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| DUSA > SEC Filings for DUSA > Form 10-Q on 12-May-2009 | All Recent SEC Filings |
12-May-2009
Quarterly Report
are registered trademarks. Several of these trademarks are also registered in
Europe, Australia, Canada, and in other parts of the world. Numerous other
trademark applications are pending.
As of March 31, 2009, we had an accumulated deficit of approximately
$143,458,000. We cannot predict whether any of our products will achieve
significant enough market acceptance or generate sufficient revenues to enable
us to become profitable on a sustainable basis. If our domestic PDT revenue
growth rates for the remainder of 2009 are comparable to prior year levels, we
expect to become cash flow positive and profitable on a quarterly basis sometime
late in 2009. We recorded significant impairment changes of goodwill during the
fourth quarter of 2007 and the third quarter of 2008. Achieving our goal of
becoming a profitable operating company is dependent upon greater acceptance of
our PDT therapy by the medical and consumer constituencies, increased sales of
our products and other factors contained in this report.
CRITICAL ACCOUNTING POLICIES
Our accounting policies are disclosed in Note 2 to the Notes to the Consolidated
Financial Statements in our Annual Report on Form 10-K for the year ended
December 31, 2008. Since all of these accounting policies do not require
management to make difficult, subjective or complex judgments or estimates, they
are not all considered critical accounting policies. We have discussed these
policies and the underlying estimates used in applying these accounting policies
with our Audit Committee. There have been no changes to our critical accounting
policies in the three months ended March 31, 2009.
RESULTS OF OPERATIONS - THREE MONTHS ENDING MARCH 31, 2009 VERSUS MARCH 31, 2008
REVENUES - Total revenues for the three-month period ended March 31, 2009 were
$7,138,000, as compared to $7,930,000 in 2008 and were comprised of the
following:
2009 2008 Increase/(Decrease)
PDT PRODUCT REVENUES
LEVULAN® KERASTICK® PRODUCT REVENUES
United States $ 5,685,000 $ 4,774,000 $ 911,000
Canada 135,000 159,000 (24,000 )
Korea 170,000 365,000 (195,000 )
Rest of world 87,000 56,000 31,000
Subtotal Levulan® Kerastick® product revenues 6,077,000 5,354,000 723,000
BLU-U® PRODUCT REVENUES
United States 642,000 476,000 166,000
Subtotal BLU-U® product revenues 642,000 476,000 166,000
TOTAL PDT PRODUCT REVENUES 6,719,000 5,830,000 889,000
TOTAL NON-PDT DRUG PRODUCT REVENUES 419,000 2,100,000 (1,681,000 )
TOTAL PRODUCT REVENUES $ 7,138,000 $ 7,930,000 $ (792,000 )
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For the three-month period ended March 31, 2009, total PDT Drug and Device
Products revenues, comprised of revenues from our Kerastick® and BLU-U®
products, were $6,719,000. This represents an increase of $889,000 or 15%, over
the comparable 2008 total of $5,830,000. The increase in revenues was driven
primarily by increased Kerastick® and BLU-U® revenues in the United States.
For the three-month period ended March 31, 2009, Kerastick® revenues were
$6,077,000, representing an increase of $723,000 or 13%, over the comparable
2008 total of $5,354,000. Kerastick® unit sales to end-users for the three-month
period ended March 31, 2009 were 51,947, including 46,662 sold in the United
States, 1,500 sold in Canada and 2,274 sold in Korea. Kerastick® units sold in
the three-month period ended March 31, 2008 were 52,110, including 43,296 sold
in the United States, 2,100 sold in Canada and 6,036 sold in Korea. Our average
net selling price for the Kerastick® increased to $115.36 per unit for the
three-month period ended March 31, 2009 from $101.33 per unit in 2008. Our
average net selling price for the Kerastick® in the US increased from $110.26
per unit in 2008 to $121.83 per unit in 2009. The increase in 2009 Kerastick®
revenues was driven mainly by an increase in both sales volumes and average net
selling price in the United States, partially offset by a decrease in
international Kerastick® revenues. The decrease in Korea is attributable to the
purchase of launch quantities in the 2008 period.
For the three-month period ended March 31, 2009, BLU-U® revenues were $642,000,
representing a $166,000 or a 35% increase, over the comparable 2008 total of
$476,000. The increase in 2009 BLU-U® revenues was driven by increased overall
sales volumes, offset in part by a decrease in our average selling price. In the
three-month period ended March 31, 2009, there were 81 units sold, versus 56
units in 2008. All of the units sold in both years were sold in the United
States. Our average net selling price for the BLU-U® decreased to $7,589 for the
three-month period ended March 31, 2009 from $8,245 for 2008. Our BLU-U®
evaluation program allows customers to take delivery for a limited number of
BLU-U® units for a period of up to four months for private practitioners and up
to
one year for hospital clinics, before a purchase decision is required. At
March 31, 2009, there were approximately 31 units in the field pursuant to this
evaluation program, compared to 58 units in the field at December 31, 2008. The
units are classified as inventory in the financial statements and are being
amortized during the evaluation period to cost of goods sold using an estimated
life for the equipment of three years.
