e10vq
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
(Mark One)
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þ |
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934 |
For the quarterly period ended September 30, 2007
or
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o |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission File Number 1-10581
BENTLEY PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
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DELAWARE
(State or other jurisdiction of
incorporation or organization)
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No. 59-1513162
(I.R.S. Employer
Identification No.) |
Bentley Park, 2 Holland Way, Exeter, New Hampshire 03833
(Current Address of Principal Executive Offices)
Registrants telephone number, including area code: (603) 658-6100
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. YES þ NO o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer,
or a non-accelerated filer. See definition of accelerated filer and large accelerated filer in
Rule 12b-2 of the Exchange Act. (Check one):
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Large accelerated filer o
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Accelerated filer þ
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Non-accelerated filer o |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act). YES o NO þ
The number
of shares of the registrants common stock outstanding as of November 8, 2007 was
22,326,135.
Bentley Pharmaceuticals, Inc. and Subsidiaries
Form 10-Q for the Quarter Ended September 30, 2007
Index
2
Bentley Pharmaceuticals, Inc. and Subsidiaries
Unaudited Consolidated Balance Sheets
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(in thousands, except per share data) |
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September 30, |
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December 31, |
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2007 |
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2006 |
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
38,452 |
|
|
$ |
12,424 |
|
Marketable securities |
|
|
560 |
|
|
|
3,177 |
|
Receivables, net |
|
|
31,469 |
|
|
|
32,963 |
|
Inventories |
|
|
15,043 |
|
|
|
16,279 |
|
Deferred taxes |
|
|
1,579 |
|
|
|
1,049 |
|
Prepaid expenses and other |
|
|
2,437 |
|
|
|
1,798 |
|
|
|
|
|
|
|
|
Total current assets |
|
|
89,540 |
|
|
|
67,690 |
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|
|
|
|
|
|
|
Non-current assets: |
|
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|
|
|
|
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Fixed assets, net |
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|
55,821 |
|
|
|
48,556 |
|
Drug licenses and related costs, net |
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|
17,147 |
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|
16,026 |
|
Restricted cash |
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|
1,000 |
|
|
|
1,000 |
|
Deferred taxes |
|
|
195 |
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|
|
240 |
|
Other |
|
|
945 |
|
|
|
844 |
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|
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Total non-current assets |
|
|
75,108 |
|
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|
66,666 |
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|
|
|
|
|
|
|
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$ |
164,648 |
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|
$ |
134,356 |
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|
|
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|
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|
|
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Liabilities and Stockholders Equity |
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Current liabilities: |
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Accounts payable |
|
$ |
15,582 |
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$ |
14,566 |
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Accrued expenses |
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|
11,276 |
|
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|
9,704 |
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Short-term borrowings |
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247 |
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Current portion of long-term debt |
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|
307 |
|
Deferred income |
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|
998 |
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|
1,045 |
|
Other current liabilities |
|
|
1,571 |
|
|
|
1,518 |
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|
|
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Total current liabilities |
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29,427 |
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|
27,387 |
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Non-current liabilities: |
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|
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Long-term debt |
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15,559 |
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|
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Deferred income |
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|
4,757 |
|
|
|
3,899 |
|
Other |
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4,055 |
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|
|
2,739 |
|
|
|
|
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|
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Total non-current liabilities |
|
|
24,371 |
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|
|
6,638 |
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|
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|
|
|
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Commitments and contingencies |
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Stockholders equity: |
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Preferred stock, $1.00 par value, authorized 2,000 shares,
issued and outstanding, none |
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|
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|
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Common stock, $0.02 par value, authorized 100,000 shares,
issued and outstanding, 22,323 and 22,262 shares |
|
|
446 |
|
|
|
445 |
|
Additional paid-in capital |
|
|
142,092 |
|
|
|
140,030 |
|
Accumulated deficit |
|
|
(46,952 |
) |
|
|
(49,016 |
) |
Accumulated other comprehensive income |
|
|
15,264 |
|
|
|
8,872 |
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|
|
|
|
|
|
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Total stockholders equity |
|
|
110,850 |
|
|
|
100,331 |
|
|
|
|
|
|
|
|
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$ |
164,648 |
|
|
$ |
134,356 |
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|
|
|
|
|
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|
The
accompanying Notes to Unaudited Condensed Consolidated Financial Statements are an integral part of these financial statements.
3
Bentley Pharmaceuticals, Inc. and Subsidiaries
Unaudited Consolidated Income Statements
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For the Three Months Ended |
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For the Nine Months Ended |
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(in thousands, except per share data) |
|
September 30, |
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September 30, |
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2007 |
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2006 |
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2007 |
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|
2006 |
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Revenues: |
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Net product sales |
|
$ |
24,131 |
|
|
$ |
22,873 |
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|
$ |
81,598 |
|
|
$ |
75,900 |
|
Licensing and collaboration revenues |
|
|
3,217 |
|
|
|
2,283 |
|
|
|
8,320 |
|
|
|
6,517 |
|
|
|
|
|
|
|
|
|
|
|
|
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Total revenues |
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|
27,348 |
|
|
|
25,156 |
|
|
|
89,918 |
|
|
|
82,417 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Cost of net product sales |
|
|
14,451 |
|
|
|
11,778 |
|
|
|
46,138 |
|
|
|
37,182 |
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|
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|
|
|
|
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|
|
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|
|
|
|
|
|
|
|
|
|
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|
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|
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Gross profit |
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|
12,897 |
|
|
|
13,378 |
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|
43,780 |
|
|
|
45,235 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Operating expenses: |
|
|
|
|
|
|
|
|
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Selling and marketing |
|
|
4,080 |
|
|
|
3,495 |
|
|
|
13,338 |
|
|
|
11,876 |
|
General and administrative |
|
|
4,098 |
|
|
|
3,751 |
|
|
|
12,016 |
|
|
|
11,320 |
|
Research and development |
|
|
3,017 |
|
|
|
2,447 |
|
|
|
9,194 |
|
|
|
7,850 |
|
Litigation settlement |
|
|
|
|
|
|
8,932 |
|
|
|
|
|
|
|
10,269 |
|
Separation costs |
|
|
846 |
|
|
|
|
|
|
|
1,153 |
|
|
|
|
|
Depreciation and amortization |
|
|
489 |
|
|
|
460 |
|
|
|
1,543 |
|
|
|
1,341 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
12,530 |
|
|
|
19,085 |
|
|
|
37,244 |
|
|
|
42,656 |
|
|
|
|
|
|
|
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
Income (loss) from operations |
|
|
367 |
|
|
|
(5,707 |
) |
|
|
6,536 |
|
|
|
2,579 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Other income (expenses): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
339 |
|
|
|
223 |
|
|
|
706 |
|
|
|
661 |
|
Interest expense |
|
|
(247 |
) |
|
|
(15 |
) |
|
|
(348 |
) |
|
|
(109 |
) |
Other, net |
|
|
(149 |
) |
|
|
|
|
|
|
84 |
|
|
|
36 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) before income taxes |
|
|
310 |
|
|
|
(5,499 |
) |
|
|
6,978 |
|
|
|
3,167 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Provision for income taxes |
|
|
911 |
|
|
|
1,730 |
|
|
|
4,509 |
|
|
|
6,607 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income |
|
$ |
(601 |
) |
|
$ |
(7,229 |
) |
|
$ |
2,469 |
|
|
$ |
(3,440 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income per common share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
(0.03 |
) |
|
$ |
(0.33 |
) |
|
$ |
0.11 |
|
|
$ |
(0.16 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted |
|
$ |
(0.03 |
) |
|
$ |
(0.33 |
) |
|
$ |
0.11 |
|
|
$ |
(0.16 |
) |
|
|
|
|
|
|
|
|
|
|
|
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Weighted average common
shares outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
22,354 |
|
|
|
22,194 |
|
|
|
22,322 |
|
|
|
22,107 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted |
|
|
22,354 |
|
|
|
22,194 |
|
|
|
22,829 |
|
|
|
22,107 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The
accompanying Notes to Unaudited Condensed Consolidated Financial Statements are an integral part of these financial statements.
4
Bentley Pharmaceuticals, Inc. and Subsidiaries
Unaudited Consolidated Statement of Changes in Stockholders Equity
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
$0.02 Par Value |
|
|
Additional |
|
|
|
|
|
|
Other |
|
|
|
|
(in thousands) |
|
Common Stock |
|
|
Paid-In |
|
|
Accumulated |
|
|
Comprehensive |
|
|
|
|
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Deficit |
|
|
Income |
|
|
Total |
|
Balance at December 31, 2006 |
|
|
22,262 |
|
|
$ |
445 |
|
|
$ |
140,030 |
|
|
$ |
(49,016 |
) |
|
$ |
8,872 |
|
|
$ |
100,331 |
|
|
Cumulative effect change in accounting
from the implementation of FIN 48 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(405 |
) |
|
|
|
|
|
|
(405 |
) |
|
Comprehensive income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,469 |
|
|
|
|
|
|
|
2,469 |
|
Other comprehensive income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation adjustment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6,392 |
|
|
|
6,392 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
8,861 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise of stock options |
|
|
46 |
|
|
|
1 |
|
|
|
191 |
|
|
|
|
|
|
|
|
|
|
|
192 |
|
Purchase of treasury shares |
|
|
(4 |
) |
|
|
|
|
|
|
(52 |
) |
|
|
|
|
|
|
|
|
|
|
(52 |
) |
Stock-based compensation |
|
|
19 |
|
|
|
|
|
|
|
1,923 |
|
|
|
|
|
|
|
|
|
|
|
1,923 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at September 30, 2007 |
|
|
22,323 |
|
|
$ |
446 |
|
|
$ |
142,092 |
|
|
$ |
(46,952 |
) |
|
$ |
15,264 |
|
|
$ |
110,850 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The
accompanying Notes to Unaudited Condensed Consolidated Financial Statements are an integral part of these financial statements.
5
Bentley Pharmaceuticals, Inc. and Subsidiaries
Unaudited Consolidated Statements of Cash Flows
|
|
|
|
|
|
|
|
|
|
|
For the Nine Months Ended |
|
(in
thousands) |
|
September 30, |
|
|
|
2007 |
|
|
2006 |
|
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
Net income (loss) |
|
$ |
2,469 |
|
|
$ |
(3,440 |
) |
Adjustments
to reconcile net income (loss) to net
cash provided by operating activities: |
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
4,959 |
|
|
|
4,038 |
|
Non-cash charge for inventory write-down and reserves |
|
|
416 |
|
|
|
|
|
Foreign currency gains |
|
|
(56 |
) |
|
|
|
|
Stock-based compensation expense |
|
|
1,923 |
|
|
|
1,633 |
|
Change in fair value of derivative instrument |
|
|
131 |
|
|
|
|
|
Loss on disposal of assets |
|
|
429 |
|
|
|
50 |
|
Other non-cash items |
|
|
8 |
|
|
|
8 |
|
(Increase) decrease in assets and
increase (decrease) in liabilities: |
|
|
|
|
|
|
|
|
Receivables,
net |
|
|
3,507 |
|
|
|
(3,805 |
) |
Inventories |
|
|
1,883 |
|
|
|
(2,118 |
) |
Deferred income taxes |
|
|
(358 |
) |
|
|
(694 |
) |
Prepaid expenses and other current assets |
|
|
(548 |
) |
|
|
229 |
|
Other assets |
|
|
(58 |
) |
|
|
(6 |
) |
Accounts payable and accrued expenses |
|
|
978 |
|
|
|
1,331 |
|
Deferred income |
|
|
399 |
|
|
|
1,351 |
|
Other liabilities |
|
|
511 |
|
|
|
7,546 |
|
|
|
|
|
|
|
|
Net cash provided by operating activities |
|
|
16,593 |
|
|
|
6,123 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
Additions to fixed assets |
|
|
(7,489 |
) |
|
|
(12,070 |
) |
Additions to drug licenses and related costs |
|
|
(1,780 |
) |
|
|
(1,803 |
) |
Proceeds from the sale of fixed assets |
|
|
30 |
|
|
|
|
|
Purchase of investments |
|
|
(2 |
) |
|
|
(2,402 |
) |
Proceeds from investments |
|
|
2,659 |
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in investing activities |
|
|
(6,582 |
) |
|
|
(16,275 |
) |
|
|
|
|
|
|
|
(Continued on following page)
The
accompanying Notes to Unaudited Condensed Consolidated Financial Statements are an integral part of these financial statements.
6
Bentley Pharmaceuticals, Inc. and Subsidiaries
Unaudited Consolidated Statements of Cash Flows (Concluded)
|
|
|
|
|
|
|
|
|
|
|
For the Nine Months Ended |
|
(in thousands) |
|
September 30, |
|
|
|
2007 |
|
|
2006 |
|
|
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
Proceeds from the exercise of stock options |
|
$ |
192 |
|
|
$ |
150 |
|
Remittance of employee tax liabilities in exchange
for common stock tendered to the Company |
|
|
(52 |
) |
|
|
(1,907 |
) |
Proceeds from borrowings |
|
|
14,807 |
|
|
|
1,404 |
|
Repayment of borrowings |
|
|
(554 |
) |
|
|
(3,700 |
) |
|
|
|
|
|
|
|
Net cash provided by (used) in financing activities |
|
|
14,393 |
|
|
|
(4,053 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of exchange rate changes on cash |
|
|
1,624 |
|
|
|
21 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase (decrease) in cash and cash equivalents |
|
|
26,028 |
|
|
|
(14,184 |
) |
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at beginning of period |
|
|
12,424 |
|
|
|
32,384 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
$ |
38,452 |
|
|
$ |
18,200 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental Disclosures of Cash Flow Information |
|
|
|
|
|
|
|
|
The Company paid cash during the period for: |
|
|
|
|
|
|
|
|
Interest |
|
$ |
22 |
|
|
$ |
110 |
|
|
|
|
|
|
|
|
Foreign income taxes |
|
$ |
4,099 |
|
|
$ |
4,372 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental Disclosures of Non-Cash Financing and Investing
Activities |
|
|
|
|
|
|
|
|
The Company has issued Common Stock as equity-based
compensation in lieu of cash during the period as follows: |
|
|
|
|
|
|
|
|
Shares |
|
|
19 |
|
|
|
14 |
|
|
|
|
|
|
|
|
Amount |
|
$ |
191 |
|
|
$ |
182 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amounts included in accounts payable at end of
period for fixed asset and drug license purchases |
|
$ |
2,202 |
|
|
$ |
3,796 |
|
|
|
|
|
|
|
|
The
accompanying Notes to Unaudited Condensed Consolidated Financial Statements are an integral part of these financial statements.
7
Bentley Pharmaceuticals, Inc. and Subsidiaries
Notes to Unaudited Condensed Consolidated Financial Statements
History and Operations
Bentley Pharmaceuticals, Inc. and Subsidiaries (which may be referred to as Bentley or the
Company), headquartered in the U.S., is an international specialty pharmaceutical company,
incorporated in the State of Delaware, focused on:
|
|
|
Specialty Generics: development, licensing and sales of generic and branded generic
pharmaceutical products and active pharmaceutical ingredients (API) and the manufacturing
of pharmaceuticals for others; and |
|
|
|
|
Drug Delivery: research, development and licensing/commercialization of advanced drug
delivery technologies and pharmaceutical products. |
Bentleys pharmaceutical product sales and licensing activities are based primarily in Spain,
where it has a significant commercial presence and manufactures and markets approximately 180
product presentations (stock keeping units, or SKUs) through three wholly-owned Spanish
subsidiaries: Laboratorios Belmac, Laboratorios Davur and Laboratorios Rimafar. Bentleys products
are in four primary therapeutic areas: cardiovascular, gastrointestinal, central nervous system and
infectious diseases. Although the majority of the Companys sales of these products are currently
in the Spanish market, it has recently focused on increasing sales in other European countries and
other geographic regions through strategic alliances with companies in these territories. The
Company continually adds to its product portfolio in response to increasing market demand for
generic and branded generic therapeutic agents and, when appropriate, divests portfolio products
considered to be redundant or that have become non-strategic. The Company manufactures its finished
dosage pharmaceutical products in its Spanish manufacturing facility which received approval from
the U.S. Food and Drug Administration (FDA) in late 2006 for the manufacture of its first U.S.
generic product. The Company owns a manufacturing facility in Spain that specializes in the
manufacturing of several API products. This facility has also been approved by the FDA for the
manufacture of one ingredient for marketing and sale in the U.S. The Company markets its API
products through its Spanish subsidiary, Bentley A.P.I. The Company also has an Irish subsidiary,
Bentley Pharmaceuticals Ireland Limited, which launched its first product in late 2006.
