10-Q
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: September 30, 2006
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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 |
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(State of Other Jurisdiction of Incorporation
or Organization)
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(I.R.S. Employer Identification No.) |
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25 Upton Drive, Wilmington, MA
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01887 |
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(Address of Principal Executive Offices)
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(Zip Code) |
(978) 657-7500
(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 is a large accelerated filer, an accelerated filer,
or a non-accelerated filer. See definition of accelerated filer in Rule 12b-2 of the Exchange
Act. (Check one):
Large Accelerated Filer o Accelerated Filer þ Non-accelerated Filer 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 November 3, 2006, the registrant had 19,480,067 shares of Common Stock, no par value per
share, outstanding.
1
DUSA Pharmaceuticals, Inc.
TABLE OF CONTENTS TO FORM 10-Q
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PAGE |
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NUMBER |
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3 |
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19 |
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35 |
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36 |
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37 |
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39 |
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51 |
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51 |
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51 |
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51 |
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52 |
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53 |
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54 |
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EX-10(a)
AMENDMENT NO. 1 TO EMPLOYMENT AGREEMENT FOR RICHARD C. CHRISTOPHER
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EX-31(a) SECTION 302 CERTIFICATION OF THE C.E.O. |
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EX-31(b) SECTION 302 CERTIFICATION OF THE C.F.O. |
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EX-32(a) SECTION 906 CERTIFICATION OF THE C.E.O. |
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EX-32(b) SECTION 906 CERTIFICATION OF THE C.F.O. |
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2
PART I.
ITEM 1. FINANCIAL STATEMENTS
DUSA PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)
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SEPTEMBER 30, |
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DECEMBER 31, |
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2006 |
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2005 |
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ASSETS |
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CURRENT ASSETS |
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Cash and cash equivalents |
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$ |
5,139,183 |
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$ |
4,210,675 |
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Marketable securities |
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13,414,499 |
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30,579,486 |
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Accrued interest receivable |
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111,952 |
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353,449 |
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Accounts receivable, net |
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1,826,197 |
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373,130 |
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Inventory |
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2,158,886 |
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1,860,793 |
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Deferred acquisition costs |
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831,875 |
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Prepaids and other current assets |
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1,463,945 |
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776,293 |
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TOTAL CURRENT ASSETS |
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24,114,662 |
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38,985,701 |
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Restricted cash |
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160,836 |
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144,541 |
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Property, plant and equipment, net |
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2,691,425 |
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2,971,869 |
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Intangible assets |
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16,183,342 |
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Goodwill |
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5,772,505 |
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Deferred charges and other assets |
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956,654 |
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228,520 |
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TOTAL ASSETS |
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$ |
49,879,424 |
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$ |
42,330,631 |
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LIABILITIES AND SHAREHOLDERS EQUITY |
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CURRENT LIABILITIES |
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Accounts payable |
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$ |
227,224 |
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$ |
934,694 |
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Accrued compensation |
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1,277,799 |
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1,071,677 |
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Other accrued expenses |
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3,469,518 |
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1,995,679 |
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Deferred revenue |
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1,066,326 |
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94,283 |
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TOTAL CURRENT LIABILITIES |
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6,040,867 |
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4,096,333 |
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Other liabilities |
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205,893 |
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205,570 |
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TOTAL LIABILITIES |
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6,246,760 |
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4,301,903 |
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COMMITMENTS AND CONTINGENCIES (NOTE 13) |
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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: 19,449,442 and
17,041,197 shares of common stock, no
par, at September 30, 2006 and December
31, 2005, respectively |
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142,870,571 |
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125,626,163 |
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Additional paid-in capital |
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3,448,899 |
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2,035,783 |
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Accumulated deficit |
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(102,618,371 |
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(89,537,470 |
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Accumulated other comprehensive loss |
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(68,435 |
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(95,748 |
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TOTAL SHAREHOLDERS EQUITY |
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43,632,664 |
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38,028,728 |
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TOTAL LIABILITIES AND SHAREHOLDERS EQUITY |
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$ |
49,879,424 |
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$ |
42,330,631 |
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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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NINE MONTHS ENDED |
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SEPTEMBER 30, |
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SEPTEMBER 30, |
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2006 |
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2005 |
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2006 |
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2005 |
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Product Revenues |
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$ |
6,062,720 |
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$ |
2,392,244 |
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$ |
17,432,350 |
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$ |
7,988,974 |
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Cost of Product Revenues and Royalties |
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2,849,485 |
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1,307,433 |
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7,635,407 |
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4,781,589 |
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GROSS MARGIN |
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3,213,235 |
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1,084,811 |
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9,796,943 |
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3,207,385 |
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Operating Costs |
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Research and Development |
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1,343,880 |
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1,414,428 |
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4,382,134 |
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4,809,294 |
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In-process Research and Development |
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1,600,000 |
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Marketing and Sales |
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3,246,886 |
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1,804,439 |
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9,114,093 |
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6,885,755 |
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General and Administrative |
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2,603,237 |
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1,663,697 |
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8,427,324 |
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5,187,415 |
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Restructuring |
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150,917 |
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150,917 |
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TOTAL OPERATING COSTS |
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7,194,003 |
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5,033,481 |
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23,523,551 |
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17,033,381 |
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LOSS FROM OPERATIONS |
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(3,980,768 |
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(3,948,670 |
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(13,726,608 |
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(13,825,996 |
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OTHER INCOME |
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Other income, net |
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194,129 |
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340,389 |
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645,707 |
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1,059,982 |
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NET LOSS |
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$ |
(3,786,639 |
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$ |
(3,608,281 |
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$ |
(13,080,901 |
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$ |
(12,766,014 |
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BASIC AND DILUTED NET LOSS PER COMMON
SHARE |
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$ |
(0.19 |
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$ |
(0.21 |
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$ |
(0.77 |
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$ |
(0.75 |
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WEIGHTED-AVERAGE NUMBER OF COMMON
SHARES OUTSTANDING, BASIC AND DILUTED |
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19,449,442 |
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16,930,746 |
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17,041,197 |
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16,920,220 |
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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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NINE MONTHS ENDED SEPTEMBER 30, |
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2006 |
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2005 |
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CASH FLOWS PROVIDED BY (USED IN) OPERATING ACTIVITIES |
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Net loss |
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$ |
(13,080,901 |
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$ |
(12,766,014 |
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Adjustments to reconcile net loss to net cash used in operating activities: |
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Amortization of premiums and accretion of discounts on marketable
securities available-for-sale |
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38,766 |
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401,221 |
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Realized gain on sale of marketable securities,
available-for-sale |
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(14,015 |
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(72,195 |
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Stock-based compensation |
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1,413,116 |
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19,444 |
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In-process research and development charge |
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1,600,000 |
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Depreciation and amortization |
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3,302,624 |
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755,593 |
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Changes in other assets and liabilities impacting cash flows from
operations (net of impact of acquisition): |
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Accrued interest receivable |
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241,497 |
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220,170 |
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Accounts receivable |
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259,100 |
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7,153 |
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Inventory |
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(79,271 |
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(651,578 |
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Prepaid and other current assets |
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(730,129 |
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(611,338 |
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Deferred charges and other assets |
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(793,082 |
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Accounts payable |
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(1,310,300 |
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(291,654 |
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Accrued compensation and other accrued expenses |
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(143,590 |
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(180,045 |
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Deferred revenue |
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971,443 |
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188,700 |
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Other liabilities |
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323 |
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12,267 |
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NET CASH USED IN OPERATING ACTIVITIES |
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(8,324,419 |
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(12,968,276 |
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CASH FLOWS PROVIDED BY (USED IN) INVESTING ACTIVITIES |
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Cash paid for acquisition, net of cash received |
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(7,767,006 |
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Purchases of marketable securities |
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(4,008,844 |
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(40,683,061 |
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Proceeds from maturities and sales of marketable securities |
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21,176,393 |
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52,901,367 |
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Restricted cash |
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(16,295 |
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(2,589 |
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Purchases of property, plant and equipment |
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(172,277 |
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(406,217 |
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NET CASH PROVIDED BY INVESTING ACTIVITIES |
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9,211,971 |
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11,809,500 |
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CASH FLOWS PROVIDED BY FINANCING ACTIVITIES |
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Proceeds from exercise of options |
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40,956 |
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232,035 |
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NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS |
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928,508 |
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(926,741 |
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CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD |
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4,210,675 |
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2,928,143 |
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CASH AND CASH EQUIVALENTS AT END OF PERIOD |
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$ |
5,139,183 |
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$ |
2,001,402 |
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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 September 30, 2006, and the Condensed Consolidated
Statements of Operations for the three and nine months ended September 30, 2006 and 2005, and
Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2006 and
2005 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, 2005 filed with the Securities and Exchange
Commission (SEC). The balance sheet as of
December 31, 2005 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.
2) SIGNIFICANT ACCOUNTING POLICIES
REVENUE RECOGNITION AND PROVISIONS FOR ESTIMATED REDUCTIONS TO GROSS REVENUES
Photodynamic Therapy (PDT) Drug and Device Products.
Revenues on the Kerastick® and BLU-U® product sales are recognized when
persuasive evidence of an arrangement exists, the price is fixed and determinable, delivery has
occurred, and collection is probable. Product sales made through distributors, historically, have
been recorded as deferred revenue until the product was sold by the distributors to the end users
because we did not have sufficient history with our distributors to be able to reliably estimate
returns. Beginning in the first quarter of 2006, we began recognizing revenue as product is sold to
distributors because we believe we have sufficient history to reliably estimate returns from
distributors as of January 1, 2006. This change in estimate was not material to the Companys
revenues or results of operations. Certain device units are held by physicians for a trial period.
No revenue is recognized on these units until the physician elects to purchase the equipment and
all other revenue recognition criteria are met.
Non-PDT Drug Products.
We
recognize revenue for these products in accordance with SECs
Staff Accounting Bulletin (SAB) No. 101, Revenue Recognition in
Financial Statements, as amended by SAB No. 104, Revenue Recognition. Our accounting policy for
revenue recognition has a substantial impact on our reported results and relies on certain
estimates that require difficult, subjective and complex judgments on the part of management. We
recognize revenue for sales when substantially all the risks and rewards of ownership have
transferred to the customer, which generally occurs on the date of shipment to wholesale customers,
with the exceptions described below. Revenue is recognized net of
revenue reserves, which consist of allowances for discounts, returns,
rebates, chargebacks, and fees paid to wholesalers under
distribution service agreements.
In the case of sales made to wholesalers as a result of incentives and that are in excess of the
wholesalers ordinary course of business inventory level, substantially all the risks and rewards
of ownership do not
6
transfer upon shipment and, accordingly, such sales are recorded as deferred revenue and the
related costs as deferred cost of revenue until the product is sold through to the wholesalers
customers on a FIFO basis.
We evaluate inventory levels at our wholesale customers, which account for the vast majority of our
sales in the Non-PDT Drug Products segment, through an analysis that considers, among other things,
wholesaler purchases, wholesaler shipments to retailers, available end-user prescription data
purchased from third parties and on-hand inventory data received directly from our two largest
wholesale customers. We believe that our evaluation of wholesaler inventory levels, as described in
the preceding sentence, allows us to make reasonable estimates for our applicable revenue related
reserves. Additionally, our products are sold to wholesalers with a product shelf life that allows
sufficient time for our wholesaler customers to sell our products in their inventory through to the
retailers and, ultimately, to the end-user consumer prior to product expiration.
Returns and allowances Our provision for returns and allowances consists of our estimates of
future sales returns, rebates and chargebacks.
Sales Returns- We account for sales returns by establishing an accrual in an amount equal to
our estimate of sales recorded for which the related products are expected to be returned. We
determine the estimate of the sales return accrual primarily based on historical experience
regarding sales returns, and also by considering other factors that could impact sales returns.
These factors include levels of inventory in the distribution channel, estimated shelf life,
product recalls, product discontinuances, price changes of competitive products, introductions
of generic products and introductions of competitive new products. It is our policy to accept
returns of Non-PDT Drug products when product is within nine months of expiration. We consider
all of these factors and adjust the accrual periodically to reflect actual experience.
Chargebacks and Rebates Chargebacks typically occur when suppliers enter into contractual
pricing arrangements with end-user customers, including certain federally mandated programs,
who then purchase from wholesalers at prices below what the supplier charges the wholesaler.
Since we only offer preferred pricing to end-user customers under federally mandated
programs, chargebacks have not been significant to the Company. Our rebate programs can
generally be categorized into the following two types: Medicaid rebates and consumer rebates.
Medicaid rebates are amounts owed based on legal requirements with public sector benefit
providers after the final dispensing of the product by a pharmacy to a benefit plan
participant. Consumer rebates are amounts owed as a result of mail-in coupons that are
distributed by health care providers to consumers at the time a prescription is written. Since
only a small percentage of our prescriptions are reimbursed under Medicaid and the quantity of
consumer coupon redemptions have not been substantial, rebates have not been significant to the
Company.
We offer many of our customers a 2% prompt pay discount. We evaluate the amounts accrued for prompt
pay discounts by analyzing the unpaid invoices in our accounts receivable aging subject to a prompt
pay discount. Prompt pay discounts are known within 15 to 30 days of sale, and therefore can be
reliably estimated based on actual and expected activity at each reporting date. The Company
records these discounts at the time of sale and they are accounted for as a reduction of revenues.
GOODWILL AND OTHER INTANGIBLE ASSETS
Goodwill and intangible assets with indefinite lives are not amortized but are reviewed annually
for impairment or more frequently if impairment indicators arise. Separable intangible assets that
are not deemed to have indefinite lives will continue to be amortized over their useful lives. The
Company has adopted December 1st as the date of the annual impairment test for goodwill.
7
STOCK-BASED COMPENSATION
Prior to January 1, 2006, we used the intrinsic value-based method to account for employee stock
option awards under the provisions of Accounting Principles Board Opinion (APB) No. 25, and to
provide disclosures based on the fair value method in the Notes to the Consolidated Financial
Statements as permitted by Statement of Financial Accounting Standards (SFAS) No. 123, as
amended. Stock or other equity-based compensation for non-employees is accounted for under the fair
value-based method as required by SFAS No. 123 and Emerging Issues Task Force (EITF) No. 96-18,
Accounting for Equity Instruments That Are Issued to Other Than Employees for Acquiring, or in
Conjunction with Selling, Goods or Services and other related interpretations. Under this method,
the equity-based instrument is valued at either the fair value of the consideration received or the
equity instrument issued on the date of grant. The resulting compensation cost is recognized and
charged to operations over the service period which, in the case of stock options, is generally the
vesting period.
In December 2004, the Financial Accounting Standards Board (FASB) issued SFAS No. 123R,
Share-Based Payment, a revision of SFAS No. 123. We adopted SFAS 123R effective January
1, 2006, using the modified prospective application method, and beginning in 2006, we measure all
employee share-based compensation awards using a fair value based method and record share-based
compensation expense in our financial statements if the requisite service to earn the award is
provided.
3) BUSINESS ACQUISITION
On March 10, 2006, the Company acquired all of the outstanding common stock of Sirius Laboratories,
Inc. (Sirius) in exchange for 2,396,245 shares of DUSA common stock and $8 million in cash.
Pursuant to the terms of the Merger Agreement, the actual number of shares that were issued in the
transaction was derived by dividing $17 million by the average closing price of the Companys
shares over the 20 trading day period prior to the close, or $7.094 per share. For accounting
purposes, these shares are valued at $7.30 per share, the average market price of the Companys
common stock over the 5 day period beginning two days prior and ending two days subsequent to the
public announcement of the signing of the First Amendment to the Merger Agreement. Sirius was a
dermatology specialty pharmaceuticals company founded in 2000 with a primary focus on the treatment
of acne vulgaris and acne rosacea. The purchase of Sirius was intended to enable DUSA to expand its
product portfolio, capitalize on cross-selling and marketing opportunities, increase its sales
force size; as well as, provide a pipeline of new products. The aggregate purchase price, net of
cash received of $0.5 million, was approximately $26.8 million, which consisted of $17.2 million in
shares of common stock, net of estimated registration costs of $0.3 million, $7.5 million in cash,
$0.3 million outstanding balance on line of credit, and transaction costs of $1.8 million, which
primarily consisted of fees for legal and financial advisory services. Of the 2,396,245 shares
issued in the acquisition, 422,892 shares have been placed in an escrow account established to
secure the indemnification obligations of the shareholders of Sirius as set forth in the Merger
Agreement. The escrow account is established for a period of two years and will be used to satisfy
liability claims, if any, made by the Company. No amounts may be distributed from the liability
escrow account unless and until any individual claim exceeds $25,000 and cumulative claims exceed
$100,000.
