TIDMMEDG TIDMMEDU

RNS Number : 0674L

Medgenics Inc

06 August 2013

 
Press Release  6 August 2013 
 

Medgenics Reports Second Quarter Financial Results

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 and six months ended June 30, 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.

Management Commentary

"The first half of 2013 was an active and productive period during which we made progress in a number of significant areas and positioned the Company to address important near term milestones," stated Andrew L. Pearlman, Ph.D., President and Chief Executive Officer of Medgenics. "We advanced our clinical programs, fortified our patent portfolio, were awarded a grant of approximately $2 million from the Israeli Office of the Chief Scientist (OCS) and raised substantial capital in a public offering to support the forward momentum of our programs.

"In April 2013 we reported interim data from our Israeli Phase IIa clinical study of EPODURE to treat anemia in patients with end-stage renal disease who are on dialysis, which showed sustained hemoglobin levels in patients for months without the need for injections of erythropoietin. We completed a number of key preparations and continue to be on target to initiate our U.S. Phase II study of EPODURE in similar patients. This will be our first U.S. clinical study for the Biopump technology. We reported the launch and enrollment of the first patient in our Phase I/II proof-of-concept clinical study of INFRADURE in the treatment of hepatitis C in Israel, and look forward to reporting interim data from this study before year-end. We expect to use data from this trial to support the clinical development and regulatory strategy for INFRADURE to treat hepatitis D, an indication for which we have U.S. orphan drug designation. We are exploring its role in treating hepatitis B as well.

"In addition, we continue to make advances in optimizing our Biopump platform through a number of developments that include enhancements to the protein expression technology and Biopump processing methods, as well as to improvements inpatient administration. These developments have the potential to further increase production and delivery of protein and to extend the duration of clinical effect," added Dr. Pearlman.

Second Quarter Financial Results

Gross research and development (R&D) expense for the second quarter of 2013 increased to $2.07 million from $1.64 million for same period in 2012. Net R&D expense for the 2013 second quarter was $0.86 million compared with net R&D expense of $1.18 million for the prior year's second quarter. The decrease in net R&D expense was due to the participation by the OCS of $1.22 million in the three months ended June 30, 2013, compared with $0.46 million in the same period in 2012, somewhat offset by the increase in the gross R&D expense.

General and administrative expense for the second quarter of 2013 decreased to $1.59 million compared with $2.77 million for the comparative quarter in 2012, due primarily to lower stock-based compensation expense related to options and restricted shares granted to directors and consultants.

Financial expenses for the quarter ended June 30, 2013 were $0.03 million, compared with $2.97 million for the same period in 2012. This decrease was mainly due to the change in valuation of the warrant liability.

Financial income for the quarter ended June 30, 2013 was $0.37 million, increasing from $0.02 million for the same period in 2012. This increase was primarily due to the change in valuation of the warrant liability.

For the second quarter of 2013 the Company reported a net loss of $2.10 million or $0.11 per share, compared with a net loss of $6.91 million or $0.69 per share for the second quarter of 2012.

Six Month Financial Results

Gross R&D expense for the first half of 2013 increased to $4.10 million from $3.23 million for same period in 2012 due to an increase in R&D personnel. Net R&D expense for the first half of 2013 was $2.89 million compared with net R&D expense of $1.75 million for the first half of 2012. The increase in net R&D expense was due to the participation by the OCS of $1.22 million in the six months ended June 30, 2013 compared with $1.49 million in the same period in 2012, and by the increase in the gross R&D expense as explained above.

General and administrative expense for the six months ended June 30, 2013 of $4.13 million was consistent with the prior-year period.

Financial income for the six months ended June 30, 2013 of $1.29 million was due primarily to the change in valuation of the warrant liability.

For the six months ended June 30, 2013, the Company reported a net loss of $5.78 million or $0.42 diluted loss per share, compared with a net loss of $9.66 million or $0.98 per share in the comparable 2012 period.

The Company ended the second quarter with cash and cash equivalents of $28.98 million, compared with $6.43 million as of December 31, 2012. Medgenics raised gross proceeds of approximately $32 million in a public offering of common stock and warrants during the first quarter of 2013. The Company used $6.18 million in net cash to fund operating activities during the first half of 2013, compared with $4.34 million for the first half of 2012.

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 tissue for the treatment of a range of chronic diseases including anemia, hepatitis, among others. For more information, please visit www.medgenics.com.

