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, 2007
Commission file number 0-17254
NOVEN PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
|
|
|
STATE OF DELAWARE
|
|
59-2767632 |
|
|
|
(State or other jurisdiction of
incorporation or organization)
|
|
(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, or a non-accelerated filer. See definition of accelerated filer and large
accelerated filer in Rule 12b-2 of the Exchange Act.
|
|
|
|
|
Large accelerated filer o
|
|
Accelerated filer x
|
|
Non-accelerated filer o |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of
the Exchange Act). Yes o No x
Indicate the number of shares outstanding of each of the issuers classes of common stock, as
of the last practicable date.
|
|
|
Class |
|
Outstanding at July 31, 2007 |
Common stock $.0001 par value
|
|
24,851,829 |
NOVEN PHARMACEUTICALS, INC. AND SUBSIDIARIES
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, 2006 as supplemented by Part II
Item 1A Risk Factors of the quarterly reports on Form 10-Q filed in 2007, as well as other
reports filed from time to time with the Securities and Exchange Commission.
Trademark Information: Vivelle®, Vivelle-Dot®, Estradot®
and Menorest are trademarks of Novartis AG or its affiliated companies; CombiPatch® and
Estalis® are registered trademarks of Vivelle Ventures LLC; Daytrana is a
trademark of Shire Pharmaceuticals Ireland Limited; Lithobid® and
Pexeva® are registered trademarks of JDS Pharmaceuticals, LLC.
2
PART I. FINANCIAL INFORMATION
Item 1 Unaudited Condensed Consolidated Financial Statements
NOVEN PHARMACEUTICALS, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Operations
Three and Six Months Ended June 30,
(in thousands, except per share amounts)
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months |
|
|
Six Months |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product revenues Novogyne: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales |
|
$ |
4,804 |
|
|
$ |
5,630 |
|
|
$ |
10,173 |
|
|
$ |
8,717 |
|
Royalties |
|
|
1,899 |
|
|
|
1,658 |
|
|
|
3,664 |
|
|
|
3,347 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total product revenues Novogyne |
|
|
6,703 |
|
|
|
7,288 |
|
|
|
13,837 |
|
|
|
12,064 |
|
Product revenues third parties |
|
|
8,359 |
|
|
|
6,016 |
|
|
|
16,831 |
|
|
|
9,887 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total product revenues |
|
|
15,062 |
|
|
|
13,304 |
|
|
|
30,668 |
|
|
|
21,951 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contract and license revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contract |
|
|
29 |
|
|
|
404 |
|
|
|
(101 |
) |
|
|
1,068 |
|
License |
|
|
3,748 |
|
|
|
3,839 |
|
|
|
7,587 |
|
|
|
4,720 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contract and license revenues |
|
|
3,777 |
|
|
|
4,243 |
|
|
|
7,486 |
|
|
|
5,788 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues |
|
|
18,839 |
|
|
|
17,547 |
|
|
|
38,154 |
|
|
|
27,739 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of products sold Novogyne |
|
|
3,285 |
|
|
|
4,459 |
|
|
|
6,244 |
|
|
|
6,602 |
|
Cost of products sold third parties |
|
|
6,029 |
|
|
|
7,428 |
|
|
|
11,997 |
|
|
|
11,425 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total cost of products sold |
|
|
9,314 |
|
|
|
11,887 |
|
|
|
18,241 |
|
|
|
18,027 |
|
Research and development |
|
|
3,185 |
|
|
|
2,890 |
|
|
|
6,651 |
|
|
|
6,372 |
|
Marketing, general and administrative |
|
|
5,709 |
|
|
|
5,638 |
|
|
|
11,130 |
|
|
|
10,376 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total expenses |
|
|
18,208 |
|
|
|
20,415 |
|
|
|
36,022 |
|
|
|
34,775 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from operations |
|
|
631 |
|
|
|
(2,868 |
) |
|
|
2,132 |
|
|
|
(7,036 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity in earnings of Novogyne |
|
|
9,174 |
|
|
|
6,762 |
|
|
|
14,077 |
|
|
|
11,089 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income, net |
|
|
1,813 |
|
|
|
1,111 |
|
|
|
3,445 |
|
|
|
1,722 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income before income taxes |
|
|
11,618 |
|
|
|
5,005 |
|
|
|
19,654 |
|
|
|
5,775 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Provision for income taxes |
|
|
4,042 |
|
|
|
1,672 |
|
|
|
7,042 |
|
|
|
1,938 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
7,576 |
|
|
$ |
3,333 |
|
|
$ |
12,612 |
|
|
$ |
3,837 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic earnings per share |
|
$ |
0.31 |
|
|
$ |
0.14 |
|
|
$ |
0.51 |
|
|
$ |
0.16 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted earnings per share |
|
$ |
0.30 |
|
|
$ |
0.14 |
|
|
$ |
0.50 |
|
|
$ |
0.16 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares
outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
24,832 |
|
|
|
23,685 |
|
|
|
24,785 |
|
|
|
23,673 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted |
|
|
25,379 |
|
|
|
24,071 |
|
|
|
25,381 |
|
|
|
23,925 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these statements.
3
NOVEN PHARMACEUTICALS, INC. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets
(in thousands, except share data)
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2007 |
|
|
2006 |
|
Assets |
|
|
|
|
|
|
|
|
Current Assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
5,403 |
|
|
$ |
9,144 |
|
Short-term investments available-for-sale, at fair value |
|
|
181,256 |
|
|
|
144,455 |
|
Trade receivable (less allowance for doubtful
accounts of $56 in 2007 and $67 in 2006) |
|
|
3,545 |
|
|
|
5,038 |
|
Milestone payment receivable Shire |
|
|
25,000 |
|
|
|
25,000 |
|
Accounts receivable Novogyne, net |
|
|
6,074 |
|
|
|
7,693 |
|
Inventories |
|
|
9,564 |
|
|
|
8,651 |
|
Net deferred income tax asset, current portion |
|
|
6,900 |
|
|
|
4,400 |
|
Prepaid income taxes |
|
|
7,565 |
|
|
|
3,416 |
|
Prepaid and other current assets |
|
|
3,240 |
|
|
|
2,410 |
|
|
|
|
|
|
|
|
|
|
|
248,547 |
|
|
|
210,207 |
|
|
|
|
|
|
|
|
|
|
Property, plant and equipment, net |
|
|
36,211 |
|
|
|
37,010 |
|
|
Other Assets: |
|
|
|
|
|
|
|
|
Investment in Novogyne |
|
|
22,006 |
|
|
|
23,296 |
|
Net deferred income tax asset |
|
|
12,469 |
|
|
|
8,308 |
|
Patent development costs, net |
|
|
2,396 |
|
|
|
2,317 |
|
Deposits and other assets |
|
|
1,768 |
|
|
|
227 |
|
|
|
|
|
|
|
|
|
|
|
38,639 |
|
|
|
34,148 |
|
|
|
|
|
|
|
|
|
|
$ |
323,397 |
|
|
$ |
281,365 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders Equity |
|
|
|
|
|
|
|
|
Current Liabilities: |
|
|
|
|
|
|
|
|
Accounts payable and accrued expenses |
|
$ |
4,690 |
|
|
$ |
5,184 |
|
Capital lease obligation current portion |
|
|
126 |
|
|
|
109 |
|
Accrued compensation and related liabilities |
|
|
4,376 |
|
|
|
5,308 |
|
Other accrued liabilities |
|
|
4,743 |
|
|
|
2,085 |
|
Deferred rent credit |
|
|
89 |
|
|
|
89 |
|
Deferred contract revenues |
|
|
728 |
|
|
|
1,527 |
|
Deferred license revenues current portion |
|
|
19,342 |
|
|
|
15,084 |
|
|
|
|
|
|
|
|
|
|
|
34,094 |
|
|
|
29,386 |
|
|
|
|
|
|
|
|
|
|
Long-Term Liabilities: |
|
|
|
|
|
|
|
|
Capital lease obligation |
|
|
204 |
|
|
|
279 |
|
Deferred license revenues |
|
|
87,343 |
|
|
|
74,188 |
|
Deferred contract revenues |
|
|
6,875 |
|
|
|
|
|
Other liabilities |
|
|
1,165 |
|
|
|
837 |
|
|
|
|
|
|
|
|
|
|
|
129,681 |
|
|
|
104,690 |
|
|
|
|
|
|
|
|
|
|
Commitments and Contingencies (Note 11) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders Equity: |
|
|
|
|
|
|
|
|
Preferred stock authorized 100,000 shares of $.01 par
value; no shares issued or outstanding |
|
|
|
|
|
|
|
|
Common stock authorized 80,000,000 shares, par value
$.0001 per share; issued and outstanding 24,851,104
at June 30, 2007 and 24,661,169 at December 31, 2006 |
|
|
2 |
|
|
|
2 |
|
Additional paid-in capital |
|
|
114,871 |
|
|
|
109,912 |
|
Retained earnings |
|
|
78,843 |
|
|
|
66,761 |
|
Common stock held in trust |
|
|
(500 |
) |
|
|
|
|
Deferred compensation obligation |
|
|
500 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
193,716 |
|
|
|
176,675 |
|
|
|
|
|
|
|
|
|
|
$ |
323,397 |
|
|
$ |
281,365 |
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these statements.
4
NOVEN PHARMACEUTICALS, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Cash Flows
Six Months Ended June 30,
(in thousands)
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
2007 |
|
|
2006 |
|
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
Net income |
|
$ |
12,612 |
|
|
$ |
3,837 |
|
Adjustments to reconcile net income to net cash flows
provided by operating activities: |
|
|
|
|
|
|
|
|
Depreciation, amortization and certain other noncash items |
|
|
2,539 |
|
|
|
2,052 |
|
Stock-based compensation expense |
|
|
1,976 |
|
|
|
1,529 |
|
Income tax benefits on exercise of stock options |
|
|
462 |
|
|
|
256 |
|
Excess tax deduction from exercise of stock options |
|
|
(392 |
) |
|
|
(214 |
) |
Deferred income tax benefit |
|
|
(6,661 |
) |
|
|
(183 |
) |
Recognition of deferred license revenues |
|
|
(7,587 |
) |
|
|
(4,720 |
) |
Equity in earnings of Novogyne |
|
|
(14,077 |
) |
|
|
(11,089 |
) |
Distributions from Novogyne |
|
|
10,975 |
|
|
|
10,210 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Decrease (increase) in trade receivable, net |
|
|
1,493 |
|
|
|
(2,947 |
) |
Decrease in accounts receivable Novogyne, net |
|
|
1,619 |
|
|
|
1,845 |
|
(Increase) decrease in inventories |
|
|
(913 |
) |
|
|
29 |
|
Decrease in prepaid income taxes |
|
|
243 |
|
|
|
3,664 |
|
Increase in prepaid and other current assets |
|
|
(830 |
) |
|
|
(1,057 |
) |
Increase in deposits and other assets |
|
|
|
|
|
|
(15 |
) |
Decrease in accounts payable and accrued expenses |
|
|
(494 |
) |
|
|
(6,179 |
) |
Decrease in accrued compensation and related liabilities |
|
|
(932 |
) |
|
|
(2,164 |
) |
Increase in other accrued liabilities |
|
|
2,128 |
|
|
|
375 |
|
Increase (decrease) in deferred contract revenue, net |
|
|
6,076 |
|
|
|
(930 |
) |
Increase in deferred license revenue |
|
|
25,000 |
|
|
|
51,000 |
|
Increase in other liabilities |
|
|
342 |
|
|
|
92 |
|
Amounts recoverable from Shire and offset against
deferred license revenue related to Daytrana approval |
|
|
|
|
|
|
14 |
|
|
|
|
|
|
|
|
Cash flows provided by operating activities |
|
|
33,579 |
|
|
|
45,405 |
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
Purchases of property, plant and equipment, net |
|
|
(1,421 |
) |
|
|
(4,405 |
) |
Payments for patent development costs, net |
|
|
(348 |
) |
|
|
(416 |
) |
Payments for deferred acquisition costs |
|
|
(1,241 |
) |
|
|
|
|
Purchase of company-owned life insurance |
|
|
(260 |
) |
|
|
(185 |
) |
Purchases of short-term investments |
|
|
(767,769 |
) |
|
|
(685,035 |
) |
Proceeds from sale of short-term investments |
|
|
730,864 |
|
|
|
588,275 |
|
|
|
|
|
|
|
|
Cash flows used in investing activities |
|
|
(40,175 |
) |
|
|
(101,766 |
) |
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
Issuance of common stock from exercise of stock options |
|
|
2,521 |
|
|
|
822 |
|
Excess tax benefit from exercise of stock options |
|
|
392 |
|
|
|
214 |
|
Payments under capital leases |
|
|
(58 |
) |
|
|
(69 |
) |
|
|
|
|
|
|
|
Cash flows provided by financing activities |
|
|
2,855 |
|
|
|
967 |
|
|
|
|
|
|
|
|
Net decrease in cash and cash equivalents |
|
|
(3,741 |
) |
|
|
(55,394 |
) |
Cash and cash equivalents, beginning of period |
|
|
9,144 |
|
|
|
66,964 |
|
|
|
|
|
|
|
|
Cash and cash equivalents, end of period |
|
$ |
5,403 |
|
|
$ |
11,570 |
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these statements.