Non-PDT Drug Product Revenues reflect the revenues generated by the products
acquired as part of our acquisition of Sirius. Total Non-PDT drug product
revenues for the three-month period ended March 31, 2009 were $419,000, compared
to $2,100,000 for the comparable 2008 period. The substantial majority of the
Non-PDT product revenues were from Nicomide® related royalties and sales of
ClindaReach®. In April 2008, we were notified by Actavis Totowa, LLC, the
manufacturer of Nicomide®, that Actavis would cease manufacturing several
prescription vitamins, including Nicomide®, due to continuing discussions with
the FDA. As we previously disclosed, Actavis Totowa had received notice that the
FDA considers prescription dietary supplements to be unapproved new drugs. In
response to this notification and subsequent discussions with the FDA, we
stopped the sale and distribution of Nicomide®as a prescription product in
June 2008.
On August 12, 2008, we entered into a worldwide non-exclusive patent License
Agreement to our patent covering Nicomide® with River's Edge Pharmaceuticals,
LLC and an amendment to our Settlement Agreement with River's Edge. The
amendment to the Settlement Agreement, which has been further amended as
described further in Note 16 Subsequent Events to the Condensed Consolidated
Financial Statements, allowed River's Edge to manufacture and market a product
that could be substitutable for Nicomide® pursuant to the terms of the License
Agreement and changed certain payment obligations of River's Edge for sales of
its substitutable product. In consideration for granting the license, we were
paid a share of the net revenues, as defined in the License Agreement, of
River's Edge's licensed product sales under the License Agreement. The
Settlement Agreement and the subsequent amendment are described in Notes 15 and
16 to the Condensed Consolidated Financial Statements.
The decrease in our total revenues for the three month period ended March 31,
2009 compared with the comparable period in 2008 results from decreases in
Non-PDT revenues and international Kerastick® revenues, partially offset by
increased PDT segment revenues in the United States. We must continue to
increase sales from these levels in order for us to become profitable. PhotoCure
received FDA approval to market Metvixia® for treatment of AKs in July 2004, and
this product, which is directly competitive with our Levulan®Kerastick® product,
is now commercially available. While we are entitled to royalties from PhotoCure
on its net sales of Metvixia®, a large dermatology company has the marketing
rights in the U.S., which may adversely affect our ability to maintain or
increase our Levulan® market. Nonetheless, we remain confident that PDT revenues
in the United States should continue to increase through increased consumption
of our PDT products by our existing customers, as well as the addition of new
customers. We expect to be able to grow our PDT segment revenues in the United
States during 2009, due in part to the 6% increase in reimbursement of our
PDT-related procedure fee, which became effective January 1, 2009, as well as
our price increases, which were effective October 1, 2008 and January 1, 2009.
We also believe that these two price increases may have impacted the purchasing
patterns of our larger customers during this quarter. Although we expect growth
in our PDT segment revenues, a portion of our customer base, i.e., those
focusing on the cosmetic market, are more susceptible to the uncertain economic
conditions facing our markets, and reduced sales to that customer base could be
expected until the economy recovers. The vast majority of our international
sales and medi-spa sales fall into this market. We expect our Non-PDT revenues
for 2009 to be significantly reduced compared to 2008 since, although we are
receiving royalties, we are no longer manufacturing and marketing Nicomide® as a
prescription product and we licensed the AVAR product line.
