UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C.  20549

FORM 10-Q

Commission File Number  1-10581

BENTLEY PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

Bentley Park, 2 Holland Way, Exeter, New Hampshire  03833

(Current Address of Principal Executive Offices)

Registrant’s 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 ý       NO o

Indicate by check mark whether the registrant is an accelerated filer (as defined in rule 12b-2 of the Exchange Act).  YES ý     NO o

The number of shares of the registrant’s common stock outstanding as of November 4, 2004 was 21,307,195.

BENTLEY PHARMACEUTICALS, INC. AND SUBSIDIARIES

FORM 10-Q FOR THE QUARTER ENDED SEPTEMBER 30, 2004

INDEX

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BENTLEY  PHARMACEUTICALS, INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

The accompanying Notes to Condensed Consolidated Financial Statements are an integral part of these financial statements.

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BENTLEY PHARMACEUTICALS, INC. AND SUBSIDIARIES

CONSOLIDATED INCOME STATEMENTS

AND STATEMENTS OF COMPREHENSIVE INCOME

The accompanying Notes to Condensed Consolidated Financial Statements are an integral part of these financial statements.

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BENTLEY PHARMACEUTICALS, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS’ EQUITY

The accompanying Notes to Condensed Consolidated Financial Statements are an integral part of these financial statements.

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BENTLEY PHARMACEUTICALS, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF CASH FLOWS

(Continued on following page)

The accompanying Notes to Condensed Consolidated Financial Statements are an integral part of these financial statements.

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BENTLEY PHARMACEUTICALS, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF CASH FLOWS (concluded)

The accompanying Notes to Condensed Consolidated Financial Statements are an integral part of these financial statements.

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BENTLEY PHARMACEUTICALS, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

HISTORY AND OPERATIONS:

Bentley Pharmaceuticals, Inc. and Subsidiaries (which may be referred to as Bentley Pharmaceuticals, Bentley, the Company, we, us or our) is a U.S.-based international specialty pharmaceutical company, incorporated in the State of Delaware, focused on:

•                 research, development and licensing/commercialization of advanced drug delivery technologies and pharmaceutical products; and

•                 development, licensing and sales of generic and branded pharmaceutical products and the manufacturing of pharmaceuticals for others.

In our research and development activities, we have U.S. and international patents and other proprietary rights to technologies that facilitate the absorption of drugs. Our pharmaceutical product sales and licensing activities are based in Spain, where we have a significant commercial presence and manufacture and market approximately 100 pharmaceutical products through three wholly-owned Spanish subsidiaries, Laboratorios Belmac, Laboratorios Davur and Laboratorios Rimafar. These products represent various dosage strengths and product formulations of more than 30 chemical entities in four primary therapeutic areas: cardiovascular, gastrointestinal, neurological and infectious diseases. We continually add to our product portfolio in response to increasing market demand for generic and branded therapeutic agents and divest portfolio products that we consider to be redundant or that have become non-strategic. Although most of our sales of these products are currently in the Spanish market, we have recently focused on increasing our sales in other European countries and other geographic regions through strategic alliances with companies in these territories. In April of 2004, we purchased a manufacturing facility located in Spain that specializes in the manufacture of several active pharmaceutical ingredients (API), of which, one ingredient has been approved by the U.S. Food and Drug Administration for marketing and sale in the U.S. We are manufacturing and marketing these products through our newly formed subsidiary, Bentley API. Additionally, we have a strategic alliance with Teva Pharmaceutical Industries Ltd. granting us the right to register and market several of Teva’s pharmaceutical products in Spain through our sales force of approximately 150 full-time personnel located in major cities throughout Spain. In addition, our Spanish manufacturing facility produces pharmaceutical products that are marketed by pharmaceutical companies both in Spain and in other markets. We have also recently entered into a multi-product collaboration agreement with Perrigo Company, the nation’s largest manufacturer of over-the-counter pharmaceutical and nutritional products for the store brand market, to co-develop and market certain generic pharmaceutical products in the U.S. and potentially other markets.

