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TOMORROW 3Q REPORT WILL TELL THE STORY
DUSA and River's Edge Announce Settlement Agreement Involving Nicomide(R)
River's Edge product no longer manufactured or distributed
DUSA Pharmaceuticals, Inc.® (NASDAQ GM: DUSA), and River's Edge Pharmaceuticals, LLC today announced that they have entered into a settlement and mutual release agreement to dismiss the lawsuit brought by DUSA against River's Edge asserting a number of claims arising out of River's Edge's alleged infringement of U.S. Patent No. 6,979,468 under which DUSA has marketed, distributed and sold Nicomide®. Under the terms of the agreement, River's Edge acknowledges the validity and enforceability of the Nicomide patent.
River's Edge has agreed to make a lump-sum settlement payment to DUSA for damages and will permanently cease the manufacture, distribution and sale of its nicotinamide product, NIC 750. River's Edge will immediately notify the drug databases that NIC 750 is no longer available.
"We are very pleased to have fully resolved the dispute with River's Edge. The settlement underscores DUSA's commitment to protecting its intellectual property," said Bob Doman, President and CEO of DUSA Pharmaceuticals, Inc. "We intend for the settlement with River's Edge to send a strong signal that, moving forward, DUSA will vigorously defend its patent estate and intellectual property."
Also, River's Edge will withdraw and cease participating in the re-examination of Nicomide's patent by the United States Patent and Trademark Office, and will consent to the return to DUSA of the entire bond, with all accrued interest, that is currently being held by the U.S. District Court, District of New Jersey.
"DUSA will continue to deploy its strategic Nicomide sales program across the U.S. Our customers and their patients have continued to support Nicomide," concluded Bob Doman.
As part of the settlement, DUSA has granted a perpetual exclusive license to River's Edge to manufacture and sell four of its products from the AVAR® line, including AVAR cleanser, AVAR gel, AVAR E-emollient cream and AVAR E-green which are non-strategic for DUSA in exchange for a royalty, including a guaranteed minimum annual royalty, for three years. DUSA will transfer its existing inventory of these products to River's Edge so that the supply of the products will not be interrupted.
About DUSA Pharmaceuticals
DUSA Pharmaceuticals, Inc. is an integrated dermatology pharmaceutical company focused on the development and marketing of its Levulan® Photodynamic Therapy (PDT) technology platform, and complementary dermatology products. Levulan PDT is currently approved for the treatment of Grade 1 or 2 actinic keratoses of the face or scalp, and is being studied for the treatment of acne. DUSA's other dermatology products include ClindaReach(TM), and Nicomide®. DUSA is also researching additional indications for internal uses of Levulan PDT. DUSA is based in Wilmington, Mass. Please visit the company's website at www.dusapharma.com for more information.
Forward Looking Statements
Except for historical information, this news release contains certain forward-looking statements that involve known and unknown risk and uncertainties, which may cause actual results to differ materially from any future results, performance or achievements expressed or implied by the statements made. These forward-looking statements relate to the cessation of commercialization of NIC 750, notification of the databases, intention to demonstrate defense of intellectual property, withdrawal from the USPTO re-exam, consent to return of the bond, deployment of sales strategies, and transfer of inventory. Furthermore, the factors that may cause differing results include the reliance on third parties, maintenance of DUSA's patent portfolio, the uncertainties of the litigation process and other risks identified in DUSA's SEC filings from time to time.
Contacts:
DUSA Pharmaceuticals, Inc.
Shari Lovell
Director, Shareholder Services
(978) 657-7500 Ext. 1121
Website: www.dusapharma.com
21st World Congress of Dermatology Highlights Clinical Significance of Photodynamic Therapy
More than 55 Presentations and Posters Featuring PDT Presented to the International Dermatology Community
DUSA Pharmaceuticals, Inc.® (NASDAQ GM: DUSA) -
Photodynamic Therapy (PDT) was a featured topic discussed during the 21st World Congress of Dermatology held September 30 - October 5, 2007 in Buenos Aires, Argentina. Approximately 55 presentations and posters focused on PDT technology, ranging from recommended use in the treatment of actinic keratoses (AKs) and cancers to a range of other skin conditions and photorejuvenation. The World Congress, held under the auspices of the International League of Dermatological Societies, hosted more than 12,000 leaders in dermatology from around the world.
"Research presented at the World Congress demonstrates that PDT is fast becoming a standard treatment for actinic keratoses (AKs) with growing interest in PDT for the treatment of acne vulgaris, photorejuvenation, BCC and other skin conditions," said Dr. Michael Gold, Medical Director, Gold Skin Care Center, Tennessee Clinical Research Center, Clinical Associate Professor of Dermatology at Vanderbilt University, and Visiting Professor of Dermatology at Shanghai Medical University, Shanghai, China. "Clearly, aminolevulinic acid (ALA) PDT will continue to have a growing role in the management of many dermatologic conditions." DUSA Pharmaceuticals, Inc.® (NASDAQ GM: DUSA) markets ALA PDT under its Levulan® Photodynamic Therapy technology platform.
The importance of ALA PDT was also reinforced recently when Drs. James Kennedy and Roy Pottier, the two Canadian researchers who pioneered the development of this therapy, were awarded the EnCana principal award at the 25th Annual Manning Innovation Awards, celebrating outstanding Canadian innovators whose research has led to important scientific and/or technological advances. The inventors were recognized for making the original discovery that was then developed and commercialized by DUSA into Levulan PDT.
"The large amount of clinical data and subsequent enthusiasm generated at the World Congress, the increasing demand for Levulan PDT treatment in the U.S. and international dermatology communities, as well as the recent recognition for the discovery of Levulan PDT, clearly underscore the significance and potential of this unique treatment modality," said Bob Doman, President and CEO of DUSA Pharmaceuticals, Inc.
Levulan PDT has regulatory approval as first-line therapy for AKs in the U.S., Canada, Argentina, Mexico, Chile, Brazil (where pricing approval is pending), Colombia and Korea.
About Actinic Keratoses
Actinic keratoses (AKs) are rough-textured, dry, scaly patches on the skin, caused by excessive exposure to ultraviolet (UV) light, such as sunlight. They are often referred to as "sun spots" and they occur most frequently on sun-exposed areas, such as the face, scalp, ears, neck, hands and arms. They form on the outermost layer of skin and they can range in color from skin toned to reddish brown. They can also range in size from as small as a pinhead to larger than a quarter.
About Levulan Photodynamic Therapy (PDT)
Levulan PDT is an advanced 2-step treatment for Grade 1 or Grade 2 actinic keratoses (AKs that have not yet become enlarged and thick) of the face or scalp. The therapy consists of treatment with Levulan® Kerastick® Topical Solution, 20% followed by illumination with blue light, and is unique because it uses a light activated drug therapy to destroy AKs.
About DUSA Pharmaceuticals
DUSA Pharmaceuticals, Inc. is an integrated dermatology pharmaceutical company focused primarily on the development and marketing of its Levulan® Photodynamic Therapy (PDT) technology platform, and complementary dermatology products. Levulan PDT is currently approved for the treatment of Grade 1 or Grade 2 actinic keratoses of the face or scalp, and is being studied for the treatment of acne. DUSA's other dermatology products include ClindaReach(TM), Nicomide® and the AVAR® line. DUSA is also researching additional indications for internal uses of Levulan PDT. Dr. Michael Gold is a consultant to DUSA and a member of its Medical Advisory Board. DUSA is based in Wilmington, Mass. Please visit the company's website at www.dusapharma.com for more information.