The Company has agreed to pay additional consideration in future periods, based upon the attainment
of defined operating objectives, including new product approvals or launches and the achievement of
pre-determined total cumulative sales milestones for the Sirius products over the period ending 42
months from the date of close. The pre-determined cumulative sales milestones for the Sirius
products and the related milestone payments are, as follows:
8
|
|
|
|
|
Cumulative |
|
Additional |
|
Sales Milestone |
|
Consideration |
|
$25.0 million |
|
$1.5 million |
35.0 million |
|
$1.0 million |
45.0 million |
|
$1.0 million |
|
|
|
|
Total |
|
$3.5 million |
|
|
|
|
In addition, there are three milestones related to new product approvals and/or launches each
in the amount of $500,000 per milestone, or $1.5 million in the aggregate, that will be paid if the
milestones are achieved. As of September 30, 2006 none of the milestones had been achieved;
however, we do anticipate that a milestone related to a new product launch could occur in early
2007.
The Company will not accrue contingent consideration obligations prior to the attainment of the
objectives. At September 30, 2006, the maximum potential future consideration pursuant to such
arrangements, to be resolved over the period ending 42 months from the date of close, is $5.0
million. If attained, a portion of the contingent consideration is payable in cash and a portion is
payable in either common stock or cash, at the Companys sole discretion. Any payments will result
in increases in goodwill at time of payment.
The acquisition was accounted for using the purchase method of accounting and the results of
operations of the acquired business since March 10, 2006, the date of acquisition, were included in
the results of the Company. The purchase price allocation is preliminary and a final determination
of required purchase accounting adjustments will be made when all necessary information is obtained
and final allocations are made. Goodwill may change as a result of final allocations. The Company
may incur costs in the future related to manufacturing concerns that were identified with the
manufacturing of one of Sirius product lines. Some of these products are in short supply or
back-order positions while such concerns are being addressed. The Company may seek indemnification
for these potential costs and lost revenues through the liability escrow agreement, and may also
seek indemnification from the manufacturer under the terms of the supply and development agreement.
The total purchase consideration was allocated to the assets acquired and liabilities assumed at
their estimated fair values as of the date of acquisition, as determined by management and, with
respect to identified intangible assets, by management with the assistance of an appraisal provided
by a third-party valuation firm. The excess of the purchase price over the amounts allocated to
assets acquired and liabilities assumed has been recorded as goodwill. The goodwill is not
deductible for tax purposes.
The following table summarizes the estimated fair value of the assets acquired and liabilities
assumed at the date of acquisition:
|
|
|
|
|
|
|
(IN THOUSANDS) |
|
Total consideration: |
|
|
|
|
|
|
|
|
|
Common stock issued, net of estimated registration costs of $295,000 |
|
$ |
17,203 |
|
Cash paid to stockholders |
|
|
8,000 |
|
Balance on line-of-credit |
|
|
251 |
|
Transaction costs accrued |
|
|
346 |
|
Transaction costs paid |
|
|
1,525 |
|
|
|
|
|
Total purchase consideration |
|
|
27,325 |
|
|
|
|
|
Allocation of the purchase consideration |
|
|
|
|
Current assets (including cash of $485), exclusive of inventory |
|
|
2,198 |
|
Inventory |
|
|
1,983 |
|
Fixed assets |
|
|
109 |
|
Long-term assets |
|
|
14 |
|
Identifiable intangible assets |
|
|
17,160 |
|
9
|
|
|
|
|
|
|
(IN THOUSANDS) |
|
In-process research and development |
|
|
1,600 |
|
Goodwill |
|
|
5,773 |
|
|
|
|
|
Total assets acquired |
|
|
28,837 |
|
|
|
|
|
|
Fair value of liabilities assumed |
|
|
(1,512 |
) |
|
|
|
|
Fair value of assets acquired and liabilities assumed |
|
$ |
27,325 |
|
|
|
|
|
The following are identified intangible assets acquired and the respective estimated periods
over which the assets will be amortized:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
WEIGHTED AVERAGE |
|
|
AMOUNT |
|
AMORTIZATION PERIOD |
|
|
(IN THOUSANDS) |
|
(IN YEARS) |
Core/Developed Technology |
|
$ |
17,160 |
|
|
|
3.78 |
|
In-process
Research and
Development |
|
$ |
1,600 |
|
|
|
|
|
The core/developed technology, comprised of the combined value of Sirius product lines, which
inherently includes the value of related patents, trademarks/trade names, as applicable, is being
amortized over its useful life, based upon the pattern in which the expected benefits will be
realized, or on a straight-line basis, whichever is greater. The core/developed technologies all
belong to the same therapeutic category, non-photodynamic therapy dermatological treatment of acne
and rosacea and are considered a single asset group for purposes of measuring impairment. The
values of the intangible assets acquired were determined using projections of revenues and expenses
specifically attributed to the intangible assets. The income streams were then discounted to
present value using estimated risk adjusted discount rates. The intangible assets were valued using
the income approach, specifically the excess earnings method. The key assumptions used in valuing
the intangible assets are discount rates of 17% for core/developed technology and 18% for
in-process research and development and an assumed tax rate of 40%. The in-process research and
development represents the estimated fair value based on risk-adjusted cash flows related to
product development projects. At the date of acquisition, the development of these projects had not
yet reached technological feasibility and the research and development in progress had no
alternative future uses. Accordingly, these costs were expensed as of the acquisition date.
The results of operations of Sirius have been included in the financial statements of the Company
since March 10, 2006, the date of acquisition. The following table reflects unaudited pro forma
results of operations of the Company for the three and nine months ended September 30, 2006 and
2005 assuming that the Sirius acquisition had occurred on
January 1, 2005 (in thousands, except per
share data):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
THREE MONTHS ENDED |
|
NINE MONTHS ENDED |
|
|
SEPTEMBER 30, |
|
SEPTEMBER 30, |
|
|
2006 |
|
2005 |
|
2006 |
|
2005 |
|
|
|
Revenues |
|
$ |
6,062,720 |
|
|
$ |
4,603,800 |
|
|
$ |
20,350,009 |
|
|
$ |
14,731,772 |
|
Net loss |
|
|
(3,100,781 |
) |
|
|
(4,078,334 |
) |
|
|
(9,185,622 |
) |
|
|
(14,309,032 |
) |
Net loss per share |
|
$ |
(0.16 |
) |
|
$ |
(0.21 |
) |
|
$ |
(0.47 |
) |
|
$ |
(0.74 |
) |
The pro-forma net loss and net loss per share for the three and nine months ended September
30, 2006 and 2005 excludes the impact of increased cost of goods sold resulting from the purchase
accounting fair value adjustment to inventory due to its non-recurring nature, and for the nine
months ended September 30, 2006 and 2005 excludes a $1.6 million charge related to purchased
in-process research and development.
10
4) GOODWILL AND INTANGIBLE ASSETS
Under Statement of Financial Accounting Standards No. 142, Goodwill and Other Intangible Assets
(SFAS No. 142), goodwill and certain intangible assets are deemed to have indefinite lives and are
not amortized, but are reviewed at least annually for impairment. Other identifiable intangible
assets are amortized over their estimated useful lives. SFAS No. 142 requires that goodwill be
tested for impairment annually, utilizing the fair value methodology. The Company has adopted
December 1st as the date of the annual impairment test for goodwill.
The following is a summary of goodwill and intangible assets as of September 30, 2006 (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GROSS |
|
|
|
|
|
|
CARRYING |
|
ACCUMULATED |
|
NET BOOK |
|
|
VALUE |
|
AMORTIZATION |
|
VALUE |
|
|
|
Goodwill |
|
$ |
5,773 |
|
|
|
|
|
|
$ |
5,773 |
|
Amortizable intangible assets: |
|
|
|
|
|
|
|
|
|
|
|
|
Core/Developed Technology |
|
|
17,160 |
|
|
|
(977 |
) |
|
|
16,183 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
22,933 |
|
|
$ |
(977 |
) |
|
$ |
21,956 |
|
|
|
|
All goodwill is associated with the Non-PDT Drug Products operating segment (see Note 11).
Amortization expense, included in cost of product revenues and royalties in the accompanying
Condensed Consolidated Statements of Operations, related to intangible assets was $437,000 and
$977,000 for the three and nine month periods ended September 30, 2006. Amortization expense
related to intangible assets is expected to be approximately $0.4 million for the remainder of 2006
and approximately $2.8 million, $3.3 million, $3.4 million, $3.2 million and $1.3 million for the
years ending December 31, 2007, 2008, 2009, 2010 and 2011, respectively.
5) MARKETABLE SECURITIES
The Companys investment securities consist of securities of the U.S. government and its agencies,
and investment grade corporate bonds, all classified as available-for-sale. As of September 30,
2006, current yields range from 2.50% to 5.74% and maturity dates range from October 15, 2006 to
September 15, 2010. The estimated fair value and cost of marketable securities at September 30,
2006 and December 31, 2005 are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SEPTEMBER 30, 2006 |
|
|
|
|
|
|
GROSS |
|
GROSS |
|
|
|
|
AMORTIZED |
|
UNREALIZED |
|
UNREALIZED |
|
FAIR |
|
|
COST |
|
GAINS |
|
LOSSES |
|
VALUE |
|
|
|
United States government securities |
|
$ |
9,568,645 |
|
|
$ |
2,061 |
|
|
$ |
(56,799 |
) |
|
$ |
9,513,907 |
|
Corporate securities |
|
|
3,914,289 |
|
|
|
|
|
|
|
(13,697 |
) |
|
|
3,900,592 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
marketable securities available-for-sale |
|
$ |
13,482,934 |
|
|
$ |
2,061 |
|
|
$ |
(70,496 |
) |
|
$ |
13,414,499 |
|
|
|
|
11
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
DECEMBER 31, 2005 |
|
|
|
|
|
|
GROSS |
|
GROSS |
|
|
|
|
AMORTIZED |
|
UNREALIZED |
|
UNREALIZED |
|
FAIR |
|
|
COST |
|
GAINS |
|
LOSSES |
|
VALUE |
|
|
|
United States government debt securities |
|
$ |
19,857,171 |
|
|
$ |
3,732 |
|
|
$ |
(72,243 |
) |
|
$ |
19,788,660 |
|
Investment grade corporate debt securities |
|
|
10,818,063 |
|
|
|
15,136 |
|
|
|
(42,373 |
) |
|
|
10,790,826 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total marketable securities available
for sale |
|
$ |
30,675,234 |
|
|
$ |
18,868 |
|
|
$ |
(114,616 |
) |
|
$ |
30,579,486 |
|
|
|
|
Net unrealized gains and losses on such securities for the three and nine months ended
September 30, 2006 were $(56,756) and $(27,313), respectively, as compared to $(166,714) and
$(413,323) for the three and nine months ended September 30, 2005. These amounts have been recorded
in accumulated other comprehensive loss, which is reported as part of shareholders equity in the
Condensed Consolidated Balance Sheets.
Realized gains on sales of marketable securities for the three and nine months ended September 30,
2006 were $0 and $14,000, respectively, as compared to $66,000 and $72,000 for the three and nine
months ended September 30, 2005. Because the Company has the ability and intent to hold its
investments until a recovery of fair value, which may be maturity, the Company does not consider
investments with unrealized losses to be other-than-temporarily impaired at September 30, 2006.
6) CONCENTRATION OF CREDIT RISK
The Company invests cash in accordance with a policy objective that seeks to preserve both
liquidity and safety of principal. The Company manages the credit risk associated with its
investments in marketable securities by investing in U.S. government securities and investment
grade corporate bonds.
The Company is also exposed to concentration of credit risk related to accounts receivable that are
generated from its customers consisting of wholesalers, distributors and direct customers. To
manage credit risk, the Company performs regular credit evaluations of its customers and provides
allowances for potential credit losses, when applicable. Concentrations of credit risk in the
Companys total revenues for the three and nine months ended September 30, 2006 and 2005, and
accounts receivable as of September 30, 2006 and December 31, 2005 are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
% OF REVENUE |
|
% OF REVENUE |
|
% OF ACCOUNTS |
|
|
THREE MONTHS ENDED |
|
NINE MONTHS ENDED |
|
RECEIVABLE AS OF |
|
|
|
|
|
SEPTEMBER 30, |
|
SEPTEMBER 30, |
|
SEPTEMBER 30, |
|
SEPTEMBER 30, |
|
SEPTEMBER 30, |
|
DECEMBER 31, |
|
|
2006 |
|
2005 |
|
2006 |
|
2005 |
|
2006 |
|
2005 |
|
|
|
Customer A |
|
|
|
|
|
|
17 |
% |
|
|
|
|
|
|
17 |
% |
|
|
|
|
|
|
6 |
% |
Customer B |
|
|
4 |
% |
|
|
13 |
% |
|
|
6 |
% |
|
|
14 |
% |
|
|
6 |
% |
|
|
|
|
Customer C |
|
|
14 |
% |
|
|
|
|
|
|
11 |
% |
|
|
|
|
|
|
24 |
% |
|
|
|
|
Customer D |
|
|
27 |
% |
|
|
|
|
|
|
19 |
% |
|
|
|
|
|
|
32 |
% |
|
|
|
|
Customer E |
|
|
7 |
% |
|
|
|
|
|
|
6 |
% |
|
|
|
|
|
|
9 |
% |
|
|
|
|
Other customers |
|
|
48 |
% |
|
|
70 |
% |
|
|
58 |
% |
|
|
69 |
% |
|
|
29 |
% |
|
|
94 |
% |
|
|
|
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.
12
7) INVENTORY
Inventory consisted of the following:
|
|
|
|
|
|
|
|
|
|
|
SEPTEMBER 30, |
|
DECEMBER 31, |
|
|
2006 |
|
2005 |
|
|
|
Finished goods |
|
$ |
987,119 |
|
|
$ |
1,004,772 |
|
BLU-U® evaluation
units |
|
|
183,183 |
|
|
|
292,129 |
|
|
|
|
|
|
|
|
|
|
Work in-process |
|
|
269,112 |
|
|
|
60,805 |
|
Raw materials |
|
|
719,472 |
|
|
|
503,087 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
2,158,886 |
|
|
$ |
1,860,793 |
|
|
|
|
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 to cost of product
revenues to approximate its net realizable value.
8) OTHER ACCRUED EXPENSES
Other accrued expenses consisted of the following:
|
|
|
|
|
|
|
|
|
|
|
SEPTEMBER 30, |
|
DECEMBER 31, |
|
|
2006 |
|
2005 |
|
|
|
Research and development costs |
|
$ |
325,001 |
|
|
$ |
347,220 |
|
Marketing and sales costs |
|
|
256,858 |
|
|
|
173,092 |
|
Product related costs |
|
|
981,481 |
|
|
|
667,388 |
|
Legal and other professional fees |
|
|
1,567,629 |
|
|
|
488,401 |
|
Employee benefits |
|
|
297,994 |
|
|
|
225,628 |
|
Other expenses |
|
|
40,555 |
|
|
|
93,950 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
3,469,518 |
|
|
$ |
1,995,679 |
|
|
|
|
9) STOCK-BASED COMPENSATION
Under the Companys 2006 Equity Compensation Plan (the 2006 Plan), the Company may grant
stock-based awards in amounts not to exceed the lesser of: (i) 20% of the total number of shares of
the Companys common stock issued and outstanding at any given time less the number of shares
issued and outstanding under any other equity compensation plan of the Company at such time; or
(ii) 3,888,488 shares less the number of shares issued and outstanding under any other equity
compensation plan of the Company from time to time. The maximum number of shares of common stock
that may be granted to any individual during any calendar year is 300,000.
The 2006 Plan is administered by the Compensation Committee of the Board of Directors (the
Committee). The 2006 Plan provides for the grant of incentive stock options (ISO), nonqualified
13
stock options (NSO), stock awards, and stock appreciation rights to (i) employees, consultants,
and
advisors; (ii) the employees, consultants, and advisors of the Companys parents, subsidiaries, and
affiliates; and (iii) and the Companys non-employee directors.
Non-Qualified Stock Options All the NSOs granted under the 2006 Plan have an expiration period
not exceeding seven years and are issued with an exercise price of not less than the market value of
the common stock on the grant date. The Committee may establish such vesting and other conditions
with respect to options as it deems appropriate. In addition, the Company initially grants each
individual who agrees to become a director 15,000 NSO to purchase common stock of the Company.
Thereafter, each director reelected at an Annual Meeting of Shareholders will automatically receive
an additional 10,000 NSO on June 30 of each year. Grants to directors immediately vest on the
date of the grant.
Incentive Stock Options ISOs granted under the 2006 Plan have an expiration period not exceeding
seven years (five years for ISOs granted to employees who are also ten percent shareholders) and
are issued with an exercise price of not less than the market value of the common stock on the grant
date. The Committee may establish such vesting and other conditions with respect to options as it
deems appropriate.
