Stem Cell Innovations/Inc · 10-K · For 12/31/99

Filed On 4/14/00   ·   SEC File 0-10379   ·   Accession Number 351532-0-4

Annual Report   ·   Form 10-K
Filing Table of Contents

Document/Exhibit                   Description                      Pages   Size 

 1: 10-K        Intertferon Sciences, Inc.                            57±   213K 
 2: EX-27       Financial Data Schedule                                1      4K 

10-K   ·   Intertferon Sciences, Inc.
Document Table of Contents

10-K
1st "Page" of 15
TOC
Top
Previous
Next
Bottom
Just 1st
 
Sponsored Ads...


UNITED STATES SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 FORM 10-K

/X/ Annual Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act
of 1934                                                                 

For the Fiscal Year Ended December 31, 1999                             

/ / 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 0-10379                                                  

 INTERFERON SCIENCES, INC.

(Exact name of registrant as specified in its charter)

Delaware                                                     22-2313648         
(State or other jurisdiction of                              (I.R.S. Employer   
incorporation or organization)                               Identification No.)

783 Jersey Avenue, New Brunswick, New Jersey                 08901              
(Address of principal executive offices)                     (Zip Code)         

Registrant's telephone number, including area code:          (732) 249-3250     

Securities registered pursuant to Section 12(b) of the Act:   None              

Securities registered pursuant to Section 12(g) of the Act:                     

Common Stock, Par Value $0.01 Per Share                                         
(Title of Class)                                                                

         Indicate by check mark whether the registrant (1) has filed all reports
required to be filed by Section 13 or 15(d) of the  Securities  Exchange  Act of
1934  during  the  preceding  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 --

                                                       ---- ----

         Indicate by check mark if disclosure of delinquent  filers  pursuant to
Item 405 of Regulation S-K is not contained  herein,  and will not be contained,
to the best of  registrant's  knowledge,  in  definitive  proxy  or  information
statements  incorporated  by  reference  in Part  III of this  Form  10-K or any
amendment to this Form 10-K. / /                                                

       As of April 1, 2000, the aggregate market value of the outstanding shares
of  the  registrant's   Common  Stock,  par  value  $.01  per  share,   held  by
non-affiliates  (assuming  for  this  calculation  only  that all  officers  and
directors  are  affiliates)  was  approximately  $14,500,000  based  on the last
reported sale price of such stock on the OTC Bulletin Board on March 31, 2000.  

         Indicate the number of shares  outstanding of each of the  registrant's
classes of common stock, as of the latest practicable date.                     

                                              Class Outstanding at April 1, 2000
                                             -----------------------------------
Common Stock, par value $.01 per share                          5,387,473 shares

 DOCUMENTS INCORPORATED BY REFERENCE

        Portions of the registrant's Proxy Statement for its 2000 Annual Meeting
of Stockholders are incorporated by reference into Part III hereof.             

10-K
2nd "Page" of 15
TOC
1st
Previous
Next
Bottom
Just 2nd

 TABLE OF CONTENTS

                                                                            Page

Item 1.  Business                                                             1 

Item 2.  Properties                                                          12 

Item 3.  Legal Proceedings                                                   12 

Item 4.  Submission of Matters to a Vote of Security Holders                 12 

Item 5.  Market for the Registrant's Common Stock and Related                   
        Stockholder Matters                                                 13

Item 6.  Selected Financial Data                                             13 

Item 7.  Management's Discussion and Analysis of Financial                      
        Condition and Results of Operations                                 14

Item 7A. Quantitative and Qualitative Disclosure About                          
        Market Risk                                                         19

Item 8.  Financial Statements and Supplementary Data                         19 

Item 9.  Changes In and Disagreements with Accountants on                       
        Accounting and Financial Disclosure                                 36

Item 10. Directors and Executive Officers of the Registrant                  37 

Item 11. Executive Compensation                                              37 

Item 12. Security Ownership of Certain Beneficial Owners                        
        and Management                                                      37

Item 13. Certain Relationships and Related Transactions                      37 

Item 14. Exhibits, Financial Statement Schedules,                               
        and Reports on Form 8-K                                             38

10-K
3rd "Page" of 15
TOC
1st
Previous
Next
Bottom
Just 3rd

PART I

Item 1. Business                                                                

(a) General Development of Business                               

         Interferon  Sciences,  Inc.  (the  "Company")  is  a  biopharmaceutical
company engaged in the study,  manufacture,  and sale of pharmaceutical products
based on its highly  purified,  multispecies,  natural  source alpha  interferon
("Natural Alpha Interferon").  The Company's ALFERON N Injection(R)  (Interferon
Alfa-n3)  product  has  been  approved  by  the  United  States  Food  and  Drug
Administration  ("FDA") for the  treatment of certain types of genital warts and
the  Company  has been  studying  its  potential  use in the  treatment  of HIV,
hepatitis C, and other indications. The Company has also been studying ALFERON N
Gel(R) and  ALFERON  LDO(R),  the  Company's  topical and oral  formulations  of
Natural Alpha Interferon, for the potential treatment of viral and immune system
diseases.                                                                       

(b) Financial Information about Business Segments                 

         The Company operates as a single line of business.  For the years ended
December 31, 1999, 1998 and 1997, domestic sales totaled $2,204,437,  $1,716,157
and $2,613,430,  respectively,  and foreign sales  (primarily  Germany)  totaled
$124,508,  $214,500 and  $314,155,  respectively.  All  identifiable  assets are
located in the United States.                                                   

(c) Narrative Description of Business                             

Scientific Background                                                           

         Interferons  are a group of proteins  produced and secreted by cells to
combat  diseases.  Researchers  have  identified  four  major  classes  of human
interferon:  alpha, beta, gamma, and omega. The Company's three ALFERON products
contain a form of alpha  interferon.  The worldwide  market for injectable alpha
interferon-based  products  has  experienced  rapid  growth  and  various  alpha
interferon injectable products are approved for 17 major medical uses worldwide.

         Alpha  interferons  are  manufactured  commercially  in three ways:  by
genetic  engineering,  by cell culture, and from human white blood cells. In the
United  States,  all three of these types of alpha  interferon  are approved for
commercial sale.                                                                

         The Company  believes  that the  potential  advantages of Natural Alpha
Interferon  over  recombinant  interferons  may be based upon  their  respective
molecular  compositions.  Natural  Alpha  Interferon  is composed of a family of
proteins containing many different molecular species of interferon. In contrast,
recombinant  alpha  interferons each contain only a single species.  Researchers
have  reported  that the  various  species  of  interferon  may  have  differing
antiviral  activity  depending upon the type of virus.  Natural Alpha Interferon
presents a broad  complement of species  which the Company  believes may account
for its higher  efficacy in laboratory  studies with the HIV virus compared with
that of  recombinant  alpha  interferon 2a and 2b (ROFERON(R) A and INTRON(R) A,
respectively).  Natural Alpha Interferon is also glycosylated (partially covered
with sugar  molecules).  Such  glycosylation  is not  present  on the  currently
marketed recombinant alpha interferons. The Company believes that the absence of
glycosylation   may  be,   in   part,   responsible   for  the   production   of
interferon-neutralizing  antibodies  seen in patients  treated with  recombinant
alpha interferon.  Although cell cultured-derived interferon is also composed of
multiple  glycosylated alpha interferon species, the types and relative quantity
of these species are different from the Company's Natural Alpha Interferon.     

         The  production of Natural Alpha  Interferon is dependent upon a supply
of human white blood cells and other  essential  materials.  The Company obtains
white blood cells from FDA- licensed blood donor centers.                       

ALFERON N Injection                                                             

         Approved  Indication.  On October 10, 1989, the FDA approved  ALFERON N
Injection  for the  intralesional  treatment of  refractory  (resistant to other
treatment)  or recurring  external  genital warts in patients 18 years of age or
older. Substantially all of the Company's revenues, to date, have been generated
from the sale of  ALFERON N  Injection  for such  treatment.  Genital  warts,  a
sexually  transmitted  disease,  are caused by certain types of human  papilloma
viruses. A published report estimates that  approximately  eight million new and
recurrent cases of genital warts occur annually in the United States alone.     

         Genital warts are usually  treated  using caustic  chemicals or through
physical  removal  methods.  These procedures can be quite painful and effective
treatment is often difficult to achieve. A topical  formulation of an interferon
inducer was approved by the FDA in 1997 for the treatment of genital  warts.  To
date, the Company does not believe that such approval has had a material adverse
effect on the sales of Alferon N Injection.                                     

         Clinical Trials for New Indications. In an effort to obtain approval to
market ALFERON N Injection for  additional  indications in the United States and
around the world, the Company has conducted, and is currently planning,  various
clinical trials for new indications.                                            

         HIV-infected   patients.   The  Human  Immunodeficiency  Virus  ("HIV")
infection  is at epidemic  levels in the world.  The World  Health  Organization
projects  that this virus will affect 30 to 40 million  people by the year 2000.
HIV  infection  usually  signals  the  start  of  a  progressive   disease  that
compromises  the  immune  systems,   ultimately  resulting  in  Acquired  Immune
Deficiency  Syndrome  ("AIDS").  The United States  Centers for Disease  Control
estimates that as of the middle of 1999, there were approximately 285,000 people
living with AIDS in the United States.                                          

         An article published in AIDS Research and Human Retroviruses in 1993 by
investigators  at Walter  Reed Army  Institute  of Research  ("Walter  Reed") in
collaboration  with  the  Company's   scientists   indicated  that  the  various
interferon  species  display vast  differences  in their ability to affect virus
replication.  Walter Reed  researchers  found that the  Company's  Natural Alpha
Interferon  was 10 to 100 times  more  effective  than equal  concentrations  of
recombinant  alpha  interferon  2a  and  2b,   respectively,   in  blocking  the
replication of HIV-1,  the AIDS virus,  in infected  human cells  (monocytes) in
vitro.                                                                          

         Moreover, the Company's scientists were able to separate members of the
interferon  family in single  protein  fractions  or clusters of proteins  using
advanced  fractionation  techniques.  The  individual  fractions were tested for
their  ability to block HIV  replication  in the  laboratory by  researchers  at
Walter Reed. They found that the unusual  anti-HIV  activity was attributable to
very specific fractions in the Company's product.  The most active fractions are
not present in marketed recombinant interferon products.                        

         This information  provided additional support for a long-held belief of
the Company that its Natural Alpha Interferon has unique  anti-viral  properties
distinguishing it from recombinant  interferon products. In addition,  published
reports  of  trials  using   recombinant   alpha   interferon  in   asymptomatic
HIV-infected  patients  indicated that while high doses blocked virus production
in many cases, such doses resulted in high levels of adverse reactions,  thereby
limiting the usefulness of the recombinant  product.  These facts led the Walter
Reed researchers to conduct a Phase 1 clinical trial with the Company's  product
in asymptomatic HIV-infected patients.                                          

         In March  1992,  Walter  Reed  launched a Phase 1  clinical  trial with
asymptomatic  HIV-infected patients to investigate the safety and tolerance,  at
several dose regimens, of ALFERON N Injection,  self-injected subcutaneously for
periods of up to 24 weeks.  The  investigators  concluded that the treatment was
"surprisingly"  well tolerated by patients,  at all dose  regimens.  Preliminary
findings  were reported by Walter Reed at the IXth  International  Conference on
AIDS in  Berlin in 1993.  The  investigators  also  reported  that the  expected
interferon side effects,  such as flu-like symptoms,  were rare or absent in the
majority of patients treated with the Company's product.                        

         Although this Phase 1 clinical trial was designed  primarily to provide
safety  information  on various  doses of ALFERON N Injection  used for extended
periods  of time,  there  were  encouraging  indications  that  certain  disease
parameters had stabilized or even improved in certain patients by the end of the
experimental treatment.                                                         

         In a follow-up  analysis of patients'  blood testing data, it was found
after an average  of 16 months  after  treatment,  CD4 white  blood cell  counts
remained essentially  unchanged or were higher than at the onset of the trial in
11 of 20 patients. In addition, while on treatment, the amount of HIV detectable
in the  patients'  blood,  as  measured by  polymerize  chain  reaction  ("PCR")
testing,  declined  in a dose  dependent  manner  (the  greatest  declines  were
observed in the highest dose group).  Also,  none of the patients  were found to
have developed neutralizing  antibodies to Natural Alpha Interferon,  even after
being treated three times weekly for many months. These results were reported at
the Third  International  Congress  on  Biological  Response  Modifiers  held in
Cancun,  Mexico in January 1995 and were selected for a poster  presentation  at
the 35th Interscience  Conference on Antimicrobial  Agents and Chemotherapy held
in San Francisco in September 1995. An extensive report was published in the May
1996 Issue of the Journal of Infectious Diseases.                               

         It is  important  to note that,  because  of the small  number of study
participants  and the absence of a control  group,  no firm  conclusions  can be
drawn  from these  observations.  However,  based on the safety and  preliminary
efficacy  data  obtained  from this trial and after  meeting  with the FDA,  the
Company  conducted a multi-center  Phase 3 clinical trial of ALFERON N Injection
in HIV-infected patients, which was completed in December 1997. This randomized,
double-blind,  placebo-controlled  trial was designed to evaluate the safety and
efficacy of ALFERON N Injection in the treatment of HIV-positive patients,  some
of whom may have been  taking  other  FDA-approved  antiviral  agents.  Enrolled
patients were required to have CD4 white blood cell counts of at least 250 cells
per  micrometer  and a viral burden (as  determined  by PCR testing) of at least
2,000 RNA copies per milliliter.  The Company completed the analysis of the data
collected from the 16 investigator  sites and attended a pre-filing meeting with
the FDA in  mid-March  1998.  Shortly  after that  meeting,  the FDA advised the
Company that, although ALFERON N Injection  demonstrated  biological activity in
this  Phase 3 clinical  trial,  the  results  were  insufficient  for filing for
approval  for this  additional  indication  for ALFERON N  Injection.  While the
results  over  the  course  of  treatment   demonstrated   benefits   that  were
statistically  significant  for  the  group  of  patients  receiving  ALFERON  N
Injection and highly statistically significant for the subgroup of such patients
with high CD4 counts, the study's primary efficacy variable  (reduction in viral
load)  was  not  met  at the  time  point  specified  in the  protocol  (end  of
treatment).  The FDA  therefore  indicated  that an  additional  trial  would be
necessary  to  evaluate  further the  efficacy  of ALFERON N Injection  for this
indication.  The Company does not currently  intend to pursue this program until
it obtains  substantial  additional  funding or enters into  collaboration  with
another company for such purpose.                                               

         There can be no assurance that ALFERON N Injection for the treatment of
patients  with HIV  will be  cost-effective,  safe,  and  effective  or that the
Company will be able to obtain FDA approval for such use.  Furthermore,  even if
such approval is obtained,  there can be no assurance  that such product will be
commercially  successful or will produce significant revenues or profits for the
Company.                                                                        

         Hepatitis C. Chronic  viral  hepatitis is a liver  infection  caused by
various  hepatitis  viruses.  The United  States  Centers  for  Disease  Control
estimates  that nearly four million  people in the United  States are  presently
infected with the hepatitis C virus  ("HCV"),  a majority of whom become chronic
carriers  and will suffer  gradual  deterioration  of their  liver and  possibly
cancer  of  the  liver.   Several  brands  of   recombinant   interferon  and  a
cell-cultured  interferon have been approved for the treatment of hepatitis C in
the United States and by various regulatory agencies worldwide.  See "Business -
ALFERON N Injection -  Competition."  However,  reports have indicated that many
patients  either do not respond to treatment  with the  recombinant  products or
relapse  after  treatment.   The  Company  has  conducted  three   multi-center,
randomized, open-label, dose ranging Phase 2 clinical trials utilizing ALFERON N
Injection  with  patients  chronically  infected  with HCV. The objective of the
Company's  HCV  clinical  studies  was to compare  the safety  and  efficacy  of
different doses of Natural Alpha  Interferon  injected  subcutaneously  in naive
(previously  untreated),  refractory  (unsuccessfully  treated with  recombinant
interferon),  and relapsing (initially  responded to recombinant  interferon but
later relapsed) patients.                                                       

         The results in naive  patients  indicated a significant  dose-dependent
response at the end of treatment  favoring the highest dose group.  In addition,
treatment  of naive  patients  with  ALFERON N  Injection  did not  produce  any
interferon-neutralizing antibodies. An oral presentation of the results in naive
patients was given at the American  Association  for the Study of Liver Diseases
("AASLD")  meeting that took place in November  1995.  The results of this study
were published in the February 1997 issue of Hepatology.                        

         The   results  in   refractory   patients   indicated   a   significant
dose-dependent response at the end of treatment favoring the highest dose group.
A poster  presentation  of the results in  refractory  patients was given at the
AASLD meeting that took place in November 1995.                                 

         As a result of the  promising  results  obtained  in the study on naive
patients,  the study on relapsing patients,  which was accruing patients slowly,
was terminated early so that the Company could concentrate its limited resources
on pursuing the Phase 3 trials in naive patients, discussed below.              

         After  meeting  with the FDA,  the Company  commenced in 1996 a Phase 3
multi-center,  open label,  randomized,  controlled  clinical  trial designed to
evaluate  the  safety  and  efficacy  of ALFERON N  Injection  in naive  chronic
hepatitis C patients.  The trial was conducted at 26 sites located in the United
States and Canada and a total of 321 people were treated. The trial consisted of
a 24-week  treatment  phase and 24-week  follow-up  and also included an interim
analysis after  approximately  one-half of the enrolled  patients  completed the
treatment and follow-up phases.                                                 

         On April 2, 1998,  the Company  announced it had  completed the interim
analysis of the results for approximately half of the enrolled patients.  If the
results  of the  interim  analysis  had  demonstrated  at a very  high  level of
statistical  significance  that  ALFERON N Injection is  effective,  the Company
intended to seek FDA  approval  while  continuing  to follow the other  enrolled
patients.  However,  while  the  efficacy  analysis  indicated  that  ALFERON  N
Injection  and the control  treatment  (an approved  therapy)  appeared to yield
similar results,  the study protocol  required a showing of superiority in order
to meet the  criteria  for  statistical  significance  in the interim  analysis.
Therefore the Company did not seek FDA approval  based on the interim  analysis.
The  Phase 3 study  was  completed  in 1998.  The  Company  completed  the final
analysis  of the data in March  1999,  and met  with  the FDA to  determine  the
acceptability  of the  results for filing  purposes.  At that  meeting,  the FDA
advised the Company that the results of the trial were  insufficient to file for
approval because the designed endpoint of the trial (which required a showing of
superiority in sustained  normalization of liver enzymes at the end of treatment
and after six months of follow up) was not met. Therefore,  the FDA informed the
Company  that an  additional  trial would be required  to further  evaluate  the
efficacy of Alferon N Injection for this  indication.  At the present time,  the
Company does not have the resources necessary to conduct an additional study and
does not plan to initiate  such a study unless it can find a sponsor to continue
this program.                                                                   

         HIV and Hepatitis C Co-Infected  Patients.  In December  1997,  patient
enrollment  commenced  in a Phase 2  multi-center,  open  label  clinical  trial
designed to evaluate  the safety and efficacy of ALFERON N Injection in patients
co-infected  with HIV and HCV.  This  study has been  concluded  and the data is
presently being analyzed.                                                       

         Multiple Sclerosis.  Multiple sclerosis ("MS") is a chronic,  sometimes
progressive,  immune-mediated  disease of the  central  nervous  system  that is
believed to occur in genetically  predisposed  individuals following exposure to
an  environmental  factor,  such as virus  infection.  The  disease  affects  an
estimated  250,000  to  350,000  people in the United  States,  primarily  young
adults.  Symptoms of MS,  including vision  problems,  muscle weakness,  slurred
speech,  and poor  coordination,  are believed to occur when the  patient's  own
cells attack and ultimately destroy the insulating myelin sheath surrounding the
brain and spinal  cord nerve  fibers,  resulting  in  improper  transmission  of
signals throughout the nervous system.                                          

         In the United States,  two  recombinant  forms of beta  interferon have
been approved for the treatment of relapsing-remitting  MS. However,  reports in
the scientific  literature  and elsewhere  have  indicated that the  significant
adverse reactions  associated with the treatments may limit their usefulness for
a subset of patients.  In addition,  Copaxone(R),  a non-interferon  product was
approved by the FDA to treat  relapsing-remitting  multiple sclerosis.  Based in
part on  encouraging  anecdotal  reports on the use of ALFERON N Injection in MS
patients,  as well as a  recent  poster  presentation  entitled  "Management  of
Interferon-(beta)1b   (Betaseron)  Failures  in  MS  With   Interferon-(alpha)n3
(Alferon N)",  given at the Charcot  Foundation  Meeting in Switzerland in March
2000, the Company would like to conduct a clinical trial in order to investigate
the potential use of ALFERON N Injection for the treatment of MS.  However,  the
timing of this  trial will be  dependent  upon the  Company's  ability to obtain
additional funding or a sponsor.                                                

         Other HPV Indications or Routes of Administration.  The Company is also
evaluating  whether to  investigate  the potential use of ALFERON N Injection by
subcutaneous  systemic  administration  for  the  treatment  of  genital  warts.
Currently, the approved route of administration is intralesional and requires up
to 16 office  visits  to the  medical  practitioner.  If  subcutaneous  systemic
treatment   were   found  to  be   efficacious,   patients   could   potentially
self-administer  the  product as they have done in many of the  clinical  trials
conducted by the Company. This would make treatment considerably more convenient
for patients.                                                                   

         In addition,  in the following two publications:  "Adjuvant  Interferon
for Anal Condyloma,  A Prospective Randomized Trial", Dis Colon Rectum 1994, and
"Interferon as an Adjuvant Treatment for Genital Condyloma  Acuminatum",  Intl J
Gynecol  Obstet 1995, in which  ALFERON N Injection  was studied in  conjunction
with other  treatments for genital warts, the authors reported that the addition
of ALFERON N Injection to the other ablative therapies significantly reduced the
recurrence  rates. The Company is evaluating  whether to conduct clinical trials
to further  investigate  the potential use of ALFERON N Injection as an adjuvant
to other genital wart treatments in the event it obtains additional funding.    

