ORTEC INTERNATIONAL INC
10QSB, 1998-11-10
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
                  SEPTEMBER 30, 1998

[  ]              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)

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

             3960 BROADWAY
           NEW YORK, NEW YORK                                    10032
(ADDRESS OF PRINCIPAL EXECUTIVE OFFICES)                       (ZIP CODE)
</TABLE>

                                 (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 5,894,190 (as
of November 2, 1998)
<PAGE>   2
                            ORTEC INTERNATIONAL, INC.
                    INDEX TO QUARTERLY REPORT ON FORM 10-QSB
                FILED WITH THE SECURITIES AND EXCHANGE COMMISSION
                        QUARTER ENDED SEPTEMBER 30, 1998


                              ITEMS IN FORM 10-QSB

<TABLE>
<CAPTION>
                                                                                Page
                                                                                ----
<S>                                                                             <C>
Facing page

Part I

         Item 1.           Financial Statements.                                  1

         Item 2.           Plan of Operation.                                    10

Part II

         Item 1.           Legal Proceedings and Claims.                        None

         Item 2.           Changes in Securities and Use                          13
                           of Proceeds.

         Item 3.           Default Upon Senior Securities.                      None

         Item 4.           Submission of Matters to                               13
                           a Vote of Security Holders.

         Item 5.           Other Information.                                   None

         Item 6.           Exhibits and Reports on Form 8-K.                      15

Signatures
</TABLE>



<PAGE>   3
                                     PART I
                                        
Item 1. FINANCIAL STATEMENTS
                                        
                           ORTEC INTERNATIONAL, INC.
                        (A DEVELOPMENT STAGE ENTERPRISE)
                                 BALANCE SHEETS
                                  (UNAUDITED)


<TABLE>
<CAPTION>

                                                  SEPTEMBER 30,       DECEMBER 31,
                                                      1998                1997
                                                      ----                ----
<S>                                               <C>                 <C>
                     ASSETS

Current assets:
  Cash and equivalents                            $   745,423         $11,950,693
  Marketable securities                             8,944,785           1,584,035
  Other current assets                                  2,957               7,075
                                                  -----------         -----------
Total current assets                                9,693,165          13,541,803
                                                  -----------         -----------

Property and equipment, at cost:
  Laboratory equipment                                781,632             602,697
  Office furniture and equipment                      531,405             323,871
  Leasehold improvements                            1,194,443             675,906
                                                  -----------         -----------
                                                    2,507,480           1,602,474

  Accumulated depreciation and
    amortization                                      893,908             606,243
                                                  -----------         -----------
                                                    1,613,572             996,231
                                                  -----------         -----------

Other assets:
  Patent application costs net of
   accumulated amortization of $54,461
   at September 30, 1998 and $31,047
   at December 31, 1997                               439,134             406,166
  Deposits                                             34,112              54,214
                                                  -----------         -----------

Total other assets                                    473,246             460,380
                                                  -----------         -----------

Total Assets                                      $11,779,983         $14,998,414
                                                  -----------         -----------
</TABLE>

See notes to condensed unaudited financial statements.

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


<TABLE>
<CAPTION>

                                                  SEPTEMBER 30,       DECEMBER 31,
                                                      1998                1997
                                                      ----                ----
<S>                                               <C>                 <C>
       LIABILITIES AND SHAREHOLDERS' EQUITY

Current liabilities:
 Accounts payable and accrued
  liabilities                                     $   605,266         $   452,443
 Capital lease obligations - current                   37,470              43,102
 Loans payable - current                              109,359              63,547
                                                  -----------         -----------
Total current liabilities                             752,095             559,092
                                                  -----------         -----------

Long-term liabilities:
 Capital lease obligations - noncurrent                 9,614              34,608
 Loans payable - noncurrent                         1,175,412             688,096
                                                  -----------         -----------
Total long-term liabilities                         1,185,026             722,704
                                                  -----------         -----------
Commitments and contingencies

