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Bentley Pharmaceuticals Reports Second Quarter Results.


Revenues Increase 8% Amid Spanish Price Reductions

Company moves closer to extending patent protection on Testim[R]

EXETER, N.H. -- Bentley Pharmaceuticals, Inc. (NYSE NYSE

See: New York Stock Exchange
: BNT BNT Bentley Pharmaceuticals, Inc. (stock symbol)
BNT Boston Naming Test (psychology)
BNT Bermuda National Trust
BNT Bulgarian National TV
BNT Broadband Network Termination
BNT Binary File Transfer
), a specialty pharmaceutical company, today reported financial results for the three and six months ended June 30, 2007.

Bentley's consolidated revenues increased 8% to $31.2 million from $29.0 million reported in the second quarter of 2006. Bentley's results in the second quarter of 2007 reflect the impact of a full quarter of reduced selling prices on the Company's Spanish pharmaceutical products. Price reductions were implemented by the Spanish government
  • Chief of State
  • King Juan Carlos I, since November 22 1975
  • Head of Government
  • President of the Government: José Luis Rodríguez Zapatero, elected 14 March 2004.
 on March 1, 2007. Increased unit volume has offset the impact of the price reductions on revenues. Revenues remained consistent with the comparable quarter of the prior year when expressed in constant currency.

Gross margins on net product sales decreased to 44% in the second quarter of 2007 compared to 53% in the second quarter of 2006. The decrease reflects the impact of price reductions as well as a $0.1 million increase in the inventory obsolescence ob·so·les·cent  
adj.
1. Being in the process of passing out of use or usefulness; becoming obsolete.

2. Biology Gradually disappearing; imperfectly or only slightly developed.
 reserve related to U.S. simvastatin simvastatin /sim·va·stat·in/ (sim´vah-stat?in) an antihyperlipidemic agent that acts by inhibiting cholesterol synthesis, used in the treatment of hypercholesterolemia and other forms of dyslipidemia and to lower the risks associated  inventories. Bentley's licensing and collaboration revenues increased $0.3 million in the second quarter of 2007 due to increased royalties on sales of Testim[R]. Operating expenses Operating expenses

The amount paid for asset maintenance or the cost of doing business, excluding depreciation. Earnings are distributed after operating expenses are deducted.
 increased 16% to $13.4 million in the second quarter of 2007 compared to the same period of the prior year. Included in the operating expenses were increased research and development investments of approximately $1.0 million primarily related to Nasulin[TM], Bentley's intranasal in·tra·na·sal
adj.
Within the nose.
 insulin product candidate. The combination of reduced gross profit and increased operating expenses resulted in net income of $0.7 million or $0.03 per diluted share in the second quarter of 2007 compared to $2.6 million or $0.12 per diluted share in the second quarter of 2006.

John Sedor, president of Bentley, commented on the pricing challenges faced by the Company's generic business as well as progress made by the Company's drug delivery business in clinical trials and patent issuances. "This was a challenging three months for our generics business which saw a double digit Noun 1. double digit - a two-digit integer; from 10 to 99
integer, whole number - any of the natural numbers (positive or negative) or zero; "an integer is a number that is not a fraction"
 percentage reduction in pricing for the quarter in our Spanish business. The government reduction in reimbursement rates went into effect in March 2007, and this was the first quarter where we experienced the full impact. We initiated an aggressive price reduction on certain products in our portfolio in the hopes of strengthening our market position. This did yield some increases in volume but overall our market share is unchanged."

Sedor continued, "In our drug delivery business, we are progressing with our U.S. Phase II Nasulin trials. We have also initiated Nasulin Phase II clinical trials Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored
phase II
 in India which are designed for 80-90 patients. We expect the India trials to be completed in early 2008. In June we presented three abstracts of our Nasulin clinical trials at the American Diabetes Association's 67th Annual Meeting. These abstracts were titled: "Interim Results of a Randomized ran·dom·ize  
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment.
, Single-Dose, 4-Way Crossover, Pharmacokinetic Study of Intranasal Insulin Spray (Nasulin[TM]), Injectable in·ject·a·ble
adj.
Capable of being injected. Used of a drug.

n.
A drug or medicine that can be injected.
 Regular Insulin (Humulin R[R]), Injectable Fast-Acting Insulin (Humalog[R]), and Saline Nasal Spray Nasal sprays are used for the nasal delivery of a drug or drugs, generally to alleviate cold or allergy symptoms such as nasal congestion. Although delivery methods vary, most nasal sprays function by instilling a fine mist into the nostril by action of a hand-operated pump  in Patients with Type I Diabetes Type I diabetes
Also called juvenile diabetes. Type I diabetes typically begins early in life. Affected individuals have a primary insulin deficiency and must take insulin injections.