The Company has U.S. and international patents and other proprietary rights to technologies
that facilitate the absorption of drugs. Bentley is developing products that incorporate its drug
delivery technologies and has licensed applications of its proprietary CPE-215® drug delivery
technology to Auxilium Pharmaceuticals, Inc., which launched Testim® in the U.S. market in February
2003. Testim, which incorporates Bentleys CPE-215 drug delivery technology, is a gel indicated
for testosterone replacement therapy. Bentley continues to seek other pharmaceutical and
biotechnology companies to form additional strategic alliances to facilitate the development and
commercialization of other products using its drug delivery technologies, including the delivery of
insulin to diabetic patients intranasally and the treatment of nail fungus infections topically.
In addition, Bentley continues to seek alliances with academic organizations to explore the
delivery of macromolecules.
On October 23, 2007 the Company announced a plan to spin-off its drug delivery business, which
is subject to a number of conditions. Management expects that shares of the new specialty
pharmaceutical drug delivery company, CPEX Pharmaceuticals, Inc. (which may be referred to as
CPEX), will be distributed to Bentley stockholders by means of a stock dividend. On the record
date, which has not yet been set, each Bentley stockholder will be entitled to receive shares of
CPEX in connection with the spin-off of the drug delivery businesses. The spin-off would result in
CPEX operating as an independent entity with publicly traded common stock. Bentley would not have
any ownership interest in CPEX subsequent to the spin-off.
8
In connection with the spin-off, CPEX and Bentley expect to enter into a series of agreements,
including a separation and distribution agreement, a transition services agreement, an employee
matters agreement and a tax allocation agreement. Consummation of the separation is subject to
certain conditions, including final approval by the Bentley Board of Directors, approval for
listing of CPEX common stock on an exchange, and the effectiveness of the registration statement
filed with the Securities and Exchange Commission in connection with the separation. Approval by
Bentleys stockholders is not required as a condition to the consummation of the proposed
separation.
The Company has incurred and is expected to continue to incur legal, tax and other strategic
consulting costs specifically associated with the planned spin-off. These costs totaled $846,000
and $1,153,000 in the three and nine months ended September 30, 2007, respectively, and have been
reported as separation costs within operating expenses in the Companys Unaudited Consolidated
Income Statements. Approximately $307,000 of
separation costs incurred during the first two quarters of 2007 were
reclassified from general and administrative expenses to separation costs to conform with the current
period presentation.
Basis
of Unaudited Condensed Consolidated Financial Statements
The
Unaudited Condensed Consolidated Financial Statements of Bentley as of September 30, 2007 and for
the three and nine months ended September 30, 2007 and 2006, included herein, have been prepared by
the Company, without audit, pursuant to the rules and regulations of the Securities and Exchange
Commission. 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 insofar as such information was disclosed in the Companys
consolidated financial statements for the year ended
December 31, 2006. These Unaudited Condensed
Consolidated Financial Statements should be read in conjunction with the summary of significant
accounting policies and the audited consolidated financial statements and notes thereto included in
Bentleys Annual Report on Form 10-K for the year ended December 31, 2006, referred to as our 2006
Form 10-K.
In the opinion of management, the accompanying Unaudited Condensed Consolidated
Financial
Statements as of September 30, 2007 and for the three and nine months ended September 30, 2007 and
2006 are presented on a basis consistent with the audited consolidated financial statements for the
year ended December 31, 2006 and contain all adjustments, consisting only of normal recurring
adjustments, necessary to present fairly Bentleys financial
position as of September 30, 2007 and December 31, 2006 and
the results of its operations for the three and nine months ended September 30, 2007
and 2006 and cash flows for the nine months ended September 30,
2007 and 2006. The results of operations for the three and nine months ended September 30, 2007 should
not necessarily be considered indicative of the results to be expected for any subsequent period or
for the full year ending December 31, 2007.
Cash and cash equivalents
The Company considers all highly liquid investments with remaining maturities of three months
or less when purchased to be cash equivalents for purposes of
classification in the Unaudited Consolidated
Balance Sheets and the Unaudited Consolidated Statements of Cash Flows. Investments in securities that do not
meet the definition of cash equivalents are classified as
marketable securities in the Unaudited Consolidated
Balance Sheets.
Included in cash and cash equivalents at September 30, 2007 and December 31, 2006 are
approximately $23,782,000 and $357,000, respectively, of short-term investments considered to be
cash equivalents, as the original maturity dates of such investments were three months or less when
purchased.
Fair value of financial instruments
On January 1, 2007, the Company adopted Statement of Financial Accounting Standards (SFAS)
No. 157, Fair Value Measurements (SFAS No. 157), which provides guidance for measuring the fair
value of assets and liabilities, and requires expanded disclosures about fair value measurements.
SFAS No. 157 indicates that fair value should be determined based on the assumptions marketplace
participants would use in pricing the asset or liability, and provides additional guidelines to
consider in determining the market-based measurement. The adoption of SFAS No. 157 did not have a
material impact on the Companys Unaudited Condensed
Consolidated Financial Statements.
9
Receivables
Receivables consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
September 30, 2007 |
|
|
December 31, 2006 |
|
Trade receivables (of which $0 and
$247, respectively, collateralize short-term
borrowings with Spanish financial
institutions) |
|
$ |
26,443 |
|
|
$ |
27,880 |
|
VAT receivable |
|
|
2,453 |
|
|
|
3,151 |
|
Royalties receivable |
|
|
3,065 |
|
|
|
2,261 |
|
Other |
|
|
123 |
|
|
|
82 |
|
|
|
|
|
|
|
|
|
|
|
32,084 |
|
|
|
33,374 |
|
Less-allowance for doubtful accounts |
|
|
(615 |
) |
|
|
(411 |
) |
|
|
|
|
|
|
|
|
|
$ |
31,469 |
|
|
$ |
32,963 |
|
|
|
|
|
|
|
|
Inventories
Inventories are stated at the lower of cost or market, cost being determined on the first in,
first out (FIFO) method. Reserves for slow moving and obsolete inventories are provided based on
historical experience and current product demand.
Balances are comprised of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
September 30, 2007 |
|
|
December 31, 2006 |
|
Raw materials |
|
$ |
10,034 |
|
|
$ |
8,669 |
|
Finished goods |
|
|
5,818 |
|
|
|
7,621 |
|
|
|
|
|
|
|
|
|
|
|
15,852 |
|
|
|
16,290 |
|
Less allowance for slow moving
inventory |
|
|
(809 |
) |
|
|
(11 |
) |
|
|
|
|
|
|
|
|
|
$ |
15,043 |
|
|
$ |
16,279 |
|
|
|
|
|
|
|
|
Included in the Companys inventories at September 30, 2007 and December 31, 2006 are $137,000
and $1,338,000, respectively, related to the Companys first U.S. generic product which was
launched in late December 2006. The Company has accounted for these goods as consigned inventories
that have been shipped to the Companys collaborator. Market price conditions and demand for this
product are less favorable than originally estimated. As a result, in the nine months ended
September 30, 2007, the Company recorded net adjustments totaling $1,010,000 to write-down these
inventories to their net realizable value and reserve for slow moving inventories. In accordance
with its collaboration agreement, the Company is liable for a portion of these adjustments and has
therefore recorded a net charge of approximately $416,000 to cost
of net product sales in the Unaudited Consolidated Income Statement, reflecting its share of
these adjustments.
The Company has received certain payments from its collaborator in anticipation of future
sales of the consigned products. As of September 30, 2007 and December 31, 2006, the Company has
recorded $311,000 and $481,000, respectively, as payments from its collaborator net of adjustments,
which have been recorded in other current liabilities on the
Unaudited Consolidated Balance Sheets.
10
Fixed assets
Fixed assets consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
September 30, 2007 |
|
|
December 31, 2006 |
|
Land |
|
$ |
3,035 |
|
|
$ |
2,875 |
|
Buildings and improvements |
|
|
25,194 |
|
|
|
17,538 |
|
Equipment |
|
|
25,432 |
|
|
|
20,591 |
|
Furniture and fixtures |
|
|
2,310 |
|
|
|
2,138 |
|
Other |
|
|
338 |
|
|
|
394 |
|
|
|
|
|
|
|
|
|
|
|
56,309 |
|
|
|
43,536 |
|
Capital in-progress |
|
|
19,539 |
|
|
|
20,213 |
|
|
|
|
|
|
|
|
|
|
|
75,848 |
|
|
|
63,749 |
|
Less accumulated depreciation |
|
|
(20,027 |
) |
|
|
(15,193 |
) |
|
|
|
|
|
|
|
|
|
$ |
55,821 |
|
|
$ |
48,556 |
|
|
|
|
|
|
|
|
Depreciation expense of approximately $271,000 and $234,000 has been charged to operations as
a component of depreciation and amortization expense in the
Unaudited Consolidated Income Statements for the
nine months ended September 30, 2007 and 2006, respectively.
Depreciation expense totaling approximately
$3,416,000 and $2,697,000 has been included in cost of net product
sales in the Unaudited Consolidated Income Statement during the nine months
ended September 30, 2007 and 2006, respectively.
Long-term debt
Long-term debt consists of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
September 30, 2007 |
|
|
December 31, 2006 |
|
Loans payable |
|
$ |
15,559 |
|
|
$ |
307 |
|
Less-current portion of long-term debt |
|
|
|
|
|
|
(307 |
) |
|
|
|
|
|
|
|
|
|
$ |
15,559 |
|
|
$ |
|
|
|
|
|
|
|
|
|
On June 29, 2007, the Companys subsidiary, Laboratorios Belmac (Belmac), entered into a
loan agreement with a Spanish financial institution, pursuant to which Belmac borrowed 11,000,000
Euros (approximately $15,559,000 at September 30, 2007). In accordance with the loan agreement,
Belmac will be charged interest on the loan at a variable rate, reset quarterly, equal to the Euro
Interbank Offered Rate, plus 0.5%, plus a single, up-front fee of 0.2%. The interest rate under the
loan at September 30, 2007 was 5.02%. The principal of the loan will be repaid in quarterly
installments of 412,500 Euros (approximately $583,000) beginning December 31, 2008, with the
balance due on December 31, 2013. Maturities on the long-term debt are as follow (in thousands):
|
|
|
|
|
|
|
Year |
|
Principal Payment |
|
|
2007 |
|
$ |
|
|
|
2008 |
|
|
583 |
|
|
2009 |
|
|
2,334 |
|
|
2010 |
|
|
2,334 |
|
|
2011 |
|
|
2,334 |
|
|
2012 and 2013 |
|
|
7,974 |
|
|
|
|
|
|
|
|
Total |
|
$ |
15,559 |
|
|
|
|
|
|
Pursuant to financial covenants in the loan agreement, Belmac must (i) maintain a net
financial debt to net equity ratio of less than 0.33 to 1; (ii) maintain a net financial debt to
operating profit ratio of less than 2.75 to 1; and (iii) not have either such ratio increase in any
fiscal year by more than 20% over the respective ratio from the prior fiscal year. In addition,
Belmacs obligations under the loan agreement have been guaranteed by Bentley and Bentleys other
subsidiaries in Spain. Belmac has agreed to pledge assets at the request of the financial
institution if Belmac fails to comply with these financial covenants and Belmac has also agreed to
not pledge any assets to any other party. The loan may be prepaid at any time without a fee.
11
In previous years, the Company entered into loan agreements with the Spanish government as a
part of government-sponsored research-funding programs. The loans were non-interest bearing and
payable in annual installments beginning in 2005. These loans were repaid in full in the nine
months ended September 30, 2007.
Stockholders equity
A substantial amount of the Companys business is conducted in Europe and is therefore
influenced by fluctuations in the U.S. Dollars value in relation to other currencies, specifically
the Euro. The exchange rates at September 30, 2007 and December 31, 2006 are as follows:
|
|
|
|
|
|
|
|
U.S. Dollars per Euro |
|
September 30, 2007 |
|
December 31, 2006 |
|
|
YTD weighted average exchange rate |
|
1.34 |
|
1.26 |
|
|
Exchange rate |
|
1.41 |
|
1.31 |
|
The net effect of foreign currency translation on the Companys Unaudited Consolidated
Balance Sheet for the three and nine months ended September 30, 2007 was a net increase of
$4,374,000 and $6,392,000, respectively, and the cumulative historical effect as of September 30,
2007 was an increase of $15,264,000, as reflected in accumulated
other comprehensive income. The carrying value of assets and liabilities can be materially
affected by changes in foreign currency exchange rates, as can the revenues and expenses.
Supplemental
disclosures related to Unaudited Consolidated Statements of Cash Flows
During the nine months ended September 30, 2007, the Chief Executive Officer (CEO), the
President, and the Chief Medical Officer (CMO) of the Company were issued an aggregate of 11,150
shares of Bentley Common Stock, before tax withholdings, upon vesting of their respective
restricted stock unit awards. At the request of the recipients, the Company withheld approximately
3,783 shares of Common Stock, with a fair market value of approximately $45,000, in order to
satisfy minimum federal and statutory tax withholding requirements. The shares of Common Stock
withheld were recorded at fair market value and are held by the Company as treasury shares. As of
September 30, 2007 and December 31, 2006, the Company has recorded approximately 853,000 and
849,100 shares, respectively, as treasury stock, with an historical cost of $10,833,300 and
$10,781,700, respectively, which has been accounted for as a reduction of additional paid in
capital in the Unaudited Condensed Consolidated Financial Statements.
During the nine months ended September 30, 2006, the CEO and the CMO of the Company and the
former CFO of the Company exercised stock options to purchase an aggregate of 650,400 shares of the
Companys Common Stock. In satisfaction of the option exercise prices, the Company received an
aggregate of approximately 254,300 shares of previously acquired Bentley Common Stock, with a fair
market value of approximately $3,314,000. The Company withheld a total of approximately 144,400
shares of Common Stock, with a fair market value of approximately $1,900,000, from these employees
in order to satisfy minimum federal and statutory tax withholding requirements. The shares of
Common Stock acquired by the Company in connection with these stock option exercises were recorded
at fair market value and are held by the Company as treasury shares. In addition, in accordance
with the separation agreement with the Former CFO, an additional 1,604 shares of Common Stock
associated with a grant of restricted stock units became vested and issuable to the Former CFO on
September 30, 2006. The Company withheld a total of 584 shares of Common Stock with a fair market
value of approximately $7,000 from the issuance of those shares in order to satisfy minimum federal
and statutory tax withholding requirements.
12
Revenue recognition
Revenue on product sales is recognized when persuasive evidence of an arrangement exists, the
price is fixed and final, delivery has occurred and there is a reasonable assurance of collection
of the sales proceeds. The Company generally obtains purchase authorizations from its customers for
a specified amount of product at a specified price and considers delivery to have occurred when the
customer takes possession of the product. The Company provides its customers with a limited right
of return. Revenue is recognized upon delivery and a reserve for sales returns is recorded when
considered appropriate. The Company has demonstrated the ability to make reasonable and reliable
estimates of product returns in accordance with SFAS No. 48, Revenue Recognition When Right of
Return Exists, (SFAS No. 48) and of allowances for doubtful accounts based on significant
historical experience.
Revenue from service, research and development, and licensing agreements is recognized when
the service procedures have been completed or as revenue recognition criteria have been met for
each separate unit of accounting as defined in Emerging Issues Task Force (EITF) Issue No. 00-21,
Accounting for Revenue Arrangements with Multiple Deliverables.
The Company has deferred the recognition of approximately $5,755,000 and $4,944,000 of
revenues as of September 30, 2007 and December 31, 2006, respectively, for which the earnings
process has not been completed.
