Noven Pharmaceuticals, Inc.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
Quarterly Report Pursuant to Section 13 or 15 (d) of the Securities Exchange Act of 1934
For the quarterly period ended June 30, 2008
Commission file number 0-17254
NOVEN PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
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STATE OF DELAWARE
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59-2767632 |
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(State or other jurisdiction of
incorporation or organization)
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(I.R.S. Employer
Identification Number) |
11960 S.W. 144th Street, Miami, FL 33186
(Address of principal executive offices) (Zip Code)
(305) 253-5099
(Registrants telephone number, including area code)
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 x No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated
filer, a non-accelerated filer, or a smaller reporting company. See the definitions of large
accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the
Exchange Act.
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Large accelerated filer o
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Accelerated filer x
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Non-accelerated filer o
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Smaller reporting company o |
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(Do not check if a smaller reporting company) |
|
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of
the Exchange Act). Yes o No x
Indicate the number of shares outstanding of each of the issuers classes of common stock, as
of the latest practicable date.
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Class
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Outstanding at July 31, 2008 |
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Common stock $.0001 par value
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24,895,185 |
NOVEN PHARMACEUTICALS, INC.
INDEX
Cautionary Factors: Statements in this report that are not descriptions of historical
facts are forward-looking statements provided under the safe harbor protection of the Private
Securities Litigation Reform Act of 1995. Our actual results, performance and achievements may be
materially different from those expressed or implied by such statements and readers should consider
the risks and uncertainties associated with our business that are discussed in Item 1A of Part I of
our Annual Report on Form 10-K for the year ended December 31, 2007 as supplemented by Part II
Item 1A Risk Factors of this quarterly report on Form 10-Q, as well as other reports filed
from time to time with the Securities and Exchange Commission.
Trademark Information: Lithobid® and Pexeva® are registered
trademarks, and Mesafem and Stavzor are trademarks of Noven Therapeutics,
LLC; Vivelle® is a registered trademark of Novartis Pharmaceuticals Corporation;
Estradot® (foreign) and Vivelle-Dot® are registered trademarks, and Menorest
is a trademark, of Novartis AG; CombiPatch® and Estalis® (United States) are
registered trademarks of Vivelle Ventures LLC; and Daytrana® is a registered trademark
of Shire Pharmaceuticals Ireland Limited.
2
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
NOVEN PHARMACEUTICALS, INC. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets
(in thousands, except share data) (unaudited)
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June 30, |
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December 31, |
|
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2008 |
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2007 |
|
Assets |
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|
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|
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Current Assets: |
|
|
|
|
|
|
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|
Cash and cash equivalents |
|
$ |
35,405 |
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|
$ |
13,973 |
|
Short-term investments available-for-sale, at fair value |
|
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|
|
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|
21,565 |
|
Accounts receivable (less allowances of $264 at 2008
and $252 at 2007) |
|
|
8,302 |
|
|
|
6,956 |
|
Milestone payment receivable Shire |
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|
25,000 |
|
|
|
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|
Accounts receivable Novogyne, net |
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|
6,592 |
|
|
|
8,683 |
|
Inventories |
|
|
16,278 |
|
|
|
12,136 |
|
Net deferred income tax asset, current portion |
|
|
8,786 |
|
|
|
7,614 |
|
Prepaid income taxes |
|
|
3,596 |
|
|
|
4,925 |
|
Prepaid and other current assets |
|
|
4,358 |
|
|
|
5,251 |
|
|
|
|
|
|
|
|
|
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|
108,317 |
|
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|
81,103 |
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Non-current Assets: |
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Property, plant and equipment, net |
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35,415 |
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|
36,213 |
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Investments in auction rate securities |
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17,510 |
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|
32,835 |
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Investment in Novogyne |
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25,959 |
|
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|
24,310 |
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Net deferred income tax asset, non-current portion |
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|
63,827 |
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|
58,053 |
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Intangible assets, net |
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37,190 |
|
|
|
38,773 |
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Goodwill |
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14,407 |
|
|
|
14,734 |
|
Deposits and other non-current assets |
|
|
972 |
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|
677 |
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|
|
|
|
|
|
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|
195,280 |
|
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|
205,595 |
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|
|
|
|
|
|
|
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|
$ |
303,597 |
|
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$ |
286,698 |
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|
|
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Liabilities and Stockholders Equity |
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Current Liabilities: |
|
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Accounts payable and accrued expenses |
|
$ |
6,809 |
|
|
$ |
8,399 |
|
Accrued compensation and related liabilities |
|
|
5,440 |
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|
9,801 |
|
Other accrued liabilities |
|
|
17,193 |
|
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|
15,270 |
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Current portion of long-term obligations |
|
|
3,416 |
|
|
|
3,421 |
|
Deferred license and contract revenues, current portion |
|
|
26,252 |
|
|
|
20,188 |
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|
|
|
|
|
|
|
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59,110 |
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|
57,079 |
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Non-current Liabilities: |
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Long-term obligations, less current portion |
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5,095 |
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|
8,438 |
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Deferred license and contract revenues, non-current portion |
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|
94,991 |
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|
85,056 |
|
Other non-current liabilities |
|
|
1,165 |
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|
1,831 |
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|
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|
|
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101,251 |
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|
95,325 |
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|
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Total Liabilities |
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|
160,361 |
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152,404 |
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Commitments and Contingencies (Note 14) |
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Stockholders Equity: |
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Preferred stock authorized 100,000 shares par value $.01 per
share; no shares issued or outstanding |
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Common stock authorized 80,000,000 shares, par value
$.0001 per share; 25,217,530 and 24,881,867
issued at June 30, 2008 and December 31, 2007 |
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2 |
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2 |
|
Additional paid-in capital |
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|
120,916 |
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|
118,561 |
|
Retained earnings |
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27,957 |
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|
20,855 |
|
Accumulated other comprehensive loss |
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|
(515 |
) |
|
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|
Treasury stock, at cost - 322,345 shares at June 30, 2008
and December 31, 2007 |
|
|
(5,124 |
) |
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|
(5,124 |
) |
Common stock held in trust |
|
|
(1,256 |
) |
|
|
(950 |
) |
Deferred compensation obligation |
|
|
1,256 |
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|
950 |
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|
|
|
|
|
|
|
|
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143,236 |
|
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|
134,294 |
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|
|
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|
|
|
|
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$ |
303,597 |
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|
$ |
286,698 |
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|
|
|
|
|
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|
The accompanying notes to condensed consolidated financial statements are an integral part of these financial statements.
3
NOVEN PHARMACEUTICALS, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Operations
(in thousands, except per share amounts)
(unaudited)
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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2008 |
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2007 |
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2008 |
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2007 |
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Revenues: |
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Product revenues Novogyne: |
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Product sales, net |
|
$ |
5,553 |
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|
$ |
4,804 |
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|
$ |
7,984 |
|
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$ |
10,173 |
|
Royalties |
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|
2,349 |
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|
1,899 |
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4,529 |
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|
3,664 |
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|
Total net product revenues Novogyne |
|
|
7,902 |
|
|
|
6,703 |
|
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|
12,513 |
|
|
|
13,837 |
|
Product revenues, net third parties |
|
|
11,641 |
|
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|
8,359 |
|
|
|
23,226 |
|
|
|
16,831 |
|
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|
|
|
|
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Total net product revenues |
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|
19,543 |
|
|
|
15,062 |
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|
|
35,739 |
|
|
|
30,668 |
|
License and
contract revenues |
|
|
5,060 |
|
|
|
3,777 |
|
|
|
10,346 |
|
|
|
7,486 |
|
|
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|
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|
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|
|
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Total net revenues |
|
|
24,603 |
|
|
|
18,839 |
|
|
|
46,085 |
|
|
|
38,154 |
|
|
|
|
|
|
|
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|
|
|
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|
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Costs and Expenses: |
|
|
|
|
|
|
|
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|
|
|
|
|
|
|
|
Cost of products sold Novogyne |
|
|
3,463 |
|
|
|
3,285 |
|
|
|
6,789 |
|
|
|
6,244 |
|
Cost of products sold third parties |
|
|
9,320 |
|
|
|
6,029 |
|
|
|
17,303 |
|
|
|
11,997 |
|
|
|
|
|
|
|
|
|
|
|
|
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|
Total cost of products sold |
|
|
12,783 |
|
|
|
9,314 |
|
|
|
24,092 |
|
|
|
18,241 |
|
Research and development |
|
|
3,293 |
|
|
|
3,185 |
|
|
|
6,612 |
|
|
|
6,651 |
|
Selling and marketing |
|
|
5,336 |
|
|
|
221 |
|
|
|
10,159 |
|
|
|
461 |
|
General and
administrative |
|
|
8,906 |
|
|
|
5,488 |
|
|
|
15,928 |
|
|
|
10,669 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total costs and expenses |
|
|
30,318 |
|
|
|
18,208 |
|
|
|
56,791 |
|
|
|
36,022 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from operations |
|
|
(5,715 |
) |
|
|
631 |
|
|
|
(10,706 |
) |
|
|
2,132 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity in earnings of Novogyne |
|
|
12,429 |
|
|
|
9,174 |
|
|
|
20,696 |
|
|
|
14,077 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income, net |
|
|
500 |
|
|
|
1,813 |
|
|
|
1,122 |
|
|
|
3,445 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income before income taxes |
|
|
7,214 |
|
|
|
11,618 |
|
|
|
11,112 |
|
|
|
19,654 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Provision for income taxes |
|
|
2,704 |
|
|
|
4,042 |
|
|
|
4,010 |
|
|
|
7,042 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
4,510 |
|
|
$ |
7,576 |
|
|
$ |
7,102 |
|
|
$ |
12,612 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic earnings per share |
|
$ |
0.18 |
|
|
$ |
0.31 |
|
|
$ |
0.29 |
|
|
$ |
0.51 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted earnings per share |
|
$ |
0.18 |
|
|
$ |
0.30 |
|
|
$ |
0.29 |
|
|
$ |
0.50 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
Weighted average number of common shares
outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
24,603 |
|
|
|
24,832 |
|
|
|
24,582 |
|
|
|
24,785 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted |
|
|
24,754 |
|
|
|
25,379 |
|
|
|
24,710 |
|
|
|
25,381 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes to condensed consolidated financial statements are an integral part of these financial statements.
4
NOVEN PHARMACEUTICALS, INC. AND SUBSIDIARIES
Condensed Consolidated Statement of Changes in Stockholders Equity and Comprehensive Income
(in thousands)
(unaudited)
|
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|
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|
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|
|
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|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional |
|
|
|
|
|
|
Other |
|
|
|
|
|
|
|
|
|
|
|
|
Common Stock |
|
|
Paid-in |
|
|
Retained |
|
|
Comprehensive |
|
|
Treasury |
|
|
|
|
|
|
|
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Earnings |
|
|
Loss |
|
|
Stock |
|
|
Other |
|
|
Total |
|
Balance at December 31, 2007 |
|
|
24,560 |
|
|
$ |
2 |
|
|
$ |
118,561 |
|
|
$ |
20,855 |
|
|
$ |
|
|
|
$ |
(5,124 |
) |
|
$ |
|
|
|
$ |
134,294 |
|
Issuance of shares pursuant to employee
equity plan |
|
|
1 |
|
|
|
|
|
|
|
10 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10 |
|
Stock-based compensation expense and
issuance of shares to officers and
outside directors |
|
|
334 |
|
|
|
|
|
|
|
2,345 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,345 |
|
Common stock held in trust |
|
|
(19 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(306 |
) |
|
|
(306 |
) |
Deferred compensation obligation |
|
|
19 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
306 |
|
|
|
306 |
|
Comprehensive income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,102 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,102 |
|
Other comprehensive income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized loss on investments in auction
rate securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(515 |
) |
|
|
|
|
|
|
|
|
|
|
(515 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
6,587 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2008 |
|
|
24,895 |
|
|
$ |
2 |
|
|
$ |
120,916 |
|
|
$ |
27,957 |
|
|
$ |
(515 |
) |
|
$ |
(5,124 |
) |
|
$ |
|
|
|
$ |
143,236 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes to condensed consolidated financial statements are an integral part of these financial statements.
5
NOVEN PHARMACEUTICALS, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Cash Flows
(in thousands)
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
Six Months ended June 30, |
|
|
|
2008 |
|
|
2007 |
|
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
Net income |
|
$ |
7,102 |
|
|
$ |
12,612 |
|
Adjustments to reconcile net income to net cash flows
(used in) provided by operating activities: |
|
|
|
|
|
|
|
|
Depreciation, amortization and certain other noncash items |
|
|
4,568 |
|
|
|
2,539 |
|
Inventory write-offs |
|
|
3,871 |
|
|
|
682 |
|
Stock-based compensation expense |
|
|
2,345 |
|
|
|
1,976 |
|
Income tax benefits on exercise of stock options |
|
|
|
|
|
|
462 |
|
Excess tax benefit from exercise of stock options |
|
|
|
|
|
|
(392 |
) |
Deferred income tax benefit |
|
|
(6,946 |
) |
|
|
(6,661 |
) |
Recognition of deferred license and contract revenues |
|
|
(10,346 |
) |
|
|
(7,486 |
) |
Equity in earnings of Novogyne |
|
|
(20,696 |
) |
|
|
(14,077 |
) |
Distributions from Novogyne |
|
|
17,247 |
|
|
|
10,975 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
(Increase) decrease in accounts receivable trade, net |
|
|
(1,346 |
) |
|
|
1,493 |
|
Increase in milestone payment receivable Shire |
|
|
(25,000 |
) |
|
|
|
|
Decrease in accounts receivable Novogyne, net |
|
|
2,091 |
|
|
|
1,619 |
|
Increase in inventories |
|
|
(8,013 |
) |
|
|
(1,595 |
) |
Decrease in prepaid income taxes |
|
|
3,129 |
|
|
|
243 |
|
Decrease (increase) in prepaid and other current assets |
|
|
113 |
|
|
|
(830 |
) |
Increase in deposits and other assets |
|
|
(176 |
) |
|
|
|
|
Decrease in accounts payable and accrued expenses |
|
|
(1,897 |
) |
|
|
(494 |
) |
Decrease in accrued compensation and related liabilities |
|
|
(4,324 |
) |
|
|
(932 |
) |
Increase in other accrued liabilities |
|
|
1,923 |
|
|
|
2,128 |
|
Increase in deferred license and contract revenues |
|
|
26,345 |
|
|
|
30,975 |
|
Increase in other liabilities |
|
|
97 |
|
|
|
342 |
|
|
|
|
|
|
|
|
Cash flows (used in) provided by operating activities |
|
|
(9,913 |
) |
|
|
33,579 |
|
|
|
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
Purchases of property, plant and equipment |
|
|
(1,205 |
) |
|
|
(1,421 |
) |
Payments for intangible assets |
|
|
(152 |
) |
|
|
(348 |
) |
Payments for deferred acquisition costs |
|
|
|
|
|
|
(1,241 |
) |
Purchase of company-owned life insurance |
|
|
(335 |
) |
|
|
(260 |
) |
Purchases of investments |
|
|
(62,800 |
) |
|
|
(767,769 |
) |
Proceeds from sale of investments |
|
|
99,175 |
|
|
|
730,864 |
|
|
|
|
|
|
|
|
Cash flows provided by (used in) investing activities |
|
|
34,683 |
|
|
|
(40,175 |
) |
|
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
Issuance of common stock from exercise of stock options |
|
|
10 |
|
|
|
2,521 |
|
Excess tax benefit from exercise of stock options |
|
|
|
|
|
|
392 |
|
Payments of long-term obligations |
|
|
(3,348 |
) |
|
|
(58 |
) |
|
|
|
|
|
|
|
Cash flows (used in) provided by financing activities |
|
|
(3,338 |
) |
|
|
2,855 |
|
|
|
|
|
|
|
|
Net increase in cash and cash equivalents |
|
|
21,432 |
|
|
|
(3,741 |
) |
Cash and cash equivalents, beginning of period |
|
|
13,973 |
|
|
|
9,144 |
|
|
|
|
|
|
|
|
Cash and cash equivalents, end of period |
|
$ |
35,405 |
|
|
$ |
5,403 |
|
|
|
|
|
|
|
|
The accompanying notes to condensed consolidated financial statements are an integral part of these financial statements.
6
NOVEN PHARMACEUTICALS, INC.
Notes to Unaudited Condensed Consolidated Financial Statements
1. DESCRIPTION OF BUSINESS AND BASIS OF PRESENTATION:
Since its incorporation in Delaware in 1987, Noven Pharmaceuticals, Inc. (Noven) has been
primarily engaged in the research, development, manufacture and marketing of advanced transdermal
drug delivery technologies and prescription transdermal products.
Noven and Novartis Pharmaceuticals Corporation (Novartis) established a joint venture,
Vivelle Ventures LLC (d/b/a Novogyne Pharmaceuticals) (Novogyne), effective May 1, 1998, to
market and sell womens prescription healthcare products in the United States and Canada. These
products include Novens transdermal hormone therapy product delivery systems marketed under the
brand names Vivelle-Dot® and CombiPatch®. Noven accounts for its 49%
investment in Novogyne under the equity method and reports its share of Novogynes earnings as
Equity in earnings of Novogyne on its Condensed Consolidated Statements of Operations. Noven
defers the recognition of 49% of its profit on products sold to Novogyne until the products are
sold by Novogyne to third party customers.
On August 14, 2007 (the Closing Date), Noven acquired JDS Pharmaceuticals, LLC (JDS), a
privately-held specialty pharmaceutical company that currently markets three branded prescription
psychiatry products through a targeted sales force and has additional products in development.
Effective January 8, 2008, JDSs name was changed to Noven Therapeutics, LLC (Noven
Therapeutics). With the acquisition of Noven Therapeutics, Noven now operates in two segments
distinguished along product categories: (i) the Noven Transdermals segment, which currently
engages in the research, development, manufacturing and licensing to partners of transdermal drug
delivery technologies and prescription transdermal products; and (ii) the Noven Therapeutics
segment, which currently engages in the development, marketing and sales of pharmaceutical
products. See Note 15 Segment and Customer Data for Novens segment reporting.
