for the three months ended March 31, 2012.

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 tissue for the treatment of a range of chronic diseases including anemia, hepatitis and hemophilia, among others.

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.

 

 

MEDGENICS, INC. AND ITS SUBSIDIARY

 (A Development Stage Company)

CONSOLIDATED BALANCE SHEETS

    U.S. dollars in thousands     March 31, December 31, 2013 2012 Unaudited ASSETS   CURRENT ASSETS:   Cash and cash equivalents $ 32,463 $ 6,431 Accounts receivable and prepaid expenses   572   539   Total current assets   33,035   6,970   LONG-TERM ASSETS:   Restricted lease deposits 45 62 Severance pay fund   229   283   Total long-term assets   274   345     PROPERTY AND EQUIPMENT, NET   350   352   DEFERRED ISSUANCE EXPENSES   -   40   Total assets $ 33,659 $ 7,707    

MEDGENICS, INC. AND ITS SUBSIDIARY

(A Development Stage Company)

CONSOLIDATED BALANCE SHEETS

U.S. dollars in thousands

   

 

March 31,

December 31,

2013 2012 Unaudited   LIABILITIES AND STOCKHOLDERS' EQUITY   CURRENT LIABILITIES:   Trade payables $ 951 $ 877 Other accounts payable and accrued expenses   1,718     1,473     Total current liabilities   2,669     2,350     LONG-TERM LIABILITIES:   Accrued severance pay 1,429 1,492 Liability in respect of warrants   1,017     1,931     Total long-term liabilities   2,446     3,423     Total liabilities   5,115     5,773       STOCKHOLDERS' EQUITY:   Common stock - $0.0001 par value;

100,000,000 shares authorized; 18,481,308 and 12,307,808 shares issued and outstanding at March 31, 2013 and December 31, 2012, respectively

2 1 Additional paid-in capital 96,797 66,509 Deficit accumulated during the development stage   (68,255 )   (64,576 )   Total stockholders' equity   28,544     1,934     Total liabilities and stockholders' equity $ 33,659   $ 7,707      

MEDGENICS, INC. AND ITS SUBSIDIARY

(A Development Stage Company)

CONSOLIDATED STATEMENTS OF OPERATIONS

U.S. dollars in thousands (except share and per share data)

  Three months ended

March 31,

2013   2012     Research and development expenses $ 2,031 $ 1,592   Less - Participation by the Office of the Chief Scientist   -     (1,022 )   Research and development expenses, net 2,031 570   General and administrative expenses   2,546     1,359     Operating loss (4,577 ) (1,929 )   Financial expenses (14 ) (801 ) Financial income   915     18     Loss before taxes on income (3,676 ) (2,712 )   Taxes on income   3     -     Loss $ (3,679 ) $ (2,712 )   Basic loss per share $ (0.24 ) $ (0.28 ) $ (0.28 ) Diluted loss per share $ (0.29 )   15,222,268     9,753,725   Weighted average number of Common stock used in computing basic loss per share Weighted average number of Common stock used in computing diluted loss per share   15,634,768     9,753,725