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 March 31, 2008
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, a non-accelerated filer or a smaller reporting company. See the definitions of large
accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the
Exchange Act. (Check one):
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Large accelerated filer: o
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Accelerated filer: þ
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Non-accelerated filer: o
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Smaller reporting company: o |
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(Do not check if a smaller reporting company) |
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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 May 7, 2008 was 22,452,165.
Bentley Pharmaceuticals, Inc. and Subsidiaries
Form 10-Q for the Quarter Ended March 31, 2008
Index
2
Bentley Pharmaceuticals, Inc. and Subsidiaries
Unaudited Consolidated Balance Sheets
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March 31, |
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December 31, |
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(in thousands, except per share data) |
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2008 |
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2007 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
33,279 |
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$ |
33,706 |
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Marketable securities |
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1,084 |
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1,010 |
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Receivables, net |
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46,137 |
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39,324 |
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Inventories |
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19,536 |
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17,658 |
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Deferred taxes |
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1,038 |
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1,067 |
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Prepaid expenses and other |
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1,827 |
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1,915 |
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Total current assets |
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102,901 |
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94,680 |
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Non-current assets: |
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Fixed assets, net |
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63,620 |
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59,191 |
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Drug licenses and related costs, net |
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17,613 |
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16,624 |
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Restricted cash |
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1,000 |
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1,000 |
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Deferred taxes |
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348 |
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676 |
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Other |
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1,016 |
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925 |
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Total non-current assets |
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83,597 |
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78,416 |
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Total assets |
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$ |
186,498 |
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$ |
173,096 |
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Liabilities and Stockholders Equity |
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Current liabilities: |
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Accounts payable |
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$ |
18,664 |
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$ |
19,413 |
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Accrued expenses |
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13,643 |
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10,623 |
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Short-term borrowings |
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186 |
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116 |
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Current portion of long-term debt |
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1,304 |
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608 |
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Deferred income |
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1,296 |
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1,186 |
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Other current liabilities |
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1,206 |
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1,137 |
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Total current liabilities |
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36,299 |
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33,083 |
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Non-current liabilities: |
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Long-term debt |
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16,076 |
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15,595 |
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Deferred income |
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6,620 |
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5,976 |
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Other |
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2,645 |
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2,470 |
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Total non-current liabilities |
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25,341 |
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24,041 |
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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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Common stock, $0.02 par value, authorized 100,000 shares,
issued and outstanding, 22,450 and 22,376 shares |
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448 |
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447 |
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Additional paid-in capital |
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144,533 |
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143,269 |
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Accumulated deficit |
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(45,672 |
) |
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(46,736 |
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Accumulated other comprehensive income |
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25,549 |
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18,992 |
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Total stockholders equity |
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124,858 |
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115,972 |
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Total liabilities and stockholders equity |
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$ |
186,498 |
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$ |
173,096 |
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The accompanying Notes to Unaudited Condensed Consolidated Financial Statements are an integral part of these financial statements.
3
Bentley Pharmaceuticals, Inc. and Subsidiaries
Unaudited Consolidated Income Statements
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For the Three Months Ended |
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March 31, |
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(in thousands, except per share data) |
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2008 |
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2007 |
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Revenues: |
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Net product sales |
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$ |
36,364 |
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$ |
29,114 |
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Licensing and collaboration revenues |
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3,649 |
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2,277 |
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Total revenues |
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40,013 |
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31,391 |
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Cost of net product sales |
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19,947 |
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15,897 |
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Gross profit |
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20,066 |
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15,494 |
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Operating expenses: |
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Selling and marketing |
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5,763 |
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4,445 |
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General and administrative |
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4,213 |
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3,577 |
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Research and development |
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2,804 |
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2,675 |
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Separation costs |
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3,834 |
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69 |
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Depreciation and amortization |
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526 |
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508 |
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Total operating expenses |
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17,140 |
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11,274 |
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Income from operations |
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2,926 |
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4,220 |
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Other income (expenses): |
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Interest income |
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260 |
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182 |
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Interest expense |
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(279 |
) |
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(50 |
) |
Other, net |
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99 |
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89 |
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Income before income taxes |
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3,006 |
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4,441 |
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Provision for income taxes |
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1,942 |
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2,081 |
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Net income |
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$ |
1,064 |
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$ |
2,360 |
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Net income per common share: |
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Basic |
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$ |
0.05 |
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$ |
0.11 |
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Diluted |
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$ |
0.05 |
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$ |
0.10 |
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Weighted average common shares outstanding: |
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Basic |
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22,469 |
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22,293 |
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Diluted |
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|
23,588 |
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22,534 |
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The accompanying Notes to Unaudited Condensed Consolidated Financial Statements are an integral part of these financial statements.
4
Bentley Pharmaceuticals, Inc. and Subsidiaries
Unaudited Consolidated Statement of Changes in Stockholders Equity
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Accumulated |
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$0.02 Par Value |
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Additional |
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Other |
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Common Stock |
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Paid-In |
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Accumulated |
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Comprehensive |
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(in thousands, except per share data) |
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Shares |
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Amount |
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Capital |
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Deficit |
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Income |
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Total |
|
Balance at January 1, 2008 |
|
|
22,376 |
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|
$ |
447 |
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|
$ |
143,269 |
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|
$ |
(46,736 |
) |
|
$ |
18,992 |
|
|
$ |
115,972 |
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|
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Comprehensive income: |
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Net income |
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|
|
|
|
|
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|
1,064 |
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|
|
|
|
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|
1,064 |
|
Other comprehensive income: |
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|
|
|
|
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|
|
|
|
|
|
|
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Foreign currency translation adjustment |
|
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|
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|
|
|
|
|
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|
|
|
|
|
|
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|
6,557 |
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|
6,557 |
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Comprehensive income |
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|
|
|
|
|
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|
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|
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$ |
7,621 |
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Exercise of stock options |
|
|
66 |
|
|
|
1 |
|
|
|
454 |
|
|
|
|
|
|
|
|
|
|
|
455 |
|
Stock-based compensation |
|
|
8 |
|
|
|
|
|
|
|
810 |
|
|
|
|
|
|
|
|
|
|
|
810 |
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|
|
|
|
|
|
|
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|
|
|
|
|
|
|
|
|
Balance at March 31, 2008 |
|
|
22,450 |
|
|
$ |
448 |
|
|
$ |
144,533 |
|
|
$ |
(45,672 |
) |
|
$ |
25,549 |
|
|
$ |
124,858 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
The accompanying Notes to Unaudited Condensed Consolidated Financial Statements are an integral part of these financial statements.
5
Bentley Pharmaceuticals, Inc. and Subsidiaries
Unaudited Consolidated Statements of Cash Flows
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For the Three Months Ended |
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March 31, |
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(in thousands) |
|
2008 |
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|
2007 |
|
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
Net income |
|
$ |
1,064 |
|
|
$ |
2,360 |
|
Adjustments to reconcile net income to net
cash provided by operating activities: |
|
|
|
|
|
|
|
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Depreciation and amortization |
|
|
1,744 |
|
|
|
1,548 |
|
Non-cash charge for inventory write-down and reserves |
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|
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|
302 |
|
Non-cash charge for write-down of intangible assets |
|
|
195 |
|
|
|
47 |
|
Foreign currency gains |
|
|
(206 |
) |
|
|
(74 |
) |
Stock-based compensation expense |
|
|
810 |
|
|
|
559 |
|
Change in fair value of derivative instrument |
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|
129 |
|
|
|
9 |
|
Loss on disposal of assets |
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|
44 |
|
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|
63 |
|
Other non-cash items |
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|
3 |
|
|
|
3 |
|
(Increase) decrease in assets and
increase (decrease) in liabilities: |
|
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|
|
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Receivables, net |
|
|
(3,907 |
) |
|
|
(88 |
) |
Inventories |
|
|
(555 |
) |
|
|
(447 |
) |
Deferred income taxes |
|
|
451 |
|
|
|
46 |
|
Prepaid expenses and other current assets |
|
|
166 |
|
|
|
(288 |
) |
Other assets |
|
|
(51 |
) |
|
|
(24 |
) |
Accounts payable and accrued expenses |
|
|
401 |
|
|
|
2,756 |
|
Deferred income |
|
|
214 |
|
|
|
98 |
|
Other liabilities |
|
|
60 |
|
|
|
998 |
|
|
|
|
|
|
|
|
Net cash provided by operating activities |
|
|
562 |
|
|
|
7,868 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
Additions to fixed assets |
|
|
(1,628 |
) |
|
|
(1,954 |
) |
Additions to drug licenses and related costs |
|
|
(661 |
) |
|
|
(515 |
) |
Proceeds from maturity of investments |
|
|
|
|
|
|
2,661 |
|
|
|
|
|
|
|
|
Net cash (used in) provided by investing activities |
|
|
(2,289 |
) |
|
|
192 |
|
|
|
|
|
|
|
|
(Continued on following page)
The accompanying Notes to Unaudited Condensed Consolidated Financial Statements are an integral part of these financial statements.
6
Bentley Pharmaceuticals, Inc. and Subsidiaries
Unaudited Consolidated Statements of Cash Flows (Concluded)
|
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|
|
|
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|
|
|
|
For the Three Months Ended |
|
|
|
March 31, |
|
(in thousands) |
|
2008 |
|
|
2007 |
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
Proceeds from the exercise of stock options |
|
$ |
455 |
|
|
$ |
|
|
Proceeds from borrowings |
|
|
172 |
|
|
|
|
|
Repayment of borrowings |
|
|
(116 |
) |
|
|
(554 |
) |
|
|
|
|
|
|
|
Net cash provided by (used in) financing activities |
|
|
511 |
|
|
|
(554 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of exchange rate changes on cash |
|
|
789 |
|
|
|
151 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (decrease) increase in cash and cash equivalents |
|
|
(427 |
) |
|
|
7,657 |
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at beginning of period |
|
|
33,706 |
|
|
|
12,424 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
$ |
33,279 |
|
|
$ |
20,081 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental Disclosures of Cash Flow Information |
|
|
|
|
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|
The Company paid cash during the period for: |
|
|
|
|
|
|
|
|
Interest |
|
$ |
240 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental Disclosures of Non-Cash Financing and Investing
Activities |
|
|
|
|
|
|
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|
The Company has issued Common Stock as stock-based compensation
in lieu of cash during the period as follows: |
|
|
|
|
|
|
|
|
Shares |
|
|
8 |
|
|
|
9 |
|
|
|
|
|
|
|
|
Amount |
|
$ |
113 |
|
|
$ |
75 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amounts included in accounts payable at end of period for
fixed asset and drug license purchases |
|
$ |
434 |
|
|
$ |
1,267 |
|
|
|
|
|
|
|
|
The accompanying Notes to Unaudited Condensed Consolidated Financial Statements are an integral part of these financial statements.
7
Bentley Pharmaceuticals, Inc. and Subsidiaries
Notes to Unaudited Condensed Consolidated Financial Statements
History and Operations
Bentley Pharmaceuticals, Inc. and Subsidiaries (which may be referred to as Bentley
Pharmaceuticals, 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 200
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, through its Spanish subsidiary, Bentley A.P.I., 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.
Bentley is also in the business of development, licensing and commercialization of
pharmaceutical products utilizing its validated drug delivery technology. Bentley has U.S. and
international patents and other proprietary rights to technologies that facilitate the absorption
of drugs. Bentley develops and co-develops products that incorporate its drug delivery
technologies. Bentleys platform drug delivery technology utilizes CPE-215® to enhance permeation
and absorption of pharmaceutical molecules across biological membranes such as the skin, nasal
mucosa and eye. Bentley has licensed applications of its proprietary CPE-215 drug delivery
technology to Auxilium Pharmaceuticals, Inc., which launched Testim in the United States in
February 2003. Testim, which is the first product incorporating Bentleys CPE-215 drug delivery
technology, is a gel indicated for testosterone replacement therapy.
Planned Spin-off
On October 23, 2007, the Company announced a plan to spin-off its drug delivery business in a
transaction that is subject to certain conditions. Management expects that shares of the new
specialty pharmaceutical drug delivery company, CPEX Pharmaceuticals, Inc. (CPEX), will be
distributed to Bentley stockholders by means of a stock dividend. On the record date, which has not
yet been set, each Bentley stockholder will be entitled to receive shares of CPEX in connection
with the spin-off of the drug delivery business. The spin-off would result in CPEX operating as an
independent entity with publicly traded common stock. Bentley would not have any ownership interest
in CPEX subsequent to the spin-off.