COST OF PRODUCT REVENUES - Cost of product revenues for the three-month period
ended March 31, 2009 were $1,938,000 as compared to $1,701,000 in 2008. A
summary of the components of cost of product revenues and royalties is provided
below:
Increase/
2009 2008 (Decrease)
Levulan® Kerastick® Cost of Product Revenues and
Royalties
Direct Levulan® Kerastick® Product costs $ 564,000 $ 638,000 $ (74,000 )
Other Levulan® Kerastick® production costs
including internal costs assigned to support
products, net 359,000 10,000 349,000
Royalty and supply fees 253,000 248,000 5,000
Subtotal Levulan® Kerastick® Cost of Product
Revenues and Royalties 1,176,000 896,000 280,000
BLU-U® Cost of Product Revenues
Direct BLU-U® Product Costs 291,000 201,000 90,000
Other BLU-U® Product Costs including internal costs
assigned to support products; as well as, costs
incurred to ship, install and service the BLU-U® in
physicians offices 248,000 177,000 71,000
Subtotal BLU-U® Cost of Product Revenues 539,000 378,000 161,000
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Increase/
2009 2008 (Decrease)
TOTAL PDT DRUG AND DEVICE COST OF PRODUCT REVENUES
AND ROYALTIES 1,715,000 1,274,000 441,000
Non-PDT Drug Cost of Product Revenues and Royalties 223,000 427,000 (204,000 )
TOTAL COST OF PRODUCT REVENUES AND ROYALTIES $ 1,938,000 $ 1,701,000 $ 237,000
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MARGINS - Total product margins for the three-month period ended March 31, 2009 was $5,200,000 as compared to $6,229,000 for the comparable 2008 period, as shown below:
Increase/
2009 2008 (Decrease)
Levulan® Kerastick® Gross
Margin $ 4,901,000 81 % $ 4,458,000 83 % $ 443,000
BLU-U® Gross Margin 103,000 16 % 98,000 21 % 5,000
Total PDT Drug and Device Gross
Margin $ 5,004,000 74 % $ 4,556,000 78 % $ 448,000
Total Non-PDT Drug Gross Margin 196,000 47 % $ 1,673,000 80 % (1,477,000 )
TOTAL GROSS MARGIN $ 5,200,000 73 % $ 6,229,000 79 % $ (1,029,000 )
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Kerastick® gross margins for the three-month period ended March 31, 2009 were
81% versus 83% for the comparable 2008 period. The decrease in the Kerastick®
margin is mainly attributable to the absence of production volumes associated
with initial stocking orders from our international partners, which occurred in
the first quarter of 2008, partially offset by an increase in both sales volumes
and the average selling price in the U.S. Our long-term goal is to achieve
higher gross margins on Kerastick® sales which will be significantly dependent
on increased volume. We believe that we can achieve improved gross margins on
our Kerastick® during 2009 due to the anticipated increased volumes from
continued growth in the U.S.
BLU-U® margins for the three month period ended March 31, 2009 were 16% versus
21% for the comparable 2008 period. The decrease in gross margin is a result of
a decrease in the average selling price per unit; as well as, increased overall
costs incurred to support the product line. Our short-term strategy is to at a
minimum breakeven on device sales in an effort to drive Kerastick® sales
volumes.
Non-PDT Drug Product Margins reflect the gross margin generated by the products
acquired as part of our merger with Sirius. Total margin for the three-month
period ended March 31, 2009 was 47% compared with 80% for the comparable period
in 2008. Non-PDT Product margins in 2009 were negatively impacted by our
discontinuance of sales of Nicomide® as a prescription product.
RESEARCH AND DEVELOPMENT COSTS - Research and development costs for the
three-month period ended March 31, 2009 were $1,185,000 as compared to
$2,186,000 in the comparable 2008 period. The decrease in 2009 compared to 2008
was due primarily to the absence of spending related to our Phase IIb clinical
trial on acne, which concluded in October 2008, and a one-time $0.6 million
Prescription Drug User Fee Act (PDUFA) charge, which occurred in the first
quarter of 2008, related to our approved AK indication.
Based on the results of the Phase IIb clinical trial, which were previously
announced, we will not pursue further clinical development of Levulan® PDT with
BLU-U® for moderate to severe acne. However, we do expect to continue to support
investigator initiated studies in moderate to severe acne with Levulan and
various light sources. In May 2009 we filed a 510(k) application with the FDA
for an expansion of our BLU-U® label to include severe acne. We previously had
filed a patent application to cover an invention arising from the study.
We initiated a Phase II pilot clinical trial, which we expect will include up to
36 patients at multiple centers across the United States, for the treatment of
actinic keratoses and reduction of non-melanoma skin cancers in immunosuppressed
solid organ transplant recipients, or SOTR, who have demonstrated that they are
at risk of developing multiple squamous cell carcinomas. An Orphan Drug
Designation Application with respect to the prevention of cancer occurrence in
these patients is pending with the FDA, and we expect a decision by FDA by the
end of the second quarter of 2009. We expect enrollment of these patients to
take approximately one year. We expect to receive preliminary results from the
study in approximately 15 months and full results in approximately two years. We
expect that our overall research and development costs for 2009 will remain
below 2008 levels since we will not have expenditures relating to the acne
trial.
We have entered into a series of agreements for our research projects and
clinical studies. As of March 31, 2009 future minimum payments to be made
pursuant to these agreements, under certain terms and conditions, total
approximately $788,000 for the remainder of 2009.
