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10-Q - FORM 10-Q - DUSA PHARMACEUTICALS INCy92014e10vq.htm
(DUSA LOGO)
For release at 6:30 a.m.
Contact:

Robert F. Doman, President & CEO — 978.909.2216
Richard Christopher, VP Finance & CFO — 978.909.2211
Chad Rubin, Investor Relations Contact, The Trout Group LLC — 646.378.2947
Cory Tromblee, Media Contact, MacDougall Biomedical Communications — 781.235.3060
DUSA Pharmaceuticals Reports
Second Quarter 2011 Corporate Highlights and Financial Results
Quarterly Domestic Kerastick® revenues up 21% year-over-year;
Company generates significant improvement in cash flow
Conference call and audio webcast will be held today, August 2nd, at 8:30 a.m. EDT
WILMINGTON, Mass. — August 2, 2011 — 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, 2011.
Financial highlights for the second quarter include:
    Domestic Kerastick® revenues totaled $9.1 million for the second quarter of 2011, representing a $1.6 million, or 21%, improvement year-over-year.
 
    GAAP net income was $1.1 million for the second quarter of 2011, representing year-over-year improvement of $0.9 million.
 
    Non-GAAP net income was $2.4 million for the second quarter of 2011, representing year-over-year improvement of $1.7 million. Please refer to the section entitled “Use of Non-GAAP Financial Measures” included at the end of this release.
 
    The Company generated $3.1 million in positive cash flow (change in cash and cash equivalents and marketable securities) during the second quarter of 2011.
Management Comments:
“Continued growth in our core business revenue during the second quarter has driven significant income and cash flow improvement year-over-year,” stated Robert Doman, President and CEO. “Our second quarter Kerastick® revenue growth of 21% reflects a continuation of the dynamic growth we have experienced over the past few years. The growth rate is even more impressive when taking into consideration that our Kerastick® sales volumes in the prior year quarter were positively impacted by a price increase, which we did not have this year.”
“Our non-GAAP income of $4.2 million through the first half of 2011 matches our total for all of 2010; while positive cash flow of $4.5 million through the first half of 2011 exceeds our full year 2010 cash flow by more than 50%,” continued Doman.

 


 

“Over the second half of 2011, we intend to build upon our strong year-to-date financial performance, and further leverage our growth potential. We also look forward to the initiation of our Phase 2 clinical trial of Levulan® PDT to, among other things, investigate the potential for Levulan® to reduce the occurrence rate of actinic keratoses on the face and scalp,” concluded Doman.
Second Quarter 2011 Financial Results:
Total product revenues were $9.8 million in the second quarter of 2011, an increase of $1.1 million, or 12%, from $8.7 million in the second quarter of 2010. PDT revenues totaled $9.7 million, an increase of $1.3 million, or 15%, from $8.4 million for the comparable 2010 period. The increase in PDT revenues was attributable to a $1.2 million increase in Kerastick® revenues. The Kerastick® revenue improvement was driven by a $1.6 million, or 21%, increase in domestic Kerastick® revenue which was the result of a 12% increase in volume and an 8% increase in price. The Company instituted a 5% domestic price increase on May 1, 2010, which we believe positively impacted Kerastick® sales volumes in the prior year quarter. Overall Kerastick® sales volumes increased to 65,706 in the second quarter of 2011 from 61,778 units sold in the comparable 2010 period. Domestic Kerastick® sales volumes increased by 6,720 units and were partially offset by a 2,792 unit decrease in our international sales volumes. BLU-U® revenues were relatively flat year-over-year as lower sales volumes were fully offset by an increase in our average unit selling price. There were 56 units sold during the second quarter, as compared to the 63 units sold in the comparable prior year quarter. Non-PDT revenues were $0.1 million for the quarter, down $0.2 million year-over-year.
DUSA’s net income on a GAAP basis for the second quarter of 2011 was $1.1 million, or $0.04 per common share on a diluted basis, compared to net income of $0.2 million, or $0.01 per common share on a diluted basis, in the second quarter of 2010. Net income on a GAAP basis for the three-month period ended June 30, 2011 includes $0.8 million related to the gain on the sale of the intangible assets relating to Nicomide®.
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 ended June 30, 2011 and 2010, respectively.
DUSA’s non-GAAP net income for the second quarter of 2011 was $2.4 million, or $0.09 per common share on a diluted basis, compared to net income of $0.6 million, or $0.03 per common share on a diluted basis, 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 and the proceeds from the sale of the intangible assets relating to Nicomide®, which were partially offset by an increase in our operating costs.
First Half 2011 Financial Results:
Total product revenues for the six-month period ended June 30, 2011 were $20.8 million, an increase of $3.4 million, or 20%, from $17.4 million in the comparable prior year period. PDT revenues totaled $20.7 million, an increase of $3.9 million, or 24%, from $16.7 million for the comparable 2010 period. The increase in PDT revenues was attributable to a $3.9 million increase in Kerastick® revenues. The Kerastick® revenue improvement was driven by a $4.2 million, or 28%, increase in domestic Kerastick® revenue which was the result of a 17% increase in volume and a 10% increase in price. Overall Kerastick® sales volumes increased to 140,919 units in 2011 from 123,200 units sold in 2010. Domestic Kerastick® sales volumes increased by 19,542 units, or 17%, and were partially offset by a 1,823 decrease in our international sales

