Sepracor, Inc. (SEPR)

[mlkrborn]

Japanese pharmaceutical giant Dainippon Sumitomo Pharma Co. has completed its $2.6 billion acquisition of Sepracor Inc., triggering change-in-control provisions at the local drug maker that could deliver roughly $11 million in pay and benefits to CEO Adrian Adams.

According to an April 3 regulatory filing by Marlborough, Mass.-Sepracor, Adams stands to receive a $5.6 million severance payment and another $302,892 to cover such personal expenditures as life insurance premiums, automobile expenses, a housing allowance and a medical-insurance opt-out payment. Another $4.2 million in restricted stock also is scheduled to vest, now that a change in control has occurred. The value of those vested shares is based on Dainippon Sumitomo Pharma’s $23-per-share acquisition price.

Adams also is set to receive $867,790 in tax gross-up payments to help cover the tax liabilities stemming from his change-in-control compensation.

The payment and stock-vesting only go into effect if Adams remains with the company after the change-in-control occurs. The deal officially closed Oct. 20.

Adams, who was 58 as of Sepracor’s April filing, has been the company’s CEO and president since 2007.

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Dainippon of Japan acquires US drug maker Sepracor
Dainippon Sumitomo Pharma of Japan acquiring US drug maker Sepracor for $2.6 billion
On Thursday September 3, 2009, 6:33 am EDT

Companies:Sepracor, Inc.
TOKYO (AP) -- Japanese drug company Dainippon Sumitomo Pharma Co. is acquiring U.S. drug maker Sepracor Inc. for about $2.6 billion in an effort to expand in the U.S. market, both sides said Thursday.

The deal is through a tender offer at a price of $23 per share, a 27.6 percent premium over Sepracor's closing price Tuesday, to start in early September, Dainippon said.

Under the deal, Dainippon intends to acquire all outstanding common shares of Sepracor, based in Marlborough, Massachusetts, to make it a wholly owned subsidiary, it said.

The buyout is the latest in a series of acquisitions of foreign pharmaceuticals by Japanese drug companies.

"Sepracor has pursued growth through development of its unique pipeline and introduction of innovative pharmaceutical products to the market, a strategy that fits perfectly with our management philosophy," Dainippon President Masayo Tada said.

Tada said his company hoped to become international competitive in research and expand its international operations.

Adrian Adams, President and Chief Executive Officer of Sepracor, also welcomed the deal.

"DSP is a leading Japanese pharmaceutical company with a distinguished history and an established, strong track record of operational and financial performance based on a number of successful product launches," he said.

It hopes to start selling its anti-psychotic drug Lurasidone in the U.S. by 2010, Dainippon said.

Dainippon, which has largely depended on the domestic market up to now, sees the acquisition as key to growth, according to Kyodo news agency.

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Sepracor sees FDA filing by late 2008, early 2009
Wednesday September 24, 4:38 pm ET
Sepracor expects to ask for epilepsy drug approval by the end of 2008 or early 2009

MARLBOROUGH, Mass. (AP) -- Sepracor Inc. said Wednesday it expects to ask the Food and Drug Administration for approval of an epilepsy drug candidate by the end of 2008 or early 2009.

The drug is licensed from Portugal-based Bial.

Sepracor said it is presenting data from three late-stage studies that show the once-daily drug significantly reduced the frequency of partial seizures in patients with refractory partial epilepsy. The drug works in combination with other treatments.

The results are being presented at the 8th European Congress of Epileptology in Berlin.

"These data suggest that eslicarbazepine acetate has the potential to become an important treatment option for patients in North America whose seizures are not adequately controlled with existing anti-epileptic agents," said Dr. Mark H.N. Corrigan, executive vice president of research and development at Sepracor.

The company also plans to conduct studies on the drug as a stand-alone treatment and for potential use in children.

The drug candidate is already being reviewed by European regulators.

Shares of Sepracor fell 88 cents, or 5.2 percent, to close at $16.14. The stock earlier traded at a new 52-week low of $16.14. Shares have ranged between $16.46 and $30.60 over the past year.

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LUNESTA(R) Next-Day Function and Discontinuation Data from a Long-Term 12-Week Study in Elderly Patients Presented at ECNP
Wednesday September 3, 7:00 am ET
-- Elderly patients taking LUNESTA 2 mg showed significant improvements in measures of daytime function compared to placebo over a 12-week treatment period
-- Elderly patients administered LUNESTA 2 mg showed no evidence of rebound insomnia and withdrawal symptoms were comparable to the placebo group upon discontinuation

MARLBOROUGH, Mass.--(BUSINESS WIRE)--Sepracor Inc. (Nasdaq: SEPR - News) today announced the presentation of LUNESTA® brand eszopiclone Phase IV study data at the 21st European College of Neuropsychopharmacology (ECNP) Congress in Barcelona. The poster presentations reflected results from a 12-week, double-blind, randomized safety and efficacy study of 388 elderly patients (65-85 years of age) who were administered either LUNESTA 2 mg or placebo nightly. Upon conclusion of the 12-week, double-blind treatment period, all patients received single-blind placebo for two weeks to assess rebound and withdrawal effects. This two-week, single-blind period was then followed by an additional two-week evaluation period in which patients received neither LUNESTA nor placebo in order to assess the durability of the response.

A 12-Week Study of Eszopiclone in Elderly Out-patients With Primary Insomnia: Effects of Treatment Discontinuation

In this study, sleep latency, wake time after sleep onset and total sleep time were all statistically significantly (p≤0.01) improved compared to baseline measures following discontinuation of LUNESTA treatment, indicating absence of rebound insomnia (defined as a worsening of sleep relative to pretreatment levels). Twelve weeks of nightly LUNESTA administration were not followed by withdrawal symptoms after discontinuation. Key findings from the study included:

* No statistically significant difference in Benzodiazepine Withdrawal Symptoms Questionnaire (BWSQ; an assessment of symptoms associated with benzodiazepine discontinuation) scores for LUNESTA-treated patients at the end of the double-blind treatment period (Week 12) relative to the end of the single-blind placebo administration period (Week 14). At Week 14, the BWSQ scores for patients treated with LUNESTA during the initial 12-week period were comparable to those who received placebo throughout the study duration; and
* The percentages of patients taking LUNESTA with “no insomnia” and “sub-threshold insomnia”, as measured by the Insomnia Severity Index (ISI; a measure of patients’ perception of insomnia), declined from the end of the double-blind period to the end of the 4-week follow-up period. However, despite this decline, the percentages of patients in these categories were still higher at the end of the 4-week follow-up period than they were at baseline, prior to the start of LUNESTA therapy.

The Efficacy of 12 Weeks of Eszopiclone Treatment in Elderly Patients With Primary Insomnia: Effect on Daytime Function

Electronic diaries, which were completed at the end of each day, captured patient-reported measures of daytime ability to function and duration and number of naps. Daytime function was assessed using an 11-point Likert-type scale, as well as by Insomnia Severity Index (ISI) questionnaires administered at three-week intervals. Quality of life and level of disability were also assessed using the 36-Item Short-Form Health Survey (SF-36) and Sheehan Disability Scale (SDS), respectively.