In managements opinion, the accompanying unaudited condensed consolidated financial
statements of Noven contain all adjustments (consisting of only normal recurring adjustments)
necessary to present fairly, in all material respects, the consolidated financial position of
Noven, the results of its operations, and its cash flows for the periods presented. Novens
business is subject to numerous risks and uncertainties including, but not limited to, those set
forth in Part I Item 1A of Novens Annual Report on Form 10-K for the year ended December 31,
2007 (Form 10-K), and as supplemented by Part II Item 1A Risk Factors of this quarterly
report on Form 10-Q. Accordingly, the results of operations and cash flows for the periods
presented are not, and should not be construed as, necessarily indicative of the results of
operations or cash flows which may be reported for the remainder of 2008 or for periods
thereafter.
The accompanying unaudited condensed consolidated financial statements have been prepared
pursuant to the rules and regulations of the Securities and Exchange Commission for reporting on
Form 10-Q. Pursuant to such rules and regulations, certain information and footnote disclosures
normally included in financial statements prepared in accordance with accounting principles
generally accepted in the United States of America (GAAP) have been condensed or omitted. The
unaudited condensed consolidated financial statements should be read in conjunction with the
consolidated financial statements and the notes to the consolidated financial statements
included in Novens Form
10-K. The accounting policies followed for interim financial reporting
are the same as those disclosed in Note 2 of the notes to the consolidated financial statements
included in Novens Form 10-K.
Certain reclassifications
have been made to the prior periods statement of operations and statement of cash flows to conform to the
current periods presentation.
7
2. RECENT ACCOUNTING PRONOUNCEMENTS:
The following information updates the discussion of recent accounting pronouncements in Note
2 of the consolidated financial statements included in Novens Form 10-K.
In May 2008, the Financial Accounting Standards Board (FASB) issued Statement of
Financial Accounting Standards (SFAS) No. 162, The Hierarchy of Generally Accepted Accounting
Principles (SFAS No. 162). SFAS No. 162 identifies the sources of accounting principles and the
framework for selecting the principles used in the preparation of financial statements of
nongovernmental entities that are presented in conformity with GAAP. This statement will be
effective 60 days following the Securities Exchange and Commissions approval of the Public
Company Accounting Oversight Board amendments to AU Section 411, The Meaning of Present Fairly
in Conformity With Generally Accepted Accounting Principles. Noven does not expect adoption of
SFAS No. 162 to have a material impact on its financial statements.
In March 2008, the FASB issued SFAS No. 161, Disclosures about Derivative Instruments and
Hedging Activities an amendment of FASB Statement No. 133 (SFAS No. 161). SFAS No. 161
changes the disclosure requirements for derivative instruments and hedging activities. Entities
are required to provide enhanced disclosures about: (i) how and why an entity uses derivative
instruments; (ii) how derivative instruments and related hedged items are accounted for under
SFAS No. 133 and its related interpretations; and (iii) how derivative instruments and related
hedged items affect an entitys financial position, financial performance, and cash flows. SFAS
No. 161 is effective for financial statements issued for fiscal years and interim periods
beginning after November 15, 2008, with early adoption encouraged. SFAS No. 161 encourages, but
does not require, comparative disclosures for earlier periods at initial adoption. Noven is
currently assessing the impact of adopting SFAS No. 161 and the impact it may have on Novens
consolidated financial condition, results of operations or cash flows.
3. CASH FLOW INFORMATION:
Income Tax and Interest Payments
Cash payments for income taxes were $7.5 million and $16.5 million for the six months ended
June 30, 2008 and 2007, respectively. In 2002, the State of New Jersey enacted legislation that
requires Novogyne to remit estimated state income tax payments on behalf of its owners, Noven and
Novartis. For the six months ended June 30, 2008 and 2007, Novogyne paid $1.8 million and $4.4
million, respectively, to the New Jersey Department of Revenue, representing Novens portion of
Novogynes estimated state income tax payment. These payments were deemed distributions to Noven
from Novogyne. Noven received tax refunds directly from the State of New Jersey of $2.7 million
and $2.4 million during the six months ended June 30, 2008 and 2007, respectively, related to
these state income tax payments made on Novens behalf. Cash payments for interest were not
material for the six months ended June 30, 2008 and 2007.
Non-cash Operating Activities
Noven recorded $0.5 million income tax benefit as additional paid-in capital derived from
the exercise of non-qualified stock options and disqualifying dispositions of incentive stock
options for the six months ended June 30, 2007.
Non-cash Investing Activities
Noven recorded $0.5 million in unrealized losses on its investments in auction rate
securities for the six months ended June 30, 2008. The unrealized losses were recorded as a
reduction of stockholders equity through other comprehensive income (loss).
8
4. INVESTMENTS AVAILABLE-FOR-SALE:
At June 30, 2008, Noven held investments in auction rate securities (classified as
available-for-sale) with a par value and fair value of $18.0 and $17.5 million, respectively.
Auction rate securities are floating rate debt securities with long-term nominal maturities, the
interest rates of which are reset periodically (typically every seven to thirty-five days)
through a Dutch auction process. These periodic auctions have historically provided a liquid
market for auction rate securities, as this mechanism generally allowed existing investors to
rollover their holdings and continue to own their respective securities at then-existing market
rates or to liquidate their holdings by selling their securities at par value. Beginning in
February 2008, as part of the ongoing credit market crisis, several auction rate securities from
various issuers have failed to receive sufficient order interest from potential investors to
clear successfully, resulting in auction failures. Historically, when investor demand was
insufficient, the banks running the auctions would step in and purchase the remaining securities
in order to prevent an auction failure. However, the banks have recently been allowing these
auctions to fail. As a result of failed auctions, these investments now pay interest as defined by the governing documents or indenture.
Noven liquidated $36.9 million of auction rate securities at par value during the six months
ended June 30, 2008. During the three months ended March 31, 2008, Noven recorded an unrealized
loss of $0.5 million to reduce the investments to fair value. During the three months ended June
30, 2008, Noven determined that no additional loss was required to be recorded. The unrealized
loss has been recorded as a reduction of stockholders equity through other comprehensive income
(loss). Because the investments are tax-exempt, there is no related tax effect.
Novens auction rate security investments are collateralized primarily by tax-exempt
municipal bonds and, to a lesser extent, guaranteed student loans. Noven does not hold any
auction rate securities collateralized by mortgages or collateralized debt obligations. Noven
believes these investments are of high credit quality, as all are investment grade and the
majority are rated AA or higher. Furthermore, management currently has the intent and believes
it has the ability to hold these investments until the anticipated recovery in fair value occurs.
Based on these factors, Noven believes the decline in fair value of these investments is due to
general market conditions and is temporary in nature. Noven will continue to monitor the market
for its auction rate investments. If management determines in a future period that a decline in
fair value is other than temporary, then in accordance with SFAS No. 115, Noven would be required
to recognize a realized loss in operations in the period when such determination is made.
5. FAIR VALUE MEASUREMENTS:
Noven adopted SFAS No. 157, Fair Value Measurements in 2008. SFAS No. 157, among other
things, defines fair value, establishes a consistent framework for measuring fair value and
expands disclosure for each major asset and liability category measured at fair value on either a
recurring or nonrecurring basis. SFAS No. 157 clarifies that fair value is an exit price,
representing the amount expected to be received to sell an asset or paid to transfer a liability
in an orderly transaction between market participants. As such, fair value is a market-based
measurement that should be determined based on assumptions that market participants would use in
pricing an asset or liability. To increase consistency and comparability in fair value
measurements and related disclosures, SFAS No. 157 sets forth a three-tier hierarchy for the
inputs used to measure fair value based on the degree to which such inputs are observable in the
marketplace, as follows:
|
(i) |
|
Level 1 observable inputs such as quoted prices in active markets; |
|
|
(ii) |
|
Level 2 inputs, other than the quoted prices in active markets, that are
observable either directly or indirectly; and |
|
|
(iii) |
|
Level 3 unobservable inputs for which there is little or no market data,
which require the reporting entity to develop its own assumptions. |
During the six months ended June 30, 2008, Noven recorded a $0.5 million unrealized loss on
its investments in auction rate securities which are classified as available-for-sale under SFAS
No. 115. As of June 30, 2008, the total par value and fair value of Novens investments was
$18.0 million and $17.5 million, respectively. Due to continuing auction failures beginning in
February 2008, Noven utilized valuation models to determine the fair values of its investments in
auction rate securities. The fair values of the investments were calculated based on the
following: (i) the underlying structure of each security; (ii) the present value of future
principal and interest payments discounted at rates considered to reflect current market
conditions; (iii) consideration of the probabilities of default, auction failure, or repurchase
at par for each period; and (iv) consideration of third party credit enhancement. These
estimated fair values could change significantly based on future market conditions.
9
Changes to investments measured at fair value on a recurring basis using unobservable inputs
(Level 3) during the six months ended June 30, 2008 were as follows (in thousands):
|
|
|
|
|
Balance at December 31, 2007 |
|
$ |
54,400 |
|
Purchases of investments |
|
|
550 |
|
Sales of investments at par |
|
|
(36,925 |
) |
Unrealized losses recorded as other comprehensive loss |
|
|
(515 |
) |
|
|
|
|
Balance at June 30, 2008 |
|
$ |
17,510 |
|
|
|
|
|
6. INVENTORIES:
The following are the major classes of Novens inventories (in thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2008 |
|
|
2007 |
|
Finished goods |
|
$ |
4,105 |
|
|
$ |
3,171 |
|
Work in process |
|
|
2,903 |
|
|
|
1,532 |
|
Raw materials |
|
|
9,270 |
|
|
|
7,433 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
16,278 |
|
|
$ |
12,136 |
|
|
|
|
|
|
|
|
During the six months ended June 30, 2008, Noven recorded a $3.9 million charge to cost of
products sold related to the write-off of inventories. These write-offs primarily related to an
equipment failure in transdermal manufacturing during the three months ended March 31, 2008 which
resulted in $1.8 million of Novogyne product write-offs and $1.0 million of third party HT
product write-offs, as well as inventory write-offs of approximately $0.8 million during the
three months ended June 30, 2008 due primarily to Daytrana® product that exhibited
high peel force characteristics.
Shire plc (Shire) retains title to the active methylphenidate ingredient (AMI) in
Daytrana®. The value of the AMI is neither included in Daytrana® product
revenues nor in Novens cost of products sold. Noven records AMI maintained at its manufacturing
facility as consignment inventory and bears certain manufacturing risks of loss related to the
AMI. These risks include the contractual obligation of Noven to reimburse Shire for the cost of
AMI if Noven does not meet certain minimum yields of the finished product. Shire has a
reciprocal obligation to pay Noven if the yield requirements are exceeded. Noven slightly
exceeded the yield requirements for the six months ended June 30, 2008 for product shipped to
Shire, resulting in an immaterial payment from Shire to Noven. During the six months ended June
30, 2008, Noven used $2.7 million of AMI in the finished product. Noven had $4.6 million and
$2.6 million of consignment AMI inventory on hand at June 30, 2008 and December 31, 2007,
respectively, for which Noven owed Shire approximately $0.6 million and $0.5 million as of such
respective dates, primarily as a result of product that did not meet the products release liner
removal specification. AMI is not reflected in the inventory table above.
10
7. GOODWILL AND INTANGIBLE ASSETS:
All of Novens goodwill arose from the JDS acquisition in August 2007 and, thus, relates to
the Noven Therapeutics segment. The carrying amount of goodwill is $14.4 million and $14.7
million at June 30, 2008 and December 31, 2007, respectively. Goodwill is tested for impairment
annually in the fourth quarter or more frequently, when events or other changes in circumstances
indicate that the carrying value of goodwill may not be recoverable. If after testing the
intangible assets and goodwill, Noven determines that these assets are impaired, then Noven would
be required to write-down the impaired asset to fair value in the period when the determination
is made. Such a write-down could have a material adverse effect on Novens results of operations.
During the six months ended June 30, 2008, Noven took certain actions related to the JDS
acquisition, resulting in a $0.3 million net reduction in goodwill as follows:
|
|
|
As part of the JDS acquisition, a portion of the purchase price was placed in escrow
to be distributed upon final determination of the amount of net working capital purchased
by Noven. During the three months ended June 30, 2008, Noven reached a final agreement
with the JDS sellers on the net working capital, which agreement resulted in a $1.1
million payment to Noven from the escrow account (which was paid subsequent to June 30,
2008). As a result of the working capital adjustment, Noven
adjusted the amount due from escrow by $1.0 million during the six months ended June 30,
2008 and recorded a corresponding increase of $1.0 million to goodwill. |
|
|
|
|
Also as part of the JDS acquisition, Noven recognized a favorable lease asset related
to office space in New York and a liability for employee relocation costs, based on a
tentative determination that Noven would exit the New York location by May 2008. During
the three months ended June 30, 2008, management decided to retain the New York office
space through its remaining contractual term and to not require relocation of the
remaining personnel based in New York. As a result of these decisions, Noven revised the
value of the acquired favorable lease asset and reversed the unused relocation liability,
resulting in a $1.3 million reduction in goodwill. |
Novens intangible assets, all of which are subject to amortization are summarized in the
table below as of June 30, 2008 and December 31, 2007 (amounts in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross Carrying |
|
Accumulated |
|
Net |
|
Amortization Period |
|
|
Amount |
|
Amortization |
|
Carrying Amount |
|
(years) |
As of June 30, 2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Patent development costs
|
|
$ |
4,694 |
|
|
$ |
(2,814 |
) |
|
$ |
|
1,880 |
|
|
7 - 13 |
|
Acquired product intangibles
|
|
|
37,790 |
|
|
|
(3,361 |
) |
|
|
|
34,429 |
|
|
10 |
|
Non-competition agreements
|
|
|
530 |
|
|
|
(193 |
) |
|
|
|
337 |
|
|
2 - 3 |
|
Favorable lease
|
|
|
790 |
|
|
|
(246 |
) |
|
|
|
544 |
|
2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
43,804 |
|
|
$ |
(6,614 |
) |
|
$ |
|
37,190 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31, 2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Patent development costs
|
|
$ |
4,542 |
|
|
$ |
(2,573 |
) |
|
$ |
|
1,969 |
|
|
8 - 14 |
|
Acquired product intangibles
|
|
|
37,790 |
|
|
|
(1,549 |
) |
|
|
|
36,241 |
|
|
10 |
|
Non-competition agreements
|
|
|
530 |
|
|
|
(82 |
) |
|
|
|
448 |
|
|
2 - 3 |
|
Favorable lease
|
|
|
227 |
|
|
|
(112 |
) |
|
|
|
115 |
|
10 months
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
43,089 |
|
|
$ |
(4,316 |
) |
|
$ |
|
38,773 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
11
All intangible assets above, with the exception of patent development costs with a net
carrying amount of approximately $1.9 million and $2.0 million at June 30, 2008 and December 31,
2007, respectively, were acquired on the Closing Date as part of the JDS acquisition.
Amortization expense was $1.2 million and $0.1 million for the three months ended June 30, 2008 and 2007,
respectively. Amortization expense was $2.3 million and $0.3 million for the six months ended
June 30, 2008 and 2007, respectively.
Noven estimates that the annual amortization expense for intangible assets held at June 30,
2008 for each of the five years through 2013 is as follows (amounts in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Remainder |
|
|
Years Ending December 31, |
|
|
|
of 2008 |
|
|
2009 |
|
|
2010 |
|
|
2011 |
|
|
2012 |
|
|
2013 |
|
Cost of goods sold: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intellectual property |
|
$ |
2,053 |
|
|
$ |
4,032 |
|
|
$ |
3,985 |
|
|
$ |
3,924 |
|
|
$ |
3,908 |
|
|
$ |
3,847 |
|
General and administrative: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-compete and
favorable
lease agreements |
|
|
231 |
|
|
|
413 |
|
|
|
237 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
2,284 |
|
|
$ |
4,445 |
|
|
$ |
4,222 |
|
|
$ |
3,924 |
|
|
$ |
3,908 |
|
|
$ |
3,847 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8. OTHER ACCRUED LIABILITIES:
Other accrued liabilities consist of the following (amounts in thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30, 2008 |
|
|
December 31, 2007 |
|
Income taxes payable |
|
$ |
5,437 |
|
|
$ |
2,414 |
|
Accrued Medicaid and other rebates |
|
|
2,834 |
|
|
|
4,065 |
|
Accrued market withdrawal costs |
|
|
1,950 |
|
|
|
3,300 |
|
Allowance for product returns |
|
|
2,416 |
|
|
|
1,875 |
|
Other accrued liabilities |
|
|
4,556 |
|
|
|
3,616 |
|
|
|
|
|
|
|
|
Total other accrued liabilities |
|
$ |
17,193 |
|
|
$ |
15,270 |
|
|
|
|
|
|
|
|
9. EQUITY PLANS:
Prior to January 1, 2006, all awards granted to employees under Novens 1999 Long-Term
Incentive Plan (the 1999 Plan) were stock options. In 2006, Noven began granting stock-settled
stock appreciation rights (SSARs) and nonvested shares of common stock (restricted stock).
Noven accounts for these awards in accordance with SFAS No. 123 (revised 2004), Share-Based
Payment. At June 30, 2008, there were 2,114,197 stock options and 1,543,360 SSARs issued and
outstanding under the 1999 Plan.
12
Noven has granted a total of 388,780 shares of restricted stock under the 1999 Plan. The
following table summarizes the information regarding Novens restricted stock at June 30, 2008
(shares in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
Average |
|
|
|
|
|
|
|
Grant-Date |
|
|
|
Shares |
|
|
Fair Value |
|
Nonvested at
December 31, 2007 |
|
|
6 |
|
|
$ |
22.86 |
|
Granted |
|
|
328 |
|
|
|
9.90 |
|
Vested |
|
|
(76 |
) |
|
|
11.15 |
|
|
|
|
|
|
|
|
|
Nonvested at
June 30, 2008 |
|
|
258 |
|
|
$ |
9.86 |
|
|
|
|
|
|
|
|
|
Noven granted 70,847 and 26,244 shares of restricted stock to Novens non-employee directors in June 2008 and May 2007, respectively, as
compensation for Board services. The shares vest over each directors one-year service period at
the end of each calendar quarter beginning with the end of the second quarter. As the shares
vest, those shares that have been deferred by non-employee directors under Novens deferred
compensation plan are transferred into a rabbi trust maintained by Noven. In accordance with EITF
Issue No. 97-14, Accounting for Compensation Arrangements Where Amounts Earned are Held in a
Rabbi Trust and Invested, the deferred shares were recorded at their fair value and classified
as common stock held in trust. Since the deferral relates to Noven common stock, an offsetting
amount was recorded as deferred compensation obligation in the stockholders equity section of
the consolidated balance sheets. At June 30, 2008 and December 31, 2007 there were a total of
67,515 and 48,300 shares of common stock in the rabbi trust, respectively. Restricted stock
grants during the six months ended June 30, 2008 include an aggregate 257,345 shares of
restricted stock granted to certain executive officers in 2008.