 


 

volumes. BLU-U® revenues were relatively flat year-over-year as lower sales volumes were fully offset by an increase in our average unit selling price. There were 120 units sold during the first half of 2011, as compared to the 140 units sold in the comparable prior year period. The prior year volume was positively impacted by incentive pricing offered to customers in an effort to sell off existing BLU-U® inventory in advance of the introduction of the upgraded design which became available in April 2010. Non-PDT revenues totaled $0.2 million down $0.5 million from the prior year period due to lower product sales volumes and the absence of AVAR® product line royalties.
DUSA’s net income on a GAAP basis for the six-month period ended June 30, 2011 was $0.5 million, or $0.02 per common share on a diluted basis, compared to a net loss of $0.2 million, or $0.01 per common share in 2010 on a diluted basis. Net income on a GAAP basis for the six-month period ended June 30, 2011 includes $0.8 million related to the gain on the sale of the intangible assets relating to Nicomide®.
DUSA’s non-GAAP net income for the six-month period ended June 30, 2011 was $4.2 million, or $0.16 per common share on a diluted basis, compared to net income of $0.6 million, or $0.03 per common share on a diluted basis in 2010. The improvement in the Company’s non-GAAP profitability was primarily the result of the year-over-year increase in our PDT revenues and the proceeds from the sale of the intangible assets relating to Nicomide®, which were partially offset by an increase in our operating costs.
As of June 30, 2011, total cash, cash equivalents, and marketable securities were $24.1 million, compared to $19.6 million at December 31, 2010. The Company generated $4.5 million in positive cash flow (change in cash and cash equivalents and marketable securities) during the first half of 2011.
Other updates:
  o   The Company plans on initiating an exploratory DUSA-sponsored clinical trial designed to study the broad area application and/or short drug incubation, or BASDI, method of using the Levulan® Kerastick® in the second half of 2011. We have finalized the design of the study and are in the process of selecting the clinical sites. The protocol objectives are to compare the safety and efficacy of various incubation times (1, 2, or 3 hours) of Levulan® plus BLU-U® PDT versus vehicle plus BLU-U® for the treatment of multiple actinic keratoses (AKs) of the face or scalp and to investigate the potential to reduce the occurrence rate of AKs in the treatment areas.
 
  o   On June 30, 2011, the Company sold the patent which covers Nicomide®, together with the trademarks Nicomide® and Nicomide-T®, and related domain names to Acella Pharmaceuticals, LLC for cash consideration, which was paid on the closing of the transaction and resulted in a $750,000 gain this quarter.

 


 

Conference Call and Audio Webcast Details and Dial-in Information:
In conjunction with this announcement, DUSA will host a conference call and audio webcast today:
Tuesday, August 2, 2011 — 8:30 a.m. EDT
North American callers dial:
877-645-6210
International callers dial:
970-315-0447
Participant Conference ID: 85095288
To access the call online via webcast, please click here, or visit http://bit.ly/pD5Rok.
A telephone replay will be available shortly after the live call concludes. To access the replay, dial 855-859-2056 (North American callers) or 404-537-3406 (International callers). The telephone replay and webcast will also be accessible on the investors section of our website approximately six hours following the call at www.dusapharma.com.

