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 June 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
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No. 59-1513162 |
(State or other jurisdiction of
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(I.R.S. Employer |
incorporation or organization)
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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):
Large accelerated filer o Accelerated filer þ Non-accelerated filer o
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act). YES o NO þ
The number
of shares of the registrants common stock outstanding as of August 9, 2007 was
22,308,129.
Bentley Pharmaceuticals, Inc. and Subsidiaries
Form 10-Q for the Quarter Ended June 30, 2007
Index
2
Bentley Pharmaceuticals, Inc. and Subsidiaries
Consolidated Balance Sheets
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(in thousands, except per share data) |
|
June 30, |
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December 31, |
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2007 |
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|
2006 |
|
Assets |
|
|
|
|
|
|
|
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Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
35,661 |
|
|
$ |
12,424 |
|
Marketable securities |
|
|
529 |
|
|
|
3,177 |
|
Receivables, net |
|
|
34,222 |
|
|
|
32,963 |
|
Inventories, net |
|
|
15,801 |
|
|
|
16,279 |
|
Deferred taxes |
|
|
1,257 |
|
|
|
1,049 |
|
Prepaid expenses and other |
|
|
2,116 |
|
|
|
1,798 |
|
|
|
|
|
|
|
|
Total current assets |
|
|
89,586 |
|
|
|
67,690 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-current assets: |
|
|
|
|
|
|
|
|
Fixed assets, net |
|
|
51,404 |
|
|
|
48,556 |
|
Drug licenses and related costs, net |
|
|
16,425 |
|
|
|
16,026 |
|
Restricted cash |
|
|
1,000 |
|
|
|
1,000 |
|
Deferred taxes |
|
|
148 |
|
|
|
240 |
|
Other |
|
|
1,009 |
|
|
|
844 |
|
|
|
|
|
|
|
|
Total non-current assets |
|
|
69,986 |
|
|
|
66,666 |
|
|
|
|
|
|
|
|
|
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$ |
159,572 |
|
|
$ |
134,356 |
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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 |
|
$ |
16,224 |
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$ |
14,566 |
|
Accrued expenses |
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|
12,180 |
|
|
|
9,704 |
|
Short-term borrowings |
|
|
|
|
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|
247 |
|
Current portion of long-term debt |
|
|
|
|
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|
307 |
|
Deferred income |
|
|
853 |
|
|
|
1,045 |
|
Other current liabilities |
|
|
1,253 |
|
|
|
1,518 |
|
|
|
|
|
|
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|
Total current liabilities |
|
|
30,510 |
|
|
|
27,387 |
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Non-current liabilities: |
|
|
|
|
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|
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Long-term debt |
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|
14,807 |
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|
|
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Deferred income |
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|
4,305 |
|
|
|
3,899 |
|
Other |
|
|
3,772 |
|
|
|
2,739 |
|
|
|
|
|
|
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Total non-current liabilities |
|
|
22,884 |
|
|
|
6,638 |
|
|
|
|
|
|
|
|
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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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|
Common stock, $0.02 par value, authorized 100,000 shares,
issued and outstanding, 22,297 and 22,262 shares |
|
|
445 |
|
|
|
445 |
|
Additional paid-in capital |
|
|
141,194 |
|
|
|
140,030 |
|
Accumulated deficit |
|
|
(46,351 |
) |
|
|
(49,016 |
) |
Accumulated other comprehensive income |
|
|
10,890 |
|
|
|
8,872 |
|
|
|
|
|
|
|
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Total stockholders equity |
|
|
106,178 |
|
|
|
100,331 |
|
|
|
|
|
|
|
|
|
|
$ |
159,572 |
|
|
$ |
134,356 |
|
|
|
|
|
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|
The accompanying Notes to Condensed Consolidated Financial Statements are an integral part of these financial statements.
3
Bentley Pharmaceuticals, Inc. and Subsidiaries
Consolidated Income Statements
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For the Three Months Ended |
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For the Six Months Ended |
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(in thousands, except per share data) |
|
June 30, |
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June 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 |
|
$ |
28,353 |
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|
$ |
26,457 |
|
|
$ |
57,467 |
|
|
$ |
53,027 |
|
Licensing and collaboration revenues |
|
|
2,826 |
|
|
|
2,526 |
|
|
|
5,103 |
|
|
|
4,234 |
|
|
|
|
|
|
|
|
|
|
|
|
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Total revenues |
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|
31,179 |
|
|
|
28,983 |
|
|
|
62,570 |
|
|
|
57,261 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Cost of net product sales |
|
|
15,790 |
|
|
|
12,471 |
|
|
|
31,687 |
|
|
|
25,404 |
|
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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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|
15,389 |
|
|
|
16,512 |
|
|
|
30,883 |
|
|
|
31,857 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Operating expenses: |
|
|
|
|
|
|
|
|
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|
|
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Selling and marketing |
|
|
4,813 |
|
|
|
4,242 |
|
|
|
9,258 |
|
|
|
8,381 |
|
General and administrative |
|
|
4,579 |
|
|
|
3,665 |
|
|
|
8,225 |
|
|
|
7,569 |
|
Research and development |
|
|
3,502 |
|
|
|
2,495 |
|
|
|
6,177 |
|
|
|
5,403 |
|
Litigation settlement |
|
|
|
|
|
|
733 |
|
|
|
|
|
|
|
1,337 |
|
Depreciation and amortization |
|
|
546 |
|
|
|
445 |
|
|
|
1,054 |
|
|
|
881 |
|
|
|
|
|
|
|
|
|
|
|
|
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Total operating expenses |
|
|
13,440 |
|
|
|
11,580 |
|
|
|
24,714 |
|
|
|
23,571 |
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|
|
|
|
|
|
|
|
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|
|
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|
|
|
|
|
|
|
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|
|
|
|
|
|
|
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|
Income from operations |
|
|
1,949 |
|
|
|
4,932 |
|
|
|
6,169 |
|
|
|
8,286 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Other income (expenses): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
185 |
|
|
|
185 |
|
|
|
367 |
|
|
|
438 |
|
Interest expense |
|
|
(51 |
) |
|
|
(34 |
) |
|
|
(101 |
) |
|
|
(94 |
) |
Other, net |
|
|
144 |
|
|
|
36 |
|
|
|
233 |
|
|
|
36 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income before income taxes |
|
|
2,227 |
|
|
|
5,119 |
|
|
|
6,668 |
|
|
|
8,666 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Provision for income taxes |
|
|
1,517 |
|
|
|
2,484 |
|
|
|
3,598 |
|
|
|
4,877 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
710 |
|
|
$ |
2,635 |
|
|
$ |
3,070 |
|
|
$ |
3,789 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
Net income per common share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
0.03 |
|
|
$ |
0.12 |
|
|
$ |
0.14 |
|
|
$ |
0.17 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted |
|
$ |
0.03 |
|
|
$ |
0.12 |
|
|
$ |
0.14 |
|
|
$ |
0.16 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Weighted average common
shares outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
22,318 |
|
|
|
22,170 |
|
|
|
22,305 |
|
|
|
22,063 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted |
|
|
22,892 |
|
|
|
22,876 |
|
|
|
22,695 |
|
|
|
23,380 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying Notes to Condensed Consolidated Financial Statements are an integral part of these financial statements.
4
Bentley Pharmaceuticals, Inc. and Subsidiaries
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 No. 48 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(405 |
) |
|
|
|
|
|
|
(405 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income (loss): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,070 |
|
|
|
|
|
|
|
3,070 |
|
Other comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation adjustment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,018 |
|
|
|
2,018 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
5,088 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise of stock options |
|
|
25 |
|
|
|
|
|
|
|
25 |
|
|
|
|
|
|
|
|
|
|
|
25 |
|
Purchase of treasury shares |
|
|
(4 |
) |
|
|
|
|
|
|
(52 |
) |
|
|
|
|
|
|
|
|
|
|
(52 |
) |
Stock-based compensation |
|
|
14 |
|
|
|
|
|
|
|
1,191 |
|
|
|
|
|
|
|
|
|
|
|
1,191 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2007 |
|
|
22,297 |
|
|
$ |
445 |
|
|
$ |
141,194 |
|
|
$ |
(46,351 |
) |
|
$ |
10,890 |
|
|
$ |
106,178 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying Notes to Condensed Consolidated Financial Statements are an integral part of these financial statements.
5
Bentley Pharmaceuticals, Inc. and Subsidiaries
Consolidated Statements of Cash Flows
|
|
|
|
|
|
|
|
|
|
|
For the Six Months Ended |
|
(in thousands) |
|
June 30, |
|
|
|
2007 |
|
|
2006 |
|
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
Net income |
|
$ |
3,070 |
|
|
$ |
3,789 |
|
Adjustments to reconcile net income to net
cash provided by operating activities: |
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
3,259 |
|
|
|
2,630 |
|
Non-cash charge for inventory write-down and reserves |
|
|
422 |
|
|
|
|
|
Foreign currency gains |
|
|
(56 |
) |
|
|
|
|
Equity-based compensation expense |
|
|
1,191 |
|
|
|
958 |
|
Change in fair value of derivative instrument |
|
|
31 |
|
|
|
|
|
Loss on disposal of assets |
|
|
353 |
|
|
|
52 |
|
Other non-cash items |
|
|
6 |
|
|
|
6 |
|
(Increase) decrease in assets and
increase (decrease) in liabilities: |
|
|
|
|
|
|
|
|
Receivables |
|
|
(503 |
) |
|
|
(4,117 |
) |
Inventories |
|
|
429 |
|
|
|
(2,073 |
) |
Deferred income taxes |
|
|
(82 |
) |
|
|
(112 |
) |
Prepaid expenses and other current assets |
|
|
(287 |
) |
|
|
208 |
|
Other assets |
|
|
(131 |
) |
|
|
(187 |
) |
Accounts payable and accrued expenses |
|
|
3,535 |
|
|
|
2,828 |
|
Deferred income |
|
|
89 |
|
|
|
863 |
|
Other liabilities |
|
|
270 |
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by operating activities |
|
|
11,596 |
|
|
|
4,845 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
Additions to fixed assets |
|
|
(4,258 |
) |
|
|
(7,316 |
) |
Additions to drug licenses and related costs |
|
|
(1,205 |
) |
|
|
(871 |
) |
Purchase of investments |
|
|
|
|
|
|
(2,377 |
) |
Proceeds from investments |
|
|
2,661 |
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in investing activities |
|
|
(2,802 |
) |
|
|
(10,564 |
) |
|
|
|
|
|
|
|
(Continued on following page)
The accompanying Notes to Condensed Consolidated Financial Statements are an integral part of these financial statements.
6
Bentley Pharmaceuticals, Inc. and Subsidiaries
Consolidated Statements of Cash Flows (Concluded)
|
|
|
|
|
|
|
|
|
|
|
For the Six Months Ended |
|
(in thousands) |
|
June 30, |
|
|
|
2007 |
|
|
2006 |
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
Proceeds from the exercise of stock options |
|
$ |
25 |
|
|
$ |
115 |
|
Remittance of employee tax liabilities in exchange
for common stock tendered to the Company |
|
|
(52 |
) |
|
|
(1,713 |
) |
Proceeds from borrowings |
|
|
14,807 |
|
|
|
1,404 |
|
Repayment of borrowings |
|
|
(554 |
) |
|
|
(2,870 |
) |
|
|
|
|
|
|
|
Net cash provided by (used) in financing activities |
|
|
14,226 |
|
|
|
(3,064 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of exchange rate changes on cash |
|
|
217 |
|
|
|
360 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase (decrease) in cash and cash equivalents |
|
|
23,237 |
|
|
|
(8,423 |
) |
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at beginning of period |
|
|
12,424 |
|
|
|
32,384 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
$ |
35,661 |
|
|
$ |
23,961 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental Disclosures of Cash Flow Information |
|
|
|
|
|
|
|
|
The Company paid cash during the period for: |
|
|
|
|
|
|
|
|
Interest |
|
$ |
11 |
|
|
$ |
90 |
|
|
|
|
|
|
|
|
Foreign income taxes |
|
$ |
1,541 |
|
|
$ |
2,152 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 |
|
|
15 |
|
|
|
9 |
|
|
|
|
|
|
|
|
Amount |
|
$ |
139 |
|
|
$ |
127 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amounts included in accounts payable at end of
period for fixed asset and drug license purchases |
|
$ |
1,326 |
|
|
$ |
2,096 |
|
|
|
|
|
|
|
|
The accompanying Notes to Condensed Consolidated Financial Statements are an integral part of these financial statements.
