Quarterlytics / Healthcare / Medical - Instruments & Supplies / Antares Pharma Inc.

Antares Pharma Inc.

atrs · NASDAQ Healthcare
Claim this profile
Ticker atrs
Exchange NASDAQ
Sector Healthcare
Industry Medical - Instruments & Supplies
Employees 51-200
← All annual reports
FY2006 Annual Report · Antares Pharma Inc.
Sign in to download
Loading PDF…
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, 2006 

[ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF 
THE SECURITIES EXCHANGE ACT OF 1934 
For transition period from __________ to __________ 

Commission file number 1-32302 

ANTARES PHARMA, INC.  
(Exact name of registrant as specified in its charter) 

Delaware 
State or other jurisdiction of incorporation or organization 

41-1350192 
(I.R.S. Employer Identification Number) 

250 Phillips Boulevard, Suite 290, Ewing, NJ  08618 
(Address of principal executive offices)          (Zip Code) 

Registrant’s telephone number, including area code: 

(609) 359-3020 

SECURITIES REGISTERED PURSUANT TO SECTION 12 (b) OF THE ACT: Common Stock, $.01 Par Value 

SECURITIES REGISTERED PURSUANT TO SECTION 12 (g) OF THE ACT:  None 

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. 
 YES[  ]  NO[X] 

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act.  
 YES[  ]  NO[X] 

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  the  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. [X] 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer.  
See  definition  of  “accelerated  filer  and  large  accelerated  filer”  in  Rule  12b-2  of  the  Exchange  Act.    (Check  one): 

Large Accelerated filer [  ]   Accelerated filer [  ]  Non-accelerated filer [X]  

Indicate by check mark if the registrant is a shell company (as defined in Rule 12b-2 of the Act). YES[  ]    NO[X] 

Aggregate market value of the voting and non-voting common stock held by nonaffiliates of the registrant as of June 30, 
2006, was approximately $49,800,000 (based upon the last reported sale price of $1.15 per share on June 30, 2006, on 
The American Stock Exchange).  

There were 53,427,955 shares of common stock outstanding as of March 12, 2007. 

DOCUMENTS INCORPORATED BY REFERENCE 

Portions of the definitive proxy statement for the registrant’s 2007 annual meeting of stockholders to be filed within 120 
days after the end of the period covered by this annual  report on Form 10-K are  incorporated by  reference  into Part III 
of this annual report on Form 10-K.

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
PART I 

Item 1.  

BUSINESS 

SPECIAL NOTE REGARDING FORWARD LOOKING STATEMENTS 

This report contains forward-looking statements within the meaning of Section 27A of the Securities Act, Section 
21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act, and the Private Securities Litigation 
Reform  Act  of  1995  that  are  subject  to  risks  and  uncertainties.  You  should  not  place  undue  reliance  on  those 
statements  because  they  are  subject  to  numerous  uncertainties  and  factors  relating  to  our  operations  and  business 
environment, all of which are difficult to predict and many of which are beyond our control. These statements often 
include words such as “may,” “believe,” “expect,” “anticipate,” “intend,” “plan,” “estimate” or similar expressions. 
These  statements  are  based  on  assumptions  that  we  have  made  in  light  of  our  industry  experience  as  well  as  our 
perceptions of historical trends, current conditions, expected future developments and other factors we believe are 
appropriate  under  the  circumstances.  As  you  read  and  consider  this  report,  you  should  understand  that  these 
statements are not guarantees of performance results. They involve risks, uncertainties and assumptions. Although 
we  believe  that  these  forward-looking  statements  are  based  on  reasonable  assumptions,  you  should  be  aware  that 
many factors could affect our actual financial results or results of operations and could cause actual results to differ 
materially from those in the forward-looking statements. You should keep in mind that forward-looking statements 
made by us in this report speaks only as of the date of this report. Actual results could differ materially from those 
currently anticipated as a result of a number of risk factors, including, but not limited to, the risks and uncertainties 
discussed  under  the  caption  “Risk  Factors.”    New  risks  and  uncertainties  come  up  from  time  to  time,  and  it  is 
impossible for us to predict these events or how they may affect us. We have no duty to, and do not intend to update 
or  revise  the  forward-looking  statements  in  this  report  after  the  date  of  this  report.  In  light  of  these  risks  and 
uncertainties,  you  should  keep  in  mind  that  any  forward-looking  statement  in  this  report  or  elsewhere  might  not 
occur. 

Overview 

Antares Pharma, Inc. (“Antares” or the “Company”) is a specialized pharma product development and pipeline 
company with patented drug delivery platforms including Advanced Transdermal Delivery (ATD™) gels, fast-melt 
oral  (Easy  Tec™)  tablets,  disposable  mini-needle  injection  systems  (Vibex™),  and  reusable  needle-free  injection 
systems (VISION® AND Valeo™). Antares’ lead proprietary ATD™ gel product is Anturol™ oxybutynin for the 
treatment of overactive bladder (OAB). These platforms and products are summarized and briefly described below: 

Delivery Platforms 

Transdermal Drug 
Delivery Platforms 

Advanced Transdermal 
(ATD™) Gel 

Systematic or 
Topical 

Fast-Melt Oral 
Disintegrating Tablets 
Platform 

Injection Device 
Platforms 

Easy Tec™ 

Needle-Free Reusable Injectors (MJ Platform) 
Medi-Jector VISION®  and Valeo™ 

Mini-Needle Disposable Injectors  
(AJ Platform) Vibex™ 

Vaccine Intradermal Injectors 

2 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Product Candidates 

Transdermal Delivery Gels 

Indication 

Partners 

Formulation 
Development 

Preclinical 
Testing 

Clinical Phase 
I                   II             III 

Regulatory 
Submission 

Commercialization 

Product 
Estradiol ATD™ (Elestrin® ) 

Testosterone ATD™ 
(Libi-Gel™) for Women 

Anturol™ (oxybutynin) ATD™ 

Hot flashes and vaginal 
atrophy hormone therapy 

Female sexual dysfunction 
Overactive bladder 
syndrome 

Ibuprofen Gel 

Pain, inflammation 

ATD™ Gel 

CNS 

Estradiol+Progestin  
ATD™ E2/NETA 
Nesterone® Gel 

Hormone therapy 

Contraception 

AP-1081 Contraceptive ATD™ 

Contraception 

AP-1022 Alprazolam ATD™ 
Testosterone ATD™  
for Men 

Anti-anxiety 
Hypogonadism 
Sexual dysfunction 

NSAID ATO™ Gel 

Pain, inflammation 

BioSante 

BioSante 

None 

Various 
(Non-U.S.) 

Undisclosed 

Solvay 
Population 
Council 

None 

None 

None 

None 

Fast-Melt Oral Dissolve Disintegrating Tablets (EasyTec™) 

Product 

Indication 

Partners 

Formulation 
Development 

Preclinical 
Testing 

Clinical Phase 
I                   II             III 

Regulatory 
Submission 

Commercialization 

Undisclosed 

Opioid dependence 

Undisclosed 

AP-159 

Pain 

None 

Indication 

partners 

Concept 

Prototype for  
Clinical Evaluation 

Design 
Finalization 

Regulatory 
Submission 

Commercialization 

Injection Devices 

Product 
Vision® Needle-free injector 

Insulin/Other 

Vision® Needle-free injector 
Vision® Needle-free injector 

hGH 
Undisclosed 

Vibex™ Mini-needle injector 
Platform: 

- AJ3 (short prefill) 
- AJ4 (long prefill) 
- AJID (vaccines) 
- AJIM (intramuscular)      

Valeo™ MJ8 next generation 
needle-free injector 

Various 

Lilly 
Ferring, JCR, 
SciGen 
Teva 

None 
Undisclosed 
None 
Undisclosed 

Undisclosed 

Various 

3 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Transdermal Drug Delivery Platform 

Antares’ transdermal drug delivery platform is dedicated to developing gels that offer a cosmetically superior 
option to patches, while delivering medication efficiently with less potential for skin irritation and minimizing the 
gastrointestinal impact, as well as, the initial liver metabolism effect of some orally ingested drugs. The Company’s 
gels  are  hydro-alcoholic  and  contain  a  combination  of  permeation  enhancers  to  promote  rapid  drug  absorption 
through the skin following application typically to the arms, shoulders, or abdomen. The Company’s transdermal gel 
systems provide the options for delivering both systemically (penetrating into and through the subcutaneous tissues 
and then into the circulatory system) as well as locally (e.g. topically for skin and soft tissue injury, infection and 
local  inflammation).  Typically,  the  gel  is  administered  daily,  and  is  effective  on  a  sustained  release  basis  over 
approximately  a  24-hour  period  of  time.  The  Company’s  gel  systems  are  known  as  our  Advanced  Transdermal 
Delivery (“ATD™”) gels. 

Fast-Melt Oral Disintegrating Tablets 

Our  Easy  Tec™  fast-melt  oral  disintegrating  tablets  are  designed  to  help  patients  who  experience  difficulty 
swallowing pills, tablets or capsules, while providing the same effectiveness as conventional oral dosage forms. Our 
tablet features a “disintegrant addition” that facilitates the disintegration of the oral drug to promote quick and easy 
administration in saliva without water. This could play an important role in our ability to target the pediatric market 
segment as well as the rapidly expanding geriatric market. We believe that the ability of Easy Tec™ tablets to be 
manufactured  without  specialized  equipment  and  their  non-effervescent  (highly  moisture  sensitive)  qualities 
represents several significant processing and packaging advantages over conventional competitors. Our Easy Tec™ 
tablets  may  also  be  of  interest  to  pharmaceutical  firms  seeking  line  extensions  in  the  marketplace  and  could 
represent a step in our evolution as a specialty pharmaceutical company with its own products.  

Injection Device Platforms 

Antares’  injection  device  platform  features  three  distinct  products:  reusable  needle-free  injectors,  disposable 

mini-needle injectors, and its vaccine intradermal injectors. Each product is briefly described below: 

•  Reusable  needle-free  injectors  deliver  precise  medication  doses  through  high-speed,  pressurized  liquid 
penetration  of  the  skin  without  a  needle.  These  reusable,  variable-dose  devices  are  engineered  to  last  for  a 
minimum  of  two  years  and  are  designed  for  easy  use,  facilitating  self-injection  with  a  disposable  syringe  to 
assure  safety  and  efficacy.  The  associated  disposable,  plastic,  needle-free  syringe  is  designed  to  last  for 
approximately one week. 

The Company has sold the Medi-Jector VISION® for use in more than 30 countries to deliver either insulin or 
human growth hormone (“hGH”). The Medi-Jector VISION® employs a disposable plastic needle-free syringe, 
which  offers  high  precision  liquid  medication  delivery  through  an  opening  that  is  approximately  half  the 
diameter of a standard, 30-gauge needle. The product is available over-the-counter (“OTC”) or by prescription 
in the United States for use by patients with diabetes, and available through our partners in Europe, Japan and 
Asia for hGH. To date, we believe that more than 100 million such injections have been performed worldwide. 

•  Disposable mini-needle injectors (“Vibex™”) employ the same basic technology developed for the Medi-Jector 
VISION®,  combining  spring-powered  source  with  a  tiny  hidden  needle  in  a  disposable,  single-use  injection 
system compatible with conventional glass drug containers. The Vibex™ system is designed to economically 
provide  highly  reliable  subcutaneous  injections  with  reduced  discomfort  and  improved  convenience  in 
conjunction with the enhanced safety of a shielded needle. After use, the device can be disposed of without the 
typical  “sharps”  disposal  concerns.  Antares  and  its  potential  partners  have  successfully  tested  the  device  in 
multiple patient preference and bioavailability tests, and the Company continues to explore product extensions 
within this category, including multiple dose, variable dose and user-fillable applications.  

•  Vaccine intradermal injectors are a variation of the Vibex™ disposable mini-needle injection technology and 
are  being  developed  to  deliver  vaccines  into  the  dermal  and  subdermal  layers  of  the  skin  (a  preferred  site  of 
administration in the vaccine industry). The Company believes that this proprietary device will offer easier and 
more rapid dosing compared with conventional needle-based devices. 

4 

 
 
 
 
 
 
 
 
 
 
 
 
 
History 

On  January  31,  2001,  the  Company  (formerly  known  as  Medi-Ject  Corporation  or  “Medi-Ject”)  completed  a 
business  combination  to  acquire  the  three  operating  subsidiaries  of  Permatec  Holding  AG  (“Permatec”), 
headquartered in Basel, Switzerland. Medi-Ject was at that time, focused on delivering drugs across the skin using 
needle-free technology, and Permatec specialized in delivering drugs across the skin using transdermal patch and gel 
technologies as well as developing fast-melt tablet technology. With both companies focused on drug delivery but 
with  a  focus  on  different  sectors,  it  was  believed  that  a  business  combination  would  be  attractive  to  both 
pharmaceutical  partners  and  to  the  Company’s  stockholders.  Upon  completion  of  the  transaction  the  Company’s 
name was changed from Medi-Ject Corporation to Antares Pharma, Inc.  

The  U.S.  device  operation,  located  in  Minneapolis,  Minnesota,  develops,  manufactures  with  partners  and 
markets novel medical devices, called jet injectors or needle-free injectors, which allow people to self-inject drugs at 
home.  The  Company  makes  a  reusable,  needle-free,  spring-action  injector  device  known  as  the  Medi-Jector 
VISION®. Using an adapter, the liquid drug is drawn from a conventional vial into the plastic needle-free syringe, 
through a small hole at the end of the syringe. When the syringe is held against an appropriate part of the body and 
the  spring  is  released,  a  piston  drives  the  fluid  stream  into  the  tissues  beneath  the  skin,  from  where  the  drug  is 
dispersed into systemic circulation. A person may re-arm the device and repeat the process or attach a new sterile 
syringe between injections.  

The Company was a pioneer in the invention of home use needle-free injection systems in the late 1970s. Prior 
to  that,  needle-free  injection  systems  were  powered  by  large  air  compressors  or  were  relatively  complex  and 
expensive,  so  their  use  was  limited  to  mass  vaccination  programs  by  the  military,  school  health  programs  or  for 
patients classified as needle phobic. Early injectors were painful in comparison to today’s injectors, and their large 
size made home use difficult. The first home insulin injector was five times as heavy as the current injector, which 
today  weighs  five  ounces.  Today  our  insulin  injector  sells  at  a  retail  price  of  under  $300  compared  to  $799  nine 
years  ago.  The  first  growth  hormone  injector  was  introduced  in  Europe  in  1994.  This  was  the  Company’s  first 
success in achieving distribution of its device through a license to a pharmaceutical partner, and it has resulted in 
continuing market growth and, the Company believes, a high degree of customer satisfaction. Distribution of growth 
hormone  injectors  has  expanded  through  the  Company’s  pharmaceutical  company  relationships  to  now  include 
Japan and other Asian countries.  

The Company has also developed variations of the jet injector by adding a very small hidden needle to a pre-
filled, single-use disposable injector, called the Vibex™ mini-needle injection system. The mini-needle platform is 
an alternative to the Vision® system for use with unit dose injectable drugs and is suitable for branded and branded 
generic injectables. 

Antares is also committed to drug delivery by way of its transdermal gel formulations and its fast-melt tablet 
products.  The  Company  believes  that  its  transdermal  gels  have  advantages  in  cost,  cosmetic  elegance,  ease  of 
application  and  lack  of  irritancy  as  compared  to  better-known  transdermal  patches  and  have  applications  in  such 
therapeutic  markets  as  hormone  replacement,  over  active  bladder,  osteoporosis,  cardiovascular,  pain  management 
and central nervous system therapies.  The Company also believes that its proprietary fast-melt tablets can enable 
delivery of certain drugs orally, such as nonsteroidal anti-inflammatory drugs.  

The Company’s first transdermal and fast-melt tablet products were developed in Argentina under Permatec’s 
name in the mid-1990s. Subsequently, the Argentine operations were moved to Basel, Switzerland, in late 1999. The 
transdermal  product  effort  initially  resulted  in  the  commercialization  of  a  seven-day  estradiol  patch  in  certain 
countries of South America  in 2000. Over time, Permatec’s research efforts moved away from the  more crowded 
transdermal  patch  field  and  focused  on  transdermal  gel  formulations,  which  allow  the  delivery  of  estrogens, 
progestins, testosterone and other drugs in a gel base without the need for occlusive or potentially irritating adhesive 
bandages. We believe the commercial potential for transdermal gels is attractive, and several licensing agreements 
with pharmaceutical companies of various sizes have led to successful clinical evaluation of Antares’ formulations. 
The Company is now also developing its own transdermal gel-based products for the market and has reported Phase 
II clinical results for Anturol™, its oxybutynin gel for overactive bladder.  

5 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
The Company operates in the specialized drug delivery sector of the pharmaceutical industry. Companies in this 
sector  generally  leverage  technology  and  know-how  in  the  area  of  drug  formulation  and/or  delivery  devices  to 
pharmaceutical manufacturers through licensing and development agreements while continuing to develop their own 
products  for  the  marketplace.  The  Company  also  views  many  pharmaceutical  and  biotechnology  companies  as 
collaborators  and  primary  customers.  The  Company  has  negotiated  and  executed  licensing  relationships  in  the 
growth  hormone  segment  (needle-free  devices  in  Europe  and  Asia)  and  the  transdermal  hormone  gels  segment 
(several  development  programs  in  place  worldwide,  including  the  United  States  and  Europe).  In  addition,  the 
Company continues to market needle-free devices for the home administration of insulin in the U.S. market through 
distributors and has licensed its technology in the diabetes and obesity fields to Eli Lilly and Company.  

 The  Company  is  a  Delaware  corporation.  Principal  executive  offices  are  located  at  Princeton  Crossroads 
Corporate  Center,  250  Phillips  Boulevard,  Suite  290,  Ewing,  New  Jersey  08618;  telephone  (609)  359-3020.  The 
Company has wholly-owned subsidiaries in Switzerland (Antares Pharma AG and Antares Pharma IPL AG) and the 
Netherlands Antilles (Permatec NV). 

Industry Trends  

Based upon experience in the industry, the Company believes the following significant trends in healthcare have 

important implications for the growth of its business. 

  When a drug loses patent protection, the branded version of the drug typically faces competition from generic 
alternatives.  It  may  be  possible  to  preserve  market  share  by  altering  the  delivery  method,  e.g.,  a  single  daily 
controlled  release  dosage form  rather  than two  to four pills  a  day.  The Company  expects  branded pharmaceutical 
companies will continue to seek differentiating drug delivery characteristics to defend against generic competition 
and to optimize convenience to patients. The altered delivery method may be an injection device or a novel oral or 
transdermal formulation that may offer therapeutic advantages, convenience or improved dosage schedules. Major 
pharmaceutical companies now focus on life cycle management of their products to maximize return on investment 
and often consider phased product improvement opportunities to maintain competitiveness. 

The increasing trend of major pharmaceutical companies marketing directly to consumers, as well as focus on 
patient rights may encourage the use of innovative, user-friendly drug delivery systems. Part of this trend involves 
offering  patients  a  wider  choice  of  dosage  forms.  The  Company  believes  the  patient-friendly  attributes  of  its 
transdermal gels, fast-melt tablets and injection technologies meet these market needs. 

The  Company  envisions  its  transdermal  gel  formulations  as  a  next-generation  technology,  replacing  many 
transdermal patch products with more patient-friendly products. Topical gels offer patients more choices and added 
convenience  with  no  compromise  of  efficacy.  Our  gel  technology  is  based  upon  so-called  GRAS  (“Generally 
Recognized as Safe”) substances, meaning the toxicology profiles of the ingredients are known and widely used. We 
believe this approach has a major regulatory benefit and may reduce the cost and time of product development and 
approval.  

  Many drugs, including selected hormones and protein biopharmaceuticals, are degraded in the gastrointestinal 
tract and may only be administered through the skin, the lung or by injection. Pulmonary delivery is complex and 
has recently been commercialized for limited therapeutic proteins intended for systemic delivery. Injection therefore 
remains  the  mainstay  of  protein  delivery.  The  growing  number  of  protein  biopharmaceuticals  requiring  injection 
may have limited commercial potential if patient compliance with conventional injection treatment is not optimal. 
The failure to take all prescribed injections can lead to increased health complications for the patient, decreased drug 
sales  for  pharmaceutical  companies  and  increased  healthcare  costs  for  society.  In  addition,  it  is  becoming 
increasingly  recognized  that  conventional  needles  and  syringes  are  inherently  unreliable  and  require  special  and 
often costly disposal methods.  

In  addition  to  the  increase  in  the  number  of  drugs  requiring  self-injection,  recommended  changes  in  the 
frequency of insulin injections for the treatment of diabetes also may contribute to an increase in the number of self-
injections. For many years, the standard treatment protocol was for insulin to be administered once or twice daily for 
the  treatment  of  diabetes.  However,  according  to  major  studies  (the  Diabetes  Control  and  Complications  Trial), 
tightly controlling the disease by, among other things, administration of insulin as many as four to six times a day, 

6 

 
 
 
 
 
 
 
 
 
 
  
 
 
 
can decrease its debilitating effects. The Company believes that with the increasing incidence of diabetes coupled 
with an increasing awareness of this disease, the benefits of tightly controlling diabetes will become more widely 
known,  and  the  number  of  insulin  injections  self-administered  by  people  with  diabetes  will  increase.  The  need  to 
increase the number of insulin injections given per day may also motivate patients with diabetes to seek alternatives 
to traditional needles and syringes.  

Due  to  the  substantial  costs  involved,  marketing  efforts  are  not  currently  focused  on  drug  applications 
administered  by  healthcare  professionals.  Jet  injection  systems,  however,  may  be  attractive  to  hospitals,  doctors’ 
offices and clinics, and such applications may be explored in the future. The issues raised by accidental needle sticks 
and disposal of used syringes have led to the development of syringes with sheathed needles as well as the practice 
of administering injections through intravenous tubing to reduce the number of contaminated needles. In 1998, the 
State  of  California  banned  the  use  of  exposed  needles  in  hospitals  and  doctors’  offices,  if  alternatives  exist,  and 
several  additional  states  have  adopted  similar  legislation.  In  November  2000  the  Federal  Government  issued 
guidelines  encouraging  institutions  to  replace  needles  wherever  practical.  The  Company  believes  that  needle-free 
injection  systems  or  its  shielded  mini-needle  products  may  be  attractive  to  healthcare  professionals  as  a  further 
means to reduce accidental needle sticks and the burdens of disposing of contaminated needles.  

The importance of vaccines in industrialized and emerging nations is expanding as the prevalence of infectious 
diseases  increases.  New  vaccines  and  improved  routes  of administration  are  the  subject  of  intense  research  in  the 
pharmaceutical industry and the Company has been researching the feasibility of using its devices for vaccines and 
new vaccine ingredients including evaluating opportunities in recent bio-terrorism initiatives. 

The Company’s fast-melt technology also addresses industry trends by focusing on the needs of specific market 
segments  such  as  geriatric  and  pediatric  patients  who  often  have  difficulty  swallowing  conventional  oral 
medications.  We  believe  that  better  health  outcomes  can  be  expected  when  patients  are  compliant  with 
recommended medication regimens. The Company’s fast-melt technology offers consumers a potentially important 
alternative oral delivery system.  

Market Opportunity  

According  to  a  March  2006  Cowen  &  Co.  publication,  the  worldwide  market  for  urinary  incontinence  is 
estimated  to  be  $1.6  billion  in  2005  and  growing  to  $2.6  billion  by  2010.  Older  incontinence  drugs,  such  as 
immediate release oxybutynin, are plagued by anticholinergic effects including moderate to severe dry mouth (seen 
in  70%  of  the  patients),  constipation  and  confusion.  It  is  also  estimated  that  half  of  the  20  million  U.S.  adults 
suffering  from  overactive  bladder  either  are  too  embarrassed  to  discuss  the  symptoms  or  are  not  aware  that 
pharmacological  treatment  is  available.  It  is  further  estimated  that  only  47%  of  U.S.  incontinence  patients  sought 
treatment in 2005 and that 16% of incontinence patients were compliant with their treatment in 2005 estimated to 
increase to only 18% by 2010. 

According to a March 2006 Cowen & Co. publication, the worldwide hormone replacement market is expected 
to grow from $1.3 billion in 2005 to $1.9 billion by 2010. Further growth in this sector may be achieved by the use 
of  testosterone  products  in  both  male  and  female  applications.  According  to  the  same  comprehensive  study  by 
Cowen  &  Co.,  the  female  sexual  dysfunction  (“FSD”)  market  is  estimated  to  be  78  million  sufferers  worldwide 
rising to 95 million by 2010. Additionally, the worldwide sexual dysfunction market is projected to be $3.9 billion in 
2005  growing  to  $5.6  billion  by  2010.  The  importance  of  gel  products  containing  testosterone  for  men  has  been 
exemplified with the success of Androgel® (Unimed-Solvay) for treatment of male hypogonadism, where sales in 
the U.S. were recently estimated at approximately $500 million per year. A new market opportunity also exists with 
the  use  of  low  dose  testosterone  for  treatment  of  FSD,  a  disorder  according  to  published  reports  that  affects  an 
estimated 40-55% of all women and for which no drug is currently approved in the U.S. Antares Pharma, along with 
its  U.S.  partner  BioSante,  has  a  low  dose  testosterone  product  named  Libi-Gel™,  which  has  completed  Phase  II 
testing  for  FSD  and  is  currently  in  Phase  III  clinical  trials.  We  have  the  exclusive  market  rights  in  Europe  and 
elsewhere outside the United States for Libi-Gel™. As evidenced in Europe and, more specifically, in France, the 
leading country in the use of transdermal hormone replacement therapy, the Company believes that patient demand 
for transdermal hormone therapy products will continue to increase.  Evidence of this belief is the recent commercial 
launch,  in  France,  by  Proctor  and  Gamble  of  the  Intrinsa®  Patch,  a  testosterone  transdermal  patch  for  FSD. 
According  to an  industry  report, 64.8%  of  treated  menopausal  women  in  France used  either patch (44.7%)  or gel 

7 

 
 
 
 
 
 
 
 
 
 
 
(20.1%) therapy. Gel products are also being formulated to address equally large opportunities in other sectors of the 
pharmaceutical  industry,  including  cardiovascular,  pain,  infectious  diseases,  addiction  and  central  nervous  system 
therapies.  

The field of melt-in-the-mouth, or fast-dissolve, tablets clearly has a significant role to play in effective product 
administration  to  the  elderly  and  to  those  who  have  difficulty  swallowing.  While  many  products  have  been 
developed to meet this need, many have disadvantages, including lack of applicability to all drug candidates, dose 
limitations, high cost of manufacturing, and product robustness issues that can challenge packaging and distribution 
systems. Using its Easy Tec™ technology, Antares has undertaken to develop products that could be applicable over 
a  wide  dose  range,  could  be  manufactured  under  conventional  conditions  and  would  meet  the  standards  of 
performance  necessary  to  provide  the  desired  patient  benefits  of  rapid  dissolution,  good  mouth  feel  and  ease  of 
handling. 

To date, needles and syringes are the mainstay for drugs that require injection.  The Company believes that a 
significant  portion  of  these  needles  and  syringes  are  used  for  the  administration  of  drugs  that  could  be  delivered 
using  its  injectors,  but  only  a  small  percentage  of  people  who  self-administer  drugs  currently  use  jet  injection 
systems.  The  Company  believes  that  this  lack  of  market  penetration  is  due  to  older  examples  of  needle-free 
technology not meeting customer needs owing to cost and performance limitations as well as the small size of the 
companies directly marketing the technology to consumers not being able to gain a significant “share of voice” in 
the marketplace. The Company believes that its technology overcomes most of these limitations of the past and that 
its  business  model  of  working  with  pharmaceutical  company  partners  has  the  potential  for  improved  market 
penetration. However, to date neither the Company nor its competitors have achieved substantial market penetration.  

Antares’  device  focus  is  specifically  on  the  market  for  delivery  of  self-administered  injectable  drugs.  The 
largest  and  most  mature  segments  of  this  market  consist  of  insulin  for  patients  with  diabetes  and  human  growth 
hormone  for  children  with  growth  retardation.  According  to  a  March  2006  publication  by  Cowen  &  Co.,  the 
worldwide insulin market is estimated to grow from $7.7 billion in 2005 to $14.6 billion in 2010, of which $2 billion 
in 2010 is inhaled insulin. The Company believes that the number of insulin injections will increase with time as the 
result of new diabetes management techniques, which recommend more frequent injections as evidenced by the U.S. 
insulin market projected to grow from $2.7 billion in 2005 to $5.8 billion in 2010. A second attractive market has 
developed with growth hormone; children and young adults suffering from growth retardation take daily hormone 
injections for an average of five years. The number of children with growth retardation is small relative to diabetes, 
but most children are needle averse. The Company’s pharmaceutical partner in Europe, Ferring Pharmaceuticals BV 
(“Ferring”), has made significant inroads using its injectors in the hGH market, and the Company expects similar 
progress in other geographic regions where partnerships have already been established. Other injectable drugs that 
are presently self-administered and may be suitable for injection with the Company’s systems include therapies for 
the  prevention  of  blood  clots  and  the  treatment  of  multiple  sclerosis,  migraine  headaches,  inflammatory  diseases, 
impotence,  infertility,  AIDS  and  hepatitis.  Antares  also  believes  that  many  injectable  drugs  currently  under 
development will be administered by self-injection once they reach the market. This is supported by the continuing 
development  of  important  chronic  care  products  that  can only  be  given by  injection,  the  ongoing  effort  to  reduce 
hospital and institutional costs by early patient release, and the gathering momentum of new classes of drugs that 
require  injection.  A  partial  list  of  such  drugs  introduced  in  recent  years  that  all  require  home  injection  include 
Enbrel®  (Amgen,  Wyeth)  for  treatment  of  rheumatoid  arthritis,  Aranesp®  (Amgen)  for  treatment  of  anemia, 
Kineret® (Amgen) and Humira® (Abbott) for rheumatoid arthritis, Forteo™ (Lilly) for treatment of osteoporosis, 
Intron®  A  (Schering  Plough)  and  Roferon®  (Roche)  for  hepatitis  C,  Lantus®  (Aventis  Pharma)  for  diabetes, 
Rebif®  (Serono)  for  multiple  sclerosis,  Copaxone®  (Teva)  for  multiple  sclerosis  and  Gonal-F®  for  fertility 
treatment.  We  believe  the  dramatic  increase  in  numbers  of  products  for  self-administration  by  injection  and  the 
breadth of therapeutic areas covered by this partial listing represents an opportunity for Antares’ device portfolio.  

Products and Technology  

Antares is leveraging its experience in drug delivery systems to enhance the product performance of established 
drugs  as  well  as  new  drugs  in  development.  The  Company’s  current  technology  platforms  include  transdermal 
Advanced Transdermal Delivery (ATD™) gels; fast-melt oral disintegrating tablets (Easy Tec™); disposable mini-
needle  injection  systems  (Vibex™);  and  reusable  needle-free  injection  systems  (Medi-Jector  VISION®  and 
Valeo™).  

8 

 
 
 
 
 
 
 
 
 
Transdermal Drug Delivery 

Transdermal drug delivery has emerged as a generally safe and patient-friendly method of drug delivery. The 
commercialization of transdermal patches for controlled drug delivery began over two decades ago and has resulted 
in  the  appearance  of  diverse  products  on  the  market.  Among  them  are  nitroglycerin  for  angina,  scopolamine  for 
motion  sickness,  fentanyl  for  pain  control,  nicotine  for  smoking  cessation,  estrogen  for  HT,  clonidine  for 
hypertension, lidocaine for topical anesthesia, testosterone for hypogonadism, and a combination of ethinyl estradiol 
and norelgestromin for contraception. Skin penetration enhancers are often used to enhance drug permeation through 
the dermal layers.  

The  primary  goal  of  transdermal  drug  delivery  is  to  effectively  penetrate  the  surface  of  the  skin  via  topical 
administration,  such  as  a  patch  or  gel.  When  successful,  transdermal  drug  delivery  provides  an  easy  and  painless 
method  of  administration.  The  protective  capabilities  of  the  skin,  however,  often  act  as  a  barrier  to  effective 
delivery. Since the primary role of the skin is to provide protection against infection and physical damage, the organ 
often  prevents  many  pharmaceuticals  from  entering  the  body  as  well.  Large  molecules  may  not  be  as  effectively 
absorbed  by  the  skin  and  enter  the  body  in  prohibitively  small  amounts,  significantly  reducing  their  therapeutic 
potential. As a result, a limited number of active substances are able to cross the skin’s surface. 

Despite these limitations, transdermal drug delivery is still viewed as a highly attractive route of administration 
for certain therapeutics. As a high concentration of capillaries is located immediately below the skin, transdermal 
administration provides an easy  means of access to systemic circulation. Transdermal  systems can be designed to 
minimize absorption of the active drug in the blood circulation as is needed in topical applications. This allows a 
build-up  of  drug  in  the  layers  underlying  the  skin,  leading  to  an  increased  residence  time  in  the  targeted  tissue. 
Transdermal systems can also be designed to release an active ingredient over extended periods of time, providing 
benefits similar to depot injections and implants, without the need for an invasive procedure. If required, patients are 
also  able  to  interrupt  dosing  by  removing  a  patch  or  discontinuing  the  application  of  a  gel.  Finally,  this  delivery 
technology minimizes first-pass metabolism by the liver as well as many of the gastrointestinal concerns of many 
orally ingested drugs. 

Transdermal Gels 

  While  transdermal  patches  remain  an  important  aspect  of  the  transdermal  drug  delivery  market,  transdermal 
gels have emerged as a viable means of administering a wide array of active pharmaceutical treatments. The concept 
of  transdermal  gels  parallels  that  of  the  transdermal  patch  in  the  creation of  a  drug reservoir  to  provide  sustained 
delivery of therapeutic quantities of a drug. While a patch provides this from an external reservoir, gel formulations 
create a subdermal reservoir of the medication. 

To  address  the  penetration  capabilities  of  transdermal  products,  Antares  has  developed  its  ATD™  gel 
technology that utilizes a combination of permeation enhancers to further bolster a pharmaceutical agent’s ability to 
penetrate the skin. This new generation of products leads to a sustained plasma profile of the active agent, without 
the irritation and cosmetic concerns often associated with patches. 

Gels also provide drug developers with an opportunity to explore a wide variety of potential applications. Due 
to  the  physicochemical  properties  of  the  excipients  employed  in  gels,  combined  with  the  enhanced  solubilization 
properties,  a  broad  range  of  active  agents  can  be  formulated.  These  solubilization  properties  allow  for  higher 
concentrations  of  the  active  ingredient  to  be  incorporated  for  delivery.  The  enhanced  viscosity  in  gels  further 
enhances the patient’s ability to apply the product with little-to-no adverse cosmetic effect. There is also relatively 
little limitation in the surface area to which a gel can be applied, as opposed to patches, allowing greater quantities 
of drug to be transported if required.  

