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Davis Select US Equity

Davis Select US Equity (DUSA)

32.78
0.00
(0.00%)
Closed March 29 04:00PM
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(0.00%)

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Key stats and details

Current Price
32.78
Bid
32.00
Ask
32.89
Volume
-
0.00 Day's Range 0.00
0.00 52 Week Range 0.00
Market Cap
Previous Close
32.78
Open
-
Last Trade
Last Trade Time
Financial Volume
-
VWAP
-
Average Volume (3m)
-
Shares Outstanding
11,250,000
Dividend Yield
-
PE Ratio
6.42
Earnings Per Share (EPS)
5.1
Revenue
6.52M
Net Profit
57.4M

About Davis Select US Equity

The investment seeks long-term growth of capital. The fund's investment adviser uses the Davis Investment Discipline to invest the fund's portfolio principally in common stocks (including indirect holdings of common stock through depositary receipts) issued by foreign companies, including countries ... The investment seeks long-term growth of capital. The fund's investment adviser uses the Davis Investment Discipline to invest the fund's portfolio principally in common stocks (including indirect holdings of common stock through depositary receipts) issued by foreign companies, including countries with developed or emerging markets. The fund may invest in large, medium or small companies without regard to market capitalization. Show more

Sector
Mgmt Invt Offices, Open-end
Industry
Mgmt Invt Offices, Open-end
Headquarters
Wilmington, Delaware, USA
Founded
1970

DUSA Latest News

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DUSA Discussion

View Posts
surf1944 surf1944 11 years ago
6:37AM DUSA Pharma to be acquired by Sun Pharma for $8.00 per share in cash in a tender offer (DUSA) 5.78 : Under the terms of the agreement, a 100% subsidiary of Sun Pharmaceutical Industries will commence a tender offer for all of the outstanding common stock of DUSA at a price of $8.00 per share in cash, a 38% premium to the closing price of DUSA's common stock on Nov 7, 2012. The transaction has a total cash value of ~ $230 million. The transaction has been unanimously approved by the boards of directors of both companies and DUSA's board has recommended that the company's shareholders tender their shares pursuant to the tender offer.
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SPM555 SPM555 11 years ago
DUSA recently broke above some key resistance and is now trading and consolidating right smack dab at it's 52 week high range. The past few weeks have formed a tight flag pattern and by all accounts it looks very close to testing a breakout from that pattern.

http://ichartpennystocks.com/forum/big-board-stocks-over-5/dusa-dusa-pharmaceuticals-inc-nasdaq-gm/#p470

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surf1944 surf1944 12 years ago
6:31AM DUSA Pharma demonstrates positive results in Phase 2 Actinic Keratoses extremities study; study showed a statistically significant lesion reduction (DUSA) 5.38 : Co announced results of an investigational study designed to examine and compare the safety and efficacy of broad area application of the Levulan Kerastick with or without occlusive dressing in conjunction with the BLU-U for the treatment of minimally to moderately thick actinic keratoses on the upper extremities. The study showed a statistically significant lesion reduction and complete clearance of actinic keratoses of the extremities when compared to treatment with vehicle. The use of occlusion resulted in a statistically significant improvement in lesion clearance rates compared to treatment without occlusion. The safety profile seen in this study is consistent with what has been seen in previous clinical studies involving Levulan Photodynamic Therapy and is similar to that seen in the current labeling.
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surf1944 surf1944 12 years ago
2) DUSA Pharmaceuticals Inc. (DUSA)
Sector: Healthcare
Industry: Drug Manufacturers - Other
Market Cap: $132.63M
Beta: 0.80

DUSA Pharmaceuticals Inc. has a Current Ratio of 6.61, a Quick Ratio of 6.03, and a 5-Year Projected Earnings Per Share Growth Rate of 27.00%. The short interest was 5.76% as of 07/08/2012. DUSA Pharmaceuticals, Inc., a vertically integrated dermatology company, develops and markets Levulan photodynamic therapy (PDT) and other products for common skin conditions primarily in the United States, Canada, and Korea. The company's marketed products include Levulan Kerastick 20% Topical Solution with PDT, as well as the BLU-U brand light source for the treatment of non-hyperkeratotic actinic keratoses of the face or scalp. It also markets the BLU-U without Levulan PDT for the treatment of moderate inflammatory acne vulgaris and general dermatological conditions.


http://seekingalpha.com/article/710571-5-high-growth-healthcare-stocks-fueled-by-large-cash-reserves?source=yahoo
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surf1944 surf1944 12 years ago
7:53AM On The Wires (WIRES) DUSA Pharmaceuticals (DUSA) announced that patient enrollment is complete in its Phase 2 clinical trial studying the broad area application with 1, 2 and 3-hour drug incubation for the treatment of actinic keratoses of the face or scalp. Co also completed enrollment in its pilot Phase 2 clinical trial studying the safety and efficacy of treating AKs on the upper extremities
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surf1944 surf1944 12 years ago
3. DUSA Pharmaceuticals Inc. (DUSA): Develops and markets Levulan photodynamic therapy and other products for common skin conditions primarily in the United States, Canada, and Korea. Market cap at $135.58M. Price at $5.63. PEG at 0.85. Revenue grew by 28.54% during the most recent quarter ($15.27M vs. $11.88M y/y). Accounts receivable grew by 15.48% during the same time period ($3.73M vs. $3.23M y/y). Receivables, as a percentage of current assets, decreased from 12.2% to 10.31% during the most recent quarter (comparing 3 months ending 2011-12-31 to 3 months ending 2010-12-31).

http://seekingalpha.com/article/493441-5-undervalued-healthcare-stocks-with-positive-receivables-trends?source=yahoo
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Reecy Reecy 12 years ago
I saw where it went up, still wondering if this is a good entry point or if I should wait a bit and see what happens today. From everything I've read the company looks great. Any thoughts?
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mlkrborn mlkrborn 12 years ago
DUSA soars 20% in afternoon trading Market Pulse Archives

March 6, 2012, 3:12 p.m. EST



By Val Brickates Kennedy



BOSTON (MarketWatch) -- Shares of DUSA Pharmaceuticals /quotes/zigman/54163/quotes/nls/dusa DUSA +21.72% soared 20% to $5.62 Tuesday after the company reported a higher quarterly profit. Analysts at C.K. Cooper initiated coverage of the stock with a buy rating, while Roth Capital analyst Scott Henry raised his price target for the stock to $7 a share.
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Penny Roger$ Penny Roger$ 12 years ago
~ Monday! $DUSA ~ Earnings posted, pending or coming soon! In Charts and Links Below!

~ $DUSA ~ Earnings expected on Monday *
Want more like this? Search Keyword: MACMONEY >>> http://tinyurl.com/MACMONEY <<<
One or more of many earnings sites has alerted this security has or will be posting earnings on or around the day of this message.








http://stockcharts.com/h-sc/ui?s=DUSA&p=D&b=3&g=0&id=p88783918276&a=237480049




http://stockcharts.com/h-sc/ui?s=DUSA&p=W&b=3&g=0&id=p54550695994



~ Google Finance: http://www.google.com/finance?q=DUSA
~ Google Fin Options: hhttp://www.google.com/finance/option_chain?q=DUSA#
~ Yahoo! Finance ~ Stats: http://finance.yahoo.com/q/ks?s=DUSA+Key+Statistics
~ Yahoo! Finance ~ Profile: http://finance.yahoo.com/q/pr?s=DUSA
Finviz: http://finviz.com/quote.ashx?t=DUSA
~ BusyStock: http://busystock.com/i.php?s=DUSA&v=2


<<<<<< http://www.earningswhispers.com/stocks.asp?symbol=DUSA >>>>>>



http://investorshub.advfn.com/boards/post_prvt.aspx?user=251916

*If the earnings date is in error please ignore error. I do my best.
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surf1944 surf1944 12 years ago
sold my DUSA position on the gap this morning
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surf1944 surf1944 12 years ago
http://www.secform4.com/insider-trading/879993.htm
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surf1944 surf1944 13 years ago
http://www.dusapharma.com/august-2-2011.html
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surf1944 surf1944 13 years ago
http://www.insidercow.com/history/company.jsp?company=dusa&B1=Search!
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surf1944 surf1944 13 years ago
http://www.secform4.com/insider-trading/879993.htm
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surf1944 surf1944 13 years ago
DUSA Pharmaceuticals: Recent Pullback Provides Attractive Entry Point

DUSA Pharmaceuticals, Inc. (DUSA), based in Wilmington, MA., is a dermatology company engaged in the development and commercialization of Levulan photodynamic therapy (PDT). Utilizing its proprietary Kerastick 20% Topical Solution with PDT and the BLU-U brand light source for the treatment of non-hyperkeratotic actinic keratoses (AKs) of the face or scalp, the company aims to continue focusing on growing domestic PDT revenues and generate positive cash flows. AKs are precancerous skin lesions caused by chronic sun exposure that can develop over time into a form of skin cancer called squamous cell carcinoma (approximately 10% will turn cancerous). The Kerastick is a proprietary applicator that delivers Levulan, while the BLU-U is the patented light device, and they are regulated as a combination therapy with unified labeling. While the recent price action of the stock is enough to induce cardiac arrest in even the most calm and collected investors, last Thursday’s (May 5) earnings release and conference call provide multiple reasons for exploiting the recent pullback to initiate or add to current long positions.

Financials and Forecast: DUSA uses a razor-razorblade business model (definition here). The company makes virtually no profit (<5% profit margin) on the sale of the BLU-U device and derives profits from the Kerastick sales. Due to the price increase set to take effect at the beginning of this year, it is likely that many sales ordinarily placed in the 1st quarter were pulled ahead into Q4, thereby “inflating” Q4 2010. Indeed, the 4Q 2010 numbers (earnings release) were impressive. Furthermore, because Q1 2010 did not have a price increase, the year-over-year comparisons (due to the seasonality of the business, year-over-year numbers are more relevant) might have been less favorable than expected. These potential headwinds, along with institutional selling, possibly explains the stock sell off in recently. DUSA put all these fears to rest though with its most recent earnings report. Revenues also increased substantially, with total revenue increasing 27% YoY to $11.1 MM and domestic PDT revenues increasing 33% YoY to $10.7 MM . Furthermore, the gross margin for Kerastick’s ($10.2 MM of the $10.7 total) increased to 89%, an increase over the 4th quarter’s 87%. Management expects to exceed 90% this year. The Kerastick revenue improvement was driven by a 22% increase in sales volumes and an 11% increase in average selling price. The company generated $1.4 MM in positive cash flow (change in cash and cash equivalents and marketable securities) in Q1 2011. While the company reported a net loss, this was mainly due to a non-cash charge for the change in the fair-value of warrants. Management expects to incur no tax expense for the year, as NOLs are expected to cover any profits. The company reported the sale of 64 BLU-U units during the first quarter, as compared with the 77 units sold in the comparable prior year quarter. While disappointing upon first glance, for various reasons related to favorable pricing previously and sales reps, this number does not imply a slowdown in the current growth rate.