Stocks in a New Uptrend (Aroon) (DUSA)
Wow up 33%, i picked this up right! for a change, No, havent surfed for many years, i fish in alaska. Good luck to us, the word is realy getting out today on this one. D
Welcome aboard DUSA and your name makes me guess you are a fellow "surfer"
Hey Surf, Im in on this now, Ill be here for the long haul, uup-up & away! D
DUSA's Levulan(R) Kerastick(R) Receives Marketing Approval in Korea
Levulan(R) Approval in Korea Expands DUSA's Global Market Reach
DUSA Pharmaceuticals, Inc.® (NASDAQ GM: DUSA), is pleased to announce that the Korea Food and Drug Administration (KFDA) has approved Levulan® Kerastick® for Photodynamic Therapy (PDT) for the treatment of actinic keratoses (AKs) through its marketing partner Daewoong Pharmaceutical Co., Ltd and its affiliate, DNC Daewoong Derma & Plastic Surgery Network Company (DNCompany). Having received approval, market launch is expected in the first quarter of 2008.
"The approval of Levulan in Korea is another important milestone for DUSA, which reinforces our strategy of gaining worldwide distribution of Levulan PDT in conjunction with strategic partners," said Bob Doman, President and CEO of DUSA. "We were particularly impressed with how quickly Daewoong filed and gained regulatory approval in Korea. Daewoong, with an existing customer base of over 2,500 dermatologists and plastic surgeons, is well positioned to gain rapid penetration in the Asian markets."
In early January 2007, DUSA entered into an exclusive marketing, distribution and supply agreement with Daewoong Pharmaceutical Co., Ltd and DNCompany. Under the terms of this collaborative agreement, DUSA will manufacture and supply Levulan, while Daewoong Pharmaceutical Co., Ltd and DNCompany will market and distribute Levulan in 11 Asian countries, including Korea.
"The approval of Levulan in Korea is the beginning of a new opportunity for Daewoong and DNCompany to expand our dermatology products," said Shin Hee Soo, CEO of DNCompany. "Korea is considered a pioneer market in skin care in Asia and the approval of Levulan in Korea will be seen as the first step of success in the Asian market. We have expectations that the product will be commercially available in 11 Asian countries, including China, where we have already begun the regulatory approval process."
Currently, Levulan PDT is approved for sale in the U.S., Canada, several Latin American markets and now Korea.
About Actinic Keratoses
Actinic keratoses (AKs) are rough-textured, dry, scaly patches on the skin, caused by excessive exposure to ultraviolet (UV) light, such as sunlight. They are often referred to as "sun spots" and they occur most frequently on sun exposed areas such as the face, scalp, ears, neck, hands and arms. They form on the outermost layer of skin and they can range in color from skin toned to reddish brown. They can also range in size from as small as a pinhead to larger than a quarter.
About Levulan Photodynamic Therapy (PDT)
Levulan Photodynamic Therapy (PDT) is an advanced 2-step treatment for Grade 1 or Grade 2 actinic keratoses (AKs that have not yet become enlarged and thick) of the face or scalp. The treatment is unique because it uses a light activated drug therapy to selectively destroy AKs. The therapy consists of treatment with Levulan® Kerastick® Topical Solution, 20% followed by illumination with a blue light source.
About DUSA Pharmaceuticals
DUSA Pharmaceuticals, Inc. is an integrated dermatology pharmaceutical company focused primarily on the development and marketing of its Levulan® Photodynamic Therapy (PDT) technology platform, and complementary dermatology products. Levulan PDT is currently approved for the treatment of Grade 1 or Grade 2 actinic keratoses of the face or scalp, and is being studied for the treatment of acne. DUSA's other dermatology products include ClindaReach(TM), Nicomide® and the AVAR® line. DUSA is also researching additional indications for internal uses of Levulan PDT. DUSA is based in Wilmington, MA. Please visit the company's website at www.dusapharma.com for more information.
About Daewoong Pharmaceutical Co., Ltd.
Established in 1945, Daewoong Pharmaceutical Co., Ltd. has the largest prescription drug sales in Korea and envisions itself to become a top 50 global healthcare company by 2010. Daewoong has maintained a steady growth rate in the double digits and has paid surplus dividends for the last 40 years. In addition to its product portfolio, which includes 10 blockbuster products, Daewoong has built strong core competency for new drug development and has cultivated a cooperative culture for collaboration with global partners. In the future, Daewoong will expand its global business with its foreign branches and global partners and become a global healthcare group which contributes to improving the quality of life for people worldwide.
About DNCompany
DNCompany was established in 2001 as Daewoong's affiliate to specialize in the marketing of products in the Asian dermatology and beauty markets.
Yesterday must have been a trading bottom for DUSA, in the green but, not going to hold for this long.
Bought back some DUSA, looks like this stocks are for trading only!
DUSA Pharmaceuticals Reports Second Quarter 2007 Corporate Highlights and Financial Results
Revenues total $6.9 million; Non-GAAP Bottom Line improves 44%; Initial Latin American Orders Received
DUSA Pharmaceuticals, Inc. (NASDAQ GM: DUSA), a dermatology company that is developing and marketing Levulan® photodynamic therapy (PDT) and other products targeting patients with common skin conditions, reported today its corporate highlights and financial results for the second quarter ended June 30, 2007.
Total product revenues for the quarter were $6.9 million as compared to $6.6 million for the comparable 2006 period. PDT revenues totaled $4.1 million versus $3.8 million for the comparable 2006 period. The increase in PDT revenues was driven primarily by a 19% increase in U.S. Levulan® Kerastick® revenue. Despite the anticipated impact on Nicomide® from the March 2007 lifting of the preliminary injunction which previously had prohibited River's Edge from selling its niacinamide based product, non-PDT revenues remained relatively flat year-over-year at $2.8 million.
Total product revenues for the six-months ended June 30, 2007 were $13.5 million as compared to $11.4 million for the comparable 2006 period. PDT revenues totaled $8.6 million versus $7.7 million in the comparable 2006 period. Non-PDT revenues totaled $4.9 million versus $3.7 million in the comparable 2006 period. Non-PDT revenues for 2006 represent the period following our merger with Sirius Laboratories, Inc.®, which occurred on March 10, 2006.
For the three-month and six-month periods ended June 30, 2007, DUSA's net loss on a GAAP basis was ($2.5) million, or ($0.13) per common share, and ($5.8) million, or ($0.30) per common share, respectively. GAAP net losses for the comparable 2006 periods were ($4.7) million, or ($0.24) per common share, and ($9.3) million, or ($0.50) per common share. On a non-GAAP basis, the Company's net losses for the three-month and six-month periods ended June 30, 2007 were ($2.0) million, or ($0.10) per common share, and ($5.1) million, or ($0.26) per common share, respectively. Non-GAAP net losses for the comparable 2006 periods were ($3.6) million, or ($0.18) per common share, and ($6.2) million, or ($0.33) per common share. The quarterly non-GAAP net loss represents a 44% decrease from the prior year. Investors are encouraged to refer to the "Use of Non-GAAP Financial Measures" section and the accompanying financial table for a reconciliation of GAAP to non-GAAP information.
Corporate Updates:
- Latin American launch of Levulan® PDT.
- We have been actively working with our Latin American marketing
partner, Stiefel Laboratories, Inc., to obtain acceptable final pricing
from the Brazilian regulatory authorities. At the same time, Stiefel
has been moving forward with launch plans for the other Latin American
countries. Subsequent to the end of the quarter, we received our first
purchase orders from Stiefel for distribution of the Levulan®
Kerastick® in Argentina and Mexico. In light of the unexpected delay
in receiving acceptable final pricing in Brazil, we are in the process
of amending certain terms of the original Stiefel agreement to reflect
current plans to launch in the other Latin American countries prior to
Brazil.
- Product Development.