The 2006 Plan replaced the Companys 1996 Omnibus Plan (the 1996 Plan), which expired on June 6,
2006. A summary of stock option transactions in both the 1996 Plan and the 2006 Plan follows:
|
|
|
|
|
|
|
|
|
|
|
WEIGHTED |
|
WEIGHTED |
|
|
NUMBER |
|
AVERAGE |
|
|
OF SHARES |
|
EXERCISE |
|
|
(IN THOUSANDS) |
|
PRICE |
OUTSTANDING AT DECEMBER 31, 2005 |
|
|
2,850,250 |
|
|
$ |
11.85 |
|
Options granted |
|
|
415,500 |
|
|
|
6.65 |
|
Options cancelled/forfeited/expired |
|
|
(443,437 |
) |
|
|
8.50 |
|
Options exercised |
|
|
(12,000 |
) |
|
|
3.41 |
|
OUTSTANDING AT SEPTEMBER 30, 2006 |
|
|
2,810,313 |
|
|
$ |
11.65 |
|
EXERCISABLE AT SEPTEMBER 30, 2006 |
|
|
1,998,318 |
|
|
$ |
12.86 |
|
The weighted average remaining contractual term was approximately 3.4 years for stock options
outstanding and approximately 5.8 years for stock options exercisable as of September 30, 2006.
The total intrinsic value (the excess of the market price over the exercise price) was
approximately $592,000 and $487,000 for stock options outstanding and exercisable, respectively, as
of September 30, 2006. The total intrinsic value for stock options exercised in 2006 was
approximately $45,000. At September 30, 2006, total unrecognized estimated compensation cost
related to non-vested stock options granted prior to that date was $3,590,000, which was expected
to be recognized over a weighted average period of 2.1 years.
The amount of cash received from the exercise of stock options in 2006 was approximately $41,000
and the related tax deduction was approximately $14,000 in 2006.
The fair value of stock options granted was estimated on the date of grant using a Black-Scholes
option valuation model that uses the assumptions in the following table. The Companys employee
stock options have various restrictions that reduce option value, including vesting provisions and
restrictions on transfer and hedging, among others, and are often exercised prior to their
contractual maturity.
The weighted-average estimated fair value of employee stock options granted during the nine months
ended September 30, 2006 was $4.62 per share using the Black-Scholes option valuation model with
the following weighted-average assumptions (annualized percentages):
14
|
|
|
|
|
|
|
NINE MONTHS |
|
|
ENDED |
|
|
SEPTEMBER 30, 2006 |
Volatility |
|
|
63.7 |
% |
Risk-free interest rate |
|
|
5.10 |
% |
Expected dividend yield |
|
|
0 |
% |
Expected life-directors and officers |
|
8.0 |
years |
Expected life-non-officer employees |
|
6.3 |
years |
The Company used a combination of historical and implied volatility of market-traded options
in the Companys stock for the expected volatility assumption input to the Black-Scholes model,
consistent with the guidance in FAS 123R and the SECs SAB No. 107. Prior to the first quarter of fiscal 2006, the Company had used its
historical stock price for purposes of its pro forma information. The decision to use a combination
of historical and implied volatility data to estimate expected volatility was based upon the
availability of actively traded options on the Companys stock and the Companys assessment that
the combination is more representative of future stock price trends than historical volatility alone.
The risk-free interest rate assumption is based upon observed interest rates appropriate for the
term of the Companys employee stock options. The expected life is based on the Companys
historical option cancellation and employee exercise information. The expected life of employee
stock options represents the weighted-average period the stock options are expected to remain
outstanding post-vesting. In calculating the expected life of the options for 2006, the Company
classified its grantee population into two groups, directors and officers and non-officer
employees. As share-based compensation expense recognized in the Consolidated Statements of
Operations for fiscal 2006 is based on awards ultimately expected to vest, it is reduced for
estimated forfeitures. FAS 123R requires forfeitures to be estimated at the time of grant and
revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. In
2006, departure rates, defined as the annual percentage of options forfeited or exercised early due
to departure, were estimated to be approximately 2.96% for officers and directors and 10.53% for
non-officer employees based on historical experience. Prior to 2006, the Company had used a
company-wide weighted average expected life of five years for grants in 2005, 2004 and 2003 and
seven years for grants in 2002.
Total estimated share-based compensation expense, related to all of the Companys share-based
awards, recognized for the three and nine months ended September 30, 2006 was comprised as follows:
|
|
|
|
|
|
|
|
|
|
|
THREE MONTHS ENDED |
|
|
NINE MONTHS ENDED |
|
|
|
SEPTEMBER 30, 2006 |
|
|
SEPTEMBER 30, 2006 |
|
Cost of product revenues |
|
$ |
24,000 |
|
|
$ |
61,000 |
|
Research and development |
|
|
101,000 |
|
|
|
263,000 |
|
Selling and marketing |
|
|
123,000 |
|
|
|
270,000 |
|
General & administrative |
|
|
195,000 |
|
|
|
819,000 |
|
|
|
|
|
|
|
|
Share-based compensation expense |
|
$ |
443,000 |
|
|
$ |
1,413,000 |
|
Prior to adopting the provisions of FAS 123R, the Company recorded estimated compensation
expense for employee stock options based upon their intrinsic value on the date of grant pursuant
to APB 25, Accounting for Stock Issued to Employees and
provided the required pro forma disclosures of FAS 123. Because the Company established the
exercise price based on the fair market value of the Companys stock at the date of grant, the
stock options had no intrinsic value upon grant, and therefore no estimated expense was recorded
prior to adopting FAS 123R.
15
For purposes of pro forma disclosures under FAS 123 for the three and nine months ended September
30, 2005, the estimated fair value of the stock options was amortized to expense over the stock
options vesting periods. The pro forma effects of recognizing estimated compensation expense under
the fair value method on net loss and loss per common share for the three and nine months ended
September 30, 2005 were as follows:
|
|
|
|
|
|
|
|
|
|
|
THREE MONTHS ENDED |
|
NINE MONTHS ENDED |
|
|
SEPTEMBER 30, 2005 |
|
SEPTEMBER 30, 2005 |
|
|
|
Net loss, as reported |
|
$ |
(3,608,281 |
) |
|
$ |
(12,766,014 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Add: stock-based compensation expense included in
reported
net loss |
|
|
|
|
|
|
19,444 |
|
Deduct: Share-based employee compensation expense
determined under the fair value based method for all
awards |
|
|
(339,471 |
) |
|
|
(1,439,514 |
) |
Pro forma net loss |
|
$ |
(3,947,752 |
) |
|
$ |
(14,186,084 |
) |
|
|
|
Loss per common share: |
|
$ |
(0.21 |
) |
|
$ |
(0.75 |
) |
|
|
|
Basic and diluted loss per share as reported |
|
$ |
(0.02 |
) |
|
$ |
(0.09 |
) |
|
|
|
Basic and diluted loss per share pro forma |
|
$ |
(0.23 |
) |
|
$ |
(0.84 |
) |
|
|
|
The pro forma effects of estimated share-based compensation expense on net loss and loss per
common share for the nine months ended September 30, 2005 were estimated at the date of grant using
the Black-Scholes option-pricing model based on the following assumptions (annualized percentages):
|
|
|
|
|
Volatility |
|
|
69.4 |
% |
Risk-free interest rate |
|
|
3.72 |
% |
Dividend yield |
|
|
0.0 |
% |
Expected life (years) |
|
|
5.0 |
|
The Black-Scholes weighted average estimated fair value of stock options granted during the
nine months ended September 30, 2005 was $6.55 per share.
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 periods ended September 30, 2006, and 2005, stock options, warrants and
rights totaling approximately 3,110,000 and 3,396,000 shares, respectively, have been excluded from
the computation of diluted net loss per share as the effect would be antidilutive. The 2,396,245
shares issued in the Sirius acquisition, which includes 422,892 shares placed into the liability
escrow account, are included in the weighted average number of shares outstanding from the date of
issuance, March 10, 2006.
11) SEGMENT REPORTING
Beginning in the first quarter of 2006 with the acquisition of
Sirius, the Company has
two reportable operating segments, Photodynamic Therapy (PDT) Drug and Device Products and
Non-Photodynamic Therapy (Non-PDT) Drug Products. Prior to the beginning of the first quarter of
2006, the Company was a single reportable segment entity. 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 operating
segments for the periods presented. The Company does not allocate research and development, selling
and marketing and general and administrative expenses to its reportable operating segments, because
these activities are managed at a corporate level.
16
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
THREE MONTHS ENDED |
|
NINE MONTHS ENDED |
|
|
|
|
|
SEPTEMBER 30, |
|
SEPTEMBER 30, |
|
SEPTEMBER 30, |
|
SEPTEMBER 30, |
|
|
2006 |
|
2005 |
|
2006 |
|
2005 |
|
|
|
REVENUES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PDT Drug & Device Product Revenues |
|
$ |
3,235,000 |
|
|
$ |
2,392,000 |
|
|
$ |
10,929,000 |
|
|
$ |
7,989,000 |
|
Non-PDT Drug Product Revenues |
|
|
2,828,000 |
|
|
|
|
|
|
|
6,503,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Revenues |
|
|
6,063,000 |
|
|
|
2,392,000 |
|
|
|
17,432,000 |
|
|
|
7,989,000 |
|
COSTS OF REVENUES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PDT Drug & Device Cost of Product |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues and Royalties |
|
|
1,243,000 |
|
|
|
1,307,000 |
|
|
|
3,971,000 |
|
|
|
4,782,000 |
|
Non-PDT Drug Cost of Product |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues and Royalties |
|
|
1,606,000 |
|
|
|
|
|
|
|
3,664,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Costs of Product Revenues and
Royalties |
|
|
2,849,000 |
|
|
|
1,307,000 |
|
|
|
7,635,000 |
|
|
|
4,782,000 |
|
GROSS MARGINS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PDT Drug and Device Product Gross Margin |
|
|
1,992,000 |
|
|
|
1,085,000 |
|
|
|
6,958,000 |
|
|
|
3,207,000 |
|
Non-PDT Drug Product Gross Margin |
|
|
1,222,000 |
|
|
|
|
|
|
|
2,839,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Gross Margins |
|
$ |
3,214,000 |
|
|
$ |
1,085,000 |
|
|
$ |
9,797,000 |
|
|
$ |
3,207,000 |
|
During the three and nine months ended September 30, 2006 and 2005, the Company derived
revenues from the following geographies (as a percentage of product revenues):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ending September 30, |
|
Nine Months Ending September 30, |
|
|
|
|
|
2006 |
|
2005 |
|
2006 |
|
2005 |
|
|
|
United States |
|
|
96 |
% |
|
|
87 |
% |
|
|
94 |
% |
|
|
86 |
% |
Canada |
|
|
4 |
% |
|
|
13 |
% |
|
|
6 |
% |
|
|
14 |
% |
|
|
|
Total |
|
|
100 |
% |
|
|
100 |
% |
|
|
100 |
% |
|
|
100 |
% |
Asset information by reportable segment is not reported to or reviewed by the chief operating
decision makers and, therefore, we have not disclosed asset information for each reportable
segment.
12) COMPREHENSIVE LOSS
For the three and nine months ended September 30, 2006 and 2005, comprehensive loss consisted of
the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
THREE MONTHS ENDED |
|
NINE MONTHS ENDED |
|
|
SEPTEMBER 30, |
|
SEPTEMBER 30, |
|
|
|
|
|
2006 |
|
2005 |
|
2006 |
|
2005 |
|
|
|
NET LOSS |
|
$ |
(3,786,639 |
) |
|
$ |
(3,608,281 |
) |
|
$ |
(13,080,901 |
) |
|
$ |
(12,766,014 |
) |
Change in net unrealized gains
and losses on marketable
securities available-for-sale |
|
|
(56,756 |
) |
|
|
(166,714 |
) |
|
|
(27,313 |
) |
|
|
(413,323 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COMPREHENSIVE LOSS |
|
$ |
(3,843,395 |
) |
|
$ |
(3,774,995 |
) |
|
$ |
(13,108,214 |
) |
|
$ |
(13,179,337 |
) |
|
|
|
17
Accumulated other comprehensive loss consists of net unrealized gains and losses on marketable
securities available-for-sale, which is reported as part of shareholders equity in the Condensed
Consolidated Balance Sheets.
13) COMMITMENTS AND CONTINGENCIES
LEGAL MATTERS:
RIVERS EDGE
On March 28, 2006, a lawsuit was filed by Rivers Edge Pharmaceuticals, LLC against us alleging,
among other things, that, prior to our merger with the former Sirius Laboratories, Inc. Sirius
agreed to authorize Rivers Edge to market a generic version of Nicomide®, and that the
United States patent covering Nicomide® issued to Sirius in December, 2005 is invalid.
Nicomide® is one of the key products DUSA acquired from Sirius in our merger. The
declaratory judgment suit was filed in the United States District Court for the Northern District
of Georgia, Gainesville Division. On June 19, 2006, the Georgia court dismissed Rivers Edge
complaint.
Rivers Edge has also filed an application with the U.S. Patent and Trademark Office requesting
reexamination of the Nicomide patent. We have notified the Patent Office that we do not object to
the reexamination process and we expect the Patent Office to notify the parties about its decision
to accept or deny the patent reexamination process shortly.
On April 20, 2006, we filed a patent infringement suit in the United States District Court in
Trenton, New Jersey alleging that a Rivers Edge niacinamide product infringes our U.S. patent
6,979,468. On May 12, 2006, the New Jersey court granted our motion and entered an order for
preliminary injunction, effective May 15, 2006, enjoining Rivers Edge from selling its niacinamide
formula drug as a generic substitute for Nicomide®. We have posted $750,000 in lieu of a
performance bond with the Court which bears interest. The parties are in the discovery stage of
the New Jersey litigation. A motion to stay this litigation while the patent reexamination process
takes its course was denied. An unfavorable ruling in the Patent Office or in the New Jersey
litigation with respect to the validity of the Nicomide patent would allow generic manufacturers to
compete directly with us and could have a material impact on the Companys revenues, results of
operations and liquidity.
The Company has not accrued any amounts for potential contingencies as of September 30, 2006, as
these amounts are neither probable nor estimable.
14) RECENT ACCOUNTING PRONOUNCEMENTS
In June 2006, the FASB issued Interpretation No. 48 (FIN
48), Accounting for Uncertainty in Income Taxes, an interpretation of FASB Statement No. 109,
Accounting for Income Taxes. The interpretation prescribes a recognition threshold and measurement
attribute for the financial statement recognition and measurement of a tax position taken or
expected to be taken, in a tax return. FIN 48 also provides guidance on derecognition,
classification, interest and penalties accounting in interim periods, disclosure and transition.
The interpretation is effective for fiscal years beginning after December 15, 2006. The Company is
in the process of determining the effects that adoption of FIN 48 will have on the Companys
financial position, cash flows and results of operations.
In September 2006, the FASB issued SFAS No. 157, Fair Market Measurements (SFAS 157), which
establishes a framework for measuring fair value and expands disclosures about the use of fair
value measurements and liabilities in interim and annual reporting periods subsequent to initial
recognition. Prior to SFAS 157, which emphasizes that fair value is a market-based measurement and
not an entity-specific measurement, there were different definitions of fair value and limited
definitions for applying those definitions in GAAP. SFAS 157 is effective for the Company on a
prospective basis for the
18
reporting period beginning January 1, 2008. The effect of adoption on the Companys financial
position and results of operations have not been determined.
In September 2006, the SEC
staff published SAB 108, Considering the Effects of Prior Year Misstatements when Quantifying
Misstatements in Current Year Financial Statements (SAB 108). SAB 108 provides interpretive
guidance on how the effects of the carryover or reversal of prior year misstatements should be
considered in quantifying a current year misstatement. The SAB is effective for fiscal years ending
after November 15, 2006. Application of this SAB will not alter previous conclusions and is not
expected to impact the Companys financial position, results of operations or cash flows.
15) SUBSEQUENT EVENT
On October 18,
2006 the Companys Board of Directors extended the term of Two Hundred Fifty
Thousand (250,000) Class B warrants, originally issued to the Companys Chairman of the Board of
Directors and Chief Executive Officer at the time of DUSAs initial public offering, for an
additional four years to January 29, 2011. An additional Fifty Thousand (50,000) of the Three
Hundred Thousand (300,000) Class B warrants he currently owns
will lapse if they are not exercised prior to January
29, 2007. The warrants have an exercise price of CDN $6.79 per share. No other terms of the
warrants were amended. There are no other holders of the Class B warrants. The Company will
record a non-cash charge to earnings of approximately $500,000 during the fourth quarter of 2006
related to the extension of the warrants.