5
NOVEN PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Unaudited Condensed Consolidated Financial Statements
1. |
|
DESCRIPTION OF BUSINESS: |
Noven Pharmaceuticals, Inc. (Noven) was incorporated in Delaware in 1987 and is engaged
in the research, development, manufacture and marketing of advanced transdermal drug delivery
technologies and prescription transdermal products.
Noven and Novartis Pharmaceuticals Corporation (Novartis) entered into 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 estrogen delivery systems marketed under the brand
names Vivelle®, 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 July 9, 2007, Noven entered into an agreement to acquire JDS Pharmaceuticals, LLC
(JDS). JDS is a privately-held specialty pharmaceutical company that currently markets two
branded prescription psychiatry products through a targeted sales force and is advancing a
pipeline of products in development (see Note 12 Subsequent Event).
2. |
|
BASIS OF PRESENTATION: |
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 consolidated 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, 2006 (Form 10-K), and as supplemented by Part II Item 1A Risk
Factors of the quarterly reports on Form 10-Q filed in 2007. 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 2007 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 have been condensed or omitted.
The unaudited condensed consolidated financial statements should be read in conjunction with
the financial statements and the notes to the 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 financial statements included in Novens Form 10-K.
Certain reclassifications have been made to the prior periods balance sheet and statement
of cash flows to conform to the current periods presentation.
6
4. |
|
CASH FLOW INFORMATION: |
|
|
|
Income Tax and Interest Payments |
Cash payments for income taxes, net of refunds, were $14.1 million and $0.2 million for the
six months ended June 30, 2007 and 2006, respectively. Cash payments for interest were not
material for the six months ended June 30, 2007 and 2006.
|
|
Non-cash Operating Activities |
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. Through June
30, 2007 and in 2006, Novogyne paid $4.4 million and $2.2 million, respectively, to the New
Jersey Department of Revenue, representing Novens portion of Novogynes estimated state income
tax payment. These payments were deemed a distribution to Noven from Novogyne.
5. |
|
RECENT ACCOUNTING PRONOUNCEMENTS: |
In February 2007, the Financial Accounting Standards Board (FASB) issued Statement of
Financial Accounting Standards No. 159, The Fair Value Option for Financial Assets and
Financial LiabilitiesIncluding an amendment of FASB Statement No. 115 (SFAS 159). This
Statement permits entities to choose to measure many financial instruments and certain other
items at fair value and applies to all entities, including not-for-profit organizations. Most
of the provisions of this statement apply only to entities that elect the fair value option.
However, the amendment to FASB Statement No. 115, Accounting for Certain Investments in Debt
and Equity Securities, applies to all entities with available-for-sale and trading securities.
SFAS 159 is effective for financial statements issued for fiscal years beginning after November
15, 2007. Early adoption is permitted as of the beginning of a fiscal year that begins on or
before November 15, 2007, provided the entity also elects to apply the provisions of FASB
Statement No. 157, Fair Value Measurements. Noven is currently assessing the impact of
adopting SFAS 159 and the impact it may have on Novens results of operations and financial
condition.
The following are the major classes of inventories (in thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2007 |
|
|
2006 |
|
Finished goods |
|
$ |
2,327 |
|
|
$ |
893 |
|
Work in process |
|
|
2,273 |
|
|
|
2,851 |
|
Raw materials |
|
|
4,964 |
|
|
|
4,907 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
9,564 |
|
|
$ |
8,651 |
|
|
|
|
|
|
|
|
The Drug Enforcement Administration (DEA) controls access to controlled substances,
including methylphenidate, the active ingredient in Daytrana. Shire plc (Shire)
retains title to the active methylphenidate ingredient (AMI) in Daytrana. AMI is
not included in Daytrana product revenues or 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 yield
requirements 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, 2007, resulting in an immaterial payment from Shire to Noven. During the
six months ended June 30, 2007, Noven used $3.9 million of AMI in the finished product. Noven
had $1.5 million and $1.0 million of consignment AMI inventory on hand at June 30, 2007 and
December 31, 2006, respectively, which is not reflected in the table above.
7
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) to employees and non-vested shares
(restricted stock) to non-employee directors in lieu of stock options. Noven accounts for
these awards in accordance with Statement of Financial Accounting Standards No. 123 (revised
2004), Share-Based Payment. At June 30, 2007, there were 2,697,186 stock options and 402,796
SSARs issued and outstanding under the 1999 Plan.
Noven granted 26,244 and 34,344 shares of restricted stock to its non-employee directors
in May 2007 and 2006, respectively. 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 Emerging Issues Task Force 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 balance sheet. As of June 30, 2007, there were a total
of 28,620 shares of common stock in the rabbi trust.
The following table summarizes information regarding Novens restricted stock at June 30,
2007 (shares in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
2007 |
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
Average |
|
|
|
|
|
|
|
Grant-Date |
|
|
|
Shares |
|
|
Fair Value |
|
|
|
|
|
|
|
|
|
|
Nonvested at
December 31, 2006 |
|
|
8 |
|
|
$ |
17.47 |
|
Granted |
|
|
26 |
|
|
|
22.86 |
|
Vested |
|
|
(14 |
) |
|
|
19.80 |
|
Forfeited |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nonvested at
June 30, 2007 |
|
|
20 |
|
|
$ |
22.86 |
|
|
|
|
|
|
|
|
|
8
During the three months ended June 30, 2007, Noven granted 4,238 SSARs. The assumptions
used to value the SSARs for the three months ended June 30, 2007 and 2006 were as follows:
|
|
|
|
|
|
|
|
|
|
|
2007 |
|
|
2006 |
|
|
|
|
|
|
|
|
|
|
Volatility |
|
|
45.8 |
% |
|
|
55.1 |
% |
Risk free interest rate |
|
|
4.59 |
% |
|
|
4.95 |
% |
Expected life (years) |
|
|
5 |
|
|
|
5 |
|
Total stock-based compensation recognized in Novens statements of operations for the three
and six months ended June 30, 2007 and 2006 was as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months |
|
|
Six Months |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Marketing, general and administrative |
|
$ |
739 |
|
|
$ |
745 |
|
|
$ |
1,478 |
|
|
$ |
1,142 |
|
Research and development |
|
|
127 |
|
|
|
133 |
|
|
|
254 |
|
|
|
224 |
|
Total cost of products sold |
|
|
122 |
|
|
|
102 |
|
|
|
244 |
|
|
|
163 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
988 |
|
|
$ |
980 |
|
|
$ |
1,976 |
|
|
$ |
1,529 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tax benefit recognized related to
compensation expense |
|
$ |
302 |
|
|
$ |
239 |
|
|
$ |
661 |
|
|
$ |
358 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
There were no stock-based compensation costs capitalized as part of inventory or fixed
assets for the six months ended June 30, 2007 or 2006.
Cash received from options exercised under all share-based payment arrangements for the six
months ended June 30, 2007 and 2006 was $2.5 million and $0.8 million, respectively. The tax
benefit realized on the tax deductions from option exercises under stock-based compensation
arrangements totaled $0.5 million and $0.3 million for the three and six months ended June 30,
2007 and 2006, of which $0.4 million and $0.2 million was reported as cash flow from financing
activities for the six months ended June 30, 2007 and 2006, respectively.
9
Stock option and SSAR transactions related to the 1999 Plan are summarized as follows for
the six months ended June 30, 2007 (options/SSARs and aggregate intrinsic value in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
Average |
|
|
|
|
|
|
|
Average |
|
|
Aggregate |
|
|
Remaining |
|
|
|
Options/ |
|
|
Exercise |
|
|
Intrinsic |
|
|
Contractual |
|
|
|
SSARs |
|
|
Price |
|
|
Value |
|
|
Term |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at
beginning of the period |
|
|
3,275 |
|
|
$ |
19.26 |
|
|
|
|
|
|
|
|
|
Granted |
|
|
4 |
|
|
|
23.08 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
(161 |
) |
|
|
15.82 |
|
|
$ |
1,576 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Canceled and expired |
|
|
(18 |
) |
|
|
17.37 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at end
of the period |
|
|
3,100 |
|
|
$ |
19.46 |
|
|
$ |
16,181 |
|
|
|
3.6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding and exercisable
at end of the period |
|
|
1,988 |
|
|
$ |
21.33 |
|
|
$ |
8,014 |
|
|
|
2.8 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested or expected to vest
at end of the period |
|
|
2,708 |
|
|
$ |
19.64 |
|
|
$ |
13,767 |
|
|
|
3.5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of June 30, 2007, 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 $6.9 million before the effect of income taxes, of which $2.0 million,
$2.5 million, $1.6 million and $0.8 million is expected to be incurred in the remainder of 2007
and in 2008, 2009 and 2010, respectively. The weighted-average period over which this
compensation cost is expected to be recognized is two years.
8. |
|
ACCOUNTING FOR UNCERTAINTY IN 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 $1.2 million, including $0.3 million in interest and
penalties. If the $1.2 million was ultimately recognized, only $0.9 million would affect the
effective tax rate due to approximately $0.3 million in federal tax benefit. As of June 30,
2007 the gross amount of unrecognized tax benefits was approximately $1.6 million. Interest and
penalties related to income taxes are classified as a component of income tax expense. It is
reasonably possible that the gross amount of unrecognized tax benefits may increase by
approximately $0.6 million within 12 months after June 30, 2007.
10
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
years 2004-2006 remain open and subject to examination by the Internal Revenue Service.
Noven files and remits state income taxes in various states where Noven has determined it is
required to file state income taxes, and Novens filings with those states remain open for
audit, inclusively, for the years 2002-2006. Noven is not aware of any examinations currently
taking place related to its 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 may increase Novens income tax liabilities or decrease
the amount of deferred tax assets and may also materially change the amount of unrecognized
income tax benefits for tax positions taken.
9. |
|
CONTRACT AND LICENSE AGREEMENTS: |
|
|
|
Daytrana |
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 FDA; and (iii) three installments of $25.0 million each are payable upon Shires
achievement of $25.0 million, $50.0 million and $75.0 million in annual
Daytrana net sales, respectively. Shire launched the product in June
2006. Shires net sales of Daytrana exceeded the threshold for the first and
second sales milestones in the fourth quarter of 2006 and the second quarter of 2007,
respectively. Noven received a $25.0 million payment from Shire in the first quarter of 2007
related to the first sales milestone. Noven recorded a $25.0 million receivable from Shire at
June 30, 2007 related to the second sales milestone. For purposes of the sales milestones,
Shires annual net sales are measured quarterly on a trailing 12-month basis, with each
milestone payment due 45 days after the end of the first calendar quarter during which trailing
12-month sales exceed the applicable threshold. 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. Noven also manufactures and
supplies finished product for Shire.
|
|
Amphetamine Transdermal System |
In addition to Novens agreements with Shire related to Daytrana, in June 2004
Noven entered into an agreement with Shire for the development of a transdermal amphetamine
patch for ADHD, and in July 2006, Noven and Shire amended this agreement. Under the amended
agreement, Shire paid Noven a non-refundable $1.0 million in August 2006, in exchange for the
option of purchasing, for an additional $5.9 million, the exclusive developmental rights to the
product. The amended agreement further provided that Noven would perform certain early-stage
development activities which were previously to be performed by Shire. Noven completed a Phase
I clinical study for the product in March 2007. In June 2007, Shire exercised its option to
acquire the exclusive development rights to the product and Noven received the $5.9 million
option payment. This $5.9 million, as well as the initial $1.0 million received from Shire for
the grant of the option, was included in deferred contract revenues on Novens balance sheet as
of June 30, 2007. Shire has requested modifications to the patch formulation in order to align
the amphetamine patch with Shires future direction in ADHD, and has agreed to pay Noven for
its development efforts in this regard.
