Looks like xopenex blew out my and IJ's est. $31.6M puts them at $90M year to date. We'll have to wait for the cc for more detail.
Friday October 19, 7:01 am Eastern Time
Press Release
SOURCE: Sepracor Inc.
Sepracor Announces Third Quarter 2001 Financial Results
MARLBOROUGH, Mass., Oct. 19 /PRNewswire/ -- Sepracor Inc. (Nasdaq: SEPR - news) today announced its consolidated financial results for the third quarter of 2001. For the three months ended September 30, 2001, Sepracor's consolidated revenues were $36.7 million, of which revenues from pharmaceutical sales were $31.6 million, and the net loss applicable to common shares was $36.4 million, or $0.47 per share. These consolidated results compare with consolidated revenues of $11.5 million, of which revenues from pharmaceutical sales were $9.6 million, and a net loss applicable to common shares of $45.2 million, or $0.62 per share, for the three months ended September 30, 2000.
For the nine months ended September 30, 2001, Sepracor's consolidated revenues were $114.8 million, of which revenues from pharmaceutical sales were $90.0 million, and the net loss applicable to common shares was $121.7 million, or $1.57 per share. This compares with consolidated revenues of $60.9 million, of which revenues from pharmaceutical sales were $32.6 million, and a net loss applicable to common shares of $130.6 million, or $1.80 per share, for the nine months ended September 30, 2000.
Sepracor's consolidated financial results for the third quarter of 2000 included the results of BioSphere Medical, Inc., which was approximately 56% owned by Sepracor at September 30, 2000. In July 2001, BioSphere completed a public offering of 4,600,000 shares of its common stock, including 2,600,000 shares owned by Sepracor. As a result of the offering, Sepracor's ownership of BioSphere was reduced to approximately 26%. Effective July 2001, Sepracor ceased to consolidate BioSphere's financial results.
As of September 30, 2001, Sepracor had approximately $479 million in consolidated cash, cash equivalents and marketable securities.
Self-Developed and Self-Marketed Programs
XOPENEX® brand levalbuterol HCl -- A Supplemental New Drug Application (sNDA) seeking clearance to market XOPENEX inhalation solution at lower dosage strengths for the treatment or prevention of bronchospasm in patients 4 to 11 years old is under review at the U.S. Food and Drug Administration (FDA). Results of a large-scale (n=340), randomized, double-blind, placebo- controlled, parallel-group, pediatric study were included in the supplemental filing to the FDA.
Launched in May 1999, XOPENEX is sold in the U.S. through Sepracor's sales force and is co-promoted by the Ross Products Division of Abbott Laboratories. Sepracor now markets XOPENEX inhalation solution in dosage strengths of 0.63 mg and 1.25 mg for nebulizer use. Additional delivery formulations for levalbuterol are in development. Large-scale studies are currently underway for levalbuterol in a hydrofluoroalkane (HFA) metered dose inhaler in children, adolescents and adults.
SOLTARA(TM) brand tecastemizole (formerly norastemizole) -- On May 9, 2001, Sepracor announced that the FDA accepted for review the New Drug Application (NDA) for SOLTARA brand tecastemizole 15 mg and 30 mg capsules for the treatment of allergic rhinitis. The NDA contained data from seven large- scale allergic rhinitis studies, more than 30 smaller clinical trials, and 200 preclinical studies. Sepracor's clinical studies included patients with seasonal and perennial allergic rhinitis. In these studies, over 3,700 subjects were treated with SOLTARA at doses ranging from 2 mg to 300 mg. In addition to SOLTARA capsules, Sepracor is developing a SOLTARA pseudoephedrine combination product for the treatment of allergic rhinitis, as well as a syrup and a rapidly dissolving tablet. Prescription antihistamine product sales in the U.S. in 2000 were approaching $5 billion, which represents a growth rate of more than 20 percent over the previous year, according to IMS Health information.
ESTORRA(TM) brand esopiclone -- Sepracor has completed 19 clinical trials, including three pivotal studies, for ESTORRA brand esopiclone for the treatment of sleep disorders. All pivotal studies necessary for inclusion in the NDA have been completed. Data from the studies have shown the drug to be successful in achieving the targeted endpoints of hypnotic efficacy and well tolerated with no evidence of any clinically relevant residual effects. NDA preparation for ESTORRA continues. Sleep disorders affect approximately 85 million people in the U.S. The U.S. market for prescription sleep products is approaching $1 billion and growing at a rate of 30 percent per year, according to IMS Health information.
(S)-Oxybutynin -- Sepracor has initiated a twelve-week, Phase III study for (S)-oxybutynin in a sustained-release formulation for the treatment of overactive bladder. The study will include approximately 850 patients at 70 sites throughout the U.S. A pharmacokinetic and pharmacodynamic (PK/PD) analysis of (S)-oxybutynin was successfully completed earlier this year. The sustained-release formulation was designed to provide a more constant level of drug therapy and should permit once-a-day dosing with less peak to trough variability, and an improved therapeutic profile. Worldwide sales of prescription stress and urge urinary incontinence products were approximately $1 billion in 2000, according to IMS Health information.