ITEM 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
OVERVIEW
DUSA is a
dermatology company that is developing and marketing Levulan photodynamic therapy
and other products for common skin conditions. Our current marketed products include
Levulan® Kerastick® 20% Topical Solution with PDT, the BLU-U®
brand light source, Nicomide®, Nicomide-T® and the AVAR® line of
products. We acquired Nicomide®, Nicomide-T®, the AVAR® line of
products, among others, and certain product candidates in early stages of development, which target
the treatment of acne vulgaris and acne rosacea, as well as psoriasis, in connection with our
recent merger with Sirius Laboratories, Inc., or Sirius, which was
completed on March 10, 2006.
We are also continuing to seek to acquire and/or license additional dermatology products that
complement our current product portfolio that would provide our sales force with additional
complementary products to sell in the near to medium term.
Our drug, Levulan® brand of aminolevulinic acid HCl, or ALA, is being used with light,
for use in a broad range of medical conditions. When we use Levulan® and follow it with
exposure to light to treat a medical condition, it is known as Levulan® photodynamic
therapy, or Levulan® PDT. When we use Levulan® and follow it with exposure to
light to detect medical conditions it is known as Levulan® photodetection, or
Levulan® PD.
Two of our products, Levulan® Kerastick® 20% Topical Solution with PDT and
the BLU-U® brand light source were launched in the United States, or U.S., in September
2000 for the treatment of actinic keratoses, or AKs, of the face or scalp. 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 U.S.
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, a dermatology specialty pharmaceuticals company, was founded in 2000 with a primary focus
on the treatment of acne vulgaris and acne rosacea. We believe this acquisition has allowed us to
expand our product portfolio, capitalize on cross-selling and marketing opportunities, increased
our sales force size, as well as providing a pipeline of new products.
Nicomide® is an oral prescription vitamin supplement, and Nicomide-T® is a
topical cosmetic product.
19
Both products target the acne and acne rosacea markets. Acne rosacea is a condition that primarily
affects the skin of the face and typically first appears between the ages of 30 and 60 as a
transient flushing or blushing on the nose, cheeks, chin or forehead, progressing in many patients
to a papulopustular form clinically similar to acne vulgaris (inflammatory acne). Given its
resemblance to inflammatory acne, and the general publics limited knowledge of rosacea, the
condition is frequently mistaken by patients as adult acne. If untreated, rosacea has the tendency
to worsen over time, although it can also wax and wane. The AVAR line of products includes a number
of leave-on and cleanser formulations of sodium sulfacetamide and sulphur, a drug combination long
known to have anti-acne, anti-inflammatory properties.
We are a vertically integrated company, primarily responsible for regulatory, sales, marketing,
customer service, manufacturing of our Kerastick®, and other related product activities.
Our current objectives include increasing the sales of our non-PDT products in the United States
and our PDT products in the United States, Canada and Latin America, continuing our efforts of exploring partnership opportunities for Levulan® PDT
for non-dermatology indications, and for dermatology in Europe and elsewhere, and continuing our
clinical development programs. To further these objectives, we entered into a marketing and distribution
agreement with Stiefel Laboratories, Inc. in January 2006 granting Stiefel an exclusive right to
distribute the Levulan® Kerastick® in Mexico, Central and South America. On
October 17, 2006, we announced that regulatory approval had been obtained in Brazil. We anticipate
the Brazilian launch will occur in early 2007. During 2004 we signed clinical trial agreements
with the National Cancer Institute, or NCI, Division of Cancer Prevention, or DCP, for the clinical
development of Levulan® PDT for the treatment of high-grade dysplasia, or HGD, within
Barretts Esophagus, or BE, and oral cavity dysplasia treatment, and are working with the NCI DCP
to advance the development of these programs. In addition, we continue to support independent
investigator trials to advance research in the use and applicability of Levulan® PDT for
other indications in dermatology, and selected internal indications.
We are developing Levulan® PDT and PD under an exclusive worldwide license of patents
and technology from PARTEQ Research and Development Innovations, the licensing arm of Queens
University, Kingston, Ontario, Canada. We also own or license certain other patents relating to
methods for using pharmaceutical formulations which contain Levulan® and related
processes and improvements.
In the United States, AVAR®, AVAR Green®, AVAR-e
®, AVAR-e
Green®, AVAR Cleanser®, BLU-U®,
DUSA®, DUSA
Pharmaceuticals, Inc.®, Levulan®, Kerastick®, Sirius Laboratories,
Inc.®, METED
®
, Nicomide
®,
Nicomide-T
®, Psoriacap
® and
Psoriatec® 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.
Historically, we devoted most of our resources to fund research and development efforts in order to
advance the Levulan® PDT/PD technology platform. In addition, we are continuing to
evaluate and develop several potential products that we acquired in our merger with Sirius which
target patients with acne and rosacea.
As of September 30, 2006, we had an accumulated deficit of approximately $102,618,000. We expect to
continue to incur operating losses until sales of our products increase substantially. Achieving
our goal of becoming a profitable operating company is dependent upon greater acceptance of our PDT
therapy by the medical and consumer constituencies, and increasing
sales of the products we acquired from Sirius.
We operate in a highly regulated and competitive environment. Our competitors include larger fully
integrated pharmaceutical companies and biotechnology companies. Many of the organizations
competing with us have substantially greater capital resources, larger research and development
staffs and facilities, greater experience in drug development and in obtaining regulatory
approvals, and greater manufacturing and sales and marketing capabilities than we do. Particularly
in the field of acne and rosacea, we compete with well-established therapies, such as
over-the-counter topical medications for
20
mild cases, and prescription topical medications or oral antibiotics for mild to moderate cases, as
well as various laser and non-laser light sources. The entry of new products from time to time,
including as recently as the quarter ended September 30, 2006, could cause fluctuations in our
product revenues in this market.
Marketing and sales activities since the October 2003 launch of our sales force have resulted in
significant additional revenues as well as expenses. Kerastick® unit sales to end-users
were 27,480 and 95,358 for the three and nine-month periods ended September 30, 2006, respectively,
including 2,400 and 12,990, respectively, sold in Canada. This represents an increase from 20,286
and 69,162 Kerastick® units sold in the three and nine-month periods ended September 30,
2005, respectively, including 2,520 and 9,990, respectively, sold in Canada.
The net number of BLU-U® units placed in doctors offices during the three months ended
September 30, 2006 and 2005 was 69 and 98, respectively, including 9 and 22 placed in Canada,
respectively. As of September 30, 2006 and December 31, 2005 there were 1,548 and 1,337 units in
doctors offices, consisting of 1,328 and 1,142 in the U.S. and 220 and 195 in Canada,
respectively. During 2005 we began a BLU-U® marketing effort to allow prospective
customers to evaluate a BLU-U for a short period of time prior to making a purchase decision.
BLU-U® commercial light sources placed in physicians offices pursuant to the Companys
BLU-U® evaluation program are classified as inventory in the accompanying Consolidated
Balance Sheets. The Company amortizes the cost of the evaluation units during the evaluation period
to cost of product revenues to approximate its net realizable value.
Net revenues generated by the products acquired as part of our acquisition of Sirius totaled
$2,828,000 and $6,503,000 for the three-month period ended September 30, 2006 and the period March
10, 2006 (date of acquisition) through September 30, 2006, respectively. The substantial majority
of these revenues were from sales of Nicomide®. We have continued our efforts to
penetrate the market for both PDT and non-PDT products by expanding our sales coverage in key
geographic locations, including areas not previously served by Sirius. We are encouraged with the
year-over-year increase in sales, as well as the positive feedback we continue to receive from
physicians across the country that believe Levulan® PDT should become a routine part of
standard dermatological practice. We are currently exploring opportunities to develop, market, and
distribute our Levulan® PDT platform in Europe and/or other countries outside of the
United States, Canada and Latin America following our recently completed agreement with Stiefel
Laboratories, Inc. We cannot predict when product sales may offset the costs associated with our
efforts to penetrate the PDT market; however, based on current revenue expectations we believe that
we will approach positive cash flow from operations more quickly than we otherwise would have
without the Sirius acquisition. We are aware that physicians have been using Levulan®
with the BLU-U® using drug incubation times shorter than our approved label specifies,
with light devices manufactured by other companies, and for uses other than our FDA-approved use.
While we are not permitted to market our products for so-called off-label uses, we believe that
these activities are positively affecting the sales of our products.
We believe that the activities of compounding pharmacies are negatively impacting our sales growth.
We believe that some compounding pharmacies are exceeding the legal limits for their activities,
including manufacturing and/or selling quantities of ALA in circumstances which may be inducing
purchasers to infringe our intellectual property. Since December 2004,
we filed lawsuits against two compounding pharmacies and several
physicians. All of these lawsuits
have been settled favorably to us. Recently, we filed a suit against a
chemical supplier as part of our ongoing strategy to protect our intellectual property. See section
entitled Part II. Other Information, Item 1. Legal Proceedings.
In connection with our merger with Sirius, we have assumed a number of key agreements relating to
the manufacture and supply of the Sirius current and potential products, and relating to the
development of
21
certain product candidates. We intend to continue to use third-party manufacturers for such
products. The Sirius products are distributed through several major wholesalers in the United
States pursuant to customary industry arrangements. The foregoing agreements are discussed later in
this report.
Certain of the products acquired in connection with the Sirius merger must meet certain minimum
manufacturing and labeling standards established by the FDA and applicable to products marketed
without approved marketing applications. FDA regulates such products under its marketed unapproved
drugs compliance policy guide entitled, Marketed New Drugs without Approved NDAs or ANDAs. Under
this policy, FDA recognizes that certain unapproved products, based on the introduction date of
their active ingredients and the lack of safety concerns, have been marketed for many years and, at
this time, will not be the subject of any enforcement action. FDA is encouraging manufacturers of
such products to submit applications to obtain marketing approval and we have begun discussions
with FDA to begin that process. FDAs enforcement discretion policy does not apply to drugs or
firms that may be in violation of regulatory requirements other than preapproval submission
requirements and FDA may bring an action against a drug or a firm when FDA concludes that such
other violations exist. The contract manufacturer of Nicomide has received a request from the FDA
for labeling information and justification for the belief that the product is exempt from drug
approval requirements and has been cited for GMP violations, however, we believe the GMP issues do
not directly involve our products. There can be no assurance that the FDA will continue this policy
or not take a contrary position with any individual products. If the FDA were to do so, we may be
required to market these products as over-the-counter products or as dietary supplements under
applicable legislation, or withdraw such products from the market, unless and until we submit a
marketing application and obtain FDA marketing approval.
As a result of our due diligence efforts, including inspection of the third-party manufacturers, we
are working with the supplier of the AVAR® line of products to address certain
manufacturing concerns that were identified during due diligence. Some of these products are on
back-order while such concerns are being addressed. Revenues from these products are not material
to the Companys overall revenues.
On March 28, 2006, a lawsuit was filed by Rivers Edge Pharmaceuticals, LLC against us alleging,
among other things, that, prior to our merger with the former Sirius Laboratories, Inc. Sirius
agreed to authorize Rivers Edge to market a generic version of Nicomide®, and that the
United States patent covering Nicomide® issued to Sirius in December, 2005 is invalid.
Nicomide® is the key product DUSA acquired from Sirius in our merger. The declaratory
judgment suit was filed in the United States District Court for the Northern District of Georgia,
Gainesville Division. On June 19, 2006, the Georgia court dismissed Rivers Edge complaint.
Rivers Edge has also filed an application with the U.S. Patent and Trademark Office requesting
reexamination of the Nicomide patent. We have notified the Patent Office that we do not object to
the reexamination process and we expect the Patent Office to notify the parties about its decision
to accept or deny the patent reexamination process shortly.
On April 20, 2006, we filed a patent infringement suit in the United States District Court in
Trenton, New Jersey alleging that a Rivers Edge niacinamide product infringes our U.S. patent
6,979,468. On May 12, 2006, the New Jersey court entered an order for preliminary injunction, which
was effective May 15, 2006, enjoining Rivers Edge from selling its niacinamide formula drug as a
generic substitute for Nicomide®. We have posted $750,000 in lieu of a performance bond
with the Court which bears interest. The parties are in the discovery stage of the New Jersey
litigation. A motion to stay this litigation while the patent reexamination process takes its
course was denied. An unfavorable ruling in the Patent Office or in the New Jersey litigation with
respect to the validity of the Nicomide patent would allow generic manufacturers to compete
directly with us and could have a material impact on the Companys revenues, results of operations
and liquidity.
22
On May 30, 2006, we entered into a patent license agreement under which we granted PhotoCure ASA a
non-exclusive license under the patents we license from PARTEQ for ALA esters. In addition, we
granted a non-exclusive license to PhotoCure for its existing formulations of Hexvix®
and Metvix® (known in the U.S. as Metvixia®) for any patent we own now or in
the future. PhotoCure is obligated to pay royalties on sales of its ester products to the extent
they are covered by our patents in the US and certain other territories. As part of the agreement,
PhotoCure paid us a prepaid royalty in the amount of $1 million, which we received during the
three-month period ended June 30, 2006.
We continue to believe that issues related to reimbursement have negatively impacted the economic
competitiveness of our therapy with other AK therapies and have hindered its adoption. We are aware
that some physicians believe that current reimbursement levels do not fully reflect the efforts
required to routinely execute our therapy in their practices. We support efforts to improve
reimbursement levels to physicians. Such efforts included working with the Centers for Medicare and
Medicaid Services, or CMS, and the American Academy of Dermatology, or AAD, on matters related to
the PDT procedure fee and the separate drug reimbursement fee. Physicians can also bill for any
applicable visit fees. Effective January 1, 2006, the CMS average national reimbursement for the
use of Levulan® PDT for AKs Ambulatory Patient Classifications code (APC code) was
increased. The APC code is used by many hospitals. The CMS Current Procedural Terminology code
(CPT code), which is used by private physician clinics using Levulan® PDT for treating
AKs was not increased for 2006 from 2005 levels as had originally been proposed by CMS. However,
CMS recently published proposed fees for January 1, 2007, and beyond, that include increases to the
CPT code used by private physician clinics using Levulan® PDT for treating AKs. The
proposed increases will be phased in over four years, beginning
January 1, 2007, and completing
January 1, 2010. We will continue to support ongoing efforts that might lead to further increases
in reimbursement in the future; and intend to continue supporting efforts to seek reimbursement for
our FDA-cleared use of the BLU-U® alone in the treatment of mild to moderate
inflammatory acne of the face.
Most major private insurers have approved coverage for our AK therapy. We believe that due to these
efforts, plus future improvements, along with our education and marketing programs, a more
widespread adoption of our therapy should occur over time. As of September 30, 2006, we had a staff
of 78 full-time employees and 2 part-time employees, as compared to 64 full-time employees and 2
part-time employees at the end of 2005, including marketing and sales, production, maintenance,
customer support, and financial operations personnel, as well as those who support research and
development programs for dermatology and internal indications. During 2006 we expanded our sales
capacity to 37 from 26 at the end of 2005. We may add and/or replace employees during 2006 as
business circumstances deem necessary.
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, 2005. Since all of
these accounting policies do not require management to make difficult, subjective or complex
judgments or estimates, they are not all considered critical accounting policies. We have discussed
these policies and the underlying estimates used in applying these accounting policies with our
audit committee. We consider the following policies and estimates to be critical to our financial
statements.
REVENUE RECOGNITION AND PROVISIONS FOR ESTIMATED REDUCTIONS TO GROSS REVENUES
Photodynamic Therapy (PDT) Drug and Device Products.
Revenues on the Kerastick® and BLU-U® product sales are recognized when
persuasive evidence of an arrangement exists, the price is fixed and determinable, delivery has
occurred, and collection is probable. Product sales made through distributors, historically, have
been recorded as deferred revenue until the product was sold by the distributors to the end users
because we did not have sufficient history with our
23
distributor to be able to reliably estimate returns. Beginning in 2006, we began recognizing
revenue as product is sold to distributors because we now believe have sufficient history to
reliably estimate returns from distributors. Certain device units are held by physicians for a
trial period. No revenue is recognized on these units until the physician elects to purchase the
equipment and all other revenue recognition criteria are met.
Non-PDT Drug Products.
We recognize revenue for these products in accordance with SAB No. 101, Revenue Recognition in
Financial Statements, as amended by SAB No. 104, Revenue Recognition. Our accounting policy for
revenue recognition has a substantial impact on our reported results and relies on certain
estimates that require difficult, subjective and complex judgments on the part of management. We
recognize revenue for sales when substantially all the risks and rewards of ownership have
transferred to the customer, which generally occurs on the date of shipment to wholesale customers,
with the exceptions described below. Revenue is recognized net of revenue reserves, which consists
of allowances for discounts, returns, rebates chargebacks and fees paid to wholesalers under
distribution service agreements.