Noven has granted a total of 50,000 restricted stock units under the 1999 Plan. These
restricted stock units were awarded to Novens former Chief Executive Officer in January 2008 as
part of a separation agreement. The fair value of this award (approximately $0.7 million) was
charged to operations in 2007.
The assumptions used to value the SSARs for the three months ended June 30, 2008 and 2007
were as follows:
|
|
|
|
|
|
|
|
|
|
|
2008 |
|
|
2007 |
|
Volatility |
|
|
50.5 |
% |
|
|
45.8 |
% |
Risk free interest rate |
|
|
3.22 |
% |
|
|
4.59 |
% |
Expected life (years) |
|
|
4.8 |
|
|
|
5.0 |
|
Dividend yield |
|
|
0.0 |
% |
|
|
0.0 |
% |
13
Total stock-based compensation recognized in Novens consolidated statements of operations
for the three and six months ended June 30, 2008 and 2007 was as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
Selling and marketing |
|
$ |
169 |
|
|
$ |
111 |
|
|
$ |
323 |
|
|
$ |
222 |
|
General and administrative |
|
|
1,159 |
|
|
|
628 |
|
|
|
1,627 |
|
|
|
1,256 |
|
Research and development |
|
|
85 |
|
|
|
127 |
|
|
|
176 |
|
|
|
254 |
|
Total cost of products sold |
|
|
74 |
|
|
|
122 |
|
|
|
219 |
|
|
|
244 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
1,487 |
|
|
$ |
988 |
|
|
$ |
2,345 |
|
|
$ |
1,976 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tax benefit recognized
related to
compensation expense |
|
$ |
511 |
|
|
$ |
302 |
|
|
$ |
804 |
|
|
$ |
661 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation costs of $0.1 million for the three months ended June 30, 2008 and
2007, respectively, and $0.2 million for the six months ended June 30, 2008 and 2007,
respectively, were included in manufacturing expenses, which are included in the determination of
inventory costs. In any given period, the amount of stock-based compensation costs included in
ending inventory is not material. There were no stock-based compensation costs capitalized as
part of fixed assets for the three and six months ended June 30, 2008 or 2007.
Cash received from options exercised under all share-based payment arrangements for the six
months ended June 30, 2008 and 2007 was $10,000 and $2.5 million, respectively. There was no tax
benefit realized on the tax deductions from option exercises under stock-based compensation
arrangements for the six months ended June 30, 2008 as an immaterial amount of stock
options/SSARs were exercised during this period. The tax benefit realized on the tax deductions
from option exercises under stock-based compensation arrangements was $0.5 million for the six
months ended June 30, 2007, of which $0.4 million was reported as cash flow from financing
activities for the six months ended June 30, 2007.
Stock option and SSAR transactions related to the 1999 Plan are summarized as follows for
the six months ended June 30, 2008 (options/SSARs and aggregate intrinsic value in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
Average |
|
|
|
|
|
|
|
Average |
|
|
Aggregate |
|
|
Remaining |
|
|
|
Options/ |
|
|
Exercise |
|
|
Intrinsic |
|
|
Contractual |
|
|
|
SSARs |
|
|
Price |
|
|
Value |
|
|
Term |
|
Outstanding at
December 31, 2007 |
|
|
3,511 |
|
|
$ |
16.83 |
|
|
|
|
|
|
|
|
|
Granted |
|
|
476 |
|
|
|
9.87 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
(1 |
) |
|
|
10.89 |
|
|
$ |
3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Canceled and expired |
|
|
(329 |
) |
|
|
18.73 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at
June 30, 2008 |
|
|
3,657 |
|
|
$ |
15.94 |
|
|
$ |
581 |
|
|
|
4.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding and exercisable
at end of the period |
|
|
2,062 |
|
|
$ |
17.30 |
|
|
$ |
185 |
|
|
|
2.7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
14
As of June 30, 2008, the unamortized compensation expense that Noven expects to record in
future periods related to currently outstanding unvested stock options, SSARs and restricted
stock is approximately $11.7 million before the effect of income taxes, of which $2.7 million,
$4.0 million, $2.9 million, $1.8 million and $0.3 million is expected to be incurred in the
remainder of 2008 and in 2009, 2010, 2011 and 2012, respectively. The weighted-average period
over which this compensation cost is expected to be recognized is 2.5 years. As of June 30,
2008, approximately 3,368,362 outstanding options/SSARs are vested or expected to vest. Such
options have a weighted average exercise price of $16.13, $0.5 million aggregate intrinsic value
and a weighted average remaining life of 5.95 years as of June 30, 2008.
10. INCOME TAXES:
On January 1, 2007, Noven adopted the provisions of, and began accounting for uncertainty in
income taxes in accordance with, FASB Interpretation No. 48, Accounting for Uncertainty in
Income Taxes an interpretation of FASB Statement 109 (FIN 48). This interpretation requires
companies to determine whether it is more likely than not that a tax position will be sustained
upon examination by the appropriate taxing authorities before any part of the benefit can be
recorded in the financial statements. FIN 48 clarifies the accounting for income taxes by
prescribing a minimum recognition threshold a tax position is required to meet before recognition
in the financial statements. FIN 48 requires a two-step approach when evaluating a tax position
based on recognition (Step 1) and measurement (Step 2).
Upon adoption of FIN 48, and as a result of the recognition and measurement of Novens tax
positions as of January 1, 2007, Noven recognized a charge of approximately $0.5 million to the
January 1, 2007 retained earnings balance. The gross amount of unrecognized tax benefits as of
the date of adoption, January 1, 2007, was $0.9 million. If the $0.9 million were ultimately
recognized, approximately $0.6 million would affect the effective tax rate due to approximately
$0.3 million in related federal tax benefit. As of June 30, 2008 the gross amount of
unrecognized tax benefits was approximately $1.3 million. If the $1.3 million is ultimately
recognized, approximately $0.9 million would affect the effective tax rate due to approximately
$0.4 million in related federal tax benefit. Interest and penalties related to income taxes are
classified as a component of
income tax expense. Approximately $0.4 million and $0.5 million were accrued for interest
and penalties as of June 30, 2008 and December 31, 2007, respectively. Noven does not expect the
gross amount of unrecognized tax benefits to significantly increase or decrease within twelve
months after June 30, 2008. All of Novens unrecognized tax benefits pertain to state tax
positions.
Noven is periodically audited by federal and state taxing authorities. The outcome of these
audits may result in Noven being assessed taxes in addition to amounts previously paid. The
accruals are determined based upon Novens best estimate of possible assessments by the Internal
Revenue Service (IRS) or other taxing authorities and are adjusted, from time to time, based
upon changing facts and circumstances. Federal returns for years 2004 2006 remain open and
subject to examination by the IRS. Noven files and remits state income taxes in various states
where Noven has determined it is required to file state income taxes. Novens filings with those
states remain open for audit for the years 2003 2006. Other than routine state tax inquiries,
there are no examinations currently taking place related to income taxes in any jurisdiction. It
is possible that examinations may be initiated by any jurisdiction where Noven operates, or where
it can be determined that Noven operates, and the results of which can materially change the
amount of unrecognized income tax benefits for tax positions taken, which may increase Novens
income tax liabilities or decrease the amount of deferred tax assets.
At June 30, 2008 and December 31, 2007, net deferred tax assets were $72.6 million and $65.7
million, respectively. Realization of these deferred tax assets depends upon the generation of
sufficient future taxable income. A valuation allowance is established if it is more likely than
not that all or a portion of the deferred tax asset will not be realized. Noven Therapeutics
files separate state income tax returns in states where Noven Therapeutics has determined that it
is required to file state income taxes. As a result, state deferred tax assets relating to Noven
Therapeutics are evaluated separately in determining whether the state deferred tax assets are
realizable. Noven expects that Noven Therapeutics will incur taxable losses in the next few
years due to future expected clinical trial expenditures related to product development and
selling and marketing costs required to commercialize its products. These expected taxable
losses create negative evidence indicating the need for a valuation allowance at June 30, 2008
and December 31, 2007. Novens valuation allowance for state deferred tax assets was $3.3
million and $3.2 million as of June 30, 2008 and December 31, 2007, respectively, due to
uncertainties in realizing these state deferred tax assets based on Novens projection of future
state taxable income relating to Noven Therapeutics. If Noven determines, based on future Noven
Therapeutics profitability that these state deferred tax assets will more likely than not be
realized, a release of all, or part, of the related valuation allowance could result in an
immediate income tax benefit in the period the valuation allowance is released.
15
11. CONTRACT AND LICENSE AGREEMENTS:
SHIRE COLLABORATION
Noven has developed a once-daily transdermal methylphenidate patch for Attention Deficit
Hyperactivity Disorder (ADHD) called Daytrana®. In the first quarter of 2003 Noven
licensed to Shire the exclusive global rights to market Daytrana® for payments by
Shire of up to $150.0 million. In consideration for this licensing transaction, Shire agreed to
pay Noven as follows: (i) $25.0 million was paid upon closing of the transaction in April 2003;
(ii) $50.0 million was paid in April 2006 upon receipt of final marketing approval by the United
States Food and Drug Administration (FDA); and (iii) three installments of $25.0 million each
payable upon Shires achievement of $25.0 million, $50.0 million and $75.0 million in annual
Daytrana® net sales, respectively. Noven received the first $25.0 million sales
milestone in the first quarter of 2007 and the second $25.0 million sales milestone in the third
quarter of 2007. Noven has been advised by Shire that Shires net sales of Daytrana®
during the 12 months ended June 30, 2008 have triggered the third and final $25.0 million sales
milestone due to be paid to Noven during the third quarter of
2008. As a result, Novens balance sheet reflects a milestone payment receivable from Shire
of $25.0 million as of June 30, 2008. Noven is currently deferring and recognizing approval and
sales milestones as license revenues on a straight-line basis, beginning on the date the
milestone is achieved through the first quarter of 2013, which is Novens current best estimate
of the end of the useful economic life of the product.
SYNTHON PHARMACEUTICALS COLLABORATION
In November 2005, JDS entered into an asset purchase agreement with Synthon Pharmaceuticals,
Inc. (Synthon) for the purchase of Pexeva®. In this transaction, JDS purchased
certain assets related to Pexeva® including the New Drug Application (NDA),
intellectual property (including patents and trademarks) and certain finished goods inventory.
The purchase of Pexeva® included a cash payment at the time of closing and an
obligation to make certain future fixed payments and certain contingent payments.
Following the JDS acquisition, Noven became responsible for the possible future contingent
payments of up to $11.5 million under the asset purchase agreement with Synthon. As of June 30,
2008 and December 31, 2007, $8.2 million and $11.5 million of these milestones were reflected as
liabilities on Novens consolidated balance sheets. In April 2008, Noven made a milestone payment
of $3.3 million to Synthon as a result of Pexeva® achieving certain sales levels in
2007.
12. INVESTMENT IN VIVELLE VENTURES LLC (d/b/a NOVOGYNE):
Noven shares in the earnings of Novogyne, after satisfaction of an annual preferred return
of $6.1 million to Novartis, according to an established formula. Novens share of Novogynes
earnings increases as Novogynes product sales increase, subject to a cap of 49%. Novogyne
earned sufficient income in the first quarter of 2008 and 2007 to meet Novartis annual preferred
return for those years and for Noven to recognize earnings from Novogyne under the formula.
16
During the three and six months ended June 30, 2008 and 2007, Noven had the following
transactions with Novogyne (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months |
|
|
Six Months |
|
|
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales |
|
$ |
5,553 |
|
|
$ |
4,804 |
|
|
$ |
7,984 |
|
|
$ |
10,173 |
|
Royalties |
|
|
2,349 |
|
|
|
1,899 |
|
|
|
4,529 |
|
|
|
3,664 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
7,902 |
|
|
$ |
6,703 |
|
|
$ |
12,513 |
|
|
$ |
13,837 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reimbursed expenses |
|
$ |
7,381 |
|
|
$ |
7,021 |
|
|
$ |
14,653 |
|
|
$ |
14,106 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reimbursed expenses are primarily comprised of selling and marketing expenses paid by Noven
on behalf of Novogyne. As of June 30, 2008 and December 31, 2007, Noven had amounts due from
Novogyne of $6.6 million and $8.7 million, respectively.
The unaudited condensed statements of operations of Novogyne for the three and six months
ended June 30, 2008 and 2007 are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months |
|
|
Six Months |
|
|
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
Gross revenues |
|
$ |
50,054 |
|
|
$ |
42,915 |
|
|
$ |
95,348 |
|
|
$ |
80,208 |
|
Sales allowances |
|
|
5,702 |
|
|
|
6,837 |
|
|
|
11,555 |
|
|
|
10,999 |
|
Sales return allowances |
|
|
585 |
|
|
|
(60 |
) |
|
|
500 |
|
|
|
(9 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales allowances and returns |
|
|
6,287 |
|
|
|
6,777 |
|
|
|
12,055 |
|
|
|
10,990 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues |
|
|
43,767 |
|
|
|
36,138 |
|
|
|
83,293 |
|
|
|
69,218 |
|
Cost of sales |
|
|
8,788 |
|
|
|
7,795 |
|
|
|
16,596 |
|
|
|
14,842 |
|
Selling, general and
administrative expenses |
|
|
9,798 |
|
|
|
9,579 |
|
|
|
18,810 |
|
|
|
19,712 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income from operations |
|
|
25,181 |
|
|
|
18,764 |
|
|
|
47,887 |
|
|
|
34,664 |
|
Interest income |
|
|
174 |
|
|
|
165 |
|
|
|
441 |
|
|
|
497 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
25,355 |
|
|
$ |
18,929 |
|
|
$ |
48,328 |
|
|
$ |
35,161 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Novens equity in earnings of Novogyne |
|
$ |
12,429 |
|
|
$ |
9,174 |
|
|
$ |
20,696 |
|
|
$ |
14,077 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The activity in the Investment in Novogyne account for the six months ended June 30, 2008 is
as follows (in thousands):
|
|
|
|
|
Investment in Novogyne, beginning of period |
|
$ |
24,310 |
|
Equity in earnings of Novogyne |
|
|
20,696 |
|
Cash distributions from Novogyne |
|
|
(17,247 |
) |
Deemed distribution by Novogyne for state
income tax payment |
|
|
(1,800 |
) |
|
|
|
|
Investment in Novogyne, end of period |
|
$ |
25,959 |
|
|
|
|
|
17
Subject to the approval of Novogynes management committee, Novogyne may, from time to time,
distribute cash to Novartis and Noven based upon a contractual formula. For the three and six
months ended June 30, 2008, Noven received cash distributions representing return on investment
of $6.3 million and $17.2 million, respectively, from Novogyne. For the three and six months
ended June 30, 2007, Noven received cash distributions representing return on investment of $1.2
million and $11.0 million, respectively, from Novogyne. In addition, as discussed in Note 3, tax
payments of $1.8 million and $4.4 million were made by Novogyne on Novens behalf to the New
Jersey Department of Revenue during the six months ended June 30, 2008 and 2007, respectively.
These amounts were recorded as reductions in the investment in Novogyne when received (or in the
case of tax payments, when paid).
13. SHARE REPURCHASE PROGRAM:
In September 2007, Novens Board of Directors authorized a share repurchase program under
which Noven may acquire up to $25.0 million of its common stock. As of December 31, 2007, Noven
had repurchased 322,345 shares of its common stock at an aggregate price of approximately $5.1
million. These shares remained in treasury as of June 30, 2008 and December 31, 2007. No shares
were repurchased under the program during the six months ended June 30, 2008.
14. COMMITMENTS AND CONTINGENCIES:
HORMONE THERAPY (HT) STUDIES:
Since 2002, several studies, including the Womens Health Initiative (WHI) study performed
by the National Institutes of Health (NIH) and a study performed by the National Cancer
Institute (NCI), have identified increased risks from the use of HT, including increased risks
of invasive breast cancer, ovarian cancer, stroke, heart attacks and blood clots. As a result of
the findings from these and other studies, the FDA has required that black box labeling be
included on all HT products marketed in the United States to warn, among other things, that these
products have been associated with increased risks for heart disease, heart attacks, strokes and
breast cancer and that they are not approved for heart disease prevention. Since the July 2002
publication of the WHI and NCI study data, total United States prescriptions have declined for
substantially all HT products, including our HT products in the aggregate. Researchers continue
to analyze data from the WHI study and other studies. Other studies evaluating HT are currently
underway or in the planning stage. In particular, a private foundation has commenced a clinical
study aimed at determining whether estrogen therapy (ET) use, by women aged 42 to 58, reduces
the risk of heart disease. The study also seeks to determine if transdermal estrogen patches are
more or less beneficial than an oral HT product. While our HT products are not being used in the
study, the market for our HT products could be adversely affected if this study finds that a
transdermal estrogen patch is less beneficial than other dosage forms, and Noven could be subject
to increased product liability risk if HT patch products are found to increase the risk of
adverse health consequences. Novens products have been named in lawsuits filed against Noven,
Novogyne and Novartis.
SUPPLY AGREEMENTS:
Novens supply agreement with Novogyne for Vivelle® and Vivelle-Dot®
patches expired in January 2003. While the parties have continued to operate in accordance with
certain of the supply agreements pricing terms, there is no assurance that the parties will
continue to do so. Novogynes designation of a new supplier and approval of a new supply
agreement would require the affirmative vote of four of the five members of Novogynes Management
Committee. Since Noven appoints two members of Novogynes Management Committee, both Novartis
and Noven must agree on Novogynes supplier. In connection with a transition to
Vivelle-Dot®, effective December 2006, Noven ceased supplying Vivelle®
product to Novogyne.
18
Noven and Shire are parties to a long-term supply agreement under which Noven manufactures
and supplies Daytrana® to Shire at a fixed price. During the three months ended June
30, 2008 and 2007, Novens product sales of Daytrana® to Shire were $2.7 million and
$5.2 million, respectively. During the six months ended June 30, 2008 and 2007, Novens product
sales of Daytrana® to Shire were $5.7 million and $9.6 million, respectively. The
supply agreement gives Shire the right to qualify a second manufacturing source and purchase a
portion of its requirements from that source. If Shire were to exercise this right, Novens
financial results from sales of Daytrana® would be adversely affected.