- We began enrollment of our Phase IIb clinical trial of Levulan® PDT
for the treatment of moderate to severe acne during the first quarter
of 2007. We currently have 11 clinical sites that have accrued 54
patients in the trial.
- Management.
- Robert Doman was elected by the Board of Directors as President and
Chief Executive Officer on June 14, 2007, following the Company's
Annual Shareholders Meeting.
- Legal Proceedings.
- During the quarter, DUSA continued to execute marketing strategies
aimed at retaining Nicomide® market share versus the River's Edge
product, which re-entered the market as a result of the March 7, 2007,
dissolution of a preliminary injunction. On June 14, 2007, the court
granted DUSA's request to amend its complaint to assert claims against
River's Edge for violations of the Lanham Act and infringement of our
copyright. Also, the court dismissed the various state law claims that
River's Edge had alleged against us. The court has also ordered that
the parties participate in a non-binding mediation. The mediation is
set to occur on August 9, 2007. DUSA believes that the River's Edge
product re-entered the market in late March 2007 and expects its
presence to adversely impact Nicomide® sales throughout the
litigation process.
Management Comments:
"During the quarter, we invested a considerable amount of sales resources on the launch of our new product, ClindaReach(TM), and instituted strategies aimed at mitigating the effects of the reentry of the River's Edge product to the market," stated President and CEO Robert Doman. "While managing these additional factors, we are pleased to report that we were able to grow our U.S. Kerastick® revenue by 19% year over year."
"Our Phase IIb clinical trial of Levulan® PDT for the treatment of moderate to severe acne is now well underway", Doman continued.
"We are also pleased to report that, subsequent to the end of the quarter, we received our first purchase orders for Levulan® Kerastick® units for Latin America. This is a significant step forward as we continue to expand our PDT franchise globally," concluded Doman.
Financial Summary:
Revenues for the three and six-month periods ended June 30, 2007 were $6,862,000 and $13,539,000, respectively, as compared to $6,619,000 and $11,370,000, respectively for the comparable 2006 periods, and were comprised of the following:
Three-months ended Six-months ended
June 30, June 30,
-------------------------------------------------------------------------
2007 2006 2007 2006
(Unaudited) (Unaudited) (Unaudited) (Unaudited)
-------------------------------------------------------------------------
PDT Drug & Device Product
Revenues
Kerastick® Product
Revenues:
United States $3,461,000 $2,912,000 $7,185,000 $5,722,000
Canada 192,000 420,000 393,000 763,000
--------------------------------------------------------------------------
Subtotal Kerastick®
Product Revenues 3,653,000 3,332,000 7,578,000 6,485,000
BLU-U® Product
Revenues:
United States 380,000 451,000 946,000 1,117,000
Canada 29,000 59,000 94,000 92,000
--------------------------------------------------------------------------
Subtotal BLU-U®
Product Revenues 409,000 510,000 1,040,000 1,209,000
Total PDT Drug & Device
Product Revenues 4,062,000 3,842,000 8,618,000 7,694,000
Total Non-PDT Drug Product
Revenues 2,800,000 2,777,000 4,921,000 3,676,000
--------------------------------------------------------------------------
TOTAL PRODUCT REVENUES $6,862,000 $6,619,000 $13,539,000 $11,370,000
--------------------------------------------------------------------------
--------------------------------------------------------------------------
The increase in Kerastick® revenues for the three-month period ended June 30, 2007 from the comparable 2006 period was driven by increased sales volumes and an increase in the average net unit selling price. There were 35,886 Levulan® Kerastick® units sold for the three months ended June 30, 2007 versus 34,944 units sold in the comparable 2006 period. The Company's average net selling price for the Levulan® Kerastick® increased to $101.78 in the second quarter of 2007 from $95.36 in the second quarter of 2006. The decrease in BLU-U® revenue was the result of lower overall sales volumes which were partially offset by an increase in the average selling price of this product. There were 46 units sold for the three months ended June 30, 2007 versus 66 units sold in the comparable 2006 period. The average net selling price for the BLU-U® increased to $8,269 for the three months ended June 30, 2007 from $7,454 in the comparable 2006 period. Non-PDT drug product revenues represent the revenues generated by the products acquired as part of DUSA's merger with Sirius. The substantial majority of this revenue is attributable to sales of Nicomide®. Non-PDT revenues for the three-month period ended June 30, 2007 were consistent with revenues in the comparable 2006 period. Non-PDT revenues for the six-month period ended June 30, 2006 reflects only the period March 10, 2006 (date of merger) through June 30, 2006.
Total product margins for the three-month period ended June 30, 2007 were 74% versus 55% in the prior year. Total PDT drug and device product margins for the second quarter of 2007 were $2.9 million, or 72%, versus $2.6 million, or 68% for the comparable 2006 period. Levulan® Kerastick® gross margins for the three-month period ended June 30, 2007 were 79%, versus 77% for the comparable 2006 period. Similar to the increase in revenues, the increase in margin is mainly attributable to increases in both unit sales volumes and average selling prices. BLU-U® margins for the second quarter of 2007 were 12%, versus 9% for the comparable 2006 period. Non-PDT drug product margins reflect the margin generated by the products acquired as part of DUSA's March 10, 2006 merger with Sirius. Total non-PDT gross margins for the three-month period ended June 30, 2007 were 77% compared with 36% for the comparable 2006 period. In 2006, non-PDT margins were negatively impacted by the recording of intangible asset amortization and the fair value adjustment to inventory.
Total operating costs for the three-month period ended June 30, 2007 were $7.7 million, compared with $8.5 million in the comparable 2006 period. Research and development costs remained relatively flat at $1.6 million as the increased spending on the Company's Phase IIb clinical trial on acne was offset by reduced spending for the development of Levulan® to treat photodamaged skin and Barrett's Esophagus. Marketing and sales costs increased to $3.3 million for the second quarter of 2007 from $3.2 million in the comparable 2006 period due primarily to increased spending on the launch of ClindaReach. General and administrative costs decreased to $2.8 million in the second quarter of 2007 from $3.8 million in the comparable 2006 period. This decrease is mainly attributable to lower legal and other professional services costs incurred during the second quarter of 2007 primarily involving the River's Edge case. General and administrative expenses are highly dependent on the Company's legal and other professional fees, which can vary significantly from period to period particularly in light of DUSA's litigation strategy to protect its intellectual property.
As of June 30, 2007, total cash, cash equivalents, and U.S. government securities were $13.0 million, compared to $18.2 million at December 31, 2006. The decrease is primarily attributable to cash expended to fund operational expenses. Net cash expenditures for second quarter of 2007 were $3.4 million.