We are developing products that incorporate our drug delivery technologies and have licensed applications of our proprietary CPE-215® drug delivery technology to Auxilium Pharmaceuticals, Inc., which launched Testim™, the first product incorporating our drug delivery technology, in February 2003. Testim is a gel indicated for testosterone replacement therapy, which restores serum testosterone levels in men and thereby improves symptoms of health problems associated with low testosterone levels (hypogonadism), including loss of muscle mass and a decrease in sexual desire, sexual motivation and frequency of spontaneous erections. 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

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delivery technologies, including product candidates that deliver insulin to diabetic patients intranasally and treat nail fungus infections topically.

The Company’s Common Stock began trading on the New York Stock Exchange (NYSE) on May 12, 2004, under the trade symbol BNT. Prior thereto, the Company’s stock was traded on the American Stock Exchange.

BASIS OF CONDENSED CONSOLIDATED FINANCIAL STATEMENTS:

The consolidated financial statements of Bentley Pharmaceuticals as of September 30, 2004 and for the three and nine months ended September 30, 2004 and 2003, included herein, have been prepared by us, 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 our consolidated financial statements for the year ended December 31, 2003. These condensed consolidated financial statements should be read in conjunction with the summary of significant accounting policies and the audited consolidated financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2003.

In the opinion of management, the accompanying unaudited condensed consolidated financial statements as of September 30, 2004 and for the three and nine months ended September 30, 2004 and 2003 are presented on a basis consistent with the audited consolidated financial statements for the year ended December 31, 2003 and contain all adjustments, consisting only of normal recurring adjustments, necessary to present fairly Bentley’s financial position as of September 30, 2004 and the results of its operations and cash flows for the three and nine months ended September 30, 2004 and 2003. The results of operations for the three and nine months ended September 30, 2004 should not necessarily be considered indicative of the results to be expected for the full year ending December 31, 2004.

CASH AND CASH EQUIVALENTS AND RESTRICTED CASH:

Included in cash and cash equivalents at September 30, 2004 and December 31, 2003 are approximately $2,897,000 and $29,156,000, respectively, of short-term investments considered to be cash equivalents, as the remaining maturity dates of such investments were three months or less when purchased.

The Company acquired intellectual property during the year ended December 31, 2003 for $1,000,000 plus future royalties on sales and licensing income. In connection with the acquisition, the Company obtained a renewable, irrevocable letter of credit in the amount of $1,000,000 in favor of the seller to guarantee future royalty payments. This irrevocable letter of credit was renewed in June of 2004 for a one year period. The $1,000,000 used to secure the letter of credit has been classified as restricted cash in the Consolidated Balance Sheets as of September 30, 2004 and December 31, 2003.

MARKETABLE SECURITIES:

The Company has investments in securities, with maturities of greater than three months when purchased, which are classified as available-for-sale, totaling $476,000 as of September 30, 2004, compared to $1,252,000 as of December 31, 2003. The Company’s investments are carried at amortized cost which approximates fair value due to the short-term nature of these investments.

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Accordingly, no unrealized gains or losses have been recognized on these investments. Should the fair values differ significantly from the amortized costs, unrealized gains or losses would be included as a component of other comprehensive income (loss).

INVENTORIES:

Inventories are stated at the lower of cost or market, cost being determined on the first in, first out (“FIFO”) method, and are comprised of the following (in thousands):

FIXED ASSETS:

Fixed assets consist of the following (in thousands):

In April of 2004, we purchased a Spanish manufacturing facility and related machinery and equipment, used to manufacture active pharmaceutical ingredients, for approximately $3,309,000. We are manufacturing and marketing some of these products through our newly formed subsidiary, Bentley API. The 20,000 square foot facility is currently FDA approved for one product, which it sells to several customers, including customers in the United States.

In order to support the Company’s growth in Europe, we are increasing capacity at our finished pharmaceutical product manufacturing facility through a series of improvements. During the nine months ended September 30, 2004, the Company invested over $6,000,000 in machinery, equipment and improvements, including new high speed manufacturing and packaging equipment.

Depreciation expense of approximately $516,000 and $256,000 has been charged to operations as a component of depreciation and amortization expense in the Consolidated Income Statements for the nine months ended September 30, 2004 and 2003, respectively. We have included depreciation totaling approximately $1,488,000 and $741,000 in cost of net product sales during the three months ended September 30, 2004 and 2003, respectively.

