TIDMMEDG TIDMMEDU
RNS Number : 3196D
Medgenics Inc
14 May 2012
Press Release 14 May 2012
Medgenics Announces First Quarter 2012 Financial Results
Medgenics, Inc. (NYSE Amex: 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 announced financial results for three month
ended March 31, 2012, 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 audited consolidated financial
statements containing the information highlighted below, as well as
additional information regarding the Company. The Form 10-Q is
available at www.sec.gov and at www.medgenics.com.
First Quarter Financial Results
Gross research and development ("R&D") expense for the first
quarter of 2012 increased to $1.59 million from $1.17 million for
same period in 2011. This increase is due to increased use of
materials and sub-contractors in anticipation of four planned
trials, including two Phase II trials of EPODURE(TM) one in Israel
and one in the U.S., and two trials of INFRADURE(TM) in Israel; and
an increase in R&D headcount.
General and administrative expense for the first quarter of 2012
was $1.36 million compared with $0.78 million for the first quarter
of 2011, primarily due to higher legal and professional services
fees and to increased activities in the U.S. as part of forthcoming
clinical trials.
Financial expense for the first quarter of 2012 increased to
$0.80 million from $0.11 million for the same period in 2011; and
financial income for the first quarter of 2012 decreased to $0.02
million from $1.70 million in the same period of 2011. Both of
these changes are mainly a result of changes in valuation of the
warrant liability.
The Company reported a net loss for the first quarter of 2012 of
$2.71 million or $0.28 per share, compared with a net loss for the
first quarter of 2011 of $0.34 million or $0.06 per share.
As of March 31, 2012 Medgenics had cash and cash equivalents of
$2.59 million, compared with $5.00 million as of December 31, 2011.
Net cash used in operating activities in the first quarter of 2012
was $2.36 million compared with $1.53 million used in the first
quarter of 2011.
"We have executed well on our plan, progressing as forecasted,
particularly on clinical and regulatory milestones. We have
recently been awarded an Israeli government grant of up to an
approximately $2.2 million from the Office of the Chief Scientist
to advance our manufacturing process in Israel and to advance the
establishment of a U.S. center to process Biopumps in a GMP
facility to supply our planned clinical trial needs in the US,"
stated Andrew L. Pearlman, Ph.D., Chief Executive Officer of
Medgenics.
About Medgenics
Medgenics is developing and commercializing Biopump(TM), 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 and hemophilia, among others. 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:
-- EPODURE(TM) to produce and deliver erythropoietin for many
months from a single administration, has demonstrated elevation and
stabilization of hemoglobin levels in anemic patients for six to
more than 36 months in a Phase I/II dose-ranging trial, and is
about to commence a Phase IIa safety/efficacy trial in dialysis
patients in Q2 2012 in Israel. An Investigational New Drug
application has been filed with the FDA to initiate a Phase IIb
study to evaluate the safety and efficacy of EPODURE in the
treatment of anemia in dialysis patients in the U.S.
-- INFRADURE(TM) for sustained production and delivery of
interferon-alpha for use in the treatment of hepatitis is awaiting
final approval of two Phase I/II trials in Israel in hepatitis C,
slated to commence in Q3 2012, and is filed for Orphan Drug
Designation with the FDA to treat hepatitis D.
-- HEMODURE(TM) for sustained production and delivery of
clotting Factor VIII therapy for the sustained prophylactic
treatment of hemophilia is now in development.
Medgenics is focused on the development and manufacturing of its
innovative Biopumps, aiming to bring them to market via strategic
partnerships with major pharmaceutical and/or medical device
companies.
In addition to treatments for anemia, hepatitis 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:
Medgenics, Inc. Phone: +972 4 902 8900
Dr. Andrew L. Pearlman
Andrew.pearlman@medgenics.com
LHA Phone: 212-838-3777
Anne Marie Fields
afields@lhai.com
@LHA_IR_PR
Abchurch Communications Phone: +44 207 398 7719
Adam Michael
Joanne Shears
Jamie Hooper
jamie.hooper@abchurch-group.com
SVS Securities plc (Joint Broker) Phone: +44 207 638 5600
Alex Mattey
Ian Callaway
Nomura Code Securities (Joint Broker) Phone: +44 207 776 1219
Jonathan Senior
- Tables to Follow -
MEDGENICS, INC. AND ITS SUBSIDIARY
(A Development Stage Company)
CONSOLIDATED BALANCE SHEETS
----------------------------
U.S. dollars in thousands
December
March 31, 31,
2012 2011
---------- ---------
Unaudited
----------
ASSETS
CURRENT ASSETS:
Cash and cash equivalents $ 2,593 $ 4,995
Accounts receivable and prepaid expenses 1,807 1,122
---------- ---------
Total current assets 4,400 6,117
---------- ---------
LONG-TERM ASSETS:
Restricted lease deposits 57 52
Severance pay fund 267 259
---------- ---------
Total long-term assets 324 311
---------- ---------
PROPERTY AND EQUIPMENT, NET 435 434
---------- ---------
DEFERRED ISSUANCE EXPENSES 42 -
---------- ---------
Total assets $ 5,201 $ 6,862
========== =========
December
March 31, 31,
2012 2011
---------- ---------
Unaudited
----------
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES:
Trade payables $ 824 $ 903
Other accounts payable and accrued expenses 1,146 1,156
Total current liabilities 1,970 2,059
---------- ---------
LONG-TERM LIABILITIES:
Accrued severance pay 1,422 1,328
Liability in respect of warrants 1,274 478
---------- ---------
Total long-term liabilities 2,696 1,806
---------- ---------
Total liabilities 4,666 3,865
---------- ---------
COMMITMENTS AND CONTINGENCIES
STOCKHOLDERS' EQUITY:
Common stock - $0.0001 par value;
100,000,000 shares authorized; 9,772,725
and 9,722,725 shares issued and outstanding
at March 31, 2012 and December 31, 2011,
respectively 1 1
Additional paid-in capital 52,751 52,501
Deficit accumulated during the development
stage (52,217) (49,505)
---------- ---------
Total stockholders' equity 535 2,997
---------- ---------
Total liabilities and stockholders' equity $ 5,201 $ 6,862
========== =========
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 Period from
March 31, January
27, 2000
(inception)
through
March 31,
-----------------------
2012 2011 2012
---------- ---------- -------------
Unaudited
---------------------------------------
Research and development expenses $ 1,592 $ 1,174 $ 32,034
Less - Participation by the Office
of the Chief
Scientist (1,022) - (6,315)
U.S. Government grant - - (244)
Participation by third party - - (1,067)
---------- ---------- -------------
Research and development expenses,
net 570 1,174 24,408
General and administrative expenses 1,359 780 27,757
Other income:
Excess amount of participation in
research and development from third
party - - (2,904)
---------- ---------- -------------
Operating loss (1,929) (1,954) (49,261)
Financial expenses (801) (106) (3,682)
Financial income 18 1,722 373
---------- ---------- -------------
Loss before taxes on income (2,712) (338) (52,570)
Taxes on income - - 76
---------- ---------- -------------
Loss $ (2,712) $ (338) $ (52,646)
========== ========== =============
Basic and diluted loss per share $ (0.28) $ (0.063)
========== ==========
Weighted average number of Common
stock used in computing basic and
diluted loss per share 9,753,725 5,370,270
========== ==========
- Ends -
This information is provided by RNS
The company news service from the London Stock Exchange
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