To reflect these latest developments, I believe a conservative estimate of 28% growth in revenue for domestic PDT with stable international sales produces revenues of $45 MM and $57 MM for 2011 and 2012. On the liabilities side, 5 sales reps were added and can be expected to increase marketing and sales by $1 million to $14.2 million, and the new clinical trials can be expected to raise R&D costs $2-3 million to approximately $8 million on an annual basis. General and administrative rising slightly to $9.5 million is reasonable. Ultimately, this leads to an annual increase in cash and non-GAAP earnings of approximately $5-6 MM, or $0.20-0.25/share with approximately $1/share in cash at the end of 2011. For 2012, net income could conceivably come in as high as $15-16 MM or ~$0.60/share with nearly $40 MM in cash on hand. Given the single digit market penetration, this is a conservative estimate in my opinion, and a valuation at 4-5x revenue would suggest a value of no less $7 per share by the end of the year (fully diluted share count of 27.5 million shares). Net loss carry forwards of approximately $2-3 MM per year are expected to eliminate tax liability for 2011 and partially in 2012 and years beyond. For DUSA’s very detailed 10k, see the SEC website here.

Pipeline: DUSA is not currently developing any new products but is focused on enhancing the label for Levulan PDT. DUSA is currently designing and finalizing protocols for a phase 2 clinical trial with plans to initiate in Q2 2011 for the broad application of Kerasticks with short (1-3 hour) incubation times. If there is any negative to the current earnings report, it relates to this clinical trial. Management previously expected a trial to start in the 2nd quarter, but has now delayed that as the details continue to be finalized. While slightly disappointing, this does not change the fundamental picture. The fact that DUSA was willing to spend the extra time at the expense of guidance to make sure the trial is sufficiently powered and properly designed is not a bad sign and does not reflect poorly on the company. Globally, the aim of this trial will be to allow DUSA to market to providers a 1 day treatment option rather than the FDA approved method, which is a two stage process involving 1) application of the product to the target lesions with Levulan Kerastick Topical Solution, followed 14 to 18 hours later by 2) illumination with blue light using the BLU-U® Blue Light Photodynamic Therapy Illuminator. While likely that many of the physicians currently execute this 1 day treatment as an “off-label” use, DUSA’s sales reps’ hands are tied and cannot market this short incubation time.

Conclusion and Future Directions: Unlike many small-cap biotech companies focused on developing candidates and securing FDA approval while fighting the cash burn, DUSA is in the ramp-up phase and is generating significant positive cash flow. In the author’s opinion, now that DUSA is approaching its fair value (~7-8$/share), I believe a potential acquirer (e.g. larger dermatology player) may acquire DUSA and gain access to the near 90% gross margins and rapid growth. Furthermore, with the potential to eliminate redundancies (58% of revenues were SG&A + marketing in Q1 2011) and take advantage of significant NOLs, DUSA is an attractive M&A target.

Disclosure: I am long DUSA.

http://seekingalpha.com/article/268997-dusa-pharmaceuticals-recent-pullback-provides-attractive-entry-point?source=yahoo
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surf1944 surf1944 13 years ago
Dermatologists Take Note of DUSA's Skin Cancer Treatment

http://seekingalpha.com/article/268592-dermatologists-take-note-of-dusa-s-skin-cancer-treatment?source=yahoo
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DADDY FAT SAXX DADDY FAT SAXX 13 years ago
WOW!!! This one took off today
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surf1944 surf1944 13 years ago
DUSA Pharmaceuticals Reports Full Year 2010 Corporate Highlights and Financial Results

Record Fourth Quarter Results Drive the Company to its First Full Year of Profitability and Positive Cash Flow

Fourth Quarter Highlighted by 45% Domestic PDT Revenue Growth

Conference call will be held today, March 3rd, at 8:30am EDT

A patient receiving Levulan photodynamic therapy. (Photo:
Press Release Source: DUSA Pharmaceuticals, Inc. On Thursday March 3, 2011, 6:30 am EST

WILMINGTON, Mass.--(BUSINESS WIRE)-- DUSA Pharmaceuticals, Inc.® (NASDAQ GM: DUSA), a dermatology company that is developing and marketing Levulan® Photodynamic Therapy (PDT) and other products focused on patients with common skin conditions, reported today its corporate highlights and financial results for the fourth quarter and full year ended December 31, 2010.

Fourth quarter and full year financial highlights:

* For the first time in its history, the Company reached profitability on both a GAAP and non-GAAP basis; as well as, generated positive cash flow (change in cash and cash equivalents and marketable securities) for the full year 2010.
o GAAP net income was $2.9 million for the fourth quarter and $2.7 million for the full year 2010, representing year-over-year improvements of $2.5 million and $5.2 million, respectively.
o Non-GAAP net income was a record $3.0 million for the fourth quarter and $4.2 million for the full year 2010, representing year-over-year improvements of $2.1 million and $5.2 million, respectively.
o The Company generated $2.7 million in positive cash flow during the fourth quarter and $3.0 million in positive cash flow for the full year 2010.
* Domestic PDT revenues reached a record high of $11.7 million for the fourth quarter of 2010, representing a $3.6 million or 45% improvement as compared to the prior year quarter. Full year 2010 domestic PDT revenues totaled $34.7 million, representing an $8.0 million or 30% improvement year-over-year.

Management Comments:

“2010 was a landmark year for DUSA,” stated Robert Doman, President and CEO. “For the first time in our history, we reached profitability and generated positive cash flow on a full year basis.”

“Our record fourth quarter results, highlighted by a 45% year-over-year increase in our domestic PDT revenues, 88% gross margin achievement on the Kerastick®, and $3.0 million in non-GAAP income, allowed us to deliver on our goals of achieving profitability and positive cash flow for 2010. We were also pleased with the 91 BLU-U® units sold, a 69% increase from the same quarter the previous year,” continued Doman.

“The strength of our fourth quarter results clearly demonstrates the continued uptake of Levulan® and BLU-U® by the dermatological community. At this point, with mid-single digit market penetration, we believe that there is significant upside potential for Levulan® PDT. As we enter 2011, we intend to build the business on the momentum created in 2010 by expanding our sales force headcount by 5 and by planning to initiate a clinical trial in the second quarter aimed at expanding the label on our approved actinic keratosis indication as we continue our efforts to drive shareholder value,” concluded Doman.

Other 2010 Highlights:

* On May 7, 2010, the Company announced that the United States Patent and Trademark Office had issued a notice of allowance for a key patent related to its proprietary PDT light source, the BLU-U®, Blue Light Photodynamic Therapy Illuminator. The patent, which issued on May 25, 2010, has method of treatment claims which cover the use of DUSA’s blue light technology and aminolevulinic acid HCL (Levulan®) for the treatment of actinic keratosis as well as the diagnosis and treatment of other disease states such as acne, cancer, psoriasis and photodamaged skin. The patent also has claims that cover DUSA’s blue light technology in conjunction with its proprietary Levulan® Kerastick® formulation of aminolevulinic acid HCL. The patent covers our approved Levulan® PDT therapy until June 2019.
* On June 24, 2010, the Company announced that the United States Patent and Trademark Office (USPTO) had completed its re-examination of US Patent No. 5,079,262, “Method of detection and treatment of malignant and non-malignant lesions utilizing 5-aminolevulinic acid.” Subsequently, the USPTO issued an Ex Parte Re-examination Certificate which affirms the patent’s original seven claims and adds eight claims. This patent covers the use of aminolevulinic acid, the active ingredient in DUSA’s Levulan® Kerastick®, for the treatment of actinic keratoses with light. This patent will expire on September 30, 2013. Additional patents cover DUSA’s Levulan® Kerastick® formulation of aminolevulinic acid HCl in conjunction with its proprietary blue light technology until June 2019 (see above).
* On October 26, 2010, the Company announced that it had been named to Deloitte’s 2010 Technology Fast 500 list for the third consecutive year. Deloitte recognized DUSA as one of the Top 500 fastest growing technology, media, telecommunications, life sciences, and clean technology companies in North America. Rankings are based on percentage of fiscal year revenue growth during the period 2005-2009.

Looking Forward into 2011:

* In support of our rapidly expanding domestic PDT business, effective January 1, 2011 the Company has expanded its sales force by adding 4 territory managers and 1 regional sales manager. The sales force now stands at 40 territories and 5 regions.
* During late 2010, the Company began preparations to initiate a DUSA-sponsored clinical trial to support the addition to our label of a broad area application, short drug incubation, or BASDI, method of using the Levulan® PDT. The purpose of the planned Phase 2 clinical trial, at 8 sites and with approximately 160 patients, will be to investigate the optimal incubation time that Levulan® remains on the skin prior to use of our BLU-U®, which, if successful and with agreement with the FDA, could then be used in a subsequent Phase 3 study. The Phase 2 study objectives would be to determine and compare the safety and efficacy of the BASDI method of using Levulan® PDT as compared to vehicle with light, and to evaluate the effect of incubation times (1, 2 or 3 hours) on the treatment of multiple actinic keratoses and photodamage of the face or scalp. We are finalizing the clinical protocol, and are targeting the initiation of the study for the second quarter of 2011.

http://finance.yahoo.com/news/DUSA-Pharmaceuticals-Reports-bw-1781593760.html?x=0&.v=1
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surf1944 surf1944 14 years ago
DUSA Pharmaceuticals (DUSA)
Market Cap: $55.44 million
DUSA Pharmaceuticals(DUSA) is a vertically integrated dermatology company that is developing and marketing Levulan photodynamic therapy and other products for common skin conditions. With 99% increases in DUSA share value from one year ago, investors who haven't heard of this small-cap stock will likely be taking notice of the high-value and low financial commitment

http://www.thestreet.com/story/10848413/2/9-biotech-penny-stocks-to-buy.html
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surf1944 surf1944 14 years ago
DUSA: A Great Value in Micro Cap Biotech

http://seekingalpha.com/article/222372-dusa-a-great-value-in-micro-cap-biotech?source=yahoo
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surf1944 surf1944 14 years ago
DUSA Pharmaceuticals Reports Second Quarter 2010 Corporate Highlights and Financial Results
Domestic Kerastick® revenues up 35% year over year; Company generates Q2 profits
Conference call will be held today, August 3rd, at 8:30 am EDT

http://finance.yahoo.com/news/DUSA-Pharmaceuticals-Reports-prnews-1018213533.html?x=0&.v=1
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surf1944 surf1944 14 years ago
6:34AM DUSA Pharma reports U.S. patent office upholds key photodynamic therapy patent (DUSA) 2.16 : Co announces that the United States Patent and Trademark Office has completed its re-examination of US Patent No. 5,079,262, "Method of detection and treatment of malignant and non-malignant lesions utilizing 5-aminolevulinic acid." In its latest communication, the USPTO issued a Notice of Intent to Issue Ex Parte Re-examination Certificate which affirms the patent's original seven claims and adds eight claims. This patent covers the use of aminolevulinic acid, the active ingredient in DUSA's Levulan Kerastick, for the treatment of actinic keratoses with light.
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surf1944 surf1944 14 years ago
DUSA Pharmaceuticals Reports First Quarter 2010 Corporate Highlights and Financial Results
Q1 Domestic Kerastick(R) Revenues up 33% year over year; Domestic PDT Revenues up 27%
Company generates $0.9 million in positive cash flow
Conference call will be held today, May 11th, at 8:30am EDT

Press Release Source: DUSA Pharmaceuticals, Inc. On Tuesday May 11, 2010, 6:30 am EDT
WILMINGTON, Mass., May 11 /PRNewswire-FirstCall/ -- DUSA Pharmaceuticals, Inc.® (NASDAQ GM: DUSA), a dermatology company that is developing and marketing Levulan® Photodynamic Therapy (PDT) and other products focused on patients with common skin conditions, reported today its corporate highlights and financial results for the first quarter ended March 31, 2010.