Shareholders' equity:
 Common stock, $.001 par value;
  authorized, 10,000,000 shares;
  issued and outstanding shares -
  5,895,290 at September 30, 1998 and
  5,760,734 at December 31, 1997                        5,895               5,761
 Additional paid-in capital                        27,349,925          26,397,307
 Deficit accumulated during the
  development stage                               (17,502,646)        (12,686,450)
 Treasury stock, at cost (1,000 shares
  at September 30, 1998)                              (10,312)
                                                  -----------         -----------

Total shareholders' equity                          9,842,862          13,716,618
                                                  -----------         -----------

Total Liabilities and
 Shareholders' Equity                             $11,779,983         $14,998,414
                                                  -----------         -----------
</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
                                                                      Nine months         (inception) to
                                 Quarter ended September 30,      ended September 30,    September 30, 1998
                                 ---------------------------      -------------------    ------------------
                                    1998         1997           1998             1997
                                    ----         ----           ----             ----
<S>                            <C>            <C>            <C>          <C>             <C>
Revenue
  Interest income              $   147,889    $    63,824     $   466,375  $   221,603     $    996,192  
                               -----------    -----------     -----------  -----------     ------------

Expenses
  Research and development         494,016        309,901       1,281,446      823,455         5,814,698
  Rent                              64,907         49,153         171,453      153,949           500,900
  Consulting                       338,226        149,223         575,604      265,464         1,807,908
  Personnel                        683,732        391,752       2,090,988    1,001,419         5,867,795
  General and administrative       405,298        321,449       1,085,998      912,804         4,240,858
  Interest and other expense        27,617         11,531          77,082       35,087           266,679
                               -----------    -----------     -----------  -----------      ------------
                              
                                 2,013,796      1,233,009       5,282,571    3,192,178        18,498,838
                               -----------    -----------     -----------  -----------      ------------

Net loss                       $(1,865,907)   $(1,169,185)    $(4,816,196) $(2,970,575)     $(17,502,646)
                               -----------    -----------     -----------  -----------      ------------

Net loss per share                   $(.32)         $(.25)          $(.82)       $(.64)           $(5.55)
                                     -----          -----           -----        -----            ------

Weighted average common
  stock outstanding (basic
  and diluted)                   5,894,123      4,655,401       5,843,239    4,631,458         3,152,456
                                 ---------      ---------       ---------    ---------         ---------


</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 
                                                                                        accumulated 
                                              Common Stock            Additional           in the 
                                                                       Paid-in          development       Treasury
                                         Shares        Amount          Capital             stage            Stock          Total   
                                         ------        ------          -------          -----------       --------      ----------
<S>                                   <C>              <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            5           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     Treasury
                                    Shares        Amount       Capital          stage          Stock         Total
                                   ---------      ------     -----------     -----------     --------     -----------
<S>                                <C>            <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         Treasury 
                                      Shares      Amount           Capital            stage             Stock            Total
                                      ---------   ------        ------------       ------------        --------       -----------
<S>                                   <C>         <C>           <C>                <C>                 <C>            <C>
(brought forward)                     4,601,963   $4,602        $15,573,183        $ (7,860,787)                      $ 7,716,998
               
Exercise of warrants                  1,158,771    1,159         10,821,632                                            10,822,791
Share issuance costs                                               (657,508)                                             (657,508)
Stock options and warrants                     
 issued for services                                                660,000                                               660,000
Net loss for the year ended
 December 31, 1997                                                                   (4,825,663)                       (4,825,663)
                                      ---------   ------        -----------        ------------                       -----------
Balance - December 31, 1997           5,760,734    5,761         26,397,307         (12,686,450)                       13,716,618