 


 

Revenues Table, Condensed Consolidated Balance Sheets, Condensed Consolidated Statement of Operations and GAAP to Non-GAAP reconciliation follow:
Revenues for the three and six-month periods were comprised of the following:
                                 
    Three-months ended June 30,     Six-months ended June 30,  
    2011     2010     2011     2010  
    (Unaudited)     (Unaudited)     (Unaudited)     (Unaudited)  
PDT Drug & Device Product Revenues
                               
Kerastick® Product Revenues:
                               
United States
  $ 9,136,000     $ 7,568,000     $ 19,323,000     $ 15,117,000  
Canada
          169,000       183,000       225,000  
Korea
    83,000       104,000       199,000       213,000  
Rest of World
          132,000       8,000       219,000  
 
                       
Subtotal Kerastick® Product Revenues
    9,219,000       7,973,000       19,713,000       15,774,000  
BLU-U® Product Revenues:
                               
United States
    452,000       438,000       940,000       928,000  
Canada
                      5,000  
 
                       
Subtotal BLU-U® Product Revenues
    452,000       438,000       940,000       933,000  
 
                       
Total PDT Drug & Device Product Revenues
    9,671,000       8,411,000       20,653,000       16,707,000  
 
                       
Total Non-PDT Product Revenues
    92,000       290,000       192,000       708,000  
 
                       
TOTAL PRODUCT REVENUES
  $ 9,763,000     $ 8,701,000     $ 20,845,000     $ 17,415,000  
 
                       

 


 

DUSA Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets
                 
    June 30,   December 31,
    2011   2010
    (Unaudited)   (Unaudited)
ASSETS
               
CURRENT ASSETS
               
Cash and cash equivalents
  $ 20,742,907     $ 8,884,402  
Marketable securities
    3,378,403       10,762,559  
Accounts receivable, net
    2,157,047       3,311,467  
Inventory
    2,985,693       2,165,220  
Prepaid and other current assets
    1,121,303       1,344,062  
       
TOTAL CURRENT ASSETS
    30,385,353       26,467,710  
Restricted cash
    175,306       174,753  
Property, plant and equipment, net
    1,575,680       1,582,777  
Deferred charges and other assets
    66,333       68,099  
       
TOTAL ASSETS
  $ 32,202,672     $ 28,293,339  
       
 
               
LIABILITIES AND SHAREHOLDERS’ EQUITY
               
CURRENT LIABILITIES
               
Accounts payable
  $ 1,128,250     $ 162,742  
Accrued compensation
    788,790       2,243,997  
Other accrued expenses
    2,572,295       2,348,838  
Deferred revenue
    601,814       712,338  
       
TOTAL CURRENT LIABILITIES
    5,091,149       5,467,915  
Deferred revenues
    1,822,628       1,917,237  
Warrant liability
    4,267,923       1,203,553  
Other liabilities
    166,412       181,153  
       
TOTAL LIABILITIES
    11,348,112       8,769,858  
 
               
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: 24,649,364 and 24,239,365 shares of common stock, no par, at June 30, 2011 and December 31, 2010, respectively
    151,985,400       151,703,468  
Additional paid-in capital
    9,971,055       9,399,434  
Accumulated deficit
    (141,150,905 )     (141,656,600 )
Accumulated other comprehensive loss
    49,010       77,179  
       
TOTAL SHAREHOLDERS’ EQUITY
    20,854,560       19,523,481  
 
               
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY
  $ 32,202,672     $ 28,293,339  
       

 


 

DUSA Pharmaceuticals, Inc.
Condensed Consolidated Statement of Operations
                                 
    Three-months ended June 30,     Six-months ended June 30,  
    2011     2010     2011     2010  
    (Unaudited)     (Unaudited)     (Unaudited)     (Unaudited)  
Product revenues
  $ 9,762,822     $ 8,700,937     $ 20,844,886     $ 17,414,817  
Cost of product revenues and royalties
    1,594,189       1,782,108       3,354,559       3,600,293  
 
                       
Gross margin
    8,168,633       6,918,829       17,490,327       13,814,524  
Operating costs:
                               
Research and development
    1,108,774       1,250,411       2,432,418       2,360,078  
Marketing and sales
    3,288,573       3,137,985       7,261,797       6,751,784  
General and administrative
    2,554,787       2,247,066       5,012,034       4,710,230  
Gain on sale of assets
    (750,000 )           (750,000 )      
 
