e10vq
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 10-Q
(Mark One)
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þ |
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934 |
For the quarterly period ended: June 30, 2009
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o |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission file number: 001-31533
DUSA PHARMACEUTICALS, INC.
(Exact Name of Registrant as Specified in Its Charter)
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New Jersey
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22-3103129 |
(State of Other Jurisdiction of
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(I.R.S. Employer Identification No.) |
Incorporation or Organization) |
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25 Upton Drive, Wilmington, MA
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01887 |
(Address of Principal Executive Offices)
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(Zip Code) |
(978) 657-7500
(Registrants Telephone Number, Including Area Code)
(Former Name, Former Address and Former Fiscal Year,
if Changed Since Last Report)
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. Yes þ No o
Indicate by check mark whether the registrant has submitted electronically and posted on its
corporate Web site, if any, every Interactive Data File required to be submitted and posted
pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months
(or for such shorter period that the registrant was required to submit and post such files). Yes
o No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a
non-accelerated filer, or a smaller reporting company. See the definitions of large accelerated
filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act.
(Check one):
Large accelerated filer o |
Accelerated filer o |
Non-accelerated filer þ (Do not check if a smaller reporting company) |
Smaller reporting company o |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act). Yes o No þ
As of August 10, 2009, the registrant had 24,108,908 shares of Common Stock, no par value per
share, outstanding.
DUSA PHARMACEUTICALS, INC.
TABLE OF CONTENTS TO FORM 10-Q
2
PART I.
ITEM 1. FINANCIAL STATEMENTS
DUSA PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)
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June 30, |
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December 31, |
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2009 |
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2008 |
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ASSETS |
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CURRENT ASSETS |
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Cash and cash equivalents |
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$ |
3,894,037 |
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$ |
3,880,673 |
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Marketable securities, at fair value |
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12,488,406 |
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15,002,830 |
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Accrued interest receivable |
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144,523 |
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155,728 |
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Accounts receivable, net of allowance for
doubtful accounts of $125,000 and $98,000
in 2009 and 2008, respectively |
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1,550,149 |
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2,367,803 |
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Inventory |
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2,550,463 |
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2,812,825 |
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Prepaid and other current assets |
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1,341,263 |
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1,718,073 |
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TOTAL CURRENT ASSETS |
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21,968,841 |
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25,937,932 |
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Restricted cash |
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174,080 |
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173,844 |
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Property, plant and equipment, net |
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1,773,485 |
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1,937,978 |
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Deferred charges and other assets |
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68,099 |
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160,700 |
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TOTAL ASSETS |
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$ |
23,984,505 |
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$ |
28,210,454 |
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LIABILITIES AND SHAREHOLDERS EQUITY |
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CURRENT LIABILITIES |
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Accounts payable |
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$ |
466,984 |
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$ |
305,734 |
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Accrued compensation |
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497,848 |
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1,515,912 |
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Other accrued expenses |
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2,423,767 |
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3,226,571 |
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Deferred revenues |
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717,897 |
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611,602 |
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TOTAL CURRENT LIABILITIES |
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4,106,496 |
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5,659,819 |
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Deferred revenues |
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3,633,727 |
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4,157,305 |
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Warrant liability |
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498,188 |
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436,458 |
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Other liabilities |
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144,069 |
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244,673 |
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TOTAL LIABILITIES |
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8,382,480 |
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10,498,255 |
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COMMITMENTS AND CONTINGENCIES (NOTE 16) |
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SHAREHOLDERS EQUITY |
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Capital Stock |
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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 June 30, 2009 and December 31,
2008, respectively |
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151,683,399 |
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151,663,943 |
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Additional paid-in capital |
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7,915,624 |
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7,514,900 |
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Accumulated deficit |
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(144,310,565 |
) |
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(141,850,925 |
) |
Accumulated other comprehensive income |
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313,567 |
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384,281 |
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TOTAL SHAREHOLDERS EQUITY |
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15,602,025 |
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17,712,199 |
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TOTAL LIABILITIES AND SHAREHOLDERS EQUITY |
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$ |
23,984,505 |
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$ |
28,210,454 |
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See the accompanying Notes to the Condensed Consolidated Financial Statements.
3
DUSA PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
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Three-months ended |
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Six-months ended |
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June 30, |
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June 30, |
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2009 |
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2008 |
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2009 |
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2008 |
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Product revenues |
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$ |
6,965,541 |
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$ |
8,112,239 |
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$ |
14,103,810 |
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$ |
16,041,739 |
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Cost of product revenues |
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1,440,864 |
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1,787,694 |
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3,379,090 |
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3,488,011 |
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GROSS MARGIN |
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5,524,677 |
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6,324,545 |
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10,724,720 |
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12,553,728 |
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Operating costs: |
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Research and development |
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1,076,709 |
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1,375,302 |
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2,261,804 |
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3,561,511 |
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Marketing and sales |
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3,037,311 |
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3,496,233 |
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6,447,415 |
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6,553,434 |
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General and administrative |
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2,340,947 |
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2,325,137 |
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4,482,397 |
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4,692,961 |
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Settlements, net |
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75,000 |
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(47,825 |
) |
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75,000 |
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(283,425 |
) |
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TOTAL OPERATING COSTS |
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6,529,967 |
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7,148,847 |
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13,266,616 |
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14,524,481 |
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LOSS FROM OPERATIONS |
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(1,005,290 |
) |
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(824,302 |
) |
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(2,541,896 |
) |
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(1,970,753 |
) |
Gain (loss) on change in
fair value of warrants |
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73,183 |
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468,411 |
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(61,730 |
) |
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123,869 |
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Other income, net |
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79,398 |
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217,100 |
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143,986 |
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423,952 |
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NET LOSS |
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$ |
(852,709 |
) |
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$ |
(138,791 |
) |
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$ |
(2,459,640 |
) |
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$ |
(1,422,932 |
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BASIC AND DILUTED NET LOSS PER
COMMON SHARE |
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$ |
(0.04 |
) |
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$ |
(0.01 |
) |
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$ |
(0.10 |
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$ |
(0.06 |
) |
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WEIGHTED AVERAGE NUMBER OF
COMMON SHARES OUTSTANDING,
BASIC AND DILUTED |
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24,100,874 |
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24,078,610 |
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24,095,149 |
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24,078,514 |
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See the accompanying Notes to the Condensed Consolidated Financial Statements.
4
DUSA PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)
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Six-months ended |
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June 30, |
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2009 |
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2008 |
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CASH FLOWS FROM OPERATING ACTIVITIES |
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Net loss |
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$ |
(2,459,640 |
) |
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$ |
(1,422,932 |
) |
Adjustments to reconcile net loss to net cash (used in) provided by
operating activities: |
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Accretion (amortization) of premiums and discounts on marketable securities |
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22,708 |
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(108,441 |
) |
Realized loss on sales of marketable securities |
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36,822 |
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13,488 |
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Share-based compensation |
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424,593 |
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689,550 |
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Depreciation and amortization |
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236,371 |
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311,191 |
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Loss (gain) on change in fair value of warrants |
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61,730 |
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(123,869 |
) |
Deferred revenues recognized |
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(413,734 |
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(640,168 |
) |
Changes in other assets and liabilities impacting cash flows from operations |
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Accounts receivable |
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817,654 |
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461,727 |
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Inventory |
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262,362 |
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(159,383 |
) |
Prepaid and other current assets |
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376,810 |
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174,498 |
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Accrued interest receivable |
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11,205 |
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(78,292 |
) |
Deferred charges and other assets |
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92,601 |
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57,543 |
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Accounts payable, accrued compensation and other accrued expenses |
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(1,659,618 |
) |
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(652,044 |
) |
Deferred revenues |
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(3,549 |
) |
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1,643,937 |
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Other liabilities |
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(100,604 |
) |
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(34,005 |
) |
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NET CASH (USED IN) PROVIDED BY OPERATING ACTIVITIES |
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(2,294,289 |
) |
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132,800 |
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CASH FLOWS FROM INVESTING ACTIVITIES |
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Cash paid for contingent consideration |
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(250,000 |
) |
Purchases of marketable securities |
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(9,038,979 |
) |
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(19,406,775 |
) |
Proceeds from maturities and sales of marketable securities |
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11,423,159 |
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18,078,809 |
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Restricted cash |
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(236 |
) |
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(1,908 |
) |
Purchases of property, plant and equipment |
|
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(71,878 |
) |
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(291,823 |
) |
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NET CASH PROVIDED BY (USED IN) INVESTING ACTIVITIES |
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2,312,066 |
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(1,871,697 |
) |
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CASH FLOWS FROM FINANCING ACTIVITIES |
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Proceeds from exercise of options |
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4,000 |
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Settlements of restricted stock for tax withholding obligations |
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(4,413 |
) |
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NET CASH (USED IN) PROVIDED BY FINANCING ACTIVITIES |
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(4,413 |
) |
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4,000 |
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NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS |
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13,364 |
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(1,734,897 |
) |
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CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD |
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3,880,673 |
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4,713,619 |
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CASH AND CASH EQUIVALENTS AT END OF PERIOD |
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$ |
3,894,037 |
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$ |
2,978,722 |
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See the accompanying Notes to the Condensed Consolidated Financial Statements.
5
DUSA PHARMACEUTICALS, INC.
NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
1) BASIS OF PRESENTATION
The Condensed Consolidated Balance Sheet as of June 30, 2009, the Condensed Consolidated Statements
of Operations for the three and six-month periods ended June 30, 2009 and 2008, and the Condensed
Consolidated Statements of Cash Flows for the six month periods ended June 30, 2009 and 2008 of
DUSA Pharmaceuticals, Inc. (the Company or DUSA) have been prepared in accordance with
accounting principles generally accepted in the United States of America (U.S. GAAP). These
condensed consolidated financial statements are unaudited but include all normal recurring
adjustments, which management of the Company believes to be necessary for fair presentation of the
periods presented. The results of the Companys operations for any interim period are not
necessarily indicative of the results of the Companys operations for any other interim period or
for a full year.
Certain information and footnote disclosures normally included in financial statements prepared in
accordance with U.S. GAAP have been condensed or omitted. These condensed consolidated financial
statements should be read in conjunction with the Consolidated Financial Statements and Notes to
the Consolidated Financial Statements included in our Annual Report on Form 10-K for the year ended
December 31, 2008 filed with the Securities and Exchange Commission. The balance sheet as of
December 31, 2008 has been derived from the audited financial statements at that date but does not
include all of the information and footnotes required by U.S. GAAP for complete financial
statements.
We evaluated all subsequent events that occurred after the balance sheet date through August 10,
2009, the day prior to the issuance of these financial statements.
2) NEW ACCOUNTING PRONOUNCEMENTS
Recently Adopted Accounting Standards
Effective January 1, 2009, we implemented Statement of Financial Accounting Standards No. 141(R),
Business Combinations, or SFAS 141(R). This standard requires an acquiring company to measure all
assets acquired and liabilities assumed, including contingent considerations and all contractual
contingencies, at fair value as of the acquisition date. In addition, an acquiring company is
required to capitalize IPR&D and either amortize it over the life of the product, or write it off
if the project is abandoned or impaired. The adoption of this standard did not have a material
impact on our financial position or results of operations, as SFAS 141(R) is applicable to
acquisitions completed after January 1, 2009, and we did not complete any business combination
transactions during the first six months of 2009.
In April 2009, the FASB issued FSP No. FAS 107-1 and APB 28-1, Interim Disclosures about Fair Value
of Financial Instruments , which requires disclosures about the fair value of our financial
instruments for which it is practicable to estimate that value, whether recognized or not
recognized in the balance sheets, in the interim reporting periods as well as in the annual
reporting periods. In addition, the FSP requires disclosures of the methods and significant
assumptions used to estimate the fair value of those financial instruments. The adoption of this
FSP did not impact our financial position or results of operations.
In April 2009, the FASB issued FSP No. FAS 115-2 and FAS 124-2, Recognition and Presentation of
Other-Than-Temporary Impairments, which establishes a new method of recognizing and reporting
other-than-temporary impairments of debt securities and requires additional disclosures related to
debt and equity securities. This FSP does not change existing recognition and measurement guidance
related to other-than-temporary impairments of equity securities. The adoption of this FSP was not
material to our financial position or results of operations.
In May 2009, the FASB issued SFAS No. 165, Subsequent Events, or SFAS 165, which provides guidance
to establish general standards of accounting for, and disclosures of, events that occur after the
balance sheet date but before financial statements are issued or are available to be issued. SFAS
165 is effective for interim or fiscal periods ending after June 15, 2009. We adopted this
statement effective June 15, 2009.
3) FAIR VALUE MEASUREMENTS
As defined in FASB Statement No. 157, Fair Value Measurements (SFAS 157) fair value is the price
that would be received to sell an asset or paid to transfer a liability in an orderly transaction
between market participants at the measurement date. Financial assets and liabilities carried at
fair value are classified and disclosed in one of the following three categories:
Level 1: Quoted market prices in active markets for identical assets or liabilities.
Level 2: Observable market based inputs or unobservable inputs that are corroborated by market
data.
Level 3: Unobservable inputs that are not corroborated by market data.
6
Level 1 primarily consists of financial instruments whose value is based on quoted market prices
such as exchange-traded instruments and listed equities.
Level 2 includes financial instruments that are valued using models or other valuation
methodologies. These models are primarily industry-standard models that consider various
assumptions, including time value, yield curve, prepayment speeds, default rates, loss severity,
current market and contractual prices for the underlying financial instruments, as well as other
relevant economic measures. Substantially all of these assumptions are observable in the
marketplace, can be derived from observable data or are supported by observable levels at which
transactions are executed in the marketplace. Financial instruments in this category include
corporate debt and government-backed securities.
Level 3 is comprised of financial instruments whose fair value
is estimated based on internally developed models or
methodologies utilizing significant inputs that are generally
less readily observable. The following table presents
information about the Companys assets and liabilities that
are measured at fair value on a recurring basis as of June 30,
2009, and indicates the fair value hierarchy of the valuation
techniques the Company utilized to determine such fair value:
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Level 2 |
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Assets: |
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United States government-backed securities |
|
$ |
11,166,000 |
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Corporate debt securities |
|
|
1,322,000 |
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Total assets |
|
$ |
12,488,000 |
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Level 3 |
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Liabilities: |
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Warrant liability |
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|
498,000 |
|
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Total liabilities |
|
$ |
498,000 |
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|
Changes in Level 3 Recurring Fair Value Measurements:
The table below includes a rollforward of the balance sheet amounts for the six-month period ended
June 30, 2009 for the warrant liability, which is classified as Level 3. When a determination is
made to classify a financial instrument within Level 3, the determination is based upon the
significance of the unobservable parameters to the overall fair value measurement. However, Level 3
financial instruments typically include, in addition to the unobservable components, observable
components (that is, components that are actively quoted and can be validated to external sources).
Accordingly, the gains and losses in the table below include changes in fair value due in part to
observable factors that are part of the methodology.
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Fair Value Measurements Using Significant Unobservable Inputs (Level 3) |
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Six-month period ended June 30, 2009 |
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Change in |
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Unrealized |
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(Gains)/Losses |
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Related to |
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Purchases, |
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Financial |
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Sales, |
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Transfers |
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Instruments |
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Fair Value at |
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Total |
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Issuances, |
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In and/or |
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Fair Value at |
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Held at |
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January 1, |
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Unrealized |
|
|
Settlements, |
|
|
Out of |
|
|
June 30, |
|
|
June 30, |
|
|
|
2009 |
|
|
(Gains)/Losses |
|
|
net |
|
|
Level 3 |
|
|
2009 |
|
|
2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant Liability |
|
$ |
436,000 |
|
|
$ |
62,000 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
498,000 |
|
|
$ |
62,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The recorded amounts of the Companys cash and cash equivalents, accrued interest receivable,
accounts receivable and accounts payable at June 30, 2009 approximate fair value.
7
4) WARRANTS
On October 29, 2007, the Company sold, through a private placement, 4,581,043 shares of its common
stock and warrants to purchase 1,145,259 shares of common stock with an exercise price of $2.85.
The warrants have a 5.5 year term and became exercisable on April 30, 2008. The warrants are
recorded as a derivative liability at fair value.