7
Bentley Pharmaceuticals, Inc. and Subsidiaries
Notes to 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 most 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, including research using biodegradable NanocapletTM
technology.
Basis of Condensed Consolidated Financial Statements
The Condensed Consolidated Financial Statements of Bentley as of June 30, 2007 and for the
three and six months ended June 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
8
31, 2006. These
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 June 30, 2007 and for the three and six months ended June 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 June 30, 2007 and the
results of its operations and cash flows for the three and six months ended June 30, 2007 and 2006.
The results of operations for the three and six months ended June 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 Consolidated
Balance Sheets and the Consolidated Statements of Cash Flows. Investments in securities that do not
meet the definition of cash equivalents are classified as marketable securities in the Consolidated
Balance Sheets.
Included in cash and cash equivalents at June 30, 2007 and December 31, 2006 are approximately
$9,839,000 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.
Receivables
Receivables consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30, 2007 |
|
|
December 31, 2006 |
|
Trade receivables (of which $0 and
$2,595, respectively,
collateralize short-term
borrowings with Spanish financial
institutions) |
|
$ |
27,207 |
|
|
$ |
27,880 |
|
VAT receivable |
|
|
4,783 |
|
|
|
3,151 |
|
Royalties receivable |
|
|
2,675 |
|
|
|
2,261 |
|
Other |
|
|
90 |
|
|
|
82 |
|
|
|
|
|
|
|
|
|
|
|
34,755 |
|
|
|
33,374 |
|
Less-allowance for doubtful accounts |
|
|
(533 |
) |
|
|
(411 |
) |
|
|
|
|
|
|
|
|
|
$ |
34,222 |
|
|
$ |
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.
9
Balances are comprised of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30, 2007 |
|
|
December 31, 2006 |
|
Raw materials |
|
$ |
10,382 |
|
|
$ |
8,669 |
|
Finished goods |
|
|
6,196 |
|
|
|
7,621 |
|
|
|
|
|
|
|
|
|
|
|
16,578 |
|
|
|
16,290 |
|
Less allowance for slow moving
inventory |
|
|
(777 |
) |
|
|
(11 |
) |
|
|
|
|
|
|
|
|
|
$ |
15,801 |
|
|
$ |
16,279 |
|
|
|
|
|
|
|
|
Included in the Companys inventories at June 30, 2007 and December 31, 2006 are $298,000
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 six months ended June
30, 2007, the Company recorded adjustments totaling $1,035,000 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 charge of approximately $422,000 to cost of sales, 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 June 30, 2007 and December 31, 2006, the Company has
recorded $132,000 and $481,000, respectively, as payments from its collaborator net of adjustments,
which have been recorded in other current liabilities on the Condensed Consolidated Balance Sheets.
Fixed assets
Fixed assets consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30, 2007 |
|
|
December 31, 2006 |
|
Land |
|
$ |
2,926 |
|
|
$ |
2,875 |
|
Buildings and improvements |
|
|
23,822 |
|
|
|
17,538 |
|
Equipment |
|
|
23,831 |
|
|
|
20,591 |
|
Furniture and fixtures |
|
|
2,108 |
|
|
|
2,138 |
|
Other |
|
|
284 |
|
|
|
394 |
|
|
|
|
|
|
|
|
|
|
|
52,971 |
|
|
|
43,536 |
|
Capital in-progress |
|
|
16,264 |
|
|
|
20,213 |
|
|
|
|
|
|
|
|
|
|
|
69,235 |
|
|
|
63,749 |
|
Less accumulated depreciation |
|
|
(17,831 |
) |
|
|
(15,193 |
) |
|
|
|
|
|
|
|
|
|
$ |
51,404 |
|
|
$ |
48,556 |
|
|
|
|
|
|
|
|
Depreciation expense of approximately $179,000 and $148,000 has been charged to
operations as a component of depreciation and amortization expense in the Consolidated Income
Statements for the six months ended June 30, 2007 and 2006, respectively. Depreciation totaling
approximately $2,205,000 and $1,749,000 has been included in cost of net product sales during the
six months ended June 30, 2007 and 2006, respectively.
Long-term debt
Long-term debt consists of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30, 2007 |
|
|
December 31, 2006 |
|
Loans payable |
|
$ |
14,807 |
|
|
$ |
307 |
|
Less-current portion of long-term debt |
|
|
|
|
|
|
(307 |
) |
|
|
|
|
|
|
|
|
|
$ |
14,807 |
|
|
$ |
|
|
|
|
|
|
|
|
|
10
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 $14,807,000 at June 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 was 5.02% at June 30, 2007. The principal of the loan will be repaid in quarterly installments
of 412,500 Euros (approximately $555,300) beginning December 31, 2008, with the balance due on
December 31, 2013. Maturities on the long-term debt are as follow (in thousands):
|
|
|
|
|
2007 |
|
$ |
-- |
|
2008 |
|
|
555 |
|
2009 |
|
|
2,221 |
|
2010 |
|
|
2,221 |
|
2011 |
|
|
2,221 |
|
2012 and 2013 |
|
|
7,589 |
|
|
|
|
|
Total |
|
$ |
14,807 |
|
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.
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 six months
ended June 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 June 30, 2007 and December 31, 2006 are as follows:
|
|
|
|
|
|
|
|
|
U.S. Dollars per Euro |
|
June 30, 2007 |
|
December 31, 2006 |
YTD weighted average exchange rate |
|
|
1.33 |
|
|
|
1.26 |
|
Exchange rate |
|
|
1.35 |
|
|
|
1.31 |
|
The net effect of foreign currency translation on our Condensed Consolidated Financial
Statements for the three and six months ended June 30, 2007 was a net increase of $808,000 and
$2,018,000, respectively, and the cumulative historical effect as of June 30, 2007 was an increase
of $10,890,000, as reflected in our Consolidated Balance Sheets as 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 Consolidated Statements of Cash Flows
During the six months ended June 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 upon vesting of their respective restricted stock unit awards before tax
withholdings. 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. These shares of Common Stock were recorded at
fair market value and are held by the Company as treasury shares. As of June 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.
During the six months ended June 30, 2006, the CEO and the CMO of the Company exercised stock
options to purchase an aggregate of 533,300 shares of the Companys Common Stock. In satisfaction
of the option exercise prices, the Company received an aggregate of approximately 177,800 shares of
previously acquired Bentley Common Stock, with a fair market value of approximately
11
$2,347,500. The
Company withheld a total of approximately 129,600 shares of Common Stock, with a fair market value
of approximately $1,712,800, 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.
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 Statement of Financial Accounting Standards
(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 $4,491,000 and $4,797,000 of licensing revenues as of June 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 $4,810,000 and $3,982,000 in the six
months ended June 30, 2007 and 2006, respectively.
Provision for income taxes
The Company adopted the provisions of Financial Standards Accounting Board Interpretation No.
48, Accounting for Uncertainty in Income Taxes (FIN No. 48) an interpretation of FASB Statement
No. 109, Accounting for Income Taxes, (SFAS No. 109) on January 1, 2007. The purpose of
FIN No. 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 No. 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 No. 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 six months ended June 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
12
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.
As a result of reporting taxable income in Spain, the Company recorded provisions for foreign
income taxes totaling $3,598,000 and $4,877,000 for the six months ended June 30, 2007 and 2006,
respectively. The provisions represented 31% and 34% of the pre-tax income reported in Spain for
the six months ended June 30, 2007 and 2006, respectively. The provisions represented 54% and 56%
of consolidated pre-tax income for the six months ended June 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. See
further information regarding the Companys consolidated tax provision by tax jurisdiction in the
Results of Operations section of Item 2, Managements Discussion and Analysis of Financial
Condition and Results of Operations.
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 $5,078,000 and
$5,510,000 for the six months ended June 30, 2007 and 2006, respectively. Accordingly, 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 per common share
Basic net income 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 six months ended June 30, 2007 and 2006.
The following is a reconciliation between basic and diluted net income per common share for
the three and six months ended June 30, 2007 and 2006. Dilutive securities issuable for the three
and six months ended June 30, 2007 include approximately 574,000 and 390,000 dilutive incremental
shares, respectively issuable as a result of various stock options that are outstanding.
For the Three Months Ended June 30, 2007 (in thousands, except per share data):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of Dilutive |
|
|
|
|
Basic EPS |
|
Securities |
|
Diluted EPS |
Net Income |
|
$ |
710 |
|
|
$ |
|
|
|
$ |
710 |
|
Weighted Average
Common Shares
Outstanding |
|
|
22,318 |
|
|
|
574 |
|
|
|
22,892 |
|
Net Income Per
Common Share |
|
$ |
0.03 |
|
|
$ |
|
|
|
$ |
0.03 |
|
13
For the Three Months Ended June 30, 2006 (in thousands, except per share data):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of Dilutive |
|
|
|
|
Basic EPS |
|
Securities |
|
Diluted EPS |
Net Income |
|
$ |
2,635 |
|
|
$ |
|
|
|
$ |
2,635 |
|
Weighted Average
Common Shares
Outstanding |
|
|
22,170 |
|
|
|
706 |
|
|
|
22,876 |
|
Net Income Per
Common Share |
|
$ |
0.12 |
|
|
$ |
|
|
|
$ |
0.12 |
|
For the Six Months Ended June 30, 2007 (in thousands, except per share data):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of Dilutive |
|
|
|
|
Basic EPS |
|
Securities |
|
Diluted EPS |
Net Income |
|
$ |
3,070 |
|
|
$ |
|
|
|
$ |
3,070 |
|
Weighted Average
Common Shares
Outstanding |
|
|
22,305 |
|
|
|
390 |
|
|
|
22,695 |
|
Net Income Per
Common Share |
|
$ |
0.14 |
|
|
$ |
|
|
|
$ |
0.14 |
|
For the Six Months Ended June 30, 2006 (in thousands, except per share data):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of Dilutive |
|
|
|
|
Basic EPS |
|
Securities |
|
Diluted EPS |
Net Income |
|
$ |
3,789 |
|
|
$ |
|
|
|
$ |
3,789 |
|
Weighted Average
Common Shares
Outstanding |
|
|
22,063 |
|
|
|
1,317 |
|
|
|
23,380 |
|
Net Income Per
Common Share |
|
$ |
0.17 |
|
|
$ |
(0.01 |
) |
|
$ |
0.16 |
|
Excluded from the diluted EPS presentation for the three and six months ended June 30,
2007 were options to purchase an aggregate of approximately 1,618,000 and 2,242,000 shares of
Common Stock, respectively, at exercise prices greater than the average fair value of the Common
Stock for the three and six months ended June 30, 2007.