8
In connection with the spin-off, CPEX and Bentley expect to enter into a series of agreements,
including a separation and distribution agreement, a transition services agreement, an employee
matters agreement and a tax sharing agreement. Consummation of the spin-off is subject to several
conditions, including final approval of the spin-off by the Bentley Board of Directors, receipt of an opinion to the effect that Bentley and CPEX each will be solvent and adequately
capitalized immediately after the distribution of the CPEX common stock, and that Bentley has
sufficient surplus under Delaware law to declare the dividend of CPEX common stock to Bentley
stockholders, and the
effectiveness of the Form 10 filed with the Securities and Exchange Commission for the registration
of the securities of CPEX. Approval by Bentleys stockholders is not required as a condition to the
consummation of the proposed spin-off.
Merger Agreement with Teva Pharmaceutical Industries Ltd.
On March 31, 2008, the Company announced that it had entered into a definitive agreement with
Teva Pharmaceutical Industries Ltd. (Teva) whereby Teva will acquire Bentley following the
spin-off of Bentleys drug delivery business to its stockholders. The boards of directors of both
companies have unanimously approved the transaction. Closing is subject to certain conditions,
including completion of the proposed spin-off of Bentleys drug delivery business, antitrust
approvals, the approval of Bentleys stockholders and other customary closing conditions. Mr.
James Murphy, Bentleys Chairman and Chief Executive Officer, Mr. Michael McGovern, Bentleys
Vice Chairman and Mr. McGoverns wife, who currently hold an aggregate of approximately 13.8% of the outstanding Bentley
shares, have agreed to vote their shares in favor of the transaction. Approval by Tevas
stockholders is not required. The transaction is expected to close by the third quarter of 2008.
Teva will fund the acquisition from its internal resources.
Based on the exercise price and number of outstanding shares and options of Bentley as of the
signing, and prior to any potential tax or options adjustments as a result of the spin-off, the
purchase price per share of Bentley common stock to be paid by Teva in the acquisition is
approximately $15.02. If the value of the CPEX stock distributed to
Bentley stockholders in the
spin-off described above exceeds the thresholds set forth in the merger agreement, then the per
share price would be reduced by a percentage of that excess. This reduction is designed to
compensate Teva for tax liabilities it may assume as a result of the spin-off. In addition, in
order to account for the equitable adjustment to the exercise price and number of Bentley options
and restricted stock units that will be made in connection with the spin-off of CPEX, the per share
price to Bentley stockholders will be recalculated prior to the stockholders meeting in order to
spread the aggregate purchase price across all shares of Bentley
common stock and restricted stock units then outstanding and
all options for Bentley common stock with an exercise price less than the price per share to be
paid in the acquisition. The final price per share, reflecting any potential adjustments as a
result of the spin-off, will be announced by Bentley at least
14 days prior to its stockholders
meeting relating to the transaction.
The Company has incurred and is expected to continue to incur legal, tax and other strategic
consulting costs specifically associated with the planned spin-off of its drug delivery business
and merger with Teva. These costs totaled approximately $3,834,000 and $69,000 for the three
months ended March 31, 2008 and 2007, respectively, and have been reported as separation costs
within operating expenses in the Companys Unaudited Consolidated Income Statements. Separation
costs totaling $69,000 for the three months ended March 31, 2007 were reclassified from general and
administrative expenses to separation costs to conform to the current period presentation.
Basis of Unaudited Condensed Consolidated Financial Statements
The Unaudited Condensed Consolidated Financial Statements of Bentley as of March 31, 2008 and
for the three months ended March 31, 2008 and 2007, included herein, have been prepared by the
Company, without audit, pursuant to the rules and regulations of the Securities and Exchange
Commission. Certain information and footnote disclosures normally included in financial statements
prepared in accordance with accounting principles generally accepted in the United States of
America have been condensed or omitted insofar as such information was disclosed in the Companys
consolidated financial statements for the year ended December 31, 2007. These Unaudited Condensed
Consolidated Financial Statements should be read in conjunction with the summary of significant
accounting policies and the audited consolidated financial
9
statements and notes thereto included in Bentleys Annual Report on Form 10-K for the year ended
December 31, 2007, referred to as our 2007 Form 10-K.
In the opinion of management, the accompanying Unaudited Condensed Consolidated Financial
Statements as of March 31, 2008 and for the three months ended March 31, 2008 and 2007 are
presented on a basis consistent with the audited consolidated financial statements for the year
ended December 31, 2007 and contain all adjustments, consisting only of normal recurring
adjustments, necessary to present fairly Bentleys financial position as of March 31, 2008 and the results of its operations and cash flows for the three months ended March
31, 2008 and 2007. The results of operations for the three months ended March 31, 2008 should not
necessarily be considered indicative of the results to be expected for any subsequent period or for
the full year ending December 31, 2008.
Cash and cash equivalents
The Company considers all highly liquid investments with remaining maturities of three months
or less when purchased to be cash equivalents for purposes of classification in the Unaudited
Consolidated Balance Sheets and the Unaudited Consolidated Statements of Cash Flows. Investments in
securities that do not meet the definition of cash equivalents are classified as marketable
securities in the Unaudited Consolidated Balance Sheets.
Included in cash and cash equivalents at March 31, 2008 and December 31, 2007 are
approximately $10,463,000 and $9,704,000, respectively, of short-term investments considered to be
cash equivalents, as the original maturity dates of such investments were three months or less when
purchased.
Fair value measurements
The following tables present the Companys assets and liabilities measured at fair value on a
recurring basis as of March 31, 2008 and the amounts as they correspond to the respective level
within the fair value hierarchy established by SFAS No. 157.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements at March 31, 2008 Using: |
|
|
|
|
|
|
|
Quoted Prices in |
|
|
|
|
|
|
Significant |
|
|
|
|
|
|
|
Active Markets for |
|
|
Significant Other |
|
|
Unobservable |
|
|
|
Total at |
|
|
Identical Assets |
|
|
Observable Inputs |
|
|
Inputs |
|
(In Thousands) |
|
March 31, 2008 |
|
|
(Level 1) |
|
|
(Level 2) |
|
|
(Level 3) |
|
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Marketable Securities |
|
$ |
1,084 |
|
|
$ |
1,084 |
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flow hedges |
|
$ |
571 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
571 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10
|
|
|
|
|
|
|
Fair Value Measurements at |
|
|
|
March 31, 2008 Using |
|
|
|
Significant Unobservable Inputs |
|
|
|
(Level 3) |
|
(In Thousands) |
|
Cash Flow Hedges |
|
Beginning Balance at January 1, 2008 |
|
$ |
374 |
|
Total gains or losses (realized/unrealized): |
|
|
|
|
Included in earnings (or changes in net assets) |
|
|
197 |
|
Included in other comprehensive income |
|
|
|
|
Purchases, issuances, and settlements |
|
|
|
|
Transfers in and/or out of Level 3 |
|
|
|
|
|
|
|
|
Ending balance at March 31, 2008 |
|
$ |
571 |
|
|
|
|
|
|
|
|
|
|
The amount of total gains or losses for the
period included in earnings (or changes in net
assets) attributable to the change in unrealized
gains or losses relating to assets still held at
March 31, 2008 |
|
$ |
|
|
|
|
|
|
Gains and losses (realized and unrealized) included in earnings (or changes in net assets) for
the three months ended March 31, 2008 are reported in Other income (expenses) in the Companys Unaudited
Consolidated Income Statements.
|
|
|
|
|
|
|
Other income (expenses) |
Total gains or losses included in earnings (or changes in net
assets) for the three months ended March 31, 2008
|
|
$ |
197 |
|
|
|
|
|
|
|
|
|
|
|
Changes in unrealized gains or losses relating to assets
held at March 31, 2008
|
|
$ |
|
|
|
|
|
|
|
The following table presents the Companys assets measured at fair value on a nonrecurring
basis as of March 31, 2008 and the amounts as they correspond to the respective level within the
fair value hierarchy established by SFAS No. 157.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(In Thousands) |
|
|
|
|
|
Fair Value Measurements at March 31, 2008 Using: |
|
|
|
|
|
|
|
|
|
|
Quoted Prices in |
|
|
Significant |
|
|
|
|
|
|
|
|
|
|
|
|
|
Active Markets |
|
|
Other |
|
|
Significant |
|
|
|
|
|
|
Total at |
|
|
for Identical |
|
|
Observable |
|
|
Unobservable |
|
|
Total |
|
|
|
March 31, |
|
|
Assets |
|
|
Inputs |
|
|
Inputs |
|
|
Gains |
|
Assets: |
|
2008 |
|
|
(Level 1) |
|
|
(Level 2) |
|
|
(Level 3) |
|
|
(Losses) |
|
Drug licenses and
related costs, net |
|
$ |
17,613 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
17,613 |
|
|
$ |
(195 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In accordance with the recognition and measurement provisions of Statement of Financial
Accounting Standards No. 144, Accounting for the Impairment of Long-Lived Assets, drug licenses and
related costs are reviewed at least annually, or more frequently if events or changes in
circumstances indicate that the assets may be impaired, comparing the carrying amounts to their
estimated future undiscounted cash flows and adjusting for any diminution in value. During the
quarter ended March 31, 2008, the Company recorded impairment losses of approximately $195,000 in
research and development on the Companys Unaudited
Consolidated Income Statement. These impairment losses relate to the
specialty generics business.
Receivables
Receivables consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
March 31, 2008 |
|
|
December 31, 2007 |
|
Trade receivables |
|
$ |
38,112 |
|
|
$ |
32,279 |
|
VAT, income
and social security taxes receivable |
|
|
5,369 |
|
|
|
4,333 |
|
Royalties receivable |
|
|
3,291 |
|
|
|
3,237 |
|
Other |
|
|
171 |
|
|
|
161 |
|
|
|
|
|
|
|
|
|
|
|
46,943 |
|
|
|
40,010 |
|
Less-allowance for doubtful accounts |
|
|
(806 |
) |
|
|
(686 |
) |
|
|
|
|
|
|
|
|
|
$ |
46,137 |
|
|
$ |
39,324 |
|
|
|
|
|
|
|
|
11
Inventories
Inventories are stated at the lower of cost or market, cost being determined on the first in,
first out method. Reserves for slow moving and obsolete inventories are provided based on
historical experience and current product demand.
Balances are comprised of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
March 31, 2008 |
|
|
December 31, 2007 |
|
Raw materials |
|
$ |
13,364 |
|
|
$ |
11,802 |
|
Finished goods |
|
|
6,324 |
|
|
|
6,798 |
|
|
|
|
|
|
|
|
|
|
|
19,688 |
|
|
|
18,600 |
|
Less allowance for slow moving
inventory |
|
|
(152 |
) |
|
|
(942 |
) |
|
|
|
|
|
|
|
|
|
$ |
19,536 |
|
|
$ |
17,658 |
|
|
|
|
|
|
|
|
At
December 31, 2007, the Companys inventories included raw
materials and consigned inventories related to the Companys first U.S. generic product launched
in late December 2006. Market price conditions and demand for this product were less favorable
than originally estimated and these inventories, which had a gross
value of approximately $480,000 in raw materials and $321,000 in
finished goods, were fully
reserved as of December 31, 2007 and subsequently written-off in the first quarter of 2008.
Fixed assets
Fixed assets consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
March 31, 2008 |
|
|
December 31, 2007 |
|
Land |
|
$ |
3,298 |
|
|
$ |
3,128 |
|
Buildings and improvements |
|
|
28,158 |
|
|
|
26,185 |
|
Equipment |
|
|
29,126 |
|
|
|
26,813 |
|
Furniture and fixtures |
|
|
2,602 |
|
|
|
2,537 |
|
Other |
|
|
372 |
|
|
|
350 |
|
|
|
|
|
|
|
|
|
|
|
63,556 |
|
|
|
59,013 |
|
Capital in-progress |
|
|
25,131 |
|
|
|
22,314 |
|
|
|
|
|
|
|
|
|
|
|
88,687 |
|
|
|
81,327 |
|
Less accumulated depreciation |
|
|
(25,067 |
) |
|
|
(22,136 |
) |
|
|
|
|
|
|
|
|
|
$ |
63,620 |
|
|
$ |
59,191 |
|
|
|
|
|
|
|
|
Depreciation expense of approximately $98,000 and $91,000 has been charged to operations as a
component of depreciation and amortization expense in the Unaudited Consolidated Income Statements
for the three months ended March 31, 2008 and 2007, respectively. Depreciation totaling
approximately $1,218,000 and $1,040,000 has been included in cost of net product sales in the
Unaudited Consolidated Income Statements for the three months ended March 31, 2008 and 2007,
respectively.