Condensed Consolidated Balance Sheets, Condensed Consolidated Statement of Operations and GAAP to Non-GAAP reconciliation follow:
DUSA Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets
June 30, December 31,
2007 2006
(Unaudited)
---------------------------------------------------------------------------
ASSETS
CURRENT ASSETS
--------------------------------------------------------------------------
Cash and cash equivalents $3,028,932 $3,267,071
Marketable securities 10,020,979 14,943,196
--------------------------------------------------------------------------
Accrued interest receivable 76,840 158,374
Accounts receivable, net 1,858,270 2,060,565
--------------------------------------------------------------------------
Inventory 2,912,166 2,343,472
Prepaid and other current assets 1,078,409 1,535,819
---------------------------------------------------------------------------
TOTAL CURRENT ASSETS 18,975,596 24,308,497
Restricted cash 166,813 162,805
--------------------------------------------------------------------------
Property, plant and equipment, net 2,421,531 2,567,286
Goodwill 6,272,505 5,772,505
--------------------------------------------------------------------------
Deferred charges and other assets 1,026,272 944,720
--------------------------------------------------------------------------
TOTAL ASSETS $28,862,717 $33,755,813
--------------------------------------------------------------------------
--------------------------------------------------------------------------
LIABILITIES AND SHAREHOLDERS' EQUITY
CURRENT LIABILITIES
--------------------------------------------------------------------------
Accounts payable $1,167,478 $649,523
Accrued compensation 750,100 1,674,470
--------------------------------------------------------------------------
Other accrued expenses 2,782,808 3,841,891
Deferred revenue 412,002 57,270
--------------------------------------------------------------------------
TOTAL CURRENT LIABILITIES 5,112,388 6,223,154
Other liabilities 2,244,146 1,199,086
--------------------------------------------------------------------------
TOTAL LIABILITIES 7,356,534 7,422,240
--------------------------------------------------------------------------
SHAREHOLDERS' EQUITY
Capital Stock
---------------------------------------------------------------------------
Authorized: 100,000,000 shares; 40,000,000
shares designated as common stock, no par,
and 60,000,000 shares issuable in series or
classes; and 40,000 junior Series A preferred
shares. Issued and outstanding: 19,495,067
and 19,480,067 shares of common stock, 143,250,537 142,959,298
no par, at June 30, 2007 and December 31,
2006 respectively
Additional paid-in capital 5,038,324 4,320,625
--------------------------------------------------------------------------
Accumulated deficit (126,735,309) (120,886,977)
Accumulated other comprehensive loss (47,369) (59,373)
--------------------------------------------------------------------------
TOTAL SHAREHOLDERS' EQUITY 21,506,183 26,333,573
--------------------------------------------------------------------------
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY $28,862,717 $33,755,813
--------------------------------------------------------------------------
--------------------------------------------------------------------------
DUSA Pharmaceuticals, Inc. Condensed Consolidated Statement of Operations
(Unaudited)
Three-months ended Six-months ended
June 30, June 30,
--------------------------------------------------------------------------
2007 2006 2007 2006
(Unaudited) (Unaudited) (Unaudited) (Unaudited)
Product Revenues $6,862,198 $6,619,109 $13,539,038 $11,369,630
Cost of Product
Revenues and Royalties 1,776,491 2,995,163 3,932,643 4,785,922
--------------------------------------------------------------------------
Gross Margin 5,085,707 3,623,946 9,606,395 6,583,708
Operating Costs:
Research and
Development 1,576,909 1,527,523 3,103,013 3,038,254
In-process research
and development - - - 1,600,000
Marketing and Sales 3,309,583 3,176,523 6,840,290 5,867,207
General and
Administrative 2,832,576 3,753,796 5,856,025 5,824,087
--------------------------------------------------------------------------
Total Operating Costs 7,719,068 8,457,842 15,799,328 16,329,548
--------------------------------------------------------------------------
Loss from Operations (2,633,361) (4,833,896) (6,192,933) (9,745,840)
--------------------------------------------------------------------------
Other Income
Other Income, net 155,954 179,942 344,598 451,578
--------------------------------------------------------------------------
Net Loss $(2,477,407) $(4,653,954) $(5,848,335) $(9,294,262)
--------------------------------------------------------------------------
--------------------------------------------------------------------------
Basic and Diluted Net
Loss per Common Share $(0.13) $(0.24) $(0.30) $(0.50)
--------------------------------------------------------------------------
--------------------------------------------------------------------------
Weighted Average
Number of Common
Shares 19,487,485 19,448,824 19,483,796 18,544,084
Use of Non-GAAP Financial Measures
In addition to reporting financial results in accordance with GAAP, DUSA has provided in the table below non-GAAP financial measures adjusted to exclude share-based compensation expense, amortization of intangible assets, and an in-process research and development charge related to the Company's merger with Sirius in the first quarter of 2006. The Company believes this presentation is useful to help investors better understand DUSA's financial performance, competitive position and prospects for the future. The Company uses the modified prospective method to report compensation charges associated with the expensing of stock options. Management believes these non-GAAP financial measures assist in providing a more complete understanding of the Company's underlying operational results and trends, and in allowing for a more comparable presentation of results. Management uses these measures along with their corresponding GAAP financial measures to help manage the Company's business and to help evaluate DUSA's performance compared to the marketplace. However, the presentation of non-GAAP financial measures is not meant to be considered in isolation or as superior to or as a substitute for financial information provided in accordance with GAAP. The non-GAAP financial measures used by the Company may be calculated differently from, and, therefore, may not be comparable to, similarly titled measures used by other companies.
Investors are encouraged to review the reconciliations of these non-GAAP financial measures to the comparable GAAP results, contained in the table below.
Three-months ended Six-months ended
June 30, June 30,
--------------------------------------------------------------------------
2007 2006 2007 2006
(Unaudited) (Unaudited) (Unaudited) (Unaudited)
GAAP Net Loss $(2,477,407) $(4,653,954) $(5,848,335) $(9,294,262)
Intangible Asset
Amortization (a) - 437,309 - 539,348
In-Process R&D (b) - - - 1,600,000
Stock Based
Compensation © 475,514 651,868 717,698 970,064
---------------------------------------------------------------------------
Non-GAAP Adjusted Net
Loss $(2,001,893) $(3,564,777) $(5,130,637) $(6,184,850)
--------------------------------------------------------------------------
--------------------------------------------------------------------------
Non-GAAP Basic and
Diluted Net Loss per
Common Share $(0.10) $(0.18) $(0.26) $(0.33)
--------------------------------------------------------------------------
--------------------------------------------------------------------------
Weighted Average Number
of Common Shares 19,487,485 19,448,824 19,483,796 18,544,084
(a) Amortization of intangible assets from date of merger (March 10, 2006)
through the end of periods identified.
(b) In-process research and development, one-time charge.
© Share based compensation expense resulting from the adoption of SFAS
123(R).
Conference Call Details and Dial-in Information
In conjunction with this announcement, DUSA will host a conference call
today:
Tuesday, August 7th - 8:30 a.m. Eastern
If calling from the US or Canada use the following toll-free number:
800.647.4314 Password - DUSA
For international callers use
435.871.6103 Password - DUSA
A recorded replay of the call will be available
North American callers use 877.863.0350
International callers use 858.244.1268
The call will be accessible on our web site approximately one hour following the call at www.dusapharma.com.
About DUSA Pharmaceuticals
DUSA Pharmaceuticals, Inc. is an integrated dermatology specialty pharmaceutical company focused primarily on the development and marketing of its Levulan® Photodynamic Therapy (PDT) technology platform, and complementary dermatology products. Levulan® PDT is currently approved for the treatment of Grade 1 and Grade 2 actinic keratoses of the face and scalp, and is being developed for the treatment of acne. DUSA's other dermatology products include ClindaReach(TM), Nicomide®, and the AVAR® line. DUSA is also supporting development of certain internal indications of Levulan® PDT. DUSA is based in Wilmington, Mass. Please visit our Web site at www.dusapharma.com.
Except for historical information, this news release contains certain forward-looking statements that represent our current expectations and beliefs concerning future events, and involve certain known and unknown risk and uncertainties. These forward-looking statements relate to management's belief regarding reentry of the River's Edge niacinamide product, expectations for an adverse impact on Nicomide® sales, and beliefs concerning non-GAAP financial measures. These forward-looking statements are further qualified by important factors that could cause actual results to differ materially from future results, performance or achievements expressed or implied by those in the forward-looking statements made in this release. These factors include, without limitation, the uncertainties of the litigation process, actions by health or securities regulatory authorities, changing market and regulatory conditions, the maintenance of our patent portfolio, dependence on third-party manufacturers, the ability to maintain our sales force and impact of sales activities, and other risks and uncertainties identified in DUSA's Form 10-K for the year ended December 31, 2006.