Assumptions used for the Black-Scholes option-pricing models as of June 30, 2009 and December 31,
2008 are as follows:
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
|
2009 |
|
2008 |
Expected volatility |
|
|
82.9 |
% |
|
|
75.0 |
% |
Remaining contractual term (years) |
|
|
3.83 |
|
|
|
4.33 |
|
Risk-free interest rate |
|
|
2.09 |
% |
|
|
1.55 |
% |
Expected dividend yield |
|
|
0 |
% |
|
|
0 |
% |
Common stock price |
|
$ |
1.10 |
|
|
$ |
1.05 |
|
5) MARKETABLE SECURITIES
The Companys investment securities consist
of securities of the U.S. government and its
agencies, and investment grade corporate
bonds. The Company has historically
classified all investment securities as
available-for-sale and recorded such
investments at fair market value. Since the
Companys investments are managed by a
third-party investment advisor pursuant to a
discretionary arrangement, for securities
with unrealized losses at June 30, 2009 and
2008, which totaled $0 and $36,000,
respectively, an other-than-temporary
impairment was considered to have occurred
and the cost basis of such securities were
written down to their fair values with the
amount of the write-down included in earnings
as realized losses in the accompanying
Condensed Consolidated Statements of
Operations. As of June 30, 2009, current
yields range from 0.41% to 6.23% and maturity
dates range from September 2009 to January
2013. The estimated fair value and cost of
marketable securities at June 30, 2009 and
December 31, 2008 are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2009 |
|
|
Amortized |
|
Unrealized |
|
Fair |
|
|
Cost |
|
Gains |
|
Value |
|
|
|
United States government-backed securities |
|
$ |
10,934,000 |
|
|
$ |
232,000 |
|
|
$ |
11,166,000 |
|
Corporate securities |
|
|
1,240,000 |
|
|
|
82,000 |
|
|
|
1,322,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total marketable securities available-for-sale |
|
$ |
12,174,000 |
|
|
$ |
314,000 |
|
|
$ |
12,488,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2008 |
|
|
Amortized |
|
Unrealized |
|
Fair |
|
|
Cost |
|
Gains |
|
Value |
|
|
|
United States government-backed securities |
|
$ |
11,956,000 |
|
|
$ |
357,000 |
|
|
$ |
12,313,000 |
|
Corporate securities |
|
|
2,662,000 |
|
|
|
28,000 |
|
|
|
2,690,000 |
|
|
|
|
Total marketable securities available-for-sale |
|
$ |
14,618,000 |
|
|
$ |
385,000 |
|
|
$ |
15,003,000 |
|
|
|
|
The change in net unrealized gains on such securities for the three and six-month
periods ended June 30, 2009 were ($1,000) and ($71,000), respectively, as compared to ($180,000)
and $(13,000) for the three and six-month periods ended June 30, 2008, and have been recorded in
accumulated other comprehensive income, which is reported as part of shareholders equity in the
Condensed Consolidated Balance Sheets.
6) CONCENTRATIONS
The Company is exposed to concentrations of credit risk related to accounts receivable that are
generated from its customers. From time to time, the Company is also exposed to concentrations of
revenues with significant customers, including its international distribution partners and domestic
wholesalers. To manage credit risk, the Company performs regular credit evaluations of its
customers and provides allowances for potential credit losses, when applicable. Concentrations in
the
8
Companys total revenues for the three and six-months ended June 30, 2009 and 2008, and
accounts receivable as of June 30, 2009 and December 31, 2008 are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
% of revenue |
|
% of revenue |
|
|
|
|
three months ended |
|
six months ended |
|
% of accounts receivable |
|
|
June 30, |
|
June 30, |
|
June 30, |
|
June 30, |
|
June 30, |
|
December 31, |
|
|
2009 |
|
2008 |
|
2009 |
|
2008 |
|
2009 |
|
2008 |
|
|
|
Customer A |
|
|
3 |
% |
|
|
3 |
% |
|
|
3 |
% |
|
|
2 |
% |
|
|
4 |
% |
|
|
11 |
% |
Customer B |
|
|
2 |
% |
|
|
12 |
% |
|
|
1 |
% |
|
|
12 |
% |
|
|
6 |
% |
|
|
|
|
Customer C |
|
|
1 |
% |
|
|
15 |
% |
|
|
1 |
% |
|
|
11 |
% |
|
|
|
|
|
|
|
|
Customer D |
|
|
|
|
|
|
5 |
% |
|
|
|
|
|
|
5 |
% |
|
|
1 |
% |
|
|
|
|
Customer E |
|
|
4 |
% |
|
|
2 |
% |
|
|
3 |
% |
|
|
3 |
% |
|
|
|
|
|
|
1 |
% |
Customer F |
|
|
5 |
% |
|
|
|
|
|
|
4 |
% |
|
|
|
|
|
|
4 |
% |
|
|
9 |
% |
Other customers |
|
|
85 |
% |
|
|
63 |
% |
|
|
88 |
% |
|
|
67 |
% |
|
|
85 |
% |
|
|
79 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
100 |
% |
|
|
100 |
% |
|
|
100 |
% |
|
|
100 |
% |
|
|
100 |
% |
|
|
100 |
% |
The Company is dependent upon sole-source suppliers for a number of its products.
There can be no assurance that these suppliers will be able to meet the Companys future
requirements for such products or parts or that they will be available at favorable terms. Any
extended interruption in the supply of any such products or parts or any significant price increase
could have a material adverse effect on the Companys operating results in any given period.
7) INVENTORY
Inventory consisted of the following:
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
|
2009 |
|
2008 |
|
|
|
Finished goods |
|
$ |
1,486,000 |
|
|
$ |
1,348,000 |
|
BLU-U® evaluation units |
|
|
78,000 |
|
|
|
166,000 |
|
Work in process |
|
|
436,000 |
|
|
|
698,000 |
|
Raw materials |
|
|
550,000 |
|
|
|
601,000 |
|
|
|
|
Total |
|
$ |
2,550,000 |
|
|
$ |
2,813,000 |
|
|
|
|
BLU-U® commercial light sources placed in physicians offices for an initial evaluation
period are included in inventory until all revenue recognition criteria are met. The Company
amortizes the cost of the evaluation units during the evaluation period of three years to cost of
product revenues to approximate its net realizable value.
8) OTHER ACCRUED EXPENSES
Other accrued expenses consisted of the following:
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
|
2009 |
|
2008 |
|
|
|
Research and development costs |
|
$ |
110,000 |
|
|
$ |
190,000 |
|
Marketing and sales costs |
|
|
275,000 |
|
|
|
191,000 |
|
Reserve for sales returns and allowances |
|
|
350,000 |
|
|
|
500,000 |
|
Accrued FDA fees |
|
|
|
|
|
|
589,000 |
|
Due to former Sirius shareholders |
|
|
205,000 |
|
|
|
|
|
Other product related costs |
|
|
686,000 |
|
|
|
824,000 |
|
Legal and other professional fees |
|
|
456,000 |
|
|
|
467,000 |
|
Employee benefits |
|
|
296,000 |
|
|
|
278,000 |
|
Other expenses |
|
|
46,000 |
|
|
|
188,000 |
|
|
|
|
Total |
|
$ |
2,424,000 |
|
|
$ |
3,227,000 |
|
|
|
|
9
9) SHARE-BASED COMPENSATION
Total share-based compensation expense, related to all of the Companys share-based awards,
recognized for the three and six-month periods ended June 30, 2009 and 2008 included the following
line items:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three-months ended |
|
Six-months ended |
|
|
June 30, 2009 |
|
June 30, 2008 |
|
June 30, 2009 |
|
June 30, 2008 |
|
|
|
Cost of product revenues |
|
$ |
14,000 |
|
|
$ |
17,000 |
|
|
$ |
34,000 |
|
|
$ |
41,000 |
|
Research and development |
|
|
31,000 |
|
|
|
69,000 |
|
|
|
81,000 |
|
|
|
190,000 |
|
Marketing and sales |
|
|
18,000 |
|
|
|
34,000 |
|
|
|
3,000 |
|
|
|
(27,000 |
) |
General and administrative |
|
|
163,000 |
|
|
|
238,000 |
|
|
|
307,000 |
|
|
|
486,000 |
|
|
|
|
Share-based compensation expense |
|
$ |
226,000 |
|
|
$ |
358,000 |
|
|
$ |
425,000 |
|
|
$ |
690,000 |
|
|
|
|
The weighted-average estimated fair values of employee stock options granted during the three and
six-month periods ended June 30, 2009 were $0.80 and $0.81 per share, respectively, using the
Black-Scholes option valuation model with the following weighted-average assumptions (annualized
percentages):
|
|
|
|
|
|
|
|
|
|
|
Three-months |
|
Six-months |
|
|
ended June 30, 2009 |
Expected volatility |
|
|
74.6 |
% |
|
|
73.5 |
% |
Risk-free interest rate |
|
|
2.42 |
% |
|
|
1.99 |
% |
Expected dividend yield |
|
|
0 |
% |
|
|
0 |
% |
Expected life-directors and officers |
|
|
6.5 |
|
|
|
6.5 |
|
Expected life-non-officer employees |
|
|
5.7 |
|
|
|
5.7 |
|
A summary of stock option activity is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Average |
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
Remaining |
|
|
|
|
|
|
|
|
|
|
Average |
|
|
Contractual |
|
|
Aggregate |
|
|
|
|
|
|
|
Exercise |
|
|
Term |
|
|
Intrinsic |
|
|
|
|
|
|
|
Price |
|
|
(Years) |
|
|
Value |
|
|
Outstanding, beginning of period, April 1, 2009 |
|
|
3,588,975 |
|
|
$ |
8.28 |
|
|
|
|
|
|
$ |
|
|
Options granted |
|
|
95,000 |
|
|
$ |
1.15 |
|
|
|
|
|
|
|
|
|
Options forfeited |
|
|
(36,575 |
) |
|
$ |
2.07 |
|
|
|
|
|
|
|
|
|
Options expired |
|
|
(54,125 |
) |
|
$ |
9.52 |
|
|
|
|
|
|
|
|
|
Options exercised |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding, end of period |
|
|
3,593,275 |
|
|
$ |
8.14 |
|
|
|
3.9 |
|
|
$ |
50 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable, end of period |
|
|
2,556,925 |
|
|
$ |
10.63 |
|
|
|
3.0 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options vested and expected to vest, end of period |
|
|
3,435,324 |
|
|
$ |
8.44 |
|
|
|
3.8 |
|
|
$ |
42 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At June 30, 2009 the total amount of unrecognized compensation expense related to grants of options
was $1,199,000.
During the first quarter of 2009 and the second quarter of 2008, respectively, the Company issued
280,000 and 102,000 unvested shares of common stock to its officers. The Company also issued 45,000
shares of unvested common stock to its Board of Directors during the first quarter of 2009. The
unvested shares of common stock vest over 4 years at a rate of 25% per year. The fair value on the
date of grant was $1.22 and $2.20 per share in 2009 and 2008, respectively. At June 30, 2009 the
total amount of unrecognized compensation expense related to grants of unvested common stock was
$477,000. The unrecognized compensation related to unvested common stock will be recognized over a
weighted-average period of 3.4 years. The weighted average grant date fair value of the 22,750
shares that vested during the period and the 393,250 unvested shares of common stock at June 30,
2009 were $2.20 and $1.39, respectively.
10
10) BASIC AND DILUTED NET LOSS PER SHARE
Basic net loss per common share is based on the weighted-average number of shares outstanding
during each period. For the three and six-month periods ended June 30, 2009, and 2008, stock
options, unvested shares of common stock, warrants and rights totaling approximately 5,382,000 and
4,542,000 shares, respectively, have been excluded from the computation of diluted net loss per
share as the effect would be antidilutive.
11) SEGMENT REPORTING
The Company has two reportable operating segments: Photodynamic Therapy (PDT) Drug and Device
Products and Non-Photodynamic Therapy (Non-PDT) Products. Operating segments are defined as
components of the Company for which separate financial information is available to manage resources
and evaluate performance regularly by the chief operating decision maker. The table below presents
the revenues, costs of revenues and gross margins attributable to these reportable segments for the
periods presented. The Company does not allocate research and development, selling and marketing
and general and administrative expenses to its reportable segments, because these activities are
managed at a corporate level.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three-month period ended |
|
Six-month period ended |
|
|
June 30, |
|
June 30, |
|
June 30, |
|
June 30, |
|
|
2009 |
|
2008 |
|
2009 |
|
2008 |
|
|
|
REVENUES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PDT drug and device product revenues |
|
$ |
6,418,000 |
|
|
$ |
5,429,000 |
|
|
$ |
13,137,000 |
|
|
$ |
11,259,000 |
|
Non-PDT product revenues |
|
|
548,000 |
|
|
|
2,683,000 |
|
|
|
967,000 |
|
|
|
4,783,000 |
|
|
|
|
Total revenues |
|
|
6,966,000 |
|
|
|
8,112,000 |
|
|
|
14,104,000 |
|
|
|
16,042,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COSTS OF REVENUES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PDT drug and device cost of
product revenues |
|
|
1,286,000 |
|
|
|
1,169,000 |
|
|
|
3,001,000 |
|
|
|
2,443,000 |
|
Non-PDT cost of product revenues |
|
|
155,000 |
|
|
|
618,000 |
|
|
|
378,000 |
|
|
|
1,045,000 |
|
|
|
|
Total costs of product revenues |
|
|
1,441,000 |
|
|
|
1,787,000 |
|
|
|
3,379,000 |
|
|
|
3,488,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GROSS MARGIN |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PDT drug and device product gross
margin |
|
|
5,132,000 |
|
|
|
4,260,000 |
|
|
|
10,136,000 |
|
|
|
8,816,000 |
|
Non-PDT product gross margin |
|
|
393,000 |
|
|
|
2,065,000 |
|
|
|
589,000 |
|
|
|
3,738,000 |
|
|
|
|
Total gross margin |
|
$ |
5,525,000 |
|
|
$ |
6,325,000 |
|
|
$ |
10,725,000 |
|
|
$ |
12,554,000 |
|
|
|
|
During the three and six-month periods ended June 30, 2009 and 2008, the Company derived revenues
from the following geographies based on the location of the customer (as a percentage of product
revenues):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three-months ended |
|
Six-months ended |
|
|
June 30, |
|
June 30, |
|
June 30, |
|
June 30, |
|
|
2009 |
|
2008 |
|
2009 |
|
2008 |
|
|
|
United States |
|
|
95 |
% |
|
|
93 |
% |
|
|
95 |
% |
|
|
94 |
% |
Canada |
|
|
2 |
% |
|
|
3 |
% |
|
|
2 |
% |
|
|
2 |
% |
Korea |
|
|
2 |
% |
|
|
2 |
% |
|
|
2 |
% |
|
|
3 |
% |
Other |
|
|
1 |
% |
|
|
2 |
% |
|
|
1 |
% |
|
|
1 |
% |
|
|
|
Total |
|
|
100 |
% |
|
|
100 |
% |
|
|
100 |
% |
|
|
100 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Asset information by reportable segment is not reported to or reviewed by the chief operating
decision maker and, therefore, the Company has not disclosed asset information for each reportable
segment.
11
12) COMPREHENSIVE LOSS
For the three and six-month periods ended June 30, 2009 and 2008, comprehensive loss consisted of
the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three-months ended |
|
Six-months ended |
|
|
June 30, |
|
June 30, |
|
|
2009 |
|
2008 |
|
2009 |
|
2008 |
|
|
|
NET LOSS |
|
$ |
(853,000 |
) |
|
$ |
(139,000 |
) |
|
$ |
(2,460,000 |
) |
|
$ |
(1,423,000 |
) |
Change in net
unrealized gains on
marketable securities
available-for-sale |
|
|
(1,000 |
) |
|
|
(180,000 |
) |
|
|
(71,000 |
) |
|
|
(13,000 |
) |
|
|
|
COMPREHENSIVE LOSS |
|
$ |
(854,000 |
) |
|
$ |
(319,000 |
) |
|
$ |
(2,531,000 |
) |
|
$ |
(1,436,000 |
) |
|
|
|
13) STIEFEL AGREEMENT
In January 2006, as amended in September 2007, the Company licensed to Stiefel Laboratories, Inc.
the exclusive Latin American rights to market Levulan® PDT for payments by Stiefel of up
to $2,250,000. The Company also manufactures and supplies finished product for Stiefel, which the
Company began shipping in September 2007. In consideration for the transaction Stiefel agreed to
pay the Company as follows: (i) $375,000 upon launch of the product in either Mexico or Argentina;
(ii) $375,000 upon receipt of acceptable pricing approval in Brazil; (iii) two installments of
$375,000 each for cumulative end-user sales in Brazil totaling 150,000 units and 300,000 units, and
(iv) two installments of $375,000 each for cumulative sales in countries excluding Brazil totaling
150,000 units and 300,000 units. Stiefel launched the product in October 2007 in Mexico and
Argentina and in April 2008 in Brazil. The Company is deferring and recognizing approval and sales
milestones as license revenues on a straight-line basis, beginning on the date the milestone is
achieved through the fourth quarter of 2015, which is the term of the Stiefel Agreement. Stiefel
pays a fixed price per unit for the inventory as well as a royalty based on a percentage of the net
sales price to end-users. During the six-month periods ended June 30, 2009 and 2008 the Companys
sales of Levulan® Kerastick® to Stiefel were $0 and $202,000, respectively.