Excluded from the diluted EPS presentation for the three and six months ended June 30, 2006
were options to purchase an aggregate of approximately 644,000 and 10,000 shares of Common Stock,
respectively, at exercise prices greater than the average fair value of the Common Stock for the
three and six months ended June 30, 2006.
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 June 30, 2007, approximately
4,451,000 shares of Common Stock have been reserved for issuance under the Plans. Approximately
4,192,000 of the shares are outstanding, excluding 40,000 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 259,000 shares is
available for future issuance for any type of award allowed under the plan.
During the six months ended June 30, 2007, the Company issued approximately 20,200 shares of
Common Stock upon the vesting of restricted stock units, approximately 4,700 shares of Common Stock
upon exercise of stock options and approximately 14,500 shares of Common Stock as share-based
compensation in lieu of cash contributions to the Companys 401(k) Plan. The Company also withheld
14
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 20,000 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 June 30, 2007 and 2006 was
approximately $508,000 and $363,000, respectively. Share-based compensation expense recorded for
stock option and restricted stock unit awards to employees and non-employee directors for the six
months ended June 30, 2007 and 2006 was approximately $1,005,000 and $826,000, respectively.
The related expenses were recorded in the Companys Condensed Consolidated Income Statements
as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended |
|
|
For the Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
Cost of net product sales |
|
$ |
7 |
|
|
$ |
5 |
|
|
$ |
15 |
|
|
$ |
15 |
|
Selling and marketing expenses |
|
|
4 |
|
|
|
3 |
|
|
|
9 |
|
|
|
8 |
|
General and administrative expenses |
|
|
309 |
|
|
|
217 |
|
|
|
619 |
|
|
|
521 |
|
Research and development expenses |
|
|
188 |
|
|
|
138 |
|
|
|
362 |
|
|
|
282 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
508 |
|
|
$ |
363 |
|
|
$ |
1,005 |
|
|
$ |
826 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 14,501 and 8,791 shares in the six months ended June 30, 2007 and 2006 as
matching contributions for the Companys 401(k) Plan. General and administrative expenses include
approximately $63,800 and $60,000 of such non-cash share-based compensation for the six months
ended June 30, 2007 and 2006, respectively. Research and development expenses include approximately
$75,100 and $70,000 of such non-cash share-based compensation for the six months ended June 30,
2007 and 2006, respectively.
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
15
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 as of and for the three and six months ended June 30, 2007 and
2006 and as of 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).
As of and for the Three Months Ended June 30, 2007 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Specialty Generics |
|
Drug Delivery |
|
|
|
|
Europe |
|
U.S. |
|
Europe |
|
U.S. |
|
Consolidated |
Net product sales |
|
$ |
28,161 |
|
|
$ |
192 |
|
|
$ |
|
|
|
$ |
|
|
|
|
28,353 |
|
Licensing and collaboration revenues |
|
|
171 |
|
|
|
|
|
|
|
|
|
|
|
2,655 |
|
|
|
2,826 |
|
Total revenue |
|
|
28,332 |
|
|
|
192 |
|
|
|
|
|
|
|
2,655 |
|
|
|
31,179 |
|
Cost of net product sales |
|
|
15,447 |
|
|
|
343 |
|
|
|
|
|
|
|
|
|
|
|
15,790 |
|
Gross Profit |
|
|
12,885 |
|
|
|
(151 |
) |
|
|
|
|
|
|
2,655 |
|
|
|
15,389 |
|
Selling and marketing expense |
|
|
4,813 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,813 |
|
General and administrative expense |
|
|
2,393 |
|
|
|
(8 |
) |
|
|
|
|
|
|
2,194 |
|
|
|
4,579 |
|
Research and development expense |
|
|
519 |
|
|
|
|
|
|
|
1,491 |
|
|
|
1,492 |
|
|
|
3,502 |
|
Depreciation and amortization
expense |
|
|
284 |
|
|
|
39 |
|
|
|
|
|
|
|
223 |
|
|
|
546 |
|
Income from operations |
|
|
4,876 |
|
|
|
(182 |
) |
|
|
(1,491 |
) |
|
|
(1,254 |
) |
|
|
1,949 |
|
Interest income |
|
|
70 |
|
|
|
|
|
|
|
|
|
|
|
115 |
|
|
|
185 |
|
Interest expense |
|
|
(48 |
) |
|
|
|
|
|
|
|
|
|
|
(3 |
) |
|
|
(51 |
) |
Other income (expense), net |
|
|
144 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
144 |
|
Income before income taxes |
|
|
5,042 |
|
|
|
(182 |
) |
|
|
(1,491 |
) |
|
|
(1,142 |
) |
|
|
2,227 |
|
Provision for income taxes |
|
|
1,517 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,517 |
|
Net income (loss) |
|
|
3,525 |
|
|
|
(182 |
) |
|
|
(1,491 |
) |
|
|
(1,142 |
) |
|
|
710 |
|
Expenditures for fixed assets |
|
|
2,296 |
|
|
|
|
|
|
|
|
|
|
|
8 |
|
|
|
2,304 |
|
Expenditures for drug licenses |
|
|
565 |
|
|
|
|
|
|
|
|
|
|
|
125 |
|
|
|
690 |
|
As of and for the Three Months Ended June 30, 2006 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Specialty Generics |
|
Drug Delivery |
|
|
|
|
Europe |
|
U.S. |
|
Europe |
|
U.S. |
|
Consolidated |
Net product sales |
|
$ |
26,457 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
26,457 |
|
Licensing and collaboration revenues |
|
|
165 |
|
|
|
|
|
|
|
|
|
|
|
2,361 |
|
|
|
2,526 |
|
Total revenues |
|
|
26,622 |
|
|
|
|
|
|
|
|
|
|
|
2,361 |
|
|
|
28,983 |
|
Cost of net product sales |
|
|
12,471 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
12,471 |
|
Gross profit |
|
|
14,151 |
|
|
|
|
|
|
|
|
|
|
|
2,361 |
|
|
|
16,512 |
|
Selling and marketing expense |
|
|
4,242 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,242 |
|
General and administrative expense |
|
|
1,710 |
|
|
|
|
|
|
|
19 |
|
|
|
1,936 |
|
|
|
3,665 |
|
Research and development expense |
|
|
459 |
|
|
|
|
|
|
|
1,018 |
|
|
|
1,018 |
|
|
|
2,495 |
|
Litigation settlement |
|
|
227 |
|
|
|
506 |
|
|
|
|
|
|
|
|
|
|
|
733 |
|
Depreciation and amortization
expense |
|
|
260 |
|
|
|
21 |
|
|
|
|
|
|
|
164 |
|
|
|
445 |
|
Income from operations |
|
|
7,253 |
|
|
|
(527 |
) |
|
|
(1,037 |
) |
|
|
(757 |
) |
|
|
4,932 |
|
Interest income |
|
|
9 |
|
|
|
|
|
|
|
|
|
|
|
176 |
|
|
|
185 |
|
Interest expense |
|
|
(34 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(34 |
) |
Other income (expense), net |
|
|
36 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
36 |
|
Income before income taxes |
|
|
7,264 |
|
|
|
(527 |
) |
|
|
(1,037 |
) |
|
|
(581 |
) |
|
|
5,119 |
|
Provision for income taxes |
|
|
2,484 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,484 |
|
Net income (loss) |
|
|
4,780 |
|
|
|
(527 |
) |
|
|
(1,037 |
) |
|
|
(581 |
) |
|
|
2,635 |
|
Expenditures for fixed assets |
|
|
3,937 |
|
|
|
|
|
|
|
|
|
|
|
97 |
|
|
|
4,034 |
|
Expenditures for drug licenses |
|
|
210 |
|
|
|
|
|
|
|
|
|
|
|
140 |
|
|
|
350 |
|
16
As of and for the Six Months Ended June 30, 2007 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Specialty Generics |
|
Drug Delivery |
|
|
|
|
Europe |
|
U.S. |
|
Europe |
|
U.S. |
|
Consolidated |
Net product sales |
|
$ |
57,067 |
|
|
$ |
400 |
|
|
$ |
|
|
|
$ |
|
|
|
|
57,467 |
|
Licensing and collaboration
revenues |
|
|
285 |
|
|
|
|
|
|
|
|
|
|
|
4,818 |
|
|
|
5,103 |
|
Total revenues |
|
|
57,352 |
|
|
|
400 |
|
|
|
|
|
|
|
4,818 |
|
|
|
62,570 |
|
Cost of net product sales |
|
|
30,843 |
|
|
|
844 |
|
|
|
|
|
|
|
|
|
|
|
31,687 |
|
Gross profit |
|
|
26,509 |
|
|
|
(444 |
) |
|
|
|
|
|
|
4,818 |
|
|
|
30,883 |
|
Selling and marketing expense |
|
|
9,258 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9,258 |
|
General and administrative expense |
|
|
4,667 |
|
|
|
(28 |
) |
|
|
|
|
|
|
3,586 |
|
|
|
8,225 |
|
Research and development expense |
|
|
1,000 |
|
|
|
|
|
|
|
2,588 |
|
|
|
2,589 |
|
|
|
6,177 |
|
Litigation settlement |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization
expense |
|
|
558 |
|
|
|
78 |
|
|
|
|
|
|
|
418 |
|
|
|
1,054 |
|
Income from operations |
|
|
11,026 |
|
|
|
(494 |
) |
|
|
(2,588 |
) |
|
|
(1,775 |
) |
|
|
6,169 |
|
Interest income |
|
|
135 |
|
|
|
|
|
|
|
|
|
|
|
232 |
|
|
|
367 |
|
Interest expense |
|
|
(93 |
) |
|
|
|
|
|
|
|
|
|
|
(8 |
) |
|
|
(101 |
) |
Other income (expense), net |
|
|
236 |
|
|
|
|
|
|
|
|
|
|
|
(3 |
) |
|
|
233 |
|
Income before income taxes |
|
|
11,304 |
|
|
|
(494 |
) |
|
|
(2,588 |
) |
|
|
(1,554 |
) |
|
|
6,668 |
|
Provision for income taxes |
|
|
3,598 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,598 |
|
Net income (loss) |
|
|
7,706 |
|
|
|
(494 |
) |
|
|
(2,588 |
) |
|
|
(1,554 |
) |
|
|
3,070 |
|
Expenditures for fixed assets |
|
|
4,230 |
|
|
|
|
|
|
|
|
|
|
|
28 |
|
|
|
4,258 |
|
Expenditures for drug licenses |
|
|
901 |
|
|
|
32 |
|
|
|
|
|
|
|
272 |
|
|
|
1,205 |
|
As of and for the Six Months Ended June 30, 2006 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Specialty Generics |
|
Drug Delivery |
|
|
|
|
Europe |
|
U.S. |
|
Europe |
|
U.S. |
|
Consolidated |
Net product sales |
|
$ |
53,027 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
53,027 |
|
Licensing and collaboration
revenues |
|
|
239 |
|
|
|
|
|
|
|
|
|
|
|
3,995 |
|
|
|
4,234 |
|
Total revenues |
|
|
53,266 |
|
|
|
|
|
|
|
|
|
|
|
3,995 |
|
|
|
57,261 |
|
Cost of net product sales |
|
|
25,404 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
25,404 |
|
Gross profit |
|
|
27,862 |
|
|
|
|
|
|
|
|
|
|
|
3,995 |
|
|
|
31,857 |
|
Selling and marketing expense |
|
|
8,381 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8,381 |
|
General and administrative expense |
|
|
3,486 |
|
|
|
|
|
|
|
68 |
|
|
|
4,015 |
|
|
|
7,569 |
|
Research and development expense |
|
|
953 |
|
|
|
|
|
|
|
2,225 |
|
|
|
2,225 |
|
|
|
5,403 |
|
Litigation settlement |
|
|
389 |
|
|
|
948 |
|
|
|
|
|
|
|
|
|
|
|
1,337 |
|
Depreciation and amortization
expense |
|
|
514 |
|
|
|
42 |
|
|
|
|
|
|
|
325 |
|
|
|
881 |
|
Income from operations |
|
|
14,139 |
|
|
|
(990 |
) |
|
|
(2,293 |
) |
|
|
(2,570 |
) |
|
|
8,286 |
|
Interest income |
|
|
55 |
|
|
|
|
|
|
|
|
|
|
|
383 |
|
|
|
438 |
|
Interest expense |
|
|
(94 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(94 |
) |
Other income (expense), net |
|
|
36 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
36 |
|
Income before income taxes |
|
|
14,136 |
|
|
|
(990 |
) |
|
|
(2,293 |
) |
|
|
(2,187 |
) |
|
|
8,666 |
|
Provision for income taxes |
|
|
4,877 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,877 |
|
Net income (loss) |
|
|
9,259 |
|
|
|
(990 |
) |
|
|
(2,293 |
) |
|
|
(2,187 |
) |
|
|
3,789 |
|
Expenditures for fixed assets |
|
|
7,137 |
|
|
|
|
|
|
|
|
|
|
|
179 |
|
|
|
7,316 |
|
Expenditures for drug licenses |
|
|
556 |
|
|
|
|
|
|
|
|
|
|
|
315 |
|
|
|
871 |
|
17
As of June 30, 2007 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Specialty Generics |
|
Drug Delivery |
|
|
|
|
Europe |
|
U.S. |
|
Europe |
|
U.S. |
|
Consolidated |
Receivables, net |
|
$ |
31,438 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
2,784 |
|
|
|
34,222 |
|
Other current assets |
|
|
44,676 |
|
|
|
248 |
|
|
|
|
|
|
|
10,440 |
|
|
|
55,364 |
|
Fixed assets |
|
|
48,718 |
|
|
|
|
|
|
|
|
|
|
|
2,686 |
|
|
|
51,404 |
|
Drug licenses and related costs |
|
|
11,312 |
|
|
|
1,783 |
|
|
|
|
|
|
|
3,330 |
|
|
|
16,425 |
|
Other non-current assets |
|
|
917 |
|
|
|
|
|
|
|
|
|
|
|
1,240 |
|
|
|
2,157 |
|
Total assets |
|
|
137,061 |
|
|
|
2,031 |
|
|
|
|
|
|
|
20,480 |
|
|
|
159,572 |
|
Current liabilities |
|
|
27,108 |
|
|
|
250 |
|
|
|
|
|
|
|
3,152 |
|
|
|
30,510 |
|
Long term debt |
|
|
14,807 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
14,807 |
|
Other non-current liabilities |
|
|
8,077 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8,077 |
|
Total liabilities |
|
|
49,992 |
|
|
|
250 |
|
|
|
|
|
|
|
3,152 |
|
|
|
53,394 |
|
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 |
|
|
|
3,120 |
|
|
|
|
|
|
|
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 |
|
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, as well as
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 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
financial statements.