Debt
Short-term borrowings consist of the following:
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2008 |
|
|
2007 |
|
|
|
(In Thousands) |
|
Revolving lines of credit payable to Spanish
financial institutions, weighted average
interest rate is 5.06% and 5.05%,
respectively |
|
$ |
186 |
|
|
$ |
116 |
|
|
|
|
|
|
|
|
12
The Company maintains revolving line of credit facilities with Spanish financial institutions,
which entitled the Company to borrow up to $7,743,000 and $7,218,000 at March 31, 2008 and
December 31, 2007,
respectively, at interest rates ranging from 4.92% to 5.12%. The facilities are scheduled to mature
on various dates through December 15, 2008 and are renewable.
Long-term debt consists of the following:
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2008 |
|
|
2007 |
|
|
|
(In Thousands) |
|
Loans payable |
|
$ |
17,380 |
|
|
$ |
16,203 |
|
Less-current portion of long-term debt |
|
|
(1,304 |
) |
|
|
(608 |
) |
|
|
|
|
|
|
|
Total long-term debt |
|
$ |
16,076 |
|
|
$ |
15,595 |
|
|
|
|
|
|
|
|
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 (equal to approximately $17,380,000 at March 31, 2008). In accordance with the loan
agreement, Belmac is 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 March 31, 2008 was
5.2%. The principal of the loan will be repaid in quarterly installments of 412,500 Euros (equal to
approximately $652,000 at March 31, 2008) beginning December 31, 2008, with the balance due on
December 31, 2013. Maturities on the long-term debt, as expressed in U.S. dollars as of March 31,
2008 are as follows (in thousands):
|
|
|
|
|
Year |
|
Principal Payment |
|
2008 |
|
$ |
652 |
|
2009 |
|
|
2,607 |
|
2010 |
|
|
2,607 |
|
2011 |
|
|
2,607 |
|
2012 |
|
|
2,607 |
|
2013 |
|
|
6,300 |
|
|
|
|
|
Total |
|
$ |
17,380 |
|
|
|
|
|
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.
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 March 31, 2008 and December 31, 2007 are as follows:
|
|
|
|
|
|
|
|
|
U.S. Dollars per Euro |
|
March 31, 2008 |
|
December 31, 2007 |
YTD weighted average exchange rate |
|
|
1.50 |
|
|
|
1.37 |
|
Exchange rate |
|
|
1.58 |
|
|
|
1.47 |
|
The net effect of foreign currency translation on the Companys net assets for the three
months ended March 31, 2008 was an increase of $6,557,000 which has been included in other
comprehensive income. The cumulative historical effect of foreign currency translation as of March
31, 2008 and December 31, 2007 totaled $25,549,000 and $18,992,000, respectively, as reflected in
accumulated other comprehensive income.
13
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 No. 48,
Revenue Recognition When Right of Return Exists (SFAS No. 48), and of allowances for doubtful
accounts based on significant historical experience.
The Company earns royalty revenues on Auxiliums sales of Testim, which incorporates the
Companys CPE-215 permeation enhancement technology. Total royalty revenues recognized for the three months
ended March 31, 2008 and 2007 were $3,300,000 and $2,157,000, respectively.
The Company enters into licensing and supply agreements with certain customers that provide
for the supply of specified products at specified prices. The Companys two deliverables in these
agreements (the license and the product sales) do not meet the criteria for separation under EITF
00-21, Accounting for Revenue Arrangements with Multiple Deliverables, and are therefore accounted
for as one unit of account in accordance with EITF 00-21. Specifically, the license agreements
contain contractual restrictions whereby the licensees are obligated to purchase the licensed
products exclusively from the Company for the entire term of the related supply agreement.
Additionally, licensees are precluded from being able to sell, sub-lease or transfer their rights
or from being able to manufacture the product in-house. The Companys product sales under the
agreements are recognized in the same manner as its normal product sales. The license fees, which
are due and payable upfront, are refundable to the customer until the customer has received
marketing authorization to sell the licensed product. Accordingly, the Company defers the revenue
recognition of the license fees until the customer obtains marketing authorization. The Company
then recognizes the license fees as revenue on a straight line basis over the term of the related
supply agreement. The Company has deferred recognition of approximately $5,607,000 and $5,424,000
of license fees as of March 31, 2008 and December 31, 2007, respectively.
Provision for income taxes
The Company accounts for income taxes in accordance with SFAS No. 109, Accounting for Income
Taxes, which requires the recognition of deferred tax assets and liabilities relating to the
expected future tax consequences of events that have been recognized in the Companys consolidated
financial statements and tax returns. As permitted by Accounting Principles Board (APB) Opinion
No. 23, Accounting for Income Taxes Special Areas, provisions for income taxes on undistributed
earnings of foreign subsidiaries that are considered permanently invested are not recognized in the
Companys consolidated financial statements. The cumulative amount of foreign earnings that have
been permanently reinvested is approximately $72,500,000.
The Company had $487,000 and $763,000 of unrecognized tax benefits as of March 31, 2008 and
December 31, 2007, respectively, all of which relate to the
Companys Spanish subsidiaries and all of which would affect its effective tax rate if recognized.
14
The Company realized a decrease of approximately $181,000 in its unrecognized tax benefits during the
first quarter of 2008 as a result of the expiration of uncertain
foreign tax positions resulting
from the lapse of statute of limitations. The Company recognizes interest and penalties related to
uncertain tax positions as a component of the provision for income taxes. As of the date of
adoption, the Company had approximately $249,000 of accrued penalties and $51,000 of accrued
interest related to its uncertain tax positions. As of March 31, 2008, the Company had
approximately $86,000 of accrued penalties and $57,000 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.
As a result of reporting taxable income in Spain, the Company recorded provisions for foreign
income taxes totaling $1,942,000 and $2,081,000 for the three months ended March 31, 2008 and 2007,
respectively. The provisions represented 32% of the pre-tax income reported in Spain for each of
the three months ended March 31, 2008 and 2007. The provisions represented 65% and 47% of
consolidated pre-tax income for the three months ended March 31, 2008 and 2007, 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.
The Company generated U.S. federal net operating losses of approximately
$3,127,000 and
$723,000 in the three months ended March 31, 2008 and 2007, respectively. As future operating
profits cannot be reasonably assured, no tax benefit has been recorded for these losses. The
Company has established valuation allowances equal to the full amount of the U.S. 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 and diluted net income per common share is based on the weighted average number of
shares of common stock outstanding during each period in accordance with SFAS No. 128, Earnings per
Share. The effects on the Companys outstanding stock options were considered in the diluted net
income per share calculation for the three months ended March 31, 2008 and 2007.
The following is a reconciliation between basic and diluted net income per common share for
the three months ended March 31, 2008 and 2007. Dilutive securities issuable for the three months
ended March 31, 2008 and 2007 include approximately 1,119,000 and 241,000 dilutive incremental
shares, respectively, issuable as a result of various stock options and unvested restricted stock
units that are outstanding.
For the Three Months Ended March 31, 2008 (in thousands, except per share data):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of Dilutive |
|
|
|
|
Basic EPS |
|
Securities |
|
Diluted EPS |
Net income |
|
$ |
1,064 |
|
|
$ |
|
|
|
$ |
1,064 |
|
Weighted average common
shares outstanding |
|
|
22,469 |
|
|
|
1,119 |
|
|
|
23,588 |
|
Net income per common share |
|
$ |
0.05 |
|
|
$ |
|
|
|
$ |
0.05 |
|
15
For the Three Months Ended March 31, 2007 (in thousands, except per share data):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of Dilutive |
|
|
|
|
Basic EPS |
|
Securities |
|
Diluted EPS |
Net income |
|
$ |
2,360 |
|
|
$ |
|
|
|
$ |
2,360 |
|
Weighted average common
shares outstanding |
|
|
22,293 |
|
|
|
241 |
|
|
|
22,534 |
|
Net income per common share |
|
$ |
0.11 |
|
|
$ |
|
|
|
$ |
0.10 |
|
For the three months ended March 31, 2008 and 2007, options to purchase 10,000 and 2,434,000
shares, respectively, of Common Stock were excluded from the diluted EPS presentation as determined
under the treasury stock method, because their exercise prices were greater than the average market
value of the common stock during the period.
Share-based compensation plans
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 March 31, 2008, approximately
4,307,000 shares of Common Stock have been reserved for issuance under the Plans of which
approximately 3,796,000 of the shares are subject to outstanding stock options and approximately
186,000 shares are subject to outstanding restricted stock units. The balance of approximately
325,000 shares is available for future issuance under the Amended and Restated 2005 Equity and
Incentive Plan (the Amended Plan), which is the successor to all the Companys other equity
Plans. Of the shares available for future issuance, approximately 2,100 are available only for
future grants of stock options, while the remainder are available for any type of award allowed
under the Amended Plan.
The Company also sponsors a 401(k) Plan for eligible employees and matches eligible
contributions with shares of the Companys Common Stock. In March 2008, the Companys Board of
Directors authorized an increase of 50,000 shares in the number of shares of Common Stock reserved
for issuance pursuant to the 401(k) Plan.
Common stock and restricted stock unit transactions
During the three months ended March 31, 2008, the Company issued approximately 42,100 shares
of Common Stock upon the exercise of stock options and approximately 7,700 shares of Common Stock
as share-based compensation in lieu of cash contributions to the Companys 401(k) Plan.
Additionally, during the three months ended March 31, 2008, the Company issued 24,000 shares of
Common Stock to non-employee directors from vested but contingently issuable restricted stock units
pursuant to an issuance election made by those non-employee directors.
Stock-based compensation
Stock-based compensation expense recorded for stock option and restricted stock unit awards to
employees, non-employee directors and one consultant for the three months ended March 31, 2008 and
2007 was approximately $697,000 and $484,000, respectively. The related expenses were recorded in
the Companys Unaudited Consolidated Income Statements as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended March 31, |
|
|
|
2008 |
|
|
2007 |
|
Cost of net product sales |
|
$ |
10 |
|
|
$ |
8 |
|
Selling and marketing expenses |
|
|
5 |
|
|
|
5 |
|
General and administrative expenses |
|
|
409 |
|
|
|
310 |
|
Research and development expenses |
|
|
273 |
|
|
|
161 |
|
|
|
|
|
|
|
|
|
|
$ |
697 |
|
|
$ |
484 |
|
|
|
|
|
|
|
|
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.
16
Stock-based compensation expense recorded for matching contributions for the Companys 401(k)
Plan totaled $113,000 and $75,000 for the three months ended March 31, 2008 and 2007, respectively.
The related expenses were recorded in the Companys Unaudited Consolidated Income Statements as
follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended March 31, |
|
|
|
2008 |
|
|
2007 |
|
General and administrative expenses |
|
$ |
57 |
|
|
$ |
31 |
|
Research and development expenses |
|
|
56 |
|
|
|
44 |
|
|
|
|
|
|
|
|
|
|
$ |
113 |
|
|
$ |
75 |
|
|
|
|
|
|
|
|
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 was based in both the U.S. and Europe and is focused on
the advancement of proprietary drug delivery technologies that enhance or facilitate the absorption
of pharmaceutical compounds across various membranes. The Company ceased its European drug delivery
activities effective December 31, 2007. As a result, the Companys drug delivery activities are now
solely based in the U.S. The Companys activities consist primarily of licensing, product research
and development, business development activities, corporate
management and administration. The Company plans on spinning-off its drug delivery business pursuant to which shares of the new
specialty pharmaceutical drug delivery company, CPEX, will be distributed to Bentley stockholders
by means of a stock dividend. See Item 2, Managements Discussion and Analysis of Financial
Condition and Results of Operations.
Set forth in the tables below is certain financial information with respect to the Companys
business and geographical segments for the three months ended March 31, 2008 and 2007 and as of
March 31, 2008 and December 31, 2007. The 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, 2007 (the 2007 Form 10-K).
