ORTEC INTERNATIONAL INC
10QSB, 1997-08-12
MEDICAL LABORATORIES
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<PAGE>   1
================================================================================

                       SECURITIES AND EXCHANGE COMMISSION

                             WASHINGTON, D.C. 20549

                                  -------------

                                   FORM 10-QSB

                                  -------------
(Mark One)

[X]      QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
         EXCHANGE ACT OF 1934 FOR THE QUARTER ENDED JUNE 30, 1997

[ ]      TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
         EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM         TO


                         COMMISSION FILE NUMBER 0-27368


                            ORTEC INTERNATIONAL, INC.
        (EXACT NAME OF SMALL BUSINESS ISSUER AS SPECIFIED IN ITS CHARTER)

           DELAWARE                                       11-3068704
(STATE OR OTHER JURISDICTION OF                        (I.R.S. EMPLOYER
INCORPORATION OR ORGANIZATION)                         IDENTIFICATION NO.)

                                  3690 BROADWAY
                            NEW YORK, NEW YORK 10032
               (ADDRESS OF PRINCIPAL EXECUTIVE OFFICES) (ZIP CODE)

                                 (212) 740-6999
                 ISSUER'S TELEPHONE NUMBER, INCLUDING AREA CODE


                                ----------------


Check whether the issuer (1) filed all reports required to be filed by Section
13 or 15(d) of the Securities Exchange Act during the past 12 months (or for
such shorter period that the Registrant was required to file such reports), and
(2) has been subject to such filing requirements for the past 90 days.
Yes X   No
    ---    ---

        The number of shares outstanding of the issuer's common stock is
4,644,510 (as of August 7, 1997).


                           -------------------------

================================================================================
<PAGE>   2
                            ORTEC INTERNATIONAL, INC.
                    INDEX TO QUARTERLY REPORT ON FORM 10-QSB
                FILED WITH THE SECURITIES AND EXCHANGE COMMISSION
                           QUARTER ENDED JUNE 30, 1997


                              ITEMS IN FORM 10-QSB



Facing page                                                              Page

Part I

         Item 1.     Financial Statements.                                 1

         Item 2.     Plan of Operation.                                   11

Part II

         Item 1.     Legal Proceedings and Claims.                       None

         Item 2.     Changes in Securities.                               13

         Item 3.     Default Upon Senior Securities.                     None

         Item 4.     Submission of Matters to                            None
                     a Vote of Security Holders.

         Item 5.     Other Information.                                  None

         Item 6.     Exhibits and Reports on Form 8-K.                    14

Signatures
<PAGE>   3
                                       PART I

Item 1.  FINANCIAL STATEMENTS

                              ORTEC INTERNATIONAL, INC.


                          (A DEVELOPMENT STAGE ENTERPRISE)
                                   BALANCE SHEETS
                                     (Unaudited)


<TABLE>
<CAPTION>
                                              JUNE 30,        DECEMBER 31,
                                                1997             1996
                                                ----             ----
<S>                                          <C>              <C>
            ASSETS

Current assets:
  Cash and equivalents                       $5,535,349       $7,453,229
  Prepaid expenses                                6,020            7,616
  Other current assets                            1,803            1,958
                                             ----------       ----------

Total current assets                          5,543,172        7,462,803
                                             ----------       ----------

Property and equipment, at cost:
  Laboratory equipment                          584,647          578,530
  Office furniture and equipment                302,873          170,830
  Leasehold improvements                        601,224          462,995
                                             ----------       ----------
                                              1,488,744        1,212,355
  Accumulated depreciation and
   amortization                                 456,616          321,646
                                             ----------       ----------

                                              1,032,128          890,709
                                             ----------       ----------

Other assets:
  Patent application costs net of
   accumulated amortization of $16,006
   at June 30, 1997 and $1,210 at
   December 31, 1996                            407,440          409,147
  Deposits                                       30,057           29,266
                                             ----------       ----------

Total other assets                              437,497          438,413
                                             ----------       ----------

Total Assets                                 $7,012,797       $8,791,925
                                             ==========       ==========
</TABLE>

See notes to condensed unaudited financial statements.