Patients administered LUNESTA reported significant improvements from baseline in key measures of daytime function versus the placebo group when averaged over the 12-week, double-blind treatment period. These measures included improvements in:

* Daytime alertness (p<0.001) scores
* Ability to function (p<0.001) scores
* Ability to concentrate (p<0.001) scores; and
* Sense of physical well-being (p<0.001) scores.

The abovementioned parameters were also statistically significantly improved versus placebo during the first three weeks of treatment, and these improvements were sustained through the last three weeks of the double-blind period.

Both number of naps and total daily nap time decreased from baseline for subjects who napped for both the LUNESTA and placebo treatment groups, and these decreases were statistically significantly different between the two treatment groups (p=0.0064 for number of naps and p=0.0138 for daily nap time) during the first three weeks of the study but not for the remainder of the study period.

Using the ISI, patients administered LUNESTA reported significant improvements versus the placebo treatment group on several of the extended items that measured next-day function. At Week 12, these statistically significant differences were seen in measures of:

* Improved sleep quality (p<0.0001) scores;
* Improvement in feeling refreshed/rested (p=0.0001) scores;
* Reduced daytime fatigue (p=0.0104) scores; and
* Reduced number of nights per week with sleep difficulties (p=0.0023) scores.

These abovementioned ISI measures, as well as attention/concentration, were also statistically significantly improved for patients taking LUNESTA versus patients administered placebo when averaged over the double-blind treatment period. There were no significant differences from placebo in ISI scores measuring attention, concentration, relationship enjoyment or mood disturbance.

Results of the SF-36 showed that patients administered LUNESTA reported statistically significantly improved general health (p=0.0088) and vitality (p=0.0084) at Week 12 versus patients administered placebo. Patients administered LUNESTA showed general improvements from baseline in the social life and family life/home responsibilities items of the SDS versus patients administered placebo, which were statistically significant when measured at Week 6 (p=0.0154 for social life and p=0.0279 for family life/home responsibilities), but not at Week 12. A numerical difference in scores was seen in the work/school item of the SDS, but this difference was not statistically significant.

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Sepracor Pharma Range-Bound
Thursday July 31, 3:28 pm ET
By Jason Napodano, CFA

Sales of Sepracor Inc.'s (NasdaqGS: SEPR - News) insomnia drug Lunesta remain weak after growth of only 4% in the second quarter. With several new sleep medications coming to the market in the next few years, we see little that can be done to reaccelerate trends in the U.S. and drive market share back above 15%. As such, we find it hard to believe Sepracor's stock will outperform while Lunesta treads water.

Thankfully, we are pleased to see the management looking to move beyond Lunesta and expanding its respiratory franchise with the recent additions of two new products and several technology licensing deals. Additionally, the mid-stage pipeline is progressing nicely and the stock is very attractively valued.

Sales of asthma drug Xopenex also disappointed in the most recent quarter, but we chalk that up to more seasonality than fundamentals. The management is working to improve the policy regarding Xopenex. New draft legislation should help improve trends in the second half of the year. The best opportunity to re-accelerate the topline could come with the approval of eslicarbazepine acetate in early 2010.

The management should exit 2008 with roughly $900 million in cash on hand. This is a significant amount and affords management the ability to seek more deals in the coming quarters. Sepracor is very attractively valued at only 13.2x our 2008 EPS forecast of $1.37. This should help support the stock at the current level. Our near-term target predicts some recovery back to the $22 level.

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Sepracor Announces Senior Management Appointments
Tuesday August 19, 4:00 pm ET

MARLBOROUGH, Mass.--(BUSINESS WIRE)--Sepracor Inc. (Nasdaq: SEPR - News) today announced the appointment of two senior managers to key strategic and operational roles within the organization. Richard Ranieri has been appointed to the newly created position of Executive Vice President, Human Resources and Administration, and Julio Casoy, M.D., has been appointed Senior Vice President, Medical Affairs.

“I am pleased to announce the addition of such accomplished professionals to Sepracor’s human resource and research and development teams,” said Adrian Adams, President and Chief Executive Officer. “Richard brings with him a wealth of successful human resource, operational and general management experience, and his leadership skills will be integral to our plan and vision for continued organizational growth. Julio’s appointment to lead our medical affairs organization supports our focus on deepening and broadening our management team’s strength and capabilities and reinforces our objective of delivering enhanced performance and productivity across our commercial and research and development organizations.”

Mr. Ranieri joins Sepracor from Neurocrine Biosciences, Inc. where he was Senior Vice President and Chief Administrative Officer. Mr. Ranieri managed and directed Neurocrine Biosciences’ human resources function and its corporate communications, operations and purchasing. He also served as a corporate officer and was a member of the senior management team as well as Secretary to the Compensation Committee of the Board of Directors. Prior to his tenure with Neurocrine Biosciences, Mr. Ranieri served as Senior Vice President, Human Resources at Genencor International Inc. for approximately 12 years, contributing to its growth from a start-up to a publicly traded company with over 2,000 employees worldwide. Prior to joining Genencor, Mr. Ranieri spent over 15 years with GlaxoSmithKline where he held a variety of human resources and sales management positions.

Dr. Casoy joins Sepracor from Shire Pharmaceuticals where he served as Senior Vice President, Global Medical Affairs since 2005. Dr. Casoy was responsible for providing direction and oversight for all medical affairs activities supporting Shire’s drug development programs and marketed products worldwide. In addition, he was responsible for developing and directing objectives, policies and programs pertaining to global medical affairs activities and responsibilities and was a member of the research and development leadership team. Prior to his tenure at Shire Pharmaceuticals, Dr. Casoy served as Vice President of Global Medical Affairs, Compliance and Intercontinental Medical Director at Wyeth.

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Sepracor Announces Full Support of PhRMA's Revised Code on Interactions with Healthcare Professionals
Monday July 14, 8:21 am ET

MARLBOROUGH, Mass.--(BUSINESS WIRE)--Sepracor Inc. (Nasdaq: SEPR - News) today announced its intention to fully support the Pharmaceutical Research and Manufacturers of America’s (PhRMA) updated and enhanced Code on Interactions with Healthcare Professionals (PhRMA Code). The purpose of the revised PhRMA Code includes addressing interactions with respect to marketed pharmaceutical products and related pre-launch activities, and the industry’s relationships with clinical investigators and others as they relate to the clinical research process.

“Sepracor has always been committed to responsible and ethical interactions with healthcare professionals,” said Adrian Adams, President and Chief Executive Officer of Sepracor. “This new PhRMA Code serves to underscore the importance of maintaining an appropriate, two-way, educational or informational communication between healthcare professionals and pharmaceutical industry representatives. During the next six months, we intend to update our policies and procedures to ensure compliance with not only the letter, but the spirit, of the standards set forth in the new PhRMA Code.”

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LUNESTA(R) Study of Patients with Insomnia and Co-Morbid Generalized Anxiety Disorder (GAD) Published in Archives of General Psychiatry
Monday May 12, 7:00 am ET
-- Study is first published, large-scale, double-blind randomized trial examining use of insomnia and anxiety treatments in patients with co-morbid insomnia and GAD
-- Co-administration of LUNESTA(R) brand eszopiclone and anti-anxiety agent associated with significantly improved measures of sleep, daytime functioning, anxiety and mood
-- At least two-thirds of patients with GAD also have at least one symptom of co-morbid insomnia

MARLBOROUGH, Mass.--(BUSINESS WIRE)--Sepracor Inc. (Nasdaq: SEPR - News) today announced the publication of a study of LUNESTA tablets in patients with insomnia and co-morbid generalized anxiety disorder (GAD) in the May issue of the Archives of General Psychiatry. This 595-patient study examined the safety and efficacy of LUNESTA co-administered with escitalopram oxalate, which is commonly used in the treatment of anxiety, versus co-administration of escitalopram and placebo in patients with insomnia and co-existing GAD. The study also evaluated the potential for co-administration of LUNESTA to increase the magnitude and/or accelerate the anxiolytic response versus escitalopram alone.