LITIGATION, CLAIMS AND ASSESSMENTS:
In September 2005, Noven, Novogyne and Novartis were served with a summons and complaint
from an individual plaintiff in Superior Court of New Jersey Law Division, Atlantic County in
which the plaintiff claims personal injury allegedly arising from the use of HT products,
including Vivelle®. The plaintiff claims compensatory, punitive and other damages in
an unspecified amount. Noven does not expect any activity in this case in the near future, as
the court has entered an order to stay proceedings in all its pending and future HT cases except
for cases where Wyeth Pharmaceuticals and its affiliates and Pfizer Inc. are the defendants.
In April 2006, an individual plaintiff and her husband filed a complaint in the United
States District Court, District of Minnesota against Noven, Novogyne, Novartis, Wyeth Inc. and
Wyeth Pharmaceuticals, Inc. alleging liability in connection with personal injury claims
allegedly arising from the use of HT products, including Novens CombiPatch® product.
The plaintiffs claim compensatory and other damages in an unspecified amount.
In July 2006, four complaints were filed in the United States District Court, District of
Minnesota against Noven and other pharmaceutical companies by four separate individual
plaintiffs, each filing alone or with her husband. Three of the complaints also name Novartis as
a defendant, and of these, two name Novogyne as a defendant as well. Each complaint alleges
liability in connection with personal injury claims allegedly arising from the use of HT
products, including Vivelle® in one case and CombiPatch® in two of the
cases. The plaintiffs in each case claim compensatory and other damages in an unspecified amount.
Noven has established an accrual for the expected legal fees related to the cases referenced
above, although the amount is not material.
In July 2008, one additional complaint was filed in the United States District Court,
District of Minnesota against Wyeth Inc. and other named pharmaceutical companies, including
Noven, Novogyne and Novartis. The complaint alleges liability in connection with personal injury
claims allegedly arising from the use of HT products, including Vivelle-Dot®. The
plaintiffs claim compensatory and other damages in an unspecified amount.
Each of the aforementioned federal court cases has been, or is expected to be, transferred
to the federal multi-district litigation proceedings that are pending in the United States
District Court, Eastern District of Arkansas.
Novartis has advised Noven that Novartis is currently named as a defendant in at least 31
additional lawsuits that include approximately 32 plaintiffs that allege liability in connection
with personal injury claims allegedly arising from the use of HT patches distributed and sold by
Novartis and Novogyne, including Novens Vivelle-Dot®, Vivelle®, and
CombiPatch® products. Novogyne has been named as a defendant in one lawsuit in
addition to the four lawsuits referenced above. Novartis has indicated that it will seek
indemnification from Noven and Novogyne to the extent permitted by the agreements between and
among Novartis, Novogyne and Noven. Novogynes aggregate limit under its claims-made insurance
policy as of June 30, 2008 was $10.0 million. Novogyne has established reserves in the amount of
$9.1 million with an offsetting insurance recovery of $7.0 million for expected defense and
settlement expenses as well as for estimated future cases alleging use of Novens HT products.
This accrual represents Novartis managements best estimate as of June 30, 2008.
19
In June 2007, Johnson-Matthey Inc. filed a complaint in the United States District Court,
Eastern District of Texas against Noven alleging that Noven was infringing one of its patents
through Novens manufacture and sale of Daytrana®. The plaintiff is seeking
injunctions from further infringement and claiming compensatory and other damages in an
unspecified amount. In July 2007, Johnson-Matthey added Shire as a defendant in this lawsuit.
Noven intends to vigorously defend all of the foregoing lawsuits, but the outcome of these
lawsuits cannot ultimately be predicted.
Noven is a party to other pending legal proceedings arising in the normal course of
business, none of which Noven believes is material to its consolidated financial condition,
results of operations or cash flows.
FDA WARNING LETTER:
Noven and Shire have received reports from some consumers concerning the difficulty of
removing the release liner from Daytrana® patches. In the first quarter of 2007,
Noven, together with Shire, implemented enhancements to the Daytrana® release liner.
While the enhanced release liner has reduced the level of consumer reports, some patients and
caregivers continue to have difficulty in removing the release liner from some
Daytrana® patches. Noven and Shire continue to monitor and review release liner
complaints and the manufacturing process to determine whether modifications to the product or
process can improve the long-term ease of use and address the issues raised by the FDA in the
warning letter described below. Daytranas market share based on total prescriptions
declined in the three months ended June 30, 2008.
In July 2007, Noven received from the FDA a list of observations on Form 483 following an
on-site inspection of its manufacturing facilities. The majority of the observations in the Form
483 related to the Daytrana® patch and difficulties experienced by some patients in
removing the release liner, including certain product lots that utilize the enhanced release
liner. In July 2007, Noven submitted to the FDA its response to the Form 483.
In the third quarter of 2007, Shire initiated two voluntary market withdrawals of a portion
of the Daytrana® product on the market primarily in response to feedback from patients
and caregivers who experienced difficulty removing the release liner from some
Daytrana® patches. Noven paid Shire $3.3 million in February 2008 related to the
withdrawals. These costs were charged to operations in 2007.
In January 2008, Noven received a warning letter from the FDA in connection with the FDAs
July 2007 inspection of its manufacturing facilities. In the warning letter, which is posted at
the FDAs website, the FDA cited Current Good Manufacturing Practice deficiencies related to: (i)
peel force specifications for removal of Daytranas release liner; and (ii) data supporting the
peel force characteristics of Daytranas enhanced release liner throughout the products shelf
life. Noven submitted its response to the warning letter on January 30, 2008. In March 2008,
the Florida District Office of the FDA indicated that Novens response appears to be satisfactory
and stated that Novens response had been forwarded to the FDAs Center for Drug Evaluation and
Research for further review. In April 2008, a Noven stability protocol identified certain
Daytrana® lots exhibiting high peel force characteristics. In June 2008, Shire
initiated the voluntary recall of two lots of Daytrana® that did not meet the
products release liner removal specification. Noven has agreed to pay Shire $1.95 million
related to this recall, of which $0.25 million and $1.7 million were charged to operations in the
first and second quarters of 2008, respectively.
Noven believes it has
identified the root cause and has identified potential solutions related to
this issue, although it will take time to test the effectiveness of the potential solutions and to determine whether such
solutions satisfactorily resolve the issue. Noven cannot assure that there will be a satisfactory resolution of the peel force
issue. Failure to adequately address the issues raised by the FDA in the warning letter as well
as the production and other issues involving Daytrana® could result in additional
regulatory action, including fines, recalls of products, injunctions, seizures, suspension of
production or withdrawal of the approval of products. Any such regulatory action would be
expected to have a material adverse effect on Noven, including the potential for litigation
related to this matter, harm to Novens reputation and various costs associated with the
foregoing.
20
CONTRACT AND LICENSE AGREEMENTS:
Noven is obligated to perform under its contract and license agreements. In certain
circumstances, Noven is required to indemnify its licensees from damages caused by the products
Noven manufactures as well as claims or losses related to patent infringement.
NOVEN THERAPEUTICS COMMITMENTS:
Noven Therapeutics has certain commitments and contingencies related to contractual
arrangements, primarily related to milestone payments for development, FDA submission, FDA
approval and commercial sales of current and developmental products. As of June 30, 2008 and
December 31, 2007, Noven Therapeutics was responsible for up to $20.2 million and $23.5 million
in such contingent milestones, respectively. As of June 30, 2008 and December 31, 2007, $8.2
million and $11.5 million of these milestones, respectively, were reflected as liabilities in
Novens consolidated balance sheets and, as discussed in Note 11, in April 2008, Noven made a
milestone payment of $3.3 million to Synthon.
EMPLOYMENT AGREEMENT AND BONUS PLAN:
Effective April 29, 2008, Peter Brandt was appointed to the offices of President and Chief
Executive Officer and to Novens Board of Directors. In connection with Mr. Brandts appointment
as an executive officer, Noven and Mr. Brandt entered into an employment agreement, dated April
29, 2008 (the Agreement). The initial two-year term of the Agreement expires on April 28, 2010
and will continue for consecutive
one-year terms unless it is terminated by either party under certain conditions. Mr.
Brandts base salary under the Agreement is approximately $0.7 million, subject to further
increases at the discretion of the Board of Directors. Mr. Brandts annual target incentive bonus
under Novens annual incentive plan during the term will be at least 75% of his base salary.
In connection with the Agreement, Mr. Brandt was granted the following equity awards under
the 1999 Plan: (i) SSARs with an aggregate fair value of $1.3 million to acquire 311,529 shares
of Novens common stock at an exercise price of $9.10 per share (the market price on the grant
date) which vest at a rate of 25% per year on each anniversary of the grant date; and (ii)
250,000 shares of restricted stock. The shares of restricted stock vest as follows: (a) 50,000
shares immediately upon grant; (b) 16,667 shares on the first anniversary of the grant date; (c)
16,666 shares on the second anniversary of the grant date; (d) 16,666 shares on the third
anniversary of the grant date; (e) 50,000 shares upon Noven attaining pre-tax income of $50.0
million or more over any four consecutive quarterly periods; (f) 50,000 shares upon Noven
attaining pre-tax income of $75.0 million or more over any four consecutive quarterly periods;
and (g) 50,000 shares upon Noven attaining pre-tax income of $100.0 million or more over any four
consecutive quarterly periods. On the grant date, the restricted shares had an aggregate fair
value of $2.3 million, of which $455,000 related to the vested shares was immediately charged to
operations and $455,000 pertaining to 50,000 shares is being amortized ratably over the 3-year
vesting period. The balance of $1.4 million is and will be amortized over periods which reflect
managements current best estimate of when the specified performance targets will be achieved.
Noven has a formula bonus plan that includes company and individual performance goals. Under
the plan, a fixed percentage of each eligible employees base salary is established as a target
incentive bonus award for such employee. To the extent that actual company performance is equal
to, exceeds or is less than the company performance targets, an employees bonus award may be
equal to, greater than or less than his or her target award. An employees non-financial goals
are then considered in determining his or her final bonus award. Managements estimate of the
bonus accrual is expensed over the year in which it is earned.
21
15. SEGMENT AND CUSTOMER DATA:
The accounting policies of the segments are the same as those described in Note 2 of the
notes to the financial statements included in Novens Form 10-K. The table below presents
segment information for the periods identified and reconciles segment information to the
applicable consolidated amounts. There are no inter-segment revenues. The results of the Noven
Therapeutics segment are included in Novens consolidated results beginning on the date of
acquisition (August 14, 2007). Consequently, Novens results for the three and six month period
ended June 30, 2007 do not include the results of the Noven Therapeutics segment. Prior year
comparative data is provided for the Noven Transdermals segment:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months |
|
|
Six Months |
|
|
|
Ended June 30, |
|
|
Ended June 30, |
|
|
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
(in thousands): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Noven Transdermals: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product revenues |
|
$ |
12,968 |
|
|
$ |
15,062 |
|
|
$ |
23,459 |
|
|
$ |
30,668 |
|
License and contract revenues |
|
|
5,060 |
|
|
|
3,777 |
|
|
|
10,346 |
|
|
|
7,486 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues |
|
|
18,028 |
|
|
|
18,839 |
|
|
|
33,805 |
|
|
|
38,154 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of products sold |
|
|
(10,761 |
) |
|
|
(9,314 |
) |
|
|
(20,034 |
) |
|
|
(18,241 |
) |
Research and development |
|
|
(2,436 |
) |
|
|
(3,185 |
) |
|
|
(4,814 |
) |
|
|
(6,651 |
) |
Selling and marketing |
|
|
(213 |
) |
|
|
(221 |
) |
|
|
(407 |
) |
|
|
(461 |
) |
Equity in earnings of Novogyne |
|
|
12,429 |
|
|
|
9,174 |
|
|
|
20,696 |
|
|
|
14,077 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Segment contribution |
|
|
17,047 |
|
|
|
15,293 |
|
|
|
29,246 |
|
|
|
26,878 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Noven Therapeutics: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product revenues |
|
|
6,575 |
|
|
|
|
|
|
|
12,280 |
|
|
|
|
|
Cost of products sold |
|
|
(2,022 |
) |
|
|
|
|
|
|
(4,058 |
) |
|
|
|
|
Research and development |
|
|
(857 |
) |
|
|
|
|
|
|
(1,798 |
) |
|
|
|
|
Selling and marketing |
|
|
(5,123 |
) |
|
|
|
|
|
|
(9,752 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Segment contribution |
|
|
(1,427 |
) |
|
|
|
|
|
|
(3,328 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unallocated income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative |
|
|
(8,906 |
) |
|
|
(5,488 |
) |
|
|
(15,928 |
) |
|
|
(10,669 |
) |
Interest income, net |
|
|
500 |
|
|
|
1,813 |
|
|
|
1,122 |
|
|
|
3,445 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income before income taxes |
|
$ |
7,214 |
|
|
$ |
11,618 |
|
|
$ |
11,112 |
|
|
$ |
19,654 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Segment assets consisted of the following as of June 30, 2008 and December 31, 2007 (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2008 |
|
|
2007 |
|
Noven Transdermals |
|
$ |
113,295 |
|
|
$ |
83,912 |
|
Noven Therapeutics |
|
|
55,848 |
|
|
|
57,893 |
|
Assets not allocated to segments |
|
|
134,454 |
|
|
|
144,893 |
|
|
|
|
|
|
|
|
Total Assets |
|
$ |
303,597 |
|
|
$ |
286,698 |
|
|
|
|
|
|
|
|
16. SUBSEQUENT EVENT NEW CREDIT FACILITY
In July 2008, Noven entered into an agreement for a $15.0 million credit facility. In connection with the
credit facility and in lieu of granting a security interest in Novens assets, Noven granted
a negative pledge in favor of the lender, whereby Noven agreed not to pledge, grant any security
interest in, or allow any lien or encumbrance in or on, certain of Novens financial assets.
As of the date of this report, no borrowings were outstanding under this facility.
22
|
|
|
Item 2. |
|
Managements Discussion and Analysis of Financial Condition and Results of Operations |
The following section addresses material aspects of our consolidated financial condition as of
June 30, 2008, and our consolidated results of operations for the three months ended June 30, 2008
(the 2008 Quarter) and June 30, 2007 (the 2007 Quarter), and the six months ended June 30, 2008
(the 2008 Period) and June 30, 2007 (the 2007 Period). The contents of this section include:
|
|
|
An executive summary of our consolidated results of operations for the 2008 Quarter; |
|
|
|
|
An overview of Noven and our Novogyne joint venture; |
|
|
|
|
An overview of Noven Therapeutics; |
|
|
|
|
A review of certain items that may affect the historical or future comparability of our consolidated results of operations; |
|
|
|
|
An analysis of our consolidated results of operations and our liquidity and capital resources; |
|
|
|
|
An outlook that includes our current financial guidance; |
|
|
|
|
A discussion of how we apply our critical accounting estimates; and |
|
|
|
|
A discussion of recently-issued accounting standards. |
This discussion should be read in conjunction with Novens consolidated financial statements
for the three and six months ended June 30, 2008 and 2007 and the related notes included elsewhere
in this Form 10-Q, as well as the section Managements Discussion and Analysis of Financial
Condition and Results of Operations from our Form 10-K.
Executive Summary
The following Executive Summary is qualified in its entirety by the more detailed discussion
and analysis of our financial condition and results of operations appearing in this Item 2 as well
as in our consolidated financial statements and related notes included in this Form 10-Q.
Our financial results for the 2008 Quarter include the results of operations of Noven
Therapeutics, a specialty pharmaceutical company that we acquired in August 2007. The 2008 Quarter
also included a $1.7 million charge related to reimbursements to Shire in connection with the
voluntary recall of two lots of Daytrana® product initiated in the 2008 Quarter (the
Recall Charge).
Including the impact of the Recall Charge, we reported net income of $4.5 million ($0.18
diluted earnings per share) for the 2008 Quarter, compared to net income of $7.6 million ($0.30
diluted earnings per share) for the 2007 Quarter.
Our net revenues in the 2008 Quarter were $24.6 million, 31% higher than the $18.8 million
reported in the 2007 Quarter. This increase reflects the recognition of $6.6 million in net
revenues associated with Noven Therapeutics sales of Pexeva® and Lithobid®
products and increased license and contract revenues, primarily due to amortization of additional
Daytrana® milestones received in 2007.
Gross margin, as a percentage of net product revenues, was 35% in the 2008 Quarter compared to
38% in the 2007 Quarter. Gross margin in the 2008 Quarter was adversely affected by increased
quality assurance activities and expenses, primarily related to Daytrana® production.
This decrease in gross margin was partially offset by sales of Pexeva® and
Lithobid® in 2008, which have a higher gross margin than the products that we
manufacture and sell to partners.
23
Research and development expenses for the 2008 Quarter were $3.3 million, relatively unchanged
from the $3.2 million reported in the 2007 Quarter. Selling and marketing expenses for the 2008
Quarter increased to $5.3 million from $0.2 million for the 2007 Quarter due to the addition of
Noven Therapeutics. General and
administrative expenses increased $3.4 million, or 62%, due to a $1.7 million charge related to
reimbursements due to Shire in connection with the voluntary recall of two lots of
Daytrana®, an increase in professional fees and the addition of Noven Therapeutics.
We recognized $12.4 million in earnings from Novogyne in the 2008 Quarter, an increase of 35%
compared to the 2007 Quarter. Net revenues at Novogyne increased 21% to $43.8 million in the 2008
Quarter, primarily due to increased sales of Vivelle-Dot®. Novogynes gross margin
percentage for the 2008 Quarter increased slightly to 80%. Novogynes selling, general and
administrative expenses for the 2008 Quarter were $9.8 million, largely unchanged from the 2007
Quarter. Novogynes net income for the 2008 Quarter increased 34% to $25.4 million compared to
$18.9 million in the 2007 Quarter.
At June 30, 2008, Noven had $52.9 million in cash and cash equivalents and other non-current
investments ($35.4 million and $17.5 million, respectively). This compares with $68.4 million in
cash and cash equivalents, short-term investments and other non-current investments ($14.0 million,
$21.6 million and $32.8 million, respectively) at December 31, 2007. Novens investments at June
30, 2008 consisted of auction rate securities with a fair value of $17.5 million, all of which have
been classified as non-current on Novens consolidated balance sheet following failed auctions
occurring since February 2008. Novens auction rate securities are collateralized primarily by
tax-exempt municipal bonds, and to a lesser extent, guaranteed student loans. As of June 30, 2008,
Noven had recorded unrealized losses totaling $0.5 million relating to its investments in auction
rate securities.
