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EX-31.A - EX-31.A - DUSA PHARMACEUTICALS INC | y91167exv31wa.htm |
EX-32.B - EX-32.B - DUSA PHARMACEUTICALS INC | y91167exv32wb.htm |
EX-32.A - EX-32.A - DUSA PHARMACEUTICALS INC | y91167exv32wa.htm |
EX-31.B - EX-31.B - DUSA PHARMACEUTICALS INC | y91167exv31wb.htm |
10-Q - FORM 10-Q - DUSA PHARMACEUTICALS INC | y91167e10vq.htm |
Exhibit 99.1
For release at 6:30 am
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
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
First Quarter 2011 Corporate Highlights and Financial Results
First Quarter 2011 Corporate Highlights and Financial Results
Q1 Domestic Kerastick®Revenues up 35% year-over-year;
Domestic PDT Revenues up 33%
Domestic PDT Revenues up 33%
Conference call and audio webcast will be held today, May 5th, at 8:30 am EDT
WILMINGTON, Mass. May 5, 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 first quarter ended March 31, 2011.
Highlights for the first quarter include:
| Total product revenues were $11.1 million for the quarter, representing a $2.4 million or 27% year-over-year improvement. |
o | Domestic PDT revenues totaled $10.7 million for the quarter, representing a $2.6 million or 33% year-over-year improvement. |
o | Domestic Kerastick® revenues totaled $10.2 million for the quarter, representing a $2.6 million or 35% year-over-year improvement. |
| Kerastick® gross margins for the quarter reached a record high at 89%. |
| The Company experienced a $1.8 million bottom line year-over-year improvement on a non-GAAP basis for the quarter. Please refer to the section entitled Use of Non-GAAP Financial Measures included at the end of this release. |
| The Company generated $1.4 million in positive cash flow (change in cash and cash equivalents and marketable securities) during the first quarter of 2011. |
| The Company expanded its sales force to 45 with the addition of 5 individuals. |
Management Comments:
We are off to a great start in 2011, stated Robert Doman, President and CEO. Continued growth
of our core domestic PDT revenues, as well as record gross margins, drove significant
year-over-year improvement in our non-GAAP profitability and cash flow.
The results of the quarter are even more impressive given the fact that they followed our record
performance of the fourth quarter of 2010, continued Doman.
As the year progresses, we remain focused on building upon the momentum we have created in the
marketplace by further leveraging our expanding sales force in an effort to increase market
penetration and acceptance of Levulan® PDT, concluded Doman.
Other updates:
o | At present, we are continuing to evaluate the initiation of a DUSA-sponsored clinical trial designed to study the broad area application and/or short drug incubation, or BASDI, method of using the Levulan® Kerastick®. The protocol objectives would be 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 of the face or scalp. The timing on the initiation of this study has been delayed as we refine the protocol in consultation with outside experts. We expect to complete our evaluation and determine next steps in the coming months. |
First Quarter 2011 Financial Results:
Total product revenues were $11.1 million in the first quarter of 2011, an increase of $2.4 million
or 27% from $8.7 million in the first quarter of 2010. PDT revenues totaled $11.0 million, an
increase of $2.7 million or 32% from $8.3 million for the comparable 2010 period. The increase in
PDT revenues was attributable to a $2.7 million increase in Kerastick® revenues. The
Kerastick® revenue improvement was driven by a 22% increase in sales volumes and an 11%
increase in our average selling price. Kerastick® sales volumes increased to 75,213
units sold in the first quarter of 2011 from 61,422 units sold in the comparable 2010 period.
Domestic Kerastick® sales volumes increased by 12,822 units or 22% and were supplemented
by a 969 unit increase in our international sales volumes. BLU-U® revenues were flat
year-over-year at $0.5 million. There were 64 units sold during the first quarter, as compared to
the 77 units sold in the comparable prior year quarter. The average selling price of the unit
increased by 20% year-over-year due to the absence of incentive pricing offered to customers in the
first quarter of 2010 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 2010. Non-PDT revenues were
$0.1 million for the quarter, down $0.3 million year-over-year.