“Patients suffering from insomnia may have co-existing medical and psychiatric illnesses,” said Mark H.N. Corrigan, M.D., Executive Vice President, Research and Development at Sepracor. “In fact, studies indicate that approximately ten percent of the adult population suffers from chronic insomnia, and that in approximately 80 percent of these patients, insomnia co-exists with other psychiatric and medical illnesses. The results of this study are consistent with results of other studies of LUNESTA evaluating insomnia with major depressive disorder and symptoms associated with perimenopause, which have shown that improvements in sleep can have positive effects on the co-morbid condition.”

“To my knowledge, this is the first large-scale, double-blind, randomized clinical trial published that assessed the use of an insomnia treatment in conjunction with a selective serotonin reuptake inhibitor, or SSRI, in the treatment of patients with insomnia and co-morbid GAD,” said W. Vaughn McCall, M.D., Professor and Chairman of the Department of Psychiatry and Behavioral Medicine at the Wake Forest University School of Medicine. “In this study, patients with insomnia and co-morbid GAD who took LUNESTA and escitalopram co-therapy showed improvements in measures of sleep and anxiety. Given the high incidence of insomnia symptoms co-existing with GAD, and the results seen in this clinical trial, I believe that further study of insomnia and its relationship to GAD is warranted.”

In this multicenter, randomized, double-blind, placebo-controlled, parallel-group study, patients 18 to 64 years of age who met DSM-IV-TR®1 criteria for insomnia and GAD were administered 10 mg of escitalopram nightly, plus either placebo or LUNESTA 3 mg nightly for eight weeks. The eight weeks of double-blind treatment were followed by a two-week run-out period in which all patients were administered escitalopram and placebo to evaluate the potential for rebound insomnia and withdrawal effects associated with LUNESTA discontinuation.

Patients treated with LUNESTA and escitalopram co-therapy demonstrated significant (p<0.001) improvement in all measured sleep parameters when averaged over the eight-week, double-blind period, including the primary endpoint of sleep latency (25-minute decrease in sleep onset), sleep maintenance and total sleep time (TST; 60-minute increase), compared with patients who were treated with escitalopram and placebo (11.5-minute decrease for sleep onset and 35-minute increase for TST). LUNESTA-escitalopram co-therapy also resulted in significant (p≤0.007) patient-reported improvements from baseline in daytime symptoms of insomnia, including daytime alertness, ability to function, ability to concentrate and physical well-being compared to escitalopram-placebo administration when averaged over the treatment period. Consistent with other published studies of LUNESTA, there was no evidence of tolerance (diminution of effect over time), rebound insomnia or serious withdrawal syndrome following discontinuation from this study.

When evaluating anxiolytic effects of the two treatment arms, patients administered LUNESTA and escitalopram co-therapy demonstrated significant (p<0.05) improvements from baseline in total HAM-A (Hamilton Anxiety Rating Scale, a standard scale used to assess anxiety in clinical trials and consisting of a list of symptoms commonly associated with anxiety, including insomnia) scores for each week of the study. CGI-I (Clinical Global Impression of Improvement, a scale that captures physicians’ ratings of patients’ mental illness symptoms) scores were significantly (p<0.02) improved in the LUNESTA-escitalopram treatment group at each time point versus the placebo-escitalopram group. CGI-S (Clinical Global Impression of Severity) scores were not significantly different after Week 1.

Since anxiety and depression can co-exist, symptoms of depression were also evaluated using the clinician-rated HAM-D17 (Hamilton Depression Rating Scale) throughout the study. The Hamilton Depression Rating Scale is a standard scale used to assess depression in clinical trials and consists of a list of symptoms commonly associated with depression (including insomnia).

The LUNESTA-escitalopram group demonstrated reductions from baseline in HAM-D17 scores that were statistically significantly greater (p<0.05) than those seen in the placebo-escitalopram group at each week of the eight-week, double-blind treatment period. In this study, LUNESTA and escitalopram were generally well tolerated.

This publication can be accessed on the Archives of General Psychiatry web site at www.archgenpsychiatry.com.

Approximately ten percent of adults in the U.S. suffer from chronic insomnia, symptoms of which include difficulty falling asleep, awakening frequently during the night and/or waking up too early with an inability to fall back to sleep, resulting in patients feeling unrefreshed.

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Susquehanna Lowers Sepracor Rating
Thursday March 27, 4:46 pm ET
Susquehanna Financial Analyst Downgrades Sepracor, Says Revenue to Fall Short of Estimates

NEW YORK (AP) -- Shares of Sepracor Inc. fell Thursday, as a Susquehanna Financial analyst cut her rating on the drug developer, citing a lack of confidence in company's revenue guidance.
Analyst Angela Larson said that while there is no new news out on Sepracor, a continued review of her financial assumptions, recently reported prescription trends, and the stock's valuation led her to lower her rating on the Marlborough, Mass.-based company to "Negative" from "Neutral.

Sepracor makes asthma drug Xopenex, sleeping pill Lunesta and Brovana, which treats chronic lung diseases such as bronchitis and emphysema.

Sepracor has forecast 2008 total sales of $1.29 billion to $1.39 billion, but based on prescription trends and market dynamics Larson only models revenue of $1.20 billion, since Xopenex HFA sales haven't proved as strong as was hoped.

"Additionally, we have been disappointed by the launch of Brovana, and are concerned that the launch of newly acquired products (Omnaris and Alvesco) will move Brovana and other more mature products down in the sales force priorities and lead to disappointing sales," Larson wrote in a note to clients.

She also cited R&D spending as a concern, given that only $24 million out of $190 million being spent is supporting products that are highlighted as key pipeline assets, and 60 percent appears to be allocated for overhead, discovery, or other activities.

Larson noted that Sepracor is cash flow positive and has a strong cash balance of more than $1 billion, but said this is balanced out by the company's roughly $725 million of long-term debt.

Shares fell $1.05 cents, or 6 percent, to $17.72. Shares have fallen from a year-ago high of $57.11 to reach a low of $16.85 earlier this month.

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Sepracor Cuts 2008 Earnings Guidance
Friday February 29, 8:50 am ET
Sepracor Sees Full-Year Earnings Between $1.40 and $1.80 Per Share

continue to stay away, insiders/funds seem to still be sellers, SEPR may be heading to $10

MARLBOROUGH, Mass. (AP) -- Sepracor Inc., a research-based pharmaceutical company, on Friday cut its full-year 2008 earnings outlook.

Sepracor projected full-year 2008 earnings per share of $1.40 to $1.80, on revenue of $1.35 billion to $1.45 billion. In October, the company forecast earnings per share between $2.35 and $2.45. The company said Friday it plans to restate its financial statements back to 2005 to reduce the amount of product revenue earned, due to government pricing.