                                      1
<PAGE>   4
                            ORTEC INTERNATIONAL, INC.
                        (A DEVELOPMENT STAGE ENTERPRISE)
                                 BALANCE SHEETS
                                   (Unaudited)



<TABLE>
<CAPTION>
                                                 JUNE 30,        DECEMBER 31,
                                                   1997             1996
                                                   ----             ----
<S>                                            <C>               <C>
   LIABILITIES AND SHAREHOLDERS' EQUITY

Current liabilities:
  Accounts payable and accrued
   liabilities                                 $   489,867        $   570,397
  Capital lease obligations - current               41,845              5,738
  Loan payable - current                            36,637             38,018
                                               -----------        -----------

Total current liabilities                          568,349            614,153
                                               -----------        -----------

Long-term liabilities:
  Capital lease obligations - noncurrent            56,031              9,846
  Loan payable - noncurrent                        432,245            450,928
                                               -----------        -----------

Total long-term liabilities                        488,276            460,774
                                               -----------        -----------

Total liabilities                                1,056,625          1,074,927
                                               -----------        -----------

Commitments and contingencies

Stockholders' equity:
  Common stock, $.001 par value;
   authorized, 10,000,000 shares;
   issued and outstanding shares -
   4,642,527 at June 30, 1997 and
   4,601,963 at December 31, 1996                    4,642              4,602
  Additional paid-in capital                    15,613,707         15,573,183
  Deficit accumulated during the
   development stage                            (9,662,177)        (7,860,787)
                                               -----------        -----------

Total stockholders' equity                       5,956,172          7,716,998
                                               -----------        -----------

Total Liabilities and
 Stockholders' Equity                          $ 7,012,797        $ 8,791,925
                                               ===========        ===========
</TABLE>


See notes to condensed unaudited financial statements.

                                      2
<PAGE>   5
                            ORTEC INTERNATIONAL, INC.
                        (A DEVELOPMENT STAGE ENTERPRISE)
                            STATEMENTS OF OPERATIONS
                                   (Unaudited)



<TABLE>
<CAPTION>
                                                                                                           Cumulative from
                                                                                                           March 12, 1991
                                       Quarter ended June 30,            Six months ended June 30,         (inception) to
                                       ----------------------            -------------------------          June 30, 1997
                                       1997             1996               1997            1996            ---------------
                                       ----             ----               ----            ----
<S>                                <C>               <C>               <C>                <C>               <C>
Revenue
  Interest income                  $   73,918        $   37,314        $   157,779        $    71,785        $   395,994
                                   ----------        ----------        -----------        -----------        -----------

Expenses
  Research and development            240,861           166,397            513,554            387,852          3,867,970
  Rent                                 53,431             8,195            104,796             14,638            267,745
  Consulting                           54,098           154,510            116,241            195,443            873,637
  Personnel                           316,216           125,473            609,667            265,489          2,485,065
  General and administrative          320,445           135,044            591,355            261,888          2,425,727
  Other expense, net                   11,376            27,150             23,556             28,177            138,027
                                   ----------        ----------        -----------        -----------        -----------

                                      996,427           616,769          1,959,169          1,153,487         10,058,171
                                    ---------         ---------          ---------          ---------          ---------
Net loss                           $ (922,509)       $ (579,455)       $(1,801,390)       $(1,081,702)       $(9,662,177)
                                   ==========        ==========        ===========        ===========        ===========

Net loss per share                 $     (.19)       $     (.15)       $      (.37)       $      (.28)       $     (3.22)
                                    ---------         ---------          ---------          ---------          ---------

Weighted average common and
 common equivalent shares
 outstanding                        4,946,121         3,941,686          4,930,948          3,809,433          3,003,450
                                   ==========        ==========        ===========        ===========        ===========
</TABLE>



See notes to condensed unaudited financial statements.