17
For the Three Months Ended March 31, 2008 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Specialty Generics |
|
Drug Delivery |
|
|
|
|
Europe |
|
U.S. |
|
Europe |
|
U.S. |
|
Consolidated |
Net product sales |
|
$ |
36,364 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
36,364 |
|
Licensing and collaboration revenues |
|
|
199 |
|
|
|
|
|
|
|
|
|
|
|
3,450 |
|
|
|
3,649 |
|
Total revenues |
|
|
36,563 |
|
|
|
|
|
|
|
|
|
|
|
3,450 |
|
|
|
40,013 |
|
Cost of net product sales |
|
|
19,913 |
|
|
|
34 |
|
|
|
|
|
|
|
|
|
|
|
19,947 |
|
Gross profit |
|
|
16,650 |
|
|
|
(34 |
) |
|
|
|
|
|
|
3,450 |
|
|
|
20,066 |
|
Selling and marketing expense |
|
|
5,763 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,763 |
|
General and administrative expense |
|
|
2,703 |
|
|
|
(17 |
) |
|
|
|
|
|
|
1,527 |
|
|
|
4,213 |
|
Research and development expense |
|
|
692 |
|
|
|
|
|
|
|
|
|
|
|
2,112 |
|
|
|
2,804 |
|
Separation Costs |
|
|
1,960 |
|
|
|
|
|
|
|
|
|
|
|
1,874 |
|
|
|
3,834 |
|
Depreciation and amortization
expense |
|
|
334 |
|
|
|
20 |
|
|
|
|
|
|
|
172 |
|
|
|
526 |
|
Income from operations |
|
|
5,198 |
|
|
|
(37 |
) |
|
|
|
|
|
|
(2,235 |
) |
|
|
2,926 |
|
Interest income |
|
|
113 |
|
|
|
|
|
|
|
|
|
|
|
147 |
|
|
|
260 |
|
Interest expense |
|
|
(277 |
) |
|
|
|
|
|
|
|
|
|
|
(2 |
) |
|
|
(279 |
) |
Other income (expense), net |
|
|
99 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
99 |
|
Income before income taxes |
|
|
5,133 |
|
|
|
(37 |
) |
|
|
|
|
|
|
(2,090 |
) |
|
|
3,006 |
|
Provision for income taxes |
|
|
1,942 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,942 |
|
Net income (loss) |
|
|
3,191 |
|
|
|
(37 |
) |
|
|
|
|
|
|
(2,090 |
) |
|
|
1,064 |
|
Expenditures for fixed assets |
|
|
1,590 |
|
|
|
|
|
|
|
|
|
|
|
38 |
|
|
|
1,628 |
|
Expenditures for drug licenses |
|
|
661 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
661 |
|
For the Three Months Ended March 31, 2007 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Specialty Generics |
|
Drug Delivery |
|
|
|
|
Europe |
|
U.S. |
|
Europe |
|
U.S. |
|
Consolidated |
Net product sales |
|
$ |
28,906 |
|
|
$ |
208 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
29,114 |
|
Licensing and collaboration revenues |
|
|
114 |
|
|
|
|
|
|
|
|
|
|
|
2,163 |
|
|
|
2,277 |
|
Total revenues |
|
|
29,020 |
|
|
|
208 |
|
|
|
|
|
|
|
2,163 |
|
|
|
31,391 |
|
Cost of net product sales |
|
|
15,396 |
|
|
|
501 |
|
|
|
|
|
|
|
|
|
|
|
15,897 |
|
Gross profit |
|
|
13,624 |
|
|
|
(293 |
) |
|
|
|
|
|
|
2,163 |
|
|
|
15,494 |
|
Selling and marketing expense |
|
|
4,445 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,445 |
|
General and administrative expense |
|
|
2,275 |
|
|
|
|
|
|
|
|
|
|
|
1,302 |
|
|
|
3,577 |
|
Research and development expense |
|
|
481 |
|
|
|
|
|
|
|
1,097 |
|
|
|
1,097 |
|
|
|
2,675 |
|
Separation Costs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
69 |
|
|
|
69 |
|
Depreciation and amortization
expense |
|
|
274 |
|
|
|
39 |
|
|
|
|
|
|
|
195 |
|
|
|
508 |
|
Income from operations |
|
|
6,149 |
|
|
|
(332 |
) |
|
|
(1,097 |
) |
|
|
(500 |
) |
|
|
4,220 |
|
Interest income |
|
|
65 |
|
|
|
|
|
|
|
|
|
|
|
117 |
|
|
|
182 |
|
Interest expense |
|
|
(45 |
) |
|
|
|
|
|
|
|
|
|
|
(5 |
) |
|
|
(50 |
) |
Other income (expense), net |
|
|
92 |
|
|
|
|
|
|
|
|
|
|
|
(3 |
) |
|
|
89 |
|
Income before income taxes |
|
|
6,261 |
|
|
|
(332 |
) |
|
|
(1,097 |
) |
|
|
(391 |
) |
|
|
4,441 |
|
Provision for income taxes |
|
|
2,081 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,081 |
|
Net income (loss) |
|
|
4,180 |
|
|
|
(332 |
) |
|
|
(1,097 |
) |
|
|
(391 |
) |
|
|
2,360 |
|
Expenditures for fixed assets |
|
|
1,934 |
|
|
|
|
|
|
|
|
|
|
|
20 |
|
|
|
1,954 |
|
Expenditures for drug licenses |
|
|
336 |
|
|
|
32 |
|
|
|
|
|
|
|
147 |
|
|
|
515 |
|
As of March 31, 2008 (in thousands):
18
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Specialty Generics |
|
Drug Delivery |
|
|
|
|
Europe |
|
U.S. |
|
Europe |
|
U.S. |
|
Consolidated |
Receivables, net |
|
$ |
42,866 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
3,271 |
|
|
$ |
46,137 |
|
Other current assets |
|
|
36,358 |
|
|
|
|
|
|
|
|
|
|
|
20,406 |
|
|
|
56,764 |
|
Fixed assets |
|
|
60,851 |
|
|
|
|
|
|
|
|
|
|
|
2,769 |
|
|
|
63,620 |
|
Drug licenses and related costs |
|
|
14,320 |
|
|
|
455 |
|
|
|
|
|
|
|
2,838 |
|
|
|
17,613 |
|
Other non-current assets |
|
|
1,280 |
|
|
|
|
|
|
|
|
|
|
|
1,084 |
|
|
|
2,364 |
|
Total assets |
|
|
155,675 |
|
|
|
455 |
|
|
|
|
|
|
|
30,368 |
|
|
|
186,498 |
|
Current liabilities |
|
|
32,401 |
|
|
|
|
|
|
|
|
|
|
|
3,898 |
|
|
|
36,299 |
|
Long term debt |
|
|
16,076 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
16,076 |
|
Non-current liabilities |
|
|
9,265 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9,265 |
|
Total liabilities |
|
|
57,742 |
|
|
|
|
|
|
|
|
|
|
|
3,898 |
|
|
|
61,640 |
|
As of December 31, 2007 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Specialty Generics |
|
Drug Delivery |
|
|
|
|
Europe |
|
U.S. |
|
Europe |
|
U.S. |
|
Consolidated |
Receivables, net |
|
$ |
36,071 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
3,253 |
|
|
$ |
39,324 |
|
Other current assets |
|
|
32,707 |
|
|
|
274 |
|
|
|
|
|
|
|
22,375 |
|
|
|
55,356 |
|
Fixed assets |
|
|
56,391 |
|
|
|
|
|
|
|
|
|
|
|
2,800 |
|
|
|
59,191 |
|
Drug licenses and related costs |
|
|
13,206 |
|
|
|
476 |
|
|
|
|
|
|
|
2,942 |
|
|
|
16,624 |
|
Other non-current assets |
|
|
1,514 |
|
|
|
|
|
|
|
|
|
|
|
1,087 |
|
|
|
2,601 |
|
Total assets |
|
|
139,889 |
|
|
|
750 |
|
|
|
|
|
|
|
32,457 |
|
|
|
173,096 |
|
Current liabilities |
|
|
28,282 |
|
|
|
315 |
|
|
|
|
|
|
|
4,486 |
|
|
|
33,083 |
|
Long term debt |
|
|
15,595 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
15,595 |
|
Non-current liabilities |
|
|
8,446 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8,446 |
|
Total liabilities |
|
|
52,323 |
|
|
|
315 |
|
|
|
|
|
|
|
4,486 |
|
|
|
57,124 |
|
The majority of the Companys revenues are generated from products sold in Spain. Revenues
from products sold in Spain totaled $24,969,000 and $21,734,000 in the three months ended March 31,
2008 and 2007, respectively. Revenues from licensing and collaboration revenues in Spain totaled
$199,000 and $114,000 in the three months ended March 31, 2008 and 2007, respectively.
Set forth in the table below is a summary of our revenues from external customers including a
breakout of our revenues for our major product lines for the three months ended March 31, 2008 and
2007 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
% of |
|
|
|
|
|
|
% of |
|
|
|
|
|
|
|
Total |
|
|
|
|
|
|
Total |
|
|
|
March 31, 2008 |
|
|
Revenues |
|
|
March 31, 2007 |
|
|
Revenues |
|
Omeprazole |
|
$ |
5,830 |
|
|
|
15 |
% |
|
$ |
4,421 |
|
|
|
14 |
% |
Simvastatin |
|
|
1,796 |
|
|
|
4 |
% |
|
|
1,705 |
|
|
|
6 |
% |
Enalapril |
|
|
1,754 |
|
|
|
4 |
% |
|
|
1,705 |
|
|
|
6 |
% |
Lansoprazole |
|
|
1,402 |
|
|
|
4 |
% |
|
|
1,170 |
|
|
|
4 |
% |
Paroxetine |
|
|
1,280 |
|
|
|
3 |
% |
|
|
1,346 |
|
|
|
4 |
% |
All other products |
|
|
8,435 |
|
|
|
21 |
% |
|
|
8,560 |
|
|
|
27 |
% |
Sales to licensees and others |
|
|
15,867 |
|
|
|
40 |
% |
|
|
10,207 |
|
|
|
32 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net product sales |
|
|
36,364 |
|
|
|
91 |
% |
|
|
29,114 |
|
|
|
93 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Licensing and collaborations |
|
|
3,649 |
|
|
|
9 |
% |
|
|
2,277 |
|
|
|
7 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Revenues |
|
$ |
40,013 |
|
|
|
100 |
% |
|
$ |
31,391 |
|
|
|
100 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Recently issued accounting pronouncements
19
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. The Company has adopted SFAS No. 159 as of January 1,
2008 through March 31, 2008 and has not elected to measure any of its financial instruments or other items at fair value
that are not currently required to be measured at fair value.
In June 2007, the FASB ratified the consensus reached by the EITF on Issue No. 07-3,
Accounting for Nonrefundable Advance Payments for Goods or Services Received for Use in Future
Research and Development Activities (EITF Issue No. 07-3). EITF Issue No. 07-3 states that
nonrefundable advance payments for goods or services that will be used or rendered for future
research and development activities should be deferred and capitalized. Such amounts should be
recognized as an expense as the related goods are delivered or the related services performed. If
an entity does not expect the goods to be delivered or services to be rendered, the capitalized
advance payment should be charged to expense. The Company adopted EITF Issue No. 07-3 as of January
1, 2008. The Company often enters into agreements for research and development goods and service,
however the adoption of EITF 07-03 did not have a material impact on the Companys consolidated
financial statements.
In December 2007, the FASB issued SFAS No. 141(R), Business Combinations (SFAS No. 141(R)),
which replaces SFAS No. 141. SFAS No. 141(R) establishes principles and requirements for how an
acquirer recognizes and measures in its financial statements the identifiable assets acquired, the
liabilities assumed, any noncontrolling interest in the acquiree and the goodwill acquired. The
Statement also establishes disclosure requirements which will enable users to evaluate the nature
and financial effects of the business combination. SFAS No. 141(R) is effective for fiscal years
beginning after December 15, 2008. The Company has not determined the effect that the application
of SFAS No. 141(R) will have on its consolidated financial statements.
In December 2007, the FASB issued SFAS No. 160, Noncontrolling Interests in Consolidated
Financial Statements an amendment of Accounting Research Bulletin No. 51 (SFAS No. 160) which
establishes accounting and reporting standards for ownership interests in subsidiaries held by
parties other than the parent, the amount of consolidated net income attributable to the parent and
to the noncontrolling interest, changes in a parents ownership interest and the valuation of
retained noncontrolling equity investments when a subsidiary is deconsolidated. The Statement also
establishes reporting requirements that provide sufficient disclosures that clearly identify and
distinguish between the interests of the parent and the interests of the noncontrolling owners.
SFAS No. 160 is effective for fiscal years beginning after December 15, 2008. The Company has not
determined the effect that the application of SFAS No. 160 will have on its consolidated financial
statements.
In December 2007, the FASB ratified the consensus reached by the EITF on Issue No. 07-1,
Accounting for Collaborative Agreements (EITF Issue No. 07-1). EITF Issue No. 07-1 provides the
definition of a collaborative agreement and guidelines to assist an entity in determining whether
or not it is a party in a collaborative agreement. EITF Issue No. 07-1 states that costs incurred
and revenues generated from transactions with third parties shall be reported in accordance with
EITF Issue No. 99-19, Reporting Revenue Gross as a Principal versus Net as an Agent. EITF Issue
No. 07-1 also provides minimum disclosure requirements for an entitys collaboration agreements and
transition guidance. EITF Issue No. 07-1 is effective for fiscal years beginning after December 15,
2008. The Company is evaluating the impact that the adoption of EITF Issue No. 07-1 will have on
its consolidated financial statements.