Reclassifications
Certain costs incurred in general and administrative expenses in prior periods associated with
a litigation settlement in December of 2006 have been reclassified from general and administrative
expenses to litigation settlement to conform with the Companys current presentation.
18
|
|
|
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, 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 Annual
Report on Form 10-K under Item 1A, Risk Factors.
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
26% of our net product revenues in the three months ended June 30, 2007. We market our branded
generic and generic products to physicians, pharmacists and hospitals through our three separate
sales and marketing 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 E.U. As of June 30, 2007 approximately 31% 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 inventory write-downs and obsolescence reserves of approximately $422,000 to cost of
sales in the six months ended June 30, 2007.
While the pricing of our pharmaceutical products is influenced by market forces (size of the
market, number of competitors, etc.), our pricing is also subject to governmental price controls in
Spain and other countries. 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 it will reimburse 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 offset the impact of
the reduced selling prices on our net product sales, our gross margins have decreased from 52% in
the six months ended June 30, 2006 to 46% in the six months ended June 30, 2007 (excluding
inventory write-downs associated with our U.S. generic simvastatin discussed above). We have
implemented strategies to mitigate lower selling prices which include strategies to reduce
19
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
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. 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,
including research using biodegradable NanocapletTM technology.
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 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. development and clinical 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 second quarter, had the following impact on the
results of our operations when reported in U.S. Dollars: (1) total revenues were increased by
approximately $1,847,000, (2) gross profit was increased by approximately $842,000, (3) operating
expenses and other income (expense) were increased by approximately $602,000, (4) provision for
income taxes was increased by approximately $102,000, which resulted in (5) an aggregate increase
in net income of approximately $138,000. An increase in the weighted average value of the Euro in
relation to the U.S. Dollar over the first half of the prior year, had the following impact on the
results of our operations when reported in U.S. Dollars: (1) total
20
revenues were increased by approximately $4,265,000, (2) gross profit was increased by
approximately $1,979,000, (3) operating expenses and other income (expense) were increased by
approximately $1,298,000, (4) provision for income taxes was increased by approximately $275,000,
which resulted in (5) an aggregate increase in net income of approximately $406,000.
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 June 30, 2007 versus Three Months Ended June 30, 2006
Revenues by Segment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended June 30, |
|
Change |
(in thousands) |
|
2007 |
|
% |
|
2006 |
|
% |
|
$ |
|
% |
|
|
|
|
|
|
|
Specialty Generics |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net product sales |
|
$ |
28,353 |
|
|
|
91 |
% |
|
$ |
26,457 |
|
|
|
91 |
% |
|
$ |
1,896 |
|
|
|
7 |
% |
Licensing and collaboration
revenues |
|
|
171 |
|
|
|
* |
|
|
|
166 |
|
|
|
1 |
% |
|
|
5 |
|
|
|
3 |
% |
|
|
|
|
|
|
|
|
|
|
28,524 |
|
|
|
91 |
% |
|
|
26,623 |
|
|
|
92 |
% |
|
|
1,901 |
|
|
|
7 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Drug Delivery |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Licensing and collaboration revenues |
|
|
2,655 |
|
|
|
9 |
% |
|
|
2,360 |
|
|
|
8 |
% |
|
|
295 |
|
|
|
13 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
31,179 |
|
|
|
100 |
% |
|
$ |
28,983 |
|
|
|
100 |
% |
|
$ |
2,196 |
|
|
|
8 |
% |
|
|
|
|
|
|
|
Total revenues for the three months ended June 30, 2007 increased $2,196,000, or 8% 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 $2,655,000 in the second quarter of
2007 due to increased royalties earned on sales of Testim. Based on industry sources, Testim was
reported to capture approximately 20% of all testosterone gel replacement prescriptions in the U.S.
market as of June 30, 2007, compared to approximately 19% of all testosterone gel replacement
prescriptions as of June 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:
21
For the three months ended June 30, 2007:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands) |
|
Revenues Within Spain |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues |
|
|
|
|
|
|
|
|
Branded |
|
|
|
|
|
|
|
|
|
Outside of |
|
|
|
|
|
% of Total |
Product Line |
|
Generics |
|
Generics |
|
Other |
|
Spain |
|
Total |
|
Revenues |
|
Omeprazole |
|
$ |
410 |
|
|
$ |
3,955 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
4,365 |
|
|
|
14 |
% |
Enalapril |
|
|
1,237 |
|
|
|
373 |
|
|
|
|
|
|
|
|
|
|
|
1,610 |
|
|
|
5 |
% |
Simvastatin |
|
|
204 |
|
|
|
1,251 |
|
|
|
|
|
|
|
|
|
|
|
1,455 |
|
|
|
5 |
% |
Lansoprazole |
|
|
910 |
|
|
|
287 |
|
|
|
|
|
|
|
|
|
|
|
1,197 |
|
|
|
4 |
% |
Paroxetine |
|
|
366 |
|
|
|
793 |
|
|
|
|
|
|
|
|
|
|
|
1,159 |
|
|
|
4 |
% |
All other products |
|
|
2,880 |
|
|
|
3,353 |
|
|
|
92 |
|
|
|
1,157 |
|
|
|
7,482 |
|
|
|
24 |
% |
Sales to licensees and others |
|
|
|
|
|
|
|
|
|
|
3,317 |
|
|
|
7,768 |
|
|
|
11,085 |
|
|
|
35 |
% |
Licensing and collaborations |
|
|
|
|
|
|
|
|
|
|
171 |
|
|
|
2,655 |
|
|
|
2,826 |
|
|
|
9 |
% |
|
Total Revenues |
|
$ |
6,007 |
|
|
$ |
10,012 |
|
|
$ |
3,580 |
|
|
$ |
11,580 |
|
|
$ |
31,179 |
|
|
|
100 |
% |
|
% of Q-2 2007 Revenues |
|
|
19 |
% |
|
|
32 |
% |
|
|
12 |
% |
|
|
37 |
% |
|
|
100 |
% |
|
|
|
|
For the three months ended June 30, 2006:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands) |
|
Revenues Within Spain |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues |
|
|
|
|
|
|
|
|
Branded |
|
|
|
|
|
|
|
|
|
Outside of |
|
|
|
|
|
% of Total |
Product Line |
|
Generics |
|
Generics |
|
Other |
|
Spain |
|
Total |
|
Revenues |
|
Omeprazole |
|
$ |
712 |
|
|
$ |
4,310 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
5,022 |
|
|
|
17 |
% |
Simvastatin |
|
|
482 |
|
|
|
1,492 |
|
|
|
|
|
|
|
|
|
|
|
1,974 |
|
|
|
7 |
% |
Enalapril |
|
|
1,379 |
|
|
|
407 |
|
|
|
|
|
|
|
|
|
|
|
1,786 |
|
|
|
6 |
% |
Lansoprazole |
|
|
665 |
|
|
|
211 |
|
|
|
|
|
|
|
|
|
|
|
876 |
|
|
|
3 |
% |
Paroxetine |
|
|
398 |
|
|
|
799 |
|
|
|
|
|
|
|
|
|
|
|
1,197 |
|
|
|
4 |
% |
All other products |
|
|
2,478 |
|
|
|
2,609 |
|
|
|
171 |
|
|
|
270 |
|
|
|
5,528 |
|
|
|
19 |
% |
Sales to licensees and others |
|
|
|
|
|
|
|
|
|
|
4,285 |
|
|
|
5,789 |
|
|
|
10,074 |
|
|
|
35 |
% |
Licensing and collaborations |
|
|
|
|
|
|
|
|
|
|
166 |
|
|
|
2,360 |
|
|
|
2,526 |
|
|
|
9 |
% |
|
Total Revenues |
|
$ |
6,114 |
|
|
$ |
9,828 |
|
|
$ |
4,622 |
|
|
$ |
8,419 |
|
|
$ |
28,983 |
|
|
|
100 |
% |
|
% of Q-2 2006 Revenues |
|
|
21 |
% |
|
|
34 |
% |
|
|
16 |
% |
|
|
29 |
% |
|
|
100 |
% |
|
|
|
|
Branded Generic Pharmaceutical Products
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands) |
|
For the Three Months Ended June 30, |
|
Change |
|
|
2007 |
|
% |
|
2006 |
|
% |
|
$ |
|
% |
|
|
|
|
|
|
|
Branded Generic Product Sales: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Enalapril |
|
$ |
1,237 |
|
|
|
21 |
% |
|
$ |
1,379 |
|
|
|
22 |
% |
|
$ |
(142 |
) |
|
|
-10 |
% |
Lansoprazole |
|
|
910 |
|
|
|
15 |
% |
|
|
665 |
|
|
|
11 |
% |
|
|
245 |
|
|
|
37 |
% |
Codeisan |
|
|
739 |
|
|
|
12 |
% |
|
|
611 |
|
|
|
10 |
% |
|
|
128 |
|
|
|
21 |
% |
Ibuprofen |
|
|
644 |
|
|
|
11 |
% |
|
|
367 |
|
|
|
6 |
% |
|
|
277 |
|
|
|
75 |
% |
Mio Relax |
|
|
448 |
|
|
|
7 |
% |
|
|
400 |
|
|
|
7 |
% |
|
|
48 |
|
|
|
12 |
% |
All other branded
generic products |
|
|
2,029 |
|
|
|
34 |
% |
|
|
2,692 |
|
|
|
44 |
% |
|
|
(663 |
) |
|
|
- 25 |
% |
|
|
|
|
|
|
|
Total branded generic sales |
|
$ |
6,007 |
|
|
|
100 |
% |
|
$ |
6,114 |
|
|
|
100 |
% |
|
$ |
(107 |
) |
|
|
- 2 |
% |
|
|
|
|
|
|
|
Sales of our branded generic pharmaceutical products decreased by 8% in constant currency
when compared to the three months ended June 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 $302,000, or 42%, as a result of the price reductions.