     Marketing  and  Distribution.  The  Company  has focused its efforts in the
United States on making additional sales to existing customers. The Company does
not  have its own  sales  force.  In June  1998,  the  Company  entered  into an
agreement appointing  Integrated  Commercialization  Solutions,  Inc. ("ICS"), a
subsidiary of Bergen Brunswig Corporation, as the sole United States distributor
of ALFERON N  Injection.  ICS  distributes  ALFERON N Injection  to  wholesalers
throughout the United States.  The Company does not believe that the loss of any
one wholesaler  would have a material  adverse effect on the Company's  sales or
Financial position.  Pursuant to such agreement,  ICS also provides clinical and
product information,  reimbursement  information and services, and management of
patient assistance services. Most of the Company's sales have been in the United
States.                                                                         

         Manufacturing.   The  purified   drug   concentrate   utilized  in  the
formulation  of ALFERON N Injection is  manufactured  in the Company's  facility
located in New Brunswick,  New Jersey, and ALFERON N Injection is formulated and
packaged at a production  facility located in McPherson,  Kansas and operated by
Abbott  Laboratories  Inc.  ("Abbott")  pursuant  to  a  processing  and  supply
agreement  entered into in September 1994. Under the terms of the agreement with
Abbott, the Company pays Abbott an agreed price to formulate and package ALFERON
N Injection in accordance with  specifications  provided by the Company.  At the
present time, the Company has discontinued  production of crude interferon.  The
Company  intends to convert  intermediates  to finished  product as needed.  The
Company believes it has produced sufficient  inventory of these intermediates to
satisfy its  clinical  and  commercial  needs for the  foreseeable  future.  See
"Business  -  ALFERON  N  Injection  -  Clinical  Trials  for New  Indications,"
"Management's  Discussion  and  Analysis of Financial  Condition  and Results of
Operations," "Business - Governmental Regulation," and "Properties."            

         Competition. Presently, INTRON A, manufactured by Schering Plough Corp.
("Schering"), is the one other injectable interferon product approved by the FDA
for the  treatment of genital  warts.  INTRON A is made from  recombinant  alpha
interferon.  Since the  production  of INTRON A is not  dependent on a source of
human blood  cells,  it may be able to be  produced  in greater  volume and at a
lower cost than ALFERON N Injection. Currently, the Company's wholesale price on
a per unit basis of ALFERON N  Injection  is  substantially  higher than that of
INTRON  A.  In  1997,   3M   Pharmaceuticals   received  FDA  approval  for  its
immune-response modifier,  Aldara(R), a self-administered topical cream, for the
treatment  of external  genital and  perianal  warts.  ALFERON N Injection  also
competes with surgical,  chemical,  and other methods of treating genital warts.
The Company  cannot assess the impact from  products  developed by the Company's
competitors  or advances in other  methods of the  treatment of genital warts on
the commercial viability of its product.                                        

         If and when the Company obtains approvals for additional indications of
ALFERON N  Injection,  it expects to compete  primarily  on the basis of product
performance  and price with a number of  pharmaceutical  companies,  both in the
United States and abroad.                                                       

         A number of synthetic  antiviral  compounds  have been  approved in the
United  States and certain  foreign  countries for the  treatment,  primarily in
combination  therapy,  of HIV infection and AIDS. Shown in Table 1 below are the
drugs,  which are  currently  approved in the United States for the treatment of
patients infected with HIV.                                                     

                                                        [Enlarge/Download Table]


         Table 1: HIV Antiretroviral Drugs Approved in the United States                       
                                                                                               

Class of Drug                Brand Name      Generic Name               Manufacturer           
---------------------------------------------------------------------------------------------- 

Nucleoside Reverse           Combivir(R)     Zidovudine + Lamivudine    Glaxo Wellcome         
Transcriptase Inhibitors     Epivir(R)       Lamivudine                 Glaxo Wellcome         
                             Hivid(R)        Zalcitabine                Hoffmann-La Roche      
                             Retrovir(R)     Zidovudine                 Glaxo Wellcome         
                             Videx(R)        Didanosine                 Bristol-Myers Squibb   
                             Zerit(R)        Stavudine                  Bristol-Myers Squibb   
                             Ziagen(R)       Abacavir                   Glaxo Wellcome         
Non-Nucleoside Reverse       Rescriptor(R)   Delavirdine                Pharmacia & Upjohn     
Transcriptase Inhibitors     Viramune(R)     Nevirapine                 Boehringer Ingelheim   
                             Sustiva(R)      Efavirenz                  DuPont-Merck           
Protease Inhibitors          Crixivan(R)     Indinavir                  Merck & Co.            
                             Invirase(R)     Saquinavir                 Hoffmann-La Roche      
                             Fortovase(R)    Saquinavir                 Hoffmann-La Roche      
                             Norvir(R)       Ritonavir                  Abbott Laboratories    
                             Viracept(R)     Nelfinavir                 Agouron Pharmaceuticals
                             Agenerase(R)    Amprenavir                 Glaxo Wellcome         


         Schering's  recombinant  interferon product is already approved for the
treatment of hepatitis C and hepatitis B in the United States and other markets,
as well as for many other  medical  uses.  Roche  Pharmaceuticals's  recombinant
interferon  product has been  approved  for the  treatment of hepatitis C in the
United  States and for other  medical  uses in the United  States and in foreign
countries. In addition, Amgen Inc.'s recombinant interferon,  Infergen(R),  also
known as consensus  interferon product, as well as Glaxo Wellcome's cell culture
derived interferon,  Wellferon(R), are approved for the treatment of hepatitis C
in the United States.                                                           

         In the United States, two recombinant forms of beta interferon, Biogen,
Inc.'s  Avonex(R) and Berlex  Laboratories'  Betaseron(R) as well as Teva Marion
Partners'  Copaxone(R),  a  non-interferon  product,  have been approved for the
treatment of relapsing-remitting MS.                                            

         Many of the  Company's  potential  competitors  are among  the  largest
pharmaceutical  companies  in the  world,  are well  known to the public and the
medical  community,  and have  substantially  greater  financial  resources  and
product development,  manufacturing, and marketing capabilities than the Company
or its marketing  partners.  Therefore,  there can be no assurance  that, if the
Company is able to obtain  regulatory  approval of ALFERON N  Injection  for the
treatment of any additional diseases, it will be able to achieve any significant
penetration into those markets.                                                 

ALFERON N Gel                                                                   

         ALFERON N Gel is a topical,  Natural Alpha Interferon preparation which
the Company has  developed  and  believes  has  potential  in the  treatment  of
cervical dysplasia, intravaginal warts, and mucocutaneous and genital herpes.   

         Cervical  Dysplasia.  Affecting  approximately  500,000 to one  million
women each year in the United  States  alone,  cervical  dysplasia,  or abnormal
cervical cells, has been identified as a potential precursor to cervical cancer.
Cervical  cancer  strikes  approximately  13,000 women in the United States each
year,  causing 5,000  deaths,  and is  responsible  for more than half a million
deaths worldwide.  Cervical  dysplasia is caused by certain strains of the human
papillomavirus  ("HPV"),  the same family of viruses that causes  genital warts.
The Company has completed a small Phase 2 dose-ranging study using ALFERON N Gel
at the  Columbia-Presbyterian  Medical  Center in New York for the  treatment of
mild cervical dysplasia.  Pap smears,  identification tests for the presence and
type of virus,  and cervical  biopsies  indicated  that ALFERON N Gel appears to
have the potential  for improving the course of cervical  dysplasia as indicated
in the majority of patients who  completed  the  treatment  course.  The Company
presently does not plan to start additional  clinical trials for this indication
unless it can find a sponsor.                                                   

         Other  Widespread  Dermatological  Lesions  Potentially  Treatable with
ALFERON N Gel Therapy.  Nearly 30 million  people in the U.S. are infected  with
the herpes  simplex  type II virus,  which is the  infectious  virus that causes
genital herpes. Up to 500,000 new cases are reported each year, according to the
Alan  Guttmacher  Institute.  To  date,  there is no cure  for  genital  herpes.
Preliminary  findings with a previous  formulation of recombinant  interferon in
the Company's  proprietary gel showed  significant  shortening of the contagious
period and relief of symptoms,  but the Company will not start  clinical  trials
unless additional funding or a sponsor is secured.                              

         ALFERON N Gel may also be beneficial to immunocompromised patients with
mucocutaneous  herpes.  Patients with this form of herpes suffer from persistent
skin lesions,  which have become  resistant to existing  therapies.  The Company
will not start clinical trials for this indication unless additional  funding or
a sponsor is secured.                                                           

         ALFERON N Gel may also be of benefit to patients who have  intravaginal
warts.  However,  the Company will not start clinical trials for this indication
unless additional funding or a sponsor is secured.                              

         Marketing  and  Distribution.  The Company does not have any  marketing
agreement  with respect to ALFERON N Gel and, if FDA  approval is  obtained,  no
assurance  can be given that the Company  will be able to enter into a marketing
agreement on terms  satisfactory to the Company.  The Company may also choose to
market ALFERON N Gel itself if FDA approval is obtained.                        

         Competition.  The Company  believes that three  antiviral  products are
presently  sold in the United  States for the  treatment  of  recurrent  genital
herpes:  Zovirax(R)  (manufactured  by  Glaxo  Wellcome,  Inc.)  which  contains
acyclovir and is administered  orally,  topically,  or intravenously,  Famvir(R)
(manufactured by SmithKline Beecham  Pharmaceuticals) which contains famcyclovir
and is  administered  orally,  and Valtrex(R)  (manufactured  by Glaxo Wellcome,
Inc.) which contains  valacyclovir  and is also  administered  orally.  The only
current treatment for cervical dysplasia in the United States is surgery,  while
intravaginal warts are treated with ablative therapy.                           

ALFERON LDO                                                                     

         ALFERON  LDO  is a  low  dose  oral  liquid  Natural  Alpha  Interferon
preparation  which the Company has  developed  and believes has potential in the
treatment  of several  quality-of-life  parameters  of  importance  to  patients
infected with HIV.                                                              

         Clinical  Trials for ALFERON LDO. As described  below,  the Company has
completed two Phase 2 clinical  trials for its ALFERON LDO  formulation  for the
treatment of HIV-infected patients. In addition, a National Institute of Allergy
and  Infectious  Diseases  ("NIAID")  sponsored  Phase 3 trial  in  HIV-infected
patients  has been  concluded  in which  ALFERON LDO was  included as one of the
treatments.                                                                     

         HIV-infected  patients.  The Company  has  completed  two  double-blind
studies at Mount Sinai Medical Center in New York involving ALFERON LDO. One was
a  placebo-controlled  study in AIDS-related  complex ("ARC") patients,  and the
other was a dose  ranging  study in AIDS or ARC  patients.  The results from the
placebo-controlled  study  did not  demonstrate  a  significant  improvement  or
alteration  in the  expected  progression  of  the  disease,  although  patients
receiving  ALFERON LDO reported greater energy and appetite than those given the
placebo.  The results from the dose ranging study indicate that one of the doses
may promote weight gain and an increase in energy and overall well-being. At the
insistence  of AIDS  groups and  community-based  physicians  who had been using
low-dose oral  formulations of interferon in their practice,  the NIAID launched
in 1996 a Phase 3 trial of  three  preparations  of  low-dose  oral  interferon,
including ALFERON LDO and matching placebos.  An advisory committee comprised of
representatives  from the  Company  and  other  interferon  manufacturers,  AIDS
Support groups, the FDA, and the National  Institutes of Health was organized to
design this multicenter study, which examined the effectiveness of low dose oral
alpha interferon therapy on several quality-of-life  parameters of importance to
patients  infected  with  HIV.  Patients  enrolled  in the study  were  randomly
assigned to one of four treatment groups, with all participants  receiving three
preparations.  In three of the groups, patients received one active compound and
two placebos.  Patients in the fourth group received only  placebos.  This was a
double-blind study and had a six-month  treatment phase and six-month  follow-up
period. While in the study, patients were permitted to take antiretroviral drugs
and therapies against  opportunistic  infections.  The Company provided clinical
quantities of ALFERON LDO for use in the study.                                 

         In June 1997, NIAID terminated enrollment in this study with 247 out of
the  required 560  patients  enrolled.  Even though the trial did not enroll the
number of patients the advisory  committee had deemed  necessary to determine if
the drugs were effective,  the results were recently published in the Journal of
Acquired  Immune  Deficiency  Syndromes in December of 1999. In that article the
authors concluded: "Although the trial was designed to enroll 560 study subjects
and was prematurely  terminated  because of slow accrual and  discontinuation of
participants,  the small differences among the arms in the primary and secondary
endpoints  do not support  claims of efficacy  for the  measures  studied."  The
Company does not presently anticipate the further development of ALFERON LDO for
this use or any other use unless a sponsor is secured.                          

         Marketing  and  Distribution.  The  Company  does not have a  marketing
agreement  with  respect to ALFERON LDO and,  if FDA  approval of ALFERON LDO is
obtained,  no assurance can be given that the Company will be able to enter into
a marketing  agreement for such products on terms  satisfactory  to the Company.
The  Company may also  choose to market  ALFERON  LDO itself if FDA  approval is
obtained.                                                                       

         Competition.  Under the terms of a licensing agreement (as amended, the
"Amarillo  Agreement") with Amarillo  Bioscience,  Inc.  (formerly Amarillo Cell
Culture  Company,  Incorporated)  ("Amarillo") (i) the Company has the exclusive
right to sell ALFERON LDO,  containing  Natural Alpha Interferon,  in the United
States and all foreign  countries  other than Japan,  (ii)  Amarillo  and Pharma
Pacific  Management  Pty.  Ltd.  ("PPM"),  a company  which has also  obtained a
license  from  Amarillo,  each has the right to sell any  interferon  other than
Natural Alpha  Interferon in the United States and all foreign  countries  other
than Japan, and (iii) Hayashibara  Biochemical  Laboratory has the right to sell
its low dose alpha  interferon  in Japan.  See "Business -- Licenses and Royalty
Obligations." Therefore,  with respect to low dose oral interferon products, the
Company will potentially  compete with Amarillo and PPM in the United States and
in the  rest  of  the  world  except  Japan  and  with  Hayashibara  Biochemical
Laboratory in Japan. In addition,  the Company will potentially compete with the
manufacturers  of the synthetic  antiviral  compounds that have been approved in
the United  States and certain  foreign  countries  for the treatment of HIV and
AIDS. (See "Business -- ALFERON N Injection -- Competition").                   

Patents                                                                         

         In 1996, the Company was issued a United States patent, comprised of 15
claims, for Natural Alpha Interferon.  The two major claims are for (i) a highly
purified  Natural Alpha  Interferon  composition  produced from human peripheral
blood  leukocytes and (ii) an improved method to produce this  composition.  The
issuance of this patent gives the Company  protection for the manufacture,  use,
and sale of its  Natural  Alpha  Interferon  product  in the  United  States and
prevents a competitor from producing or using  equivalent  products derived from
human  peripheral  blood  leukocytes.  Patents have also been issued in selected
foreign countries. In 1997, the Company was issued a second United States patent
which  broadens  the  scope of the  first one to cover  certain  individual,  or
mixtures of, alpha interferon species present in Natural Alpha Interferon.      

         Also in 1996, the Company was issued a United States patent,  comprised
of four claims that will expand the Company's portfolio on overall  technologies
in the interferon field. The biological activities of interferon take place when
the interferon binds to Type 1-interferon  receptor proteins,  which are present
in  various  human  cells.  The  major  claim is the  composition  claim  for an
interferon receptor protein  specifically binding alpha and beta, but not gamma,
interferons.  The receptor,  which is isolated from a cancerous cell line, binds
both  natural and  recombinant  alpha  interferons  and is a variant form of the
human  interferon  receptor (Type 1) which has been found in some cases of acute
leukemia.  The claimed receptor  protein could be used to produce  anti-receptor
antibodies  that may have  potential  use in  diagnostic  testing  for tumors or
cancers which have an abnormal number of receptors. The claimed receptor protein
may also have  potential use as a therapeutic  agent for those  diseases,  which
have  aberrant  production of  interferon,  by binding to and  neutralizing  the
excess interferon.                                                              

         The United  States  Patent  and  Trademark  Office has also  issued two
patents  to  the  Company,   which   disclose  and  claim   topical   interferon
preparations.  The patents  encompass  interferon  preparations  for the topical
delivery  of one or more  interferons  to the site of a disease  which  responds
therapeutically to interferon,  and a system for delivering interferon topically
which prevents oxidation of the protein. The inventions  specifically  encompass
the topical  treatment for treating viral  diseases,  such as herpes  genitalis,
with alpha interferon.                                                          

         In 1999, the Company was issued a United States patent, comprised of 16
claims,  that  describes an innovative  method for recovery of white blood cells
from  recycled  filters.  Major blood  centers in the United  States and foreign
countries  have been  adopting a process to use  filters to deplete  white blood
cells (leukoreduction) from plasma, red blood cells, platelets,  and other blood
preparations.  Typically,  these  filters  which contain a large amount of white
blood cells are discarded. The new invention provides an efficient back-flushing
method to recover  functional  white blood cells from these  filters.  The white
blood  cells  recovered  can be used for  production  of  interferons  and other
cytokines  for use as  therapeutic  products.  They can also be used for further
isolation of subsets of white blood cells for  development of new  immunological
products.  This invention  protects the Company's ability to utilize white blood
cells collected in the filters for interferon production when the leukoreduction
process is uniformly  implemented  in blood  centers.  An  international  patent
application was filed in December 1998.                                         

Licenses and Royalty Obligations                                                

         F.  Hoffmann-LaRoche  Ltd. and Hoffmann-La  Roche, Inc.  (collectively,
"Hoffmann")  have been issued patents  covering  human alpha  interferon in many
countries  throughout the world.  In 1995, the Company  obtained a non-exclusive
perpetual  license from Hoffmann  (the  "Hoffmann  Agreement")  which grants the
Company the worldwide rights to make, use, and sell,  without a potential patent
infringement  claim from Hoffmann,  any formulation of Natural Alpha Interferon.
The  Hoffmann  Agreement  permits  the  Company to grant  marketing  rights with
respect to Natural Alpha Interferon  products to third parties,  except that the
Company cannot grant marketing rights with respect to injectable products in any
country in which  Hoffmann has patent rights  covered by the Hoffmann  Agreement
(the  "Hoffmann  Territory")  to any third  party not  listed on a  schedule  of
approximately 50 potential  marketing  partners without the consent of Hoffmann,
which consent cannot be unreasonably withheld.                                  