In the case of sales made to wholesalers as a result of incentives and that are in excess of the
wholesalers ordinary course of business inventory level, substantially all the risks and rewards
of ownership do not transfer upon shipment and, accordingly, such sales are recorded as deferred
revenue and the related costs as deferred cost of revenue until the product is sold through to the
wholesalers customers on a FIFO basis.
We evaluate inventory levels at our wholesale customers, which account for the vast majority of our
sales in the Non-PDT Drug Products segment, through an analysis that considers, among other things,
wholesaler purchases, wholesaler shipments to retailers, available end-user prescription data
purchased from third parties and on-hand inventory data received directly from our two largest
wholesale customers. We believe that our evaluation of wholesaler inventory levels, as described in
the preceding sentence, allows us to make reasonable estimates for our applicable revenue related
reserves. Additionally, our products are sold to wholesalers with a product shelf life that allows
sufficient time for our wholesaler customers to sell our products in their inventory through to the
retailers and, ultimately, to the end-user consumer prior to product expiration.
A summary of activity in the Companys gross revenue reserves follows for each of the periods
presented:
|
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|
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|
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|
|
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|
|
|
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|
|
|
|
|
|
FOR THE THREE-MONTH PERIOD |
|
|
|
|
|
|
|
|
ENDED SEPTEMBER 30, 2006: |
|
|
|
|
|
|
|
|
PROVISION |
|
PROVISION |
|
ACTUAL |
|
|
|
|
|
|
|
|
RELATED TO |
|
FOR |
|
RETURNS |
|
|
|
|
|
|
|
|
SALES MADE |
|
SALES |
|
OR CREDITS |
|
|
|
|
BALANCE |
|
IN THE |
|
MADE IN |
|
IN THE |
|
BALANCE |
|
|
AT JULY 1, |
|
CURRENT |
|
PRIOR |
|
CURRENT |
|
AT SEPTEMBER |
|
|
2006 |
|
PERIOD |
|
PERIODS |
|
PERIOD |
|
30, 2006 |
|
|
|
Accrued Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Returns and allowances |
|
$ |
252,000 |
|
|
$ |
304,000 |
|
|
$ |
|
|
|
$ |
(236,000 |
) |
|
$ |
320,000 |
|
Accounts receivable: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Prompt payment discounts |
|
$ |
26,000 |
|
|
$ |
67,000 |
|
|
$ |
|
|
|
$ |
(65,000 |
) |
|
$ |
28,000 |
|
24
|
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|
FOR THE NINE-MONTH PERIOD ENDED SEPTEMBER 30, 2006: |
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|
|
|
|
|
|
|
|
|
|
PROVISION |
|
|
|
|
|
ACTUAL |
|
|
|
|
|
|
|
|
BALANCE |
|
RELATED TO |
|
PROVISION |
|
RETURNS |
|
|
|
|
|
|
|
|
ACQUIRED AS |
|
SALES MADE |
|
FOR SALES |
|
OR CREDITS |
|
|
|
|
|
|
|
|
PART OF |
|
IN THE |
|
MADE IN |
|
IN THE |
|
BALANCE AT |
|
|
BALANCE AT |
|
SIRIUS |
|
CURRENT |
|
PRIOR |
|
CURRENT |
|
SEPTEMBER |
|
|
JANUARY 1, 2006 |
|
ACQUISITION |
|
PERIOD |
|
PERIODS |
|
PERIOD |
|
30, 2006 |
|
|
|
Accrued Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Returns and
allowances |
|
$ |
|
|
|
$ |
357,000 |
|
|
$ |
594,000 |
|
|
$ |
|
|
|
$ |
(631,000 |
) |
|
$ |
320,000 |
|
Accounts receivable: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Prompt payment
discounts |
|
$ |
|
|
|
$ |
|
|
|
$ |
151,000 |
|
|
$ |
|
|
|
$ |
($123,000 |
) |
|
$ |
28,000 |
|
Our provision for returns and allowances consists of our estimates of future sales returns,
rebates and chargebacks.
Sales Returns- We account for sales returns in accordance with SFAS No. 48 by establishing an
accrual in an amount equal to our estimate of sales recorded for which the related products are
expected to be returned. We determine the estimate of the sales return accrual primarily based on
historical experience regarding sales returns, but also by considering other factors that could
impact sales returns. These factors include levels of inventory in the distribution channel,
estimated shelf life, product recalls, product discontinuances, price changes of competitive
products, introductions of generic products and introductions of competitive new products. It is
our policy to accept returns of Non-PDT Drug products when product is within nine months of
expiration. We consider all of these factors and adjust the accrual periodically to reflect actual
experience.
Chargebacks and Rebates Chargebacks typically occur when suppliers enter into contractual
pricing arrangements with end-user customers, including certain federally mandated programs, who
then purchase from wholesalers at prices below what the supplier charges the wholesaler. Since we
only offer preferred pricing to end-user customers under federally mandated programs, chargebacks
have not been significant to the Company. Our rebate programs can generally be categorized into the
following two types: Medicaid rebates and consumer rebates. Medicaid rebates are amounts owed based
on legal requirements with public sector benefit providers after the final dispensing of the
product by a pharmacy to a benefit plan participant. Consumer rebates are amounts owed as a result
of mail-in coupons that are distributed by health care providers to
consumers at the time a
prescription is written. Since only a small percentage of our prescriptions are reimbursed under
Medicaid and the quantity of consumer coupon redemptions have not been substantial, rebates have
not been significant to the Company. Chargebacks and rebates in the aggregate were $46,000 and
$136,000, for the three and nine month periods ended September 30, 2006, respectively.
We offer many of our customers a 2% prompt pay discount. We evaluate the amounts accrued for prompt
pay discounts by analyzing the unpaid invoices in our accounts receivable aging subject to a prompt
pay discount. Prompt pay discounts are known within 15 to 30 days of sale, and therefore can be
reliably estimated based on actual and expected activity at each reporting date. The Company
records these discounts at the time of sale and they are accounted for as a reduction of revenues.
Historically, our adjustments to actual have not been material. The sensitivity of our estimates
can vary by type of revenue reserve. Our estimate associated with returns and allowances is
evaluated based primarily on historical returns experience relative to sales volumes, but also
considers the length of time from the sale to the lapse of the return right. There have been no
material adjustments to our accruals based on actual returns.
INVENTORY
Inventories are stated at the lower of cost or market value. Cost is determined using the first-in,
first-out
25
method. Inventories are continually reviewed for slow moving, obsolete and excess items.
Inventory items identified as slow-moving are evaluated to determine if an adjustment is required.
Additionally, our industry is characterized by regular technological developments that could result
in obsolete inventory. Although we make every effort to assure the reasonableness of our estimates,
any significant unanticipated changes in demand, technological development, or significant changes
to our business model could have a significant impact on the value of our inventory and our results
of operations. We use sales projections to estimate the appropriate level of inventory reserves, if
any, that are necessary at each balance sheet date.
VALUATION OF LONG-LIVED AND INTANGIBLE ASSETS
We review our long-lived and intangible assets for impairment whenever events or changes in
circumstances indicate that the carrying amount of a long-lived or intangible asset may not be
recoverable or that the useful lives of these assets are no longer appropriate. Recoverability of
assets to be held and used is measured by a comparison of the carrying amount of an asset to future
undiscounted net cash flows expected to be generated by the asset. When it is determined that the
carrying value of a long-lived asset is not recoverable, the asset is written down to its estimated
fair value on a discounted cash flow basis.
Goodwill is deemed to have an indefinite life and is no longer amortized, but is reviewed at least
annually for impairment, utilizing the fair value methodology. The Company has adopted December
1st as the date of the annual impairment test for goodwill.
STOCK-BASED COMPENSATION
In December 2004, the Financial Accounting Standards Board (FASB) issued SFAS No. 123R,
Share-Based Payment, a revision of SFAS Statement No. 123. We adopted SFAS 123R effective January
1, 2006, using the modified prospective application method, and beginning with the first quarter of
2006, we measure all employee share-based compensation awards using a fair value based method and
record share-based compensation expense in our financial statements if the requisite service to
earn the award is provided. The pro forma results and assumptions used in fiscal years 2005, 2004
and 2003 were based solely on historical volatility of our common stock over the most recent period
commensurate with the estimated expected life of our stock options. The adoption of SFAS No. 123R
did not affect our net cash flow, but it did have a material negative impact on our results of
operations. In accordance with SFAS 123R, we recognize the expense attributable to stock awards
that are granted or vest in periods ending subsequent to December 31, 2005 in the accompanying
condensed consolidated statements of operations.
In connection with our adoption of SFAS 123R, we refined our valuation assumptions and the
methodologies used to derive those assumptions; however, we elected to continue using the
Black-Scholes option valuation model. Concurrent with our adoption of SFAS 123R, we determined that
a combination of historical and implied volatility for traded options on DUSAs stock would be a
better measure of market conditions and expected volatility than historical volatility of our
common stock alone. Previously, we used historical stock price volatility as it was the most
reliable source of volatility data. We estimate the weighted-average expected life of our
stock-option awards based on historical cancellation and exercise data related to our stock-based
awards as well as the contractual term and vesting terms of the awards. In calculating the expected
life of the options for 2006, we classified our grantee population into two groups, directors and
officers and non-officer employees. Prior to the first quarter of 2006, we had used a company-wide
weighted average expected life of five years for grants in 2005, 2004 and 2003 and seven years for
grants in 2002. Stock-based compensation expense related to stock options is recognized net of
estimated forfeitures. We estimated forfeitures based on our historical experience. In the first
quarter of 2006, departure rates, defined as the annual percentage of options forfeited or
exercised early due to departure, were estimated to be approximately 2.96% for officers and
directors and 10.53% for non-officer employees.
RECENT ACCOUNTING PRONOUNCEMENTS
26
In
June 2006, the FASB issued Interpretation No. 48 (FIN
48), Accounting for Uncertainty in Income Taxes, an interpretation of FASB Statement No. 109,
Accounting for Income Taxes. The interpretation prescribes a recognition threshold and measurement
attribute for the financial statement recognition and measurement of a tax position taken or
expected to be taken, in a tax return. FIN 48 also provides guidance on derecognition,
classification, interest and penalties accounting in interim periods, disclosure and transition.
The interpretation is effective for fiscal years beginning after
December 15, 2006. We are in the process of determining the
effects that adoption of FIN 48 will have on our financial position, cash flows and results of operations.
In September 2006, the FASB issued SFAS No. 157, Fair Market Measurements (SFAS 157), which
establishes a framework for measuring fair value and expands disclosures about the use of fair
value measurements and liabilities in interim and annual reporting periods subsequent to initial
recognition. Prior to SFAS 157, which emphasizes that fair value is a market-based measurement and
not an entity-specific measurement, there were different definitions of fair value and limited
definitions for applying those definitions in GAAP. SFAS 157 is effective for the Company on a
prospective basis for the reporting period beginning January 1,
2008. The effect of adoption on our financial position and results of operations have not been determined.
In
September 2006, SEC staff published SAB 108, Considering the Effects of Prior Year Misstatements when Quantifying Misstatements in
Current Year Financial Statements (SAB 108). SAB 108 provides interpretive guidance on how the
effects of the carryover or reversal of prior year misstatements should be considered in
quantifying a current year misstatement. The SAB is effective for fiscal years ending after
November 15, 2006. Application of this SAB will not alter previous conclusions and is not expected
to impact our financial position, results of operations or cash flows.
RESULTS OF OPERATIONS THREE MONTHS ENDED SEPTEMBER 30, 2006 VERSUS SEPTEMBER 30, 2005
27
REVENUES Total revenues for the three and nine month periods ended September 30, 2006
were $6,063,000 and $17,432,000, respectively as compared to $2,392,000 and $7,989,000 in 2005, and
were comprised of the following:
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|
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|
|
|
|
|
|
|
THREE MONTHS ENDED SEPTEMBER 30, |
|
NINE MONTHS ENDED SEPTEMBER 30, |
|
|
(UNAUDITED) |
|
INCREASE/ |
|
(UNAUDITED) |
|
INCREASE/ |
|
|
2006 |
|
2005 |
|
(DECREASE) |
|
2006 |
|
2005 |
|
(DECREASE) |
|
|
|
PDT PRODUCT REVENUES |
|
|
|
|
|
|
|
|
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|
|
|
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|
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|
|
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|
|
KERASTICK® PRODUCT REVENUES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United States |
|
$ |
2,490,000 |
|
|
$ |
1,630,000 |
|
|
$ |
860,000 |
|
|
$ |
8,212,000 |
|
|
$ |
5,389,000 |
|
|
$ |
2,823,000 |
|
Canada |
|
|
176,000 |
|
|
|
176,000 |
|
|
|
|
|
|
|
939,000 |
|
|
|
693,000 |
|
|
|
246,000 |
|
|
|
|
Subtotal Kerastick® product revenues |
|
|
2,666,000 |
|
|
|
1,806,000 |
|
|
|
860,000 |
|
|
|
9,151,000 |
|
|
|
6,082,000 |
|
|
|
3,069,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BLU-U® PRODUCT REVENUES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United States |
|
|
516,000 |
|
|
|
462,000 |
|
|
|
54,000 |
|
|
|
1,633,000 |
|
|
|
1,489,000 |
|
|
|
144,000 |
|
Canada |
|
|
53,000 |
|
|
|
124,000 |
|
|
|
(71,000 |
) |
|
|
145,000 |
|
|
|
418,000 |
|
|
|
(273,000 |
) |
|
|
|
Subtotal BLU-U® product revenues |
|
|
569,000 |
|
|
|
586,000 |
|
|
|
(17,000 |
) |
|
|
1,778,000 |
|
|
|
1,907,000 |
|
|
|
(129,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL PDT PRODUCT REVENUES |
|
|
3,235,000 |
|
|
|
2,392,000 |
|
|
|
843,000 |
|
|
|
10,929,000 |
|
|
|
7,989,000 |
|
|
|
2,940,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL NON-PDT DRUG PRODUCT REVENUES |
|
|
2,828,000 |
|
|
|
|
|
|
|
2,828,000 |
|
|
|
6,503,000 |
|
|
|
|
|
|
|
6,503,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL PRODUCT REVENUES |
|
$ |
6,063,000 |
|
|
$ |
2,392,000 |
|
|
$ |
3,671,000 |
|
|
$ |
17,432,000 |
|
|
$ |
7,989,000 |
|
|
$ |
9,443,000 |
|
|
|
|
For the three and nine month periods ended September 30, 2006 total PDT Drug and Device Products
revenues were $3,235,000 and $10,929,000, respectively. This represents an increase of $843,000 or
35%, and $2,940,000 or 37%, over the comparable 2005 totals of $2,392,000 and $7,989,000,
respectively. The incremental revenue on a year-to-date basis was driven by increased
Kerastick® revenues which were partially offset by decreased BLU-U® revenues.
For the three and nine month periods ended September 30, 2006, Kerastick® revenues were
$2,666,000 and $9,151,000, respectively, representing a $860,000 or
48%, and $3,069,000 or 50%, increase over the comparable 2005 totals of $1,806,000 and $6,082,000, respectively.
Kerastick® unit sales to end-users were 27,480 and 95,358 for the three and nine-month
periods ended September 30, 2006, respectively, including 2,400 and 12,990, respectively, sold in
Canada. This represents an increase from 20,286 and 69,162 Kerastick® units sold in the
three and nine-month periods ended September 30, 2005, respectively, including 2,520 and 9,990,
respectively, sold in Canada. Our average net selling price for the Kerastick®
increased to $95.96 for the first nine months of 2006 from $87.93 for the first nine months of
2005.
Our average net selling price for the Kerastick® includes sales made directly to our
end-user customers, as well as sales made to our distributors, both in the United States during
2005 and Canada during 2005 and 2006. The increase in 2006 Kerastick® revenues was
driven mainly by increased sales volumes, an increase in our average unit selling price, a
reduction in our overall sales volume discount programs, and increased levels of direct
distribution to customers. Effective January 1, 2006, DUSA became the sole US distributor of the
Kerastick®.
28
For the three and nine month periods ended September 30, 2006, BLU-U® revenues were
$569,000 and $1,778,000, respectively, representing a $17,000 or 3%
decrease, and $129,000 or 7%, decrease over the comparable 2005 totals of $586,000 and $1,907,000, respectively. The decrease in
2006 BLU-U® revenue was driven by lower overall sales volumes which were partially
offset by an increase in our average selling price. In the three and nine-month periods ended
September 30, 2006, there were 77 and 235 units sold, respectively, versus 82 units and 294 units
in the comparable 2005 periods. The 2006 total consists of 210 units sold in the United States and
25 sold in Canada by Coherent-AMT. The 2005 total consists of 219 sold in the United States and 75
sold in Canada. Our average net selling price for the BLU-U® increased to $7,392 for
the first nine months of 2006 from $6,390 for the first nine months of 2005. The decrease in
BLU-U® units sold in the three and nine-month periods ended September 30, 2006 compared
to the same periods in 2005 is due primarily to the implementation of a more focused sales strategy
aimed at increasing Kerastick® sales volumes in existing accounts; as well as, a
decrease in BLU-U® discounting programs.