At June 30, 2009 and December 31, 2008 the total revenues deferred associated with shipments to
Stiefel were $327,000 and $389,000, respectively, in accordance with the Companys policy of
deferring revenues during a products launch phase and recognizing revenues based on end-user
demand. Deferred revenues at June 30, 2009 and December 31, 2008 associated with milestone payments
received from Stiefel were $578,000 and $621,000, respectively.
The agreement with Stiefel also establishes minimum purchase quantities over the first five years
following regulatory approval. The first contract year for all countries other than Brazil began in
October 2007, and for Brazil began in April 2008. For the contract years ended in October 2008 and
April 2009 Stiefel did not meet its minimum purchase obligations under the agreement. The agreement
provides that within 60 days of the year end, Stiefel is required to pay the Company the difference
between its actual purchases and the contractual minimums (a gross up payment). If Stiefel fails
to make the gross up payment, the Companys remedies include, without limitation, appointing one or
more distributors in the territory or terminating the agreement. Stiefel did not make either of the
gross up payments within the contractual time periods, and the parties are presently discussing
actions to be taken, if any, due to the shortfall. Also, since Stiefels sales to third parties
during the contract years ended October 2008 and April 2009 were below its minimum purchase
obligations, Stiefel has the unilateral right to terminate the contract. Stiefel has not exercised
this right.
14) DAEWOONG AGREEMENT
In January 2007 the Company licensed to Daewoong the exclusive rights to market Levulan®
PDT in Korea and other Asia Pacific countries for payments by Daewoong of up to $3,500,000. The
Company also manufactures and supplies finished product for Daewoong, which the Company began
shipping in October 2007. In consideration for the transaction Daewoong agreed to pay the Company
as follows: (i) $1,000,000 upon contract signing; (ii) $1,000,000 upon achieving regulatory
approval in Korea; and (iii) two installments of $750,000 each for cumulative end-user sales
totaling 200,000 units and 500,000 units. Daewoong launched the product in November 2007 in Korea.
The Company is deferring and recognizing the up-front and regulatory approval milestones as license
revenues on a straight-line basis, beginning with product launch in the territory through the
fourth quarter of 2016, which is the term of the Daewoong Agreement. Daewoong pays a fixed price
per unit for the inventory and an Excess Purchase Price, as defined in the Agreement, if the
Average Selling Price to end-users during any calendar quarter exceeds a certain threshold. During
the six month periods ended June 30, 2009 and 2008, the Companys sales of Levulan®
Kerastick® to Daewoong were $0 and $998,000, respectively. At June 30, 2009 and December
31, 2008 the total revenues deferred associated with shipments to Daewoong were $951,000 and
$1,144,000, respectively, in accordance with the Companys policy of deferring revenues during a
products launch phase and recognizing revenues based on end-user demand. Deferred revenues at June
30, 2009 and December 31, 2008 associated with milestone payments received from Daewoong were
$1,541,000 and $1,643,000, respectively. The agreement with Daewoong also establishes a cumulative
minimum purchase quantity over the first five years following regulatory approval. If Daewoong
12
fails to meet its minimum purchase quantities, the Company may, in addition to other remedies, at
its sole discretion, appoint one or more other distributors in the covered territories, or
terminate the agreement.
15) SETTLEMENTS, NET
Rivers Edge Litigation Settlement
As part of the settlement of litigation between DUSA and Rivers Edge Pharmaceuticals, LLC in
October 2007, the parties entered into a Settlement Agreement and Mutual Release (the Settlement
Agreement) to dismiss the lawsuit brought by DUSA against Rivers Edge asserting a number of
claims arising out of Rivers Edges alleged infringement of the Companys Nicomide®
patent, U.S. Patent No. 6,979,468, under which DUSA formerly marketed, distributed and sold
Nicomide®. As part of the terms of this agreement, Rivers Edge agreed to pay to DUSA
$25.00 for every bottle of Rivers Edge product above 5,000 bottles that was substituted for
Nicomide® after September 30, 2007. The net gain from settlement of the Rivers Edge
litigation for the three and six-month periods ended June 30, 2008 was $48,000 and $283,000,
respectively, and is recorded in the accompanying Condensed Consolidated Statement of Operations in
Settlements, net. There were no related gains or losses recorded in 2009.
On August 12, 2008, the Company entered into a worldwide non-exclusive patent License Agreement to
its patent covering Nicomide® with Rivers Edge Pharmaceuticals, LLC and an amendment to
its Settlement Agreement with Rivers Edge. The amendment to the Settlement Agreement, which has
been further amended in April 2009 as described in the following paragraph, had allowed Rivers
Edge to manufacture and market a prescription product that could be substitutable for
Nicomide® pursuant to the terms of the License Agreement and changed certain payment
obligations of Rivers Edge for sales of its substitutable product. In consideration for granting
the license, the Company was being paid a share of the net revenues, as defined in the License
Agreement, of Rivers Edges licensed product sales under the License Agreement. Royalty revenues
recorded pursuant to the License Agreement are recorded in Product Revenues in the accompanying
Consolidated Statements of Operations.
In April 2009, the Company and Rivers Edge entered into an Amendment to the License Agreement (the
License Amendment). The License Amendment granted Rivers Edge an exclusive license to U.S.
Patent, No. 6,979,468, and a license to use all know-how and the trademark associated with the
Licensed Products worldwide. Under the License Amendment, DUSA is required to transfer all of its
rights, title and interest in and to the DUSAs patent, know-how and trademark relating to the
Licensed Products (but not the copyright registration relating to product labeling) to Rivers Edge
upon the Companys receipt of $5,000,000. Of the $5,000,000, Rivers Edge is required to make a
minimum guaranteed payment to the Company of $2,600,000, in thirteen monthly installments of
$200,000, subject to reduction under certain conditions, and pay additional consideration of
$2,400,000 payable over time based on a share of Rivers Edges net revenues as defined in the
License Amendment. The License Agreement, as amended, has a term of 30 months, subject to a further
extension under certain circumstances to 48 months, and may be terminated early by Rivers Edge on
30 days prior written notice to the Company. Under the License Agreement, Rivers Edge has assumed
all regulatory responsibilities for the Licensed Products. If the License
Agreement is terminated prior to the payment of the $5,000,000, all of the rights and licenses granted by the
Company to Rivers Edge will revert to the Company. The Company is recording the revenue from the
License Amendment on a cash basis. The Company has received the first $200,000 installment payment
under the License Amendment during the three-month period ended June 30, 2009, which is included in
Product Revenues in the accompanying Consolidated Statements of Operations. The Company has not
received payments which were due on June 1, July 1 and August 1, 2009.
Winston Laboratories Arbitration Settlement
In October 2008, the Company was notified that Winston Laboratories, Inc. had filed a demand for
arbitration against the Company. The demand for arbitration arose out of the 2006 Micanol License
Agreement and subsequent 2006 Micanol
Transition License Agreement (together the Agreement), and claimed that the Company breached the
Agreement. Winston Laboratories claimed damages in excess of $2.0 million. The matter was settled
on April 28, 2009 for cash consideration of $75,000, and a mutual release.
16) COMMITMENTS AND CONTINGENCIES
Business Acquisition
On March 10, 2006, the Company acquired all of the outstanding common stock of Sirius Laboratories,
Inc (Sirius). The Company agreed to pay additional consideration in future periods to the former
Sirius shareholders based upon the achievement of total cumulative sales milestones for the Sirius
products over the period beginning with the closing of the acquisition and ending December 31,
2011. The first cumulative sales milestone was achieved during 2008, and accordingly a cash payment
in the amount of $1.5 million was paid to the former Sirius shareholders in that year. The payment
made during 2008 was recorded initially as goodwill and then subsequently deemed impaired and
expensed during the same period as described below.
13
If the remaining sales milestones are attained, they will be paid in either common stock or cash,
at the Companys sole discretion. The remaining cumulative sales milestones and related
consideration are, as follows:
|
|
|
|
|
|
|
Additional |
Cumulative Sales Milestone: |
|
Consideration: |
|
$35.0 million |
|
$1.0 million |
$45.0 million |
|
$1.0 million |
|
|
|
Total |
|
$2.0 million |
|
|
|
Third Amendment to Merger Agreement
In April 2009, the Company and the former shareholders of Sirius Laboratories, Inc., some of whom
were acting through their shareholder representatives, entered into a letter agreement providing
for the consent of the former Sirius shareholders to the Amendment to the License Agreement with
Rivers Edge mentioned above in Note 15 Settlements, Net, a release, and the Third Amendment to the
Merger Agreement, dated as of December 30, 2005, by and among the DUSA Pharmaceuticals, Inc.,
Sirius Laboratories, Inc. and the shareholders of Sirius. Pursuant to the Merger Agreement prior to
this amendment, the Company agreed to pay additional consideration after the closing of the merger
to the former shareholders of Sirius based upon the attainment of pre-determined total cumulative
sales milestones for the products acquired from Sirius over the period ending 50 months from the
date of the March 2006 closing of the original Merger Agreement. Pursuant to the documents entered
into in April 2009, the Company has agreed to extend the Milestone Termination Date from 50 months
from the date of the closing of the original Merger Agreement until December 31, 2011 and to
include in the definition of Net Sales, in the Merger Agreement, payments which the Company may
receive from the divestiture of Sirius products. The Third Amendment to the Merger Agreement also
removes the Companys obligation to market the Sirius products according to certain previously
required standards and allows the Company to manage all business activities relating to the
products acquired from Sirius without further approval from the former Sirius shareholders.
In April 2009 the Company paid to the former Sirius shareholders, on a pro rata basis, $100,000. In
addition, in the event that the $1,000,000 milestone payment that would become due to the former
Sirius shareholders under the Merger Agreement if cumulative Net Sales of the Sirius products reach
$35,000,000 is not, in fact, triggered by the new Milestone Termination Date, then the Company has
agreed to pay $250,000 to the former Sirius shareholders on a pro rata basis on or before January
6, 2012. The $100,000 payment to Sirius shareholders, along with the present value of the
guaranteed $250,000 milestone payment, or $205,000, have been included in general and
administrative expense for the three and six-month periods ended June 30, 2009 in the accompanying
Condensed Consolidated Statement of Operations.
The Company has not accrued amounts for any other potential contingencies as of June 30, 2009.
ITEM 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
OVERVIEW
We are a vertically integrated dermatology company that is developing and marketing
Levulan® photodynamic therapy, or PDT, and other products for common skin conditions.
Our marketed products include Levulan® Kerastick® 20% Topical Solution with
PDT, the BLU-U® brand light source, and ClindaReach®.
Historically, we devoted most of our resources to advancing the development and marketing of our
Levulan® PDT technology platform. In addition to our marketed products, our drug,
Levulan® brand of aminolevulinic acid HCl, or ALA, in combination with light, has been
studied in a broad range of medical conditions. When Levulan® is used and followed with
exposure to light to treat a medical condition, it is known as Levulan® PDT. The
Kerastick® is our proprietary applicator that delivers Levulan®. The
BLU-U® is our patented light device.
The Levulan® Kerastick® 20% Topical Solution with PDT and the
BLU-U® were launched in the United States, or U.S., in September 2000 for the treatment
of non-hyperkeratotic actinic keratoses, or AKs, of the face or scalp under a former dermatology
collaboration. 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. In addition, in September 2003
we received clearance from the United States Food and Drug Administration, or FDA, to market the
BLU-U® without Levulan® PDT for the treatment of moderate inflammatory acne
vulgaris and general dermatological conditions.
Sirius Laboratories, Inc., or Sirius, a dermatology specialty pharmaceuticals company, was founded
in 2000 with a primary focus on the treatment of acne vulgaris and acne rosacea.
Nicomide® was its key product, a vitamin-mineral product prescribed by dermatologists.
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
14
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®, or License Agreement, with Rivers Edge Pharmaceuticals, LLC,
or Rivers Edge, and an amendment to our Settlement Agreement with Rivers Edge regarding earlier
litigation. See Note 15 of the Notes to the Condensed Consolidated Financial Statements. The
amendment to the Settlement Agreement allowed Rivers Edge to manufacture and market a prescription
product that could be substitutable for Nicomide® pursuant to the terms of the License
Agreement and changed certain payment obligations of Rivers 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 Rivers Edges licensed product sales. In April 2009, we and
Rivers Edge entered into an Amendment to the License Agreement, or License Amendment. The License
Amendment grants Rivers Edge an exclusive license to U.S. Patent, No. 6,979,468, and a license to
use all know-how and the trademark associated with the Licensed Products worldwide. Under the
License Amendment, we are required to transfer all of our rights, title and interest in and to
DUSAs patent, know-how and trademark relating to the Licensed Products (but not the copyright
registration relating to product labeling) to Rivers Edge upon our receipt of $5,000,000. Of the
$5,000,000, Rivers Edge is required to make a minimum guaranteed payment to us of $2,600,000, in
thirteen monthly installments of $200,000, subject to reduction under certain conditions, and pay
additional consideration of $2,400,000 payable over time based on a share of Rivers Edges net
revenues as defined in the License Amendment. The License Agreement, as amended, has a term of 30
months, subject to a further extension under certain circumstances to 48 months, and may be
terminated early by Rivers Edge on 30 days prior written notice. Under the License Agreement,
Rivers Edge has assumed all regulatory responsibilities for the
Licensed Products. If the License Agreement is terminated prior to the payment of the $5,000,000, all of the rights and
licenses granted by us to Rivers Edge will revert to us. We are recording the revenue under the
License Amendment on a cash basis. We received the first $200,000 installment payment under the
License Amendment during the three-month period ended June 30, 2009, which is included in Product
Revenues in the accompanying Consolidated Statements of Operations. The Company has not received
the payments which were due on June 1, July 1 and August 1, 2009. We are evaluating our options to
collect the outstanding amounts due from Rivers Edge under the
License Agreement, as amended, and have not yet
determined our course of action.
We are marketing Levulan® PDT under an exclusive worldwide license of patents and
technology from PARTEQ Research and Development Innovations, the licensing arm of Queens
University, Kingston, Ontario, Canada. In January, 2009, we filed a request for reexamination with
the USPTO of one of the Queens patents that cover our approved indication for AK. We also own or
license certain other patents relating to our BLU-U® device and methods for using
pharmaceutical formulations which contain our drug and related processes and improvements. In the
United States, DUSA®, DUSA Pharmaceuticals, Inc.®, Levulan®,
Kerastick®, BLU-U®, Nicomide®, Nicomide-T®,
ClindaReach®, Meted®, and Psoriacap® 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 June 30, 2009, we had an accumulated deficit of approximately $144,311,000. 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.
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 not all of
these accounting policies 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. With the exception of the updated listed below, there have been no material changes to
our critical accounting policies in the six months ended June 30, 2009.
Fair Value Measurements of Marketable Securities
In determining the fair value of our marketable securities, we consider the level of market
activity and the availability of prices for the specific securities that we hold. For our Level 2
financial instruments, comprising our corporate debt and United States government-backed
securities, we use quoted market prices, broker or dealer quotations, or alternative pricing
sources with reasonable levels of price transparency in the determination of value. We also access
publicly available market activity from third party databases and credit ratings of the issuers of
the securities we hold to corroborate the data used in the fair value calculations obtained from
our primary source. We also take into account credit rating changes, if any, of the securities or
recent marketplace activity. We do not have any Level 1 or Level 3 marketable securities.