                       
Total operating costs
    6,202,134       6,635,462       13,956,249       13,822,092  
 
                       
Income/(loss) from operations
    1,966,499       283,367       3,534,078       (7,568 )
 
                       
Other income:
                               
Loss on change in fair value of warrants
    (875,437 )     (157,015 )     (3,064,370 )     (356,290 )
Other income, net
    19,533       61,842       35,987       127,569  
 
                       
Net income/(loss)
  $ 1,110,595     $ 188,194     $ 505,695     $ (236,289 )
 
                      
Basic net income/(loss) per common share
  $ 0.05     $ 0.01     $ 0.02     $ (0.01 )
 
                      
Diluted net income/(loss) per common share
  $ 0.04     $ 0.01     $ 0.02     $ (0.01 )
 
                      
Weighted average number of basic common shares
    24,539,627       24,187,569       24,412,221       24,155,194  
 
                       
Weighted average number of diluted common shares
    26,813,329       24,566,476       26,334,058       24,155,194  
 
                       

 


 

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 certain items including share-based compensation expense, consideration provided to the former Sirius shareholders, and the change in fair value of warrants. The Company believes that this presentation is useful to help investors better understand DUSA’s financial performance and competitive position. Management uses these measures along with their corresponding GAAP financial measures to help manage the Company’s business, evaluate DUSA’s performance, and incentivize employees. 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 June 30,     Six-months ended June 30,  
    2011     2010     2011     2010  
    (Unaudited)     (Unaudited)     (Unaudited)     (Unaudited)  
GAAP net income/(loss)
  $ 1,110,595     $ 188,194     $ 505,695     $ (236,289 )
Share-based compensation (a)
    374,972       276,254       571,621       488,031  
Consideration to former Sirius shareholders (b)
    4,500       4,500       9,000       9,000  
Change in fair value of warrants (c)
    875,437       157,015       3,064,370       356,290  
 
                       
Non-GAAP adjusted net income
  $ 2,365,504     $ 625,963     $ 4,150,686     $ 617,032  
 
                       
Non-GAAP basic net income per common share
  $ 0.10     $ 0.03     $ 0.17     $ 0.03  
 
                       
Non-GAAP diluted net income per common share
  $ 0.09     $ 0.03     $ 0.16     $ 0.03  
 
                       
Weighted average number of basic common shares
    24,539,627       24,187,569       24,412,221       24,155,194  
 
                       
Weighted average number of diluted common shares
    26,813,329       24,566,476       26,334,058       24,155,194  
 
                       
 
(a)   Share-based compensation expense based on the fair value of the awards granted to employees.
 
(b)   Accretion of milestone related to Sirius Laboratories acquisition.
 
(c)   Non-cash loss on change in fair value of warrants.

 


 

About DUSA Pharmaceuticals
DUSA Pharmaceuticals, Inc. is an integrated dermatology pharmaceutical company focused primarily on the development and marketing of its Levulan® PDT technology platform, and other dermatology products. Levulan® Kerastick® for topical solution plus DUSA’s BLU-U® Blue Light Photodynamic Therapy Illuminator is currently approved for the treatment of minimally to moderately thick actinic keratoses (AKs) of the face or scalp. DUSA also sells other dermatology products, including ClindaReach®. DUSA is based in Wilmington, Mass. Please visit our website at www.dusapharma.com.
Except for historical information, this news release contains certain forward-looking statements that represent our current expectations and beliefs concerning future events, and involve certain known and unknown risk and uncertainties. These forward-looking statements relate to management’s intentions to build on financial performance, belief concerning the impact of a price increase, expectations concerning initiation of a BASDI clinical study and timing thereof, and management’s beliefs concerning non-GAAP financial measures. These forward-looking statements are further qualified by important factors that could cause actual results to differ materially from future results, performance or achievements expressed or implied by those in the forward-looking statements made in this release. These factors include, without limitation, marketing of competitive products, actions by health regulatory authorities, clinical trial risks, expenses and results, changing economic conditions, the status of our patent portfolio, reliance on third parties, including sole source vendors, sufficient funding, and other risks and uncertainties identified in DUSA’s Form 10-K for the year ended December 31, 2010.
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