During the fourth quarter of 2005, we introduced a BLU-U® evaluation program, which, for
a limited number of BLU-U® units, allows customers to take delivery of a unit for a
period of up to 4 months for private practitioners and up to one year for hospital clinics, before
a purchase decision is required. At September 30, 2006, there were approximately 50 units in the
field pursuant to this evaluation program. 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 3 years.
Non-PDT Drug Product Revenues reflect the revenues generated by the products acquired as part of
our March 10, 2006 acquisition of Sirius. Total revenues for the three months ended September 30,
2006 and for the period March 10, 2006 through September 30, 2006 were $2,828,000 and $6,503,000,
respectively. The substantial majority of the Non-PDT product revenues were from sales of
Nicomide®. The products acquired from Sirius all belong to the same therapeutic
category, non-photodynamic therapy dermatological treatment of acne and rosacea.
The increase in our total revenues results from the Sirius acquisition, as well as the efforts of
our sales force and related marketing and sales activities. With respect to United States sales, we
increased our average selling prices, increased our direct selling efforts, became the sole US
distributor of the Kerastick®, and reduced our overall sales volume discount programs,
all of which have had a positive impact on our average selling prices during 2006. However, we must
increase sales significantly from these levels in order for us to become profitable. We remain
confident that sales should continue to increase through increased consumption of our products by
our existing customers, as well as the addition of new customers. However, should one or more
generic niacinamide products remain on the market for any significant length of time, our revenues
of Nicomide® could be significantly eroded, which would make it more difficult to
achieve profitability.
COST OF PRODUCT SALES AND ROYALTIES Cost of product revenues and royalties for the three and
nine-month periods ended September 30, 2006 were $2,849,000 and $7,635,000, respectively, as
compared to $1,307,000 and $4,782,000 in the comparable periods in 2005. A summary of the
components of cost of product revenues and royalties is provided below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
|
|
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
Increase/ |
|
|
|
2006 |
|
|
2005 |
|
|
(Decrease) |
|
Kerastick® Cost of Product Revenues and Royalties |
|
|
|
|
|
|
|
|
|
|
|
|
|
Direct Kerastick® Product costs |
|
$ |
380,000 |
|
|
$ |
369,000 |
|
|
$ |
11,000 |
|
Other Kerastick® Product costs including internal costs assigned to support products |
|
|
224,000 |
|
|
|
354,000 |
|
|
|
(130,000 |
) |
Royalty and supply fees (1) |
|
|
126,000 |
|
|
|
93,000 |
|
|
|
33,000 |
|
|
|
|
|
|
|
|
|
|
|
29
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
|
|
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
Increase/ |
|
|
|
2006 |
|
|
2005 |
|
|
(Decrease) |
|
Subtotal Kerastick Cost of Product Revenues and Royalties |
|
|
730,000 |
|
|
|
816,000 |
|
|
|
(86,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
BLU-U® Cost of Product Revenues |
|
|
|
|
|
|
|
|
|
|
|
|
|
Direct BLU-U® Product Costs |
|
|
263,000 |
|
|
|
284,000 |
|
|
|
(21,000 |
) |
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 |
|
|
250,000 |
|
|
|
207,000 |
|
|
|
43,000 |
|
|
|
|
|
|
|
|
|
|
|
Subtotal BLU-U® Cost of Product Revenues |
|
|
513,000 |
|
|
|
491,000 |
|
|
|
22,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL PDT DRUG & DEVICE COST OF PRODUCT REVENUES AND ROYALTIES |
|
|
1,243,000 |
|
|
|
1,307,000 |
|
|
|
(64,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL NON-PDT DRUG COST OF PRODUCT REVENUES AND ROYALTIES (2) |
|
|
1,606,000 |
|
|
|
|
|
|
|
1,606,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL COST OF PRODUCT REVENUES AND ROYALTIES |
|
$ |
2,849,000 |
|
|
$ |
1,307,000 |
|
|
$ |
1,542,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30, |
|
|
|
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
Increase/ |
|
|
|
2006 |
|
|
2005 |
|
|
(Decrease) |
|
Kerastick® Cost of Product Revenues and Royalties |
|
|
|
|
|
|
|
|
|
|
|
|
|
Direct Kerastick® Product costs |
|
$ |
1,318,000 |
|
|
$ |
1,339,000 |
|
|
|
($21,000 |
) |
Other Kerastick® Product costs including internal costs assigned to support products |
|
|
636,000 |
|
|
|
985,000 |
|
|
|
(349,000 |
) |
Royalty and supply fees (1) |
|
|
461,000 |
|
|
|
318,000 |
|
|
|
143,000 |
|
|
|
|
|
|
|
|
|
|
|
Subtotal Kerastick® Cost of Product Revenues and Royalties |
|
|
2,415,000 |
|
|
|
2,642,000 |
|
|
|
(227,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
BLU-U® Cost of Product Revenues |
|
|
|
|
|
|
|
|
|
|
|
|
|
Direct BLU-U® Product Costs |
|
|
802,000 |
|
|
|
998,000 |
|
|
|
(196,000 |
) |
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 |
|
|
754,000 |
|
|
|
1,142,000 |
|
|
|
(388,000 |
) |
|
|
|
|
|
|
|
|
|
|
Subtotal BLU-U® Cost of Product Revenues |
|
|
1,556,000 |
|
|
|
2,140,000 |
|
|
|
(584,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL PDT DRUG & DEVICE COST OF PRODUCT REVENUES AND ROYALTIES |
|
|
3,971,000 |
|
|
|
4,782,000 |
|
|
|
(811,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL NON-PDT DRUG COST OF PRODUCT REVENUES AND ROYALTIES (2) |
|
|
3,664,000 |
|
|
|
|
|
|
|
3,664,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL COST OF PRODUCT REVENUES AND ROYALTIES |
|
$ |
7,635,000 |
|
|
$ |
4,782,000 |
|
|
$ |
2,853,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
amortization of an upfront fee and ongoing royalties paid to Draxis Health, Inc., on sales of the
Levulan® Kerastick® in Canada. |
|
2) |
|
Non-PDT Drug Cost of Product Revenues and Royalties reflect the costs associated with the
products acquired as part of our March 10, 2006 merger with Sirius. |
MARGINS Total product margins for the three and nine month periods ended September 30, 2006 were
$3,214,000 and $9,797,000, respectively, as compared to $1,085,000 and $3,207,000 for the
comparable 2005 periods, as shown below:
30
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
|
|
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase/ |
|
|
|
2006 |
|
|
2005 |
|
|
(Decrease) |
|
|
|
|
|
|
|
|
Kerastick® Gross Margin |
|
$ |
1,935,000 |
|
|
|
73 |
% |
|
$ |
990,000 |
|
|
|
55 |
% |
|
$ |
945,000 |
|
BLU-U® Gross Margin |
|
|
57,000 |
|
|
|
10 |
% |
|
|
95,000 |
|
|
|
16 |
% |
|
|
(38,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total PDT Drug & Device Gross Margin |
|
$ |
1,992,000 |
|
|
|
62 |
% |
|
$ |
1,085,000 |
|
|
|
45 |
% |
|
$ |
907,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Non-PDT Drug Gross Margin |
|
|
1,222,000 |
|
|
|
43 |
% |
|
|
|
|
|
|
|
|
|
|
1,222,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL GROSS MARGIN |
|
$ |
3,214,000 |
|
|
|
53 |
% |
|
$ |
1,085,000 |
|
|
|
45 |
% |
|
$ |
2,129,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30, |
|
|
|
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase/ |
|
|
|
2006 |
|
|
2005 |
|
|
(Decrease) |
|
Kerastick® Gross Margin |
|
$ |
6,736,000 |
|
|
|
74 |
% |
|
$ |
3,440,000 |
|
|
|
57 |
% |
|
$ |
3,296,000 |
|
BLU-U® Gross Margin |
|
|
222,000 |
|
|
|
13 |
% |
|
|
(233,000 |
) |
|
|
(12 |
%) |
|
|
455,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total PDT Drug & Device Gross Margin |
|
$ |
6,958,000 |
|
|
|
64 |
% |
|
$ |
3,207,000 |
|
|
|
40 |
% |
|
|
3,751,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Non-PDT Drug Gross Margin |
|
|
2,839,000 |
|
|
|
44 |
% |
|
|
|
|
|
|
|
|
|
|
2,839,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL GROSS MARGIN |
|
$ |
9,797,000 |
|
|
|
56 |
% |
|
$ |
3,207,000 |
|
|
|
40 |
% |
|
$ |
6,590,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the three and nine month periods ended September 30, 2006 total PDT Drug and Device
Product Margins were 62% and 64%, respectively, versus 45% and 40% for the comparable 2005 periods.
The incremental margin was driven by positive margin gains on both the Kerastick® and
BLU-U®.
Kerastick® gross margins for the three and nine month periods ended September 30, 2006
were 73% and 74%, respectively, versus 55% and 57% for the comparable 2005 periods. Similar to the
increase in revenues, the increase in margin is mainly attributable to an increase in our average
unit selling price, increased levels of direct distribution to customers eliminating the cost of
distributors; as well as a reduction in our overall sales volume discount programs. Our long-term
goal is to achieve higher gross margins on Kerastick® sales which will be significantly
dependent on increased volume.
BLU-U® margins for the three and nine month periods ended September 30, 2006 were 10%
and 13%, respectively, versus 16% and (12%) for the comparable 2005 periods. The increase in margin
is a result of an increase in the average selling price per unit; as well as, lower overall costs
incurred to support the product line. Our short-term strategy is to at a minimum breakeven on
device sales in an effort to drive Kerastick® sales volumes.
Non-PDT Drug Product Margins reflect the margin generated by the products acquired as part of our
March 10, 2006 merger with Sirius Laboratories. Total margin for the three-month period ended
September 30, 2006 and the period March 10, 2006 (date of acquisition) through September 30, 2006
was 43% and 44%, respectively. Non-PDT Drug Product Margins were negatively impacted by the
recording of the inventory acquired in the Sirius merger at its fair value, in accordance with
purchase accounting rules. The full impact of this adjustment was recognized over the six months
following the acquisition which ended in September 2006.
RESEARCH AND DEVELOPMENT COSTS Research and development costs for the three and nine month
periods ended September 30, 2006 were $1,344,000 and $4,382,000, as compared to $1,414,000 and
$4,809,000 in the comparable 2005 periods. The decrease is due to decreased spending on our
clinical
programs. We completed both our Phase II acne study and our interim analysis study on photodamaged
31
skin in the first quarter of 2006. The decrease was somewhat offset by the recording
of stock-based compensation expense of $101,000 and $264,000 for the three-and nine month periods
ended September 30, 2006, respectively, resulting from the adoption of FAS 123R.
Research and development expenses are expected to increase once our Phase IIb clinical trial for
acne commences, and to an even greater extent at such time as we may commence Phase III trials in
any indication. On September 27, 2004, DUSA signed a clinical trial agreement with the National
Cancer Institute, Division of Cancer Prevention, or NCI DCP, for the clinical development of
Levulan® PDT for the treatment of high-grade dysplasia within Barretts Esophagus. In
addition, to further our objectives concerning treatment of internal indications using
Levulan® PDT, on November 4, 2004, we signed an additional clinical trial agreement with
the NCI DCP for the treatment of oral cavity dysplasia. DUSA and the NCI DCP are working together
to prepare overall clinical development plans for Levulan® PDT in these indications,
starting with Phase I/II trials, and continuing through Phase III studies, if appropriate. DUSA and
the NCI DCP have prepared protocols for the initial Phase I/II clinical studies in both
indications. The NCI DCP is currently working with DUSA and investigators to finalize the clinical
trial designs. The NCI DCP will use its resources to file its own Investigational New Drug
applications with the FDA. Our costs related to these studies will be limited to providing
Levulan®, laser devices, fiber optics, our proprietary light device sheath and the
necessary training for the investigators involved. All other costs of these studies will be the
responsibility of the NCI DCP. We have options on new intellectual property and, subject to
successful clinical trial results, intend to seek FDA approvals in due course. In preparation for
new Phase II clinical trials for the treatment of high-grade dysplasia associated with Barretts
esophagus, our small single-center pilot Phase II clinical trial using our proprietary endoscopic
light delivery device is continuing.
We have retained the services of a regulatory consultant to assist us with seeking foreign
marketing approvals for our products, which will also cause research and development expenses to
increase.
MARKETING AND SALES COSTS Marketing and sales costs for the three and nine-month periods ended
September 30, 2006 were $3,247,000 and $9,114,000, respectively, as compared to $1,804,000 and
$6,886,000 for the comparable 2005 periods. These costs consist 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 $2,391,000 and $6,243,000 for the three and nine-month
periods ended September 30, 2006, compared to $1,566,000 and $5,256,000 in the comparable periods
in 2005. The increase in this category is due to increased headcount in 2006 in comparison to
2005, primarily as the result of the Sirius acquisition. The remaining expenses consist of
tradeshows, miscellaneous marketing and outside consultants totaling $733,000 and $2,600,000 for
the three and nine month periods ended September 30, 2006, respectively, compared to $238,000 and
$1,630,000for the comparable 2005 periods. The increased spending in this category is due primarily
to additional expenses related to the Sirius acquisition. We also recorded compensation expense of
$123,000 and $270,000 for the three-and nine month periods ended September 30, 2006, respectively,
resulting from the adoption of FAS 123R.
GENERAL AND ADMINISTRATIVE COSTS General and administrative costs for the three and nine-month
periods ended September 30, 2006 were $2,603,000 and $8,427,000, respectively, as compared to
$1,663,000 and $5,187,000 for the comparable 2005 periods. The increase is mainly attributable to
incremental legal fees primarily related to the Rivers Edge litigation, compensation expense of
$194,000 and $818,000 for the three-and nine month periods ended September 30, 2006, resulting from
the adoption of FAS 123R, and incremental costs associated with the acquisition of Sirius. General
and administrative expenses are highly dependent on our legal and other professional fees, which
can vary significantly from period to period particularly in light of our litigation strategy to
protect our intellectual property.
32
LIQUIDITY AND CAPITAL RESOURCES
We believe that we have sufficient cash to continue to fund our sales and marketing expenses at
current levels, planned research and development activities for our Levulan® PDT/PD
platform, and to fund operations and capital expenditures for the foreseeable future. We have
invested our funds in liquid investments, so that we will have ready access to these cash reserves,
as needed, for the funding of development plans on a short-term and long-term basis. At September
30, 2006, we had approximately $18,554,000 of total liquid assets, comprised of $5,139,000 of cash
and cash equivalents and marketable securities available-for-sale totaling $13,415,000. As of
September 30, 2006, these securities had yields ranging from 2.50% to 5.74% and maturity dates
ranging from October 15, 2006 to September 15, 2010. Our
net cash used in operations for the nine months ended September 30,
2006 was $8,300,000, versus $13,000,000 used in the comparable 2005 period. The
year over year decrease is directly attributable to an improvement in
our net loss, net of non-cash charges, primarily due to increased
revenues and related product margins. We expect our cash flows to
continue to improve with the growth of existing products, the
introduction of new products, and the international expansion of
Levulan. At the same time, we are expecting our research and
development spending to
increase as we execute our Phase II and potential Phase III clinical trials.
However, if our cash flows from operations do not continue to
improve, we may need to consider either reducing our operating
expenses or raising additional capital to fund our operations.
As of September 30, 2006, working capital (total current assets minus total current liabilities)
was 18,074,000, as compared to $34,889,000 as of December 31, 2005. Total current assets decreased
by $14.9 million during the nine months ended September 30, 2006, due primarily to $9.3 million
spent on the acquisition of Sirius, including $1.8 million of acquisition costs, as well as the
continued funding of our operating loss. Total current liabilities increased by $1.9 million during
the same period due primarily to an increase in accrued expenses and an increase in deferred
revenue resulting from a prepaid royalty received under our patent license agreement with PhotoCure
ASA pursuant to which PhotoCure will pay royalties on sales of its Metvix® and
Hexvix® ester products as well as new products as long as we hold patents in the United
States of America and certain other territories, offset in part by a decrease in accounts payable.