Antares’ Advanced Transdermal Delivery (ATD™) System 

Antares’ ATD™ system successfully penetrates the skin to deliver a variety of treatments. The gels consist of a 
hydro-alcoholic base including a combination of permeation enhancers. The gels are also designed to be absorbed 
quickly  through  the  skin  after  application  typically  to  the  arms,  shoulders,  or  abdomen.  In  comparison  with 
commonly used patch delivery systems, the gels cause minimal skin irritation or occlusion following application and 

9 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
possess  a  distinct  cosmetic  advantage  over  other  approaches.  The  following  is  a  summary  of  the  benefits  of  our 
ATD™ gel platform: 

Benefits of ATD™ Gel Platform 

•  Discrete 
•  Easy application 
•  Cosmetically appealing compared with patches 
•  Reduced irritancy compared with patches 
•  Application of once per day for most products 
•  Potential for delivery of larger medication doses 
•  Potential for delivery of multiple active drugs 
•  Ability to be either systemic or topical 

Antares’ ATD™ gels can deliver both a single active ingredient as well as a combination of active ingredients 
with different release profiles, and have demonstrated potential in a variety of therapeutic areas. One of our licensed 
gels, an estrogen gel for women to treat vasomotor symptoms associated with menopause (Elestrin®), has recently 
been  approved  by  the  FDA.    Other  current  ATD™  drug  gels  in  development  encompass  an  oxybutynin  gel  for 
treatment of over active bladder (Anturol™), a low dose testosterone gel to treat low libido in women (Libi-Gel™), 
a  testosterone  gel  for  men  to  treat  hypogonadism,  a  contraception  gel,  a  gel  for  an  undisclosed  central  nervous 
system  (“CNS”)  disorder  with  a  pharmaceutical  partner  and  an  alprazolam  gel  for  anti-anxiety.  Antares  has  also 
licensed  an  ibuprofen  gel  in  11  countries  for  several  years.  ATD™  gels  may  be  extended  to  a  variety  of  fields, 
including  the  treatment  of  cardiovascular  disease  and  chronic  pain,  in  which  potent  compounds  may  require 
alternatives to oral and injectable delivery for the following reasons: 

•  poor oral uptake; 
•  high first-pass liver effect;  
•  requirement for less frequent administration; 
•  desire to provide an alternative dosage form;   
•  reducing peak plasma levels to avoid side effects; and 
•  reduction in gastrointestinal side effects. 

The Company has also formulated several combination gels demonstrating the ability to deliver multiple actives 

with different release profiles. 

Oral Delivery 

The majority of all drugs are administered orally. Despite this, there remain limitations for those patients who 
have  difficulty  swallowing  conventional  oral  dosage  forms  or  where  an  underlying  disease  state  (for  example, 
migraine, Parkinsonism or cancer) impacts a person’s ability to swallow. Additionally, where patients are resistant 
to oral drug delivery, the phenomenon of “cheeking” (hiding a pill between the cheek and gum) and subsequent drug 
disposal is quite well known. New generations of oral product forms are being developed to address these issues. 

Fast-Dissolving Tablets 

Fast-dissolving tablet technology is an oral delivery method that offers an alternative to patients who experience 
difficulty  ingesting  conventional  oral  dosage  forms.  As  a  result,  formulators  are  focusing  on  the  development  of 
tablet dosage formulations for oral administration that dissolve rapidly in saliva without need for the patient to drink 
water.  This  formulation  is  easy  to  take  and  possesses  similar  therapeutic  benefits  to  traditional  oral  technologies, 
thus appealing to a wide demographic population. 

One  of  the  primary  realities  influencing  the  development  of  fast-dissolving  technologies  is  the  increased  life 
expectancy of a growing geriatric population. As many elderly individuals experience difficulty taking conventional 
oral dosage forms, such as solutions, suspensions, tablets and capsules, the need for more user-friendly formulations 

10 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
is  expanding.  While  swallowing  difficulties  often  affect  the  elderly  population,  many  young  individuals  also 
experience  difficulty  as  a  result  of  underdeveloped  muscular  and  nervous  systems.  Other  groups,  including  the 
mentally  ill,  the  developmentally  disabled  and  uncooperative  patients  also  require  special  attention.  Other 
circumstances,  such  as  motion  sickness,  allergic  attacks  and  an  unavailable  source  of  water  also  necessitate  fast-
dissolving oral formulations. 

The  development  of  a  fast-dissolving  tablet  also  provides  pharmaceutical  companies  with  an  opportunity  for 
product line extensions. A wide range of drugs (e.g. neuroleptics, cardiovascular drugs, analgesics, antihistamines, 
and drugs for erectile dysfunction) may be considered candidates for this technology.  

Antares’ Easy Tec™ Fast-Melt Oral Disintegrating Tablet 

Antares’  patented  Easy  Tec™  technology  is  based  on  the  simultaneous  use  of  two  disintegrants  in  an  oral 
formulation. Two primary advantages of Easy Tec™ over competing technologies are that Easy Tec™ tablets can 
be manufactured with conventional tableting equipment and no unique packaging requirements are necessary. The 
Company  also  believes  that  Easy  Tec™  possesses  several  other  key  advantages  over  competing  fast-melt 
technologies; 

Easy Tec™ Competitive Advantages 

•  Higher drug dose loading is possible 
•  Friability within pharmaceutical specifications 
•  Moisture sensitivity lower compared with many competitor products 
•  Blister packaging sufficient to prevent moisture uptake 
•  Cost-effective, easy, time-saving process 
•  Easily transferable to final product site 
•  No specific facility required, compared to effervescent products 

In addition to being easy to take, such products are perceived as being fast acting because of rapid dispersion in 
the  mouth.    Additionally,  there  may  be  further  benefits  if  Easy  Tec™  can  be  formulated  with  certain  actives  to 
provide buccal absorption.  Antares believes that there may be attractive opportunities to develop its own fast-melt 
products  using  generic  active  ingredients  as  part  of  its  specialty  pharmaceutical  strategy  and  to  achieve  product 
approval based  on  an  Abbreviated  New  Drug Application (“ANDA”)  or 505(b)(2)  filing  in  the United  States  and 
equivalent  regulatory  submissions  in  other  parts  of  the  world.  Antares  has  formulated  its  first  Easy  Tec™  based 
product,  a  non-steroidal  anti  inflammatory  (NSAID)  generic  currently  called  AP-1022  for  the  treatment  of  pain.  
Additionally, the Company has signed a feasibility and development agreement with an unnamed partner in the area 
of opioid dependence. 

Injection Delivery 

According  to  industry  sources,  an  estimated  9-12  billion  needles  and  syringes  are  sold  each  year.  While  the 
need for these components will always exist, burgeoning development efforts are focused on easing the dependence 
on  needles  in  favor  of  more  user-friendly  injection  systems.  Currently  available  data  suggest  that  injection  with 
needle-free systems matches the performance of needle-based systems with regard to drug bioavailability, and offers 
benefits in the speed and quality of injections as well as the lack of requirement for needle disposal.  

Needle-Free Injection 

The most significant challenge beyond discovery of new molecules is how to effectively deliver them by means 
other than conventional injection technology. The majority of these molecules have not, to date, been amenable to 
oral  administration  due  to  a  combination  of  several  factors,  including  breakdown  in  the  gastrointestinal  tract, 
fundamentally  poor  absorption,  or  high  first  pass  liver  metabolism.  Pulmonary  delivery  of  these  molecules,  as  an 
alternative  to  injections,  has  also  been  pursued  and  only  recently  one  such  application  has  been  approved  by  the 
FDA. It remains to be seen how clinical success will be accepted by patients, doctors and third party payers. Many 

11 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
companies have expended considerable effort in searching for less invasive ways to deliver such molecules that may 
allow them to achieve higher market acceptance, particularly for those requiring patient self-administration. 

Needle-free injection is a form of parenteral drug delivery that continues to gain acceptance among the medical 
community. Encompassing a wide variety of sizes and designs, this technology operates by using pressure to force 
the  drug,  in  solution  or  suspension,  through  a  minute  perforation,  creating  an  ultra-thin  stream  of  liquid  that 
penetrates  the  skin  and  deposits  the  drug  into  the  subcutaneous  tissue.  Needle-free  injection  systems  are  being 
developed as small, pre-filled single-use devices, refillable devices for repeat usage and specialized systems for high 
throughput applications in mass immunization campaigns. 

Needle-free injection represents a combination of an accepted technology - injection, with the elimination of the 
part of the injection – the needle, that concerns patient’s that have to self administer and health care professionals 
concerned  about  risks  to  themselves.  Improving  patient  comfort  through  needle-free  injection  may  increase 
compliance  and  mitigate  the  problem  of  daily  injections.  Needle-free  delivery  eliminates  the  risk  of  needlestick 
injuries  as  well,  which  occurs  frequently  in  institutions  in  the  U.S.,  and  can  result  in  disease  transmission  to 
healthcare  workers.  In  response  to  concerns  about  needlestick  injuries,  the  Occupational  Safety  and  Health 
Administration (“OSHA”) issued a Bloodborne Pathogens Standard in November 1999, updated in 2001, mandating 
the  use  of  safer  needles  and  requiring  that  healthcare  facilities  perform  annual  reviews  of  safety  and  compliance 
programs. The National Institute for Occupational Safety and Health has also urged healthcare providers to avoid 
unnecessary use of needles where safe and effective alternatives are available.  

One  of  the  primary  factors  influencing  development  in  the  category  of  needle-free  injection  is  the  inherent 
problematic dependence on needles. It is also recognized that greater willingness to accept injection therapy could 
have a beneficial impact on disease outcomes. For example, patients with diabetes appear to be reluctant to engage 
in  intensive  disease  management,  at  least  in  part  because  of  concerns  over  increased  frequency  of  injections. 
Similarly,  patients  with  diabetes  who  are  ineffectively  managed  with  oral  hypoglycemic  agents  are  reluctant  to 
transition to insulin injections in a timely manner because of injection concerns.  

The advent of these technologies has, to date, had a minor influence within the injectable sector, and they have 
failed  to  produce  the  deep  market  penetration  that  many  within  the  industry  believe  they  are  capable  of  gaining. 
Several  factors  are  believed  to  contribute  to  this  lack  of  market  penetration,  beginning  with  older  needle-free 
injection systems. Many of the early needle-free injection systems had an assortment of drawbacks associated with 
both  performance  and  cost  efficiency.  With  potential  consumers  aware  of  these  historical  shortcomings,  current 
technologies promising greater efficiency and lower prices have failed to gain wide acceptance in the industry.  

Antares’ Medi-Jector Series of Needle-Free Injectors 

The  Medi-Jector  VISION®  represents  the  seventh  in  a  series  of  Medi-Jector  devices,  with  each  generation 
offering  improvements  over  the  previous  versions.  Antares  pioneered  the  development  of  needle-free  injection 
systems for individual use in 1979 and remains among the industry leaders as the technology continues to advance 
and is marketed worldwide. The Company’s current revenue stream is derived primarily from sales of needle-free 
injectors and related disposable syringes for human growth hormone delivery in Europe and elsewhere.  

Medi-Jector VISION® (MJ7) 

The Medi-Jector VISION® has been sold for use in more than 30 countries to deliver either insulin or human 
growth hormone. The product features a reusable, spring-based power source and disposable needle-free syringes, 
which eliminate the need for routine maintenance of the nozzle and allow for easy viewing of the medication dose 
prior  to  injection.  The  device’s  primary  advantage  over  earlier  devices  is  its  ease  of  use  and  cost  efficiency.  The 
product is also reusable, with each device designed to last for approximately 3,000 injections (or approximately two 
years) while the needle-free syringe is disposable after approximately one week of continuous use.  

Antares believes this method of administration is a particularly attractive alternative to the needle and syringe 

for the groups of patients described below.  

12 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
Patient Candidates for Needle-Free Injection 

•  Young adults and children 
•  Patients looking for an alternative to needles 
•  Patients mixing insulins 
•  Patients unable to comply with a prescribed needle program 
•  Patients transitioning from oral medication to insulin 
•  New patients beginning an injection treatment program 

The Medi-Jector VISION® is primarily used in the U.S. to provide a needle-free means of administering insulin 
to  patients  with  diabetes.  Patients  with  insulin-dependent  diabetes  are  often  required  to  make  a  life-long 
commitment to daily self-administration of insulin. In an effort to improve both the comfort and performance of this 
injected hormone, needle-free injection could become an important alternative method of choice for administration.  

The  Medi-Jector  VISION®  administers  insulin  by  using  a  spring  to  push  insulin  in  solution  or  suspension 
through  a  micro-fine  opening  in  the  needle-free  syringe.  The  opening  is  approximately  half  the  diameter  of  a 
standard 30-gauge needle. A fine liquid stream of insulin then penetrates the skin, and the insulin dose is dispersed 
into the layer of fatty, subcutaneous tissue. The insulin is subsequently distributed throughout the body, successfully 
producing the desired effect. 

The  Medi-Jector  VISION®  is  primarily  used  in  Europe,  Asia,  Japan  and  elsewhere  to  provide  a  needle-free 
means of administering human growth hormone to patients with growth retardation. The Company typically sells its 
injection devices to partners in these markets who manufacture and/or market human growth hormone directly. The 
partners then market the Company’s device with their growth hormone. The Company receives benefits from these 
agreements in the form of product sales and royalties on sales of products. 

Development Efforts: MJ8 (Valeo™) Needle-Free Injection Systems 

In addition to the Medi-Jector VISION®, Antares is also developing a reusable Medi-Jector device, the Medi-
Jector  MJ8  (Valeo™)  with  unique  needle-free  injection  capabilities.  The  Medi-Jector  Valeo™  accepts  a 
conventional  drug  cartridge  to  create  a  completely  self-contained,  multi-dose,  needle-free  injection  system.  With 
these  improvements,  the  Medi-Jector  Valeo™  aspires  to  provide  more  user-friendly  capabilities  than  its 
predecessors and, if marketed, the Company believes it would be the smallest reusable needle-free injector on the 
market.  

Vibex™ Pre-filled, Disposable Mini-Needle Injector 

Beyond reusable needle-free injector technologies, the Company has designed disposable, mini-needle devices 
to address acute medical needs, such as allergic reactions, migraine headaches, acute pain and other daily therapies, 
as  well  as  for  the  delivery  of  vaccines.  The  Company’s  proprietary  Vibex™  disposable,  mini-needle  product 
combines  a  low-energy,  spring-based  power  source  with  a  small,  hidden  needle,  which  delivers  the  needed  drug 
solution subcutaneously or, in the case of vaccines, subdermally.  

In order to minimize the anxiety and perceived pain associated with injection-based technologies, the Vibex™ 
disposable mini-needle injector features a triggering collar that shields the needle from view. The patented retracting 
collar  springs back  and  locks  in  place  as  a  protective  needle  guard  after  the  injection, making  the device  safe  for 
general disposal. In clinical studies, this device has outperformed other delivery methods in terms of completeness 
of injection, while limiting pain and bleeding. A summary of the key benefits of the Vibex™ disposable mini-needle 
product is provided below. 

13 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Benefits of Vibex™ Disposable Mini-Needle Injectors 

•  Rapid injection 
•  Eliminates sharps disposal 
•  Ease of use in emergencies 
•  Reduces psychological barriers since the patient never sees the needle 
•  Highly dependable subcutaneous injection 
•  Designed around conventional cartridges or pre-filled syringes 

The primary  goal  of  the  Vibex™  disposable  mini-needle  injector  is  to  provide  a  fast,  safe,  and  time-efficient 
method  of  self-injection  that  addresses  the  patient’s  need  for  immediate  relief.  This  device  is  designed  around 
conventional  cartridges  or  pre-filled  syringes,  which  are  primary  drug  containers,  offering  ease  of  transition  for 
potential pharmaceutical partners. 

Disposable Mini-Needle Vaccine Delivery Device 

Antares’  disposable vaccine delivery device  is  at  an  earlier  stage  and  is  derived from  its  mini-needle  injector 
technology  (see  above  section).  The  disposable  device  is  designed  to  deliver  vaccines  intradermally  and  to 
subdermal  layers  of  the  skin.  Effective  intradermal  injection  methods,  using  variants  of  conventional  needles, 
depend  extensively  on  the  skill  of  the  person  administering  the  injection.  Antares’  vaccine  delivery  technology 
simplifies the process for intradermal delivery, minimizing the dependence on skilled individuals administering the 
injection, and providing for a more comfortable means of vaccine delivery. 

Research and Development 

  We currently have one pharmaceutical product candidate in our own clinical studies listed below. Additionally, 
pharmaceutical  partners  are  developing  compounds  using  our  technology  (see  “Collaborative  Arrangements  and 
License Agreements”).   

ANTUROL™.  We  are  currently  evaluating  Anturol™  for  the  treatment  of  over  active  bladder  (OAB). 
Anturol™  is  the  anticholinergic  oxybutynin  delivered  by  our  proprietary  ATD™  gel  that  is  used  to  achieve 
therapeutic blood levels of the active compound that can be sustained over 24 hours after a single, daily application. 
It  is  believed  that  Anturol™  may  offer  equal  or  increased  oxybutynin  to  the  metabolite  ratio,  thus  resulting  in 
decreased  reporting  of  adverse  events  when  compared  to  patients  taking  comparable  oral  products.  In  addition, 
Anturol™ may also be more cosmetically appealing than patches and have less irritation and allergic reactions as 
well as comparable or decreased reporting of adverse events. 

Background and Statistics 

OAB affects more than 20 million adults and is one of the fastest growing segments in the urology market. It is 
characterized by involuntary muscle contractions resulting in urine leakage. Symptoms include urinary frequency, 
urgency and urge incontinence. While OAB may occur at any age, it is most common among the elderly, affecting 
up to 61% of those over 65, particularly post-menopausal women. A recent SCRIP Report showed the incontinence 
market growing at 40% per year. 

Treatment currently consists of oral administration of compounds such as oxybutynin, tolteradine, darifenacin, 
solifenacin, and trospium each of which have significant side effects, including dry mouth (seen in 70% of patients), 
nausea,  dry  eyes,  and  constipation.  It  is  estimated  that  half  of  the  adults  suffering  from  OAB  either  are  too 
embarrassed to discuss their symptoms or are not aware that pharmacological treatment is available. It is estimated 
by Cowen & Co. in their March 2006 publication that just 16% of incontinence patients were compliant with their 
treatment in 2005 improving modestly to 18% in 2010. 

14 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Summary of Clinical Data 

In  February  2006,  the  Company  announced  the  results  of  its  Phase  II  dose  ranging  study  for  its  ATD™ 
oxybutynin based gel product called Anturol™. The study was an open label, single period, randomized study using 
48  healthy  subjects  and  three  different  doses  of  Anturol™  over  a  20  day  period.  Variables  tested  included 
accumulation of the dose, dose proportionality, decay of plasma levels, skin tolerability and other adverse events. 

The  overall  conclusions  of  the  study  were  positive.  Dose  proportionality  occurred  within  the  tested  dosing 
range. A steady state was achieved after 3 applications (i.e., 3 days). Efficacy appeared comparable to oral products 
marketed. The incidences of dry mouth were minimal and similar to other transdermals while significantly improved 
over comparable oral medications. Additionally, skin tolerance (i.e. local skin irritation) was excellent. 

A Phase III study has been preliminarily approved by the FDA and will include patients with urge and mixed 
urinary incontinence. The study will be a multi-center study over a 12 week period with Anturol™ applied once a 
day compared to a placebo. 

Proprietary Rights 

  When appropriate, the Company actively seeks protection for its products and proprietary information by means 
of U.S. and international patents and trademarks.  The Company currently holds approximately 70 patents and has 
an  additional  98  applications  pending  in  the  U.S.  and  other  countries.  Late  in  2006  the  Company  received  two 
notices of allowances from the U.S. patent office on patents expected to be issued shortly in our ATD™ gel platform 
including a patent related to our formulation of Elestrin®, an estradiol gel product approved by the FDA for hormone 
replacement therapy and a patent related to our core gel technology.  Our patents have expiration dates ranging from 
2015 to 2022. In addition to issued patents and patent applications, we are also protected by trade secrets in all of 
our technology platforms. 

Some of the Company’s technology is developed on its behalf by independent outside contractors. To protect 
the rights of its proprietary know-how and technology, Company policy requires all employees and consultants with 
access  to  proprietary  information  to  execute  confidentiality  agreements  prohibiting  the  disclosure  of  confidential 
information  to  anyone  outside  the  Company.  These  agreements  also  require  disclosure  and  assignment  to  the 
Company of discoveries and inventions made by such individuals while devoted to Company-sponsored activities. 
Companies  with  which  Antares  has  entered  into  development  agreements  have  the  right  to  certain  technology 
developed in connection with such agreements.  

Manufacturing  

  We  do  not  have  the  resources,  facilities  or  capabilities  to  commercially  manufacture  any  of  our  product 
candidates. We have no current plans to establish a manufacturing facility. We expect that we will be dependent to a 
significant  extent  on  contract  manufacturers  for  commercial  scale  manufacturing  of  our  product  candidates  in 
accordance with regulatory standards. 

Contract manufacturers may utilize their own technology, technology developed by us, or technology acquired 
or  licensed  from  third  parties.  When  contract  manufacturers  develop  proprietary  process  technology  and  have 
ownership of the Drug Master File (DMF), our reliance on such contract manufacturers is increased, and we may 
have  to  obtain  a  license  from  such  contract  manufacturers  to  have  our  products  manufactured  by  another  party. 
Technology  transfer  from  the  original  contract  manufacturer  may  be  required.  Any  such  technology  transfer  may 
also require transfer of requisite data for regulatory purposes, including information contained in a proprietary DMF 
held  by  a  contract  manufacturer.  FDA  approval  of  the  new  manufacturer  and  manufacturing  site  would  also  be 
required. 

  We  have  not  contracted  with  a  commercial  supplier  of  pharmaceutical  chemicals,  to  supply  us  with  active 
pharmaceutical  ingredients  of  oxybutynin  for  Anturol™  in  a  manner  that  meets  FDA  requirements.  We  have 
contracted  with  Patheon,  Inc.  (Patheon),  a  manufacturing  development  company,  to  supply  clinical  quantities  of 
Anturol™  gel  in  a  manner  that  may  meet  FDA  requirements.  The  FDA  has  not  approved  the  manufacturing 
processes of Patheon at this time. 

15 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The  Company  is  responsible  for  U.S.  device  manufacturing  in  compliance  with  current  Quality  System 
Regulations (“QSR”) established by the Food and Drug Administration and by the centralized European regulatory 
authority  (Medical  Device  Directive).  Injector  and  disposable  parts  are  manufactured  by  third-party  suppliers  and 
are assembled by a third-party supplier. Packaging is performed by a third-party supplier under the direction of the 
Company. Product release is performed by the Company.  

The  ATD™  Gel  formulations  for  clinical  studies  have,  in  the  past,  been  manufactured  by  contract  under  the 
Company’s supervision. Early in 2005, Antares Pharma AG, our wholly owned subsidiary in Switzerland, received a 
GMP approval for the production and wholesaling of medicaments in small scale quantities.  

Marketing  

The Company expects to currently market most of its products through other more substantial pharmaceutical 
and  medical  device  companies  while  continuing  direct-to-consumer  marketing  of  its  insulin  injection  devices  and 
related disposable components in the U.S. In the future as the Company develops more products in niche therapeutic 
areas, it may decide to incorporate limited sales and marketing capabilities. 

During 2006, 2005 and 2004, international revenue accounted for approximately 63%, 77% and 82% of total 
revenue, respectively. Europe accounted for 83%, 71% and 83% of international revenue in 2006, 2005 and 2004, 
respectively,  with  the  remainder  coming  primarily  from  Asia.  Ferring  accounted  for  39%,  48%  and  47%  of  the 
Company’s worldwide revenues in 2006, 2005 and 2004, respectively. BioSante Pharmaceuticals, Inc. accounted for 
24%,  7%  and  11%  and  JCR  Pharmaceuticals,  Co.,  Ltd.  accounted  for  4%,  12%  and  6%  of  the  Company’s 
worldwide  revenues  in  2006,  2005  and  2004,  respectively.  Revenue  from  Ferring  and  JCR  resulted  from  sales  of 
injection devices and related disposable components for its hGH formulation. Revenue from BioSante resulted from 
license fees, development fees, milestone payments and clinical testing supplies for hormone replacement therapy 
transdermal gel formulations. 

Collaborative Arrangements and License Agreements 

The  following  table  describes  significant  existing  pharmaceutical  and  device  relationships,  and  license 

agreements. 

Partner 

BioSante  

Compound/Product 
Estradiol (Elestrin®) 

Solvay  

Undisclosed 

Undisclosed 

Ferring 

Testosterone (Libi-Gel™) 

Estradiol/NETA 

Undisclosed 
Development Agreement 
Undisclosed 
Development Agreement 
MJ-7 and undisclosed 

Teva Pharmaceuticals, Ltd. 

Undisclosed 

Eli Lilly and Company 

MJ-7 and undisclosed 

JCR Pharmaceuticals Co., Ltd. 

SciGen Pte Ltd. 

Teva/Sicor 

Teva/Sicor 

MJ-7 

MJ-7 

Undisclosed 

Undisclosed 

Market Segment 
Hormone replacement therapy  
(North America, other countries) 

Female sexual dysfunction 
 (North America, other countries) 
Hormone replacement therapy 
(Worldwide) 
Central Nervous System 

Technology 
ATD™ Gel 

ATD™ Gel 

ATD™ Gel 

ATD™ Gel 

Opioid dependence 

ODT 

Growth Hormone 
(U.S. and Europe) 
Undisclosed 
(United States) 
Diabetes and Obesity  
(Worldwide) 
Growth Hormone 
(Japan) 
Growth Hormone 
(Asia/Pacific) 
Undisclosed 
(U.S. and Canada) 
Undisclosed 
(United States) 

Needle Free 
Device 
Needle Free 
Device 
Needle Free 
Device 
Needle Free 
Device 
Needle Free 
Device 
Undisclosed 
Disposable Device 
Undisclosed 
Disposable Device 

16 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
This  table  summarizes  agreements  under  which  the  Company’s  partners  are  selling  products,  conducting 
clinical  evaluation,  and  performing  development  of  the  Company’s  products.  For  competitive  reasons,  the 
Company’s partners may not divulge their name, the product name or the exact stage of clinical development.  

In June 2000, the Company granted an exclusive license to BioSante to develop and commercialize three of the 
Company’s gel technology products and one patch technology product for use in hormone replacement therapy in 
North America and other countries. Subsequently, the license for the patch technology product was returned to the 
Company in exchange for a fourth gel based product. BioSante paid the Company $1 million upon execution of the 
agreement and is also required to pay the Company royalty payments once commercial sales of the products have 
begun. The royalty payments are based on a percentage of sales of the products and must be paid for a period of 10 
years following the first commercial sale of the products, or when the last patent for the products expires, whichever 
is later. The agreement also provides for milestone payments to the Company upon the occurrence of certain events 
related  to  regulatory  filings  and  approvals.    In  November  2006  BioSante  entered  into  a  sublicense  and  marketing 
agreement  with  Bradley  Pharmaceuticals,  Inc.  for  Elestrin®  (formerly  Bio-E-Gel).    BioSante  received  an  upfront 
payment  from  Bradley  which  triggered  a  payment  to  the  Company  of  $875,000.    In  December  2006  the  FDA 
approved  for  marketing  Elestrin®  in  the  United  States  triggering  payments  to  the  Company  totaling  $2.6  million, 
which  will  be  received  in  2007.    In  addition,  the  Company  will  receive  royalties  on  sales  of  Elestrin®  as  well  as 
potential sales-based milestone payments when marketed by Bradley. 

In  June  1999,  the  Company  granted  an  exclusive  license  to  Solvay  for  the  Company’s  transdermal  gel 
technology  for  delivery  of  an  estradiol/progestin  combination  for  hormone  replacement  therapy.  The  exclusive 
license  applies  to  all  countries  and  territories  in  the  world,  except  for  North  America,  Japan  and  Korea.  The 
agreement contains a development plan under which the Company and Solvay collaborate to bring the product to 
market. Solvay must pay the Company a license fee of $5 million in four separate payments, all of which are due 
upon completion of various phases of the development plan. To date, the Company has received $1.75 million of 
this fee.  Recently, development work performed by Solvay has been limited due to concerns about certain forms of 
hormone replacement therapy that have been debated in scientific literature.  When and if commercial sale of the 
product  begins,  Solvay  is  required  to,  on  a  quarterly  basis,  pay  the  Company  a  royalty  based  on  a  percentage  of 
sales. The royalty payments will be required for a period of 15 years or when the last patent for the product expires, 
whichever is later. 

In  August  2001,  Solvay  entered  into  an  exclusive  agreement  with  BioSante  in  which  Solvay  has  sublicensed 
from BioSante the U.S. and Canadian rights to the Company’s estrogen/progestin combination transdermal hormone 
replacement gel product, one of the drug-delivery products the Company previously licensed to BioSante. Under the 
terms of this license agreement between the Company and BioSante, the Company received a portion of the up front 
payment  made  by  Solvay  to  BioSante.  The  Company  is  also  entitled  to  a  portion  of  any  milestone  payments  or 
royalties BioSante receives from Solvay under the sublicense agreement. 

In  January  2003,  the  Company  entered  into  a  revised  License  Agreement  with  Ferring,  under  which  the 
Company  licensed  certain  of  its  intellectual  property  and  extended  the  territories  available  to  Ferring  for  use  of 
certain of the Company’s reusable needle-free injection devices to include all countries and territories in the world 
except  Asia/Pacific.  Specifically,  the  Company  granted  to  Ferring  an  exclusive,  royalty-bearing  license,  within  a 
prescribed manufacturing territory, to utilize certain of the Company’s reusable needle-free injector devices for the 
field of human growth hormone until the expiration of the last to expire of the patents in any country in the territory. 
The Company granted to Ferring similar non-exclusive rights outside of the prescribed manufacturing territory. In 
addition, the Company granted to Ferring a non-exclusive right to make and have made the equipment required to 
manufacture the licensed products, and an exclusive, royalty-free license in a prescribed territory to use and sell the 
licensed products under certain circumstances. The Company also granted to Ferring a right of first offer to obtain 
an  exclusive  worldwide  license  to  manufacture  and  sell  the  Company’s  early  version  of  a  disposable  mini-needle 
device in a specified field. 

In  September  2003,  the  Company  entered  into  a  Development  and  License  Agreement  (the  “License 
Agreement”) with Eli Lilly and Company. Under the License Agreement, the Company granted Lilly an exclusive 
license to certain of the Company’s needle-free technology in the fields of diabetes and obesity.  

17 

 
 
 
 
 
 
 
 
 
 
 
 
In 2004, JCR Pharmaceuticals Co., Ltd. initiated a campaign to broaden its marketing efforts for human growth 
hormone  under  a  purchase  agreement  with  our  needle  free  injector,  MJ-7.  In  1999,  SciGen  Pte  Ltd.  began 
distribution in Asia of our needle free injector MJ-7 for human growth hormone. 

In  November  2005,  the  Company  signed  an  agreement  with  Sicor  Pharmaceuticals  Inc.,  an  affiliate  of  Teva 
Pharmaceutical  Industries  Ltd.,  under  which  Sicor  is  obligated  to  purchase  all  of  its  injection  delivery  device 
requirements from Antares for an undisclosed product to be marketed in the United States. Sicor also received an 
option for rights in other territories. The license agreement included, among other things, an upfront cash payment, 
milestone fees, a negotiated purchase price for each device sold, and royalties on sales of their product. 

In July 2006, the Company entered into an exclusive License Development and Supply Agreement with Sicor 
Pharmaceuticals Inc., an affiliate of Teva Pharmaceutical Industries Ltd. Pursuant to the agreement, the affiliate is 
obligated to purchase all of its delivery device requirements from Antares for an undisclosed product to be marketed 
in  the  United  States  and  Canada.  Antares  received  an  upfront  cash  payment,  and  will  receive  milestone  fees,  a 
negotiated purchase price for each device sold, as well as royalties on sales of their product.  

In September 2006, the Company entered into a Supply Agreement with Teva Pharmaceutical Industries Ltd. 
Pursuant to the agreement, Teva is obligated to purchase all of its delivery device requirements from Antares for an 
undisclosed product to be marketed in the United States. Antares received an upfront cash payment, and will receive 
milestone fees and a royalty payment on Teva’s net sales, as well as a purchase price for each device sold.   

Distribution/supply  agreements  are  arrangements  under  which  the  Company’s  products  are  supplied  to  end-
users through the distributor or supplier. The Company provides the distributor/supplier with injection devices and 
related disposable components, and the distributor/supplier often receives a margin on sales. The Company currently 
has  a  number  of  distribution/supply  arrangements  under  which  the  distributors/suppliers  sell  the  Company’s 
injection devices and related disposable components for use with insulin.  

Competition  

Competition in the pharmaceutical formulation sector is significant, mature and dominated by companies like 
ALZA  Corporation,  Elan  Corporation  plc,  SkyePharma  plc  and  Alkermes,  Inc.  Competition  in  the  gel  market 
includes companies like NexMed, Inc., Cellegy Pharmaceuticals, Inc., Bentley Pharmaceuticals, Inc., Novavax, Inc. 
and  many  others.    Competition  in  the  fast-melt  market  includes  Eurand,  Cardinal  Health,  Yamanouchi 
Pharmaceutical Co., Ltd. and many others.  Competition in the disposable, single-use injector market includes, but is 
not  limited  to,  OwenMumford  Ltd.,  The  Medical  House  and  Pharma-Pen,  Inc.  (formerly  Innoject,  Inc.),  while 
competition in the reusable needle-free injector market includes Bioject Medical Technologies Inc. and The Medical 
House.  

Competition in the injectable drug delivery market is intensifying. The Company clearly faces competition from 
traditional  needles  and  syringes  as  well  as  newer  pen-like  and  sheathed  needle  syringes  and  other  needle-free 
injection systems as well as alternative drug delivery methods including oral, transdermal and pulmonary delivery 
systems. Nevertheless, the majority of injections are still currently administered using needles. Because injections 
are typically only used when other drug delivery methods are not feasible, the needle-free injection systems may be 
made obsolete by the development or introduction of drugs or drug delivery methods which do not require injection 
for the treatment of conditions the Company has currently targeted. In addition, because the Company intends to, at 
least  in  part,  enter  into  collaborative  arrangements  with  pharmaceutical  companies,  the  Company’s  competitive 
position  will  depend  upon  the  competitive  position  of  the  pharmaceutical  company  with  which  it  collaborates  for 
each drug application.  