Contacts:
DUSA Pharmaceuticals, Inc.
Robert F. Doman
President & CEO
(978) 909-2216
DUSA Pharmaceuticals, Inc.
Richard Christopher
VP Finance & CFO
(978) 909-2211
DUSA Pharmaceuticals, Inc.
Shari Lovell
Director, Shareholder Services
(416) 363-5059
The Trout Group LLC
Chad Rubin
Investor Relations Contact
(646) 378-2947
Source: Market Wire (August 7, 2007 - 5:30 AM EST)
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DUSA 2.24 -0.08
Today 5d 1m 3m 1y 5y 10y
DUSA Pharmaceuticals Reports Second Quarter 2007 Corporate Highlights and Financial Results
Revenues total $6.9 million; Non-GAAP Bottom Line improves 44%; Initial Latin American Orders Received
DUSA Pharmaceuticals, Inc. (NASDAQ GM: DUSA), a dermatology company that is developing and marketing Levulan® photodynamic therapy (PDT) and other products targeting patients with common skin conditions, reported today its corporate highlights and financial results for the second quarter ended June 30, 2007.
Total product revenues for the quarter were $6.9 million as compared to $6.6 million for the comparable 2006 period. PDT revenues totaled $4.1 million versus $3.8 million for the comparable 2006 period. The increase in PDT revenues was driven primarily by a 19% increase in U.S. Levulan® Kerastick® revenue. Despite the anticipated impact on Nicomide® from the March 2007 lifting of the preliminary injunction which previously had prohibited River's Edge from selling its niacinamide based product, non-PDT revenues remained relatively flat year-over-year at $2.8 million.
Total product revenues for the six-months ended June 30, 2007 were $13.5 million as compared to $11.4 million for the comparable 2006 period. PDT revenues totaled $8.6 million versus $7.7 million in the comparable 2006 period. Non-PDT revenues totaled $4.9 million versus $3.7 million in the comparable 2006 period. Non-PDT revenues for 2006 represent the period following our merger with Sirius Laboratories, Inc.®, which occurred on March 10, 2006.
For the three-month and six-month periods ended June 30, 2007, DUSA's net loss on a GAAP basis was ($2.5) million, or ($0.13) per common share, and ($5.8) million, or ($0.30) per common share, respectively. GAAP net losses for the comparable 2006 periods were ($4.7) million, or ($0.24) per common share, and ($9.3) million, or ($0.50) per common share. On a non-GAAP basis, the Company's net losses for the three-month and six-month periods ended June 30, 2007 were ($2.0) million, or ($0.10) per common share, and ($5.1) million, or ($0.26) per common share, respectively. Non-GAAP net losses for the comparable 2006 periods were ($3.6) million, or ($0.18) per common share, and ($6.2) million, or ($0.33) per common share. The quarterly non-GAAP net loss represents a 44% decrease from the prior year. Investors are encouraged to refer to the "Use of Non-GAAP Financial Measures" section and the accompanying financial table for a reconciliation of GAAP to non-GAAP information.
Corporate Updates:
- Latin American launch of Levulan® PDT.
- We have been actively working with our Latin American marketing
partner, Stiefel Laboratories, Inc., to obtain acceptable final pricing
from the Brazilian regulatory authorities. At the same time, Stiefel
has been moving forward with launch plans for the other Latin American
countries. Subsequent to the end of the quarter, we received our first
purchase orders from Stiefel for distribution of the Levulan®
Kerastick® in Argentina and Mexico. In light of the unexpected delay
in receiving acceptable final pricing in Brazil, we are in the process
of amending certain terms of the original Stiefel agreement to reflect
current plans to launch in the other Latin American countries prior to
Brazil.
- Product Development.
- We began enrollment of our Phase IIb clinical trial of Levulan® PDT
for the treatment of moderate to severe acne during the first quarter
of 2007. We currently have 11 clinical sites that have accrued 54
patients in the trial.
- Management.
- Robert Doman was elected by the Board of Directors as President and
Chief Executive Officer on June 14, 2007, following the Company's
Annual Shareholders Meeting.
- Legal Proceedings.
- During the quarter, DUSA continued to execute marketing strategies
aimed at retaining Nicomide® market share versus the River's Edge
product, which re-entered the market as a result of the March 7, 2007,
dissolution of a preliminary injunction. On June 14, 2007, the court
granted DUSA's request to amend its complaint to assert claims against
River's Edge for violations of the Lanham Act and infringement of our
copyright. Also, the court dismissed the various state law claims that
River's Edge had alleged against us. The court has also ordered that
the parties participate in a non-binding mediation. The mediation is
set to occur on August 9, 2007. DUSA believes that the River's Edge
product re-entered the market in late March 2007 and expects its
presence to adversely impact Nicomide® sales throughout the
litigation process.
Management Comments:
"During the quarter, we invested a considerable amount of sales resources on the launch of our new product, ClindaReach(TM), and instituted strategies aimed at mitigating the effects of the reentry of the River's Edge product to the market," stated President and CEO Robert Doman. "While managing these additional factors, we are pleased to report that we were able to grow our U.S. Kerastick® revenue by 19% year over year."
"Our Phase IIb clinical trial of Levulan® PDT for the treatment of moderate to severe acne is now well underway", Doman continued.
"We are also pleased to report that, subsequent to the end of the quarter, we received our first purchase orders for Levulan® Kerastick® units for Latin America. This is a significant step forward as we continue to expand our PDT franchise globally," concluded Doman.
Financial Summary:
Revenues for the three and six-month periods ended June 30, 2007 were $6,862,000 and $13,539,000, respectively, as compared to $6,619,000 and $11,370,000, respectively for the comparable 2006 periods, and were comprised of the following:
Three-months ended Six-months ended
June 30, June 30,
-------------------------------------------------------------------------
2007 2006 2007 2006
(Unaudited) (Unaudited) (Unaudited) (Unaudited)
-------------------------------------------------------------------------
PDT Drug & Device Product
Revenues
Kerastick® Product
Revenues:
United States $3,461,000 $2,912,000 $7,185,000 $5,722,000
Canada 192,000 420,000 393,000 763,000
--------------------------------------------------------------------------
Subtotal Kerastick®
Product Revenues 3,653,000 3,332,000 7,578,000 6,485,000
BLU-U® Product
Revenues:
United States 380,000 451,000 946,000 1,117,000
Canada 29,000 59,000 94,000 92,000
--------------------------------------------------------------------------
Subtotal BLU-U®
Product Revenues 409,000 510,000 1,040,000 1,209,000
Total PDT Drug & Device
Product Revenues 4,062,000 3,842,000 8,618,000 7,694,000
Total Non-PDT Drug Product
Revenues 2,800,000 2,777,000 4,921,000 3,676,000
--------------------------------------------------------------------------
TOTAL PRODUCT REVENUES $6,862,000 $6,619,000 $13,539,000 $11,370,000
--------------------------------------------------------------------------
--------------------------------------------------------------------------
The increase in Kerastick® revenues for the three-month period ended June 30, 2007 from the comparable 2006 period was driven by increased sales volumes and an increase in the average net unit selling price. There were 35,886 Levulan® Kerastick® units sold for the three months ended June 30, 2007 versus 34,944 units sold in the comparable 2006 period. The Company's average net selling price for the Levulan® Kerastick® increased to $101.78 in the second quarter of 2007 from $95.36 in the second quarter of 2006. The decrease in BLU-U® revenue was the result of lower overall sales volumes which were partially offset by an increase in the average selling price of this product. There were 46 units sold for the three months ended June 30, 2007 versus 66 units sold in the comparable 2006 period. The average net selling price for the BLU-U® increased to $8,269 for the three months ended June 30, 2007 from $7,454 in the comparable 2006 period. Non-PDT drug product revenues represent the revenues generated by the products acquired as part of DUSA's merger with Sirius. The substantial majority of this revenue is attributable to sales of Nicomide®. Non-PDT revenues for the three-month period ended June 30, 2007 were consistent with revenues in the comparable 2006 period. Non-PDT revenues for the six-month period ended June 30, 2006 reflects only the period March 10, 2006 (date of merger) through June 30, 2006.