Sales of Enalapril, the Companys top-selling branded generic product also decreased 10% for the
same reason. The impact of price reductions was partially offset by increased unit volume in the
second 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.
22
Generic Pharmaceutical Products
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands) |
|
For the Three Months Ended June 30, |
|
Change |
|
|
2007 |
|
% |
|
2006 |
|
% |
|
$ |
|
% |
|
|
|
|
|
|
|
Generic Product Sales: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Omeprazole |
|
$ |
3,955 |
|
|
|
40 |
% |
|
$ |
4,310 |
|
|
|
44 |
% |
|
$ |
(355 |
) |
|
|
-8 |
% |
Simvastatin |
|
|
1,251 |
|
|
|
12 |
% |
|
|
1,492 |
|
|
|
15 |
% |
|
|
(241 |
) |
|
|
-16 |
% |
Trimetazidine |
|
|
816 |
|
|
|
8 |
% |
|
|
586 |
|
|
|
6 |
% |
|
|
230 |
|
|
|
39 |
% |
Paroxetine |
|
|
793 |
|
|
|
8 |
% |
|
|
799 |
|
|
|
8 |
% |
|
|
(6 |
) |
|
|
-1 |
% |
Pentoxifylline |
|
|
652 |
|
|
|
7 |
% |
|
|
676 |
|
|
|
7 |
% |
|
|
(24 |
) |
|
|
-4 |
% |
All other generic products |
|
|
2,545 |
|
|
|
25 |
% |
|
|
1,965 |
|
|
|
20 |
% |
|
|
580 |
|
|
|
30 |
% |
|
|
|
|
|
|
|
Total generic sales |
|
$ |
10,012 |
|
|
|
100 |
% |
|
$ |
9,828 |
|
|
|
100 |
% |
|
$ |
184 |
|
|
|
2 |
% |
|
|
|
|
|
|
== |
Sales of our generic pharmaceutical products increased 2% when compared to the three
months ended June 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
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands) |
|
For the Three Months Ended June 30, |
|
|
Change |
|
|
|
2007 |
|
|
2006 |
|
|
$ |
|
|
% |
|
Specialty generics |
|
$ |
11,085 |
|
|
$ |
10,074 |
|
|
$ |
1,011 |
|
|
|
10 |
% |
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 Condensed Consolidated Income Statements. As of June 30, 2007, our Spanish
operations have executed 213 license agreements for product registrations, of which 20 with
customers in Spain and 96 with customers outside of Spain, cover actively marketed products that
are generating revenues. The remaining licenses (10 with customers in Spain, 11 with customers in
Ireland and 76 with customers outside of Spain and Ireland) are for products that are awaiting
regulatory approvals. Additionally, we have 16 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 June 30, 2007 increased $1,011,000 when compared to
the second quarter of 2006; however, sales to licenses and others increased by 2% 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.
Licensing and Collaboration Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands) |
|
For the Three Months Ended June 30, |
|
|
Change |
|
|
|
2007 |
|
|
2006 |
|
|
$ |
|
|
% |
|
Specialty generics |
|
$ |
171 |
|
|
$ |
165 |
|
|
$ |
6 |
|
|
|
4 |
% |
Drug delivery |
|
|
2,655 |
|
|
|
2,361 |
|
|
|
294 |
|
|
|
12 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
2,826 |
|
|
$ |
2,526 |
|
|
$ |
300 |
|
|
|
12 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Licensing and collaboration revenues increased by 12% and accounted for 9% of total
revenues for the three months ended June 30, 2007 and 2006. Our licensing and collaboration
revenues are
23
primarily royalties earned from sales of Testim. Testim royalties totaled $2,653,000 in the three
months ended June 30, 2007 compared to $2,354,000 in the three months ended June 30, 2006 as a
result of increased market share. Testim royalties recorded in the three months ended June 30,
2006 included a one-time increase of approximately $479,000, or $0.02 per share, due to a change in
estimate which, based on historical experience, allowed us to reasonably estimate future product
returns on sales of Testim. Testim royalties increased 41% in the second quarter of 2007 when
excluding the one-time increase in royalties in the prior year quarter.
Gross Profit
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands) |
|
For the Three Months Ended June 30, |
|
|
Change |
|
|
|
2007 |
|
|
2006 |
|
|
$ |
|
|
% |
|
Specialty generics |
|
$ |
12,734 |
|
|
$ |
14,151 |
|
|
$ |
(1,417 |
) |
|
|
-10 |
% |
Drug delivery |
|
|
2,655 |
|
|
|
2,361 |
|
|
|
294 |
|
|
|
12 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
15,389 |
|
|
$ |
16,512 |
|
|
$ |
(1,123 |
) |
|
|
-7 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit decreased by approximately $1,123,000, or 7% when compared to the three
months ended June 30, 2006. Despite an increase in unit volume, gross profit reported by our
specialty generics business decreased by 10% when compared to the same quarter of the prior year.
Gross profit related to our specialty generics business also includes adjustments totaling $120,000
to the reserve for slow moving inventory in the three months ended June 30, 2007 for U.S.
simvastatin inventories. Excluding the inventory write-down of $120,000, our gross margins on net product
sales decreased from 53% to 45% in the three months ended June 30, 2006 and 2007, respectively, as
a result of the price reductions. The prior year gross margin included a $460,000 benefit (2%
increase) resulting from a change in estimate due to a lower than expected pharmaceutical tax
assessment. 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
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands) |
|
For the Three Months Ended June 30, |
|
|
Change |
|
|
|
2007 |
|
|
2006 |
|
|
$ |
|
|
% |
|
Specialty generics |
|
$ |
4,813 |
|
|
$ |
4,242 |
|
|
$ |
571 |
|
|
|
13 |
% |
Drug delivery |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
4,813 |
|
|
$ |
4,242 |
|
|
$ |
571 |
|
|
|
13 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling and marketing expenses for the three months ended June 30, 2007 increased 13% from
the same period in the prior year, or 6% when expressed in constant currency due to increased sales
volume. As a percentage of net product sales, selling and marketing expenses increased from 16% in
the three months ended June 30, 2006, to 17% in the three months ended June 30, 2007.
General and Administrative Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands) |
|
For the Three Months Ended June 30, |
|
|
Change |
|
|
|
2007 |
|
|
2006 |
|
|
$ |
|
|
% |
|
Specialty generics |
|
$ |
2,385 |
|
|
$ |
1,710 |
|
|
$ |
675 |
|
|
|
39 |
% |
Drug delivery |
|
|
2,194 |
|
|
|
1,955 |
|
|
|
239 |
|
|
|
12 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
4,579 |
|
|
$ |
3,665 |
|
|
$ |
914 |
|
|
|
25 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative expenses increased 25% when compared to the same period in the
prior year. Drug delivery personnel costs included in general and administrative expenses increased approximately $290,000 during the quarter
primarily due to
24
increased headcount. These increases were partially offset by reduced strategic
consulting expenses compared to the same period in 2006. Increased general and administrative
expenses in our specialty generics business include approximately $231,000 of intellectual property
filing and maintenance costs,
approximately $143,000 due to fluctuations in foreign currency rates and approximately
$103,000 of increased personnel costs. Total general and administrative expenses as a percent of
total revenues increased to approximately 15% in the three months ended June 30, 2007, compared to
approximately 13% of total revenues in the three months ended June 30, 2006.
Research and Development Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands) |
|
For the Three Months Ended June 30, |
|
|
Change |
|
|
|
2007 |
|
|
2006 |
|
|
$ |
|
|
% |
|
Specialty generics |
|
$ |
519 |
|
|
$ |
459 |
|
|
$ |
60 |
|
|
|
13 |
% |
Drug delivery |
|
|
2,983 |
|
|
|
2,036 |
|
|
|
947 |
|
|
|
47 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
3,502 |
|
|
$ |
2,495 |
|
|
$ |
1,007 |
|
|
|
40 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development expenses have increased by approximately $1,007,000 compared to
the second 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 $15,000,000 to
$16,000,000.
Litigation Settlement Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands) |
|
For the Three Months Ended June 30, |
|
Change |
|
|
2007 |
|
2006 |
|
$ |
|
% |
Specialty generics |
|
$ |
|
|
|
$ |
733 |
|
|
$ |
(733 |
) |
|
|
* |
|
We incurred litigation defense costs of $733,000 in the three months ended June 30, 2006
associated with a claim settled in late 2006. See Other liabilities in the Notes to Condensed
Consolidated Financial Statements for additional information. These amounts have been reclassified
from general and administrative expenses on our Condensed Consolidated Income Statements for the
prior year periods.
Provision for Income Taxes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands) |
|
For the Three Months Ended June 30, |
|
|
2007 |
|
2006 |
|
|
Spain |
|
Ireland |
|
U.S. |
|
Consol. |
|
Spain |
|
Ireland |
|
U.S. |
|
Consol. |
|
|
|
|
|
Income (loss) before income taxes |
|
$ |
5,278 |
|
|
$ |
(1,727 |
) |
|
$ |
(1,324 |
) |
|
$ |
2,227 |
|
|
$ |
7,279 |
|
|
$ |
(1,052 |
) |
|
$ |
(1,108 |
) |
|
$ |
5,119 |
|
Provision (benefit) for income taxes |
|
|
1,517 |
|
|
|
(216 |
) |
|
|
(422 |
) |
|
|
879 |
|
|
|
2,484 |
|
|
|
(132 |
) |
|
|
(415 |
) |
|
|
1,937 |
|
Valuation allowance |
|
|
|
|
|
|
216 |
|
|
|
422 |
|
|
|
638 |
|
|
|
|
|
|
|
132 |
|
|
|
415 |
|
|
|
547 |
|
|
|
|
|
|
Net provision for income taxes |
|
|
1,517 |
|
|
|
|
|
|
|
|
|
|
|
1,517 |
|
|
|
2,484 |
|
|
|
|
|
|
|
|
|
|
|
2,484 |
|
|
|
|
|
|
Net income (loss) |
|
$ |
3,761 |
|
|
$ |
(1,727 |
) |
|
$ |
(1,324 |
) |
|
$ |
710 |
|
|
$ |
4,795 |
|
|
$ |
(1,052 |
) |
|
$ |
(1,108 |
) |
|
$ |
2,635 |
|
|
|
|
|
|
Effective tax rate |
|
|
29 |
% |
|
|
0 |
% |
|
|
0 |
% |
|
|
68 |
% |
|
|
34 |
% |
|
|
0 |
% |
|
|
0 |
% |
|
|
49 |
% |
|
|
|
|
|
25
As a result of reporting taxable income in Spain, we recorded provisions for foreign
income taxes totaling $1,517,000 and $2,484,000 for the three months ended June 30, 2007 and 2006,
respectively. Current period foreign income taxes are net of tax contingency reversals totaling
approximately $272,000 that expired during the period. The provisions represented 29% and 34% of
the pre-tax income reported in Spain of $5,278,000 and $7,279,000 for the three months ended June
30, 2007 and 2006, respectively. The provisions represented 68% and 49% of consolidated pre-tax
income for the three months ended June 30, 2007 and 2006, respectively.