The Company earns royalty revenues on Auxiliums sales of Testim, which incorporates the
Companys CPE-215 permeation enhancement technology. Since 2003, Auxilium has sold Testim to
pharmaceutical wholesalers and chain drug stores, which have the right to return purchased product
prior to the units being dispensed through patient prescriptions. Historically, customer returns
were not able to be reasonably estimated. Therefore, in accordance with SFAS No. 48, the Company
deferred the recognition of royalty revenues on product shipments of Testim until the units were
dispensed through patient prescriptions. In June 2006, the Company determined that it could
reasonably estimate future product returns on sales of Testim based on historical return
experience. As a result the Company recorded a change in estimate and recognized its deferred
Testim royalties. The Company recognized royalty revenues of $7,879,000 and $6,089,000 in the nine
months ended September 30, 2007 and 2006, respectively.
Provision for income taxes
On January 1, 2007, the Company adopted the provisions of Financial Standards Accounting Board
Interpretation No. 48, Accounting for Uncertainty in Income Taxes (FIN 48) an interpretation of
FASB Statement No. 109, Accounting for Income Taxes, (SFAS No. 109). The purpose of FIN 48 is to
clarify and set forth consistent rules for accounting for uncertain tax positions in accordance
with SFAS No. 109 by requiring the application of a more likely than not threshold for the
recognition and derecognition of tax positions. As a result of the implementation of FIN 48, the
Company recorded a $405,000 increase in its non-current liabilities during the quarter ended March
31, 2007 for uncertain tax positions which was accounted for as an increase to the January 1, 2007
accumulated deficit. In order to conform with the balance sheet disclosure requirements of FIN 48,
the Company also reclassified its previously recorded liabilities of $546,000 for uncertain tax
positions from accrued expenses to other non-current liabilities during the quarter ended March 31,
2007. The Company had $935,000 of unrecognized tax benefits at the adoption date, all of which
would affect its effective tax rate if recognized. The Companys unrecognized tax benefits
decreased by $272,000 during the nine months ended September 30, 2007 as a result of the expiration
of certain foreign tax contingencies. The Company recognizes interest and penalties related to
uncertain tax positions as a component of the provision for income taxes. As of the date of
adoption, the Company had approximately $249,000 of accrued penalties and $51,000 of accrued
interest related to its uncertain tax positions. Tax years ranging from 2002 to 2006 remain open to
examination by the major taxing authorities in jurisdictions where the Company is subject to
taxation, principally the U.S. and Spain.
13
As a result of reporting taxable income in Spain, the Company recorded provisions for foreign
income taxes totaling $4,509,000 and $6,607,000 for the nine months ended September 30, 2007 and
2006, respectively. The provisions represented 31% and 57% of the pre-tax income reported in Spain
for the nine months ended September 30, 2007 and 2006, respectively. The provisions represented
65% and 209% of consolidated pre-tax income for the nine months ended September 30, 2007 and 2006,
respectively.
The Company maintains various agreements by and between Bentley Pharmaceuticals, Inc. and its
subsidiaries. Income and expenses resulting from these agreements are eliminated in consolidation;
however, the related transactions affect the Companys consolidated income tax provision.
As future operating profits in the U.S. and Ireland cannot be reasonably assured, no tax
benefit has been recorded in the Unaudited Consolidated Income
Statement for the related losses, which totaled approximately $7,775,000 and
$8,474,000 for the nine months ended September 30, 2007 and 2006, respectively. The
Company has established valuation allowances equal to the full amount of the U.S. and Irish
deferred tax assets. Should the Company determine that it is more likely than not that it will
realize certain of its net deferred tax assets for which it has previously provided a valuation
allowance, an adjustment would be required to reduce the existing valuation allowance.
Basic and diluted net income (loss) per common share
Basic net income (loss) per common share is based on the weighted average number of shares of Common
Stock outstanding during each period. The Company included the dilutive effect of outstanding stock
options, as calculated using the treasury stock method and restricted stock units, when determining
the diluted net income per common share for the three and nine months ended September 30, 2007 and
2006.
The following is a reconciliation between basic and diluted net income per common share for
the nine months ended September 30, 2007. There is no dilutive effect of equity securities on the
Companys earnings per share for the three months ended September 30, 2007 and the three and nine
months ended September 30, 2006 due to the net losses reported in those periods. Dilutive
securities issuable for the nine months ended September 30, 2007 include approximately 507,000
dilutive incremental shares issuable as a result of various stock options and unvested restricted
stock units that are outstanding.
For the Nine Months Ended September 30, 2007 (in thousands, except per share data):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of Dilutive |
|
|
|
|
|
|
Basic EPS |
|
Securities |
|
Diluted EPS |
|
|
Net Income |
|
$ |
2,469 |
|
|
$ |
|
|
|
$ |
2,469 |
|
|
|
Weighted Average Common |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares Outstanding |
|
|
22,322 |
|
|
|
507 |
|
|
|
22,829 |
|
|
|
Net Income Per Common |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share |
|
$ |
0.11 |
|
|
$ |
|
|
|
$ |
0.11 |
|
|
Excluded from the diluted EPS presentation for the three months ended September 30, 2007 were
approximately 3,890,000 shares underlying outstanding stock options and 218,000 shares underlying
outstanding restricted stock units as the incremental effect of those shares would be anti-dilutive
in that period.
Excluded
from the diluted EPS presentation for the nine months ended
September 30, 2007 were approximately 1,902,000 shares
underlying outstanding stock options at exercise prices greater than
the average fair value of the Common Stock for the nine months ended
September 30, 2007 as the incremental effect of those shares would be
anti-dilutive in that period.
Excluded from the diluted EPS presentation for the three and nine months ended September 30,
2006 were approximately 3,699,000 shares underlying outstanding stock options and 111,000 shares
14
underlying outstanding restricted stock units as the incremental effect of those shares would be
anti-dilutive in those periods.
Share-based compensation
The Company has in effect equity incentive plans (the Plans), pursuant to which directors,
officers, employees and consultants of the Company have been awarded grants of restricted stock
units and options to purchase the Companys Common Stock. As of September 30, 2007, approximately
4,420,000 shares of Common Stock have been reserved for issuance under the Plans. Approximately
4,108,000 of the shares are outstanding, excluding 50,000 shares underlying restricted stock units,
contingently issuable to non-employee directors pursuant to the terms and conditions of the
respective restricted stock unit agreements. The balance of approximately 311,000 shares is
available for future issuance for any type of award allowed under the plan.
During the nine months ended September 30, 2007, the Company issued approximately 20,200
shares of Common Stock upon the vesting of restricted stock units, approximately 26,000 shares of
Common Stock upon exercise of stock options and approximately 18,800 shares of Common Stock as
share-based compensation in lieu of cash contributions to the Companys 401(k) Plan. The Company
also withheld approximately 4,300 shares upon the vesting of restricted stock units in order to
satisfy minimum federal and statutory tax withholding requirements, which were recorded as treasury
stock. An additional 30,000 restricted stock units vested during the period and are contingently
issuable to non-employee directors pursuant to the terms and conditions of the respective
restricted stock unit agreements.
Share-based compensation expense recorded for stock option and restricted stock unit awards to
employees and non-employee directors for the three months ended September 30, 2007 and 2006 was
approximately $666,000 and $598,000, respectively. Share-based compensation expense recorded for
stock option and restricted stock unit awards to employees and non-employee directors for the nine
months ended September 30, 2007 and 2006 was approximately $1,670,000 and $1,424,000, respectively.
The
related expenses were recorded in the Companys Unaudited Consolidated Income Statements
as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended |
|
|
For the Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
Cost of net product sales |
|
$ |
10 |
|
|
$ |
4 |
|
|
$ |
25 |
|
|
$ |
19 |
|
Selling and marketing expenses |
|
|
5 |
|
|
|
2 |
|
|
|
13 |
|
|
|
10 |
|
General and administrative expenses |
|
|
410 |
|
|
|
392 |
|
|
|
1,029 |
|
|
|
913 |
|
Research and development expenses |
|
|
241 |
|
|
|
200 |
|
|
|
603 |
|
|
|
482 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
666 |
|
|
$ |
598 |
|
|
$ |
1,670 |
|
|
$ |
1,424 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
No related compensation expense was capitalized as the cost of an asset and there was no
impact on net cash provided by operating activities or net cash used in financing activities as a
result of these share-based transactions.
The Company issued 18,800 and 13,900 shares in the nine months ended September 30, 2007 and
2006, respectively, as matching contributions for the Companys 401(k) Plan. General and
administrative expenses include approximately $92,000 and $87,000 of such non-cash share-based
compensation for the nine months ended September 30, 2007 and 2006, respectively. Research and
development expenses include approximately $99,000 and $120,000 of such non-cash share-based
compensation for the nine months ended September 30, 2007 and 2006, respectively.
15
Business segment information
SFAS No. 131, Disclosures About Segments of an Enterprise and Related Information, defines how
operating segments are determined and requires disclosure of certain financial and descriptive
information about a companys operating segments. The Company, headquartered in the U.S., is an
international specialty pharmaceutical company which operates in two business segments, specialty
generics and drug delivery, and two geographical locations (Europe and the U.S.).
The Companys specialty generics segment is based in Europe and develops and manufactures a
growing portfolio of generic and branded generic pharmaceuticals in Europe for the treatment of
cardiovascular, gastrointestinal, infectious and central nervous system diseases through its
subsidiary, Laboratorios Belmac, and markets these pharmaceutical products through its
subsidiaries, Laboratorios Belmac, Laboratorios Davur, Laboratorios Rimafar and Bentley
Pharmaceuticals Ireland. The U.S. operations of this segment include any sales of generic
pharmaceuticals in the U.S. and continued research and development activities to bring additional
generic pharmaceutical products into the U.S. This segment also manufactures and sells active
pharmaceutical ingredients through its subsidiary, Bentley A.P.I.
The Companys drug delivery segment is based in both the U.S. and Europe and is focused on the
advancement of proprietary drug delivery technologies that enhance or facilitate the absorption of
pharmaceutical compounds across various membranes. In the U.S., the Companys activities consist
primarily of licensing, product research and development, business development activities,
corporate management and administration.
Set forth in the tables below is certain financial information with respect to the Companys
business and geographical segments for the three and nine months ended September 30, 2007 and 2006
and as of September 30, 2007 and December 31, 2006. These segments use the same accounting policies
as those described in the summary of significant accounting policies in Note 2 of the Companys
Annual Report on Form 10-K for the year ended December 31, 2006 (the 2006 Form 10-K).
For the Three Months Ended September 30, 2007 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Specialty Generics |
|
Drug Delivery |
|
|
|
|
Europe |
|
U.S. |
|
Europe |
|
U.S. |
|
Consolidated |
Net product sales |
|
$ |
23,930 |
|
|
$ |
201 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
24,131 |
|
Licensing and collaboration revenues |
|
|
148 |
|
|
|
|
|
|
|
|
|
|
|
3,069 |
|
|
|
3,217 |
|
Total revenues |
|
|
24,078 |
|
|
|
201 |
|
|
|
|
|
|
|
3,069 |
|
|
|
27,348 |
|
Cost of net product sales |
|
|
14,291 |
|
|
|
160 |
|
|
|
|
|
|
|
|
|
|
|
14,451 |
|
Gross Profit |
|
|
9,787 |
|
|
|
41 |
|
|
|
|
|
|
|
3,069 |
|
|
|
12,897 |
|
Selling and marketing expense |
|
|
4,080 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,080 |
|
General and administrative expense |
|
|
2,021 |
|
|
|
(8 |
) |
|
|
|
|
|
|
2,085 |
|
|
|
4,098 |
|
Research and development expense |
|
|
341 |
|
|
|
|
|
|
|
1,338 |
|
|
|
1,338 |
|
|
|
3,017 |
|
Separation costs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
846 |
|
|
|
846 |
|
Depreciation and amortization expense |
|
|
290 |
|
|
|
39 |
|
|
|
|
|
|
|
160 |
|
|
|
489 |
|
Income (loss) from operations |
|
|
3,055 |
|
|
|
10 |
|
|
|
(1,338 |
) |
|
|
(1,360 |
) |
|
|
367 |
|
Interest income |
|
|
188 |
|
|
|
|
|
|
|
|
|
|
|
151 |
|
|
|
339 |
|
Interest expense |
|
|
(246 |
) |
|
|
|
|
|
|
|
|
|
|
(1 |
) |
|
|
(247 |
) |
Other income (expense), net |
|
|
(147 |
) |
|
|
|
|
|
|
|
|
|
|
(2 |
) |
|
|
(149 |
) |
Income (loss) before income taxes |
|
|
2,850 |
|
|
|
10 |
|
|
|
(1,338 |
) |
|
|
(1,212 |
) |
|
|
310 |
|
Provision for income taxes |
|
|
911 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
911 |
|
Net income (loss) |
|
|
1,939 |
|
|
|
10 |
|
|
|
(1,338 |
) |
|
|
(1,212 |
) |
|
|
(601 |
) |
Expenditures for fixed assets |
|
|
3,174 |
|
|
|
|
|
|
|
|
|
|
|
57 |
|
|
|
3,231 |
|
Expenditures for drug licenses |
|
|
575 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
575 |
|
16
For the Three Months Ended September 30, 2006 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Specialty Generics |
|
Drug Delivery |
|
|
|
|
Europe |
|
U.S. |
|
Europe |
|
U.S. |
|
Consolidated |
Net product sales |
|
$ |
22,834 |
|
|
$ |
39 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
22,873 |
|
Licensing and collaboration revenues |
|
|
170 |
|
|
|
|
|
|
|
|
|
|
|
2,113 |
|
|
|
2,283 |
|
Total revenues |
|
|
23,004 |
|
|
|
39 |
|
|
|
|
|
|
|
2,113 |
|
|
|
25,156 |
|
Cost of net product sales |
|
|
11,739 |
|
|
|
39 |
|
|
|
|
|
|
|
|
|
|
|
11,778 |
|
Gross profit |
|
|
11,265 |
|
|
|
|
|
|
|
|
|
|
|
2,113 |
|
|
|
13,378 |
|
Selling and marketing expense |
|
|
3,495 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,495 |
|
General and administrative expense |
|
|
1,901 |
|
|
|
|
|
|
|
1 |
|
|
|
1,849 |
|
|
|
3,751 |
|
Research and development expense |
|
|
421 |
|
|
|
|
|
|
|
1,013 |
|
|
|
1,013 |
|
|
|
2,447 |
|
Litigation settlement |
|
|
7,764 |
|
|
|
1,168 |
|
|
|
|
|
|
|
|
|
|
|
8,932 |
|
Depreciation
and amortization expense |
|
|
270 |
|
|
|
21 |
|
|
|
|
|
|
|
169 |
|
|
|
460 |
|
Loss from operations |
|
|
(2,586 |
) |
|
|
(1,189 |
) |
|
|
(1,014 |
) |
|
|
(918 |
) |
|
|
(5,707 |
) |
Interest income |
|
|
55 |
|
|
|
|
|
|
|
|
|
|
|
168 |
|
|
|
223 |
|
Interest expense |
|
|
(15 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(15 |
) |
Loss before income taxes |
|
|
(2,546 |
) |
|
|
(1,189 |
) |
|
|
(1,014 |
) |
|
|
(750 |
) |
|
|
(5,499 |
) |
Provision for income taxes |
|
|
1,730 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,730 |
|
Net loss |
|
|
(4,276 |
) |
|
|
(1,189 |
) |
|
|
(1,014 |
) |
|
|