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STOCKHOLDERS’ EQUITY:

A substantial amount of our business is conducted in Europe and is therefore influenced by fluctuations in the U.S. Dollar’s value against other currencies, principally the Euro. The exchange rates at September 30, 2004 and December 31, 2003 were .81 Euros and .80 Euros per U.S. Dollar, respectively. The weighted average exchange rates for the three months ended September 30, 2004 and 2003 were .82 Euros and .89 Euros per U.S. Dollar, respectively. The weighted average exchange rates for the nine months ended September 30, 2004 and 2003 were .82 Euros and .90 Euros per U.S. Dollar, respectively. The effect of foreign currency fluctuations on long lived assets for the nine months ended September 30, 2004 was a decrease of $643,000 and the cumulative historical effect was an increase of $4,526,000, as reflected in our Consolidated Balance Sheets as accumulated other comprehensive income. Although exchange rates fluctuated significantly in recent years, we do not believe that the effect of foreign currency fluctuation is material to our results of operations as the expenses related to much of our foreign currency revenues are in the same functional currency, the Euro, as those revenues. However, the carrying value of assets and liabilities can be materially impacted by foreign currency translation, as can the translated amounts of revenues and expenses.

During the nine months ended September 30, 2004, we received proceeds totaling $600,000 from the issuance of 400,000 shares of Common Stock upon exercise of common stock warrants and an additional $2,461,000 from the issuance of 319,000 shares of Common Stock upon the exercise of stock options. We also issued approximately 12,000 shares of Common Stock as equity-based compensation in lieu of cash contributions to the Company-sponsored 401(k) retirement savings plan. Additionally, we granted to our employees and directors stock options to purchase approximately 542,000 shares of Common Stock during the nine months ended September 30, 2004.

LICENSING AND COLLABORATION REVENUES:

Our licensee, Auxilium Pharmaceuticals, Inc., launched its testosterone replacement gel, Testim, which utilizes our patented CPE-215 drug delivery technology, during the first quarter of 2003. Auxilium paid a $500,000 milestone payment to us during the first quarter of 2003, which we recorded as licensing and collaboration revenues in the Consolidated Income Statement for the three months ended March 31, 2003. In connection with the Testim product launch, we began earning royalty revenues on a percentage of Testim sales as defined in the licensing agreement with Auxilium. Royalty revenues on Testim product sales are recognized based on an estimate of Auxilium’s sell-through of the Testim product based on prescriptions filled, until such time that returns from wholesalers and pharmacies can be reasonably estimated. At that time, we expect to record a one-time increase in licensing and collaboration revenues related to the recognition of previously deferred revenue. For the three and nine months ended September 30, 2004, we recognized royalty revenues of approximately $800,000 and $2,000,000, respectively, compared to $335,000 and $543,000 in the three and nine months ended September 30, 2003, respectively. The difference between the total amount earned from Auxilium under the royalty arrangement and the amount recognized as a component of licensing and collaboration revenues is recorded as a component of deferred income in the Consolidated Balance Sheets. As of September 30, 2004 and December 31, 2003, deferred income from Testim royalties was approximately $1,240,000 and $634,000, respectively. We will continue to use available market information to determine the amount and timing of royalty revenue recognition until such time that returns from wholesalers and pharmacies can be reasonably estimated.

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OTHER INCOME (EXPENSES):

In addition to interest income on our investment and cash balances and interest expense on our debt obligations, other income (expenses) for the three and nine months ended September 30, 2004 includes the reversal of previously accrued tax assessments, as well as interest and penalties associated with the settlement of the tax audit of our Spanish subsidiary’s tax years 1998 - 2000 (see Provision for Income Taxes footnote below). We recorded a pre-tax benefit totaling $1,467,000 ($954,000 after taxes) as a component of other income (expenses) as the result of the reversal of previously accrued pharmaceutical tax assessments in Spain. These assessments had been accrued to be paid to the Spanish government as a vehicle to help reduce the impact of the rising health care costs in Spain. Due to recent changes in the pharmaceutical industry in Spain and a change in the Spanish political environment, these liabilities no longer exist. Accordingly, these accruals were reversed during the quarter ended June 30, 2004.