Highlights for the first quarter include:


•Total product revenues were $8.7 million for the quarter, representing a $1.6 million or 22% year-over-year improvement.
•Domestic PDT revenues totaled $8.0 million for the quarter, representing a $1.7 million or 27% year-over-year improvement.
•Domestic Kerastick® revenues totaled $7.5 million for the quarter, representing a $1.9 million or 33% year-over-year improvement.
•Kerastick® gross margins for the quarter matched a record high at 86%.
•The Company experienced significant bottom line improvement on both a GAAP and non-GAAP basis for the quarter.
•GAAP net loss for the quarter was $0.4 million, representing a $1.2 million or 74% year-over-year improvement.
•The Company reached break-even on a non-GAAP basis for the quarter, representing a $1.3 million year-over-year improvement.
•The Company generated $0.9 million in positive cash flow (change in cash and cash equivalents and marketable securities) during the first quarter of 2010.




Management Comments:

"We are encouraged by the solid financial results reported for the first quarter of 2010. For the second consecutive quarter, the Company was able to generate positive cash flow, while at the same time deliver both significant top and bottom line improvement," stated Robert Doman, President and CEO.

"Our core Domestic PDT business continues to show significant progress with Kerastick® revenues up 33% driven in part by solid execution from our sales and marketing team. We have now experienced 18 consecutive quarters of year-over-year Kerastick® volume growth," continued Doman.

"We are off to a strong start in 2010. We have a large, growing market opportunity in the U.S. for Levulan PDT on our approved indication for the treatment of actinic keratoses. For the remainder of the year, we will focus on driving the continued adoption of our therapy as we strive towards our goals of becoming both cash flow positive and profitable on an annualized basis," concluded Doman.

First Quarter 2010 Financial Results:

Total product revenues were $8.7 million in the first quarter of 2010, up 22% from $7.1 million in the first quarter of 2009. PDT revenues totaled $8.3 million, up $1.6 million or 23% from $6.7 million for the comparable 2009 period. The increase in PDT revenues was attributable to a 28% increase in Kerastick® revenues, which was partially offset by a 23% decrease in BLU-U® revenues. The Kerastick® revenue increase was driven by a 27% increase in our domestic Kerastick® volume and a 5% increase in our average selling price. Global Kerastick® sales volumes were up 18% year-over- year, there were 61,422 units sold in the first quarter of 2010 and 51,947 units sold in the first quarter of 2009. Domestic Kerastick® sales volumes increased by 12,552 units or 27% and were partially offset by a 3,077 unit decrease in our international sales volumes. The BLU-U® revenue decrease was driven by a 5% decrease in sales volume and an 18% decrease in our average selling price. There were 77 units sold during the quarter, representing a 4 unit decrease over the prior year quarterly total of 81 units. The average selling price of the unit decreased as result of incentive pricing offered to customers in an effort to sell off our existing BLU-U inventory in advance of the introduction of the upgraded design which became available in April. Non-PDT revenues totaled $0.4 million and were flat versus prior year.

DUSA's net loss on a GAAP basis for the first quarter of 2010 was $0.4 million or $0.02 per common share, compared to a net loss of $1.6 million or $0.07 per common share in the first quarter of 2009. The decrease in our net loss was primarily the result of the year-over-year increase in our domestic Kerastick® revenues.

DUSA reached breakeven on a non-GAAP basis for the first quarter of 2010, compared to a net loss of $1.3 million or $0.05 per common share in the first quarter of 2009. Please refer to the "Use of Non-GAAP Financial Measures" section and the accompanying financial table included at the end of this release for a reconciliation of GAAP results to non-GAAP results for the three month periods ending March 31, 2009 and 2010, respectively.

As of March 31, 2010, total cash, cash equivalents, and U.S. government securities were $17.6 million, compared to $16.7 million at December 31, 2009, an increase of $0.9 million during the quarter.

Other Updates:


•The Company was recently advised that a receiver had been appointed for the laboratory that it was using to perform analytical release testing and stability testing for its Levulan® Kerastick® product due to non-payment of its bank loan. As a result, this laboratory is no longer able to perform these services on an on-going basis. DUSA has engaged the services of a new laboratory and has successfully completed the transfer of the technology and analytical test methods. On May 5, 2010, following discussions with the FDA, the Company filed a 30-day Changes Being Effected (CBE-30) supplement to validate the use of the new laboratory. The Company has sufficient Kerastick® inventory on-hand to meet projected demand beyond June 4, 2010, the end of the 30-day review period. If the FDA review process is delayed beyond our expectations, we would likely experience a back order on our Levulan® Kerastick® for a period of time, which would have a negative effect on our revenues. The Company believes it is on schedule for a successful transition.
•On May 7, 2010, the Company announced that the United States Patent and Trademark Office had issued a notice of allowance for a key new patent related to its proprietary PDT light source, the BLU-U®, Blue Light Photodynamic Therapy Illuminator. The new patent will have method of treatment claims which cover the use of DUSA's blue light technology and aminolevulinic acid HCL (Levulan®) for the treatment of actinic keratosis as well as the diagnosis and treatment of other disease states such as acne, cancer, psoriasis and photodamaged skin. The patent also has claims that will cover DUSA's blue light technology in conjunction with its proprietary Levulan® Kerastick® formulation of aminolevulinic acid HCL. The patent, once issued, which is scheduled to occur on May 25, 2010, will cover our approved Levulan® PDT therapy until June, 2019.





Conference Call Details and Dial-in Information:



In conjunction with this announcement, DUSA will host a conference call today:

Tuesday, May 11th - 8:30 am EDT

If calling from North America use the following toll-free number:

800-647-4314

International callers use:

502-719-4466

Password - DUSA



A recorded replay of the call will be available approximately 15 minutes following the call.

North American callers use:

877-863-0350

International callers use:

858-244-1268



The call will be accessible on our web site approximately four hours following the call at www.dusapharma.com.

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surf1944 surf1944 14 years ago
DUSA Pharmaceuticals Reports Notice of Allowance for Key PDT Device Patent
New patent will cover Levulan® PDT therapy until 2019

Press Release Source: DUSA Pharmaceuticals, Inc. On Friday May 7, 2010, 6:30 am EDT
WILMINGTON, Mass., May 7 /PRNewswire-FirstCall/ -- DUSA Pharmaceuticals, Inc.® (NASDAQ GM: DUSA), a dermatology company that is developing and marketing Levulan® Photodynamic Therapy (PDT), today announced that the United States Patent and Trademark Office has issued a notice of allowance for a key patent related to its proprietary PDT light source, the BLU-U®, Blue Light Photodynamic Therapy Illuminator. The new patent will have method of treatment claims which cover the use of DUSA's blue light technology and aminolevulinic acid HCL (Levulan®) for the treatment of actinic keratosis as well as the diagnosis and treatment of other disease states such as acne, cancer, psoriasis and photodamaged skin. The patent also has claims that will cover DUSA's blue light technology in conjunction with its proprietary Levulan® Kerastick® formulation of aminolevulinic acid HCL. The patent, once issued, which is scheduled to occur on May 25, 2010, will cover our approved Levulan® PDT therapy until June, 2019.

Robert Doman, DUSA's President and CEO, said, "This patent further strengthens the protection of our Levulan® PDT therapy because the claims cover the use of the BLU-U®, aminolevulinic acid, and our proprietary Levulan Kerastick formulation together to treat actinic keratoses." Mr. Doman continued, "The successful execution of this intellectual property protection strategy significantly enhances DUSA's patent portfolio for our Levulan® PDT technology. This provides DUSA with the opportunity to continue on its path of revenue growth and additional time to explore new indications and life cycle management strategies."
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surf1944 surf1944 14 years ago
Photodynamic therapy gains favor in treating precancerous skin conditionsPublish date: May 1, 2010
By: Jane Schwanke
Source: Dermatology Times

Nashville, Tenn. — The popularity of photodynamic therapy (PDT) for treating precancer skin conditions has increased exponentially over the past decade. The reasons are many, according to Michael Gold, M.D., medical director, Gold Skin Care Center, and clinical assistant professor, Vanderbilt University School of Medicine, department of dermatology, Nashville, Tenn.

“The literature has progressively supported the effectiveness of photodynamic therapy,” he tells Dermatology Times. “For pre-skin cancers, the number of dermatologists that are using PDT is more than it was five years ago, and much more than it was even two years ago.”

PDT topicals

In the United States, there are the two main topical compounds used in conjunction with PDT for treating precancers in the skin: Levulan Photodynamic Therapy (DUSA Pharmaceuticals) and Metvixia (methyl aminolevulinate cream 16.8 percent, Galderma).

In this country, Levulan is used only as a Food and Drug Administration-indication for treating actinic keratosis (AKs) and not skin cancers. Literature has supported its effectiveness as well as the reduced recurrence rate of pre-skin cancers.

“Levulan has been in use for about 10 years, and when it first came out, the reimbursement rates for doctors were abysmal,” Dr. Gold says. “But through the work of the AAD (American Academy of Dermatology), the company, and lots of grassroots support, the reimbursement rates have become sufficient to make it a useful therapy. If you use a therapy and you lose money, you’re not going to do it.”

Metvixia, used in Europe to treat nonmelanoma skin cancers and AKs, was approved in the United States strictly for treating AKs.

“Metvixia is an incredible skin cancer drug, but for a variety of different reasons — some of which we may never know — it was not granted approval in the U.S. for treating that condition,” Dr. Gold says.

“The problem with Metvixia is that it’s a little more difficult to use and it requires a different light source,” he explains. “Its uptake here in this country over the past year, which is when it came to the U.S., has been very slow. In Europe, it’s the only drug, so it is used all the time.”

Gaining favor

Today, medical insurance covers the use of PDT for AKs, but not for skin cancers or acne. Its track record for treating pre-skin cancers is a significant contributor to its success.

Now that insurers are covering it, nearly all dermatologists are using it as one of the first treatment choices for AKs, according to Dr. Gold.

Before the boom in PDT, Levulan and Metvixia for treating pre-skin cancers, topicals like diclofenac (Solaraze, PharmaDerm) and imiquimod (Aldara, Graceway) were most popular. But while the results are good, many patients couldn’t tolerate the redness, according to Dr. Gold. And the No. 1 treatment — cryotherapy or liquid nitrogen — also has side affects, some of which can be permanent.

“A patient could end up with hypopigmentation that lasted for long periods of time,” he says. “But PDT is really user-friendly.”

You apply a medicine, let it incubate on the skin, and then apply a light. It can be blue, red or pulsed light from either a pulsed dye laser or an intense pulsed light and the AKs go away. It’s fairly simple to use for the doctors, and fairly easy for the patient. And that’s another reason why it’s caught on so well — people realize it’s not hard to do, Dr. Gold says.

Proper procedures

“I’ve been using PDT for about 10 years and I have many patients who come back and say they would rather have this treatment than anything else,” he says. “And again, there’s enough literature out there to show that it really works, and it makes the skin look good, too.

“Patients must stay out of the sun for up to 48 hours after treatment, but that is the only after-care that is really needed,” he adds. “If the procedure is done properly, the incidence of adverse events is extremely low, as shown in clinical studies.”

PDT treatments should be administered only by dermatologists, according to Dr. Gold, because “sometimes, non-dermatologists may misdiagnose conditions or not diagnose them correctly.”

Today more than ever, the literature on PDT supports both Levulan and Metvixia in the treatment of AKs. Dr. Gold believes that if dermatologists aren’t using them, they are certainly missing an opportunity.