(750 |
) |
|
|
(7,229 |
) |
Expenditures for fixed assets |
|
|
4,597 |
|
|
|
|
|
|
|
|
|
|
|
157 |
|
|
|
4,754 |
|
Expenditures for drug licenses |
|
|
572 |
|
|
|
|
|
|
|
|
|
|
|
360 |
|
|
|
932 |
|
For the Nine Months Ended September 30, 2007 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Specialty Generics |
|
Drug Delivery |
|
|
|
|
Europe |
|
U.S. |
|
Europe |
|
U.S. |
|
Consolidated |
Net product sales |
|
$ |
80,997 |
|
|
$ |
601 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
81,598 |
|
Licensing and collaboration revenues |
|
|
433 |
|
|
|
|
|
|
|
|
|
|
|
7,887 |
|
|
|
8,320 |
|
Total revenues |
|
|
81,430 |
|
|
|
601 |
|
|
|
|
|
|
|
7,887 |
|
|
|
89,918 |
|
Cost of net product sales |
|
|
45,134 |
|
|
|
1,004 |
|
|
|
|
|
|
|
|
|
|
|
46,138 |
|
Gross profit (loss) |
|
|
36,296 |
|
|
|
(403 |
) |
|
|
|
|
|
|
7,887 |
|
|
|
43,780 |
|
Selling and marketing expense |
|
|
13,338 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13,338 |
|
General and administrative expense |
|
|
6,689 |
|
|
|
(36 |
) |
|
|
|
|
|
|
5,363 |
|
|
|
12,016 |
|
Research and development expense |
|
|
1,341 |
|
|
|
|
|
|
|
3,926 |
|
|
|
3,927 |
|
|
|
9,194 |
|
Separation costs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,153 |
|
|
|
1,153 |
|
Depreciation and amortization expense |
|
|
848 |
|
|
|
117 |
|
|
|
|
|
|
|
578 |
|
|
|
1,543 |
|
Income (loss) from operations |
|
|
14,080 |
|
|
|
(484 |
) |
|
|
(3,926 |
) |
|
|
(3,134 |
) |
|
|
6,536 |
|
Interest income |
|
|
323 |
|
|
|
|
|
|
|
|
|
|
|
383 |
|
|
|
706 |
|
Interest expense |
|
|
(339 |
) |
|
|
|
|
|
|
|
|
|
|
(9 |
) |
|
|
(348 |
) |
Other income (expense), net |
|
|
89 |
|
|
|
|
|
|
|
|
|
|
|
(5 |
) |
|
|
84 |
|
Income (loss) before income taxes |
|
|
14,153 |
|
|
|
(484 |
) |
|
|
(3,926 |
) |
|
|
(2,765 |
) |
|
|
6,978 |
|
Provision for income taxes |
|
|
4,509 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,509 |
|
Net income (loss) |
|
|
9,644 |
|
|
|
(484 |
) |
|
|
(3,926 |
) |
|
|
(2,765 |
) |
|
|
2,469 |
|
Expenditures for fixed assets |
|
|
7,404 |
|
|
|
|
|
|
|
|
|
|
|
85 |
|
|
|
7,489 |
|
Expenditures for drug licenses |
|
|
1,591 |
|
|
|
32 |
|
|
|
|
|
|
|
157 |
|
|
|
1,780 |
|
17
For the Nine Months Ended September 30, 2006 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Specialty Generics |
|
Drug Delivery |
|
|
|
|
Europe |
|
U.S. |
|
Europe |
|
U.S. |
|
Consolidated |
Net product sales |
|
$ |
75,861 |
|
|
$ |
39 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
75,900 |
|
Licensing
and collaboration revenues |
|
|
409 |
|
|
|
|
|
|
|
|
|
|
|
6,108 |
|
|
|
6,517 |
|
Total revenues |
|
|
76,270 |
|
|
|
39 |
|
|
|
|
|
|
|
6,108 |
|
|
|
82,417 |
|
Cost of net product sales |
|
|
37,143 |
|
|
|
39 |
|
|
|
|
|
|
|
|
|
|
|
37,182 |
|
Gross profit |
|
|
39,127 |
|
|
|
|
|
|
|
|
|
|
|
6,108 |
|
|
|
45,235 |
|
Selling and marketing expense |
|
|
11,876 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
11,876 |
|
General and
administrative expense |
|
|
5,507 |
|
|
|
|
|
|
|
68 |
|
|
|
5,745 |
|
|
|
11,320 |
|
Research and
development expense |
|
|
1,374 |
|
|
|
|
|
|
|
3,238 |
|
|
|
3,238 |
|
|
|
7,850 |
|
Litigation settlement |
|
|
8,034 |
|
|
|
2,235 |
|
|
|
|
|
|
|
|
|
|
|
10,269 |
|
Depreciation
and amortization expense |
|
|
784 |
|
|
|
63 |
|
|
|
|
|
|
|
494 |
|
|
|
1,341 |
|
Income (loss) from operations |
|
|
11,552 |
|
|
|
(2,298 |
) |
|
|
(3,306 |
) |
|
|
(3,369 |
) |
|
|
2,579 |
|
Interest income |
|
|
110 |
|
|
|
|
|
|
|
|
|
|
|
551 |
|
|
|
661 |
|
Interest expense |
|
|
(109 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(109 |
) |
Other income (expense), net |
|
|
36 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
36 |
|
Income (loss) before income taxes |
|
|
11,589 |
|
|
|
(2,298 |
) |
|
|
(3,306 |
) |
|
|
(2,818 |
) |
|
|
3,167 |
|
Provision for income taxes |
|
|
6,607 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6,607 |
|
Net income (loss) |
|
|
4,982 |
|
|
|
(2,298 |
) |
|
|
(3,306 |
) |
|
|
(2,818 |
) |
|
|
(3,440 |
) |
Expenditures for fixed assets |
|
|
11,734 |
|
|
|
|
|
|
|
|
|
|
|
336 |
|
|
|
12,070 |
|
Expenditures for drug licenses |
|
|
1,128 |
|
|
|
|
|
|
|
|
|
|
|
675 |
|
|
|
1,803 |
|
As of September 30, 2007 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Specialty Generics |
|
Drug Delivery |
|
|
|
|
Europe |
|
U.S. |
|
Europe |
|
U.S. |
|
Consolidated |
Receivables, net |
|
$ |
28,345 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
3,124 |
|
|
$ |
31,469 |
|
Other current assets |
|
|
44,042 |
|
|
|
55 |
|
|
|
|
|
|
|
13,974 |
|
|
|
58,071 |
|
Fixed assets |
|
|
53,174 |
|
|
|
|
|
|
|
|
|
|
|
2,647 |
|
|
|
55,821 |
|
Drug
licenses and related costs |
|
|
12,357 |
|
|
|
1,746 |
|
|
|
|
|
|
|
3,044 |
|
|
|
17,147 |
|
Other non-current assets |
|
|
993 |
|
|
|
|
|
|
|
|
|
|
|
1,147 |
|
|
|
2,140 |
|
Total assets |
|
|
138,911 |
|
|
|
1,801 |
|
|
|
|
|
|
|
23,936 |
|
|
|
164,648 |
|
Current liabilities |
|
|
25,105 |
|
|
|
398 |
|
|
|
|
|
|
|
3,924 |
|
|
|
29,427 |
|
Long term debt |
|
|
15,559 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
15,559 |
|
Other
non-current liabilities |
|
|
8,812 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8,812 |
|
Total liabilities |
|
|
49,476 |
|
|
|
398 |
|
|
|
|
|
|
|
3,924 |
|
|
|
53,798 |
|
As of December 31, 2006 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Specialty Generics |
|
Drug Delivery |
|
|
|
|
Europe |
|
U.S. |
|
Europe |
|
U.S. |
|
Consolidated |
Receivables, net |
|
$ |
30,558 |
|
|
$ |
39 |
|
|
$ |
|
|
|
$ |
2,366 |
|
|
$ |
32,963 |
|
Other current assets |
|
|
21,758 |
|
|
|
1,338 |
|
|
|
|
|
|
|
11,631 |
|
|
|
34,727 |
|
Fixed assets |
|
|
45,738 |
|
|
|
|
|
|
|
|
|
|
|
2,818 |
|
|
|
48,556 |
|
Drug
licenses and related costs |
|
|
10,697 |
|
|
|
1,833 |
|
|
|
|
|
|
|
3,496 |
|
|
|
16,026 |
|
Other non-current assets |
|
|
885 |
|
|
|
|
|
|
|
|
|
|
|
1,199 |
|
|
|
2,084 |
|
Total assets |
|
|
109,636 |
|
|
|
3,210 |
|
|
|
|
|
|
|
21,510 |
|
|
|
134,356 |
|
Current liabilities |
|
|
24,651 |
|
|
|
|
|
|
|
|
|
|
|
2,736 |
|
|
|
27,387 |
|
Non-current liabilities |
|
|
6,638 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6,638 |
|
Total liabilities |
|
|
31,289 |
|
|
|
|
|
|
|
|
|
|
|
2,736 |
|
|
|
34,025 |
|
18
Subsequent event
In accordance with the Companys litigation settlement with Ethypharm S.A. Spain and Ethypharm
S.A. France (or Ethypharm) in late 2006, the Company made its first scheduled $1,000,000 annual
payment to Ethypharm in October of 2007. The remaining three annual payments of $1,000,000 are
scheduled to be made in the fourth quarters of 2008, 2009 and 2010.
Recently issued accounting pronouncements
On January 1, 2007, the Company
adopted SFAS No. 157, Fair Value Measurements (SFAS No. 157), which provides guidance
for measuring the fair value of assets and liabilities, and requires expanded disclosures about fair value
measurements. SFAS No. 157 indicates that fair value should be determined based on the assumptions marketplace
participants would use in pricing the asset or liability, and provides additional guidelines to consider in
determining the market-based measurement. The adoption of SFAS No. 157 did not have a material impact on the
Companys Unaudited Condensed Consolidated Financial Statements.
In February 2007, the Financial Accounting Standards Board (FASB) issued SFAS No. 159, The
Fair Value Option for Financial Assets and Financial Liabilities, including an amendment of FASB
Statement No. 115, (SFAS No. 159). SFAS No. 159 permits entities to choose to measure many
financial instruments and certain other items at fair value that are not currently required to be
measured at fair value. SFAS No. 159 also establishes presentation and disclosure requirements
designed to facilitate comparisons between entities that choose different measurement attributes
for similar types of assets and liabilities. SFAS No. 159 becomes effective for the Company as of
January 1, 2008. The Company is currently evaluating the impact of SFAS No. 159 on the Companys
consolidated financial statements.
In June 2007, the FASB ratified the consensus reached by the EITF on Issue No. 07-3,
"Accounting for Nonrefundable Advance Payments for Goods or Services Received for Use in Future
Research and Development Activities (EITF Issue No. 07-3). EITF Issue No. 07-3 states that
nonrefundable advance payments for goods or services that will be used or rendered for future
research and development activities should be deferred and capitalized. Such amounts should be
recognized as an expense as the related goods are delivered or the related services performed. If
an entity does not expect the goods to be delivered or services to be rendered, the capitalized
advance payment should be charged to expense. EITF Issue No. 07-3 is effective for fiscal years
beginning after December 15, 2007 and earlier application is not permitted. The Company often enters into agreements for research and development goods and service. As such,
the Company is evaluating the impact that the adoption of EITF Issue No. 07-3 will have on its
consolidated financial statements.
19
|
|
|
Item 2. |
|
Managements Discussion and Analysis of Financial Condition and Results of
Operations |
You should read the following discussion and analysis together with all financial and
non-financial information appearing elsewhere in this report and with our consolidated financial
statements and related notes included in our 2006 Annual Report on Form 10-K, referred to as our
2006 Form 10-K, which has been previously filed with the SEC. In addition to historical
information, the following discussion and other parts of this report contain forward-looking
information that involves risks and uncertainties. Our actual results could differ materially from
those anticipated by such forward-looking information due to competitive factors and other risks
discussed in our 2006 Form 10-K under Item 1A, Risk Factors.
Planned Spin-off
On October 23, 2007, we announced a plan to spin-off our drug delivery business, which is
subject to a number of conditions. We expect that shares of the new specialty pharmaceutical drug
delivery company, CPEX Pharmaceuticals, Inc. (which may be referred to as CPEX), will be
distributed to Bentley stockholders by means of a stock dividend. On the record date, which has not
yet been set, each Bentley stockholder will be entitled to receive shares of CPEX in connection
with the spin-off of the drug delivery businesses. The spin-off would result in CPEX operating as
an independent entity with publicly traded common stock. Bentley would not have any ownership
interest in CPEX subsequent to the spin-off.
In connection with the spin-off, CPEX and Bentley expect to enter into a series of agreements,
including a separation and distribution agreement, a transition services agreement, an employee
matters agreement and a tax allocation agreement. Consummation of the separation is subject to
certain conditions, including final approval by the Bentley Board of Directors, approval for
listing of CPEX common stock on an exchange, and the effectiveness of the registration statement
filed with the Securities and Exchange Commission in connection with the separation. Approval by
Bentleys stockholders is not required as a condition to the consummation of the proposed
separation.
We have incurred and expect to continue to incur legal, tax and other strategic consulting
costs specifically associated with the planned spin-off. These costs
totaled $846,000 and
$1,153,000 in the three and nine months ended September 30, 2007, respectively, and have been
reported as separation costs within operating expenses in the
Unaudited Consolidated Income
Statements.
Overview
We are a specialty pharmaceutical company focused on:
|
|
|
Specialty Generics: development, licensing and sales of generic and branded generic
pharmaceutical products and active pharmaceutical ingredients and the manufacturing of
pharmaceuticals for ourselves and others in Spain, other parts of Europe and international
markets, including the U.S. market; and |
|
|
|
|
Drug Delivery: research, development and licensing/commercialization of advanced
proprietary drug delivery technologies for new and existing pharmaceutical products. |
Generic Pharmaceuticals
Our pharmaceutical product sales activities are based in Spain, where we have a significant
commercial presence and we manufacture and market approximately 180 product presentations or SKUs
in four primary therapeutic areas: cardiovascular, gastrointestinal, central nervous system and
infectious diseases. Revenues derived from our top three product lines, represented approximately
30% of our net product revenues in the three months ended September 30, 2007. We market our branded
generic and generic products to physicians, pharmacists and hospitals through our three separate
sales and marketing
20
organizations based in Spain: Laboratorios Belmac, Laboratorios Davur and
Laboratorios Rimafar. In past years we expanded our geographic sales to countries outside of Spain
including the U.S. and several countries in the European Union. As of September 30, 2007
approximately 28% of our net product sales were derived from sales outside of Spain. Our generic
simvastatin product, which is manufactured at our FDA approved finish dosage facility in Spain, was
launched in the U.S. in December of 2006. The launch of our first U.S. generic product marked a
significant strategic milestone for us; however, due to market price conditions and limited demand,
sales of our generic simvastatin have been determined to be less favorable than our initial
projections. As a result, we have recorded net charges of
approximately $416,000 to cost of net product sales
for inventory write-downs and obsolescence reserves in the nine months ended September 30, 2007.
While the pricing of our pharmaceutical products is influenced by market forces (size of the
market, number of competitors, etc.), our pricing in Spain and other countries is also subject to
governmental price controls. The majority of our products are subject to price controls set in
place by the Spanish government. The Spanish government enacted legislation effective March 1, 2007
which reduced the amount reimburses for pharmaceutical products. As a result of the legislation our
sales force began marketing our products at lower selling prices in Spain as early as February
2007. We also experienced reduced sales levels in the beginning of the first quarter of 2007 as
Spanish wholesalers and pharmacies minimized order quantities until they were able to purchase our
products at the new lower prices. Once we began selling at the new prices we experienced an
increase in the number of our units sold. While the increased unit volume has substantially offset
the impact of the reduced selling prices on our net product sales, our gross margins have decreased
from 51% in the nine months ended September 30, 2006 to 44% in the nine months ended September 30,
2007 (excluding inventory write-downs associated with our U.S. generic simvastatin discussed
above). We have implemented strategies to mitigate lower selling prices, including strategies to
reduce manufacturing costs and increase sales volumes. We are seeking to continue expanding our
product sales in other geographic regions, including the U.S., through strategic alliances. We are
targeting markets that offer compatible regulatory approval regimes and attractive product margins.
In addition, we expect to grow our business by developing and acquiring rights to market additional
products to sell through our sales organization and our strategic alliances. We continually acquire
rights to new products in response to increasing market demand for generic and branded generic
therapeutic products.
We also manufacture and market active pharmaceutical ingredients, or API, through our
subsidiary, Bentley A.P.I. Our API facility has been approved by the FDA for the manufacture of
one ingredient for marketing and sale in the U.S. In addition, our Spanish pharmaceutical product
manufacturing facility produces pharmaceutical products that are marketed by other pharmaceutical
companies both in Spain and in other international markets, including the U.S.