Government Regulation 

  We  and  our  collaborative  partners  are  subject  to,  and  any  potential  products  discovered,  developed  and 
manufactured by us or our collaborative partners must comply with, comprehensive regulation by the FDA in the 
United States and by comparable authorities in other countries. These national agencies and other federal, state, and 
local  entities  regulate,  among  other  things,  the  pre-clinical  and  clinical  testing,  safety,  effectiveness,  approval, 
manufacturing operations, quality, labeling, distribution, marketing, export, storage, record keeping, event reporting, 

18 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
advertising and promotion of pharmaceutical products and medical devices. Facilities and certain company records 
are also subject to inspections by the FDA and comparable authorities or their representatives. The FDA has broad 
discretion in enforcing the FD&C Act and the regulations thereunder, and noncompliance can result in a variety of 
regulatory  steps  ranging  from  warning  letters,  product  detentions,  device  alerts  or  field  corrections  to  mandatory 
recalls, seizures, injunctive actions and civil or criminal actions or penalties.  

Transdermal  and  topical  products  indicated  for  the  treatment  of  systemic  or  local  treatments  respectively  are 
regulated  by  the  FDA  in  the  U.S.  and  other  similar  regulatory  agencies  in  other  countries  as  drug  products. 
Transdermal and topical products are considered to be controlled release dosage forms and may not be marketed in 
the U.S. until they have been demonstrated to be safe and effective. The regulatory approval routes for transdermal 
and topical products include the filing of an NDA for new drugs, new indications of approved drugs or new dosage 
forms of approved drugs. Alternatively, these dosage forms can obtain marketing approval as a generic product by 
the  filing  of  an  ANDA,  providing  the  new  generic  product  is  bioequivalent  to  and  has  the  same  labeling  as  a 
comparable approved product or as a filing under Section 505(b)(2) where there is an acceptable reference product. 
Many topical products for local treatment do not require the filing of either an NDA or ANDA, providing that these 
products comply with existing OTC monographs. The combination of the drug, its dosage form and label claims, 
and FDA requirement will ultimately determine which regulatory approval route will be required. 

The process required by the FDA before a new drug (pharmaceutical product) or a new route of administration 

of a pharmaceutical product may be approved for marketing in the United States generally involves: 

(cid:131)  pre-clinical laboratory and animal tests; 
(cid:131)  submission to the FDA of an IND application, which must be in effect before clinical trials may begin; 
(cid:131)  adequate  and  well  controlled  human  clinical  trials  to  establish  the  safety  and  efficacy  of  the  drug  for  its 

intended indication(s); 

(cid:131)  FDA compliance inspection and/or clearance of all manufacturers; 
(cid:131)  submission to the FDA of an NDA; and 
(cid:131)  FDA review of the NDA or product license application in order to determine, among other things, whether 

the drug is safe and effective for its intended uses. 

Pre-clinical tests include laboratory evaluation of product chemistry and formulation, as well as animal studies, 
to  assess  the  potential  safety  and  efficacy  of  the  product.  Certain  pre-clinical  tests  must  comply  with  FDA 
regulations regarding current good laboratory practices. The results of the pre-clinical tests are submitted to the FDA 
as part of an IND, to support human clinical trials and are reviewed by the FDA, with patient safety as the primary 
objective, prior to the IND commencement of human clinical trials.  

Clinical trials are conducted according to protocols that detail matters such as a description of the condition to 
be  treated,  the  objectives  of  the  study,  a  description  of  the  patient  population  eligible  for  the  study  and  the 
parameters to be used to monitor safety and efficacy. Each protocol must be submitted to the FDA as part of the 
IND. Protocols must be conducted in accordance with FDA regulations concerning good clinical practices to ensure 
the  quality  and  integrity  of  clinical  trial  results  and  data.  Failure  to  adhere  to  good  clinical  practices  and  the 
protocols  may  result  in  FDA  rejection  of  clinical  trial  results  and  data,  and  may  delay  or  prevent  the  FDA  from 
approving the drug for commercial use.  

Clinical trials are typically conducted in three sequential Phases, which may overlap. During Phase I, when the 
drug is initially given to human subjects, the product is tested for safety, dosage tolerance, absorption, distribution, 
metabolism and excretion. Phase I studies are often conducted with healthy volunteers depending on the drug being 
tested; however, in oncology, Phase I trials are more often conducted in cancer patients. Phase II involves studies in 
a limited patient population, typically patients with the conditions needing treatment, to: 

(cid:131)  evaluate preliminarily the efficacy of the product for specific, targeted indications; 
(cid:131)  determine dosage tolerance and optimal dosage; and 
(cid:131)  identify possible adverse effects and safety risks. 

Pivotal or Phase III adequate and well-controlled trials are undertaken in order to evaluate efficacy and safety in 
a  comprehensive  fashion  within  an  expanded  patient  population  for  the  purpose  of  registering  the  new  drug.  The 

19 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
FDA  may  suspend  or  terminate  clinical  trials  at  any  point  in  this  process  if  it  concludes  that  patients  are  being 
exposed to an unacceptable health risk or if they decide it is unethical to continue the study. Results of pre-clinical 
and clinical trials must be summarized in comprehensive reports for the FDA. In addition, the results of Phase III 
studies  are  often  subject  to  rigorous  statistical  analyses.  This  data  may  be  presented  in  accordance  with  the 
guidelines for the International Committee of Harmonization that can facilitate registration in the United States, the 
EU and Japan. 

FDA  approval  of  our  own  and  our  collaborators’  products  is  required  before  the  products  may  be 
commercialized  in  the  United  States.  FDA  approval  of  an  NDA  will  be  based,  among  other  factors,  on  the 
comprehensive  reporting  of  clinical  data,  risk/benefit  analysis,  animal  studies  and  manufacturing  processes  and 
facilities. The process of obtaining NDA approvals from  the FDA can be costly and time consuming and may be 
affected by unanticipated delays. 

Among  the  conditions  for  NDA  approval  is  the  requirement  that  the  prospective  manufacturer’s  procedures 
conform  to  current  good  manufacturing  practices,  which  must  be  followed  at  all  times.  In  complying  with  this 
requirement, manufacturers, including a drug sponsor’s third-party contract manufacturer, must continue to expend 
time,  money  and  effort  in  the  area  of  production,  quality  assurance  and  quality  control  to  ensure  compliance. 
Domestic  manufacturing  establishments  are  subject  to  periodic  inspections  by  the  FDA  in  order  to assess,  among 
other things, compliance with current good manufacturing practices. To supply products for use in the United States, 
foreign manufacturing establishments also must comply with current good manufacturing practices and are subject 
to periodic inspection by the FDA or by regulatory authorities in certain countries under reciprocal agreements with 
the FDA. 

A sNDA is a submission to an existing NDA that provides for changes to the NDA and therefore requires FDA 
approval. Changes to the NDA that require FDA approval are the subject of either the active ingredients, the drug 
product and/or the labeling. A supplement is required to fully describe the change. There are two types of sNDAs 
depending  on  the  content  and  extent  of  the  change.  These  two  types  are  (i)  supplements  requiring  FDA  approval 
before the change is made and (ii) supplements for changes that may be made before FDA approval. Supplements to 
the  labeling  that  change  the Indication Section require prior  FDA  approval  before  the change  can  be  made  to  the 
labeling, e.g. a new indication. 

Both before and after market approval is obtained, a product, its manufacturer and the holder of the NDA for 
the product are subject to comprehensive regulatory oversight. Violations of regulatory requirements at any stage, 
including  after  approval,  may  result  in  various  adverse  consequences,  including  the  FDA’s  delay  in  approving  or 
refusal  to  approve  a  product,  withdrawal  of  an  approved  product  from  the  market  and  the  imposition  of  criminal 
penalties  against  the  manufacturer  and  NDA holder.  In  addition,  later discovery  of previously  unknown problems 
may result in restrictions on the product, manufacturer or NDA holder, including withdrawal of the product from the 
market.  Furthermore,  new  government  requirements  may  be  established  that  could  delay  or  prevent  regulatory 
approval of our products under development. 

FDA approval is required before a generic equivalent can be marketed. We seek approval for such products by 
submitting  an  ANDA  to  the  FDA.  When  processing  an  ANDA,  the  FDA  waives  the  requirement  of  conducting 
complete  clinical  studies,  although 
it  normally  requires  bioavailability  and/or  bioequivalence  studies. 
“Bioavailability”  indicates  the  rate  and  extent  of  absorption  and  levels  of  concentration  of  a  drug  product  in  the 
blood  stream  needed  to  produce  a  therapeutic  effect.  “Bioequivalence”  compares  the  bioavailability  of  one  drug 
product with another, and when established, indicates that the rate of absorption and levels of concentration of the 
active drug substance in the body are equivalent for the generic drug and the previously approved drug. An ANDA 
may be submitted for a drug on the basis that it is the equivalent of a previously approved drug or, in the case of a 
new dosage form, is suitable for use for the indications specified.  

Before approving a product, the FDA also requires that our procedures and operations or those of our contracted 
manufacturer  conform  to  Current  Good  Manufacturing  Practice  (“cGMP”)  regulations,  relating  to  good 
manufacturing practices as defined in the U.S. Code of Federal Regulations. We and our contracted manufacturer 
must follow the cGMP regulations at all times during the manufacture of our products. We will continue to spend 
significant time, money and effort in the areas of production and quality testing to help ensure full compliance with 
cGMP regulations and continued marketing of our products now or in the future.  

20 

 
 
 
 
 
 
 
 
 
 
 
 
If the FDA believes a company is not in compliance with cGMP, sanctions may be imposed upon that company 

including:  

(cid:131)  withholding  from  the  company  new  drug  approvals  as  well  as  approvals  for  supplemental  changes  to 

existing applications; 

(cid:131)  preventing the company from receiving the necessary export licenses to export its products; and 
(cid:131)  classifying the company as an “unacceptable supplier” and thereby disqualifying the company from selling 

products to federal agencies. 

The timing of final FDA approval of an ANDA depends on a variety of factors, including whether the applicant 
challenges  any  listed  patents  for  the  drug  and  whether  the  brand-name  manufacturer  is  entitled  to  one  or  more 
statutory  exclusivity  periods,  during  which  the  FDA  may  be  prohibited  from  accepting  applications  for,  or 
approving, generic products. In certain circumstances, a regulatory exclusivity period can extend beyond the life of a 
patent,  and  thus  block  ANDAs  from  being  approved  on  the  patent  expiration  date.  For  example,  in  certain 
circumstances the FDA may extend the exclusivity of a product by six months past the date of patent expiry if the 
manufacturer  undertakes  studies  on  the  effect  of  their  product  in  children,  a  so-called  pediatric  extension.  The 
pediatric extension results from a 1997 law designed to reward branded pharmaceutical companies for conducting 
research  on  the  effects  of  pharmaceutical  products  in  the  pediatric  population.  As  a  result,  under  certain 
circumstances,  a  branded  company  can  obtain  an  additional  six  months  of  market  exclusivity  by  performing 
pediatric research.  

In May 1992, Congress enacted the Generic Drug Enforcement Act of 1992, which allows the FDA to impose 
debarment and other penalties on individuals and companies that commit certain illegal acts relating to the generic 
drug  approval  process.  In  some  situations,  the  Generic  Drug  Enforcement  Act  requires  the  FDA  to  not  accept  or 
review ANDAs for a period of time from a company or an individual that has committed certain violations. It also 
provides  for  temporary  denial  of  approval  of  applications  during  the  investigation  of  certain  violations  that  could 
lead to debarment and also, in more limited circumstances, provides for the suspension of the marketing of approved 
drugs by the affected company. Lastly, the Generic Drug Enforcement Act allows for civil penalties and withdrawal 
of previously approved applications. Neither we nor any of our employees have ever been subject to debarment.  

Drug delivery systems such as injectors may be legally marketed as a medical device or may be evaluated as 
part  of  the  drug  approval  process  in  connection  with  an  NDA  or  a  Product  License  Application  (“PLA”). 
Combination drug/device products raise unique scientific, technical and regulatory issues. The FDA has established 
an Office of Combination Products to address the challenges associated with the premarket review and regulation of 
combination  products.  New  drug/delivery  combinations  may  require  designation  from  the  Office  of  Combination 
Products to determine assignment to the appropriate regulatory center. To the extent permitted under the FD&C Act 
and current FDA policy, the Company intends to seek the required approvals and clearance for the use of its new 
injectors, as modified for use in specific drug applications under the medical device provisions, rather than under the 
new drug provisions, of the FD&C Act. 

Products regulated as medical devices can be commercially distributed in the United States if they have been 
found  substantially  equivalent  to  a  marketed  product  or  approved  by  the  FDA,  or  have  been  exempted  from  the 
FD&C  Act  and  regulations  thereunder.  Under  Section  510(k)  of  the  FD&C  Act  (“510(k)  notification”),  certain 
products qualify for a pre-market notification (“PMN”) of the manufacturer’s intention to commence marketing the 
product.  The  manufacturer  must,  among  other  things,  establish  in  the  PMN  that  the  product  to  be  marketed  is 
substantially equivalent to another legally marketed product (that is, that it has the same intended use and that it is as 
safe  and  effective  as  a  legally  marketed  device  and  does  not  raise  questions  of  safety  and  effectiveness  that  are 
different from those associated with the legally marketed device). Marketing may commence when the FDA issues a 
letter finding substantial equivalence to such a legally marketed device. The FDA may require, in connection with a 
PMN, that it be provided with animal and/or human test results. If a medical device does not qualify for the 510(k) 
procedure, the manufacturer must file a pre-market approval (“PMA”) application under Section 515 of the FD&C 
Act. A PMA must show that the device is safe and effective and is generally a much more complex submission than 
a 510(k) notification, typically requiring more extensive pre-filing testing and a longer FDA review process.  

In addition to submission when a device is being introduced into the market for the first time, a PMN is also 
required  when  the  manufacturer  makes  a  change  or  modification  to  a  previously  marketed  device  that  could 

21 

 
 
 
 
 
 
 
 
 
 
 
 
significantly affect safety or effectiveness, or where there is a major change or modification in the intended use or in 
the  manufacture  of  the  device.  When  any  change  or  modification  is  made  in  a  device  or  its  intended  use,  the 
manufacturer is expected to make the initial determination as to whether the change or modification is of a kind that 
would  necessitate  the  filing  of  a  new  510(k)  notification.  The  Medi-Jector  VISION®  injection  system  is  a  legally 
marketed  device  under  Section  510(k)  of  the  FD&C  Act.  In  the  future  the  Company  or  its  partners  may  submit 
510(k) notifications with regard to further device design improvements and uses with additional drug therapies. 

If  the  FDA  concludes  that  any  or  all  of  the  Company’s  new  injectors  must  be  handled  under  the  new  drug 
provisions of the FD&C Act, substantially greater regulatory requirements and approval times will be imposed. Use 
of a modified new product with a previously unapproved new drug likely will be handled as part of the NDA for the 
new drug itself. Under these circumstances, the device component will be handled as a drug accessory and will be 
approved, if ever, only when the NDA itself is approved. The Company’s injectors may be required to be approved 
as  a  combination drug/device  product  under  a  supplemental  NDA for  use  with  previously  approved  drugs. Under 
these circumstances, the Company’s device could be used with the drug only if and when the supplemental NDA is 
approved for this purpose. It is possible that, for some or even all drugs, the FDA may take the position that a drug-
specific approval must be obtained through a full NDA or supplemental NDA before the device may be packaged 
and sold in combination with a particular drug. 

To  the  extent  that  the  Company’s  modified  injectors  are  packaged  with  the  drug,  as  part  of  a  drug  delivery 
system, the entire package may be subject to the requirements for drug/device combination products. These include 
drug manufacturing requirements, drug adverse reaction reporting requirements, and all of the restrictions that apply 
to  drug  labeling  and  advertising.  In  general,  the  drug  requirements  under  the  FD&C  Act  are  more  onerous  than 
medical device requirements. These requirements could have a substantial adverse impact on the Company’s ability 
to commercialize its products and its operations.  

The FD&C Act also regulates quality control and manufacturing procedures by requiring the Company and its 
contract  manufacturers  to  demonstrate  compliance  with  the  current  Quality  System  Regulations  (“QSR”).  The 
FDA’s interpretation and enforcement of these requirements have been increasingly strict in recent years and seem 
likely to be even more stringent in the future. The FDA monitors compliance with these requirements by requiring 
manufacturers to register with the FDA and by conducting periodic FDA inspections of manufacturing facilities. If 
the  inspector  observes  conditions  that  might  violate  the  QSR,  the  manufacturer  must  correct  those  conditions  or 
explain  them  satisfactorily.  Failure  to  adhere  to  QSR  requirements  would  cause  the  devices  produced  to  be 
considered in violation of the FDA Act and subject to FDA enforcement action that might include physical removal 
of the devices from the marketplace.  

The FDA’s Medical Device Reporting Regulation requires companies to provide information to the FDA on the 
occurrence of any death or serious injuries alleged to have been associated with the use of their products, as well as 
any product malfunction that would likely cause or contribute to a death or serious injury if the malfunction were to 
recur. In addition, FDA regulations prohibit a device from being marketed for unapproved or uncleared indications. 
If  the  FDA  believes  that  a  company  is  not  in  compliance  with  these  regulations,  it  could  institute  proceedings  to 
detain or seize company products, issue a recall, seek injunctive relief or assess civil and criminal penalties against 
the company or its executive officers, directors or employees.  

In addition to regulations enforced by the FDA, we must also comply with regulations under the Occupational 
Safety  and  Health  Act,  the  Environmental  Protection  Act,  the  Toxic  Substances  Control  Act,  the  Resource 
Conservation and Recovery Act and other federal, state and local regulations.  

In addition to regulations in the United States, we are subject to various foreign regulations governing clinical 
trials  and  the  commercial  sales  and  distribution  of  our  products.  We  must  obtain  approval  of  a  product  by  the 
comparable regulatory authorities of foreign countries before we can commence clinical trials or marketing of the 
product in those countries. The requirements governing the conduct of clinical trials, product licensing, pricing and 
reimbursement and the regulatory approval process all vary greatly from country to country. Additionally, the time it 
takes  to  complete  the  approval  process  in  foreign  countries  may  be  longer  or  shorter  than  that  required  for  FDA 
approval. Foreign regulatory approvals of our products are necessary whether or not we obtain FDA approval for 
such products. Finally, before a new drug may be exported from the United States, it must either be approved for 

22 

 
 
 
 
 
 
 
 
 
 
 
 
marketing in the United States or meet the requirements of exportation of an unapproved drug under Section 802 of 
the Export Reform and Enhancement Act or comply with FDA regulations pertaining to INDs. 

Under European Union regulatory systems, we are permitted to submit marketing authorizations under either a 
centralized  or  decentralized  procedure.  The  centralized  procedure  provides  for  the  grant  of  a  single  marketing 
authorization that is valid for all  member states of the European Union. The decentralized procedure provides for 
mutual recognition of national approval decisions by permitting the holder of a national marketing authorization to 
submit an application to the remaining member states. Within 90 days of receiving the applications and assessment 
report, each member state must decide whether to recognize approval.  

Sales of medical devices outside of the U.S. are subject to foreign legal and regulatory requirements. Certain of 
the Company’s transdermal and injection systems have been approved for sale only in certain foreign jurisdictions. 
Legal  restrictions  on  the  sale  of  imported  medical  devices  and  products  vary  from  country  to  country.  The  time 
required to obtain approval by a foreign country may be longer or shorter than that required for FDA approval, and 
the requirements may differ. Antares relies upon the companies marketing its injectors in foreign countries to obtain 
the  necessary  regulatory  approvals  for  sales  of  the  Company’s  products  in  those  countries.  Generally,  products 
having an effective 510(k) clearance or PMA may be exported without further FDA authorization.  

The Company has obtained ISO 13485: 2003 certification, the medical device industry standard for its quality 
systems.  This  certification  shows  that  the  Company’s  development  and  manufacturing  comply  with  standards  for 
quality  assurance,  design  capability  and  manufacturing  process  control.  Such  certification,  along  with  compliance 
with  the  European  Medical  Device  Directive  enables  the  Company  to  affix  the  CE  Mark  to  current  products  and 
supply  the device  with  a  Declaration of  Conformity.  Semi-annual  audits  by  the  Company’s notified body,  British 
Standards Institute, are required to demonstrate continued compliance.  

The  Company  has  also  received  GMP  approval  from  the  Swiss  Medical  Institute  for  the  production  and 
wholesaling of medicaments, specifically related to its Advanced Transdermal Delivery (ATD™) gels. This allows 
the Company to produce clinical trial materials and related packaging as well as production of intermediate products 
and end-user medicaments. 

Employees  

  We believe that our success is largely dependent upon our ability to attract and retain qualified personnel in the 
research, development, manufacturing, business development and commercialization fields. As of March 15, 2007, 
we  had  27  full-time  and  3  part-time  employees  worldwide,  of  whom  15  are  in  the  United  States.  Of  the  30 
employees,  16  are  primarily  involved  in  research,  development  and  manufacturing  activities,  2  are  primarily 
involved  in  business  development  and  commercialization,  with  the  remainder  engaged  in  executive  and 
administrative capacities. Although we believe that we are appropriately sized to focus on our mission, we intend to 
add personnel with specialized expertise, as needed. 

  We  believe  that  we  have  been  successful  to  date  in  attracting  skilled  and  experienced  scientific  and  business 
professionals. We consider our employee relations to be good, and none of our employees are represented by any 
labor union or other collective bargaining unit. However, competition for personnel is intense and we cannot assure 
that we will continue to be able to attract and retain personnel of high caliber. 

23 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Item 1A.  

RISK FACTORS 

The following “risk factors” contain important information about us and our business and should be read in 
their entirety. Additional risks and uncertainties not known to us or that we now believe to be not material could 
also  impair  our  business.  If  any  of  the  following  risks  actually  occur,  our  business,  results  of  operations  and 
financial condition could suffer significantly. As a result, the market price of our common stock could decline and 
you could lose all of your investment. In this Section, the terms “we” and “our” refer to Antares Pharma, Inc. 

Risks Related to Our Operations 

We have incurred significant losses to date, and there is no guarantee that we will ever become profitable  

  We incurred net losses of ($8,099,846) and ($8,497,956) in the fiscal years ended 2006 and 2005, respectively. 
In addition, we have accumulated aggregate net losses from the inception of business through December 31, 2006 of 
($99,322,453).  The  costs  for  research  and  product  development  of  our  drug  delivery  technologies  along  with 
marketing  and  selling  expenses  and  general  and  administrative  expenses  have  been  the  principal  causes  of  our 
losses.  We may not ever become profitable and if we do not become profitable your investment would be harmed. 

We may need additional capital in the future in order to continue our operations 

In  February  of  2007  we  received  gross  proceeds  of  $5,000,000  upon  closing  of  the  first  tranche  of  a 
$10,000,000 credit facility, to help fund working capital needs.  A second tranche of $5,000,000 is available after 
September  30,  2007  but  before  December  31,  2007  under  certain  conditions.    In  March  of  2006  we  completed  a 
private placement of our common stock in which we received aggregate gross proceeds of $10,962,500. We believe 
that  the  combination  of  the  debt  and  equity  financings  and  projected  product  sales,  product  development,  license 
revenues, milestone payments and royalties will provide us with sufficient funds to support operations beyond 2007. 
However,  if  we  need  additional  financing  and  are  unable  to  obtain  such  financing  when  needed,  or  obtain  it  on 
favorable terms, we may be required to curtail development of new drug technologies, limit expansion of operations, 
accept financing terms that are not as attractive as we may desire or be forced to liquidate and close operations. 

Long-term  capital  requirements  will  depend  on  numerous  factors,  including,  but  not  limited  to,  the  status  of 
collaborative  arrangements,  the  progress  of  research  and  development  programs  and  the  receipt  of  revenues  from 
sales of products. Our ability to achieve and/or sustain profitable operations depends on a number of factors, many 
of which are beyond our control. These factors include, but are not limited to, the following:  

(cid:131)  the demand for our technologies from current and future biotechnology and pharmaceutical partners;  
(cid:131)  our ability to manufacture products efficiently, at the appropriate commercial scale, and with the required 

quality;  

(cid:131)  our ability to increase and continue to outsource manufacturing capacity to allow for new product 

introductions;  

(cid:131)  the level of product competition and of price competition;  
(cid:131) 
our ability to develop, maintain or acquire patent positions; 
(cid:131) 
patient acceptance of our current and future products; 
(cid:131)  our ability to develop additional commercial applications for our products;  
(cid:131)  our limited regulatory and commercialization experience; 
(cid:131)  our reliance on outside consultants; 
(cid:131)  our ability to obtain regulatory approvals;  
(cid:131)  our ability to attract the right personnel to execute our plans; 
(cid:131)  our ability to control costs; and  
(cid:131)  general economic conditions.  

As we changed our business model to be more commercially oriented by further developing our own products, we 
may not have sufficient resources to fully execute our plan. 

  We  must  make  choices  as  to  the  drugs  that  we  will  combine  with  our  transdermal  gel,  fast-melt  tablet  and 
disposable mini-needle and reusable needle free technologies to move into the marketplace. We may not make the 

24 

 
 
 
  
  
 
 
 
 
 
  
 
 
correct choice of drug or technologies when combined with a drug, which may not be accepted by the marketplace 
as we expected or at all. FDA approval processes for the drugs and drugs with devices may be longer in time and/or 
more  costly  and/or  require  more  extended  clinical  evaluation  than  anticipated.  Funds  required  to  bring  our  own 
products  to  market  may  be  more  than  anticipated  or  may  not  be  available  at  all.  We  have  limited  experience  in 
development  of  compounds  and  in  regulatory  matters  and  bringing  such  products  to  market;  therefore,  we  may 
experience difficulties in making this change or not be able to achieve the change at all. 

We currently depend on a limited number of customers for the majority of our revenue, and the loss of any one of 
these customers could substantially reduce our revenue and impact our liquidity 

During 2006, we derived approximately 39% and 24% of our revenue, from Ferring and BioSante, respectively.  

The loss of either of these customers/partners could cause our revenues to decrease significantly, increase our 
continuing  losses  from  operations  and,  ultimately,  could  require  us  to  cease  operating.  If  we  cannot  broaden  our 
customer base, we will continue to depend on a few customers for the majority of our revenues. Additionally, if we 
are unable to negotiate favorable business terms with these customers in the future, our revenues and gross profits 
may be insufficient to allow us to achieve and/or sustain profitability or continue operations.  

The Company has entered into three License, Development and/or Supply agreements since November of 2005 
with Teva Pharmaceutical Industries Ltd. and/or an affiliate of Teva.  Although certain upfront payments have been 
received,  there  have  been  no  commercial  sales  and  there  can  be  no  assurance  that  there  ever  will  be  commercial 
sales under these agreements or any other agreements we have with third parties. 

If we or our third-party manufacturer are unable to supply Ferring with our devices pursuant to our current license 
agreement with Ferring, Ferring would own a fully paid up license for certain of our intellectual property  

Pursuant to our license agreement with Ferring, we licensed certain of our intellectual property related to our 
needle-free injection devices, including a license that allows Ferring to manufacture our devices on its own under 
certain circumstances for use with its human growth hormone product.  In accordance with the license agreement, 
we entered into a manufacturing agreement with a third party to manufacture our devices for Ferring. If we or this 
third party are unable to meet our obligations to supply Ferring with our devices, Ferring would own a fully paid up 
license  to  manufacture  our  devices  and  to  use  and  exploit  our  intellectual  property  in  connection  with  Ferring’s 
human growth hormone product. In such event, we would no longer receive manufacturing margins from Ferring.  

If we do not develop and maintain relationships with manufacturers of our drug candidates, then we may not 
successfully manufacture and sell our pharmaceutical products.  

We  do  not  possess  the  capabilities,  resources  or  facilities  to  manufacture  Anturol™,  which  is  currently  in 
development  for  over  active  bladder,  or  any  other  of  our  future  drug  candidates.  We  must  contract  with 
manufacturers to produce Anturol™ according to government regulations. Our future development and delivery of 
our  product  candidates  depends  on  the  timely,  profitable  and  competitive  performance  of  these  manufacturers.  A 
limited number of manufacturers exist which are capable of manufacturing our product candidates. We may fail to 
contract with the necessary manufacturers or we may contract with manufactures on terms that may not be favorable 
to us. Our manufacturers must obtain FDA approval for their manufacturing processes, and we have no control over 
this approval process. 

We  have  not  contracted  with  a  commercial  supplier  of  active  pharmaceutical  ingredients  of  oxybutynin  for 
Anturol™ at this time. We are currently working towards selecting a manufacturer to provide us with oxybutynin in 
a manner which meets FDA requirements. 

We  have  contracted  with  Patheon,  a  manufacturing  development  company,  to  supply  clinical  quantities  of 
Anturol™ in a  manner that meets FDA requirements. The FDA has not approved the  manufacturing processes of 
Patheon. Any failure by Patheon to achieve compliance with FDA standards could significantly harm our business 
since we do not currently have an approved secondary manufacturer for Anturol™.  

25 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
We have limited device manufacturing experience and may experience manufacturing difficulties related to the use 
of new device materials and procedures, which could increase our production costs and, ultimately, decrease our 
profits  

Our  past  assembly,  testing  and  device  manufacturing  experience  for  certain  of  our  device  technologies  has 
involved the assembly of products from  machined stainless steel and composite components in limited quantities. 
Our  planned  future  drug  delivery  device  technologies  necessitate  significant  changes  and  additions  to  our 
manufacturing  and  assembly  process  to  accommodate  new  components.  These  systems  must  be  manufactured  in 
compliance with regulatory requirements, in a timely manner and in sufficient quantities while maintaining quality 
and  acceptable  manufacturing  costs.  In  the  course  of  these  changes  and  additions  to  our  manufacturing  and 
production  methods, we  may  encounter difficulties,  including problems  involving scale-up,  yields, quality  control 
and  assurance,  product  reliability,  manufacturing  costs,  existing  and  new  equipment,  component  supplies  and 
shortages of personnel, any of which could result in significant delays in production. Additionally, we entered into a 
manufacturing  agreement  under  which  a  third  party  assembles  our  MJ7  devices  and  certain  related  disposable 
component parts. There can be no assurance that this third-party manufacturer will be able to meet these regulatory 
requirements  or  our  own  quality  control  standards.  Therefore,  there  can  be  no  assurance  that  we  will  be  able  to 
successfully  produce  and  manufacture  our  products.  Any  failure  to  do  so  would  negatively  impact  our  business, 
financial  condition  and  results  of  operations.  We  continue  to  outsource  manufacturing  of  our  disposable  injection 
products  to  third  parties.  Such  products  will  be  price  sensitive  and  may  be  required  to  be  manufactured  in  large 
quantities,  and  we  have  no  assurance  that  this  can  be  done.    Additionally,  we  have  not  entered  into  any 
manufacturing agreement for these products. 

Our  products  have  achieved  only  limited  acceptance  by  patients  and  physicians,  which  continues  to  restrict 
marketing penetration and the resulting sales of more units 

Our  business  ultimately  depends  on  patient  and  physician  acceptance  of  our  needle-free  and  mini-needle 
injectors,  transdermal  gels,  fast-melt  tablets  and  our  other  drug  delivery  technologies  as  an  alternative  to  more 
traditional  forms  of  drug  delivery,  including  injections  using  a  needle,  orally  ingested  drugs  and  more  traditional 
transdermal  patch  products.  To  date,  our  device  technologies  have  achieved  only  limited  acceptance  from  such 
parties.  The  degree  of  acceptance  of  our  drug  delivery  systems  depends  on  a  number  of  factors.  These  factors 
include, but are not limited to, the following:  

advantages over alternative drug delivery systems or similar products from other companies;  

•  
•   demonstrated clinical efficacy, safety and enhanced patient compliance;  
•  
•  
•   marketing and distribution support; and 
•  

cost-effectiveness;  
convenience and ease of use of injectors and transdermal gels;  

successful launch of our pharmaceutical partners products which utilize our devices. 

Physicians may refuse to prescribe products incorporating our drug delivery technologies if they believe that the 
active  ingredient  is  better  administered  to  a  patient  using  alternative  drug  delivery  technologies,  that  the  time 
required to explain use of the technologies to the patient would not be offset by advantages, or they believe that the 
delivery method will result in patient noncompliance. Factors such as patient perceptions that a gel is inconvenient 
to apply or that devices do not deliver the drug at the same rate as conventional drug delivery methods may cause 
patients to reject our drug delivery technologies. Because only a limited number of products incorporating our drug 
delivery technologies are commercially available, we cannot yet fully assess the level of market acceptance of our 
drug delivery technologies.  

A  2002  National  Institute  of  Health  (“NIH”)  study  and  the  2003  findings  from  the  Million  Women  Study  first 
launched in 1997 in the U.K. questioned the safety of hormone replacement therapy for menopausal women, and our 
female hormone replacement therapy business may suffer as a result  

In July 2002, the NIH halted a long-term study, known as the Women’s Health Initiative, being conducted on 
oral female hormone replacement therapy (“HRT”) using a combination of estradiol and progestin because the study 
showed an increased risk of breast cancer, heart disease and blood clots in women taking the combination therapy. 
The arm of the study using estrogen alone was stopped in March 2004 after the NIH concluded that the benefits of 

26 

 
 
 
 
 
 
 
 
 
 
 
estrogen did not outweigh the stroke risk for women in this trial. The halted study looked at only one brand of oral 
combined HRT and of estrogen, and there is no information on whether brands with different levels of hormones 
would carry the same risk. In January 2003, the FDA announced that it would require new warnings on the labels of 
HRT  products,  and  it  advised  patients  to  consult  with  their  physicians  about  whether  to  continue  treatment  with 
continuous  combined  HRT  and  to  limit  the  period  of  use  to  that  required  to  manage  post-menopausal  vasomotor 
symptoms only. Subsequently, additional analysis from the NIH study has suggested a slight increase in the risk of 
cognitive dysfunction developing in patients on long-term combined HRT. The Million Women Study, conducted in 
the U.K., confirmed that current and recent use of HRT increases a woman’s chance of developing breast cancer and 
that  the  risk  increased  with  duration  of  use.  Other  HRT  studies  have  found  potential  links  between  HRT  and  an 
increased risk of dementia and asthma. These results and recommendations impacted the use of HRT, and product 
sales  have  diminished  significantly.  We  cannot  yet  assess  the  impact  any  of  the  studies’  results  may  have  on  our 
contracts  or  on  our  partners’  perspective  of  the  market  for  transdermal  gel  products  designed  for  HRT.  We  also 
cannot predict whether our alternative route of transdermal administration of HRT products will carry the same risk 
as  the  oral  products  used  in  the  study.    In  2006  the  FDA  approved  Elestrin®,  an  estrogen  gel  developed  by  our 
partner BioSante for the treatment of vasomotor symptoms associated with menopause.  The determination by the 
FDA  of  Elestrin’s  efficacy  and  safety  may  not  impact  the  acceptance  by  physicians  and  patients  of  this  newly 
approved product. 