In March 2008, the FASB issued SFAS No. 161, Disclosures about Derivative Instruments and
Hedging Activities, as an amendment to SFAS No. 133, Accounting for Derivative Instruments and
20
Hedging Activities (SFAS No. 161). SFAS No. 161 required that objectives for using derivative
instruments be disclosed in terms of underlying risk and accounting designation. The fair
value of derivative instruments and their gains and losses will need to be presented in tabular
format in order to present a more complete picture of the effects of using derivative instruments.
SFAS No. 161 is effective for financial statements issued for fiscal years beginning after November
15, 2008. The Company is currently evaluating the impact of adopting this pronouncement.
Reclassifications
Certain costs included in general and administrative expenses in prior periods associated with
the planned spin-off have been reclassified from general and administrative expenses to separation
costs to conform with the Companys current presentation.
21
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 2007 Annual Report on Form 10-K, which has been
previously filed with the SEC. Except for the historical information contained herein, the
foregoing discussion contains forward-looking statements that involve risks and uncertainties. Our
actual results could differ materially from those projected in the forward-looking statements
discussed herein due to competitive factors and other risks discussed in our 2007 Annual Report on
Form 10-K under Item 1A, Risk Factors.
Planned Spin-off
On October 23,
2007, the Company announced a plan to spin-off its drug delivery business. The
transaction is subject to certain conditions. Management expects that shares of the new
specialty pharmaceutical drug delivery company, CPEX Pharmaceuticals, Inc. (CPEX), will be
distributed to Bentley stockholders by means of a stock dividend. On the record date, which has not
yet been set, each Bentley stockholder will be entitled to receive shares of CPEX in connection
with the spin-off of the drug delivery business. The spin-off would result in CPEX operating as an
independent entity with publicly traded common stock. Bentley would not have any ownership interest
in CPEX subsequent to the spin-off.
In connection with the spin-off, CPEX and Bentley expect to enter into a series of agreements,
including a separation and distribution agreement, a transition services agreement, an employee
matters agreement and a tax sharing agreement. Consummation of the spin-off is subject to
several conditions, including final approval of the spin-off by the Bentley Board of Directors, receipt of an opinion to the effect that Bentley and CPEX each will be solvent and adequately
capitalized immediately after the distribution of the CPEX common stock, and that Bentley has
sufficient surplus under Delaware law to declare the dividend of CPEX common stock to Bentley
stockholders, and
the effectiveness of the Form 10 filed with the Securities and Exchange Commission for the
registration of the securities of CPEX. Approval by Bentleys stockholders is not required as a
condition to the consummation of the proposed spin-off.
Merger Agreement with Teva Pharmaceutical Industries Ltd.
On March 31, 2008, the Company announced that it had entered into a definitive agreement with
Teva Pharmaceutical Industries Ltd. (Teva) whereby Teva will acquire Bentley following the
spin-off of Bentleys drug delivery business to its stockholders. The boards of directors of both
companies have unanimously approved the transaction. Closing is subject to certain conditions,
including completion of the proposed spin-off of Bentleys drug delivery business, antitrust
approvals, the approval of Bentleys stockholders and other customary closing conditions. Mr.
James Murphy, Bentleys Chairman and Chief Executive Officer, Mr. Michael McGovern, Bentleys
Vice Chairman and Mr. McGoverns wife, who currently hold an aggregate of approximately 13.8% of the outstanding Bentley
shares, have agreed to vote their shares in favor of the transaction. Approval by Tevas
stockholders is not required. The transaction is expected to close by the third quarter of 2008.
Teva will fund the acquisition from its internal resources.
Based on the exercise price and number of outstanding shares and options of Bentley as of the
signing, and prior to any potential tax or options adjustments as a result of the spin-off, the
purchase price per share of Bentley common stock to be paid by Teva in the acquisition is
approximately $15.02. If the value of the CPEX stock distributed to
Bentley stockholders in the
spin-off described above exceeds the thresholds set forth in the merger agreement, then the per
share price would be reduced by a percentage of that excess. This reduction is designed to
compensate Teva for tax liabilities it may assume as a result of the spin-off. In addition, in
order to account for the equitable adjustment to the exercise price and number of Bentley options
and restricted stock units that will be made in connection with the spin-off of CPEX, the per share
price to Bentley stockholders will be recalculated prior to the stockholders meeting in order to
spread the aggregate purchase price across all shares of Bentley
common stock and restricted stock units then outstanding and
all options for Bentley common stock with an exercise price less than the price per share to be
paid in the acquisition. The final price
22
per share, reflecting any potential adjustments as a
result of the spin-off, will be announced by Bentley at least
14 days prior to its stockholders
meeting relating to the transaction.
The Company has incurred and is expected to continue to incur legal, tax and other strategic
consulting costs specifically associated with the planned spin-off of its drug delivery business
and merger with Teva. These costs totaled approximately $3,834,000 and $69,000 for the three
months ended March 31, 2008 and 2007, respectively, and have been reported as separation costs
within operating expenses in the Companys Unaudited Consolidated Income Statements. Separation
costs totaling $69,000 for the three months ended March 31, 2007 were reclassified from general and
administrative expenses to separation costs to conform to the current period presentation.
Overview
We are an international specialty pharmaceutical company, headquartered in the U.S., that is
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. |
Specialty Generic Pharmaceuticals
Our pharmaceutical product sales and licensing activities are based primarily in Spain, where
we have a significant commercial presence and manufacture and market approximately 200 product
presentations (also known as stock keeping units, 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 product revenues in the three
months ended March 31, 2008. 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 several countries in the European
Union. As of March 31, 2008 approximately 32% of our net product sales were derived from sales
outside of Spain. The launch of simvastatin, our first U.S. generic product, in December 2006
marked a significant strategic milestone for us; however, due to market price conditions and
limited demand, sales of our generic simvastatin were less favorable than our initial projections.
As a result, we reduced the carrying value of these inventories to zero at December 31, 2007 and
subsequently wrote those inventories off in the first quarter of 2008. As a result of these market
conditions and adjustments, we also reassessed the carrying value of our U.S. simvastatin drug
license at December 31, 2007. Due to the inability to generate net profits on these products and
the lack of additional orders, we reduced the carrying value of this drug license to zero at
December 31, 2007, and effective in April 2008, we terminated our product development, license and
manufacturing agreement with our collaborator for generic simvastatin.
While the pricing of our pharmaceutical products is influenced by market forces (size of the
market, number of competitors, etc.) our pricing in Spain and other countries is also subject to
governmental price controls. The majority of our products are subject to price controls set in
place by the Spanish government. The Spanish government enacted legislation effective March 1, 2007
which reduced the amount it reimburses for pharmaceutical products. As a result of the legislation
our sales force began marketing our products at lower selling prices in Spain as early as February
2007. We also experienced reduced sales levels in the beginning of the first quarter of 2007 as
Spanish wholesalers and pharmacies minimized order quantities until they were able to purchase our
products at the new lower prices. Once we began selling at the new prices we experienced an
increase in the number of our units sold. While the increased unit volume has substantially offset
the impact of the reduced selling prices on our net product sales, our gross margins have decreased
23
compared to periods prior to 2007. Gross margins were 45% in the three months ended March 31, 2007
and 2008. The products most affected by the price reductions are two of our top selling product
lines, omeprazole and simvastatin. We have implemented strategies to mitigate lower selling
prices, including strategies to reduce manufacturing costs and increase sales volumes.
We are seeking to continue expanding our product sales in other geographic regions through
strategic alliances. We are targeting markets that offer compatible regulatory approval regimes and
attractive product margins. In addition, we expect to grow our business by developing and acquiring
rights to market additional products to sell through our sales organization and our strategic
alliances. We continually acquire rights to new products in response to increasing market demand
for generic and branded generic therapeutic products.
We also manufacture and market active pharmaceutical ingredients 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.
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 in the United States in February 2003. Testim, which
is the first product incorporating our CPE-215 drug delivery technology, 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 delivery of insulin to diabetic patients
intranasally. It is these products, including Nasulin, our intransal product candidate, and the
CPE-215 technology that we plan to spin-off to stockholders in CPEX Pharmaceuticals, Inc.
Our U.S. research and development activities are primarily focused on the development of
Nasulin, our intranasal insulin product candidate. In 2004, we concluded a Phase IIA study for
Nasulin in Type I diabetic patients using our CPE-215 technology. We reported the results of that
trial in an abstract titled Intranasal Insulin Administration in Type 1 Diabetic Patients
Utilizing CPE-215 Technology at the American Diabetes Association 65th Scientific
Sessions, September 10-14, 2005, in San Diego, California. 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 in healthy non-diabetic volunteers and advanced
our Phase IIA studies in the U.S. in Type 1 diabetic patients. In first quarter of 2007, we
completed preparations for a Phase II study in India in Type 2 diabetic patients 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 Scientific Sessions in Chicago, Illinois in June
2007. We expect the U.S. development and clinical programs for Nasulin to continue and expand
domestically and internationally. We expect to incur, and upon
consummation of the spin-off, for CPEX to incur, increased costs from the advancement of our
clinical programs and from continued product formulation and testing efforts.
Effect of Foreign Currency Fluctuations
A substantial amount of our business is conducted in Europe and is therefore influenced by
fluctuations in the U.S. Dollars value in relation to other currencies, particularly the Euro. An
increase in the weighted average value of the Euro in relation to the U.S. Dollar over the prior
year first quarter, had the following impact on the results of our operations when reported in U.S.
Dollars: (1) total revenues were increased by approximately $4,607,000, (2) gross profit was
increased by approximately $2,107,000, (3) operating expenses increased by approximately
$1,307,000, (4) provision for income taxes was increased by approximately $243,000, and (5) our
resulting net income was increased by approximately $557,000.
24
The following discussion includes references to 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.
CONSOLIDATED RESULTS OF OPERATIONS:
Three Months Ended March 31, 2008 compared to Three Months Ended March 31, 2007
Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended March 31, |
|
Change |
(in thousands) |
|
2008 |
|
% |
|
2007 |
|
% |
|
$ |
|
% |
|
|
|
|
|
|
|
Specialty Generics |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net product sales |
|
$ |
36,364 |
|
|
|
91 |
% |
|
$ |
29,114 |
|
|
|
93 |
% |
|
$ |
7,250 |
|
|
|
25 |
% |
Licensing and collaboration revenues |
|
|
199 |
|
|
|
* |
|
|
|
114 |
|
|
|
* |
|
|
|
85 |
|
|
|
75 |
% |
|
|
|
|
|
|
|
|
|
|
36,563 |
|
|
|
91 |
% |
|
|
29,228 |
|
|
|
93 |
% |
|
|
7,335 |
|
|
|
25 |
% |
Drug Delivery |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Licensing and collaboration revenues |
|
|
3,450 |
|
|
|
9 |
% |
|
|
2,163 |
|
|
|
7 |
% |
|
|
1,287 |
|
|
|
60 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
40,013 |
|
|
|
100 |
% |
|
$ |
31,391 |
|
|
|
100 |
% |
|
$ |
8,622 |
|
|
|
27 |
% |
|
|
|
|
|
|
|
Total revenues for the three months ended March 31, 2008 increased $8,622,000 from the same
period in the prior year. Our specialty generics business continued to experience increased demand
when compared to the first quarter of 2007. Our net product sales increased by 10% over the
comparable period of the prior year when expressed in constant currency. Our drug delivery revenues
increased 60% from the first quarter of 2007 due to increased royalties earned on sales of Testim.
Based on industry sources, Testim was reported to capture approximately 22% of all testosterone gel
replacement prescriptions in the U.S. market as of March 31, 2008, compared to approximately 19% of
all testosterone gel replacement prescriptions as of March 31, 2007.