Drug Delivery Technologies and Products
We develop and co-develop products that incorporate our drug delivery technologies. We have
licensed applications of our proprietary CPE-215 drug delivery technology to Auxilium
Pharmaceuticals, Inc., which launched Testim, the first product incorporating our CPE-215 drug
delivery technology, in the United States in February 2003. Testim is a gel indicated for
testosterone replacement therapy. Testim is also approved for marketing in 15 European countries
and Canada. On August 29, 2007, we received a new patent from the European Patent Office,
effectively extending patent coverage for Testim through April 2023 in covered territories. We are
in discussions with other pharmaceutical and biotechnology companies to form additional strategic
alliances to facilitate the development and commercialization of other products using our drug
delivery technologies, including the delivery of insulin to diabetic patients intranasally and the
treatment of nail fungus infections topically. In addition, we continue to seek alliances with
academic organizations to explore the delivery of macromolecules.
Research and Development Focus
Our U.S. research and development activities are primarily focused on the development of
NasulinTM, our intranasal insulin product candidate. In 2004 we concluded a Phase IIA
study of Nasulin in
21
Type I diabetic patients using our CPE-215 technology. The full results of that
trial were published in 2006 in the journal Diabetes Technology & Therapeutics, Volume 8, Number 1.
In 2006, we completed an additional Phase I study in Ireland and advanced our Phase IIA studies in
the U.S. In the first quarter of 2007 we completed preparations for a Phase II study in India
which began in the second quarter of 2007. Portions of the results from our U.S. and Irish studies
were presented at the American Diabetes Association 67th Sessions in Chicago, IL in June
2007. We expect the U.S. clinical development programs for Nasulin to continue and expand both
outside and inside the U.S. We are also continuing our clinical programs to support our strategy
for the distribution of our generic pharmaceutical products in other countries, including the U.S.
We expect to continue to invest our resources to conduct clinical trials and support the required
regulatory submissions for our clinical programs. As a result, we expect to incur increased costs
for product formulation, research and clinical development efforts.
Effect of Foreign Currency Fluctuations
A substantial amount of our business is conducted in Europe and, therefore our results, which
are measured in U.S. Dollars, are influenced by fluctuations in the U.S. Dollars value in relation
to other currencies, specifically the Euro. An increase in the weighted average value of the Euro
in relation to the U.S. Dollar over the prior year third quarter, had the following impact on the
results of our operations when reported in U.S. Dollars: (1) total revenues were increased by
approximately $1,835,000, (2) gross profit was increased by approximately $765,000, (3) operating
expenses and other income (expense) were increased by approximately $579,000, (4) provision for
income taxes was increased by approximately $82,000, which resulted in (5) an aggregate decrease in
net loss of approximately $104,000. An increase in the weighted average value of the Euro in
relation to the U.S. Dollar over the first nine months of the prior year, had the following impact
on the results of our operations when reported in U.S. Dollars: (1) total revenues were increased
by approximately $6,100,000, (2) gross profit was increased by approximately $2,745,000, (3)
operating expenses and other income (expense) were increased by approximately $1,834,000, (4)
provision for income taxes was increased by approximately $357,000, which resulted in (5) an
aggregate increase in net income of approximately $554,000.
This section includes constant currency measures. Constant currency removes from financial
data the impact of changes in exchange rates between the U.S. Dollar and other currencies,
particularly the Euro, by translating current period financial data into U.S. Dollars using the
same foreign currency exchange rates that were used to translate the financial data for the
previous period. We believe presenting certain results on a constant currency basis is useful to
investors because it allows a more meaningful comparison of the performance of our European
operations from period to period.
RESULTS OF OPERATIONS:
Three Months Ended September 30, 2007 versus Three Months Ended September 30, 2006
Revenues by Segment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended September 30, |
|
Change |
|
(in thousands) |
|
2007 |
|
|
% |
|
|
2006 |
|
|
% |
|
|
$ |
|
|
% |
|
|
|
|
|
|
|
|
Specialty Generics |
|
| |
|
|
| | |
|
| |
|
|
|
| |
|
| |
|
|
|
| |
Net product sales |
|
$ |
24,131 |
|
|
|
88 |
% |
|
$ |
22,873 |
|
|
|
91 |
% |
|
$ |
1,258 |
|
|
|
5 |
% |
Licensing and collaboration revenues |
|
|
148 |
|
|
|
1 |
% |
|
|
170 |
|
|
|
1 |
% |
|
|
(22 |
) |
|
|
-13 |
% |
|
|
|
|
|
|
|
|
|
|
24,279 |
|
|
|
89 |
% |
|
|
23,043 |
|
|
|
92 |
% |
|
|
1,236 |
|
|
|
5 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Drug Delivery |
|
|
| |
|
|
| |
|
|
|
|
|
|
| |
|
|
|
|
|
|
| |
Licensing and collaboration revenues |
|
|
3,069 |
|
|
|
11 |
% |
|
|
2,113 |
|
|
|
8 |
% |
|
|
956 |
|
|
|
45 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
27,348 |
|
|
|
100 |
% |
|
$ |
25,156 |
|
|
|
100 |
% |
|
$ |
2,192 |
|
|
|
9 |
% |
|
|
|
|
|
|
|
22
Total revenues for the three months ended September 30, 2007 increased $2,192,000, or 9% from
the same period in the prior year. Our specialty generics business experienced increased demand
when compared to the comparable quarter of 2006. However, price reductions in Spain have resulted
in net product sales that are consistent with the comparable period of 2006 when expressed in
constant currency. Our drug delivery licensing revenues grew to $3,069,000 in the third quarter of
2007 due to increased royalties earned on sales of Testim. Based on industry sources, Testim was
reported to capture approximately 21% of all testosterone gel replacement prescriptions in the U.S.
market as of September 30, 2007, compared to approximately 18% as of September 30, 2006.
Our revenues are generated through our primary sales channels of branded generic
pharmaceuticals, generic pharmaceuticals and sales to licensees and others, as well as licensing
and collaboration arrangements. The following is a summary of our revenues by sales channel and
top-selling product lines:
For the three months ended September 30, 2007:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands) |
|
Revenues Within Spain |
|
|
Revenues |
|
|
|
|
|
|
|
|
|
|
|
Branded |
|
|
|
|
|
|
|
|
|
|
Outside of |
|
|
|
|
|
|
% of Total |
|
Product Line |
|
Generics |
|
|
Generics |
|
|
Other |
|
|
Spain |
|
|
Total |
|
|
Revenues |
|
|
Omeprazole |
|
$ |
406 |
|
|
$ |
4,091 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
4,497 |
|
|
|
16 |
% |
Enalapril |
|
|
1,227 |
|
|
|
348 |
|
|
|
|
|
|
|
|
|
|
|
1,575 |
|
|
|
6 |
% |
Simvastatin |
|
|
153 |
|
|
|
1,041 |
|
|
|
|
|
|
|
|
|
|
|
1,194 |
|
|
|
4 |
% |
Lansoprazole |
|
|
805 |
|
|
|
294 |
|
|
|
|
|
|
|
|
|
|
|
1,099 |
|
|
|
4 |
% |
Paroxetine |
|
|
297 |
|
|
|
795 |
|
|
|
|
|
|
|
|
|
|
|
1,092 |
|
|
|
4 |
% |
All other products |
|
|
2,624 |
|
|
|
2,603 |
|
|
|
105 |
|
|
|
426 |
|
|
|
5,758 |
|
|
|
21 |
% |
Sales to
licensees and others |
|
|
|
|
|
|
|
|
|
|
3,075 |
|
|
|
5,841 |
|
|
|
8,916 |
|
|
|
33 |
% |
Licensing
and collaborations |
|
|
|
|
|
|
|
|
|
|
148 |
|
|
|
3,069 |
|
|
|
3,217 |
|
|
|
12 |
% |
|
Total Revenues |
|
$ |
5,512 |
|
|
$ |
9,172 |
|
|
$ |
3,328 |
|
|
$ |
9,336 |
|
|
$ |
27,348 |
|
|
|
100 |
% |
|
% of Q3 2007 Revenues |
|
|
20 |
% |
|
|
34 |
% |
|
|
12 |
% |
|
|
34 |
% |
|
|
100 |
% |
|
|
|
|
For the three months ended September 30, 2006:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands) |
|
Revenues Within Spain |
|
|
Revenues |
|
|
|
|
|
|
|
|
|
|
Branded |
|
|
|
|
|
|
|
|
|
|
Outside of |
|
|
|
|
|
|
% of Total |
|
Product Line |
|
Generics |
|
|
Generics |
|
|
Other |
|
|
Spain |
|
|
Total |
|
|
Revenues |
|
|
Omeprazole |
|
$ |
671 |
|
|
$ |
3,896 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
4,567 |
|
|
|
18 |
% |
Simvastatin |
|
|
457 |
|
|
|
1,371 |
|
|
|
|
|
|
|
|
|
|
|
1,828 |
|
|
|
7 |
% |
Enalapril |
|
|
1,241 |
|
|
|
347 |
|
|
|
|
|
|
|
|
|
|
|
1,588 |
|
|
|
6 |
% |
Lansoprazole |
|
|
633 |
|
|
|
219 |
|
|
|
|
|
|
|
|
|
|
|
852 |
|
|
|
4 |
% |
Paroxetine |
|
|
319 |
|
|
|
774 |
|
|
|
|
|
|
|
|
|
|
|
1,093 |
|
|
|
4 |
% |
All other products |
|
|
2,408 |
|
|
|
2,580 |
|
|
|
301 |
|
|
|
473 |
|
|
|
5,762 |
|
|
|
23 |
% |
Sales to
licensees and others |
|
|
|
|
|
|
|
|
|
|
2,642 |
|
|
|
4,541 |
|
|
|
7,183 |
|
|
|
29 |
% |
Licensing
and collaborations |
|
|
|
|
|
|
|
|
|
|
170 |
|
|
|
2,113 |
|
|
|
2,283 |
|
|
|
9 |
% |
|
Total Revenues |
|
$ |
5,729 |
|
|
$ |
9,187 |
|
|
$ |
3,113 |
|
|
$ |
7,127 |
|
|
$ |
25,156 |
|
|
|
100 |
% |
|
% of Q3 2006 Revenues |
|
|
23 |
% |
|
|
37 |
% |
|
|
12 |
% |
|
|
28 |
% |
|
|
100 |
% |
|
|
|
|
Branded Generic Pharmaceutical Products
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended September 30, |
|
Change |
|
(in thousands) |
|
2007 |
|
|
% |
|
|
2006 |
|
|
% |
|
|
$ |
|
|
% |
|
|
|
|
|
|
|
|
Branded Generic Product Sales: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Enalapril |
|
$ |
1,227 |
|
|
|
22 |
% |
|
$ |
1,241 |
|
|
|
22 |
% |
|
$ |
(14 |
) |
|
|
-1 |
% |
Lansoprazole |
|
|
805 |
|
|
|
15 |
% |
|
|
633 |
|
|
|
11 |
% |
|
|
172 |
|
|
|
27 |
% |
Codeisan |
|
|
621 |
|
|
|
11 |
% |
|
|
588 |
|
|
|
10 |
% |
|
|
33 |
|
|
|
6 |
% |
Ibuprofen |
|
|
549 |
|
|
|
10 |
% |
|
|
354 |
|
|
|
6 |
% |
|
|
195 |
|
|
|
55 |
% |
Mio Relax |
|
|
465 |
|
|
|
8 |
% |
|
|
397 |
|
|
|
7 |
% |
|
|
68 |
|
|
|
17 |
% |
All other branded generic products |
|
|
1,845 |
|
|
|
34 |
% |
|
|
2,516 |
|
|
|
44 |
% |
|
|
(671 |
) |
|
|
- 27 |
% |
|
|
|
|
|
|
|
Total branded generic sales |
|
$ |
5,512 |
|
|
|
100 |
% |
|
$ |
5,729 |
|
|
|
100 |
% |
|
$ |
(217 |
) |
|
|
- 4 |
% |
|
|
|
|
|
|
|
23
Sales of our branded generic pharmaceutical products decreased by 8% in constant currency when
compared to the three months ended September 30, 2006 due to the recent price reductions in Spain.
Excluded from the top five branded generic products listed above are branded generic sales of
omeprazole, which decreased approximately $265,000, or 39%, and sales of branded generic
simvastatin, which decreased approximately $304,000, or 67%, primarily due to the price reductions.
The impact of price reductions was partially offset by increased unit volume in the third quarter
of 2007, primarily from sales of ibuprofen and lansoprazole. While we expect to continue to
develop, acquire, launch and support new and existing branded generic products, our growth strategy
is also focused on sales of generic products and sales outside of Spain.
Generic Pharmaceutical Products
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended September 30, |
|
Change |
(in thousands) |
|
2007 |
|
% |
|
2006 |
|
% |
|
$ |
|
% |
Generic Product Sales: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Omeprazole |
|
$ |
4,091 |
|
|
|
45 |
% |
|
$ |
3,896 |
|
|
|
43 |
% |
|
$ |
195 |
|
|
|
5 |
% |
Simvastatin |
|
|
1,041 |
|
|
|
11 |
% |
|
|
1,371 |
|
|
|
15 |
% |
|
|
(330 |
) |
|
|
-24 |
% |
Paroxetine |
|
|
795 |
|
|
|
9 |
% |
|
|
774 |
|
|
|
8 |
% |
|
|
21 |
|
|
|
3 |
% |
Pentoxifylline |
|
|
682 |
|
|
|
7 |
% |
|
|
654 |
|
|
|
7 |
% |
|
|
28 |
|
|
|
4 |
% |
Trimetazidine |
|
|
636 |
|
|
|
7 |
% |
|
|
586 |
|
|
|
6 |
% |
|
|
50 |
|
|
|
9 |
% |
All other generic products |
|
|
1,927 |
|
|
|
21 |
% |
|
|
1,906 |
|
|
|
21 |
% |
|
|
21 |
|
|
|
1 |
% |
|
|
|
|
|
|
|
Total generic sales |
|
$ |
9,172 |
|
|
|
100 |
% |
|
$ |
9,187 |
|
|
|
100 |
% |
|
$ |
(15 |
) |
|
|
-0 |
% |
|
|
|
|
|
|
|
Sales of our generic pharmaceutical products remained constant when compared to the three
months ended September 30, 2006, but decreased by 5% in constant currency as a result of the recent
price reductions in Spain. While we also experienced an increased unit volume in our generic sales,
primarily from sales of omeprazole and simvastatin, the increase was not enough to offset the
effect of the price reductions. We expect to continue to increase our generic drug portfolio and
increase our generic drug sales in Spain as products patent protection rights expire in the
future.
Sales to Licensees and Others
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended September 30, |
|
Change |
(in thousands) |
|
2007 |
|
2006 |
|
$ |
|
% |
Specialty generics |
|
$ |
8,916 |
|
|
$ |
7,183 |
|
|
$ |
1,733 |
|
|
|
24 |
% |
In addition to manufacturing and selling our own branded generic and generic products, we
license the right to market products to others within and outside of Spain. These license
agreements are usually accompanied by long-term exclusive supply agreements, whereby our licensees
purchase the licensed products from our manufacturing facility. These purchases are recorded as net
product sales in our Unaudited Consolidated Income Statements. As of September 30, 2007, our
Spanish operations have executed 213 license agreements for product registrations, of which 28 with
customers in Spain and 104 with customers outside of Spain, cover actively marketed products that
are generating revenues. The remaining licenses (1 with a customer in Spain, 11 with customers in
Ireland and 69 with customers outside of Spain and Ireland) are for products that are awaiting
regulatory approvals. Additionally, we have 15 contract manufacturing agreements in effect in Spain
and 6 contract manufacturing agreements in effect in other countries. Our clients market these
products under their own names and with their own labeling. Many of the products we manufacture
for others use the same active ingredients that are used in our own marketed products. Sales to
licensees and others in the three months ended September 30,
2007 increased $1,733,000 when
compared to the third quarter of 2006; however, sales to licenses and others increased by 19% in
constant currency. Sales to our licensees and contract manufacturing customers are usually of
larger quantities and occur on a less frequent basis than our normal sales in Spain. Therefore, the
shipment of one order, or delayed shipment of one order, could cause significant fluctuations from
quarter to quarter.