If transdermal gels do not achieve greater market acceptance, we may be unable to achieve profitability 

Because  transdermal  gels  are  a  newer,  less  understood  method  of  drug  delivery,  our  potential  partners  and 
consumers  have  little  experience  with  such  products.  Our  assumption  of  higher  value  may  not  be  shared  by  the 
potential partner and consumer. To date, transdermal gels have gained successful entry into only a limited number of 
markets.  There  can  be no  assurance  that  transdermal  gels  will  ever  gain market  acceptance  beyond  these  markets 
sufficient to allow us to achieve and/or sustain profitable operations in this product area.  

  We are developing Anturol, our oxybutynin gel for overactive bladder.  We may seek a pharmaceutical partner 
to assist in the payment for the development and marketing of this potential product.  We may be unsuccessful in 
partnering Anturol which may delay or affect the timing of the clinical program due to availability of resources. 

We rely on third parties to supply components for our products, and any failure to retain relationships with these 
third parties could negatively impact our ability to manufacture our products  

Certain of our technologies contain a number of customized components manufactured by various third parties. 
Regulatory requirements applicable to manufacturing can make substitution of suppliers costly and time-consuming. 
In the event that we could not obtain adequate quantities of these customized components from our suppliers, there 
can  be  no  assurance  that  we  would  be  able  to  access  alternative  sources  of  such  components  within  a  reasonable 
period  of  time,  on  acceptable  terms  or  at  all.  The  unavailability  of  adequate  quantities,  the  inability  to  develop 
alternative sources, a reduction or interruption in supply or a significant increase in the price of components could 
have a material adverse effect on our ability to manufacture and market our products.  

We may be unable to successfully expand into new areas of drug delivery technology, which could negatively impact 
our business as a whole  

  We  intend  to  continue  to  enhance  our  current  technologies.  Even  if  enhanced  technologies  appear  promising 
during various stages of development, we may not be able to develop commercial applications for them because  

the potential technologies may fail clinical studies;  

•   
•   we may not find a pharmaceutical company to adopt the technologies;  
it may be difficult to apply the technologies on a commercial scale;  
•  
• 
the technologies may not be economical to market; or  
•  we may not receive necessary regulatory approvals for the potential technologies.  

  We  have  not  yet  completed  research  and  development  work  or  obtained  regulatory  approval  for  any 
technologies for use with any drugs other than insulin, human growth hormone and estradiol (Elestrin®). There can 
be no assurance that any newly developed technologies will ultimately be successful or that unforeseen difficulties 

27 

 
 
 
 
 
 
 
 
 
 
 
will  not  occur  in  research  and  development,  clinical  testing,  regulatory  submissions  and  approval,  product 
manufacturing  and  commercial  scale-up,  marketing,  or  product  distribution  related  to  any  such  improved 
technologies  or  new  uses.  Any  such  occurrence  could  materially  delay  the  commercialization  of  such  improved 
technologies or new uses or prevent their market introduction entirely.  

As  health  insurance  companies  and other  third-party payors  increasingly  challenge  the  products  and  services  for 
which they will provide coverage, our individual consumers may not be able to receive adequate reimbursement or 
may be unable to afford to use our products, which could substantially reduce our revenues and negatively impact 
our business as a whole 

Our injector device products are currently sold in the European Community (“EC”) and elsewhere for use with 
human growth hormone and in the United States for use with insulin. In the case of human growth hormone, our 
products are generally provided to users at no cost by the drug supplier. In the United States the injector products are 
marketed and available for use with insulin.  

Although it is impossible for us to identify the amount of sales of our products that our customers will submit 
for  payment  to  third-party  insurers,  at  least  some  of  these  sales  may  be  dependent  in  part  on  the  availability  of 
adequate reimbursement from these third-party healthcare payors. Currently, insurance companies and other third-
party  payors  reimburse  the  cost  of  certain  technologies  on  a  case-by-case  basis  and  may  refuse  reimbursement  if 
they  do  not  perceive  benefits  to  a  technology’s  use  in  a  particular  case.  Third-party  payors  are  increasingly 
challenging the pricing of medical products and services, and there can be no assurance that such third-party payors 
will not in the future increasingly reject claims for coverage of the cost of certain of our technologies. Insurance and 
third-party  payor  practice  vary  from  country  to  country,  and  changes  in  practices  could  negatively  affect  our 
business  if  the  cost  burden  for  our  technologies  were  shifted  more  to  the  patient.  Therefore,  there  can  be  no 
assurance  that  adequate  levels  of  reimbursement  will  be  available  to  enable  us  to  achieve  or  maintain  market 
acceptance  of  our  technologies  or  maintain  price  levels  sufficient  to  realize  profitable  operations.  There  is  also  a 
possibility of increased government control or influence over a broad range of healthcare expenditures in the future. 
Any such trend could negatively impact the market for our drug delivery products and technologies.  

Elestrin®,  for  which  we  will  receive  royalties  from  our  partner  based  on  any  commercial  sales,  has  not  been 
commercially launched to date.  Therefore, we have no way of knowing at this time if health insurance companies 
will reimburse patients for the use of Elestrin®.  

The  loss  of  any  existing  licensing  agreements  or  the  failure  to  enter  into  new  licensing  agreements  could 
substantially affect our revenue  

One  of  our  business  pathways  requires  us  to  enter  into  license  agreements  with  pharmaceutical  and 
biotechnology companies covering the development, manufacture, use and marketing of drug delivery technologies 
with specific drug therapies. Under these arrangements, the partner companies typically assist us in the development 
of systems for such drug therapies and collect or sponsor the collection of the appropriate data for submission for 
regulatory approval of the use of the drug delivery technology with the licensed drug therapy. Our licensees may 
also be responsible for distribution and marketing of the technologies for these drug therapies either worldwide or in 
specific territories. We are currently a party to a number of such agreements, all of which are currently in varying 
stages  of  development.  We  may  not  be  able  to  meet  future  milestones  established  in  our  agreements  (such 
milestones  generally  being  structured  around  satisfactory  completion  of  certain  phases  of  clinical  development, 
regulatory approvals and commercialization of our product) and thus, would not receive the fees expected from such 
arrangements,  related  future  royalties  or  product  sales.  Moreover,  there  can  be  no  assurance  that  we  will  be 
successful  in  executing  additional  collaborative  agreements  or  that  existing  or  future  agreements  will  result  in 
increased  sales  of  our  drug  delivery  technologies.  In  such  event,  our  business,  results  of  operations  and  financial 
condition could be adversely affected, and our revenues and gross profits may be insufficient to allow us to achieve 
and/or  sustain profitability.  As  a  result  of our  collaborative  agreements,  we  are  dependent  upon  the  development, 
data collection and marketing efforts of our licensees. The amount and timing of resources such licensees devote to 
these efforts are not within our control, and such licensees could make material decisions regarding these efforts that 
could  adversely  affect  our  future  financial  condition  and  results  of  operations.  In  addition,  factors  that  adversely 
impact  the  introduction  and  level  of  sales  of  any  drug  or  drug  device  covered  by  such  licensing  arrangements, 

28 

 
 
 
 
 
 
 
 
 
 
including  competition  within  the  pharmaceutical  and  medical  device  industries,  the  timing  of  regulatory  or  other 
approvals and intellectual property litigation, may also negatively affect sales of our drug delivery technology.  

The failure of any of our third-party licensees to develop, obtain regulatory approvals for, market, distribute and 
sell our products as planned may result in us not meeting revenue and profit targets  

Pharmaceutical  company  partners  help  us  develop,  obtain  regulatory  approvals  for,  manufacture  and  sell  our 
products. If one or more of these pharmaceutical company partners fail to pursue the development or marketing of 
the products as planned, our revenues and profits may not reach expectations or may decline. We may not be able to 
control the timing and other aspects of the development of products because pharmaceutical company partners may 
have priorities that differ from ours. Therefore, commercialization of products under development may be delayed 
unexpectedly.  Generally  speaking,  in  the  near  term,  we  do  not  intend  to  have  a  direct  marketing  channel  to 
consumers  for  our  drug  delivery  products  or  technologies  except  through  current  distributor  agreements  in  the 
United  States  for  our  insulin  delivery  device.  Therefore,  the  success  of  the  marketing  organizations  of  our 
pharmaceutical company partners, as well as the level of priority assigned to the marketing of the products by these 
entities,  which  may  differ  from  our  priorities,  will  determine  the  success  of  the  products  incorporating  our 
technologies. Competition in this market could also force us to reduce the prices of our technologies below currently 
planned levels, which could adversely affect our revenues and future profitability.  

If we cannot develop and market our products as rapidly or cost-effectively as our competitors, then we may never 
be able to achieve profitable operations. 

Competitors  in  the  over  active  bladder,  transdermal  gel  drug  delivery  and  needle-free  injector  and  other 
markets,  some  with  greater  resources  and  experience  than  us,  may  enter  these  markets,  as  there  is  an  increasing 
recognition of a need for less invasive methods of delivering drugs. Additionally, there is an ever increasing list of 
competitors  in  the  oral  disintegrating  fast-melt  tablet  business.  Our  success  depends,  in  part,  upon  maintaining  a 
competitive  position  in  the  development  of  products  and  technologies  in  rapidly  evolving  fields.  If  we  cannot 
maintain  competitive  products  and  technologies,  our  current  and  potential  pharmaceutical  company  partners  may 
choose to adopt the drug delivery technologies of our competitors. Drug delivery companies that compete with our 
technologies  include  Bioject  Medical  Technologies,  Inc.,  Bentley  Pharmaceuticals,  Inc.,  Auxillium,  BioChemics, 
Inc.,  Aradigm,  Cellegy  Pharmaceuticals,  Inc.,  Watson  Pharmaceuticals,  Cardinal  Health,  CIMA  Laboratories, 
Laboratoires  Besins-Iscovesco,  MacroChem  Corporation,  NexMed,  Inc.,  The  Medical  House  and  Novavax,  Inc., 
along with other companies. We also compete generally with other drug delivery, biotechnology and pharmaceutical 
companies engaged in the development of alternative drug delivery technologies or new drug research and testing. 
Many of these competitors have substantially greater financial, technological, manufacturing, marketing, managerial 
and  research  and  development  resources  and  experience  than  we  do,  and,  therefore,  represent  significant 
competition.  

Additionally,  new  drug  delivery  technologies  are  mostly  used  only  with  drugs  for  which  other  drug  delivery 
methods are not possible, in particular with biopharmaceutical proteins (drugs derived from living organisms, such 
as  insulin  and  human  growth  hormone)  that  cannot  currently  be  delivered  orally  or  transdermally.  Transdermal 
patches and gels are also used for drugs that cannot be delivered orally or where oral delivery has other limitations 
(such  as  high  first  pass  drug  metabolism,  meaning  that  the  drug  dissipates  quickly  in  the  digestive  system  and, 
therefore,  requires  frequent  administration).  Many  companies,  both  large  and  small,  are  engaged  in  research  and 
development  efforts  on  less  invasive  methods  of  delivering  drugs  that  cannot  be  taken  orally.  The  successful 
development and commercial introduction of such non-injection techniques could have a material adverse effect on 
our business, financial condition, results of operations and general prospects.  

Competitors  may  succeed  in  developing  competing  technologies  or  obtaining  governmental  approval  for 
products before we do. Competitors’ products may gain market acceptance more rapidly than our products, or may 
be  priced  more  favorably  than  our  products.  Developments  by  competitors  may  render  our  products,  or  potential 
products, noncompetitive or obsolete.  

29 

 
 
 
 
 
 
 
 
 
 
 
 
 
Although  we  have  applied  for,  and  have  received,  several  patents,  we  may  be  unable  to  protect  our  intellectual 
property, which would negatively affect our ability to compete  

Our  success  depends,  in  part,  on  our  ability  to  obtain  and  enforce  patents  for  our  products,  processes  and 
technologies and to preserve our trade secrets and other proprietary information. If we cannot do so, our competitors 
may exploit our innovations and deprive us of the ability to realize revenues and profits from our developments.  

  We  currently  hold  approximately  70  patents  and  have  an  additional  98  applications  pending  in  the  U.S.  and 
other countries. Late in 2006 we received two notices of allowances from the U.S. patent office on patents expected 
to  be  issued  shortly  in  our  ATD™  gel  platform  including  a  patent  related  to  our  formulation  of  Elestrin®,  an 
estradiol  gel  product  approved  by  the  FDA  for  hormone  replacement  therapy  and  a  patent  related  to  our  core  gel 
technology.  The patents have expiration dates ranging from 2015 to 2022. In addition to issued patents and patent 
applications, we are also protected by trade secrets in all of our technology platforms. 

Any  patent  applications  we  may  have  made  or  may  make  relating  to  inventions  for  our  actual  or  potential 
products,  processes  and  technologies  may  not  result  in  patents  being  issued  or  may  result  in  patents  that  provide 
insufficient or incomplete coverage for our inventions. Our current patents may not be valid or enforceable and may 
not  protect  us  against  competitors  that  challenge  our  patents,  obtain  their  own  patents  that  may  have  an  adverse 
effect on our ability to conduct business, or are able to otherwise circumvent our patents. Further, we may not have 
the necessary financial resources to enforce or defend our patents or patent applications.  

To  protect  our  trade  secrets  and  proprietary  technologies  and  processes,  we  rely,  in  part,  on  confidentiality 
agreements  with  employees,  consultants  and  advisors.  These  agreements  may  not  provide  adequate  protection  for 
our trade secrets and other proprietary information in the event of any unauthorized use or disclosure, or if others 
lawfully and independently develop the same or similar information.  

Others may bring infringement claims against us, which could be time-consuming and expensive to defend  

Third parties may claim that the manufacture, use or sale of our drug delivery technologies infringe their patent 
rights.    If  such  claims  are  asserted,  we  may  have  to  seek  licenses,  defend  infringement  actions  or  challenge  the 
validity of those patents in court.  If we cannot obtain required licenses, or obtain licenses on acceptable terms, we 
may not be able to continue to develop and commercialize our product candidates.  Even if we were able to obtain 
rights  to  a  third  party’s  intellectual  property,  these  rights  may  be  non-exclusive,  thereby  giving  our  competitors 
potential access to the same  intellectual property.  If we are found liable for infringement or are not able to have 
these patents declared invalid, we may be liable for significant monetary damages, encounter significant delays in 
bringing  products  to  market  or  be  precluded  from  participating  in  the  manufacture,  use  or  sale  of  products  or 
methods  of  drug  delivery  covered  by  patents  of  others.    Even  if  we  were  able  to  prevail,  any  litigation  could  be 
costly and time-consuming and could divert the attention of our management and key personnel from our business 
operations.  We may not have identified, or be able to identify in the future, United States or foreign patents that 
pose a risk of potential infringement claims.  Furthermore, in the event a patent infringement suit is brought against 
us,  the  development,  manufacture  or  potential  sale  of  product  candidates  claimed  to  infringe  on  a  third  party’s 
intellectual property may have to stop or be delayed.  Ultimately, we may be unable to commercialize some of our 
product candidates as a result of patent infringement claims, which could harm our business. 

  We are aware of a recently issued US Patent relating to a gel formulation of oxybutynin.  We believe that we do 
not infringe this patent and that it should not have been issued.  We may seek to invalidate this patent but there can 
be no assurance that we will prevail.  If the patent is determined to be valid and if Anturol™ is approved, we may be 
delayed in our marketing and the potential market value of Anturol™ may be affected. 

If  the  pharmaceutical  companies  to  which  we  license  our  technologies  lose  their  patent  protection  or  face  patent 
infringement claims for their drugs, we may not realize our revenue or profit plan  

The drugs to which our drug delivery technologies are applied are generally the property of the pharmaceutical 
companies. Those drugs may be the subject of patents or patent applications and other forms of protection owned by 
the  pharmaceutical  companies  or  third  parties.  If  those  patents  or  other  forms  of  protection  expire,  become 

30 

 
 
 
 
 
 
 
 
 
  
 
 
 
 
ineffective  or  are  subject  to  the  control  of  third  parties,  sales  of  the  drugs  by  the  collaborating  pharmaceutical 
company may be restricted or may cease. Our expected revenues, in that event, may not materialize or may decline. 

Our  business  may  suffer  if  we  lose  certain  key  officers  or  employees  or  if  we  are  not  able  to  add  additional  key 
officers or employees necessary to reach our goals 

The success of our business is materially dependent upon the continued services of certain of our key officers 
and  employees.  The  loss  of  such  key  personnel  could  have  a  material  adverse  effect  on  our  business,  operating 
results or financial condition. There can be no assurance that we will be successful in retaining key personnel. We 
consider our employee relations to be good; however, competition for personnel is intense and we cannot assume 
that we will continue to be able to attract and retain personnel of high caliber. 

We are involved in international markets, and this subjects us to additional business risks  

  We have offices and a research facility in Basel, Switzerland, and we also license and distribute our products in 
the  European  Community,  Asia  and  the  United  States.  These  geographic  localities  provide  economically  and 
politically stable environments in which to operate. However, in the future, we intend to introduce products through 
partnerships in other countries. As we expand our geographic market, we will face additional ongoing complexity to 
our business and may encounter the following additional risks:  

•  
increased complexity and costs of managing international operations;  
•   protectionist laws and business practices that favor local companies;  
•   dependence on local vendors;  
•   multiple, conflicting and changing governmental laws and regulations;  
•   difficulties in enforcing our legal rights;  
•  
•   political and economic instability.  

reduced or limited protections of intellectual property rights; and  

A  significant  portion  of  our  international  revenues  is  denominated  in  foreign  currencies.  An  increase  in  the 
value  of  the  U.S.  dollar  relative  to  these  currencies  may  make  our  products  more  expensive  and,  thus,  less 
competitive in foreign markets.  

If  we  make  any  acquisitions,  we  will  incur  a  variety  of  costs  and  might  never  successfully  integrate  the  acquired 
product or business into ours.  

  We might attempt to acquire products or businesses that we believe are a strategic complement to our business 
model.  We  might  encounter  operating  difficulties  and  expenditures  relating  to  integrating  an  acquired  product  or 
business. These acquisitions might require significant management attention that would otherwise be available for 
ongoing development of our business. In addition, we might never realize the anticipated benefits of any acquisition. 
We might also make dilutive issuances of equity securities, incur debt or experience a decrease in cash available for 
our operations, or incur contingent liabilities and/or amortization expenses relating to goodwill and other intangible 
assets, in connection with future acquisitions. 

If we do not have adequate insurance for product liability claims, then we may be subject to significant expenses 
relating to these claims. 

The Company’s business entails the risk of product liability claims. Although the Company has not experienced 
any material product liability claims to date, any such claims could have a material adverse impact on its business. 
The  Company  maintains  product  liability  insurance  with  coverage  of  $5  million  per  occurrence  and  an  annual 
aggregate maximum of $5 million. The Company evaluates its insurance requirements on an ongoing basis. 

Risks Related to Regulatory Matters 

We or our licensees may incur significant costs seeking approval for our products, which could delay the realization 
of revenue and, ultimately, decrease our revenues from such products  

31 

  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The  design,  development,  testing,  manufacturing  and  marketing  of  pharmaceutical  compounds,  medical 
nutrition  and  diagnostic  products  and  medical  devices  are  subject  to  regulation  by  governmental  authorities, 
including  the  FDA  and  comparable  regulatory  authorities  in  other  countries.  The  approval  process  is  generally 
lengthy, expensive and subject to unanticipated delays. Currently, we, along with our partners, are actively pursuing 
marketing approval for a number of products from regulatory authorities in other countries and anticipate seeking 
regulatory approval from the FDA for products developed internally and pursuant to our license agreements.  In the 
future we,  or our partners, may  need  to  seek  approval for newly  developed products.  Our  revenue and  profit  will 
depend, in part, on the successful introduction and marketing of some or all of such products by our partners or us.  

Applicants for FDA approval often must submit extensive clinical data and supporting information to the FDA. 
Varying  interpretations  of  the  data  obtained  from  pre-clinical  and  clinical  testing  could  delay,  limit  or  prevent 
regulatory approval of a drug product. Changes in FDA approval policy during the development period, or changes 
in  regulatory  review  for  each  submitted  new  drug  application  also  may  cause  delays  or  rejection  of  an  approval. 
Even if the FDA approves a product, the approval may limit the uses or “indications” for which a product may be 
marketed, or may require further studies. The FDA also can withdraw product clearances and approvals for failure to 
comply with regulatory requirements or if unforeseen problems follow initial marketing.  

  We  are  currently  evaluating  Anturol™  for  the  treatment  of  overactive  bladder  (OAB).  Anturol™  is  the 
anticholinergic oxybutynin delivered by our proprietary ATD™ gel that is used to achieve therapeutic blood levels 
of the active compound that can be sustained over 24 hours after a single, daily application. 

In February 2006, we announced the results of our Phase II dose ranging study for our ATD™ oxybutynin gel 
product  Anturol™.    The  study  was  an  open  label,  single  period,  randomized  study  using  48  healthy  subjects  and 
three different doses of Anturol™ over a 20 day period.  Our overall conclusions of the study were positive. 

The FDA however, may not concur with our analysis of the data and we may never receive FDA approval for 

Anturol™ and without FDA approval, we cannot market or sell Anturol™. 

Additionally,  we  are  developing,  with  partners,  injection  devices  for  use  with  our  partner’s  drugs.    The 
regulatory  path  for  approval  of  such  combination  products  maybe  subject  to  review  by  several  centers  within  the 
FDA  and  although  precedent  and guidance  exists  for  the requirements  for  such  combination products,  there  is no 
assurance that the FDA will not change what it requires or how it reviews such submissions.  Additionally, there is 
no  assurance  that  the FDA will  not require  human  clinical  testing  in  order  to  commercialize  these  devices.   Such 
changes in review processes or the requirement for clinical studies could delay anticipated launch dates or be at a 
cost  which  makes  launching  the  device  cost  prohibitive  for  our  partners.    Such  delay  or  failure  to  launch  these 
devices could adversely affect our revenues and future profitability. 

In other jurisdictions, we, and the pharmaceutical companies with whom we are developing technologies, must 
obtain  required  regulatory  approvals  from  regulatory  agencies  and  comply  with  extensive  regulations  regarding 
safety and quality. If approvals to market the products are delayed, if we fail to receive these approvals, or if we lose 
previously received approvals, our revenues may not materialize or may decline. We may not be able to obtain all 
necessary regulatory approvals. We may be required to incur significant costs in obtaining or maintaining regulatory 
approvals.  

The 505(b)(2) regulatory pathway for many of our potential pharmaceutical products is uncertain and could result 
in unexpected costs and delays of approvals. 

Transdermal  and  topical  products  indicated  for  the  treatment  of  systemic  or  local  treatments  respectively  are 
regulated  by  the  FDA  in  the  U.S.  and  other  similar  regulatory  agencies  in  other  countries  as  drug  products.  
Transdermal and topical products are considered to be controlled release dosage forms and may not be marketed in 
the U.S. until they have been demonstrated to be safe and effective.  The regulatory approval routes for transdermal 
and topical products include the filing of an NDA for new drugs, new indications of approved drugs or new dosage 
forms of approved drugs.  Alternatively, these dosage forms can obtain marketing approval as a generic product by 
the  filing  of  an  ANDA,  providing  the  new  generic  product  is  bioequivalent  to  and  has  the  same  labeling  as  a 
comparable approved product or as a filing under Section 505(b)(2) where there is an acceptable reference product.  
Other topical products for local treatment do not require the filing of either an NDA or ANDA, providing that these 

32 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
products comply with existing OTC monographs.  The combination of the drug, its dosage form and label claims 
and FDA requirement will ultimately determine which regulatory approval route will be required. 

  Many  of  our  transdermal  product  candidates  may  be  developed  via  the  505(b)(2)  route.  The  505(b)(2) 
regulatory pathway is continually evolving and advice provided in the present is based on current standards, which 
may  or  may  not  be  applicable  when  we  potentially  submit  an  NDA.    Additionally,  we  must  reference  the  most 
similar predicate products when submitting a 505(b)(2) application. It is therefore probable that: 

•  

•  

should a more appropriate reference product(s) be approved by the FDA at any time before or during the 
review of our NDA, we would be required to submit a new application referencing the more appropriate 
product;  
the FDA cannot disclose whether such predicate product(s) is under development or has been submitted at 
any time during another company’s review cycle. 

Accordingly, these regulations and the FDA’s interpretation of them might impair our ability to obtain product 

approval or effectively market our products. 

Our  business  could  be  harmed  if  we  fail  to  comply  with  regulatory  requirements  and,  as  a  result,  are  subject  to 
sanctions  

If we, or pharmaceutical companies with whom we are developing technologies, fail to comply with applicable 
regulatory  requirements,  the  pharmaceutical  companies,  and  we,  may  be  subject  to  sanctions,  including  the 
following:  

fines;  

injunctions;  

•   warning letters;  
•  
•   product seizures or recalls;  
•  
•     refusals to permit products to be imported into or exported out of the applicable regulatory jurisdiction;  
•  
•   withdrawals of previously approved marketing applications; or  
•  

total or partial suspension of production;  

criminal prosecutions.  

Our revenues may be limited if the marketing claims asserted about our products are not approved  

Once  a  drug  product  is  approved  by  the  FDA,  the  Division  of  Drug  Marketing,  Advertising  and 
Communication, the FDA’s marketing surveillance department within the Center for Drugs, must approve marketing 
claims asserted by our pharmaceutical company partners. If we or a pharmaceutical company partner fails to obtain 
from  the  Division  of  Drug  Marketing  acceptable  marketing  claims  for  a  product  incorporating  our  drug 
technologies, our revenues from that product may be limited. Marketing claims are the basis for a product’s labeling, 
advertising and promotion. The claims the pharmaceutical company partners are asserting about our drug delivery 
technologies, or the drug product itself, may not be approved by the Division of Drug Marketing.  

Product liability claims related to participation in clinical trials or the use or misuse of our products could prove to 
be costly to defend and could harm our business reputation  

The testing, manufacturing and marketing of products utilizing our drug delivery technologies may expose us to 
potential product liability and other claims resulting from their use in practice or in clinical development. If any such 
claims  against  us  are  successful,  we  may  be  required  to  make  significant  compensation  payments.  Any 
indemnification  that  we  have  obtained,  or  may  obtain,  from  contract  research  organizations  or  pharmaceutical 
companies conducting human clinical trials on our behalf may not protect us from product liability claims or from 
the costs of related litigation. Similarly, any indemnification we have obtained, or may obtain, from pharmaceutical 
companies  with  whom  we  are  developing  drug  delivery  technologies  may  not  protect  us  from  product  liability 
claims from the consumers of those products or from the costs of related litigation. If we are subject to a product 
liability claim, our product liability insurance may not reimburse us, or may not be sufficient to reimburse us, for 
any expenses or losses that may have been suffered. A successful product liability claim against us, if not covered 

33 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
by,  or  if  in  excess  of  our  product  liability  insurance,  may  require us  to  make  significant  compensation payments, 
which would be reflected as expenses on our statement of operations. Adverse claim experience for our products or 
licensed technologies or medical device, pharmaceutical or insurance industry trends may make it difficult for us to 
obtain product liability insurance or we may be forced to pay very high premiums, and there can be no assurance 
that insurance coverage will continue to be available on commercially reasonable terms or at all.  

Risks Related to our Common Stock  

Together, certain of our stockholders own or have the right to acquire a significant portion of our stock and could 
ultimately control decisions regarding our company and impact stock price   

As a result of our reverse business combination with Permatec in January 2001 and subsequent additional debt 
and equity financings, Permatec Holding AG and its controlling shareholder, Dr. Jacques Gonella, own a substantial 
portion (as of March 15, 2007, approximately 18%) of our outstanding shares of common stock. Dr. Gonella, who is 
the  Chairman  of  our  Board  of  Directors,  also  owns  warrants  to  purchase  an  aggregate  of  4,198,976  shares  of 
common  stock  and  options  to  purchase  114,500  shares  of  common  stock.  Additionally,  five  investors  (Crestview 
Capital Master Fund, North Sound Funds, Perceptive Life Sciences Fund, SCO Capital Group and SDS Funds)  own 
warrants  that  are,  as of  March  15, 2007,  exercisable  into an  aggregate of 5,977,733  shares  of our  common  stock. 
Some  of  these  investors  may  also  directly  own  shares of our  common  stock.    If  Dr. Gonella  and  all  of  the  above 
investors exercised all of the warrants and options owned by them, Dr. Gonella would own approximately 21%, and 
the five investors as a group would own, at a minimum, over 9% of our common stock.  

Because the parties described above either currently own or could potentially own a large portion of our stock, 
they  may  be  able  to  generally  determine  or  they  may  be  able  to  significantly  influence  the  outcome  of  corporate 
actions requiring stockholder approval. As a result, these parties may be in a position to control matters affecting our 
company, including decisions as to our corporate direction and policies; future issuances of certain securities; our 
incurrence  of  debt;  amendments  to  our  certificate  of  incorporation  and  bylaws;  payment  of  dividends  on  our 
common stock; and acquisitions, sales of our assets, mergers or similar transactions, including transactions involving 
a change of control. As a result, some investors may be unwilling to purchase our common stock. In addition, if the 
demand for our common stock is reduced because of these stockholders’ control of the Company, the price of our 
common stock could be adversely affected.  Additionally, future sales of large blocks of our common stock by any 
of the above investors could substantially adversely affect our stock price.   

Future conversions or exercises by holders of warrants or options could substantially dilute our common stock 

As of March 15, 2007, we have warrants outstanding that are exercisable, at prices ranging from $0.55 per share 
to $5.00 per share, for an aggregate of approximately 21,400,000 shares of our common stock. We also have options 
outstanding  that  are  exercisable,  at  exercise  prices  ranging  from  $0.70  to  $15.65  per  share,  for  an  aggregate  of 
approximately  5,050,000  shares  of  our  common  stock.  Purchasers  of  common  stock  could  therefore  experience 
substantial dilution of their investment upon exercise of the above warrants or options.  The majority of the shares of 
common stock issuable upon exercise of the warrants or options held by these investors are currently registered. 

Sales of our common stock by our officers and directors may lower the market price of our common stock  

As of March 15, 2007, our officers and directors beneficially owned an aggregate of approximately 15,500,000 
shares  (or  approximately  26%)  of  our  common  stock,  including  stock  options  exercisable  within  60  days.  If  our 
officers  and  directors,  or  other  stockholders,  sell  a  substantial  amount  of  our  common  stock,  it  could  cause  the 
market price of our common stock to decrease and could hamper our ability to raise capital through the sale of our 
equity securities.  

We do not expect to pay dividends in the foreseeable future  

  We intend to retain any earnings in the foreseeable future for our continued growth and, thus, do not expect to 
declare or pay any cash dividends in the foreseeable future.  

34 

 
  
 
 
  
 
 
 
 
 
 
 
 
 
 
Anti-takeover effects of certain certificate of incorporation and bylaw provisions could discourage, delay or prevent 
a change in control. 

Our  certificate  of  incorporation  and  bylaws  could  discourage,  delay  or  prevent  persons  from  acquiring  or 
attempting to acquire us. Our certificates of incorporation authorizes our board of directors, without action of our 
stockholders,  to  designate  and  issue  preferred  stock  in  one  or  more  series,  with  such  rights,  preferences  and 
privileges as the board of directors shall determine. In addition, our bylaws grant our board of directors the authority 
to adopt, amend or repeal all or any of our bylaws, subject to the power of the stockholders to change or repeal the 
bylaws. In addition, our bylaws limit who may call meetings of our stockholders. 

Item 1B.  UNRESOLVED STAFF COMMENTS 

None. 

Item 2. 

DESCRIPTION OF PROPERTY 

The  Company  leases  approximately  7,000  square  feet  of  office  space  in  Ewing,  New  Jersey  for  its  corporate 
headquarters facility. The lease will terminate in January 2012. The Company believes the facility will be sufficient 
to meet its requirements through the lease period at this location. 

The Company leases approximately 9,300 square feet of office and laboratory space in Plymouth, a suburb of 
Minneapolis,  Minnesota,  and  subleases  approximately  half  of  this  space  to  another  company.  The  lease  will 
terminate in April 2011.  The Company believes the facilities will be sufficient to meet its requirements through the 
lease period at this location. 

The Company also leases approximately 650 square meters of facilities in Basel, Switzerland, for office space 
and formulation and analytical laboratories. The lease will terminate in September 2008. The Company believes the 
facilities will be sufficient to meet its requirements through the lease period at this location. 

Item 3. 

LEGAL PROCEEDINGS 

None. 

Item 4. 

SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS 

None.  

35 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
PART II 

Item 5.  MARKET  FOR  REGISTRANT’S  COMMON  EQUITY,  RELATED  STOCKHOLDER  MATTERS  AND 

ISSUER PURCHASES OF EQUITY SECURITIES. 

The  Company’s  Common  Stock  trades  on  the  American  Stock  Exchange  under  the  symbol  “AIS.”    The 
following  table  sets  forth  the  per  share  high  and  low  closing  sales  prices  of  the  Company’s  Common  Stock,  as 
reported by the American Stock Exchange, for each quarterly period during the two most recent fiscal years.  

2006: 

First Quarter 
Second Quarter 
Third Quarter 
Fourth Quarter 

2005: 

First Quarter 
Second Quarter 
Third Quarter 
Fourth Quarter 

High 

Low 

$
$
$
$

$
$
$
$

1.89 
1.75 
1.35 
1.38 

1.46 
1.15 
1.22 
1.61 

$
$
$
$

$
$
$
$

1.10  
1.09  
0.86  
1.00  

0.88  
0.70  
0.78  
0.86  

Common Shareholders  

As of March 15, 2007, the Company had 136 shareholders of record of its common stock. 

Dividends 

The Company has not paid or declared any cash dividends on its common stock during the past nine years. The 
Company has no intention of paying cash dividends in the foreseeable future on common stock. The Company paid 
semi-annual dividends on Series A Convertible Preferred Stock (“Series A”) at an annual rate of 10%, payable on 
May 10 and November 10 each year. In June 2005, all of the Series A was converted into common stock. In addition 
to  the  stated  10%  dividend,  the  Company  had  been  obligated  to  pay  income  tax  withholding  on  the  dividend 
payment, which equates to an effective dividend rate of 14.2%. Such tax withholding payments have been reflected 
as  dividends,  to  the  extent  they  were  non-recoverable.  The  Series  A  agreement  had  a  provision  that  allowed  the 
Company to pay the dividend by issuance of the same stock when funds were not available. The Company exercised 
this provision for ten of the last twelve dividend payments. 

36 

 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Item 6.  

SELECTED FINANCIAL DATA 

The following table summarizes certain selected financial data. The selected financial data is derived from, and is 
qualified  by  reference  to,  our  financial  statements  accompanying  this  report  (amounts  expressed  in  thousands, 
except per share amounts).  