PROVISION FOR INCOME TAXES:

A tax review of our Spanish subsidiary, Laboratorios Belmac S.A., by the Spanish tax authorities for the tax years 1998, 1999 and 2000, which had commenced over a year ago, was completed in the second quarter of 2004. As a result of this audit, our subsidiary has been assessed an additional tax liability of approximately $604,000, which has been recorded as a component of provision for income taxes for the three months ended June 30, 2004 and the nine months ended September 30, 2004, and approximately $193,000 for related interest and penalties, which have been recorded as components of other income (expenses), in the consolidated income statements for the three months ended June 30, 2004 and the nine months ended September 30, 2004.

As a result of reporting taxable income in Spain, we recorded provisions for foreign income taxes totaling $1,344,000 and $1,513,000 for the three months ended September 30, 2004 and 2003, respectively. The effective tax rate for the three months ended September 30, 2004 is 49% compared to 53% in the prior year third quarter. We have recorded provisions for foreign income taxes totaling $4,706,000 ($4,102,000 income tax expense on operations plus $604,000 recorded as a result of the tax audit of our Spanish subsidiary in the second quarter of 2004) and $4,469,000 for the nine months ended September 30, 2004 and 2003, respectively. The effective tax rate in Spain for the nine months ended September 30, 2004 is 56%; however, when the $604,000 tax audit settlement related to prior years is excluded, the effective tax rate is 49% compared to 50% in the comparable nine month period of the prior year.

As future domestic operating profits cannot be reasonably assured, no tax benefit has been recorded for U.S. losses, which totaled $896,000 and $958,000 for the three months ended September 30, 2004 and 2003, respectively, and $2,378,000 and $2,423,000 for the nine months ended September 30, 2004 and 2003, respectively. Accordingly, we have established a valuation allowance equal to the full amount of the U.S. deferred tax assets. The provisions for income taxes differ from the amounts computed by applying the U.S. federal income tax rate of 34% to pre-tax income, primarily as a result of the increase in the valuation allowance to offset U.S. deferred tax assets, certain nondeductible expenses in Spain and the higher statutory income tax rate of 35% in Spain.

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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. During the second quarter of 2004, we identified certain tax contingencies that we determined were probable and reasonably estimable. Consequently, we have included a charge totaling $188,000 in the provision for income taxes in the second quarter of 2004 related to these contingencies. No other potential tax contingencies were considered probable or reasonably estimable by the Company at period end. However, there is the possibility that the ultimate resolution of such potential contingencies could have an adverse effect on our results of operations.

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. The dilutive effect of our outstanding stock options and stock purchase warrants, as calculated using the treasury stock method, were considered in the net income per share calculations for the three and nine months ended September 30, 2004 and 2003.

The following is a reconciliation between basic and diluted net income per common share for the three and nine months ended September 30, 2004 and 2003. Dilutive securities issuable for the three and nine months ended September 30, 2004 include approximately 1,697,000 and 2,008,000 shares, respectively, issuable as a result of various stock options and warrants that are outstanding and exercisable.  Dilutive securities issuable for the three and nine months ended September 30, 2003 include approximately 4,317,000 and 3,686,000 shares, respectively, issuable as a result of exercisable Class B Warrants, stock purchase warrants and stock options that were outstanding and exercisable at that time.

(in thousands, except per share data)

For the Three Months Ended September 30, 2004:

For the Three Months Ended September 30, 2003:

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For the Nine Months Ended September 30, 2004:

For the Nine Months Ended September 30, 2003:

Excluded from the diluted EPS presentation, because their exercise prices were greater than the average fair value of the Common Stock in the respective periods, were options and warrants to purchase an aggregate of approximately 740,000 and 583,000 shares of Common Stock, for the three and nine months ended September 30, 2004, respectively, and options and warrants to purchase an aggregate of 185,000 and 347,000 shares of Common Stock, for the three and nine months ended September 30, 2003, respectively.