Total prescriptions for Vivelle-Dot® increased 6% in the 2008 Quarter compared to
the 2007 Quarter, and total prescriptions for Novogynes products, taken as a whole, increased 2%.
By comparison, the overall U.S. HT market declined 6% for the same period. Total prescriptions for
Daytrana® (launched in June 2006) decreased 11% in the 2008 Quarter compared to the 2007
Quarter, while prescriptions for ADHD stimulant therapies as a class increased 8% over the same
period. Total prescriptions for Pexeva® decreased 6% in the 2008 Quarter compared to
the 2007 Quarter, while for the same period prescriptions for the selective serotonin re-uptake
inhibitor (SSRI) class were largely unchanged. Reflecting ongoing generic substitution, total
prescriptions for Lithobid® decreased 32% in the 2008 Quarter compared to the 2007
Quarter.
In
July 2008, Noven received final FDA approval of
Stavzor (valproic acid delayed
release capsules) in the treatment of manic episodes associated with bipolar disorder, adjunctive
therapy in multiple seizure types (including epilepsy), and prophylaxis of migraine headaches.
Stavzor is expected to be launched by the Noven Therapeutics sales force in August
2008. In addition, sales of Daytrana® by Shire during the 12 months ended June 30, 2008
were sufficient to trigger the third and final $25.0 million sales milestone.
Overview of Noven and our Novogyne Joint Venture
Our transdermal business is focused on developing advanced transdermal patches. We presently
derive the majority of our transdermal revenues from sales of transdermal patches for use in
menopausal HT. In the United States, our HT products are marketed and sold by Novogyne
Pharmaceuticals, the joint venture that we formed with Novartis in 1998. Our business, financial
condition and results of operations are significantly dependent upon Novogyne and its marketing of
our HT products in the United States. A discussion of Novogynes results of operations and their
impact
on our results can be found under the caption Results of OperationsEquity in Earnings of
Novogyne. In all countries other than the United States, Canada and Japan, we have licensed the
marketing rights to these products to Novartis Pharma, which is an affiliate of Novartis.
We hold a 49% equity interest in Novogyne, and Novartis holds the remaining 51% equity
interest. Under the terms of the joint venture agreements, we manufacture and supply our HT
products to Novogyne, perform marketing, sales and promotional activities, and receive royalties
from Novogyne based on Novogynes sales of the estrogen therapy (ET) products. Novartis
distributes Vivelle-Dot® and CombiPatch® and provides certain other services
to Novogyne, including financial and accounting functions.
24
Novartis is entitled to an annual $6.1 million preferred return from Novogyne, which has the
effect of reducing our share of Novogynes income in the first quarter of each year. After the
annual preferred return to Novartis, our share of Novogynes income increases as product sales
increase, subject to a maximum of 49%. Our share of Novogynes income was $12.4 million and $9.2
million for the 2008 Quarter and the 2007 Quarter, respectively. The income we recognize from
Novogyne is a non-cash item. Any cash we receive from Novogyne is in the form of cash
distributions declared by Novogynes Management Committee. Accordingly, the amount of cash that we
receive from Novogyne in any period is typically not the same as the amount of income we recognize
from Novogyne for that period. For the 2008 Period and the 2007 Period, we received $17.2 million
and $11.0 million, respectively, in distributions from Novogyne, which accounted for a substantial
portion of our net operating cash flows for these periods. We expect that for the next several
years a substantial portion of our earnings will be generated through our interest in Novogyne and
a substantial portion of our cash flow will also be generated through our interest in Novogyne.
Any failure by Novogyne to remain profitable or to continue to make distributions would have a
material adverse effect on our consolidated results of operations and financial condition.
Overview of Noven Therapeutics
Noven Therapeutics is a specialty pharmaceutical company that currently markets three branded
prescription psychiatry products (Stavzor, Pexeva® and
Lithobid®) and is advancing developmental products in psychiatry and womens health
including Mesafem, a non-hormonal therapy for the treatment of vasomotor symptoms associated with
menopause. We will seek to leverage Noven Therapeutics marketing and sales infrastructure with
next-generation psychiatry/CNS products, and with complementary products that we will seek to
develop and/or acquire. To bring Noven Therapeutics pipeline of products under development to
market, we plan to increase our research and development expenses significantly over the next
several years. See Managements Discussion and Analysis of Financial Condition and Results of
Operations Outlook.
Certain Items that May Affect Historical or Future Comparability
Set forth below are certain items that may affect the historical or future comparability of
our consolidated results of operations and financial condition. Such disclosure is not intended to
address every item that may affect the historical or future comparability of our consolidated
results of operations or financial condition and such disclosure should be read in conjunction with
the discussion and analysis of our consolidated results of operations, liquidity and capital
resources and outlook appearing elsewhere in this Item 2.
Acquisition of JDS Pharmaceuticals, LLC in 2007
We acquired JDS (now Noven Therapeutics) on August 14, 2007. We accounted for the acquisition
of JDS using the purchase method of accounting. The purchase price exceeded the amounts allocated
to the tangible and intangible assets acquired and liabilities assumed by approximately $14.4
million, which has been recorded as goodwill, all of which is deductible for tax purposes.
25
We acquired $39.1 million in identifiable intangible assets in the JDS acquisition, which
relate to: (i) intellectual property rights associated with Noven Therapeutics products approved
by the FDA; (ii) a favorable lease intangible asset; and (iii) non-competition agreements with two
former executives of JDS. At June 30, 2008, the carrying amount of Novens intangible assets
(excluding goodwill, but including certain patent development costs unrelated to the JDS
acquisition) totaled $37.2 million. Noven estimates that the annual amortization expense for
intangible assets held at June 30, 2008 for each of the five years through 2013 will be as follows
(amounts in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Remainder |
|
|
Years Ending December 31, |
|
|
|
of 2008 |
|
|
2009 |
|
|
2010 |
|
|
2011 |
|
|
2012 |
|
|
2013 |
|
Cost of goods sold: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intellectual property |
|
$ |
2,053 |
|
|
$ |
4,032 |
|
|
$ |
3,985 |
|
|
$ |
3,924 |
|
|
$ |
3,908 |
|
|
$ |
3,847 |
|
General and administrative: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-compete and
favorable
lease agreements |
|
|
231 |
|
|
|
413 |
|
|
|
237 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
2,284 |
|
|
$ |
4,445 |
|
|
$ |
4,222 |
|
|
$ |
3,924 |
|
|
$ |
3,908 |
|
|
$ |
3,847 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
We are required to test our intangible assets with indefinite lives, which currently include
only the goodwill acquired as a result of the JDS acquisition, for impairment on an annual basis or
more frequently if indicators of impairment arise. Goodwill is tested for impairment annually in
the fourth quarter. Although we have not experienced any indicators which would call for an
earlier impairment test, we cannot assure that goodwill will not be impaired when we perform our
annual test in the fourth quarter. We are required to test our intangible assets with finite lives
if events or changes in circumstances indicate that the asset might be impaired. If after testing
the intangible assets and goodwill, we determine that these assets are impaired, then we would be
required to write-down the impaired asset to fair value in the period when the determination is
made. Such a write-down could have a material adverse effect on our results of operations.
Daytrana®
Daytrana® is Novens transdermal methylphenidate system for the treatment of ADHD,
which we have licensed globally to Shire. Noven and Shire have received reports from some
consumers concerning the difficulty of removing the release liner from certain Daytrana®
patches. In the first quarter of 2007, Noven, together with Shire, implemented enhancements to the
Daytrana® release liner. While the enhanced release liner has reduced the level of
consumer reports, some patients and caregivers continue to have difficulty in removing the release
liner from some Daytrana® patches. Noven and Shire continue to monitor and review
release liner complaints and the manufacturing process to determine whether modifications to the
product or process can improve the long-term ease of use and address the issues raised by the FDA
in the warning letter described below. Daytranas® market share based on total
prescriptions declined in the 2008 Quarter.
In July 2007, Noven received from the FDA a list of observations on Form 483 following an
on-site inspection of our manufacturing facilities. The majority of the observations in the Form
483 related to the Daytrana® patch and difficulties experienced by some patients in
removing the release liner, including certain product lots that utilize the enhanced release liner.
In July 2007, Noven submitted to the FDA its response to the Form 483.
In the third quarter of 2007, Shire initiated two voluntary market withdrawals of a portion of
the Daytrana® product on the market primarily in response to feedback from patients and
caregivers who experienced difficulty removing the release liner from some Daytrana®
patches. Noven paid Shire $3.3 million in February 2008 related to the withdrawals. This payment
was charged to operations in 2007.
In January 2008, Noven received a warning letter from the FDA in connection with the FDAs
July 2007 inspection of its manufacturing facilities. In the warning letter, which is posted at
the FDAs website, the FDA cited Current Good Manufacturing Practice deficiencies related to: (i)
peel force specifications for removal of Daytranas release liner; and (ii) data supporting the
peel force characteristics of Daytranas enhanced release liner throughout the products shelf
life. We submitted our response to the warning letter on January 30, 2008. In March 2008, the
Florida District Office of the FDA indicated that our response appears to be satisfactory and
stated that our response had been forwarded to the FDAs Center for Drug Evaluation and Research
for further review. In April 2008, a Noven stability protocol identified certain Daytrana®
lots exhibiting high peel force characteristics. In June 2008, Shire initiated the voluntary
recall of two lots of Daytrana® that did not meet the products release liner removal
specification. We have agreed to pay Shire $1.95 million related to this recall, of which $0.25
million and $1.7 million was charged to operations in the first and second quarters of 2008,
respectively.
26
We believe we have identified the root cause and have identified potential solutions related to
this issue, although it will take time to test the effectiveness of the potential solutions and to determine whether such solutions satisfactorily resolve the issue.
We cannot assure that there will be a satisfactory resolution of the peel force issue.
Failure to adequately address the issues raised by the FDA in the warning letter as well as the
production and other issues involving Daytrana® could result in additional regulatory
action, including fines, recalls of products, injunctions, seizures, suspension of production or
withdrawal of the approval of products. Any such regulatory action would be expected to have a
material adverse effect on us, including the potential for litigation related to this matter, harm
to our reputation and various costs associated with the foregoing.
Results of Operations
Our business is comprised of two reportable segments distinguished along product categories:
(i) Noven Transdermals, which currently engages in the research, development, manufacturing and
licensing to partners of transdermal drug delivery technologies and prescription transdermal
products, including product sales to Shire, Novartis Pharma and Novogyne as well as our equity in
earnings of Novogyne; and (ii) Noven Therapeutics, which currently engages in the development,
marketing, sales and distribution of pharmaceutical products.
We evaluate segment performance based on segment contribution, which consists of segment gross
margin less direct research and development expenses and direct selling and marketing expenses,
plus (in the case of Noven Transdermals) our equity in earnings of Novogyne. Shared corporate
general and administrative expenses and interest income are not allocated to our operating
segments. The contribution of our Noven Transdermals segment includes $12.4 million and $20.7
million of equity in earnings of Novogyne recognized in the 2008 Quarter and Period, respectively.
We acquired the Noven Therapeutics business on August 14, 2007. Consequently, the results of the
Noven Therapeutics segment are not included in the 2007 Quarter or Period. The negative
contribution of our Noven Therapeutics segment in the 2008 Quarter and Period reflects the impact
of $5.1 million and $9.8 million, respectively, in selling and marketing expenses in support of
Noven Therapeutics currently marketed products, including approximately $0.9 million in the 2008
Period of expenses in connection with the Stavzor launch.
27
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months |
|
|
Six Months |
|
|
|
Ended June 30, |
|
|
Ended June 30, |
|
|
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
(in thousands): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Noven Transdermals: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product revenues |
|
$ |
12,968 |
|
|
$ |
15,062 |
|
|
$ |
23,459 |
|
|
$ |
30,668 |
|
License and contract revenues |
|
|
5,060 |
|
|
|
3,777 |
|
|
|
10,346 |
|
|
|
7,486 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues |
|
|
18,028 |
|
|
|
18,839 |
|
|
|
33,805 |
|
|
|
38,154 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of products sold |
|
|
(10,761 |
) |
|
|
(9,314 |
) |
|
|
(20,034 |
) |
|
|
(18,241 |
) |
Research and development |
|
|
(2,436 |
) |
|
|
(3,185 |
) |
|
|
(4,814 |
) |
|
|
(6,651 |
) |
Selling and marketing |
|
|
(213 |
) |
|
|
(221 |
) |
|
|
(407 |
) |
|
|
(461 |
) |
Equity in earnings of Novogyne |
|
|
12,429 |
|
|
|
9,174 |
|
|
|
20,696 |
|
|
|
14,077 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Segment contribution |
|
|
17,047 |
|
|
|
15,293 |
|
|
|
29,246 |
|
|
|
26,878 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Noven Therapeutics: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product revenues |
|
|
6,575 |
|
|
|
|
|
|
|
12,280 |
|
|
|
|
|
Cost of products sold |
|
|
(2,022 |
) |
|
|
|
|
|
|
(4,058 |
) |
|
|
|
|
Research and development |
|
|
(857 |
) |
|
|
|
|
|
|
(1,798 |
) |
|
|
|
|
Selling and marketing |
|
|
(5,123 |
) |
|
|
|
|
|
|
(9,752 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Segment contribution |
|
|
(1,427 |
) |
|
|
|
|
|
|
(3,328 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unallocated income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative |
|
|
(8,906 |
) |
|
|
(5,488 |
) |
|
|
(15,928 |
) |
|
|
(10,669 |
) |
Interest income, net |
|
|
500 |
|
|
|
1,813 |
|
|
|
1,122 |
|
|
|
3,445 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income before income taxes |
|
$ |
7,214 |
|
|
$ |
11,618 |
|
|
$ |
11,112 |
|
|
$ |
19,654 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
28
Three and Six months ended June 30, 2008 compared to the Three and Six months ended June 30, 2007
Revenues
Total revenues for the three and six months ended June 30, 2008 and 2007 are summarized as
follows (dollar amounts in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months |
|
|
|
|
|
|
Six Months |
|
|
|
|
|
|
Ended June 30, |
|
|
|
|
|
|
Ended June 30, |
|
|
|
|
|
|
2008 |
|
|
2007 |
|
|
% Change |
|
|
2008 |
|
|
2007 |
|
|
% Change |
|
Noven Transdermals |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Novogyne: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales |
|
$ |
5,553 |
|
|
$ |
4,804 |
|
|
|
16 |
% |
|
$ |
7,984 |
|
|
$ |
10,173 |
|
|
|
-22 |
% |
Royalties |
|
|
2,349 |
|
|
|
1,899 |
|
|
|
24 |
% |
|
|
4,529 |
|
|
|
3,664 |
|
|
|
24 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product revenues Novogyne |
|
|
7,902 |
|
|
|
6,703 |
|
|
|
18 |
% |
|
|
12,513 |
|
|
|
13,837 |
|
|
|
-10 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Third Parties: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales |
|
|
4,978 |
|
|
|
8,271 |
|
|
|
-40 |
% |
|
|
10,779 |
|
|
|
16,684 |
|
|
|
-35 |
% |
Royalties |
|
|
88 |
|
|
|
88 |
|
|
|
0 |
% |
|
|
167 |
|
|
|
147 |
|
|
|
14 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product revenues third
parties |
|
|
5,066 |
|
|
|
8,359 |
|
|
|
-39 |
% |
|
|
10,946 |
|
|
|
16,831 |
|
|
|
-35 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total product revenues |
|
|
12,968 |
|
|
|
15,062 |
|
|
|
-14 |
% |
|
|
23,459 |
|
|
|
30,668 |
|
|
|
-24 |
% |
License and contract revenues |
|
|
5,060 |
|
|
|
3,777 |
|
|
|
34 |
% |
|
|
10,346 |
|
|
|
7,486 |
|
|
|
38 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Transdermals |
|
|
18,028 |
|
|
|
18,839 |
|
|
|
-4 |
% |
|
|
33,805 |
|
|
|
38,154 |
|
|
|
-11 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Noven Therapeutics |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Third Parties: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales |
|
|
6,575 |
|
|
|
|
|
|
|
N/A |
|
|
|
12,280 |
|
|
|
|
|
|
|
N/A |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Revenues |
|
$ |
24,603 |
|
|
$ |
18,839 |
|
|
|
31 |
% |
|
$ |
46,085 |
|
|
$ |
38,154 |
|
|
|
21 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Revenues
As described in more detail below, our net revenues in the 2008 Quarter were $24.6 million, an
increase of 31% compared to $18.8 million reported in the 2007 Quarter. This increase reflects the
addition of $6.6 million in net revenues associated with our sales of Pexeva® and
Lithobid®
products through Noven Therapeutics, which was acquired in August 2007. We also realized a
$1.3 million, or 34%, increase in license and contract revenues compared to the 2007 Quarter. In
addition, the 2008 Quarter benefited from the fulfillment of backorders that resulted from
production issues related to our Noven Transdermals segment in the prior quarter. These increases
were partially offset by a $2.5 million decrease in Daytrana® sales in the 2008 Quarter.
As described in more detail below, our net revenues in the 2008 Period were $46.1 million, an
increase of 21% compared to $38.2 million reported in the 2007 Period. This increase reflects the
addition of $12.3 million in net revenues associated with our sales of Pexeva® and
Lithobid® products through Noven Therapeutics. We also realized a $2.9 million, or 38%,
increase in license and contract revenues compared to the 2007 Period. These increases were offset
by a $7.2 million decrease in product revenues from our Noven Transdermals segment comprised of a
$4.0 million decrease in sales of Daytrana and a $3.2 million decrease in the sale of HT products
in the 2008 Period.
Product Revenues Novogyne
Product revenues Novogyne consists of our sales of
Vivelle-Dot®/Estradot® and CombiPatch® to Novogyne at a fixed
price for resale and product sampling by Novogyne primarily in the United States as well as the
royalties we receive as a result of Novogynes sales of Vivelle-Dot®.
29
The $1.2 million increase in Novogyne product revenues for the 2008 Quarter primarily resulted
from the timing of orders from Novogyne. By product, Vivelle-Dot® increased $0.4
million, Combipatch® increased $0.5 million, and royalties increased $0.4 million due to
increased sales by Novogyne to its customers for the 2008 Quarter.