2006 

2005 

2004 

2003 

2002 

At December 31, 

Balance Sheet Data:      

  $

Cash and cash equivalents      
Short-term investments      
Working capital (deficit)      
Total assets      
Long-term liabilities, less current maturities    
Accumulated deficit      
Total stockholders’ equity  

2,706 
4,953 
5,979 
11,534 
3,556 
(99,322) 
5,080 

  $

   $

  $

2,718 
- 
965 
6,166 
3,062 
(91,123)   
757 

1,652 
7,972 
8,489 
13,178 
3,339 
(82,575) 
8,189 

  $ 

1,929  
-  
615  
5,955  
3,558  
  (74,127 ) 
307  

268 
- 
(2,972) 
6,409 
1,247 
(41,166) 
655 

Statement of Operations Data: 

Product sales 

Development revenue 

Licensing fees 

Royalties 

Revenues 

Cost of revenues 

Research and development (3) 

Sales, marketing and business development 

General and administrative (3) (4) 

Goodwill impairment charge 

Operating expenses 

Operating loss 
Net other income (expense) 

Net loss 

Deemed dividend to warrant holder 

Preferred stock dividends 

Net loss applicable to common shares 

Net loss per common share (1) (2) 

  $

  $

Year Ended December 31, 

2006 

2005 

2004 

2003 

2002 

  $

2,195 

  $

1,512 

  $

1,834 

  $ 

2,647  

   $

2,422 

594 

1,254 

225 

4,268 

1,556 

3,778 

1,350 

5,861 

- 

10,989 

(8,277) 
177 

(8,100) 

(99) 

- 

184 

374 

155 

2,225 

1,137 

3,677 

1,161 

4,839 

- 

9,677 

(8,589)   
91 

(8,498)   

- 

197 

635 

80 

2,746 

1,372 

2,870 

676 

6,203 

- 

9,749 

(8,375) 
26 

(8,349) 

- 

(50)   

(100) 

310  

695  

135  

3,787  

2,008  

2,389  

462  

7,562  

-  

  10,413  

(8,634 ) 
  (24,184 ) 

  (32,818 ) 

-  

(143 ) 

935 

639 

- 

3,996 

2,574 

3,331 

798 

5,555 

2,000 

11,684 

(10,262) 
(1,347) 

(11,609) 

- 

(100) 

(8,199) 

  $

(8,548)    $

(8,449) 

  $  (32,961 ) 

   $ (11,709) 

(0.16) 

  $

(0.21)    $

(0.23) 

  $ 

(2.18 ) 

   $

(1.22) 

Weighted average number of common shares  

51,582 

41,460 

36,348 

  15,093  

9,618 

(1)  Basic and diluted loss per share amounts are identical as the effect of potential common shares is anti-dilutive. 
(2)  The Company has not paid any dividends on its Common Stock since inception.  
(3) 

In 2006 the Company reclassified expenses for quality and regulatory activities previously reported as general and administrative expenses 
to  research  and  development  expenses.    The  amounts  of  the  reclassifications  were  $268,  $234,  $280  and  $413  in  2005,  2004,  2003  and 
2002, respectively.  
In 2006, 2004, 2003 and 2002 the Company recorded non-cash patent impairment charges of $139, $233, $974 and $435, respectively. 

(4) 

37 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
  
  
 
 
 
 
 
 
  
 
 
 
 
 
  
 
 
 
 
 
  
 
 
 
 
  
 
 
 
  
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
  
  
 
 
 
 
 
 
  
 
 
 
 
 
  
 
 
 
 
 
  
 
 
 
 
 
 
  
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
  
  
 
 
 
 
 
 
  
 
 
 
 
 
  
 
 
 
 
 
  
 
 
 
 
 
  
 
 
 
 
 
  
 
 
 
 
  
 
 
 
 
  
 
 
 
  
 
 
 
 
 
  
 
 
 
 
  
 
   
 
 
 
 
 
 
 
 
 
  
  
 
 
 
 
 
 
 
 
 
 
 
  
  
 
 
 
 
  
 
Item  7.  

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF 
OPERATIONS 

You should read the following discussion in conjunction with Item 1A.. (“Risk Factors”) and our audited financial statements 
included elsewhere in this report. Some of the statements in the following discussion are forward-looking statements. See 
“Special Note Regarding Forward-Looking Statements.” 

Overview  

The  Company  develops,  produces  and  markets  pharmaceutical  delivery  products,  including  transdermal  gels, 
oral  fast  melting  tablets  and  reusable  needle-free  and  disposable  mini-needle  injector  systems.    In  addition,  the 
Company  has  several  products  and  compound  formulations  under  development.    The  Company  has  operating 
facilities in the U.S. and Switzerland.  The U.S. operation develops reusable needle-free and disposable mini-needle 
injector systems and manufactures and markets reusable needle-free injection devices and related disposables. These 
operations,  including  all  manufacturing  and  some  U.S.  administrative  activities,  are  located  in  Minneapolis, 
Minnesota.    The  Company  also  has  operations  located  in Basel,  Switzerland, which  consist  of  administration  and 
facilities  for  the  development  of  transdermal  gels  and  oral  fast  melt  tablet  products.    The  Swiss  operations  focus 
principally  on  research,  development  and  commercialization  of  pharmaceutical  products  and  include  a  number  of 
license agreements with pharmaceutical companies for the application of its drug delivery systems.  The Company’s 
corporate offices are located in Ewing, New Jersey. 

The  Company  operates  as  a  specialty  pharmaceutical  company  in  the  broader  pharmaceutical  industry.  
Companies in this sector generally bring technology and know-how in the area of drug formulation and/or delivery 
to  pharmaceutical  product  marketers  through  licensing  and  development  agreements  while  actively  pursuing 
development of its own products.  The Company currently views pharmaceutical and biotechnology companies as 
primary  customers.    The  Company  has  negotiated  and  executed  licensing  relationships  in  the  growth  hormone 
segment (reusable needle-free devices in Europe and Asia) and the transdermal gels segment (several development 
programs  in  place  worldwide,  including  the  United  States  and  Europe).    In  addition,  the  Company  continues  to 
market  reusable  needle-free  devices  for  the  home  or  alternate  site  administration  of  insulin  in  the  U.S.  market 
through  distributors,  has  granted  a  development  license  to  its  reusable  needle-free  technology  in  the  diabetes  and 
obesity  fields  to  Eli  Lilly  and  Company  on  a  worldwide  basis,  and  has  licensed  both  disposable  and  reusable 
injection devices to Teva Pharmaceuticals for use in undisclosed fields and territories. 

The Company is reporting a net loss of $8,099,846 for the year ended December 31, 2006 and expects to report 
a  net  loss for  the  year  ending  December  31,  2007,  as  marketing  and development  costs  related  to bringing future 
generations  of  products  to  market  continue.    Long-term  capital  requirements  will  depend  on  numerous  factors, 
including the status of collaborative arrangements and payments received under such arrangements, the progress of 
research and development programs, the receipt of revenues from sales of products and royalties and the ability to 
control costs.   

38 

 
 
 
 
 
 
 
 
 
Critical Accounting Policies and Use of Estimates 

In preparing the financial statements in conformity with U.S. generally accepted accounting principles (GAAP), 
management must make decisions that impact reported amounts and related disclosures. Such decisions include the 
selection of  the  appropriate accounting principles  to  be  applied  and  the  assumptions on  which  to base  accounting 
estimates.  In  reaching  such  decisions,  management  applies  judgment  based  on  its  understanding  and  analysis  of 
relevant  circumstances.  Note  2  to  the  consolidated  financial  statements  provides  a  summary  of  the  significant 
accounting policies followed in the preparation of the consolidated financial statements. The following accounting 
policies  are  considered  by  management  to  be  the  most  critical  to  the  presentation  of  the  consolidated  financial 
statements because they require the most difficult, subjective and complex judgments. 

Revenue Recognition  

The majority of the Company’s revenue relates to product sales for which revenue is recognized upon shipment, 
with  limited  judgment  required  related  to  product  returns.  Product  sales  are  shipped  FOB  shipping  point.  The 
Company also enters into license arrangements that are often complex as they may involve a license, development 
and  manufacturing  components.  Licensing  revenue  recognition  requires  significant  management  judgment  to 
evaluate  the  effective  terms  of  agreements,  the  Company’s  performance  commitments  and  determination  of  fair 
value  of  the  various  deliverables  under  the  arrangement.  In  December  2002,  the  Emerging  Issues  Task  Force 
(“EITF”) issued EITF 00-21, Revenue Arrangements with Multiple Deliverables, which addresses certain aspects of 
revenue  recognition  for  arrangements  that  include  multiple  revenue-generating  activities.  EITF  00-21  addresses 
when  and,  if  so,  how  an  arrangement  involving  multiple  deliverables  should  be  divided  into  separate  units  of 
accounting.  In  some  arrangements,  the  different  revenue-generating  activities  (deliverables)  are  sufficiently 
separable,  and  there  exists  sufficient  evidence  of  their  fair  values  to  separately  account  for  some  or  all  of  the 
deliverables (that is, there are separate units of accounting). In other arrangements, some or all of the deliverables 
are  not  independently  functional,  or  there  is  not  sufficient  evidence  of  their  fair  values  to  account  for  them 
separately.  The  Company’s  ability  to  establish  objective  evidence  of  fair  value  for  the  deliverable  portions  of  the 
contracts may significantly impact the time period over which revenues will be recognized. For instance, if there is 
no objective fair value of undelivered elements of a contract, then the Company may be required to treat a multi-
deliverable contract as one unit of accounting, resulting in all revenue being deferred and recognized over the entire 
contract  period.  EITF  00-21  does  not  change  otherwise  applicable  revenue  recognition  criteria.  In  arrangements 
where  the  deliverables  cannot  be  separated,  revenue  related  to  up-front,  time-based  and  performance-based 
payments is being recognized over the entire contract performance period. For major licensing contracts, this results 
in  the  deferral  of  significant  revenue  amounts  ($4,569,938  at  December  31,  2006)  where  non-refundable  cash 
payments  have  been  received,  but  the  revenue  is  not  immediately  recognized  due  to  the  long-term  nature  of  the 
respective agreements. Subsequent factors affecting the initial estimate of the effective terms of agreements could 
either increase or decrease the period over which the deferred revenue is recognized.  

In connection with a license agreement entered into with Eli Lilly and Company in 2003, the Company issued 
to  Lilly  a  ten-year  warrant  to  purchase  1,000,000  shares  of  the  Company’s  common  stock  at  an  exercise  price  of 
$3.776 per share. At the time of issue, the Company determined that the fair value of the warrant was $2,943,739 
using  the  Black  Scholes  option  pricing  model.  EITF  01-9,  Accounting  for  Consideration  Given  by  a  Vendor  to  a 
Customer  (Including  a  Reseller  of  the  Vendor’s  Products),  requires  that  the  value  of  the  warrants  be  treated  as  a 
reduction in revenue. The fair value of the warrant was recorded to additional paid-in capital and to prepaid license 
discount, a contra equity account. The prepaid license discount will be reduced on a straight-line basis over the term 
of the agreement, offsetting revenue generated under the agreement. If during its periodic impairment assessment the 
Company  concludes  that  the  revenues  from  this  arrangement  will  not  exceed  the  costs,  including  prepaid  license 
discount, part or all of the remaining prepaid license discount would be charged to operations at that time. 

Due to the requirement to defer significant amounts of revenue and the extended period over which the revenue 
will  be  recognized,  along  with  the  requirement  to  amortize  the  prepaid  license  discount  and  certain  deferred 
development costs over an extended period of time, revenue recognized and cost of sales may be materially different 
from cash flows. 

On  an  overall  basis,  the  Company’s  reported  revenues  can  differ  significantly  from  billings  and/or  accrued 
billings based on terms in agreements with customers. The table below is presented to help explain the impact of the 

39 

 
 
 
 
 
 
 
 
 
 
 
 
deferral  of  revenue  and  amortization  of  prepaid  license  discount  on  reported  revenues,  and  is  not  meant  to  be  a 
substitute for accounting or presentation requirements under U.S. generally accepted accounting principles.  

Product sales 
Development fees 
Licensing fees and milestone payments 
Royalties 

Billings received and/or accrued per contract terms   
Deferred billings received and/or accrued 
Deferred revenue recognized 
Amortization of prepaid license discount 

Total revenue as reported 

2006 

  $ 2,195,218 
785,720 
2,082,742 
140,110 
5,203,790 
(1,409,268) 
670,126 
(196,249) 
  $ 4,268,399 

2005 
  $1,511,929  
214,210  
275,524  
105,276  
2,106,939  
(360,949 ) 
675,005  
(196,249 ) 
  $2,224,746  

2004 

   $ 1,834,431 
  445,625 
84,449 
- 
 2,364,505 
  (259,537) 
  837,238 
  (196,250) 
   $ 2,745,956 

Valuation of Long-Lived and Intangible Assets and Goodwill 

Long-lived  assets,  including  patent  rights,  are  reviewed  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 asset. This analysis can be very subjective as the Company relies upon signed distribution or 
license agreements with variable cash flows to substantiate the recoverability of long-lived 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 fair value of the assets. Assets to be disposed of are reported at the lower of the 
carrying amount or fair value less costs to sell. 

In  the  fourth  quarter  of  each  year  the  Company  updated  its  long-range  business  plan.  The  Company  then 
reviewed  patent  costs  for  impairment  and  identified  patents  related  to  products  for  which  there  were  no  signed 
distribution or license agreements or for which no revenues or cash flows were included in the business plan.  In 
2006 and 2004 the Company recognized impairment charges of $138,632 and $233,062, respectively, in general and 
administrative  expenses,  which  represented  the  gross  carrying  amount,  net  of  accumulated  amortization,  for  the 
identified patents. After the impairment charge, the gross carrying amount and accumulated amortization of patents, 
which  are  the  only  intangible  assets  of  the  Company  subject  to  amortization,  were  $1,526,714  and  $713,122, 
respectively, at December 31, 2006. The Company’s estimated aggregate patent amortization expense for the next 
five years is $95,000 in 2007, $90,000 in each of 2008, 2009 and 2010, and $42,000 in 2011. 

The  Company  evaluates  the  carrying  value  of  goodwill  during  the  fourth  quarter  of  each  year  and  between 
annual evaluations if events occur or circumstances change that would more likely than not reduce the fair value of 
the  reporting  unit  below  its  carrying  amount.  Such  circumstances  could  include,  but  are  not  limited  to:  (1)  a 
significant  adverse  change  in  legal  factors  or  in  business  climate,  (2)  unanticipated  competition,  (3)  an  adverse 
action  or  assessment  by  a  regulator,  or  (4)  a  sustained  significant  drop  in  the  Company’s  stock  price.  When 
evaluating whether goodwill is impaired, the Company compares the fair value of the Minnesota operations to the 
carrying amount, including goodwill. If the carrying amount of the Minnesota operations exceeds its fair value, then 
the amount of the impairment loss must be measured. The impairment loss would be calculated by comparing the 
implied fair value of goodwill to its carrying amount. In calculating the implied fair value of goodwill, the fair value 
of the Minnesota operations would be allocated to all of its other assets and liabilities based on their fair values. The 
excess of the fair value of the Minnesota operations over the amount assigned to its other assets and liabilities is the 
implied  fair  value  of  goodwill.  An  impairment  loss  would  be  recognized  when  the  carrying  amount  of  goodwill 
exceeds  its  implied  fair  value.  The  Company’s  evaluation  of  goodwill  completed  during  2006,  2005  and  2004 
resulted in no impairment losses. 

40 

 
 
 
 
 
 
  
 
 
 
  
 
 
  
 
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Results of Operations 

Years Ended December 31, 2006, 2005 and 2004 

Revenues 

Total revenue was $4,268,399, $2,224,746 and $2,745,956 for the years ended December 31, 2006, 2005 and 
2004,  respectively.    The  increase  in  2006  was  spread  among  all  revenue  categories,  but  was  primarily  due  to 
increases  in  licensing  revenue  and  product  sales.    The  licensing  revenue  increase  was  mainly  due  to  $875,000 
received  under  a  sublicense  arrangement  related  to  an  existing  license  agreement  with  BioSante  Pharmaceuticals, 
Inc.  The increase in product sales was mainly due to an increase in sales to the Company’s major customer, Ferring.  
The  decrease  in  2005  resulted  primarily  from  reductions  in  product  sales  to  Ferring  and  reductions  in  licensing 
revenue, which was mainly due to the extension of revenue recognition periods of certain development and license 
agreements, resulting in the recognition of remaining deferred revenue over longer periods.  

Product sales include sales of reusable needle-free injector devices, related parts, disposable components, and 
repairs. In 2006, 2005 and 2004, revenue from sales of needle-free injector devices totaled $804,481, $549,070 and 
$621,518, respectively.  Sales of disposable components in 2006, 2005 and 2004 totaled $1,326,758, $896,764 and 
$1,143,071, respectively.  The increase in device and disposable revenue in 2006 compared to 2005 was due mainly 
to an increase in sales to Ferring.  This increase followed two years of decreasing sales that occurred while Ferring 
was working down high inventory levels they had accumulated in prior years.   

Development revenue was $593,797, $183,760 and $196,648 for the years ended December 31, 2006, 2005 and 
2004, respectively.   The increase in 2006 was attributable to projects related to injector systems and transdermal gel 
technologies,  but  resulted  primarily  from  one  agreement  related  to  use  of  the  Company’s  proprietary  ATD™  gel 
technology.  In 2006 the Company also generated development fees of approximately $217,000 in connection with 
an  agreement  related  to  its  oral  fast  melting  tablet  technology,  all  of  which  was  deferred  and  is  expected  to  be 
recognized as revenue in 2007.  In 2005 approximately half of the development revenue was generated from projects 
related  to  injector  devices,  with  most  of  this  coming  from  one-time  projects.  The  remainder  of  the  recognized 
development revenue in 2005 and substantially all of the recognized development revenue in 2004 was generated 
under  licensing  and  development  agreements  related  to  use  of  the  Company’s  transdermal  gel  technology.    The 
Company  also  generated  development  fees  of  approximately  $260,000  in  2004  under  a  device  development 
agreement, substantially all of which was deferred and is being recognized over the life of the associated agreement.  

Licensing revenue was $1,254,250, $374,021 and $634,542 for the years ended December 31, 2006, 2005 and 
2004,  respectively.  The  increase  in  2006  compared  to  2005  was  primarily  due  to  $875,000  received  under  a 
sublicense arrangement related to an existing license agreement with BioSante Pharmaceuticals, Inc.  In November 
2006 BioSante entered into a marketing agreement with Bradley Pharmaceuticals, Inc. for Elestrin® (formerly Bio-
E-Gel).    BioSante  received  an  upfront  payment  from  Bradley  which  triggered  a  payment  to  the  Company  of 
$875,000.  In December 2006 the FDA approved for marketing Elestrin® in the United States triggering payments to 
the Company totaling $2.6 million, which will be received in 2007.  In addition, the Company will receive royalties 
on sales of Elestrin® as well as potential sales-based milestone payments when marketed by Bradley.  The decrease 
in 2005 compared to 2004 was primarily the result of a decrease in deferred revenue recognized due to an increase 
in the revenue recognition periods of two projects following an extension of the estimated project end dates.  

Royalty revenue was $225,134, $155,036 and $80,335 for the years ended December 31, 2006, 2005 and 2004, 
respectively. Royalty revenue has all been related to the Vision® reusable needle-free injection device, and has been 
generated primarily under the License Agreement with Ferring dated January 22, 2003, described in more detail in 
Note 9 to the Consolidated Financial Statements.  Royalties from Ferring are earned on device sales and in 2006 and 
2005 additional royalties were earned under a provision in the Ferring agreement triggered by the achievement of 
certain quality standards.  The increase in 2006 was due to increases both in royalties earned from device sales and 
in the royalty earned under the quality standards provision. Even though device sales decreased in 2005 compared to 
2004,  the  royalty  revenue  from  Ferring  increased,  which  was  mainly  due  to  royalties  earned  under  the  quality 
standards provision. Royalties under the quality standards provision were not earned in 2004. 

41 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
Cost of Revenues 

The costs of product sales are primarily related to reusable injection devices and disposable components. Cost 
of sales as a percentage of product sales were 59%, 69% and 71% for the years ended December 31, 2006, 2005 and 
2004,  respectively.    The  decrease  in  2006  was  due  to  a  combination  of  factors  including  a  change  in  the  mix  of 
products sold and a higher sales volume absorbing a slightly decreased level of fixed overhead costs. 

The  cost  of  development  revenue  consists  of  labor  costs,  direct  external  costs  and  an  allocation  of  certain 
overhead expenses based on actual costs and time spent in these revenue-generating activities.  Cost of development 
revenue  as  a  percentage  of  development  revenue  can  fluctuate  considerably  between  periods  depending  on  the 
development  projects  in  process.    In  some  cases  development  projects  are  substantially  labor  based,  resulting  in 
relatively  high  margins,  while  in  other  cases  development  projects  include  a  significant  amount  of  external  cost 
passed through to the customer at little or no markup, resulting in lower margins.  Cost of development revenue as a 
percentage  of  development  revenue  was  44%,  51%  and  34%  for  the  years  ended  December  31,  2006,  2005  and 
2004, respectively. The 2005 percentage was slightly higher than 2006 and 2004 due mainly to projects having more 
direct external costs that were billed to customers with little or no markup.  

Research and Development 

Research  and  development  expenses  were  $3,778,469,  $3,677,015  and  $2,869,317  for  the  years  ended 
December 31, 2006, 2005 and 2004, respectively. The overall increase in 2006 compared to 2005 was primarily due 
to  an  increase  in  stock  based  compensation  expense  of  approximately  $128,000.  The  majority  of  research  and 
development  expenses  consist  of  external  costs  for  studies  and  analysis  activities,  design  work  and  prototype 
development.  The portion of expenses related to device development projects increased slightly in 2006 compared 
to 2005, but over 75% of the total research and development expenses in each year were generated in connection 
with development projects related to transdermal gels and oral fast melt tablet products.  The increase in 2005 from 
2004 was primarily due to development projects related to transdermal gels, including Phase II studies of Anturol™, 
and oral fast melt tablet products and consisted mainly of increases in external costs for studies and analysis work 
around platform validation and proof-of-concept work.   

Sales, Marketing and Business Development 

Sales, marketing and business development expenses were $1,349,678, $1,160,752 and $675,878 for the years 
ended December 31, 2006, 2005 and 2004, respectively. The increase in 2006 compared to 2005 was due mainly to 
an increase in professional services in connection with business development projects related to transdermal gels and 
oral fast melt tablets, along with an increase in stock based compensation expense of approximately $80,000.  The 
increase in 2005 compared to 2004 was due to increases in clinical studies related to injector devices and increases 
in  business  development  activities  which  most  directly  impacted  payroll,  travel  and  professional  services.  The 
increases  in  payroll  and  travel  expenses  resulted  primarily  from  the  addition  of  a  vice-president  of  corporate 
business development in February of 2005. The professional services increase was mainly due to the utilization of 
consultants for various sales and marketing and business development projects.  

General and Administrative 

General  and  administrative  expenses  were  $5,861,111,  $4,839,408  and  $6,203,125  for  the  years  ended 
December 31, 2006, 2005 and 2004, respectively.  The increase in 2006 compared to 2005 was due primarily to an 
increase  in  stock  based  compensation  expense  of  approximately  $826,000,  along  with  an  increase  in  patent 
impairment charges of $138,632.  The decrease in 2005 compared to 2004 was due primarily to decreases in legal 
expenses of $188,231 and professional services and investor relations expenses of $872,662, along with a decrease 
in  patent  impairment  charges  from  $233,062  in  2004  to  none  in  2005.  The  patent  impairment  charges  were 
recognized  in  connection  with  certain  patents  related  to  products  for  which  there  were  no  signed  distribution  or 
license agreements or for which no revenue or cash flows were projected in the Company’s long-term business plan. 
The  impairment  charges represented  the  gross  carrying  amount  net of  accumulated  amortization for  the  identified 
patents.   

42 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Other Income (Expense) 

Other income (expense), net, was $176,983, $91,218 and $26,134 for the years ended December 31, 2006, 2005 
and 2004, respectively. The increase in 2006 compared to 2005 was primarily due to an increase in interest income 
resulting from investment of the proceeds from the private placement of common stock in the first quarter of 2006, 
partially offset by an increase in foreign exchange losses related mainly to the impact of exchange rate fluctuations 
on liabilities due in foreign currencies.  The increase in 2005 was primarily due to a reduction in interest expense in 
2005 as compared to 2004.  

Liquidity and Capital Resources  

The  Company  has  not  historically  generated,  and  does  not  currently  generate,  enough  revenue  to  provide  the 
cash needed to support its operations, and has continued to operate primarily by raising capital and incurring debt.  
In  order  to  better  position  the  Company  to  take  advantage  of  potential  growth  opportunities  and  to  fund  future 
operations, the Company raised additional capital in the first quarter of 2006.  The Company received net proceeds 
of $9,782,055 in  a  private placement  of  its  common  stock  in  which  a  total  of  8,770,000  shares  of  common  stock 
were  sold  at  a  price  of $1.25  per  share.   In  connection with  the private  placement,  the  Company  issued  five-year 
warrants to purchase an aggregate of 7,454,500 shares of common stock with an exercise price of $1.50 per share.  
In 2006 the Company also received proceeds of $1,335,086 in connection with warrant and stock option exercises 
which resulted in the issuance of 1,443,470 shares of common stock. 

In February of 2007 the Company received gross proceeds of $5,000,000 upon closing of the first tranche of a 
$10,000,000  credit  facility,  to  help  fund  additional  working  capital  needs.    A  second  tranche  of  $5,000,000  is 
available after September 30, 2007 but before December 31, 2007 upon certain conditions.  The per annum interest 
rate is equal to the sum of the yield for three-year US treasury bills as quoted by Bloomberg, plus 800 basis points 
calculated (i) in the case of the first tranche, on the business day prior to the first funding date and (ii) in the case of 
the  second  tranche,  on  the  business  day  prior  to  the  second  funding  date  (as  such  term  is  defined  in  the  Credit 
Agreement).  In addition, once set, the applicable interest rate for each tranche will be fixed for the applicable term.  
The maturity date (i) with respect to the first tranche is forty-two months from the first funding date and (ii) with 
respect  to  the  second  tranche  is  thirty-six  months  from  the  second  funding  date.    The  credit  agreement  contains 
certain covenants and provisions that affect the Company, including, without limitation, covenants and provisions 
that: 

• 
• 
• 

• 

• 

restrict its ability to create or incur indebtedness (subject to enumerated exceptions);  
restrict its ability to create or incur certain liens on its property (subject to enumerated exceptions); 
in  certain  circumstances,  require  it  to  maintain,  on  a  consolidated  basis,  unrestricted  cash  and  cash 
equivalents of at least $2,500,000;  
in certain circumstances, restrict its ability to declare or pay any dividends on any shares of its capital 
stock, purchase or redeem any shares of its capital stock, return any capital to any holder of its equity 
securities or payment of certain bonuses;  
restrict its ability to make certain investments. 

In  connection  with  the  credit  facility,  the  Company  issued  warrants  to  purchase  a  total  of  640,000  shares  of 
common stock at an exercise price of $1.25, of which 240,000 will vest on the occurrence of the drawdown of the 
second tranche.   

The  Company  believes  that  the  combination  of  the  recent  debt  and  equity  financings  and  projected  product 
sales,  product  development,  license  revenues,  milestone  payments  and  royalties  will  provide  sufficient  funds  to 
support operations for at least the next 12 months.  During 2007, the Company believes capital expenditures may 
increase  to  over  $1.5  million  primarily  in  connection  with  tooling  and  production  equipment  related  to  injection 
device  deals.  The  Company  does  not  currently  have  any  bank  credit  lines.    If  the  Company  does  need  additional 
financing and is unable to obtain such financing when needed, or obtain it on favorable terms, the Company may be 
required to curtail development of new drug technologies, limit expansion of operations or accept financing terms 
that are not as attractive as the Company may desire.   

43 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
Net Cash Used in Operating Activities 

Operating cash inflows are generated primarily from product sales, license and development fees and royalties.  
Operating  cash  outflows  consist  principally  of  expenditures  for  manufacturing  costs,  general  and  administrative 
costs, research and development projects and sales, marketing and business development activities.  Net cash used in 
operating activities was $6,118,050, $7,218,529 and $7,167,313 for the years ended December 31, 2006, 2005 and 
2004, respectively.  This was primarily the result of net losses of $8,099,846, $8,497,956 and $8,348,532 in 2006, 
2005 and 2004, respectively, adjusted by noncash expenses and changes in operating assets and liabilities.   

Noncash  expenses  totaled  $1,798,524,  $695,967  and  $1,915,862  in  2006,  2005  and  2004,  respectively.    The 
increase  in  2006  compared  to  2005  was  primarily  the  result  of  an  increase  in  noncash  stock-based  compensation 
expense of nearly $1.0 million, which was principally due to the adoption of SFAS No. 123R in 2006.  The decrease 
in 2005 from 2004 was due mainly to decreases in patent rights impairment charges and stock-based compensation 
expense.  Stock-based compensation expense in 2004 was higher due to more frequent utilization of common stock 
and warrants as compensation for external consultants. 

In 2006, the change in operating assets and liabilities generated cash of $183,272.  This was primarily the net 
result of increases in accounts receivable of $616,327 and deferred revenue of $818,234.  Both increases reflect the 
increase in revenue generating activity in 2006 compared to 2005.  The accounts receivable increase was due to an 
increase in product sales activity, royalties and development revenue near the end of 2006 as compared to 2005.  In 
2006 the amount received from license fees, development fees and milestone payments increased compared to 2005, 
as did the portion of these payments that was deferred and is being recognized as revenue over various periods. 

The change in operating assets and liabilities in 2005 generated cash of $583,460. This resulted mainly from the 
increases in accounts payable and accrued expenses of $501,614 and $194,782, respectively. These increases were 
primarily due to increased research and development activities near the end of the year, particularly in connection 
with development projects related to transdermal gels, and increased accruals related to executive bonuses. Partially 
offsetting these increases was an increase in prepaid expenses and other assets, which utilized cash of $210,753, and 
a decrease in deferred revenue of $63,098. The increase in prepaid expenses and other assets was almost entirely due 
to payments  made in connection with development projects related to transdermal gels. The reduction in deferred 
revenue  was  the  result  of  recognizing  as  revenue  amounts  that  had  previously  been  deferred,  which  exceeded 
amounts deferred during the year totaling approximately $610,000. 

The change in operating assets and liabilities in 2004 utilized cash of $734,643. This resulted primarily from 
decreases  in  deferred  revenue  and  accrued  expenses  of  $577,700  and  $216,011,  respectively,  plus  an  increase  in 
other assets of $232,644, partially offset by decreases in accounts and other receivables of $66,177 and inventory of 
$133,064 and an increase in accounts payable of $214,367. The decrease in deferred revenue was mainly due to the 
amortization  of  amounts  deferred  in  prior  years,  partially  offset  by  approximately  $250,000  of  development  fees 
deferred  during  the  year.  Related  to  the  development  fees  deferred  in  2004  were  deferred  costs  that  totaled 
approximately  $200,000,  which  is  the  primary  reason  other  assets  increased.  Receivables  decreased  at  the  end  of 
2004  compared  to  2003  mainly  due  to  a  reduction  in  billable  development  activity  at  the  Antares/Switzerland 
operations.  The  decrease  in  inventory  is  mainly  the  result  of  the  timing  of  purchases  of  finished  goods  from  the 
third-party supplier versus shipments to customers. At the end of 2003 the Company had a large amount of finished 
goods in inventory that was shipped to a customer in early January 2004. The increase in accounts payable in 2004 
compared to 2003 was mainly due to an increase in operating expense activity at the end of 2004 compared to 2003, 
particularly in the areas of research and development and business development.  

Net Cash Provided by (Used in) Investing Activities 

Investing activities are comprised primarily of short-term investment purchases and maturities.  All short-term 
investments are commercial paper or U.S. government agency discount notes that mature within six to ten months of 
purchase and are classified as held-to-maturity because the Company has the positive intent and ability to hold the 
securities  to  maturity.      In  2006  and  2004  the  use  of  cash  to  purchase  securities  exceeded  cash  generated  from 
maturities  by  $4,851,551  and  $7,889,565,  respectively,  due  to  the  investment  of  excess  funds  from  the  private 
placements in each of those years.  In 2005, maturities exceeded purchases by $7,941,688, as cash was required to 
fund operations and was not available for reinvestment.  Investing activities in 2006, 2005 and 2004 also included 

44 

 
 
 
 
 
 
 
 
  
 
 
 
 
 
additions to patent rights of $142,751, $154,193 and $76,193, respectively, and purchases of equipment, furniture 
and fixtures of $35,703, $89,651 and $218,038, respectively.  The 2004 purchases consisted primarily of furniture 
and office equipment in connection with the move of the Minnesota operations to new office and laboratory space, 
new disposable component tooling, and upgrades to computer hardware and software. 

Net Cash Provided by Financing Activities 

Net cash provided by financing activities totaled $11,117,141, $619,700 and $15,140,603 for the years ended 
December 31, 2006, 2005 and 2004, respectively. In 2006, the Company received $1,335,086 from the exercise of 
warrants and stock options and received net proceeds of $9,782,055 from the private placement of common stock in 
which a total of 8,770,000 shares of common stock were sold at a price of $1.25 per share.  In 2005, the Company 
received $476,000 from the sale of common stock and $193,700 from the exercise of warrants, which was partially 
offset by the payment of preferred stock dividends of $50,000. In 2004, net cash provided by financing activities 
resulted primarily from net proceeds of $13,753,400 from the private placement of common stock and proceeds of 
$1,472,500  from  the  exercise  of  warrants,  partially  offset  by  principal  payments  on  capital  lease  obligations  of 
$35,297 and payment of preferred stock dividends of $50,000.  

The Company’s contractual cash obligations at December 31, 2006 are associated with operating leases and are 

summarized in the following table:   

Total contractual cash obligations       $1,201,263 

Total 

Off Balance Sheet Arrangements 

Less than 
1 year 
  $329,894 

Payment Due by Period 
1-3 
years 
  $729,294 

4-5  
years 
  $142,075 

   After 5 years 
- 
  $ 

The  Company  does  not  have  any  off-balance  sheet  arrangements,  including  any  arrangements  with  any 

structured finance, special purpose or variable interest entities. 

