EXTON, Pa., March 18 /PRNewswire-FirstCall/ -- Antares Pharma, Inc. , a specialty drug delivery/pharmaceutical company focused on the growing lifestyle products sector, today announced financial results for the fourth quarter of 2004 and year-end 2004.
Recent Operational Highlights
-- First Proprietary Pharmaceutical Product Filed as IND with FDA:
Based on evidence provided by the Company to the FDA, it was granted
the right to proceed directly into a Phase II dose ranging study and
conduct only a single Phase III study of its lead proprietary
pharmaceutical product, AP-1034, an oxybutynin ATD(TM) gel for the
expanding therapeutic area of overactive bladder (OAB). Antares
confirmed that this progress was a major milestone in its strategic
plans and is believed to bode well for its other gel-based products
in the future.
-- Continuing Progress in Pivotal Phase III Clinical Trial for
Estradiol Gel Announced by North American Licensee: The Company's
North American licensee, BioSante Pharmaceuticals, Inc. completed
enrollment of more than 450 women in a pivotal Phase III clinical
trial for its transdermal bio-identical estradiol gel,
Bio-E-Gel(TM), which is based on Antares' ATD(TM) gel technology.
Filing with the FDA is expected by the end of the second quarter of
2005. Antares has also initiated development of European
registrations for its own ATD(TM) estradiol gel.
-- Key Advantages of ATD(TM) Gel Technology Compared to Patches: The
Company's North American Licensee, BioSante Pharmaceuticals, Inc.,
reported positive Phase II results of its testosterone gel product,
LibiGel(TM), which is based on Antares ATD(TM) gel technology.
Advantages of this gel formulation of testosterone include minimal
site irritation, normal blood level range and no serious adverse
effects when compared to patches. Antares has initiated development
of its own European registration for ATD(TM) testosterone gel for
women with low libido.
-- European Patent Received for Easy Tec(TM) Fast-Melt Technology (with
a Lead Product Candidate Identified): Oral fast-melt tablets is one
of the fastest growing areas in drug delivery, and Antares Pharma
believes it is well positioned to progress with its first
commercial, generic-based product utilizing this technology.
-- Positive Results from Study in Japan Using the Company's Needle-Free
Injection Device for the Delivery of Human Growth Hormone: A study
by Dr. Yutaka Igarashi of the Igarashi Children's Clinic in Miyagi,
Japan, demonstrated positive results, including all subjects
expressing a desire to continue using the Medi-Jector VISION(R)
after completion of the study. Antares Pharma believes that this
represents another confirmation of the desire to use its needle-free
device when patients are aware of this product and are provided that
option.
-- Introduction of the Company's Needle-Free Injection Device for Use
with Insulin in India: Initial sales of recombinant human insulin
along with Antares Pharma's needle-free injection device (the
Medi-Jector VISION(R)) began under a market evaluation in India
under the trade name Recojet(TM). India is now one of the fastest
growing markets for diabetes.
Fourth Quarter Results
Net loss per common share decreased to $0.06 per share in the fourth quarter 2004 from $0.15 per share in the fourth quarter 2003 due to a smaller net loss by approximately $240,000 in 2004 and also to an increase in average common shares outstanding of 20,168,285 to 39,982,515 from 19,814,230 as a result of the first quarter 2004 private equity placement.
Total revenues for the quarter decreased 23% to approximately $716,000 from approximately $928,000 for the same quarter in 2003. The reduction in development revenues continued as the Company's new focus has been to concentrate on developing its technologies for commercial applications rather than licensing its technology out at an early stage. Gross margin percentage decreased in the fourth quarter of 2004 to 49.9% from 57.5% in the comparable quarter of 2003 as the mix of revenues changed as more development fees with higher margins were received in 2003. Total operating expenses decreased approximately $190,000 or 6% to $3.0 million in the fourth quarter 2004 from $3.2 million in the same period in 2003 due to continued cost controls while total operating losses remained approximately the same for the three-month periods ended December 31, 2004 and 2003.
At December 31, 2004, the Company had $9.6 million in cash, cash equivalents and short-term investments, compared to $1.9 million at December 31, 2003.