“By now, most dermatologists know about PDT and these topicals,” he says. “It’s not hard for most people to get on board with this treatment, if they aren’t already. The companies are available to help. My belief is, if you’re not offering this to your patients, then you’re not offering the full service.”



http://www.modernmedicine.com/modernmedicine/Dermatology/Photodynamic-therapy-gains-favor-in-treating-preca/ArticleStandard/Article/detail/666086?contextCategoryId=40160
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surf1944 surf1944 14 years ago
http://www.nasdaq.com/asp/quotes_sec.asp?symbol=dusa&selected=dusa
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surf1944 surf1944 14 years ago
DUSA Pharma DUSA Roth Capital Buy $4
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surf1944 surf1944 14 years ago
DUSA Pharmaceuticals Reports Full Year 2009 Corporate Highlights and Financial Results
Company reaches profitability and generates $1.6 million in positive cash flow in Q4
Conference call will be held on March 3rd at 8:30 am

Press Release Source: DUSA Pharmaceuticals, Inc. On Wednesday March 3, 2010, 6:30 am EST
WILMINGTON, Mass., March 3 /PRNewswire-FirstCall/ -- DUSA Pharmaceuticals, Inc.® (NASDAQ GM: DUSA), a dermatology company that is developing and marketing Levulan® Photodynamic Therapy (PDT) and other products focused on patients with common skin conditions, reported today its corporate highlights and financial results for the fourth quarter and full year ended December 31, 2009.

Fourth quarter and full year financial highlights include:


•The Company generated $1.6 million in positive cash flow (change in cash and cash equivalents and marketable securities) during the fourth quarter of 2009. Cash burn for the full year 2009 improved by $1.9 million from $4.1 million in 2008 to $2.2 million in 2009.
•The Company reached profitability on both a GAAP and non-GAAP basis during the fourth quarter of 2009.
•GAAP net income for the fourth quarter of 2009 was $0.4 million, representing a $2.4 million improvement year-over-year.
•Non-GAAP net income for the fourth quarter of 2009 was $0.9 million, representing a $2.3 million improvement year-over-year.
•The Company experienced significant bottom line improvement on both a GAAP and non-GAAP basis for the year.
•GAAP net loss was $2.5 million, representing a $3.7 million or 60% year-over-year improvement.
•Non-GAAP net loss was $1.0 million, representing a $2.9 million or 74% year-over-year improvement.
•Domestic PDT revenues totaled $8.0 million for the fourth quarter of 2009, representing a $0.9 million or 13% improvement as compared to the fourth quarter of 2008. Full year 2009 domestic PDT revenues totaled $26.7 million, representing a $4.7 million or 21% improvement year-over-year.

Management Comments:

"We are extremely excited to report our fourth quarter and full year 2009 financial results. Record revenues, fueled by strong domestic PDT revenue growth, combined with reductions in our overall spending, allowed us to deliver on our goals to become cash flow positive and profitable during the fourth quarter of 2009," stated Robert Doman, President and CEO.

"Our ability to reach these unprecedented Company milestones drove significant bottom line financial improvement in 2009. The achievement of record PDT revenues in the fourth quarter also serves as further evidence that PDT is becoming increasingly more accepted by the medical dermatology community for the treatment of actinic keratoses (AKs)," continued Doman.

"As we head into 2010, we intend to build upon the many achievements and momentum of 2009 by increasing PDT penetration into the AK market, while at the same time advancing our research and development endeavors," concluded Doman.

Fourth Quarter 2009 Financial Results:

Total product revenues were $8.8 million in the fourth quarter of 2009, an increase of $1.0 million or 13% from $7.8 million in the fourth quarter of 2008. PDT revenues totaled $8.5 million, an increase of $1.0 million or 13% from $7.5 million for the comparable 2008 period. The increase in PDT revenues was attributable to a $1.2 million increase in Kerastick® revenues, which was partially offset by a $0.2 million decrease in BLU-U® revenues. The Kerastick® revenue improvement was driven by a 6% increase in our domestic Kerastick® volume and a 12% increase in our average selling price. Kerastick® sales volumes increased to 64,904 in the fourth quarter of 2009 from 62,260 units sold in the comparable 2008 period. Domestic Kerastick® sales volumes increased by 3,216 units or 6% and were partially offset by a 572 unit decrease in our international sales volumes. The BLU-U® revenue decrease was due to lower sales volumes. There were 54 units sold during the quarter, as compared to the 75 units sold in the prior year. Non-PDT revenues totaled $0.3 million and were relatively flat versus the comparable 2008 period.

DUSA's net income on a GAAP basis for the fourth quarter of 2009 was $0.4 million, or $0.02 per common share, compared to a net loss of $2.0 million, or $0.08 per common share, in the fourth quarter of 2008.

Please refer to the section entitled "Use of Non-GAAP Financial Measures" and the accompanying financial table included at the end of this release for a reconciliation of GAAP to non-GAAP results for the three and twelve-month periods ended December 31, 2009 and 2008, respectively.

DUSA's non-GAAP net income for the fourth quarter of 2009 was $0.9 million, or $0.04 per common share, compared to a net loss of $1.4 million, or $0.06 per common share, in the prior year period. The improvement in the Company's profitability was primarily the result of the year-over-year increase in our PDT revenues as well as lower operating costs.

Full Year 2009 Financial Results:

Total product revenues for the year ended December 31, 2009 were $29.8 million, an increase of $0.3 million or 1% from $29.5 million in 2008. PDT revenues totaled $28.3 million, an increase of $4.4 million or 18% from $23.9 million for 2008. The increase in PDT revenues was attributable to a $4.3 million increase in Kerastick® revenues and a $0.1 million increase in BLU-U® revenues. The Kerastick® revenue improvement was driven by an 11% increase in our domestic Kerastick® volume and an overall 12% increase in our average selling price. Kerastick® sales volumes increased to 220,288 units in 2009 from 207,516 units sold in 2008. Domestic Kerastick® sales volumes increased by 19,182 units or 11% and were partially offset by a 6,410 decrease in our international sales volumes. The BLU-U® revenue increase was driven by a 10% increase in sales volume. There were 252 units sold during 2009, representing a 23 unit increase over the prior year total of 229 units. Non-PDT revenues totaled $1.5 million versus $5.6 million for the comparable 2008 period. Non-PDT revenues were adversely impacted by the absence of Nicomide® sales in 2009. In response to discussions with the Food and Drug Administration (FDA) regarding our marketing of certain products considered by the FDA to be marketed unapproved drugs, the Company stopped shipping Nicomide® into the wholesale channel in June of 2008.

DUSA's net loss on a GAAP basis for the twelve months ended December 31, 2009 was $2.5 million or $0.10 per common share, compared to a net loss of $6.3 million or $0.26 per common share in 2008.

DUSA's non-GAAP net loss for the twelve months ending December 31, 2009 was $1.0 million or $0.04 per common share in 2009, compared to $3.9 million or $0.16 per common share in 2008. The decrease in our net loss was primarily the result of the year-over-year increase in our PDT revenues as well as a decrease in our operating costs due mainly to the absence of spending on our Phase IIb acne clinical trial which concluded in 2008, and a Prescription Drug User Fee Act (PDUFA) charge accrued in the prior year period.

As of December 31, 2009, total cash, cash equivalents, and marketable securities were $16.7 million, compared to $18.9 million at December 31, 2008. Annual cash burn improved by $1.9 million from $4.1 million in 2008 to $2.2 million in 2009. The Company generated $1.6 million in positive cash flow during the fourth quarter of 2009.

Other Highlights:


•Solid Organ Transplant Recipients (SOTRs) Clinical Development:
•In May 2009, the Company announced the initiation of its Phase II clinical trial that will examine the safety and efficacy of broad area PDT for the treatment of AKs and the prevention of new non-melanoma skin cancer (NMSC) in high risk chronically immunosuppressed solid organ transplant recipients (SOTRs). All seven clinical sites have been initiated and trial enrollment is currently underway. Patient enrollment is expected to take at least one year. We plan to present preliminary results in approximately 15 months and full results in approximately two years.
•In 2008, the Company filed an Orphan Drug Designation Application with the FDA for the prevention of cancer occurrence in SOTRs. DUSA received initial correspondence that the application was not granted on the basis that the agency believed that the prevalence of the target population with the disease state is greater than 200,000, which is the maximum number of patients allowed under the Orphan Drug legislation. The Company met with the FDA during the third quarter of 2009 to clarify and explain further the application and, based on that meeting, the agency invited DUSA to submit an amendment to the application for further evaluation. A draft amendment was prepared and submitted in January 2010, and a follow-on meeting with the agency was requested. Last week, FDA indicated that a meeting was not necessary and suggested that we formally submit the amended application to the agency. We expect to make the formal submission this month.
•In October 2009, the Company announced that it had been named to Deloitte's Technology Fast 500 list for the second consecutive year. Deloitte recognized DUSA as one of the Top 500 fastest growing technology, media, telecommunications and life sciences companies in North America in terms of percentage revenue growth over a five year period.
•In October 2009, the Company announced that cumulative global sales volumes of the Levulan® Kerastick®, an integral part of the Levulan® Photodynamic Therapy (PDT) technology platform, surpassed one million units.
•In late 2009, the FDA approved the use of the Kerastick® Krusher™ tool for the preparation of the Levulan® Kerastick®. The FDA also approved the decrease in Levulan® Kerastick® preparation time from 3 minutes to 30 seconds. We believe that the reduction in dissolution time significantly improves the ease of use for health care professionals.




Conference Call Details and Dial-in Information:

In conjunction with this announcement, DUSA will host a conference call today:

Wednesday, March 3rd – 8:30 a.m. Eastern

If calling from the U.S. or Canada use the following toll-free number:

800.647.4314

Password – DUSA

For international callers use

502.498.8422

Password – DUSA

A recorded replay of the call will be available approximately 15 minutes following the call.

U.S. or Canada callers use 877.863.0350

International callers use 858.244.1268

The call will be accessible on our web site approximately six hours following the call at www.dusapharma.com
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surf1944 surf1944 14 years ago
Thaanks for the note, DUSA has lined up on the chart to run into some news, be it qtr report or a conference....

surf
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schlitz schlitz 14 years ago
grabbed some @ 1.40. this from another board:

DUSA earnings march 3th and will show profit

DUSA at ROTH Capital Partners to Hold 22nd Annual OC Growth Stock Conference March 15-17, 2010

15m cash, 4m a year burn, 0 debt, low float- Outstanding: 24.11M
Float: 19.81M
% Held by Insiders 18.34%
% Held by Institutions 44.00%
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surf1944 surf1944 14 years ago
http://www.form4oracle.com/company/dusa-pharmaceuticals-inc-dusa/company-transactions?id=328
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surf1944 surf1944 14 years ago
6:33AM DUSA Pharma announces independent study utilizing cyclic levulan PDT finds 95% reduction in new squamous cell carcinoma lesions in solid organ transplant recipients over a 2 yr period (DUSA) 1.41 : Co announces the results of an independent investigator study just published in the online version of Dermatologic Surgery demonstrate that Levulan Photodynamic Therapy (PDT) may reduce the rate of recurrence of squamous cell carcinomas in solid organ transplant recipients, a population with a high incidence of nonmelanoma skin cancer. This pilot study, which will also appear in the print version of the December issue of Dermatologic Surgery, was conducted by researchers at the University of Minnesota Department of Dermatology and found that the median number of SCCs was reduced by 79% at 12 months after cyclic Levulan PDT treatment and by 95% at 24 months, when compared to the pre-PDT year measurement date. "These results are another step forward in managing and improving the health of SOTR patients who have a much higher risk than the general population of developing SCCs, a skin cancer that is often times deadly in this patient population..."
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surf1944 surf1944 14 years ago
http://www.mffais.com/dusa
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surf1944 surf1944 14 years ago
DUSA Pharmaceuticals Reports Third Quarter 2009 Corporate Highlights and Financial Results
Q3 Domestic PDT revenues up 32% year over year; Q3 Non-GAAP loss improves 86% year over year to ($0.2) million

Press Release
Source: DUSA Pharmaceuticals, Inc.
On 6:30 am EST, Friday November 6, 2009

Companies:Dusa Pharmaceuticals Inc.
WILMINGTON, Mass., Nov. 6 /PRNewswire-FirstCall/ -- DUSA Pharmaceuticals, Inc.® (Nasdaq GM: DUSA), a dermatology company that is developing and marketing Levulan® Photodynamic Therapy (PDT) and other products focused on patients with common skin conditions, reported today its corporate highlights and financial results for the third quarter ended September 30, 2009.