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: +1 212-838-3777 
 Anne Marie Fields 
 afields@lhai.com 
Abchurch Communications                Phone: +44 207 398 7718 
 Joanne Shears 
 Jamie Hooper 
 Harriet Rae 
 Harriet.rae@abchurch-group.com 
Nomura Code Securities (NOMAD & Joint  Phone: +44 207 776 1200 
 Broker) 
 Jonathan Senior 
 Giles Balleny 
SVS Securities plc (Joint Broker)      Phone: +44 207 638 5600 
 Alex Brearley 
 

-Tables to follow-

MEDGENICS, INC. AND ITS SUBSIDIARY

(A Development Stage Company)

 
 CONSOLIDATED BALANCE SHEETS 
------------------------------------------------------------------------ 
 U.S. dollars in thousands 
                                                                December 
                                                 June 30,          31, 
                                            ------------------ 
                                              2013      2012      2012 
                                            --------  --------  -------- 
                                               (Unaudited) 
                                            ------------------ 
ASSETS 
 
CURRENT ASSETS: 
 
 Cash and cash equivalents                  $ 28,979   $ 9,040   $ 6,431 
 Accounts receivable and prepaid expenses      1,818     1,702       539 
                                            --------  --------  -------- 
 
Total current assets                          30,797    10,742     6,970 
                                            --------  --------  -------- 
 
LONG-TERM ASSETS: 
 
 Restricted lease deposits                        43        57        62 
 Severance pay fund                              243       264       283 
Property and equipment, net                      410       407       352 
                                            --------  --------  -------- 
 
Total long-term assets                           696       728       697 
                                            --------  --------  -------- 
 
 
DEFERRED ISSUANCE EXPENSES                         -         -        40 
                                            --------  --------  -------- 
 
Total assets                                $ 31,493  $ 11,470   $ 7,707 
                                            ========  ========  ======== 
 
 
 

The accompanying notes are an integral part of the interim consolidated financial statements.

MEDGENICS, INC. AND ITS SUBSIDIARY

(A Development Stage Company)

 
 CONSOLIDATED BALANCE SHEETS 
--------------------------------------------------------------------------------- 
 U.S. dollars in thousands 
                                                                       December 
                                                      June 30,            31, 
                                                -------------------- 
                                                  2013       2012        2012 
                                                --------  ----------  ----------- 
                                                    (Unaudited) 
                                                -------------------- 
 
LIABILITIES AND STOCKHOLDERS' EQUITY 
 
CURRENT LIABILITIES: 
 
Trade payables                                     $ 901       $ 917        $ 877 
Other accounts payable and accrued expenses        1,425       1,249        1,473 
                                                -------- 
 
Total current liabilities                          2,326       2,166        2,350 
                                                --------  ----------  ----------- 
 
LONG-TERM LIABILITIES: 
 
Accrued severance pay                              1,446       1,387        1,492 
Liability in respect of warrants                     654       4,107        1,931 
                                                --------  ----------  ----------- 
 
Total long-term liabilities                        2,100       5,494        3,423 
                                                --------  ----------  ----------- 
 
Total liabilities                                  4,426       7,660        5,773 
                                                --------  ----------  ----------- 
 
STOCKHOLDERS' EQUITY: 
 
Common stock - $ 0.0001 par value; 
 100,000,000 shares authorized; 18,481,308, 
 11,746,251 and 12,307,808 shares issued 
 and outstanding at June 30, 2013, June 
 30, 2012 and December 31, 2012, respectively          2           1            1 
Additional paid-in capital                        97,419      62,972       66,509 
Deficit accumulated during the development 
 stage                                          (70,354)    (59,163)     (64,576) 
                                                --------  ----------  ----------- 
 
Total stockholders' equity                        27,067       3,810        1,934 
                                                --------  ----------  ----------- 
 
Total liabilities and stockholders' 
 equity                                         $ 31,493    $ 11,470      $ 7,707 
                                                ========  ==========  =========== 
 
 

The accompanying notes are an integral part of the interim consolidated financial statements.

MEDGENICS, INC. AND ITS SUBSIDIARY

(A Development Stage Company)

 
 CONSOLIDATED STATEMENTS OF OPERATIONS 
 U.S. dollars in thousands (except share and per share data) 
                                                                                    Period 
                                                                                  from January 
                                                                                    27, 2000 
                                                                                  (inception) 
                                    Six months ended       Three months ended       through 
                                         June 30,               June 30,            June 30, 
                                  ---------------------  ---------------------- 
                                     2013       2012        2013        2012         2013 
                                  ----------  ---------  ----------  ----------  ------------- 
                                                           Unaudited 
                                  ------------------------------------------------------------ 
 
Research and development 
 expenses                            $ 4,104    $ 3,231     $ 2,073     $ 1,639       $ 41,733 
 