Commenting on the events of the fourth quarter, Jack E. Stover, President and Chief Executive Officer of Antares Pharma, said, "Foregoing relatively small-dollar development fees this quarter in order to build a stronger, more sustainable revenue stream for 2006 and beyond is a tradeoff Antares is delighted to make. Our product pipeline has expanded significantly, and we continue to be pleased with our progress in leveraging our technologies as a specialty drug delivery/pharmaceutical company while managing our costs at a lower level in 2004 than 2003."
Total Year Results
Net loss per common share decreased to $0.23 per share from $2.18 per share due primarily to the absence of non-cash debt conversion and extinguishment charges in 2004, an increase in average common shares outstanding of 21,255,089 to 36,347,892 from 15,092,803 shares resulting from the Spring 2004 private equity placement, and a smaller net operating loss in 2004 than in 2003.
For the year 2004, total revenue decreased 27% to $2.7 million in 2004 from $3.8 million in 2003. The two key factors were one time only revenue in 2003 which occurred when our largest European customer launched its sale of our Medi-Jector VISION(R) devices and the company's strategic decision to de-emphasize early stage development deals, thus bolstering its own product pipeline. Gross margin as a percent of total revenue increased 3.0 percentage points to 50% from 47% while gross margin dollars were approximately $400,000 less than the previous year due primarily to lower product sales. Operating expenses decreased approximately $665,000, or 6.4%, due primarily to decreases in payroll and investor relations expenses and were partially offset by smaller increases in R&D and sales, marketing and business development expenses.
About Antares Pharma
Antares Pharma is a specialty drug delivery/pharmaceutical company focused on the growing lifestyle products sector and committed to leveraging its multiple drug delivery platforms to add value to existing drugs and to create new products and devices. The Company's current technology platforms include transdermal (Advanced Transdermal Delivery ATD(TM)) gels, disposable mini- needle injection systems (Vibex(TM)), reusable needle-free injection systems (VISION(R) and Valeo(TM)), and fast-melt oral (Easy Tec(TM)) tablets. The Company currently has active partnering programs with several pharmaceutical and distribution companies for a number of indications and applications, including diabetes, growth disorders, obesity, female sexual dysfunction and other hormone therapy.
Antares Pharma currently distributes its needle-free injector systems in more than 30 countries and markets the same technology for use with human growth hormone through licensees in most major regions of the world. Licensees also market an ibuprofen gel using Antares Pharma's ATD(TM) technology in several major European countries. In addition, Antares Pharma is undertaking development or is conducting research on several product opportunities that will form the basis of its specialty pharma program. Antares Pharma's corporate headquarters is in Exton, Pennsylvania, with subsidiaries performing research, development, manufacturing and product commercialization activities in Minneapolis, Minnesota and Basel, Switzerland.
Statements included in this press release that are not historical in nature are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. The Company cautions readers that forward-looking statements are subject to certain risks and uncertainties, which could cause actual results to differ materially and which are identified from time to time in the Company's reports filed with the U.S. Securities and Exchange Commission. Antares Pharma claims the protection of the Safe Harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.
For more information, visit Antares Pharma's web site at http://www.antarespharma.com/ and its needle-free product website, http://www.mediject.com/. Information included on the Company's website is not incorporated herein by reference or otherwise.