                                         3
<PAGE>   6
                            ORTEC INTERNATIONAL, INC.
                        (A DEVELOPMENT STAGE ENTERPRISE)
                       STATEMENTS OF SHAREHOLDERS' EQUITY
                                   (Unaudited)



<TABLE>
<CAPTION>
                                                                                         Deficit
                                             Common Stock                               accumulated
                                                                        Additional         in the
                                                                         Paid-in        development
                                      Shares           Amount            Capital           stage              Total
                                      ------           ------           ----------     ------------           -----
<S>                                 <C>               <C>             <C>              <C>                <C>
Issuance of stock:
 Founders                            1,553,820        $  1,554        $     (684)                         $       870
 First private placement               217,440             217            64,783                               65,000
 The Director                          149,020             149           249,851                              250,000
 Second private placement               53,020              53           499,947                              500,000
 Share issuance expenses                                                 (21,118)                             (21,118)
Net loss for the period from
 March 12, 1991 (inception) to
  December 31, 1991                                                                     $  (281,644)         (281,644)
                                     ---------        --------        ----------        -----------       -----------

Balance - December 31, 1991          1,973,300           1,973           792,779           (281,644)          513,108

Issuance of stock:
 Second private placement               49,320              49           465,424                              465,473
 Stock purchase agreement with
  The Director                          31,820              32           299,966                              299,998
 Share issuance expenses                                                 (35,477)                             (35,477)
Net loss for the year ended
 December 31, 1992                                                                         (785,941)         (785,941)
                                     ---------        --------        ----------        -----------       -----------

Balance - December 31, 1992          2,054,440           2,054         1,522,692         (1,067,585)          457,161

Issuance of stock:
 Third private placement               132,150             132         1,321,368                            1,321,500
 Stock purchase agreement with
  Home Insurance Company               111,111             111           999,888                              999,999
 Stock purchase agreement with
  The Director                          21,220              21           199,979                              200,000
 Shares issued in exchange
  for commissions earned                   600               1             5,999                                6,000
 Share issuance expenses                                                (230,207)                            (230,207)
Net loss for the year ended
 December 31, 1993                                                                       (1,445,624)       (1,445,624)
                                     ---------        --------        ----------        -----------       -----------

Balance - December 31, 1993          2,319,521        $  2,319        $3,819,719        $(2,513,209)      $ 1,308,829
                                     ---------        --------        ----------        -----------       -----------
</TABLE>



See notes to condensed unaudited financial statements.





                                         4
<PAGE>   7
                            ORTEC INTERNATIONAL, INC.
                        (A DEVELOPMENT STAGE ENTERPRISE)
                       STATEMENTS OF SHAREHOLDERS' EQUITY
                                   (Unaudited)


<TABLE>
<CAPTION>
                                                                              Deficit
                                                                             accumulated
                                    Common Stock          Additional            in the
                                  ------------------      Paid-in            development
                                  Shares      Amount       Capital              stage           Total
                                  ------     -------     ------------       ------------      -------
<S>                              <C>         <C>         <C>              <C>              <C>
  (brought forward)              2,319,521    $2,319     $ 3,819,719      $(2,513,209)     $ 1,308,829


Issuance of stock:
 Fourth private placement           39,451        40         397,672                           397,712
 Stock purchase agreement with
  Home Insurance Company            50,000        50         499,950                           500,000
 Share issuance expenses                                      (8,697)                           (8,697)
Net loss for the year ended
 December 31, 1994                                                         (1,675,087)      (1,675,087)
                                 ---------    ------     -----------      -----------      -----------

Balance - December 31, 1994      2,408,972     2,409       4,708,644       (4,188,296)         522,757

Rent forgiveness                                              40,740                            40,740
Net loss for the year ended
 December 31, 1995                                                         (1,022,723)      (1,022,723)
                                 ---------    ------     -----------      -----------      -----------

Balance - December 31, 1995      2,408,972     2,409       4,749,384       (5,211,019)        (459,226)