New Accounting Pronouncements 

In December 2004, the Financial Accounting Standards Board (“FASB”) issued SFAS No. 123 (Revised 2004), 
“Share-Based  Payment.”  SFAS No. 123R  is  a  revision  of  SFAS No. 123,  “Accounting  for  Stock-Based 
Compensation” and supersedes APB Opinion No. 25, “Accounting for Stock Issued to Employees” and its related 
implementation  guidance.  Among  other  items,  the  standard  requires  that  the  compensation  cost  relating  to  share-
based  payment  transactions  be  recognized  in  the  consolidated  statement  of  operations.  SFAS No. 123R  focuses 
primarily on accounting for transactions in which an entity obtains employee services through share-based payment 
transactions. As of January 1, 2006, the Company adopted the fair value method of accounting for employee stock 
compensation  cost  pursuant  to  SFAS  No.  123R,  which  requires  a  public  entity  to  measure  the  cost  of  employee 
services received in exchange for the award of equity instruments based on the fair value of the award at the date of 
grant.    The  cost  will  be  recognized  over  the  period  during  which  an  employee  is  required  to  provide  services  in 
exchange for the award.  Prior to January 1, 2006, the Company used the intrinsic value method under APB Opinion 
No. 25.  Accordingly, compensation expense was recognized for restricted stock granted to employees, but was not 
recognized  for  employee  stock  options  other  than  the  intrinsic  value  of  options  when  the  exercise  price  of  the 
options was below their fair value on the date of grant. The Company is using the modified prospective transition 
method  in  implementing  SFAS  No.  123R.    Under  that  transition  method,  compensation  cost  recognized  in  2006 
includes: (1) compensation cost for all stock-based payments granted prior to, but not yet vested as of December 31, 
2005, based on the grant date fair value calculated in accordance with the original provisions of SFAS No. 123, and 
(2) compensation cost for all stock-based payments granted subsequent to December 31, 2005, based on the grant-
date fair value calculated in accordance with the provisions of SFAS No. 123R.  In accordance with the modified 
prospective transition method, results for prior periods have not been restated and do not include the impact of SFAS 
No. 123R.  As a result of adopting SFAS No. 123R, the Company’s net loss for the year ended December 31, 2006 
was approximately $1,050,000 more than if it had continued to account for stock-based compensation under APB 

45 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Opinion  No.  25.    Note  2  to  the  Consolidated  Financial  Statements contains  pro  forma  disclosures  regarding  the 
effect on net loss and net loss per share as if the fair value method of accounting for stock-based compensation had 
been applied in the two years prior to adoption.   

In  June  2006,  the  FASB  issued  Interpretation  No. 48,  “Accounting  for  Uncertainty  in  Income  Taxes —  an 
interpretation  of  FASB  Statement  No. 109.”  This  interpretation  clarifies  the  accounting  for  uncertainty  in  income 
taxes recognized in an enterprise’s financial statements in accordance with FASB Statement No. 109, “Accounting 
for Income Taxes.” This interpretation prescribes a recognition threshold and measurement attribute for the financial 
statement  recognition  and  measurement  of  a  tax  position  taken  or  expected  to  be  taken  in  a  tax  return.  It  also 
provides guidance on derecognition, classification, interest and penalties, accounting in interim periods, disclosure 
and  transition.  This  interpretation  is  effective  beginning  in  fiscal  year  2007.  The  Company  does  not  believe  the 
implementation of this standard will have a material impact on the consolidated financial statements.  

In  September  2006,  the  FASB  issued  Statement  of  Financial  Accounting  Standards  (“SFAS”)  No. 157,  “Fair 
Value Measurements” which is effective for fiscal years beginning after November 15, 2007 and for interim periods 
within those years. This statement defines fair value, establishes a framework for measuring fair value and expands 
the related disclosure requirements. The Company is currently evaluating the potential impact of this statement on 
the consolidated financial statements.  

In September 2006, the Staff of the SEC issued Staff Accounting Bulletin (“SAB”) No. 108, Considering the 
Effects  of  Prior  Year  Misstatements  when  Quantifying  Misstatements  in  Current  Year  Financial  Statements. 
SAB No. 108  provides  guidance  on  the  consideration  of  the  effects  of  prior  year  misstatements  in  quantifying 
current  year  misstatements  for  the  purpose  of  determining  whether  the  current  year’s  financial  statements  are 
materially misstated. SAB No. 108 is effective for fiscal years ending after November 15, 2006. This bulletin did not 
have an impact on our consolidated financial statements.  

Item 7(A).  QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK  

The Company’s primary  market risk exposure is foreign exchange rate fluctuations of the Swiss Franc to the 
U.S. dollar as the financial position and operating results of the Company’s subsidiaries in Switzerland are translated 
into U.S. dollars for consolidation. The Company’s exposure to foreign exchange rate fluctuations also arises from 
transferring  funds  to  its  Swiss  subsidiaries  in  Swiss  Francs.  Most  of  the  Company’s  sales  and  licensing  fees  are 
denominated  in  U.S.  dollars,  thereby  significantly  mitigating  the  risk  of  exchange  rate  fluctuations  on  trade 
receivables. The effect of foreign exchange rate fluctuations on the Company’s financial results for the years ended 
December  31,  2006,  2005  and  2004  was  not  material.  Beginning  in  2003  the  Company  also  has  exposure  to 
exchange rate fluctuations between the Euro and the U.S. dollar. The licensing agreement entered into in January 
2003 with Ferring, discussed in Note 9 to the Consolidated Financial Statements, established pricing in Euros for 
products sold under the existing supply agreement and for all royalties. In March 2007 the Company amended the 
2003 agreement with Ferring to principally establish prices in U.S. dollars rather than Euros.  The Company does 
not currently use derivative financial instruments to hedge against exchange rate risk. Because exposure increases as 
intercompany  balances  grow,  the  Company  will  continue  to  evaluate  the  need  to  initiate  hedging  programs  to 
mitigate the impact of foreign exchange rate fluctuations on intercompany balances. 

Typically,  our  short-term  investments  are  commercial  paper  or  U.S.  government  agency  discount  notes  that 
mature within six to ten months of purchase. The market value of such investments fluctuates with current market 
interest  rates.  In  general,  as  rates  increase,  the  market  value  of  a  debt  instrument  is  expected  to  decrease.  The 
opposite is also true. To minimize such market risk, we have in the past and to the extent possible, will continue in 
the future, to hold such debt instruments to maturity at which time the debt instrument will be redeemed at its stated 
or face value. Due to the short duration and nature of these instruments, we do not believe that we have a material 
exposure to interest rate risk related to our investment portfolio.  

46 

 
  
 
 
  
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
Item 8. 

FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA. 

ANTARES PHARMA, INC. 
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS 

Report of Independent Registered Public Accounting Firm 

Consolidated Balance Sheets as of December 31, 2006 and 2005 

Consolidated Statements of Operations for the Years Ended December 31, 2006, 2005 and 2004 

Consolidated Statements of Stockholders’ Equity and Comprehensive Loss for the 
    Years Ended December 31, 2006, 2005 and 2004 

Consolidated Statements of Cash Flows for the Years Ended December 31, 2006, 2005 and 2004 

Notes to Consolidated Financial Statements 

48 

49 

50 

51 

52 

53 

47 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM 

The Board of Directors and Shareholders  
Antares Pharma, Inc.:  

We  have  audited  the  accompanying  consolidated  balance  sheets  of  Antares  Pharma,  Inc.  and  subsidiaries  (the 
“Company”)  as  of  December  31,  2006  and  2005,  and  the  related  consolidated  statements  of  operations, 
stockholders’ equity  and  comprehensive  loss,  and  cash flows  for each  of  the  years  in  the  three-year  period  ended 
December 31, 2006. 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  the  standards  of  the  Public  Company  Accounting  Oversight  Board 
(United  States).  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 Antares Pharma, Inc. and subsidiaries as of December 31, 2006 and 2005, and the results of 
their  operations  and  their  cash  flows  for  each  of  the  years  in  the  three-year  period  ended  December  31,  2006,  in 
conformity with U.S. generally accepted accounting principles.  

As  discussed  in  Note  2  to  the  consolidated  financial  statements,  the  Company  adopted  Statement  of  Financial 
Accounting Standards No. 123R, “Share-Based Payment,” on January 1, 2006. 

/s/ KPMG LLP 

Minneapolis, Minnesota 
March 26, 2007 

48 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ANTARES PHARMA, INC. 
CONSOLIDATED BALANCE SHEETS 

December 31, 

December 31, 

2006 

2005 

Assets 
Current Assets: 

Cash and cash equivalents 
Short-term investments 
Accounts receivable, less allowance for doubtful accounts of $10,000 and 

  $ 

2,706,047  
4,953,421  

   $ 

2,718,472 
- 

$20,800, respectively 

Other receivables 
Inventories 
Prepaid expenses and other current assets 

Total current assets 

Equipment, furniture and fixtures, net 
Patent rights, net 
Goodwill 
Other assets 

855,866  
55,794  
84,779  
221,669  
8,877,576  

382,096  
813,592  
1,095,355  
365,864  

223,944 
48,185 
36,022 
286,185 
  3,312,808 

477,608 
936,939 
  1,095,355 
343,654 

Total Assets 

  $  11,534,483  

   $ 

6,166,364 

Liabilities and Stockholders’ Equity 
Current Liabilities: 

Accounts payable 
Accrued expenses and other liabilities 
Deferred revenue 

Total current liabilities 

Deferred revenue – long term 
Total liabilities 

Stockholders’ Equity: 

Common Stock:  $0.01 par; authorized 100,000,000 shares; 
53,319,622 and 43,019,486 issued and outstanding at 
December 31, 2006 and 2005, respectively 

Additional paid-in capital 
Prepaid license discount 
Accumulated deficit 
Accumulated other comprehensive loss 

Total Liabilities and Stockholders’ Equity 

  $ 

813,014  
1,071,086  
1,014,337  
2,898,437  

3,555,601  
6,454,038  

   $ 

945,028 
798,468 
604,143 
  2,347,639 

  3,062,076 
  5,409,715 

533,196  
106,792,974  
(2,305,929 ) 
(99,322,453 ) 
(617,343 ) 
5,080,445  
  $  11,534,483  

430,195 
  94,547,105 
  (2,502,178) 
 (91,123,107) 
(595,366) 
756,649 
6,166,364 

   $ 

See accompanying notes to consolidated financial statements. 

49 

 
 
  
 
 
  
 
 
 
 
  
 
 
 
  
  
 
 
 
  
  
 
 
 
  
  
 
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
  
 
 
 
  
 
 
  
 
 
  
 
  
 
 
 
  
  
 
 
 
 
  
  
 
 
 
  
  
 
 
 
  
  
 
 
 
  
 
 
  
 
 
  
 
 
  
  
 
 
 
  
 
  
 
 
  
  
 
 
 
  
  
 
 
 
  
  
 
 
 
  
  
 
 
 
  
 
 
  
 
  
 
  
 
  
 
 
 
  
 
 
 
ANTARES PHARMA, INC. 
CONSOLIDATED STATEMENTS OF OPERATIONS 

Revenue: 

Product sales 
Development revenue 
Licensing revenue 
Royalties 

Total revenue 

Cost of revenue: 

Cost of product sales 
Cost of development revenue 
Total cost of revenue 

Gross profit 

Operating expenses: 

Research and development 
Sales, marketing and business development 
General and administrative 

Years Ended December 31, 

2006 

2005 

2004 

  $ 

2,195,218 
593,797 
1,254,250 
225,134 
4,268,399 

  $  1,511,929  
183,760  
374,021  
155,036  
2,224,746  

   $ 

1,834,431 
196,648 
634,542 
80,335 
  2,745,956 

1,293,192 
262,778 
1,555,970 
2,712,429 

3,778,469 
1,349,678 
5,861,111 
10,989,258 

1,042,504  
94,241  
1,136,745  
1,088,001  

3,677,015  
1,160,752  
4,839,408  
9,677,175  

  1,304,504 
67,798 
  1,372,302 
  1,373,654 

  2,869,317 
675,878 
  6,203,125 
  9,748,320 

Operating loss 

(8,276,829) 

(8,589,174 ) 

  (8,374,666) 

Other income (expense): 
Interest income 
Interest expense 
Foreign exchange losses 
Other, net 

353,236 
(3,132) 
(128,268) 
(44,853) 
176,983

128,832  
(576 ) 
(36,718 ) 
(320 ) 
91,218 

120,292 
(100,471) 
(6,849) 
13,162 
26,134

Net loss 

(8,099,846) 

(8,497,956 ) 

  (8,348,532) 

Deemed dividend to warrant holders 
Preferred stock dividends 

(99,500) 
- 

-  
(50,000 ) 

- 
(100,000) 

Net loss applicable to common shares 

  $ 

 (8,199,346) 

  $ 

(8,547,956 ) 

   $ 

 (8,448,532) 

Basic and diluted net loss per common share 

  $ 

 (0.16) 

  $ 

 (0.21 ) 

   $ 

 (0.23) 

Basic and diluted weighted average common shares 

outstanding 

51,582,111 

41,459,533  

  36,347,892 

See accompanying notes to consolidated financial statements. 

50 

 
 
 
  
 
 
 
 
  
 
 
 
 
  
  
 
 
 
 
  
 
 
 
  
 
 
 
  
 
 
 
  
 
 
 
 
  
  
 
 
 
 
 
  
  
 
 
 
 
  
 
 
  
 
 
 
  
 
 
  
 
 
 
 
  
  
 
 
 
 
 
  
  
 
 
 
 
  
 
 
  
 
 
 
  
 
 
 
  
 
 
 
 
  
  
 
 
 
 
  
 
 
 
 
  
  
 
 
 
 
 
  
  
 
 
 
 
  
 
 
 
  
 
 
 
  
 
 
 
  
 
 
 
 
 
 
  
  
 
 
 
 
  
 
 
 
 
  
  
 
 
 
 
  
 
 
 
  
 
 
 
 
 
  
  
 
 
 
 
 
 
 
  
  
 
 
 
 
 
 
  
  
 
 
 
 
  
 
 
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY AND COMPREHENSIVE LOSS 

Years Ended December 31, 2004, 2005 and 2006 

ANTARES PHARMA, INC. 

Convertible Preferred Stock
Series D

Series A 

Common Stock

Accumulated
Other

Number of 
 Shares 

Amount  
15  

1,450   $ 

Number of
 Shares 

Amount 

Number 
of 
 Shares 

 Amount 

Additional 
Paid-In 
Capital 

Prepaid 
License 
Discount 

Accumulated
Deficit 

Comprehen-
sive 
Loss 

Total 
Stockholders’
Equity 

243,749 $

2,437

19,831,296 $

198,313  $

77,747,461   $ 

 (2,894,677)$

 (74,126,619)$

 (619,836) $

307,094 

-

-
-
-

- 

- 
-
-

- 

13,753,400 
1,547,888
825,381

-

-
-
-

196,250
-
-
-
-
(2,698,427)
-
-
-
-

196,249
-
-
-
-

-  

-  
-  
-  

-  
50  
-  
-  
-  
1,500  
(1,500 ) 
-  
-  
-  

-  
-  
-  
-  
-  
-    

-  
-  
-  

-  
-  
-  
-  
-  
-   $ 

-  

-  
-  
-  

-  
-  
-  
-  
-  
15  
(15 ) 
-  
-  
-  

-  
-  
-  
-  
-  
-  

-  
-  
-  

-  
-  
-  
-  
-  
-  

(180,161)

(1,801)

1,801,610

18,016 

(16,215 )   

-
-
-

-
-
-
-
-
63,588
(63,588)
-
-
-

-
-
-

15,120,000
3,480,500
185,000

-
-
-
-
-
636
(636)
-
-
-

-
-
-
-
-
40,418,406
1,835,880
400,000
315,200
50,000

151,200 
34,805
1,850

- 
-
-
-
-
404,184 
18,359
4,000
3,152
500

- 
-
-
-
-

-
-
-
-
-

-
-
-
-
-
-  

-
-
-

-
-
-
-
-
- $

-
-
-
-
-
-

-
-
-

-
-
-
-
-
-

43,019,486  

430,195   

8,770,000
1,443,470
86,666

87,700 
14,435
866

-
-
-
-
-

- 
-
-
-
-

13,602,200  
1,513,083  
823,531  

-  
50,000  
-  
-  
-  
93,720,060  

(17,708 )   
472,000  
190,548  
182,205  

-  
-  
-  
-  
-  
94,547,105    

9,694,355  
1,320,651  
1,131,363  

-  
99,500  
-  
-  
-  

-
(100,000)
(8,348,532)
-
-
(82,575,151)
-
-
-
-

-
(50,000)
(8,497,956)
-
-

- 
-
-
(42,642)
-
(662,478)
-
-
-
-

- 
-
-
67,112
-

 (2,502,178) 

 (91,123,107) 

 (595,366)  

-
-
-

196,249
-
-
-
-

-
-
-

-
(99,500)
(8,099,846)
-
-

- 
-
-

- 
-
-
(21,977)
-

53,319,622 $

533,196  $

106,792,974   $ 

 (2,305,929)$

 (99,322,453)$

 (617,343) $

See accompanying notes to consolidated financial statements. 

51 

196,250 
(50,000)
(8,348,532)
(42,642)
(8,391,174)
8,188,839 
-
476,000
193,700
182,705

196,249 
(50,000)
(8,497,956)
67,112
(8,430,844)
756,649 

9,782,055 
1,335,086
1,132,229

196,249 
-
(8,099,846)
(21,977)
(8,121,823)
5,080,445 

December 31, 2003 

Preferred Series D converted 

into common stock 

Issuance of common stock in private 

placement 
Exercise of warrants 
Stock-based compensation 

Amortization of prepaid  

license discount 

Preferred stock dividends 
Net loss 
Translation adjustments 
Comprehensive loss 
December 31, 2004 
Preferred stock conversions 
Issuance of common stock 
Exercise of warrants 
Stock-based compensation 

Amortization of prepaid  

license discount 

Preferred stock dividends 
Net loss 
Translation adjustments 
Comprehensive loss 
December 31, 2005 

Issuance of common stock in 
private placement 

Exercise of warrants and options 
Stock-based compensation 

Amortization of prepaid  

license discount 

Deemed dividend to warrant holder 
Net loss 
Translation adjustments 
Comprehensive loss 
December 31, 2006 

 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ANTARES PHARMA, INC. 
CONSOLIDATED STATEMENTS OF CASH FLOWS 

Cash flows from operating activities: 

Net loss 

Years Ended December 31, 

2006 

2005 

2004 

  $ 

 (8,099,846) 

  $ 

 (8,497,956 ) 

   $ 

 (8,348,532) 

Adjustments to reconcile net loss to net 
cash used in operating activities: 

Patent rights impairment charge 
Depreciation and amortization 
Loss on disposal and abandonment of assets 
Stock-based compensation expense  
Noncash interest expense 
Amortization of prepaid license discount 
Changes in operating assets and liabilities: 

Accounts receivable 
Other receivables 
Inventories 
Prepaid expenses and other current assets 
Other assets 
Accounts payable 
Accrued expenses and other current liabilities 
Due to related parties 
Deferred revenue 

Net cash used in operating activities 

Cash flows from investing activities: 

Purchase of short-term investments 
Proceeds from maturity of short-term investments 
Additions to patent rights 
Purchases of equipment, furniture and fixtures 

Net cash provided by (used in) investing activities 

Cash flows from financing activities: 

Proceeds from issuance of common stock, net 
Proceeds from exercise of warrants and stock options 
Principal payments on capital lease obligations 
Payment of preferred stock dividends 

Net cash provided by financing activities 

138,632 
297,375 
- 
1,166,268 
- 
196,249 

(616,327) 
(101,684) 
(48,757) 
114,446 
(13,038) 
(155,391) 
185,789 
- 
818,234 
(6,118,050) 

(10,694,799) 
5,843,248 
(142,751) 
(35,703) 
(5,030,005) 

9,782,055 
1,335,086 
- 
- 
11,117,141 

-  
317,013  
-  
182,705  
-  
196,249  

48,710  
35,881  
56,322  
(210,753 ) 
20,002  
501,614  
194,782  
-  
(63,098 ) 
(7,218,529 ) 

(5,955,789 ) 
13,897,477  
(154,193 ) 
(89,651 ) 
7,697,844  

476,000  
193,700  
-  
(50,000 ) 
619,700  

233,062 
580,080 
5,701 
825,381 
75,388 
196,250 

200,855 
(134,678) 
133,064 
(16,873) 
(232,644) 
214,367 
(216,011) 
(105,023) 
(577,700) 
  (7,167,313) 

 (19,889,565) 
  12,000,000 
(76,193) 
(218,038) 
  (8,183,796) 

  13,753,400 
  1,472,500 
(35,297) 
(50,000) 
  15,140,603 

Effect of exchange rate changes on cash and cash equivalents 

18,489 

(32,951 ) 

(65,901) 

Net increase (decrease) in cash and cash equivalents 
Cash and cash equivalents: 
Beginning of year 
End of year 

(12,425) 

1,066,064  

(276,407) 

2,718,472 
2,706,047 

  $ 

1,652,408  
2,718,472  

  1,928,815 
1,652,408 

   $ 

  $ 

See accompanying notes to consolidated financial statements. 

52 

 
 
 
 
 
  
 
 
 
 
 
 
  
 
 
 
 
  
  
 
 
 
 
 
  
  
 
 
 
 
  
 
 
 
  
 
 
 
  
 
 
 
  
 
 
 
  
 
 
 
  
 
 
 
 
  
  
 
 
 
 
  
 
 
 
  
 
 
 
  
 
 
 
  
 
 
 
  
 
 
 
  
 
 
 
  
 
 
 
  
 
 
 
  
 
 
 
  
 
 
 
 
  
  
 
 
 
 
 
  
  
 
 
 
 
  
 
 
  
 
 
  
 
 
 
  
 
 
 
  
 
 
 
 
  
  
 
 
 
 
 
  
  
 
 
 
 
  
 
 
  
 
 
  
 
 
 
  
 
 
 
  
 
 
 
 
  
  
 
 
 
 
  
 
 
 
 
 
  
  
 
 
 
 
  
 
 
 
 
  
  
 
 
 
 
  
 
 
ANTARES PHARMA, INC. 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS 

1.  Description of Business  

 Antares Pharma, Inc. (“Antares”) is a specialty drug delivery/pharmaceutical company utilizing its experience 
and expertise in drug delivery systems to enhance the performance of established and developing pharmaceuticals. 
The  Company  currently  has  three  primary  delivery  platforms  (1)  transdermal  gels,  (2)  fast-melt  tablets,  and  (3) 
injection  devices.  The  corporate  headquarters  are  located  in  Ewing,  New  Jersey,  with  research  and  production 
facilities  for  the  injection  devices  in  Minneapolis,  Minnesota,  and  research,  development  and  commercialization 
facilities for the transdermal gels and fast-melt tablets in Basel, Switzerland.  

2.  Summary of Significant Accounting Policies 

Basis of Presentation 

The accompanying consolidated financial statements include the accounts of Antares Pharma, Inc. and its three 
wholly-owned  subsidiaries.  All  significant  intercompany  accounts  and  transactions  have  been  eliminated  in 
consolidation. 

Foreign Currency Translation 

The majority of the foreign subsidiaries revenues are denominated in U.S. dollars, and any required funding of 
the subsidiaries is provided by the U.S. parent. Nearly all operating expenses of the foreign subsidiaries, including 
labor,  materials,  leasing  arrangements  and  other  operating  costs,  are  denominated  in  Swiss  Francs.  Additionally, 
bank accounts held by foreign subsidiaries are denominated in Swiss Francs, there is a low volume of intercompany 
transactions and there is not an extensive interrelationship between the operations of the subsidiaries and the parent 
company.  As  such,  under  Financial  Accounting  Standards  Board  Statement  No.  52,  “Foreign  Currency 
Translation,”  the  Company  has  determined  that  the  Swiss  Franc  is  the  functional  currency  for  its  three  foreign 
subsidiaries. The reporting currency for the Company is the United States Dollar (“USD”). The financial statements 
of  the  Company’s  three  foreign  subsidiaries  are  translated  into  USD  for  consolidation  purposes.  All  assets  and 
liabilities  are  translated  using  period-end  exchange  rates  and  statements  of  operations  items  are  translated  using 
average exchange rates for the period. The resulting translation adjustments are recorded as a separate component of 
stockholders’ equity. Sales to certain customers by the U.S. parent are in currencies other than the U.S. dollar and 
are  subject  to  foreign  currency  exchange  rate  fluctuations.  Foreign  currency  transaction  gains  and  losses  are 
included in the statements of operations. 

Cash Equivalents  

The  Company  considers  highly  liquid  debt  instruments  with  original  maturities  of  90  days  or  less  to  be  cash 

equivalents.  

Short-Term Investments 

All short-term investments are commercial paper or U.S. government agency discount notes that mature within 
one year of purchase and are classified as held-to-maturity because the Company has the positive intent and ability 
to  hold  the  securities  to  maturity.  The  securities  are  carried  at  their  amortized  cost.  At  December  31,  2006  the 
securities had a fair value of $4,951,654 and a carrying value of $4,953,421. At December 31, 2005 there were no 
short-term investments. 

Inventories  

Inventories  are  stated  at  the  lower  of  cost  or  market.  Cost  is  determined  on  a  first-in,  first-out  basis.  Certain 
components  of  the  Company’s  products  are  provided  by  a  limited  number  of  vendors,  and  the  Company’s 
production and assembly operations are outsourced to a third-party supplier. Disruption of supply from key vendors 
or the third-party supplier may have a material adverse impact on the Company’s operations. 

53 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Equipment, Furniture, and Fixtures  

Equipment, furniture, and fixtures are stated at cost and are depreciated using the straight-line method over their 
estimated useful lives ranging from three to ten years. Certain equipment and furniture held under capital leases is 
classified in equipment, furniture and fixtures and is amortized using the straight-line method over the lesser of the 
lease  term  or  estimated  useful  life,  and  the  related  obligations  are  recorded  as  liabilities.  Lease  amortization  is 
included in depreciation expense.  Depreciation expense was $144,225, $192,869 and $423,107 for the years ended 
December 31, 2006, 2005 and 2004, respectively.  

Goodwill 

The  Company  evaluates  the  carrying  value  of  goodwill  during  the  fourth  quarter  of  each  year  and  between 
annual evaluations if events occur or circumstances change that would more likely than not reduce the fair value of 
the Minnesota reporting unit below its carrying amount. Such circumstances could include, but are not limited to: (1) 
a  significant  adverse  change  in  legal  factors  or  in  business  climate,  (2)  unanticipated  competition,  (3)  an  adverse 
action  or  assessment  by  a  regulator,  or  (4)  a  sustained  significant  drop  in  the  Company’s  stock  price.  When 
evaluating whether goodwill is impaired, the Company compares the fair value of the Minnesota operations to the 
carrying amount, including goodwill. If the carrying amount of the Minnesota operations exceeds its fair value, then 
the amount of the impairment loss must be measured. The impairment loss would be calculated by comparing the 
implied fair value of goodwill to its carrying amount. In calculating the implied fair value of goodwill, the fair value 
of the Minnesota operations would be allocated to all of its other assets and liabilities based on their fair values. The 
excess of the fair value of the Minnesota operations over the amount assigned to its other assets and liabilities is the 
implied  fair  value  of  goodwill.  An  impairment  loss  would  be  recognized  when  the  carrying  amount  of  goodwill 
exceeds  its  implied  fair  value.  The  Company’s  evaluation  of  goodwill  completed  during  2006,  2005  and  2004 
resulted in no impairment losses. 

Patent Rights 

The Company capitalizes the cost of obtaining patent rights. These capitalized costs are being amortized on a 
straight-line basis over periods ranging from six to ten years beginning on the earlier of the date the patent is issued 
or  the  first  commercial  sale  of  product  utilizing  such  patent  rights.  Amortization  expense  for  the  years  ended 
December 31, 2006, 2005 and 2004 was $153,150, $129,349 and $156,970, respectively.   

Impairment of Long-Lived Assets and Long-Lived Assets to Be Disposed Of 

Long-lived  assets,  including  patent  rights,  are  reviewed  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 asset. This analysis can be very subjective as the Company relies upon signed distribution or 
license agreements with variable cash flows to substantiate the recoverability of long-lived 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 fair value of the assets. Assets to be disposed of are reported at the lower of the 
carrying amount or fair value less costs to sell. 

In  the  fourth  quarter  of  each  year  the  Company  updates  its  long-range  business  plan.  The  Company  then 
reviews  patent  costs  for  impairment  and  identifies  patents  related  to  products  for  which  there  are  no  signed 
distribution or license agreements or for which no revenues or cash flows are included in the business plan. In 2006 
and  2004  the  Company  recognized  impairment  charges  of  $138,632  and  $233,062,  respectively,  in  general  and 
administrative  expenses,  which  represented  the  gross  carrying  amount  net  of  accumulated  amortization  for  the 
identified patents. After the impairment charge, the gross carrying amount and accumulated amortization of patents, 
which  are  the  only  intangible  assets  of  the  Company  subject  to  amortization,  were  $1,526,714  and  $713,122, 
respectively, at December 31, 2006. The Company’s estimated aggregate patent amortization expense for the next 
five years is $95,000 in 2007, $90,000 in each of 2008, 2009 and 2010, and $42,000 in 2011. 

54 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Fair Value of Financial Instruments 

All financial instruments are carried at amounts that approximate estimated fair value.  

Revenue Recognition  

The  Company  sells  its  proprietary  reusable  needle-free  injectors  and  related  disposable  products  through 
pharmaceutical and medical product distributors. The Company’s reusable injectors and related disposable products 
are not interchangeable with any competitive products and must be used together. The Company recognizes revenue 
upon shipment when title transfers. The Company offers no price protection or return rights other than for customary 
warranty claims. Sales terms and pricing are governed by sales and distribution agreements. 

The  Company  also  records  revenue  from  license  fees,  milestone  payments  and  royalties.  License  fees  and 
milestone  payments  received  under  contracts  originating  prior  to  June  15,  2003  are  accounted  for  under  the 
cumulative deferral method. This method defers milestone payments with amortization to income over the contract 
term  on  a  straight-line  basis  commencing  with  the  achievement  of  a  contractual  milestone.  If  the  Company  is 
required to refund any portion of a milestone payment, the milestone will not be amortized into revenue until the 
repayment obligation no longer exists.  

The  Company  recognizes  royalty  revenues  upon  the  sale  of  licensed  products  by  the  licensee.  The  Company 
occasionally receives payment of up-front royalty advances from licensees. Under the cumulative deferral method 
for contracts prior to June 15, 2003, if specific objective evidence of fair value exists, revenues from up-front royalty 
payments are deferred until earned through the sale of licensed product or the termination of the agreement based on 
the terms of the license. If specific objective evidence of fair value does not exist, revenues from up-front royalty 
payments are recognized using the cumulative deferral method.  

In December 2002, the Emerging Issues Task Force (“EITF”) issued EITF 00-21, Revenue Arrangements with 
Multiple  Deliverables.  This  Issue  addresses  certain  aspects  of  the  accounting  by  a  vendor for  arrangements  under 
which it will perform multiple revenue-generating activities. In some arrangements, the different revenue-generating 
activities  (deliverables)  are  sufficiently  separable,  and  there  exists  sufficient  evidence  of  their  fair  values  to 
separately  account  for  some  or  all  of  the  deliverables  (that  is,  there  are  separate  units  of  accounting).  In  other 
arrangements, some or all of the deliverables are not independently functional, or there is not sufficient evidence of 
their fair values to account for them separately. This Issue addresses when and, if so, how an arrangement involving 
multiple  deliverables  should  be  divided  into  separate  units  of  accounting.  This  Issue  does  not  change  otherwise 
applicable revenue recognition criteria.  

Under  EITF  00-21,  an  up-front  license  payment  is  evaluated  to  determine  whether  or  not  it  meets  the 
requirements  to  be  considered  a  separate  unit  of  accounting.  If  it  meets  the  separation  criteria  it  is  recognized  as 
revenue  when  received  or  over  the  development  period  if  the  license  and  development  are  a  combined  unit  of 
accounting. If it does not meet the separation criteria, then an up-front payment is deferred and would be recognized 
consistent with the remaining deliverables. 

If the Company earns development fees for time and material costs incurred in connection with a development 
agreement, the development fees will be recognized as revenue when earned if that portion of the agreement meets 
the separation criteria of EITF 00-21. If the separation criteria are not met, the development fees received would be 
recognized  consistent  with  the  remaining  deliverables.  Likewise,  the  labor  and  material  costs  related  to  the 
development  fees  are  recognized  as  a  cost  of  sales  when  incurred  if  the  separation  criteria  are  met,  and  are 
capitalized and amortized on a straight-line basis over the same period as the development fees if the criteria are not 
met. 

In connection with a license agreement entered into with Eli Lilly and Company, the Company issued to Lilly a 
ten-year warrant to purchase 1,000,000 shares of the Company’s common stock at an exercise price of $3.776 per 
share.  At  the  time  of  issue  the  Company  determined  that  the  fair  value  of  the  warrant  was  $2,943,739  using  the 
Black-Scholes option pricing model.  EITF 01-9, Accounting  for  Consideration Given  by  a  Vendor  to  a  Customer 
(Including a Reseller of the Vendor’s Products), requires that the value of the warrants be treated as a reduction in 
revenue. The fair value of the warrant was recorded to additional paid-in capital and to prepaid license discount, a 

55 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
contra  equity  account.  The  prepaid  license  discount  will  be  reduced  on  a  straight-line  basis  over  the  term  of  the 
agreement,  offsetting  revenue  generated  under  the  agreement.  If  during  its  periodic  impairment  assessment  the 
Company  concludes  that  the  revenues  from  this  arrangement  will  not  exceed  the  costs,  including  prepaid  license 
discount, part or all of the remaining prepaid license discount would be charged to operations at that time. 

Stock-Based Compensation 

As  of  January  1,  2006,  the  Company  adopted  the  fair  value  method  of  accounting  for  employee  stock 
compensation  cost  pursuant  to  SFAS  No.  123R,  which  requires  a  public  entity  to  measure  the  cost  of  employee 
services received in exchange for the award of equity instruments based on the fair value of the award at the date of 
grant.    The  cost  will  be  recognized  over  the  period  during  which  an  employee  is  required  to  provide  services  in 
exchange for the award.  Prior to January 1, 2006, the Company used the intrinsic value method under APB Opinion 
No. 25.  Accordingly, compensation expense was recognized for restricted stock granted to employees, but was not 
recognized  for  employee  stock  options  other  than  the  intrinsic  value  of  options  when  the  exercise  price  of  the 
options was below their fair value on the date of grant. The Company is using the modified prospective transition 
method  in  implementing  SFAS No.  123R.   Under  that  transition  method,  for  the  portion of  awards  that  vested  in 
2006, compensation cost recognized during the year includes: (1) compensation cost for all stock-based payments 
granted  prior  to,  but  not  yet  vested  as  of  December  31,  2005,  based  on  the  grant  date  fair  value  calculated  in 
accordance with the original provisions of SFAS No. 123, and (2) compensation cost for all stock-based payments 
granted  subsequent  to  December  31,  2005,  based  on  the  grant-date  fair  value  calculated  in  accordance  with  the 
provisions  of  SFAS  No.  123R.    In  accordance  with  the  modified  prospective  transition  method,  results  for  prior 
periods have not been restated and do not include the impact of SFAS No. 123R. 