Our revenues are generated through our primary sales channels of branded generic
pharmaceuticals, generic pharmaceuticals, sales to licensees and others and licensing and
collaboration revenues. The following is a summary of our revenues by sales channel and top-selling
product lines:
25
For the three months ended March 31, 2008:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands) |
|
Revenues Within Spain |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues |
|
|
|
|
|
|
|
|
Branded |
|
|
|
|
|
|
|
|
|
Outside of |
|
|
|
|
|
% of Total |
Product Line |
|
Generics |
|
Generics |
|
Other |
|
Spain |
|
Total |
|
Revenues |
|
Omeprazole |
|
$ |
499 |
|
|
$ |
5,331 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
5,830 |
|
|
|
15 |
% |
Simvastatin |
|
|
290 |
|
|
|
1,506 |
|
|
|
|
|
|
|
|
|
|
|
1,796 |
|
|
|
4 |
% |
Enalapril |
|
|
1,381 |
|
|
|
373 |
|
|
|
|
|
|
|
|
|
|
|
1,754 |
|
|
|
4 |
% |
Lansoprazole |
|
|
1,002 |
|
|
|
400 |
|
|
|
|
|
|
|
|
|
|
|
1,402 |
|
|
|
4 |
% |
Paroxetine |
|
|
464 |
|
|
|
816 |
|
|
|
|
|
|
|
|
|
|
|
1,280 |
|
|
|
3 |
% |
All other products |
|
|
3,268 |
|
|
|
3,889 |
|
|
|
310 |
|
|
|
968 |
|
|
|
8,435 |
|
|
|
21 |
% |
Sales to licensees and others |
|
|
|
|
|
|
|
|
|
|
5,241 |
|
|
|
10,626 |
|
|
|
15,867 |
|
|
|
40 |
% |
Licensing and collaborations |
|
|
|
|
|
|
|
|
|
|
199 |
|
|
|
3,450 |
|
|
|
3,649 |
|
|
|
9 |
% |
|
Total Revenues |
|
$ |
6,904 |
|
|
$ |
12,315 |
|
|
$ |
5,750 |
|
|
$ |
15,044 |
|
|
$ |
40,013 |
|
|
|
100 |
% |
|
% of Q-1 2008 Revenues |
|
|
17 |
% |
|
|
31 |
% |
|
|
14 |
% |
|
|
38 |
% |
|
|
100 |
% |
|
|
|
|
For the three months ended March 31, 2007:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands) |
|
Revenues Within Spain |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues |
|
|
|
|
|
|
|
|
Branded |
|
|
|
|
|
|
|
|
|
Outside of |
|
|
|
|
|
% of Total |
Product Line |
|
Generics |
|
Generics |
|
Other |
|
Spain |
|
Total |
|
Revenues |
|
Omeprazole |
|
$ |
551 |
|
|
$ |
3,870 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
4,421 |
|
|
|
14 |
% |
Simvastatin |
|
|
366 |
|
|
|
1,339 |
|
|
|
|
|
|
|
|
|
|
|
1,705 |
|
|
|
6 |
% |
Enalapril |
|
|
1,314 |
|
|
|
391 |
|
|
|
|
|
|
|
|
|
|
|
1,705 |
|
|
|
6 |
% |
Lansoprazole |
|
|
856 |
|
|
|
314 |
|
|
|
|
|
|
|
|
|
|
|
1,170 |
|
|
|
4 |
% |
Paroxetine |
|
|
449 |
|
|
|
897 |
|
|
|
|
|
|
|
|
|
|
|
1,346 |
|
|
|
4 |
% |
All other products |
|
|
3,460 |
|
|
|
3,868 |
|
|
|
275 |
|
|
|
957 |
|
|
|
8,560 |
|
|
|
27 |
% |
Sales to licensees and others |
|
|
|
|
|
|
|
|
|
|
3,670 |
|
|
|
6,537 |
|
|
|
10,207 |
|
|
|
32 |
% |
Licensing and collaborations |
|
|
|
|
|
|
|
|
|
|
114 |
|
|
|
2,163 |
|
|
|
2,277 |
|
|
|
7 |
% |
|
Total Revenues |
|
$ |
6,996 |
|
|
$ |
10,679 |
|
|
$ |
4,059 |
|
|
$ |
9,657 |
|
|
$ |
31,391 |
|
|
|
100 |
% |
|
% of Q-1 2007 Revenues |
|
|
22 |
% |
|
|
34 |
% |
|
|
13 |
% |
|
|
31 |
% |
|
|
100 |
% |
|
|
|
|
Branded Generic Pharmaceutical Products
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended March 31, |
|
Change |
(in thousands) |
|
2008 |
|
% |
|
2007 |
|
% |
|
$ |
|
% |
|
|
|
|
|
|
|
Branded Generic Product Sales: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Enalapril |
|
$ |
1,381 |
|
|
|
20 |
% |
|
$ |
1,314 |
|
|
|
19 |
% |
|
$ |
67 |
|
|
|
5 |
% |
Codeisan |
|
|
1,186 |
|
|
|
17 |
% |
|
|
1,270 |
|
|
|
18 |
% |
|
|
(84 |
) |
|
|
-7 |
% |
Lansoprazole |
|
|
1,002 |
|
|
|
15 |
% |
|
|
856 |
|
|
|
12 |
% |
|
|
146 |
|
|
|
17 |
% |
Ibuprofen |
|
|
648 |
|
|
|
9 |
% |
|
|
483 |
|
|
|
7 |
% |
|
|
165 |
|
|
|
34 |
% |
Omeprazole |
|
|
499 |
|
|
|
7 |
% |
|
|
551 |
|
|
|
8 |
% |
|
|
(52 |
) |
|
|
-9 |
% |
All other branded products |
|
|
2,188 |
|
|
|
32 |
% |
|
|
2,522 |
|
|
|
36 |
% |
|
|
(334 |
) |
|
|
-13 |
% |
|
|
|
|
|
|
|
Total branded generic sales |
|
$ |
6,904 |
|
|
|
100 |
% |
|
$ |
6,996 |
|
|
|
100 |
% |
|
$ |
(92 |
) |
|
|
-1 |
% |
|
|
|
|
|
|
|
Sales of our branded generic pharmaceutical products decreased by 14% in constant currency
when compared to the three months ended March 31, 2007 due largely to decreased unit volume,
primarily from sales of Mio Relax, Codeisan and Pentoxifilline, and from the effect of the price
reductions established during the first quarter of 2007 in Spain. We experienced a 52% decrease in
sales of Mio Relax, as the Spanish government has mandated the discontinued use of the active
pharmaceutical ingredient found in Mio Relax, Carisoprodol, in all products sold, commencing June 1
2008. We also experienced a 7% decrease in sales of Codeisan, our leading cough product, as a
result of a mild cold, cough and flu season. While we expect to continue to develop, acquire,
launch and support new and existing branded generic products, our growth strategy is focused on
sales of generic products and sales outside of Spain.
26
Generic Pharmaceutical Products
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended March 31, |
|
Change |
(in thousands) |
|
2008 |
|
% |
|
2007 |
|
% |
|
$ |
|
% |
|
|
|
|
|
|
|
Generic Product Sales: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Omeprazole |
|
$ |
5,331 |
|
|
|
43 |
% |
|
$ |
3,870 |
|
|
|
36 |
% |
|
$ |
1,461 |
|
|
|
38 |
% |
Simvastatin |
|
|
1,506 |
|
|
|
12 |
% |
|
|
1,339 |
|
|
|
13 |
% |
|
|
167 |
|
|
|
12 |
% |
Paroxetine |
|
|
816 |
|
|
|
7 |
% |
|
|
897 |
|
|
|
8 |
% |
|
|
(81 |
) |
|
|
-9 |
% |
Trimetazidine |
|
|
633 |
|
|
|
5 |
% |
|
|
729 |
|
|
|
7 |
% |
|
|
(96 |
) |
|
|
-13 |
% |
Pentoxifylline |
|
|
598 |
|
|
|
5 |
% |
|
|
704 |
|
|
|
7 |
% |
|
|
(106 |
) |
|
|
-15 |
% |
All other generic products |
|
|
3,431 |
|
|
|
28 |
% |
|
|
3,140 |
|
|
|
29 |
% |
|
|
291 |
|
|
|
9 |
% |
|
|
|
|
|
|
|
Total generic sales |
|
$ |
12,315 |
|
|
|
100 |
% |
|
$ |
10,679 |
|
|
|
100 |
% |
|
$ |
1,636 |
|
|
|
15 |
% |
|
|
|
|
|
|
|
Sales of our generic pharmaceutical products increased by 1% in constant currency when
compared to the three months ended March 31, 2007. We experienced 14% unit volume increases, which
were offset by price reductions established during the first quarter of 2007 in Spain. We
experienced significant sales increases of omeprazole, which offset the effect of the price
reductions. We expect to continue to increase our generic drug portfolio and increase our generic
drug sales in Spain as products patent protection rights expire in the future.
Sales to Licensees and Others
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended March 31, |
|
Change |
(in thousands) |
|
2008 |
|
2007 |
|
$ |
|
% |
|
|
|
|
|
|
|
|
|
|
|
Specialty generics |
|
$ |
15,867 |
|
|
$ |
10,207 |
|
|
$ |
5,660 |
|
|
|
55 |
% |
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 (and are recorded as net product
sales in the Condensed Consolidated Income Statements).
Sales to licensees and others increased by $5,660,000 or 55% compared to the three months
ended March 31, 2007. The increased sales are due to our increased focus on geographic expansion
and growth. Sales under our license agreements are generally larger order quantities which ship at
less frequent intervals than our net product sales within Spain. As a result, a delay in the timing
of such shipments could have a significant affect on recorded revenues from period to period.
Licensing and Collaboration Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended March 31, |
|
|
Change |
|
(in thousands) |
|
2008 |
|
|
2007 |
|
|
$ |
|
|
% |
|
| |
|
|
| |
|
|
|
| |
|
|
| |
Specialty generics |
|
$ |
199 |
|
|
$ |
114 |
|
|
$ |
85 |
|
|
|
75 |
% |
Drug delivery |
|
|
3,450 |
|
|
|
2,163 |
|
|
|
1,287 |
|
|
|
60 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
3,649 |
|
|
$ |
2,277 |
|
|
$ |
1,372 |
|
|
|
60 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Licensing and collaboration revenues increased by 60% and accounted for 9% of total revenues
for the three months ended March 31, 2008 compared to 7% for the three months ended March 31, 2007.
Our licensing and collaboration revenues are primarily royalties earned from sales of Testim.
These royalties totaled $3,300,000 in the first quarter of 2008 compared to $2,157,000 in the first
quarter of 2007.
27
Gross Profit
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended March 31, |
|
|
Change |
|
(in thousands) |
|
2008 |
|
|
2007 |
|
|
$ |
|
|
% |
|
| |
|
|
| |
|
|
|
| |
|
|
| |
Specialty generics |
|
$ |
16,616 |
|
|
$ |
13,331 |
|
|
$ |
3,285 |
|
|
|
25 |
% |
Drug delivery |
|
|
3,450 |
|
|
|
2,163 |
|
|
|
1,287 |
|
|
|
60 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
20,066 |
|
|
$ |
15,494 |
|
|
$ |
4,572 |
|
|
|
30 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit increased by approximately $4,572,000, or 30% when compared to the three months
ended March 31, 2007, primarily from increased specialty generics sales to licensees and from
Testim royalties reported by our drug delivery business. As a result of increased unit volume,
gross profit reported by our specialty generics business increased by 25% when compared to the same
quarter of the prior year. We estimate that the price reductions in Spain that commenced in 2007
reduced our gross margin on net product sales by 12% in the first quarter of 2008. Gross profit
related to our specialty generics business also includes a $302,000 adjustment to write-down our
U.S. generic inventory to its net realizable value in the three months ended March 31, 2007.
Gross margins on net product sales remained constant at 45% in the
three months ended March 31, 2008 and 2007. We expect our margins to
gradually improve over time as we continue to implement our strategies to mitigate the impact of
the price reductions.
Selling and Marketing Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended March 31, |
|
Change |
(in thousands) |
|
2008 |
|
2007 |
|
$ |
|
% |
| |
|
|
| |
|
|
|
| |
|
|
| |
Specialty generics |
|
$ |
5,763 |
|
|
$ |
4,445 |
|
|
$ |
1,318 |
|
|
|
30 |
% |
Selling and marketing expenses for the three months ended March 31, 2008 increased 13% from
the same period in the prior year when expressed in constant currency primarily as a result of
increased sales commissions in the first quarter of 2008 as compared to the same period in 2007. As
a percentage of net product sales, selling and marketing expenses increased from 15% in the three
months ended March 31, 2007, to 16% in the three months ended March 31, 2008.