         Under the terms of the Hoffmann Agreement,  the Company is obligated to
pay  Hoffmann an aggregate  royalty on net sales (as  defined) of Natural  Alpha
Interferon  products by the Company in an amount equal to (i) 8% of net sales in
the Hoffmann  Territory,  and 2% of net sales outside the Hoffmann  Territory of
products manufactured in the Hoffmann Territory,  up to $75,000,000 of net sales
in any calendar year and (ii) 9.5% of net sales in the Hoffmann  Territory,  and
2% of net sales outside the Hoffmann  Territory of products  manufactured in the
Hoffmann Territory,  in excess of $75,000,000 of net sales in any calendar year,
provided  that the total  royalty  payable in any calendar year shall not exceed
$8,000,000.  The Hoffmann Agreement can be terminated by the Company on 30 days'
notice with respect to the United States patent,  any individual foreign patent,
or all patents owned by Hoffmann.  If the Hoffmann  Agreement is terminated with
respect to the patents owned by Hoffmann in a specified country, such country is
no longer included in the Hoffmann Territory. Accordingly, the Company would not
be permitted to market any formulation of alpha interferon in such country.     

         In 1989,  the Company  entered into the Amarillo  Agreement.  Amarillo,
which is located in  Amarillo,  Texas,  is in the  business of the  research and
development of animal health products and became a public company in 1996. Under
the terms of the Amarillo  Agreement,  the Company has a  non-exclusive  license
under all of Amarillo's  issued  patents,  patent  applications,  and "know-how"
relating to the treatment of humans by the oral  administration of Natural Alpha
Interferon  in low doses.  In  addition,  Amarillo has the right to purchase the
Company's  Natural Alpha  Interferon  for use in the animal health market and is
obligated to pay  royalties to the Company  based upon sales using the Company's
Natural Alpha Interferon.                                                       

         The Company will be  obligated to pay Amarillo  royalties of 10% on the
sales of Natural Alpha Interferon  products using Amarillo's patented technology
as determined under the Amarillo Agreement.  In addition, the Company is a party
to certain license  agreements,  including the Hoffmann  Agreement,  pursuant to
which it is obligated to pay royalties  based upon  commercial  exploitation  of
ALFERON N Gel and ALFERON LDO. Under the terms of such license  agreements,  the
Company  would pay  royalties of up to 13.5% and 19.5% of net sales of ALFERON N
Gel and ALFERON LDO, respectively.                                              

         In addition,  the Company agreed to pay GP Strategies  Corporation ("GP
Strategies"),  formerly named National Patent Development Corporation, a royalty
of $1  million  in  connection  with the  acquisition  of  certain  intellectual
property and technology rights from GP Strategies. Such amount is payable if and
when the Company  generates  income before taxes,  limited to 25% of such income
before  income  taxes per year  until the amount is paid in full.  To date,  the
Company  has not  generated  income  before  taxes  and  therefore  has not paid
royalties to GP Strategies.                                                     

Governmental Regulation                                                         

         Regulations imposed by U.S. federal,  state, and local authorities,  as
well as their  counterparts in other countries,  are a significant factor in the
conduct of the research,  development,  manufacturing,  and marketing activities
for present and proposed products developed by the Company.                     

         The  Company's  or  its  licensees'  potential  products  will  require
regulatory  approval by  governmental  agencies prior to  commercialization.  In
particular,  human  medical  products are subject to rigorous  pre-clinical  and
clinical  testing and other approval  procedures by the FDA in the United States
and similar health  authorities in foreign  countries.  Various  federal and, in
some  cases,  state  statutes  and  regulations  also  govern or  influence  the
manufacturing,  safety, labeling, storage, record keeping, and marketing of such
products,  including the use, manufacture,  storage,  handling,  and disposal of
hazardous  materials and certain waste products.  The process of obtaining these
approvals and the  subsequent  compliance  with  applicable  federal and foreign
statutes  and  regulations  involves a  time-consuming  process and requires the
expenditure of substantial resources.                                           

         The effect of government  regulation may be to delay for a considerable
period of time or prevent  the  marketing  of any  product  that the Company may
develop and/or impose costly procedures on the Company's activities,  the result
of which may be to furnish an advantage to the Company's competitors.  Any delay
in  obtaining or failure to obtain such  approvals  would  adversely  affect the
marketing of the Company's products and the ability to earn product revenue.    

         Before  testing  of any  agents  with  potential  therapeutic  value in
healthy  human  test  subjects  or  patients  may  begin,  stringent  government
requirements for pre-clinical data must be satisfied.  These data, obtained from
studies in several  animal  species,  as well as from  laboratory  studies,  are
submitted in a Notice of Claimed Investigational Exemption for a New Drug or its
equivalent  in  countries  outside  the U.S.  where  clinical  studies are to be
conducted.  If the  necessary  authorizations  are  received,  the Company  then
conducts clinical tests of its products on human beings at various  unaffiliated
medical  centers and  institutions.  Initial trials (Phase 1) are conducted on a
small  number of  volunteers  to  determine  whether  the drug is safe for human
beings.  If the initial  trials  demonstrate  the safety of the product,  trials
(Phase 2) are then conducted on patients  affected with the disease or condition
under  investigation  to  establish  the proper  dose and dosing  interval.  The
findings  of these  trials  are then used to design  and  implement  large-scale
controlled  trials (Phase 3) to provide  statistical  proof of effectiveness and
adequate evidence of safety to meet FDA and/or foreign approval requirements.   

         The FDA closely monitors the progress of each of the phases of clinical
testing and may, at its discretion,  re-evaluate,  alter,  suspend, or terminate
the testing based on the data which have been  accumulated to that point and its
assessment of the risk/benefit ratio to the patient. Estimates of the total time
required for completing  clinical testing vary between four and ten years.  Upon
successful  completion  of clinical  testing of a new drug, a company  typically
submits a New Drug  Application  ("NDA"),  or for  biological  products  such as
Natural  Alpha  Interferon,  a Product and  Establishment  License  Applications
("PLA/ELA") to the FDA  summarizing  the results and  observations  of the drugs
during the clinical trials.                                                     

         Each  facility,  in which  products are produced and packaged,  whether
operated  by the Company or a third  party,  must meet the FDA's  standards  for
current  good  manufacturing  practices  and  must  also be  approved  prior  to
marketing any product  produced or packaged in such  facility.  Any  significant
change in the production process which may be commercially  required,  including
changes in sources of certain raw  materials,  or any change in the  location of
the  production  facilities  will also  require  FDA  approval.  To the extent a
portion of the manufacturing process for a product is handled by an entity other
than the Company,  the Company must similarly receive FDA approval for the other
entity's  participation in the  manufacturing  process.  The Company has entered
into an agreement with Abbott,  pursuant to which Abbott formulates and packages
ALFERON N Injection.  The Company presently has a biologic establishment license
for the facilities in which it produces ALFERON N Injection,  which includes the
facilities  in which  Abbott  formulates  and packages  ALFERON N Injection.  In
addition, FDA approval would have to be obtained if the Company should choose to
use an outside formulator and/or packager for ALFERON N Gel or ALFERON LDO.     

         Once the  manufacture  and sale of a product is  approved,  various FDA
regulations  govern the  production  processes and marketing  activities of such
product. A post-marketing  testing,  surveillance,  and reporting program may be
required to monitor the product's  usage and effects.  Product  approvals may be
withdrawn,  or other  actions  may be ordered,  if  compliance  with  regulatory
standards is not maintained.                                                    

         Each individual lot of Natural Alpha Interferon produced must be tested
for  compliance  with  specifications  and released for sale by the FDA prior to
distribution in the marketplace. Even after initial FDA marketing approval for a
product has been granted,  further studies may be required to provide additional
data on safety or  efficacy;  to obtain  approval  for  marketing a product as a
treatment  for  specific  diseases  other than those for which the  product  was
originally  approved;  to change the dosage levels of a product;  to support new
safety  or  efficacy   claims  for  the  product;   or  to  support  changes  in
manufacturing methods, facilities, sources of raw materials, or packaging.      

         In many markets, effective commercialization also requires inclusion of
the product in national, state, provincial, or institutional formularies or cost
reimbursement  systems.  The impact of new or changed laws or regulations cannot
be predicted  with any  accuracy.  The Company uses its own staff of  regulatory
affairs   professionals  and  outside   consultants  to  enable  it  to  monitor
compliance,  not only with FDA laws and  regulations,  but also  with  state and
foreign government laws and regulations.                                        

         Promotional  and  educational  communications  by the  Company  and its
distributors  also are  regulated by the FDA and are  governed by statutory  and
regulatory  restrictions and FDA policies  regarding the type and extent of data
necessary to support  claims that may be made.  The Company  currently  does not
have data  adequate  to satisfy  FDA  requirements  with  respect  to  potential
comparative  claims between Natural Alpha  Interferon and competing  recombinant
interferon products.                                                            

         For  marketing  outside the United  States,  the  Company  will also be
subject to foreign  regulatory  requirements  governing  human clinical  trials,
manufacturing,  and marketing approval for drugs and other medical products. The
requirements  governing  the  conduct of  clinical  trials,  product  licensing,
pricing,  and reimbursement vary widely from country to country.  In addition to
its United States approval, ALFERON N Injection has received regulatory approval
in Mexico, Germany, Hong Kong, and Singapore, and registration filings have been
submitted in certain other countries.                                           

         Under certain circumstances,  the Company may be required to obtain FDA
authorization to export products for sale in foreign countries. For instance, in
most cases,  the Company may not export  products that have not been approved by
the FDA unless it first  obtains an export permit from the FDA.  However,  these
FDA export  restrictions  generally do not apply if the  Company's  products are
exported in conformance  with their United States  approvals or are manufactured
outside the United  States.  At the present time,  the Company does not have any
foreign manufacturing facilities.                                               

Research Staff and Employees                                                    

         As of March 15,  2000,  the Company had 35  employees,  15 of whom work
less than full time. Of the 35 employees,  6 hold Ph.D. degrees, 1 holds an M.D.
degree and 13 hold other  degrees in  scientific  or technical  fields.  Of such
employees,  approximately 6 were engaged in research and product development,  9
were engaged in quality  control,  regulatory and quality  assurance and product
and process  improvement  for  manufacturing,  8 were engaged in engineering and
maintenance,  3  were  engaged  in  medical  affairs  and  9  were  general  and
administrative personnel.                                                       

Research and Development                                                        

         During the years ended  December 31, 1999,  1998, and 1997, the Company
expended   approximately  $3.1  million,   $8.7  million,   and  $11.9  million,
respectively   for  research  and  development.   Substantially   all  of  these
expenditures were for Company-sponsored research and development programs.      

Executive Officers of the Registrant                                            

         The  following  table sets forth the names of the  principal  executive
officers  of the  Company  as of March  15,  2000 and their  positions  with the
Company.  The principal  business  experience of the executive  officers for the
last five years is also described below.                                        

                                                                [Download Table]


                                                                         
Name                                 Age  Position                       

Samuel H. Ronel, Ph.D                63   Chairman of the Board          

Lawrence M. Gordon                   46   Chief Executive Officer and a  
                                          Director                       

Stanley G. Schutzbank, Ph.D., R.A.C. 54   President and a Director       

Donald W. Anderson                   50   Controller (Principal          
                                          Accounting and Financial       
                                          Officer) and Secretary         

Mei-June Liao, Ph.D.                 48   Vice President, Research and   
                                          Development                    

James R. Knill, M.D.                 67   Vice President, Medical Affairs

Robert P. Hansen                     56   Vice President, Manufacturing  


         Samuel H. Ronel,  Ph.D.  has been Chairman of the Board since  February
1997 and was Vice  Chairman of the Board from January 1996 to February  1997 and
President,  Chief Executive Officer,  and a director of the Company from 1981 to
January 1996. He was  responsible  for the interferon  research and  development
program since its inception in 1979.  Dr. Ronel joined GP Strategies in 1970 and
served as the Vice President of Research and Development of GP Strategies and as
the President of Hydro Med Sciences,  a division of GP Strategies,  from 1976 to
September   1996.   Dr.  Ronel  served  as  President  of  the   Association  of
Biotechnology  Companies,  an  international  organization  representing  United
States and foreign  biotechnology firms, from 1986-88 and has served as a member
of its Board of  Directors  until  1993.  Dr.  Ronel was elected to the Board of
Directors of the  Biotechnology  Industry  Organization from 1993 to 1995 and to
the Governing Body of the Emerging  Companies  Section from 1993 to 1997.  Since
1999 he has been a member of the  Technology  Advisory  Board of the New  Jersey
Economic Development Authority.                                                 

         Lawrence M. Gordon has been Chief  Executive  Officer and a director of
the Company since January 1996,  Vice President of the Company from June 1991 to
January 1996, General Counsel of the Company from 1984 to January 1996.         

         Stanley G.  Schutzbank,  Ph.D.  has been President of the Company since
January 1996, Executive Vice President of the Company from 1981 to January 1996,
and a  director  of the  Company  since  1981 and has been  associated  with the
interferon  research and development  program since its inception in 1979. He is
involved with all facets of  administration  and planning of the Company and has
coordinated compliance with FDA regulations governing manufacturing and clinical
testing of  interferon,  leading to the approval of ALFERON N Injection in 1989.
Dr. Schutzbank joined GP Strategies in 1972 and served as the Corporate Director
of Regulatory and Clinical  Affairs of GP Strategies from 1976 to September 1996
and as Executive  Vice  President  of Hydro Med Sciences  from 1982 to September
1996. Dr. Schutzbank is a member of the Regulatory Affairs Professionals Society
and has served as Chairman of the Regulatory  Affairs  Certification  Board from
its  inception  until 1994.  Dr.  Schutzbank  received the 1991 Richard E. Greco
Regulatory  Affairs  Professional  of the  Year  Award  for  his  leadership  in
developing  the United  States  Regulatory  Affairs  Certification  Program.  In
September 1995, Dr. Schutzbank was elected to serve as  President-elect in 1996,
President in 1997, and Chairman of the Board in 1998 of the  Regulatory  Affairs
Professionals Society.                                                          

         Donald W.  Anderson has been the  Controller  of the Company since 1981
and Corporate  Secretary of the Company since 1988. He was an officer of various
subsidiaries of GP Strategies from 1976 to September 1996.                      

         Mei-June Liao,  Ph.D. has been Vice President, Research and Development
 of the Company since March 1995. She has served as a Director, Research & Deve-
lopment  since 1987,  and held senior  positions in the Company's  Research &   
Development  Department  since 1983. Dr. Liao received her Ph.D. from Yale Univ-
ersity and completed a three-year postdoctoral appointment at the  Massachusetts
Institute of Technology  under the direction of Nobel  Laureate in Medicine,    
Professor H. Gobind  Khorana. Dr. Liao has authored many scientific publications
and invention disclosures.                                                    

         James R. Knill,  M.D. has been Vice  President,  Medical Affairs of the
Company since  September 1996 and a consultant to the Company from November 1995
to September  1996. Dr. Knill was employed as Vice President of Medical  Affairs
for  Cytogen  Corporation  from  1994  to 1995  and as  consultant  for  Cytogen
Corporation from 1995 to July 1996. He was previously  employed for more than 20
years as Vice President of Medical Affairs for Bristol-Myers Squibb Company.    

         Robert P. Hansen has been Vice President,  Manufacturing of the Company
since  February 1997. He served as a Director of  Manufacturing  since 1995, and
held senior positions in the Company's Manufacturing Department since 1987.     

(d) Financial Information About Foreign and Domestic Operations and Export Sales

         All of the Company's material operations and sales are conducted in the
United States.                                                                  

Item 2.  Properties                                                             

         The  Company's  executive  offices  and  its  research  and  production
facilities  are located at 783 Jersey Avenue,  New Brunswick,  New Jersey 08901,
and its telephone number is (732) 249-3250.                                     

         The Company owns two freestanding  buildings  comprising  approximately
44,000 square feet which are located in New Brunswick,  New Jersey.  The Company
uses  the  facilities  for  staff  offices,  for the  conversion  of  interferon
intermediates to finished product,  for quality control and research activities,
and for the storage of raw, in process and finished materials.                  

         The Company  believes  that its current  facilities  and  equipment are
suitable  and  adequate  for research  and  development  and the  conversion  of
interferon intermediates to finished product, and in good condition.            

Item 3.  Legal Proceedings                                                      

The Company is not a party to any legal proceedings.          

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

         No matters  were  submitted  to a vote of security  holders  during the
fourth quarter of the fiscal year covered by this report.                       

10-K
4th "Page" of 15
TOC
1st
Previous
Next
Bottom
Just 4th

 PART II

Item 5. Market for the Registrant's Common Stock and Related Stockholder Matters

         The  Common  Stock is  traded on the OTC  Bulletin  Board and is quoted
under the symbol IFSC. On April 13, 1999, the Common Stock was delisted from the
NASDAQ  National   Market  System  for  failure  to  maintain   certain  listing
requirements. The following table sets forth for each period indicated, the high
and low sales  prices for the Common  Stock as reported  on the NASDAQ  National
Market System  through April 13, 1999 and on the OTC Bulletin  Board  commencing
April 14, 1999.                                                                 

         All prices have been  adjusted for a  one-for-five  reverse stock split
effective as of January 6, 1999.                                                

                                                                [Download Table]


                             1 9 9 9                         1 9 9 8         
                            ------------                    -----------      
                                                                             

Quarter                 High          Low               High          Low    
-------                 ----          ---               ----          ---    
First.......          $ 2 1/2       $ 3/4            $ 46 7/8      $ 18 29/32
Second....              1             3/16             35 15/16       4 17/32
Third......               1/2         7/32              6 1/4         2 1/2  
Fourth.....               15/32       1/8               8 3/4         1 13/32


  As of April 1, 2000, the Company had 720 stockholders of record.

         The Company has not paid any  dividends  on the Common  Stock since its
inception and does not contemplate  paying  dividends on the Common Stock in the
foreseeable future.                                                             

                                                        [Enlarge/Download Table]


Item 6.  Selected Financial Data                                                       
--------------------------------                                                       
(Thousands of dollars except per share data)                                           

                                                          Year Ended December 31,      
                                    1999           1998       1997       1996      1995
                                    ----           ----       ----       ----      ----
                                                                                       

Revenues                            $2,329    $  2,007   $  2,956    $ 2,092   $ 1,296 
Cost of goods sold and excess/                                                         
  idle production costs              3,552        6,533      1,858     1,400     3,076 

Research and development                                                               
  costs, net                         3,060       8,655     11,864      6,400     3,726 

General and administrative                                                             
  expense                            2,315       4,570      4,389      3,405     1,940 

Loss from operations*               (5,420)    (20,841)   (22,410)   (12,426)   (7,447)
Interest (expense and financing                                                        
  costs) income, net                  (530)        253        670        441        75 

Gain on sale of state net                                                              
  operating loss carryovers          2,349                                             

Net loss*                           (3,602)    (21,325)   (21,740)   (11,986)   (7,372)
Basic and diluted loss per                                                             
   share of common stock**            (.71)      (6.67)     (8.15)     (5.98)    (5.55)

Dividends                              NONE       NONE       NONE       NONE      NONE 
----------------------------------                                                     

*The  Company  has  suffered   recurring  losses  from  operations  and  has  an
accumulated  deficit that raise  substantial doubt about its ability to continue
as a going concern (see Note 3 to the Consolidated Financial Statements).       