Total product margins for the three-month period ended June 30, 2007 were 74% versus 55% in the prior year. Total PDT drug and device product margins for the second quarter of 2007 were $2.9 million, or 72%, versus $2.6 million, or 68% for the comparable 2006 period. Levulan® Kerastick® gross margins for the three-month period ended June 30, 2007 were 79%, versus 77% for the comparable 2006 period. Similar to the increase in revenues, the increase in margin is mainly attributable to increases in both unit sales volumes and average selling prices. BLU-U® margins for the second quarter of 2007 were 12%, versus 9% for the comparable 2006 period. Non-PDT drug product margins reflect the margin generated by the products acquired as part of DUSA's March 10, 2006 merger with Sirius. Total non-PDT gross margins for the three-month period ended June 30, 2007 were 77% compared with 36% for the comparable 2006 period. In 2006, non-PDT margins were negatively impacted by the recording of intangible asset amortization and the fair value adjustment to inventory.
Total operating costs for the three-month period ended June 30, 2007 were $7.7 million, compared with $8.5 million in the comparable 2006 period. Research and development costs remained relatively flat at $1.6 million as the increased spending on the Company's Phase IIb clinical trial on acne was offset by reduced spending for the development of Levulan® to treat photodamaged skin and Barrett's Esophagus. Marketing and sales costs increased to $3.3 million for the second quarter of 2007 from $3.2 million in the comparable 2006 period due primarily to increased spending on the launch of ClindaReach. General and administrative costs decreased to $2.8 million in the second quarter of 2007 from $3.8 million in the comparable 2006 period. This decrease is mainly attributable to lower legal and other professional services costs incurred during the second quarter of 2007 primarily involving the River's Edge case. General and administrative expenses are highly dependent on the Company's legal and other professional fees, which can vary significantly from period to period particularly in light of DUSA's litigation strategy to protect its intellectual property.
As of June 30, 2007, total cash, cash equivalents, and U.S. government securities were $13.0 million, compared to $18.2 million at December 31, 2006. The decrease is primarily attributable to cash expended to fund operational expenses. Net cash expenditures for second quarter of 2007 were $3.4 million.
Condensed Consolidated Balance Sheets, Condensed Consolidated Statement of Operations and GAAP to Non-GAAP reconciliation follow:
DUSA Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets
June 30, December 31,
2007 2006
(Unaudited)
---------------------------------------------------------------------------
ASSETS
CURRENT ASSETS
--------------------------------------------------------------------------
Cash and cash equivalents $3,028,932 $3,267,071
Marketable securities 10,020,979 14,943,196
--------------------------------------------------------------------------
Accrued interest receivable 76,840 158,374
Accounts receivable, net 1,858,270 2,060,565
--------------------------------------------------------------------------
Inventory 2,912,166 2,343,472
Prepaid and other current assets 1,078,409 1,535,819
---------------------------------------------------------------------------
TOTAL CURRENT ASSETS 18,975,596 24,308,497
Restricted cash 166,813 162,805
--------------------------------------------------------------------------
Property, plant and equipment, net 2,421,531 2,567,286
Goodwill 6,272,505 5,772,505
--------------------------------------------------------------------------
Deferred charges and other assets 1,026,272 944,720
--------------------------------------------------------------------------
TOTAL ASSETS $28,862,717 $33,755,813
--------------------------------------------------------------------------
--------------------------------------------------------------------------
LIABILITIES AND SHAREHOLDERS' EQUITY
CURRENT LIABILITIES
--------------------------------------------------------------------------
Accounts payable $1,167,478 $649,523
Accrued compensation 750,100 1,674,470
--------------------------------------------------------------------------
Other accrued expenses 2,782,808 3,841,891
Deferred revenue 412,002 57,270
--------------------------------------------------------------------------
TOTAL CURRENT LIABILITIES 5,112,388 6,223,154
Other liabilities 2,244,146 1,199,086
--------------------------------------------------------------------------
TOTAL LIABILITIES 7,356,534 7,422,240
--------------------------------------------------------------------------
SHAREHOLDERS' EQUITY
Capital Stock
---------------------------------------------------------------------------
Authorized: 100,000,000 shares; 40,000,000
shares designated as common stock, no par,
and 60,000,000 shares issuable in series or
classes; and 40,000 junior Series A preferred
shares. Issued and outstanding: 19,495,067
and 19,480,067 shares of common stock, 143,250,537 142,959,298
no par, at June 30, 2007 and December 31,
2006 respectively
Additional paid-in capital 5,038,324 4,320,625
--------------------------------------------------------------------------
Accumulated deficit (126,735,309) (120,886,977)
Accumulated other comprehensive loss (47,369) (59,373)
--------------------------------------------------------------------------
TOTAL SHAREHOLDERS' EQUITY 21,506,183 26,333,573
--------------------------------------------------------------------------
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY $28,862,717 $33,755,813
--------------------------------------------------------------------------
--------------------------------------------------------------------------
DUSA Pharmaceuticals, Inc. Condensed Consolidated Statement of Operations
(Unaudited)
Three-months ended Six-months ended
June 30, June 30,
--------------------------------------------------------------------------
2007 2006 2007 2006
(Unaudited) (Unaudited) (Unaudited) (Unaudited)
Product Revenues $6,862,198 $6,619,109 $13,539,038 $11,369,630
Cost of Product
Revenues and Royalties 1,776,491 2,995,163 3,932,643 4,785,922
--------------------------------------------------------------------------
Gross Margin 5,085,707 3,623,946 9,606,395 6,583,708
Operating Costs:
Research and
Development 1,576,909 1,527,523 3,103,013 3,038,254
In-process research
and development - - - 1,600,000
Marketing and Sales 3,309,583 3,176,523 6,840,290 5,867,207
General and
Administrative 2,832,576 3,753,796 5,856,025 5,824,087
--------------------------------------------------------------------------
Total Operating Costs 7,719,068 8,457,842 15,799,328 16,329,548
--------------------------------------------------------------------------
Loss from Operations (2,633,361) (4,833,896) (6,192,933) (9,745,840)
--------------------------------------------------------------------------
Other Income
Other Income, net 155,954 179,942 344,598 451,578
--------------------------------------------------------------------------
Net Loss $(2,477,407) $(4,653,954) $(5,848,335) $(9,294,262)
--------------------------------------------------------------------------
--------------------------------------------------------------------------
Basic and Diluted Net
Loss per Common Share $(0.13) $(0.24) $(0.30) $(0.50)
--------------------------------------------------------------------------
--------------------------------------------------------------------------
Weighted Average
Number of Common
Shares 19,487,485 19,448,824 19,483,796 18,544,084
Use of Non-GAAP Financial Measures
In addition to reporting financial results in accordance with GAAP, DUSA has provided in the table below non-GAAP financial measures adjusted to exclude share-based compensation expense, amortization of intangible assets, and an in-process research and development charge related to the Company's merger with Sirius in the first quarter of 2006. The Company believes this presentation is useful to help investors better understand DUSA's financial performance, competitive position and prospects for the future. The Company uses the modified prospective method to report compensation charges associated with the expensing of stock options. Management believes these non-GAAP financial measures assist in providing a more complete understanding of the Company's underlying operational results and trends, and in allowing for a more comparable presentation of results. Management uses these measures along with their corresponding GAAP financial measures to help manage the Company's business and to help evaluate DUSA's performance compared to the marketplace. However, the presentation of non-GAAP financial measures is not meant to be considered in isolation or as superior to or as a substitute for financial information provided in accordance with GAAP. The non-GAAP financial measures used by the Company may be calculated differently from, and, therefore, may not be comparable to, similarly titled measures used by other companies.