STOCK BASED COMPENSATION:

We have stock-based employee compensation plans that are described more fully in Note 11 of the Notes to Consolidated Financial Statements included in the Annual Report on Form 10-K for the year ended December 31, 2003. We account for these plans under the recognition and measurement principles of Accounting Principles Board (“APB”) Opinion No. 25, Accounting for Stock Issued to Employees, and related Interpretations. Options granted under these plans have exercise prices equal to or greater than the market value of the underlying Common Stock on the dates of grant, which is generally the date on which compensation is measured. In addition to these plans, we also sponsor a 401 (k) retirement savings plan for eligible employees and match eligible contributions with shares of the Company’s Common Stock. From time to time, at the discretion of the Compensation Committee of the Board of Directors, the Company grants shares of its Common Stock to employees in lieu of cash compensation. Related stock-based employee compensation costs are reflected in the Consolidated Income Statements and Statements of Cash Flows.

General and administrative expenses for the three and nine months ended September 30, 2004 include $14,000 and $61,000, respectively, of non-cash equity-based compensation. General and administrative expenses for the three and nine months ended September 30, 2003 include $75,000 and $177,000, respectively, of non-cash equity-based compensation. Research and development expenses for the three and nine months ended September 30, 2004 include $24,000 and $106,000, respectively, of non-cash equity-based compensation. Research and development expenses for the three and nine months ended September 30, 2003 include $65,000 and $200,000, respectively, of non-cash equity-based compensation.

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The following table illustrates the effect on net income per share if we had applied the fair value recognition provisions of Statement of Financial Accounting Standards (“SFAS”) No. 123, Accounting for Stock-Based Compensation, to stock-based employee compensation.

The preceding pro forma results were calculated using the Black-Scholes option pricing model with the following weighted average assumptions (results may vary depending on the assumptions applied within the model):

Stock or other equity-based compensation for non-employees is accounted for under the fair value method as required by SFAS No. 123 and Emerging Issues Task Force (“E1TF”) issue No. 96-18, Accounting for Equity Instruments That Are Issued to Other Than Employees for Acquiring, or in Conjunction with Selling, Goods or Services and other related interpretations.

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RECLASSIFICAT1ONS:

Certain prior period amounts have been reclassified to conform with the current period’s presentation. Such reclassifications are not material to the Consolidated Financial Statements.

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Item 2.   Management’s Discussion and Analysis of Financial Condition and Results of Operations

The following discussion and analysis should be read 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 Annual Report on Form 10-K for the year ended December 31, 2003, which has been previously filed with the Securities and Exchange Commission. In addition to historical information, the following discussion and other parts of this report contain forward-looking information that involves risks and uncertainties. Our actual results could differ materially from those anticipated by such forward-looking information due to competitive factors and other risks discussed below under the caption “Important Factors That May Affect Future Results”.

RESULTS OF OPERATTONS:

Three Months Ended September 30, 2004 versus Three Months Ended September 30, 2003

Revenues

Total revenues for the three months ended September 30, 2004 increased 22% from the same period in the prior year. However, our total revenues increased approximately 12% when expressed in constant currency. An increase in the weighted average value of the Euro, in relation to the U.S. Dollar, had the effect of increasing revenues by approximately $1,378,000, partially offsetting the impact of price reductions in Spain.  Price reductions were mandated for certain pharmaceutical products by the Spanish government in late 2003, which we put into effect on December 1, 2003. Over the past nine months, we have implemented several initiatives to reduce our production costs and increase our margins on several of our products affected by the price reductions. Additionally, through strategic pricing, we have been able to increase our market share on these and other products. The advancement of our proprietary drug delivery programs in the U.S., as evidenced by the growing royalty stream from sales of Testim, the first marketed product incorporating our CPE-215 drug delivery technology, have increased our revenues by approximately $456,000 in the three months ended September 30, 2004 over the same period in the prior year.

Our revenues are generated through our live primary sales channels: branded pharmaceuticals, generic pharmaceuticals, contract manufacturing for other pharmaceutical companies, sales outside of Spain and licensing and collaborations. Set forth below is a summary of our revenues by sales channel and top-selling product lines:

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For the three months ended September 30, 2004 (in thousands):