24
Licensing and Collaboration Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended September 30, |
|
|
Change |
|
(in thousands) |
|
2007 |
|
|
2006 |
|
|
$ |
|
|
% |
|
Specialty generics |
|
$ |
148 |
|
|
$ |
170 |
|
|
$ |
(22 |
) |
|
|
-13 |
% |
Drug delivery |
|
|
3,069 |
|
|
|
2,113 |
|
|
|
956 |
|
|
|
45 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
3,217 |
|
|
$ |
2,283 |
|
|
$ |
934 |
|
|
|
41 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Licensing and collaboration revenues increased by 41% and accounted for 12% and 9% of total
revenues for the three months ended September 30, 2007 and 2006, respectively. Our licensing and
collaboration revenues are primarily royalties earned from sales of Testim. Testim royalties
increased 46% from $2,107,000 in the three months ended September 30, 2006 to $3,069,000 in the
three months ended September 30, 2007 as a result of increased market share.
Gross Profit
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended September 30, |
|
|
Change |
|
(in thousands) |
|
2007 |
|
|
2006 |
|
|
$ |
|
|
% |
|
Specialty generics |
|
$ |
9,828 |
|
|
$ |
11,265 |
|
|
$ |
(1,437 |
) |
|
|
-13 |
% |
Drug delivery |
|
|
3,069 |
|
|
|
2,113 |
|
|
|
956 |
|
|
|
45 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
12,897 |
|
|
$ |
13,378 |
|
|
$ |
(481 |
) |
|
|
-4 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit decreased by approximately $481,000, or 4% when compared to the three months
ended September 30, 2006. Despite an increase in unit volume, gross profit reported by our
specialty generics business decreased by 13% when compared to the same quarter of the prior year.
Our gross margins on net product sales decreased from 49% to 40% in the three months ended
September 30, 2006 and 2007, respectively, as a result of the price reductions. We expect our
margins to gradually improve over time as we continue to implement our strategies to mitigate the
impact of the price reductions.
Selling and Marketing Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended September 30, |
|
|
Change |
|
(in thousands) |
|
2007 |
|
|
2006 |
|
|
$ |
|
|
% |
|
Specialty generics |
|
$ |
4,080 |
|
|
$ |
3,495 |
|
|
$ |
585 |
|
|
|
17 |
% |
Selling and marketing expenses for the three months ended September 30, 2007 increased 17%
from the same period in the prior year, or 8% when expressed in constant currency due to increased
sales volume. As a percentage of net product sales, selling and marketing expenses increased from
15% to 17% in the three months ended September 30, 2006 and 2007, respectively.
General and Administrative Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended September 30, |
|
|
Change |
|
(in thousands) |
|
2007 |
|
|
2006 |
|
|
$ |
|
|
% |
|
Specialty generics |
|
$ |
2,013 |
|
|
$ |
1,901 |
|
|
$ |
112 |
|
|
|
6 |
% |
Drug delivery |
|
|
2,085 |
|
|
|
1,850 |
|
|
|
235 |
|
|
|
13 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
4,098 |
|
|
$ |
3,751 |
|
|
$ |
347 |
|
|
|
9 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative expenses increased 9% when compared to the same period in the prior
year. Increases in drug delivery headcount and outside professional service costs included in
general and administrative expenses were partially offset by approximately $600,000 of reduced
severance costs related to
25
a change in our Chief Financial Officer in September 2006. Increased general and
administrative expenses in our specialty generics business include approximately $137,000 due to
fluctuations in foreign currency rates. Total general and administrative expenses as a percent of
total revenues remain consistent at 15% for the three months ended September 30, 2007 and 2006.
Research and Development Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended September 30, |
|
|
Change |
|
(in thousands) |
|
2007 |
|
|
2006 |
|
|
$ |
|
|
% |
|
Specialty generics |
|
$ |
341 |
|
|
$ |
421 |
|
|
$ |
(80 |
) |
|
|
-19 |
% |
Drug delivery |
|
|
2,676 |
|
|
|
2,026 |
|
|
|
650 |
|
|
|
32 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
3,017 |
|
|
$ |
2,447 |
|
|
$ |
570 |
|
|
|
23 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development expenses have increased by approximately $570,000 compared to the
third quarter of 2006 primarily from increased costs to support our Nasulin clinical program. We
plan to increase research and development costs as we continue to conduct our Nasulin clinical
trials throughout 2007. Although cost estimates and timing of our trials are subject to change, we
expect consolidated research and development expenses for 2007 to be approximately $13,000,000 to
$16,000,000.
Litigation Settlement Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended September 30, |
|
Change |
(in thousands) |
|
2007 |
|
2006 |
|
$ |
|
% |
Specialty generics |
|
$ |
|
|
|
$ |
8,932 |
|
|
$ |
(8,932 |
) |
|
|
* |
|
Litigation settlement expenses for the three months ended September 30, 2006 include
$7,546,000 representing the present value of our loss contingency stemming from litigation for
which we reached an agreement on settlement terms. In addition, we incurred litigation defense
costs of $1,386,000 in the three months ended September 30, 2006 associated with the settled claim
in late 2006.
Separation Costs
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended September 30, |
|
Change |
(in thousands) |
|
2007 |
|
2006 |
|
$ |
|
% |
Drug delivery |
|
$ |
846 |
|
|
$ |
|
|
|
$ |
846 |
|
|
|
* |
|
As noted above, we have incurred legal, tax and other strategic consulting costs specifically
associated with a planned spin-off of the drug delivery business. These costs include the services
of lawyers, accountants, tax and compensation consultants needed to effectively complete the spin.
Separation costs for the three months ended September 30, 2007 were $846,000. We expect to continue
to incur these costs as we proceed with the planned spin-off and other strategic alternatives.
26
Provision for Income Taxes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended September 30, |
|
|
2007 |
|
2006 |
(in thousands) |
|
Spain |
|
Ireland |
|
U.S. |
|
Consol. |
|
Spain |
|
Ireland |
|
U.S. |
|
Consol. |
Income (loss) before income taxes |
|
$ |
3,008 |
|
|
$ |
(1,496 |
) |
|
$ |
(1,202 |
) |
|
$ |
310 |
|
|
$ |
(2,545 |
) |
|
$ |
(1,015 |
) |
|
$ |
(1,939 |
) |
|
$ |
(5,499 |
) |
Provision (benefit) for income taxes |
|
|
911 |
|
|
|
(187 |
) |
|
|
(306 |
) |
|
|
418 |
|
|
|
1,730 |
|
|
|
(126 |
) |
|
|
(690 |
) |
|
|
914 |
|
Valuation allowance |
|
|
|
|
|
|
187 |
|
|
|
306 |
|
|
|
493 |
|
|
|
|
|
|
|
126 |
|
|
|
690 |
|
|
|
816 |
|
|
|
|
|
|
Net provision for income taxes |
|
|
911 |
|
|
|
|
|
|
|
|
|
|
|
911 |
|
|
|
1,730 |
|
|
|
|
|
|
|
|
|
|
|
1,730 |
|
|
|
|
|
|
Net income (loss) |
|
$ |
2,097 |
|
|
$ |
(1,496 |
) |
|
$ |
(1,202 |
) |
|
$ |
(601 |
) |
|
$ |
(4,275 |
) |
|
$ |
(1,015 |
) |
|
$ |
(1,939 |
) |
|
$ |
(7,229 |
) |
|
|
|
|
|
Effective tax rate |
|
|
30 |
% |
|
|
0 |
% |
|
|
0 |
% |
|
|
294 |
% |
|
|
68 |
% |
|
|
0 |
% |
|
|
0 |
% |
|
|
31 |
% |
|
|
|
|
|
As a result of reporting taxable income in Spain in 2007, we recorded a provision for foreign
income taxes totaling $911,000 for the three months ended September 30, 2007. This represented 30%
of the pre-tax income reported in Spain of $3,008,000. As future operating profits in the U.S and
Ireland cannot be reasonably assured, no tax benefit has been recorded for the related losses,
which totaled approximately $2,698,000 for the three months ended September 30, 2007. Accordingly,
we have established valuation allowances equal to the full amount of the U.S. and Irish deferred
tax assets. The provision represented 294% of consolidated pre-tax income for the three months
ended September 30, 2007. The current statutory tax rate in Spain of 32.5% is expected be reduced
to 30% effective January 1, 2008 in accordance with Spanish governmental regulations.
We recorded a provision for foreign income taxes totaling $1,730,000 for the three months
ended September 30, 2006, which represented 68% of the Spanish pre-tax loss of $2,545,000. This
effective tax rate was significantly above the 2006 Spanish statutory tax rate of 35% primarily due
to a $7,546,000 loss contingency recorded in September 2006 for litigation proceedings in Spain for
which a $2,746,000 tax benefit was not recognized in the 2006 period. The $1,730,000 provision for
income taxes represented 31% of the consolidated pre-tax loss in the three months ended September
30, 2006. The tax benefit of the loss contingency was subsequently recognized in the fourth
quarter of 2006.
Should we determine that it is more likely than not that we will realize certain of our net
deferred tax assets for which we have previously provided a valuation allowance, an adjustment
would be required to reduce the existing valuation allowance. In addition, we operate within
multiple taxing jurisdictions and are subject to audit in those jurisdictions. These audits can
involve complex issues, which may require an extended period of time for resolution. No additional
potential tax contingencies were considered to be probable and reasonably estimable as of September
30, 2007. However, there is the possibility that the ultimate resolution of such potential
contingencies could have an adverse effect on our consolidated financial statements in the future.
Net (Loss) Income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended September 30, |
|
|
Change |
|
(in thousands) |
|
2007 |
|
|
2006 |
|
|
$ |
|
|
% |
|
Specialty generics |
|
$ |
1,949 |
|
|
$ |
(5,465 |
) |
|
$ |
7,414 |
|
|
|
136 |
% |
Drug delivery |
|
|
(2,550 |
) |
|
|
(1,764 |
) |
|
|
(786 |
) |
|
|
-45 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
(601 |
) |
|
$ |
(7,229 |
) |
|
$ |
6,628 |
|
|
|
92 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
We reported income from operations of $367,000 in the three months ended September 30, 2007
compared to loss from operations of $5,707,000 in the three months ended September 30, 2006. The
combination of income from operations of $367,000 and the net non-operating expense of $57,000, and
the provision for income taxes of $911,000, resulted in net loss of $601,000, or $(0.03) per basic
common
27
share on 22,354,000 weighted average basic common shares outstanding in the three months ended
September 30, 2007, compared to net loss of $7,229,000, or $(0.33) per basic common share on
22,194,000 weighted average basic common shares outstanding in the same period of the prior year.
28
Nine Months Ended September 30, 2007 versus Nine Months Ended September 30, 2006
Revenues by Segment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Nine Months Ended September 30, |
|
Change |
(in thousands) |
|
2007 |
|
% |
|
2006 |
|
% |
|
$ |
|
% |
Specialty Generics |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net product sales |
|
$ |
81,598 |
|
|
|
91 |
% |
|
$ |
75,900 |
|
|
|
92 |
% |
|
$ |
5,698 |
|
|
|
8 |
% |
Licensing and collaboration revenues |
|
|
433 |
|
|
|
* |
|
|
|
409 |
|
|
|
* |
|
|
|
24 |
|
|
|
6 |
% |
|
|
|
|
|
|
|
|
|
|
82,031 |
|
|
|
91 |
% |
|
|
76,309 |
|
|
|
92 |
% |
|
|
5,722 |
|
|
|
7 |
% |
|
Drug Delivery |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Licensing and
collaboration
revenues |
|
|
7,887 |
|
|
|
9 |
% |
|
|
6,108 |
|
|
|
8 |
% |
|
|
1,779 |
|
|
|
29 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
89,918 |
|
|
|
100 |
% |
|
$ |
82,417 |
|
|
|
100 |
% |
|
$ |
7,501 |
|
|
|
9 |
% |
|
|
|
|
|
|
|
Revenues. Set forth below is a summary of our revenues by sales channel and top-selling
product lines:
For the nine months ended September 30, 2007:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands) |
|
Revenues Within Spain |
|
Revenues |
|
|
|
|
|
|
|
|
Branded |
|
|
|
|
|
|
|
|
|
Outside of |
|
|
|
|
|
% of Total |
Product Line |
|
Generics |
|
Generics |
|
Other |
|
Spain |
|
Total |
|
Revenues |
|
Omeprazole |
|
$ |
1,367 |
|
|
$ |
11,916 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
13,283 |
|
|
|
15 |
% |
Enalapril |
|
|
3,778 |
|
|
|
1,112 |
|
|
|
|
|
|
|
|
|
|
|
4,890 |
|
|
|
5 |
% |
Simvastatin |
|
|
723 |
|
|
|
3,631 |
|
|
|
|
|
|
|
|
|
|
|
4,354 |
|
|
|
5 |
% |
Paroxetine |
|
|
1,112 |
|
|
|
2,485 |
|
|
|
|
|
|
|
|
|
|
|
3,597 |
|
|
|
4 |
% |
Lansoprazole |
|
|
2,571 |
|
|
|
895 |
|
|
|
|
|
|
|
|
|
|
|
3,466 |
|
|
|
4 |
% |
All other products |
|
|
8,964 |
|
|
|
9,824 |
|
|
|
472 |
|
|
|
2,540 |
|
|
|
21,800 |
|
|
|
24 |
% |
Sales to licensees and others |
|
|
|
|
|
|
|
|
|
|
10,062 |
|
|
|
20,146 |
|
|
|
30,208 |
|
|
|
34 |
% |
Licensing and collaborations |
|
|
|
|
|
|
|
|
|
|
433 |
|
|
|
7,887 |
|
|
|
8,320 |
|
|
|
9 |
% |
|
Total Revenues |
|
$ |
18,515 |
|
|
$ |
29,863 |
|
|
$ |
10,967 |
|
|
$ |
30,573 |
|
|
$ |
89,918 |
|
|
|
100 |
% |
|
% of YTD 2007 Revenues |
|
|
21 |
% |
|
|
33 |
% |
|
|
12 |
% |
|
|
34 |
% |
|
|
100 |
% |
|
|
|
|
For the nine months ended September 30, 2006:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands) |
|
Revenues Within Spain |
|
Revenues |
|
|
|
|
|
|
|
|
Branded |
|
|
|
|
|
|
|
|
|
Outside of |
|
|
|
|
|
% of Total |
Product Line |
|
Generics |
|
Generics |
|
Other |
|
Spain |
|
Total |
|
Revenues |
|
Omeprazole |
|
$ |
2,012 |
|
|
$ |
12,589 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
14,601 |
|
|
|
18 |
% |
Enalapril |
|
|
3,538 |
|
|
|
1,477 |
|
|
|
|
|
|
|
|
|
|
|
5,015 |
|
|
|
6 |
% |
Simvastatin |
|
|
1,383 |
|
|
|
4,334 |
|
|
|
|
|
|
|
|
|
|
|
5,717 |
|
|
|
7 |
% |
Paroxetine |
|
|
1,094 |
|
|
|
2,389 |
|
|
|
|
|
|
|
|
|
|
|
3,483 |
|
|
|
4 |
% |
Lansoprazole |
|
|
1,958 |
|
|
|
671 |
|
|
|
|
|
|
|
|
|
|
|
2,629 |
|
|
|
3 |
% |
All other products |
|
|
7,693 |
|
|
|
8,172 |
|
|
|
782 |
|
|
|
1,100 |
|
|
|
17,747 |
|
|
|
22 |
% |
Sales to licensees and others |
|
|
|
|
|
|
|
|
|
|
9,553 |
|
|
|
17,155 |
|
|
|
26,708 |
|
|
|
32 |
% |
Licensing and collaborations |
|
|
|
|
|
|
|
|
|
|
409 |
|
|
|
6,108 |
|
|
|
6,517 |
|
|
|
8 |
% |
|
Total Revenues |
|
$ |
17,678 |
|
|
$ |
29,632 |
|
|
$ |
10,744 |
|
|
$ |
24,363 |
|
|
$ |
82,417 |
|
|
|
100 |
% |
|
% of YTD 2006 Revenues |
|
|
21 |
% |
|
|
36 |
% |
|
|
13 |
% |
|
|
30 |
% |
|
|
100 |
% |
|
|
|
|
29
Total revenues for the nine months ended September 30, 2007 increased 9% to $89,918,000 from
the same period in 2006, or 2% when expressed in constant currency. Favorable fluctuations in
foreign currency rates increased year-to-date 2007 revenues by approximately $6,100,000 when
compared to the same nine month period of 2006. In addition to the effect of favorable currency
rates, current period growth was driven primarily by increased product sales to our licensees and
others of approximately $1,366,000 (net of currency fluctuations) and approximately $1,790,000 of
increased royalty revenue from the sales of Testim. These increases, along with increased API
sales, were partially offset by the effect price reductions in Spain that were implemented in the
first quarter of this year.