Analysts surveyed by Thomson Financial, on average, estimate 2008 earnings of $2.30 per share on revenue of $1.34 billion.

In a note to investors, Citi Investment Research analyst Andrew Swanson said, "2008 guidance (is) not as bad as it look." Swanson noted the sales outlook beat his estimates of $1.32 billion and said a decline in sales and marketing spending implied a big cut in direct-to-consumer spending.

He said the earnings-per-share outlook is based on research and development spending that could exceed $300 million, based on the midpoint. He had forecast spending closer to $200 million, a difference that amounts to about $1 per share.

Sepracor shares fell $1.34, or 5.9 percent, to $21.50 in premarket trading. They closed at $22.84 on Thursday.

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AP
Sepracor Partners to Sell Epilepsy Drug
Wednesday January 2, 7:48 am ET
Sepracor Enters Partnership With Bial to Finish Developing and Sell New Epilepsy Drug

MARLBOROUGH, Mass. (AP) -- Drug developer Sepracor Inc. said Wednesday it is partnering with Portugal-based drug developer Bial to develop and sell a new epilepsy drug.
Sepracor will file a new drug application with the Food and Drug Administration, as early as late 2008 or early 2009. Bial is entitled to a $75 million payment upfront, and milestone payments up to $100 million.

The compound, called BIA 2-093, has already been tested in three late-stage studies involving more than 1,000 patients. Sepracor's drugs include Lunesta for insomnia and Xopenex for asthma.

Shares of Sepracor closed at $26.25 Monday.

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Strong Volume Gainers (SEPR)

Sepracor Inc. Announces Third Quarter 2007 Results and Planned Reduction in Operating Expenses for 2008

Financial Highlights

* Third quarter total revenues were $283.9 million
* Generated net income of $42.9 million or $0.37 per diluted share
* Total revenues increased 6.4% for Nine Months 2007 to $893.5 million vs. Nine Months 2006
* Cash and short- and long-term investments grew to $932.3 million
* Anticipated 2008 fully diluted earnings per share range of approximately $2.35-$2.45 per share

Other Operational Highlights

* Established partnerships for development and commercialization of eszopiclone with Eisai Co. Ltd. for Japan and GlaxoSmithKline for all markets outside of North America and Japan
* Planned reduction in sales and marketing expenses of approximately $90-$100 million for 2008, including an anticipated reduction of approximately 300 sales force positions

Sepracor Inc. (Nasdaq: SEPR) today announced its consolidated financial results for the third quarter and nine months ended September 30, 2007.

For the three months ended September 30, 2007, total revenues were approximately $283.9 million, which reflects a 1.9% decrease from third quarter 2006 revenues of $289.3 million. Net income for the quarter was approximately $42.9 million, or $0.37 per diluted share compared to $64.4 million, or $0.56 per diluted share for the third quarter of 2006, which reflects a 34% decrease per diluted share.

Total revenues for the nine months ended September 30, 2007 increased to $893.5 million, which reflects a 6.4% increase from revenues of $839.4 million for the same period in 2006. Net income for the nine months ended September 30, 2007 was approximately $71.6 million, or $0.61 per diluted share, compared to $85.5 million, or $0.74 per diluted share, for the nine months ended September 30, 2006. Included in the results for the nine months ended September 30, 2007 is an after-tax charge of $32.9 million, or $0.28 per share, that was applied during the first quarter and relates to the settlement of two class action lawsuits related to tecastemizole.

As of September 30, 2007, Sepracor had approximately $932.3 million in cash and short- and long-term investments, an increase of $71.4 million from the second quarter 2007.

Sepracor recently completed an evaluation of its sales force structure, sizing and allocation that was initiated in the second quarter of 2007. This evaluation has resulted in a decision to reduce the number of sales force positions by approximately 300. This, together with other anticipated cost reduction initiatives across the business, has resulted in a projected reduction in sales and marketing expenses of approximately $90-$100 million for 2008. Sepracor’s overall guidance for 2007 remains unchanged from the last quarter with anticipated total revenues for 2007 of between $1.23-$1.30 billion. Sepracor has narrowed the fully diluted earnings per share (EPS) range to $1.05-$1.15 for 2007 from the previous guidance of $1.00-1.30, based on 118 million weighted average shares outstanding. This range not only includes the after-tax charge relating to the settlement of the tecastemizole litigation of $0.28 per share, but also includes expected restructuring charges during the fourth quarter of 2007 that the company will incur related principally to the sales force reorganization during the fourth quarter of 2007. Sepracor anticipates returning to earnings momentum in 2008 with a projected fully diluted EPS range of approximately $2.35-$2.45 per share, based on 119 million weighted average shares outstanding.

“This past quarter we made substantial progress securing corporate partnerships for LUNESTA outside the U.S., which we believe will add significant long-term value to the franchise. These partnership milestones, together with the ongoing development of a more focused, targeted and productive commercial organization, are key components that we believe will help us to execute our future growth strategy,” said Adrian Adams, President and Chief Executive Officer of Sepracor. “We are looking forward to the next phase of growth for Sepracor, a phase during which we intend not only to improve cost structures, but also more fully leverage our product franchises, grow and differentiate our research and development pipeline and aggressively pursue synergistic corporate development and licensing opportunities.”

LUNESTA brand eszopiclone revenues grew to $160.9 million in the third quarter of 2007 compared to $141.6 million for the same quarter in 2006, which was a 13.6% increase. LUNESTA is indicated for the treatment of insomnia. Year to date (January-September 2007) prescriptions grew by 10.6% to approximately 5.24 million compared with the same period in 2006. Unrestricted coverage of LUNESTA under managed care also grew to 85% of managed care lives compared to 77% for AMBIEN CR®.

XOPENEX® brand levalbuterol HCl Inhalation Solution, which is a short-acting beta-agonist indicated for the treatment or prevention of bronchospasm in patients with reversible obstructive airway disease, had revenues of $94.4 million for the third quarter, compared to $125.4 million for the same quarter in 2006. The reduction of XOPENEX Inhalation Solution revenues in the third quarter 2007 compared to the third quarter 2006 were primarily attributable to the impact of the decision made by the Centers for Medicare and Medicaid Services (CMS) during the second quarter 2007 to institute a new, bundled, payment amount for XOPENEX Inhalation Solution and generic albuterol inhalation solution products. The new reimbursement rate, which went into effect on July 1, 2007, translated into a significantly lower per-unit payment for the 1.25 mg dose of XOPENEX Inhalation Solution (the dose most commonly used by Medicare Part B beneficiaries), compared to the rate paid in the previous quarter. Historically, it has been estimated that approximately 25-30 percent of XOPENEX Inhalation Solution units were subject to reimbursement under Medicare Part B, and 70-75 percent of XOPENEX Inhalation Solution units sold were through retail, hospital-based and other channels.

XOPENEX HFA® brand levalbuterol tartrate Inhalation Aerosol, a metered-dose inhaler (MDI) formulation of levalbuterol, had revenues of $17.3 million during the third quarter, reflecting a 32.3% increase over revenues of $13.1 million for the same period in 2006. This increase we believe was principally due to the continued transition of patients previously using chlorofluorocarbon (CFC) albuterol MDIs. CFC-containing albuterol MDIs are required to be phased-out before the end of 2008, with patients increasingly transitioning to HFA MDIs. Almost one-half of the short-acting beta-agonist market is still comprised of CFC albuterol MDIs, representing a sizeable remaining market opportunity for the XOPENEX HFA product.

