Attached files
| file | filename |
|---|---|
| EX-31.A - EX-31.A - DUSA PHARMACEUTICALS INC | y90065exv31wa.htm |
| EX-32.B - EX-32.B - DUSA PHARMACEUTICALS INC | y90065exv32wb.htm |
| EX-31.B - EX-31.B - DUSA PHARMACEUTICALS INC | y90065exv31wb.htm |
| EX-32.A - EX-32.A - DUSA PHARMACEUTICALS INC | y90065exv32wa.htm |
| EX-21.A - EX-21.A - DUSA PHARMACEUTICALS INC | y90065exv21wa.htm |
| EX-23.A - EX-23.A - DUSA PHARMACEUTICALS INC | y90065exv23wa.htm |
| 10-K - FORM 10-K - DUSA PHARMACEUTICALS INC | y90065e10vk.htm |
Exhibit 99.1
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
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
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
Conference call will be held today, March 3rd, at 8:30am EDT
WILMINGTON, Mass. — March 3,
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 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. |
| • | 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. | |
| • | 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. | |
| • | 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. |
Fourth
Quarter 2010 Financial Results:
Total product revenues were a record $12.0 million in the
fourth quarter of 2010, an increase of $3.2 million or 37%
from $8.8 million in the fourth quarter of 2009. PDT
revenues totaled $11.9 million, an increase of
$3.4 million or 40% from $8.5 million for the
comparable 2009 period. The increase in PDT revenues was
attributable to a $3.1 million increase in
Kerastick®
revenues and a $0.3 million increase in
BLU-U®
revenues. The
Kerastick®
revenue improvement was driven by a 31% increase in sales
volumes and a 7% increase in our average selling price.
Kerastick®
sales volumes increased to 85,122 units sold in the fourth
quarter of 2010 from 64,904 units sold in the comparable
2009 period. Domestic
Kerastick®
sales volumes increased by 22,170 units or 36% and were
offset by a 1,952 unit decrease in our international sales
volumes.
BLU-U®
revenues totaled $0.7 million, up $0.3 million
year-over-year.
There were 91 units sold during the fourth quarter, as
compared to the 54 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 was $2.9 million or
$0.12 per common share for the fourth quarter of 2010, compared
to net income of $0.4 million or $0.02 per common share in
the fourth quarter of 2009.
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, 2010 and 2009,
respectively.
DUSA’s non-GAAP net income for the fourth quarter of 2010
was $3.0 million or $0.12 per common share, compared to a
net income of $0.9 million or $0.04 per common share in the
prior year period. The improvement in the Company’s
profitability was the result of the
year-over-year
increase in our PDT revenues, which was partially offset by an
increase in our operating costs.
Full Year
2010 Financial Results:
Total product revenues for the year ended December 31, 2010
were $37.4 million, an increase of $7.6 million or 26%
from $29.8 million in 2009. PDT revenues totaled
$36.4 million, an increase of $8.1 million or 29% from
$28.3 million for the comparable 2009 period. The increase
in PDT revenues was attributable to an $8.1 million
increase in
Kerastick®
revenues. The
Kerastick®
revenue improvement was driven by a 19% increase in volume, a 9%
increase in average selling price; as well as, the acceleration
of the recognition of $0.6 million in deferred revenues and
milestone payments associated with the termination in September
2010 of our Marketing, Distribution and Supply Agreement with
Stiefel Laboratories, Inc. for Latin America.
Kerastick®
sales volumes increased to 262,046 units in 2010 from
220,288 units sold in 2009. Domestic
Kerastick®
sales volumes increased by 49,554 units or 25% and were
partially offset by a 7,796 decrease in our international sales
volumes.
BLU-U®
revenues were relatively flat
year-over-year
at $1.9 million as incremental volume was fully offset by a
lower average selling price. There were 270 units sold
during 2010, as compared to the 252 units sold in the prior
year. The decreased average selling price in 2010 is reflective
of lower pricing offered to customers in advance of the
introduction of the upgraded
BLU-U®
design which became available in April 2010. Non-PDT revenues
totaled $1.0 million down $0.5 million from the prior
year due to the absence of
Nicomide®
royalties from River’s Edge Pharmaceuticals, LLC.
DUSA’s net income on a GAAP basis for the year ended
December 31, 2010 was $2.7 million or $0.11 per common
share, compared to a net loss of ($2.5) million or ($0.10)
per common share in 2009.
DUSA’s non-GAAP net income for the year ended
December 31, 2010 was $4.2 million or $0.17 per common
share in 2010, compared to a net loss of ($1.0) million or
($0.04) per common share in 2009. The improvement in the
Company’s non-GAAP profitability was the result of the
year-over-year
increase in our PDT revenues and the recognition of
$0.5 million in income from operations related to the
termination of the Stiefel Agreement, both of which were
partially offset by an increase in our operating costs.