Third quarter and year-to-date financial highlights include:

Domestic PDT revenues totaled $6.2 million for the third quarter of 2009, representing a $1.5 million, or 32%, improvement as compared to the third quarter of 2008. Year-to-date 2009 domestic PDT revenues totaled $18.7 million, representing a $3.8 million, or 25%, improvement year over year.
Domestic Kerastick® revenues totaled $5.8 million for the third quarter of 2009, representing a $1.4 million, or 32%, improvement as compared to the third quarter of 2008. Year-to-date 2009 domestic Kerastick® revenues totaled $17.1 million, representing a $3.4 million, or 25%, improvement year over year.
Domestic BLU-U® revenues totaled $0.5 million for the third quarter of 2009, representing a $0.1 million, or 22%, improvement as compared to the third quarter of 2008. Year-to-date 2009 domestic BLU-U® revenues totaled $1.6 million, representing a $0.4 million, or 32%, improvement year over year.
Kerastick® gross margins for the third quarter of 2009 reached a record high of 86%.
Non-GAAP loss for the third quarter of 2009 improved 86% year over year, and narrowed to $0.2 million.

Management Comments:

"We are excited to report the improvement in many of our key financial indicators this quarter," stated Robert Doman, President and CEO. "The combination of strong top line PDT revenue growth, the achievement of record Kerastick margins, and reductions in our overall spending drove our non-GAAP loss to a record low point."

"We experienced significant growth in Kerastick revenue during the third quarter. This is due in part to solid execution by the sales and marketing team and a 33% increase in BLU-U volume year-to-date. This represents the 16th consecutive quarter of year over year domestic Kerastick growth."

"In October, we announced an important milestone in the Company's history, having surpassed cumulative Kerastick sales of one million units. The achievement of this milestone demonstrates the relevance that PDT is gaining in the medical dermatology community," continued Doman.

"For the remainder of the year, we will focus our efforts on further capitalizing on the significant growth potential that exists for Levulan PDT in the treatment of actinic keratoses (AKs)," concluded Doman.

Third Quarter 2009 Financial Results:

Total product revenues were $6.9 million in the third quarter of 2009, up 21% from $5.7 million in the third quarter of 2008. PDT revenues totaled $6.7 million, up $1.5 million, or 30%, from $5.2 million for the comparable 2008 period. The increase in PDT revenues was attributable to a 32% increase in Kerastick® revenues and a 7% increase in BLU-U® revenues. The Kerastick® revenue improvement was driven by a 20% increase in our domestic Kerastick® volume and an overall 10% increase in our average selling price. Kerastick® sales volumes increased to 53,622 in the third quarter of 2009 from 44,668 units sold in the third quarter of 2008. Domestic Kerastick® sales volumes increased by 7,938 units, or 20%, and were supplemented by a 1,016 unit increase in our international sales volumes. The BLU-U® revenue increase was driven by a 4% increase in sales volume. There were 59 units sold during the quarter, as compared to the prior year quarterly total of 57 units. Non-PDT revenues totaled $0.2 million versus $0.6 million for the comparable 2008 period. Non-PDT revenues were adversely impacted by the absence of Nicomide® royalty revenues in 2009. DUSA has not received the installment payments due under its exclusive Nicomide® patent license agreement with River's Edge since June 2009. The Company is currently evaluating its options to collect the amounts due from River's Edge.

DUSA's net loss on a GAAP basis for the third quarter of 2009 was ($0.4) million, or ($0.02) per common share, compared to a net loss of ($2.8) million, or ($0.12) per common share, in the third quarter of 2008.

DUSA's non-GAAP net loss for the third quarter of 2009, after adjustments for stock-based compensation expense, consideration provided to the former Sirius shareholders, and the non-cash change in fair value of warrants, was ($0.2) million, or ($0.01) per common share, compared to a net loss of ($1.6) million, or ($0.07) per common share, in the prior year period. The decrease in the Company's net loss was primarily the result of the year over year increase in our PDT revenues and lower operating costs due to the absence of spending on our Phase IIb acne clinical trial which concluded in 2008.

Please refer to the section entitled "Use of Non-GAAP Financial Measures" and the accompanying financial table included at the end of this release for a reconciliation of GAAP to non-GAAP results for the three and nine month periods ending September 30, 2008 and 2009, respectively.

Year-to-Date 2009 Financial Results:

Total product revenues for the nine month period ended September 30, 2009 were $21.0 million, down 3% from $21.8 million in comparable prior year period. PDT revenues totaled $19.8 million, up $3.4 million, or 21% from $16.4 million for the comparable 2008 period. The increase in PDT revenues was attributable to a 20% increase in Kerastick® revenues and a 26% increase in BLU-U® revenues. The Kerastick® revenue improvement was driven by a 13% increase in our domestic Kerastick® volume and an overall 13% increase in our average selling price. Kerastick® sales volumes increased to 155,384 in 2009 from 145,256 units sold in 2008. Domestic Kerastick® sales volumes increased by 15,966 units, or 13%, and were partially offset by a 5,838 unit decrease in our international sales volumes. The BLU-U® revenue increase was driven by a 29% increase in sales volume. There were 198 units sold during in 2009, representing a 44 unit increase over the prior year total of 154 units. Non-PDT revenues totaled $1.2 million versus $5.4 million for the comparable 2008 period. Non-PDT revenues were adversely impacted by the absence of Nicomide® sales in 2009. In response to discussions with the Food and Drug Administration (FDA) regarding our marketing of certain products considered by the FDA to be marketed unapproved drugs, the Company stopped shipping Nicomide® into the wholesale channel in June of 2008.

DUSA's net loss on a GAAP basis for the nine months ended September 30, 2009 was ($2.9) million or ($0.12) per common share, compared to a net loss of ($4.3) million or ($0.18) per common share in 2008.

DUSA's non-GAAP net loss, after adjustments for stock-based compensation expense, a milestone payment made related to the Sirius acquisition, consideration provided to the former Sirius shareholders, and the non-cash change in fair value of warrants, for the nine months ending September 30, 2009 was ($1.9) million, or ($0.08) per common share, in 2009, compared to ($2.5) million, or ($0.10) per common share, in 2008. The decrease in our net loss was primarily the result of the year over year decrease in our operating costs due mainly to the absence of spending on our Phase IIb acne clinical trial which concluded in 2008, and a Prescription Drug User Fee Act (PDUFA) charge accrued in the prior year period.

As of September 30, 2009, total cash, cash equivalents, and marketable securities were $15.0 million, compared to $18.9 million at December 31, 2008.

Other Updates:


Solid Organ Transplant Recipients Clinical Development.
In May 2009, the Company announced the initiation of its Phase II clinical trial that is examining the safety and efficacy of PDT for the treatment of broad area AKs and the prevention of squamous cell carcinomas in high risk chronically immunosuppressed solid organ transplant recipients. All seven clinical sites have been initiated and trial enrollment is currently underway.
In May 2008, DUSA filed an Orphan Drug Designation application with the FDA with respect to the prevention of cancer occurrence in these patients. The Company received initial correspondence that the application was not granted on the basis that the agency believes that the prevalence of the target population with the disease state is greater than 200,000, which is the maximum number of patients allowed under the Orphan Drug legislation. During the third quarter of 2009, DUSA met with the FDA to clarify and explain in more detail our rationale for the application and, based on that meeting, the agency has invited us to submit an amendment to our application for further evaluation. DUSA is in the process of drafting the amendment and expects to submit it to the FDA later this month.


BLU-U® Claims Expansion.
In May 2009, the Company filed a 510(k) application with the FDA to expand the allowed claims on BLU-U® to include severe acne. The filing was based on the results of our Phase IIb clinical trial. We received a response to our application from the FDA in June 2009. The agency requested additional information in order to complete its review of our application, including supplementary clinical data in support of our claims. Based on the FDA's requests and the anticipated costs of additional clinical trials, the Company has decided not to pursue the 510(k) application for an expansion of the BLU-U® claims at this time.

Revenues Table, Condensed Consolidated Balance Sheets, Condensed Consolidated Statement of Operations and GAAP to Non-GAAP reconciliation follow:

Revenues for the three month and nine month periods were comprised of the following:


Three-months ended Nine-months ended
September 30, September 30,
2009 2008 2009 2008
(Unaudited) (Unaudited) (Unaudited) (Unaudited)

PDT Drug & Device Product Revenues
Kerastick® Product Revenues:
United States $5,790,000 $4,374,000 $17,096,000 $13,720,000
Canada 162,000 72,000 404,000 449,000
Korea 201,000 186,000 498,000 710,000
Other 91,000 99,000 261,000 289,000
Subtotal Kerastick®
Product Revenues 6,244,000 4,731,000 18,259,000 15,168,000
BLU-U® Product Revenues:
United States 456,000 376,000 1,577,000 1,198,000
Korea - 50,000 - 50,000
Subtotal BLU-U®
Product Revenues 456,000 426,000 1,577,000 1,248,000
Total PDT Drug & Device
Product Revenues 6,700,000 5,157,000 19,836,000 16,416,000
Total Non-PDT Product
Revenues 230,000 569,000 1,198,000 5,352,000
TOTAL PRODUCT REVENUES $6,930,000 $5,726,000 $21,034,000 $21,768,000


DUSA Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets

September 30, December 31,
2009 2008
(Unaudited)
--------------------------
ASSETS
CURRENT ASSETS
Cash and cash equivalents $5,016,994 $3,880,673
Marketable securities 10,012,948 15,002,830
Accounts receivable, net 2,519,214 2,367,803
Inventory 2,336,167 2,812,825
Prepaid and other current assets 1,647,408 1,873,801
--------- ---------
TOTAL CURRENT ASSETS 21,532,731 25,937,932
Restricted cash 174,170 173,844
Property, plant and equipment, net 1,721,488 1,937,978
Deferred charges and other assets 68,099 160,700
------ -------
TOTAL ASSETS $23,496,488 $28,210,454
=========== ===========

LIABILITIES AND SHAREHOLDERS' EQUITY
CURRENT LIABILITIES
Accounts payable $188,417 $305,734
Accrued compensation 889,230 1,515,912
Other accrued expenses 2,343,822 3,226,571
Deferred revenue 1,045,505 611,602
--------- -------
TOTAL CURRENT LIABILITIES 4,466,974 5,659,819
Deferred revenues 3,061,700 4,157,305
Warrant liability 474,137 436,458
Other liabilities 133,544 244,673
------- -------
TOTAL LIABILITIES 8,136,355 10,498,255