Exercise of options and
 warrants                               134,556      134            526,368                                               526,502
Share issuance costs                                                (20,000)                                              (20,000)
Stock options and warrants
 issued for services                                                446,250                                               446,250
Net loss for the nine months
 ended September 30, 1998                                                            (4,816,196)                       (4,816,196)
Purchase of treasury stock                                                                             $(10,312)          (10,312)
                                      ---------    ------       -----------        ------------        --------       -----------
Balance - September 30, 1998          5,895,290    $5,895       $27,349,925        $(17,502,646)       $(10,312)      $ 9,842,862
                                      ---------    ------       -----------        ------------        --------       -----------
</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
                                                          Quarter ended                Nine months ended            March 12, 1991
                                                          September 30,                  September 30,              (inception) to
                                                 ---------------------------     ----------------------------     September 30, 1998
                                                      1998            1997            1998            1997        ------------------
                                                      ----            ----            ----            ----        
<S>                                               <C>             <C>             <C>             <C>             <C>

Cash flows from operating activities:

Net loss                                          $(1,865,987)    $(1,169,185)    $ (4,816,196)   $(2,970,575)    $(17,502,646)
Adjustments to reconcile net loss
 to net cash used in operating
 activities:
 Depreciation and amortization                        109,364          84,131          311,079        233,897          958,606
 Unrealized loss on marketable
  securities                                                                                                            11,404
 Realized loss on marketable
  securities                                                                                                             5,250
 Non cash stock compensation and
  interest                                             33,750          60,000          446,250         60,000        1,258,250
 Changes in operating assets and
  liabilities
   Other current assets                               130,130          (3,244)           4,118         (1,493)          (2,957)
   Accounts payable and accrued
    liabilities                                       318,888            (468)         152,823        (80,998)         693,093
                                                  -----------     -----------     ------------    -----------     ------------

 Net cash used in operating
  activities                                       (1,273,775)     (1,028,766)      (3,901,926)    (2,759,169)     (14,579,000)
                                                  -----------     -----------     ------------    -----------     ------------

Cash flows from investing activities:

 Purchases of property and equipment,
  excluding capital leases                           (107,289)        (14,638)        (905,006)      (190,660)      (2,420,414)
 Payments for patent application                      (40,295)            537          (56,382)       (12,552)        (493,595)
 Organization costs                                                                                                    (10,238)
 Deposits                                                 282            (857)          20,102         (1,648)         (32,129)
 Purchases of marketable securities                (3,686,128)                     (17,481,750)                    (19,604,971)
 Sales of marketable securities                     4,499,000                       10,121,000                      10,643,532
                                                  -----------     -----------     ------------    -----------     ------------

Net cash provided by (used in)
 investing activities                                 665,570         (14,958)      (8,302,036)      (204,860)     (11,917,815)
                                                  -----------     -----------     ------------    -----------     ------------
</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>
                                                                                                                  Cumulative from
                                                                                                                   March 12, 1991
                                                           Quarter Ending              Nine Months                (Inception) to
                                                           September 30,            Ended September 30,         September 30, 1998
                                                       ---------------------       ----------------------       ------------------
                                                         1998          1997        1998           1997
                                                         ----          ----        ----           ----
<S>                                                  <C>          <C>          <C>           <C>                   <C>
Cash flows from financing activities:

Proceeds from issuance of notes payable                                                                                 515,500
Repayment of notes payable                                                                                         $   (515,500)
Proceeds from issuance of common stock               $   82,299   $    30,689   $   526,502    $   71,253            28,604,528
Share issuance expenses                                                             (20,000)                         (2,547,697)
Purchase of treasury stock                              (10,312)                    (10,312)                            (10,312)
Proceeds of issuance from loans payable                                             600,000                           1,425,850
Repayment of loan payable                               (25,988)       (8,888)      (66,872)      (28,952)             (170,011)
Repayment of capital lease obligations                  (10,969)       (8,332)      (30,626)      (26,407)              (60,120)
                                                      ---------      --------       -------      --------           -----------
Net cash provided by financing activities                35,030        13,469       998,692        15,894            27,242,238
                                                      ---------      --------       -------      --------           -----------
Net increase (decrease) in cash
 and cash equivalents                                  (573,175)   (1,030,255)  (11,205,270)   (2,948,135)              745,423