Issuance of stock:
  Initial public offering        1,200,000     1,200       5,998,800                         6,000,000
  Exercise of warrants              33,885        34          33,851                            33,885
  Fifth private placement          959,106       959       6,219,838                         6,220,797
  Share issuance expenses                                 (1,580,690)                       (1,580,690)
  Non-cash stock compensation
   and interest                                              152,000                           152,000
Net loss for the year ended
 December 31, 1996                                                         (2,649,768)      (2,649,768)
                                 ---------    ------     -----------      -----------      -----------

Balance - December 31, 1996      4,601,963    $4,602     $15,573,183      $(7,860,787)      $7,716,998
                                 ---------    ------     ------------      -----------      ----------
</TABLE>


See notes to condensed unaudited financial statements.





                                         5
<PAGE>   8
                            ORTEC INTERNATIONAL, INC.
                        (A DEVELOPMENT STAGE ENTERPRISE)
                       STATEMENTS OF SHAREHOLDERS' EQUITY
                                   (Unaudited)

<TABLE>
<CAPTION>
                                                                            Deficit
                                                                           accumulated
                                    Common Stock         Additional          in the
                                  -----------------       Paid-in          development
                                  Shares     Amount       Capital            stage             Total
                                  ------     ------      ------------     ------------         -----
<S>                              <C>         <C>         <C>              <C>               <C>
  (brought forward)              4,601,963    $4,602     $ 15,573,183      $(7,860,787)     $ 7,716,998

Issuance of stock:
 Exercise of warrants               40,564        40           40,524                            40,564
Net loss for the six months
 ended June 30, 1997                                                        (1,801,390)      (1,801,390)
                                 ---------    ------     ------------      -----------      -----------

Balance - June 30, 1997          4,642,527    $4,642     $ 15,613,707      $(9,662,177)      $5,956,172
                                 ---------    ------     ------------      -----------      -----------
</TABLE>



See notes to condensed unaudited financial statements.








                                                                          







                                         6
<PAGE>   9
                            ORTEC INTERNATIONAL, INC.
                        (A DEVELOPMENT STAGE ENTERPRISE)
                            STATEMENTS OF CASH FLOWS
                                   (Unaudited)

<TABLE>
<CAPTION>
                                                                                                   Cumulative from
                                                                                                    March 12, 1991
                                       Quarter ended June 30,     Six months ended June 30,         (inception) to
                                       ----------------------     -------------------------          June 30, 1997
                                          1997         1996         1997            1996           ----------------
                                          ----         ----         ----            ----
<S>                                    <C>          <C>         <C>            <C>                <C>
Cash flows from operating activities:

 Net loss                              $(922,509)   $(579,455)  $(1,801,390)    $(1,081,702)       $(9,662,177)
 Adjustments to reconcile net loss
  to net cash used in operating
  activities:

   Deferred occupancy costs                                                          (1,327)
   Depreciation and amortization          77,639       15,529       149,766          30,208            482,860
   Unrealized loss on marketable
    securities                                                                                          67,204
   Realized loss on marketable
    securities                                                                                           5,250
   Non cash stock compensation and
    interest                                          152,000                       152,000            152,000
   Rent forgiveness                                                                                     40,740
   Changes in operating assets and
    liabilities
     Prepaid expenses                     (2,270)                     1,596                             (6,020)
     Other current assets                    156            1           155             (13)            (1,803)
     Accounts payable and accrued
      liabilities                       (100,070)    (173,984)      (80,530)       (453,874)           489,867
                                       ---------    ---------   -----------     -----------        -----------

Net cash used in operating
 activities                             (947,054)    (585,909)   (1,730,403)     (1,354,708)        (8,432,079)
                                       ---------    ---------   -----------     -----------        -----------
Cash flows from investing activities:

 Purchases of property and equipment    (120,844)    (150,586)     (276,389)       (367,035)        (1,488,744)
 Payments for patent application          (3,303)     (21,222)      (13,089)        (25,002)          (423,446)
 Organization costs                                                                                   ( 10,238)
 Deposits                                    816       (1,734)         (791)         (2,065)          ( 30,057)
 Purchases of marketable securities                                                                   (594,986)
 Sale of marketable securities                                                                         522,532
                                       ---------    ---------   -----------     -----------        -----------
Net cash (used in) provided by
 investing activities                   (123,331)    (173,542)     (290,269)     (  394,102)        (2,024,939)
                                       ---------    ---------   -----------     -----------        -----------
</TABLE>

See notes to condensed unaudited financial statements.