BROVANA® Inhalation Solution, a long-term, twice-daily maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), which was commercially introduced in April 2007, had revenues of $2.4 million for the quarter. A significant portion of patients with COPD are Medicare beneficiaries, and the majority of future BROVANA revenues are expected to come from non-retail channels such as home health care. During the second quarter, CMS announced its preliminary determination that BROVANA should be awarded a unique reimbursement, or J Code, for billing purposes under the Medicare Part B benefit. The final determination is expected in the fourth quarter of 2007 and, if favorable, would become effective on January 1, 2008. Prior to that time, CMS has instructed providers to bill BROVANA reimbursement claims under a miscellaneous J Code.

Sepracor continues to earn royalty revenues on sales of out-licensed antihistamine products, which include Schering-Plough’s CLARINEX® brand desloratadine, sanofi-aventis’ ALLEGRA® brand fexofenadine HCl and UCB’s XYZAL®/XUSAL™ brand levocetirizine. These products had combined royalty revenues of $8.7 million in the third quarter of 2007 compared to $9.2 million for the same quarter in 2006. In October 2007, UCB and sanofi-aventis launched XYZAL in the U.S., and Sepracor is entitled to earn royalties on product sales.

Sepracor’s early-stage portfolio continues to advance. SEP-225289, a novel triple reuptake inhibitor for the treatment of depression, began a Phase II proof-of-concept study during the fourth quarter of 2007. SEP-225441, a compound for the treatment of generalized anxiety disorder, is expected to initiate a Phase II proof-of-concept study during the fourth quarter 2007. SEP-227162, a dual reuptake inhibitor for the treatment of depression, is expected to begin a Phase II proof-of-concept study during the second quarter of 2008. Additionally, Sepracor anticipates submitting three new Investigational New Drug Applications during the fourth quarter 2007 for product opportunities in depression, and potentially broader clinical application to conditions such as pain, bipolar disease, fibromyalgia and panic disorder.

About Sepracor

Sepracor Inc. is a research-based pharmaceutical company dedicated to treating and preventing human disease by discovering, developing and commercializing innovative pharmaceutical products that are directed toward serving unmet medical needs. Sepracor’s drug development program has yielded a portfolio of pharmaceutical products and candidates with a focus on respiratory and central nervous system disorders. Sepracor’s corporate headquarters are located in Marlborough, Massachusetts.

Forward-Looking Statement

This news release contains forward-looking statements that involve risks and uncertainties, including statements with respect to the successful development and commercialization of the company’s pharmaceutical products under development; the safety, efficacy, potential benefits, possible uses and commercial success of LUNESTA brand eszopiclone, XOPENEX brand levalbuterol HCl Inhalation Solution, XOPENEX HFA brand levalbuterol tartrate Inhalation Aerosol, BROVANA brand arformoterol Inhalation Solution, and all of the company’s pharmaceutical candidates; the planned reduction in sales and marketing expenses and other cost-saving initiatives; the value added by Sepracor’s partnerships for eszopiclone outside the U.S.; the potential receipt of partnership milestones; the future growth of the company’s research and development pipeline and its ability to aggressively pursue synergistic corporate development and licensing opportunities; the expected reduction in sales and marketing expenses; the reorganization and restructuring of the company’s commercial functions and its new focus on enhanced productivity; the sizeable remaining market opportunity for the XOPENEX HFA product and Sepracor’s ability to capture a portion of the HFA market; and Sepracor’s expected future growth, profitability and 2007 and 2008 EPS guidance. Among the factors that could cause actual results to differ materially from those indicated by such forward-looking statements are: Sepracor’s ability to fund, and the results of, further clinical trials with respect to products under development; the timing and success of submission, acceptance, and approval of regulatory filings; the scope of Sepracor’s trademarks, patents and the patents of others and the success of challenges by others of Sepracor’s patents; the clinical benefits and commercial success of the company’s products; changes in the use and/or label of LUNESTA or Sepracor’s other products; the outcome of litigation and regulatory decisions relating to Sepracor’s patents, products and product candidates; the outcome of CMS’s final determination as to whether or not to award a unique reimbursement J Code for BROVANA; Sepracor’s ability to successfully implement its strategy to reduce sales and marketing expenses; the effects and outcome of the SEC’s inquiry into Sepracor’s stock option granting practices; private insurers such as managed care organizations, adopting their own coverage restrictions or demanding price concessions in response to state, Federal or administrative action, such as CMS's new, bundled, payment amount for XOPENEX Inhalation Solution; the ability of the company to attract and retain qualified personnel; the ability of the company to successfully collaborate with third parties; the performance of Sepracor’s licensees, including Eisai and GlaxoSmithKline, and other collaboration partners and its ability to enter into new licenses and collaborations; the continued ability of Sepracor to meet its debt obligations when due; and certain other factors that may affect future operating results are detailed in the company’s quarterly report on Form 10-Q for the quarter ended June 30, 2007 filed with the Securities and Exchange Commission and other reports filed with the SEC.

In addition, the statements in this press release represent Sepracor's expectations and beliefs as of the date of this press release. Sepracor anticipates that subsequent events and developments may cause these expectations and beliefs to change. However, while Sepracor may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Sepracor's expectations or beliefs as of any date subsequent to the date of this press release.

Lunesta, Xopenex, Xopenex HFA and Brovana, are registered trademarks of Sepracor Inc. Clarinex is a registered trademark of Schering Corporation. Allegra is a registered trademark of Merrell Pharmaceuticals. Xusal is a trademark and Xyzal is a registered trademark of UCB, Societe Anonyme. Ambien CR is a registered trademark of sanofi-aventis.

In conjunction with this Third Quarter 2007 Financial Results press release, Sepracor will host a conference call and live webcast beginning at 8:30 a.m. ET on Oct. 30, 2007. To participate via telephone, dial 973-582-2749, referring to access code 9192732. Please call ten minutes prior to the scheduled conference call time. For live webcasting, go to the Sepracor web site at www.sepracor.com and access the For Investors section. Click on either the live webcast link or microphone icon to listen. Please go to the web site at least 15 minutes prior to the call in order to register, download, and install any necessary software. A PDF of the slides will be available in the For Investors section of the web site as well as in the left-hand navigation menu of the webcast viewer just prior to the start of the call. A replay of the call will be accessible by telephone after 11:00 a.m. ET and will be available for approximately one week. To replay the call, dial 973-341-3080, access code 9192732. A replay of the web cast will be archived on the Sepracor web site in the For Investors section.