Cash and cash equivalents at beginning of period      1,318,598     5,525,349    11,950,693     7,453,229
                                                     ----------   -----------    ----------    ----------           -----------
Cash and cash equivalents at end of period           $  745,423   $ 4,505,094   $   745,423   $ 4,505,094           $   745,423
                                                     ----------   -----------   -----------    ----------           -----------
</TABLE>


See notes to condensed unaudited financial statements.


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

                          NOTES TO FINANCIAL STATEMENTS

                           SEPTEMBER 30, 1998 AND 1997


NOTE 1 - FINANCIAL STATEMENTS

         The condensed balance sheet as of September 30, 1998 and the statements
of operations, shareholders' equity and cash flows for the three and nine month
periods ended September 30, 1998 and 1997 and for the period from March 12, 1991
(inception) to September 30, 1998 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 September 30, 1998 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, 1997
annual report on Form 10-KSB filed with the Securities and Exchange Commission.
The results of operations for the nine months ended September 30, 1998 is 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 had granted Ortec a license for a term of
ten years, with automatic renewals by Ortec for two additional ten-year periods,
to commercially use and exploit the Technology for the development of products.
In April, 1998, Dr. Eisenberg assigned his patent for the Technology to Ortec.


                                        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 Company's Composite Cultured Skin to be used in skin
replacement procedures.


ITEM 2.  PLAN OF OPERATION

OPERATIONS FOR THE NEXT TWELVE MONTHS

         During the next two months the Company expects to continue to enroll
patients in its pilot human clinical trial for the use of its Composite Cultured
Skin for the treatment of donor site wounds and in December 1998 to submit an
Investigational Device Exemption ("IDE") application to the FDA for a pivotal
human clinical trial of its product for donor site wounds. The Company expects,
subject to FDA approval, to initiate a multi-hospital donor site pivotal trial
during the first quarter of 1999. The Company's goal is to complete patient
enrollment for the donor site pivotal trial by the second quarter of 1999.
                                                                               
         Patient enrollment in the venous ulcers pilot trial is expected to be
concluded by the first quarter of 1999. The Company expects to initiate a venous
ulcers pivotal trial, subject to FDA approval, by the second quarter of 2000.

         During the third quarter of 1998 the Company continued to take the
steps required to enable it to submit to the FDA by the first quarter of 1999 a
Humanitarian Device Exemption application ("HDE") for its Composite Cultured
Skin in treating EB patients. The granting of the HDE by the FDA within the time
the Company anticipates should enable the Company to begin commercial marketing
of its Composite Cultured Skin for the treatment of EB patients by the end of
1999.

         By the end of 1998 the Company also expects to submit an IDE
application to the FDA for a pilot human clinical trial for the use of its
Composite Cultured Skin in the treatment of diabetic ulcers with the
expectation, subject to FDA approval, that patient enrollment will commence
during the second quarter of 1999 and be completed during the third quarter of
1999. Initiation of the diabetic ulcers pilot trial would bring to four the
total number of human clinical trials in which the use of the Company's
Composite Cultured Skin will be evaluated for the treatment of different skin
disorders and injuries.
                                                                               
         During the third quarter of 1998, the Company continued to focus on the
development of its cryopreservation technique. The Company expects to be able to
validate the use of its Composite Cultured Skin in cryopreserved form by
December 1998 and to use a cryopreserved product in its human clinical trials,
subject to FDA approval, sometime in the first half of 1999.


                                       10
<PAGE>   13
EMPLOYEES

         The Company currently employs 39 full time employees, 30 of whom are
involved in research and development or in the conduct of the human clinical
trials. The Company's other employees are its executive officers and clerical
support staff.