Less - Participation by the 
 Office of the Chief Scientist       (1,218)    (1,486)     (1,218)       (464)        (8,267) 
U.S. Government grant                      -          -           -           -          (244) 
Participation by third party               -          -           -           -        (1,067) 
                                  ----------  ---------  ----------  ----------  ------------- 
 
Research and development 
 expenses, net                         2,886      1,745         855       1,175         32,155 
 
General and administrative 
 expenses                              4,134      4,133       1,588       2,774         37,729 
 
Other income: 
Excess amount of participation 
 in research and development 
 from third party                          -          -           -           -        (2,904) 
                                  ----------  ---------  ----------  ----------  ------------- 
 
Operating loss                       (7,020)    (5,878)     (2,443)     (3,949)       (66,980) 
 
Financial expenses                      (39)    (3,773)        (25)     (2,972)        (4,072) 
Financial income                       1,286          1         371          17            369 
                                  ----------  ---------  ----------  ----------  ------------- 
 
Loss before taxes on income          (5,773)    (9,650)     (2,097)     (6,904)       (70,683) 
 
Taxes on income                            5          8           2           8            100 
                                  ----------  ---------  ----------  ----------  ------------- 
 
Loss                               $ (5,778)  $ (9,658)   $ (2,099)   $ (6,912)     $ (70,783) 
                                  ==========  =========  ==========  ==========  ============= 
 
Basic loss per share                $ (0.34)   $ (0.98)    $ (0.11)    $ (0.69) 
                                  ==========  =========  ==========  ========== 
 
Diluted loss per share              $ (0.42)   $ (0.98)    $ (0.11)    $ (0.69) 
 
Weighted average number of 
 Common stock used in computing 
 basic loss per share             16,850,657  9,893,072  18,410,951  10,032,760 
                                  ==========  =========  ==========  ========== 
Weighted average number of 
 Common stock used in computing 
 diluted loss per share           16,895,741  9,893,072  18,410,951  10,032,760 
                                  ==========  =========  ==========  ========== 
 

The accompanying notes are an integral part of the interim consolidated financial statements.

MEDGENICS, INC. AND ITS SUBSIDIARY

(A Development Stage Company)

 
 STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY 
 U.S. dollars in thousands (except share and per share data) 
                                                                                       Deficit 
                                                                                      accumulated 
                                                                         Additional   during the         Total 
                                                                           paid-in    development    stockholders' 
                                                        Common stock       capital       stage          equity 
                                                     ------------------  ----------  ------------  --------------- 
                                                       Shares    Amount 
                                                     ----------  ------ 
 
Balance as of December 31, 2011                       9,722,725     $ 1    $ 52,501    $ (49,505)          $ 2,997 
 
Stock based compensation related to issuance 
 of restricted common stock, January 2012                35,000     (*)          55             -               55 
Issuance of Common stock to consultants at 
 $ 4.84 and $ 8.79 per share, March and June 
 2012                                                    30,000     (*)         204             -              204 
Issuance of Common stock and warrants at $ 
 4.90 per unit, net, June 2012                        1,944,734     (*)       8,407             -            8,407 
Exercise of options and warrants, January through 
 June 2012                                               13,792     (*)         117             -              117 
Stock based compensation related to options 
 and warrants granted to consultants and employees            -       -       1,688             -            1,688 
Loss                                                          -       -           -       (9,658)          (9,658) 
                                                     ----------  ------  ----------  ------------  --------------- 
 
Balance as of June 30, 2012 (Unaudited)              11,746,251     $ 1    $ 62,972    $ (59,163)          $ 3,810 
                                                     ==========  ======  ==========  ============  =============== 
 
   (*)      Represents an amount lower than $ 1. 

The accompanying notes are an integral part of the interim consolidated financial statements.

MEDGENICS, INC. AND ITS SUBSIDIARY

(A Development Stage Company)

 
 STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY (DEFICIT) 
 U.S. dollars in thousands (except share data) 
                                                                                       Deficit 
                                                                                      accumulated 
                                                                         Additional   during the       Total 
                                                                           paid-in    development   stockholders' 
                                                        Common stock       capital       stage         equity 
                                                     ------------------  ----------  ------------  -------------- 
                                                       Shares    Amount 
                                                     ----------  ------ 
 
Balance as of December 31, 2012                      12,307,808     $ 1    $ 66,509    $ (64,576)         $ 1,934 
 