Investors are encouraged to review the reconciliations of these non-GAAP financial measures to the comparable GAAP results, contained in the table below.
Three-months ended Six-months ended
June 30, June 30,
--------------------------------------------------------------------------
2007 2006 2007 2006
(Unaudited) (Unaudited) (Unaudited) (Unaudited)
GAAP Net Loss $(2,477,407) $(4,653,954) $(5,848,335) $(9,294,262)
Intangible Asset
Amortization (a) - 437,309 - 539,348
In-Process R&D (b) - - - 1,600,000
Stock Based
Compensation © 475,514 651,868 717,698 970,064
---------------------------------------------------------------------------
Non-GAAP Adjusted Net
Loss $(2,001,893) $(3,564,777) $(5,130,637) $(6,184,850)
--------------------------------------------------------------------------
--------------------------------------------------------------------------
Non-GAAP Basic and
Diluted Net Loss per
Common Share $(0.10) $(0.18) $(0.26) $(0.33)
--------------------------------------------------------------------------
--------------------------------------------------------------------------
Weighted Average Number
of Common Shares 19,487,485 19,448,824 19,483,796 18,544,084
(a) Amortization of intangible assets from date of merger (March 10, 2006)
through the end of periods identified.
(b) In-process research and development, one-time charge.
© Share based compensation expense resulting from the adoption of SFAS
123(R).
Conference Call Details and Dial-in Information
In conjunction with this announcement, DUSA will host a conference call
today:
Tuesday, August 7th - 8:30 a.m. Eastern
If calling from the US or Canada use the following toll-free number:
800.647.4314 Password - DUSA
For international callers use
435.871.6103 Password - DUSA
A recorded replay of the call will be available
North American callers use 877.863.0350
International callers use 858.244.1268
The call will be accessible on our web site approximately one hour following the call at www.dusapharma.com.
About DUSA Pharmaceuticals
DUSA Pharmaceuticals, Inc. is an integrated dermatology specialty pharmaceutical company focused primarily on the development and marketing of its Levulan® Photodynamic Therapy (PDT) technology platform, and complementary dermatology products. Levulan® PDT is currently approved for the treatment of Grade 1 and Grade 2 actinic keratoses of the face and scalp, and is being developed for the treatment of acne. DUSA's other dermatology products include ClindaReach(TM), Nicomide®, and the AVAR® line. DUSA is also supporting development of certain internal indications of Levulan® PDT. DUSA is based in Wilmington, Mass. Please visit our Web site at www.dusapharma.com.
Except for historical information, this news release contains certain forward-looking statements that represent our current expectations and beliefs concerning future events, and involve certain known and unknown risk and uncertainties. These forward-looking statements relate to management's belief regarding reentry of the River's Edge niacinamide product, expectations for an adverse impact on Nicomide® sales, and beliefs concerning non-GAAP financial measures. These forward-looking statements are further qualified by important factors that could cause actual results to differ materially from future results, performance or achievements expressed or implied by those in the forward-looking statements made in this release. These factors include, without limitation, the uncertainties of the litigation process, actions by health or securities regulatory authorities, changing market and regulatory conditions, the maintenance of our patent portfolio, dependence on third-party manufacturers, the ability to maintain our sales force and impact of sales activities, and other risks and uncertainties identified in DUSA's Form 10-K for the year ended December 31, 2006.
Contacts:
DUSA Pharmaceuticals, Inc.
Robert F. Doman
President & CEO
(978) 909-2216
DUSA Pharmaceuticals, Inc.
Richard Christopher
VP Finance & CFO
(978) 909-2211
DUSA Pharmaceuticals, Inc.
Shari Lovell
Director, Shareholder Services
(416) 363-5059
The Trout Group LLC
Chad Rubin
Investor Relations Contact
(646) 378-2947
Source: Market Wire (August 7, 2007 - 5:30 AM EST)
News by QuoteMedia
www.quotemedia.com
Bought back some DUSA, always sell the gaps(this one went through the gap area) OUCH.........
Bullish MACD Crossovers (NASDAQ) from stockcharts.com nightly scan for (DUSA)
June 14, 2007 - 12:43 PM EDT
DUSA 3.75 0.33
Today 5d 1m 3m 1y 5y 10y
DUSA Pharmaceuticals, Inc. Elects Robert F. Doman as Chief Executive Officer
DUSA Pharmaceuticals, Inc. (NASDAQ GM: DUSA) reports that Robert F. Doman, DUSA's President and a member of the Board of Directors, was elected today, following the annual meeting of shareholders, to the additional position of Chief Executive Officer, reporting to the Board of Directors. D. Geoffrey Shulman, MD, DUSA's current Chairman of the Board and CEO, continues with DUSA as Chairman of the Board and takes on the title of Chief Strategic Officer.
Dr. Shulman said, "Since joining DUSA in January 2005, Bob has done an excellent job in managing the day-to-day operations of the Company. He has re-organized and transformed the Company into a cohesive, highly effective team. Therefore, the additional responsibility of becoming CEO is both a natural evolution for the Company, and a well-deserved next step for Bob."
"Since founding the Company, Geoff has brought DUSA to the commercial enterprise it is today", said Mr. Doman. "On behalf of the Company, I want to thank him for his contributions and vision and am pleased that DUSA will continue to benefit from Geoff's experience and leadership in his new role as Chairman and Chief Strategic Officer."
"Since coming on board with DUSA in 2005", Mr. Doman continued, "we have seen the Company grow into a strong dermatology franchise with multiple marketed products, an expanding pipeline and increasing global presence. I look forward to my expanded role as CEO and to driving the growth and development of the Company."
Mr. Doman has more than 25 years experience in the medical device and pharmaceutical industries, with domestic and international experience in general management, acquisitions/licensing, business development, sales, marketing and strategic planning. Prior to joining DUSA, Mr. Doman served as President of Leach Technology Group, the medical device division of Leach Holding Corporation, a privately owned company that was sold to Esterline Technologies. From 1999 to 2000, he was President, Device Product Development, of West Pharmaceutical Services, a manufacturer of systems and device components for parenterally administered medicines and drugs. Prior to joining West Pharmaceutical Services, he worked for the Convatec division of Bristol-Myers Squibb from 1991 to 1999 in positions that included: Vice President, Worldwide Marketing and Business Development; Vice President and General Manager, U.S. Wound and Skin Care; and Vice President, U.S. Operations. During this time, he also had significant exposure to the field of dermatology. From 1976 until 1990, he worked for Critikon, Inc., a Johnson & Johnson company, in various sales, sales management and marketing positions, eventually rising to become Business Director of the Vascular Access Unit.
About DUSA
DUSA Pharmaceuticals, Inc. is an integrated dermatology pharmaceutical company focused primarily on the development and marketing of its Levulan® Photodynamic Therapy (PDT) technology platform, and complementary dermatology products. Levulan PDT is currently indicated for the treatment of minimally to moderately thick actinic keratoses (Grade 1 or 2) of the face or scalp, and is being studied for the treatment of acne. DUSA's other dermatology products include ClindaReach(TM), Nicomide® and the AVAR® line. DUSA is also sponsoring research for additional indications for internal uses of Levulan PDT. DUSA is based in Wilmington, MA. Please visit the Company's website at www.dusapharma.com for more information.