Mentioned in: Diabetic Ketoacidosis
 Mellitus," "Results of a Randomized, Single-Dose, 2/3-Way Crossover Comparison Study of Intranasal Insulin Spray (Nasulin[TM]) and Injectable Fast-Acting Insulin (Humalog[R]) in Normal Nonsmoking non·smok·ing  
adj.
1. Not engaging in the smoking of tobacco: nonsmoking passengers.

2. Designated or reserved for nonsmokers: the nonsmoking section of a restaurant.
 and Smoking Subjects," and "Intranasal Insulin Spray (Nasulin[TM]) in Healthy Subjects: Choice of Nostril nostril /nos·tril/ (nos´tril) either of the nares.

nos·tril
n.
A naris.



nostril

either of the two apertures (nares) of the nose that lead into the nasal cavity.
". These presentations created more visibility for Nasulin and effectively communicated our continuing progress in bringing this therapy to the next level."

Mr. Sedor then commented on status of the Company's patents, "Progress continues on our pending applications with the U.S. Patent and Trademark Office. We are gratified grat·i·fy  
tr.v. grat·i·fied, grat·i·fy·ing, grat·i·fies
1. To please or satisfy: His achievement gratified his father. See Synonyms at please.

2.
 to have received a broad U.S. patent in July which we believe will provide us with far-reaching protection for the use of our intranasal drug delivery technology with other peptides as well as a wide range of peptidomimetics and proteins. Additionally, in April, we filed a Supplementary Reply and more recently filed our Supplemental Response with amendments to our Testim patent claims. Our current patent covering Testim is scheduled to expire in June 2008. We believe a new patent covering testosterone testosterone (tĕstŏs`tərōn), principal androgen, or male sex hormone. One of the group of compounds known as anabolic steroids, testosterone is secreted by the testes (see testis) but is also synthesized in small quantities in the  gels utilizing our CPE-215[R] drug delivery technology will be issued in late 2007 or early 2008 - extending our protection through 2023."

Bentley's results by operating segment were as follows:
[TABLE OMITTED]


Significant components of Bentley's revenues for the three months ended June 30, 2007 are summarized below:
[TABLE OMITTED]


Significant components of Bentley's revenues for the three months ended June 30, 2006 are summarized below:
[TABLE OMITTED]


Bentley's consolidated revenues increased 9% (2% in constant currency) to $62.6 million in the first half of 2007 compared to $57.3 million reported in the first half of 2006. Gross margins on net product sales decreased to 45% compared to 52% in the first six months of 2006. The Spanish price reductions and $0.4 million of inventory reserves and write-downs on U.S. simvastatin inventories have decreased gross profit to $30.9 million in the first six months of 2007 compared to $31.9 million in the first six months of 2006. Bentley's licensing and collaboration revenues increased $0.9 million or 21% compared to the first six months of 2006, primarily from increased royalties on sales of Testim. Operating expenses increased 5% to $24.7 million compared to $23.6 million in the same period of the prior year. The combination of reduced gross profit and increased operating expenses resulted in net income of $3.0 million or $0.14 per diluted share in the first six months of 2007 compared to $3.8 million or $0.16 per diluted share in the same period of the prior year.

Bentley's results by operating segment were as follows:
[TABLE OMITTED]


Significant components of Bentley's revenues for the six months ended June 30, 2007 are summarized below:
[TABLE OMITTED]


Significant components of Bentley's revenues for the six months ended June 30, 2006 are summarized below:
[TABLE OMITTED]


The Company uses both GAAP GAAP

See: Generally Accepted Accounting Principles


GAAP

See generally accepted accounting principles (GAAP).
 and certain non-GAAP measures to assess performance. The Company's management believes the non-GAAP measure of EBITDA (Earnings Before Interest, Taxes, Depreciation and Amortization) A metric used to show a company's profitability, but not its cash flow. EBITDA became popular in the 1980s to show the potential profitability of leveraged buyouts, but has become  may also provide useful supplemental information to investors in order that they may evaluate Bentley's financial performance using the same measures as management. The Company's management believes that with this supplemental information investors are afforded greater transparency in assessing the Company's financial performance. This non-GAAP financial measure should not be considered as a substitute for, nor superior to, measures of financial performance prepared in accordance with GAAP.

Set forth below is a reconciliation of our "EBITDA" to our net income, the most directly comparable financial measure calculated and presented in accordance with GAAP.
[TABLE OMITTED]
[TABLE OMITTED]


EBITDA is calculated as earnings before interest, income taxes, depreciation and amortization. The Company uses EBITDA as a supplemental financial measure of its operational performance. Management believes EBITDA to be an important measure as it excludes the effects of items which primarily reflect the impact of long-term investment decisions, rather than the performance of the Company's day-to-day operations. The Company believes that this measurement is useful to measure a company's ability to service debt and to meet other payment obligations or as a valuation measurement. As compared to net income according to according to
prep.
1. As stated or indicated by; on the authority of: according to historians.