ANTARES PHARMA, INC. CONSOLIDATED STATEMENTS OF OPERATIONS Fourth Quarter Ended December 31, 2004 2003 Revenues $715,580 $928,457 Cost of revenues 358,346 394,433 Gross margin 357,234 534,024 Operating expenses 2,970,148 3,160,074 Net operating loss (2,612,914) (2,626,050) Other income (expense) 68,580 (159,914) Net loss (2,544,334) (2,785,964) Preferred stock dividends (50,000) (92,857) Net loss applicable to common shares $(2,594,334) $(2,878,821) Basic and diluted net loss per common share $(0.06) $(0.15) Basic and diluted weighted average common shares outstanding 39,982,515 19,814,230 ANTARES PHARMA, INC. CONSOLIDATED BALANCE SHEETS December 31, 2004 2003 Assets Current Assets: Cash and cash equivalents $1,652,408 $1,928,815 Short-term investments 7,971,625 - Accounts receivable, less allowance for doubtful accounts of $22,500 and $21,500, respectively 277,606 481,886 Other receivables 64,359 7,947 Inventories 92,344 225,408 Prepaid expenses and other assets 81,009 61,239 Total current assets 10,139,351 2,705,295 Equipment, furniture and fixtures, net 611,920 801,369 Patent rights, net 947,459 1,214,356 Goodwill 1,095,355 1,095,355 Other assets 383,518 138,478 Total Assets $13,177,603 $5,954,853 Liabilities and Shareholders' Equity Current Liabilities: Accounts payable $476,509 $253,336 Accrued expenses and other liabilities 626,583 827,676 Due to related parties - 162,964 Capital lease obligations - current maturities - 36,003 Deferred revenue 547,006 809,945 Total current liabilities 1,650,098 2,089,924 Deferred revenue - long term 3,338,666 3,557,835 Total liabilities 4,988,764 5,647,759 Shareholders' Equity: Series A Convertible Preferred Stock: $0.01 par; authorized 10,000 shares; 1,500 and 1,450 issued and outstanding at December 31, 2004 and 2003, respectively 15 15 Series D Convertible Preferred Stock: $0.01 par; authorized 245,000 shares; 63,588 and 243,749 issued and outstanding at December 31, 2004 and 2003, respectively 636 2,437 Common Stock: $0.01 par; authorized 100,000,000 shares; 40,418,406 and 19,831,296 issued and outstanding at December 31, 2004 and 2003, respectively 404,184 198,313 Additional paid-in capital 94,479,402 77,771,149 Prepaid license discount (2,698,427) (2,894,677) Accumulated deficit (82,575,151) (74,126,619) Deferred compensation (759,342) (23,688) Accumulated other comprehensive loss (662,478) (619,836) 8,188,839 307,094 Total Liabilities and Shareholders' Equity $13,177,603 $5,954,853 ANTARES PHARMA, INC. CONSOLIDATED STATEMENTS OF OPERATIONS Years Ended December 31, 2004 2003 2002 Revenues: Product sales $1,834,431 $2,646,628 $2,421,804 Development revenue 196,648 310,035 935,324 Licensing fees 634,542 695,244 638,633 Royalties 80,335 134,937 - Total revenue 2,745,956 3,786,844 3,995,761 Cost of sales: Cost of product sales 1,304,504 1,917,647 2,301,994 Cost of development revenue 67,798 90,236 271,286 Total cost of sales 1,372,302 2,007,883 2,573,280 Gross margin 1,373,654 1,778,961 1,422,481 Operating expenses: Research and development 3,546,438 3,493,966 3,654,333 Sales, marketing and business development 675,878 462,376 797,655 General and administrative 5,526,004 6,456,659 5,232,389 Goodwill impairment charge - - 2,000,000 9,748,320 10,413,001 11,684,377 Net operating loss (8,374,666) (8,634,040) (10,261,896) Other income (expense): Loss on debt extinguishments - (885,770) - Loss on conversions of debt to equity - (16,283,677) - Loss on common stock warrants - (5,960,453) - Interest expense (100,471) (920,130) (1,297,440) Interest income 120,292 16,541 19,748 Foreign exchange gains (losses) (6,849) 1,926 (68,395) Other, net 13,162 (152,361) (782) 26,134 (24,183,924) (1,346,869) Net loss (8,348,532) (32,817,964) (11,608,765) Preferred stock dividends (100,000) (142,857) (100,000) Net loss applicable to common shares $(8,448,532) $(32,960,821) $(11,708,765) Basic and diluted net loss per common share $(0.23) $(2.18) $(1.22) Basic and diluted weighted average common shares outstanding 36,347,892 15,092,803 9,617,749
Antares Pharma, Inc.CONTACT: Jack E. Stover, President and CEO, +1-610-458-6200, orLawrence M. Christian, CFO and Vice President - Finance, +1-610-458-6200, bothof Antares Pharma, Inc.; or Ira Weingarten/Steve Chizzik, EquityCommunications, +1-805-897-1880, for Antares Pharma, Inc.