15
RESULTS OF OPERATIONS THREE AND SIX MONTHS ENDED JUNE 30, 2009 VERSUS JUNE 30, 2008
REVENUES Total revenues for the three and six-month periods ended June 30, 2009 were $6,966,000
and $14,104,000, respectively, as compared to $8,112,000 and $16,042,000 in 2008, and were
comprised of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
|
|
Six months ended |
|
|
|
|
June 30, |
|
|
|
|
|
June 30, |
|
|
|
|
|
|
|
|
|
|
|
|
INCREASE/ |
|
|
|
|
|
|
|
|
|
INCREASE/ |
|
|
2009 |
|
2008 |
|
(DECREASE) |
|
2009 |
|
2008 |
|
(DECREASE) |
|
|
|
PDT PRODUCT REVENUES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LEVULAN®
KERASTICK®
PRODUCT REVENUES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United States |
|
$ |
5,621,000 |
|
|
$ |
4,572,000 |
|
|
|
$1,049,000 |
|
|
$ |
11,306,000 |
|
|
|
$9,346,000 |
|
|
|
$1,960,000 |
|
Canada |
|
|
108,000 |
|
|
|
218,000 |
|
|
|
(110,000 |
) |
|
|
243,000 |
|
|
|
377,000 |
|
|
|
(134,000 |
) |
Korea |
|
|
126,000 |
|
|
|
159,000 |
|
|
|
(33,000 |
) |
|
|
296,000 |
|
|
|
524,000 |
|
|
|
(228,000 |
) |
Other |
|
|
84,000 |
|
|
|
133,000 |
|
|
|
(49,000 |
) |
|
|
171,000 |
|
|
|
190,000 |
|
|
|
(19,000 |
) |
Subtotal
Levulan®
Kerastick®
product revenues |
|
|
5,939,000 |
|
|
|
5,082,000 |
|
|
|
857,000 |
|
|
|
12,016,000 |
|
|
|
10,437,000 |
|
|
|
1,579,000 |
|
BLU-U® PRODUCT
REVENUES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United States |
|
|
479,000 |
|
|
|
347,000 |
|
|
|
132,000 |
|
|
|
1,121,000 |
|
|
|
822,000 |
|
|
|
299,000 |
|
|
|
|
Subtotal
BLU-U® product
revenues |
|
|
479,000 |
|
|
|
347,000 |
|
|
|
132,000 |
|
|
|
1,121,000 |
|
|
|
822,000 |
|
|
|
299,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL PDT PRODUCT REVENUES |
|
|
6,418,000 |
|
|
|
5,429,000 |
|
|
|
989,000 |
|
|
|
13,137,000 |
|
|
|
11,259,000 |
|
|
|
1,878,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL NON-PDT PRODUCT
REVENUES |
|
|
548,000 |
|
|
|
2,683,000 |
|
|
|
(2,135,000 |
) |
|
|
967,000 |
|
|
|
4,783,000 |
|
|
|
(3,816,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL PRODUCT REVENUES |
|
$ |
6,966,000 |
|
|
$ |
8,112,000 |
|
|
$ |
(1,146,000 |
) |
|
$ |
14,104,000 |
|
|
$ |
16,042,000 |
|
|
$ |
(1,938,000 |
) |
|
|
|
For the three and six-month periods ended June 30, 2009, total PDT Drug and Device Products
revenues, comprised of revenues from our Kerastick® and BLU-U® products, were
$6,418,000 and $13,137,000, respectively. This represents an increase of $989,000, or 18%, and
$1,878,000, or 17%, over the comparable 2008 totals of $5,429,000 and $11,259,000, respectively.
The incremental revenue was driven primarily by increased Kerastick® revenues and
BLU-U® revenues in the United States.
For the three and six-month periods ended June 30, 2009, Kerastick® revenues were
$5,939,000, and $12,016,000, respectively, representing a $857,000, or 17%, and $1,579,000, or 15%,
increase over the comparable 2008 totals of $5,082,000 and $10,437,000, respectively.
Kerastick® unit sales to end-users were 49,815 and 101,762, for the three and six-month
periods ended June 30, 2009, respectively, including on a year-to date basis 2,700 sold in Canada
and 3,726 sold in Korea. This represents an increase from 48,478 and 100,588 Levulan®
Kerastick® units sold in the three and six-month periods ended June 30, 2008,
respectively, including on a year-to date basis 4,800 sold in Canada and 8,100 sold in Korea. Our
overall average net selling price for the Kerastick® increased to $116.41 per unit for
the first six months of 2009 from $102.21 per unit for the first six months of 2008. Our average
net selling price for the Kerastick® in the United States increased to $121.75 per unit
in 2009 from $110.16 per unit in 2008. The increase in 2009 Kerastick® revenue was
driven by increased sales volumes in the United States along with the increase in our overall
average unit selling price.
For the three and six-month periods ended June 30, 2009, BLU-U® revenues were $479,000
and $1,121,000, respectively, representing a $132,000, or 38%, and $299,000, or 36%, increase over
the comparable 2008 totals of $347,000 and $822,000, respectively. The increase in year-to-date
2009 BLU-U® revenues was driven by increased overall sales volumes, partially offset by
a decrease in our average selling price. In the three and six-month periods ended June 30, 2009,
there were 58 and 139 units sold, respectively, versus 41 and 97 units sold, respectively, in the
comparable 2008 periods. All of the units sold
in
16
both years were sold in the United States. In
2009 on a year-to-date basis, our average net selling price for the BLU-U® decreased to
$7,637 from $8,134 in 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 June 30, 2009, there were approximately 25 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 Product revenues for the three and six-month periods ended
June 30, 2009 were $548,000 and $967,000, respectively, compared to $2,683,000 and $4,783,000,
respectively for the comparable 2008 periods. The substantial majority of the Non-PDT product
revenues were from Nicomide® related royalties from Rivers Edge, as further described
below, 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.
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 (the
License Agreement) to our patent covering Nicomide® with Rivers Edge Pharmaceuticals,
LLC and an amendment to our Settlement Agreement with Rivers Edge. In April 2009, we and Rivers
Edge entered into an Amendment to the License Agreement (the License Amendment) which granted
Rivers Edge an exclusive license to U.S. Patent, No. 6,979,468, and a license to use all know-how
and the trademark associated with the Licensed Products worldwide. Under the License Amendment,
DUSA is required to transfer all of its rights, title and interest in and to the DUSAs patent,
know-how and trademark relating to the Licensed Products (but not the copyright registration
relating to product labeling) to Rivers Edge upon our receipt of $5,000,000. Of the $5,000,000,
Rivers Edge is required to make a minimum guaranteed payment to us of $2,600,000, in thirteen
monthly installments of $200,000, subject to reduction under certain conditions, and pay additional
consideration of $2,400,000 payable over time based on a share of Rivers Edges net revenues as
defined in the License Amendment. The License Agreement, as amended, has a term of 30 months,
subject to a further extension under certain circumstances to 48 months, and may be terminated
early by Rivers Edge on 30 days prior written notice to us. Under the License Agreement, Rivers
Edge has assumed all regulatory responsibilities for the Licensed Products. If Rivers Edge
terminates the License Agreement prior to the payment of the $5,000,000, all of the rights and
licenses granted by us to Rivers Edge will revert to us. We are recording the revenue under the
License Amendment on a cash basis. We received the first $200,000 installment payment under the
License Amendment during the three-month period ended June 30, 2009, which is included in Product
Revenues in the accompanying Consolidated Statements of Operations. We have not received payments
which were due on June 1, July 1 and August 1, 2009. We are evaluating our options to collect the
outstanding amounts due from Rivers Edge under the License Agreement, as amended, and have not yet
determined our course of action.
The decrease in our total revenues for the three and six month periods ended June 30, 2009 compared
with the comparable periods 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.
We cannot provide any assurance that we will be able to increase sales sufficiently to become
profitable, and we cannot provide assurance that a material increase in sales will necessarily
cause us to be 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. 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 Medicare 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 caused some of our larger customers to accelerate their purchases in 2008, prior
to the price increases becoming effective, thus affecting our first half of 2009 revenues.
Although we expect growth in our PDT segment revenues, we are susceptible to the uncertain economic
conditions, particularly with our customer base in the U.S. that focuses on the cosmetic market and
with the international markets. Reduced sales to the cosmetic customer base and softness in the
international markets could be expected until the economy recovers. We expect our Non-PDT revenues
for the full year 2009 to be significantly reduced compared to 2008 since we are no longer
manufacturing and marketing Nicomide® and are experiencing difficulty collecting
payments due under the Nicomide® License Agreement.
COST OF PRODUCT REVENUES Cost of product revenues for the three and six-month periods ended June
30, 2009 were $1,441,000 and $3,379,000 as compared to $1,787,000 and $3,488,000 in the comparable
periods in 2008. A summary of the components of cost of product revenues and royalties is provided
below:
17
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
THREE MONTHS ENDED JUNE 30, |
|
|
|
|
|
|
|
|
|
|
INCREASE/ |
|
|
2009 |
|
2008 |
|
(DECREASE) |
|
|
|
Levulan® Kerastick® cost of product revenues and royalties
|
|
|
|
|
|
|
|
|
|
|
|
|
Direct Levulan® Kerastick® product costs |
|
$ |
539,000 |
|
|
$ |
594,000 |
|
|
$ |
(55,000 |
) |
Other Levulan® Kerastick® production costs including internal
costs assigned to support products, net |
|
|
89,000 |
|
|
|
(8,000 |
) |
|
|
97,000 |
|
Royalty and supply fees (1) |
|
|
235,000 |
|
|
|
223,000 |
|
|
|
12,000 |
|
|
|
|
Subtotal Levulan® Kerastick® cost of product revenues and royalties |
|
$ |
863,000 |
|
|
$ |
809,000 |
|
|
$ |
54,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BLU-U® cost of product revenues |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Direct BLU-U® product costs |
|
$ |
209,000 |
|
|
$ |
147,000 |
|
|
$ |
62,000 |
|
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 |
|
|
214,000 |
|
|
|
213,000 |
|
|
|
1,000 |
|
|
|
|
Subtotal BLU-U® cost of product revenues |
|
$ |
423,000 |
|
|
$ |
360,000 |
|
|
$ |
63,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL PDT DRUG AND DEVICE COST OF PRODUCT REVENUES AND ROYALTIES |
|
$ |
1,286,000 |
|
|
$ |
1,169,000 |
|
|
$ |
117,000 |
|
|
|
|
Non-PDT cost of product revenues and royalties |
|
$ |
155,000 |
|
|
$ |
618,000 |
|
|
$ |
(463,000 |
) |
|
|
|
TOTAL COST OF PRODUCT REVENUES AND ROYALTIES |
|
$ |
1,441,000 |
|
|
$ |
1,787,000 |
|
|
$ |
(346,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SIX MONTHS ENDED JUNE 30, |
|
|
|
|
|
|
|
|
|
|
INCREASE/ |
|
|
2009 |
|
2008 |
|
(DECREASE) |
|
|
|
Levulan® Kerastick® cost of product revenues and royalties
|
|
|
|
|
|
|
|
|
|
|
|
|
Direct Levulan® Kerastick® product costs |
|
$ |
1,103,000 |
|
|
$ |
1,232,000 |
|
|
$ |
(129,000 |
) |
Other Levulan® Kerastick® production costs including
internal costs assigned to support products, net |
|
|
448,000 |
|
|
|
2,000 |
|
|
|
446,000 |
|
Royalty and supply fees (1) |
|
|
488,000 |
|
|
|
471,000 |
|
|
|
17,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subtotal Levulan® Kerastick® cost of product revenues and
royalties |
|
$ |
2,039,000 |
|
|
$ |
1,705,000 |
|
|
$ |
334,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BLU-U® cost of product revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
Direct BLU-U® product costs |
|
$ |
500,000 |
|
|
$ |
348,000 |
|
|
$ |
152,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 |
|
|
462,000 |
|
|
|
390,000 |
|
|
|
72,000 |
|
|
|
|
Subtotal BLU-U® cost of product revenues |
|
$ |
962,000 |
|
|
$ |
738,000 |
|
|
$ |
224,000 |
|
|
|
|
TOTAL PDT DRUG AND DEVICE COST OF PRODUCT REVENUES AND ROYALTIES |
|
$ |
3,001,000 |
|
|
$ |
2,443,000 |
|
|
$ |
558,000 |
|
|
|
|
Non-PDT cost of product revenues and royalties |
|
$ |
378,000 |
|
|
$ |
1,045,000 |
|
|
$ |
(667,000 |
) |
|
|
|
TOTAL COST OF PRODUCT REVENUES AND ROYALTIES |
|
$ |
3,379,000 |
|
|
$ |
3,488,000 |
|
|
$ |
(109,000 |
) |
|
|
|
|
|
|
1) |
|
Royalty and supply fees reflect amounts paid to our licensor, PARTEQ Research and Development
Innovations, the licensing arm of Queens University, Kingston, Ontario, and ongoing royalties
paid to Draxis Health, Inc., on sales of the Levulan® Kerastick® in Canada. |
18
MARGINS Total product margins for the three and six-month periods ended June 30, 2009 were
$5,525,000 and $10,725,000, respectively, as compared to $6,325,000 and $12,554,000 for the
comparable 2008 periods, as shown below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
THREE MONTHS ENDED JUNE 30, |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
INCREASE/ |
|
|
|
2009 |
|
|
|
|
|
|
2008 |
|
|
|
|
|
|
(DECREASE) |
|
Levulan® Kerastick® gross margin |
|
$ |
5,076,000 |
|
|
|
85 |
% |
|
$ |
4,273,000 |
|
|
|
84 |
% |
|
$ |
803,000 |
|
BLU-U® gross margin |
|
|
56,000 |
|
|
|
12 |
% |
|
|
(13,000 |
) |
|
|
(4 |
)% |
|
|
69,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total PDT drug & device gross margin |
|
$ |
5,132,000 |
|
|
|
80 |
% |
|
$ |
4,260,000 |
|
|
|
78 |
% |
|
$ |
872,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Non-PDT gross margin |
|
|
393,000 |
|
|
|
72 |
% |
|
|
2,065,000 |
|
|
|
77 |
% |
|
$ |
(1,672,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL GROSS MARGIN |
|
$ |
5,525,000 |
|
|
|
79 |
% |
|
$ |
6,325,000 |
|
|
|
78 |
% |
|
$ |
(800,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SIX MONTHS ENDED JUNE 30, |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
INCREASE/ |
|
|
|
2009 |
|
|
|
|
|
|
2008 |
|
|
|
|
|
|
(DECREASE) |
|
Levulan® Kerastick® gross margin |
|
$ |
9,977,000 |
|
|
|
83 |
% |
|
$ |
8,731,000 |
|
|
|
84 |
% |
|
$ |
1,246,000 |
|
BLU-U® gross margin |
|
|
159,000 |
|
|
|
14 |
% |
|
|
85,000 |
|
|
|
10 |
% |
|
|
74,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total PDT drug & device gross margin |
|
$ |
10,136,000 |
|
|
|
77 |
% |
|
$ |
8,816,000 |
|
|
|
78 |
% |
|
$ |
1,320,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Non-PDT gross margin |
|
|
589,000 |
|
|
|
61 |
% |
|
|
3,738,000 |
|
|
|
78 |
% |
|
$ |
(3,149,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL GROSS MARGIN |
|
$ |
10,725,000 |
|
|
|
76 |
% |
|
$ |
12,554,000 |
|
|
|
78 |
% |
|
$ |
(1,829,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Kerastick® gross margins for the three and six-month periods ended June 30, 2009 were
85% and 83% versus 84% for both periods in 2008. The margin improvement for the second quarter is
attributable to increased U.S. sales volumes and an increased overall average selling price. 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 could achieve improved gross
margins on our Kerastick® during 2009 from further growth in the U.S.
BLU-U® margins for the three and six-month periods ended June 30, 2009 were 12% and 14%,
respectively, versus (4%) and 10% for the comparable 2008 periods. The increase in gross margin is
a result of increased sales volumes, partially offset by a decrease in our average selling price.
It is important for us to sell BLU-U® units in an effort to drive Kerastick®
sales volumes and accordingly, we may sell BLU-Us at low profit margins. Non-PDT Product gross
margins reflect the gross margin generated by the products acquired as part of our merger with
Sirius. Total gross margins for the three and six-month periods ended June 30, 2009 were 72% and
61%, respectively, compared to 77% and 78%, respectively, in the comparable prior year periods.