         In addition, the Company expects to employ an additional 11 persons
during the next twelve months, primarily for scientific research and development
and process manufacturing to enable the Company to proceed with and meet its
clinical trial and product development goals.


CASH REQUIREMENTS

         The Company estimates that it has sufficient funds necessary to operate
through approximately January 2000. In the last quarter of 1997 the Company
received net proceeds of $10,168,756 as a result of the exercise of 1,083,780 of
its publicly-traded Class A Warrants, which expired on December 31, 1997. In the
second quarter of 1998 the Company received net proceeds of $159,000 as the
result of the exercise of 11,400 shares of its publicly traded Class B Warrants,
which expire January 18, 1999. The Company may have to secure additional funds
prior to January 2000, particularly if it conducts clinical trials with larger
patient pools than presently anticipated, to complete its human clinical trials,
to secure FDA pre-market approval for commercial sales and thereafter to produce
and market its Composite Cultured Skin in commercial quantities. The Company is
exploring securing strategic corporate partnerships as one means for securing
such additional funding.

         See "Forward Looking Information May Prove Inaccurate."

CLINICAL TRIALS AND PRODUCT RESEARCH AND DEVELOPMENT

         The Company has spent $1,178,836 in 1997, $1,281,446 in the nine months
ended September 30, 1998, and $494,016 in the third quarter of 1998, and an 
aggregate of approximately $5,814,698 from its inception through September 30, 
1998, for 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 hospitals 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 month period ending September 30, 1999, in order to continue its 
human clinical trials program for applications of the Company's Composite 
Cultured Skin, continue its efforts to secure FDA pre-market approval for 
commercial sales and thereafter to produce and market its Compute Culture Skin
in  commercial quantities.                               

            See "Forward Looking Information May Prove Inaccurate."

                                       11
<PAGE>   14
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

         (c)  Recent Sales of Unregistered Securities.

         During the third quarter of 1998 the Company granted three employees
five year options under its Employee Stock Option Plan to purchase an aggregate
of 6,500 shares of Common Stock, at exercise prices ranging from $9.125 to
$13.875 per share. Such grants were in consideration for services rendered to
the Company.

         The grants of such options were not registered under the Securities Act
of 1933, as amended (the "Act"), as they did not constitute sales of securities.
However, the sale by the Company of the shares issuable upon exercise of such
options granted under the Company's Employee Stock Option Plan, have all been
registered under the Act.


ITEM 4.           SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS

                  The Company's 1998 Annual Meeting of Shareholders was held on
August 11, 1998 at the Audubon Biomedical Science and Technology Park, 3960
Broadway, New York, New York. At the meeting, the shareholders voted on four
matters and all of such matters were approved.

         The first matter was the election of the members of the Board of
Directors. The six directors elected and the tabulation of the votes (both in
person and by proxy) was as follows:

<TABLE>
<CAPTION>
         NOMINEES FOR
           DIRECTORS                        FOR                    WITHHELD                  AGAINST
           ---------                        ---                    --------                  -------
<S>                                     <C>                        <C>                       <C>
         Steven Katz                    5,069,216                      0                       1,000
         Mark Eisenberg                 5,069,216                      0                       1,000
         Ron Lipstein                   5,069,216                      0                       1,000
         Alain Klapholz                 5,069,216                      0                       1,000
         Joseph Stechler                5,069,216                      0                       1,000
         Steven Lillien                 5,069,216                      0                       1,000
</TABLE>


                                       13
<PAGE>   16
         There were no broker held non-voted shares represented at the meeting
with respect to this matter. There was no other director whose term of office as
a director continued after the meeting.