As stated above, we acquired all of the outstanding common stock of Sirius in March 2006 in
exchange for 2,396,245 shares of DUSA common stock and cash. At closing, we paid $8.0 million less
certain expenses, in cash, and 1,973,353 shares of DUSAs common stock, no par value
per share to the shareholders of Sirius and issued an additional 422,892
shares to an escrow agent to be held for up to two years subject to certain
indemnification provisions of the Merger Agreement. See Note 3 to the Notes to the Condensed Consolidated Financial
Statements for the effect of purchase method accounting on the value of the acquisition. We have
agreed to pay additional consideration in future periods, based upon the attainment of defined
operating objectives, including new product approvals or launches and the achievement of
pre-determined total cumulative sales milestones for the Sirius products. The pre-determined
cumulative sales milestones for the Sirius products and the related milestone payments are, as
follows:
|
|
|
|
|
Cumulative Sales Milestone: |
|
Additional Consideration: |
|
$25.0 million |
|
$1.5 million |
35.0 million |
|
$1.0 million |
45.0 million |
|
$1.0 million |
|
|
|
|
Total |
|
$3.5 million |
|
|
|
|
In addition, there are three milestones related to new product approvals and/or launches each
in the amount of $500,000 per milestone, or $1.5 million in the aggregate, that will be paid if the
milestones are achieved. If attained, a portion of the contingent consideration is payable in cash
and a portion is payable in either common stock or cash, at our sole discretion, any such
payments will result in increases in goodwill at the time of the payment. As of September 30, 2006
none of these milestones had been achieved.
We are still actively seeking to further expand or enhance our business by using our resources to
acquire by license, purchase or other arrangements, additional businesses, new technologies, or
products in the
field of dermatology. For 2006, we are focusing primarily on increasing the sales of the
Levulan®
33
Kerastick® and the BLU-U®, as well as the Non
Photodynamic Therapy Drug Products, advancing our Phase II study for use of Levulan® PDT
in acne, and continuing to pursue our product development pipeline.
DUSA has no off-balance sheet financing arrangements.
CONTRACTUAL OBLIGATIONS AND OTHER COMMERCIAL COMMITMENTS
ALTANA, INC.
In September 2005, the former Sirius entered into a development and product license agreement with
Altana, Inc. relating to a reformulated dermatology product. The agreement was assigned to us by
virtue of the Sirius merger. According to the agreement, we will pay for all development costs.
Should development efforts be successful, Altana will manufacture the product for us and we will be
obligated to pay royalties, including certain minimum royalties on net sales of the product. The
agreement expires six years after the first commercial sale of the product.
ACTAVIS TOTOWA, LLC
Under an agreement dated May 18, 2001, and amended on February 8, 2006, the former Sirius entered
into an arrangement for the supply of
Nicomide®
with Amide Pharmaceuticals, Inc., now known as Actavis Totowa, LLC. The agreement
was assigned to us as part of the Sirius merger. Currently, Actavis
Totowa supplies all of our
requirements; however, we have the right to use a second source for a significant portion of our
needs if we choose to do so. The agreement expires on February 8, 2009. During September, we
reported that Actavis Totowa had received a warning letter from the FDA regarding certain regulatory observations. The primary observations were not related to
Nicomide. However, with respect to Nicomide and certain other
products manufactured by Actavis Totowa that
would be covered under FDAs recent compliance policy guide entitled, Marketed New Drugs without
Approved NDAs or ANDAs, the FDA has requested that the manufacturer provide a copy of the labeling
and information providing the basis for an exemption from the drug approval requirements.
HARMONY LABS, INC.
Under an agreement dated September 18, 2001, and amended on February 16, 2006 and March 10, 2006,
the former Sirius entered into an arrangement for the manufacturing and supply of the
AVAR® line of products and Nicomide-T® with Harmony Labs, Inc. The agreement
was assigned to us as part of the Sirius merger. Currently, Harmony supplies all of our
requirements; however, we have the right to use a second source for a significant portion of our
needs if we choose to do so. The agreement expires on February 16, 2009.
L. PERRIGO COMPANY
On October 25, 2005, the former Sirius entered into a supply agreement with L. Perrigo Company 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 are responsible for all development costs and for obtaining all necessary regulatory
approvals. 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.
WINSTON LABORATORIES, INC.
On or about January 30, 2006 Winston Laboratories, Inc. and the former Sirius entered into a
license
34
agreement relating to a Sirius product, Psoriatec® (known by Winston as Micanol)
revising a former agreement. Winston Laboratories, Inc. is controlled by Dr. Joel Bernstein, a
principal shareholder of the former Sirius. This agreement was assigned to us as part of the Sirius
Merger. The 2006 agreement grants an exclusive license, with limitation on rights to sublicense, to
all property rights, including all intellectual property and improvements, owned or controlled by
Winston to manufacture, sell and distribute products containing anthralin, in the United States. We
will pay royalties on net sales of the product, and certain minimum royalties are due each year to
maintain the license. We have an option to purchase the product from Winston at certain times
during the two-year term of the agreement. The agreement is due to expire on January 31, 2008,
subject to rights to extend or terminate the agreement earlier. Minimum royalties to Winston
Laboratories are $300,000 per year ending January 31, 2008.
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 September 30, 2006:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
1 Yr or less |
|
2-3 Years |
|
4-5 Years |
|
After 5 |
Operating lease obligations |
|
$ |
2,826,000 |
|
|
$ |
683,000 |
|
|
$ |
864,000 |
|
|
$ |
904,000 |
|
|
$ |
375,000 |
|
Purchase obligations (1,2) |
|
|
2,183,000 |
|
|
|
1,326,000 |
|
|
|
857,000 |
|
|
|
|
|
|
|
|
|
Minimum royalty obligations |
|
$ |
2,273,000 |
|
|
$ |
636,000 |
|
|
$ |
772,000 |
|
|
$ |
672,000 |
|
|
$ |
193,000 |
|
|
|
|
1) |
|
Research and development projects include various commitments including obligations for
our Phase II clinical study for moderate to severe acne. |
|
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. |
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. However, the overall net effect of inflation on our operations is expected to be
minimal.
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 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, which approximates cost.
As of September 30, 2006, the weighted average rate of return on our investments was 4.14%. If
market interest rates were to change immediately and uniformly by 100 basis points from levels as
of September 30, 2006, the fair market value of the portfolio would change by approximately
$201,000. Declines in interest rates could, over time, reduce our interest income.
35
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 Exchange Act 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 September 30, 2006.
Changes
In Internal Control Over Financial Reporting
Except for
the integration of Sirius Laboratories, Inc. (Sirius)
into the Companys internal control structure, the Chief
Executive Officer and Chief Financial Officer have concluded that
there have been no changes in the Companys internal control
over financial reporting during the quarter ended September 30,
2006 that have materially affected, or are reasonably likely to
materially affect, the Companys internal control over financial
reporting. The Company considers the acquisition of Sirius to be
material to its results of operations, financial position and cash
flows. As permitted by the rules and regulations of the SEC, the
Company will exclude Sirius from its annual assessment for the year
ending December 31, 2006.
FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q, including the Managements Discussion and Analysis, and certain
written and oral statements incorporated herein by reference of DUSA Pharmaceuticals, Inc.
(referred to as DUSA, we, and us) contain forward-looking statements that have been made
pursuant to the provisions of the Private Securities Litigation Reform Act of 1995 and Section 27A
of the Securities Act of 1933, as amended. Such forward-looking statements are based on current
expectations, estimates, beliefs and projections about future events, including, without limitation
statements regarding our use of estimates and assumptions in the preparation of our financial
statements and policies, including certain pro forma financial
statements, the allocation of the purchase price of Sirius, the
amortization of goodwill, intent to hold investments until fair value
is recovered, and the impact on us of
the adoption of certain accounting standards, belief concerning the impact of compounding
pharmacies, our obligation to make certain milestone and royalty payments to third parties, our
beliefs and intent regarding the third-party manufacture of our
products, and the availability of
inventory of our products and expectation for time and impact of being out-of-stock, the outcome
and costs of litigation to which we are a party, the anticipated
launch of product in Brazil, our beliefs regarding our recent merger with
Sirius Laboratories, Inc. and the benefits, effects, impact and risks thereof, for off-label uses,
our goal of achieving profitability and the impact of potential generic products, our beliefs
regarding our sales and marketing efforts, competition with other
companies, beliefs regarding improvement of cash flows,
attainment of positive cash flow, the adoption of our products, and the outcome of such efforts,
our beliefs regarding the use of our products and technologies for off-label uses, by third
parties, our beliefs regarding our compliance with applicable laws, rules and regulations and
possible need to seek FDA approval, expectations for the reexamination process of the Nicomide
patent, and beliefs concerning the loss of patent protection through
patent reexamination or the Rivers Edge litigation, our
beliefs and intentions regarding available reimbursement for our products and changes to applicable
CPT codes, belief concerning adoption of our AK therapy, the
possibility of adding employees, belief
regarding estimates for reserves, expectation for amortization on core/developed technology, our
expectation regarding the margins on our products, our beliefs regarding the current and future
clinical development and testing of our potential products and
technologies and the costs thereof and impact on revenues,
our expectations and beliefs regarding our future sales, expenses and losses, the sufficiency of our
capital resources and our needs for additional capital, expectations of royalties from PhotoCure,
and the possibility of the holders of options and warrants to purchase our common stock exercising
these securities. Words such as anticipates, expects, intends, plans, believes, seeks,
estimates, or variations of such words and similar expressions, are intended to identify such
forward-looking statements. These statements are not guarantees of future performance and are
subject to certain risks, uncertainties and assumptions that are difficult to predict particularly
in the highly regulated pharmaceutical industry in which we operate. Therefore, actual results may
differ materially from those expressed or forecasted in any such forward-looking statements. Such
risks and uncertainties include changing market, regulatory and marketplace conditions, actual
clinical results of our trials, our ability to sell, market and develop our products and product
candidates, the potential need to hire additional personnel or retain existing personnel, the
impact of competitive products and pricing, the timely development, FDA approval, and market
acceptance of our products, the maintenance of our patent portfolio, changes in our long and short
term goals, financial and operational risks associated with our recent merger with Sirius
Laboratories, Inc., the litigation process, the ability to obtain competitive levels of
reimbursement by third-party payors, and other risks noted herein and in our other SEC filings from
36
time to time and those set forth herein under Risk Factors on pages 40 through 52, as well as
those noted in the documents incorporated herein by reference. Unless required by law, we undertake
no obligation to update publicly any forward-looking statements, whether as a result of new
information, future events or otherwise. However, readers should carefully review the statements
set forth in other reports or documents we file from time to time with the Securities and Exchange
Commission, particularly our Quarterly Reports on Form 10-Q and any Current Reports on Form 8-K.
PART II OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS.
PHOTOCURE ASA
On May 30, 2006, we entered into a patent license agreement with PhotoCure ASA whereby in
settlement of patent disputes we granted a non-exclusive license to PhotoCure under the patents we
license from PARTEQ, the licensing arm of Queens University, Kingston, Ontario Canada for esters of
aminolevulinic acid (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 patents that may issue to DUSA or that we may license in
the future. We received a $1.0 million prepaid royalty during the quarter ended June 30, 2006.
PhotoCure received FDA approval to market Metvixia for treatment of actinic keratosis in July 2004
and it would be directly competitive with our Levulan Kerastick product should PhotoCure decide to
begin marketing this product. While we are entitled to royalties from PhotoCure on its net sales of
Metvixia, this product may adversely affect our ability to maintain or increase our market.
LEVULAN® SUITS
Since December 2004, we filed lawsuits against physicians in several states to prevent their
unlicensed use of versions of our Levulan® brand of aminolevulinic acid HCl (ALA)
produced, by third-parties for use in our patented photodynamic therapy (PDT) treatment for actinic
keratosis, basal cell carcinoma, acne and other dermatological conditions. The suits allege that
these physicians perform patient treatments
that are covered under patents exclusively licensed by DUSA, resulting in direct infringement of
these patent(s). Additionally, some physicians are also being sued
for infringement of DUSAs trademarks
and for violations of the Lanham Act for using the Levulan® brand name on their web
sites and promotional materials, but performing patient treatments with ALA obtained from other
sources. All of the lawsuits have settled favorably to us and the physicians
have entered Consent Judgments which provide DUSA with the right
to review their books and records.
More recently, we sued a chemical supplier in United States District Court for the District of
Arizona alleging that it induces physicians to infringe patents licensed to us, among other things.
While we believe that certain actions of compounding pharmacies and others go beyond the activities
which are permitted under the Food, Drug and Cosmetic Act and have advised the FDA and local health
authorities of our concerns, we cannot be certain that our lawsuits will be successful in curbing
the practices of these companies or that regulatory authorities will intervene to stop their
activities. In addition, there may be other compounding pharmacies which are following FDA
guidelines, or others conducting illegal activities of which we are not aware, which may be
negatively impacting our sales revenues.
We have also settled or obtained judgments against compounding pharmacies.
RIVERS EDGE
On March 28, 2006, a lawsuit was filed by Rivers Edge Pharmaceuticals, LLC against us alleging,
among
37
other things, that, prior to our merger with the former Sirius Laboratories, Inc. Sirius agreed to
authorize Rivers Edge to market a generic version of Nicomide®, and that the United
States patent covering Nicomide® issued to Sirius in December, 2005 is invalid.
Nicomide® is one of the key products DUSA acquired from Sirius in our merger. The
declaratory judgment suit was filed in the United States District Court for the Northern District
of Georgia, Gainesville Division. On June 19, 2006, the Georgia court dismissed Rivers Edge
complaint.
Rivers Edge has also filed an application with the U.S. Patent and Trademark Office requesting
reexamination of the Nicomide patent. We have notified the Patent Office that we do not object to
the reexamination process and we expect the Patent Office to notify the parties about its decision
to accept or deny the patent reexamination process shortly.
On April 20, 2006, we filed a patent infringement suit in the United States District Court in
Trenton, New Jersey alleging that a Rivers Edge niacinamide product infringes our U.S. patent
6,979,468. On May 12, 2006, the New Jersey court entered an order for preliminary injunction, which
was effective May 15, 2006, enjoining Rivers Edge from selling its niacinamide formula drug as a
generic substitute for Nicomide®. We have posted $750,000 in lieu of a performance bond
with the Court which bears interest. The parties are in the discovery stage of the New Jersey
litigation. A motion to stay this litigation while the patent reexamination process takes its
course was denied. An unfavorable ruling in the Patent Office or in the New Jersey litigation with
respect to the validity of the Nicomide patent would allow generic manufacturers to compete
directly with us and could have a material impact on the Companys revenues, results of operations
and liquidity.
38
ITEM 1A. RISK FACTORS.
A description of the risk factors associated with our business is set forth below. This description
includes any material changes to and supersedes the description of the risk factors associated with
our business previously disclosed in Item 1.A. of our 2005 Annual Report on Form 10-K for the year
ended December 31, 2005.
You should carefully consider and evaluate all of the information in, or incorporated by reference
in, this Current Report on Form 10-Q. 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 value of the securities being offered by this
report.
This section of the Quarterly Report on Form 10-Q contains forward-looking 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
results could differ materially from those anticipated in these forward-looking statements for many
reasons, including the risks 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.
We Have Only Limited Experience Marketing And Selling Pharmaceutical Products 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 dermatology products in the United States
and the rest of the world, except Canada, and Mexico and Central and South America, where we have
distributors. We are doing so without the experience of having marketed pharmaceutical products
prior to 2000. In October 2003, DUSA began hiring a small direct sales force and we increased the
size of our sales force to market our products in the United States. In addition, our sales
personnel have only recently begun to sell and market the products we acquired in our merger with
Sirius. If our sales and marketing efforts fail, then sales of the Kerastick®, the
BLU-U®, Nicomide® and other products will be adversely affected.
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, a broader adoption of our therapy and sales of our products could be
negatively impacted. Although 2005 reimbursement changes related to AK were made, some physicians
still believe that reimbursement levels do not fully reflect the required efforts to routinely
execute our therapy in their practices.
If insurance companies do not cover, or stop covering products which are currently covered,
including Nicomide®, our sales could be dramatically reduced.
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®, Nicomide®
, Nicomide-T®, the AVAR® line of
products, METED®
, Psoriacap®
and Psoriatec®, Any Supply Or
Manufacturing Problems Could Negatively Impact Our Sales.
39
If we experience problems producing 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 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.
During the quarter ended September, 30, 2006, the sole supplier of Nicomide®
received a warning letter from the FDA regarding certain regulatory observations. The primary
observations noted in the warning letter were not related to Nicomide®. However, with
respect to Nicomide® and certain other products manufactured by this supplier, the FDA
has requested that the manufacturer provide a copy of the labeling and information providing the
basis for an exemption from the drug approval requirements. The FDA regulates such products under
the compliance policy guide entitled, Marketed New Drugs
without Approved NDAs or ANDAs. DUSA worked with the manufacturer in order to respond to the FDA.