During the three and six-month periods ended June 30, 2009, Non-PDT Product margins 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 and six-month
periods ended June 30, 2009 were $1,077,000 and $2,262,000 as compared to $1,375,000 and $3,562,000
in the comparable 2008 periods. 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 $600,000 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 received a response to our application from the FDA in June 2009. The agency has requested
additional information in order to complete its review of our application, which includes
supplementary clinical data in support of our claims. We have requested a meeting with the FDA to
clarify our position, and we are currently evaluating our next steps regarding to the application.
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 in
the incidence of non-melanoma skin cancers in immunosuppressed solid organ transplant recipients,
or SOTRs, who have demonstrated that they are at risk of developing multiple squamous cell
carcinomas. 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. In May
2008, we filed an Orphan Drug Designation Application with the FDA for the prevention of cancer
occurrence in these patients with the FDA. We recently received correspondence from the FDA that
our application
19
was not granted on the basis that the agency believes that the prevalence of the
target population with this disease state is greater than 200,000, which is the maximum number of
patients allowed under the Orphan Drug legislation. We have requested a meeting with the FDA to
provide further clarification on the application and the related target population.
We have entered into a series of agreements for our research projects and clinical studies. As of
June 30, 2009 future minimum payments to be made pursuant to these agreements, under certain terms
and conditions, total approximately $531,000 for the remainder of 2009.
MARKETING AND SALES COSTS Marketing and sales costs for the three and six-month periods ended
June 30, 2009 were $3,037,000 and $6,447,000, respectively, as compared to $3,496,000 and
$6,553,000 for the comparable 2008 periods. 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 $2,247,000 and $4,556,000 for the three and six-month
periods ended June 30, 2009, compared to $2,290,000 and $4,375,000 in the comparable periods in
2008. The increase in spending in 2009 on a year-to-date basis is due to additional marketing and
sales headcount. The remaining expenses consisted of tradeshows, miscellaneous marketing and
outside consultants totaling $790,000 and $1,891,000 for the three and six-month periods ended June
30, 2009, compared to $1,206,000 and $2,178,000 for the comparable 2008 periods. The decrease in
this category is due primarily to a decrease in tradeshow and other promotional spending in 2009.
We expect marketing and sales costs for the full year 2009 to remain relatively constant with the
2008 levels.
GENERAL AND ADMINISTRATIVE COSTS General and administrative costs for the three and six-month
periods ended June 30, 2009 were $2,341,000 and $4,482,000, respectively, as compared to $2,325,000
and $4,692,000 for the comparable 2008 periods. The decrease on a year-to-date basis is mainly
attributable to a decrease in compensation-related costs, offset by the payment of $100,000 and
accrual of $205,000 related to the Third Amendment to the Merger Agreement and related documents
between us and the former Sirius shareholders entered into in April 2009. General and
administrative expenses are highly dependent on our legal and other professional fees, which can
vary significantly from period to period.
SETTLEMENTS, NET During the second quarter of 2009, we settled the arbitration case against us
brought by Winston Laboratories, Inc., or Winston, for a payment of $75,000, and a mutual release
and other customary terms. The arbitration case, initiated in October 2008, alleged that we
breached the 2006 Micanol License Agreement and subsequent 2006 Micanol Transition License
Agreement.
During the fourth quarter of 2007 we entered into a Settlement Agreement and Mutual Release with
Rivers Edge Pharmaceuticals, LLC. Under the terms of the Settlement Agreement, Rivers 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 and six-month
periods ended June 30, 2009 the net gain from settlement of litigation was $0 for both periods as
compared to $48,000 and 283,000 for the comparable 2008 periods. The payments under the Settlement
Agreement ceased in 2008 due to an amendment which the parties entered into effective as of July 3,
2008. See Note 15 to the Condensed Consolidated Financial Statements.
OTHER INCOME, NET Other income for the three and six-month periods ended June 30, 2009,
decreased to $79,000 and $144,000, respectively, from $217,000 and $424,000 during the comparable
2008 periods. This decrease reflects an increase in our average investable cash balances during
2009 as compared to 2008 along with a general decrease in interest rates over the same timeframe.
GAIN (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 decrease (increase) in the liability during the three and
six-month periods ended June 30, 2009 were $73,000 and ($62,000), respectively, from $468,000 and
$124,000 during the comparable 2008 periods, which resulted in a non-cash gains or losses in all
periods. The decreases or increases in fair value of the warrants are due primarily to changes in
our stock price and the length of time remaining prior to their expiration.
NET LOSS For the three and six-month periods ended June 30, 2009, we incurred net losses of
$853,000, or $0.04 per share, and $2,460,000, or $0.10 per share, respectively, as compared to net
losses $139,000, or $0.01 per share, and $1,423,000, or $0.06 per share for the comparable 2008
periods. The increase in the net loss is attributable to the reasons discussed above.
LIQUIDITY AND CAPITAL RESOURCES
At June 30, 2009, we had approximately $16,382,000 of total liquid assets, comprised of $3,894,000
of cash and cash equivalents and marketable securities available-for-sale totaling $12,488,000. 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. As of June 30,
2009, our marketable securities had a weighted average yield to maturity of 3.84% and maturity
dates ranging from September 2009 to January 2013. Our net cash used in operations for the
six-month period ended June 30, 2009 was $2,294,000 versus net cash provided by operations of
$133,000 the comparable prior year period. The year-over-year decrease in cash from operations is
primarily attributable to an increase in our net loss, a one-time payment of a significant
20
FDA fee,
a bonus payout in 2009 that did not occur in 2008, and a year-over-year decrease in payments
received from our international distributor partners. As of June 30, 2009 working capital (total
current assets minus total current liabilities) was $17,862,000, as compared to $20,278,000 as of
December 31, 2008. Total current assets decreased by $3,969,000 during the six-month period ended
June 30, 2009, due primarily to decreases in our marketable securities, accounts receivable,
inventory and prepaid and other current asset balances. Total current liabilities decreased by
$1,553,000 during the same period due primarily to a decrease in accrued compensation and other
accrued expenses. In response to the instability in the financial markets, we regularly review our
marketable securities holdings, and have reduced or avoided investing in securities deemed to have
increased risk..
Since our inception, we have generated significant losses while we have conducted preclinical and
clinical trials, engaged in research and development and dedicated resources to the
commercialization of our products. We have also incurred significant losses from the impairment of
assets acquired in the acquisition of Sirius. We have funded our operations primarily through
public offerings, private placements of equity securities and payments received under our
collaboration agreements. We expect to incur significant additional research and development and
other costs including costs related to preclinical studies and clinical trials. Our costs,
including research and development costs for our product candidates and sales, marketing and
promotion expenses for any of our existing or future products to be marketed by us or our
collaborators may exceed revenues in the future, which may result in continued losses from
operations.
We may expand or enhance our business in the future by using our resources to acquire by license,
purchase or other arrangements, additional businesses, new technologies, or products in the field
of dermatology. For 2009, we are focusing primarily on increasing the sales of the
Levulan® Kerastick® and the BLU-U®, as well as the
Non-Photodynamic Therapy Drug Products and advancing our Phase II study for use of
Levulan® PDT in SOTR.
If we continue to be unprofitable and do not become cash flow positive from operations within a
reasonable time, we may reduce our headcount or reduce spending in other areas. We may also seek to
raise funds through financing transactions. We cannot predict whether financing will be available
at all or on reasonable terms.
As part of our merger with Sirius, as amended, we agreed to pay additional consideration to the
former shareholders of Sirius in future periods, based upon the attainment of pre-determined total
cumulative sales milestones for the Sirius products over the period ending December 31, 2011. The
pre-determined cumulative sales milestones for the Sirius products and the related milestone
payments which may be paid in cash or shares, as we may determine, are as follows:
|
|
|
|
|
|
|
Additional |
|
Cumulative Sales Milestone: |
|
Consideration: |
|
$35.0 million |
|
$1.0 million |
$45.0 million |
|
$1.0 million |
|
|
|
|
|
|
|
|
|
Total |
|
$2.0 million |
|
|
|
|
The first cumulative sales milestone at $25.0 million was achieved during the third quarter of
2008, and a cash payment in the amount of $1.5 million was paid to the former Sirius shareholders
during that period. The payment was recorded initially as goodwill and then subsequently deemed
impaired and expensed during the same period. In April 2009, we entered into the Third Amendment to
the Merger Agreement, or Third Amendment, as described in Note 16 to the Notes to the Condensed
Consolidated Financial Statements. As consideration for the Third Amendment and related documents,
we paid the former Sirius shareholders $100,000 on a pro rata basis and have guaranteed a payment
of $250,000 in January 2012 to the former Sirius shareholders if the $35,000,000 sales milestone is
not triggered.
We have no off-balance sheet financing arrangements.
Contractual Obligations and Other Commercial Commitments
L. PERRIGO COMPANY
On October 25, 2005, the former Sirius entered into a supply agreement with L. Perrigo Company, or
Perrigo, for the exclusive manufacture and supply of a proprietary device/drug kit designed by
Sirius pursuant to an approved ANDA owned by Perrigo. The agreement was assigned to us as part of
the Sirius merger. We were responsible for all development costs and for obtaining all necessary
regulatory approvals and launched the product, ClindaReach®, in March 2008. Perrigo is
entitled to royalties on net sales of the product, including certain minimum annual royalties,
which commenced May 1, 2006, in the amount of $250,000. The initial term of the agreement expires
in July, 2011 and may be renewed based on certain minimum purchase levels and other terms and
conditions.
MERGER WITH SIRIUS LABORATORIES, INC.
In March 2006, we closed our merger to acquire all of the common stock of Sirius Laboratories Inc.
in exchange for cash and common stock worth up to $30,000,000. Of the up to $30,000,000, up to
$5,000,000, ($1,500,000 of which would be paid in
21
cash, and $3,500,000 of which would be paid in
cash or common stock) may be paid based on a combination of new product approvals or launches, and
achievement of certain pre-determined total cumulative sales milestones for Sirius products. With
the launch of ClindaReach®, one of the new Sirius products, we were obligated to make a
cash payment of $500,000 to the former shareholders of Sirius. Also, as a consequence of the
decision not to launch the product under development with Altana and pursuant to the terms of the
merger agreement with Sirius, we paid $250,000 on a pro rata basis to the former Sirius
shareholders. Similarly, with our decision in early 2008 not to develop a third product from a list
of product candidates acquired as part of the merger, we paid another $250,000 on a pro rata basis
to the former Sirius shareholders. The payments for ClindaReach® and the other two
product decisions satisfy our obligations for the $1,500,000 portion of the purchase price
mentioned above. In the third quarter of 2008, the first of the pre-determined total cumulative
sales milestones for Sirius products was achieved, and accordingly, we made a cash payment of
$1,500,000 to the former Sirius shareholders in consideration of the milestone achievement. In
connection with the Third Amendment, we paid the former Sirius shareholders $100,000 on a pro rata
basis. In addition, in the event that the $1,000,000 milestone payment that would become due to
the former Sirius shareholders under the Merger Agreement if cumulative Net Sales of the Sirius
products reach $35,000,000 is not, in fact, triggered by the new Milestone Termination Date, then
we have agreed to pay $250,000 to the former Sirius shareholders on a pro rata basis on or before
January 6, 2012. The $100,000 payment to Sirius shareholders, along with the present value of the
guaranteed $250,000 milestone payment, or $205,000, have been included in general and
administrative expense for the three and six-month periods ended June 30, 2009 in the accompanying
Condensed Consolidated Statement of Operations.
PARTEQ AGREEMENT
We license certain patents underlying our Levulan® PDT/PD systems under a license
agreement with PARTEQ Research and Development Innovations, or PARTEQ. Under the agreement, we have
been granted an exclusive worldwide license, with a right to sublicense, under PARTEQ patent
rights, to make, have made, use and sell certain products, including ALA. The agreement covers
certain use patent rights. When we sell our products directly, we have agreed to pay to PARTEQ
royalties of 6% and 4% on 66% of the net selling price in countries where patent rights do and do
not exist, respectively. In cases where we have a sublicensee, we will pay 6% and 4% when patent
rights do and do not exist, respectively, on our net selling price less the cost of goods for
products sold to the sublicensee, and 6% of payments we receive on sales of products by the
sublicensee. We are also obligated to pay to PARTEQ 5% of any lump sum sublicense fees received,
such as milestone payments, excluding amounts designated by the sublicensee for future research and
development efforts.
Annual minimum royalties to PARTEQ must total at least CDN $100,000 ($87,000 as of June 30, 2009).
NATIONAL BIOLOGICAL CORPORATION AMENDED AND RESTATED PURCHASE AND SUPPLY AGREEMENT
On June 29, 2009, we extended the term of the 2004 Amended and Restated Purchase and Supply
Agreement with National Biological Corporation, or NBC, one of the manufacturers of our
BLU-U® light source, until June 30, 2011. We have an option to further extend the term
for an additional two (2) years if it purchases a certain number of units. The parties agreed upon
a tiered price schedule based on the volume of purchases and updated certain quality control
provisions. All other terms and conditions of the 2004 agreement remain in effect.
SOCHINAZ SA
Under an agreement dated December 24, 1993, Sochinaz SA manufactures and supplies our requirements
of Levulan® from its FDA approved facility in Switzerland. The agreement expires on
December 31, 2009 and we are in discussions with Sochinaz regarding terms for its renewal. While we
can obtain alternative supply sources in certain circumstances, any new supplier
would have to be inspected and qualified by the FDA. If we fail to renew the agreement with
Sochinaz, it could have a material negative effect on our financial position and results of
operation.
LEASE AGREEMENTS
We have entered into lease commitments for office space in Wilmington, Massachusetts, and Toronto,
Ontario. The minimum lease payments disclosed below include the non-cancelable terms of the leases.
In the fourth quarter of 2008, we vacated the Toronto, Ontario office and have subleased the space
through June 30, 2010.
RESEARCH AGREEMENTS
We have entered into various agreements for research projects and clinical studies. As of June 30,
2009, future payments to be made pursuant to these agreements, under certain terms and conditions,
totaled approximately $1,202,000. Included in this future minimum payment is a master service
agreement, effective June 15, 2001, with Therapeutics, Inc., which is renewable on an annual basis,
to engage Therapeutics to manage the clinical development of our products in the field of
dermatology. The agreement was renewed on June 15, 2009 for a one year period. Therapeutics is
entitled to receive a bonus valued at $50,000, in cash or stock at our discretion, upon each
anniversary of the effective date.
22
Our contractual obligations and other commercial commitments to make future payments under
contracts, including lease agreements, research and development contracts, manufacturing contracts,
or other related agreements are as follows at June 30, 2009:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
1 Yr or less |
|
|
2-3 Years |
|
|
4-5 Years |
|
|
After 5 |
|
Operating lease obligations |
|
$ |
1,437,000 |
|
|
$ |
441,000 |
|
|
$ |
960,000 |
|
|
$ |
36,000 |
|
|
$ |
|
|
Purchase obligations (1, 2) |
|
|
3,124,000 |
|
|
|
2,676,000 |
|
|
|
448,000 |
|
|
|
|
|
|
|
|
|
Minimum royalty obligations (3) |
|
|
741,000 |
|
|
|
336,000 |
|
|
|
297,000 |
|
|
|
108,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total obligations |
|
$ |
5,302,000 |
|
|
$ |
3,453,000 |
|
|
$ |
1,705,000 |
|
|
$ |
144,000 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1) |
|
Research and development projects include various commitments including obligations for our
study on 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. |
|
2) |
|
In addition to the obligations disclosed above, we have contracted with Therapeutics, Inc.,
a clinical research organization, to manage the clinical development of our products in the
field of dermatology. This organization has the opportunity for additional stock grants,
bonuses, and other incentives for each product indication ranging from $250,000 to
$1,250,000, depending on the regulatory phase of development of products under Therapeutics
management. |
|
3) |
|
Minimum royalty obligations relate to our agreements with PARTEQ and Perrigo described above. |
Rent expense incurred under operating leases was approximately $97,000 and $196,000 for the three
and six-month periods ended June 30, 2009, respectively, compared to $111,000 and $221,000 for the
comparable 2008 periods.