Branded Generic Pharmaceutical Products
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Nine Months Ended September 30, |
|
Change |
(in thousands) |
|
2007 |
|
% |
|
2006 |
|
% |
|
$ |
|
% |
Branded Generic Product Sales: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Enalapril |
|
$ |
3,778 |
|
|
|
20 |
% |
|
$ |
3,538 |
|
|
|
20 |
% |
|
$ |
240 |
|
|
|
7 |
% |
Codeisan |
|
|
2,630 |
|
|
|
14 |
% |
|
|
2,051 |
|
|
|
12 |
% |
|
|
579 |
|
|
|
28 |
% |
Lansoprazole |
|
|
2,571 |
|
|
|
14 |
% |
|
|
1,958 |
|
|
|
11 |
% |
|
|
613 |
|
|
|
31 |
% |
Ibuprofen |
|
|
1,676 |
|
|
|
9 |
% |
|
|
1,097 |
|
|
|
6 |
% |
|
|
579 |
|
|
|
53 |
% |
Omeprazole |
|
|
1,367 |
|
|
|
8 |
% |
|
|
2,012 |
|
|
|
11 |
% |
|
|
(645 |
) |
|
|
-32 |
% |
All other branded generic
products |
|
|
6,493 |
|
|
|
35 |
% |
|
|
7,022 |
|
|
|
40 |
% |
|
|
(529 |
) |
|
|
-8 |
% |
|
|
|
|
|
|
|
Total branded generic sales |
|
$ |
18,515 |
|
|
|
100 |
% |
|
$ |
17,678 |
|
|
|
100 |
% |
|
$ |
837 |
|
|
|
5 |
% |
|
|
|
|
|
|
== |
Sales of our branded generic pharmaceutical products during the nine months ending September
30, 2007 increased 5% when compared to the same period in 2006. Excluding the effect of
fluctuations in foreign currency exchange rates, sales of our branded generic pharmaceutical
products decreased 2% when compared to the nine months ending September 30, 2006 as a result of
price reductions in Spain. Among products most affected by the price reductions was our branded
generic omeprazole, sales of which decreased 32% despite consistent unit volume. Increased unit
volume in the nine months ended September 30, 2007, primarily from sales of our enalapril, codeisan
and lansoprazole, helped offset the impact of price reductions.
Generic Pharmaceutical Products
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Nine Months Ended September 30, |
|
Change |
(in thousands) |
|
2007 |
|
% |
|
2006 |
|
% |
|
$ |
|
% |
Generic Product Sales: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Omeprazole |
|
$ |
11,916 |
|
|
|
40 |
% |
|
$ |
12,589 |
|
|
|
42 |
% |
|
$ |
(673 |
) |
|
|
-5 |
% |
Simvastatin |
|
|
3,631 |
|
|
|
12 |
% |
|
|
4,334 |
|
|
|
15 |
% |
|
|
(703 |
) |
|
|
-16 |
% |
Paroxetine |
|
|
2,485 |
|
|
|
8 |
% |
|
|
2,389 |
|
|
|
8 |
% |
|
|
96 |
|
|
|
4 |
% |
Trimetazidine |
|
|
2,181 |
|
|
|
7 |
% |
|
|
1,679 |
|
|
|
6 |
% |
|
|
502 |
|
|
|
30 |
% |
Pentoxifylline |
|
|
2,038 |
|
|
|
7 |
% |
|
|
1,932 |
|
|
|
6 |
% |
|
|
106 |
|
|
|
5 |
% |
All other generic products |
|
|
7,612 |
|
|
|
26 |
% |
|
|
6,709 |
|
|
|
23 |
% |
|
|
903 |
|
|
|
13 |
% |
|
|
|
|
|
|
|
Total generic sales |
|
$ |
29,863 |
|
|
|
100 |
% |
|
$ |
29,632 |
|
|
|
100 |
% |
|
$ |
231 |
|
|
|
1 |
% |
|
|
|
|
|
|
== |
Sales of our generic pharmaceutical products increased 1% during the nine months ending
September 30, 2007 when compared to the same period 2006. Excluding the effect of fluctuations in
foreign currency exchange rates, sales of our branded generic pharmaceutical products decreased 6%
due to the recent price reductions in Spain. Generic sales of omeprazole and simvastatin, which
were among the products more affected by the price reductions, decreased approximately $1,376,000.
Increased unit volume in the nine months ended September 30, 2007, primarily from sales of
omeprazole, simvastatin and trimetazidine, helped offset the impact of price reductions.
30
Sales to Licensees and Others
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Nine Months Ended September 30, |
|
Change |
(in thousands) |
|
2007 |
|
2006 |
|
$ |
|
% |
Specialty generics |
|
$ |
30,208 |
|
|
$ |
26,708 |
|
|
$ |
3,500 |
|
|
|
13 |
% |
Sales to licensees and others in the nine months ended September 30, 2007 increased 13% when
compared to the same nine month period of the prior year. An increase in the weighted average
value of the Euro over the past year, in relation to the U.S. Dollar, had the effect of increasing
our revenues from sales to licensees and others by approximately $2,134,000. See the explanation
under Sales to Licensees and Others for the three months ended September 30, 2007.
Licensing and Collaboration Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Nine Months Ended September 30, |
|
|
Change |
|
(in thousands) |
|
2007 |
|
|
2006 |
|
|
$ |
|
|
% |
|
Specialty generics |
|
$ |
433 |
|
|
$ |
409 |
|
|
$ |
24 |
|
|
|
6 |
% |
Drug delivery |
|
|
7,887 |
|
|
|
6,108 |
|
|
|
1,779 |
|
|
|
29 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
8,320 |
|
|
$ |
6,517 |
|
|
$ |
1,803 |
|
|
|
28 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Licensing and collaboration revenues accounted for 9% of total revenues in the nine months
ended September 30, 2007 and totaled $8,320,000. These revenues included increased Testim royalties
of approximately $1,790,000 in the nine months ended September 30, 2007. See the explanation under
Licensing and Collaboration Revenues for the three months ended September 30, 2007.
Gross Profit
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Nine Months Ended September 30, |
|
|
Change |
|
(in thousands) |
|
2007 |
|
|
2006 |
|
|
$ |
|
|
% |
|
Specialty generics |
|
$ |
35,893 |
|
|
$ |
39,127 |
|
|
$ |
(3,234 |
) |
|
|
-8 |
% |
Drug delivery |
|
|
7,887 |
|
|
|
6,108 |
|
|
|
1,779 |
|
|
|
29 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
43,780 |
|
|
$ |
45,235 |
|
|
$ |
(1,455 |
) |
|
|
-3 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit decreased by approximately $1,455,000, or 3%, in the nine months ended September
30, 2007 when compared to the nine months ended September 30, 2006. Gross margins on net product
sales were 43% in the nine months ended September 30, 2007 versus 51% in the nine months ended
September 30, 2006. We have recorded net adjustments totaling $1,010,000 to write-down our U.S.
generic inventory to its net realizable value and reserve for slow moving inventories. In accordance with our
collaboration agreement, we are liable for a portion of these adjustments and have therefore recorded a net
charge of approximately $416,000 to cost of net product sales in the nine months ended September 30, 2007.
Excluding these inventory adjustments, our gross margins on net product
sales decreased from 51% to 44% in the nine months ended September 30, 2006 and 2007, respectively,
as a result of price reductions in Spain. See the explanation under
Gross Profit for the three
months ended September 30, 2007.
Selling and Marketing Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Nine Months Ended September 30, |
|
|
Change |
|
(in thousands) |
|
2007 |
|
|
2006 |
|
|
$ |
|
|
% |
|
Specialty generics |
|
$ |
13,338 |
|
|
$ |
11,876 |
|
|
$ |
1,462 |
|
|
|
12 |
% |
Selling and marketing expenses for the nine months ended September 30, 2007 increased 12% from
the same period in the prior year; however, selling and marketing expenses increased 4% when
expressed in
31
constant currency. Selling and marketing expenses as a percentage of net product sales
remained relatively constant at 16% in the nine months ended September 30, 2007 and 2006.
General and Administrative Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Nine Months Ended September 30, |
|
|
Change |
|
(in thousands) |
|
2007 |
|
|
2006 |
|
|
$ |
|
|
% |
|
Specialty generics |
|
$ |
6,653 |
|
|
$ |
5,507 |
|
|
$ |
1,146 |
|
|
|
21 |
% |
Drug delivery |
|
|
5,363 |
|
|
|
5,813 |
|
|
|
(450 |
) |
|
|
-8 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
12,016 |
|
|
$ |
11,320 |
|
|
$ |
696 |
|
|
|
6 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative expenses for the nine months ended September 30, 2007 increased 6%
from the same period in the prior year. The $1,146,000 change in our specialty generics business
reflects an increase of $412,000 from fluctuations in foreign currency exchange rates and
approximately $407,000 of intellectual property filing and maintenance costs incurred to support
our continued revenue growth. The $450,000 decrease in our drug delivery business reflects reduced
strategic consulting expenses compared to the same period in 2006. General and administrative
expenses as a percentage of total revenues decreased to 13% for the nine months ended September 30,
2007 compared to 14% for the nine months ended September 30, 2006.
Research and Development Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Nine Months Ended September 30, |
|
|
Change |
|
(in thousands) |
|
2007 |
|
|
2006 |
|
|
$ |
|
|
% |
|
Specialty generics |
|
$ |
1,341 |
|
|
$ |
1,374 |
|
|
$ |
(33 |
) |
|
|
-2 |
% |
Drug delivery |
|
|
7,853 |
|
|
|
6,476 |
|
|
|
1,377 |
|
|
|
21 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
9,194 |
|
|
$ |
7,850 |
|
|
$ |
1,344 |
|
|
|
17 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development expenses for the nine months ended September 30, 2007 increased 17%
from the same period in the prior year. The increase is directly attributed to the advancement of
our research and development programs in the Drug Delivery segment of our business. See the
explanation under Research and Development Expenses for the three months ended September 30, 2007.
We expect to continue to incur increased costs to support our clinical programs for the remainder
of 2007.
Litigation Settlement Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Nine Months Ended September 30, |
|
Change |
(in thousands) |
|
2007 |
|
2006 |
|
$ |
|
% |
Specialty generics |
|
$ |
|
|
|
$ |
10,269 |
|
|
$ |
(10,269 |
) |
|
|
* |
|
We incurred litigation settlement and defense costs of $10,269,000 in the nine months ended
September 30, 2006 associated with a claim settled in late 2006.
Separation Costs
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Nine Months Ended September 30, |
|
Change |
(in thousands) |
|
2007 |
|
2006 |
|
$ |
|
% |
Drug delivery |
|
$ |
1,153 |
|
|
$ |
|
|
|
$ |
1,153 |
|
|
|
* |
|
32
Separation costs for the nine months ended September 30, 2007 totaled $1,153,000, primarily
for external advisors to the Company incurred in connection with our planned spin-off of the drug
delivery business. See the explanation under Separation Costs for the three months ended September
30, 2007.
Provision for Income Taxes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Nine Months Ended September 30, |
|
|
2007 |
|
2006 |
(in thousands) |
|
Spain |
|
|
Ireland |
|
|
U.S. |
|
|
Consol. |
|
|
Spain |
|
|
Ireland |
|
|
U.S. |
|
|
Consol. |
|
|
|
|
|
|
Income (loss) before income taxes |
|
$ |
14,753 |
|
|
$ |
(4,526 |
) |
|
$ |
(3,249 |
) |
|
$ |
6,978 |
|
|
$ |
11,630 |
|
|
$ |
(3,347 |
) |
|
$ |
(5,116 |
) |
|
$ |
3,167 |
|
Provision (benefit) for income taxes |
|
|
4,509 |
|
|
|
(566 |
) |
|
|
(888 |
) |
|
|
3,055 |
|
|
|
6,607 |
|
|
|
(418 |
) |
|
|
(1,863 |
) |
|
|
4,326 |
|
Valuation allowance |
|
|
|
|
|
|
566 |
|
|
|
888 |
|
|
|
1,454 |
|
|
|
|
|
|
|
418 |
|
|
|
1,863 |
|
|
|
2,281 |
|
|
|
|
|
|
Net provision for income taxes |
|
|
4,509 |
|
|
|
|
|
|
|
|
|
|
|
4,509 |
|
|
|
6,607 |
|
|
|
|
|
|
|
|
|
|
|
6,607 |
|
|
|
|
|
|
Net income (loss) |
|
$ |
10,244 |
|
|
$ |
(4,526 |
) |
|
$ |
(3,249 |
) |
|
$ |
2,469 |
|
|
$ |
5,023 |
|
|
$ |
(3,347 |
) |
|
$ |
(5,116 |
) |
|
$ |
(3,440 |
) |
|
|
|
|
|
Effective tax rate |
|
|
31 |
% |
|
|
0 |
% |
|
|
0 |
% |
|
|
65 |
% |
|
|
57 |
% |
|
|
0 |
% |
|
|
0 |
% |
|
|
209 |
% |
|
|
|
|
|
We have recorded provisions for foreign income taxes totaling $4,509,000 and $6,607,000 for
the nine months ended September 30, 2007 and 2006, respectively. The provisions represented 31%
and 57% of the pre-tax income reported in Spain of $14,753,000 and $11,630,000 for the nine months
ended September 30, 2007 and 2006, respectively. The 2006 effective tax rate for Spain is higher
than that for 2007 primarily due to the $7,546,000 loss contingency recorded in Spain in September
2006 for which no tax benefit was recorded in that period. We subsequently recorded a tax benefit
of $2,746,000 in the provision for income taxes upon finalization of the litigation settlement in
the fourth quarter of 2006. As future operating profits in the U.S and Ireland cannot be
reasonably assured, no tax benefit has been recorded for the related losses, which totaled
approximately $7,775,000 and $8,463,000 for the nine months ended September 30, 2007 and 2006,
respectively. Accordingly, we have established valuation allowances equal to the full amount of the
U.S. and Irish deferred tax assets. Consequently, the provisions represented 65% and 209% of
consolidated pre-tax income for the nine months ended September 30, 2007 and 2006, respectively.
Net
Income (Loss)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Nine Months |
|
|
|
|
|
|
Ended September 30, |
|
|
Change |
|
(in thousands, except per share data) |
|
2007 |
|
|
2006 |
|
|
$ |
|
|
% |
|
Specialty generics |
|
$ |
9,160 |
|
|
$ |
2,684 |
|
|
$ |
6,476 |
|
|
|
241 |
% |
Drug delivery |
|
|
(6,691 |
) |
|
|
(6,124 |
) |
|
|
(567 |
) |
|
|
-9 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net
income (loss) |
|
$ |
2,469 |
|
|
$ |
(3,440 |
) |
|
$ |
5,909 |
|
|
|
172 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
income (loss) per common share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
0.11 |
|
|
$ |
(0.16 |
) |
|
$ |
0.27 |
|
|
|
169 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted |
|
$ |
0.11 |
|
|
$ |
(0.16 |
) |
|
$ |
0.27 |
|
|
|
169 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
22,322 |
|
|
|
22,107 |
|
|
|
215 |
|
|
|
1 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted |
|
|
22,829 |
|
|
|
22,107 |
|
|
|
722 |
|
|
|
3 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
We reported net income of $2,469,000 in the nine months ended September 30, 2007 compared to
the net loss of $3,440,000 in the nine months ended September 30, 2006. The combination of income
from operations of $6,536,000 and the non-operating items, primarily a provision for income taxes
of $4,509,000 and the net of other income and expenses totaling $442,000 resulted in net income of
$2,469,000, or $0.11 per basic common share ($0.11 per diluted common share) on 22,322,000 weighted
average basic common
33
shares outstanding (22,829,000 weighted average diluted common shares
outstanding) in the period ended September 30, 2007, compared to net loss of $3,440,000, or $(0.16)
per basic common share on 22,107,000 weighted average basic common shares outstanding in the period
ended September 30, 2006.