General and Administrative Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended March 31, |
|
|
Change |
|
(in thousands) |
|
2008 |
|
|
2007 |
|
|
$ |
|
|
% |
|
| |
|
|
| |
|
|
|
| |
|
|
| |
Specialty generics |
|
$ |
2,686 |
|
|
$ |
2,275 |
|
|
$ |
411 |
|
|
|
18 |
% |
Drug delivery |
|
|
1,527 |
|
|
|
1,302 |
|
|
|
225 |
|
|
|
17 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
4,213 |
|
|
$ |
3,577 |
|
|
$ |
636 |
|
|
|
18 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative expenses increased 18% when compared to the same period in the
prior year. General and administrative expenses in the first quarter of 2007 were reduced by
$215,000 as a result of a change in estimate of drug delivery management bonuses. Increased
general and administrative expenses in our specialty generics business included increased personnel
costs and approximately $313,000 due to fluctuations in foreign currency rates. Total general and
administrative expenses remained constant as a percent of total revenues at approximately 11% in
the three months ended March 31, 2008 and 2007.
28
Research and Development Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended March 31, |
|
|
Change |
|
(in thousands) |
|
2008 |
|
|
2007 |
|
|
$ |
|
|
% |
|
Specialty generics |
|
$ |
692 |
|
|
$ |
481 |
|
|
$ |
211 |
|
|
|
44 |
% |
Drug delivery |
|
|
2,112 |
|
|
|
2,194 |
|
|
|
(82 |
) |
|
|
-4 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
2,804 |
|
|
$ |
2,675 |
|
|
$ |
129 |
|
|
|
5 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development expenses which are primarily related to the continued development of
our intranasal drug candidate, Nasulin, increased by approximately $129,000 compared to the first
quarter of 2007. We plan to increase research and development costs
as we continue to conduct and, following the spin-off, CPEX conducts our
Nasulin clinical trials throughout 2008. Research and development expenses in the first quarter of
2007 were reduced by $251,000 as a result of a change in estimate of drug delivery management
bonuses.
Separation Costs
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change |
|
(in thousands) |
|
2008 |
|
|
2007 |
|
|
$ |
|
|
% |
|
Specialty generics |
|
$ |
1,960 |
|
|
$ |
|
|
|
$ |
1,960 |
|
|
|
* |
|
Drug Delivery |
|
$ |
1,874 |
|
|
|
69 |
|
|
|
1,805 |
|
|
|
* |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
3,834 |
|
|
$ |
69 |
|
|
$ |
3,765 |
|
|
|
* |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As noted above, we have incurred legal, tax and other strategic consulting costs specifically
associated with our planned spin-off of the drug delivery business and our planned merger with Teva
Pharmaceutical Industries Ltd. These costs include the services of lawyers, investment bankers,
accountants, tax and compensation consultants needed to effectively complete the spin-off and
merger activities.
Provision for Income Taxes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended March 31, |
|
|
2008 |
|
2007 |
(in thousands) |
|
Spain |
|
Ireland |
|
U.S. |
|
Consol. |
|
Spain |
|
Ireland |
|
U.S. |
|
Consol. |
|
|
|
|
|
Income (loss) before income taxes
Specialty generics |
|
$ |
6,139 |
|
|
$ |
(6 |
) |
|
$ |
(1,037 |
) |
|
$ |
5,096 |
|
|
$ |
6,468 |
|
|
$ |
(1,098 |
) |
|
$ |
(390 |
) |
|
$ |
4,980 |
|
Drug delivery |
|
|
|
|
|
|
|
|
|
|
(2,090 |
) |
|
|
(2,090 |
) |
|
|
|
|
|
|
(206 |
) |
|
|
(333 |
) |
|
|
(539 |
) |
|
|
|
|
|
Total Income (loss) before income
taxes |
|
|
6,139 |
|
|
|
(6 |
) |
|
|
(3,127 |
) |
|
|
3,006 |
|
|
|
6,468 |
|
|
|
(1,304 |
) |
|
|
(723 |
) |
|
|
4,441 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Provision (benefit) for income taxes |
|
|
1,943 |
|
|
|
(1 |
) |
|
|
(862 |
) |
|
|
1,080 |
|
|
|
2,081 |
|
|
|
(163 |
) |
|
|
(160 |
) |
|
|
1,758 |
|
Valuation allowance |
|
|
|
|
|
|
|
|
|
|
862 |
|
|
|
862 |
|
|
|
|
|
|
|
163 |
|
|
|
160 |
|
|
|
323 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net provision for income taxes |
|
|
1,943 |
|
|
|
(1 |
) |
|
|
|
|
|
|
1,942 |
|
|
|
2,081 |
|
|
|
|
|
|
|
|
|
|
|
2,081 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) |
|
$ |
4,196 |
|
|
$ |
(5 |
) |
|
$ |
(3,127 |
) |
|
$ |
1,064 |
|
|
$ |
4,387 |
|
|
$ |
(1,304 |
) |
|
$ |
(723 |
) |
|
$ |
2,360 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effective tax rate |
|
|
32 |
% |
|
|
17 |
% |
|
|
0 |
% |
|
|
65 |
% |
|
|
32 |
% |
|
|
0 |
% |
|
|
0 |
% |
|
|
47 |
% |
|
|
|
|
|
As a result of reporting taxable income in Spain, we recorded provisions for foreign income
taxes totaling $1,942,000 and $2,081,000 for the three months ended March 31, 2008 and 2007,
respectively. The provisions in both years represented 32% of the pre-tax income reported in Spain
of $6,139,000 and $6,468,000 for the three months ended March 31, 2008 and 2007, respectively. The
provisions represented 65% and 47% of consolidated pre-tax income for the three months ended March
31, 2008 and 2007, respectively.
29
Effective October 2005,
we executed intercompany agreements between Bentley Pharmaceuticals,
Inc. and Bentley Pharmaceuticals Ireland Limited to license non-U.S. rights of certain technologies
owned by Bentley Pharmaceuticals, Inc. and provide for cost-sharing of subsequent development
efforts on those technologies. As a result of these agreements, Bentley Pharmaceuticals Ireland
generated a net loss of approximately $1,304,000 in the three months ended March 31, 2007. No tax
benefits were recorded for these Irish losses as it was not likely that such deferred tax assets
would be realized at that time. Accordingly, the Company established valuation allowances equal to
the full amount of the Irish deferred tax assets for the three months ended March 31, 2007. In late
2007, these agreements were cancelled and all charges from Bentley Pharmaceuticals, Inc. to Bentley
Pharmaceuticals Ireland Ltd in connection with these agreements were subsequently credited and the
valuation allowance previously established for Bentley Pharmaceuticals Ireland was reversed.
Bentley Pharmaceuticals Ireland Limited generated a net loss of $6,000 in the three months ended
March 31, 2008. No valuation allowance has been recorded for Irish tax losses generated in the
first quarter of 2008 as based on the assessment of all evidence available at March 31, 2008
management believes that it is more likely than not that Bentley Pharmaceuticals Ireland Limited
will be able to realize its deferred tax assets in the future.
As future operating profits in the U.S cannot be reasonably assured, no tax benefit has been
recorded for the related losses, which totaled approximately $3,127,000 and $723,000 for the three
months ended March 31, 2008 and 2007, 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 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. We have total
unrecognized tax benefits of $343,000 at March 31, 2008.
Net Income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months |
|
|
|
|
|
|
Ended March 31, |
|
|
Change |
|
(in thousands, except per share data) |
|
2008 |
|
|
2007 |
|
|
$ |
|
|
% |
|
Specialty Generics |
|
$ |
3,154 |
|
|
$ |
3,848 |
|
|
$ |
(694 |
) |
|
|
-18 |
% |
Drug Delivery |
|
|
(2,090 |
) |
|
|
(1,488 |
) |
|
|
(602 |
) |
|
|
-40 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net income |
|
$ |
1,064 |
|
|
$ |
2,360 |
|
|
$ |
(1,296 |
) |
|
|
-55 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income per common share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
0.05 |
|
|
$ |
0.11 |
|
|
$ |
(0.06 |
) |
|
|
-55 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted |
|
$ |
0.05 |
|
|
$ |
0.10 |
|
|
$ |
(0.05 |
) |
|
|
-50 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
22,469 |
|
|
|
22,293 |
|
|
|
176 |
|
|
|
1 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted |
|
|
23,588 |
|
|
|
22,534 |
|
|
|
1,054 |
|
|
|
5 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
We reported income from operations of $2,926,000 in the three months ended March 31, 2008
compared to $4,220,000 in the three months ended March 31, 2007. The combination of income from
operations of $2,926,000 and the non-operating items, primarily the provision for income taxes of
$1,942,000, resulted in net income of $1,064,000, or $0.05 per basic common share ($0.05 per
diluted common share) on 22,469,000 weighted average basic common shares outstanding (23,588,000
weighted average diluted common shares outstanding) in the three months ended March 31, 2008,
compared to net income of $2,360,000, or $0.11 per basic common share ($0.10 per diluted common
share) on 22,293,000 weighted average basic common shares outstanding (22,534,000 weighted average
diluted common shares outstanding) in the same period of the prior year.
LIQUIDITY AND CAPITAL RESOURCES:
Total assets increased from $173,096,000 at December 31, 2007 to $186,498,000 at March 31,
2008, primarily from an increase in accounts receivable, fixed assets and inventory balances.
Stockholders equity increased from $115,972,000 at December 31, 2007 to $124,858,000 at March 31,
2008. The increase in stockholders equity reflects $1,064,000 of net income generated during the
quarter. Total assets and liabilities both reflect the effect of fluctuations in the
Euro/U.S. Dollar exchange rate, which resulted in a net increase of
$6,557,000 to stockholders equity in the first quarter
of 2008.
Cash and cash equivalents decreased by approximately 1% or $427,000 from $33,706,000 at
December 31, 2007 to $33,279,000 at March 31, 2008. Cash flows from operations provided $562,000
(see below), cash flows from investing activities used $2,289,000 (primarily from additions to
fixed assets and drug licenses), and cash flows from financing activities provided cash of $511,000
(primarily related to the
30
exercise of stock options in the period). Cash and cash equivalents at March 31, 2008 include
approximately $10,463,000 of short-term liquid investments considered to be cash equivalents.
Receivables increased by approximately $6,813,000 from $39,324,000 at December 31, 2007 to
$46,137,000 at March 31, 2008. Fluctuations in foreign currency exchange rates increased
receivables by $3,908,000. 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 increased by approximately $1,878,000 from $17,658,000 at December 31, 2007
to $19,536,000 at March 31, 2008. The increase was primarily due to increases in raw materials
needed to meet projected future demand. In addition, fluctuations in foreign currency had the
effect of increasing inventories by approximately $1,324,000.
The combined total of accounts payable and accrued expenses increased from $30,036,000 at
December 31, 2007 to $32,307,000 at March 31, 2008. Fluctuations in foreign currency exchange
rates had the effect of increasing accounts payable and accrued expenses by $1,951,000. The
remaining increase was primarily attributable to separation costs related to the spin-off of the
Companys drug delivery business and merger transaction with Teva Pharmaceuticals.
Short-term borrowings increased $70,000 in the first quarter of 2008 due to additional
borrowings on the Companys credit lines. Current portion of long-term debt increased from $608,000
at December 31, 2007 to $1,304,000 at March 31, 2008. At December 31, 2007, only the first debt
payment due in December 2008 was classified as current whereas at March 31, 2008, two debt payments
were classified as current.
Other liabilities totaled $3,851,000 at March 31, 2008, of which $1,206,000 was classified as
current on the Unaudited Consolidated Balance Sheet. Other liabilities totaled $3,607,000 at
December 31, 2007, of which $1,137,000 was classified as current on the Unaudited Consolidated
Balance Sheet. Other liabilities primarily consist of the liability resulting from the settlement
of litigation in 2006. At March 31, 2008, the net present value of the remaining settlement
liability was $2,785,000, of which $1,000,000 was classified as current.
Operating activities for the three months ended March 31, 2008 provided net cash of $562,000,
which is a decrease of $7,306,000 when compared to the three months ended March 31, 2007. This
change primarily results from the timing of receivables ($3,819,000), the timing of accounts
payable and accrued expenses ($2,355,000) and a decrease in net income of $1,296,000.
Investing activities for the three months ended March 31, 2008 used net cash of $2,289,000 for
additions to fixed assets ($1,628,000) and additions to drug licenses and related costs ($661,000).
In the first quarter of 2007, investing activities provided net cash of $192,000 as a result of
proceeds from the maturity of investments which offset additions to fixed assets and drug licenses
and related costs.
Financing activities during the three months ended March 31, 2008 provided net cash of
$511,000 primarily from the proceeds from the exercise of stock options. Financing activities for
the three months ended March 31, 2007 used net cash of $554,000 for the repayment of short-term
borrowings and long-term debt.