Contacts:
DUSA Pharmaceuticals, Inc.
Shari Lovell
Director, Shareholder Services
(416) 363-5059
(416) 363-6602 (FAX)
Website: www.dusapharma.com
Investor Relations Contact:
The Trout Group LLC
Chad Rubin, Vice President
(646) 378-2947
Email: CRubin@troutgroup.com
Russell Microcap Deletions as of June 11, 2007
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Gap filled with a "white candle" & may be the start of a tradeable bottom for DUSA.
This just shows you that when a small cap biotech stock gaps up, they usually go back to that gap area(about 90% drop back) DUSA may be a trade at around $2.75-3.00............
Anyone would be crazy not to sell some DUSA today(they always seem to fill their gaps)
FDA news:
Press Release Source: DUSA Pharmaceuticals, Inc.
DUSA Pharmaceuticals Receives Orphan Drug Designation for Levulan(R) PDT to Treat Esophageal Dysplasia
Thursday May 17, 8:00 am ET
Researchers' Study Shows Promising Treatment for People Suffering from Barrett's Esophagus, a Leading Cause of Esophageal Cancer
WILMINGTON, MASSACHUSETTS--(MARKET WIRE)--May 17, 2007 -- DUSA Pharmaceuticals, Inc. (NASDAQ GM: DUSA) announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for Levulan® (aminolevulinic acid HCl) Photodynamic Therapy (PDT) for the treatment of esophageal dysplasia. This disease occurs in some patients with Barrett's esophagus, a leading cause of esophageal cancer. The incidence of esophageal cancer is one of the most rapidly growing in the U.S., with more than 11,000 new diagnoses each year. Patients diagnosed with high grade dysplasia are at high risk for developing esophageal cancer and currently have limited treatment options.
"We are pleased to receive orphan drug designation for Levulan" said Robert Doman, DUSA's President and Chief Operating Officer. "We believe that Levulan, in combination with our proprietary endoscopic light delivery system, is ideal for this significant unmet medical need and we are excited that it may someday provide patients at high risk of developing esophageal cancer with an effective and well tolerated therapeutic alternative."
Independent investigator clinical studies have reported that treatment of dysplasia with ALA PDT may help avoid the need for the removal of the esophagus and its associated morbidity. Findings from the study, "Low Incidence of Esophageal Adenocarcinoma Following Optimal Regimen of ALA PDT for High Grade Dysplasia in Barrett's Esophagus," will be presented at the Digestive Disease Week (DDW) meeting in Washington, D.C. on Sunday, May 20, 2007.
"This is a potential breakthrough for Barrett's patients and we've demonstrated this treatment can work effectively," says Laurance Lovat, M.D., senior lecturer and consultant gastroenterologist, University College Hospital in London, and lead investigator for the independent research being presented at DDW. "This non-surgical treatment would allow us to eradicate precancerous cells without having the patient suffer the unpleasant side effects of current treatments including severe scarring or the radical invasive removal of the esophagus. This option appears much safer and requires less recovery time." DUSA provided the Levulan® to support this study.
Barrett's esophagus
Barrett's esophagus is a precancerous condition in which the lining of the esophagus is replaced with abnormal cells that could lead to dysplasia, and ultimately, esophageal cancer. Barrett's esophagus affects an estimated 700,000 adults in the United States and is often associated with gastroesophageal reflux disease or GERD. Treatments currently available for severe precancerous tissue changes or high grade dysplasia, include highly invasive esphagectomy (surgical removal of the esophagus) and endoscopic therapies, which carry the risk of severe scarring of the esophagus. Although the exact cause of Barrett's esophagus is unknown, people with chronic GERD (gastroesophageal reflux disease), obese people, men, and Caucasians are at increased risk of developing the disease.
About Levulan PDT
Photodynamic therapy is a photochemical process that involves the interaction of a photosensitizer, light, and oxygen to selectively destroy malignant or certain benign, but rapidly growing cells. The procedure involves administration of a drug and subsequent illumination of the target cells with an appropriate light to activate the PDT process. Levulan® is DUSA's proprietary formulation of aminolevulinic acid (ALA), a compound that is found naturally in the human body. When taken systemically, Levulan® is converted into a photosensitizer by rapidly growing cells, such as those found in esophageal dysplasia, where it can then be activated by light. This light is delivered to the target tissue using DUSA's proprietary light delivery system which allows the endoscopic light treatment to be performed more rapidly, under direct visualization and with greater precision.
About the Orphan Drug Act
The Orphan Drug Act (ODA) encourages drug companies to seek regulatory approval for products that treat a rare disease or condition that affects a relatively small number of people. Once the company receives approval from the Food and Drug Administration to market its orphan-designated product, the company is entitled to seven (7) years of marketing exclusivity for the orphan indication. Orphan Drug Designation also makes it possible to apply for various government funding grants and tax incentives to support the development program for that indication.
About DUSA Pharmaceuticals, Inc.
DUSA Pharmaceuticals, Inc. is an integrated dermatology pharmaceutical company focused primarily on the development and marketing of its Levulan® Photodynamic Therapy (PDT) technology platform, and complementary dermatology products. Levulan PDT is currently indicated for the treatment of minimally to moderately thick actinic keratoses (Grade 1 or 2) of the face or scalp, and is being studied for the treatment of acne. DUSA's other dermatology products include ClindaReach(TM), Nicomide® and the AVAR® line. DUSA is also sponsoring research for additional indications for internal uses of Levulan PDT. DUSA is based in Wilmington, MA. Please visit the company's website at www.dusapharma.com for more information.
Forward Looking Statements
Except for historical information, this news release contains certain forward-looking statements that involve known and unknown risk and uncertainties, which may cause actual results to differ materially from any future results, performance or achievements expressed or implied by the statements made. These forward-looking statements relate to belief that Levulan PDT is ideal for this disease and may provide future therapy, and possible effect of the treatment and its benefits. Furthermore, the factors that may cause differing results include the ability to penetrate the market, the regulatory process, sufficient funding, maintenance of DUSA's patent portfolio, reliance on third parties, and other risks identified in DUSA's SEC filings from time to time, including its annual report on Form 10-K for the year ended December 31, 2006.
Contact:
Contacts:
Media Contact:
Spectrum Science Communications
Annie Moore
(202) 955-6222 x 2547
Email: amoore@spectrumscience.com
Source: DUSA Pharmaceuticals, Inc.
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http://www.dusapharma.com/
http://finance.yahoo.com/q/h?s=DUSA
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DUSA Pharmaceuticals, Inc., an integrated dermatology pharmaceutical company, develops and markets Levulan photodynamic therapy (PDT) and other products for common skin conditions. Its products include Levulan Kerastick 20% Topical Solution with PDT and the BLU-U brand light source for the treatment of actinic keratoses of the face or scalp. Kerastick is a disposable applicator used for the rapid preparation and uniform application of Levulan topical solution in standardized doses. The BLU-U is used without Levulan to treat moderate inflammatory acne vulgaris and general dermatological conditions. The company is also developing Levulan PDT, a Phase II clinical trial product to treat photodamaged skin, moderate to severe acne vulgaris, Barrett�s esophagus dysplasia using DUSA endoscopic light delivery system, and oral cavity dysplasia. In addition, the company is developing non-PDT drug products, including Nicomide, Nicomide-T, AVAR products, and Psoriatec for the treatment of acne vulgaris and acne rosacea, as well as psoriasis; ClindaReach; Meted Shampoo; and Psoriacap. The company was founded in 1991 and is based in Wilmington, Massachusetts.
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