As a result of adopting SFAS No. 123R, the Company’s net loss for the year ended December 31, 2006 was 
approximately  $1,050,000  more  than  if  it  had  continued  to  account  for  stock-based  compensation  under  APB 
Opinion No. 25.     

Had compensation cost been determined based on the fair value at the grant date for stock options under SFAS 
No. 123R for the years ended December 31, 2005 and 2004, the net loss applicable to common shares and loss per 
common share would have increased to the pro-forma amounts shown below: 

Net loss applicable to common stockholders: 

As reported 
Stock based employee compensation expense 

recognized 

Fair-value method compensation expense 

Pro Forma net loss 

Basic and diluted net loss per common share: 

As reported 
Stock based employee compensation expense 

recognized 

Fair-value method compensation expense 
Pro Forma net loss per common share 

2005 

2004 

  $

 (8,547,956) 

  $ 

 (8,448,532 ) 

176,298 
(1,069,103) 
 (9,440,761) 

272,569  
(1,141,813 ) 
 (9,317,776 ) 

  $ 

 (0.21) 

  $ 

 (0.23 ) 

- 
(0.02) 
 (0.23) 

  $ 

-  
(0.03 ) 
 (0.26 ) 

  $

  $

  $

The  Company  accounts  for  stock-based  instruments  granted  to  nonemployees  under  the  fair  value  method  of 
SFAS 123R and Emerging Issues Task Force (“EITF”) 96-18, “Accounting for Equity Instruments That Are issued 
to Other Than Employees for Acquiring, or in Conjunction with Selling Goods or Services.”  Under SFAS 123R, 
options  granted  to  nonemployees  are  recorded  at  their  fair  value  on  the  measurement  date,  which  is  typically  the 
vesting date. 

56 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Product Warranty  

The Company provides a warranty on its reusable needle-free injector devices. Warranty terms for devices sold 
to end-users by dealers and distributors are included in the device instruction manual included with each device sold. 
Warranty  terms  for  devices  sold  to  corporate  customers  who  provide  their  own  warranty  terms  to  end-users  are 
included  in  the  contracts  with  the  corporate  customers.  The  Company  is  obligated  to  repair  or  replace,  at  the 
Company’s  option,  a  device  found  to  be  defective  due  to  use  of  defective  materials  or  faulty  workmanship.  The 
warranty does not apply to any product that has been used in violation of instructions as to the use of the product or 
to any product that has been neglected, altered, abused or used for a purpose other than the one for which it was 
manufactured. The warranty also does not apply to any damage or defect caused by unauthorized repair or the use of 
unauthorized parts. Warranty periods on devices range from 24 to 30 months from either the date of retail sale of the 
device  by  a  dealer  or  distributor  or  the  date  of  shipment  to  a  customer  if  specified  by  contract.  The  Company 
recognizes the estimated cost of warranty obligations at the time the products are shipped based on historical claims 
incurred by the Company. Actual warranty claim costs could differ from these estimates. Warranty liability activity 
is as follows:  

Balance at  
Beginning of  
Year 

Provisions 

Claims 

Balance at  
End of  
Year 

2006 
2005 

  $ 
  $ 

25,000 
30,000 

 $ 
 $ 

4,066  $
6,212  $

 (9,066)
 (11,212)

$
$

20,000 
25,000 

Research and Development  

Research and development costs are expensed as incurred.  

Use of Estimates  

The  preparation  of  financial  statements  in  conformity  with  U.S.  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.  The  Company’s  significant  accounting  estimates  relate  to  the 
revenue recognition periods for license revenues, product warranty accruals and determination of the fair value and 
recoverability of goodwill and patent rights. Actual results could differ from these estimates. 

Income Taxes  

 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. 
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. Due to 
historical net losses of the Company, a valuation allowance is established to offset the deferred tax asset. 

Net Loss Per Share  

Basic  EPS  is  computed  by  dividing  net  income  or  loss  available  to  common  stockholders  by  the  weighted-
average number of common shares outstanding for the period. Diluted EPS is computed similar to basic earnings per 
share  except  that  the  weighted  average  shares  outstanding  are  increased  to  include  additional  shares  from  the 
assumed exercise of stock options, warrants, convertible debt or convertible preferred stock, if dilutive. The number 
of additional shares is calculated by assuming that outstanding stock options or warrants were exercised and that the 
proceeds from such exercise were used to acquire shares of common stock at the average market price during the 
reporting period.  If the convertible preferred stock were dilutive, any applicable dividends would be removed and 
the shares issued would be assumed to be outstanding for the dilutive period. All potentially dilutive common shares 
were excluded from the calculation because they were anti-dilutive for all periods presented.  

57 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Potentially dilutive securities at December 31, 2006, 2005 and 2004, excluded from dilutive loss per share as 

their effect is anti-dilutive, are as follows: 

Stock options and warrants 
Potentially dilutive shares from Series D 

convertible preferred stock 

Reclassifications 

2006 

2005 

2004 

  25,699,542 

  19,840,298 

   20,256,591  

-

-

635,880  

Certain  prior  year  amounts  have  been  reclassified  to  conform  to  the  current  year  presentation.  These 
reclassifications did not impact previously reported net loss or net loss per share. In 2006 the Company reclassified 
expenses for quality and regulatory activities previously reported as general and administrative expenses to research 
and development expenses.  The amounts of the reclassifications were $267,529 and $233,682 in 2005 and 2004, 
respectively.  

New Accounting Pronouncements 

In December 2004, the Financial Accounting Standards Board (“FASB”) issued SFAS No. 123 (Revised 2004), 
“Share-Based  Payment.”  SFAS No. 123R  is  a  revision  of  SFAS No. 123,  “Accounting  for  Stock-Based 
Compensation” and supersedes APB Opinion No. 25, “Accounting for Stock Issued to Employees” and its related 
implementation  guidance.  Among  other  items,  the  standard  requires  that  the  compensation  cost  relating  to  share-
based  payment  transactions  be  recognized  in  the  consolidated  statement  of  operations.  SFAS No. 123R  focuses 
primarily on accounting for transactions in which an entity obtains employee services through share-based payment 
transactions. As of January 1, 2006, the Company adopted the fair value method of accounting for employee stock 
compensation  cost  pursuant  to  SFAS  No.  123R,  which  requires  a  public  entity  to  measure  the  cost  of  employee 
services received in exchange for the award of equity instruments based on the fair value of the award at the date of 
grant.    The  cost  will  be  recognized  over  the  period  during  which  an  employee  is  required  to  provide  services  in 
exchange for the award.  Prior to January 1, 2006, the Company used the intrinsic value method under APB Opinion 
No. 25.  Accordingly, compensation expense was recognized for restricted stock granted to employees, but was not 
recognized  for  employee  stock  options  other  than  the  intrinsic  value  of  options  when  the  exercise  price  of  the 
options was below their fair value on the date of grant. The Company is using the modified prospective transition 
method  in  implementing  SFAS  No.  123R.    Under  that  transition  method,  compensation  cost  recognized  in  2006 
includes: (1) compensation cost for all stock-based payments granted prior to, but not yet vested as of December 31, 
2005, based on the grant date fair value calculated in accordance with the original provisions of SFAS No. 123, and 
(2) compensation cost for all stock-based payments granted subsequent to December 31, 2005, based on the grant-
date fair value calculated in accordance with the provisions of SFAS No. 123R.  In accordance with the modified 
prospective transition method, results for prior periods have not been restated and do not include the impact of SFAS 
No. 123R.     

In  June  2006,  the  FASB  issued  Interpretation  No. 48,  “Accounting  for  Uncertainty  in  Income  Taxes —  an 
interpretation  of  FASB  Statement  No. 109.”  This  interpretation  clarifies  the  accounting  for  uncertainty  in  income 
taxes recognized in an enterprise’s financial statements in accordance with FASB Statement No. 109, “Accounting 
for Income Taxes.” This interpretation prescribes a recognition threshold and measurement attribute for the financial 
statement  recognition  and  measurement  of  a  tax  position  taken  or  expected  to  be  taken  in  a  tax  return.  It  also 
provides guidance on derecognition, classification, interest and penalties, accounting in interim periods, disclosure 
and  transition.  This  interpretation  is  effective  beginning  in  fiscal  year  2007.  The  Company  does  not  believe  the 
implementation of this standard will have a material impact on the consolidated financial statements.  

In September 2006, the FASB issued Statement of Financial Accounting Standards (“SFAS”) No. 157, “Fair 
Value Measurements” which is effective for fiscal years beginning after November 15, 2007 and for interim periods 
within those years. This statement defines fair value, establishes a framework for measuring fair value and expands 
the related disclosure requirements. The Company is currently evaluating the potential impact of this statement on 
the consolidated financial statements.  

58 

 
 
 
 
  
 
 
 
 
 
  
 
 
  
 
 
 
 
 
 
 
 
  
 
  
 
  
In September 2006, the Staff of the SEC issued Staff Accounting Bulletin (“SAB”) No. 108, Considering the 
Effects  of  Prior  Year  Misstatements  when  Quantifying  Misstatements  in  Current  Year  Financial  Statements. 
SAB No. 108  provides  guidance  on  the  consideration  of  the  effects  of  prior  year  misstatements  in  quantifying 
current  year  misstatements  for  the  purpose  of  determining  whether  the  current  year’s  financial  statements  are 
materially misstated. SAB No. 108 is effective for fiscal years ending after November 15, 2006. This bulletin did not 
have an impact on our consolidated financial statements.  

Liquidity 

The  Company  has  not  historically  generated,  and  does  not  currently  generate,  enough  revenue  to  provide  the 
cash needed to support its operations, and has continued to operate primarily by raising capital and incurring debt.  
In  order  to  better  position  the  Company  to  take  advantage  of  potential  growth  opportunities  and  to  fund  future 
operations, the Company raised additional capital in the first quarter of 2006.  The Company received net proceeds 
of $9,782,055 in  a  private placement  of  its  common  stock  in  which  a  total  of  8,770,000  shares  of  common  stock 
were  sold  at  a  price  of $1.25  per  share.   In  connection with  the private  placement,  the  Company  issued  five-year 
warrants to purchase an aggregate of 7,454,500 shares of common stock with an exercise price of $1.50 per share.  
In 2006 the Company also received proceeds of $1,335,086 in connection with warrant and stock option exercises 
which resulted in the issuance of 1,443,470 shares of common stock. 

In February of 2007 the Company received gross proceeds of $5,000,000 upon closing of the first tranche of a 

$10,000,000 credit facility, to help fund additional working capital needs. 

The  Company  believes  that  the  combination  of  the  recent  debt  and  equity  financings  and  projected  product 
sales,  product  development,  license  revenues,  milestone  payments  and  royalties  will  provide  sufficient  funds  to 
support operations for at least the next 12 months.  During 2007, the Company believes capital expenditures may 
increase  to  over  $1.5  million  primarily  in  connection  with  tooling  and  production  equipment  related  to  injection 
device  deals.  The  Company  does  not  currently  have  any  bank  credit  lines.    If  the  Company  does  need  additional 
financing and is unable to obtain such financing when needed, or obtain it on favorable terms, the Company may be 
required to curtail development of new drug technologies, limit expansion of operations or accept financing terms 
that are not as attractive as the Company may desire.   

3.  Composition of Certain Financial Statement Captions 

Inventories: 

Raw material 
Finished goods 

Equipment, furniture and fixtures: 

Furniture, fixtures and office equipment 
Production equipment 
Less accumulated depreciation 

Patent rights: 

Patent rights 
Less accumulated amortization 

Accrued expenses and other liabilities: 

Accrued employee compensation and benefits 
Other liabilities 

59 

December 31,   

December 31,   

2006 

2005 

  $ 

  $ 

16,828  
67,951  
84,779  

   $ 

   $ 

22,854 
13,168 
36,022 

  $  1,233,538  
2,130,992  
(2,982,434 ) 
382,096  

  $ 

   $  1,161,004 
  2,068,887 
 (2,752,283) 
477,608 

   $ 

  $  1,526,714  
(713,122 ) 
813,592  

  $ 

   $  1,493,069 
(556,130) 
936,939 

   $ 

  $ 

660,248  
410,838  
  $  1,071,086  

   $ 

   $ 

371,033 
427,435 
798,468 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
  
 
 
  
  
 
 
 
  
 
 
 
  
  
 
 
 
  
 
  
 
 
  
  
 
 
 
  
 
 
 
  
  
 
 
 
  
 
 
4.  Leases  

The Company has non-cancelable operating leases for its corporate headquarters facility in Ewing, New Jersey, 
its  office,  research  and  development  facility  in  Minneapolis,  MN  and  for  its  office  and  research  facility  in  Basel, 
Switzerland.  The  leases  require  payment  of  all  executory  costs  such  as  maintenance  and  property  taxes.  The 
Company also leases certain equipment and furniture under various operating leases.  

Rent expense, net, incurred for the years ended December 31, 2006, 2005 and 2004 was $352,473, $375,090 

and $436,152, respectively.  

Future minimum annual operating lease payments are as follows as of December 31, 2006:  

2007 
2008 
2009 
2010 
2011 
Thereafter 
Total future minimum lease payments 

Amount 

$ 

329,894 
320,685 
209,806 
198,803 
133,580 
8,495 
$  1,201,263 

5. 

Income Taxes      

The Company incurred losses for both book and tax purposes in each of the years in the three-year period ended 
December 31, 2006, and, accordingly, no income taxes were provided. The Company was subject to taxes in both 
the U.S. and Switzerland in each of the years in the three-year period ended December 31, 2006. Effective tax rates 
differ from statutory income tax rates in the years ended December 31, 2006, 2005 and 2004 as follows:  

Statutory income tax rate 
State income taxes, net of federal benefit 
Research and experimentation credit 
Valuation allowance increase 
Effect of foreign operations 
Expiration of net operating losses 
Intangibles impairment 
Foreign net operating loss carryforwards 
Other 

2006 

2005 

2004 

(34.0)%  
(0.7) 
(0.3) 
21.9 
13.1 
0.8 
— 
— 
(0.8) 
0.0%  

(34.0)%  
(0.0) 
(0.8) 
21.0 
12.8 
0.2 
— 
— 
0.8 
0.0%  

(34.0)% 
(0.0) 
0.1 
5.4 
8.1 
3.0 
— 
15.7 
1.7 
0.0% 

60 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Deferred tax assets as of December 31, 2006 and 2005 consist of the following:  

Net operating loss carryforward – U.S. 
Net operating loss carryforward – Switzerland 
Research and development tax credit carryforward 
Deferred revenue 
Depreciation and amortization 
Other 

Less valuation allowance 

2006 

2005 

  $ 15,251,000 
3,862,000 
891,000 
1,048,000 
280,000 
1,256,000 
22,588,000 
(22,588,000) 
— 

  $

  $ 14,753,000  
2,875,000  
867,000  
876,000  
287,000  
873,000  
20,531,000  
(20,531,000 ) 
—  

  $

The  valuation  allowance  for  deferred  tax  assets  as  of  December  31,  2006  and  2005  was  $22,588,000  and 
$20,531,000, respectively. The net change in the total valuation allowance for the years ended December 31, 2006 
and 2005 was an increase of $2,057,000 and $1,220,000, respectively. In assessing the realizability of deferred tax 
assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets 
will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable 
income  during  the  periods  in  which  those  temporary  differences  become  deductible.  Management  considers  the 
scheduled reversal of deferred tax liabilities, projected future taxable income and tax planning strategies in making 
this  assessment.  Due  to  the  uncertainty  of  realizing  the  deferred  tax  asset,  management  has  recorded  a  valuation 
allowance against the entire deferred tax asset. 

The  Company  has  a  U.S.  federal  net  operating  loss  carryforward  at  December  31,  2006,  of  approximately 
$42,000,000,  which,  subject  to  limitations  of  Internal  Revenue  Code  Section  382,  is  available  to  reduce  income 
taxes  payable  in  future  years.  If  not  used,  this  carryforward  will  expire  in  years  2007  through  2026,  with 
approximately  $1,789,000  expiring  over  the  next  three  years.  Additionally,  the  Company  has  a  research  credit 
carryforward of approximately $891,000. These credits expire in years 2008 through 2026. 

The  Company  also  has  a  Swiss  net  operating  loss  carryforward  at  December  31,  2006,  of  approximately 
$28,600,000, which is available to reduce income taxes payable in future years. If not used, this carryforward will 
expire in years 2007 through 2013, with approximately $5,900,000 expiring over the next three years.  

Utilization of U.S. net operating losses and tax credits of Antares Pharma, Inc. are subject to annual limitations 
under  Internal  Revenue  Code  Sections 382 and 383,  respectively,  as  a  result  of  significant  changes  in  ownership, 
including the business combination with Permatec, private placements, warrant exercises and conversion of Series D 
Convertible  Preferred  Stock.  Subsequent  significant  equity  changes,  including  exercise  of  outstanding  warrants, 
could further limit the utilization of the net operating losses and credits. The annual limitations have not yet been 
determined; however, when the annual limitations are determined, the gross deferred tax assets for the net operating 
losses and tax credits will be reduced with a reduction in the valuation allowance of a like amount. 

6.  Stockholders’ Equity  

Common Stock 

In the first quarter of 2006, the Company received proceeds of $9,782,055, which was net of offering costs of 
$1,180,445, in a private placement of its common stock in which a total of 8,770,000 shares of common stock were 
sold at a price of $1.25 per share.  In connection with the private placement, the Company issued five-year warrants 
to purchase an aggregate of 7,454,500 shares of common stock with an exercise price of $1.50 per share. 

In November 2005, in connection with a License Development and Supply Agreement discussed further in Note 

10, the Company sold 400,000 shares of its common stock at $1.25 per share.  

61 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  Warrant  and  stock  option  exercises  during  2006  and  2005  resulted  in  proceeds  of  $1,335,086  and  $193,700, 
respectively,  and  in  the  issuance  of  1,517,020  and  315,200  shares  of  common  stock,  respectively.    In  connection 
with  the  exercise  of  210,000  warrants,  the  Company  agreed  to  issue  new  three-year  warrants  for  the  purchase  of 
105,000 shares of common stock with an exercise price of $1.35. The new warrants were issued in 2006. 

During the first quarter of 2004 the Company received net proceeds of $13,753,400 in three private placements 
of its common stock. A total of 15,120,000 shares of common stock were sold to investors at a price of $1.00 per 
share. The Company also issued to the investors five-year warrants to purchase an aggregate of 5,039,994 shares of 
common stock at an exercise price of $1.25 per share. Additionally, warrants for the purchase of 1,612,000 shares of 
common stock at an exercise price of $1.00 per share were issued to the placement agent as a commission. 

During 2004 the Company received proceeds of $1,472,500 in connection with the issuance of 3,480,500 shares 
of common stock from the exercise of warrants. Of the shares issued, 2,932,500 were in connection with warrants 
exercised after the Company had offered a 30% discount in the exercise price to holders of warrants with an exercise 
price of under $1.00. In connection with the exercise of these warrants the Company recognized interest expense of 
$75,388, which represents the difference between the fair values of the warrants  on  the  exercise  date  before  and 
after applying the discount. Fair value was determined using the Black-Scholes option pricing model. 

During each of the years 2005 and 2004 a total of 50,000 shares of common stock were issued to consultants or 
professional  services  organizations  as  compensation  for  services  rendered.  The  total  value  of  the  shares  issued  in 
each year was $44,000 and $54,550, respectively. In 2004 the Company issued 35,000 shares of common stock to 
directors at a value of $30,300. Common stock values were based on the market price of the stock on the dates the 
shares were issued. 

Stock-Based Compensation to Chief Executive Officer 

Jack E. Stover was appointed President and Chief Operating Officer on July 22, 2004, and was appointed Chief 
Executive  Officer  on  September  1,  2004.  The  terms  of  the  employment  agreement  with  Mr. Stover  included  the 
issuance of options to purchase 500,000 shares of common stock at $0.70 per share and an additional issuance of 
options to purchase 40,000 shares of common stock in January of 2005, with all options vesting over four years. The 
employment  agreement  also  included  the  issuance  of  100,000  shares  of  common  stock,  of  which  50,000  shares 
vested immediately and the remaining 50,000 shares vested on the first anniversary of his employment. In addition, 
Mr. Stover was granted 459,999 restricted shares that would vest upon attainment of certain criteria.  The Company 
recorded compensation expense of $35,000 related to the shares with immediate vesting and deferred compensation 
expense  of  $35,000  related  to  the  shares  vesting  over  one  year.  The  amounts  recorded  were  based  on  the  market 
value  of  the  stock  on  the  measurement  date.  The deferred  compensation  expense was recognized ratably  over  the 
one-year vesting period. Compensation expense of $20,417 and $14,583 was recognized in connection with these 
shares during the years ended December 31, 2005 and 2004, respectively.  In the second quarter of 2006, Mr. Stover 
was  awarded  86,666  shares  of  common  stock  after  attainment  of  a  triggering  event  defined  in  his  employment 
agreement.    He  can  earn  up  to  an  additional  373,333  shares  of  common  stock  upon  the  occurrence  of  various 
triggering  events,  which  include  attainment  of  specified  gross  revenue  and  market  cap  levels  and  achievements 
related to merger and acquisition based activities.  

Series A Convertible Preferred Stock 

In June 2005, all 1,500 outstanding shares of Series A Convertible Preferred Stock (“Series A”) were converted 
into 1,200,000 shares of common stock. On November 10, 1998, the Company had sold 1,000 shares of Series A 
and warrants to purchase 56,000 shares of common stock to Elan International Services, Ltd., for total consideration 
of $1,000,000. The Series A carried a 10% dividend which was payable semi-annually.  

Series D Convertible Preferred Stock 

In  June  and  September  of  2005,  the  remaining  30,000  and  33,588  shares  of  Series  D  Preferred  Stock, 
respectively, were converted into 300,000 and 335,880 shares of common stock.  In August 2004, 180,161 shares of 
Series D Preferred Stock were converted into 1,801,610 shares of common stock.  Each share of Series D Preferred 

62 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
was convertible into ten shares of the Company’s Common Stock, resulting in an aggregate of 2,437,490 shares of 
Common Stock issuable upon conversion of the Series D Preferred.  

Stock Options and Warrants  

The Company’s stock option and equity incentive plans allow for the grants of options, restricted stock and/or 
performance awards to officers, directors, consultants and employees.  Under the Company’s recently adopted 2006 
Equity Incentive Plan, the maximum number of shares of stock that may be granted to any one participant during a 
calendar year is 500,000 shares, and no more than 500,000 shares may be issued as restricted stock grants, restricted 
stock units and performance awards.  Options to purchase shares of Common Stock are granted at exercise prices 
not less than 100% of fair market value on the dates of grant.  The term of the options range from three to eleven 
years and they vest in varying periods.  As of December 31, 2006, these plans had 3,745,242 shares available for 
grant.  Stock option exercises are satisfied through the issuance of new shares. 

A summary of stock option activity under the plans as of December 31, 2006 and the changes during the year 

then ended is as follows: 

Outstanding at December 31, 2005 

Granted/Issued 
Exercised 
Cancelled 

Outstanding at December 31, 2006 

Number of 
 Shares 
3,255,901 
1,535,000 
(3,333) 
(360,809) 
4,426,759 

Weighted
Average
Exercise
 Price ($)   
1.76 
1.48 
1.32 
2.00 
1.65 

Exercisable at December 31, 2006 

3,007,039 

1.79 

Weighted  
Average 
Remaining 
Contractual
Term (Years)   

Aggregate 
Intrinsic 
Value ($)   

7.1 

6.7 

276,055 

176,792 

The  intrinsic  value  of  stock  options  exercised  in  the  year  ended  December  31,  2006  was  $1,133.    As  of 
December  31,  2006,  there  was  approximately  $1,300,000  of  total  unrecognized  compensation  cost  related  to 
nonvested  outstanding  stock  options  that  is  expected  to  be  recognized  over  a  weighted  average  period  of 
approximately 2.1 years.   

The  per  share  weighted  average  fair  value  of  options  granted  during  2006,  2005  and  2004  was  estimated  as 
$1.35, $1.25 and $0.87, respectively, on the date of grant using the Black-Scholes option pricing model based on the 
assumptions noted in the table below.  Expected volatilities are based on the historical volatility of the Company’s 
stock.  The weighted average expected life is based on both historical and anticipated employee behavior. 

Risk-free interest rate 
Annualized volatility 
Weighted average expected life, in years 
Expected dividend yield 

December 31, 

2006 

2005 

2004 

4.5%  
126.0%  
7.0 
0.0%  

3.9%
131.0%
7.0 
0.0%

3.7%
124.0%
5.0 
0.0%

The employment agreements with the Chief Executive Officer, Chief Financial Officer and other members of 
executive  management  include  stock-based  incentives  under  which  the  executives  could  be  awarded  up  to 
approximately  1,365,000  shares  of  common  stock  upon  the  occurrence  of  various  triggering  events.    The  Chief 
Executive  Officer  was  awarded  86,666  of  these  shares  in  the  second  quarter  of  2006  when  one  of  the  triggering 
events was reached.  A total of approximately $23,000 in compensation expense was recorded in 2006 in connection 
with  these  shares.    The  weighted  average  grant  date  fair  value  of  the  remaining  awards  considered  probable  of 
achievement was $0.40 per share which resulted in a total fair value of $80,000, of which approximately $23,000 is 
expected to be recognized after December 31, 2006 over a weighted average period of 8 months.   

63 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
  
 
 
 
 
 
 
  
 
 
 
 
 
 
  
 
 
 
 
 
 
  
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
As  compensation  to  non-employees  for  professional  services,  in  2006  and  2004  the  Company  issued  options 
and warrants to purchase a total of 277,500 and 550,000 shares of the Company’s common stock, respectively.  The 
Company recorded these options and warrants at their fair values, using the Black-Scholes option pricing model, of 
$116,909 and $502,293 in 2006 and 2004, respectively. The options and warrants have exercise prices ranging from 
$0.55 to $5.00 per share and expire three to five years after issuance.  

Certain warrants to acquire 8,097,640 shares of common stock at exercise prices ranging from $1.00 to $1.25 
have  full  antidilution  protection  which  reduces  the  exercise  price  of  the  warrants  to  the  effective  price  paid  or 
payable under new stock or stock equivalent issuances. 

Stock option and warrant activity is summarized as follows:  

Options 

Warrants 

Outstanding at December 31, 2003 

Granted/Issued 
Exercised 
Cancelled 

Outstanding at December 31, 2004 

Granted/Issued 
Exercised 
Cancelled 

Outstanding at December 31, 2005 

Granted/Issued 
Exercised 
Cancelled 

  Number of  

Shares 
  1,984,888 
  1,351,650 
— 

(62,044)   

  3,274,494 
225,000 
— 

(243,593)   

  3,255,901 
  1,535,000 

(3,333)   
(360,809)   

Weighted 
  Average Price   
2.33 
  $ 
1.06 
— 
2.00 
1.79 
1.34 
— 
1.80 
1.76 
1.48 
1.32 
2.00 
1.65 

  Number of   

Shares 
  13,420,603 
7,051,994 
(3,480,500)   
(10,000)   

  16,982,097 
— 

(315,200)   
(82,500)   

  16,584,397 
7,659,500 
(1,513,687)   
(1,457,427)   

  21,272,783 

Weighted 
  Average Price   
1.44  
  $ 
1.25  
0.42  
2.40  
1.43  
—  
0.61  
2.37  
1.44  
1.49  
0.97  
3.48  
1.35  

Outstanding at December 31, 2006 

  4,426,759 

The  following  table  summarizes  information  concerning  currently  outstanding  and  exercisable  options  and 

warrants by price range at December 31, 2006:  

Number of Shares 
Outstanding 

Outstanding 
Weighted Average 
Remaining Life 
In Years 

Exercisable 

Weighted Average 
Exercise Price 

Number 
Exercisable 

Weighted Average 
Exercise Price 

533,000 
  2,645,550 
930,000 
311,609 
  6,600 
  4,426,759 

  6,220,979 
  6,342,304 
  7,559,500 
  1,150,000 
  21,272,783 

  25,699,542 

7.5 
7.5 
6.7 
4.0 
1.1 
7.1 

1.7 
2.0 
4.1 
6.0 
2.9 

3.6 

$  0.71 
1.42 
1.77 
4.56 
  11.12 
 1.65 

0.83 
1.25 
1.50 
3.81 
1.35 

1.40 

334,474 
  1,424,356 
930,000 
311,609 
6,600 
  3,007,039 

  6,220,979 
  6,342,304 
  7,559,500 
  1,150,000 
  21,272,783 

  24,279,822 

  $  0.71 
1.40 
1.77 
4.56 
  11.12 
 1.79 

0.83 
1.25 
1.50 
3.81 
1.35 

1.40 

Price Range 
Pursuant  to  Option 
Plans: 
$ 

0.70 to 0.96 
1.01 to 1.56 
1.77 
4.56 
9.05 to 15.65 

Warrants: 
$ 

0.55 to 1.10 
1.25 
1.35 to 1.50 
3.00 to 5.00 

Total Options & 
Warrants 

64 

 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
  
 
 
 
   
 
   
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
7.  Employee Savings Plan  

The Company has an employee savings plan that covers all U.S. employees who have met minimum age and 
service requirements. Under the plan, eligible employees may contribute up to 50% of their compensation into the 
plan.  At  the  discretion  of  the  Board  of  Directors,  the  Company  may  contribute  elective  amounts  to  the  plan, 
allocated  in  proportion  to  employee  contributions  to  the  plan,  employee’s  salary,  or  both.  For  the  years  ended 
December  31,  2006,  2005  and  2004,  the  Company  elected  to  make  contributions  to  the  plan  totaling  $68,369, 
$73,955 and $65,571, respectively.  

8.  Supplemental Disclosures of Cash Flow Information  

Cash  paid  for  interest  during  the  years  ended  December  31,  2006,  2005  and  2004  was  $3,132,  $576  and 

$25,106, respectively.  

9.  License Agreements 

Teva License Development and Supply Agreements 

In September 2006, the Company entered into a Supply Agreement with Teva Pharmaceutical Industries Ltd. 
Pursuant to the agreement, Teva is obligated to purchase all of its delivery device requirements from Antares for an 
undisclosed product to be marketed in the United States. Antares received an upfront cash payment, and will receive 
milestone  fees  and  a  royalty  payment  on  Teva’s  net  sales,  as  well  as  a  purchase  price  for  each  device  sold.    The 
upfront payment is being recognized as revenue over the development period.  The milestone fees and royalties will 
be recognized as revenue when earned. 

In  July  2006,  the  Company  entered  into  an  exclusive  License  Development  and  Supply  Agreement  with  an 
affiliate of Teva, Sicor Pharmaceuticals Inc.  Pursuant to the agreement, the affiliate is obligated to purchase all of 
its delivery device requirements from Antares for an undisclosed product to be marketed in the United States and 
Canada. Antares received an upfront cash payment, and will receive milestone fees, a negotiated purchase price for 
each device sold, as well as royalties on sales of their product.  Based on an analysis under EITF 00-21, the entire 
arrangement  is  considered  a  single  unit  of  accounting.    Therefore,  payments  received  and  development  costs 
incurred  will  be  deferred  and  will  be  recognized  from  the  start  of  manufacturing  through  the  end  of  the  initial 
contract period.   

In  November  2005,  the  Company  signed  an  agreement  with  an  affiliate  of  Teva,  Sicor  Pharmaceuticals  Inc., 
under  which  Sicor  is  obligated  to  purchase  all  of  its  injection  delivery  device  requirements  from  Antares  for  an 
undisclosed product to be marketed in the United States. Sicor also received an option for rights in other territories. 
The license agreement included, among other things, an upfront cash payment, milestone fees, a negotiated purchase 
price  for  each  device  sold,  and  royalties  on  sales  of  their  product.    In  addition,  pursuant  to  a  Stock  Purchase 
Agreement, Sicor purchased 400,000 shares of Antares common stock at a per share price of $1.25. Antares granted 
Sicor certain registration rights with respect to the purchased shares of common stock.  Based on an analysis under 
EITF  00-21,  the  entire  arrangement  is  considered  a  single  unit  of  accounting.    Therefore,  payments  received  and 
development costs incurred will be deferred and will be recognized from the start of manufacturing through the end 
of the initial contract period.   

Eli Lilly Development and License Agreement 

On  September  12,  2003,  the  Company  entered  into  a  Development  and  License  Agreement  (the  “License 
Agreement”) with Eli Lilly and Company. Under the License Agreement, the Company granted Lilly an exclusive 
license  to  certain  of  the  Company’s  reusable  needle-free  technology  in  the  fields  of  diabetes  and  obesity.  The 
Company also granted an option to Lilly to apply the technology in one additional therapeutic area. Additionally, the 
Company  issued  to  Lilly  a  ten-year  warrant  to  purchase  shares  of  the  Company’s  common  stock.  The  Company 
granted  Lilly  certain  registration  rights  with  respect  to  the  shares  of  common  stock  issuable  upon  exercise  of  the 
warrant. At the time of the grant, the Company determined that the fair value of the warrant was $2,943,739 using 
the Black-Scholes option pricing model. The fair value of the warrant was recorded to additional paid in capital and 
to prepaid license discount, a contra equity account.  

65 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The Company analyzed this contract to determine the proper accounting treatment under EITF 00-21, discussed 
in  Note  2.  The  Company  reached  the  conclusion  that  although  there  are  multiple  deliverables  in  the  contract,  the 
entire contract must be accounted for as one unit of accounting. Therefore, all revenue will be deferred when billed 
under the contract terms and will be recognized into revenue on a straight-line basis over the remaining life of the 
contract. All related costs will also be deferred and recognized as expense over the remaining life of the contract on 
a straight-line basis. The prepaid license discount will be amortized against revenue on a straight-line basis over the 
life of the contract. If during its periodic impairment assessment the Company concludes that the revenues from this 
arrangement will not exceed the costs, including prepaid license discount, part or all of the remaining prepaid license 
discount would be charged to earnings at that time. 

Ferring License Agreement 

The  Company  entered  into  a  License  Agreement,  dated  January  22,  2003,  with  Ferring,  under  which  the 
Company  licensed  certain  of  its  intellectual  property  and  extended  the  territories  available  to  Ferring  for  use  of 
certain  of  the  Company’s  reusable  needle-free  injector  devices.  Specifically,  the  Company  granted  to  Ferring  an 
exclusive,  perpetual,  irrevocable,  royalty-bearing  license,  within  a  prescribed  manufacturing  territory,  to 
manufacture certain of the Company’s reusable needle-free injector devices for the field of human growth hormone. 
The Company granted to Ferring similar non-exclusive rights outside of the prescribed manufacturing territory. In 
addition, the Company granted to Ferring a non-exclusive right to make and have made the equipment required to 
manufacture the licensed products, and an exclusive, perpetual, royalty-free license in a prescribed territory to use 
and sell the licensed products.  