DUSAs net loss on a GAAP basis was $0.6 million or $0.02 per common share for the first quarter of
2011, compared to a net loss of $0.4 million or $0.02 per common share in the first quarter of
2010. Our financial results on a GAAP basis have been negatively impacted by the fair value
accounting over the warrants issued in conjunction with a 2007 equity financing transaction. The
fair value accounting of the warrants is subject to significant fluctuation based on changes in our
stock price. Appreciation in DUSAs stock price has resulted the recording of significant non-cash
charges related to the change in the fair value of warrants in our Statement of Operations. The
non-cash charges recorded in the first quarter of 2011 and 2010 were $2.2 million and $0.2 million,
respectively.
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 month periods ended March 31, 2011 and 2010, respectively.
DUSAs non-GAAP net income for the first quarter of 2011 was $1.8 million or $0.07 per common
share, compared to breakeven in the prior year period. The improvement in the Companys
profitability was mainly the result of the year-over-year increase in our PDT revenues, which was
partially offset by an increase in our operating costs.
As of March 31, 2011, total cash, cash equivalents, and U.S. government securities were $21.1
million, compared to $19.6 million at December 31, 2010, representing an increase of $1.4 million
during the 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:
Thursday, May 5th 8:30 am EDT
North American callers dial:
877-645-6210
International callers dial:
970-315-0447
Participant Conference ID: 63830923
North American callers dial:
877-645-6210
International callers dial:
970-315-0447
Participant Conference ID: 63830923
To access the call online via webcast, please click here, or visit http://bit.ly/ioG9Oa.
A telephone replay will be available shortly after the live call concludes. To access the replay,
dial 800-642-1687 (North American callers) or 706-645-9291 (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-month periods were comprised of the following:
3-months ended March 31, | ||||||||
2011 | 2010 | |||||||
(Unaudited) | (Unaudited) | |||||||
PDT Drug & Device Product Revenues |
||||||||
Kerastick® Product Revenues: |
||||||||
United States |
$ | 10,187,000 | $ | 7,549,000 | ||||
Canada |
183,000 | 57,000 | ||||||
Korea |
116,000 | 109,000 | ||||||
Rest of World |
7,000 | 87,000 | ||||||
Subtotal Kerastick® Product Revenues |
10,493,000 | 7,802,000 | ||||||
BLU-U® Product Revenues: |
||||||||
United States |
489,000 | 489,000 | ||||||
Canada |
| 5,000 | ||||||
Subtotal BLU-U® Product Revenues |
489,000 | 494,000 | ||||||
Total PDT Drug & Device Product Revenues |
10,982,000 | 8,296,000 | ||||||
Total Non-PDT Drug Product Revenues |
100,000 | 418,000 | ||||||
TOTAL PRODUCT REVENUES |
$ | 11,082,000 | $ | 8,714,000 | ||||
DUSA Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets
Condensed Consolidated Balance Sheets
March 31, | December 31, | |||||||
2011 | 2010 | |||||||
(Unaudited) | (Unaudited) | |||||||
ASSETS |
||||||||
CURRENT ASSETS |
||||||||
Cash and cash equivalents |
$ | 12,474,249 | $ | 8,884,402 | ||||
Marketable securities |
8,593,100 | 10,762,559 | ||||||
Accounts receivable, net |
2,708,462 | 3,311,467 | ||||||
Inventory |
2,528,236 | 2,165,220 | ||||||
Prepaid and other current assets |
1,123,366 | 1,344,062 | ||||||
TOTAL CURRENT ASSETS |
27,427,413 | 26,467,710 | ||||||
Restricted cash |
175,028 | 174,753 | ||||||
Property, plant and equipment, net |
1,552,104 | 1,582,777 | ||||||
Deferred charges and other assets |
132,833 | 68,099 | ||||||
TOTAL ASSETS |