INFLATION
Although inflation rates have been comparatively low in recent years, inflation is expected to
apply upward pressure on our operating costs. We have included an inflation factor in our cost
estimates.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Our exposure to market risk for changes in interest rates relates primarily to our investment
portfolio. We do not use derivative financial instruments in our investment portfolio. Our
investment policy specifies credit quality standards for our investments and limits the amount of
credit exposure to any non-U.S. government single issue, issuer or type of investment. Our
investments consist of United States government securities and high grade corporate bonds. All
investments are carried at market value.
As of June 30, 2009, the weighted average yield to maturity on our investments was 3.84%. If market
interest rates were to increase immediately and uniformly by 100 basis points from levels as of
June 30, 2009, the fair market value of the portfolio would decline by $115,000. Declines in
interest rates could, over time, reduce our interest income.
ITEM 4. CONTROLS AND PROCEDURES
We carried out an evaluation, under the direction of our Chief Executive Officer and Chief
Financial Officer, of the effectiveness of the design and operation of our disclosure controls and
procedures (as defined in the Securities Exchange Act of 1934, Rules 13a-15(e) and 15d-15(e)).
Based upon that evaluation, the Chief Executive Officer and Chief Financial Officer concluded that
our disclosure controls and procedures were effective as of June 30, 2009.
There have been no changes in our internal control over financial reporting that occurred during
the quarter ended June 30, 2009 that have materially affected, or are reasonably likely to
materially affect, our internal control over financial reporting.
Forward-Looking Statements Safe Harbor
This report, including the Managements Discussion and Analysis of Financial Condition and Results
of Operations, contains various forward-looking statements within the meaning of Section 27A of
the Securities Act of 1933 and 21E of the Securities Exchange Act of 1934 which represent our
expectations or beliefs concerning future events, including, but not limited to managements
statements regarding our focus for 2009, our use of estimates and assumptions in the preparation of
our financial statements and policies and impact on us of the adoption of certain accounting
standards, managements beliefs regarding the unique nature of Levulan® and its use and
potential use, expectations regarding the enrollment and timing of
23
results of clinical trials and
investigator studies, future development of Levulan® and our other products and other
potential indications, beliefs concerning manufacture of the BLU-U®, intention to
pursue licensing, marketing, co-promotion, collaboration or acquisition opportunities, status of
clinical programs for all other indications and beliefs regarding potential efficacy and marketing,
our beliefs regarding the safety, simplicity, reliability and cost-effectiveness of certain light
sources, expectations regarding additional market expansion and increased sales, expectations
regarding the marketing and distribution of Levulan® Kerastick® by Daewoong
Pharmaceutical Co., Ltd. and Stiefel Laboratories, Inc., beliefs regarding the clinical benefit of
Levulan® PDT for other indications, expectations regarding the confidentiality of our
proprietary information, statements of our intentions to seek additional U.S. and foreign
regulatory approvals, and to market and increase sales outside the U.S., beliefs regarding
regulatory classifications, filings, timelines, off-label use and environmental compliance, beliefs
concerning patent disputes and litigation, intentions to defend our patent estate, the impact of a
third-partys regulatory compliance and fulfillment of contractual obligations, beliefs concerning
the impact of price increases, expectations of increases or decreases in cost of product sales,
expected use of cash resources, requirements of cash resources for our future liquidity, beliefs
regarding investments, beliefs regarding economic conditions, beliefs concerning increased margins,
expectations regarding outstanding options and warrants and our dividend policy, anticipation of
increases or decreases in personnel, beliefs regarding the effect of reimbursement policies on
revenues and acceptance of our therapies, expectations for future strategic opportunities and
research and development programs and expenses, expectations for continuing operating losses and
competition including from Metvixia®, expectations for growth of PDT segment revenues
and reduction of Non-PDT segment revenues, expectations regarding the adequacy and availability of
insurance, expectations regarding general and administrative costs, expectations regarding legal
expenses, sales and marketing costs and research and development costs, levels of interest income
and our capital resource needs, intention to raise additional funds to meet capital requirements
and the potential dilution and impact on our business, potential for additional inspection and
testing of our manufacturing facilities or additional FDA actions, beliefs regarding the adequacy
of our inventory of Kerastick® and BLU-U® units, our manufacturing
capabilities and the impact of inventories on revenues, beliefs regarding interest rate risks to
our investments and effects of inflation, beliefs regarding the impact of any current or future
legal proceedings, dependence on key personnel, and beliefs concerning product liability insurance,
the enforceability of our patents, the impact of generic products, our beliefs regarding our sales
and marketing efforts, competition with other companies, the adoption of our products, and the
outcome of such efforts, our beliefs regarding the use of our products and technologies by third
parties, our beliefs regarding our compliance with applicable laws, rules and regulations, our
beliefs regarding available reimbursement for our products, our beliefs regarding the current and
future clinical development and testing of our potential products and technologies and the costs
thereof, the volatility of our stock price, the impact of our rights plan, the possibility that the
holders of options and warrants will purchase our common stock by exercising these securities,
statements regarding milestone payments to former Sirius shareholders, statements regarding the
possibility of other companies distributing our products, statements regarding failure to renew the
agreement with Sochinaz, statements regarding our royalty revenues, statements regarding the impact
of our marketing and sales efforts on revenues and financial conditions and statements regarding
the termination of the agreement with Rivers Edge. These forward-looking statements are further
qualified by important factors that could cause actual results to differ materially from those in
the forward-looking statements. These factors include, without limitation, changing market and
regulatory conditions, actual clinical results of our trials, the impact of competitive products,
pricing and timely development, FDA and foreign regulatory approval, and market acceptance of our
products, environmental risks relating to our products, reliance on third-parties for the
production, manufacture, sales and marketing of our products, the availability of products for
acquisition and/or license on terms agreeable to us, sufficient sources of funds and profitability,
the securities
regulatory process, the maintenance of our patent portfolio and ability to obtain competitive
levels of reimbursement by third-party payors, none of which can be assured. Results actually
achieved may differ materially from expected results included in these statements as a result of
these or other factors.
PART II OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS.
In October 2008, we were notified that Winston Laboratories, Inc. had filed a demand for
arbitration against us. The demand for arbitration arose out of the 2006 Micanol License Agreement
and subsequent 2006 Micanol Transition License Agreement, which we refer to together as the
Agreement, and claimed that we breached the Agreement. The matter was settled on April 28, 2009
for cash consideration of $75,000, a mutual release and other customary terms.
ITEM 1A. RISK FACTORS
Investing in our common stock is very speculative and involves a high degree of risk. You should
carefully consider and evaluate all of the information in, or incorporated by reference in, this
report. The following are among the risks we face related to our business, assets and operations.
They are not the only ones we face. Any of these risks could materially and adversely affect our
business, results of operations and financial condition, which in turn could materially and
adversely affect the trading price of our common stock and you might lose all or part of your
investment.
24
This report contains forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995 that involve risks and uncertainties, such as statements of our
plans, objectives, expectations and intentions. We use words such as anticipate, believe,
expect, future and intend and similar expressions to identify forward-looking statements. Our
actual business, financial condition and results of operations could differ materially from those
anticipated in these forward-looking statements for many reasons, including the factors described
below and elsewhere in this report. You should not place undue reliance on these forward-looking
statements, which apply only as of the date of this report.
Risks Related To DUSA
We Are Not Currently Profitable And May Not Be Profitable In The Future Unless We Can Successfully
Market And Sell Significantly Higher Quantities Of Our Products.
If We Do Not Become Profitable, We May Need More Capital.
We have approximately $16,382,000 in cash, cash equivalents and marketable securities as of June
30, 2009. Our cash, cash equivalents and marketable securities should be sufficient for current
operations for at least the next 12 months. If we are unable to become profitable in the near term,
we may have to reduce our headcount, curtail certain variable expenses, or raise funds through
financing transactions. We cannot predict whether financing will be available at all or on
reasonable terms.
If A Competitive Product Is Successful Our Market Share Could Decrease and Our Ability Become
Profitable Could Be Delayed
On May 30, 2006, we entered into a patent license agreement with PhotoCure ASA whereby we granted a
non-exclusive license to PhotoCure under the patents we license from PARTEQ, for esters of ALA.
Furthermore, we granted a non-exclusive license to PhotoCure for its existing formulations of its
Hexvix® and Metvix® (known in the United States as Metvixia®)
products for any DUSA patents that may issue or be licensed by us in the future. PhotoCure received
FDA approval to market Metvixia® for treatment of AKs in July 2004 and it is directly
competitive with our Levulan® Kerastick® product. Metvixia® is now
commercially available and its price is comparable to the price of Levulan®. We are
entitled to royalties from PhotoCure on its net sales of Metvixia, however, since it is marketed in
the U.S. by a large dermatology company, which has a large sales force and considerably more
resources than we have, our ability to maintain or increase our market could be significantly
hampered.
Our Ability To Become Profitable May Be Delayed Since We No Longer Sell Nicomide® As A
Prescription Product.
On August 12, 2008, we entered into a worldwide non-exclusive patent License Agreement to our
patent covering Nicomide® with Rivers Edge Pharmaceuticals, LLC and an amendment to our
Settlement Agreement with Rivers Edge which we entered into in October 2007 to settle certain
patent litigation. The amendment to the Settlement Agreement allows Rivers Edge to manufacture and
market a prescription product that could be substitutable for Nicomide® pursuant to the
terms of the License Agreement and changes certain payment obligations of Rivers 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 Rivers Edges licensed product sales under
the License Agreement. In April 2009, we and Rivers Edge entered into an Amendment to the License
Agreement (the License Amendment). The License Amendment grants Rivers Edge an exclusive license
to U.S. Patent, No.
6,979,468, and a license to use all know-how and the trademark associated with the Licensed
Products worldwide. Under the License Amendment, we are required to transfer all of our rights,
title and interest in and to our patent, know-how and trademark relating to the Licensed Products
(but not the copyright registration relating to product labeling) to Rivers Edge upon our receipt
of $5,000,000. Of the $5,000,000, Rivers Edge is required to make a minimum guaranteed payment to
us of $2,600,000, in thirteen monthly installments of $200,000, subject to reduction under certain
conditions, and pay additional consideration of $2,400,000 payable over time based on a share of
Rivers Edges net revenues as defined in the License Amendment. We received the first $200,000
installment payment under the License Amendment during the three-month period ended June 30, 2009,
which is included in Product Revenues in the accompanying Consolidated Statements of Operations.
We have not received payments which were due on June 1, July 1 and August 1, 2009. We are
evaluating our options to collect the outstanding amounts due from Rivers Edge under the License
Agreement, as amended, and have not yet determined our course of action. The License Agreement, as amended, has
a term of 30 months, subject to a further extension under certain circumstances to 48 months, and
may be terminated early by Rivers Edge on 30 days prior written notice to us. Under the License
Agreement, Rivers Edge has assumed all regulatory responsibilities for the Licensed Products. If
the License Agreement is terminated prior to the payment of the $5,000,000, all of the
rights and licenses granted by us to Rivers Edge will revert to us. Once we receive $5,000,000
under the terms of the License Agreement, we will no longer receive any revenues from sales of this
product. If the License Agreement is terminated before we receive $5,000,000, we may
consider selling the product in accordance with the Dietary Supplement Health and Education Act,
but in that case, we would expect volume and revenues to be lower than historical levels.
25
Another company has launched a substitutable niacinamide product. In July 2009, Rivers Edge filed
a lawsuit against it alleging infringement of this patent, and the validity of the
Nicomide® patent could be tested again. It is too early in the litigation to assess the
possible outcomes. Also, new products have been launched that are competing with
Nicomide®.
If Product Sales Do Not Continue to Increase, We May Not Be Able To Advance Development Of Our
Other Potential Products As Quickly As We Would Like To, Which Would Delay The Approval Process And
Marketing Of New Potential Products, if approved.
If we do not generate sufficient revenues from our approved products, we may be forced to delay or
abandon our development program for solid organ transplant recipients or other programs we may wish
to initiate. The pharmaceutical development and commercialization process is time consuming and
costly, and any delays might result in higher costs which could adversely affect our financial
condition and results of operations. Without sufficient product sales, we would need alternative
sources of funding. There is no guarantee that adequate funding sources could be found to continue
the development of our technology.
Any Failure To Comply With Ongoing Governmental Regulations In The United States And Elsewhere Will
Limit Our Ability To Market Our Products And Become Profitable.
The manufacture and marketing of our products are subject to continuing FDA review as well as
comprehensive regulation by the FDA and by state and local regulatory authorities. These laws
require, among other things:
|
|
|
approval of manufacturing facilities, including adherence to good manufacturing
and laboratory practices during production and storage, |
|
|
|
|
controlled research and testing of some of these products even after approval, |
|
|
|
|
control of marketing activities, including advertising and labeling, and |
|
|
|
|
state permits for the sale and distribution of products manufactured out-of-state. |
If we, or any of our contract manufacturers, fail to comply with these requirements, we may be
limited in the jurisdictions in which we are permitted to sell our products. Additionally, if we or
our manufacturers fail to comply with applicable regulatory approval requirements, a regulatory
agency may:
|
|
|
send warning letters, |
|
|
|
|
impose fines and other civil penalties on us, |
|
|
|
|
seize our products, |
|
|
|
|
suspend our regulatory approvals, |
|
|
|
|
cease the manufacture of our products, |
|
|
|
|
refuse to approve pending applications or supplements to approved applications filed by us, |
|
|
|
|
refuse to permit exports of our products from the United States, |
|
|
|
|
require us to recall products, |
|
|
|
|
require us to notify physicians of labeling changes and/or product related problems, |
|
|
|
|
impose restrictions on our operations, and/or |
|
|
|
|
criminally prosecute us. |
We and our manufacturers must continue to comply with cGMP and Quality System Regulation, or QSR,
and equivalent foreign regulatory requirements. The cGMP requirements govern quality control and
documentation policies and procedures. In complying with cGMP and foreign regulatory requirements,
we and our third-party manufacturers will be obligated to expend time, money and effort in
production, record keeping and quality control to assure that our products meet applicable
specifications and other requirements.
26
Manufacturing facilities are subject to ongoing periodic inspection by the FDA, including
unannounced inspections. We cannot guarantee that our third-party supply sources, including our
sole source supplier for the active ingredients in Levulan® and the BLU-U® or
our own Kerastick® facility, will continue to meet all applicable FDA regulations. If
we, or any of our manufacturers, including without limitation, the manufacturer of the
BLU-U®, who has received warning letters from the FDA, fail to maintain compliance with
FDA regulatory requirements, it would be time consuming and costly to remedy the problem(s) or to
qualify other sources. These consequences could have a significant adverse effect on our financial
condition and operations. As part of our FDA approval for the Levulan®
Kerastick® for AK, we were required to conduct two Phase IV follow-up studies. We
successfully completed the first study; and submitted our final report on the second study to the
FDA in January 2004. The FDA has requested additional information, which was provided to them in
June 2008. We are awaiting their response. Additionally, if previously unknown problems with the
product, a manufacturer or its facility are discovered in the future, changes in product labeling
restrictions or withdrawal of the product from the market may occur. Any such problems could affect
our ability to become profitable.
The Current Global Credit And Financial Market Conditions May Affect Our Business.
Sales of our products are dependent, in large part, on reimbursement from government health and
administration authorities, private health insurers, distribution partners and other organizations.
As a result of the current global credit and financial market conditions, government authorities
and private insurers may be unable to satisfy their reimbursement obligations or may delay payment.
In addition, federal and state health authorities may reduce Medicare and Medicaid reimbursements,
and private insurers may increase their scrutiny of claims. A reduction in the availability or
extent of reimbursement could negatively affect our product sales and revenues.
Due to the recent tightening of global credit, there may be disruption or delay in the performance
by our third-party contractors, suppliers or collaborators. We rely on third parties for several
important aspects of our business, including the active ingredient in Levulan® and key
portion of the BLU-U®, portions of our product manufacturing, royalty revenues, clinical
development of future collaboration products, conduct of clinical trials and the supply of raw
materials. If such third parties are unable to satisfy their commitments to us, our business would
be adversely affected. See Risk Factor Our Ability To Become Profitable May Be Delayed Since We
No Longer Sell Nicomide® As A Prescription Product.
If the Economic Slowdown Affects Our Market, Our Cash Burn Will Increase And Our Ability To Achieve
Profitability Will Be Delayed.
We are aware that a portion of our revenues is generated by patients that pay for their procedures
out-of-pocket. We believe that the recession may be causing these patients to postpone or cancel
their procedures, reducing our volume, and, if this continues, we will be required to use more of
our cash. This could cause a delay in our ability to achieve profitability on a sustainable basis.