11
10. |
|
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 2007 and 2006 to meet Novartis annual
preferred return for those years and for Noven to recognize earnings from Novogyne under the
formula.
During the three and six months ended June 30, 2007 and 2006, Noven had the following
transactions with Novogyne (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months |
|
|
Six Months |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales |
|
$ |
4,804 |
|
|
$ |
5,630 |
|
|
$ |
10,173 |
|
|
$ |
8,717 |
|
Royalties |
|
|
1,899 |
|
|
|
1,658 |
|
|
|
3,664 |
|
|
|
3,347 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
6,703 |
|
|
$ |
7,288 |
|
|
$ |
13,837 |
|
|
$ |
12,064 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reimbursed expenses |
|
$ |
7,021 |
|
|
$ |
6,648 |
|
|
$ |
14,106 |
|
|
$ |
13,918 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of June 30, 2007 and December 31, 2006, Noven had amounts due from Novogyne of $6.1
million and $7.7 million, respectively.
The unaudited condensed statements of operations of Novogyne for the three and six months
ended June 30, 2007 and 2006 are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months |
|
|
Six Months |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross revenues |
|
$ |
42,915 |
|
|
$ |
35,665 |
|
|
$ |
80,208 |
|
|
$ |
72,934 |
|
Sales allowances |
|
|
6,837 |
|
|
|
3,546 |
|
|
|
10,999 |
|
|
|
7,339 |
|
Sales return allowances |
|
|
(60 |
) |
|
|
1,487 |
|
|
|
(9 |
) |
|
|
3,383 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales allowances and returns |
|
|
6,777 |
|
|
|
5,033 |
|
|
|
10,990 |
|
|
|
10,722 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues |
|
|
36,138 |
|
|
|
30,632 |
|
|
|
69,218 |
|
|
|
62,212 |
|
Cost of sales |
|
|
7,795 |
|
|
|
7,162 |
|
|
|
14,842 |
|
|
|
14,683 |
|
Selling, general and
administrative expenses |
|
|
9,579 |
|
|
|
9,596 |
|
|
|
19,712 |
|
|
|
18,753 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income from operations |
|
|
18,764 |
|
|
|
13,874 |
|
|
|
34,664 |
|
|
|
28,776 |
|
Interest income |
|
|
165 |
|
|
|
162 |
|
|
|
497 |
|
|
|
314 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
18,929 |
|
|
$ |
14,036 |
|
|
$ |
35,161 |
|
|
$ |
29,090 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Novens equity in earnings of Novogyne |
|
$ |
9,174 |
|
|
$ |
6,762 |
|
|
$ |
14,077 |
|
|
$ |
11,089 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
12
The activity in the Investment in Novogyne account for the six months ended June 30, 2007
is as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
Investment in Novogyne, beginning of period |
|
$ |
23,296 |
|
Equity in earnings of Novogyne |
|
|
14,077 |
|
Cash distributions from Novogyne |
|
|
(10,975 |
) |
Non-cash distribution from Novogyne (Note 4) |
|
|
(4,392 |
) |
|
|
|
|
Investment in Novogyne, end of period |
|
$ |
22,006 |
|
|
|
|
|
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, 2007, Noven received cash distributions representing return on
investment of $1.2 million and $11.0 million from Novogyne, respectively. For the three and six
months ended June 30, 2006, Noven received cash distributions representing return on investment
of $2.9 million and $10.2 million from Novogyne, respectively. In addition, as discussed in Note
4, tax payments of $4.4 million and $2.2 million were made by Novogyne on Novens behalf to the
New Jersey Department of Revenue during the six months ended June 30, 2007 and 2006,
respectively. These amounts were recorded as reductions in the investment in Novogyne when
received (or in the case of the tax payment, when paid).
11. |
|
COMMITMENTS AND CONTINGENCIES: |
|
|
|
HT Studies |
As a result of the findings from the Womens Health Initiative (WHI) study and other
studies previously disclosed in Novens Form 10-K, the FDA has required that black box
labeling be included on all menopausal hormone therapy (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.
Researchers continue to analyze data from both arms of the WHI study and other studies.
Other studies evaluating HT are currently underway or in the planning stages. The market for
Novens products could be adversely affected if these studies find 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. Noven is currently named as a defendant in six product liability lawsuits
involving its HT
products and Noven may have liability with respect to other actions in which it has not,
to date, been made a party. See Litigation, Claims and Assessments below for a further
discussion on related product liability lawsuits.
Since the July 2002 publication of the WHI and other study data, total United States
prescriptions have declined for substantially all HT products, including Novens products in
the aggregate. Prescriptions for CombiPatch®, Novens combination
estrogen/progestin patch, continue to decline in the post-WHI environment. Novogyne recorded
the acquisition of the marketing rights for Novens CombiPatch® product at cost and
Novogyne tests this asset for impairment on a periodic basis. Further adverse change in the
market for HT products could have a material adverse impact on the ability of Novogyne to
recover its investment in these rights, which could require Novogyne to record an impairment
loss on the CombiPatch® intangible asset. Impairment of the CombiPatch®
intangible asset would adversely affect Novogynes and Novens financial results. Management
cannot predict whether these or other studies will have additional adverse effects on Novens
liquidity and results of operations, or Novogynes ability to recover the net carrying value of
the CombiPatch® intangible asset.
13
In July 2007, the FDA completed an on-site inspection of Novens manufacturing facilities.
At the completion of the inspection, Noven received from the FDA a list of observations on
Form 483. The majority of the observations in the Form 483 relate to the Daytrana
patch and difficulties experienced by some patients in removing the release liner of the
Daytrana patch, including certain product lots that utilize an enhanced release
liner. Noven has submitted its response to the observations to the FDA. No assurance can be
given that Novens response will be acceptable to the FDA or
satisfactorily address the FDAs
concerns, and there can be no assurance that the FDA will not take regulatory action that could
adversely affect Novens business, results of operations and financial position.
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.
|
|
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.
Novartis has advised Noven that Novartis has been named as a defendant in at least 25
lawsuits that include approximately 26 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
14
by the agreements between and
among Novartis, Novogyne and Noven. Novogynes aggregate limit under its claims-made insurance
policy as of June 30, 2007 was $10.0 million. Novogyne has established reserves in the amount
of $10.1 million with an offsetting insurance recovery of $7.8 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, 2007.
Noven intends to defend all of the foregoing lawsuits vigorously, but the outcome of these
product liability lawsuits cannot ultimately be predicted.
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 its manufacture and sale of Daytrana. The plaintiff is seeking injunctions
from further infringement and claiming compensatory and other damages in an unspecified amount.
Noven intends to vigorously defend this lawsuit. In July 2007, Johnson-Matthey added Shire as a defendant to this lawsuit after Shire filed a
declaratory judgment against Johnson-Matthey in the United States District Court, Eastern District
of Pennsylvania.
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 financial position, results of
operations or cash flows.
Noven announced on July 10, 2007 that it had agreed to acquire JDS, a privately-held
specialty pharmaceutical company that currently markets two branded prescription psychiatry
products through a targeted sales force and is advancing a pipeline of products in psychiatry
and womens health. Pursuant to an Agreement and Plan of Merger (the Merger Agreement),
dated July 9, 2007 by and among Noven, Noven Acquisition, LLC, a Delaware limited liability
company and an indirect wholly owned subsidiary of Noven (Merger Sub), JDS, and Satow
Associates, LLC, solely in its capacity as representative of the equity holders of JDS (the
Member Representative), Merger Sub would merge with and into JDS (the Merger), with JDS
continuing as the surviving company and as an indirect wholly owned subsidiary of Noven
following the Merger. Subject to the terms and conditions of the Merger Agreement, at the
effective time of the Merger, the outstanding equity interests of JDS will be converted into
the right to receive an aggregate amount of $125.0 million in cash (the Merger
Consideration). A portion of the Merger Consideration in an amount equal to $10.0 million
will be placed in an escrow account from the effective time of the Merger until December 31,
2008 to satisfy post-closing indemnity claims by Noven in connection with the Merger Agreement,
as well as certain
expenses incurred by the Member Representative. In addition, Noven agreed to assume
approximately $10.0 million in net non-contingent liabilities, and to pay to third parties up to $22 million in product development and sales milestones that
could become due over the next five years if the milestones are achieved.
The Merger is subject to a number of customary closing conditions, including, but not
limited to, receipt of certain regulatory approvals of, and other third-party consents to, the
Merger. As of June 30, 2007, Noven incurred approximately $1.2 million in direct costs related
to the acquisition of JDS, which amounts are recorded as deferred acquisition cost and included
in deposits and other assets on Novens balance sheet. If and when the transaction closes,
Noven estimates incurring an aggregate $6.0 million in such direct costs. As of the date of
this filing, Noven had incurred $2.6 million in direct costs related to the acquisition, which
would be expensed immediately were the transaction terminated.
Upon closing, Noven expects to record a significant one-time charge for purchased
in-process research and development related to the allocated purchase price of acquired
products in the development pipeline. The amount of this charge has not yet been determined,
but it is expected to significantly exceed 50% of the transaction consideration. This charge
will materially and adversely impact Novens financial results in the quarter of closing and
for full-year
2007. In addition, beginning in the 2007 third quarter, Novens financial results
will reflect significant amortization and other integration-related expenses associated with
the JDS acquisition. The amount of these ongoing expenses is still under analysis.
15
Item 2.
Managements Discussion and Analysis of Financial
Condition and Results of Operations
The following section addresses material aspects of our financial condition at June 30, 2007,
and our results of operations for the three months ended June 30, 2007 (the 2007 Quarter) and
June 30, 2006 (the 2006 Quarter), and the six months ended June 30, 2007 (the 2007 Period) and
June 30, 2006 (the 2006 Period). The contents of this section include:
|
|
|
An executive summary of our results of operations for the 2007 Quarter; |
|
|
|
|
An overview of Noven and our Novogyne joint venture; |
|
|
|
|
A review of certain items that may affect the historical or future comparability of our
results of operations; |
|
|
|
|
An analysis of our results of operations and our liquidity and capital resources; |
|
|
|
|
A discussion of how we apply our critical accounting estimates; |
|
|
|
|
A discussion of recently-issued accounting standards; and |
|
|
|
|
An outlook that includes our current financial guidance. |
This discussion should be read in conjunction with Novens financial statements for the three
and six months ended June 30, 2007 and 2006 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 financial statements and related notes included in this Form 10-Q.
The financial highlights of the 2007 Quarter included sales growth for our lead products,
significant improvement in our overall gross margin, and strong financial results by our Novogyne
joint venture.
For the 2007 Quarter, we reported net income of $7.6 million ($0.30 diluted earnings per
share) compared to $3.3 million ($0.14 diluted earnings per share) for the 2006 Quarter. Net
revenues for the 2007 Quarter increased 7% to $18.8 million, primarily reflecting increased
Daytrana product sales to Shire.
Our gross margin percentage for the 2007 Quarter was 38% compared to 11% in the 2006 Quarter.
Gross margin in the 2006 Quarter was negatively affected by start-up and other expenses associated
with the initial production of Daytrana, which was launched in the 2006 Quarter. Gross margin in
the 2007 Quarter benefited from higher product revenues, higher facility utilization, and cost
savings associated with a cost reduction program implemented in the third quarter of 2006.