The $1.3 million decrease in Novogyne product revenues for the 2008 Period primarily resulted
from a $2.7 million decline of Vivelle-Dot® product revenues, partially offset by a $0.6
million increase in unit sales of CombiPatch® due to the timing of orders from Novogyne,
as well as an increase of $0.9 million in royalties due to increased sales by Novogyne to their
customers for the 2008 Period. The decline in Vivelle-Dot® product revenues is
attributable to the timing of orders and shipments primarily as a result of order backlogs
originating in the first quarter of 2008. During the first quarter of 2008, production issues
(discussed further below under Gross Margin) primarily related to an equipment failure in
transdermal manufacturing resulted in write-offs of inventory representing approximately $1.6
million of potential first quarter revenue, creating a backlog of unfilled orders as of the end of
the first quarter. As a result of the backlog, Novogyne adjusted orders to ensure that the supply
of product to end users would not be interrupted and Novens revenues were approximately $2.6
million lower than expected for the 2008 Period. We expect to fill the remaining orders during the
remainder of 2008. Our expectations for aggregate HT product revenues in future periods are
addressed under Outlook below.
Product Revenues Third Parties
Product revenues third parties consist of: (i) sales of Estradot®,
Estalis® and Menorest hormone therapy patches to Novartis Pharma at a price based on a
percentage of Novartis Pharmas net selling price (subject to certain minima) for resale primarily
outside the United States and Japan, together with royalties generated from Novartis Pharmas sales
of Estradot® in Canada; (ii) sales of Daytrana® to Shire for commercial
resale in the United States; and (iii) beginning on August 14, 2007, Novens commercial sales of
Pexeva® and Lithobid® to trade customers, including wholesalers, distributors
and chain pharmacies.
The $3.3 million decrease in product revenues third parties in our Noven Transdermals
segment for the 2008 Quarter compared to the 2007 Quarter consisted of a $2.5 million decline in
sales of Daytrana®, a $0.6 million decline in sales of Estradot® and a $0.3
million decline related to pricing. The decline in Daytrana® sales was primarily due to
the timing of orders and delays in the release of product due to additional quality control
procedures that were implemented in 2008. The decline in Estradot® sales relates to a
timing of orders from Novartis Pharma. With respect to pricing, we recognize the benefit from price
increases for our third party HT product through periodic price reconciliation payments received
from Novartis Pharma. We receive such payments from time to time upon Novartis Pharmas
determination that its actual sales price of our product entitles us to receive amounts in excess
of the minimum transfer price at which we initially sold the product to Novartis Pharma. We
recognized $0.3 million of such payments in the 2007 Quarter. There were no such payments in the
2008 Quarter.
The $5.9 million decrease in product revenues third parties in our Noven Transdermals
segment for the 2008 Period compared to the 2007 Period consisted of a $4.0 million decline in unit
sales of Daytrana®, a $1.5 million decline in third-party revenues from our HT products
and a $0.4 million decline due to pricing. The decrease in Daytrana® product revenues
was largely attributable to delays in the release of product at the end of the 2008 Quarter, the
timing of orders and, to a lesser extent, decreased demand. The decline in third-party HT
product revenues is attributable to the timing of orders and shipments primarily as a result
of order backlogs originating in the first quarter of 2008. In addition, Noven realized a lower
benefit from price increases for our third party HT product through periodic price reconciliation
payments received from Novartis as discussed above. We recognized $1.2 million and $1.6 million of
such payments in the 2008 Period and 2007 Period, respectively.
Noven Therapeutics, which was acquired in August 2007, generated $6.6 million and $12.3
million of net revenues in the 2008 Quarter and 2008 Period, respectively, from sales of
Pexeva® and Lithobid®.
30
License and Contract Revenues
License revenues consist of the recognition of non-refundable up-front, milestone
and similar payments under license agreements. Contract revenues consist of the recognition of
payments received as work is performed on research and development projects. The payments received
may take the form of non-refundable up-front payments, payments received upon the completion of
certain phases of development work and success milestone payments.
License and contract revenues increased $1.3 million for the 2008 Quarter compared to the 2007
Quarter, primarily attributable to an increase in license revenues due to an increase in
amortization of milestone payments received from Shire related to the license of
Daytrana®.
License and contract revenues increased $2.9 million for the 2008 Period compared to the 2007
Period, attributable to a $2.1 million increase in license revenues primarily due to an increase in
amortization of milestone payments received from Shire related to the license of
Daytrana®. In addition, contract revenues increased $0.8 million due to $0.5 million in
additional work performed on developmental products and a $0.3 million reversal in the 2007 Period
of contract revenues resulting from a change in the estimate of the amount of work to be completed
on a contract.
Gross to Net Revenues
We record revenues net of sales allowances for rebates, chargebacks, cash and other discounts,
as well as sales returns allowances. Sales returns allowances for the Noven Transdermals segment
consist of changes in allowances for returns for product recalls and/or products voluntarily
withdrawn from the market, and, for the Noven Therapeutics segment, consist of changes in
allowances for returns. The following table sets forth the reconciliation of our gross revenues to
net revenues for the three and six months ended June 30, 2008 and 2007, respectively (dollar
amounts in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
|
|
|
|
|
% of |
|
|
|
|
|
|
% of |
|
|
|
|
|
|
% of |
|
|
|
|
|
|
% of |
|
|
|
|
|
|
|
gross |
|
|
|
|
|
|
gross |
|
|
|
|
|
|
gross |
|
|
|
|
|
|
gross |
|
|
|
2008 |
|
|
revenues |
|
|
2007 |
|
|
revenues |
|
|
2008 |
|
|
revenues |
|
|
2007 |
|
|
revenues |
|
Noven Transdermals: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross revenues |
|
$ |
18,386 |
|
|
|
100 |
% |
|
$ |
18,898 |
|
|
|
100 |
% |
|
$ |
34,399 |
|
|
|
100 |
% |
|
$ |
38,213 |
|
|
|
100 |
% |
Sales returns allowances |
|
|
358 |
|
|
|
2 |
% |
|
|
59 |
|
|
|
0 |
% |
|
|
594 |
|
|
|
2 |
% |
|
|
59 |
|
|
|
0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues |
|
$ |
18,028 |
|
|
|
98 |
% |
|
$ |
18,839 |
|
|
|
100 |
% |
|
$ |
33,805 |
|
|
|
98 |
% |
|
$ |
38,154 |
|
|
|
100 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Noven Therapeutics: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross revenues |
|
$ |
10,133 |
|
|
|
100 |
% |
|
|
|
|
|
|
|
|
|
$ |
19,641 |
|
|
|
100 |
% |
|
|
|
|
|
|
|
|
Cash discounts |
|
|
193 |
|
|
|
2 |
% |
|
|
|
|
|
|
|
|
|
|
385 |
|
|
|
2 |
% |
|
|
|
|
|
|
|
|
Medicaid, Medicare & State
program rebates and
credits including
redemption offers |
|
|
1,289 |
|
|
|
13 |
% |
|
|
|
|
|
|
|
|
|
|
3,578 |
|
|
|
18 |
% |
|
|
|
|
|
|
|
|
Chargebacks |
|
|
365 |
|
|
|
4 |
% |
|
|
|
|
|
|
|
|
|
|
632 |
|
|
|
3 |
% |
|
|
|
|
|
|
|
|
Wholesaler fees |
|
|
608 |
|
|
|
6 |
% |
|
|
|
|
|
|
|
|
|
|
1,202 |
|
|
|
6 |
% |
|
|
|
|
|
|
|
|
Sales returns |
|
|
1,103 |
|
|
|
11 |
% |
|
|
|
|
|
|
|
|
|
|
1,564 |
|
|
|
8 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales and returns allowances |
|
|
3,558 |
|
|
|
35 |
% |
|
|
|
|
|
|
|
|
|
|
7,361 |
|
|
|
37 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues |
|
$ |
6,575 |
|
|
|
65 |
% |
|
|
|
|
|
|
|
|
|
$ |
12,280 |
|
|
|
63 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
31
Gross Margin:
This section discusses gross margins relating to our product revenues: (i) across all of our
products (Overall Gross Margin); (ii) on our transdermal product revenues from Novogyne (Gross
Margin Novogyne), which for accounting purposes is considered a related party; (iii) on our
transdermal product revenues from third parties (Gross Margin Third Parties); and (iv) on our
Noven Therapeutics products. Product revenues from third parties include HT product sales to
Novartis Pharma for resale primarily outside the United States and Japan, as well as
Daytrana® product sales to Shire. Noven Therapeutics product revenues include sales of
Pexeva® and Lithobid® to trade customers for the 2008 Quarter and Period.
For our Noven Transdermals segment, the allocation of manufacturing expenses impacts our
determination of inventory costs and, consequently, gross margins for each of our products.
Manufacturing expenses, which totaled $8.6 million and $16.5 million in the 2008 Quarter and the
2008 Period, respectively, include compensation and benefits, supplies and tools, equipment costs,
depreciation and amortization, and insurance costs and represent a substantial portion of our
inventory production costs. Manufacturing expenses for the 2007 Quarter and the 2007 Period were
$6.5 million and $13.1 million, respectively. The allocation of manufacturing expenses among
manufactured products requires us to make significant estimates that involve subjective and often
complex judgments. Using different estimates would likely result in materially different results
for Gross Margin Novogyne and Gross Margin Third Parties than are presented in the gross
margin table below.
Our gross margins are summarized as follows (dollar amounts in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
Noven Transdermals |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Novogyne: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product revenues |
|
$ |
7,902 |
|
|
|
|
|
|
$ |
6,703 |
|
|
|
|
|
|
$ |
12,513 |
|
|
|
|
|
|
$ |
13,837 |
|
|
|
|
|
Cost of products sold |
|
|
3,463 |
|
|
|
|
|
|
|
3,285 |
|
|
|
|
|
|
|
6,789 |
|
|
|
|
|
|
|
6,244 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
4,439 |
|
|
|
56 |
% |
|
|
3,418 |
|
|
|
51 |
% |
|
|
5,724 |
|
|
|
46 |
% |
|
|
7,593 |
|
|
|
55 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Third parties: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product revenues |
|
|
5,066 |
|
|
|
|
|
|
|
8,359 |
|
|
|
|
|
|
|
10,946 |
|
|
|
|
|
|
|
16,831 |
|
|
|
|
|
Cost of products sold |
|
|
7,298 |
|
|
|
|
|
|
|
6,029 |
|
|
|
|
|
|
|
13,245 |
|
|
|
|
|
|
|
11,997 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit (loss) |
|
|
(2,232 |
) |
|
|
-44 |
% |
|
|
2,330 |
|
|
|
28 |
% |
|
|
(2,299 |
) |
|
|
-21 |
% |
|
|
4,834 |
|
|
|
29 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Noven Transdermals: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product revenues |
|
|
12,968 |
|
|
|
|
|
|
|
15,062 |
|
|
|
|
|
|
|
23,459 |
|
|
|
|
|
|
|
30,668 |
|
|
|
|
|
Cost of products sold |
|
|
10,761 |
|
|
|
|
|
|
|
9,314 |
|
|
|
|
|
|
|
20,034 |
|
|
|
|
|
|
|
18,241 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
2,207 |
|
|
|
17 |
% |
|
|
5,748 |
|
|
|
38 |
% |
|
|
3,425 |
|
|
|
15 |
% |
|
|
12,427 |
|
|
|
41 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Noven Therapeutics |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product revenues |
|
|
6,575 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
12,280 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of products sold |
|
|
2,022 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,058 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
4,553 |
|
|
|
69 |
% |
|
|
|
|
|
|
|
|
|
|
8,222 |
|
|
|
67 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Company |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product revenues |
|
|
19,543 |
|
|
|
|
|
|
|
15,062 |
|
|
|
|
|
|
|
35,739 |
|
|
|
|
|
|
|
30,668 |
|
|
|
|
|
Cost of products sold |
|
|
12,783 |
|
|
|
|
|
|
|
9,314 |
|
|
|
|
|
|
|
24,092 |
|
|
|
|
|
|
|
18,241 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
$ |
6,760 |
|
|
|
35 |
% |
|
$ |
5,748 |
|
|
|
38 |
% |
|
$ |
11,647 |
|
|
|
33 |
% |
|
$ |
12,427 |
|
|
|
41 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
32
In general, Noven Therapeutics products have higher gross margins than our transdermal
products because we sell these products directly to trade customers at wholesale and commercial
prices. Our sales of HT products to Novogyne for resale in the United States have a higher gross
margin than our other transdermal products, reflecting favorable pricing, larger production orders
and other factors. Our sales of HT products to Novartis Pharma for resale in international markets
generally have lower gross margins than sales of HT products sold to Novogyne due to, among other
things, unfavorable pricing environments in foreign markets, and smaller production orders. Our
gross margin on product sales of Daytrana® to Shire has been negatively affected by the
factors described below.
As noted in the tables above, Overall Gross Margin declined in the 2008 Quarter compared to
the 2007 Quarter. Overall Gross Margin in the 2008 Quarter was negatively affected by: (i) the
addition of $2.1 million in manufacturing costs over the 2007 Quarter, primarily in the quality
area, of which, $1.0 million related to costs associated with the Daytrana® peel force
issue; and (ii) inventory write-offs of $0.8 million due to Daytrana® product exhibiting
high peel force characteristics. Overall Gross Margin in the 2008 Quarter benefited from the
addition of our Pexeva® and Lithobid® products, which had net sales of $6.6
million and related cost of products sold of $2.0 million, resulting in a gross margin of 69% for
those products.
As noted in the tables above, Overall Gross Margin declined in the 2008 Period compared to the
2007 Period. Overall Gross Margin in the 2008 Period was negatively affected by: (i) inventory
write-offs of $2.8 million, primarily related to an equipment failure in transdermal manufacturing
(comprised of $1.8 million of Novogyne product write-offs and $1.0 million of third party HT
product write-offs), as well as additional manufacturing costs incurred in the 2008 Quarter to
address this issue; (ii) inventory write-offs of approximately $0.8 million due to
Daytrana® product exhibiting high peel force characteristics; (iii) the addition of
approximately $3.4 million in manufacturing costs over the 2007 Period, primarily in the quality
assurance area, of which, approximately $1.2 million related to costs associated with the
Daytrana® peel force issue; and (iv) significantly lower product revenues in our Noven
Transdermals segment, primarily related to the timing of shipments, delays in the release of
Daytrana® product at the end of the 2008 Quarter and the production issues for our HT
product. Overall Gross Margin in the 2008 Period benefited from the addition of our
Pexeva® and Lithobid® products, which had net sales of $12.3 million and
related cost of products sold of $4.1 million, resulting in a gross margin of 67% for those
products and a decrease product inventory at Novogyne which resulted in approximately $0.7 million
of recognized deferred profit on product sold to Novogyne.
We sell Daytrana® finished product to Shire at a fixed cost, so our profit on
product sales of Daytrana® depends on our ability to manufacture the product efficiently
and to fully utilize our facilities. For the 2008 Quarter, Daytrana® product revenues
were $2.7 million and cost of products sold related to Daytrana® was $5.2 million,
resulting in negative gross margin for the product. This compares with a gross profit of $1.3
million and gross margin of 25% for the 2007 Quarter. For the 2008 Period, Daytrana®
product revenues were $5.7 million and cost of products sold related to Daytrana®
was $8.5 million, resulting in negative gross margin for the product. This compares with a
gross profit of $2.1 million and gross margin of 22% for the 2007 Period. Daytrana®
gross margin was negatively affected in the 2008 Quarter and the 2008 Period by increased
manufacturing and quality assurance related expenditures, including, as discussed above,
approximately $1.2 million related to costs associated with the Daytrana® peel force
issue.
For the remainder of 2008, we expect to continue to incur increased quality assurance costs
related to our continued efforts to improve our quality assurance systems and to address the issues
raised by the FDA in the July 2007 Form 483 and January 2008 warning letter, and a significant
portion of these continuing costs will be allocated to Daytrana®, which will negatively
affect the gross margin on sales of this product in the remainder of 2008 and beyond.
Our expectations for gross margins in future periods are addressed under Outlook below.
33
Operating Expenses
Operating expenses for the three and six months ended June 30, 2008 and 2007 are summarized as
follows (dollar amounts in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months |
|
|
Six Months |
|
|
|
Ended June 30, |
|
|
Ended June 30, |
|
|
|
2008 |
|
|
2007 |
|
|
% Change |
|
|
2008 |
|
|
2007 |
|
|
% Change |
|
Research and
development |
|
$ |
3,293 |
|
|
$ |
3,185 |
|
|
|
3 |
% |
|
$ |
6,612 |
|
|
$ |
6,651 |
|
|
|
-1 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling and marketing |
|
|
5,336 |
|
|
|
221 |
|
|
|
N/M |
|
|
|
10,159 |
|
|
|
461 |
|
|
|
N/M |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and
administrative |
|
|
8,906 |
|
|
|
5,488 |
|
|
|
62 |
% |
|
|
15,928 |
|
|
|
10,669 |
|
|
|
49 |
% |
N/M Not Meaningful
Research and Development
Research and development expenses include costs associated with, among other things, product
formulation, pre-clinical testing, clinical studies, regulatory and medical affairs, production for
clinical and regulatory purposes, production related development engineering for developmental
products, and the personnel associated with each of these functions. The $0.1 million increase in
research and development expenses for the 2008 Quarter, compared to the 2007 Quarter, was primarily
attributable to the $0.8 million addition of Noven Therapeutics expenses which were partially
offset by a $0.7 million decrease in pre-clinical testing and clinical research costs in our Noven
Transdermals segment. Research and development expenses for the 2008 Period, compared to the 2007
Period, were relatively unchanged as the $1.8 million decrease in pre-clinical testing and clinical
research costs in our Noven Transdermals segment were offset by the addition of $1.8 million in
Noven Therapeutics expenses, primarily related to regulatory and medical affairs expenses.
Selling and Marketing
The $5.1 million and $9.7 million increases in selling and marketing costs for the 2008
Quarter and 2008 Period, compared to the 2007 Quarter and 2007 Period, respectively, were
attributable to the addition of Noven Therapeutics in August 2007.
General and Administrative
General and administrative expenses increased $3.4 million, or 62%, for the 2008 Quarter,
compared to the 2007 Quarter. The increase was primarily due to a $1.7 million charge related to
reimbursements owed to Shire in connection with the voluntary recall of two lots of
Daytrana®, a $0.7 million increase in salary and related benefits, including stock-based
compensation, and a $0.4 million increase in professional fees, mostly attributable to recruiting
fees, as well as a $0.6 million increase in other general and administrative expenses, primarily as
a result of the addition of Noven Therapeutics.