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 $3,051,000 and
$2,160,000 for the three months ended June 30, 2007 and 2006, respectively. Accordingly, the
Company has established valuation allowances equal to the full amount of the U.S. and Irish
deferred tax assets.
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 June 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 Income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months |
|
|
|
|
(in thousands, except per share data) |
|
Ended June 30, |
|
|
Change |
|
|
|
2007 |
|
|
2006 |
|
|
$ |
|
|
% |
|
Specialty Generics |
|
$ |
3,343 |
|
|
$ |
4,253 |
|
|
$ |
(910 |
) |
|
|
-21 |
% |
Drug Delivery |
|
|
(2,633 |
) |
|
|
(1,618 |
) |
|
|
(1,015 |
) |
|
|
-63 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net income |
|
$ |
710 |
|
|
$ |
2,635 |
|
|
$ |
(1,925 |
) |
|
|
-73 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income per common share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
0.03 |
|
|
$ |
0.12 |
|
|
$ |
(0.09 |
) |
|
|
-75 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted |
|
$ |
0.03 |
|
|
$ |
0.12 |
|
|
$ |
(0.09 |
) |
|
|
-75 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
22,318 |
|
|
|
22,170 |
|
|
|
148 |
|
|
|
1 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted |
|
|
22,892 |
|
|
|
22,876 |
|
|
|
16 |
|
|
|
0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
We reported income from operations of $1,949,000 in the three months ended June 30, 2007
compared to $4,932,000 in the three months ended June 30, 2006. The combination of income from
operations of $1,949,000 and the non-operating items of $278,000, and the provision for income
taxes of $1,517,000, resulted in net income of $710,000, or $0.03 per
basic common share ($0.03 per diluted common share) on 22,318,000 weighted average basic common shares outstanding (22,892,000
weighted average diluted common shares outstanding) in the three months ended June 30, 2007,
compared to net income of $2,635,000, or $0.12 per basic common share ($0.12 per diluted common
share) on 22,170,000 weighted average basic common shares outstanding (22,876,000 weighted average
diluted common shares outstanding) in the same period of the prior year.
26
Six Months Ended June 30, 2007 versus Six Months Ended June 30, 2006
Revenues by Segment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Six Months Ended June 30, |
|
|
|
|
|
Change |
(in thousands) |
|
2007 |
|
% |
|
2006 |
|
% |
|
$ |
|
% |
|
|
|
|
|
|
|
Specialty Generics |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net product sales |
|
$ |
57,467 |
|
|
|
92 |
% |
|
$ |
53,027 |
|
|
|
93 |
% |
|
$ |
4,440 |
|
|
|
8 |
% |
Licensing and collaboration
revenues |
|
|
285 |
|
|
|
* |
|
|
|
239 |
|
|
|
* |
|
|
|
46 |
|
|
|
19 |
% |
|
|
|
|
|
|
|
|
|
|
57,752 |
|
|
|
92 |
% |
|
|
53,266 |
|
|
|
93 |
% |
|
|
4,486 |
|
|
|
8 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Drug Delivery |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Licensing and collaboration revenues |
|
|
4,818 |
|
|
|
8 |
% |
|
|
3,995 |
|
|
|
7 |
% |
|
|
823 |
|
|
|
21 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
62,570 |
|
|
|
100 |
% |
|
$ |
57,261 |
|
|
|
100 |
% |
|
$ |
5,309 |
|
|
|
9 |
% |
|
|
|
|
|
|
|
Revenues. Set forth below is a summary of our revenues by sales channel and
top-selling product lines:
For the six months ended June 30, 2007:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands) |
|
Revenues Within Spain |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues |
|
|
|
|
|
|
|
|
Branded |
|
|
|
|
|
|
|
|
|
Outside of |
|
|
|
|
|
% of Total |
Product Line |
|
Generics |
|
Generics |
|
Other |
|
Spain |
|
Total |
|
Revenues |
|
Omeprazole |
|
$ |
961 |
|
|
$ |
7,825 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
8,786 |
|
|
|
14 |
% |
Enalapril |
|
|
2,551 |
|
|
|
764 |
|
|
|
|
|
|
|
|
|
|
|
3,315 |
|
|
|
5 |
% |
Simvastatin |
|
|
570 |
|
|
|
2,590 |
|
|
|
|
|
|
|
|
|
|
|
3,160 |
|
|
|
5 |
% |
Paroxetine |
|
|
815 |
|
|
|
1,690 |
|
|
|
|
|
|
|
|
|
|
|
2,505 |
|
|
|
4 |
% |
Lansoprazole |
|
|
1,766 |
|
|
|
601 |
|
|
|
|
|
|
|
|
|
|
|
2,367 |
|
|
|
4 |
% |
All other products |
|
|
6,340 |
|
|
|
7,221 |
|
|
|
367 |
|
|
|
2,114 |
|
|
|
16,042 |
|
|
|
26 |
% |
Sales to licensees and others |
|
|
|
|
|
|
|
|
|
|
6,987 |
|
|
|
14,305 |
|
|
|
21,292 |
|
|
|
34 |
% |
Licensing and collaborations |
|
|
|
|
|
|
|
|
|
|
285 |
|
|
|
4,818 |
|
|
|
5,103 |
|
|
|
8 |
% |
|
Total Revenues |
|
$ |
13,003 |
|
|
$ |
20,691 |
|
|
$ |
7,639 |
|
|
$ |
21,237 |
|
|
$ |
62,570 |
|
|
|
100 |
% |
|
% of YTD 2007 Revenues |
|
|
21 |
% |
|
|
33 |
% |
|
|
12 |
% |
|
|
34 |
% |
|
|
100 |
% |
|
|
|
|
For the six months ended June 30, 2006:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands) |
|
Revenues Within Spain |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues |
|
|
|
|
|
|
|
|
|
|
Branded |
|
|
|
|
|
|
|
|
|
|
Outside of |
|
|
|
|
|
|
% of Total |
|
Product Line |
|
Generics |
|
|
Generics |
|
|
Other |
|
|
Spain |
|
|
Total |
|
|
Revenues |
|
|
Omeprazole |
|
$ |
1,341 |
|
|
$ |
8,693 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
10,034 |
|
|
|
18 |
% |
Enalapril |
|
|
2,297 |
|
|
|
1,130 |
|
|
|
|
|
|
|
|
|
|
|
3,427 |
|
|
|
6 |
% |
Simvastatin |
|
|
926 |
|
|
|
2,963 |
|
|
|
|
|
|
|
|
|
|
|
3,889 |
|
|
|
7 |
% |
Paroxetine |
|
|
775 |
|
|
|
1,615 |
|
|
|
|
|
|
|
|
|
|
|
2,390 |
|
|
|
4 |
% |
Lansoprazole |
|
|
1,325 |
|
|
|
452 |
|
|
|
|
|
|
|
|
|
|
|
1,777 |
|
|
|
3 |
% |
All other products |
|
|
5,285 |
|
|
|
5,592 |
|
|
|
481 |
|
|
|
627 |
|
|
|
11,985 |
|
|
|
21 |
% |
Sales to licensees and others |
|
|
|
|
|
|
|
|
|
|
6,911 |
|
|
|
12,614 |
|
|
|
19,525 |
|
|
|
34 |
% |
Licensing and collaborations |
|
|
|
|
|
|
|
|
|
|
239 |
|
|
|
3,995 |
|
|
|
4,234 |
|
|
|
7 |
% |
|
Total Revenues |
|
$ |
11,949 |
|
|
$ |
20,445 |
|
|
$ |
7,631 |
|
|
$ |
17,236 |
|
|
$ |
57,261 |
|
|
|
100 |
% |
|
% of YTD 2006 Revenues |
|
|
21 |
% |
|
|
36 |
% |
|
|
13 |
% |
|
|
30 |
% |
|
|
100 |
% |
|
|
|
|
27
Total revenues for the six months ended June 30, 2007 increased 9% to $62,570,000 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 $4,265,000 when
compared to the same six month period of 2006. In addition to the favorable currency rates, current
period growth was driven primarily by (1) increased sales of our products to our licensees and
others of approximately $1,767,000; increased API sales of approximately $1,373,000 and (2)
approximately $869,000 of increased licensing and collaboration revenues, primarily royalty revenue
from the sales of Testim.
Branded Generic Pharmaceutical Products
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands) |
|
For the Six Months Ended June 30, |
|
Change |
|
|
2007 |
|
% |
|
2006 |
|
% |
|
$ |
|
% |
|
|
|
|
|
|
|
Branded Generic Product Sales: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Enalapril |
|
$ |
2,551 |
|
|
|
20 |
% |
|
$ |
2,297 |
|
|
|
19 |
% |
|
$ |
254 |
|
|
|
11 |
% |
Codeisan |
|
|
2,009 |
|
|
|
15 |
% |
|
|
1,463 |
|
|
|
12 |
% |
|
|
546 |
|
|
|
37 |
% |
Lansoprazole |
|
|
1,766 |
|
|
|
14 |
% |
|
|
1,325 |
|
|
|
11 |
% |
|
|
441 |
|
|
|
33 |
% |
Ibuprofen |
|
|
1,127 |
|
|
|
9 |
% |
|
|
743 |
|
|
|
6 |
% |
|
|
384 |
|
|
|
52 |
% |
Omeprazole |
|
|
961 |
|
|
|
7 |
% |
|
|
1,341 |
|
|
|
11 |
% |
|
|
(380 |
) |
|
|
-28 |
% |
All other branded generic
products |
|
|
4,589 |
|
|
|
35 |
% |
|
|
4,780 |
|
|
|
41 |
% |
|
|
(191 |
) |
|
|
-4 |
% |
|
|
|
|
|
|
|
Total branded generic sales |
|
$ |
13,003 |
|
|
|
100 |
% |
|
$ |
11,949 |
|
|
|
100 |
% |
|
$ |
1,054 |
|
|
|
9 |
% |
|
|
|
|
|
|
== |
Sales of our branded generic pharmaceutical products during the first half of 2007
increased 9% when compared to the first half of 2006. Excluding the effect of fluctuations in
foreign currency exchange rates, sales of our branded generic pharmaceutical products increased 1%
when compared to the first half of 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
28% despite consistent unit volume. Increased unit volume in the six months ended June 30, 2007,
primarily from sales of our enalapril, codeisan and lansoprazole, helped offset the impact of price
reductions. Sales of our branded generic omeprazole decreased 28% as a result of the price
reductions.