As of December 31, 2010, total cash, cash equivalents, and
marketable securities were $19.6 million, compared to
$16.7 million at December 31, 2009. The Company
generated $3.0 million in positive cash flow (change in
cash and cash equivalents and marketable securities) during 2010.
Conference
Call Details and Dial-in Information:
In conjunction with this announcement, DUSA will host a
conference call today:
Thursday,
March
3rd —
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
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
877-863-0350
International callers use:
858-244-1268
The call will be accessible on 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 twelve-month periods were comprised
of the following:
|
Three-Months Ended |
Twelve-Months Ended |
|||||||||||||||
| December 31, | December 31, | |||||||||||||||
| 2010 | 2009 | 2010 | 2009 | |||||||||||||
| (Unaudited) | (Unaudited) | (Unaudited) | (Unaudited) | |||||||||||||
|
PDT Drug & Device Product Revenues
|
||||||||||||||||
|
Kerastick®
Product Revenues:
|
||||||||||||||||
|
United States
|
$ | 10,981,000 | $ | 7,660,000 | $ | 32,761,000 | $ | 24,756,000 | ||||||||
|
Canada
|
112,000 | 139,000 | 491,000 | 543,000 | ||||||||||||
|
Korea
|
101,000 | 148,000 | 423,000 | 646,000 | ||||||||||||
|
Rest-of-world
|
4,000 | 173,000 | 839,000 | 434,000 | ||||||||||||
|
Subtotal
Kerastick®
Product Revenues
|
11,198,000 | 8,120,000 | 34,514,000 | 26,379,000 | ||||||||||||
|
BLU-U®
Product Revenues:
|
||||||||||||||||
|
United States
|
669,000 | 366,000 | 1,892,000 | 1,943,000 | ||||||||||||
|
Canada
|
12,000 | 16,000 | 17,000 | 16,000 | ||||||||||||
|
Subtotal
BLU-U®
Product Revenues
|
681,000 | 382,000 | 1,909,000 | 1,959,000 | ||||||||||||
|
Total PDT Drug & Device Product Revenues
|
11,879,000 | 8,502,000 | 36,423,000 | 28,338,000 | ||||||||||||
|
Total Non-PDT Product Revenues
|
124,000 | 272,000 | 1,010,000 | 1,470,000 | ||||||||||||
|
TOTAL PRODUCT REVENUES
|
$ | 12,003,000 | $ | 8,774,000 | $ | 37,433,000 | $ | 29,808,000 | ||||||||
DUSA
Pharmaceuticals, Inc.
Condensed
Consolidated Balance Sheets
|
December 31, |
December 31, |
|||||||
| 2010 | 2009 | |||||||
| (Unaudited) | (Unaudited) | |||||||
|
ASSETS
|
||||||||
|
CURRENT ASSETS
|
||||||||
|
Cash and cash equivalents
|
$ | 8,884,402 | $ | 7,613,378 | ||||
|
Marketable securities
|
10,762,559 | 9,055,959 | ||||||
|
Accounts receivable, net
|
3,311,467 | 2,629,189 | ||||||
|
Inventory
|
2,165,220 | 2,170,275 | ||||||
|
Prepaid and other current assets
|
1,344,062 | 1,561,467 | ||||||
|
TOTAL CURRENT ASSETS
|
26,467,710 | 23,030,268 | ||||||
|
Restricted cash
|
174,753 | 174,255 | ||||||
|
Property, plant and equipment, net
|
1,582,777 | 1,660,755 | ||||||
|
Deferred charges and other assets
|
68,099 | 68,099 | ||||||
|
TOTAL ASSETS
|
$ | 28,293,339 | $ | 24,933,377 | ||||
| LIABILITIES AND SHAREHOLDERS’ EQUITY | ||||||||
|
CURRENT LIABILITIES
|
||||||||
|
Accounts payable
|
$ | 162,742 | $ | 630,144 | ||||
|
Accrued compensation
|
2,243,997 | 1,260,609 | ||||||
|
Other accrued expenses
|
2,348,838 | 2,456,612 | ||||||
|
Deferred revenue
|
712,338 | 902,597 | ||||||
|
TOTAL CURRENT LIABILITIES
|
5,467,915 | 5,249,962 | ||||||
|
Deferred revenues
|
1,917,237 | 2,906,020 | ||||||
|
Warrant liability
|
1,203,553 | 812,905 | ||||||
|
Other liabilities
|
181,153 | 123,016 | ||||||
|
TOTAL LIABILITIES
|
8,769,858 | 9,091,903 | ||||||
|
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: 24,239,365 and
24,108,908 shares of common stock, no par, at
December 31, 2010 and December 31, 2009, respectively
|
151,703,468 | 151,683,399 | ||||||
|
Additional paid-in capital
|
9,399,434 | 8,291,805 | ||||||
|
Accumulated deficit
|
(141,656,600 | ) | (144,359,217 | ) | ||||
|
Accumulated other comprehensive loss
|
77,179 | 225,487 | ||||||
|
TOTAL SHAREHOLDERS’ EQUITY
|
19,523,481 | 15,841,474 | ||||||
|
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY
|
$ | 28,293,339 | $ | 24,933,377 | ||||
DUSA
Pharmaceuticals, Inc.