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: 24,108,908
and 24,089,452 shares of common
stock, no par, at September 30,
2009 and December 31, 2008,
respectively 151,683,399 151,663,943
Additional paid-in capital 8,122,801 7,514,900
Accumulated deficit (144,725,805) (141,850,925)
Accumulated other comprehensive loss 279,738 384,281
TOTAL SHAREHOLDERS' EQUITY 15,360,133 17,712,199
---------- ----------

TOTAL LIABILITIES AND SHAREHOLDERS'
EQUITY $23,496,488 $28,210,454
=========== ===========


DUSA Pharmaceuticals, Inc.
Consolidated Statement of Operations

Three-months ended Nine-months ended
September 30, September 30,
2009 2008 2009 2008
(Unaudited) (Unaudited) (Unaudited) (Unaudited)

Product revenues $6,930,110 $5,726,071 $21,033,920 $21,767,810
Cost of product revenues
and royalties 1,594,692 1,462,028 4,973,782 4,950,039
Gross margin 5,335,418 4,264,043 16,060,138 16,817,771
Operating costs:
Research and development 963,245 1,487,816 3,225,049 5,049,327
Marketing and sales 3,013,351 2,967,431 9,460,766 9,520,865
General and
administrative 1,877,928 1,911,028 6,360,325 6,603,989
Impairment charge for
contingent
consideration - 1,500,000 - 1,500,000
Settlements, net - 650 75,000 (282,775)
Total operating costs 5,854,524 7,866,925 19,121,140 22,391,406
Loss from operations (519,106) (3,602,882) (3,061,002) (5,573,635)
Other income:
Other income, net 79,815 114,260 223,801 538,212
Gain/(loss) on change in
fair value of warrants 24,051 651,767 (37,679) 775,636
Net loss $(415,240) $(2,836,855) $(2,874,880) $(4,259,787)
Basic and diluted net
loss per common share $(0.02) $(0.12) $(0.12) $(0.18)
Weighted average number
of common shares 24,108,908 24,078,610 24,099,786 24,078,546

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 stock-based compensation expense, consideration provided to the former Sirius shareholders, and the non-cash change in fair value of warrants. The Company believes that this presentation is useful to help investors better understand DUSA's financial performance, competitive position and prospects for the future. Management believes that 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 Nine-months ended
September 30, September 30,
2009 2008 2009 2008
(Unaudited) (Unaudited) (Unaudited) (Unaudited)


GAAP net loss $(415,240) $(2,836,855) $(2,874,880) $(4,259,787)
Stock-based
compensation (a) 207,178 353,262 631,770 1,042,812
Payment on
acquisition (b) - 1,500,000 - 1,500,000
Consideration to former
Sirius shareholders (c) 5,000 - 310,000 -
Change in fair value
of warrants (d) (24,051) (651,767) 37,679 (775,636)
Non-GAAP adjusted
net loss $(227,113) $(1,635,360) $(1,895,431) $(2,492,611)
Non-GAAP basic and
diluted net loss
per common share $(0.01) $(0.07) $(0.08) $(0.10)
Weighted average
number of common
shares 24,108,908 24,078,610 24,099,786 24,078,546

(a) Stock-based compensation expense resulting from the application
of SFAS 123®.
(b) Milestone payment related to Sirius Laboratories acquisition.
(c) Payment of $100,000 and accrual of $210,000 related to the release,
consent and the third amendment to the merger agreement between DUSA
and the former Sirius shareholders.
(d) Non-cash gain/loss on change in fair value of warrants.

Conference Call Details and Dial-in Information

In conjunction with this announcement, DUSA will host a conference call

today:


Friday, November 6th - 8:30 a.m. Eastern
If calling from the U.S. or Canada use the following toll-free number:
800.647.4314
Password - DUSA
For international callers use 502.498.8422
Password - DUSA
A recorded replay of the call will be available approximately 15
minutes following the call
U.S. or Canada callers use 877.863.0350
International callers use 858.244.1268

The call will be accessible on our web site approximately six hours following the call at www.dusapharma.com.

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surf1944 surf1944 14 years ago
DUSA Pharmaceuticals Surpasses One Million in Cumulative Levulan(R) Kerastick(R) Sales Units
Press Release
Source: DUSA Pharmaceuticals, Inc.
On 6:30 am EDT, Wednesday October 28, 2009

Companies:Dusa Pharmaceuticals Inc.
WILMINGTON, Mass., Oct. 28 /PRNewswire-FirstCall/ -- DUSA Pharmaceuticals, Inc.® (Nasdaq GM: DUSA), a specialty pharmaceutical company focused on dermatology, announced today that global sales volumes of the Levulan® Kerastick®, an integral part of the Levulan® Photodynamic Therapy (PDT) technology platform, surpassed one million units.

"The achievement of this milestone signifies that dermatologists in the U.S. and abroad continue to embrace Levulan PDT for Grade 1 and 2 actinic keratoses (AKs) of the face and scalp and the beneficial outcomes it offers their patients," said Bob Doman, DUSA's President and Chief Executive Officer.

"We believe that Levulan PDT is one of the fastest growing office based procedures in dermatology today, having achieved a 39% compounded annual growth rate in worldwide Kerastick revenues over the past four years," continued Doman.

"PDT is an important, versatile technology that should be integrated more frequently in clinical dermatology practice," said Jill Waibel, M.D., a dermatologist in private practice at Palm Beach Esthetic Dermatology & Laser Center, West Palm Beach, Florida.

"We are excited to have reached the one million Kerastick sales milestone, and believe that significant growth potential exists for Levulan PDT in the treatment of AKs and other potential indications," Doman concluded.

DUSA continues to explore other potential indications for the utilization of Levulan PDT for the treatment of various skin conditions and has initiated a pilot study on Levulan PDT for the treatment of AKs and the prevention of new non-melanoma skin cancer in chronically immunosuppressed solid organ transplant recipients.

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surf1944 surf1944 15 years ago
DUSA Pharmaceuticals Reports Second Quarter 2009 Corporate Highlights and Financial Results
Q2 Domestic PDT revenues up 24% year over year; Kerastick margins reach a record high of 85%
Press Release
Source: DUSA Pharmaceuticals, Inc.
On Tuesday August 11, 2009, 6:30 am EDT

Companies:DUSA Pharmaceuticals Inc.
WILMINGTON, Mass., Aug. 11 /PRNewswire-FirstCall/ -- DUSA Pharmaceuticals, Inc.(®) (NASDAQ GM: DUSA), a dermatology company that is developing and marketing Levulan(®) Photodynamic Therapy (PDT) and other products focused on patients with common skin conditions, reported today its corporate highlights and financial results for the second quarter ended June 30, 2009.

Financial highlights for the second quarter and first half of the year include:

Domestic PDT revenues totaled $6.1 million for the second quarter of 2009, representing a $1.2 million, or 24%, improvement as compared to the second quarter of 2008. First half 2009 domestic PDT revenues totaled $12.4 million, representing a $2.3 million, or 22%, improvement year over year.
Domestic Kerastick(®) revenues totaled $5.6 million for the second quarter of 2009, representing a $1.0 million, or 23%, improvement as compared to the second quarter of 2008. First half 2009 domestic Kerastick(® )revenues totaled $11.3 million, representing a $2.0 million, or 21%, improvement year over year.
Domestic BLU-U(®) revenues totaled $0.5 million for the second quarter of 2009, representing a $0.1 million, or 38%, improvement as compared to the second quarter of 2008. First half 2009 domestic BLU-U(®) revenues totaled $1.1 million, representing a $0.3 million, or 36%, improvement year over year.
Kerastick(®) gross margins for the second quarter of 2009 reached a record high of 85%.

Management Comments:

"While overall revenues were down for the quarter, due to the loss of Nicomide(®) sales, continued growth in our core PDT business helped to partially offset the year over year shortfall," stated Robert Doman, President and CEO. "In the face of a challenging economic environment, our domestic PDT business experienced strong growth in the second quarter. Domestic PDT growth was driven by increased penetration and utilization of our therapy in the medical dermatology and hospital segments of our business."

"We are pleased to announce another successful BLU-U(®) sales quarter. Despite a difficult capital equipment market, first half BLU-U(®) unit sales were up 43% as compared to the prior year," continued Doman.

"For the second half of the year, we expect to see expanded adoption of our therapy by the marketplace. While we expect that adverse economic conditions will negatively impact the international markets and the non-reimbursed cosmetic/medi spa segment of our business in the U.S., the medical dermatology segment of our business continues to demonstrate robust growth. We also look forward to the further advancement of our solid organ transplant recipients (SOTRs) clinical trial which was initiated in May," concluded Doman.

Second Quarter 2009 Financial Results:

Total product revenues were $7.0 million in the second quarter of 2009, down 14% from $8.1 million in the second quarter of 2008. PDT revenues totaled $6.4 million, up $1.0 million, or 18%, from $5.4 million for the comparable 2008 period. The increase in PDT revenues was attributable to a 17% increase in Kerastick(®) revenues and a 38% increase in BLU-U(®) revenues. The Kerastick(® )revenue increase was driven by an 11% increase in our domestic Kerastick(®) volume and an overall 14% increase in our average selling price. Kerastick(®) sales volumes increased to 49,815 in the second quarter of 2009 from 48,478 units sold in the second quarter of 2008. Domestic Kerastick(®) sales volumes increased by 4,662 units, or 11%, and were partially offset by a 3,325 unit decrease in our international sales volumes. The BLU-U(®) revenue increase was driven by a 41% increase in sales volume. There were 58 units sold during the quarter, representing a 17 unit increase over the prior year quarterly total of 41 units. Non-PDT revenues totaled $0.5 million versus $2.7 million for the comparable 2008 period. Non-PDT revenues were adversely impacted by the absence of Nicomide(® )sales in 2009. In response to discussions with the Food and Drug Administration (FDA) regarding our marketing of certain products considered by the FDA to be marketed unapproved drugs, the Company stopped shipping Nicomide(® )into the wholesale channel in June of 2008.

DUSA's net loss on a GAAP basis for the second quarter of 2009 was ($0.9) million, or ($0.04) per common share, compared to a net loss of ($0.1) million, or ($0.01) per common share, in the second quarter of 2008.

DUSA's non-GAAP net loss for the second quarter of 2009, after adjustments for stock-based compensation expense, consideration provided to the former Sirius shareholders, and the non-cash change in fair value of warrants, was ($0.4) million, or ($0.02) per common share, compared to a net loss of ($0.2) million, or ($0.01) per common share, in the prior year period. The increase in our net loss was primarily the result of the year over year shortfall in our Non-PDT revenues, which was partially offset by incremental PDT revenues, lower operating costs due to the absence of spending on our Phase IIb acne clinical trial which concluded in 2008 and lower promotional expenses associated with the non-PDT product segment.

Please refer to the section entitled "Use of Non-GAAP Financial Measures" and the accompanying financial table included at the end of this release for a reconciliation of GAAP to non-GAAP results for the three and six month periods ending June 30, 2008 and 2009, respectively.