Issuance of Common stock and warrants at $ 
 5.24 per share and $ 0.01 per warrant, net 
 of issuance costs in the amount of $ 3,050           6,070,000       1      28,820             -          28,821 
Stock based compensation related to Common 
 stock to consultants at $ 7.25 per share (**)           55,000     (*)         494             -             494 
Issuance and vesting of restricted common 
 stock                                                   45,000     (*)         274             -             274 
Exercise of warrants and options                          3,500     (*)          13             -              13 
Stock based compensation related to options 
 and warrants granted to consultants and employees            -       -       1,309             -           1,309 
Loss                                                          -       -           -       (5,778)         (5,778) 
                                                     ----------  ------  ----------  ------------  -------------- 
 
Balance as of June 30, 2013 (unaudited)              18,481,308     $ 2    $ 97,419    $ (70,354)        $ 27,067 
                                                     ==========  ======  ==========  ============  ============== 
 

(*) Represents an amount lower than $1.

(**) Includes stock based compensation for an additional 25,000 shares which were not issued as of June 30, 2013.

The accompanying notes are an integral part of the interim consolidated financial statements.

MEDGENICS, INC. AND ITS SUBSIDIARY

(A Development Stage Company)

 
 CONSOLIDATED STATEMENTS OF CASH FLOWS 
 U.S. dollars in thousands 
                                                                    Period from 
                                                                    January 27, 
                                                                  2000 (inception) 
                                             Six months ended         through 
                                                 June 30,             June 30, 
                                           -------------------- 
                                             2013       2012           2013 
                                           ---------  ---------  ----------------- 
                                                          Unaudited 
                                           --------------------------------------- 
 
 CASH FLOWS FROM OPERATING ACTIVITIES: 
 
  Loss                                     $ (5,778)  $ (9,658)         $ (70,783) 
 
 Adjustments to reconcile loss to net 
  cash used in operating activities: 
 
 Depreciation                                     84         72              1,310 
 Loss from disposal of property and 
  equipment                                        -          -                330 
 Stock based compensation to employees 
  and consultants                              2,077      1,947             12,262 
 Interest and amortization of beneficial 
  conversion feature of convertible note           -          -                759 
 Change in fair value of convertible 
  debentures and warrants                    (1,277)      3,717              2,701 
 Accrued severance pay, net                      (6)         54              1,203 
 Exchange differences on a restricted 
  lease deposit and on long term loan              1          -                  2 
 Increase in accounts receivable and 
  prepaid expenses                           (1,256)      (580)            (1,835) 
 Increase in trade payables                       24         15              1,505 
 Increase (decrease) in other accounts 
  payable and accrued expenses                  (48)         93              1,972 
 
 Net cash used in operating activities       (6,179)    (4,340)           (50,574) 
                                           ---------  ---------  ----------------- 
 
 CASH FLOWS FROM INVESTING ACTIVITIES: 
 
 Purchase of property and equipment            (142)       (45)            (2,224) 
 Proceeds from disposal of property 
  and equipment                                    -          -                173 
 Increase in restricted lease deposit            (5)        (5)               (65) 
                                           ---------  ---------  ----------------- 
 
 Net cash used in investing activities       $ (147)     $ (50)          $ (2,116) 
                                           ---------  ---------  ----------------- 
 
 
 

The accompanying notes are an integral part of the interim consolidated financial statements.

MEDGENICS, INC. AND ITS SUBSIDIARY

(A Development Stage Company)

 
 CONSOLIDATED STATEMENTS OF CASH FLOWS 
 U.S. dollars in thousands 
                                                                     Period from 
                                                                     January 27, 
                                                                   2000 (inception) 
                                              Six months ended         through 
                                                   June 30,            June 30, 
                                             ------------------- 
                                               2013      2012           2013 
                                             --------  ---------  ----------------- 
                                                           Unaudited 
                                             -------------------------------------- 
 CASH FLOWS FROM FINANCING ACTIVITIES: 
 
 Proceeds from issuance of shares and 
  warrants, net                              $ 28,821    $ 8,407           $ 71,769 
 Deferred issuance expenses                        40          -                  - 
 Proceeds from exercise of options and 
  warrants, net                                    13         28              2,735 
 Repayment of a long-term loan                      -          -               (73) 
 Proceeds from long term loan                       -          -                 70 
 Issuance of a convertible debenture 
  and warrants                                      -          -              7,168 
 
 Net cash provided by financing activities     28,874      8,435             81,669 
                                             --------  ---------  ----------------- 
 
 Increase in cash and cash equivalents         22,548      4,045             28,979 
 
 Balance of cash and cash equivalents 
  at the beginning of the period                6,431      4,995                  - 
                                             --------  ---------  ----------------- 
 
 Balance of cash and cash equivalents 
  at the end of the period                   $ 28,979    $ 9,040           $ 28,979 
                                             ========  =========  ================= 
 