General and administrative expenses increased $5.3 million, or 49%, for the 2008 Period,
compared to the 2007 Period. The increase was primarily attributable to a $1.7 million charge
related to reimbursements owed to Shire in connection with the voluntary recall of two lots of
Daytrana®, a $1.6 million increase in professional fees, mostly attributable to
accounting, auditing and recruiting fees, a $0.3 million increase in salary and related benefits, a
$0.2 million increase in information management services and supplies, as well as a $1.3 million
increase in other general and administrative expenses areas, primarily as a result of the addition
of Noven Therapeutics.
34
Other Income and Expenses
Interest Income
Interest income decreased $1.3 million and $2.3 million for the 2008 Quarter and the 2008
Period, compared to the 2007 Quarter and the 2007 Period, respectively. This decrease was
primarily attributable to a decrease in cash available for investment as a result of the payment of
$130.4 million in connection with the JDS acquisition in August 2007, as well as additional sales
of auction rate securities at par during 2008 and lower interest rates on our remaining
investments.
Income Taxes
Our effective tax rate was approximately 36% for both the 2008 Period and the 2007 Period.
The provision for income taxes is based on the Federal statutory and state income tax rates. Net
deferred income tax assets are measured using the average graduated tax rate for the estimated
amount of annual taxable income in the years that the liability is expected to be settled or the
asset recovered. The effect of adjusting the expected tax rate related
to the net deferred income tax assets is included in the provision for income taxes. The
acquisition of JDS resulted in a significant increase in our deferred income tax assets, primarily
due to the fact that the $100.2 million expense recognized in 2007 relating to in-process research
and development is not immediately deductible for tax purposes. As of June 30, 2008 we had a net
deferred tax asset of $72.6 million compared to $65.7 million at December 31, 2007. Realization of
this deferred tax asset depends upon the generation of sufficient future taxable income. A
valuation allowance is established if it is more likely than not that all or a portion of the
deferred tax asset will not be realized. Noven Therapeutics files separate state income tax
returns in states where it has determined that it is required to file state income taxes. As a
result, state deferred tax assets relating to Noven Therapeutics are evaluated separately in
determining whether the state deferred tax assets are realizable. We expect that Noven
Therapeutics will incur taxable losses in the next few years due to expected clinical trial
expenditures related to product development. These expected taxable losses create negative
evidence indicating the need for a valuation allowance at June 30, 2008. Our valuation allowance
for state deferred tax assets was $3.3 million and $3.2 million as of June 30, 2008 and December
31, 2007, respectively, due to uncertainties in realizing these state deferred tax assets based on
our projection of future state taxable income. If we determine, based on future profitability of
Noven Therapeutics that these state deferred tax assets will more likely than not be realized, a
release of all, or part, of the related valuation allowance could result in an immediate income tax
benefit in the period the valuation allowance is released.
Equity in Earnings of Novogyne
We share in the earnings of Novogyne according to an established formula after satisfaction of
an annual preferred return of $6.1 million to Novartis. Our share of Novogynes earnings (a
non-cash item) increases as Novogynes product sales increase, subject to a cap of 49%. Novogyne
earned sufficient income in each of the first quarters of 2008 and 2007 to meet Novartis annual
preferred return for those periods and for us to recognize earnings from Novogyne under the
formula. We report our share of Novogynes earnings as Equity in earnings of Novogyne in our
unaudited consolidated statements of operations.
35
Novogyne records revenues net of sales allowances for rebates, chargebacks, cash and other
discounts and sales returns allowances. The financial results of Novogyne for the three and six
months ended June 30, 2008 and 2007 are summarized as follows (dollar amounts in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
|
2008 |
|
|
2007 |
|
|
% Change |
|
|
2008 |
|
|
2007 |
|
|
% Change |
|
Gross revenues |
|
$ |
50,054 |
|
|
$ |
42,915 |
|
|
|
17 |
% |
|
$ |
95,348 |
|
|
$ |
80,208 |
|
|
|
19 |
% |
Sales allowances |
|
|
5,702 |
|
|
|
6,837 |
|
|
|
-17 |
% |
|
|
11,555 |
|
|
|
10,999 |
|
|
|
5 |
% |
Sales returns allowances |
|
|
585 |
|
|
|
(60 |
) |
|
|
N/M |
|
|
|
500 |
|
|
|
(9 |
) |
|
|
N/M |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales and returns allowances |
|
|
6,287 |
|
|
|
6,777 |
|
|
|
-7 |
% |
|
|
12,055 |
|
|
|
10,990 |
|
|
|
10 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues |
|
|
43,767 |
|
|
|
36,138 |
|
|
|
21 |
% |
|
|
83,293 |
|
|
|
69,218 |
|
|
|
20 |
% |
Cost of sales |
|
|
8,788 |
|
|
|
7,795 |
|
|
|
13 |
% |
|
|
16,596 |
|
|
|
14,842 |
|
|
|
12 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
34,979 |
|
|
|
28,343 |
|
|
|
23 |
% |
|
|
66,697 |
|
|
|
54,376 |
|
|
|
23 |
% |
Gross margin percentage |
|
|
80 |
% |
|
|
78 |
% |
|
|
|
|
|
|
80 |
% |
|
|
79 |
% |
|
|
|
|
Selling, general and
administrative expenses |
|
|
9,798 |
|
|
|
9,579 |
|
|
|
2 |
% |
|
|
18,810 |
|
|
|
19,712 |
|
|
|
-5 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income from operations |
|
|
25,181 |
|
|
|
18,764 |
|
|
|
34 |
% |
|
|
47,887 |
|
|
|
34,664 |
|
|
|
38 |
% |
Interest income |
|
|
174 |
|
|
|
165 |
|
|
|
5 |
% |
|
|
441 |
|
|
|
497 |
|
|
|
-11 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
25,355 |
|
|
$ |
18,929 |
|
|
|
34 |
% |
|
$ |
48,328 |
|
|
$ |
35,161 |
|
|
|
37 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Novens equity in earnings of Novogyne |
|
$ |
12,429 |
|
|
$ |
9,174 |
|
|
|
35 |
% |
|
$ |
20,696 |
|
|
$ |
14,077 |
|
|
|
47 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
N/M Not Meaningful
Novogyne Net Revenues
Novogyne sells its products to trade customers, including wholesalers, distributors and chain
pharmacies. As has historically been the case, the timing of purchases by trade customers is
driven by the inventory needs of each customer and other factors, and does not necessarily track
underlying prescription trends in any given period or coincide with Novogynes quarterly financial
reporting periods. As a result, the timing of orders by trade customers is difficult to predict
and can lead to significant variability in Novogynes quarterly results.
Novogynes gross revenues increased $7.1 million for the 2008 Quarter compared to the 2007
Quarter. By product, Vivelle-Dot® and CombiPatch® increased $8.0 million and
$0.6 million, respectively, while Vivelle® (a discontinued product) decreased $1.5
million. The $8.0 million Vivelle-Dot® increase consisted of a $4.4 million increase
related to pricing and a $3.6 million increase in unit sales which is consistent with increases in
prescription trends. The $0.6 million CombiPatch® increase was primarily attributable
to a $0.4 million increase related to pricing.
Novogynes gross revenues increased $15.1 million for the 2008 Period compared to the 2007
Period. By product, Vivelle-Dot® and CombiPatch® increased $17.3 million and
$0.7 million, respectively, while Vivelle® (a discontinued product) decreased $2.9
million. The $17.3 million Vivelle-Dot® increase consisted of a $10.8 million increase
related to pricing and a $6.5 million increase in unit sales which is consistent with increases in
prescription trends. The $0.7 million CombiPatch® increase was attributable to a $0.9
million increase related to pricing, partially offset by a $0.2 million decline in unit sales which
resulted from a continued decline in the market for combination therapies, and the impact of a
competitive product.
Sales allowances consist of chargebacks, Medicaid rebates, managed healthcare rebates, cash
discounts and other allowances, which tend to fluctuate based on changes in gross revenues. These
sales allowances were 11% and 16% of gross revenues for the 2008 Quarter and the 2007 Quarter,
respectively. For the 2008 Period and the 2007 Period, these sales allowances were 12% and 14% of
gross revenues, respectively. The decrease in sales allowances as a percentage of gross revenues
for the 2008 Quarter and 2008 Period compared to the corresponding 2007 periods was attributable to decreases in estimated
managed healthcare rebate payments.
36
Sales returns allowances consist of allowances for returns of expiring product. The activity
in the sales returns allowances for the three and six months ended June 30, 2008 and 2007 was as
follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
Sales returns allowances included in net revenues |
|
$ |
585 |
|
|
$ |
(60 |
) |
|
$ |
500 |
|
|
$ |
(9 |
) |
Actual returns primarily for expiring product |
|
|
(889 |
) |
|
|
(645 |
) |
|
|
(1,499 |
) |
|
|
(1,474 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in allowances for returns primarily for expiring product |
|
$ |
(304 |
) |
|
$ |
(705 |
) |
|
$ |
(999 |
) |
|
$ |
(1,483 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
The increase in sales returns allowances for the three and six months ended June 30, 2008 is
attributable to the prior periods benefiting from reductions in allowances for returns of expiring
product due to lower than expected returns of Vivelle-Dot® and CombiPatch® in
the prior periods.
Novogyne Gross Margin
The 2% and 1% gross margin increase for the 2008 Quarter and 2008 Period compared to the 2007
Quarter and the 2007 Period, respectively, was primarily related to higher sales of
Vivelle-Dot®, which has a higher gross margin than the other products sold by Novogyne,
as well as price increases for all products and lower sales deductions as a percentage of revenues.
Novogyne Selling, General and Administrative Expenses
Novogynes selling, general and administrative expenses increased $0.2 million for the 2008
Quarter compared to the 2007 Quarter, primarily due to a $0.4 million increase in sales force and
marketing and advertising expenses and a $0.2 million increase in litigation expenses which were
partially offset by a $0.4 million decrease in sample expenses due to the timing of shipments by
Noven to Novogyne. Novogynes policy is to immediately expense samples when shipped from Noven.
Novogynes selling, general and administrative expenses decreased $0.9 million for the 2008
Period compared to the 2007 Period, primarily due to a $1.3 million decrease in sample expenses due
to the timing of shipments by Noven to Novogyne as discussed above.
37
Liquidity and Capital Resources
As of June 30, 2008 and December 31, 2007, we had the following (amounts in thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30, 2008 |
|
|
December 31, 2007 |
|
Cash and cash equivalents |
|
$ |
35,405 |
|
|
$ |
13,973 |
|
Short-term investments |
|
|
|
|
|
|
21,565 |
|
Working capital |
|
|
49,207 |
|
|
|
24,024 |
|
Cash provided by (used in) operating, investing and financing activities for the 2008 Period
and the 2007 Period is summarized as follows (amounts in thousands):
|
|
|
|
|
|
|
|
|
|
|
2008 |
|
|
2007 |
|
Cash flows: |
|
|
|
|
|
|
|
|
Operating activities |
|
$ |
(9,913 |
) |
|
$ |
33,579 |
|
Investing activities |
|
|
34,683 |
|
|
|
(40,175 |
) |
Financing activities |
|
|
(3,338 |
) |
|
|
2,855 |
|
|
|
|
|
|
|
|
Net cash flow |
|
$ |
21,432 |
|
|
$ |
(3,741 |
) |
|
|
|
|
|
|
|
Operating Activities
Net cash used in operating activities for the 2008 Period primarily resulted from the timing
of certain payments, including income tax payments of $7.5 million, payment to Shire of $3.3
million related to its 2007 withdrawal of Daytrana® product and $3.1 million in payments
related to insurance premiums. In addition, changes in working capital accounts, including an $8.0
million increase in inventories and a $4.3 million decrease in accrued compensation and related
liabilities also contributed to the net cash used in operating activities. The net operating cash
used was partially offset by the receipt of $17.2 million in distributions from Novogyne.
Net cash provided by operating activities for the 2007 Period primarily resulted from our
receipt of a $25.0 million milestone payment from Shire, our receipt of $11.0 million in
distributions from Novogyne, and our receipt of $5.9 million in connection with the development
agreements with Shire for an amphetamine transdermal patch. These amounts were partially offset by
changes in working capital due to the timing of certain payments, including $14.1 million in tax
payments, $2.6 million in compensation and related liabilities and $2.4 million related to
insurance premiums.
Investing Activities
Noven has invested a portion of its cash in short-term investments, which primarily consist of
investment grade, auction rate securities, which are categorized as available-for-sale under the
provisions of SFAS No. 115 Accounting for Certain Investments in Debt and Equity Securities.
Net cash provided by investing activities for the 2008 Period was primarily attributable to
$36.4 million in net sales of short-term investments at par, partially offset by $1.2 million in
equipment purchases to support operations.
Net cash used in investing activities for the 2007 Period was primarily attributable to $36.9
million in net purchases of short-term investments, $1.4 million in equipment purchases to support
operations and expansion of administrative offices and $1.2 million in acquisition costs related to
the August 2007 acquisition of JDS.
38
Financing Activities
Net cash used in financing activities for the 2008 Period was primarily attributable to a $3.3
million sales milestone payment to Synthon, an obligation recorded as part of the acquisition of
JDS. Net cash provided by financing activities for the 2007 Period was primarily attributable to
$2.5 million received in connection with the issuance of common stock from the exercise of stock
options. In addition, the 2007 Period benefited from $0.4 million in excess tax deductions from
the exercise of stock options.
Short-Term and Long-Term Liquidity
Our principal sources of short-term liquidity are existing cash and distributions from
Novogyne. Additional sources of short-term liquidity include cash generated from product sales,
milestones, fees and royalties under development and license agreements.
Our short-term cash flow is significantly dependent on distributions from Novogyne and sales,
royalties and license fees associated with our products. Any material decrease in sales of those
products by us or our licensees, a material decline in the HT market, the introduction of a generic
version of Vivelle-Dot, material increases in operating expenses, or the inability or failure of
Novogyne to pay distributions, would have a material adverse effect on our short-term cash flow and
require us to rely on our existing cash balances, investments, equity or debt offerings or on
borrowings to support our operations and business.
During the 2008 Period, our cash, cash equivalents and investments in auction rate securities
decreased from $68.4 million to $52.9 million. The $15.5 million used during the 2008 Period
included the payment of certain obligations previously charged to operations in 2007 and/or accrued
as of December 31, 2007, including (i) $5.4 million of employee severance, bonus and retention
payments, (ii) $3.3 million of Daytrana® voluntary market withdrawal costs, and (iii) a
$3.3 million contingent milestone payment related to sales of Pexeva®. We currently
expect net cash used in operations to decline in the second half of 2008 relative to the 2008
Period, and we believe that our existing cash balances and expected collections of receivables,
together with the available capacity under our credit facility (described below), will be
sufficient to meet our operating needs and short-term capital requirements.
We have been advised by Shire that Shires net sales of Daytrana® during the 12
months ended June 30, 2008 triggered the third and final $25.0 million sales milestone due to
be paid to Noven during the third quarter of 2008. We expect to pay income taxes related to the
Daytrana® milestones of approximately $9.1 million and $8.5 million during the remainder
of 2008 and 2009, respectively.
Our liquidity may be significantly and adversely impacted if we are unable to adequately
resolve the issues raised by the FDA in the July 2007 Form 483 and in the warning letter we
received in January 2008. No assurance can be given that Novens response to the warning letter
will be acceptable to the FDA or satisfactorily address the FDAs concerns. Failure to take
effective corrective actions can result in FDA enforcement action such as monetary fines, product
recalls, injunctions, seizures, suspension of production or withdrawal of product approval. Any
enforcement action by the FDA would have a material adverse effect on us, including the potential
loss of Daytrana® sales, the potential loss of sales of other products, the potential
for litigation related to this matter, harm to our reputation and various costs associated with the
foregoing.
We expect that the increased sales and marketing expenses relating to the operations of Noven
Therapeutics, including for the upcoming Stavzor launch, will continue during the
remainder of 2008. We expect to fund the additional sales and marketing expenses from our
operating cash flows, existing cash and investments as well as the other sources of funds described
above.
39
We have invested a significant portion of our cash in auction rate securities, which subjects
us to the liquidity risk described in Part II Item 7A Quantitative and Qualitative Disclosures
About Market Risk in our Form 10-K. During the 2008 Period, we recorded a $0.5 million unrealized
loss on our investments in auction rate securities which are classified as available for sale under
SFAS No. 115. As of June 30, 2008, the total par value and fair value of our investments was $18.0
million and $17.5 million, respectively. Due to continuing auction failures beginning in February
2008, we utilized valuation models to determine the fair values of our investments in auction rate
securities. The fair values of our investments were calculated based on the following: (i) the
underlying structure of each security; (ii) the present value of future principal and interest
payments discounted at rates considered to reflect current market conditions; (iii) consideration
of the probabilities of default, auction failure, or repurchase at par for each period; and (iv)
consideration of third party credit enhancement. These estimated fair values could change
significantly based on future market conditions.
Changes to investments measured at fair value on a recurring basis using unobservable inputs
(Level 3) during the six months ended June 30, 2008 were as follows (in thousands):
|
|
|
|
|
Balance at December 31, 2007 |
|
$ |
54,400 |
|
Purchases of investments |
|
|
550 |
|
Sales of investments at par |
|
|
(36,925 |
) |
Unrealized losses recorded as other comprehensive loss |
|
|
(515 |
) |
|
|
|
|
Balance at June 30, 2008 |
|
$ |
17,510 |
|
|
|
|
|
As a result of failed auctions, our auction rate securities pay interest at rates as defined
by the governing documents or indenture. Due to uncertainty about when we will be able to
liquidate these investments, we have classified our auction rate securities as non-current assets
as of June 30, 2008.
In July 2008, we entered into an agreement for a $15.0 million credit facility. In connection with the credit
facility and in lieu of granting a security interest in our assets, we granted a negative pledge in
favor of the lender whereby we agreed not to pledge, grant any security interest in, or allow any
lien or encumbrance in or on, certain of our financial assets. As of the date of this report, no
borrowings were outstanding under this facility.
We paid approximately $125.0 million in cash to acquire JDS in August 2007 and incurred
approximately $5.4 million in transaction-related costs. We funded the purchase price and related
transaction expenses from our sale of short-term investments. In addition, we assumed
approximately $16.1 million of accrued expenses and other current liabilities and assumed certain
contractual arrangements whereby we may be required to pay to third parties up to $23.5 million in
product development and sales milestones. In April 2008, we paid Synthon $3.3 million in
connection with a Pexeva® sales milestone.
Our liquidity for the 2007 Period benefited from $2.5 million received upon the exercise of
stock options by employees. During the 2008 Period, proceeds from exercises were not significant.