First Half 2009 Financial Results:

Total product revenues for the six month period ended June 30, 2009 were $14.1 million, down 12% from $16.0 million in comparable prior year period. PDT revenues totaled $13.1 million, up $1.9 million, or 17% from $11.3 million for the comparable 2008 period. The increase in PDT revenues was attributable to a 15% increase in Kerastick(®) revenues and a 36% increase in BLU-U(®) revenues. The Kerastick(® )revenue increase was driven by a 9% increase in our domestic Kerastick(®) volume and an overall 14% increase in our average selling price. Kerastick(®) sales volumes increased to 101,762 in the first half of 2009 from 100,588 units sold in the first half of 2008. Domestic Kerastick(®) sales volumes increased by 8,028 units, or 9%, and were partially offset by a 6,854 unit decrease in our international sales volumes. The BLU-U(®) revenue increase was driven by a 43% increase in sales volume. There were 139 units sold during the first half of 2009, representing a 42 unit increase over the prior year first half total of 97 units. Non-PDT revenues totaled $1.0 million versus $4.8 million for the comparable 2008 period. Non-PDT revenues were adversely impacted by the absence of Nicomide(® )sales in 2009.

DUSA's net loss on a GAAP basis for the six months ended June 30, 2009 was ($2.5) million or ($0.10) per common share, compared to a net loss of ($1.4) million or ($0.06) per common share in the first half of 2008.

DUSA's non-GAAP net loss, after adjustments for stock-based compensation expense, consideration provided to the former Sirius shareholders, and the non-cash change in fair value of warrants, for the six months ending June 30, 2009 was ($1.7) million, or ($0.07) per common share, in 2009, compared to ($0.9) million, or ($0.04) per common share, in 2008. The increase in our net loss was primarily the result of the year over year shortfall in our Non-PDT revenues and the absence of damages payments from River's Edge, which were partially offset by incremental PDT revenues, lower operating costs due to the absence of spending on our Phase IIb acne clinical trial which concluded in 2008, a Prescription Drug User Fee Act (PDUFA) charge accrued in the prior year period, and lower promotional expenses associated with the non-PDT product segment.

As of June 30, 2009, total cash, cash equivalents, and marketable securities were $16.4 million, compared to $18.9 million at December 31, 2008.

http://finance.yahoo.com/news/DUSA-Pharmaceuticals-Reports-prnews-3515234749.html?x=0&.v=1
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surf1944 surf1944 16 years ago
DUSA Announces Patent Licensing Agreement
Thursday August 14, 6:30 am ET

WILMINGTON, MASSACHUSETTS--(MARKET WIRE)--Aug 14, 2008 -- DUSA Pharmaceuticals, Inc.® (NASDAQ GM: DUSA) today announced that it has entered into a non-exclusive patent license agreement granting River's Edge Pharmaceuticals, LLC rights for a vitamin-mineral product (nicotinamide, zinc, copper and folic acid) in the prescription market. DUSA is taking this action in light of the entry of generic products in this market and DUSA's need to enforce its intellectual property rights while trying to avoid litigation. DUSA, which previously sold its patented product in this market, now plans to sell its product under the dietary supplement rules as a result of discussions with the Food and Drug Administration. The one-year agreement is subject to an extension under certain terms and conditions and does not include a trademark license. As part of the agreement, DUSA will receive a share of the net revenues River's Edge generates.

"DUSA is pleased to have reached this new patent license agreement," said Bob Doman, President and CEO of DUSA. "We believe that this agreement and other commercial strategies will allow DUSA to maximize the value of this asset."

In October 2007, DUSA and River's Edge signed a settlement and mutual release to settle patent litigation, which is being amended to accommodate this new patent license agreement.

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surf1944 surf1944 16 years ago
DUSA Announces Update on Nicomide(R) Status
Friday July 18, 9:00 am ET

WILMINGTON, MASSACHUSETTS--(MARKET WIRE)--Jul 18, 2008 -- DUSA Pharmaceuticals, Inc.® (NASDAQ GM: DUSA) reported today that Nicomide®, a vitamin-mineral product currently prescribed by dermatologists, will no longer be manufactured and marketed as a prescription product. The decision comes as a proactive action in response to discussions with the Food and Drug Administration (FDA).

Shortly after DUSA acquired Nicomide through its merger with Sirius Laboratories, Inc. in March 2006, the FDA announced the strengthening of its efforts to enforce and implement its policy entitled "Marketed New Drugs without Approved NDAs or ANDAs" which seeks to ensure that certain prescription products, like Nicomide, which were historically marketed without approved FDA pre-market applications, comply in a timely manner with current regulations.

DUSA has placed a voluntary hold on existing inventory of Nicomide under its control pending an upcoming meeting with the FDA. The disposition of this inventory will be determined by the outcome of the meeting. In parallel, repackaging efforts are underway to re-label additional inventory with DSHEA (Dietary Supplement Health and Education Act) compliant labeling.

The company's total revenues for the full year ended December 31, 2007 and three-month period ended March 31, 2008 were $27.7 million and $7.9 million, respectively. Of the total revenues for these periods, $9.4 million and $2.1 million, respectively, were derived from the sale of Non-Photodynamic Therapy (Non-PDT) products. Nicomide represented the substantial majority of DUSA's Non-PDT revenues in both periods. The company expects both the price and volumes of the Nicomide DSHEA labeled product to be considerably less than historical Nicomide levels.

"After reviewing various options, this commercial strategy, in light of the current regulatory environment, will allow DUSA to explore new marketing channels, product categories (DSHEA) and the possible sale or licensing of the product in order to meet strong product demand while DUSA complies with FDA policy guidelines," said Bob Doman, President and CEO of DUSA. "The company's focus has and will be to maximize revenue across its entire product portfolio which includes Levulan® Photodynamic Therapy (PDT) and to continue to explore new strategic opportunities that will position DUSA as a leader in the dermatology community."

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 2 actinic keratoses of the face or scalp, and is being studied for the treatment of acne. DUSA's other dermatology product is ClindaReach(TM). DUSA is also researching additional indications for internal uses of Levulan PDT including oral Leukoplakia. DUSA is based in Wilmington, Mass. Please visit the company's website at www.dusapharma.com for more information.
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surf1944 surf1944 16 years ago
Dusa Pharmaceuticals files shelf registration
Friday May 16, 2:36 pm ET
Dusa files shelf registration to offer up to $75 million of securities

WILMINGTON, Mass. (AP) -- Dusa Pharmaceuticals Inc., which makes dermatology products, said Friday it has filed a shelf registration statement with the Securities and Exchange Commission to offer up to $75 million of securities.
The registration enables the company to raise funds from the sale of its securities in one or more offerings, subject to market conditions and Dusa's capital needs.

Dusa said it has no immediate plans to raise funds.

Shares remained unchanged from Thursday's close at $2.22 in afternoon trading.


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surf1944 surf1944 16 years ago
DUSA Pharmaceuticals Reports First Quarter 2008 Corporate Highlights and Financial Results
Wednesday May 7, 6:30 am ET

Q1 Levulan(R) Kerastick(R) unit sales up 36% year over year;

Non-GAAP loss narrows to ($0.6) million in Q108;

Pricing approval received for Levulan(R) Kerastick(R) in Brazil

WILMINGTON, MASSACHUSETTS--(MARKET WIRE)--May 7, 2008 -- 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 first quarter ended March 31, 2008.

Total product revenues were $7.9 million in the first quarter of 2008, up 19% from $6.7 million in the first quarter of 2007. PDT revenues totaled $5.8 million, up 28% from $4.6 million for the comparable 2007 period. The increase in PDT revenues was attributable to a 36% increase in Kerastick® revenues, driven by 21% domestic volume growth, as well as international expansion into both Latin America and Korea. Overall Kerastick sales volumes increased 36% from 38,370 units in the first quarter of 2007 to 52,110 units in the first quarter of 2008. Non-PDT revenues were flat at $2.1 million. Non-PDT revenues were primarily driven by the sales of Nicomide® which were adversely impacted by the residual levels of the River's Edge product remaining in the distribution channel following the settlement of the litigation between the Company and River's Edge.

DUSA's net loss on a GAAP basis for the first quarter of 2008 was ($1.3) million or ($0.05) per common share, compared to a net loss of ($3.4) million or ($0.17) per common share in the first quarter of 2007.

DUSA's non-GAAP net loss for the first quarter of 2008 was ($0.6) million or ($0.03) per share common, compared to a net loss of ($3.1) million or ($0.16) per share common in the first quarter of 2007, an improvement of 81%. The first quarter 2008 non-GAAP net loss excludes share-based compensation expense of $0.3 million and a non-cash loss on the change in the fair value of warrants of $0.3 million. Please refer to the "Use of Non-GAAP Financial Measures" section and the accompanying financial table included at the end of this release for a reconciliation of GAAP results to non-GAAP results for the three month periods ending March 31, 2007 and 2008, respectively.

As of March 31, 2008, total cash, cash equivalents, and U.S. government securities were $22.9 million, compared to $23.0 million at December 31, 2007. During the first quarter, the Company received a milestone payment from Stiefel Laboratories, Inc. ($0.4 million); as well as, made a milestone payment to the former Sirius shareholders (-$0.3 million). Cash expenditures for the first quarter of 2008, net of non-recurring items, were $0.2 million.

Other updates:
http://biz.yahoo.com/iw/080507/0394545.html
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surf1944 surf1944 16 years ago
Phase I Clinical Trial of Photodynamic Therapy (PDT) Underway for Potential New Treatment of Oral Precancerous Lesions
Thursday May 1, 6:30 am ET

DUSA Pharmaceuticals, Inc.(R) collaborates with the National Cancer Institute to evaluate Levulan(R) (aminolevulinic acid, ALA) PDT as treatment for oral leukoplakia

WILMINGTON, MASSACHUSETTS--(MARKET WIRE)--May 1, 2008 -- A Phase I clinical trial, using a DUSA Pharmaceuticals, Inc. (NASDAQ GM: DUSA) product, has been launched by the National Cancer Institute (NCI) to study an entirely new approach for the prevention of oral cancer, which may affect more than 30,000 Americans this year.(1) Chronic mouth lesions, the most common of which is a condition known as oral leukoplakia, are early indicators of oral cancer. There is currently no effective treatment for preventing the progression of oral leukoplakia to cancer. The long-term goal is to examine aminolevulinic acid (ALA) photodynamic (PDT) therapy as a preventive treatment for oral cancer by the selective removal of oral leukoplakia.

Oral leukoplakia is a condition involving the formation of white spots on the surfaces of the mouth and tongue. Previous studies have shown that ALA PDT may be used to identify and treat the condition.(2)(3)(4) ALA, the active ingredient in DUSA's product, Levulan®, is a chemical that is produced naturally at low levels in humans. If ALA is given to the body at higher levels, the drug can build up inside of pre-cancerous cells. When a laser light is pointed at a pre-cancerous cell, ALA may increase the effect of the laser causing the cell to die. This is called photodynamic therapy (PDT). The purpose of the present trial is to examine the safety and tolerability of orally administered ALA PDT and to determine the optimal dose of light therapy.

"The commencement of this trial is a critical first step towards identifying a novel therapeutic intervention that may prevent the progression of precancerous lesions into oral cancer," said Dr. Stuart J. Wong, Protocol Lead Investigator, Medical College of Wisconsin. "The data obtained from this study will be critical to the design of future trials that can examine the effectiveness of ALA PDT for the treatment of oral leukoplakia and/or prevention of oral cancer." Patient selection has begun at the Medical College of Wisconsin, with the University of Chicago to follow as a second site.