If any of our large customers were to suffer economic hardship and fail to pay us for their
purchases of our products, our ability to reach profitability could be delayed.
We Have Significant Losses And Anticipate Continued Losses.
We have a history of operating losses. We expect to have continued losses until sales of our
products increase substantially. We incurred net losses of $6,250,000, $14,714,000 and $31,350,000
for the years ended December 31, 2008, 2007 and 2006, respectively, and $2,460,000 for the
six-month period ended June 30, 2009. As of June 30, 2009, our accumulated deficit was
approximately $144,000,000. 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 at all.
If We Are Unable To Obtain The Necessary Capital To Fund Our Operations, We Will Have To Delay Our
Development Program And May Not Be Able To Complete Our Clinical Trials.
We will need substantial additional funds to fully develop, manufacture, market and sell other
potential products. We may obtain funds through other public or private financings, including
equity financing, and/or through collaborative arrangements. Depending on the extent of available
funding, we may delay, reduce in scope or eliminate our SOTR research and development program. We
may also choose to license rights to third parties to commercialize products or technologies that
we would otherwise have attempted to develop and commercialize on our own which could reduce our
potential revenues.
The availability of additional capital to us is uncertain. There can be no assurance that
additional funding will be available to us on favorable terms, if at all. Any equity financing, if
needed, would likely result in dilution to our existing shareholders, and debt financing, if
available, would likely involve significant cash payment obligations and include restrictive
covenants that would adversely affect the operation of our business. Failure to raise capital if
needed could materially adversely affect our business, our financial condition, results of
operations and cash flows.
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If We Are Not Successful With The Reexamination Of Our Patent, We Could Lose Market Share.
In January 2009, we filed a request for reexamination with the United States Patent and Trademark
Office (USPTO) of one of the patents licensed from Queens University covering certain methods of
using our product, Levulan® , for our FDA-approved indication. The USPTO accepted our
request for reexamination during the first quarter of 2009. There is no guarantee that the process
will be successful since the USPTO reviews the entire prosecution history of a patent during a
reexamination and could determine that some or all of the patent claims are invalid. Typically, a
reexamination takes approximately 18 months to complete. The patent is due to expire in 2013. If
the USPTO finds that the patent is invalid, generic competitors could enter the market and we could
lose market share. This would adversely affect our financial condition and results of operations
and possibly prevent us from becoming profitable.
We Have Limited Patent Protection, And If We Are Unable To Protect Our Proprietary Rights,
Competitors Might Be Able To Develop Similar Products To Compete With Our Products And Technology.
Our ability to compete successfully depends, in part, on our ability to defend patents that have
issued, obtain new patents, protect trade secrets and operate without infringing the proprietary
rights of others. We have no compound patent protection for our Levulan® brand of the
compound ALA. Our basic ALA patents are for methods of detecting and treating various diseased
tissues using ALA (or related compounds called precursors), in combination with light. We own or
exclusively license ALA patents and patent applications related to the following:
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unique physical forms of ALA. |
We also own patents covering our BLU-U® and our Kerastick®. However, other
third-parties may have blue light devices or drug delivery devices that do not infringe our
patents.
The patents relating to methods of using ALA for detecting or treating disease, other than for acne
and our approved indication for AKs of the face or scalp, started to expire in July 2009. The
patents covering our AK product do not start to expire until 2013. In January 2009, we filed an
application with the USPTO for reexamination of one of our patents. If the USPTO determines that
the patent is invalid, generic competitors could enter the market.
We have limited ALA patent protection outside the United States, which may make it easier for
third-parties to compete there. Our basic method of treatment patents and applications have
counterparts in only six foreign countries, and certain countries under the European Patent
Convention. Even where we have patent protection, there is no guarantee that we will be able to
enforce our patents. Additionally, enforcement of a given patent may not be practicable or an
economically viable alternative.
Some of the indications for which we may develop PDT therapies may not be covered by the claims in
any of our existing patents. Even with the issuance of additional patents to us, other parties are
free to develop other uses of ALA, including medical uses, and to market ALA for such uses,
assuming that they have obtained appropriate regulatory marketing approvals. ALA in the chemical
form has been commercially supplied for decades, and is not itself subject to patent protection.
There are reports of third-parties conducting clinical studies with ALA in countries outside the
United States where PARTEQ, the licensor of our ALA patents, does not have patent protection. In
addition, a number of third-parties are seeking patents for uses of ALA not covered by our patents.
These other uses, whether patented or not, and the commercial availability of ALA, could limit the
scope of our future operations because ALA products could come on the market which would not
infringe our patents but would compete with our Levulan® products even though they are
marketed for different uses.
On August 12, 2008, we entered into a worldwide non-exclusive patent License Agreement to our
patent covering Nicomide® with Rivers Edge and an amendment to our Settlement Agreement
with Rivers Edge. The amendment to the Settlement Agreement allows Rivers Edge to manufacture and
market a prescription product that could be substitutable for Nicomide® pursuant to the
terms of the License Agreement and changes certain payment obligations of Rivers 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 Rivers Edges licensed product sales under
the License Agreement. In April 2009, we and Rivers Edge entered into an Amendment to the License
Agreement (the License Amendment) originally entered into in August 2008. The License Amendment
grants Rivers Edge an exclusive license to U.S. Patent, No. 6,979,468, and a license to use all
know-how and the trademark associated with the Licensed Products worldwide. Under the License
Amendment, DUSA is required to transfer all of its rights, title and interest in and to DUSAs
patent know-how and trademark relating to the Licensed Products (but not the copyright registration
relating to product labeling) to Rivers Edge upon our receipt of $5,000,000. Of the $5,000,000,
Rivers Edge is required to make a minimum guaranteed payment to us of $2,600,000, in thirteen
monthly installments of $200,000, subject to reduction under certain conditions, and pay additional
consideration of $2,400,000 payable over time based on a share of Rivers Edges net revenues as
defined in the License Amendment. We received the first
$200,000 installment payment under the License Amendment during the three-month period ended June
30, 2009, which is
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included in Product Revenues in the accompanying Consolidated Statements of
Operations. We have not received payments which were due on June 1, July 1 and August 1, 2009. We
are evaluating our options to collect the outstanding amounts due from Rivers Edge under the
License Agreement, as amended, and have not yet determined our course of action. The License Agreement, as
amended, has a term of 30 months, subject to a further extension under certain circumstances to 48
months, and may be terminated early by Rivers Edge on 30 days prior written notice to us. Under
the License Agreement, Rivers Edge has assumed all regulatory responsibilities for the Licensed
Products. If the License Agreement is terminated prior to the payment of the $5,000,000,
all of the rights and licenses granted by us to Rivers Edge will revert to us.
Another company has launched a substitutable niacinamide product. In July 2009, Rivers Edge filed
a lawsuit against them alleging infringement of this patent, and the validity of the
Nicomide® patent could be tested again. It is too early in the litigation to assess the
possible outcomes. Also, new products have been launched that are competing with
Nicomide®. These events could negatively impact our royalty revenues and delay our
ability to be profitable.
Furthermore, 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.
While we attempt to protect our proprietary information as trade secrets through agreements with
each employee, licensing partner, consultant, university, pharmaceutical company and agent, we
cannot guarantee that these agreements will provide effective protection for our proprietary
information. It is possible that all of the following issues could negatively impact our ability to
be profitable:
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Litigation Is Expensive And We May Not Be Able To Afford The Costs.
The costs of litigation or any proceeding relating to our intellectual property or contractual
rights could be substantial even if resolved in our favor. Some of our competitors have far greater
resources than we do and may be better able to afford the costs of complex litigation. Also, in a
lawsuit against a third-party for infringement of our patents in the United States, that
third-party may challenge the validity of our patent(s) as could happen in the Rivers Edge
litigation mentioned above. We cannot guarantee that a third-party will not claim, with or without
merit, that our patents are not valid or that we have infringed their patent(s) or misappropriated
their proprietary material. We could get drawn or decide to join into, this litigation. Defending
these types of legal actions involve considerable expense and could negatively affect our financial
results.
Additionally, if a third-party were to file a United States patent application, or be issued a
patent claiming technology also claimed by us in a pending United States application(s), we may be
required to participate in interference proceedings in the USPTO to determine the priority of the
invention. A third-party could also request the declaration of a patent interference between one of
our issued United States patents and one of its patent applications. Any interference proceedings
likely would require participation by us and/or PARTEQ, which could involve substantial legal fees
and result in a loss or lessening of our patent protection.
Since We Now Operate The Only FDA Approved Manufacturing Facility For The Kerastick® And
Continue To Rely Heavily On Sole Suppliers For The Manufacture Of Levulan®, The
BLU-U®, And Meted®, Any Supply Or Manufacturing Problems Could Negatively
Impact Our Sales As Occurred With Nicomide®.
If we experience problems producing Levulan® Kerastick® units in our
facility, or if any of our contract suppliers fail to supply our requirements for products, our
business, financial condition and results of operations would suffer. Although we have received
approval by the FDA to manufacture the BLU-U® and the Levulan®
Kerastick® in our Wilmington, Massachusetts facility, at this time, with respect to the
BLU-U® , we expect to utilize our own facility only as a back-up to our current third
party manufacturer or for repairs.
Manufacturers and their subcontractors often encounter difficulties when commercial quantities of
products are manufactured for the first time, or large quantities of products are manufactured,
including problems involving:
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product yields, |
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quality control, |
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component and service availability, |
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compliance with FDA regulations, and
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the need for further FDA approval if manufacturers make material
changes to manufacturing processes and/or facilities. |
We cannot guarantee that problems will not arise with production yields, costs or quality as we and
our suppliers manufacture our products. Any manufacturing problems could delay or limit our
supplies which would hinder our marketing and sales efforts. If our facility, any facility of our
contract manufacturers, or any equipment in those facilities is damaged or destroyed, we may not be
able to quickly or inexpensively replace it. Likewise, if there are quality or supply problems with
any components or materials needed to manufacturer our products, we may not be able to quickly
remedy the problem(s). Any of these problems could cause our sales to suffer and could increase
costs.
The third-party contract relating to the supply of the active ingredient in Levulan® is
scheduled to expire in December of this year. If we cannot renew this agreement on terms which are
acceptable to us, we would need to find a new source of supply. If we have any delay or problems
with a new manufacturer, our revenues and results of operations could suffer.
We Have Only Limited Experience Marketing And Selling Pharmaceutical Products Outside of the United
States And As A Result, Our Revenues From Product Sales May Suffer.
If we are unable to successfully market and sell sufficient quantities of our products, revenues
from product sales will be lower than anticipated and our financial condition may be adversely
affected. We are responsible for marketing our products in the United States and the rest of the
world, except Canada, Latin America and parts of Asia, where we have distributors. We are in
negotiations with Stiefel, our distributor in Latin America, because they did not purchase the
required minimum number of Kerastick® units under our agreement. Both parties have the
right to terminate the contract. Stiefel has announced that it plans to be acquired by
GlaxoSmithKline, or GSK, and we do not know whether GSK wants to continue to distribute the
Levulan® Kerastick®. If our sales and marketing efforts fail, then sales of
the Levulan® Kerastick®, the BLU-U®, and other products will be
adversely affected, which would adversely affect our financial condition.
The Commercial Success Of Any Product That We May Develop Will Depend Upon The Degree Of Market
Acceptance Of Our Products Among Physicians, Patients, Health Care Payors, Private Health Insurers
And The Medical Community.
Our ability to commercialize any product that we may develop will be highly dependent upon the
extent to which the product gains market acceptance among physicians, patients, health care payors,
such as Medicare and Medicaid, private health insurers, including managed care organizations and
group purchasing organizations, and the medical community. If a product does not achieve an
adequate level of acceptance, we may not generate material product revenues, and we may not become
profitable. The degree of market acceptance of our currently marketed products and our SOTR product
candidate, if approved for commercial sale, will depend on a number of factors, including:
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the effectiveness, or perceived effectiveness, of our product in comparison to competing products; |
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the existence of any significant side effects, as well as their severity in comparison to any
competing products, |
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potential advantages over alternative treatments, |
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the ability to offer our product for sale at competitive prices, |
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relative convenience and ease of administration, |
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the strength of marketing and distribution support, and |
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sufficient third-party coverage or reimbursement. |
If We Cannot Improve Physician Reimbursement And/Or Convince More Private Insurance Carriers To
Adequately Reimburse Physicians For Our Product, Sales May Suffer.
Without adequate levels of reimbursement by government health care programs and private health
insurers, the market for our Levulan® Kerastick® for AK therapy will be
limited. While we continue to support efforts to improve reimbursement levels to physicians and are
working with the major private insurance carriers to improve coverage for our therapy, if our
efforts are not successful, broader adoption of our therapy and sales of our products could be
negatively impacted. Although positive
reimbursement changes related to AK were made over the last five years, some physicians still
believe that reimbursement levels do not fully reflect the required efforts to routinely execute
our therapy in their practices.
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If insurance companies do not cover our products, or stop covering our products which are covered,
our sales could be dramatically reduced.
We Have Only Three Therapies That Have Received Regulatory Approval Or Clearance, And We Cannot
Predict Whether We Will Ever Develop Or Commercialize Any Other Levulan® Products.
Our Potential Products Are In Early Stages Of Development And May Never Result In Any Commercially
Successful Products.
To be profitable, we must successfully research, develop, obtain regulatory approval for,
manufacture, introduce, market and distribute our products. Except for Levulan® PDT for
AKs, the BLU-U® for acne, the ClindaReach® pledget and several other products
we acquired in our merger with Sirius, all of our other potential product candidates are at an
early stage of development and subject to the risks of failure inherent in the development of new
pharmaceutical products and products based on new technologies. These risks include:
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delays in product development, clinical testing or manufacturing, |
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unplanned expenditures in product development, clinical testing or manufacturing, |
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failure in clinical trials or failure to receive regulatory approvals, |
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emergence of superior or equivalent products, |
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inability to market products due to third-party proprietary rights, and |
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failure to achieve market acceptance. |
We cannot predict how long the development of our investigational stage products will take or
whether they will be medically effective. We cannot be sure that a successful market will continue
to develop for our Levulan® drug technology.
We Must Receive Separate Approval For Any Drug or Medical Device Products Before We Can Sell Them
Commercially In The United States Or Abroad.
Any potential Levulan® product will require the approval of the FDA before it can be
marketed in the United States. Before an application to the FDA seeking approval to market a new
drug, called an NDA, can be filed, a product must undergo, among other things, extensive animal
testing and human clinical trials. The process of obtaining FDA approvals can be lengthy, costly,
and time-consuming. Following the acceptance of an NDA, the time required for regulatory approval
can vary and is usually one to three years or more. The FDA may require additional animal studies
and/or human clinical trials before granting approval. Our Levulan® PDT products are
based on relatively new technology. To the best of our knowledge, the FDA has approved only three
drugs for use in photodynamic therapy, including Levulan® . This factor may lengthen the
approval process. We face much trial and error and we may fail at numerous stages along the way.
We cannot predict whether we will obtain any other regulatory approvals. Data obtained from
preclinical testing and clinical trials can be susceptible to varying interpretations which could
delay, limit or prevent regulatory approvals. Future clinical trials may not show that
Levulan® PDT or photodetection, known as PD, is safe and effective for any new use we
may study. In addition, delays or disapprovals may be encountered based upon additional
governmental regulation resulting from future legislation or administrative action or changes in
FDA policy.
We have been informed by FDA that the agency does not believe that our application for Orphan Drug
designation of use of Levulan® in immunosuppressed solid organ transplant patients
should be granted. If we cannot obtain this designation, we may not continue to develop this
indication. We have requested a meeting with the FDA to provide further clarification on the
application and the related target population.
We have been informed by FDA that our 510(k) application for clearance of our BLU-U® to
treat severe acne requires additional clinical data. After further discussions with FDA, we may
decide to withdraw this application.
Because Of The Nature Of Our Business, The Loss Of Key Members Of Our Management Team Could Delay
Achievement Of Our Goals.
We are a small company with only 85 employees, including 2 part-time employees, as of June 30,
2009. We are highly dependent on several key officer/employees with specialized scientific and
technical skills without whom our business, financial condition and results of operations would
suffer, especially in the photodynamic therapy portion of our business. The
photodynamic therapy industry is still quite small and the number of experts is limited. The loss
of these key employees could cause significant delays in achievement of our business and research
goals since very few people with their expertise could be hired. Our growth and future success will
depend, in large part, on the continued contributions of these key individuals as well as our
ability to motivate and retain other qualified personnel in our specialty drug and light device
areas.