MARKETING AND SALES COSTS - Marketing and sales costs for the three-month period
ended March 31, 2009 were $3,410,000 as compared to $3,057,000 for the
comparable 2008 period. These costs consisted primarily of expenses such as
salaries and benefits for the marketing and sales staff, commissions, and
related support expenses such as travel, and telephone, totaling $2,309,000 for
the three-month period ended March 31, 2009, compared to $2,057,000 in the
comparable 2008 period. The increase in this category is
due to primarily to increased headcount. The remaining expenses consisted of
tradeshows, miscellaneous marketing and outside consultants totaling $1,101,000
for the three-month period ended March 31, 2009, compared to $1,000,000 for the
comparable 2008 period. The increase in this category is due primarily to an
increase in tradeshow related expenditures. We expect marketing and sales costs
for the full year 2009 to increase slightly over 2008 levels, but to decrease as
a percentage of revenues.
GENERAL AND ADMINISTRATIVE COSTS - General and administrative costs for the
three-month period ended March 31, 2009 were $2,141,000 as compared to
$2,368,000 for the comparable 2008 period. The decrease is mainly attributable
to a decrease in compensation related costs, offset by an increase in legal
expenses. General and administrative expenses are highly dependent on our legal
and other professional fees, which can vary significantly from period to period
particularly in light of our litigation strategy to protect our intellectual
property. We may incur significant legal fees in 2009 due to the arbitration
process which has been commenced by Winston Laboratories. See Note 17 to the
Condensed Consolidated Financial Statements.
NET GAIN FROM SETTLEMENT OF LITIGATION - During the fourth quarter of 2007, we
entered into a Settlement Agreement and Mutual Release with River's Edge
Pharmaceuticals, LLC. Under the terms of the Settlement Agreement, River's Edge
made a lump-sum settlement payment to us in the amount of $425,000 for damages
and paid to DUSA $25.00 for every prescription of NIC 750 above 5,000
prescriptions that were substituted for Nicomide® from September 30, 2007
through June 30, 2008. During the three-month periods ended March 31, 2009 and
2008 the net gain from settlement of litigation was $0 and $236,000,
respectively. These payments under the Settlement Agreement ceased due to an
amendment effective as of July 3, 2008. See Note 15 to the Condensed
Consolidated Financial Statements.
OTHER INCOME, NET - Other income for the three-month period ended March 31,
2009, decreased to $65,000, as compared to $207,000 during the same period in
2008. This decrease reflects a decrease in our average investable cash balances
during 2009 as compared to 2008 along with a general decrease in interest rates
over the same timeframe.
LOSS ON CHANGE IN FAIR VALUE OF WARRANTS - The warrants issued to investors in
connection with the October 29, 2007 private placement were recorded initially
at fair value and are marked to market each reporting period. The increase in
the liability during the three month periods ended March 31, 2009 and 2008 was
$135,000 and $345,000, respectively, which resulted in a non-cash loss in both
periods. The increases in fair value were due primarily to increases in our
stock price during both quarters.
NET LOSS - We incurred a net loss of $1,607,000, or $0.07 per share, for the
three-month period ended March 31, 2009, as compared to a net loss of
$1,284,000, or $0.05 per share, for the comparable 2008 period. The increase in
the net loss is attributable to the reasons discussed above.
LIQUIDITY AND CAPITAL RESOURCES
At March 31, 2009, we had approximately $17,911,000 of total liquid assets,
comprised of $3,671,000 of cash and cash equivalents and marketable securities
available-for-sale totaling $14,240,000. We believe that our liquidity will be
sufficient to meet our cash requirements for at least the next twelve months
based on our projections of revenues and spending over that timeframe. We have
invested our funds in liquid investments, so that we will have ready access to
these cash reserves, as needed, for the funding of development plans on a
short-term and long-term basis. As of March 31, 2009, these securities had a
weighted average yield of 2.98% and maturity dates ranging from May 2009 to
January 2013. Our net cash used in operations for the three-month period ended
March 31, 2009 was $841,000, versus $5,000 provided by operations in the
comparable prior year period. The year over year decrease in cash from
operations is primarily attributable to an increase in our net loss as well as a
decrease in payments received from our international distributor partners
primarily from a one-time milestone payment and purchase of launch quantities
and the absence of a bonus payout in 2008. As of March 31, 2009 working capital
(total current assets minus total current liabilities) was $18,464,000, as
compared to $20,278,000 as of December 31, 2008. Total current assets decreased
by $1,984,000 during the three-month period ended March 31, 2009, due primarily
to decreases in our marketable securities, accounts receivable, inventory and
prepaid and other current asset balances. Total current liabilities decreased by
$170,000 during the same period due primarily to a decrease in accrued
compensation, partially offset by an increase in other accrued expenses and the
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