 Supplemental disclosure of cash flow 
  information: 
 
 Cash paid during the period for: 
 
 Interest                                         $ -        $ -              $ 242 
                                             ========  =========  ================= 
 
 Taxes                                            $ 5       $ 31              $ 153 
                                             ========  =========  ================= 
 
 Supplemental disclosure of non-cash 
  flow information: 
 
 Issuance expenses paid with shares               $ -        $ -              $ 310 
                                             ========  =========  ================= 
 
 Issuance of Common stock upon conversion 
  of a convertible debenture                      $ -        $ -            $ 8,430 
                                             ========  =========  ================= 
 
 Classification of liability in respect 
  of warrants into equity due to the 
  exercise of warrants                            $ -       $ 89            $ 2,014 
                                             ========  =========  ================= 
 
 

The accompanying notes are an integral part of the interim consolidated financial statements.

MEDGENICS, INC. AND ITS SUBSIDIARY

(A Development Stage Company)

 
 NOTES TO THE INTERIM CONSOLIDATED FINANCIAL STATEMENTS 
 U.S. dollars in thousands (except share and per share data) 
 
   NOTE 1:-      GENERAL 

a. Medgenics, Inc. (the "Company") was incorporated in January 2000 in Delaware. The Company has a wholly-owned subsidiary, Medgenics Medical Israel Ltd. (formerly Biogenics Ltd.) (the "Subsidiary"), which was incorporated in Israel in March 2000. The Company and the Subsidiary are engaged in the research and development of products in the field of biotechnology and associated medical equipment and are thus considered development stage companies as defined in Accounting Standards Codification ("ASC") topic number 915, "Development Stage Entities" ("ASC 915").

On December 4, 2007 the Company's Common stock was admitted for trading on the AIM market of the London Stock Exchange.

On April 13, 2011 the Company completed an Initial Public Offering ("IPO") of its Common stock on the NYSE MKT (formerly NYSE Amex), raising $ 10,389 in net proceeds.

In February 2013, the Company closed an underwritten public offering of 5,600,000 shares of Common stock and Series 2013-A warrants to purchase up to an aggregate of 2,800,000 shares of Common stock. The shares and the warrants were sold together as a fixed combination, each consisting of one share of Common stock and a warrant to purchase one-half of a share of Common stock, at a price to the public of $ 5.25 per fixed combination. In March 2013, the underwriters exercised their option to purchase 470,000 shares of Common stock at $ 5.24 per share and 840,000 warrants to purchase 420,000 shares of Common stock at $ 0.01 per warrant. Gross proceeds were $ 31,871 or approximately $ 28,821 in net proceeds after deducting underwriting discounts and commissions of $ 2,550 and other offering costs of approximately $ 500.

b. The Company and the Subsidiary are in the development stage. As reflected in the accompanying financial statements, the Company incurred a loss for the six month period ended June 30, 2013 of $ 5,778 and had a negative cash flow from operating activities of $ 6,179 during the six month period ended June 30, 2013. The accumulated deficit as of June 30, 2013 is $ 70,354. The Company and the Subsidiary have not yet generated revenues from product sale. The Company previously generated income from partnering on development programs and expects to pursue its partnering activity. Management's plans also include seeking additional investments and commercial agreements to continue the operations of the Company and the Subsidiary.

The Company believes that the net proceeds of the underwritten public offering in February 2013, plus its existing cash and cash equivalents, should be sufficient to meet its operating and capital requirements through 2014.

c. In May 2013, the Subsidiary received approval for an additional Research and Development program from the Office of the Chief Scientist in Israel ("OCS") for the period December 2012 through November 2013. The approval allows for a grant of up to approximately $2,000 based on research and development expenses, not funded by others, of up to $3,660. As of June 30, 2013, $1,218 has been recorded as grants receivable. In July 2013, subsequent to the balance sheet date, $65 has been received.

   NOTE 2:-      SIGNIFICANT ACCOUNTING POLICIES 

The accompanying unaudited interim financial statements of the Company, have been prepared in accordance with accounting principles generally accepted in the United States of America and the rules of the Securities and Exchange Commission ("SEC") and should be read in conjunction with the audited financial statements and notes thereto included in the Annual Report on Form 10-K for the year ended December 31, 2012 ("2012 Form 10-K") as filed with the SEC. In the opinion of management, all adjustments, consisting of normal recurring adjustments, necessary for a fair presentation of financial position and the results of operations for the interim periods presented have been reflected herein. The results of operations for interim periods are not necessarily indicative of the results to be expected for the full year. Notes to the financial statements that would substantially duplicate the disclosure contained in the audited financial statements for the most recent fiscal year as reported in the 2012 Form 10-K, have been omitted.