Sepracor Inc.
Condensed Consolidated Statements of Operations
(Unaudited)

(In thousands, except per share amounts)

Three months ended Nine months ended
September 30, September 30,
2007 2006 2007 2006

Revenues:

Product sales $ 275,024 $ 280,086 $ 861,983 $ 814,018
Royalties and other 8,921 9,210 31,524 25,362
Total revenues 283,945 289,296 893,507 839,380

Cost of revenue 26,420 24,881 83,568 71,549

Gross margin 257,525 264,415 809,939 767,831

Operating expenses:
Research and development 49,025 35,520 135,184 121,149
Sales and marketing 154,648 151,154 538,282 523,750
General and administrative and patent costs 20,477 19,285 58,666 51,880
Soltara class action settlement - - 34,000 -
Total operating expenses 224,150 205,959 766,132 696,779

Income from operations 33,375 58,456 43,807 71,052

Other income (expense):
Interest income 11,173 12,319 34,882 33,103
Interest expense (88 ) (5,538 ) (2,958 ) (16,632 )
Other income (expense), net (621 ) (9 ) (907 ) (321 )
Total other income 10,464 6,772 31,017 16,150

Equity in investee loss (37 ) (212 ) (441 ) (565 )

Income before income taxes $ 43,802 $ 65,016 $ 74,383 $ 86,637

Income taxes 907 585 2,792 1,126

Net income $ 42,895 $ 64,431 $ 71,591 $ 85,511

Net income per common share - basic $ 0.40 $ 0.61 $ 0.67 $ 0.82

Net income per common share - diluted $ 0.37 $ 0.56 $ 0.61 $ 0.74

Weighted average shares outstanding - basic 107,318 104,991 106,628 104,627

Weighted average shares outstanding - diluted 116,033 115,694 116,508 115,447
Sepracor Inc.
Condensed Consolidated Balance Sheets
(Unaudited)

(In thousands)


September 30, December 31,
ASSETS 2007 2006

Cash, short and long-term investments $ 932,302 $ 1,166,324
Accounts receivable, net 154,486 175,103
Inventory, net 49,459 37,087
Property, plant and equipment, net 85,231 72,811
Investment in affiliate 4,344 5,107
Other assets 40,054 37,361

Total assets $ 1,265,876 $ 1,493,793



LIABILITIES AND STOCKHOLDERS' EQUITY

Accounts payable and accrued expenses $ 141,188 $ 123,850
Other liabilities 162,064 115,877
Debt payable 3,424 1,078
Convertible subordinated debt 720,820 1,160,820
Total stockholders' equity 238,380 92,168

Total liabilities and stockholders' equity $ 1,265,876 $ 1,493,793

Sepracor Inc.
David P. Southwell
Chief Financial Officer
or
Jonae R. Barnes
Sr. Vice President

[surf1944]

Oversold with an Improving RSI (SEPR)

[surf1944]

http://www.businessweek.com/investor/content/oct2007/pi2007105_564105.htm?campaign_id=yhoo

Sleep Drugs Rouse Big Pharma
With 25 million Americans suffering from chronic insomnia, new treatments in the pipeline could find a huge market

by Beth Piskora From Standard & Poor's Equity Research
Investing

New York may be the "City That Never Sleeps," but the rest of the U.S. seems to be getting less shut-eye as well. Pharma and biotech companies are targeting sleeping disorders, with more than a dozen insomnia compounds in phase II and phase III clinical trials.

Approximately 70 million people in the U.S. suffer regular or occasional insomnia, according to Steven Silver, a biotechnology equity analyst for Standard & Poor's. But only 10% to 15% seek treatment, in part because of the side effects associated with the current crop of insomnia drugs. An astonishing 25 million people suffer from chronic insomnia. But the medical profession increasingly believes treating insomnia is important, since lack of sleep can lead to serious disorders including heart disease.

The Food & Drug Administration has approved several prescription drugs for insomnia, and many sufferers use PM formulations of popular over-the-counter painkillers. Overall, the U.S. insomnia drug market is estimated by Wolters Kluwer Health (WLSNc.AS) at about $4.6 billion in annual sales in 2006, up from $1.3 billion in 2001, a compounded annual growth rate of 29%. Over that same period, total prescriptions rose to 56 million from 30 million, a 13% annual increase.
Influential Ads

Key products are Ambien, now generic since the U.S. patent covering the original formulation from Sanofi Aventis (SNY; $42; S&P investment rank 4-STARS, buy) expired in April; Sanofi's new Ambien CR (controlled release); Lunesta, from Sepracor (SEPR; $28; 3-STARS, hold); temazepam (generic); and zolpidem (generic). Generics are believed to account for more than two-thirds of the market.

"From a competitive standpoint, Lunesta has an advantage over the older insomnia treatments in that it may be prescribed for long-term use. Safety issues restrict the others to only short-term use," says Herman Saftlas, pharmaceutical equity analyst for Standard & Poor's. "However, Lunesta, like its rivals, is still a controlled substance."

Since many insomnia drugs are sold directly to consumers, sales are greatly influenced by consumer print and broadcast advertising. "Being similar to mood-altering drugs, anti-insomnia drugs are linked to addiction, thus the controlled-substance labeling," explains Saftlas.
Littered with Failures

He believes Sanofi has salvaged some of its Ambien franchise with patent-protected Ambien CR, which was launched in 2005. The company also has an aggressive R&D program across many different therapeutic classes, with some two dozen drugs now in late-stage development. Sepracor is also expanding its Lunesta franchise overseas, signing recent deals with Eisai (4523) to market Lunesta in Japan and with GlaxoSmithKline (GSK; $54; 4-STARS) to sell the product in Europe.

"Newer insomnia drugs now under development are being designed to reduce dependency and eliminate morning after grogginess and related side effects," says Saftlas. The insomnia area has been littered with several high-profile failures such as Goboxadol, from Merck (MRK; $52; 4-STARS), which was developed through alliances with smaller biotech companies.

Despite those failures, there are more than a dozen insomnia compounds in phase II and phase III clinical trials, many with mechanisms of action different from the ones Ambien and Lunesta use.
Three Responses Possible from FDA

S&P is specifically keeping an eye on Somaxon Pharmaceuticals (SOMX; $11; 4-STARS) and Neurocrine Biosciences (NBIX; $10; 3-STARS). According to S&P's Silver, Neurocrine's Indiplon IR (immediate release) formula could be approved as early as December. Another formulation, Indiplon MR (modified release) received a "non-approvable letter" and the company, according to Silver, has not determined a final plan for that formulation.

"When a company files for approval with the FDA, they typically get one of three responses: A) approved; B) approvable, which means that they are open to reconsidering once the company refiles with specifically requested data or follow-on trials; or C) not approvable," explains Silver. "In some cases of C, companies will request meetings with the FDA to seek clarification and then conduct further clinical trials in the hopes of refiling at a later time. In the case of Indiplon, they received an "approvable" letter, which requested further study be done. They have completed resubmission, and the drug, in its IR form, could be approved as early as December."

Meanwhile, Somaxon is expected to file with the FDA for approval of its Silenor drug in early 2008. The company had planned on an earlier submission date, but the FDA requested further data, which pushed the filing into next year. Most current insomnia drugs use mechanisms of action utilizing the GABA modulator in the brain. According to Somaxon, Silenor will block the release of histamine at the H1 receptor in the brain instead. This is Somaxon's claimed "differentiator," explains Silver, to avoid the hangover issues with other insomnia drugs.

The active ingredient in Silenor is doxepin, a psychotropic agent with antidepressant properties. In other formulations for other conditions, doxepin has been prescribed for more than 30 years. On its Web site, Somaxon claims the long use of the ingredient should overcome any concerns about its safety. "In phase III trials, Silenor showed statistically significant results in both onset [of sleep] and maintenance," says Silver.

[surf1944]

Bullish Engulfing Patterns (SEPR)

[CPTMatt]

Booo .
.