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 $17,380,000 at March 31, 2008). In accordance with the loan agreement, Belmac
is 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 March 31, 2008 was 5.2%. The principal
of the loan will be repaid in quarterly installments of 412,500 Euros (approximately $652,000)
beginning December 31, 2008, with the balance due on December 31, 2013.
31
Long-term debt,
including current portion of long-term debt, totaled $17,380,000 at March 31, 2008
compared to $16,203,000 at December 31, 2007. The increase was attributable to fluctuations in
foreign currency exchange rates. Due to the timing of the repayment stream, the current portion of
long-term debt at March 31, 2008 includes two scheduled payments whereas the balance at December
31, 2007 includes only one payment.
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.
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 affected our net product sales or income from operations for the periods presented.
Liquidity. We plan to continue making improvements to our manufacturing facilities
during 2008 that include the acquisition of additional manufacturing equipment and expansion of our
active pharmaceutical ingredients manufacturing facility, in order to accommodate our expected
growth. We plan to invest $11,000,000 to $13,000,000 in 2008, of which $1,628,000 has been invested
in the three months ended March 31, 2008. We plan to finance these expenditures from a combination
of cash flows from operations, existing cash balances and borrowings, if required. We also plan to
continue our investments in research and development projects, primarily Nasulin, our intranasal
insulin product candidate. The Company also has three remaining payment obligations of $1,000,000
to be paid in each of 2008, 2009 and 2010 in connection with the settlement of litigation in 2006.
As discussed above, we have cash and cash equivalents totaling approximately $33,279,000 as of
March 31, 2008, which we believe is sufficient to fund our operations for the foreseeable future.
Although the Company is generating positive cash flow from operations, (approximately $562,000 in
the three months ended March 31, 2008), there can be no assurance that changes in our research and
development plans, capital expenditures and/or acquisitions, or other events affecting our
operations will not result in the earlier depletion of our funds. We continue to search both
domestically and internationally for opportunities that will enable us to continue expanding our
business and explore alternative financing sources for these activities, including the possibility
of public and/or private offerings of debt and equity securities. In appropriate situations, we may
seek financial assistance from other sources, including contribution by others to joint ventures
and other collaborative or licensing arrangements for the development, testing, manufacturing and
marketing of products under development.
Critical Accounting Policies and Estimates
Our significant accounting policies are more fully described in Note 2 to our consolidated
financial statements in our 2007 Form 10-K. Certain of our accounting policies are particularly
important to the
32
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 estimates discussed in our 2007
Form 10-K and have determined that those policies remain our most critical accounting policies for
the quarter ended March 31, 2008. We did not make any changes to those policies during the quarter
ended March 31, 2008.
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, anticipate, intend, believe, will, may, could, should,
project, estimate, continue, opportunity, future, and similar expressions.
The forward-looking statements include statements about our:
|
|
|
Strategic plans; |
|
|
|
|
Sales growth; |
|
|
|
|
Anticipated sources of future revenues; |
|
|
|
|
Anticipated 2008 expenses, margins and operating performance; |
|
|
|
|
Plans for spinning-off the drug delivery business from the specialty generics
business; |
|
|
|
|
Prospects for selling the specialty generics business pursuant to an agreement
and plan of merger with Teva Pharmaceutical Industries Ltd.; |
|
|
|
|
Expected launch of new products; |
|
|
|
|
Anticipated expenses and spending; |
|
|
|
|
Planned and continuing clinical trials; |
|
|
|
|
Anticipated regulatory changes and approvals; and |
|
|
|
|
The sufficiency of capital resources to fund our operations. |
These forward-looking statements are based on our current expectations, beliefs, assumptions,
estimates, forecasts and projections for our business and the industry and markets in which we
compete. These statements are not guarantees of future performance and involve certain risks,
uncertainties and assumptions that are difficult to predict. Therefore, actual outcomes and results
may differ materially from what is expressed in such forward-looking statements. We caution
investors not to place undue reliance on the forward-looking statements contained in this report.
These statements speak only as of the date of this report, and we do not undertake any obligation
to update or revise them, except as required by law. We refer you to our description of the risk
factors related to our business, which are contained in the section entitled Risk Factors in our
2007 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.
Important Information
In connection with the merger with Teva, Bentley filed a preliminary proxy statement for its
stockholders with the Securities and Exchange Commission (the SEC). The proxy statement contains
information about Bentley, the merger with Teva and related matters. STOCKHOLDERS ARE URGED TO
READ THE DEFINITIVE PROXY STATEMENT CAREFULLY WHEN IT IS AVAILABLE, AS IT WILL CONTAIN IMPORTANT
INFORMATION THAT STOCKHOLDERS SHOULD CONSIDER BEFORE MAKING A DECISION ABOUT THE TRANSACTION. In
addition to receiving the proxy statement from Bentley by mail, stockholders will be able to obtain
the proxy statement, as well as other filings containing
33
information about Bentley, without charge,
from the SECs website at www.sec.gov or, without charge, from Bentleys website at
www.bentleypharm.com or by directing such request to Bentley Pharmaceuticals, Inc., Bentley Park, 2
Holland Way, Exeter, NH 03833, Attention: Richard Lindsay, Chief Financial Officer.
Bentley and its directors and executive officers and other persons may be deemed to be
participants in the solicitation of proxies in respect of the merger with Teva. Information
regarding Bentleys directors and executive officers is available in Bentleys 2007 Annual Report
on Form 10-K and Amendment No. 1 to the 2007 Annual Report on Form 10-K/A, which were filed with
the SEC on March 17, 2008 and April 29, 2008, respectively. Other information regarding the
participants in the proxy solicitation and a description of their direct and indirect interests, by
security holdings or otherwise, will be contained in the proxy statement and other relevant
materials to be filed with the SEC when they become available.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Foreign Currency. A substantial amount of our business is conducted in Europe and is
therefore influenced to the extent to which there are fluctuations in the U.S. Dollars value
against other currencies, specifically the Euro. Assets and liabilities of each foreign subsidiary
are translated at the rate of exchange in effect at the end of the period. Revenues and expenses
are translated at the average exchange rate for the period. Exchange rates for the periods ending
and ended March 31, 2008, December 31, 2007 and March 31, 2007 are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. Dollars per Euro |
|
March 31, 2008 |
|
December 31, 2007 |
|
March 31, 2007 |
YTD weighted average exchange rate |
|
|
1.50 |
|
|
|
1.37 |
|
|
|
1.31 |
|
Exchange rate |
|
|
1.58 |
|
|
|
1.47 |
|
|
|
1.33 |
|
After we concluded our settlement of intellectual property litigation in 2006, we entered into
forward contracts designed to reduce the effect of fluctuations in foreign currency on the
litigation settlement payments scheduled to be made annually through 2010. These contracts are
subject to foreign currency risk. Additionally, we have short-term foreign currency denominated
debt. We applied a sensitivity analysis to reflect the impact that a 10% hypothetical change in the
foreign currency rates would have on the value of our forward contracts and foreign currency
denominated debt.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Favorable (Unfavorable) |
|
|
|
|
Assuming a |
|
Assuming a |
|
|
|
|
10% Increase |
|
10% Decrease |
|
|
Financial instrument: |
|
in FX Rates |
|
in FX Rates |
|
Impact on |
|
|
|
Forward contracts (Euro) |
|
$ |
(265,912 |
) |
|
$ |
318,393 |
|
|
Fair value |
Foreign currency denominated debt |
|
$ |
(1,738,000 |
) |
|
$ |
1,738,000 |
|
|
Fair value |
There are many economic factors that can affect volatility in foreign exchange rates. As such
factors cannot be predicted, the actual impact on earnings due to a change in the respective rates
could vary substantially from the amounts calculated above.
The net effect of foreign currency translation on our Unaudited Consolidated Balance Sheet for
the three months ended March 31, 2008 was an increase of $6,557,000 and the cumulative historical
effect was an increase of $25,549,000, as reflected in our Unaudited Consolidated Balance Sheet as
accumulated other comprehensive income. The carrying values of assets and liabilities can be
materially affected by foreign currency translation, as can the translated amounts of revenues and
expenses. Nonetheless, we do not plan to modify our business practices.
34
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. However, at the present time, we do not anticipate altering our business plans and practices
to compensate for future currency fluctuations.
Interest Rates. The interest rate on our long-term debt of $16,076,000 at March 31, 2008
was 5.2%. The interest rate on our long-term debt is variable and resets quarterly. The effect of
an increase in interest rates of one percentage point (one hundred basis points) to an average of
6.2% on our long-term debt would have the effect of increasing interest expense by approximately
$161,000 annually; however, no payments are due under the loan agreement until December 31, 2008.
The weighted average interest rate on our short-term borrowings and current portion of long term
debt totaling $1,490,000 at March 31, 2008 was 5.9%. The effect of an increase in the interest rate
of one percentage point (one hundred basis points) to 6.9% on our short-term borrowings and current
portion of long term debt would have the effect of increasing interest expense by approximately
$15,000 annually.
Item 4. Controls and Procedures
Evaluation of Disclosure 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 March 31, 2008.
Remediation of Material Weakness
In our 2007 Form 10-K, management reported their conclusion that the controls over the
consolidation process for one of Bentleys subsidiaries were not effective as of December 31, 2007,
and identified the following deficiency in our internal control over financial reporting as a
material weakness in our internal control over financial reporting as of December 31, 2007:
inadequate design of our controls related to our ability to apply generally accepted
accounting principles as they relate to identifying, reconciling, and appropriately
eliminating intercompany balances for one of our subsidiaries.
During the three months ended March 31, 2008, Bentley remediated the material weakness noted
above by implementing the following measures:
|
|
|
Bentley provided additional training to finance and accounting personnel regarding
the identification, reconciliation and appropriate eliminations of intercompany
balances. |
35
|
|
|
Bentley implemented a process that ensures the timely review and approval of
intercompany accounting transactions by qualified accounting personnel. |
Changes in Internal Control over Financial Reporting
Other than the foregoing measures, which were fully implemented as of March 31, 2008, 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 March 31, 2008 that has materially
affected, or is reasonably likely to materially affect, Bentleys internal control over financial
reporting.
PART II. OTHER INFORMATION
Item 1. Legal Proceedings
In the October 2007 action commenced against our subsidiaries, Laboratorios Belmac, S.A.,
Laboratorios Davur, S.L. and Laboratorios Rimafar, S.L. by Wyeth, the 4th Commercial Court of the
City of Madrid recently granted an ex parte interim injunction against all the defendants requiring
them not to manufacture or launch their venlaflaxine products. Belmac, Davur and Rimafar have
contested the case vigorously. There was a hearing on the interim injunction on April 4, 2008, and
a decision is pending as to whether the interim injunction will be confirmed or lifted.
In the December 2004 proceeding initiated by our subsidiary, Laboratorios Belmac, S.A.,
jointly with three other Spanish manufacturers, against Warner-Lambert Company requesting the
partial revocation in Spain of European patent EP 409.281 concerning atorvastatin calcium, the
trial court had ruled in favor of Belmac in a decision rendered on September 26, 2006. On appeal,
the Barcelona Court of Appeal in March 2008 has overturned the lower court decision and declared
the patent to be valid, but the same court has also rejected the infringement counterclaims filed
by Warner-Lambert Company. Both parties have announced they intend to appeal portions of the Court
of Appeals decision to the Spanish Supreme Court.
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.
36
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.
|
|
|
|
|
|
|
BENTLEY PHARMACEUTICALS, INC.
Registrant
|
|
|
|
|
|
|
|
|
|
|
May 12, 2008 |
By: |
/s/ James R. Murphy
|
|
|
|
James R. Murphy |
|
|
|
Chairman of the Board of Directors
and Chief Executive Officer
(Principal Executive Officer) |
|
|
|
|
|
May 12, 2008 |
By: |
/s/ Richard P. Lindsay
|
|
|
|
Richard P. Lindsay |
|
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|
Vice President, Chief Financial Officer,
Secretary and Treasurer
(Principal Financial Officer) |
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Exhibit Index
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Exhibit |
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Number |
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Description of Exhibit |
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31.1
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*
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Certification of the Chief Executive Officer pursuant to Section
302 of the Sarbanes-Oxley Act of 2002. |
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31.2
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*
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Certification of the Chief Financial Officer pursuant to Section
302 of the Sarbanes-Oxley Act of 2002. |
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32.1
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*
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Certification of the Chief Executive Officer pursuant to 18 U.S.C.
Section 1350 as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002. |
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32.2
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*
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Certification of the Chief Financial Officer pursuant to 18 U.S.C.
Section 1350 as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002. |