Generic Pharmaceutical Products
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands) |
|
For the Six Months Ended June 30, |
|
Change |
|
|
2007 |
|
% |
|
2006 |
|
% |
|
$ |
|
% |
|
|
|
|
|
|
|
Generic Product Sales: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Omeprazole |
|
$ |
7,825 |
|
|
|
38 |
% |
|
$ |
8,693 |
|
|
|
43 |
% |
|
$ |
(868 |
) |
|
|
-10 |
% |
Simvastatin |
|
|
2,590 |
|
|
|
13 |
% |
|
|
2,963 |
|
|
|
14 |
% |
|
|
(373 |
) |
|
|
-13 |
% |
Paroxetine |
|
|
1,690 |
|
|
|
8 |
% |
|
|
1,615 |
|
|
|
8 |
% |
|
|
75 |
|
|
|
5 |
% |
Trimetazidine |
|
|
1,545 |
|
|
|
7 |
% |
|
|
1,136 |
|
|
|
6 |
% |
|
|
409 |
|
|
|
36 |
% |
Pentoxifylline |
|
|
1,356 |
|
|
|
7 |
% |
|
|
1,279 |
|
|
|
6 |
% |
|
|
77 |
|
|
|
6 |
% |
All other generic products |
|
|
5,685 |
|
|
|
27 |
% |
|
|
4,759 |
|
|
|
23 |
% |
|
|
926 |
|
|
|
19 |
% |
|
|
|
|
|
|
|
Total generic sales |
|
$ |
20,691 |
|
|
|
100 |
% |
|
$ |
20,445 |
|
|
|
100 |
% |
|
$ |
246 |
|
|
|
1 |
% |
|
|
|
|
|
|
== |
Sales of our generic pharmaceutical products increased 1% during the first half of 2007
when compared to the first half of 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 $1,241,000. Increased unit
volume in the six months ended June 30, 2007, primarily from sales of omeprazole, simvastatin and
trimetazidine, helped offset the impact of price reductions.
28
Sales to Licensees and Others
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands) |
|
For the Six Months Ended June 30, |
|
Change |
|
|
2007 |
|
2006 |
|
$ |
|
% |
Specialty
generics |
|
$ |
21,292 |
|
|
$ |
19,525 |
|
|
$ |
1,767 |
|
|
|
9 |
% |
Sales to licensees and others in the six months ended June 30, 2007 increased 9% when
compared to the same six month period of the prior year. A decrease in the weighted average value
of the Euro over the past year, in relation to the U.S. Dollar, had the effect of decreasing our
revenues from sales to licensees and others by approximately $1,743,000. See the explanation under
Sales to Licensees and Others for the three months ended June 30, 2007.
Licensing and Collaboration Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands) |
|
For the Six Months Ended June 30, |
|
|
Change |
|
|
|
2007 |
|
|
2006 |
|
|
$ |
|
|
% |
|
Specialty generics |
|
$ |
285 |
|
|
$ |
239 |
|
|
$ |
46 |
|
|
|
19 |
% |
Drug delivery |
|
|
4,818 |
|
|
|
3,995 |
|
|
|
823 |
|
|
|
21 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
5,103 |
|
|
$ |
4,234 |
|
|
$ |
869 |
|
|
|
21 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Licensing and collaboration revenues accounted for 8% of total revenues in the six months
ended June 30, 2007 and totaled $5,103,000. These revenues included increased Testim royalties of
approximately $828,000 in the six months ended June 30, 2007. See the explanation under Licensing
and Collaboration Revenues for the three months ended June 30, 2007.
Gross Profit
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands) |
|
For the Six Months Ended June 30, |
|
|
Change |
|
|
|
2007 |
|
|
2006 |
|
|
$ |
|
|
% |
|
Specialty generics |
|
$ |
26,065 |
|
|
$ |
27,862 |
|
|
$ |
(1,797 |
) |
|
|
-6 |
% |
Drug delivery |
|
|
4,818 |
|
|
|
3,995 |
|
|
|
823 |
|
|
|
21 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
30,883 |
|
|
$ |
31,857 |
|
|
$ |
(974 |
) |
|
|
-3 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit decreased by approximately $974,000, or 3%, in the six months ended June 30,
2007 when compared to the six months ended June 30, 2006. Gross margins on net product sales were
45% in the six months ended June 30, 2007 versus 52% in the six months ended June 30, 2006. Gross
profit related to our specialty generics business includes adjustments totaling $422,000 to write
down our U.S. generic inventory to its net realizable value and reserve for slow moving inventory.
Excluding these inventory adjustments, our gross margins on net product sales decreased from 52% to
46% in the six months ended June 30, 2006 and 2007, respectively, as a result of price reductions
in Spain. See the explanation under Gross Profit for the three months ended June 30, 2007.
Selling and Marketing Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands) |
|
For the Six Months Ended June 30, |
|
|
Change |
|
|
|
2007 |
|
|
2006 |
|
|
$ |
|
|
% |
|
Specialty generics |
|
$ |
9,258 |
|
|
$ |
8,381 |
|
|
$ |
877 |
|
|
|
10 |
% |
Drug delivery |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
9,258 |
|
|
$ |
8,381 |
|
|
$ |
877 |
|
|
|
10 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling and marketing expenses for the six months ended June 30, 2007 increased 10% from
the same period in the prior year; however, selling and marketing expenses increased 2% when
expressed in
29
constant currency. Selling and marketing expenses as a percentage of net product sales
remained relatively constant at 16% in the six months ended June 30, 2007 and 2006.
General and Administrative Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands) |
|
For the Six Months Ended June 30, |
|
|
Change |
|
|
|
2007 |
|
|
2006 |
|
|
$ |
|
|
% |
|
Specialty generics |
|
$ |
4,639 |
|
|
$ |
3,486 |
|
|
$ |
1,153 |
|
|
|
33 |
% |
Drug delivery |
|
|
3,586 |
|
|
|
4,083 |
|
|
|
(497 |
) |
|
|
-12 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
8,225 |
|
|
$ |
7,569 |
|
|
$ |
656 |
|
|
|
9 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative expenses for the six months ended June 30, 2007 increased 9%
from the same period in the prior year. The $1,153,000 change in our specialty generics business
reflects an increase of approximately $582,000 of intellectual property filing and maintenance
costs and increased general and administrative activities required to support our continued growth
and prepare for our anticipated future growth. The $497,000 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 remained consistent at 13% for the six
months ended June 30, 2007 and 2006. General and administrative expenses would have been
approximately $318,000 lower, absent the change in the weighted average value of the Euro, in
relation to the U.S. Dollar, over the past year.
Research and Development Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands) |
|
For the Six Months Ended June 30, |
|
|
Change |
|
|
|
2007 |
|
|
2006 |
|
|
$ |
|
|
% |
|
Specialty generics |
|
$ |
1,000 |
|
|
$ |
953 |
|
|
$ |
47 |
|
|
|
5 |
% |
Drug delivery |
|
|
5,177 |
|
|
|
4,450 |
|
|
|
727 |
|
|
|
16 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
6,177 |
|
|
$ |
5,403 |
|
|
$ |
774 |
|
|
|
14 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development expenses for the six months ended June 30, 2007 increased 14%
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 June 30, 2007. We
expect to continue to incur increased costs to support our clinical programs for the remainder of
2007.
Litigation Settlement Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands) |
|
For the Six Months Ended June 30, |
|
Change |
|
|
2007 |
|
2006 |
|
$ |
|
% |
Specialty generics |
|
$ |
|
|
|
$ |
1,337 |
|
|
$ |
(1,337 |
) |
|
|
* |
|
We incurred litigation defense costs of $1,337,000 in the six months ended June 30, 2006
associated with a claim settled in late 2006. See Other liabilities in the Notes to Condensed
Consolidated Financial Statements for additional information. These amounts have been reclassified
from general and administrative expenses on the Condensed Consolidated Income Statements for the
prior year periods.
30
Provision for Income Taxes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Six Months Ended June 30, |
(in thousands) |
|
2007 |
|
2006 |
|
|
Spain |
|
Ireland |
|
U.S. |
|
Consol. |
|
Spain |
|
Ireland |
|
U.S. |
|
Consol. |
|
|
|
|
|
Income (loss) before income taxes |
|
$ |
11,746 |
|
|
$ |
(3,031 |
) |
|
$ |
(2,047 |
) |
|
$ |
6,668 |
|
|
$ |
14,176 |
|
|
$ |
(2,333 |
) |
|
$ |
(3,177 |
) |
|
$ |
8,666 |
|
Provision (benefit) for income
taxes |
|
|
3,598 |
|
|
|
(379 |
) |
|
|
(582 |
) |
|
|
2,637 |
|
|
|
4,877 |
|
|
|
(292 |
) |
|
|
(1,173 |
) |
|
|
3,412 |
|
Valuation allowance |
|
|
|
|
|
|
379 |
|
|
|
582 |
|
|
|
961 |
|
|
|
|
|
|
|
292 |
|
|
|
1,173 |
|
|
|
1,465 |
|
|
|
|
|
|
Net provision for income taxes |
|
|
3,598 |
|
|
|
|
|
|
|
|
|
|
|
3,598 |
|
|
|
4,877 |
|
|
|
|
|
|
|
|
|
|
|
4,877 |
|
|
|
|
|
|
Net income (loss) |
|
$ |
8,148 |
|
|
$ |
(3,031 |
) |
|
$ |
(2,047 |
) |
|
$ |
3,070 |
|
|
$ |
9,299 |
|
|
$ |
(2,333 |
) |
|
$ |
(3,177 |
) |
|
$ |
3,789 |
|
|
|
|
|
|
Effective tax rate |
|
|
31 |
% |
|
|
0 |
% |
|
|
0 |
% |
|
|
54 |
% |
|
|
34 |
% |
|
|
0 |
% |
|
|
0 |
% |
|
|
56 |
% |
|
|
|
|
|
We have recorded provisions for foreign income taxes totaling $3,598,000 and $4,877,000
for the six months ended June 30, 2007 and 2006, respectively. The provisions represented 31% and
34% of the pre-tax income reported in Spain of $11,746,000 and $14,176,000 for the six months ended
June 30, 2007 and 2006, respectively. 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 $5,078,000 and $5,510,000 for the six months ended June 30, 2007 and 2006,
respectively. Accordingly, the Company has established valuation allowances equal to the full
amount of the U.S. and Irish deferred tax assets. Consequently, the provisions represented 54% and
56% of consolidated pre-tax income for the six months ended June 30, 2007 and 2006, respectively.
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 valuation allowances, an adjustment would
be required to reduce the existing valuation allowances. 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.
Net Income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Six Months |
|
|
|
|
(in thousands, except per share data) |
|
Ended June 30, |
|
|
Change |
|
|
|
2007 |
|
|
2006 |
|
|
$ |
|
|
% |
|
Specialty generics |
|
$ |
7,212 |
|
|
$ |
8,269 |
|
|
$ |
(1,057 |
) |
|
|
-13 |
% |
Drug delivery |
|
|
(4,142 |
) |
|
|
(4,480 |
) |
|
|
338 |
|
|
|
8 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net income |
|
$ |
3,070 |
|
|
$ |
3,789 |
|
|
$ |
(719 |
) |
|
|
-19 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income per common share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
0.14 |
|
|
$ |
0.17 |
|
|
$ |
(0.03 |
) |
|
|
-18 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted |
|
$ |
0.14 |
|
|
$ |
0.16 |
|
|
$ |
(0.02 |
) |
|
|
-13 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
22,305 |
|
|
|
22,063 |
|
|
|
242 |
|
|
|
1 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted |
|
|
23,695 |
|
|
|
23,380 |
|
|
|
315 |
|
|
|
1 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
We reported net income of $3,070,000 in the six months ended June 30, 2007 compared to
$3,789,000 in the six months ended June 30, 2006. The combination of income from operations of
$6,169,000 and the non-operating items, primarily a provision for income taxes of $3,598,000 and
the net of other income and expenses totaling $499,000 resulted in net income of $3,070,000, or
$0.14 per basic common share ($0.14 per diluted common share) on 22,305,000 weighted average basic
common shares outstanding (23,695,000 weighted average diluted common shares outstanding) in the
first half of 2007, compared to net income of $3,789,000, or $0.17 per basic common share ($0.16
per diluted common share)
on 22,063,000 weighted average basic common shares outstanding (23,380,000 weighted average
diluted common shares outstanding) in the first half of 2006.