Research and development expenses for the 2007 Quarter increased $0.3 million to $3.2 million,
primarily due to increased clinical research for developmental products. Marketing, general and
administrative expenses were largely unchanged for the 2007 Quarter.
We recognized $9.2 million in earnings from Novogyne in the 2007 Quarter, 36% higher than the
$6.8 million recognized in the 2006 Quarter. Interest income increased $0.7 million compared to
the 2006 Quarter.
Novogynes net income for the 2007 Quarter was $18.9 million, a 35% increase over the 2006
Quarter. Novogynes net revenues for the 2007 Quarter were $36.1 million, up 18% from the
16
2006 Quarter, largely reflecting increased sales of Vivelle-Dot®. Novogynes
quarterly gross margin percentage increased slightly to 78%. Novogynes selling, general and
administrative expenses were largely unchanged quarter-to-quarter.
At June 30, 2007, we had an aggregate $186.7 million in cash and cash equivalents and
short-term investments, compared to $153.6 million at year-end 2006. This increase primarily
reflected receipt of a $25.0 million milestone payment from Shire, the receipt of $11.0 million in
distributions from Novogyne, and the receipt of $5.9 million in connection with the amphetamine
transdermal system agreement with Shire, partially offset by tax payments of $14.1 million.
Total prescriptions for Vivelle-Dot® increased 4% in the 2007 Quarter compared to
the 2006 Quarter, and total prescriptions for Novogynes products, taken as a whole, increased 2%.
By comparison, the overall United States HT market declined 7% over the same period. Total
prescriptions for Daytrana decreased 6% in the 2007 Quarter compared to the quarter
ended March 31, 2007, while prescriptions for ADHD stimulant therapies as a class decreased 4% for
the same period. These declines reflect the completion of the school year during the 2007 Quarter.
On July 9, 2007, we entered into an agreement to acquire JDS Pharmaceuticals, LLC (JDS) for
approximately $125.0 million in cash payable at closing plus the assumption of approximately $10.0
million in net non-contingent liabilities. JDS is a privately-held specialty pharmaceutical company that
currently markets two branded prescription psychiatry products through a targeted sales force and
is advancing a significant pipeline of products in psychiatry and womens health. The acquisition
is a strategic transaction intended to provide us with a leveragable marketing and sales
infrastructure and to broaden our development pipeline. Closing of the transaction is expected to
occur in August 2007 upon expiration of the waiting period under
the Hart-Scott-Rodino Antitrust Improvements Act and satisfaction of other customary closing conditions.
Overview of Noven and Our Novogyne Joint Venture
We develop and manufacture advanced transdermal patches and presently derive the majority of
our 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 position 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. In most
of these markets, Vivelle® is marketed under the brand name Menorest,
Vivelle-Dot® is marketed under the brand name Estradot® and
CombiPatch® is marketed under the brand name Estalis®.
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®, Vivelle-Dot® and CombiPatch® and provides
certain other services to Novogyne, including financial and accounting functions.
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 $9.2 million and $6.8
million for the 2007 Quarter and the 2006 Quarter, respectively. The income we recognize from
Novogyne
17
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 2007 Period and the 2006 Period, we received $11.0 million and $10.2
million, respectively, in distributions from Novogyne, which, excluding the $25.0 million received
from Shire in 2007, accounted for a substantial portion of our net cash flows generated by
operating activities for these periods. We expect that for the next several years a significant
portion of our earnings will be generated through our interest in Novogyne and a significant
portion of our cash flow will also be generated through our interest in Novogyne, as well as any
additional milestone payments we may receive from Shire. Any failure by Novogyne to remain
profitable or to continue to make distributions would have a material adverse effect on our results
of operations and financial condition.
The market for HT products, including transdermals, significantly declined in the years
following the July 2002 publication of the WHI study that found adverse health risks associated
with HT, and in current periods the market continues to decline. Comparing the 2007 Quarter to the
2006 Quarter, total prescriptions dispensed in the HT market in the United States decreased 7%.
Comparing the same periods, aggregate prescriptions for our United States HT products increased 2%.
Total prescriptions in the estrogen segment of the HT market in the United States decreased 8%
comparing the same periods, while prescriptions for our Vivelle® line of products
increased 3%. Vivelle-Dot®, which represented 88% of our total United States HT
prescriptions in the 2007 Quarter, increased 4% from the 2006 Quarter. We believe that
Vivelle-Dot® patch prescriptions have benefited from patient conversions from the
original Vivelle® product (the predecessor product to Vivelle-Dot®), which
represented 3% of our total United States prescriptions in the 2007 Quarter. Vivelle® is
in the process of being discontinued in several jurisdictions where our advanced
Vivelle-Dot® ET patch has gained acceptance. We ceased manufacturing of
Vivelle® for the United States market at the end of 2006.
United States prescriptions for our CombiPatch® product (which represented
approximately 9% of our total United States HT prescriptions in the first quarter of 2007)
decreased 10% from the 2006 Quarter to the 2007 Quarter, while prescriptions for the total United
States market for fixed combination hormone therapy decreased 9%. The combination therapy arm of
the WHI studies involved an oral combination estrogen/progestin product and, accordingly, the
combination therapy segment of the HT market has experienced the most significant decline. Further
decreases above expectations for our CombiPatch® product (whether as a result of the WHI
studies, competition in the category or otherwise) could require Novogyne (which holds the
CombiPatch® marketing rights) to record an impairment loss related to these marketing
rights, which would adversely affect the results of operations of both Noven and Novogyne.
Certain Items that May Affect Historical or Future Comparability
For a discussion of certain items that may affect the historical or future comparability of
our results of operations and financial condition, see Item 7. Managements Discussion and
Analysis of Financial Condition and Results of Operations of our Form 10-K as well as the
following updated and/or supplemented items. Such disclosure is not intended to address every item
that may affect the historical or future comparability of our results of operations or financial
condition and such disclosure should be read in conjunction with the discussion and analysis of our
results of operations, liquidity and capital resources and outlook appearing elsewhere in this Item
2.
Daytrana
The DEA controls access to controlled substances, including methylphenidate, the active
ingredient in Daytrana. Manufacturers of products containing controlled substances must
annually apply to the DEA for procurement quota in order to obtain these substances for
manufacturing. At
18
this time, we have received sufficient methylphenidate quota to meet expected
Daytrana product orders from Shire for the remainder of 2007. No assurance can be
given that we will receive sufficient quota in 2008 or any other future period. Given the DEAs
current approach to awarding controlled substance quota, we expect at any given time to have
applications pending with the DEA for procurement quota (either annual or supplemental) that are
likely to be critical to continued Daytrana production. Any shortage, delay or
stoppage in the supply of the active methylphenidate ingredient could cause us to lose revenues or
incur additional costs (including those related to expedited production), which could have an
adverse effect on our results of operations in general and our gross margin in particular.
We
have received reports concerning difficulty removing the release
liner from some Daytrana patches. During the first quarter of 2007, we implemented an
enhanced release liner intended to make Daytrana easier to use. If
Daytrana sales are materially impacted because of this issue, then Novens results of
operations and financial condition would likely be adversely affected.
In July 2007, the FDA completed an on-site inspection of our manufacturing facilities. At the
completion of the inspection, we received a list of observations on Form 483. The majority of the
observations in the Form 483 relate to the Daytrana patch and difficulties experienced
by some patients in removing the release liner of the Daytrana patch, including certain
product lots that utilize an enhanced release liner. We have submitted our response to the
observations to the FDA. No assurance can be given that our response will be acceptable to the FDA
or satisfactorily address the FDAs concerns, and there can be no assurance that the FDA will not take
regulatory action that could adversely affect our business, results of operations and financial
position.
Amphetamine Transdermal System
In addition to our agreements with Shire related to Daytrana, in June 2004 we
entered into an agreement with Shire for the development of a transdermal amphetamine patch for
ADHD, and in July 2006, Noven and Shire amended this agreement. Under the amended agreement, Shire
paid us a non-refundable $1.0 million in August 2006, in exchange for the option of purchasing, for
an additional $5.9 million, the exclusive developmental rights to the product. The amended
agreement further provided that we would perform certain early-stage development activities which
were previously to be performed by Shire. We completed a Phase I clinical study for the product in
March 2007. In June 2007, Shire exercised its option to acquire the exclusive development rights
to the product and we received the $5.9 million option payment. This $5.9 million, as well as the
initial $1.0 million received from Shire for the grant of the option, was included in deferred
contract revenues on our balance sheet as of June 30, 2007. Shire has requested modifications to
the patch formulation in order to align the amphetamine patch with Shires future direction in
ADHD, and has agreed to pay us for our development efforts in this regard.
JDS Pharmaceuticals, LLC
We announced on July 10, 2007 that we had agreed to acquire JDS, a privately-held specialty
pharmaceutical company that currently markets two branded prescription psychiatry products through
a targeted sales force and is advancing a pipeline of products in psychiatry and womens health.
Pursuant to the Merger Agreement dated July 9, 2007, Merger Sub would merge with and into JDS, with
JDS continuing as the surviving company and as an indirect wholly owned subsidiary of Noven
following the Merger. Subject to the terms and conditions of the Merger Agreement, at the
effective time of the Merger, the outstanding equity interests of JDS will be converted into the
right to receive an aggregate amount of $125.0 million in cash. A portion of the Merger
Consideration in an amount equal to $10 million will be placed in an escrow account from the
effective time of the Merger until December 31, 2008 to satisfy post-closing indemnity claims by
Noven in connection
19
with the Merger Agreement, as well as certain expenses incurred by the Member Representative.
In addition, we agreed to assume approximately $10.0 million in
net non-contingent liabilities, and to pay to third parties up to
$22 million in product development and sales milestones that could
become due over the next five years if the milestones are achieved.
The Merger is subject to a number of customary closing conditions, including, but not limited
to, receipt of certain regulatory approvals of, and other third-party consents to, the Merger. As
of June 30, 2007, we have incurred approximately $1.2 million in direct costs related to the
acquisition of JDS, which amounts are recorded as deferred acquisition costs and included in
deposits and other assets on our balance sheet. If and when the transaction closes, we estimate
incurring an aggregate $6.0 million in such direct costs. As of the date of this filing, we had
incurred approximately $2.6 million in direct costs related to the acquisition, which would be
expensed immediately were the transaction terminated.
Upon closing, we expect to record a significant one-time charge for purchased in-process
research and development related to the allocated purchase price of acquired products in the
development pipeline. The amount of this charge has not yet been determined, but it is expected to
significantly exceed 50% of the transaction consideration. This charge will materially and
adversely impact our financial results in the quarter of closing and for full-year 2007. In
addition, beginning in the 2007 third quarter, our financial results will reflect significant
amortization and other integration-related expenses associated with our acquisition of JDS. The
amount of these ongoing expenses is still under analysis. For a discussion of the potential risks
and uncertainties associated with the JDS transaction, see Part II Item 1A Risk Factors of
this Form 10-Q.