   NOTE 3:-      STOCKHOLDERS' EQUITY 
   a.       General: 

In March 2013, the Compensation Committee of the Company's Board of Directors approved an amendment to the stock incentive plan increasing the number of shares of Common stock authorized for issuance thereunder to a total of 3,855,802 shares of Common stock, subject to stockholder approval. The Company's stockholders approved the amendment at the Company's annual meeting of stockholders on April 30, 2013.

   b.       Issuance of stock options, warrants and restricted shares to employees and directors: 

1. In January 2013, the Company granted 15,000 options and 7,000 shares of restricted Common stock to each of 5 non-executive Directors of the Company. These shares of Common stock are restricted in that they may not be disposed of and are not entitled to dividends. 50% of these shares were vested the day after the grant and 50% will vest one year from the grant date. All of the options are for a term of 10 years, vest in three equal installments and have an exercise price of $ 7.25. These options and shares of restricted Common stock were granted under the stock incentive plan. The fair value of these options and shares of restricted Common stock at the grant date was $ 4.449 per option and $ 7.50 per share. The Company recorded compensation expenses in the amount of $ 246 in the six months ended June 30, 2013.

2. In March 2013, the Company granted 10,000 shares of restricted Common stock to an employee. These shares are restricted in that they may not be disposed of and are not entitled to dividends. These restrictions will be removed in relation to 5,000 shares of Common stock on each of March 28, 2014 and March 28, 2015. The shares were issued under the stock incentive plan. The fair value of these shares of restricted Common stock at the grant date amounted to $ 49, and will be recognized as an expense using the straight line method.

A summary of the Company's activity for restricted shares granted to employees and directors is as follows:

 
                                             Six months ended 
             Restricted shares                 June 30, 2013 
-------------------------------------------  ---------------- 
 
Number of restricted shares as of December 
 31, 2012                                         60,357 
 
Vested                                           (35,000) 
Granted                                           45,000 
                                             ---------------- 
 
Number of restricted shares as of June 
 30, 2013                                         70,357 
                                             ================ 
 

3. In March 2013, an employee exercised options to purchase 3,500 shares of Common Stock at $ 3.64 per share or an aggregate exercise price of $ 13.

4. In March 2013, the Company granted to employees of the Company options to purchase 110,000 shares of common stock exercisable at an exercise price of $ 4.85 per share. The options have a 10 year term and vest in four equal annual tranches. The options were granted under the stock incentive plan. The fair value of these options at the grant date was $ 290.

5. In March 2013, the Company announced the appointment of a new member of the Board of Directors effective March 15, 2013. In connection with the appointment, the new board member was awarded stock options covering up to 300,000 shares of the Company's common stock, at a per share exercise price of $ 4.99, subject to approval by the NYSE MKT of an additional listing application covering the issuance of the shares underlying such options. On April 12, 2013, prior to approval by the NYSE MKT of the additional listing application, the Compensation Committee of the Company's Board of Directors determined instead to issue such options under the Company's stock incentive plan. 100,000 shares underlying such options vested immediately upon issuance in April 2013 and the remaining underlying shares will vest equally on each of March 15, 2014 and March 15, 2015, subject to continuous service through each vesting date. The options may only be exercised for cash and will expire on March 15, 2018. The Company recorded related expenses in the amount of $ 322 in the six months ended June 30, 2013.

6. A summary of the Company's activity for options and warrants granted to employees and directors is as follows:

 
                                             Six months ended 
                                               June 30, 2013 
                          ------------------------------------------------------ 
                                                       Weighted 
                             Number      Weighted       average 
                                of        average      remaining     Aggregate 
                             options      exercise    contractual     intrinsic 
                           and warrants    price     terms (years)   value price 
                          -------------  ---------  --------------  ------------ 
 
 
Outstanding at December 
 31, 2012                     2,656,587     $ 6.04 
 
Granted                         485,000     $ 5.31 
 
Expired/Forfeited              (28,994)     $ 5.41 
 
Exercised                       (3,500)     $ 3.64 
                          -------------  --------- 
 
Outstanding at June 
 30, 2013                     3,109,093     $ 5.93          $ 4.85       $ 1,646 
                          =============  =========  ==============  ============ 
 
Vested and expected 
 to vest at June 30, 
 2013                         3,054,379     $ 5.92          $ 4.82       $ 1,637 
                          =============  =========  ==============  ============ 
 
Exercisable at June 
 30, 2013                     2,014,806     $ 5.46          $ 3.86       $ 1,481 
                          =============  =========  ==============  ============ 
 

As of June 30, 2013, there was $ 2,829 of total unrecognized compensation cost related to non-vested share-based compensation arrangements granted to employees and directors. That cost is expected to be recognized over a weighted-average period of 1.7 years.