**All  periods  have been  restated  to reflect  the effect of the  one-for-four
reverse  stock split  effective  as of March 21,  1997 and for the  one-for-five
reverse  stock  split  effective  as of  January  6,  1999  (see  Note 10 to the
Consolidated Financial Statements).                                             

                                                                [Download Table]


                                                  December 31,                  

                               1999          1998       1997      1996      1995
                               -------------------------------------------------

                                                                                

Total assets                  $6,256       $6,599    $24,153   $27,743   $13,953

Working capital (deficiency)  (2,097)       (1,889)   14,529    19,929     7,062

Stockholders' equity             557        2,103     20,214    25,374    12,827


Item 7.  Management's  Discussion  and Analysis of Financial  Condition and     
Results of Operations                                         

         Since 1981, the Company has been primarily  engaged in the research and
development of pharmaceutical products containing Natural Alpha Interferon.  The
Company has experienced  significant  operating losses since its inception.  The
Company  received  FDA  approval in 1989 to market  ALFERON N  Injection  in the
United States for the treatment of certain genital warts. ALFERON N Injection is
currently  marketed  and sold in the United  States by the Company and in Mexico
and Germany by licensees. However, the Company has had limited revenues from the
sale of ALFERON N Injection to date. For the Company to operate profitably,  the
Company must sell significantly  more ALFERON N Injection.  Increased sales will
depend  primarily  upon the  expansion  of existing  markets  and/or  successful
attainment  of FDA  approval  to  market  ALFERON  N  Injection  for  additional
indications.  The future  revenues and  profitability  of, and  availability  of
capital for,  biotechnology  companies may be affected by the continuing efforts
of governmental and third-party  payors to contain or reduce the costs of health
care through  various means.  The Company has limited  financial  resources with
which to  support  future  operating  activities  and to satisfy  its  financial
obligations as they become  payable.  Consequently,  management is continuing to
actively pursue raising additional capital by either (i) issuing securities in a
private equity offering, (ii) licensing the rights to its injectable, topical or
oral formulations of alpha interferon, or (iii) selling the Company. The Company
has primarily  financed its  operations to date through  private  placements and
public offerings of the Company's securities.  This may be more difficult in the
future in light of the  results  to date of the  Company's  Phase 3  studies  of
ALFERON N Injection in HIV- and HCV-infected patients. See "Business - ALFERON N
Injection - Clinical Trials for New Indications."                               

Liquidity and Capital Resources                                                 

         As of April 10, 2000,  the Company had an aggregate of $650,000 in cash
and cash equivalents.  Until utilized,  such cash and cash equivalents are being
invested principally in short-term interest-bearing investments.                

         The Company's future capital  requirements will depend on many factors,
including:  continued scientific progress in its drug development programs;  the
magnitude of these  programs;  progress with  pre-clinical  testing and clinical
trials; the time and costs involved in obtaining regulatory approvals; the costs
involved  in  filing,  prosecuting,   and  enforcing  patent  claims;  competing
technologies  and  market   developments;   changes  in  its  existing  research
relationships;  and  the  ability  of the  Company  to  establish  collaborative
arrangements and effective commercialization activities and arrangements.       

         Based on the Company's estimates of revenues,  expenses,  and levels of
production,  management  believes  that the  cash  presently  available  will be
sufficient to enable the Company to continue  operations  through  approximately
June 30, 2000. However, actual results, especially with respect to revenues, may
differ  materially  from such  estimates,  and no  assurance  can be given  that
additional  funding will not be required  sooner than  anticipated  or that such
additional  funding,  whether from financial  markets or  collaborative or other
arrangements  with corporate  partners or from other sources,  will be available
when  needed or on terms  acceptable  to the  Company.  Insufficient  funds will
require the Company to further delay, scale back, or eliminate certain or all of
its  research  and   development   programs  or  to  license  third  parties  to
commercialize  products or technologies that the Company would otherwise seek to
develop  itself.  The Independent  Auditors'  Report dated April 10, 2000 on the
Company's  consolidated  financial  statements  as of and  for  the  year  ended
December  31,  1999 notes that the Company has  suffered  recurring  losses from
operations and has an accumulated deficit that raise substantial doubt about its
ability to continue as a going concern.                                         

         The  Company  participates  in the  State of New  Jersey's  corporation
business tax benefit certificate transfer program (the "Program"),  which allows
certain high  technology  and  biotechnology  companies  to transfer  unused New
Jersey net operating loss  carryovers to other New Jersey  corporation  business
taxpayers.  During 1999, the Company  submitted an application to the New Jersey
Economic Development Authority (the "EDA") to participate in the Program and the
application  was  approved.  The EDA then issued a  certificate  certifying  the
Company's eligibility to participate in the Program and the amount of New Jersey
net operating loss  carryovers the Company has available to transfer.  Since New
Jersey law  provides  that net  operating  losses can be carried  over for up to
seven years,  the Company may be able to transfer  its New Jersey net  operating
losses from the last seven years.  The Company  estimated that, as of January 1,
1999, it had  approximately  $85 million of unused New Jersey net operating loss
carryovers available for transfer under the Program. The Program requires that a
purchaser pay at least 75% of the amount of the surrendered tax benefit.        

         During December 1999, the Company  completed the sale of  approximately
$32 million of its New Jersey tax loss carryforwards and received $2.35 million.
In June 2000, the Company will submit an application to sell an additional  $4.8
million of tax benefits  (calculated  by  multiplying  the Company's  unused New
Jersey net operating loss  carryovers of  approximately  $53 million by 9%). The
actual  amount  of tax  benefits  the  Company  may sell  will  depend  upon the
allocation among qualifying companies of an annual pool established by the State
of New Jersey. The allocated pool for future years is $40 million per year.     

         On May 25, 1999,  the Company  announced that based upon a meeting with
the Food and Drug Administration  regarding its Phase 3 clinical trial comparing
ALFERON N Injection against Schering  Plough's  Intron(R) A for the treatment of
previously  untreated  patients  infected  with  hepatitis C virus,  it would be
required to conduct an  additional  clinical  study prior to filing for approval
with the FDA.  The FDA advised  the Company  that the results of this trial were
insufficient  to file for approval  because the  designed  endpoint of the trial
(which  required a showing of  superiority in sustained  normalization  of liver
enzymes at the end of treatment  and after six months of follow up) was not met.
At the  present  time,  the Company  does not have the  resources  necessary  to
conduct an additional study and does not plan to initiate such a study unless it
can find a sponsor to continue this program.                                    

         The  Company  has  obtained   human  white  blood  cells  used  in  the
manufacture of ALFERON N Injection from several sources,  including the American
Red Cross (the "Red Cross")  pursuant to a supply  agreement dated April 1, 1997
(the "Supply Agreement"). The Company will not need more human white blood cells
until such time as  production  of ALFERON N Injection  is resumed,  and has not
purchased any since April 1, 1998. Under the terms of the Supply Agreement,  the
Company was  obligated  to purchase a minimum  amount of human white blood cells
each month  through  March 1999 (the  "Minimum  Purchase  Commitment"),  with an
aggregate Minimum Purchase  Commitment during the period from April 1998 through
March 1999 in excess of  $3,000,000.  As of November 23, 1998,  the Company owed
the Red Cross  approximately $1.46 million plus interest at the rate of 6% annum
accruing  from April 1, 1998 (the "Red Cross  Liability")  for white blood cells
purchased pursuant to the Supply Agreement.                                     

         In an agreement  dated  November 23, 1998,  the Company agreed to grant
the Red Cross a  security  interest  in  certain  assets to secure the Red Cross
Liability and to issue to the Red Cross  300,000  shares of Common Stock (with a
market value of  $1,171,875 at December 4,  1998)and  additional  shares at some
future date as  requested  by the Red Cross.  The Red Cross  agreed that any net
proceeds  received by it upon sale of such shares  would be applied  against the
Red Cross Liability and that at such time as the Red Cross Liability was paid in
full, the Minimum Purchase  Commitment  would be deleted  effective April 1,1998
and any then  existing  breaches of the  Minimum  Purchase  Commitment  would be
waived.  In January 1999 the Company  granted the Red Cross a security  interest
(the  "Security  Interest")  in, among other things,  the Company's real estate,
equipment inventory,  receivables,  and New Jersey net operating loss carryovers
to secure  repayment  of the Red Cross  Liability,  and the Red Cross  agreed to
forbear from  exercising its rights under the Supply  Agreement,  including with
respect to collecting  the Red Cross  Liability,  until June 30, 1999 (which was
subsequently  extended  until  December 31,  1999).  On December  29, 1999,  the
Company,  the Red Cross and GP  Strategies  entered in an agreement  pursuant to
which the Red Cross agreed that until  September  30, 2000 it would forbear from
exercising its rights under (i) the Supply Agreement,  including with respect to
collecting the Red Cross Liability,  and (ii) the Security  Interest.  Under the
terms of such  agreement,  the  Company  is  allowing  the Red Cross to sell the
Company's  real estate.  In the event the Red Cross is successful in selling the
Company's  real estate,  the Company would hope to be able to enter into a lease
with the new owner, although there can be no assurance.                         

         As the liability to the Red Cross remains  unsettled until such time as
the Red Cross sells the shares they have already  received and could  receive in
the  future,  the  Company has  recorded  any shares  issued to the Red Cross as
"Settlement  Shares" within  stockholders'  equity.  Any decreases in the market
value of the Company's  common stock below $1.2 million,  until such time as the
Red Cross were to sell its shares,  would impact the value of the shares held by
the Red Cross and accordingly require an adjustment to "Settlement  Shares". Due
to the decline in the  Company's  stock price during 1999 and from  November 23,
1998 to December  31,  1998,  an  adjustment  for $550,000 and $525,000 has been
recorded  with a  corresponding  charge  to  operations  during  1999 and  1998,
respectively.  During 1999, the Red Cross sold 27,000 of the  Settlement  Shares
and sold the balance of such shares  (273,000) during the first quarter of 2000.
As a result, the net proceeds from the sales of the Settlement  Shares,  $33,000
in 1999 and  $368,000 in 2000,  were  applied  against the  liability to the Red
Cross.  The  remaining  liability  to the Red Cross at December  31, 1999 and at
April 1, 2000 was approximately $1,579,000 and $1,228,000, respectively.        

         In an agreement  dated March 25, 1999, GP Strategies  Corporation  ("GP
Strategies") agreed to lend the Company $500,000 at the rate of $250,000 a month
(the "GP Strategies Debt"). In return, the Company agreed to grant GP Strategies
(i) a first  mortgage on the Company's  real estate,  (ii) a two-year  option to
purchase the Company's real estate, provided that the Company has terminated its
operations  and the Red Cross  Liability  has been repaid,  and (iii) a two-year
right of first refusal in the event the Company desires to sell its real estate.
In addition,  the Company agreed to issue GP Strategies 500,000 shares of Common
Stock (the "GP Stock") and a five-year  warrant  (the "GP  Warrant") to purchase
500,000  shares of Common  Stock at a price of $1 per share.  The  Company  also
agreed not to increase  its payroll  during the term of the GP  Strategies  debt
without  the prior  consent of GP  Strategies.  Pursuant to the  agreement,  the
Company has issued a note to GP Strategies  representing the GP Strategies Debt,
which  note  was due on  September  30,  1999 and  bears  interest,  payable  at
maturity,  at the rate of 6% per annum.  In  addition,  at that time the Company
negotiated a  subordination  agreement  with the Red Cross pursuant to which the
Red Cross agreed that its lien on the Company's real estate is subordinate to GP
Strategies' lien. On March 27, 2000, the Company and GP Strategies  entered into
an agreement  pursuant to which (i) the GP  Strategies  Debt was extended  until
June 30, 2001, (ii) the Company agreed to file a registration statement prior to
July 31, 2000  covering the shares  issuable upon exercise of the GP Warrant and
any of the GP Shares for which Rule 144 under the Securities Act of 1933 was not
available,  and  (iii) the  Management  Agreement  between  the  Company  and GP
Strategies was terminated (see Note 13 to the Consolidated Financial Statements)
and all intercompany  accounts between the Company and GP Strategies (other than
the  GP  Strategies  Debt)  in  the  amount  of  $130,000  were  discharged  and
eliminated.  The agreement  also provides that (i) commencing on May 1, 2001 and
ending on June 30, 2001,  on any day ISI may require GP  Strategies  to exercise
the GP Warrant and sell the underlying shares, if the market price of ISI Common
Stock  exceeds  $1.00 per share on each of the 10 trading days prior to any such
day, and (ii) any proceeds from the sale of the shares issuable upon exercise of
the GP  Warrant  in excess of the  aggregate  amount  paid by GP  Strategies  to
purchase such shares,  would be deemed to reduce the then outstanding  amount of
principal and interest of the GP Strategies Debt until such amount is reduced to
zero.                                                                           

         The Company's Common Stock now trades on the OTC Bulletin Board,  which
may have a material  adverse effect on the ability of the Company to finance its
operations and on the liquidity of the Common Stock.                            

Results of Operations                                                           

Year Ended December 31, 1999 versus Year Ended December 31, 1998                

         For the year ended December 31, 1999 (the "1999 Period"), the Company's
revenues of $2,329,222  included $2,328,945 from the sale of ALFERON N Injection
and the balance from sales of research products.  Revenues of $2,007,007 for the
year ended December 31, 1998 (the "1998 Period")  included  $1,930,657  from the
sale of ALFERON N Injection and the balance from sales of research  products and
other revenues. Cost of goods sold and idle production costs totalled $3,552,026
and  $6,533,462  for  the  1999  Period  and  1998  Period,  respectively.  Idle
production  costs in the 1999 and 1998  Periods,  represented  fixed  production
costs,  which  were  incurred  after  production  of  ALFERON  N  Injection  was
discontinued in April 1998.                                                     

         In May 1997, the Company appointed  Alternate Site  Distributors,  Inc.
("ASD"),  a wholly owned  subsidiary of Bergen  Brunswig  Corporation,  the sole
United States distributor of ALFERON N Injection.  Under the agreement with ASD,
the Company sold vials to ASD, which then resold them to the  marketplace.  As a
result, the Company  recognized  revenues when it sold vials to ASD, rather than
when ASD resold them to the marketplace.  In June 1998, the Company replaced ASD
with  Integrated  Commercialization  Solutions  ("ICS"),  another  subsidiary of
Bergen  Brunswig  Corporation  better  able to handle  the  Company's  specialty
distribution  requirements.  Under the new agreement, vials are not sold to ICS,
but are instead sold by the Company directly to the marketplace,  at which time,
the  Company  recognizes  revenues.  In the 1999  Period,  the  Company  sold to
wholesalers  and other  customers in the United States 19,463 vials of ALFERON N
Injection,  compared to 13,284 vials sold by the Company during the 1998 Period.
In  addition,  foreign  sales of ALFERON N Injection  were 1,374 vials and 3,300
vials for the 1999 and 1998 periods, respectively.                              

         During 1999, a portion of the reserve for excess inventory was reversed
in the amount of $1,177,531  as compared to a provision for excess  inventory of
$3,089,841  during 1998 in order to reflect the  inventory at its  estimated net
realizable value.                                                               

         Research and development  expenses during the 1999 Period of $3,060,019
decreased by $5,594,869 from $8,654,888 for the 1998 Period, principally because
the Company has concluded its Phase 3 clinical studies of ALFERON N Injection in
HIV- and HCV-infected  patients. The Company received $29,375 in 1998, as rental
income from GP Strategies for the use of a portion of the Company's  facilities,
which offset research and development expenses.                                 

         General and administrative expenses for the 1999 Period were $2,315,010
as compared to $4,569,608  for the 1998 Period.  The decrease in the 1999 Period
was principally due to decreases in payroll and other operating expenses.       

         On February 5, 1998, the Company  completed the sale of 7,500 shares of
Series  A  Convertible  Preferred  Stock  to an  institutional  investor  for an
aggregate amount of $7,500,000.  The $7,179,000 of net proceeds were expected to
augment the  Company's  working  capital  while  awaiting the results of the two
Phase 3 clinical trials of ALFERON N Injection for the treatment of HIV-infected
and  hepatitis C  patients.  After  considering  the  reaction of the  Company's
stockholders to the issuance and the negative impact the issuance apparently had
on the Company's  market  capitalization,  the Board of Directors  determined on
February 13, 1998 to exercise an option to repurchase  the shares of Convertible
Preferred  Stock for $7,894,737  (plus accrued  dividends).  The net loss to the
Company on the repurchase of the Preferred Stock amounted to $737,037.          

         Interest  income for the 1999 Period was $6,104 as compared to $252,528
for the 1998 Period.  The  decrease of $246,424 was due to less funds  available
for investment in the 1999 Period.                                              

         Interest  expense and financing costs for the 1999 Period was $536,394,
primarily due to interest and other costs  related to the GP Strategies  Debt in
1999, as compared to zero for the 1998 Period.                                  

         During  December 1999,  the Company  completed the sale of a portion of
its New Jersey tax loss carryforwards and recorded a gain on such sale amounting
to $2,348,509, which is recorded as an income tax benefit.                      

         As a result  of the  foregoing,  the  Company  incurred  net  losses of
$3,602,083 and $21,325,301 for the 1999 Period and 1998 Period, respectively.   

Year Ended December 31, 1998 Versus Year Ended December 31, 1997                

         For the year  ended  December  31,  1998,  the  Company's  revenues  of
$2,007,007  included  $1,930,657  from the sale of ALFERON N  Injection  and the
balance  from  sales of  research  products  and  other  revenues.  Revenues  of
$2,955,802  for the year ended  December 31, 1997 (the "1997  Period")  included
$2,927,585  from the sale of ALFERON N Injection  and the balance  from sales of
research  products.  Cost of  goods  sold  and  idle  production  costs  totaled
$6,533,462  and  $1,857,959  for the 1998 Period and 1997 Period,  respectively.
Idle production costs in the 1998 Period primarily  represented fixed production
costs,  which  were  incurred  after  production  of  ALFERON  N  Injection  was
discontinued  in April  1998.  There were no idle  production  costs in the 1997
Period.                                                                         

         In May 1997, the Company appointed  Alternate Site  Distributors,  Inc.
("ASD"),  a wholly owned  subsidiary of Bergen  Brunswig  Corporation,  the sole
United States distributor of ALFERON N Injection.  Under the agreement with ASD,
the Company sold vials to ASD, which then resold them to the  marketplace.  As a
result, the Company  recognized  revenues when it sold vials to ASD, rather than
when ASD resold them to the marketplace.  In June 1998, the Company replaced ASD
with  Integrated  Commercialization  Solutions  ("ICS"),  another  subsidiary of
Bergen  Brunswig  Corporation  better  able to handle  the  Company's  specialty
distribution  requirements.  Under the new agreement, vials are not sold to ICS,
but are instead  sold by the  Company  directly  to the  marketplace,  under the
administration of ICS, at which time revenues are recognized by the Company.  In
the 1998 Period,  the Company  sold to  wholesalers  and other  customers in the
United States 13,284 vials of ALFERON N Injection, compared to 21,584 vials sold
by the Company during the 1997 Period.  In addition,  foreign sales of ALFERON N
Injection  were  3,300  vials  and 4,587  vials  for the 1998 and 1997  Periods,
respectively.                                                                   

         In light of the  results  to date of the  Company's  Phase 3 studies of
ALFERON  N  Injection  in  HIV-  and  HCV-infected  patients,  the  Company  has
written-down  the carrying  value of its inventory of ALFERON N Injection to its
estimated net realizable value. The write-downs were the result of the Company's
reassessment  of anticipated  near-term needs for product to be sold or utilized
in clinical trials (within  approximately a two-year period beginning January 1,
1998 and based on historical sales levels). As a result, during the three months
ended March 31, 1998, the Company recorded an inventory  write-off of $3,089,841
in  addition  to the  $7,254,710  inventory  write-down,  which was  recorded at
December 31,  1997.  As of December 31,  1998,  the Company  estimated  that the
remaining  inventory  value  represented  product  to be sold  within a one-year
period.                                                                         

         Research and development  expenses during the 1998 Period of $8,654,888
decreased  by  $3,209,099  from  $11,863,987  for the 1997  Period,  principally
because the Company has nearly concluded its Phase 3 clinical studies of ALFERON
N Injection in HIV- and HCV-infected  patients. The Company received $29,375 and
$234,996,  respectively,  as rental income from GP  Strategies  for the use of a
portion of the  Company's  facilities,  which offset  research  and  development
expenses.                                                                       

         General and administrative expenses for the 1998 Period were $4,569,608
as compared to  $4,389,025  for the 1997  Period.  The  increase of $180,583 was
principally  due to  increases  in  payroll  and other  operating  expenses.  GP
Strategies provides certain  administrative  services for which the Company paid
GP Strategies  $120,000 for both the 1998 and 1997 Period. In addition,  for the
1997 Period,  payments to GP Strategies for services  provided to the Company by
GP Strategies personnel amounted to $135,000. For the 1998 Period, receipts from
GP  Strategies  for  services  provided to GP  Strategies  by Company  personnel
amounted to $25,000.                                                            

         On February 5, 1998, the Company  completed the sale of 7,500 shares of
Series  A  Convertible  Preferred  Stock  to an  institutional  investor  for an
aggregate amount of $7,500,000.  The $7,179,000 of net proceeds were expected to
augment the  Company's  working  capital  while  awaiting the results of the two
Phase 3 clinical trials of ALFERON N Injection for the treatment of HIV-infected
and  hepatitis C  patients.  After  considering  the  reaction of the  Company's
stockholders to the issuance and the negative impact the issuance apparently had
on the Company's  market  capitalization,  the Board of Directors  determined on
February 13, 1998 to exercise an option to repurchase  the shares of Convertible
Preferred  Stock for $7,894,737  (plus accrued  dividends).  The net loss to the
Company on the repurchase of the Preferred Stock amounted to $737,037.          