.


Hrmm... Parabolic. Interesting

[surf1944]

Parabolic SAR Buy Signals (SEPR) from nightly stockcharts.com scan

[CPTMatt]

What the heck? You deleted my post?

[surf1944]

Time to look at SEPR again:
July 27, 2007 - 6:03 AM EST

Sepracor Inc. Announces Second Quarter 2007 Results and Significant Milestone Events

Second Quarter and First Half 2007 Highlights

* Quarterly total revenues increased 5.2% over the second quarter 2006, to $278.1 million
* Net income was $6.1 million or $0.05 per diluted share
* BROVANA™ brand arformoterol tartrate Inhalation Solution commercially introduced as a long-term, maintenance treatment for chronic obstructive pulmonary disease (COPD)
* First Half 2007 total revenues increased 10.8% over same period in 2006, to $609.6 million

Recent Accomplishments and Corporate News

* Established partnership with Eisai Co. Ltd. for development and commercialization of eszopiclone (marketed as LUNESTA® in the U.S.) in Japan
* Submitted Marketing Authorization Application (MAA) for LUNIVIA® brand eszopiclone (marketed as LUNESTA in the U.S.) for the treatment of insomnia in the European Union (EU)

Sepracor Inc. (Nasdaq: SEPR) today announced its consolidated financial results for the second quarter of 2007.

For the three months ended June 30, 2007, total revenues increased to approximately $278.1 million, which reflected a 5.2% increase from second quarter 2006 revenues of $264.4 million. Revenues from Sepracor’s pharmaceutical product sales were approximately $265.7 million during the second quarter of 2007, which was an increase of 3.6% over second quarter 2006 revenues of $256.4 million. Net income for the quarter was approximately $6.1 million, or $0.05 per diluted share compared to $11.0 million, or $0.10 per diluted share for the second quarter of 2006.

Total revenues for the six months ended June 30, 2007 increased to $609.6 million, which represented a 10.8% increase over revenues for the same period in 2006, for which total revenues were $550.1 million. Revenues from Sepracor’s pharmaceutical product sales were approximately $587 million during the first six months of 2007, which reflected a 9.9% increase over the same period in 2006, for which product sales were $533.9 million. Net income for the six months ended June 30, 2007 was approximately $28.7 million, or $0.25 per diluted share compared to $21.1 million, or $0.18 per diluted share for the six months ended June 30, 2006. Included in the results for the six months ended June 30, 2007 is an after-tax charge of $32.9 million, or $0.28 per share, that was applied during the first quarter and relates to the preliminary settlement subject to final court approval of two class action lawsuits related to tecastemizole.

As of June 30, 2007, Sepracor had approximately $860.9 million in cash and short- and long-term investments.

“This past quarter was challenging for Sepracor as we balanced regulatory, competitive and productivity challenges against potential opportunities that lie ahead for our company. While we believe this is a transition year, we have already begun to make important advances in securing the next phase of our future growth,” said Adrian Adams, President and Chief Executive Officer of Sepracor. “This is evidenced with our recently announced partnership with Eisai for expansion of our LUNESTA franchise to the Japanese market and our submission of an MAA to the European regulatory authorities for LUNIVIA. These initiatives, together with our plans to deepen our in-house strengths and capabilities, reinforce our determination to deliver stronger performance and enhanced shareholder value over time.”

LUNESTA® brand eszopiclone revenues grew to $143 million in the second quarter of 2007 compared to $139.1 million for the same quarter in 2006, which was a 2.7% increase. This growth occurred despite introduction of the generic competitor, zolpidem tartrate, which occurred during the quarter.

XOPENEX® brand levalbuterol HCl Inhalation Solution, which is a short-acting beta-agonist indicated for the treatment or prevention of bronchospasm in patients with reversible obstructive airway disease, had revenues of $104.9 million for the second quarter, compared to $115.7 million for the same quarter in 2006. During the quarter, the Centers for Medicare and Medicaid Services (CMS) issued a new, bundled, payment amount for XOPENEX Inhalation Solution and generic albuterol inhalation solution products. The new reimbursement rate, which went into effect on July 1, 2007, translated into a significantly lower per-unit payment for the 1.25 mg dose of XOPENEX Inhalation Solution (the dose most commonly used by Medicare Part B beneficiaries), compared to the rate paid in the previous quarter. In anticipation of the implementation of the new reimbursement rate, and with the subsequent expectation of decreased XOPENEX Inhalation Solution dispensation, home health care pharmacies began decreasing their inventories of XOPENEX Inhalation Solution during the month of June.

In response to the issuance of the new, lower Medicare Part B reimbursement rate for XOPENEX Inhalation Solution, Sepracor has been actively contracting with home health care and retail pharmacy providers in an effort to retain the continued availability of XOPENEX Inhalation Solution to Medicare Part B beneficiaries with respiratory disease.

XOPENEX HFA® brand levalbuterol tartrate Inhalation Aerosol, a metered-dose inhaler (MDI) formulation of levalbuterol, had revenues of $12.3 million during the second quarter, reflecting a 670% increase over revenues of $1.6 million for the same period in 2006. This increase was principally due to the continued transition of patients previously using chlorofluorocarbon (CFC) albuterol MDIs. CFC-containing albuterol MDIs are required to be phased-out before the end of 2008, with patients increasingly transitioning to HFA MDIs. Almost one-half of the market is still comprised of CFC albuterol MDIs, representing a sizeable remaining market opportunity for the XOPENEX HFA product.

Sepracor commercially introduced BROVANA, a new long-term, twice-daily maintenance treatment of bronchoconstriction in patients with COPD, in April 2007 and had revenues of $5.5 million for the quarter. A significant portion of patients with COPD are Medicare beneficiaries, and the majority of BROVANA revenues are expected from non-retail channels such as home health care. In June 2007, the Durable Medical Equipment Program Safeguard Contractors (DME-PSCs) that manage reimbursement for respiratory medications under the Medicare Part B benefit, announced the coverage criteria and instructions for billing BROVANA claims. In addition, during the second quarter CMS announced its preliminary determination that BROVANA Inhalation Solution should be awarded a unique reimbursement, or J Code, for billing purposes under the Medicare Part B benefit. The final determination is expected in the fourth quarter of 2007 and, if favorable, would become effective on January 1, 2008. Prior to that time, CMS has instructed providers to bill BROVANA reimbursement claims under a miscellaneous J Code.

Sepracor continues to earn royalty revenues on sales of out-licensed antihistamine products, which include Schering-Plough’s CLARINEX® brand desloratadine, sanofi-aventis’ ALLEGRA® brand fexofenadine HCl and UCB’s XYZAL®/XUSAL™ brand levocetirizine. These products had combined royalty revenues of $12.5 million in the second quarter of 2007, which is a 56.2% increase over royalty revenues of $8 million for the same quarter in 2006, principally due to increased growth of ALLEGRA in Japan.