The aggregate intrinsic value represents the total intrinsic value (the difference between the Company's Common share fair value as of June 30, 2013 and the exercise price, multiplied by the number of in-the-money options) that would have been received by the option holders had all option holders exercised their options on June 30, 2013.

Calculation of aggregate intrinsic value is based on the share price of the Company's Common stock as of June 30, 2013 ($ 3.80 per share, as reported on the NYSE MKT).

   c.       Issuance of shares, stock options and warrants to consultants: 

1. In January 2013, the Company issued a total of 55,000 shares of Common stock to two consultants. Total compensation, measured as the grant date fair market value of the stock, amounted to $ 494 and was recorded as an operating expense in the Statement of Operations. As part of the agreement with the consultant, the Company has an obligation to issue an additional 25,000 shares for services received during the six month period ended June 30, 2013.

2. In March 2013, the Company approved the grant to two consultants of warrants to purchase a total of 25,000 shares at an exercise price of $ 4.99 per share. The warrants have a five year term and vested immediately upon issuance in April 2013. Total compensation amounted to $ 80 and was recorded as an operating expense in the Statement of Operations.

3. In June 2013, the Company entered into an agreement with a consultant for a period of 24 months. Under the terms of the agreement, the Company will issue warrants to purchase 100,000 shares at an exercise price at the market price of the issue, with a five year term and will be immediately exercisable upon issuance. Total compensation of $10 was recorded as an operating expense in the Statement of Operations.

4. A summary of the Company's activity for warrants and options granted to consultants is as follows:

 
                                             Six months ended 
                                               June 30, 2013 
                          ------------------------------------------------------ 
                                                       Weighted 
                             Number      Weighted       average 
                                of        average      remaining     Aggregate 
                             options      exercise    contractual     intrinsic 
                           and warrants    price     terms (years)   value price 
                          -------------  ---------  --------------  ------------ 
 
Outstanding at December 
 31, 2012                       521,904     $ 7.29 
                          =============  ========= 
 
Granted                          25,000     $ 4.99 
 
Outstanding at June 
 30, 2013                       546,904     $ 7.17          $ 4.34           $ 7 
                          =============  =========  ==============  ============ 
 
Exercisable at June 
 30, 2013                       466,667     $ 7.04          $ 3.63           $ 7 
                          =============  =========  ==============  ============ 
 
 

As of June 30, 2013, there was $ 382 of total unrecognized compensation cost related to non-vested share-based compensation arrangements granted to consultants. That cost is expected to be recognized over a weighted-average period of one year.

Calculation of aggregate intrinsic value is based on the share price of the Company's Common stock as of June 30, 2013 ($ 3.80 per share, as reported on the NYSE MKT).

   d.       Compensation expenses: 

Compensation expense related to shares, warrants and options granted to employees, directors and consultants was recorded in the Statement of Operations in the following line items:

 
                                Six months ended     Three months ended 
                                    June 30,              June 30, 
                                 2013      2012       2013       2012 
 
 Research and development 
  expenses                         $ 66      $ 98       $ 42        $ 72 
 General and administrative 
  expenses                        2,011     1,849        580       1,626 
                              ---------  --------  ---------  ---------- 
 
                                $ 2,077   $ 1,947      $ 622     $ 1,698 
                              =========  ========  =========  ========== 
 
   e.       Summary of options and warrants: 

A summary of all the options and warrants outstanding as of June 30, 2013 is presented in the following table:

 
                                                               As of June 30, 2013 
                                                   ------------------------------------------- 
                                                                                   Weighted 
                                                                                    Average 
                                                                                   Remaining 
                                  Exercise      Options and     Options and       Contractual 
                                  Price per       Warrants        Warrants         Terms (in 
      Options / Warrants          Share ($)      Outstanding     Exercisable        years) 
------------------------------  -------------  --------------   ------------    -------------- 
 
Options: 
Granted to Employees 
 and Directors                      2.49-3.14         499,806        294,556               6.2 
                                    3.64-4.99         453,629        105,057               6.0 
 
                                    5.13-7.25         163,967         37,240               8.4 
                                   8.19-14.50       1,109,451        695,713               4.6 
                                                   ----------   ------------ 
                                                    2,226,853      1,132,566 
                                                   ----------   ------------ 
 