We expect this amount to fluctuate from period to period depending on the performance of our common
stock and equity award exercises. Beginning in 2006, we began granting SSARs to employees and
restricted stock to non-employee directors in lieu of stock options. These types of awards do not
provide cash to us upon their exercise. Accordingly, we expect that funds received from option
exercises will become less of a source of funds over time.
We currently have no long-term debt and have not drawn on the credit facility described above.
To the extent the sources of liquidity described above are insufficient to fund our operations, we
would expect to seek to obtain funds through a debt and/or equity financing. We cannot provide any
assurance that such financing will be available, if at all, in a timely manner, or on favorable
terms. If we are unable to obtain satisfactory financing, we may be required to delay or reduce
our proposed expenditures, plant and equipment and strategic acquisitions. Furthermore, debt
financing would likely require us to devote funds to service and ultimately repay such debt and
could subject us to financial or operational covenants that could limit or hinder our ability to
conduct our business.
40
Our strategic plan includes the acquisition of one or more products, technologies or
businesses that we believe may be complementary to our business. We expect that we will be
required to seek debt and/or equity financing to complete such an acquisition. We cannot provide
any assurance that such financing will be available, if at all, in a timely manner, or on favorable
terms.
Capital expenditures totaled $1.2 million for the 2008 Period. We expect to fund our
foreseeable capital expenditures from our operating cash flows, existing cash, short-term
investments and debt.
If our transdermal products under development are successful, we expect that our cash
requirements will increase to fund plant and equipment purchases to expand production capacity.
For our long-term operating needs, we intend to utilize funds derived from the sources described
above. To the extent available, we may use funds generated through sales of products under
development and payments received pursuant to development and licensing arrangements. If such
funds are insufficient, we may rely on debt and/or equity financing to fund such expansion. We
cannot assure that we will successfully complete the development of such products, that we will
obtain regulatory approval for any such products, that any approved product
will be produced in commercial quantities, at reasonable costs, and be successfully marketed,
or that we will successfully negotiate future licensing or product acquisition arrangements.
Because much of the cost associated with product development and expansion of manufacturing
facilities is incurred prior to product launch, if we are unsuccessful in out-licensing, or if we
are unable to launch additional commercially-viable products that we develop or that we license or
acquire from others, we will have incurred the up-front costs associated with product development
or acquisition without the benefit of the cash generated by sales of those products, which could
adversely affect our long-term liquidity needs. Factors that could impact our ability to develop
or acquire and launch additional commercially-viable products are discussed in Part I Item 1A
Risk Factors of our Form 10-K.
For the 2008 Period and 2007 Period, our equity in earnings of Novogyne and the recognition of
deferred license and contract revenues (both of which are non-cash items) contributed significantly
to our income before income taxes. Accordingly, our net income may not be reflective of our cash
flow in any given period.
Aggregate Contractual Obligations
There have been no material changes outside of the ordinary course of our business to our
aggregate contractual obligations previously disclosed in our Form 10-K since December 31, 2007.
Critical Accounting Estimates
For a discussion of our critical accounting estimates, see Managements Discussion and
Analysis of Financial Condition and Results of Operations Critical Accounting Estimates, which
is included in our Form 10-K.
Recent Accounting Pronouncements
For a discussion of recent accounting pronouncements see Note 2 Recent Accounting
Pronouncements.
41
Outlook
A summary of our current financial guidance is provided below. Our guidance includes certain
items related to the impact on our financial results of our acquisition of JDS Pharmaceuticals (now
known as Noven Therapeutics), which we acquired in August 2007. This financial guidance supersedes
all financial guidance that we may have previously provided. Any financial guidance previously
provided in areas not addressed below, whether in prior filings with the Securities and Exchange
Commission, press releases, public conference calls or otherwise, is no longer current and is
hereby withdrawn. The forward-looking information contained in this section is based on our
current assumptions and expectations, many of which are based upon matters beyond our control. In
particular, for purposes of this guidance we have assumed that, during the remainder of 2008, there
will not be any material:
|
|
|
acquisitions of products, companies, or technologies or other transactions; |
|
|
|
|
changes in Novens or Novogynes accounting or accounting principles or any of the
estimates or judgments underlying our critical accounting policies; |
|
|
|
|
regulatory or technological developments; |
|
|
|
|
changes in the supply of, demand for, or distribution of our products (including any
changes resulting from competitive products, product recalls/withdrawals, or new study
results); |
|
|
|
|
negative actions with respect to our applications for methylphenidate quota or other
disruptions in supplies of raw materials; |
|
|
|
|
adverse actions by the FDA in connection with the January 2008 warning letter or
otherwise; |
|
|
|
|
changes in our business relationships/collaborations; or |
|
|
|
|
changes in the economy or the health care sector generally. |
Financial guidance is inherently uncertain. Accordingly, we cannot assure that we will
achieve results consistent with this guidance, and our actual financial results could differ
materially from the expected results discussed below. For a discussion of certain factors that may
impact our actual financial results for the periods referenced, including additional risks and
uncertainties related to Noven Therapeutics, readers should carefully consider the risks,
uncertainties and cautionary factors discussed in Part I Item 1A Risk Factors of our Form
10-K, as well as information contained in this Form 10-Q and in other reports filed from time to
time with the Securities and Exchange Commission.
Net revenues, gross margin, expenses, net income and other aspects of our financial results
can vary substantially from quarter-to-quarter based upon a number of factors, including the timing
of product orders by our licensees, the timing of release of manufactured product following quality
control and quality assurance measures undertaken by Noven and/or its customers, the availability
of raw materials, the timing of commencement of clinical studies, and other factors.
Net Revenues. We expect total net revenues for full year 2008 to be in the $100 million to
$105 million range, reflecting: (i) a full year of sales of Pexeva® and
Lithobid®; (ii) recognition of nominal revenues associated with the expected launch of
Stavzor in the second half of 2008, reflecting the fact that, pursuant to applicable
accounting rules, we expect to recognize Stavzor revenues based on prescriptions filled as opposed to
upon shipment to trade customers; (iii) Daytrana® net sales to Shire for 2008 consistent
with 2007 levels; (iv) higher license and contract revenues compared to 2007 due to the
amortization of Daytrana® sales milestones received in 2007 and 2008; and (v) aggregate
HT product sales by Noven for sale in the U.S. and international markets consistent with 2007
levels.
Gross Margin. We expect our overall gross margin, as a percentage of product sales, to be in
the low 30% range for full year 2008. Among other factors influencing our gross margin in our
transdermal manufacturing operations, we expect to incur increased quality assurance costs related
to our continued efforts to improve our quality assurance systems and address the issues raised by
the FDA in the July 2007 Form 483 and January 2008 warning letter. A significant portion of these
costs will be allocated to Daytrana®, which will negatively affect the gross margin on
sales of this product in 2008.
Research and Development Expense. We expect our consolidated research and development expense
for full year 2008 to be, as expressed in millions of dollars, in the low-to-mid teens. Estimates
of research and development expenses for future periods are subject to substantial adjustment as
each product advances through various stages of development.
42
Selling, General and Administrative Expense. We expect our consolidated selling, general and
administrative expense for full year 2008 to be in the upper $50 million range, including selling
and promotional expenses in support of Noven Therapeutics existing products and the commercial
launch of Stavzor.
Equity in Earnings of Novogyne. We expect our equity in earnings of Novogyne to increase in
the low 20% range in 2008 compared to 2007.
Interest Income. We expect our interest income to decrease in 2008 compared to 2007,
primarily reflecting lower cash and investment balances following payment of the JDS acquisition
purchase price in August 2007, as well as additional sales of auction rate securities at par during
2008 and lower interest rates on our remaining investments.
|
|
|
Item 3. |
|
Quantitative and Qualitative Disclosure About Market Risk |
For a discussion of quantitative and qualitative impact of market risk see Part II Item 7A
Quantitative and Qualitative Disclosure About Market Risk of our Form 10-K, as supplemented by
the discussion of the liquidity and other risks associated with auction rate securities above.
43
|
|
|
Item 4. |
|
Controls and Procedures |
Disclosure Controls and Procedures
As of the end of the period covered by this report, our management evaluated, with the
participation of our Chief Executive Officer (CEO) and Chief Financial Officer (CFO), the
effectiveness of our disclosure controls and procedures pursuant to Rule 13a-15 promulgated under
the Securities Exchange Act of 1934 (the Exchange Act). Based upon that evaluation, our CEO and
CFO concluded that, as of June 30, 2008, our disclosure controls and procedures were effective in
ensuring that information relating to Noven, including its consolidated subsidiaries, required to
be disclosed in reports that it files or submits under the Exchange Act was: (1) recorded,
processed, summarized and reported within the time periods specified in the SECs rules and forms;
and (2) accumulated and communicated to our management, including our CEO and CFO, as appropriate
to allow timely decisions regarding required disclosure. However, that conclusion should be
considered in light of the various limitations described below on the effectiveness of those
controls and procedures, some of which pertain to most if not all business enterprises, and some of
which arise as a result of the nature of our business. Our management, including our CEO and CFO,
does not expect that our disclosure controls and procedures will prevent all errors and all
improper conduct. A control system, no matter how well conceived and operated, can provide only
reasonable, not absolute, assurance that the objectives of the control system are met. Further,
the design of a control system must reflect the fact that there are resource constraints, and the
benefits of controls must be considered relative to their costs. Because of the inherent
limitations in all control systems, no evaluation of controls can provide absolute assurance that
all control issues and instances of improper conduct, if any, have been detected. These inherent
limitations include the realities that judgments in decision-making can be faulty, and that
breakdowns can occur because of simple error or mistake. Additionally, controls can be circumvented
by the individual acts of some persons, by collusion of two or more people, or by management
override of the control. Further, the design of any system of controls also is based in part upon
assumptions about the likelihood of future events, and there can be no assurance that any design
will succeed in achieving its stated goals under all potential future conditions; over time,
controls may become inadequate because of changes in conditions, or the degree of compliance with
the policies or procedures may deteriorate. Because of the inherent limitations in a
cost-effective control system, misstatements due to error or fraud may occur and not be detected.
Furthermore, our level of historical and current equity participation in Novogyne may substantially
impact the effectiveness of our disclosure controls and procedures. Because we do not control
Novogyne, and Novogynes financial, accounting, inventory, sales and sales deductions functions are
performed by Novartis, our disclosure controls and procedures with respect to our equity investment
in Novogyne are necessarily more limited than those we maintain with respect to Noven.
Changes in Internal Control over Financial Reporting
No changes were made in our internal control over financial reporting during our last fiscal
quarter that have materially affected, or are reasonably likely to materially affect, our internal
control over financial reporting.
Certificates
Provided with this quarterly report on Form 10-Q are certificates of our CEO and CFO. We are
required to provide those certifications by Section 302 of the Sarbanes-Oxley Act of 2002 and the
SECs implementing regulations. This Item 4 of Part I of this quarterly report is the information
concerning the evaluation referred to in those certifications, and you should read this information
in conjunction with those certifications for a more complete understanding of the topics presented.
44
PART II. OTHER INFORMATION
|
|
|
Item 1. |
|
Legal Proceedings |
Certain lawsuits and legal proceedings in which we are involved are described in Part I, Item
3 Legal Proceedings of our Form 10-K for the year ended December 31, 2007. Except as described
below, there have been no material developments related to the legal proceedings described in our
Form 10-K during the period covered by this Form 10-Q, and through the filing of this Form 10-Q.
All proceedings described in our Form 10-K remain outstanding. In addition to the cases in which
Noven is a named defendant, Novartis has advised Noven that it has been named as a defendant in a
total of 31 cases that include approximately 32 plaintiffs that allege liability in connection with
personal injury claims allegedly arising from the use of HT patches distributed and sold by
Novartis and Novogyne, including Novens Vivelle-Dot®, Vivelle® and
CombiPatch® products.
In addition to the proceedings described in our Form 10-K, in July 2008, one additional
complaint was filed in the United States District Court, District of Minnesota against Wyeth Inc.
and other named pharmaceutical companies, including Noven, Novogyne and Novartis. The complaint
alleges liability in connection with personal injury claims allegedly arising from the use of HT
products, including Vivelle-Dot®. The plaintiffs claim compensatory and other damages
in an unspecified amount.
Each of the HT related federal court cases in which Noven is a named defendant, has been, or
is expected to be, transferred to the federal multi-district litigation proceedings that are
pending in the United States District Court, Eastern District of Arkansas.
There have been no material changes to the risk factors previously disclosed in our Form 10-K.
Readers are urged to carefully review our risk factors because they may cause our results to
differ from the forward-looking statements made in this report or otherwise made by us or on our
behalf. The risk factors are not necessarily listed in order of priority and are not the only ones
we face. If any of these risks actually occurs, our business, financial condition and results of
operations would suffer. Additional risks not presently known to us or other factors not perceived
by us to present significant risks to our business at this time also may impair our business
operation. We do not undertake to update any of these forward-looking statements or to announce the
results of any revisions to these forward-looking statements except as required by law.
45
|
|
|
Item 2. |
|
Unregistered Sales of Equity Securities and Use of Proceeds |
The following table provides information with respect to our stock repurchases during the
second quarter of 2008:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Number of |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares |
|
|
Approximate |
|
|
|
|
|
|
|
|
|
|
|
Purchased as |
|
|
Dollar Value |
|
|
|
|
|
|
|
|
|
|
|
Part of |
|
|
That May Yet |
|
|
|
Total Number of |
|
|
Average Price |
|
|
Publicly |
|
|
be Purchased |
|
|
|
Shares |
|
|
Paid |
|
|
Announced |
|
|
under the |
|
|
|
Purchased |
|
|
Per Share |
|
|
Program |
|
|
Program(1) |
|
April 1, 2008 to
April 30, 2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
19,876,238 |
|
May 1, 2008 to
May 31, 2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
19,876,238 |
|
June 1, 2008 to
June 30, 2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
19,876,238 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Totals |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
19,876,238 |
|
|
|
|
(1) |
|
In September 2007, we announced a stock repurchase program authorizing the repurchase of
up to $25.0 million of our common stock. During the third quarter of 2007, we repurchased
322,345 shares of our common stock at an aggregate price of approximately $5.1 million.
There is no expiration date specified for this program. |
|
|
|
Item 4. |
|
Submission of Matters to a Vote of Security Holders |
The following proposals were approved at our Annual Meeting of Stockholders held on June 5,
2008:
|
1. |
|
Election of the Board of Directors: |
|
|
|
|
|
|
|
|
|
|
|
For |
|
|
Withheld |
|
Sidney Braginsky |
|
|
16,224,775 |
|
|
|
5,037,645 |
|
Peter Brandt |
|
|
21,110,943 |
|
|
|
151,477 |
|
John G. Clarkson, M.D. |
|
|
16,970,502 |
|
|
|
4,291,918 |
|
Donald A. Denkhaus |
|
|
16,986,592 |
|
|
|
4,275,828 |
|
Pedro P. Granadillo |
|
|
16,989,442 |
|
|
|
4,272,978 |
|
Phillip M. Satow |
|
|
20,301,501 |
|
|
|
960,919 |
|
Robert G. Savage |
|
|
20,173,025 |
|
|
|
1,089,395 |
|
Wayne P. Yetter |
|
|
16,715,657 |
|
|
|
4,546,763 |
|
|
2. |
|
Proposal to ratify and approve the appointment of Deloitte & Touche LLP as
Novens independent registered public accounting firm for 2008: |
|
|
|
|
|
|
|
For
|
|
Against
|
|
Abstained
|
|
Broker Non-Vote |
|
|
|
|
|
|
|
21,116,342
|
|
120,537
|
|
25,538
|
|
0 |
46
|
|
|
Item 5. |
|
Other Information |
From time to time, Novens directors, executive officers and employees may adopt trading plans
intended to comply with the guidelines specified in Rule 10b5-1 under the Securities Exchange Act
of 1934. As of the date hereof, no Noven directors or executive officers, other than Jeffrey F.
Eisenberg, have a Rule 10b5-1 trading plan in place.
|
10.1 |
|
Amended and Restated Restricted Stock Agreement between Peter Brandt and Noven
Pharmaceuticals, Inc., dated May 28, 2008 (incorporated by reference to Exhibit 10.1 to
the Current Report on Form 8-K of Noven Pharmaceuticals, Inc. filed on June 2, 2008). |
|
|
10.2 |
|
Employment Agreement between Peter Brandt and Noven Pharmaceuticals, Inc.,
dated April 29, 2008 (incorporated by reference to Exhibit 10.1 to the Current Report
on Form 8-K of Noven Pharmaceuticals, Inc. filed on May 5, 2008). |
|
|
10.3 |
|
Restricted Stock Agreement between Peter Brandt and Noven Pharmaceuticals,
Inc., dated April 29, 2008 (incorporated by reference to Exhibit 10.2 to the Current
Report on Form 8-K of Noven Pharmaceuticals, Inc. filed on May 5, 2008). |
|
|
10.4 |
|
Stock Appreciation Rights Agreement between Peter Brandt and Noven
Pharmaceuticals, Inc., dated April 29, 2008 (incorporated by reference to Exhibit 10.3
to the Current Report on Form 8-K of Noven Pharmaceuticals, Inc. filed on May 5, 2008). |
|
|
10.5 |
|
Letter Agreement between W. Neil Jones and Noven Pharmaceuticals, Inc., dated
April 29, 2008 (incorporated by reference to Exhibit 10.4 to the Current Report on Form
8-K of Noven Pharmaceuticals, Inc. filed on May 5, 2008). |
|
|
31.1 |
|
Certification of Peter Brandt, President and Chief Executive Officer, pursuant
to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act
of 2002. |
|
|
31.2 |
|
Certification of Michael D. Price, Vice President and Chief Financial
Officer, pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002. |
|
|
32.1 |
|
Certification of Peter Brandt, President and Chief Executive Officer, pursuant
to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act
of 2002.* |
|
|
32.2 |
|
Certification of Michael D. Price, Vice President and Chief Financial Officer,
pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002.* |
|
|
|
* |
|
Pursuant to Item 601(b)(32) of Regulation S-K, this exhibit is furnished rather than filed
with this Form 10-Q. |
47
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.
|
|
|
|
|
|
NOVEN PHARMACEUTICALS, INC.
|
|
Date: August 7, 2008 |
By: |
/s/ Michael D. Price
|
|
|
|
Michael D. Price |
|
|
|
Vice President and
Chief Financial Officer |
|
|
48