Sepracor’s early-stage portfolio continues to advance. SEP-225289, a novel triple reuptake inhibitor for the treatment of depression, is on track to begin a proof-of-concept study during the fourth quarter of 2007. SEP-225162, a dual reuptake inhibitor for the treatment of depression, is on track for a proof-of-concept study early next year. SEP-225441, a compound for the treatment of generalized anxiety disorder and panic disorder, is expected to begin a pharmacological proof-of-concept study in the clinic in the third quarter of 2007. Additionally, Sepracor anticipates submitting two to three new Investigational New Drug Applications in the near future for product opportunities in depression, and potentially broader clinical application to conditions such as pain, bipolar disease and fibromyalgia. All of Sepracor’s drug candidates require significant research, development, successful preclinical and/or clinical testing, regulatory approval and a commitment of significant additional resources prior to commercialization.

About Sepracor

Sepracor Inc. is a research-based pharmaceutical company dedicated to treating and preventing human disease by discovering, developing and commercializing innovative pharmaceutical products that are directed toward serving unmet medical needs. Sepracor’s drug development program has yielded a portfolio of pharmaceutical products and candidates with a focus on respiratory and central nervous system disorders. Sepracor’s corporate headquarters are located in Marlborough, Massachusetts.

Forward-Looking Statement

This news release contains forward-looking statements that involve risks and uncertainties, including statements with respect to the successful development and commercialization of the company’s pharmaceutical products under development; the safety, efficacy, potential benefits, possible uses and commercial success of LUNESTA/LUNIVIA brand eszopiclone, XOPENEX brand levalbuterol HCl Inhalation Solution, XOPENEX HFA brand levalbuterol tartrate Inhalation Aerosol, BROVANA brand arformoterol tartrate Inhalation Solution, and all of the company’s pharmaceutical candidates; expectations with respect to collaborative agreements and the regulatory approval process; and Sepracor’s future growth and profitability. Among the factors that could cause actual results to differ materially from those indicated by such forward-looking statements are: Sepracor’s ability to fund and the results of further clinical trials with respect to products under development; the timing and success of submission, acceptance, and approval of regulatory filings; the scope of Sepracor’s trademarks, patents and the patents of others and the success of challenges by others of Sepracor’s patents; the clinical benefits and commercial success of the company’s products; changes in the use and/or label of LUNESTA or Sepracor’s other products; the outcome of litigation and regulatory decisions relating to Sepracor’s patents, products and product candidates; the effects and outcome of the SEC’s inquiry into Sepracor’s stock option granting practices and the related derivative lawsuits; private insurers such as managed care organizations, adopting their own coverage restrictions or demanding price concessions in response to state, Federal or administrative action, such as CMS's new, bundled, payment amount for XOPENEX Inhalation Solution; the ability of the company to attract and retain qualified personnel; the ability of the company to successfully collaborate with third parties; the performance of Sepracor’s licensees and other collaboration partners and its ability to enter into new licenses and collaborations; the availability of sufficient funds to continue research and development efforts; the continued ability of Sepracor to meet its debt obligations when due; and certain other factors that may affect future operating results are detailed in the company’s quarterly report on Form 10-Q for the quarter ended March 31, 2007 filed with the Securities and Exchange Commission and other reports filed with the SEC.

In addition, the statements in this press release represent Sepracor's expectations and beliefs as of the date of this press release. Sepracor anticipates that subsequent events and developments may cause these expectations and beliefs to change. However, while Sepracor may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Sepracor's expectations or beliefs as of any date subsequent to the date of this press release.

Brovana is a trademark and Lunesta, Lunivia, Xopenex and Xopenex HFA are registered trademarks of Sepracor Inc. Clarinex is a registered trademark of Schering Corporation. Allegra is a registered trademark of Merrell Pharmaceuticals. Xusal is a trademark and Xyzal is a registered trademark of UCB, Societe Anonyme.

In conjunction with this Second Quarter 2007 Financial Results press release, Sepracor will host a conference call and live webcast beginning at 8:30 a.m. ET on July 27, 2007. To participate via telephone, dial 973-582-2749, referring to access code 9031075. Please call ten minutes prior to the scheduled conference call time. For live webcasting, go to the Sepracor web site at www.sepracor.com and access the For Investors section. Click on either the live webcast link or microphone icon to listen. Please go to the web site at least 15 minutes prior to the call in order to register, download, and install any necessary software. A PDF of the slides will be available in the For Investors section of the web site as well as in the left-hand navigation menu of the webcast viewer just prior to the start of the call. A replay of the call will be accessible by telephone after 11:00 a.m. ET and will be available for approximately one week. To replay the call, dial 973-341-3080, access code 9031075. A replay of the web cast will be archived on the Sepracor web site in the For Investors section.

Condensed, consolidated statements of operations and consolidated balance sheets follow.
Sepracor Inc.
Condensed Consolidated Statements of Operations
(Unaudited)

(In thousands, except per share amounts)

Three months ended Six months ended
June 30, June 30,
2007 2006 2007 2006

Revenues:

Product sales $ 265,662 $ 256,427 $ 586,959 $ 533,932
Royalties and other 12,466 7,979 22,603 16,152
Total revenues 278,128 264,406 609,562 550,084

Cost of revenue 25,530 20,976 57,148 46,668

Gross margin 252,598 243,430 552,414 503,416

Operating expenses:
Research and development 45,457 36,360 86,159 85,629
Sales and marketing 191,516 182,605 383,634 372,596
General and administrative and patent costs 19,297 18,087 38,189 32,595
Litigation settlement - - 34,000 -
Total operating expenses 256,270 237,052 541,982 490,820

Income (loss) from operations (3,672 ) 6,378 10,432 12,596

Other income (expense):
Interest income 11,107 10,990 23,709 20,784
Interest expense (113 ) (5,543 ) (2,870 ) (11,094 )

Other expense, net
(558 ) (256 ) (286 ) (312 )
Total other income 10,436 5,191 20,553 9,378

Equity in investee loss (132 ) (95 ) (404 ) (353 )

Income before income taxes $ 6,632 $ 11,474 $ 30,581 $ 21,621

Income taxes 485 430 1,885 541

Net income $ 6,147 $ 11,044 $ 28,696 $ 21,080

Net income per common share - basic $ 0.06 $ 0.11 $ 0.27 $ 0.20

Net income per common share - diluted $ 0.05 $ 0.10 $ 0.25 $ 0.18

Weighted average shares outstanding - basic 106,567 104,587 106,275 104,441

Weighted average shares outstanding - diluted 116,635 115,371 116,839 115,344
Sepracor Inc.
Condensed Consolidated Balance Sheets
(Unaudited)

(In thousands)


June 30, December 31,
ASSETS 2007 2006

Cash, short and long-term investments $ 860,853 $ 1,166,324
Accounts receivable, net 105,965 175,103
Inventory, net 42,759 37,087
Property, plant and equipment, net 82,821 72,811
Investment in affiliate 4,771 5,107
Other assets 59,973 37,361

Total assets $ 1,157,142 $ 1,493,793



LIABILITIES AND STOCKHOLDERS' EQUITY

Accounts payable and accrued expenses $ 148,517 $ 123,850
Other liabilities 104,232 115,877
Debt payable 3,714 1,078
Convertible subordinated debt 720,820 1,160,820
Total stockholders' equity 179,859 92,168

Total liabilities and stockholders' equity $ 1,157,142 $ 1,493,793

Sepracor Inc.
David P. Southwell, 508-481-6700
Chief Financial Officer
or
Jonae R. Barnes, 508-481-6700
Sr. Vice President
Investor Relations


Source: Business Wire (July 27, 2007 - 6:03 AM EST)

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