Granted to Consultants 
                                    4.20-5.34          53,988         43,801               3.0 
                                    6.65-8.19         119,916         61,158               7.8 
                                        14.50          11,292              -               8.6 
                                                      185,196        104,959 
                                                   ----------   ------------ 
 
Total Options                                       2,412,049      1,237,525 
                                                   ----------   ------------ 
 
 
 
Warrants: 
Granted to Employees and 
 Directors                              2.49        882,240        882,240         2.8 
                                               ------------   ------------ 
 
Granted to Consultants             3.19-4.01         61,370         61,370         2.9 
                                        4.99         31,635         31,635         4.4 
                                        5.50         67,230         67,230         0.4 
                                  9.17-11.16        201,473        201,473         4.0 
                                                    361,708        361,708 
                                               ------------   ------------ 
 
Granted to Investors 
                                      0.0002         35,922         35,922         2.8 
                                        2.49         22,950         22,950         2.8 
                                   4.54-6.00      3,233,521      3,233,521         2.7 
                                   6.78-8.34      4,678,550      4,678,550         4.4 
                                                  7,970,943      7,970,943 
                                               ------------   ------------ 
 
Total Warrants                                    9,214,891      9,214,891 
                                               ------------   ------------ 
 
Total Option and Warrants                        11,626,940     10,452,416 
                                               ============   ============ 
 
 
   NOTE 4:-      FAIR VALUE MEASUREMENTS 

The Company classified certain warrants with down-round protection issued to the purchasers of convertible debentures in 2010 as a liability at their fair value according to ASC 815-40-15-7I. The liability in respect of these warrants will be remeasured at each reporting period until exercised or expired. Changes in the fair value of these warrants are reported in the statements of operations as financial income or expense.

The fair value of these warrants was estimated at June 30, 2013 and December 31, 2012 using the Binomial pricing model with the following assumptions:

 
                                     June 30,       December 31, 
                                       2013             2012 
                                    ---------      ------------- 
 
 Dividend yield                            0%                 0% 
 Expected volatility                   79.14%              78.1% 
 Risk-free interest rate                0.43%               0.3% 
 Contractual life (in years)             2.23                2.7 
 

The changes in level 3 liabilities measured at fair value on a recurring basis:

 
                                                      Fair value 
                                                      of liability 
                                                       in respect 
                                                      of warrants 
                                                     ------------- 
 
Balance as of December 31, 2011                              $ 478 
 
Classification of liability in respect of warrants 
 into equity due to the exercise of warrants                 (883) 
Change in the fair value of liability in respect 
 of warrants                                                 2,336 
                                                     ------------- 
 
Balance as of December 31, 2012                              1,931 
 
Change in the fair value of liability in respect 
 of warrants                                               (1,277) 
                                                     ------------- 
 
Balance as of June 30, 2013 (unaudited)                      $ 654 
                                                     ============= 
 
   NOTE 5:-      LOSS PER SHARE 

Details in the computation of diluted loss per share:

 
                                             Six months ended June 30, 
                                   --------------------------------------------- 
                                            2013                    2012 
                                   -----------------------  -------------------- 
 
                                    Weighted                 Weighted 
                                     average                  average 
                                    number of                number of 
                                     shares       Loss        shares      Loss 
                                   ----------  -----------  ----------   ------- 
 
For the computation of basic 
 loss                              16,850,657      $ 5,778   9,893,072   $ 9,658 
                                   ==========  ===========  ==========   ======= 
 
Effect of potential dilutive 
 common shares issuable upon 
 exercise of warrants classified 
 as liability                          45,084  $1,722 (**)       - (*)     - (*) 
 
For the computation of diluted 
 loss                              16,895,741      $ 7,055   9,893,072   $ 9,658 
                                   ==========  ===========  ==========   ======= 
 
 
 
                                     Three months ended June 30, 
                               ---------------------------------------- 
                                      2013                 2012 
                               -------------------  ------------------- 
 
                                Weighted             Weighted 
                                 average              average 
                                number of            number of 
                                 shares     Loss      shares     Loss 
                               ----------  -------  ----------  ------- 
 
For the computation of basic 
 and diluted loss              18,410,951  $ 2,099  10,032,760  $ 6,912 
                               ==========  =======  ==========  ======= 
 
 
   (*)      Anti-dilutive. 
   (**)     Financial income resulted from changes in fair value of warrants classified as liability. 

The total weighted average number of shares related to the outstanding options, warrants and restricted shares excluded from the calculations of diluted loss per share due to their anti-dilutive effect was 10,289,103 and 6,507,183 for the six months ended June 30, 2013 and 2012, respectively.

- - - - -

This information is provided by RNS

The company news service from the London Stock Exchange

END

IR SSIFEMFDSEFA

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