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Collaborations With Outside Scientists May Be Subject To Restriction And Change.
We work with scientific and clinical advisors and collaborators at academic and other institutions
that assist us in our research and development efforts. These scientists and advisors are not our
employees and may have other commitments that limit their availability to us. Although our advisors
and collaborators generally agree not to do competing work, if a conflict of interest between their
work for us and their work for another entity arises, we may lose their services. In addition,
although our advisors and collaborators sign agreements not to disclose our confidential
information, it is possible that valuable proprietary knowledge may become publicly known through
them.
Risks Related To Our Industry
Product Liability And Other Claims Against Us May Reduce Demand For Our Products Or Result In
Damages.
We Are Subject To Risk From Potential Product Liability Lawsuits Which Could Negatively Affect Our
Business.
The development, manufacture and sale of medical products expose us to product liability claims
related to the use or misuse of our products. Product liability claims can be expensive to defend
and may result in significant judgments against us. A successful claim could materially harm our
business, financial condition and results of operations. Additionally, we cannot guarantee that
continued product liability insurance coverage will be available in the future at acceptable costs.
If the cost is too high, we may have to self-insure.
Our Business Involves Environmental Risks And We May Incur Significant Costs Complying With
Environmental Laws And Regulations.
We have used various hazardous materials, such as mercury in fluorescent tubes in our research and
development activities. We are subject to federal, state and local laws and regulations which
govern the use, manufacture, storage, handling and disposal of hazardous materials and specific
waste products. We believe that we are in compliance in all material respects with currently
applicable environmental laws and regulations. However, we cannot guarantee that we will not incur
significant costs to comply with environmental laws and regulations in the future. We also cannot
guarantee that current or future environmental laws or regulations will not materially adversely
affect our operations, business or assets. In addition, although we believe our safety procedures
for handling and disposing of these materials comply with federal, state and local laws and
regulations, we cannot completely eliminate the risk of accidental contamination or injury from
these materials. In the event of such an accident, we could be held liable for any resulting
damages, and this liability could exceed our resources.
We May Not Be Able To Compete Against Traditional Treatment Methods Or Keep Up With Rapid Changes
In The Biotechnology And Pharmaceutical Industries That Could Make Some Or All Of Our Products
Non-Competitive Or Obsolete.
Competing Products And Technologies Based On Traditional Treatment Methods May Make Our Products Or
Potential Products Noncompetitive Or Obsolete.
Well-known pharmaceutical, biotechnology and medical device companies are marketing
well-established therapies for the treatment of AKs and acne. Doctors may prefer to use familiar
methods, rather than trying our products. Reimbursement issues affect the economic competitiveness
of our products as compared to other more traditional therapies.
Many companies are also seeking to develop new products and technologies, and receiving approval
for treatment of AKs and acne. Our industry is subject to rapid, unpredictable and significant
technological change. Competition is intense. Our competitors may succeed in developing products
that are safer or more effective than ours. Many of our competitors have substantially greater
financial, technical and marketing resources than we have. In addition, several of these companies
have significantly greater experience than we do in developing products, conducting preclinical and
clinical testing and obtaining regulatory approvals to market products for health care.
We cannot guarantee that new drugs or future developments in drug technologies will not have a
material adverse effect on our business. Increased competition could result in:
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price reductions, |
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lower levels of third-party reimbursements, |
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failure to achieve market acceptance, and |
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loss of market share, any of which could adversely affect our
business. Further, we cannot give any assurance that developments by
our competitors or future competitors will not render our technology
obsolete. |
On May 30, 2006, we entered into a patent license agreement with PhotoCure ASA whereby we granted a
non-exclusive license to PhotoCure under the patents we license from PARTEQ, for esters of ALA.
Furthermore, we granted a non-exclusive license to PhotoCure for its existing formulations of its
Hexvix® and Metvix ® (known in the United States as Metvixia®)
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products for any DUSA patents that may issue or be licensed by us in the future. PhotoCure received
FDA approval to market Metvixia® for treatment of AKs in July 2004 and it is directly
competitive with our Levulan® Kerastick® product. Metvixia® is now
commercially available and its price is comparable to the price of Levulan®. We are
entitled to royalties from PhotoCure on its net sales of Metvixia, however since it is marketed in
the U.S. by a large dermatology company which has a large sales force and considerably more
resources than we have, our ability to maintain or increase our market could be significantly
hampered.
Our Competitors In The Biotechnology And Pharmaceutical Industries May Have Better Products,
Manufacturing Capabilities Or Marketing Expertise.
We are aware of several companies commercializing and/or conducting research with ALA or
ALA-related compounds, including: medac GmbH and photonamic GmbH & Co. KG (Germany); Biofrontera,
PhotoTherapeutics, Inc. (U.K.) and PhotoCure ASA (Norway) which entered into a marketing agreement
with Galderma S.A. for countries outside of Nordic countries for certain dermatology indications.
We also anticipate that we will face increased competition as the scientific development of PDT and
PD advances and new companies enter our markets. Several companies are developing PDT agents other
than Levulan®. These include: QLT Inc. (Canada); Axcan Pharma Inc. (U.S.); Miravant,
Inc. (U.S.); and Pharmacyclics, Inc. (U.S.). There are many pharmaceutical companies that compete
with us in the field of dermatology, particularly in the acne and rosacea markets.
Axcan Pharma Inc. has received FDA approval for the use of its product, PHOTOFRIN®, for
PDT in the treatment of high grade dysplasia associated with Barretts Esophagus. Axcan is the
first company to market a PDT therapy for this indication for which we designed our proprietary
sheath device and have conducted pilot clinical trials.
We expect that our principal methods of competition with other PDT products will be based upon such
factors as:
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the ease of administration of our method of PDT, |
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the degree of generalized skin sensitivity to light, |
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the number of required doses, |
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the selectivity of our drug for the target lesion or tissue of interest, and |
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the type and cost of our light systems. |
Our primary competition in the acne market includes oral and topical antibiotics, other topical
prescription and over-the-counter products, as well as various laser and non-laser light
treatments. The market is highly competitive and other large and small companies have more
experience than we do which could make it difficult for us to penetrate the market. The entry of
new products from time to time would likely cause us to lose market share.
Risks Related To Our Stock
Our Common Stock May Not Continue To Trade On The Nasdaq Global Market, Which Could Reduce The
Value Of Your Investment And Make Your Shares More Difficult To Sell.
In order for our common stock to trade on the Nasdaq Global Market, we must continue to meet the
listing standards of that market. Among other things, those standards require that our common stock
maintain a minimum closing bid price of at least $1.00 per share. Recently, our common stock has
traded at prices near and below $1.00. On October 16, 2008, and several times since then, Nasdaq
suspended the enforcement of rules requiring a minimum $1.00 closing bid price, but the suspension
ended July 31, 2009, and the rule is now in force again. If we do not continue to meet Nasdaqs
applicable minimum listing standards, Nasdaq could delist us from the Nasdaq Global Market. If our
common stock is delisted from the Nasdaq Global Market, we could seek to have our common stock
listed on the Nasdaq Capital Market or other Nasdaq markets. However, delisting of our common stock
from the Nasdaq Global Market could hinder your ability to sell, or obtain an accurate quotation
for the price of, your shares of our common stock. Delisting could also adversely affect the
perception among investors of
DUSA and its prospects, which could lead to further declines in the market price of our common
stock. Delisting would also make it more difficult and expensive for us to raise capital. In
addition, delisting might subject us to a Securities and Exchange Commission rule that could
adversely affect the ability of broker-dealers to sell or make a market in our common stock, thus
hindering your ability to sell your shares.
Our Results Of Operations And General Market Conditions For Specialty Pharmaceutical And
Biotechnology Stocks Could Result In Sudden Changes In The Market Value Of Our Stock.
The price of our common stock has been highly volatile. These fluctuations create a greater risk of
capital losses for our shareholders as compared to less volatile stocks. From January 1, 2008 to
August 10, 2009, the price of our stock has ranged from a low of $0.87 to a high of $2.58. Factors
that contributed to the volatility of our stock during this period included:
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quarterly levels of product sales;
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clinical trial results; |
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general market conditions; |
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patent litigation; |
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increased marketing activities or press releases; and |
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changes in third-party payor reimbursement for our therapy. |
The significant general market volatility in similar stage pharmaceutical and biotechnology
companies made the market price of our common stock even more volatile.
Significant Fluctuations In Orders For Our Products, On A Monthly And Quarterly Basis, Are Common
Based On External Factors And Sales Promotion Activities. These Fluctuations Could Increase The
Volatility Of Our Stock Price.
The price of our common stock may be affected by the amount of quarterly shipments of our products
to end-users. Since our PDT products are still in relatively early stages of adoption, and sales
volumes are still low, a number of factors could affect product sales levels and growth rates in
any period. These could include the level of penetration of new markets outside of the United
States, the timing of medical conferences, sales promotion activities, and large volume purchases
by our higher usage customers. In addition, seasonal fluctuations in the number of patients seeking
treatment at various times during the year could impact sales volumes. These factors could, in
turn, affect the volatility of our stock price.
If Outstanding Options, Warrants And Rights Are Converted, The Value Of The Shares Of Common Stock
Outstanding Just Prior To The Conversion Will Be Diluted.
As of August 10, 2009, there were outstanding options and warrants to purchase 4,989,000 shares of
common stock, with exercise prices ranging from $1.08 to $31.00 per share for options, and exercise
prices ranging from $2.85 to $6.00 per share for warrants. In addition, there are 393,250 shares of
unvested common stock. The holders of the options and warrants have the opportunity to profit if
the market price for the common stock exceeds the exercise price of their respective securities,
without assuming the risk of ownership. The holders may exercise their securities during a time
when we would likely be able to raise capital from the public on terms more favorable than those
provided in these securities.
Effecting A Change Of Control Of DUSA Would Be Difficult, Which May Discourage Offers For Shares Of
Our Common Stock.
Our certificate of incorporation authorizes the board of directors to issue up to 100,000,000
shares of stock, 40,000,000 of which are common stock. The board of directors has the authority to
determine the price, rights, preferences and privileges, including voting rights, of the remaining
60,000,000 shares without any further vote or action by the shareholders. The rights of the holders
of our common stock will be subject to, and may be adversely affected by, the rights of the holders
of any preferred stock that may be issued in the future.
On September 27, 2002, we adopted a shareholder rights plan at a special meeting of DUSAs board of
directors. The rights plan could discourage, delay or prevent a person or group from acquiring 15%
or more of our common stock, thereby limiting, perhaps, the ability of our shareholders to benefit
from such a transaction.
The rights plan provides for the distribution of one right as a dividend for each outstanding share
of our common stock to holders of record as of October 10, 2002. Each right entitles the registered
holder to purchase one one-thousandths of a share of preferred stock at an exercise price of $37.00
per right. The rights will be exercisable subsequent to the date that a person or group either has
acquired, obtained the right to acquire, or commences or discloses an intention to commence a
tender offer to acquire, 15% or more of our outstanding common stock or if a person or group is
declared an Adverse Person, as such term is defined in the rights plan. The rights may be
redeemed by DUSA at a redemption price of one one-hundredth of a cent per right until ten days
following the date the person or group acquires, or discloses an intention to acquire, 15% or more,
as the case may be, of DUSA, or until such later date as may be determined by the our board of
directors.
Under the rights plan, if a person or group acquires the threshold amount of common stock, all
holders of rights (other than the acquiring person or group) may, upon payment of the purchase
price then in effect, purchase shares of common stock of DUSA
having a value of twice the purchase price. In the event that we are involved in a merger or other
similar transaction where DUSA is not the surviving corporation, all holders of rights (other than
the acquiring person or group) shall be entitled, upon payment of the purchase price then in
effect, to purchase common stock of the surviving corporation having a value of twice the purchase
price. The rights will expire on October 10, 2012, unless previously redeemed. Our board of
directors has also adopted certain amendments to DUSAs certificate of incorporation consistent
with the terms of the rights plan.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.
None.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES.
None.
34
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS.
Matters submitted to a vote of security holders of DUSA at the Annual Meeting of Shareholders held
June 9, 2009 included the election of eight (8) directors, and the ratification of the selection of
Deloitte & Touche LLP as the independent registered public accounting firm for DUSA for 2009.
a) The following persons were elected to serve as directors of the Corporation:
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Votes |
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Broker |
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Votes Cast For |
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Withheld |
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Abstained |
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Non-votes |
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John H. Abeles |
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19,075,008 |
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639,153 |
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-0- |
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-0- |
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David M. Bartash |
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19,111,596 |
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602,565 |
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-0- |
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-0- |
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Alexander W. Casdin |
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19,108,872 |
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605,289 |
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-0- |
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-0- |
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Robert F. Doman |
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19,100,208 |
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613,953 |
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-0- |
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-0- |
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Jay M. Haft |
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19,096,771 |
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617,390 |
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-0- |
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-0- |
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Marvin E. Lesser |
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19,111,159 |
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603,002 |
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-0- |
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-0- |
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Richard C. Lufkin |
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19,094,138 |
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620,023 |
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-0- |
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-0- |
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Magnus Moliteus |
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19,108,815 |
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605,346 |
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-0- |
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-0- |
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b) The shareholders ratified the selection of Deloitte & Touche LLP as the independent
registered public accounting firm for DUSA for 2009 as follows:
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Votes Cast |
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Broker |
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Votes Cast For |
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Against |
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Abstained |
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Non-votes |
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Deloitte & Touche LLP |
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19,114,558 |
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588,484 |
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11,118 |
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-0- |
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ITEM 5. OTHER INFORMATION.
None.
ITEM 6. EXHIBITS.
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EXHIBIT |
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NO. |
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DESCRIPTION OF EXHIBIT |
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3(a.1)
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Certificate of Incorporation, as amended, filed as Exhibit 3(a) to the Registrants Form 10-K for the fiscal year
ended December 31, 1998, and is incorporated herein by reference. |
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3(a.2)
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Certificate of Amendment to the Certificate of Incorporation, as amended, dated October 28, 2002 and filed as Exhibit
99.3 to the Registrants Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2002, filed November
12, 2002, and is incorporated herein by reference |
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3(b)
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By-laws of the Registrant, filed as Exhibit 3.1 to the Registrants current report on Form 8-K, filed on November 2,
2008, and is incorporated herein by reference. |
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31(a)
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Certification pursuant to Rule 13a-14(a)/15d-14(a) of the Securities Exchange Act of 1934. |
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31(b)
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Certification pursuant to Rule 13a-14(a)/15d-14(a) of the Securities Exchange Act of 1934. |
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32(a)
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Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
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32(b)
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Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
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99.1
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Press Release dated August 11, 2009 |
35
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused
this report to be signed on its behalf by the undersigned thereunto duly authorized.
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DUSA Pharmaceuticals, Inc.
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By: |
/s/ Robert F. Doman
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Robert F. Doman |
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President and Chief Executive Officer
(principal executive officer) |
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Dated August 11, 2009
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By: |
/s/ Richard C. Christopher
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Richard C. Christopher |
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Vice President, Finance and Chief Financial
Officer (principal financial officer) |
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Dated August 11, 2009
36
EXHIBIT INDEX
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3(a.1)
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Certificate of Incorporation, as amended, filed as Exhibit 3(a) to the Registrants Form 10-K for the fiscal year
ended December 31, 1998, and is incorporated herein by reference. |
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3(a.2)
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Certificate of Amendment to the Certificate of Incorporation, as amended, dated October 28, 2002 and filed as Exhibit
99.3 to the Registrants Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2002, filed November
12, 2002, and is incorporated herein by reference. |
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3(b)
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By-laws of the Registrant, filed as Exhibit 3.1 to the Registrants current report on Form 8-K, filed on November 2,
2008, and is incorporated herein by reference. |
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31(a)
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Certification pursuant to Rule 13a-14(a)/15d-14(a) of the Securities Exchange Act of 1934. |
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31(b)
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Certification pursuant to Rule 13a-14(a)/15d-14(a) of the Securities Exchange Act of 1934. |
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32(a)
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Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
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32(b)
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Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
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99.1
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Press Release dated August 11, 2009. |
37