                                         7
<PAGE>   10
                           ORTEC INTERNATIONAL, INC.
                        (A DEVELOPMENT STAGE ENTERPRISE)
                            STATEMENTS OF CASH FLOWS
                                  (Unaudited)
<TABLE>
<CAPTION>
                                                                                                        March 12, 1991
                                          Quarter ended June 30,       Six months ended June 30,        (inception) to
                                          ----------------------       -------------------------        June 30, 1997
                                           1997             1996         1997            1996           --------------
                                           ----             ----         ----            ----
<S>                                      <C>           <C>           <C>             <C>               <C>
Cash flows from financing activities:

 Proceeds from issuance of notes
  payable                                               $   197,118                   $   197,118        $    515,500
 Repayment of notes payable                                                              (515,500)           (515,500)
 Proceeds from issuance of common
  stock                                  $    36,487          2,094   $    40,564       6,014,960          17,301,798
 Share issuance expenses                                        120                      (825,977)        ( 1,876,189)
 Proceeds from loan payable                                                                                   500,000
 Repayment of loan payable                    (8,713)                     (20,064)                            (31,118)
 Proceeds from capital lease
  obligations                                 75,036         31,815       100,367          31,815             118,903
 Repayment of capital lease
  obligations                                (16,944)                     (18,075)                            (21,027)
                                         -----------    -----------   -----------     -----------        ------------

Net cash provided by financing
 activities                                   85,866        231,147       102,792       4,902,416          15,992,367
                                         -----------    -----------   -----------     -----------        ------------

Net increase (decrease) in cash             (984,519)      (528,304)   (1,917,880)      3,153,606           5,535,349

Cash at beginning of period                6,519,868      3,684,274     7,453,229           2,364
                                         -----------    -----------   -----------     -----------        ------------


Cash at end of period                    $ 5,535,349    $ 3,155,970   $ 5,535,349     $ 3,155,970        $  5,535,349
                                         -----------    -----------   -----------     -----------        ------------
</TABLE>



See notes to condensed unaudited financial statements.











                                         8
<PAGE>   11
                            ORTEC INTERNATIONAL, INC.
                        (A DEVELOPMENT STAGE ENTERPRISE)

                          NOTES TO FINANCIAL STATEMENTS

                             JUNE 30, 1996 AND 1997


NOTE 1 - FINANCIAL STATEMENTS

         The condensed balance sheet as of June 30, 1997 and the statements of
operations, shareholders' equity and cash flows for the three and six month
periods ended June 30, 1997 and 1996 and for the period from March 12, 1991
(inception) to June 30, 1997 have been prepared by the Company without audit. In
the opinion of management, all adjustments (which include only normal recurring
accrual adjustments) necessary to present fairly the financial position, results
of operations and cash flows at June 30, 1997 and for all periods presented have
been made. Certain information and footnote disclosure normally included in the
financial statements prepared in accordance with generally accepted accounting
principles have been condensed or omitted. It is suggested that these condensed
financial statements be read in conjunction with the financial statements and
notes thereto in the Company's December 31, 1996 annual report on Form 10-KSB
filed with the Securities and Exchange Commission. The results of operations for
the quarter and six months ended June 30, 1997 are not necessarily indicative of
the operating results for the full year.