         Interest  income  for the 1998  Period  was  $252,528  as  compared  to
$670,199  for the 1997  Period.  The  decrease of $417,671 was due to less funds
available for investment in the current period.                                 

         As a result  of the  foregoing,  the  Company  incurred  net  losses of
$21,325,301 and $21,739,680 for the 1998 Period and 1997 Period, respectively.  

Recent Accounting Developments                                                  

         In June  1998,  the  FASB  issued  Statement  of  Financial  Accounting
Standard No. 133 (SFAS 133),  "Accounting for Derivative Instruments and Hedging
Activities".  This Statement establishes  accounting and reporting standards for
derivatives as either assets or liabilities in the activities.  It requires that
an entity  recognize  all  derivatives  as either assets or  liabilities  in the
statement of financial  position and measure  those  instruments  at fair value.
This  Statement as amended by SFAS 137 is effective  for all fiscal  quarters of
fiscal years beginning after June 15, 2000. The Company is still  evaluating its
position with respect to the use of derivative instruments.                     

         On December 3, 1999,  the  Securities  and Exchange  Commission  issued
Staff  Accounting   Bulletin  No.  101  -  "Revenue   Recognition  in  Financial
Statements"  ("SAB No. 101").  SAB No. 101 provides the SEC staff's views on the
recognition of revenue including  nonrefundable  technology access fees received
by biotechnology companies in connection with research collaborations with third
parties. SAB No. 101 states that in certain circumstances the SEC staff believes
that up-front  fees,  even if  nonrefundable,  should be deferred and recognized
systematically over the term of the research  arrangement.  SAB No. 101, amended
by SAB  101A,  issued  on March  24,  2000,  requires  registrants  to adopt the
accounting guidance contained therein by no later than the second fiscal quarter
of the fiscal year  beginning  after December 15, 1999. The Company is currently
assessing  the  financial  impact of complying  with SAB No. 101 and has not yet
determined  whether applying the accounting  guidance of SAB No. 101 will have a
material effect on its financial position or results of operations.             

         FASB  Interpretation  No. 44 provides guidance for applying APB Opinion
No. 25, "Accounting for Stock Issued to Employees".  It applies prospectively to
new awards,  exchanges  of awards in a business  combination,  modifications  to
outstanding  awards,  and  changes in  grantee  status on or after July 1, 2000,
except for  provisions  related to repricings  and the definition of an employee
which apply to awards issued after December 15, 1998. The provisions  related to
modifications to fixed stock option awards to add a reload feature are effective
for awards modified after January 12, 2000. The Company is evaluating the impact
on its financial position and results of operations.                            

Year 2000                                                                       

         The Company did not experience any business or operational disruptions,
resulting from the Company's or its suppliers, as a result of the arrival of the
year 2000.                                                                      

Forward-Looking Statements                                                      

         This report  contains  certain  forward-looking  statements  reflecting
management's   current  views  with  respect  to  future  events  and  financial
performance.  These forward-looking  statements are subject to certain risks and
uncertainties that could cause actual results to differ materially from those in
the forward-looking statements, including, but not limited to, the risk that the
Company will run out of cash;  uncertainty of obtaining  additional  funding for
the Company; uncertainty of obtaining United States regulatory approvals for the
Company's  products under development and foreign  regulatory  approvals for the
Company's  FDA-approved  product and  products  under  development  and, if such
approvals are obtained,  uncertainty of the successful commercial development of
such products; substantial competition from companies with substantially greater
resources than the Company in the Company's present and potential businesses; no
guaranteed source of required materials for the Company's  products;  dependence
on certain distributors to market the Company's products; potential adverse side
effects from the use of the Company's  products;  potential patent  infringement
claims  against the  Company;  possible  inability of the Company to protect its
technology;   uncertainty  of  pharmaceutical   pricing;   substantial   royalty
obligations  payable  by  the  Company;  limited  production  experience  of the
Company;  risk  of  product  liability;  and  risk  of  loss  of key  management
personnel,  all of which are  difficult  to predict and many of which are beyond
the control of the Company.                                                     

Item 7A.  Quantitative and Qualitative Disclosure About Market Risk             

Not applicable.                                               

Item 8.  Financial Statements and Supplementary Data                            

INDEX TO CONSOLIDATED FINANCIAL STATEMENTS

                                                                    Page

Independent Auditors' Report                                            20      
Financial Statements:                                                           

Consolidated Balance Sheets - December 31, 1999 and 1998                21      

Consolidated Statements of Operations - Years ended                             
December 31, 1999, 1998 and 1997                                  22

Consolidated Statements of Changes in Stockholders'                             
Equity - Years ended December 31, 1999, 1998 and 1997             23

Consolidated Statements of Cash Flows - Years ended                             
December 31, 1999, 1998 and 1997                                  24

Notes to Consolidated Financial Statements                              25      

10-K
5th "Page" of 15
TOC
1st
Previous
Next
Bottom
Just 5th

INDEPENDENT AUDITORS' REPORT

The Board of Directors and Stockholders                                         
Interferon Sciences, Inc.:                                                      

         We have audited the  consolidated  financial  statements  of Interferon
Sciences,  Inc.  and  subsidiary  as listed  in the  accompanying  index.  These
consolidated  financial  statements  are  the  responsibility  of the  Company's
management.  Our  responsibility is to express an opinion on these  consolidated
financial statements based on our audits.                                       

         We conducted our audits in accordance with generally  accepted auditing
standards.  Those standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are free of material
misstatement.  An audit includes examining, on a test basis, evidence supporting
the amounts and disclosures in the financial statements.  An audit also includes
assessing the  accounting  principles  used and  significant  estimates  made by
management,  as well as evaluating the overall financial statement presentation.
We believe that our audits provide a reasonable basis for our opinion.          

         In our opinion, the consolidated financial statements referred to above
present fairly, in all material  respects,  the financial position of Interferon
Sciences,  Inc. and subsidiary at December 31, 1999 and 1998, and the results of
their  operations  and their cash flows for each of the years in the  three-year
period ended December 31, 1999 in conformity with generally accepted  accounting
principles.                                                                     

         The accompanying  consolidated  financial statements have been prepared
assuming that the Company will continue as a going concern. As discussed in Note
3 to the consolidated  financial statements,  the Company has suffered recurring
losses from  operations  and has an accumulated  deficit that raise  substantial
doubt about its ability to continue as a going  concern.  Management's  plans in
regard to these matters are also described in Note 3. The consolidated financial
statements do not include any adjustments  that might result from the outcome of
this uncertainty.                                                               

                                                            /s/ KPMG LLP

New York, New York                                                              
April 10, 2000                                                                  

10-K
6th "Page" of 15
TOC
1st
Previous
Next
Bottom
Just 6th

                                                        [Enlarge/Download Table]


                    INTERFERON SCIENCES, INC. AND SUBSIDIARY                                

                           CONSOLIDATED BALANCE SHEETS                                      

                                                        December 31,                        
                                                        ------------                        
                                                   1999              1998                   
                                                   ----              ----                   
                                                                                            

ASSETS                                                                                      

Current assets                                                                              

  Cash and cash equivalents                     $ 2,273,242        $ 1,170,861              
  Accounts and other receivables                     35,561            689,511              
  Inventories, net of reserves of                                                           
      $6,225,185 and $10,344,551                    766,000            709,784              
  Prepaid expenses and other current assets          27,018             36,511              
                                                -------------      ------------             
Total current assets                              3,101,821          2,606,667              
                                                -------------      ------------             
Property, plant and equipment, at cost                                                      
  Land                                              140,650            140,650              
  Buildings and improvements                      7,702,825          7,702,825              
  Equipment                                       4,915,798          4,928,298              
                                                --------------     ------------             
                                                 12,759,273         12,771,773              

Less accumulated depreciation                    (9,834,558)        (9,130,248)             
                                                ------------       ------------             
                                                  2,924,715          3,641,525              
                                                ------------       ------------             
Patent costs, net of accumulated amortization                                               
  of $301,339 and $270,856                          219,822            250,305              
Other assets                                         10,100            100,150              
                                                ------------       ------------             
                                                $ 6,256,458       $  6,598,647              
                                                ============       ============             
LIABILITIES AND STOCKHOLDERS' EQUITY                                                        
Current liabilities                                                                         

  Accounts payable                              $ 4,396,181       $  4,149,666              
  Accrued expenses                                  519,285            236,641              
  Amount due GP Strategies                          283,637            108,943              
                                                -------------     -------------             
Total current liabilities                         5,199,103          4,495,250              
                                                -------------     -------------             
Note payable to GP Strategies                       500,000                                 
                                                -------------     -------------             

Commitments                                                                                 

Stockholders' equity                                                                        

  Preferred stock, par value $.01 per share; authorized - 5,000,000 shares; none            
  issued and outstanding Common stock, par value $.01 per share; authorized                 

   - 55,000,000 shares; issued and outstanding                                              
   - 5,327,473 and 4,360,808 shares                  53,275             43,608              
  Capital in excess of par value                129,397,259        127,933,885              
  Accumulated deficit                          (128,812,179)      (125,210,096)             
  Settlement shares                                 (81,000)          (664,000)             
                                                --------------    -------------             
Total stockholders' equity                          557,355          2,103,397              
                                                --------------    -------------             
                                              $   6,256,458        $  6,598,647             
                                                =============     =============             
The  accompanying  notes are an integral  part of these  consolidated  financial statements.

                                                        [Enlarge/Download Table]


                    INTERFERON SCIENCES, INC. AND SUBSIDIARY                             
                      CONSOLIDATED STATEMENTS OF OPERATIONS                              
                  YEARS ENDED DECEMBER 31, 1999, 1998 AND 1997                           

                                                 1999          1998             1997     
                                               --------       --------         -------   

                                                                                         

Revenues                                                                                 

ALFERON N Injection                          $  2,328,945   $  1,930,657    $  2,927,585 
Research products and other                                                              
  revenues                                            277         76,350          28,217 
                                              ------------   ------------    ------------
Total revenues                                  2,329,222      2,007,007       2,955,802 
                                              ------------   ------------    ------------
Costs and expenses                                                                       
Cost of goods sold and excess/idle                                                       
  production costs                              3,552,026      6,533,462       1,857,959 
(Reversal) Provision for excess inventory      (1,177,531)     3,089,841       7,254,710 
Research and development                        3,060,019      8,654,888      11,863,987 
General and administrative                      2,315,010      4,569,608       4,389,025 
                                              ------------   -------------   ------------
Total costs and expenses                        7,749,524     22,847,799      25,365,681 
                                              ------------   -------------   ------------
Loss from operations                           (5,420,302)   (20,840,792)    (22,409,879)

Interest income                                     6,104        252,528         670,199 
Interest expense and financing costs             (536,394)                               
Loss on repurchase of preferred stock                             (737,037)              
                                               -----------   -------------   ------------
Loss before income tax benefit                 (5,950,592)   (21,325,301)    (21,739,680)

                                               -----------   -------------   ------------
Income tax benefit:                                                                      
Gain on sale of state net operating loss                                                 
  carryovers                                    2,348,509                                
                                              -------------  -------------   ------------
Net loss                                     $ (3,602,083)  $(21,325,301)   $(21,739,680)
                                              =============  =============   ============
Basic and diluted                                                                        

  loss per share                             $       (.71)  $      (6.67)   $      (8.15)
                                              =============  =============   ============
Weighted average number of                                                               
shares outstanding                              5,088,620      3,199,396       2,668,352 
                                              =============  =============   ============

The accompanying notes are an integral part of these consolidated financial statements   

10-K
7th "Page" of 15
TOC
1st
Previous
Next
Bottom
Just 7th

                                                        [Enlarge/Download Table]


                                                             INTERFERON SCIENCES, INC. AND SUBSIDIARY                              
                                                      CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY                   
                                                           YEARS ENDED DECEMBER 31, 1999, 1998 AND 1997                            

                                                                             Capital in                               Total        
                                     Preferred stock      Common stock       excess of      Accumulated  Settlement   stockholders'
                                     Shares   Amount   Shares     Amount     par value       deficit      shares      equity       
                                     ---------------   ------------------  ------------  --------------  ----------   -------------

                                                                                                                                   

Balance at December 31, 1996               $          2,455,239   $24,552  $107,494,394    $(82,145,115)   $           $25,373,831 
Net proceeds from sale of                                                                                                          
 common stock                                           582,418     5,824    16,429,896                                 16,435,720 
Purchase of fractional shares of                                                                                                   
 common stock resulting from                                                                                                       
 reverse stock split                                        (21)        -          (633)                                     (633) 
Common stock issued                                                                                                                
 under Company 401(k) plan                                  483         5        22,962                                     22,967 
Proceeds from exercise                                                                                                             
 of common stock options                                  3,962        40       121,395                                    121,435 
Net loss                                                                                    (21,739,680)               (21,739,680)
                                     ----------------------------------------------------------------------------------------------
Balance at December 31, 1997                          3,042,081    30,421   124,068,014    (103,884,795)                20,213,640 
Net proceeds from the sale of                                                                                                      
 common and preferred stock           7,500     75      960,000     9,600     9,123,762       9,133,437                            
Repurchase of preferred Stock        (7,500)   (75)                           (7,178,925)                               (7,179,000)
Common stock issued as payment                                                                                                     
 against negotiated settlement                                                                                                     
 and accounts payable                                   330,000     3,300      1,246,794                 (1,189,000)        61,094 
Common stock issued                                                                                                                
 as compensation                                          3,238        32        116,865                                   116,897 
Common stock issued                                                                                                                
 under Company 401(k) plan                               25,489       255        170,978                                   171,233 
Compensation paid in cash in                                                                                                       
 exchange of obligation to issue                                                                                                   
 common stock                                                                    386,397                                   386,397 
Market value adjustment                                                                                    525,000         525,000 
Net loss                                                                                     (21,325,301)              (21,325,301)
                                     ----------------------------------------------------------------------------------------------
Balance at December 31, 1998                          4,360,808    43,608     127,933,885   (125,210,096) (664,000)      2,103,397 

Common stock issued as financing cost                   500,000     5,000         495,000                                  500,000 
Common stock issued as payment against                                                                                             
 accounts payable                                       285,000     2,850         531,525                                  534,375 
Common stock issued                                                                                                                
 under Company 401(k) plan                              181,665     1,817          98,159                                   99,976 
Compensation paid in cash in exchange                                                                                              
 of obligation to issue                                                                                                            
 common stock                                                                     338,690                                  338,690 
Settlement shares sold                                                                                      33,000          33,000 
Market value adjustment                                                                                    550,000         550,000 
Net loss                                                                                      (3,602,083)               (3,602,083)
                                     ----------------------------------------------------------------------------------------------
Balance at December 31, 1999               $          5,327,473   $53,275    $129,397,259  $(128,812,179) $(81,000)       $557,355 

The accompanying notes are an integral part of these consolidated financial statements                                             


10-K
8th "Page" of 15
TOC
1st
Previous
Next
Bottom
Just 8th

                                                        [Enlarge/Download Table]


                                               INTERFERON SCIENCES, INC. AND SUBSIDIARY          
                                                 CONSOLIDATED STATEMENTS OF CASH FLOWS           
                                            YEARS ENDED DECEMBER 31, 1999, 1998 AND 1997         

                                                           1999           1998          1997     
                                                         --------       --------       --------  
                                                                                                 

Cash flows from operations:                                                                      

  Net loss                                            $ (3,602,083)  $(21,325,301)  $(21,739,680)
  Adjustments to reconcile net loss                                                              
    to net cash used for operating activities:                                                   
    Depreciation and amortization                          747,293        894,013        782,802 
    Amortization of deferred financing costs               500,000                               
    Compensation and benefits                                                                    

       paid with common stock                               99,976        288,130         22,967 
    (Reversal) provision for excess inventory           (1,177,531)     3,089,841      7,254,710 
    Non-cash deferred compensation                         338,690        386,397                
    Loss on repurchase of preferred stock                                 737,037                
    Market value adjustment                                550,000        515,625                
    Provision for impairment of equipment                                 803,217                
    Loss on sale of other assets                            51,392                               
    Change in operating assets                                                                   
       and liabilities:                                                                          
    Inventories                                          1,121,315      (466,972)     (6,258,765)
    Accounts and other receivables                         653,950       299,947        (756,421)
    Prepaid expenses and other current assets                9,493        28,842          96,666 
    Amount due to GP Strategies                            174,694       130,847          60,998 
    Accounts payable and accrued expenses                1,096,534       517,040       1,570,704 
                                                    ---------------   ------------  -------------
  Net cash provided by (used for) operations               563,723   (14,101,337)    (18,966,019)
                                                    ---------------   ------------  -------------
Cash flows from investing activities:                                                            

  Additions to property, plant and equipment                             (78,235)     (1,023,175)
  Proceeds from sale of other assets                        38,658        73,750                 
                                                    ---------------   ------------  ------------ 
  Net cash provided by (used for)                                                                
    investing activities                                   38,658        (4,485)     (1,023,175) 
                                                    ---------------   ------------  -------------
Cash flows from financing activities:                                                            

  Proceeds from GP Strategies                              500,000                               
  Net proceeds from sale of common stock                               1,954,437      16,435,720 
  Net proceeds from preferred stock offering                           7,179,000                 
  Repurchase of preferred stock                                       (7,916,037)                
  Proceeds from exercise of common stock options                                         121,435 
  Purchase of fractional shares of common stock                                             (633)
                                                    ---------------   ------------  -------------
  Net cash provided by financing activities                500,000     1,217,400      16,556,522 
                                                    ---------------   ------------  -------------
Net increase (decrease) in cash and cash equivalents     1,102,381   (12,888,422)     (3,432,672)

Cash and cash equivalents at beginning of year           1,170,861    14,059,283      17,491,955 
                                                    --------------    ------------  -------------
Cash and cash equivalents at end of year            $    2,273,242   $ 1,170,861     $14,059,283 
                                                    ==============    ============  =============

The accompanying notes are an integral part of these consolidated financial statements           


10-K
9th "Page" of 15
TOC
1st
Previous
Next
Bottom
Just 9th

INTERFERON SCIENCES, INC. AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

Note 1. Organization and Business                                               

         Interferon  Sciences,  Inc.  (the  "Company")  is  a  biopharmaceutical
company  that  operates  in a  single  segment  and is  engaged  in  the  study,
manufacture,  and sale of pharmaceutical  products based on its highly purified,
multispecies,  natural source alpha interferon ("Natural Alpha Interferon"). The
Company's ALFERON(R) N Injection  (Interferon Alfa-n3) product has been approved
by the United States Food and Drug  Administration  ("FDA") for the treatment of
certain  types of genital  warts and is being  studied for  potential use in the
treatment  of HIV,  hepatitis C, and other  indications.  Alferon N Injection is
sold  principally  in the United States,  however,  a portion is sold in foreign
countries.  For the years ended December 31, 1999, 1998 and 1997, domestic sales
totaled $2,204,437,  $1,716,157 and $2,613,430,  respectively, and foreign sales
(primarily Germany) totaled $124,508, $214,500 and $314,155,  respectively.  All
identifiable  assets are  located  in the United  States.  The  Company  also is
studying  ALFERON N Gel and  ALFERON  LDO(R),  the  Company's  topical  and oral
formulations of Natural Alpha Interferon,  for the potential  treatment of viral
and immune system diseases. (See Note 5).                                       

     Integrated  Commercialization Solutions, Inc. (ICS), a subsidiary of Bergen
Brunswig  Corporation,  is the sole  United  States  distributer  of  ALFERON  N
Injection to  wholesalers  throughout  the United  States.  The Company does not
believe that the loss of any one wholesaler  would have material  adverse effect
on the Company's sales or financial position.                                   