20
Results of Operations
Three and six months ended June 30, 2007 compared to the three and six months ended June 30,
2006
Revenues
Total revenues for the three and six months ended June 30, 2007 and 2006 are summarized as
follows (dollar amounts in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months |
|
|
Six Months |
|
|
|
2007 |
|
|
2006 |
|
|
% Change |
|
|
2007 |
|
|
2006 |
|
|
% Change |
|
Product revenues Novogyne: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales |
|
$ |
4,804 |
|
|
$ |
5,630 |
|
|
|
(15 |
%) |
|
$ |
10,173 |
|
|
$ |
8,717 |
|
|
|
17 |
% |
Royalties |
|
|
1,899 |
|
|
|
1,658 |
|
|
|
15 |
% |
|
|
3,664 |
|
|
|
3,347 |
|
|
|
9 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6,703 |
|
|
|
7,288 |
|
|
|
(8 |
%) |
|
|
13,837 |
|
|
|
12,064 |
|
|
|
15 |
% |
Product revenues third parties: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales |
|
|
8,271 |
|
|
|
5,931 |
|
|
|
39 |
% |
|
|
16,684 |
|
|
|
9,731 |
|
|
|
71 |
% |
Royalties |
|
|
88 |
|
|
|
85 |
|
|
|
4 |
% |
|
|
147 |
|
|
|
156 |
|
|
|
(6 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8,359 |
|
|
|
6,016 |
|
|
|
39 |
% |
|
|
16,831 |
|
|
|
9,887 |
|
|
|
70 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total product revenues |
|
|
15,062 |
|
|
|
13,304 |
|
|
|
13 |
% |
|
|
30,668 |
|
|
|
21,951 |
|
|
|
40 |
% |
Contract and license revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contract |
|
|
29 |
|
|
|
404 |
|
|
|
(93 |
%) |
|
|
(101 |
) |
|
|
1,068 |
|
|
|
(109 |
%) |
License |
|
|
3,748 |
|
|
|
3,839 |
|
|
|
(2 |
%) |
|
|
7,587 |
|
|
|
4,720 |
|
|
|
61 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,777 |
|
|
|
4,243 |
|
|
|
(11 |
%) |
|
|
7,486 |
|
|
|
5,788 |
|
|
|
29 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues |
|
$ |
18,839 |
|
|
$ |
17,547 |
|
|
|
7 |
% |
|
$ |
38,154 |
|
|
$ |
27,739 |
|
|
|
38 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Revenues
As described in more detail below, the 7% increase in net revenues for the 2007 Quarter as
compared to the 2006 Quarter was primarily attributable to increased sales of Daytrana
and Estradot®, partially offset by a decline in Vivelle-Dot® sales due
to the timing of orders.
As described in more detail below, the 38% increase in net revenues for the 2007 Period as
compared to the 2006 Period was primarily attributable to increased sales of Daytrana
and an increase in license revenue associated with that product. In addition, aggregate
international product sales increased due to the timing of orders and higher minimum price
reconciliation payments as compared to the 2006 Period. Aggregate sales to Novogyne increased
primarily due to increased sales of Vivelle-Dot® samples.
Product Revenues Novogyne
Product revenues Novogyne consists of our sales of
Vivelle-Dot®/Estradot®, CombiPatch® and Vivelle® to
Novogyne at a fixed price for product sampling and resale by Novogyne primarily in the United
States as well as the royalties we receive as a result of Novogynes sales of
Vivelle-Dot® and Vivelle®.
The $0.6 million decline in product revenues from Novogyne for the 2007 Quarter as compared to
the 2006 Quarter primarily related to a $1.0 million decline in unit sales of
Vivelle-Dot®, partially offset by a $0.3 million increase in unit sales of
CombiPatch®. The Vivelle-Dot® decline reflects a $1.2 million decline in
trade product sales due to the timing of orders from Novogyne, partially offset by a $0.2 million
increase in samples attributable to the timing of orders from Novogyne. The increase in
21
CombiPatch®
is due to the timing of orders and not an increase in demand, as prescription
trends continue to decline, which we believe is attributable to the ongoing effects of WHI and
other studies on combination therapy products as well as the impact of a competitive product.
The $1.8 million increase in product revenues from Novogyne for the 2007 Period as compared to
the 2006 Period primarily related to a $1.5 million increase in samples of Vivelle-Dot®
to Novogyne due to the timing of orders from Novogyne and a $0.3 million increase in royalties due
to higher sales by Novogyne for the 2007 Period.
As noted below under Novogyne Net Revenues, Novogyne sells its products to trade customers,
including wholesalers, distributors and chain pharmacies and the timing of orders by trade
customers is difficult to predict and can lead to significant variability in trade customers
ordering patterns. As a result, there may be significant period-to-period variability in
Novogynes ordering patterns from Noven.
Product Revenues Third Parties
Product revenues third parties consists of sales of Estradot®,
Estalis® and Menorest 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
Vivelle® and Estradot® in Canada. Product revenues third parties also
includes sales of Daytrana to Shire for commercial resale in the United States, which
commenced in the 2006 Quarter.
The $2.3 million increase in product revenues third parties for the 2007 Quarter as
compared to the 2006 Quarter primarily related to a $1.6 million increase in unit sales of
Daytrana and a $0.8 million increase in unit sales of Estradot®.
Daytrana product sales in the 2007 Quarter were $5.2 million compared to $3.6 million
in the 2006 Quarter. The increase in Daytrana product sales was attributable to
increased prescription demand as the product was initially launched in the 2006 Quarter. The
increase in sales of Estradot® was attributable to the timing of orders from Novartis
Pharma.
The $6.9 million increase in product revenues third parties for the 2007 Period as compared
to the 2006 Period primarily related to $6.0 million increase in unit sales of Daytrana
and a $0.8 million increase related to HT product pricing with Novartis Pharma. There were no
Daytrana product sales in the first quarter of 2006, as the product was not launched
until the 2006 Quarter. Daytrana product sales in the 2007 Period were $9.6 million
compared to $3.6 million in the 2006 Period. The increase related to HT product pricing was
primarily due to the recognition of a higher price adjustment payment received from Novartis Pharma
in the 2007 Period compared to the 2006 Period.
Contract and License Revenues
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 work and success
milestone payments. License revenues consist of the recognition of non-refundable up-front,
milestone and similar payments under license agreements.
Contract revenues declined $0.4 million and $1.2 million for the 2007 Quarter and 2007 Period
as compared to the 2006 Quarter and 2006 Period, respectively, reflecting a decline in contract
work performed and a $0.3 million reversal in the first quarter of 2007 of contract revenues
previously recognized relating to a change in estimate of work to be completed on a contract.
22
License revenues were basically unchanged for the 2007 Quarter compared to the 2006 Quarter.
License revenues increased $2.9 million for the 2007 Period compared to the 2006 Period and was
mostly attributable to a $4.0 million increase in the recognition of deferred license revenues
related to
Daytrana
due to the amortization of the $50.0 million approval milestone for
two quarters in comparison to one quarter in the 2006 Period and amortization of the $25.0 million
milestone triggered in the fourth quarter of 2006. These increases in the 2007 Period were
partially offset by the recognition of $1.0 million in deferred license revenues related to
one-time non-refundable payment from a third party for a license to certain of our patents that
occurred in the 2006 Period.
Gross Margin
This section discusses our gross margin percentages relating to our product revenues (i)
across all of our products (Overall Gross Margin), (ii) on our product revenues from Novogyne
(Gross Margin Novogyne), which for accounting purposes is considered a related party, and (iii)
on our product revenues from third parties (Gross Margin Third Parties). Product revenues
from third parties primarily include HT product sales to Novartis Pharma for resale primarily
outside the U.S. and Japan, as well as Daytrana product sales to Shire.
The allocation of overhead costs impacts our calculation of gross margins for each of our
products. Overhead costs, which were in excess of $6.0 million and $12.0 million in the three and
six months ended June 30, 2007, respectively, consist of salaries and benefits, supplies and tools,
equipment costs, depreciation, and insurance costs. Overhead costs represent a substantial portion
of our inventory production costs and the allocation of overhead among our various 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 for the three and six months ended June 30, 2007 and 2006 are summarized as
follows (dollar amounts in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months |
|
|
Six Months |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Overall
Gross Margin: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product revenues |
|
$ |
15,062 |
|
|
$ |
13,304 |
|
|
$ |
30,668 |
|
|
$ |
21,951 |
|
Cost of products sold |
|
|
9,314 |
|
|
|
11,887 |
|
|
|
18,241 |
|
|
|
18,027 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit (product revenues |
|
|
5,748 |
|
|
|
1,417 |
|
|
|
12,427 |
|
|
|
3,924 |
|
less cost of products sold) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross margin (gross profit as a
percentage of product revenues) |
|
|
38 |
% |
|
|
11 |
% |
|
|
41 |
% |
|
|
18 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months |
|
|
Six Months |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross Margin Novogyne: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product revenues |
|
$ |
6,703 |
|
|
$ |
7,288 |
|
|
$ |
13,837 |
|
|
$ |
12,064 |
|
Cost of products sold |
|
|
3,285 |
|
|
|
4,459 |
|
|
|
6,244 |
|
|
|
6,602 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit (product revenues |
|
|
3,418 |
|
|
|
2,829 |
|
|
|
7,593 |
|
|
|
5,462 |
|
less cost of products sold) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross margin (gross profit as a
percentage of product revenues) |
|
|
51 |
% |
|
|
39 |
% |
|
|
55 |
% |
|
|
45 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
23
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months |
|
|
Six Months |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
Gross Margin Third Parties: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product revenues |
|
$ |
8,359 |
|
|
$ |
6,016 |
|
|
$ |
16,831 |
|
|
$ |
9,887 |
|
Cost of products sold |
|
|
6,029 |
|
|
|
7,428 |
|
|
|
11,997 |
|
|
|
11,425 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit/(loss) (product revenues |
|
|
2,330 |
|
|
|
(1,412 |
) |
|
|
4,834 |
|
|
|
(1,538 |
) |
less cost of products sold) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross margin/(loss) (gross profit as a
percentage of product revenues) |
|
|
28 |
% |
|
|
(23 |
%) |
|
|
29 |
% |
|
|
(16 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
In general, our sales of HT products to Novogyne for resale in the U.S. have a higher gross
margin than our other 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 a lower gross margin 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 improved since launch of the product
in the 2006 Quarter, reflecting our efforts to reduce production costs and inefficiencies and the
impact of our cost reduction program initiated in the third quarter of 2006.
As noted in the tables above, Overall Gross Margin improved significantly in both the 2007
Quarter and in the 2007 Period as compared to the similar periods in 2006. During the 2006
Quarter, our Overall Gross Margin was materially and adversely affected by a negative gross margin
on product sales of Daytrana (i.e. the costs we incurred to produce the product were
greater than the revenues we realized from the sales of that product). The negative Daytrana
gross margin resulted primarily from start-up expenses associated with commencing production
of Daytrana, and production inefficiencies including lower than desired yields and
increased costs associated with meeting critical launch timelines. To a lesser extent, Overall
Gross Margin in the 2006 Quarter was also negatively affected by increased personnel and other
resources dedicated to quality control in our HT operations and by lower production volume in our
HT business due to the timing of orders.
Overall Gross Margin in the 2007 Quarter and the 2007 Period benefited from significantly
higher product revenues, primarily due to Daytrana sales; higher facility utilization,
which contributed to improved overhead absorption; and cost savings associated with our cost
reduction program that we implemented in the third quarter of 2006 to reduce costs and improve
operating efficiency. It also benefited from a $0.3 million and $0.8 million increase in price
reconciliation payments relating to international sales of our HT products for the 2007 Quarter and
in the 2007 Period in comparison to the same periods in 2006, respectively. These payments
increase product revenues without increasing costs.
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 2007 Quarter, Daytrana product revenues
were $5.2 million, and cost of products sold related to Daytrana was $3.9 million,
resulting in a gross margin on Daytrana production of 25%. This is a significant
improvement from the negative gross margin we reported for the 2006 Quarter and we continue to work
to improve the profitability of Daytrana production and to improve facility
utilization, but we cannot assure that we will be successful.
In light of the several factors discussed above which impact our Overall Gross Margin, we do
not believe that our reported gross margin for the 2007 Quarter is predictive of our expected gross
margin for the remaining quarters in 2007. In particular, variations in product revenues and
production volumes, as well as the timing and amount of methylphenidate quota that we may receive,
could materially affect our gross margin in future periods. In addition, facility utilization is
highly dependent on production volumes, which may vary based on customer ordering patterns and
other factors. Our expectations for future gross margin performance are addressed under Outlook
below.