Nicomide® is one of the key products DUSA acquired from Sirius Laboratories, Inc.
in connection with our merger completed in March, 2006. Nicomide® is an oral
prescription vitamin supplement. If the FDA is not satisfied with the response to the warning
letter issued to the manufacturer of Nicomide and/or causes the manufacturer to cease operations,
our revenues will be negatively affected.
We are also working with the supplier of the AVAR® line of products to address
certain manufacturing concerns. Some of these products are on back-order while such concerns are
being addressed, which could negatively affect revenues from these products. Revenues from these
products are not a material percentage of our overall revenues.
Manufacturers and their subcontractors often encounter difficulties when commercial quantities
of products are manufactured for the first time, or large quantities of new products are
manufactured, including problems involving:
|
|
|
product yields, |
|
|
|
|
quality control, |
|
|
|
|
component and service availability, |
|
|
|
|
compliance with FDA regulations, and |
|
|
|
|
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 seek to increase production. 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 any 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.
Any Failure To Comply With Ongoing Governmental Regulations In The United States And Elsewhere Will
Limit Our Ability To Market Our Products.
40
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, and |
|
|
|
|
control of marketing activities, including advertising and labeling. |
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 also:
|
|
|
send us warning letters, |
|
|
|
|
impose fines and other civil penalties on us, |
|
|
|
|
seize our products, |
|
|
|
|
suspend our regulatory approvals, |
|
|
|
|
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 the FDAs Good Manufacturing Practice,
commonly known as 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.
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 could request
additional information and/or studies. 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.
Manufacturing facilities are subject to ongoing periodic inspection by the FDA, including
unannounced inspections. We cannot guarantee that our third-party supply sources, 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 Nicomide, who has received a
warning letter from the
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FDA, or the manufacturer of the AVAR® products, 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 an adverse effect on our
financial condition and operations.
Certain of the products acquired in connection with the Sirius merger must meet certain
minimum manufacturing and labeling standards established by the FDA and applicable to products
marketed without approved marketing applications. FDA regulates such products under its marketed
unapproved drugs compliance policy guide entitled, Marketed New Drugs without Approved NDAs or
ANDAs. Under this policy, FDA recognizes that certain unapproved products, based on the
introduction date of their active ingredients and the lack of safety concerns, have been marketed
for many years and, at this time, will not be the subject of any enforcement action. FDA is
encouraging manufacturers of such products to submit applications to obtain marketing approval and
we have begun discussions with FDA to begin that process. FDAs enforcement discretion policy does
not apply to drugs or firms that may be in violation of regulatory requirements other than
preapproval submission requirements and FDA may bring an action against a drug or a firm when FDA
concludes that such other violations exist. The contract manufacturer of Nicomide has received a
request from the FDA for labeling information and justification for the belief that the product is
exempt from drug approval requirements and has been cited for GMP violations, however, we believe
the GMP issues do not directly involve our products. There can be no assurance that the FDA will
continue this policy or not take a contrary position with any individual products. If the FDA were
to do so, we may be required to market these products as over-the-counter products or as dietary
supplements under applicable legislation, or withdraw such products from the market, unless and
until we submit a marketing application and obtain FDA marketing approval.
If Product Sales Do Not Increase Significantly 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 we do not generate sufficient revenues from our approved products, we may be forced to
delay or abandon some or all of our product development programs. 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. Without sufficient product sales, we
might be required to seek additional funding. There is no guarantee that adequate funding sources
could be found to continue the development of all our potential products. We might be required to
commit substantially greater capital than we have available to research and development of such
products and we may not have sufficient funds to complete all or any of our development programs.
The Commercial Success Of Any Products 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 products that we may develop will be highly dependent upon
the extent to which these products gain 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 these products do
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 product candidates, if approved
for commercial sale, will depend on a number of factors, including:
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the effectiveness, or perceived effectiveness, of our products 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 products 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. |
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 $3,787,000 for the quarter ended
September 30, 2006. We incurred net losses of $14,998,709 for the year ended December 31, 2005 and
$15,628,980 for the year ended December 31, 2004. As of September 30, 2006, our accumulated
deficit was approximately $102,618,000. We cannot predict whether any of our products will achieve
significant enough market acceptance or generate sufficient revenues to enable us to become
profitable.
If We Are Unable To Protect Our Proprietary Technology, Trade Secrets Or Know-How, We May Not Be
Able To Operate Our Business Profitably.
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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methods of using ALA and its unique physical forms in combination with light, |
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compositions and apparatus for those methods, and |
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unique physical forms of ALA. |
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 are developing therapies may not be covered by the claims
in any of our existing patents. Even with the issuance of additional patents to DUSA, 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
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Levulan® products even though they are
marketed for different uses.
Nicomide
is covered by a United States patent which issued in December 2005. Rivers Edge
Pharmaceuticals LLC has filed an application with the U.S. Patent and Trademark Office for the
reexamination of the
patent. If the USPTO finds that the patent is invalid, Rivers Edge and other generics will be able
to compete with Nicomide. Recently two new products have been launched that could compete with
Nicomide®.
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:
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these persons or entities might breach the agreements, |
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we might not have adequate remedies for a breach, and/or |
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our competitors will independently develop or otherwise discover our trade secrets. |
Patent 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 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 patent litigation. For example,
third-parties may infringe one or more of our patents, and we are spending significant resources to
enforce our patent rights. Also, in a lawsuit against a third-party for infringement of our patents
in the United States, that third-party has challenged the validity of our patent(s). We cannot
guarantee that a third-party will not claim, with or without merit, that we have infringed their
patent(s) or misappropriated their proprietary material. Defending this type of legal action
involves considerable expense and could negatively affect our financial results.
Additionally, if a third-party were to file a United States patent application in the United
States, 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 United States
Patent and Trademark Office 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, could involve substantial legal fees and result in a loss or lessening of our
patent protection.
On March 28, 2006, a lawsuit was filed by Rivers Edge Pharmaceuticals, LLC against us
alleging, among other things, that, prior to the merger, Sirius Laboratories, Inc. agreed to
authorize Rivers Edge to market a generic version of Nicomide®, and that the United
States patent covering Nicomide® issued to Sirius in December, 2005 is invalid. The
declaratory judgment suit was filed in the United States District Court for the Northern District
of Georgia, Gainesville Division which has been dismissed. Nicomide is one of the key products DUSA
acquired from Sirius in its merger. On April 20, 2006, we filed a patent infringement suit in the
United States District Court in Trenton, New Jersey alleging that a Rivers Edge niacinamide
product infringes United States Patent No. 6,979,468, the patent that covers Nicomide®. On May
12, 2006, the United States District Court issued a preliminary injunction against Rivers Edge
enjoining Rivers Edge from selling its niacinamide formula drug as a generic substitute for
Nicomide®. However, if we do not ultimately prevail in our lawsuit, or the
Nicomide® patent is found to be invalid, our revenues from sales of Nicomide®
could decrease significantly.
During 2005 and 2006, we filed several lawsuits against a chemical supplier, compounding
pharmacies and physicians alleging violations of patent law. While we have been successful in
obtaining
44
a default judgment against one compounding pharmacy, settled another suit, and have
obtained consent judgments from several physicians, we do not know whether these lawsuits will
prevent others from infringing our patents or whether we will be successful in stopping these
activities which we believe are negatively affecting our revenues.
We Have Only 2 Therapies That Have Received Regulatory Approval Or Clearance And We Cannot
Predict Whether We Will Ever Develop Or Commercialize Any Other 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 and the currently marketed products we acquired in our merger
with Sirius, all of our other potential Levulan® and 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 Each Of Our Potential Products Before We Can Sell Them
Commercially In The United States Or Abroad.
All of our potential Levulan® products will require the approval of the FDA before
they can be marketed in the United States. If we fail to obtain the required approvals for these
products our revenues will be limited. 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 1 to 3 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 3
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 approval for any of our potential products. 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
are studying. 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. During September 2005, the FDA issued
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guidance for the pharmaceutical industry
regarding the development of new drugs for acne vulgaris treatment. We are developing
Levulan® PDT for acne. As a result, it is likely that the costs and time to approval
associated with seeking regulatory approval of this indication will be increased. The FDA may issue
additional guidance in the future, which may result on additional costs and delays. We must also
obtain foreign
regulatory clearances before we can market any potential products in foreign markets. The foreign
regulatory approval process includes all of the risks associated with obtaining FDA marketing
approval and may impose substantial additional costs.
Certain of the products acquired in connection with the Sirius merger must meet certain
minimum manufacturing and labeling standards established by the FDA and applicable to products
marketed without approved marketing applications. FDA regulates such products under its marketed
unapproved drugs compliance policy guide entitled, Marketed New Drugs without Approved NDAs or
ANDAs. Under this policy, FDA recognizes that certain unapproved products, based on the
introduction date of their active ingredients and the lack of safety concerns, have been marketed
for many years and, at this time, will not be the subject of any enforcement action. FDA is
encouraging manufacturers of such products to submit applications to obtain marketing approval and
we have begun discussions with FDA to begin that process. FDAs enforcement discretion policy does
not apply to drugs or firms that may be in violation of regulatory requirements other than
preapproval submission requirements and FDA may bring an action against a drug or a firm when FDA
concludes that such other violations exist. The contract manufacturer of Nicomide has received a
request from the FDA for labeling information and justification for the belief that the product is
exempt from drug approval requirements and has been cited for GMP violations, however, we believe
the GMP issues do not directly involve our products. There can be no assurance that the FDA will
continue this policy or not take a contrary position with any individual products. If the FDA were
to do so, we may be required to market these products as over-the-counter products or as dietary
supplements under applicable legislation, or withdraw such products from the market, unless and
until we submit a marketing application and obtain FDA marketing approval.
If We Are Unable To Obtain The Necessary Capital To Fund Our Operations, We Will Have To Delay Our
Development Programs And May Not Be Able To Complete Our Clinical Trials.
Since our current sales goals for our products may not be met in the future, we may need
substantial additional funds to fully develop, manufacture, market and sell our other potential
products. We may obtain funds through other public or private financings, including equity
financing, and/or through collaborative arrangements. We cannot predict whether any financing will
be available at all or on acceptable terms.
Dependent on the extent of available funding, we may delay, reduce in scope or eliminate some
of our research and development programs. 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.
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 80 employees, including 2 part-time employees as of September
30, 2006. 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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Our 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 exposes 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 in excess of our
insurance coverage 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. Now that we have established our own production line for the manufacture of the
Kerastick®, we are subject to additional environmental laws and regulations. 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 Some Or All Of
Our Programs Or Potential Products Noncompetitive Or Obsolete.
Well-known pharmaceutical, biotechnology and medical device companies are marketing
well-established therapies for the treatment of many of the same conditions that we are seeking to
treat, including AKs, acne, rosacea, photodamaged skin and Barretts esophagus. 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.
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Many companies are also seeking to develop new products and technologies, and receiving
approval for medical conditions for which we are developing treatments. 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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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 DUSA
granted a non-exclusive license to PhotoCure under the patents DUSA licenses from PARTEQ, the
licensing arm of Queens University, Kingston, Ontario Canada for esters of aminolevulinic acid
(ALA). ALA is the active ingredient in DUSAs Levulan® products. Furthermore, DUSA
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 DUSA in the future. PhotoCure
received FDA approval to market Metvixia for treatment of AKs in July 2004 and it would be directly
competitive with our Levulan Kerastick product should PhotoCure decide to begin marketing this
product. While we are entitled to royalties from PhotoCure on its net sales of Metvixia, this
product may adversely affect our ability to maintain or increase our market.
Our Products May Lose Market Share If New Manufacturers Begin Producing Competing Products That Are
Able To Penetrate Our Market.
We Have Learned That Compounding Pharmacies Are Producing A Form Of Aminolevulinic Acid HCl And Are
Marketing It To The Medical Community.
We are aware that there are compounding pharmacies that market compounded versions of
aminolevulinic acid HCl as an alternative to our Levulan® product.
Since December 2004, we filed lawsuits against two compounding
pharmarcies and physicians in several states, alleging violations of the Lanham Act for false advertising
and trademark infringement and of United States patent law. All of these lawsuits have been settled favorably to us. More recently, we have sued a
chemical supplier, Spectrum Pharmacy Products, in United States District Court for the District of
Arizona alleging that it induces physicians to infringe patents licensed to us, among other things.
While we believe that certain actions of compounding pharmacies and others go beyond the activities
which are permitted under the Food, Drug and Cosmetic Act and have advised the FDA and local health
authorities of our concerns, we cannot be certain that our lawsuits will be successful in curbing
the practices of these companies or that regulatory authorities will intervene to stop their
activities. In addition, there may be other compounding pharmacies which are following FDA
guidelines, or others conducting illegal activities of which we are not aware, which may be
negatively impacting our sales revenues.
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We also learned that Rivers Edge was marketing an alternative niacinamide product and we
filed a lawsuit against them alleging that the Rivers Edge product infringes our patent. On May
12, 2006, the
United States District Court in Trenton, New Jersey, issued a preliminary injunction against
Rivers Edge enjoining Rivers Edge from selling its niacinamide formula drug as a generic
substitute for Nicomide®.
If generic manufacturers launch products to compete with Nicomide in spite of our patent
position, or if a court or the United States Patent and Trademark Office determine that our patent
is invalid, these manufacturers may erode our market and negatively impact our sales revenues,
liquidity and operations.
Our Competitors In The Biotechnology And Pharmaceutical Industries May Have Better Products,
Manufacturing Capabilities Or Marketing Expertise.
We 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.). We are also aware of several companies commercializing
and/or conducting research with ALA or ALA-related compounds, including: medac GmbH and photonamic
GmbH & Co. KG (Germany); 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. There are many pharmaceutical companies that compete with us in the field
of dermatology, particularly in the acne and rosacea markets.
PhotoCure has received marketing approval of its ALA precursor (ALA methyl-ester) compound for
PDT treatment of AKs and basal cell carcinoma in the European Union, New Zealand, Australia and
countries in Scandinavia. We believe that PhotoCures marketing partner will begin to market its
product in direct competition with Levulan® in the U.S. under the terms of our recently
entered patent license agreement and we may lose market share.
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, which we are also pursuing.
We expect that our principal methods of competition with other PDT companies 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 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 and rosacea markets include 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. We are also
aware of new products that were launched recently which will compete with Nicomide® and
the AVAR® line of products which could negatively impact our market share.
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Risks Related To Our Stock
If Outstanding Options, Warrants And Rights Are Converted, The Value Of Those Shares Of Common
Stock Outstanding Just Prior To The Conversion Will Be Diluted.
As of September 30, 2006 there were outstanding options and warrants to purchase 3,110,313
shares of common stock, with exercise prices ranging from U.S. $1.60 to $31.00 per share, and of
CDN $6.79 per share, respectively. 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 are likely to exercise their
securities when we would probably be able to raise capital from the public on terms more favorable
than those provided in these securities.
Results Of Our 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,
2005 to November 1, 2006, the price of our stock has ranged from a low of $3.52 to a high of
$16.30. 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; 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 the 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 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.
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
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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 (or 20% or more in the case of certain parties) 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 20% of the
outstanding common stock in the case of a shareholder or group who beneficially held in excess of
15% at the record date), 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 20% 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.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS.
None.
ITEM 5. OTHER INFORMATION.
None.
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ITEM 6. EXHIBITS
10(a)
Amendment No. 1 to Employment Agreement for Richard C. Christopher.
31(a) Rule 13a-14(a)/15d-14(a) Certification of the Chief Executive Officer.
31(b) Rule 13a-14(a)/15d-14(a) Certification of the Chief Financial Officer.
32(a) Certification of the Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002; and
32(b) Certification of the Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
52
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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Date: November 6, 2006 |
By: |
/s/ D. Geoffrey Shulman
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D. Geoffrey Shulman |
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Director, Chairman and Chief
Executive Officer
(principal executive officer) |
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Date: November 6, 2006 |
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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53
EXHIBIT INDEX
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10(a) Amendment No. 1 to Employment Agreement for
Richard C. Christopher. |
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31(a) Rule 13a-14(a)/15d-14(a) Certification of the Chief Executive Officer. |
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31(b) Rule 13a-14(a)/15d-14(a) Certification of the Chief Financial Officer. |
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32(a) Certification of the Chief Executive Officer pursuant to 18 U.S.C.
Section 1350, as adopted pursuant to Section 906 of the
Sarbanes-Oxley
Act of 2002; and |
|
|
|
32(b) Certification of the Chief Financial Officer pursuant to 18 U.S.C.
Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002. |
54