NOTE 2 - FORMATION OF THE COMPANY AND BASIS OF PRESENTATION

Formation of the Company

         Ortec International, Inc. ("Ortec" or the "Company") was incorporated
in March 1991 as a Delaware corporation to secure and provide funds for the
further development of the technology developed by Dr. Mark Eisenberg of Sydney,
Australia, to replicate in the laboratory, composite cultured skin for use in
skin replacement procedures (the "Technology"). Pursuant to a license agreement
dated September 7, 1991, Dr. Eisenberg has granted Ortec a license for a term of
ten years, which may be automatically renewed by Ortec for two additional
ten-year periods, to commercially use and exploit the Technology for the
development of products, subject to certain limitations. At the expiration or
earlier termination of the agreement, Dr. Eisenberg is entitled to the exclusive
rights in the Technology, and Ortec is entitled to the exclusive rights to all
improvements to the Technology developed during the license period.









                                      9
<PAGE>   12
Basis of Presentation

         The Company is a development stage enterprise, and has neither realized
any operating revenue nor has any assurance of realizing any future operating
revenue. Successful future operations depend upon the successful development and
marketing of the composite cultured skin to be used in skin replacement
procedures.

Initial Public Offering

         On January 19, 1996, the Company completed an initial public offering
("IPO") of 1,200,000 units. Each unit consists of (i) one share of the Company's
common stock, (ii) one Class A warrant to purchase one share of common stock at
$10, originally scheduled to expire in July 1997 but extended to November 3,
1997 by the unanimous written consent of the Board of Directors of the Company
(see Part II, Item 2, hereof, "Changes in Securities") and (iii) one Class B
warrant to purchase one share of common stock at $15, expiring January 1999. The
Class A and B warrants will be redeemable by the Company at $.01 per warrant, if
the market price of the Company's common stock equals or exceeds $10 for 10
consecutive trading days during a specified period, as defined.

         The IPO raised gross proceeds of $6,000,000, of which $800,000,
$515,500 and approximately $341,000 were used to pay underwriting commissions,
notes payable and deferred offering costs, respectively, thereby providing the
Company with net proceeds of approximately $4,343,500. The Company has used and
intends to use the proceeds for continued research and development of composite
cultured skin, performing human clinical trials and general corporate purposes.

1996 Private Placement

         In November 1996, the Company completed a private placement of its
securities from which it received gross proceeds of $6,220,797 and net proceeds
of approximately $5,733,000 (after deducting approximately $487,000 in placement
fees and other expenses of such private placement). The Company sold 959,106
shares of Common Stock in such private placement at an average
price of $6.49 per share. In addition, the Company granted five-year warrants to
placement agents to purchase such number of shares equal to 10% of the number of
shares of common stock sold by such placement agent, exercisable at prices equal
to 120% of the prices paid for such shares. Pursuant to the purchasers' demand,
the Company has registered all of such 959,106 shares.

         The Company intends to use the net proceeds it has received in such
private placement offering for continued research and development of its
composite cultured skin, performing human clinical trials and for general
corporate purposes.










                                      10
<PAGE>   13
NOTE 3 - NEW ACCOUNTING PRONOUNCEMENT

         In February 1997, the Financial Accounting Standards Board issued
Statement of Financial Accounting Standards No. 128, EARNINGS PER SHARE, which
is effective for financial statements for both interim and annual periods ending
after December 15, 1997. Early adoption of the new standard is not permitted.
The new standard eliminates primary and fully diluted earnings per share and
requires presentation of basic and diluted earnings per share together with
disclosure of how the per share amounts were computed. Basic earnings per share
excludes dilution and is computed by dividing income available to common
shareholders by the weighted-average common shares outstanding for the period.
Diluted earnings per share reflects the weighted-average common shares
outstanding plus the potential dilutive effect of securities or contracts which
are convertible to common shares, such as options, warrants, and convertible
preferred stock. The adoption of this new standard is not expected to have a
material impact on the disclosure of earnings per share in the Company's
financial statements.



ITEM 2.  PLAN OF OPERATION


OPERATIONS FOR THE NEXT TWELVE MONTHS

         For the next twelve months the Company will continue to conduct human
clinical trials. To that end, the Company has recruited and intends to continue
to recruit hospital burn centers which will provide the necessary patients. In
addition, human clinical trials are presently being conducted at a research
hospital in New York City for the application of the Company's Composite
Cultured Skin in treating the symptoms of a unique disease called Epidermolysis
Bullosa ("EB"). The wounds resulting from EB are very similar to those caused by
burns and require similar treatment.