24
Operating Expenses
Operating expenses for the three and six months ended June 30, 2007 and 2006 are summarized as
follows (dollar amounts in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months |
|
|
Six Months |
|
|
|
2007 |
|
|
2006 |
|
|
% Change |
|
|
2007 |
|
|
2006 |
|
|
% Change |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
3,185 |
|
|
$ |
2,890 |
|
|
|
10 |
% |
|
$ |
6,651 |
|
|
$ |
6,372 |
|
|
|
4 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Marketing, general and
administrative |
|
|
5,709 |
|
|
|
5,638 |
|
|
|
1 |
% |
|
|
11,130 |
|
|
|
10,376 |
|
|
|
7 |
% |
Research and Development
Research and development expenses include costs associated with, among other things, product
formulation, pre-clinical testing, clinical research and 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 $0.3
million increase in research and development expenses for the 2007 Quarter as compared to the 2006
Quarter was primarily attributable to a $0.6 million increase in clinical research costs partially
offset by $0.2 million decline in development engineering related to Daytrana and other
products. The $0.3 million increase in research and development expenses for the 2007 Period as
compared to the 2006 Period was primarily due to a $0.9 million increase in clinical research costs
and a $0.2 million increase in personnel costs, partially offset by a $0.6 million decline in
development engineering related to Daytrana and other products.
Marketing, General and Administrative
Marketing, general and administrative expenses were unchanged for the 2007 Quarter as compared
to the 2006 Quarter. Marketing, general and administrative expenses for the 2007 Period as
compared to the 2006 Period increased $0.8 million. This increase was primarily attributable to a
$0.4 million increase in salary and related benefits and a $0.3 million increase in stock-based
compensation expense.
Other Income and Expenses
Interest Income
Interest income increased $0.7 million and $1.7 million for the 2007 Quarter and the 2007
Period as compared to the 2006 Quarter and the 2006 Period, respectively. These increases were
primarily attributable to an increase in cash available for investment due to our receipt from
Shire of milestone payments of $50.0 million in April 2006 and $25.0 million in March 2007.
Income Taxes
Our effective tax rate was approximately 36% and 34% for the 2007 Period and the 2006 Period,
respectively. The increase in our effective tax rate for the 2007 Period as compared to the 2006
Period related primarily to a higher percentage of our income that was subject to state income
taxes.
25
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. As of June 30, 2007, we had a net
deferred tax asset of $19.4 million. If and when the JDS acquisition closes, our deferred tax
asset is expected to significantly increase as a result of the expected one-time charge for
purchased in-process research and development related to the allocated purchase price of acquired
products in the development pipeline which is not immediately deductible for income tax purposes.
Realization of this deferred tax asset depends upon the generation of sufficient future taxable
income. Although realization is not assured, we believe it is more likely than not that the
deferred income tax asset will be realized based upon estimated future taxable income.
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 the first quarter of each of 2007 and 2006 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 statements of operations.
The financial results of Novogyne for the three and six months ended June 30, 2007 and 2006
are summarized as follows (dollar amounts in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months |
|
|
Six Months |
|
|
|
2007 |
|
|
2006 |
|
|
% Change |
|
|
2007 |
|
|
2006 |
|
|
% Change |
|
Gross revenues1 |
|
$ |
42,915 |
|
|
$ |
35,665 |
|
|
|
20 |
% |
|
$ |
80,208 |
|
|
$ |
72,934 |
|
|
|
10 |
% |
Sales allowances |
|
|
6,837 |
|
|
|
3,546 |
|
|
|
93 |
% |
|
|
10,999 |
|
|
|
7,339 |
|
|
|
50 |
% |
Sales returns allowances |
|
|
(60 |
) |
|
|
1,487 |
|
|
|
(104 |
%) |
|
|
(9 |
) |
|
|
3,383 |
|
|
|
(100 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales and returns allowances |
|
|
6,777 |
|
|
|
5,033 |
|
|
|
35 |
% |
|
|
10,990 |
|
|
|
10,722 |
|
|
|
2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues |
|
|
36,138 |
|
|
|
30,632 |
|
|
|
18 |
% |
|
|
69,218 |
|
|
|
62,212 |
|
|
|
11 |
% |
Cost of sales |
|
|
7,795 |
|
|
|
7,162 |
|
|
|
9 |
% |
|
|
14,842 |
|
|
|
14,683 |
|
|
|
1 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
28,343 |
|
|
|
23,470 |
|
|
|
21 |
% |
|
|
54,376 |
|
|
|
47,529 |
|
|
|
14 |
% |
Gross margin percentage |
|
|
78 |
% |
|
|
77 |
% |
|
|
|
|
|
|
79 |
% |
|
|
76 |
% |
|
|
|
|
Selling, general and
administrative expenses |
|
|
9,579 |
|
|
|
9,596 |
|
|
|
(0 |
%) |
|
|
19,712 |
|
|
|
18,753 |
|
|
|
5 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income from operations |
|
|
18,764 |
|
|
|
13,874 |
|
|
|
35 |
% |
|
|
34,664 |
|
|
|
28,776 |
|
|
|
20 |
% |
Interest income |
|
|
165 |
|
|
|
162 |
|
|
|
2 |
% |
|
|
497 |
|
|
|
314 |
|
|
|
58 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
18,929 |
|
|
$ |
14,036 |
|
|
|
35 |
% |
|
$ |
35,161 |
|
|
$ |
29,090 |
|
|
|
21 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Novens equity in earnings of Novogyne |
|
$ |
9,174 |
|
|
$ |
6,762 |
|
|
|
36 |
% |
|
$ |
14,077 |
|
|
$ |
11,089 |
|
|
|
27 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1 |
|
Novogynes gross revenues, which are calculated by adding sales allowances and sales
returns allowances to net revenues, are discussed in this section because Novens management
believes it is a useful measure to evaluate and compare Novogynes sales period to period in light
of the significant historic fluctuations in Novogynes sales allowances and returns. |
26
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 $7.3 million for the 2007 Quarter as compared to the 2006
Quarter. By product, Vivelle-Dot®, Estradot® and CombiPatch®
increased $6.6 million, $0.4 million and $0.3 million, respectively. The $6.6 million
Vivelle-Dot® increase consisted of a $4.2 million increase related to pricing and a $2.4
million increase in unit sales due to increased product demand and to the timing of orders. The
increase in Estradot® sales to an affiliate of Novartis Pharma in Canada was
attributable to the timing of orders. The increase in CombiPatch® was attributable to a
$0.5 million increase related to pricing, partially offset by a $0.2 million decline in unit sales
as a result of the continuing decline in the market for combination therapies as well as the impact
of a competitive product.
Novogynes gross revenues increased $7.3 million for the 2007 Period as compared to the 2006
Period. By product, Vivelle-Dot® increased $8.0 million while Estradot® and
CombiPatch® declined $0.4 million and $0.3 million, respectively. The $8.0 million
Vivelle-Dot® increase consisted of a $5.9 million increase related to pricing and a $2.1
million increase in unit sales due to increased product demand and to the timing of orders. The
decline in Estradot® sales to an affiliate of Novartis Pharma in Canada was attributable
to the timing of orders. The decline in CombiPatch® was attributable to a $0.9 million
decline in unit sales as a result of the continuing decline in the market for combination therapies
as well as the impact of a competitive product. This CombiPatch® decline was partially
offset by a $0.6 million increase related to pricing.
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 16% and 10% of gross revenues for the 2007 Quarter and the 2006 Quarter,
respectively. For the 2007 Period and the 2006 Period, these sales allowances were 14% and 10%,
respectively. The increase in sales allowances were attributable to increases in actual
managed healthcare rebates and cash discounts and allowances related to price increases that took
effect in the 2007 Quarter.
Sales returns allowances consist of allowances for returns of expiring product. The activity
for sales returns allowances for the three and six months ended June 30, 2007 and 2006 was as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months |
|
|
Six Months |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Changes in allowances for returns
primarily of expiring product |
|
$ |
(60 |
) |
|
$ |
1,487 |
|
|
$ |
(9 |
) |
|
$ |
3,383 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Actual returns primarily for expiring product |
|
$ |
(645 |
) |
|
$ |
(1,149 |
) |
|
$ |
(1,474 |
) |
|
$ |
(2,320 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
The decrease in allowances for returns of expiring product for the three and six months ended
June 30, 2007 was primarily related to lower actual returns of CombiPatch® as compared
to the same period in the prior year. The higher returns of CombiPatch® in the prior
period primarily relates to returns of a superseded packaging configuration.
27
Novogyne Gross Margin
Novogynes gross margin was unchanged for the 2007 Quarter compared to the same period of the
prior year as higher pricing was partially offset by higher aggregate sales and returns allowances
as a percentage of revenue.
The 3% gross margin increase for the 2007 Period as compared to the 2006 Period was primarily
related to higher pricing, especially for Vivelle-Dot®, and to a lesser extent an
aggregate decrease in sales returns allowances as a percentage of revenues.
Novogyne Selling, General and Administrative Expenses
Novogynes selling, general and administrative expenses were unchanged for the 2007 Quarter as
compared to the 2006 Quarter as a $0.5 million decline in HT litigation expenses was partially
offset by a $0.4 million increase in sales, marketing and advertising expenses.
Novogynes selling, general and administrative expenses increased $1.0 million for the 2007
Period as compared to the 2006 Period due to a $1.5 million increase in sample expenses due to the
timing of sample orders by Novogyne. Novogynes policy is to immediately expense samples when
shipped from Noven. In addition, sales, marketing and advertising expenses increased $0.3 million.
These increases were offset by a $0.8 million decline in HT litigation expenses.
Liquidity and Capital Resources
As of June 30, 2007 and December 31, 2006, we had the following (amounts in thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30, 2007 |
|
|
December 31, 2006 |
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
5,403 |
|
|
$ |
9,144 |
|
Short-term investments |
|
|
181,256 |
|
|
|
144,455 |
|
Working capital |
|
|
214,453 |
|
|
|
180,821 |
|
Cash provided by (used in) operating, investing and financing activities for the six months ended
June 30, 2007 and 2006 is summarized as follows (amounts in thousands):
|
|
|
|
|
|
|
|
|
|
|
Six Months |
|
|
|
2007 |
|
|
2006 |
|
|
|
|
|
|
|
|
|
|
Cash flows: |
|
|
|
|
|
|
|
|
Operating activities |
|
$ |
33,579 |
|
|
$ |
45,405 |
|
Investing activities |
|
|
(40,175 |
) |
|
|
(101,766 |
) |
Financing activities |
|
|
2,855 |
|
|
|
967 |
|
Operating Activities
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 amphetamine
transdermal system agreement with Shire. 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.
28
Net cash provided by operating activities for the 2006 Period primarily resulted from our
receipt of $50.0 million related to the Daytrana approval and $10.2 million in cash
distributions from Novogyne. These amounts were partially offset by changes in working capital due to the
timing of certain payments, including those related to insurance, compensation and related
liabilities and payments to Shire for clinical trial costs incurred in connection with obtaining
Daytrana regulatory approval.
Investing Activities
Noven invested a portion of its cash in short-term investments, which primarily consist of
investment grade, asset backed, variable rate debt obligations and municipal 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 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
JDS.
Net cash used in investing activities for the 2006 Period was primarily attributable to $96.8
million in net purchases of short-term investments, as well as the purchase of $4.4 million in
fixed assets to expand production capacity for future products.
Financing Activities
Net cash provided by financing activities for the six months ended June 30, 2007 and 2006 was
primarily attributable to $2.5 million and $0.8 million, respectively, received in connection with
the issuance of common stock from the exercise of stock options. In addition, the six months ended
June 30, 2007 and 2006 benefited from $0.4 million and $0.2 million in excess tax deductions from
the exercise of stock options, respectively.
Short-Term and Long-Term Liquidity
Our principal sources of short-term liquidity are existing cash, cash generated from product
sales, fees and royalties under development and license agreements and distributions from Novogyne.
For the 2007 Period, a significant portion of our income before income taxes was comprised of
equity in earnings of Novogyne and the recognition of deferred license revenue, both of which are
non-cash items. Accordingly, our net income may not be reflective of our short-term liquidity.
Our short-term cash flow is dependent on distributions from Novogyne and sales, royalties and
license fees associated with our transdermal products. Any decrease in sales of those products by
us or our licensees or any increase in returns of products to Novogyne (including any such changes
resulting from the HT studies), the further decline of the HT market, 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 or on borrowings to support our operations and
business.