Note 2.   Summary of Significant Accounting Policies                            

         Principles of consolidation -- The  consolidated  financial  statements
include  the  operations  of the  Company and  Interferon  Sciences  Development
Corporation ("ISD"), its wholly owned subsidiary.  All significant  intercompany
transactions and balances have been eliminated.                                 

         Cash and cash  equivalents  -- The Company  considers all highly liquid
instruments  with  maturities  of three months or less from  purchase date to be
cash equivalents.                                                               

         Property,  plant and  equipment -- Property,  plant and  equipment  are
carried  at  cost.  Major  additions  and  betterments  are  capitalized   while
maintenance  and  repairs,  which do not  extend  the lives of the  assets,  are
expensed.                                                                       

         Depreciation -- The Company  provides for depreciation and amortization
of plant and  equipment  following the  straight-line  method over the estimated
useful lives of such assets as follows:                                         

                  Class of Assets                         Estimated Useful Lives

                  Buildings and Improvements                      15 to 30 years
                  Equipment                                        5 to 10 years

         Patent  costs -- The Company  capitalizes  costs to obtain and maintain
patents  and  licenses.   Patent  costs  are  amortized   over  17  years  on  a
straight-line  basis. To the extent a patent is determined to be worthless,  the
related net capitalized cost is immediately expensed.                           

     Revenue recognition -- Sales are recorded upon shipment of product.

         Collaborative  agreement research and development  revenues and costs -
The costs of performing  research and  development  are expensed when  incurred.
Generally,  the  Company  matches its  collaborative  research  and  development
revenues in the same accounting  periods in which the related research costs are
incurred.  However, when the revenues are exhausted,  the Company has the option
to continue the research activities at its own expense.                         

         Inventories  --  Inventories,  consisting  of raw  materials,  work  in
process and finished goods,  are stated at the lower of cost or market on a FIFO
basis.  Inventory in excess of the Company's  estimated  usage  requirements  is
written down to its estimated net realizable value. Inherent in the estimates of
net realizable  value are management  estimates  related to the Company's future
manufacturing schedules, customer demand, possible alternative uses and ultimate
realization of potentially excess inventory.                                    

         Long-Lived Assets -- The Company reviews  long-lived assets and certain
identifiable   intangibles   for  impairment   whenever  events  or  changes  in
circumstances  indicate  that  the  carrying  amount  of an  asset  may  not  be
recoverable.  Recoverability  of  assets  to be held and used is  measured  by a
comparison of the carrying  amount of an asset to future net cash flows expected
to be generated by the assets. If such assets are considered to be impaired, the
impairment  to be  recognized  is measured  by the amount by which the  carrying
amount of the assets exceeds the estimated  fair value of the assets.  Assets to
be disposed of are  reported at the lower of the  carrying  amount or  estimated
fair value less costs to sell.  Due to the  circumstances  described  in Note 7,
during 1998,  the Company  ceased  production  of finished  goods  inventory and
continues to hold its long-lived  assets for use. In addition,  as the Company's
financial and operating  situation had continued to worsen (as further described
in Note 3), and after  consideration of projected revenues for 1999, the Company
determined that the carrying value of their equipment was impaired. Accordingly,
the Company  recorded a charge for  impairment  of its  equipment of $803,217 in
December  1998 to  write  down  this  equipment  to its  estimated  fair  value.
Management  has  determined,   based  on  their  best  estimates  and  available
information,  the estimated fair value of this equipment to be that amount which
could be recovered through the sale of the equipment.  No further impairment was
deemed to exist at December 31, 1999. Quoted market prices are not available.   

         Stock option plan - The Company  applies the provision of SFAS No. 123,
Accounting for Stock-Based Compensation, which requires entities to recognize as
expense over the vesting period the fair value of all stock-based  awards on the
date of grant.  As permitted  under SFAS No. 123, the Company elects to continue
to apply the  provisions  of APB Opinion No. 25 and provide pro forma net income
(loss) and pro forma earnings  (loss) per share  disclosures  for employee stock
option  grants made in 1995 and future years as if the  fair-value-based  method
defined in SFAS No. 123 had been applied and, accordingly,  no compensation cost
has  been  recognized  for  its  stock  options  in the  consolidated  financial
statements.                                                                     

         Reverse  stock  split -- As a result of a  one-for-four  reverse  stock
split  effective as of March 21, 1997,  and a  one-for-five  reverse stock split
effective as of January 6, 1999, all shares and per share  information have been
restated.                                                                       

         Loss per share -- Basic earnings  (loss) per share (EPS) are based upon
the weighted  average  number of common  shares  outstanding  during the period.
Diluted  EPS are  based  upon the  weighted  average  number  of  common  shares
outstanding  during the period  assuming the  issuance of common  shares for all
dilutive  potential  common shares  outstanding.  At December 31, 1999, 1998 and
1997, the Company's  options and warrants are  anti-dilutive and therefore basic
and diluted EPS are the same.                                                   

         Use of  Estimates  in the  Preparation  of  Financial  Statements - The
preparation  of financial  statements  in  conformity  with  generally  accepted
accounting principles requires management to make estimates and assumptions that
affect the  reported  amounts  of assets  and  liabilities,  and  disclosure  of
contingent assets and liabilities,  at the date of the financial statements, and
the  reported  amounts of revenues  and expenses  during the  reporting  period.
Actual results could differ from those estimates.                               

         Income  taxes - Income  taxes  are  accounted  for  under the asset and
liability  method.  Deferred tax assets and  liabilities  are recognized for the
future tax  consequences  attributable  to  differences  between  the  financial
statement  carrying  amounts  of  existing  assets  and  liabilities  and  their
respective  tax  bases  and for  operating  loss and tax  credit  carryforwards.
Deferred  tax  assets and  liabilities  are  measured  using  enacted  tax rates
expected  to apply to  taxable  income  in the  years in which  those  temporary
differences are expected to be recovered or settled.  The effect on deferred tax
assets and  liabilities  of a change in tax rates is recognized in income in the
period that includes the enactment date.                                        

         Reclassifications   -  Certain   balances  in  prior  years  have  been
reclassified to conform to the presentation adopted in the current year.        

Note 3.   Operations and Liquidity                                              

         The Company has  experienced  significant  operating  losses  since its
inception  in 1980.  As of December  31,  1999,  the Company had an  accumulated
deficit of approximately  $128.8 million. For the years ended December 31, 1999,
1998 and 1997,  the Company had losses from  operations  of  approximately  $5.4
million,  $20.8 million and $22.4  million,  respectively.  Although the Company
received FDA approval in 1989 to market ALFERON N Injection in the United States
for the treatment of certain genital warts and ALFERON N Injection  currently is
marketed and sold in the United  States by the  Company,  in Mexico by Industria
Farmaceutica  Andromaco,  S.A. De C.V.  and in Germany by Cell Pharm GmbH ("Cell
Pharm"),  the  Company  has had  limited  revenues  from the sale of  ALFERON  N
Injection to date. For the Company to operate profitably,  the Company must sell
significantly  more ALFERON N Injection.  Increased sales will depend  primarily
upon the  expansion of existing  markets  and/or  successful  attainment  of FDA
approval to market  ALFERON N Injection  for  additional  indications,  of which
there can be no assurance.  There can be no assurance that sufficient quantities
of ALFERON N Injection will be sold to allow the Company to operate profitably. 

         The Company has limited  financial  resources  as of December  31, 1999
with which to support future  operating  activities and to satisfy its financial
obligations as they become  payable.  Consequently,  management is continuing to
actively pursue raising additional capital by either (i) issuing securities in a
private equity offering, (ii) licensing the rights to its injectable, topical or
oral   formulations  of  alpha   interferon,   or  (iii)  selling  the  Company.
Insufficient  funds will require the Company to further  delay,  scale back,  or
eliminate  certain  or all of its  activities  or to  license  third  parties to
commercialize  products or technologies that the Company would otherwise seek to
develop itself.                                                                 

         Based on the  Company's  estimates of revenues,  expenses and levels of
production,  management  believes  that the  cash  presently  available  will be
sufficient to enable the Company to continue  operations  through  approximately
June 30, 2000. However, actual results, especially with respect to revenues, may
differ  materially  from such  estimates,  and no  assurance  can be given  that
additional  funding will not be required  sooner than  anticipated  or that such
additional  funding,  whether from financial  markets or  collaborative or other
arrangements  with corporate  partners or from other sources,  will be available
when needed or on terms acceptable to the Company.                              

Note 4.   Agreements with Hoffmann-LaRoche                                      

         F. Hoffmann-La  Roche Ltd. and  Hoffmann-LaRoche,  Inc.  (collectively,
"Hoffmann")  have been issued patents  covering  human alpha  interferon in many
countries  throughout the world.  In 1995, the Company  obtained a non-exclusive
perpetual  license from Hoffmann  (the  "Hoffmann  Agreement")  which grants the
Company the worldwide rights to make, use, and sell,  without a potential patent
infringement  claim from Hoffmann,  any formulation of Natural Alpha Interferon.
The  Hoffmann  Agreement  permits  the  Company to grant  marketing  rights with
respect to Natural Alpha Interferon  products to third parties,  except that the
Company cannot grant marketing rights with respect to injectable products in any
country in which  Hoffmann has patent rights  covered by the Hoffmann  Agreement
(the  "Hoffmann  Territory")  to any third  party not  listed on a  schedule  of
approximately 50 potential  marketing  partners without the consent of Hoffmann,
which consent cannot be unreasonably withheld.                                  

         Under the terms of the Hoffmann Agreement,  the Company is obligated to
pay  Hoffmann an aggregate  royalty on net sales (as  defined) of Natural  Alpha
Interferon  products by the Company in an amount equal to (i) 8% of net sales in
the Hoffmann  Territory,  and 2% of net sales outside the Hoffmann  Territory of
products manufactured in the Hoffmann Territory,  up to $75,000,000 of net sales
in any calendar year and (ii) 9.5% of net sales in the Hoffmann  Territory,  and
2% of net sales outside the Hoffmann  Territory of products  manufactured in the
Hoffmann Territory,  in excess of $75,000,000 of net sales in any calendar year,
provided  that the total  royalty  payable in any calendar year shall not exceed
$8,000,000.  For the years ended  December 31, 1999,  1998 and 1997, the Company
recorded  approximately  $94,000,  $77,000 and  $117,000 in royalty  expenses to
Hoffmann,  respectively. The Hoffmann Agreement can be terminated by the Company
on 30 days notice  with  respect to the United  States  patent,  any  individual
foreign patent, or all patents owned by Hoffmann.  If the Hoffmann  Agreement is
terminated with respect to the patents owned by Hoffmann in a specified country,
such country is no longer included in the Hoffmann Territory.  Accordingly,  the
Company would not be permitted to market any formulation of alpha  interferon in
such country.                                                                   

Note 5.  Research and Development Agreement with Interferon Sciences Research   
Partners, Ltd.                                                

         In 1984, the Company  organized ISD to act as the sole general  partner
of Interferon Sciences Research Partners, Ltd., a New Jersey limited partnership
(the "Partnership").  The Company and the Partnership entered into a development
contract  whereby the Company  received  substantially  all of the net  proceeds
($4,414,475)  of  the  Partnership's  public  offering  of  limited  partnership
interests.  The Company used the proceeds to perform  research,  development and
clinical testing on behalf of the Partnership for the development of ALFERON Gel
containing recombinant interferon.                                              

         In connection with the formation of the Partnership, ISD agreed to make
additional cash contributions for purposes of continuing  development of ALFERON
Gel if the Partnership exhausted its funds prior to development of such product.
ISD is wholly  dependent  upon the Company for capital to fund such  commitment.
The Partnership  exhausted its funds during 1986, and the Company  contributed a
total of  $1,997,000  during the  period  from 1986 to 1990,  for the  continued
development  of  ALFERON  Gel.  In 1987,  the  Company  filed a Product  License
Application  with the FDA for approval to market  ALFERON Gel. In February 1990,
the FDA indicated that additional process  development and clinical trials would
be necessary  prior to approval of ALFERON Gel.  The Company  believed,  at that
time, that the costs to complete the required  process  development and clinical
trials would be  substantial,  and there could be no assurance that the clinical
trials would be successful.                                                     

         As a result of the above events,  in 1992, the Company withdrew its FDA
Product License Application for ALFERON Gel containing  recombinant  interferon.
In place of single  species  recombinant  interferon,  previously  ALFERON Gel's
active  ingredient,  the Company  commenced,  in 1992,  further  development  of
ALFERON Gel using the Company's  natural source  multi-species  alpha interferon
("ALFERON N Gel"). Assuming successful  development and commercial  exploitation
of ALFERON N Gel,  which to date has not occurred,  the Company may be obligated
to pay the  Partnership  royalties  equal to 4% of the  Company's  net  sales of
ALFERON N Gel and 15% of revenues received from sublicensing ALFERON N Gel.     

Note 6.   Agreement with Cell Pharm GmbH                                        

         In 1996, the Company entered into a supply and  distribution  agreement
(the "Cell Pharm  Agreement")  with Cell Pharm.  Cell  Pharm,  headquartered  in
Hanover, Germany, is a privately owned pharmaceutical company primarily involved
in the  distribution  and manufacture of products for cancer treatment and other
uses.  The Cell Pharm  Agreement,  which  terminates  on June 30,  2001,  unless
renewed,  grants Cell Pharm rights to  distribute,  promote,  and sell ALFERON N
Injection in Germany.  The Cell Pharm  Agreement  provides that the Company will
supply Cell Pharm with ALFERON N Injection at specified  prices,  and  obligates
Cell Pharm to  purchase  specified  minimum  amounts in each annual  period.  In
addition,  Cell Pharm is  required  to pay the  Company  50% of the  incremental
revenue  Cell Pharm  receives as a result of selling  ALFERON N  Injection  at a
price higher than a specified  price.  To date, no incremental  revenue has been
generated.  Cell Pharm has informed  the Company that it is marketing  ALFERON N
Injection under the trade name  Cytoferon(R),  pursuant to Cell Pharm's existing
regulatory  approval to market  Cellferon in Germany for the  treatment of hairy
cell leukemia and for the treatment of patients who develop  antibodies  against
recombinant alpha interferons.                                                  

Note 7. Inventories                                                             

                                                                [Download Table]


         Inventories, consisting of material, labor and overhead, are classified
as follows:                                                                     

                                                                  December 31,  
                                                  1999                 1998     
                                                  -------------------------     
                                                                                

         Finished goods ................             $  361,809    $ 3,443,786  
         Work in process...............               5,296,816      6,466,914  
         Raw materials..................              1,332,560      1,143,635  
         Less reserve for excess inventory           (6,225,185)   (10,344,551) 
                                                  ------------   ------------   
                                                   $  766,000    $   709,784    
                                                  ============   ============   

         Finished  goods  inventory  consists  of vials of ALFERON N  Injection,
available  for  commercial  and  clinical use either  immediately  or upon final
release by quality assurance.                                                   

         In light of the  results  to date of the  Company's  Phase 3 studies of
ALFERON  N  Injection  in  HIV-  and  HCV-infected  patients,  the  Company  has
written-down  the carrying  value of its inventory of ALFERON N Injection to its
estimated  net  realizable  value.  The  write-down is a result of the Company's
assessment  of  anticipated  near-term  projections  of  product  to be  sold or
utilized in clinical trials, giving consideration to historical sales levels. As
a result,  inventories  at  December  31,  1999 and 1998,  reflect a reserve for
excess inventory of $6,225,185 and $10,344,551, respectively.                   

         During  1999,  the reserve  for excess  inventory  was  reversed in the
amount of $1,177,531.                                                           

         In addition,  during 1999,  approximately  $2,900,000  of inventory was
written off against the reserve for excess  inventory  since the  inventory  had
expired and could no longer be sold or used for clinical trials.                

Note 8. Preferred Stock                                                         

         On February 5, 1998, the Company  completed the sale of 7,500 shares of
Series  A  Convertible  Preferred  Stock  to an  institutional  investor  for an
aggregate amount of $7,500,000.  The $7,179,000 of net proceeds were expected to
augment the  Company's  working  capital  while  awaiting the results of the two
Phase 3 clinical trials of ALFERON N Injection for the treatment of HIV-infected
and  hepatitis C  patients.  After  considering  the  reaction of the  Company's
stockholders to the issuance and the negative impact the issuance apparently had
on the Company's  market  capitalization,  the Board of Directors  determined on
February 13, 1998 to exercise an option to repurchase  the shares of Convertible
Preferred  Stock for $7,894,737  (plus accrued  dividends).  The net loss to the
Company on the repurchase of the Preferred Stock amounted to $737,037.          

Note 9. Income Taxes                                                            

         As a result  of the loss  allocation  rules  contained  in the  Federal
income tax  consolidated  return  regulations,  approximately  $6,009,000 of net
federal  operating  loss  carry-forwards,  which  expire from 2001 to 2006,  are
available  to  the  Company  upon  ceasing  to be a  member  of GP  Strategies's
consolidated  return  group in 1991.  In  addition,  the Company has net federal
operating  loss  carry-forwards  for periods  subsequent  to May 31,  1991,  and
through December 31, 1999 of approximately $93,565,000 which expire from 2006 to
2014.  For the year ended December 31, 1999, the Company had a tax net operating
loss of $9,318,000, which expires in 2014.                                      

         The Company  believes that the events  culminating  with the closing of
its Common Stock  Offering on August 22, 1995 resulted in an "ownership  change"
under Internal Revenue Code, Section 382, with respect to its stock. The Company
believes that as a result of the  ownership  change,  the future  utility of its
pre-change net operating losses are limited to an annual amount of approximately
$3,230,000. In addition, the Company has approximately $33,000 of investment tax
credit  carry-forwards,  which  expire  in 2000 and  $488,000  of  research  and
development credit  carry-forwards,  which expire from 2000 to 2002 that are, in
accordance  with  Internal  Revenue  Code,  Section  383,  subject to the annual
limitation under Internal Revenue Code Section 382.                             

The tax effects that give rise to deferred tax assets and liabilities consist of
the following as of December 31, 1999 and 1998:                                 

                                                                [Download Table]


Deferred tax assets                             1999             1998   
-------------------                             ---------------------   
                                                                        

Net operating loss carry-forwards           $31,601,000    $ 28,644,000 
Tax credit carry-forwards                       521,000         676,000 
Inventory                                     2,117,000       3,517,000 
Property and equipment,                                                 
  principally due to differences                                        
  in basis and depreciation                     387,000         246,000 
                                           ------------     ----------- 
Net deferred tax asset                       34,626,000      33,083,000 
Valuation allowance                         (34,626,000)    (33,083,000)
                                          ------------     ------------ 
Net deferred tax asset after                                            
  valuation allowance                     $    ---        $     ---     
                                          ============     ============ 

         A valuation  allowance is provided when it is more likely than not that
some  portion  of the  deferred  tax asset will be  realized.  The  Company  has
determined,  based on the  Company's  history of annual net losses,  that a full
valuation allowance is appropriate.                                             

         The  Company  participates  in the  State of New  Jersey's  corporation
business tax benefit certificate transfer program (the "Program"),  which allows
certain high  technology  and  biotechnology  companies  to transfer  unused New
Jersey net operating loss  carryovers to other New Jersey  corporation  business
taxpayers.  During 1999, the Company  submitted an application to the New Jersey
Economic Development Authority (the "EDA") to participate in the Program and the
application  was  approved.  The EDA then issued a  certificate  certifying  the
Company's eligibility to participate in the Program and the amount of New Jersey
net operating loss  carryovers the Company has available to transfer.  Since New
Jersey law  provides  that net  operating  losses can be carried  over for up to
seven years,  the Company may be able to transfer  its New Jersey net  operating
losses from the last seven years.  The Company  estimated that, as of January 1,
1999, it had  approximately  $85 million of unused New Jersey net operating loss
carryovers available for transfer under the Program. The Program requires that a
purchaser pay at least 75% of the amount of the surrendered tax benefit.        