31
LIQUIDITY AND CAPITAL RESOURCES:
Total assets increased from $134,356,000 at December 31, 2006 to $159,572,000 at June 30,
2007, and stockholders equity increased from $100,331,000 at December 31, 2006 to $106,178,000 at
June 30, 2007. The increase in stockholders equity during the six months ended June 30, 2007
primarily reflects the net income during the six months of $3,070,000 and the effect of
fluctuations in the Euro/U.S. Dollar exchange rate, which resulted in a net increase of $2,018,000
to our stockholders equity.
Cash, cash equivalents and marketable securities increased by approximately 132% or
$20,589,000 from $15,601,000 at December 31, 2006 to $36,190,000 at June 30, 2007. Sources of cash
include loan proceeds of $14,807,000 included in cash flows from financing activities and net
income of $3,070,000 and approximately $5,206,000 of non-cash expenses included in cash flows from operating activities. Uses of cash included
additions to fixed assets totaling $4,258,000 and additions to drug licenses totaling $1,205,000.
Cash and cash equivalents at June 30, 2007 include approximately $9,839,000 of short-term liquid
investments considered to be cash equivalents.
Receivables increased by approximately 4% from $32,963,000 at December 31, 2006 to $34,222,000
at June 30, 2007. When expressed in constant currency, receivables increased $502,000, or 2%,
primarily due to increased 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 $478,000 from $16,279,000 at December 31, 2006
to $15,801,000 at June 30, 2007. Fluctuations in foreign currency had the effect of increasing
inventories by approximately $373,000. The constant currency decrease of $851,000 was primarily due
to inventory adjustments totaling $1,035,000 to write-down U.S. generic product inventories to
their net realizable value and reserve for slow moving inventories. These increases were partially
offset by the expiration of approximately $272,000 of foreign tax contingencies recorded in accrued
expenses.
The combined total of accounts payable and accrued expenses increased from $24,270,000 at
December 31, 2006 to $28,404,000 at June 30, 2007. The $4,134,000 increase was primarily
attributed to:
(1) increased accrued income taxes payable of approximately $2,294,000, (2) an increase in trade
payables of approximately $1,724,000 related to inventory purchases, and (3) fluctuations in
foreign currency exchange rates, which increased the balances by approximately $599,000.
We repaid all of our short-term borrowings and current portion of long-term debt during the
six months ended June 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. The loan includes a variable
interest rate that is reset quarterly to equal to the Euro Interbank Offered Rate, plus 0.5%. The
interest rate under the loan was 5.02% at June 30, 2007. We were also charged a single, up-front fee of 0.2%.
Principal will be repaid in quarterly installments beginning December 31, 2008, with the balance
due on December 31, 2013.
Operating activities for the six months ended June 30, 2007 provided net cash of $11,596,000,
an increase of $6,751,000 when compared to the six months ended June 30, 2006. Changes in working
capital, accounts receivable and inventory in particular, contributed to approximately $5,910,000
of this increase.
32
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 $5,463,000
during the six months ended June 30, 2007. In addition, approximately $2,661,000 of
short-term marketable securities matured during the six months ended June 30, 2007.
Financing activities during the six months ended June 30, 2007 provided net cash of
$14,226,000, and represented mainly cash proceeds from borrowings totaling $14,807,000, as
described above. See loan agreement discussion in the discussion of our debt above. These proceeds
were partially offset by net repayment of borrowings totaling $554,000.
Contractual Obligations
On June 29, 2007, our subsidiary, Laboratorios Belmac (Belmac), entered into an 11,000,000
Euro loan agreement with a Spanish financial institution, pursuant to which we recorded long-term
debt of $14,807,000. In accordance with the loan agreement, we will be charged interest on the loan
at a variable rate, reset quarterly, equal to the Euro Interbank Offered Rate, plus 0.5%. The
interest rate under the loan at June 30, 2007 was 5.02%. The principal of the loan will be repaid
in quarterly installments of 412,500 Euros (approximately $555,300) beginning December 31, 2008,
with the balance due on December 31, 2013. Maturities and estimated interest on the long-term debt
are as follows (in thousands):
|
|
|
|
|
2007 |
|
$ |
382 |
|
2008 |
|
|
1,311 |
|
2009 |
|
|
2,904 |
|
2010 |
|
|
2,790 |
|
2011 |
|
|
2,678 |
|
2012 and 2013 |
|
|
8,164 |
|
|
|
|
|
Total |
|
$ |
18,229 |
|
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 it fails to comply with its financial covenants and it has
also agreed to not pledge any assets to any other party. The loan may be prepaid at any time
without a fee.
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 plan to invest $13,000,000 to $16,000,000 in 2007 (primarily in our
manufacturing facilities), of which we have invested $4,258,000 in the six months ended June 30,
2007. We also plan to invest $15,000,000 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). As discussed above, we have cash and cash
equivalents totaling approximately $35,661,000 as of June 30, 2007, which we believe is sufficient
to fund our operations for the foreseeable future. Although we generate positive cash flow from
operations, (approximately $11,596,000 in the six months ended June 30, 2007), there
33
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 information available from other
outside sources, as appropriate. We have reviewed our critical accounting policies and estimated
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 and inventories noted below, those policies
remain our most critical accounting policies for the quarter ended June 30, 2007. We did not make
any changes to those policies during the quarter ended June 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
No. 48), an interpretation of FASB Statement No. 109, Accounting for Income Taxes. As a result of
the implementation of FIN No. 48, we recorded a $405,000 increase in our non-current liabilities
for uncertain tax positions which was accounted for as 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 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
34
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.
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; |
|
|
|
|
Expected launch of new products; |
|
|
|
|
Anticipated expenses and spending; |
|
|
|
|
Planned and continuing clinical trials; |
|
|
|
|
Anticipated regulatory changes and approvals; and |
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|
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
June 30, 2007 and December 31, 2006 are as follows:
|
|
|
|
|
|
|
|
|
U.S. Dollars per Euro |
|
June 30, 2007 |
|
December 31, 2006 |
YTD weighted average exchange rate |
|
|
1.33 |
|
|
|
1.26 |
|
Exchange rate |
|
|
1.35 |
|
|
|
1.31 |
|
The net effect of foreign currency translation on our Condensed Consolidated Financial
Statements for the six months ended June 30, 2007 was a net increase of $2,018,000 and the
cumulative historical effect as of June 30, 2007 was an increase of $10,890,000, as reflected in
our Condensed Consolidated Balance Sheets as 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.
35
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 currency on a litigation settlement liability. However, at this time,
we do not anticipate altering our business plans and practices to compensate for future currency
fluctuations on any other balances.
Interest Rates. The interest rate on our long-term borrowings was 5.02% at June 30, 2007 and
the amount of borrowings outstanding is $14,807,000 as of June 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 $148,070 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 June 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 June 30, 2007 that has
materially affected, or is reasonably likely to materially affect, Bentleys internal control over
financial reporting.
36
PART II. OTHER INFORMATION
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
Issuer Repurchases
|
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|
|
|
|
|
|
|
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|
|
|
|
|
|
|
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|
|
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|
|
|
|
|
|
Maximum Number |
|
|
|
|
|
|
|
|
|
|
Total Number of |
|
(or approximate |
|
|
Total |
|
|
|
|
|
Shares |
|
dollar value) |
|
|
Number |
|
|
|
|
|
(or Units) |
|
of Shares (or |
|
|
of Shares |
|
Average |
|
Purchased as |
|
Units) that |
|
|
(or Units) |
|
Price |
|
Part of Publicly |
|
may yet be Purchased |
|
|
Purchased |
|
Paid per |
|
Announced Plans or |
|
under the Plans or |
|
|
(1) |
|
Share(2) |
|
Programs |
|
Programs |
April 1, 2007 through April 30, 2007 |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
May 1, 2007 through May 31, 2007 |
|
|
4,311 |
|
|
$ |
11.965 |
|
|
|
|
|
|
|
|
|
June 1, 2007 through June 30, 2007 |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
4,311 |
|
|
$ |
11.965 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Represents shares withheld to satisfy minimum tax withholding liabilities of certain restricted stock unit holders. |
|
(2) |
|
Weighted average of the high and low prices on the New York Stock Exchange on the vesting date (the date the
restricted stock unit holders were entitled to receive the vested shares). |
Item 4. Submission of Matters to a Vote of Security Holders
Our Annual Meeting of Stockholders was held on May 23, 2007 for the purpose of the election of
two directors and to ratify the appointment of Bentleys independent registered public accounting
firm for the 2007 fiscal year. Proxies for the meeting were solicited pursuant to Regulation 14A of
the Securities Exchange Act of 1934, as amended, and there was no solicitation in opposition.
The following members were elected to our Board of Directors by a plurality of votes cast:
|
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|
|
|
|
|
|
|
Term |
|
|
|
|
Nominee |
|
Expiring |
|
Votes For |
|
Votes Withheld |
F. Ross Johnson |
|
|
2010 |
|
|
|
18,538,001 |
|
|
|
2,388,651 |
|
Edward J. Robinson |
|
|
2010 |
|
|
|
18,554,111 |
|
|
|
2,372,541 |
|
The proposal to ratify the appointment of Deloitte & Touche LLP as Bentleys independent
registered public accounting firm for the 2007 fiscal year required the affirmative vote of
10,297,635 shares (a majority of the shares represented in person or by proxy at the annual meeting
and entitled to vote on this proposal excluding abstentions, broker non-votes and votes withheld).
This proposal was approved by the following vote:
|
|
|
|
|
|
|
Votes For |
|
|
|
Votes Against |
20,346,930 |
|
|
|
|
248,339 |
|
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.
37
Exhibit Index
|
|
|
|
|
Exhibit |
|
|
Number |
|
Description of Exhibit |
|
10.1
|
|
*
|
|
Loan Agreement dated June 29, 2007 by and between Banco Bilbao Vizcaya Argentaria, S.A. and
Laboratorios Belmac S.A. |
|
|
|
|
|
10.2
|
|
*
|
|
Letter of guarantee dated June 29, 2007 of Bentley Pharmaceuticals, Inc. in favor of Banco Bilbao
Vizcaya Argentaria, S.A. |
|
|
|
|
|
10.3
|
|
*
|
|
Form of Restricted Stock Unit Certificate (Non-employee Directors) under the Bentley
Pharmaceuticals, Inc. Amended and Restated 2005 Equity and Incentive Plan. (Reference is made to
Exhibit 10.1 to the Registrants Form 8-K filed on May 30, 2007, Commission File No. 1-10581, which
exhibit is incorporated herein by reference. |
|
|
|
|
|
31.1
|
|
*
|
|
Certification of the Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
|
|
|
|
|
31.2
|
|
*
|
|
Certification of the Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
|
|
|
|
|
32.1
|
|
*
|
|
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. |
|
|
|
|
|
32.2
|
|
*
|
|
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. |
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.
Registrant
|
|
August 9, 2007 |
By: |
/s/ James R. Murphy
|
|
|
|
James R. Murphy |
|
|
|
Chairman of the Board of Directors
and Chief Executive Officer
(Principal Executive Officer) |
|
|
|
|
|
August 9, 2007 |
By: |
/s/ Richard P. Lindsay
|
|
|
|
Richard P. Lindsay |
|
|
|
Vice President, Chief Financial Officer,
Secretary and Treasurer
(Principal Financial Officer) |
|
|