The  Company  also  granted  to  Ferring  a  right  of  first  offer  to  obtain  an  exclusive  worldwide  license  to 

manufacture and sell the Company’s AJ-1 device for the treatment of limited medical conditions.  

As consideration for the license grants, Ferring paid the Company EUR500,000 ($532,400) upon execution of 
the License Agreement, and paid an additional EUR1,000,000 ($1,082,098) on February 24, 2003. Ferring will also 
pay the Company royalties for each device manufactured by or on behalf of Ferring, including devices manufactured 
by the Company. Beginning on January 1, 2004, EUR500,000 ($541,049) of the license fee received on February 
24,  2003,  will  be  credited  against  the  royalties  owed  by  Ferring,  until  such  amount  is  exhausted.  These  royalty 
obligations expire, on a country-by-country basis, when the respective patents for the products expire, despite the 
fact that the License Agreement does not itself expire until the last of such patents expires. The license fees have 
been deferred and are being recognized in income over the period from January 22, 2003 through expiration of the 
patents in December 2016.  

The Company also agreed that it would enter into a third-party supply agreement to supply sufficient licensed 
products to meet the Company’s obligations to Ferring under the License Agreement and under the parties’ existing 
supply agreement.  

In  March  2007  the  Company  amended  the  agreement  to  include  a  next  generation  device  and  provided  for 

payment principally in U.S. dollars rather than Euros. 

BioSante License Agreement 

In June 2000, the Company entered into an exclusive agreement to license four applications of its drug-delivery 
technology to BioSante Pharmaceuticals, Inc. in the United States, Canada, China, Australia, New Zealand, South 
Africa, Israel, Mexico, Malaysia and Indonesia (collectively, “the BioSante Territories”). The Company is required 
to  transfer  technology  know-how  to  BioSante  until  each  country’s  regulatory  authorities  approve  the  licensed 
product. BioSante will use the licensed technology for the development of hormone replacement therapy products. 
At the signing of the contract, BioSante made an upfront payment to the Company, a portion of which, per the terms 
of the contract, was used to partially offset a later payment made to the Company as a result of an upfront payment 
received by BioSante under a sublicense agreement.  The initial upfront payment received by the Company was for 
the delivery of intellectual property to BioSante.  

66 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The  Company  will  receive  payments  upon  the  achievement  of  certain  milestones  and  will  receive  from 
BioSante a royalty from the sale of licensed products. The Company will also receive a portion of any sublicense 
fees received by BioSante.  

Under the cumulative deferral method, the Company ratably recognizes revenue related to milestone payments 
from the date of achievement of the milestone through the estimated date of receipt of final regulatory approval in 
the  BioSante  Territory.  The  Company  is  recognizing  the  initial  milestone  payment  in  revenue  over  a  129-month 
period.  All  other  milestone  payments  will  be  recognized  ratably  on  a  product-by-product  basis  from  the  date  the 
milestone payment is earned and all repayment obligations have been satisfied until the receipt of final regulatory 
approval in the BioSante Territory for each respective product. It is expected that these milestones will be earned at 
various dates from January 2005 to March 2011 and will be recognized as revenue over periods of up to 75 months.  

In November 2006 BioSante entered into a sublicense and marketing agreement with Bradley Pharmaceuticals, 
Inc.  for  Elestrin®  (formerly  Bio-E-Gel).    BioSante  received  an  upfront  payment  from  Bradley  which  triggered  a 
payment to the Company of $875,000.  In December 2006 the FDA approved for marketing Elestrin® in the United 
States triggering payments to the Company totaling $2.6 million, which will be received in 2007.  In addition, the 
Company  will  receive  royalties  on  sales  of  Elestrin®  as  well  as  potential  sales-based  milestone  payments  when 
marketed by Bradley.  Because final regulatory approval for this product was obtained by BioSante and Antares has 
no  further  obligations  in  connection  with  this  product,  the  sublicense  payment  of  $875,000  was  recognized  as 
revenue in 2006.  Further sublicense payments and royalties will be recognized as revenue when due and payable. 

In  August  2001,  BioSante  entered  into  an  exclusive  agreement  with  Solvay  in  which  Solvay  has  sublicensed 
from  BioSante  the  U.S.  and  Canadian  rights  to  an  estrogen/progestogen  combination  transdermal  hormone 
replacement gel product, one of the four drug-delivery products the Company has licensed to BioSante. Under the 
terms of the license agreement between the Company and BioSante, the Company received a portion of the up front 
payment made by Solvay to BioSante, net of the portion of the initial up front payment the Company received from 
BioSante  intended  to  offset  sublicense  up  front  payments.  The  Company  is  also  entitled  to  a  portion  of  any 
milestone  payments  or royalties  BioSante  receives  from  Solvay under  the  sublicense agreement.  The  Company  is 
recognizing  the  payment  received from BioSante  in revenue  over  an  108-month period.  The  Company  received  a 
$200,000 milestone payment in January of 2003 and is recognizing revenue over a period of 91 months. All other 
milestone  payments  will  be  recognized  ratably  from  the  date  the  milestone  payment  is  earned  until  the  receipt  of 
final regulatory approval in the U.S. and Canada.  

Solvay License Agreement 

In June 1999, the Company entered into an exclusive agreement to license one application of its gel based drug-
delivery technology to Solvay Pharmaceuticals in all countries except the United States, Canada, Japan and Korea 
(collectively, ‘‘the Solvay Territories’’). The Company is required to transfer technology know-how and to provide 
developmental  assistance  to  Solvay  until  each  country’s  applicable  regulatory  authorities  approve  the  licensed 
product.  Solvay  will  reimburse  the  Company  for  all  technical  assistance  provided  during  Solvay’s  development. 
Solvay  will  use  the  licensed  technology  for  the  development  of  a  hormone  replacement  therapy  gel.  The  license 
agreement  requires  Solvay  to  pay  the  Company  milestone  payments  of  $1,000,000  upon  signing  of  the  license, 
$1,000,000  upon  the  start  of  Phase  IIb/III  clinical  trials,  as  defined  in  the  agreement,  $1,000,000  upon  the  first 
submission by Solvay to regulatory authorities in the Solvay Territories, and $2,000,000 upon the first completed 
registration in either Germany, France or the United Kingdom. The Company will receive from Solvay a 5% royalty 
from  the  sale  of  licensed  products.  In  2002  the  agreement  was  amended  to  change  the  terms  associated  with  the 
second  $1,000,000  milestone  payment,  resulting  in  a  payment  of  $500,000  received  in  2002,  and  two  $250,000 
payments to be received upon satisfaction of certain conditions.  Recently, development work performed by Solvay 
has  been  limited  due  to  concerns  about  certain  forms  of  hormone  replacement  therapy  that  have  been  debated  in 
scientific literature.    

Under the cumulative deferral method, the Company ratably recognizes revenue related to milestone payments 
from  the  date  of  achievement  of  the  milestone  through  the  estimated  date  of  the  first  completed  registration  in 
Germany, France or the United Kingdom. The Company is recognizing the first $1,000,000 milestone payment over 
a  period  of  133  months,  the  $500,000  received  in  2002  over  99  months,  and  will  recognize  the  two  $250,000 

67 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
payments and the third $1,000,000 payment from the date the milestone is earned until the estimated date of the first 
completed registration.  

10.  Segment Information and Significant Customers 

The  Company  has  one  operating  segment,  drug  delivery,  which  includes  the  development  of  drug  delivery 

transdermal and transmucosal pharmaceutical products and drug delivery injection devices and supplies.  

The  geographic  distributions  of  the  Company’s  identifiable  assets  and  revenues  are  summarized  in  the 

following tables: 

The Company has operating assets located in two countries as follows: 

Switzerland 
United States of America 

December 31, 

2006 

2005 

  $ 1,655,869  $1,339,101 
4,827,263 
  $11,534,483  $6,166,364 

9,878,614 

Revenues by customer location are summarized as follows: 

For the Years Ended December 31, 

United States of America 
Europe 
Other 

2006 

2004 

2005 
  $ 1,939,802   $ 511,567  $ 491,014 
1,866,359 
388,583 
  $ 4,268,399   $2,224,746  $2,745,956 

 1,856,847  
  471,750  

1,215,814 
497,365 

The following summarizes significant customers comprising 10% or more of total revenue for the years ended 

December 31: 

Ferring 
BioSante 
JCR 
Solvay 

2006 

2004 

2005 
  $ 1,660,016   $1,065,835  $1,299,469 
289,031 
161,097 
334,276 

 1,038,339  
  163,193  
67,535  

161,021 
258,949 
140,963 

The following summarizes significant customers comprising 10% or more of outstanding accounts receivable as 

of December 31: 

Ferring 
Undisclosed 
Teva 
SciGen, Ltd. 
Undisclosed 

2006 
  $  273,381   $
  214,967  
  155,083  
72,852  
—  

2005 
65,304 
— 
— 
56,118 
58,823 

68 

 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
11.  Quarterly Financial Data (unaudited) 

2006: 
Total revenues 
Gross profit 
Net loss applicable to common shares (2) 
Net loss per common share (2) 
Weighted average shares (1) 

2005: 
Total revenues 
Gross profit 
Net loss applicable to common shares (2) 
Net loss per common share (2) 
Weighted average shares (1) 

First 

Second 

Third 

Fourth 

  $ 

636,660  $ 
315,172 
(2,404,014) 
(.05) 
46,972,487 

859,095  $ 
427,871 
(2,456,744) 
(.05) 
52,961,664 

756,624   $  2,016,020 
  1,532,460 
436,926  
 (1,413,721) 
(1,924,867 ) 
(.04 ) 
(.03) 
 53,214,459 
53,094,622  

  $ 

554,385  $ 
246,897 
(2,272,872) 
(.06) 
40,457,850 

492,425  $ 
224,100 
(2,377,729) 
(.06) 
40,539,760 

443,978   $ 
144,096  
(1,976,629 ) 
(.05 ) 
42,171,329  

733,958 
472,908 
 (1,920,726) 
(.05) 
 42,637,420 

(1)  Loss per Common Share is computed based upon the weighted average number of shares outstanding during each period. Basic and diluted 

loss per share amounts are identical as the effect of potential Common Shares is anti-dilutive. 

(2)  The net loss applicable to common shares and net loss per common share include a deemed dividend to warrant holders of $99,500 in the 

first quarter of 2006 and preferred stock dividends of $50,000 in the second quarter of 2005. 

12.  Subsequent Event 

In February of 2007 the Company received gross proceeds of $5,000,000 upon closing of the first tranche of a 
$10,000,000 credit facility, to help fund working capital needs.  A second tranche of $5,000,000 is available after 
September 30, 2007 but before December 31, 2007.  The per annum interest rate is equal to the sum of the yield for 
three-year  US  treasury  bills  as  quoted  by  Bloomberg,  plus  800  basis  points  calculated  (i)  in  the  case  of  the  first 
tranche, on the business day prior to the first funding date and (ii) in the case of the second tranche, on the business 
day prior to the second funding date (as such term is defined in the Credit Agreement).  In addition, once set, the 
applicable interest rate for each tranche will be fixed for the applicable term.  The maturity date (i) with respect to 
the first tranche is forty-two months from the first funding date and (ii) with respect to the second tranche is thirty-
six  months  from  the  second  funding  date.    The  Company  has  pledged  certain  property  as  collateral,  including  all 
intellectual  property.  The  credit  agreement  contains  certain  covenants  and  provisions  that  affect  the  Company, 
including, without limitation, covenants and provisions that: 

• 
• 
• 

• 

• 

restrict its ability to create or incur indebtedness (subject to enumerated exceptions);  
restrict its ability to create or incur certain liens on its property (subject to enumerated exceptions); 
in  certain  circumstances,  require  it  to  maintain,  on  a  consolidated  basis,  unrestricted  cash  and  cash 
equivalents of at least $2,500,000;  
in certain circumstances, restrict its ability to declare or pay any dividends on any shares of its capital 
stock, purchase or redeem any shares of its capital stock, return any capital to any holder of its equity 
securities or payment of certain bonuses;  
restrict its ability to make certain investments. 

In  connection  with  the  credit  facility,  the  Company  issued  warrants  to  purchase  a  total  of  640,000  shares  of 
common stock at an exercise price of $1.25, of which 240,000 will vest on the occurrence of the drawdown of the 
second tranche.   

69 

 
 
 
  
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Item 9. 

CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL  
DISCLOSURE 

  None 

Item 9A.  CONTROLS AND PROCEDURES 

Disclosure Controls and Procedures. 

The  Company’s  management,  with  the  participation  of  the  Company’s  Chief  Executive  Officer  and  Chief 
Financial  Officer,  has  evaluated  the  effectiveness  of  the  Company’s  disclosure  controls  and  procedures  (as  such 
term is defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended) as of the 
end  of  the  period  covered  by  this  report.  Based  on  such  evaluation,  the  Company’s  Chief  Executive  Officer  and 
Chief Financial Officer have concluded that the Company’s disclosure controls and procedures as of the end of the 
period  covered  by  this  report  have  been  designed  and  are  functioning  effectively  to  provide  reasonable  assurance 
that the information required to be disclosed by the Company in reports filed under the Securities Exchange Act of 
1934 is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and is 
accumulated  and  communicated  to  management,  including  the  Company’s  principal  executive  and  principal 
financial  officers,  or  person  performing  similar  functions,  as  appropriate  to  allow  timely  decisions  regarding 
required disclosure.  

Internal Control over Financial Reporting. 

There have not been any changes in the Company’s internal control over financial reporting during the fiscal 
quarter  to  which  this  report  relates  that  have  materially  affected,  or  are  reasonably  likely  to  materially  affect,  the 
Company’s internal control over financial reporting. 

A  control  system,  no  matter  how  well  conceived  and  operated,  can  provide  only  reasonable,  not  absolute, 
assurance that the objectives of the control system are met. Because of the inherent limitations in all control systems, 
no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within 
the  Company  have  been  detected.  The  design  of  any  system  of  controls  also  is  based  in  part  upon  certain 
assumptions  about  the  likelihood  of  future  events,  and  there  can  be  no  assurance  that  any  design  will  succeed  in 
achieving its stated goals under all potential future conditions; over time, control may become inadequate because of 
changes in conditions, or the degree of compliance with the policies or procedures may deteriorate. Because of the 
inherent  limitations  in  a  cost-effective  control  system,  misstatements  due  to  error  or  fraud  may  occur  and  not  be 
detected. 

Item 9B.  OTHER INFORMATION 

None 

70 

 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
PART III 

Item 10.   DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE 

Information  required  by  this  item  concerning  directors  will  be  set  forth  under  the  caption  “Election  of 

Directors” in our definitive proxy statement for our 2007 annual meeting, and is incorporated herein by reference.  

Information required by this item concerning executive officers will be set forth under the caption “Executive 
Officers of the Company” in our definitive proxy statement for our 2007 annual meeting, and is incorporated herein 
by reference.  

Information  required  by  this  item  concerning  compliance  with  Section  16(a)  of  the  United  States  Securities 
Exchange  Act  of  1934,  as  amended,  will  be  set  forth  under  the  caption  “Section  16(a)  Beneficial  Ownership 
Reporting Compliance” in our definitive proxy statement for our 2007 annual meeting, and is incorporated herein by 
reference.  

Information  required  by  this  item  concerning  the  audit  committee  of  the  Company,  the  audit  committee 
financial  expert  of  the  Company  and  any material  changes  to  the  way in  which  security  holders  may  recommend 
nominees to the Company’s Board of Directors will be set forth under the caption “Corporate Governance” in our 
definitive proxy statement for our 2007 annual meeting, and is incorporated herein by reference. 

The Board of Directors adopted a Code of Business Conduct and Ethics that is applicable to all employees and 
directors.  We  will  provide  copies  of  our  Code  of  Business  Conduct  and  Ethics  without  charge  upon  request.  To 
obtain a copy, please send your written request to Antares Pharma, Inc., 250 Phillips Boulevard, Suite 290, Ewing, 
NJ    08618,  Attn:    Corporate  Secretary.      With    respect  to  any  amendments  or  waivers  of  this  Code  of  Business 
Conduct and  Ethics  (to  the  extent  applicable  to the Company’s chief executive officer,  principal accounting 
officer  or  controller,  or  persons  performing  similar    functions)    the    Company  intends  to  either  post  such 
amendments or waivers  on its website, www.antarespharma.com, or disclose such amendments or waivers pursuant 
to a Current Report on Form 8-K. 

Item 11.  EXECUTIVE COMPENSATION 

Information required by this item will be set forth under the caption “Executive Compensation” in our definitive 

proxy statement for our 2007 annual meeting, and is incorporated herein by reference.  

Item 12. 

SECURITY  OWNERSHIP  OF  CERTAIN  BENEFICIAL  OWNERS  AND  MANAGEMENT  AND 
RELATED STOCKHOLDER MATTERS 

Information  required  by  this  item  concerning  ownership  will  be  set  forth  under  the  caption  “Security 
Ownership of Certain Beneficial Owners and Management” in our definitive proxy statement for our 2007 annual 
meeting, and is incorporated herein by reference.  

71 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  The following table provides information for our equity compensation plans as of December 31, 2006: 

Number of securities
to be issued upon 
exercise of 
outstanding options,
warrants and rights

Weighted-
average 
exercise price of
outstanding 
options, 
warrants and 
rights  

Number of securities 
remaining available 
for future issuance 
under equity 
compensation plans 
(excluding shares 
reflected in the first 
column) 

4,426,759    $

1.65 

705,000  

5,131,759    $

1.76 

1.67 

3,745,242

—  

3,745,242

Plan Category 

Equity compensation plans approved 

by security holders 

Equity compensation plans not 

approved by security holders (1) 

Total 

(1) Includes shares underlying warrants granted to various consultants as compensation for professional services.  

Item 13. 

CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE 

Information  required  by  this  item  will  be  set  forth  under  the  captions  “Certain  Relationships  and  Related 
Transactions” and “Corporate Governance” in our definitive proxy statement for our 2007 annual meeting, and is 
incorporated herein by reference. 

Item 14. 

PRINCIPAL ACCOUNTANT FEES AND SERVICES 

Information required by this item will be set forth under the caption “Ratification of Selection of Independent 
Registered Public Accountants” in our definitive proxy statement for our 2007 annual meeting, and is incorporated 
herein by reference. 

72 

 
 
 
 
 
 
 
 
 
 
  
 
  
 
  
 
  
 
  
  
 
 
 
 
 
 
 
 
 
PART IV 

Item 15. 

EXHIBITS AND FINANCIAL STATEMENT SCHEDULES  

(a)  The following documents are filed as part of this report: 

(1)  Financial Statements - see Part II 

(2)  Financial Statement Schedules 

   Report of Independent Registered Public Accounting Firm on Financial Statement Schedule. 
   Schedule II – Valuation and Qualifying Accounts. 

   All other schedules have been omitted because they are not applicable, are immaterial or are not required 

because the information is included in the financial statements or the notes thereto. 

(3)  Item 601 Exhibits - see list of Exhibits below 

 (b)  Exhibits 

The following is a list of exhibits filed as part of this annual report on Form 10-K.     

Exhibit No. 
3.1 

3.2 

4.1 

4.2 

4.3 

4.4 

4.5 

4.6 

4.7 

4.8 

4.9 

4.10 

4.11 

4.12 

4.13 

Description 

  Certificate of Incorporation (Filed as an exhibit to Schedule 14A on March 18, 2005 and 

incorporated herein by reference.) 

  Bylaws (Filed as an exhibit to Schedule 14A on March 18, 2005 and incorporated herein by 

reference.) 

  Form of Certificate for Common Stock (Filed as an exhibit to Form S-1 on October 1, 1996 

and incorporated herein by reference.) 

  Registration Rights Agreement with Permatec Holding AG dated January 31, 2001 (Filed as 
Exhibit 10.2 to Form 10-K for the year ended December 31, 2000 and incorporated herein by
reference.) 

  Securities Purchase Agreement dated July 7, 2003 (Filed as exhibit 10.48 to Form 8-K on 

July 9, 2003 and incorporated by reference.) 

  Form of Registration Rights Agreement dated July 7, 2003 (Filed as exhibit 10.49 to Form 8-

K on July 9, 2003 and incorporated by reference.)  

  Voting Agreement, dated July 7, 2003, by and among Antares Pharma, Inc., XMark Fund, 

L.P. and XMark Fund, Ltd. (Filed as exhibit 10.50 to Form 8-K on July 9, 2003 and 
incorporated by reference.)  

  Form of Warrant, dated July 7, 2003 (Filed as exhibit 10.51 to Form 8-K on July 9, 2003 and 

incorporated by reference.) 

  Form of Securities Purchase Agreement dated July 17, 2003 (Filed as exhibit 10.52 to Form 

8-K on July 22, 2003 and incorporated herein by reference.) 

  Form of Registration Rights Agreement dated July 17, 2003 (Filed as exhibit 10.53 to Form 

8-K on July 22, 2003 and incorporated herein by reference.) 

  Form of Warrant, dated July 17, 2003 (Filed as exhibit 10.54 to Form 8-K on July 22, 2003 

and incorporated herein by reference.)  

  Warrant Agreement with Eli Lilly and Company dated September 12, 2003 (Filed as exhibit 

10.60 to Form 8-K on September 18, 2003 and incorporated herein by reference.) 

  Registration Rights Agreement with Eli Lilly and Company dated September 12, 2003 (Filed 
as exhibit 10.61 to Form 8-K on September 18, 2003 and incorporated herein by reference.) 
  Form of Securities Purchase Agreement dated February 10, 2004 (Filed as exhibit 10.62 to 

Form 8-K on February 10, 2004 and incorporated herein by reference.) 

  Form of Registration Rights Agreement, dated February 10, 2004 (Filed as exhibit 10.63 to 

Form 8-K on February 10, 2004 and incorporated herein by reference.) 

73 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
4.14 

4.15 

4.16 

4.17 

4.18 

4.19 

  Form of Warrant Agreement, dated February 10, 2004 (Filed as exhibit 10.64 to Form 8-K 

on February 10, 2004 and incorporated herein by reference.) 

  Stock Purchase Agreement with Sicor Pharmaceuticals, Inc., dated November 23, 2005 

(Filed as exhibit 10.55 to Form 10-K for the year ended December 31, 2005 and incorporated 
herein by reference.) 

  Form of Common Stock and Warrant Purchase Agreement, dated February 27, 2006 (Filed 
as exhibit 10.57 to Form 10-K for the year ended December 31, 2005 and incorporated 
herein by reference.) 

  Form of Investors Rights Agreement, dated March 2, 2006 (Filed as exhibit 10.58 to Form 

10-K for the year ended December 31, 2005 and incorporated herein by reference.) 

  Form of Common Stock Purchase Warrant, dated March 2, 2006 (Filed as exhibit 10.59 to 
Form 10-K for the year ended December 31, 2005 and incorporated herein by reference.) 

  Form of Common Stock Purchase Warrant and Related Schedule of Holders and Other 
Terms (Filed as exhibit 4.7 to Form S-3/A Registration Statement on May 16, 2006 and 
incorporated herein by reference.) 

4.20 

  Registration Rights Agreement by and among Antares Pharma, Inc., MMV Financial Inc. 

and HSBC Capital (Canada) Inc., dated February 26, 2007 (Filed as exhibit 4.1 to Form 8-K 
on March 2, 2007 and incorporated herein by reference.) 

4.21 

  Warrant for the Purchase of Shares of Common Stock issued by Antares Pharma, Inc. to 

MMV Financial Inc., dated February 26, 2007 (Filed as exhibit 4.2 to Form 8-K on March 2, 
2007 and incorporated herein by reference.) 

4.22 

  Warrant for the Purchase of Shares of Common Stock issued by Antares Pharma, Inc. to 

HSBC Capital (Canada) Inc., dated February 26, 2007 (Filed as exhibit 4.3 to Form 8-K on 
March 2, 2007 and incorporated herein by reference.) 

4.23 

  Credit Agreement by and among Antares Pharma, Inc., MMV Financial Inc. and HSBC 

Capital (Canada) Inc., dated February 26, 2007 (Filed as exhibit 10.1 to Form 8-K on March 
2, 2007 and incorporated herein by reference.) 

10.0 

  Stock Purchase Agreement with Permatec Holding AG, Permatec Pharma AG, Permatec 

Technologie AG and Permatec NV with First and Second Amendments  
dated July 14, 2000 (Filed as an exhibit to Schedule 14A on December 28, 2000 and 
incorporated herein by reference.) 

10.1 

  Third Amendment to Stock Purchase Agreement, dated January 31, 2001 (Filed as exhibit 
10.1 to Form 10-K for the year ended December 31, 2000 and incorporated herein by 
reference.) 

10.2* 

  Agreement with Becton Dickinson dated January 1, 1999 (Filed as exhibit 10.24 to Form 10-

10.3+ 

K for the year ended December 31, 1998 and incorporated herein by reference.) 
  1993 Stock Option Plan (Filed as an exhibit to Form S-1 on October 1, 1996 and 

incorporated herein by reference.)  

10.4+ 

  Form of incentive stock option agreement for use with 1993 Stock Option Plan (Filed as an 

exhibit to Form S-1 on October 1, 1996 and incorporated herein by reference.) 

10.5+ 

  Form of non-qualified stock option agreement for use with 1993 Stock Option Plan (Filed as 

an exhibit to Form S-1 on October 1, 1996 and incorporated herein by reference.) 

10.6+ 

  1996 Stock Option Plan, with form of stock option agreement (Filed as an exhibit to Form S-

1 on October 1, 1996 and incorporated herein by reference.) 

10.7 

  Amended and Restated 2001 Stock Option Plan for Non-Employee Directors and 

Consultants (Filed as exhibit 10.24 to Form S-8 Registration Statement on December 15, 
2003.) 

10.8 

  Amended and Restated 2001 Incentive Stock Option Plan for Employees (Filed as exhibit 

10.25 to Form S-8 Registration Statement on December 15, 2003.) 

10.9* 

  License Agreement with Solvay Pharmaceuticals BV, dated June 9, 1999 (Filed as exhibit 
10.33 to Form 10-K/A for the year ended December 31, 2001 and incorporated herein by 
reference.) 

10.10* 

  License Agreement with BioSante Pharmaceuticals, Inc., dated June 13, 2000 (Filed as 

exhibit 10.34 to Form 10-K/A for the year ended December 31, 2001 and incorporated herein 
by reference.) 

10.11* 

  Amendment No. 1 to License Agreement with BioSante Pharmaceuticals, Inc., dated May 

74 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
10.12* 

10.13* 

10.14* 

20, 2001 (Filed as exhibit 10.35 to Form 10-K/A for the year ended December 31, 2001 and 
incorporated herein by reference.) 

  Amendment No. 2 to License Agreement with BioSante Pharmaceuticals, Inc., dated July 5, 
2001 (Filed as exhibit 10.36 to Form 10-K/A for the year ended December 31, 2001 and 
incorporated herein by reference.) 

  Amendment No. 3 to License Agreement with BioSante Pharmaceuticals, Inc., dated August 
28, 2001 (Filed as exhibit 10.37 to Form 10-K/A for the year ended December 31, 2001 and 
incorporated herein by reference.) 

  Amendment No. 4 to License Agreement with BioSante Pharmaceuticals, Inc., dated August 
8, 2002 (Filed as exhibit 10.38 to Form 10-K/A for the year ended December 31, 2001 and 
incorporated herein by reference.) 

10.15* 

10.16 

  License Agreement between Antares Pharma, Inc. and Ferring, dated January 21, 2003 (Filed 
as exhibit 10.47 to Form 8-K on February 20, 2003 and incorporated herein by reference.) 
  Securities and Exchange Agreement, dated September 12, 2003 (Filed as exhibit 10.57 to 

Form 8-K on September 15, 2003 and incorporated herein by reference.) 

10.17* 

  Development and License Agreement, dated September 12, 2003, with Eli Lilly and 

Company (Filed as exhibit 10.59 to Form 8-K on September 18, 2003 and incorporated 
herein by reference.) 

10.18 

  Office lease with The Trustees Under the Will and of the Estate of James Campbell, 

10.19 

Deceased, dated February 19, 2004 (Filed as exhibit 10.65 to Form 10-K for the year ended 
December 31, 2003 and incorporated herein by reference.) 

  Form of Indemnification Agreement, dated January 2, 2004, between Antares Pharma, Inc. 
and each of its directors and executive officers (Filed as exhibit 10.66 to Form 10-K for the 
year ended December 31, 2003 and incorporated herein by reference.) 

10.20+ 

  Employment Agreement, dated July 22, 2004, with Jack E. Stover (Filed as exhibit 10.0 to 

Form 10-Q for the quarter ended September 30, 2004 and incorporated herein by reference.) 

10.21* 

  Development Supply Agreement, dated June 22, 2005 (Filed as exhibit 10.0 to Form 10-Q 

for the quarter ended June 30, 2005 and incorporated herein by reference.) 

10.22* 

  License Development and Supply Agreement with Sicor Pharmaceuticals, Inc., dated 

November 23, 2005 (Filed as exhibit 10.54 to Form 10-K for the year ended December 31, 
2005 and incorporated herein by reference.) 

10.23+ 

  Senior Management Agreement by and between Antares Pharma, Inc. and Robert F. Apple, 

dated February 9, 2006 (Filed as exhibit 10.1 to Form 8-K on February 14, 2006 and 
incorporated herein by reference.) 

10.24+ 

  2006 Equity Incentive Plan (Filed as exhibit 10.1 to Form 8-K on May 9, 2006 and 

incorporated herein by reference.) 

10.25 

  Lease Agreement, dated as of May 15, 2006, between the Company and 250 Phillips 

Associates LLC (Filed as exhibit 10.2 to Form 10-Q for the quarter ended June 30, 2006 and 
incorporated herein by reference.) 

10.26+ 

  Employment agreement with Peter Sadowski, Ph.D., dated October 13, 2006 (Filed as 
exhibit 10.1 to Form 8-K on October 16, 2006 and incorporated herein by reference.) 

10.27+ 

  Employment agreement with Dario Carrara, dated October 13, 2006 (Filed as exhibit 10.2 to 

Form 8-K on October 16, 2006 and incorporated herein by reference.) 

10.28+ 

  Employment Agreement, dated February 14, 2005, with James Hattersley (Filed as exhibit 

10.1 to Form 8-K on February 15, 2005 and incorporated herein by reference.) 

10.29+ 

  Amendment No. 1 to Employment agreement with James Hattersley, dated October 13, 2006 

(Filed as exhibit 10.3 to Form 8-K on October 16, 2006 and incorporated herein by 
reference.) 

  Code of Business Conduct and Ethics (Filed as exhibit 14.1 to Form 10-K for the year ended 

December 31, 2003 and incorporated herein by reference.) 

  Subsidiaries of the Registrant 
  Consent of Independent Registered Public Accounting Firm (KPMG LLP) 
  Section 302 CEO Certification 
  Section 302 CFO Certification 
  Section 906 CEO Certification 
  Section 906 CFO Certification 

14.1 

21.1 
23.1 
31.1 
31.2 
32.1 
32.2 

75 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
* 

+ 

  Confidential portions of this document have been redacted and have been separately filed 

with the Securities and Exchange Commission. 
Indicates management contract or compensatory plan or arrangement. 

76 

 
 
 
 
 
 
 
 
 
 
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, in the City of Ewing, 
State of New Jersey, on March 27, 2007. 

ANTARES PHARMA, INC. 

/s/Jack E. Stover 

Jack E. Stover 
President and Chief Executive Officer 

Pursuant  to  the  requirements  of  Section 13  or 15(d) of  the  Securities  Exchange  Act of  1934,  this  report  has been 
signed by the following persons on behalf of the registrant in the capacities indicated on March 27, 2007. 

Signature 

Title 

/s/Jack E. Stover 
Jack E. Stover 

/s/Robert F. Apple 
Robert F. Apple 

/s/Dr. Jacques Gonella 
Dr. Jacques Gonella 

/s/Thomas J. Garrity 
Thomas J. Garrity 

/s/Anton Gueth 
Anton Gueth 

/s/Dr. Rajesh Shrotriya 
Dr. Rajesh Shrotriya 

/s/Dr. Paul Wotton 
Dr. Paul Wotton 

/s/Dr. Leonard Jacob 
Dr. Leonard Jacob 

President, Chief Executive Officer and Director 
(principal executive officer) 

Senior Vice President and Chief Financial Officer  
(principal financial and accounting officer) 

Director, Chairman of the Board 

Director 

Director 

Director 

Director 

Director 

77 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Report of Independent Registered Public Accounting Firm on Financial Statement Schedule 

The Board of Directors and Shareholders 
Antares Pharma, Inc.: 

Under  the  date  of  March  26,  2007,  we  reported  on  the  consolidated  balance  sheets  of  Antares  Pharma,  Inc.  and 
subsidiaries  (the  Company)  as  of  December  31,  2006  and  2005,  and  the  related  consolidated  statements  of 
operations,  stockholders’  equity  and  comprehensive  loss,  and  cash  flows  for  each  of  the  years  in  the  three-year 
period ended December 31, 2006, as included in Antares Pharma, Inc.’s Annual Report on Form 10-K for the fiscal 
year  ended  December  31,  2006.  In  connection  with  our  audits  of  the  aforementioned  consolidated  financial 
statements,  we  also  audited  the  related  consolidated  financial  statement  schedule  as  listed  in  the  accompanying 
index. This consolidated financial statement schedule is the responsibility of Antares Pharma, Inc.’s management. 
Our responsibility is to express an opinion on this consolidated financial statement schedule based on our audits. 

In  our  opinion,  such  financial  statement  schedule,  when  considered  in  relation  to  the  basic  consolidated  financial 
statements taken as a whole, presents fairly, in all material respects, the information set forth therein. 

Our report on the consolidated financial statements refers to the Company's adoption of the provisions of Statement 
of Financial Accounting Standards No. 123 (Revised 2004), Share-Based Payment, on January 1, 2006. 

/s/ KPMG LLP 

Minneapolis, Minnesota 
March 26, 2007 

78 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Antares Pharma, Inc. 

Schedule II 

Valuation and Qualifying Accounts  
For the Years Ended December 31, 2006, 2005 and 2004 

Description 

Year Ended December 31, 2006 
  Allowance for doubtful accounts
  (Deducted from accounts receivable) 

Year Ended December 31, 2005 
  Allowance for doubtful accounts
  (Deducted from accounts receivable) 

Year Ended December 31, 2004 
  Allowance for doubtful accounts
  (Deducted from accounts receivable) 

  Balance at 
Beginning of
Year 

  Charged to
Costs and
Expenses 

  Balance at
End of 
Year 

Deductions 

$

20,800

$

-

$

10,800 

 $   

10,000

22,500

6,173

7,873 

20,800

21,500

1,000

- 

22,500

79