         The second matter upon which the shareholders voted was the proposal to
ratify the appointment by the Board of Directors of Grant Thornton LLP as
independent certified public accountants for the Company for 1998. The
tabulation of the votes (both in person and by proxy) was as follows:

<TABLE>
<CAPTION>
                              FOR                    AGAINST                    ABSTENTIONS
                              ---                    -------                    -----------
                         <S>                          <C>                             <C>
                           5,056,046                   10,820                          3,050
</TABLE>

         There were no broker held non-voted shares represented at the Meeting
with respect to this matter.

         The third matter upon which the shareholders voted was the proposal to
approve the Company's Amended and Restated 1996 Stock Option Plan increasing the
maximum number of shares of the Company's Common Stock for which stock options
may be granted under the Plan from 350,000 to 1,550,000. The tabulation of the
votes (both in person and by proxy) was as follows:

<TABLE>
<CAPTION>
                              FOR                    AGAINST                    ABSTENTIONS
                              ---                    -------                    -----------
                          <S>                         <C>                            <C>
                           3,306,842                   26,833                         37,798
</TABLE>

         There were 1,728,031 broker held non-voted shares represented at the
meeting with respect to this matter.

         The fourth matter upon which the shareholders voted was to amend the
Company's Certificate of Incorporation increasing the number of shares of common
stock the Company is authorized to issue from 10,000,000 shares to 25,000,000
shares. The tabulation of the votes (both in person and by proxy) was as
follows:

<TABLE>
<CAPTION>
                              FOR                    AGAINST                    ABSTENTIONS
                              ---                    -------                    -----------
                          <S>                         <C>                            <C>
                           4,998,398                   43,165                         20,385
</TABLE>


                                       14
<PAGE>   17
ITEM 6.           EXHIBITS AND REPORTS ON FORM 8-K

<TABLE>
<CAPTION>
(a)            Exhibit No.          Description
               -----------          -----------
               <S>                 <C>
                 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 *
</TABLE>

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

*        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.


                                       15
<PAGE>   18
                                   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: November 10, 1998                     By:    /s/ Steven Katz
                                               ---------------------------------
                                                   Steven Katz, PhD
                                                   President and Chief
                                                   Executive Officer
                                                   (Principal Executive Officer)



Date: November 10, 1998                     By:     /s/ Ron Lipstein
                                               ---------------------------------
                                                   Ron Lipstein
                                                   Chief Financial Officer
                                                   (Principal Financial Officer)


                                       16

<TABLE> <S> <C>

<ARTICLE> 5
       
<S>                             <C>
<PERIOD-TYPE>                   9-MOS
<FISCAL-YEAR-END>                          DEC-31-1998
<PERIOD-START>                             JAN-01-1998
<PERIOD-END>                               SEP-30-1998
<CASH>                                         745,423
<SECURITIES>                                 8,944,785
<RECEIVABLES>                                        0
<ALLOWANCES>                                         0
<INVENTORY>                                          0
<CURRENT-ASSETS>                             9,693,165
<PP&E>                                       2,507,480
<DEPRECIATION>                                 893,908
<TOTAL-ASSETS>                              11,779,983
<CURRENT-LIABILITIES>                          752,095
<BONDS>                                              0
                                0
                                          0
<COMMON>                                         5,895
<OTHER-SE>                                   9,836,967
<TOTAL-LIABILITY-AND-EQUITY>                11,779,983
<SALES>                                              0
<TOTAL-REVENUES>                               466,375
<CGS>                                                0
<TOTAL-COSTS>                                        0
<OTHER-EXPENSES>                             5,282,571
<LOSS-PROVISION>                                     0
<INTEREST-EXPENSE>                                   0
<INCOME-PRETAX>                            (4,816,196)
<INCOME-TAX>                                         0
<INCOME-CONTINUING>                        (4,816,196)
<DISCONTINUED>                                       0
<EXTRAORDINARY>                                      0
<CHANGES>                                            0
<NET-INCOME>                               (4,816,196)
<EPS-PRIMARY>                                    (.82)
<EPS-DILUTED>                                        0
        

</TABLE>


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