Consolidated
Statement of Operations
|
Three-Months Ended |
Twelve-Months Ended |
|||||||||||||||
| December 31, | December 31, | |||||||||||||||
| 2010 | 2009 | 2010 | 2009 | |||||||||||||
| (Unaudited) | (Unaudited) | (Unaudited) | (Unaudited) | |||||||||||||
|
Product revenues
|
$ | 12,002,635 | $ | 8,773,909 | $ | 37,432,998 | $ | 29,807,829 | ||||||||
|
Cost of product revenues and royalties
|
2,043,702 | 1,700,564 | 7,271,777 | 6,674,346 | ||||||||||||
|
Gross margin
|
9,958,933 | 7,073,345 | 30,161,221 | 23,133,483 | ||||||||||||
|
Operating costs:
|
||||||||||||||||
|
Research and development
|
1,285,773 | 1,088,264 | 4,929,622 | 4,313,313 | ||||||||||||
|
Marketing and sales
|
3,695,979 | 3,436,520 | 13,240,543 | 12,897,286 | ||||||||||||
|
General and administrative
|
2,204,718 | 1,910,085 | 9,123,846 | 8,270,410 | ||||||||||||
|
Settlements, net
|
— | — | — | 75,000 | ||||||||||||
|
Total operating costs
|
7,186,470 | 6,434,869 | 27,294,011 | 25,556,009 | ||||||||||||
|
Income/(loss) from operations
|
2,772,463 | 638,476 | 2,867,210 | (2,422,526 | ) | |||||||||||
|
Other income:
|
||||||||||||||||
|
Gain/(loss) on change in fair value of warrants
|
96,316 | (338,768 | ) | (390,648 | ) | (376,447 | ) | |||||||||
|
Other income, net
|
37,303 | 66,880 | 226,055 | 290,681 | ||||||||||||
|
Net income/(loss)
|
$ | 2,906,082 | $ | 366,588 | $ | 2,702,617 | $ | (2,508,292 | ) | |||||||
|
Basic and diluted net income/(loss) per common share
|
$ | 0.12 | $ | 0.02 | $ | 0.11 | $ | (0.10 | ) | |||||||
|
Weighted average number of basic common shares
|
24,231,974 | 24,108,908 | 24,188,163 | 24,102,085 | ||||||||||||
|
Weighted average number of diluted common shares
|
24,898,600 | 24,213,589 | 24,765,910 | 24,102,085 | ||||||||||||
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 |
Twelve-Months Ended |
|||||||||||||||
| December 31, | December 31, | |||||||||||||||
| 2010 | 2009 | 2010 | 2009 | |||||||||||||
| (Unaudited) | (Unaudited) | (Unaudited) | (Unaudited) | |||||||||||||
|
GAAP net income/(loss)
|
$ | 2,906,082 | $ | 366,588 | $ | 2,702,617 | $ | (2,508,292 | ) | |||||||
|
Stock-based compensation(a)
|
186,875 | 169,005 | 1,107,631 | 800,774 | ||||||||||||
|
Consideration to former Sirius shareholders(b)
|
4,500 | 4,000 | 18,000 | 314,000 | ||||||||||||
|
Change in fair value of warrants(c)
|
(96,316 | ) | 338,768 | 390,648 | 376,447 | |||||||||||
|
Non-GAAP adjusted net income/(loss)
|
$ | 3,001,141 | $ | 878,361 | $ | 4,218,896 | $ | (1,017,071 | ) | |||||||
|
Non-GAAP basic and diluted net income/(loss) per common share
|
$ | 0.12 | $ | 0.04 | $ | 0.17 | $ | (0.04 | ) | |||||||
|
Weighted average number of basic common shares
|
24,231,974 | 24,108,908 | 24,188,163 | 24,102,085 | ||||||||||||
|
Weighted average number of diluted common shares
|
24,898,600 | 24,213,589 | 24,765,910 | 24,102,085 | ||||||||||||
| (a) | Stock-based compensation expense resulting from the application of SFAS 123(R). | |
| (b) | Consideration for the release, consent and the third amendment to the merger agreement between DUSA and the former Sirius shareholders. $100K was paid in the second quarter of 2009, with an additional $250K being accrued through the fourth quarter of 2011. | |
| (c) | Non-cash gain/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 belief
concerning market potential for its products, intention to build
business, plans to initiate a clinical study, the purpose,
objectives and timing for initiation of the study and
possibilities for additional development 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,
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.
# # #