         The Company estimates that the cost to it of each human clinical trial
for burn patients and EB patients will be approximately $8,000. Such amounts
include testing for pathogens and payments to the hospital, but do not include
any allocation to the cost of such trials of salaries, rent or other overhead
expenses of the Company.

CASH REQUIREMENTS

         The Company estimates that it has sufficient funds necessary to operate
through approximately January 1999. The Company may have to secure additional
funds prior thereto or thereafter to complete its human clinical trials, if not
then already completed, to secure FDA pre-market approval for commercial sales
and thereafter to produce and market its Composite Cultured Skin









                                      11
<PAGE>   14
in commercial quantities.  See "Forward Looking Information May Prove
Inaccurate."

CLINICAL TRIALS AND PRODUCT RESEARCH AND DEVELOPMENT

         The Company has spent an aggregate of approximately $3,867,970 from its
inception through June 30, 1997 for the human clinical trials and for research
and development. That amount includes the salaries of its employees involved in
producing the Composite Cultured Skin, performing quality control, securing
hospital burn centers to participate in the human clinical trials, monitoring
the progress of the patients thereafter and to prepare reports to be filed with
the FDA. The Company anticipates that it will be required to continue to spend
additional funds for such purposes in the twelve months ending June 30, 1998 in
order to continue its human clinical trials, continue its efforts to secure FDA
pre-market approval for commercial sales and thereafter to produce and market
its Composite Cultured Skin in commercial quantities. See "Forward Looking
Information May Prove Inaccurate."

FORWARD LOOKING INFORMATION MAY PROVE INACCURATE

         This Quarterly Report on Form 10-QSB contains certain forward-looking
statements and information relating to the Company that are based on the beliefs
of Management, as well as assumptions made by and information currently
available to the Company. When used in this document, the words "anticipate,"
"believe," "estimate," and "expect" and similar expressions, as they relate to
the Company, are intended to identify forward-looking statements. Such
statements reflect the current views of the Company with respect to future
events and are subject to certain risks, uncertainties and assumptions,
including those described in this Quarterly Report on Form 10-QSB. Should one or
more of these risks or uncertainties materialize, or should underlying
assumptions prove incorrect, actual results may vary materially from those
described herein as anticipated, believed, estimated or expected. The Company
does not intend to update these forward-looking statements.













                                      12
<PAGE>   15
PART II


ITEM 2.  CHANGES IN SECURITIES

         (a)  Class A Warrants.

         The Company has outstanding 1,200,000 publicly traded Class A Warrants
(the "Class A Warrants"), each Class A Warrant entitling the holder thereof to
purchase one (1) share of Common Stock of the Company at an exercise price of
$10.00 per share. The Class A Warrants, pursuant to their original terms, were
scheduled to expire on July 19, 1997.

         On July 1, 1997, the Board of Directors of the Company resolved by
unanimous written consent to extend the term of the Class A Warrants so that the
Class A Warrants will expire at 5:00 p.m., Eastern Standard Time, on November 3,
1997. Other then the extension of the expiration date, such resolution did not
change the exercise price, the redemption provisions or any other provisions of
the Class A Warrants.

         (b)  Recent Sales of Unregistered Securities.

         During the second quarter of 1997 the Company granted one employee an
option under its Employee Stock Option Plan to purchase 5,000 shares of Common
Stock, exercisable at $7.00 per share, and expiring on April 8, 2002. Such grant
was in consideration for services rendered to the Company.