LIQUIDITY AND CAPITAL RESOURCES:
Total assets increased from $134,356,000 at December 31, 2006 to $164,648,000 at September 30,
2007, and stockholders equity increased from $100,331,000 at December 31, 2006 to $110,850,000 at
September 30, 2007. The $10,519,000 increase in stockholders equity during the nine months ended
September 30, 2007 primarily reflects the effect of fluctuations in the Euro/U.S. Dollar exchange
rate, which resulted in a net increase of $6,392,000 to our stockholders equity, net income of
$2,469,000 and $1,923,000 of stock-based compensation increasing additional paid-in capital.
Cash, cash equivalents and marketable securities increased by approximately 150% or
$23,411,000 from $15,601,000 at December 31, 2006 to $39,012,000 at September 30, 2007. Sources of
cash include loan proceeds of $14,807,000 included in cash flows from financing activities, net
income of $2,469,000 and approximately $7,810,000 of non-cash expenses included in cash flows from
operating activities. Uses of cash included additions to fixed assets totaling $7,489,000 and
additions to drug licenses totaling $1,780,000. Cash and cash equivalents at September 30, 2007
include approximately $23,782,000 of short-term liquid investments considered to be cash
equivalents.
Receivables decreased by approximately 5% from $32,963,000 at December 31, 2006 to $31,469,000
at September 30, 2007. When expressed in constant currency, receivables decreased $3,507,000, or
11%, due to a combination of lower cyclical sales in the third quarter and the timing of
collections on net product sales outside of Spain, which generally have longer negotiated
collection terms. We have not experienced any material delinquencies on any of our receivables
that have had a material effect on our financial position, results of operations or cash flows.
Inventory balances decreased by approximately $1,236,000 from $16,279,000 at December 31, 2006
to $15,043,000 at September 30, 2007. Fluctuations in foreign currency had the effect of
increasing inventories by approximately $1,062,000. The constant currency decrease of $2,298,000
was primarily due to inventory adjustments totaling $1,010,000 to write-down U.S. generic product
inventories to their net realizable value and reserve for slow moving inventories and lower
finished good inventories due to the timing of product orders.
The combined total of accounts payable and accrued expenses increased from $24,270,000 at
December 31, 2006 to $26,858,000 at September 30, 2007. The $2,588,000 increase was primarily
attributed to fluctuations in foreign currency exchange rates, which increased the balances by
approximately $1,610,000, as well as approximately $1,197,000 of increased drug delivery payables
and accrued expenses, which include accrued separation costs and accrued compensation.
We repaid all of our short-term borrowings and current portion of long-term debt outstanding
at December 31, 2006 during the nine months ended September 30, 2007. Our short-term borrowings and
current portion of long-term debt totaled $554,000 at December 31, 2006.
On June 29, 2007, we entered into an 11,000,000 Euro loan agreement with a Spanish financial
institution. As a result, we recorded long-term debt of $14,807,000 ($15,559,000 at September 30,
2007 due to changes in foreign currency rates).
Operating activities for the nine months ended September 30, 2007 provided net cash of
$16,593,000, an increase of $10,470,000 when compared to the nine months ended September 30, 2006.
Changes in working capital, accounts receivable and inventory in particular, contributed to
approximately $11,313,000 of this increase.
34
Investing activities, primarily capital expenditures to expand the capacity of our
manufacturing facilities in Spain, along with additions to drug licenses and related costs,
required cash totaling $9,269,000 during the nine months ended September 30, 2007. In addition,
approximately $2,659,000 of short-term marketable securities matured during the nine months ended
September 30, 2007.
Financing activities during the nine months ended September 30, 2007 provided net cash of
$14,393,000, and represented mainly cash proceeds from borrowings totaling $14,807,000, as
described above. These proceeds were partially offset by net repayment of borrowings totaling
$554,000.
Seasonality. In the past, we have experienced lower sales in the third calendar
quarter and higher sales in the fourth calendar quarter due to seasonality of our pharmaceutical
business. The extent of such variations is dependent upon the severity of the cough, cold and flu
season. As we market more pharmaceutical products whose sales are seasonal, seasonality of sales
may become more significant.
Effect of Inflation and Changing Prices. Neither inflation nor changing prices has materially
impacted our net product sales or income from operations for the periods presented.
Liquidity. We plan to continue making improvements to our manufacturing facilities
during 2007 that include the acquisition of additional manufacturing equipment and expansion of our
manufacturing facilities, in order to increase manufacturing efficiencies and accommodate our
expected growth. We have completed capital additions of $7,489,000 in the nine months ended
September 30, 2007. Due to delays in timing of planned capital projects, we currently expect to
invest $11,000,000 to $13,000,000 in 2007 (primarily in our manufacturing facilities), compared to
our previous estimate of $13,000,000 to $16,000,000. We expect to complete the balance of these
capital investments in 2008. We also plan to invest $13,000,000 to $16,000,000 in research and
development activities in 2007, primarily to support the continued development of Nasulin, our
intranasal insulin product. We plan to finance the remaining capital expenditures and research and
development investments from a combination of cash flows from operations and existing cash balances
(including the $14,807,000 of proceeds we received from our recent loan agreement). In accordance
with our litigation settlement with Ethypharm S.A. Spain and Ethypharm S.A. France (or Ethypharm)
in late 2006, we made a scheduled $1,000,000 annual payment to Ethypharm in October of 2007. The
remaining three annual payments of $1,000,000 are scheduled to be made in the fourth quarters of
2008, 2009 and 2010. These amounts are expected to be paid with our operating cash flows.
As discussed above, we have cash and cash equivalents totaling approximately $38,452,000 as of
September 30, 2007, which we believe is sufficient to fund our operations for the foreseeable
future. Although we generate positive cash flow from operations, (approximately $16,593,000 in the
nine months ended September 30, 2007), there can be no assurance that changes in our research and
development plans, capital expenditures and/or acquisitions, or other events affecting our
operations will not result in the earlier depletion of our funds. We continue to search both
domestically and internationally for opportunities that will enable us to continue expanding our
business and explore alternative financing sources for these activities, including the possibility
of public and/or private offerings of debt and equity securities. In appropriate situations, we may
seek financial assistance from other sources, including contribution by others to joint ventures
and other collaborative or licensing arrangements for the development, testing, manufacturing and
marketing of products under development.
Critical Accounting Policies and Estimates
Our significant accounting policies are more fully described in Note 2 to our consolidated
financial statements in our 2006 Form 10-
K. Certain of our accounting policies are particularly important to the portrayal of our financial
position, results of operations and cash flows and require the application of significant judgment
by our management; as a result they are subject to an inherent degree of uncertainty. In applying
those policies, our management uses its judgment to determine the appropriate assumptions to be
used in the determination of certain estimates. Those estimates are based on our historical
experience, terms of existing contracts, our observation of trends in the industry, information
provided by our customers and
35
information available from other outside sources, as
appropriate. We have reviewed our critical accounting policies and estimates discussed in our 2006 Form 10-K and
have determined that, with the exception of our critical accounting policies for the provision for
income taxes, inventories and clinical trial expenses noted below, those policies remain our most
critical accounting policies for the quarter ended September 30, 2007. We did not make any changes
to those policies during the nine months ended September 30, 2007.
Provision for income taxes
We have provided for current and deferred U.S. federal, state and foreign income taxes for the
current and all prior periods presented. Current and deferred income taxes have been provided with
respect to jurisdictions where certain of our subsidiaries produce taxable income. We have
provided a valuation allowance with respect to the remainder of our deferred income taxes,
consisting primarily of net operating loss carryforwards in the U.S. and Ireland, because of
uncertainty regarding their realization. Should we determine that it is more likely than not that
we will realize certain of our net deferred tax assets for which we have previously provided a
valuation allowance, an adjustment would be required to reduce the existing valuation allowance.
Effective January 1, 2007, we account for uncertain tax positions in accordance with Financial
Accounting Standards Board Interpretation No. 48, Accounting for Uncertainty in Income Taxes (FIN 48), an interpretation of FASB Statement No. 109, Accounting for Income Taxes. As a result of
the implementation of FIN 48, we recorded a $405,000 increase in our non-current liabilities
for uncertain tax positions which was accounted for an increase to the January 1, 2007 accumulated
deficit. The application of income tax law is inherently complex. Income tax laws and regulations
are voluminous and 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 frequently. Changes in our subjective assumptions and judgments
could have a material effect on our financial position, results of operations or cash flows. In
addition, as we operate within multiple taxing jurisdictions, we are subject to audit in those
jurisdictions. The ultimate resolution of tax audits may require an extended period of time.
Although we believe an adequate provision has been made for uncertain tax positions, there is the
possibility that the ultimate resolution of such positions could have an adverse effect on our
financial position, results of operations or cash flows. See Provision for income taxes in our
Notes to Unaudited Condensed Consolidated Financial Statements in Item 1 for additional information
regarding our uncertain tax positions.
Inventories
Inventories are stated at the lower of cost or market, cost being determined on the first-in,
first-out method. We analyze our inventory on a quarterly basis and write-down inventory that has a
cost basis in excess of its expected net realizable value. The determination of whether or not
inventory costs will be realized requires management estimates. Actual results may differ from
those estimates and require inventory to be written-down, resulting in a new cost basis until sold.
Reserves for slow moving or obsolete inventories are provided based on historical experience and
forecasted demand.
Clinical trial expenses
Clinical trial expenses, which are reflected in research and development expenses, result from
obligations under contract with vendors, consultants, and clinical sites in connection with
conducting clinical trials. The financial terms of these contracts are subject to negotiations
which vary from contract to contract and may result in cash flows which are not consistent with the
periods in which materials or services are provided. These costs are capitalized upon payment and
expensed according to the progress of each trial as measured by patient progression and the timing
of various aspects of the trial. The progress of the trials, including the level of services
performed, is determined for financial reporting purposes based upon judgments made after
discussions with internal personnel as well as outside service providers.
36
Important Factors That May Affect Future Results
This Quarterly Report on Form 10-Q contains forward-looking statements. These forward-looking
statements appear principally in the section entitled Managements Discussion and Analysis of
Financial Condition and Results of Operations. Forward-looking statements may appear in other
sections of this report, as well. Generally, the forward-looking statements in this report include
such words as expect, believe, continue, anticipate, estimate, may, will, could,
opportunity, future, project, and similar expressions.
The forward-looking statements include statements about our:
|
|
|
Strategic plans; |
|
|
|
|
Sales growth; |
|
|
|
|
Anticipated sources of future revenues; |
|
|
|
|
Anticipated 2007 expenses, margins and operating performance; |
|
|
|
|
Anticipated expenses associated with the planned spin-off transaction; |
|
|
|
|
Expected launch of new products; |
|
|
|
|
Anticipated expenses and spending; |
|
|
|
|
Planned and continuing clinical trials; |
|
|
|
|
Anticipated regulatory changes and approvals; and |
|
|
|
|
The sufficiency of capital resources to fund our operations. |
These forward-looking statements are based on our current expectations, beliefs, assumptions,
estimates, forecasts and projections for our business and the industry and markets in which we
compete. These statements are not guarantees of future performance and involve certain risks,
uncertainties and assumptions that are difficult to predict. Therefore, actual outcomes and results
may differ materially from what is expressed in such forward-looking statements. We caution
investors not to place undue reliance on the forward-looking statements contained in this report.
These statements speak only as of the date of this report, and we do not undertake any obligation
to update or revise them, except as required by law. We refer you to our description of the risk
factors related to our business, which are contained in the section entitled Risk Factors in our
2006 Form 10-K. As a result of these and other factors, we may experience material fluctuations in
our future operating results, which could materially affect our business, financial position, and
stock price.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Foreign Currency. A substantial amount of our business is conducted in Europe and,
therefore our results, which are measured in U.S. Dollars, are influenced by fluctuations in the
U.S. Dollars value in relation to other currencies, specifically the Euro. The exchange rates at
September 30, 2007 and December 31, 2006 are as follows:
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U.S. Dollars per Euro |
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September 30, 2007 |
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December 31, 2006 |
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YTD weighted average exchange rate |
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1.34 |
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1.26 |
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Exchange rate |
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1.41 |
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1.31 |
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The
net effect of foreign currency translation on our Unaudited
Consolidated Balance Sheet for the nine months ended September 30, 2007 was a net increase of $6,392,000 and the
cumulative historical effect as of September 30, 2007 was an increase of $15,264,000, as reflected
in accumulated other comprehensive income. The
carrying values of assets and liabilities can be materially impacted by foreign currency
translation, as can the translated amounts of revenues and expenses.
We have relied primarily upon financing activities to fund our operations in the U.S. In the
event that we are required to fund U.S. operations or cash needs with funds generated in Europe or
cash requirements in Europe with U.S. funds, currency rate fluctuations in the future could have a
significant impact on us. We entered into a cash flow hedge in 2006 designed to reduce the effect
of fluctuations in foreign
37
currency on a litigation settlement liability. However, at this time,
we do not anticipate using any similar hedging transaction or otherwise altering our business plans
and practices to compensate for future currency fluctuations affecting any other balances.
Interest Rates. The interest rate on our long-term borrowings at September 30, 2007
was 5.02% and the amount of borrowings outstanding is $15,559,000 as of September 30, 2007. The
interest rate on our long-term debt is variable and reset quarterly. The effect of an increase in
interest rates of one percentage point (one hundred basis points) to an average of 6.02% on
long-term borrowings would have the effect of increasing interest expense by approximately $155,600
annually; however, no payments are due under the loan agreement until December 31, 2008.
Item 4. Controls and Procedures
Bentley maintains disclosure controls and procedures that are designed to ensure that
information required to be disclosed in Bentleys reports that are filed or submitted under the
Securities Exchange Act of 1934, as amended (the Exchange Act) with the Securities and Exchange
Commission is recorded, processed, summarized and reported within the time periods required for
each report and that such information is reported to Bentleys management, including its principal
executive officer and principal financial officer, as appropriate, to allow timely decisions
regarding required disclosure.
Bentleys management carried out an evaluation, with the participation of Bentleys principal
executive officer and principal financial officer, of the effectiveness of Bentleys disclosure
controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of
the end of the period covered by this quarterly report. Based on that evaluation, Bentleys
principal executive officer and principal financial officer concluded that Bentleys disclosure
controls and procedures were effective as of September 30, 2007.
There was no change in Bentleys internal control over financial reporting (as defined in
Rules 13a-15(f) and 15d-15(f) under the Exchange Act) identified in connection with the evaluation
of Bentleys internal controls that occurred during the quarter ended September 30, 2007 that has
materially affected, or is reasonably likely to materially affect, Bentleys internal control over
financial reporting.
PART II. OTHER INFORMATION
Item 6. Exhibits
The Exhibits filed as part of this report are listed on the Exhibit Index immediately
preceding the exhibits, which Exhibit Index is incorporated herein by reference.
38
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused
this report to be signed on its behalf by the undersigned thereunto duly authorized.
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BENTLEY PHARMACEUTICALS, INC.
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Registrant |
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November 8, 2007
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By:
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/s/ James R. Murphy |
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James R. Murphy |
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Chairman of the Board of Directors |
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and Chief Executive Officer |
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(Principal Executive Officer) |
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November 8, 2007
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By:
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/s/ Richard P. Lindsay |
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Richard P. Lindsay |
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Vice President, Chief Financial Officer, |
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Secretary and Treasurer |
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(Principal Financial Officer) |
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Exhibit Index
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Exhibit |
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Number |
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Description of Exhibit |
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10.1
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*
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Employment Agreement dated as of August 20, 2007 by and between
Bentley Pharmaceuticals, Inc. and James R. Murphy. |
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31.1
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*
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Certification of the Chief Executive Officer pursuant to Section
302 of the Sarbanes-Oxley Act of 2002. |
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31.2
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*
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Certification of the Chief Financial Officer pursuant to Section
302 of the Sarbanes-Oxley Act of 2002. |
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32.1
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*
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Certification of the Chief Executive Officer pursuant to 18 U.S.C.
Section 1350 as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002. |
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32.2
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*
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Certification of the Chief Financial Officer pursuant to 18 U.S.C.
Section 1350 as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002. |
* Filed herewith.