About the Study

During 2004, DUSA signed a clinical trial agreement with the National Cancer Institute (NCI) Division of Cancer Prevention (DCP), for the clinical development of Levulan® photodynamic therapy (PDT) for the treatment of oral leukoplakia. The NCI DCP will be responsible for the clinical trial costs, while DUSA will provide Levulan, laser light device(s) and the necessary training for the investigators involved in the studies. In the study, the same dose of ALA will be administered orally to six groups of patients with oral leukoplakia. The oral dose will be followed in three to four hours by laser light treatment (PDT), with the first group getting the lowest light dose and increasing the light dose for each new group. Safety evaluations will be performed following treatment of each group. Biopsies of target oral lesions and/or tissue where oral lesions previously existed will be performed at registration and completion to evaluate treatment.

"DUSA is pleased to support the National Cancer Institute in the development and initiation of this pilot clinical protocol, which presents a unique opportunity to use Levulan PDT as a new treatment for oral leukoplakia, a condition for which there is no standard therapy," said Bob Doman, President and CEO of DUSA. "The launch of this trial underscores DUSA's commitment to supporting studies that will examine the potential of Levulan PDT as a preventive cancer treatment across different patient populations."

Researchers anticipate that the study will be completed within 12-24 months and based on results, hope to move forward with a phase II trial. Visit http://clinicaltrials.gov for more information on the trial.

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 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 including oral leukoplakia as described above. DUSA is based in Wilmington, Mass. Please visit the company's website at www.dusapharma.com for more information.
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surf1944 surf1944 16 years ago
Form 8-K for DUSA PHARMACEUTICALS INC

21-Apr-2008

Change in Directors or Principal Officers


Item 5.02. Departure of Directors or Certain Officers; Election of Directors;
Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

DUSA Pharmaceuticals, Inc. (NASDAQ: DUSA) has received confirmation that D. Geoffrey Shulman, MD, the Company's founder, Chief Executive Officer from 1991 to 2007, and Chairman of the Board from 1991 to 2003 and since 2005, expects to be on short-term disability leave commencing sometime in June 2008 as a result of a serious health condition. DUSA expects that he will not continue as Chairman of the Board or as Chief Strategic Officer. However, DUSA expects that Dr. Shulman will remain on the Board of Directors and will continue as an employee of the company in a reduced role. DUSA and Dr. Shulman are in discussions regarding his ongoing employment arrangements.
Except for historical information, this report contains certain forward-looking statements that involve known and unknown risk and uncertainties. These forward-looking statements relate to the expectations that Dr. Shulman will change his role with the Company, that he will continue on the Board of Directors and as an employee, and the timing for the change to be implemented. These risks and uncertainties 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, Dr. Shulman's medical condition, and other risks and uncertainties identified in DUSA's Form 10-K for the year ended December 31, 2007. Item 9.01 - Financial Statement and Exhibits.

Item No. Description

99.1 Press Release, dated April 21, 2008
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BIGWAVEDAVE BIGWAVEDAVE 16 years ago
now why arent they trading today?
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surf1944 surf1944 16 years ago
DUSA Completes Enrollment for Phase IIb Trial of Levulan(R) Photodynamic Therapy for Moderate to Severe Acne
Monday March 31, 6:30 am ET

WILMINGTON, MASSACHUSETTS--(MARKET WIRE)--Mar 31, 2008 -- DUSA Pharmaceuticals, Inc.® (NASDAQ GM: DUSA), is pleased to announce today that the acne Phase IIb trial has achieved its goal of 260 participants, thus completing enrollment. The study's objective is to determine and compare the safety and efficacy of multiple broad area photodynamic therapy (PDT) treatments with Levulan® Kerastick® in combination with BLU-U® brand blue light versus use of the BLU-U alone in patients with moderate to severe facial acne vulgaris. This trial will evaluate the incremental advantage of adding Levulan to DUSA's already FDA-cleared BLU-U blue light therapy when treating acne.

"Completion of enrollment is an important milestone as DUSA looks to achieve a moderate to severe acne indication for Levulan PDT. Once the initial results are available, which we expect this fall, DUSA will decide on the next steps needed to develop this indication for potential FDA approval," said Bob Doman, President and CEO of DUSA. "DUSA continues to support trials in order to advance therapies that offer dermatologists innovative, effective treatments for their acne patients."

This DUSA-sponsored randomized, controlled, investigator blinded study is being conducted at 14 sites across the country. Levulan in topical solution or the solution without Levulan will be applied to the full face of participants approximately 45 plus minus 15 minutes prior to treatment with 5 or 10 J/cm2 of BLU-U light. Patients will receive treatment once every three weeks with a maximum of four treatments. The primary efficacy assessment will occur three weeks after the last treatment.

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surf1944 surf1944 16 years ago
DUSA Announces Stiefel's Receipt of Pricing Approval of Levulan PDT in Brazil
Thursday March 6, 6:30 am ET

Commercial Launch to Follow

WILMINGTON, MASSACHUSETTS--(MARKET WIRE)--Mar 6, 2008 -- DUSA Pharmaceuticals, Inc.® (NASDAQ GM: DUSA), received notice on March 5, 2008 that Stiefel Laboratories, Inc., DUSA's marketing partner for Latin America, has now received final pricing approval for Levulan® (aminolevulinic acid HCl) Kerastick® for Photodynamic Therapy (PDT) for the treatment of actinic keratoses (AKs) in Brazil by the Regulatory Chamber of Medicines (Camara de Regulacao do Mercado de Medicamentos) (CMED). The market launch of Levulan PDT in Brazil is expected to follow shortly. Stiefel previously received regulatory approval for Levulan Kerastick from ANVISA (Agencia Nacional de Vigilancia Sanitaria) in 2006.

"The pricing approval and upcoming market launch of Levulan PDT in Brazil marks an important step toward bringing this unique treatment option to the dermatology community in Brazil," said Robert Doman, President and CEO of DUSA. "We are very optimistic about the potential for Levulan PDT in the Brazilian marketplace and we will continue to work closely with Stiefel to bring Levulan PDT to additional Latin American countries in the coming year."

In Latin America, Stiefel has also received regulatory approval for Levulan in Argentina, Mexico, Chile and Colombia with approvals and subsequent product launches in additional markets scheduled to follow within the next several months.

"We are very excited to bring Levulan Kerastick PDT to the Brazilian market," said Charles W. Stiefel, CEO and Chairman of the Board, Stiefel Laboratories. "We believe that our close relationships with healthcare providers in Brazil, coupled with our leading marketing and sales teams, will optimize Levulan Kerastick PDT sales and profits for both companies."

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, and are generally viewed as precancerous lesions.

About Levulan Photodynamic Therapy (PDT)

Levulan PDT is a unique 2-step treatment for Grade 1 or 2 actinic keratoses (AKs that have not yet become enlarged and thick) of the face or scalp. In the U.S., the therapy consists of treatment with Levulan® Kerastick® Topical Solution, 20% followed by illumination with DUSA's BLU-U® brand light source.



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surf1944 surf1944 16 years ago
Leading Investigators Highlight Advances in Photodynamic Therapy at the American Academy of Dermatology Annual Meeting
Wednesday February 6, 6:00 am ET

First-Line Treatment for Patients at Risk for Skin Cancer Evaluated for Potential Effectiveness for Wide Array of Dermatologic Needs

WILMINGTON, MASSACHUSETTS--(MARKET WIRE)--Feb 6, 2008 -- DUSA Pharmaceuticals, Inc. (NASDAQ GM: DUSA) -

Photodynamic Therapy (PDT) was featured as a key topic at the 66th Annual American Academy of Dermatology (AAD) Meeting in San Antonio, Texas. More than 25 presentations and posters by prominent investigators addressed PDT, focusing on the therapy's benefits and clinical developments, including the FDA-approved use of aminolevulinic acid (ALA) PDT for the treatment of mild to moderate actinic keratoses (AKs) of the face or scalp, as well as investigational uses for skin cancer, acne and numerous other skin conditions.

http://biz.yahoo.com/iw/080206/0358052.html
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surf1944 surf1944 16 years ago
Fund companies still seem to be adding to their DUSA positions:

http://moneycentral.msn.com/ownership?Symbol=DUSA
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surf1944 surf1944 16 years ago
Form 8-K for DUSA PHARMACEUTICALS INC

18-Jan-2008

Other Events


Item 8.01 Other Events.
In connection with the merger of Sirius Laboratories, Inc. ("Sirius") with DUSA Pharmaceuticals, Inc. ("DUSA"), the registrant, on March 10, 2006, DUSA became the assignee of a development, license and supply agreement between Sirius and Altana, Inc. ("Altana") entered into on June 13, 2005 (the "Agreement"). Under the Agreement, Altana developed a reformulated dermatology product pursuant to a supplement to an abbreviated new drug application ("ANDA") which was submitted by Altana to the U.S. Food and Drug Administration ("FDA"). DUSA has recently been informed by Altana that Altana received a non-approvable letter from the FDA with respect to its ANDA supplement.
Based on the FDA action which requires Altana to withdraw the ANDA supplement, DUSA will not receive pre-market approval to launch this product as previously anticipated. Furthermore, in light of preliminary market research data which was equivocal as to the potential acceptability of the product due to the changing competitive environment, DUSA no longer expects to launch this product.
Except for historical information, this report 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 expectations regarding launch of the product. Furthermore, the factors that may cause differing results include the reliance on third parties, maintenance of DUSA's patent portfolio, the uncertainties of the regulatory process and other risks identified in DUSA's SEC filings from time to time.
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surf1944 surf1944 16 years ago
The DUSA news and CC would be considered somewhat good, DUSA up over 20% in PM trading.
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surf1944 surf1944 16 years ago
DUSA Pharmaceuticals Reports Third Quarter 2007 Financial Results and Corporate Highlights
Friday November 9, 6:30 am ET

Revenues Total $5.8 Million; Bottom Line Improves 50%; Initial Latin American Orders Shipped; Nicomide(R) Lawsuit Settled; Company Enhances Cash Position

WILMINGTON, MASSACHUSETTS--(MARKET WIRE)--Nov 9, 2007 -- 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 third quarter ended September 30, 2007.

Total product revenues for the quarter were $5.8 million as compared to $6.1 million for the comparable 2006 period. PDT revenues totaled $3.5 million versus $3.2 million for the comparable 2006 period. The increase in PDT revenues was driven primarily by a 17% increase in U.S. Levulan® Kerastick® revenue. Non-PDT revenues totaled $2.3 million versus $2.8 million for the comparable 2006 period. Non-PDT revenues were primarily driven by the sales of Nicomide® which were adversely impacted by the presence of the River's Edge product, which re-entered the market as a result of the March 7, 2007 dissolution of a preliminary injunction.

Total product revenues for the nine-month period ended September 30, 2007 were $19.3 million as compared to $17.4 million for the comparable 2006 period. PDT revenues totaled $12.1 million versus $10.9 million in the comparable 2006 period. Non-PDT revenues totaled $7.2 million versus $6.5 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 nine-month periods ended September 30, 2007, DUSA's net loss on a GAAP basis was ($1.9) million, or ($0.10) per common share, and ($7.7) million, or ($0.40) per common share, respectively. GAAP net losses for the comparable 2006 periods were ($3.8) million, or ($0.19) per common share, and ($13.1) million, or ($0.77) per common share. On a non-GAAP basis, the Company's net losses for the three-month and nine-month periods ended September 30, 2007 were ($1.4) million, or ($0.07) per common share, and ($6.6) million, or ($0.34) per common share, respectively. Non-GAAP net losses for the comparable 2006 periods were ($2.9) million, or ($0.15) per common share, and ($9.1) million, or ($0.53) per common share. Both the 2007 quarterly GAAP and non-GAAP net losses represent a 50% 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.

Third Quarter Highlights:

http://biz.yahoo.com/iw/071109/0326679.html
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