         On January 20, 1996, the Company granted "lock-up warrants" to 63
persons, entitling them to purchase an aggregate of 389,045 shares of the
Company's Common Stock at a price of $1.00 per share. The issuance of such
lock-up warrants was in consideration for such 63 persons' signing lock-up
agreements agreeing not to sell or transfer shares of the Company's Common Stock
purchased at prices of $9.00 or more per share until January 20, 1997. All such
warrants expire on January 18, 2000. At different times during the second
quarter of 1997, seven persons exercised such warrants and purchased 34,504
shares of Common Stock at the $1.00 per share exercise price. During the first
quarter of 1997 an additional two persons exercised such warrants and purchased
4,077 shares of Common Stock at the $1.00 per share exercise price. There were
no underwriting discounts or commissions given or paid in connection with any of
the foregoing warrant exercises.

         The grant, offer and sale of all of the securities listed above were
sold without registration under the Securities Act of 1933, as amended (the
"Act"), as they did not involve any public offering, pursuant to the provisions
of Section 4(2) of the Act.













                                      13
<PAGE>   16
ITEM 6.  EXHIBITS AND REPORTS ON FORM 8-K


(a)      Exhibit No.       Description

           3.1             Agreement of Merger of the Skin Group, Ltd. and the
                           Company dated July 9, 1992 (1)

           3.2             Original Certificate of Incorporation (1)

           3.3             By-Laws (1)

          27.1             Financial Data Schedule *

- --------------

*        Filed herewith.

(1)      Filed as an Exhibit to the Company's Registration Statement on Form
         SB-2 (File No. 33-96090), or Amendment 1 thereto, and incorporated
         herein by reference.

(b)      Reports on Form 8-K


         On July 10, 1997, the Company filed a report on Form 8-K announcing the
extension of the term of the Class A Warrants. See Item 2 hereof, "Changes in
Securities." No other reports on Form 8-K were filed during the second quarter
of 1997.














                                      14
<PAGE>   17
                                   SIGNATURES


         In accordance with Section 13 or 15(d) of the Exchange Act, the
registrant has caused this report to be signed on its behalf by the undersigned,
thereto duly authorized.

                                               Registrant:

                                               ORTEC INTERNATIONAL, INC.



Date: August 12, 1997                          By: /s/ Steven Katz
                                                   -----------------------------
                                                   Dr. Steven Katz
                                                   President and Chief
                                                   Executive Officer
                                                   (Principal Executive Officer)



Date: August 12, 1997                          By: /s/ Ron Lipstein
                                                   -----------------------------
                                                   Ron Lipstein
                                                   Chief Financial Officer
                                                   (Principal Financial Officer)













                                      15


<TABLE> <S> <C>

<ARTICLE> 5
       
<S>                             <C>
<PERIOD-TYPE>                   6-MOS
<FISCAL-YEAR-END>                          DEC-31-1997
<PERIOD-START>                             JAN-01-1997
<PERIOD-END>                               JUN-30-1997
<CASH>                                       5,535,349
<SECURITIES>                                         0
<RECEIVABLES>                                        0
<ALLOWANCES>                                         0
<INVENTORY>                                          0
<CURRENT-ASSETS>                             5,543,172
<PP&E>                                       1,488,744
<DEPRECIATION>                                 456,616
<TOTAL-ASSETS>                               7,012,797
<CURRENT-LIABILITIES>                          568,349
<BONDS>                                              0
                                0
                                          0
<COMMON>                                         4,642
<OTHER-SE>                                   5,951,530
<TOTAL-LIABILITY-AND-EQUITY>                 7,012,797
<SALES>                                              0
<TOTAL-REVENUES>                               157,779     
<CGS>                                                0
<TOTAL-COSTS>                                        0
<OTHER-EXPENSES>                             1,959,169
<LOSS-PROVISION>                                     0
<INTEREST-EXPENSE>                                   0
<INCOME-PRETAX>                            (1,801,390)
<INCOME-TAX>                                         0
<INCOME-CONTINUING>                        (1,801,390)
<DISCONTINUED>                                       0
<EXTRAORDINARY>                                      0
<CHANGES>                                            0
<NET-INCOME>                               (1,801,390)
<EPS-PRIMARY>                                    (.37)
<EPS-DILUTED>                                        0
        

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