As discussed above, in July 2007, we agreed to acquire JDS for approximately $125.0 million in
cash payable at closing plus the assumption of approximately
$10.0 million in net non-contingent liabilities. In addition, we agreed to pay to
third parties up to $22 million in product development and sales
milestones that could become due over the next five years if the
milestones are achieved. We
intend to fund the purchase price and related transaction expenses from our existing
cash and short-term investments, which at June 30, 2007 aggregated approximately $187 million. In
addition, we expect to increase our research and development expense in the 2007-2009 timeframe by
up to an aggregate $30 million related to the development of JDS products, including
an estimated $6 million in the second half of 2007. These amounts are in addition to our
expected research and development expense for our existing programs during the same periods. We
expect to fund the additional research and development expenses from our existing cash and
short-term investments as well as the sources of funds described above.
29
We currently have no long-term debt. To the extent the sources of funds described above
together with our existing cash and short-term investments are insufficient to fund our operations,
including our anticipated increased research and development expenses, we would expect to rely on
debt financing as a source of liquidity.
Our liquidity is also dependent on our receipt from Shire of milestones payments related to
our Daytrana patch. In April 2006, we received a $50.0 million milestone payment from
Shire as a result of the final marketing approval of Daytrana by the FDA. Shires net
sales of Daytrana exceeded the threshold for the first sales milestone in the fourth
quarter of 2006 and, accordingly, we received a $25.0 million payment from Shire in the first
quarter of 2007. Shires net sales of Daytrana exceeded the threshold for the second
sales milestone in the second quarter of 2007 and, accordingly, we expect to receive a $25.0
million payment from Shire in connection with this milestone. We may also earn an additional $25.0
million milestone payment upon Shires achievement of $75.0 million in annual net sales of
Daytrana; however, there is no assurance that this milestone will be met. Shire
commercially launched the product in June 2006. For the 2007
Period, we paid an aggregate $14.1
million in taxes, the majority of which relate to the $50.0 million milestone. We expect to
continue to make tax payments on the $50.0 million milestone for the remainder of 2007 and into early
2008 and the majority of the income taxes related to the first and second milestones are expected to be paid in 2008 and into early 2009.
In July 2007, the FDA completed an on-site inspection of our manufacturing facilities. At the
completion of the inspection, we received a list of observations on Form 483. The majority of the
observations in the Form 483 relate to the Daytrana patch and difficulties experienced
by some patients in removing the release liner of the Daytrana patch, including certain
product lots that utilize an enhanced release liner. We have submitted our written response to the
observations to the FDA. No assurance can be given that our response will be acceptable to the FDA
or satisfactorily address the FDAs concerns, and there can be no assurance that the FDA will not take
regulatory action that could adversely affect our business, results of operations and financial
position.
Our liquidity for the 2007 Period benefited from $2.5 million received as the exercise price
paid by option holders in connection with their exercise of employee stock options. This amount
can be expected to fluctuate from period to period depending on the performance of Novens stock
and equity award exercises. Beginning on January 1, 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.
Capital expenditures were $1.4 million for the 2007 Period. We expect to fund our foreseeable
capital expenditures from our existing cash and short-term investments. As a general matter, we
believe that we have sufficient liquidity available to meet our operating needs and anticipated
short-term capital requirements.
If our 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 above sources, as well as funds
generated through sales of products under development or products that we may license or acquire
from others, including those acquired as part of our proposed acquisition of JDS. We expect that
such funds will be comprised of payments received pursuant to future development and licensing
arrangements, as well as direct sales of our own products. If such funds are not sufficient to
fund plant and equipment purchases to expand production capacity, we may rely on debt financing to
fund such expansion.
30
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 may 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 liquidity 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 of our Form 10-K, as
supplemented by Part II Item 1A Risk Factors of the quarterly reports on Form 10-Q filed in
2007, as well as other reports filed from time to time with the Securities and Exchange Commission.
In addition to the acquisition of JDS, our strategic plan includes the acquisition of one or
more products, technologies or businesses that we believe may be complementary to our business,
including the psychiatry franchise we expect to acquire through the JDS transaction. We expect to draw upon
our existing cash and short-term investments to fund all or a portion of these potential strategic
acquisitions. To the extent our existing cash and short-term investments are insufficient to fund
any potential acquisitions, we may be required to seek debt financing or to issue equity or debt
securities. If we ultimately are able to finance all or any portion of an acquisition through debt
financing or debt securities we would be required to devote funds to service and ultimately repay
such debt and could be subject to financial or operational covenants that could limit or hinder our
ability to conduct our business.
To the extent that we may seek debt or equity financing, no assurance can be given that
alternative financing will be available, if at all, in a timely manner, or on favorable terms. If
we are unable to obtain satisfactory alternative financing, we may be required to delay or reduce
our proposed expenditures, including expenditures for research and development, plant and equipment
and strategic acquisitions, in order to meet our future cash requirements.
Aggregate Contractual Obligations
There have been no material changes outside of the ordinary course of our business since
December 31, 2006 to our aggregate contractual obligations previously disclosed in our Form 10-K.
Critical Accounting Estimates
For a discussion of our critical accounting policies, see Managements Discussion and
Analysis of Financial Condition and Results of Operations Critical Accounting Estimates, which
is included in our Form 10-K, as updated and supplemented by the following:
Accounting for Uncertainty in Income Taxes
On January 1, 2007, we adopted the provisions of, and began accounting for uncertainty in
income taxes in accordance with 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. Under FIN 48 an enterprise cannot recognize a tax benefit for a tax position that is
not likely to be sustained. The application of income tax law is inherently complex. Laws and
regulations in this area are voluminous and are often ambiguous. As such, we are required to make
many subjective assumptions and judgments regarding our income tax exposures. Interpretations and
guidance surrounding income tax laws and regulations change over time. As a result, changes in our
subjective assumptions, estimates and judgments can materially affect amounts recognized in our
financial statements. See Note 8 to the condensed consolidated financial statements, Accounting
for Uncertainty in Income Taxes for additional information on our uncertain tax positions.
31
Recent Accounting Pronouncements
In February 2007, the FASB issued SFAS 159. This Statement permits entities to choose to
measure many financial instruments and certain other items at fair value and applies to all
entities, including not-for-profit organizations. Most of the provisions of this statement apply
only to entities that elect the fair value option. However, the amendment to FASB Statement No.
115, Accounting for Certain Investments in Debt and Equity Securities, applies to all entities
with available-for-sale and trading securities. SFAS 159 is effective for financial statements
issued for fiscal years beginning after November 15, 2007. Early adoption is permitted as of the
beginning of a fiscal year that begins on or before November 15, 2007, provided the entity also
elects to apply the provisions of FASB Statement No. 157, Fair Value Measurements. We are
assessing the impact of adopting SFAS 159 and the impact it may have on Novens results of
operations and financial condition.
Outlook
A summary of our current financial guidance is provided below. Our guidance includes certain
items related to the expected impact on our financial results of our acquisition of JDS, which is
expected to close in August 2007. This forward-looking information is based on our current
assumptions and expectations, many of which are beyond our control to achieve. In particular, for
purposes of this guidance we have assumed, among other things, that during the remainder of 2007
there will not be any material:
|
|
|
acquisitions of products, companies, or technologies or other transactions (other than
the proposed acquisition of JDS); |
|
|
|
|
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, or new study results); |
|
|
|
|
negative actions with respect to our applications for methylphenidate quota or other
disruptions in supplies of raw materials; |
|
|
|
|
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 our acquisition of JDS, readers should carefully consider the risks, uncertainties and
cautionary factors discussed in Part I Item 1A of our Form 10-K, as supplemented by Part II
Item 1A Risk Factors of the quarterly reports on Form 10-Q filed in 2007, as well as other
reports filed from time to time with the Securities and Exchange Commission.
Daytrana. We expect our product sales of Daytrana to Shire for
full-year 2007 to be in the $18 million range, subject to, among other things, demand for the
product. During 2006, we received a $50.0 million
milestone payment from Shire relating to the final marketing approval of Daytrana by
the FDA. In the fourth quarter of 2006, the first of three potential $25.0 million
Daytrana sales milestones was met, resulting in the payment of $25.0 million from Shire
to us in the first quarter of 2007. In the 2007 Quarter, the second $25.0
million Daytrana sales milestone was met, and we expect to receive payment of
$25.0 million from Shire in the 2007 third quarter. We expect to defer and recognize the approval
milestone and all 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 our current best
estimate of the end of the useful economic life of the product. Reflecting the impact of this
recognition schedule, we expect license revenues to increase substantially in 2007 compared to
2006.
32
HT Product Revenues. Given customer orders, prescription trends and other factors, we expect
Novens global HT product revenues for full-year 2007 to approximate 2006 levels.
Gross Margin Transdermal Operations. Since the launch of Daytrana in the
second quarter of 2006, we have worked to reduce costs and improve yields, and we reported
significant improvement in our quarterly overall gross margin percentage since the second quarter
of 2006. For full-year 2007, we are targeting an overall gross margin in the 35% range for our
transdermal operations, subject to a variety of factors, some of which are not within our control.
These factors include production volumes for Daytrana and our other products, our ability to effectively coordinate production
between Daytrana and our HT products to improve facility utilization, and our ability
to improve yields. These same factors could cause our gross margin related to our transdermal
operations in any particular quarter to vary significantly.
Research and Development Expense. We expect our research and development expense associated
with our transdermal product pipeline in 2007 to approach $16.0 million, depending on our ability
to advance certain development projects into human clinical studies during 2007.
Marketing, General and Administrative Expense. We expect our marketing, general and
administrative expense associated with our transdermal operations to increase in 2007 in the 5%
range over 2006 levels.
Stock-Based Compensation Expenses. Based on the expense associated with stock-based
compensation previously awarded, and our estimate of the expense associated with such compensation
that may be awarded in the course of 2007, we estimate that our total stock-based compensation
expenses for full-year 2007 will be approximately $4.1 million, compared to $3.3 million for
full-year 2006. The other financial guidance provided in this Outlook includes the effect of our
estimate of anticipated stock-based compensation expenses.
Novogyne. Based on current prescription trends and other factors, we expect Novogynes full
year 2007 net revenues to increase in the 5%-10% range compared to 2006 levels, and we expect
Novogynes net income to increase in the 10%-15% range compared to 2006 levels.
Tax Matters. We estimate that our effective tax rate for full-year 2007 will be in the 35%
range.
Capital Expenditures. We expect our capital expenditures for full-year 2007 to be
approximately in line with 2006 levels.
JDS Related Guidance. Assuming the acquisition of JDS closes as expected in August 2007, in the
second half of 2007, we expect to report:
|
|
|
aggregate product revenues from sales of JDSs
Pexeva® and Lithobid® products in the $11
million range; |
|
|
|
research and development expense associated with the products in the JDS development
pipeline in the $6 million range; and |
33
|
|
|
selling, general and administrative expenses associated with JDSs operations in the $10
million range, which expenses should be largely offset by expected gross profit from
Pexeva®
and
Lithobid®,
excluding amortization and integration-related expenses associated
with the JDS acquisition. |
In addition, assuming the JDS acquisition closes in August 2007, we expect to record a
significant one-time charge in the 2007 third quarter for purchased in-process research and
development related to the allocated purchase price of acquired products in the JDS development
pipeline. The amount of this charge has not yet been determined, but it is expected to
significantly exceed 50% of the transaction consideration. This charge will materially and
adversely impact our financial results for the 2007 third quarter, and our financial results will
reflect the impact of significant amortization and other integration-related expenses associated
with our acquisition of JDS. The amount of these ongoing expenses is still under analysis.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Not Applicable.
Item 4. Controls and Procedures
Disclosure Controls and Procedures
As of the end of the period covered by this report, we carried out an evaluation, under the
supervision and with the participation of our management, including our Chief Executive Officer and
Chief Financial Officer, of the effectiveness of the design and operation of our disclosure
controls and procedures pursuant to Rule 13a-15 promulgated under the Securities Exchange Act of
1934. Based upon that evaluation, our Chief Executive Officer and Chief Financial Officer
concluded that our disclosure controls and procedures are effective in timely alerting them to
material information relating to Noven required to be included in our periodic Securities and
Exchange Commission filings. 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 Chief Executive Officer and Chief Financial
Officer, does not expect that our disclosure controls and procedures will prevent all error 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 ourself.