2. In keeping with: according to instructions.

3.
 GAAP, this measure is more limited in scope because it does not reflect the periodic costs of certain capitalized tangible and intangible assets Intangible Asset

An asset that is not physical in nature.

Notes:
Examples are things like copyrights, patents, intellectual property, and goodwill. These are the opposite of tangible assets.
 used in generating revenues in the company's business. Management evaluates those items through other financial measures such as capital expenditures and cash flow provided by operating activities.

Cash, cash equivalents and marketable securities Marketable Securities

Very liquid securities that can be converted into cash quickly at a reasonable price.

Notes:
Marketable securities are very liquid as they tend to have maturities less than one year, and the rate at which these securities can be bought or sold has
 increased to $36.2 million at June 30, 2007 compared to $15.6 December 31, 2006. The increase reflects the closing of a $14.8 million loan agreement with a Spanish financial institution in June 2007. The proceeds will be used to help fund current and future capital and research and development projects. The Company invested $4.3 million in capital additions in the first half of 2007 compared to $7.3 million in the first half of 2006. The Company reaffirms its previous guidance that capital expenditures should be between $13.0 million and $16.0 million and research and development costs should be between $15.0 million and $16.0 million during 2007.

Management will host a conference call to discuss the second quarter 2007 results and provide a business update at 10:00 A.M. (Eastern Time) on August 2, 2007. To participate on the live call, please dial (888) 332-7254 from the U.S. and Canada or, for international callers, please dial (973) 582-2856. The access code for this call is 8987783. The conference call will also be broadcast live on the Internet and may be accessed via Bentley's web site, www.bentleypharm.com. Please dial in or log on through Bentley's web site approximately 10 minutes prior to the scheduled start time. A telephone replay will be available for 30 days by dialing (877) 519-4471 from the U.S. and Canada or (973) 341-3080 for international callers. Please reference reservation number 8987783. A replay of the conference will also be available on Bentley's web site for 30 days.

Bentley Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on advanced drug delivery technologies and generic pharmaceutical products. Bentley's proprietary drug delivery technologies enhance the absorption of pharmaceutical compounds across various membranes. Bentley manufactures and markets 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 subsidiaries -- Laboratorios Belmac, Laboratorios Davur, Laboratorios Rimafar and Bentley Pharmaceuticals Ireland. Bentley also manufactures and markets active pharmaceutical ingredients through its subsidiary, Bentley API.

Additional information regarding Bentley Pharmaceuticals may be obtained through Bentley's web site at www.bentleypharm.com.

Safe Harbor Safe Harbor

1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated.

2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive.
 Statement under the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995: This press release contains forward looking statements, including without limitation statements regarding Bentley's plans for spending on research and development and capital investment in 2007, the prospects and timetable for further clinical development of Bentley's intranasal insulin program, and the extent of Bentley's patent portfolio, including the prospects for extension of Bentley's patent claims covering the Testim product. These forward-looking statements forward-looking statement

A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections.
 are subject to a number of risks and uncertainties that could cause actual results to differ materially from future results expressed or implied by such statements. Factors that may cause such differences include, but are not limited to, risks associated with the following: the timing and results of clinical trials, the timing and nature of regulatory approvals, changes in third-party reimbursement and government mandates that impact pharmaceutical pricing, development and commercialization of Bentley's proprietary products and formulations, competition from other manufacturers of generic and proprietary pharmaceuticals, intellectual property litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute.

When a person begins a civil lawsuit, the person enters into a process called litigation.
, the efficacy and safety of Bentley's products, the unpredictability of patent protection, international operations Internal Operations (I.O., IO or I/O) is a fictional American Intelligence Agency in Wildstorm comics. It was originally called International Operations. I.O. first appeared in WildC.A.T.S. volume 1 #1 (August, 1992) and was created by Brandon Choi and Jim Lee. , and other uncertainties detailed under "Risk Factors" in Bentley's most recent Annual Report on Form 10-K Form 10-K

A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information.


Form 10-K

See 10-K.
 and its other subsequent periodic reports filed with the Securities and Exchange Commission. Bentley cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this document, and Bentley undertakes no obligation to update or revise the statements, except as may be required by law.

(tables to follow)
[TABLE OMITTED]
[TABLE OMITTED]
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Publication:Business Wire
Article Type:Financial report
Date:Aug 2, 2007
Words:1888
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