         During December 1999, the Company  completed the sale of  approximately
$32 million of its New Jersey tax loss carryforwards and received $2.35 million,
which was recorded as a gain on sale of state net operating  loss  carryovers on
its Consolidated Statement of Operations.  In June 2000, the Company will submit
an application to sell an additional $4.8 million of tax benefits (calculated by
multiplying  the Company's  unused New Jersey net operating  loss  carryovers of
approximately  $53 million by 9%). The actual amount of tax benefits the Company
may sell will depend upon the allocation among qualifying companies of an annual
pool established by the State of New Jersey. The allocated pool for future years
is $40 million per year.                                                        

Note 10.  Common Stock, Stock Options, Warrants and Other Shares Reserved       

         On January 6, 1999, the Company's  stockholders  approved a proposal to
amend  the  Company's   Restated   Certificate  of  Incorporation  to  effect  a
one-for-five  reverse  stock split of the Company's  Common  Stock.  The reverse
stock split was  effective as of January 6, 1999.  As of January 6, 1999,  there
were  21,804,138  shares of Common Stock  outstanding  and after the stock split
there were 4,360,808 shares of Common Stock outstanding.                        

         The par value of the  Common  Stock  did not  change as a result of the
reverse  stock split.  Cash was paid in lieu of  fractional  shares based on the
last reported sale price of the Common Stock on the first trading date after the
stock split.                                                                    

         The Company has a stock option plan (the  "Plan"),  which  authorizes a
committee  of the Board of  Directors to grant  options,  to purchase  shares of
Common Stock, to officers, directors,  employees and consultants of the Company.
Pursuant  to the terms of the Plan,  no option may be  exercised  after 10 years
from the date of grant.  The Plan  permits  options to be granted at a price not
less than 85% of the fair market  value,  however,  the options  granted to date
have been at fair market value of the common stock at the date of the grant.    

         At December  31,  1999,  the per share  weighted-average  fair value of
stock options granted during 1999,  1998 and 1997 was $.21,  $2.20 and $22.05 on
the  date of  grant  using  the  Black  Scholes  option-pricing  model  with the
following weighted-average  assumptions: 1999 - expected dividend yield of 0.0%,
risk-free interest rate of 6.1%,  expected  volatility of 116.4% and an expected
life of 4.0 years;  1998 - expected dividend yield of 0.0%,  risk-free  interest
rate of 4.3%,  expected  volatility of 113.9% and an expected life of 5.0 years;
1997 -  expected  dividend  yield  of  0.0%,  risk-free  interest  rate of 6.3%,
expected volatility of 85.5% and an expected life of 4.4 years.                 

         The Company  applies APB Opinion No. 25 in accounting for its Plan, and
accordingly,  no compensation  cost has been recognized for its stock options in
the consolidated financial statements.  Had the Company determined  compensation
cost based on the fair value at the grant date for its stock  options under SFAS
No.  123,  the  Company's  net loss would have been  increased  to the pro forma
amounts indicated below:                                                        

                                                                [Download Table]

                                     1999            1998           1997      
                                      ----            ----           ----     
                                                                              

Net loss            as reported     $(3,602,083)  $(21,325,301)  $(21,739,680)
                    pro forma        (4,231,122)   (21,868,534)   (24,255,223)

Basic and diluted                                                             

  loss per share    as reported     $      (.71)  $      (6.67)  $      (8.15)
                    pro forma              (.83)         (6.84)         (9.10)

         Pro forma net loss reflects  options  granted between 1995 and 1999. In
addition, compensation cost is reflected over the options' vesting period.      

         Employee  stock option  activity for options  under the Plan during the
periods indicated is as follows:                                                

                                                                [Download Table]

                                         Number of     Weighted-Average
                                          Shares       Exercise Price  

                                                                       
                                          ---------    -----------     
Balance at December 31, 1996              160,013         $35.95       
          Granted                         117,733          33.25       
          Exercised                        (2,909)         29.40       
          Forfeited                        (4,942)         30.60       
          Expired                         (57,528)         41.35       
                                        ----------                     
 Balance at December 31, 1997             212,367          33.20       

          Granted                         336,234           2.65       
             Forfeited                      9,787)         32.25       
          Expired                            (725)         46.05       
                                        ----------                     
 Balance at December 31, 1998             538,089           1.40       

          Granted                       1,487,792            .25       
          Forfeited                      (138,621)          1.40       
                                        ----------                     
  Balance at December 31, 1999         1,887,260             .25       


         On October 27, 1999, the Company  repriced all existing  employee stock
options to have an  exercise  price of $.25 (the  closing  market  price on that
date) and an  expiration  date of December 31, 2003.  Accordingly,  the weighted
average price of options  outstanding at December 31, 1999 has been re-stated to
$.25.  All other  terms and  conditions  remain the same with the  exception  of
repricing the exercise price and the new expiration date.                       

         On October 15, 1998, the Company  repriced all existing  employee stock
options to have an exercise  price of $1.40 (the  closing  market  price on that
date).                                                                          

         At December 31, 1999, the exercise price and weighted-average remaining
contractual life of outstanding options was $.25 and 4 years, respectively.     

         At December 31, 1999, 1998 and 1997, the number of options  exercisable
was  641,755,  249,434  and  153,758,  respectively,  and  the  weighted-average
exercise price of those options was $.25, $1.40 and $35.20, respectively.       

Information regarding all Options and Warrants                                  

         Changes in options  and  warrants  outstanding  during the years  ended
December  31, 1999,  1998 and 1997,  and options and  warrants  exercisable  and
shares reserved for issuance at December 31, 1999, 1998 and 1997 are as follows:

         The  following  table  includes  all  options  and  warrants  including
employee options (which are discussed above).                                   

                                                                [Download Table]


                                             Price Range        Number of  
                                              Per Share          Shares    
                                                                           

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

Outstanding at December 31, 1996        $21.80   -    $84.00       295,252 
Granted                                  25.00   -     77.90       172,619 
Exercised                                21.80   -     40.00       ( 3,962)
Terminated                               25.00   -     84.00       (68,720)
                                       ---------------------   ----------- 
Outstanding at December 31, 1997         21.80   -     77.90       395,189 
Granted                                   2.65   -     41.90       336,234 
Terminated                               25.00   -     55.00       (10,512)
                                       ---------------------   ----------- 

Outstanding at December 31, 1998          1.40   -     77.90       720,911 
Granted                                    .25   -      1.00     1,987,792 
Terminated                                1.40   -     54.00      (141,671)
                                        --------------------    ---------- 

Outstanding at December 31, 1999           .25   -     77.90     2,567,032 
                                                                ========== 

Exercisable:                                                               

December 31, 1997                        21.80   -     77.90       309,616 
                                                                ========== 
December 31, 1998                         1.40   -     77.90       432,256 
                                                                ========== 
December 31, 1999                          .25   -     77.90     1,321,527 
                                                                ========== 
Shares reserved for issuance:                                              

December 31, 1997                                                  425,879 
                                                                ========== 
December 31, 1998                                                  739,364 
                                                                ========== 
December 31, 1999                                                2,573,479 
                                                                ========== 

         Options and warrants  outstanding and exercisable,  and shares reserved
for issuance at December 31, 1999, 1998 and 1997,  include 33,282 shares under a
warrant agreement with a certain  individual.  The warrants are priced at $51.35
and $77.90 per share and expire on August 31, 2000.                             

         Options and warrants  outstanding and exercisable,  and shares reserved
for issuance at December 31, 1999,  1998 and 1997,  include  55,113 shares under
warrant  agreements with the underwriter of a 1995 Stock Offering.  The warrants
are priced at $37.20 per share and expire on August 14, 2000.                   

         Options and warrants  outstanding and exercisable,  and shares reserved
for issuance at December 31, 1999,  1998 and 1997,  include  64,413 shares under
warrant  agreements with the underwriter of a 1996 Stock Offering.  The warrants
are priced at $48.00 per share and expire on April 23, 2001.                    

         Options and warrants  outstanding  and shares  reserved for issuance at
December 31, 1999 1998 and 1997, and  exercisable at December 31, 1999 and 1998,
include 26,964 shares under warrant  agreements with the  underwriters of a 1997
Stock Offering. The warrants are priced at $36.00 per share and expire on August
18, 2002.                                                                       

         Options and warrants  outstanding and exercisable,  and shares reserved
for  issuance at December  31,  1999,  include  500,000  shares  under a warrant
agreement  with GP  Strategies.  The  warrants are priced at $1.00 per share and
expire on March 25, 2004.                                                       

         Shares  reserved  for  issuance at  December  31,  1999,  1998 and 1997
include  6,447,  18,451 and 30,690  shares under the common  stock  compensation
plan. (See Note 12).                                                            

Note 11.  Savings Plan                                                          

         The ISI Savings Plan (the "Savings Plan") permits pre-tax contributions
to the Savings Plan by  participants  pursuant to Section 401(k) of the Internal
Revenue Code of up to 15% of base compensation. The Company will match up to the
6% level of the participants  eligible  contributions.  The Savings Plan matches
40% in cash and 60% in the Company's  common stock up to the 6% level. For 1999,
the  Company's  contribution  to the Savings Plan was  $137,000,  consisting  of
$37,024 in cash and $99,976 in stock.  For 1998, the Company's  contribution  to
the Savings Plan was  $288,000,  consisting  of $116,767 in cash and $171,233 in
stock.  For 1997, the Company's  contribution  to the Savings Plan was $126,000,
consisting of $103,033 in cash and $22,967 in stock.                            

Note 12.  Common Stock Compensation and Profit Sharing Plan                     

Common Stock Compensation Plan                                                  

         Effective  October 1,  1997,  the  Company  adopted  the  Common  Stock
Compensation Plan (the "Stock Compensation Plan"),  providing key employees with
the   opportunity  of  receiving  the  Company's   common  stock  as  additional
compensation.                                                                   

         Pursuant to the terms of the Stock  Compensation  Plan,  key  employees
will  receive,  as  additional  compensation,  a  pre-determined  amount  of the
Company's common stock in three equal installments on October 1, 1998, 1999, and
2000,  provided  that the key  employees  remain in the employ of the Company at
each  such  installment  date.  As of  October  1,  1999 and  1998,  a  deferred
compensation liability of $340,821 and $412,344,  respectively,  was accrued for
these  employees  based on the common stock market price of October 1, 1997.  On
October 1, 1999 and 1998, the Company agreed to pay the additional  compensation
in cash in place of the issuance of the  Company's  common  stock.  Accordingly,
cash of  $2,131  and  $25,947,  respectively,  was paid in  satisfaction  of the
accrued  liability of $340,821 and  $412,344,  respectively.  The  difference of
$338,690 and $386,397  was  credited to  additional  paid in capital in 1999 and
1998,  respectively.  At December 31, 1999, the total number of shares  reserved
for issuance under the Stock Compensation Plan for the remaining  installment is
6,447 and the amount of $72,480 is recorded in accrued expenses.                

Profit Sharing Plan                                                             

         The Company  has a Profit  Sharing  Plan (the  "Profit  Sharing  Plan")
providing key  employees and  consultants  with an  opportunity  to share in the
profits of the Company. The Profit Sharing Plan is administered by the Company's
Compensation Committee.                                                         

         Pursuant  to the terms of the Profit  Sharing  Plan,  the  Compensation
Committee, in its sole discretion, based upon the significance of the employee's
contributions  to the operations of the Company,  selects  certain key employees
and  consultants  of the Company who are entitled to  participate  in the Profit
Sharing Plan and determines the extent of their participation. The amount of the
Company's   profits   available  for  distribution  to  the  participants   (the
"Distribution  Pool") is the lesser of (a) 10% of the  Company's  income  before
taxes and profit  sharing  expense  and (b) an amount  equal to 100% of the base
salary for such year of all the participants in the Profit Sharing Plan.        

         The Compensation  Committee may require as a condition to participation
that a  participant  remain in the  employ of the  Company  until the end of the
fiscal year for which payment is to be made.  Payments required to be made under
the  Profit  Sharing  Plan  must be made  within  10 days of the  filing  of the
Company's tax return.  To date,  there have been no contributions by the Company
under the Profit Sharing Plan.                                                  

Note 13.  Related Party Transactions                                            

         GP Strategies owns approximately 6% of the Company's common stock as of
December 31, 1999.  The Company was a party to a  management  agreement  with GP
Strategies,  pursuant  to which  certain  legal,  financial  and  administrative
services  had been  provided by  employees  of GP  Strategies.  The fee for such
services in 1999, 1998 and 1997 was $120,000 annually.  The management agreement
was  terminated  on March 27,  2000 (See Note 15). In  addition,  during 1997 GP
Strategies provided to the Company, at its estimated cost, certain personnel and
services which the Company used in its  operations.  For the year ended December
31, 1997, such charges amounted to $135,000.  During the year ended December 31,
1998, the Company  provided  certain  services to GP Strategies at the Company's
estimated   cost  of   $25,000.   Such  costs  were   included  in  general  and
administrative expense.                                                         

         The  Company  owns  the   buildings   which  contain  its  offices  and
laboratories  and until  March  1998  leased a portion  of the  buildings  to GP
Strategies. Total occupancy costs for the years ended December 31, 1998 and 1997
were approximately $1,084,000 and $1,039,000,  respectively.  GP Strategies paid
to the Company as rent GP  Strategies's  proportionate  share of such  occupancy
costs  (based on both  square  feet  occupied  and number of  personnel),  which
amounted to $29,375 and  $234,996,  respectively.  Such income was included as a
reduction to research and development expense.                                  

         See Note 15 for information  with respect to royalty  obligations to GP
Strategies.                                                                     

Note 14.  Supplemental Statement of Cash Flow Information                       

         The  Company  paid no income  taxes or interest  during the  three-year
period ended December 31, 1999.                                                 

         During the years ended  December 31, 1999,  1998 and 1997 the following
non-cash financing and investing activities occurred:                           

1999:                                                                           

         The Company issued 285,000 shares,  valued at $534,375, of Common Stock
as payment against accounts payable and the purchase of inventory.              

         As  consideration  for a loan from GP  Strategies,  the Company  issued
500,000 shares and warrants to purchase an additional 500,000 shares,  valued at
$500,000.                                                                       

1998:                                                                           

         The Company  issued 330,000 shares valued at $1,250,094 of common stock
as payment against a negotiated settlement (see Note 15) and accounts payable.  

         The Company  issued 3,238 shares  valued at $116,897 of common stock as
compensation.                                                                   

1997:                                                                           

None                                                          

Note 15.  Commitments                                                           

         The  Company  has  obtained   human  white  blood  cells  used  in  the
manufacture of ALFERON N Injection from several sources,  including the American
Red Cross (the "Red Cross")  pursuant to a supply  agreement dated April 1, 1997
(the "Supply Agreement"). The Company will not need more human white blood cells
until such time as  production  of ALFERON N Injection  is resumed,  and has not
purchased any since April 1, 1998. Under the terms of the Supply Agreement,  the
Company was  obligated  to purchase a minimum  amount of human white blood cells
each month  through  March 1999 (the  "Minimum  Purchase  Commitment"),  with an
aggregate Minimum Purchase  Commitment during the period from April 1998 through
March 1999 of in excess of $3,000,000. As of November 23, 1998, the Company owed
the Red Cross  approximately  $1.46  million plus interest at the rate of 6% per
annum  accruing from April 1, 1998 (the "Red Cross  Liability")  for white blood
cells purchased pursuant to the Supply Agreement.                               

         In an agreement  dated  November 23, 1998,  the Company agreed to grant
the Red Cross a  security  interest  in  certain  assets to secure the Red Cross
Liability and to issue to the Red Cross  300,000  shares of Common Stock (with a
market value of  $1,171,875 at December 4, 1998) and  additional  shares at some
future date as  requested  by the Red Cross.  The Red Cross  agreed that any net
proceeds  received by it upon sale of such shares  would be applied  against the
Red Cross Liability and that at such time as the Red Cross Liability was paid in
full, the Minimum Purchase  Commitment would be deleted effective April 1, 1998,
and any then  existing  breaches of the  Minimum  Purchase  Commitment  would be
waived.  In January 1999, the Company granted the Red Cross a security  interest
in,  among other  things,  the  Company's  real  estate,  equipment,  inventory,
receivables, and New Jersey net operating loss carryovers to secure repayment of
the Red Cross Liability, and the Red Cross agreed to forbear from exercising its
rights under the Supply Agreement,  including with respect to collecting the Red
Cross  Liability,  until June 30, 1999 (which was  subsequently  extended  until
December 31,  1999).  On December 29,  1999,  the Company,  the Red Cross and GP
Strategies entered into an agreement pursuant to which the Red Cross agreed that
until  September 30, 2000 it would forbear from  exercising its rights under (i)
the  Supply  Agreement,  including  with  respect  to  collecting  the Red Cross
Liability,  and (ii) the Security  Interest.  Under the terms of such agreement,
the Company is allowing the Red Cross to sell the Company's real estate.  In the
event the Red Cross is  successful  in selling the  Company's  real estate,  the
Company would hope to be able to enter into a lease with the new owner, although
there can be no assurance.                                                      

         As the liability to the Red Cross remains  unsettled until such time as
the Red Cross sells the shares they have already  received and could  receive in
the  future,  the  Company has  recorded  any shares  issued to the Red Cross as
"Settlement  Shares" within  stockholders'  equity.  Any decreases in the market
value of the Company's  common stock below $1.2 million,  until such time as the
Red Cross were to sell its shares,  would impact the value of the shares held by
the Red Cross and accordingly require an adjustment to "Settlement  Shares". Due
to the decline in the  Company's  stock price during 1999 and from  November 23,
1998 to December  31,  1998,  an  adjustment  for $550,000 and $525,000 has been
recorded  with a  corresponding  charge  to  operations  during  1999 and  1998,
respectively.  During 1999, the Red Cross sold 27,000 of the  Settlement  Shares
and sold the balance of 273,000  shares  during the first  quarter of 2000. As a
result,  the net proceeds from the sales of the  Settlement  Shares,  $33,000 in
1999 and  $368,000,  were  applied  against  the  liability  to Red  Cross.  The
remaining  liability  to the Red Cross at December 31, 1999 and at April 1, 2000
was approximately $1,579,000 and $1,228,000, respectively.                      