34
Changes in Internal Control over Financial Reporting
No changes were made in our internal control over financial reporting subsequent to the date
of our Chief Executive Officers and Chief Financial Officers evaluation 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 Chief Executive
Officer and Chief Financial Officer. 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 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.
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. The following is a description of material developments
related to our legal proceedings during the period covered by this Form 10-Q, and through the
filing of this Form 10-Q, and should be read in conjunction with the report referenced above.
Unless otherwise indicated, all proceedings discussed in the reports referenced above remain
outstanding.
In addition to the HT cases previously disclosed in our filings with the Securities and
Exchange Commission, Novartis has advised us that Novartis has been named as a defendant in at
least 25 lawsuits that include approximately 26 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 our Vivelle-Dot®, Vivelle®, and
CombiPatch® products. 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.
We intend to defend all of the foregoing lawsuits vigorously, but the outcome of these product
liability lawsuits cannot ultimately be predicted.
In June 2007, Johnson-Matthey Inc. filed a complaint in the United States District Court,
Eastern District of Texas against us alleging that we were infringing one of its patents through
our manufacture and sale of Daytrana. The plaintiff is seeking injunctions from
further infringement and claiming compensatory and other damages in an unspecified amount. We
intend to vigorously defend this lawsuit. In July 2007, Johnson-Matthey added Shire as a defendant to this lawsuit after Shire filed a
declaratory judgment against Johnson-Matthey in the United States District Court, Eastern District
of Pennsylvania.
We are a party to other pending legal proceedings arising in the normal course of business,
none of which we believe is material to our financial position or results of operations.
Item 1A.
Risk Factors
Except as described below, 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 or on our behalf. The risk factors are not 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.
35
We may not close the JDS acquisition in a timely manner or at all.
While
we currently expect to close the JDS transaction in August 2007, we may
fail to close or suffer a significant delay in closing for any reason, including but not limited to
failure or delay by either party to satisfy the closing conditions in the merger agreement, the
occurrence of any event, change or other circumstances that could give rise to the termination of
the merger agreement, or the failure to obtain regulatory approvals required for the transaction.
The required regulatory approvals may delay the transaction or result in the imposition of
conditions which could have a material adverse effect on us or otherwise cause the parties to
abandon the transaction. If we do not close the JDS transaction, we would be required to
immediately expense all direct costs incurred related to the transaction upon termination of the
merger agreement or abandonment of the transaction.
We may not realize the expected benefits of our proposed acquisition of JDS.
We may be unable to take advantage of the opportunities that we expect to obtain from the JDS
acquisition. We cannot be certain of the future success of JDSs current products and, more
importantly, those in its pipeline. The potential success of a new pharmaceutical product is
subject to many risks, including but not limited to:
|
|
|
the failure of ongoing and planned clinical trials and the risk that results
from early-stage clinical trials may not be indicative of results in later-stage trials; |
|
|
|
|
the unproven safety and efficacy of products under development; |
|
|
|
|
the difficulty of predicting FDA approvals, including the timing of approval
and that approval may not be granted at all; |
|
|
|
|
while FDA approval may be granted, the possibility that any expected period
of exclusivity may not be realized and that we may not be able to produce commercially
viable quantities; |
|
|
|
|
the difficulty of predicting acceptance and demand for new pharmaceutical products; |
|
|
|
|
the impact of competitive products and pricing; |
|
|
|
|
the possibility that any product launch may be delayed or that product
acceptance may be less than anticipated; |
|
|
|
|
the possibility that patent applications may not result in issued patents,
and that issued patents may not be enforceable or could be invalidated; |
|
|
|
|
the commercial markets that we intend to enter with new products may not
develop in the manner or to the extent that we anticipate; and |
|
|
|
|
the potential negative impact of competitive responses to our sales,
marketing and strategic efforts. |
Any of the above factors may have a material adverse effect on our business, financial position and
results of operations.
36
We expect to record a significant loss in the reporting period that we close the JDS acquisition
due to a one-time charge for purchased in-process research and development.
Upon closing the JDS transaction, we expect to record a significant one-time charge for purchased
in-process research and development related to the allocated purchase price of acquired products in
JDSs development pipeline. The amount of this charge has not yet been determined, but it is
expected to significantly exceed 50% of the transaction consideration. This charge will materially
and adversely impact our financial results in the quarter of closing and for full-year 2007.
Our proposed acquisition of JDS is expected to dilute our earnings for an undetermined period
of time.
Following the closing of the proposed JDS transaction, our financial results will reflect
significant amortization and other ongoing integration-related expenses associated with our
acquisition of JDS. The amount of these ongoing expenses is still under analysis. In addition, we
will have significant increases in our research and development expenses for an extended period of
time as we continue development of the products in JDSs pipeline. No assurance can be given as to
the future success of the products in JDSs pipeline and as to whether we will be able to recover
our initial and ongoing investment in JDS and its products.
Our proposed acquisition of JDS may expose us to unexpected costs and liabilities.
Our proposed acquisition of JDS entails an inherent risk that we could become subject to
contingent or other liabilities, including liabilities arising from events or conduct pre-dating
the acquisition. While the owners of JDS have agreed in the merger agreement to indemnify us for
certain breaches of covenants, warranties and representations, our right to indemnity is limited to
a maximum of $10 million and subject to time and other restrictions. These indemnification
obligations may be inadequate to fully address any costs or damages we may incur, and any such
costs or damages may have a material adverse effect on our business, financial position and results
of operations. We may also incur significantly greater expenditures in integrating JDS than we had
anticipated.
Our proposed acquisition of JDS will result in a substantial increase in our intangible assets,
which will subject us to the risk of impairment charges.
Our balance sheet includes intangible assets in the form of patent development costs. Upon closing
the acquisition of JDS, intangible assets and goodwill will be a significant portion of our total
assets. We are required to test our intangible assets, including our goodwill, for impairment on
an annual basis or more frequently 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.
We may not successfully integrate JDS into our existing business, or such integration may be more
costly or more difficult than expected.
The proposed JDS acquisition involves the integration of companies that have previously
operated independently, which is a complex, costly and time-consuming process. In addition, this
is the first time that we have undertaken an acquisition of this size. The difficulties of
combining the companies operations include, among other things:
|
|
|
retaining key customer and vendor relationships; |
|
|
|
|
the necessity of coordinating geographically disparate organizations,
systems and facilities; |
|
|
|
|
consolidating corporate and administrative functions and eliminating redundancies; |
|
|
|
|
limiting the diversion of management resources necessary to facilitate the integration; |
37
|
|
|
implementing compatible information and communication systems, as well as
common operating procedures; |
|
|
|
|
creating compatible financial controls and comparable human resource
management practices; |
|
|
|
|
expenses of any undisclosed or potential legal liabilities; |
|
|
|
|
preserving, and preventing disruption of, the important contractual and
other relationships of each company; and |
|
|
|
|
assimilating and retaining employees with diverse business backgrounds. |
The successful integration of JDSs business will require us to take on new functions (such as
commercial distribution and managed care) with which we do not have significant experience.
Consistent with JDSs current practice, we intend to outsource many of these functions to third
parties. No assurance can be given that we will be successful in our efforts to develop or oversee
these new capabilities in our business.
The process of integrating operations could cause an interruption of the activities of our business
(including the operations of JDSs business) and the loss of key personnel. The diversion of
managements attention, any delays or difficulties encountered in connection with the business
combination and the integration of the companies operations or the costs associated with these
activities could have a material adverse effect on our business, financial position and results of
operations. There is no assurance that we can successfully integrate JDSs business with our
operations, that we will otherwise succeed in operating JDSs business and continue the development
of its products or that the financial results of the combined companies will meet or exceed the
financial results that we would have achieved without the acquisition.
Item 4.
Submission of Matters to a Vote of Security Holders
The following proposals were approved at our Annual Meeting of Stockholders held on May 18,
2007:
1. |
|
Election of the Board of Directors: |
|
|
|
|
|
|
|
|
|
|
|
For |
|
|
Withheld |
|
Sidney Braginsky |
|
|
21,347,632 |
|
|
|
516,980 |
|
John G. Clarkson, M.D. |
|
|
21,581,662 |
|
|
|
282,950 |
|
Donald A. Denkhaus |
|
|
21,796,633 |
|
|
|
67,979 |
|
Pedro P. Granadillo |
|
|
21,582,662 |
|
|
|
281,950 |
|
Robert G. Savage |
|
|
21,582,862 |
|
|
|
281,750 |
|
Robert C. Strauss |
|
|
21,488,579 |
|
|
|
376,033 |
|
Wayne P. Yetter |
|
|
21,621,036 |
|
|
|
243,576 |
|
2. |
|
Proposal to approve an amendment to the Noven Pharmaceuticals, Inc. 1999
Long-Term Incentive Plan: |
|
|
|
|
|
|
|
|
|
|
|
|
|
For |
|
Against |
|
Abstained |
|
Broker Non-Vote |
17,507,033
|
|
|
1,034,299 |
|
|
|
14,068 |
|
|
|
3,309,212 |
|
38
3. |
|
Proposal to approve the material terms of the performance goals under the
Noven Pharmaceuticals, Inc. 1999 Long-Term Incentive Plan: |
|
|
|
|
|
|
|
For |
|
Against |
|
Abstained |
|
Broker Non-Vote |
18,105,560 |
|
435,796 |
|
14,044 |
|
3,309,212 |
4. |
|
Proposal to ratify and approve appointment of Deloitte & Touche LLP as
the independent accountants for 2007: |
|
|
|
|
|
|
|
For |
|
Against |
|
Abstained |
|
Broker Non-Vote |
21,551,284 |
|
298,368 |
|
14,467 |
|
493 |
Item 5.
Other Information
The following executive officers have currently effective trading plans intended to comply
with the guidelines specified in Rule 10b5-1 under the Securities Exchange Act of 1934: Eduardo A.
Abrao, Diane M. Barrett, Jeffrey F. Eisenberg and W. Neil Jones. Other Noven
executive officers (as well as Noven employees) may adopt Rule 10b5-1 trading plans from time to
time. These plans generally provide for the exercise of stock options and the subsequent sale of
the acquired shares on the open market, subject to specified limitations and minimum price
thresholds. Under these plans, the executive officers do not control the specific timing of any
option exercise or sale. Rule 10b5-1 permits corporate officers and directors to adopt written,
pre-arranged stock trading plans when they are not in possession of material, non-public
information. Public disclosure of the transactions under these plans is required to be made by the
executive officers through Form 144 and Form 4 filings with the SEC.
Item 6. Exhibits
|
|
|
10.1
|
|
Letter Agreement between Shire US Inc. and Noven related to Development
of Amphetamine Transdermal Delivery System, dated June 15, 2004 (with certain
provisions omitted pursuant to Rule 24b-2).* |
|
|
|
10.2
|
|
Amendment dated May 3, 2007, to Letter Agreement between Shire US Inc.
and Noven related to Development of Amphetamine Transdermal Delivery System dated
June 15, 2004 (with certain provisions omitted pursuant to Rule 24b-2).* |
|
|
|
10.3
|
|
Amendment dated June 4, 2007, to Letter Agreement between Shire US Inc.
and Noven related to Development of Amphetamine Transdermal Delivery System dated
June 15, 2004 (with certain provisions omitted pursuant to Rule 24b-2).* |
|
|
|
31.1
|
|
Certification of Robert C. Strauss, President, Chief Executive Officer
and Chairman of the Board, 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 Diane M. Barrett, 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 Robert C. Strauss, President, Chief Executive Officer
and Chairman of the Board, 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 Diane M. Barrett, 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.** |
|
|
|
* |
|
Certain exhibits and schedules to this document have not been filed. The Registrant agrees to furnish a copy of any omitted schedule or exhibit to the Securities and Exchange Commission upon request. |
|
** |
|
Pursuant to Item 601(b)(32) of Regulation S-K, this exhibit is furnished rather than
filed with this Form 10-Q. |
39
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, 2007 |
By: |
/s/ Diane M. Barrett
|
|
|
|
Diane M. Barrett |
|
|
|
Vice President and
Chief Financial Officer |
|
|
40