$ | 29,287,378 | $ | 28,293,339 | ||||
LIABILITIES AND SHAREHOLDERS EQUITY |
||||||||
CURRENT LIABILITIES |
||||||||
Accounts payable |
$ | 1,007,696 | $ | 162,742 | ||||
Accrued compensation |
401,242 | 2,243,997 | ||||||
Other accrued expenses |
2,777,896 | 2,348,838 | ||||||
Deferred revenue |
648,006 | 712,338 | ||||||
TOTAL CURRENT LIABILITIES |
4,834,840 | 5,467,915 | ||||||
Deferred revenues |
1,861,972 | 1,917,237 | ||||||
Warrant liability |
3,392,486 | 1,203,553 | ||||||
Other liabilities |
170,998 | 181,153 | ||||||
TOTAL LIABILITIES |
10,260,296 | 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: 24,413,969 and
24,239,365 shares of common stock, no
par, at March 31, 2011 and December 31,
2010, respectively |
151,638,956 | 151,703,468 | ||||||
Additional paid-in capital |
9,596,083 | 9,399,434 | ||||||
Accumulated deficit |
(142,261,500 | ) | (141,656,600 | ) | ||||
Accumulated other comprehensive loss |
53,543 | 77,179 | ||||||
TOTAL SHAREHOLDERS EQUITY |
19,027,082 | 19,523,481 | ||||||
TOTAL LIABILITIES AND SHAREHOLDERS EQUITY |
$ | 29,287,378 | $ | 28,293,339 | ||||
DUSA Pharmaceuticals, Inc.
Condensed Consolidated Statement of Operations
3-months ended March 31, | ||||||||
2011 | 2010 | |||||||
(Unaudited) | (Unaudited) | |||||||
Product revenues |
$ | 11,082,064 | $ | 8,713,880 | ||||
Cost of product revenues and royalties |
1,760,370 | 1,818,185 | ||||||
Gross margin |
9,321,694 | 6,895,695 | ||||||
Operating costs: |
||||||||
Research and development |
1,323,644 | 1,109,667 | ||||||
Marketing and sales |
3,973,224 | 3,613,799 | ||||||
General and administrative |
2,457,247 | 2,463,164 | ||||||
Total operating costs |
7,754,115 | 7,186,630 | ||||||
Income/(loss) from operations |
1,567,579 | (290,935 | ) | |||||
Other income: |
||||||||
Loss on change in fair value of warrants |
(2,188,933 | ) | (199,275 | ) | ||||
Other Income, net |
16,454 | 65,727 | ||||||
Net loss |
$ | (604,900 | ) | $ | (424,483 | ) | ||
Basic and diluted net loss per common share |
$ | (0.02 | ) | $ | (0.02 | ) | ||
Weighted average number of common shares |
24,238,398 | 24,122,459 | ||||||
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 DUSAs 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 Companys 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 Companys business and to help evaluate
DUSAs 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.
3-months ended March 31, | ||||||||
2011 | 2010 | |||||||
(Unaudited) | (Unaudited) | |||||||
GAAP net loss |
$ | (604,900 | ) | $ | (424,483 | ) | ||
Share-based compensation (a) |
196,649 | 211,777 | ||||||
Consideration to former Sirius shareholders (b) |
4,500 | 4,500 | ||||||
Change in fair value of warrants (c) |
2,188,933 | 199,275 | ||||||
Non-GAAP adjusted net income/(loss) |
$ | 1,785,182 | $ | (8,931 | ) | |||
Non-GAAP basic and diluted net income/(loss) per common share |
$ | 0.07 | $ | (0.00 | ) | |||
Weighted average number of basic common shares |
24,238,398 | 24,122,459 | ||||||
Weighted average number of diluted common shares |
25,689,483 | 24,122,459 | ||||||
(a) | Share-based compensation expense resulting from the application of SFAS 123(R). | |
(b) | Milestone payment related to Sirius Laboratories acquisition. | |
(c) | Non-cash charge on the 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 DUSAs
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 managements
expectations concerning objectives for a BASDI clinical study and timing thereof, and managements
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 and potential 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 DUSAs Form 10-K for the year ended December 31, 2010.
###