         In an agreement dated March 25, 1999, GP Strategies  agreed to lend the
Company $500,000 at the rate of $250,000 a month (the "GP Strategies  Debt"). In
return,  the Company  agreed to grant GP Strategies  (i) a first mortgage on the
Company's  real estate,  (ii) a two-year  option to purchase the Company's  real
estate,  provided that the Company has  terminated  its  operations  and the Red
Cross Liability has been repaid,  and (iii) a two-year right of first refusal in
the event the Company desires to sell its real estate. In addition,  the Company
agreed to allow a designee of GP  Strategies  to attend any meeting with the FDA
with respect to approval of ALFERON N Injection for the treatment of hepatitis C
and to issue GP Strategies  500,000 shares (the "GP Shares") of Common Stock and
five-year  warrant (the "GP Warrant") to purchase 500,000 shares of Common Stock
at a price of $1 per share. The GP Shares and GP Warrant were valued at $500,000
and recorded as a financing cost on the Consolidated Statement of Operations and
amortized over the original  period of the GP Strategies  Debt. The Company also
agreed not to increase  its payroll  during the term of the GP  Strategies  Debt
without  the prior  consent of GP  Strategies.  Pursuant to the  agreement,  the
Company has issued a note to GP Strategies  representing the GP Strategies Debt,
which  note  matured  on  September  30,  1999 and bears  interest,  payable  at
maturity,  at the rate of 6% per annum.  In addition,  at that time, the Company
negotiated a  subordination  agreement  with the Red Cross pursuant to which the
Red Cross agreed that its lien on the Company's real estate is subordinate to GP
Strategies' lien. On March 27, 2000, the Company and GP Strategies  entered into
an agreement  pursuant to which (i) the GP  Strategies  Debt was extended  until
June 30, 2001 (and  reclassified as long-term on the  accompanying  Consolidated
Balance  Sheet  at  December  31,  1999),  (ii)  the  Company  agreed  to file a
registration  statement prior to July 31, 2000 covering the shares issuable upon
exercise of the GP Warrant and any of the GP Shares for which Rule 144 under the
Securities  Act of 1933 was not available,  and (iii) the  Management  Agreement
between  the  Company  and GP  Strategies  was  terminated  (see  Note 13 to the
Consolidated  Financial  Statements) and all  intercompany  accounts between the
Company and GP Strategies  (other than the GP Strategies  Debt) were  discharged
and  eliminated.  The amount of  intercompany  accounts that were discharged and
eliminated was approximately $130,000,  which were recorded in the first quarter
of 2000.  The agreement  also  provides  that (i)  commencing on May 1, 2001 and
ending on June 30, 2001,  on any day ISI may require GP  Strategies  to exercise
the GP Warrant and sell the underlying shares, if the market price of ISI Common
Stock  exceeds  $1.00 per share on each of the 10 trading days prior to any such
day, and (ii) any proceeds from the sale of the shares issuable upon exercise of
the GP  Warrant  in excess of the  aggregate  amount  paid by GP  Strategies  to
purchase such shares,  would be deemed to reduce the then outstanding  amount of
principal and interest of the GP Strategies Debt until such amount is reduced to
zero.                                                                           

         As consideration  for the transfer to the Company of certain  licenses,
rights and assets  upon the  formation  of the  Company  by GP  Strategies,  the
Company agreed to pay GP Strategies  royalties of $1,000,000,  but such payments
will be made only with  respect to those  years in which the  Company has income
before income  taxes,  and will be limited to 25% of such income.  To date,  the
Company  has not  generated  income  before  taxes  and  therefore  has not paid
royalties to GP Strategies.                                                     

         See Notes 4 and 5 for  information  relating  to  royalties  payable to
Hoffmann and the Partnership, respectively.                                     

         In 1989, the Company entered into a license agreement with Amarillo for
co-exclusive  rights to certain low dose oral  formulations  of interferon.  The
Company  will be required to pay a royalty of 10% of net sales,  as defined,  of
products  produced and  marketed by the Company that may be developed  under the
license agreement. To date, no sales of these products have occurred, therefore,
no royalty payments have been made.                                             

Note 16.  Fair Value of Financial Instruments                                   

         The carrying values of financial  instruments,  including cash and cash
equivalents,  accounts receivable and accounts payable,  approximate fair market
values,  because of short maturities or interest rates that approximate  current
rates.                                                                          

Note 17.  Restatement of 1999 Quarterly Financial Statements (unaudited)        

         The Company has restated its  consolidated  financial  statements as of
and for the three months ended March 31, June 30, and September 30, 1999 because
of errors  discovered  for those  periods  subsequent  to the  issuance  of such
consolidated  financial  statements.  The consolidated  financial statements for
each three-month and year to date periods ended in 1999 required  restatement to
correct the reporting for inventories, Settlement Shares, deferred compensation,
cost of sales, financing costs and certain other expenses.                      

         The impact of the  restatement  on the Company's  consolidated  balance
sheets and statements of operations is summarized as follows:                   

                                                        [Enlarge/Download Table]


                         Three Months Ended        Three Months Ended       Three Months Ended   
                           March 31, 1999             June 30, 1999         September 30, 1999   
                       As Reported   Restated    As Reported  Restated    As Reported  Restated  
                       -----------   --------    -----------  --------    -----------  --------  
                                                                                                 

Operations:                                                                                      
----------                                                                                       
Total costs                                                                                      
    and expenses       $3,082,406    $3,176,294   $1,758,238  $1,692,908  $1,447,232  $1,396,584 
Loss from operations   (2,622,608)   (2,716,496)  (1,231,849) (1,166,519)   (448,957)   (398,309)
Net loss               (2,617,871)   (2,711,759)  (1,231,209) (1,415,879)   (448,957)   (648,309)
Basic and diluted loss                                                                           
    per share                (.57)         (.58)        (.26)       (.27)       (.09)       (.12)


                                                                [Download Table]


                           Six Months Ended         Nine Months Ended    
                            June 30, 1999          September 30, 1999    
                       As Reported   Restated    As Reported  Restated   
                       -----------   --------    -----------  --------   
                                                                         
Total costs                                                              
    and expenses       $4,840,644    $4,869,202  $6,287,876   $6,265,786 
Loss from operations   (3,854,457)   (3,883,015) (4,303,414)  (4,281,324)
Net loss               (3,849,080)   (4,127,638) (4,298,037)  (4,775,947)
Basic and diluted loss                                                   
    per share                (.83)         (.84)       (.92)        (.95)

                                                        [Enlarge/Download Table]


                           March 31, 1999             June 30, 1999         September 30, 1999   
                       As Reported   Restated    As Reported  Restated    As Reported  Restated  
                       -----------   --------    -----------  ---------   -----------   -------  
                                                                                                 

Balance Sheet:                                                                                   
-------------                                                                                    
Total current assets   $1,048,991    $1,857,852   $  718,748  $1,551,398  $  603,338  $1,311,338 
Total assets            4,764,092     5,572,953    4,247,024   5,079,674   3,944,781   4,652,781 
Total current                                                                                    
 liabilities            4,705,057     4,682,593    5,389,353   5,413,300   5,521,618   5,620,267 
Total stockholders'                                                                              
 equity (deficit)          59,035       890,360   (1,142,329)   (333,626) (1,576,837)   (967,486)
Total liabilities and                                                                            
 stockholders' equity   4,764,092     5,572,953    4,247,024    5,079,674   3,944,781   4,652,781


Item 9.  Changes and Disagreements with Accountants on Accounting and           
Financial Disclosure                                          

None                                                          

10-K
10th "Page" of 15
TOC
1st
Previous
Next
Bottom
Just 10th

PART III

Item 10.  Directors and Executive Officers of the Registrant                    

         Information   with   respect  to  the   directors  of  the  Company  is
incorporated  herein by reference to the Company's  definitive  proxy  statement
pursuant to Regulation  14A, which proxy  statement will be filed not later than
120 days after the end of the fiscal year covered by this report.               

Item 11.  Executive Compensation                                                

         Information  with respect to  compensation of executives of the Company
is incorporated herein by reference to the Company's  definitive proxy statement
pursuant to Regulation  14A, which proxy  statement will be filed not later than
120 days after the end of the fiscal year covered by this Report.               

Item 12. Security Ownership of Certain Beneficial Owners and Management         

         Information  with respect to Security  Ownership of Certain  Beneficial
Owners and  Management  is  incorporated  herein by reference  to the  Company's
definitive  proxy statement  pursuant to Regulation 14A, which statement will be
filed not later than 120 days after the end of the fiscal  year  covered by this
Report.                                                                         

Item 13.  Certain Relationships and Related Transactions                        

         Information   with  respect  to  Certain   Relationships   and  Related
Transactions  is  incorporated  herein by reference to the Company's  definitive
proxy  statement  pursuant to Regulation  14A, which statement will be filed not
later than 120 days after the end of the fiscal year covered by this Report.    

10-K
11th "Page" of 15
TOC
1st
Previous
Next
Bottom
Just 11th

 PART IV

Item 14.  Exhibits, Financial Statement Schedules, and Reports on Form 8-K      

  (a)(1) The following financial statements are included in Part II, Item 8:

                                                                [Download Table]

                                                                 
                                                             Page

Independent Auditors' Report                                   20
Financial Statements:                                            

   Consolidated Balance Sheets - December 31, 1999 and 1998    21

   Consolidated Statements of Operations - Years ended           

   December 31, 1999, 1998, and 1997                           22

   Consolidated Statements of Changes in Stockholders'           
   Equity - Years ended December 31, 1999, 1998 and 1997       23

   Consolidated Statements of Cash Flows - Years ended           

   December 31, 1999, 1998, and 1997                           24

   Notes to Consolidated Financial Statements                  25


         (a)(2) Schedules have been omitted because they are not required or are
not applicable,  or the required  information has been included in the financial
statements or the notes thereto.                                                

(a)(3) See accompanying Index to Exhibits                     

         (b) There were no reports  on Form 8-K filed by the  Registrant  during
the last quarter of the Period covered by this report.                          

10-K
12th "Page" of 15
TOC
1st
Previous
Next
Bottom
Just 12th

SIGNATURES

         Pursuant to the  requirements  of Section 13 or 15(d) of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on
its behalf by the undersigned, thereunto duly authorized.                       

                                                       INTERFERON SCIENCES, INC.

                                              By:   /s/ Lawrence M. Gordon
                                                    ----------------------
                                                Lawrence M. Gordon
                                                     Chief Executive Officer

Dated:  April 13, 2000                                                          

         Pursuant to the  requirements  of the Securities  Exchange Act of 1934,
this  report has been  signed  below by the  following  persons on behalf of the
registrant and in the capacities and on the dates indicated.                    

Signature                       Title                            Date           

/s/ Samuel H. Ronel             Chairman of the Board            April 13, 2000 
-------------------                                                             
Samuel H. Ronel, Ph.D.                                                          

/s/ Lawrence M. Gordon          Chief Executive Officer and Director            
----------------------          (Principal Executive Officer)    April 13, 2000 
Lawrence M. Gordon                                                              

/s/ Stanley G. Schutzbank       President and Director           April 13, 2000 
-------------------------                                                       
Stanley G Schutzbank, Ph.D.                                                     

___________________             Director                         April __, 2000 
Sheldon L. Glashow                                                              

/s/ Donald W. Anderson          Controller (Principal            April 13, 2000 
----------------------          Accounting and Financial                        
Donald W. Anderson              Officer)                                        

         The  foregoing  constitute  a majority  of the  members of the Board of
Directors.                                                                      

10-K
13th "Page" of 15
TOC
1st
Previous
Next
Bottom
Just 13th

 INDEX TO EXHIBITS

Exhibit Number                                                                  

3.1 - Restated  Certificate of  Incorporation  of the  Registrant.  Incorporated
herein by reference to Exhibit 3B of the Registrant's Annual Report on Form 10-K
for the year ended December 31, 1988.                                           

3.2 -  Certificate  of Amendment of Restated  Certificate  of  Incorporation  of
the  Registrant.  Incorporated  herein by reference to Exhibit 3.4 of           
Registration Statement No. 33-40902.                                            

3.3 -  Certificate  of Amendment of Restated  Certificate  of  Incorporation  of
the  Registrant.  Incorporated  herein by reference to Exhibit 3.2 of           
Registration Statement No. 33-40902.                                            

3.4 - Certificate of Amendment to the Restated  Certificate of  Incorporation   
of the Registrant.  Incorporated  herein by reference to Exhibit 3.4 of         
Registration Statement No. 33-00845.                                            

3.5 - Certificate of Amendment to the Restated Certificate of Incorporation of  
the Registrant.                                                                 

3.6 - By-Laws of the Registrant, as amended. Incorporated herein by reference to
Exhibit 3.2 of Registration Statement No. 2-7117.                               

4.1 - Form of  Underwriter's  Purchase  Option issued in connection with the    
August/September  1995 Offering.  Incorporated  herein by reference to          
Exhibit 4.1 of Registration Statement No. 33-59479.                             

4.2 - Form of  Underwriter's  Purchase  Option issued in connection  with the   
May 1996  Offering.  Incorporated  herein by reference to Exhibit 4.4 of        
Registration Statement No. 333-00845.                                           

4.3 - Form of  Purchase  Option  issued in  connection  with the  December  1996
Private Placement.                                                              

10.1 - Transfer and License Agreement among National Patent,Hydron Laboratories,
Inc. and the Registrant  dated as of January 1, 1981. Incorporated herein by    
reference to Exhibit 10.8 of the Registrant's Registration Statement            
No. 2-71117.                                                                    

10.2 - Registrant's  1981 Stock Option Plan, as amended.  Incorporated  herein  
by reference to Exhibit 10.3 to  Registration  Statement No. 33-59479.        

10.3 - Profit Sharing Plan of the Registrant.  Incorporated  herein by reference
to Exhibit 10X of the Registrant's Annual Report on Form 10-K for the year ended
December 31, 1988.                                                              

10.4 - License  Agreement  dated  October 20, 1989  between the  Registrant  and
Amarillo Cell Culture Company, Incorporated. Incorporated herein by reference to
Exhibit 10Y of the  Registrant's  Annual  Report on Form 10-K for the year ended
December 31, 1989.                                                              

10.5 - GP Strategies 401(k) Savings Plan dated January 9, 1992,  effective March
1, 1992.  Incorporated  herein by reference to Exhibit 10.12 to the Registrant's
Annual Report on Form 10-K for the Year ended December 31, 1992.                

10.6 - Distribution  Agreement  dated as of February 3, 1994 between  Registrant
and Industria Farmaceutica  Andromaco,  S.A. Incorporated herein by reference to
Exhibit 6(a) to the Registrant's Quarterly Report on Form 10-Q/A for the quarter
ended September 30, 1994.                                                       

10.7 -  Processing  and Supply  Agreement  dated as of September 1, 1994 between
Registrant and Sanofi Winthrop L.P.  Incorporated herein by reference to Exhibit
6(a) to the  Registrant's  Quarterly  Report on Form 10-Q for the quarter  ended
September 30, 1994.                                                             

10.8 -  Amendment  dated March 24, 1995 to  Distribution  Agreement  dated as of
February 3, 1994 between  Registrant and Industria  Farmaceutica  Andromaco S.A.
Incorporated  herein by reference to Exhibit  10.30 to the  Registrant's  Annual
Report on Form 10-K for the year ended December 31, 1994.                       

10.9 - License  Agreement,  dated as of March 29,  1995,  among the  Registrant,
Hoffmann-La Roche, Inc. and F. Hoffmann La-Roche,  Ltd.  Incorporated  herein by
reference to Exhibit 10.42 to Registration Statement No. 33-59479.              

10.10 -  Amendment  of  ACC/ISI  License  Agreement,  dated  27,  1995,  between
Registrant and Amarillo Cell Culture Company, Incorporated.  Incorporated herein
by reference to Exhibit 10.43 to Registration Statement No. 33-59479.           

10.11 - PPM/ACC Sub License  Agreement,  dated April 27,  1995,  between  Pharma
Pacific  Management Pty. Ltd., and Amarillo Cell Culture Company,  Incorporated.
Incorporated herein by reference to Exhibit 10.52 to Registration  Statement No.
33-59479.                                                                       

10.12 - Supply and Distribution  Agreement,  dated as of April 3, 1996,  between
the Registrant and Cell Pharm GmbH.  Incorporated herein by reference to Exhibit
10.56 to Registration Statement No. 333-00845.                                  

10.13 - Quality  Assurance  Agreement,  dated as of April 3, 1996,  between  the
Registrant  and Cell Pharm GmbH.  Incorporated  herein by  reference  to Exhibit
10.57 to Registration Statement No. 333-00845.                                  

10.14 - Agreement,  dated as of April 1, 1997,  between the  Registrant  and the
American  National Red Cross.  Incorporated by reference to Exhibit 10.54 of the
Registrant's Quarterly Report on Form 10-Q for the quarter ended June 30, 1997. 

10.15 - Agreement dated May 27, 1997,  between the Registrant and Alternate Site
Distributors,   Inc.   Incorporated   by  reference  to  Exhibit  10.55  of  the
Registrant's Quarterly Report on Form 10-Q for the quarter ended June 30, 1997. 

10.16 - Stock Bonus Plan.                                                       

10.17 - Form of employment agreement for participants in Stock Bonus Plan.      

10.18  - Employment Agreement, dated as of October 1, 1997, between the         
Registrant and Lawrence M. Gordon.                                              

21.0 - Subsidiaries of the Registrant. *                                        

23.1 - Consent of Independent Auditors. *                                       
-----------------                                                               

*Filed herewith                                                                 

10-K
14th "Page" of 15
TOC
1st
Previous
Next
Bottom
Just 14th

                                                    Exhibit 21

Subsidiaries of the Registrant

  Name                                                Jurisdiction

Interferon Sciences Development Corporation                  Delaware           

10-K
Last "Page" of 15
TOC
1st
Previous
Next
Bottom
Just 15th

                                                              Exhibit 23.1

 CONSENT OF INDEPENDENT AUDITORS

THE BOARD OF DIRECTORS                                                          
INTERFERON SCIENCES, INC.                                                       

         We  consent  to  incorporation  by  reference  in (i) the  Registration
Statement  (No.  33-64921)  on Form S-3,  ii) the  Registration  Statement  (No.
333-04381) on Form S-3, (iii) the Registration Statement (No. 333-19451) on Form
S-3, (iv) the  Registration  Statement  (No.  33-30209) on Form S-8, and (v) the
Registration Statement (No. 333-34203) on Form S-3 of Interferon Sciences,  Inc.
of our report dated April 10, 2000 relating to the  consolidated  balance sheets
of Interferon  Sciences,  Inc. as of December 31, 1999 and 1998, and the related
consolidated statements of operations,  changes in stockholders' equity and cash
flows for each of the years in the  three-year  period ended  December 31, 1999,
which  report  appears in the  December  31, 1999 annual  report on Form 10-K of
Interferon Sciences, Inc.                                                       

         Our report on Interferon Sciences,  Inc. and subsidiary dated April 10,
2000,  contains an  explanatory  paragraph  that states the Company has suffered
recurring  losses from  operations  and has an  accumulated  deficit  that raise
substantial  doubt  about  its  ability  to  continue  as a going  concern.  The
consolidated  financial  statements  do not include any  adjustments  that might
result from the outcome of this uncertainty.                                    

                                                                  /s/ KPMG LLP

New York, New York                                                              
April 10, 2000                                                                  

Dates Referenced Herein   and   Documents Incorporated By Reference

				Referenced-On Page
This 10-K Filing		Date		First		Last			Other Filings
		1/9/92		13
		3/1/92		13
		12/31/92		13
		2/3/94		13
		9/1/94		13
		9/30/94		13
		12/31/94		13
		3/24/95		13
		3/29/95		13
		4/27/95		13
		8/22/95		9
		4/3/96		13					S-2/A
		12/31/96		7		9			10-K
		3/21/97		4		9			DEF 14A
		4/1/97		4		13
		5/27/97		13
		6/30/97		13					10-Q
		10/1/97		9		13
		12/31/97		3		11			NT 10-K, 5, 10-K/A, 10-K
		1/1/98		4
		2/5/98		4		9
		2/13/98		4		9
		3/31/98		4					10-Q
		4/1/98		4		9
		4/2/98		3
		10/1/98		9
		10/15/98		9
		11/23/98		4		9
		12/4/98		4		9
		12/15/98		4
		12/31/98		3		15			10-K, 10-K/A, NT 10-K
		1/1/99		4		9
		1/6/99		4		9			DEFS14A
		3/25/99		4		9			4
		3/31/99		9					10-Q
		4/13/99		4
		4/14/99		4
		5/25/99		4
		6/30/99		4		9			10-Q
		9/30/99		4		9			10-Q
		10/1/99		9					4
		10/27/99		9
		12/3/99		4
		12/15/99		4
		12/29/99		4		9
For The Period Ended		12/31/99		1		15			10-K/A, NT 10-K
		1/12/00		4
		3/15/00		3
		3/24/00		4
		3/27/00		4		9			4
		3/31/00		1					NT 10-Q, 10-Q
		4/1/00		1		9
		4/10/00		4		15			4
		4/13/00		12
Filed On / Filed As Of		4/14/00
		6/15/00		4
		6/30/00		4		9			10-Q
		7/1/00		4
		7/31/00		4		9
		8/14/00		9
		8/31/00		9
		9/30/00		4		9			10-Q
		10/1/00		9
		4/23/01		9
		5/1/01		4		9			8-K
		6/30/01		4		9			10-Q, NT 10-Q
		8/18/02		9
		12/31/03		9					10KSB/A, NT 10-K, 10KSB
		3/25/04		9
Top									List All Filings