(R,R)-Formoterol -- During the quarter, Sepracor announced the advancement of (R,R)-formoterol inhalation solution into Phase III studies for the treatment of bronchospasm in patients with obstructive airway disease. Results of Sepracor's (R,R)-formoterol Phase II program demonstrated a significant improvement in FEV1 immediately after dosing and a duration of action of up to 24 hours. Currently marketed long-acting beta-agonists require twice-a-day dosing and are not currently available in an inhalation solution. The worldwide market for long-acting bronchodilators was approximately $1.8 billion in 2000, according to IMS Health information.
In Sepracor's Phase II program for obstructive airway disease, including asthma and chronic obstructive pulmonary disease (COPD), (R,R)-formoterol exhibited a rapid onset of action comparable to the short-acting bronchodilator, VENTOLIN®, as well as a duration of action of up to 24 hours in all studies. In a Phase II 340-patient multi-dose asthma trial, (R,R)-formoterol at a range of doses tested, significantly improved lung function (p< 0.001 versus placebo). These changes, measured as FEV1 increases from baseline, ranged from 24 percent to 27 percent. In these studies, (R,R)-formoterol again had a duration of action of up to 24 hours with a side effect profile comparable to other beta-agonists.
(R)-Sibutramine Metabolite -- Large-scale studies of the (R)-sibutramine metabolite continue. In preclinical trials, the (R)-sibutramine metabolite has been shown to be a potent serotonin, norepinephrine and dopamine reuptake inhibitor. The compound is being evaluated for the treatment of depression and attention deficit hyperactivity disorder.
(S)-Sibutramine Metabolite -- The (S)-sibutramine metabolite for the treatment of sexual dysfunction is currently in Phase II trials. Preclinical in vitro studies have shown the (S)-sibutramine metabolite to be a potent inhibitor of both dopamine and norepinephrine which have the potential to improve both erectile and ejaculatory dysfunction. Sepracor plans to study the (S)-sibutramine metabolite for the treatment of male and female sexual dysfunction.
SEP174559 -- Sepracor has initiated a Phase I clinical study of SEP174559 for the treatment of acute and chronic anxiety. The compound has the potential for a more rapid onset of action than presently available nonsedating anxiolytics.
Partnered Program Update
Sepracor continues to earn royalties from Aventis for sales of ALLEGRA® brand fexofenadine HCl, a nonsedating antihistamine for the treatment of allergies, in the U.S., Japan, Europe, Canada, Australia, and on sales in additional countries where Sepracor holds patents related to fexofenadine.
In September 2001, UCB announced that EU Member States granted a positive opinion for levocetirizine, a single isomer of ZYRTEC®, for the treatment of symptoms of seasonal allergic rhinitis, perennial allergic rhinitis and chronic idiopathic urticaria in adults and children aged 6 years and older. Marketed in Germany since February 2001 under the brand name XUSAL(TM), levocetirizine is expected to be launched in 15 other European countries in the coming months under the brand name XYZAL(TM). Sepracor continues to earn royalties on product sales in Germany and expects to earn royalties on sales in EU Member States upon launch.
On January 19, 2001, Schering-Plough Corporation received an approvable letter from the FDA for CLARINEX(TM) Tablets (desloratadine), an active metabolite of CLARITIN®, for the treatment of seasonal allergic rhinitis. Schering-Plough also reported that the FDA has advised the company that Good Manufacturing Practices deficiencies cited in facility inspection reports must be resolved prior to granting approval of the company's pending NDA for CLARINEX Tablets. Schering-Plough has stated that there are no outstanding scientific or clinical issues that would affect approval of the product and that they are ready to launch CLARINEX into the U.S. market upon approval. Sepracor is entitled to receive royalties on sales of CLARINEX upon launch of the product in the U.S.
In the second quarter, Sepracor was notified by Janssen Pharmaceutica, N.V., a wholly-owned subsidiary of Johnson & Johnson, that two phase II trials to evaluate the efficacy and safety of ticalopride((+)-norcisapride) in subjects with symptoms of gastroesophageal reflux disease (GERD) or gastroparesis were being suspended pending further analysis of a small number of adverse events reported in GERD and diabetic patients. Sepracor continues to work with Johnson & Johnson to assess the data from the suspended Phase II trials of ticalopride.
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 Nine months ended
September 30, September 30,
2001 2000 2001 2000
Revenues:
Product sales $31,574 $10,179 $93,039 $33,680
R&D, license fees, royalties 5,118 1,304 21,803 27,188
Total revenues 36,692 11,483 114,842 60,868
Cost of revenue 3,228 2,534 12,431 10,635
Gross margin 33,464 8,949 102,411 50,233
Operating expenses:
Research and development 56,981 34,968 154,227 105,480
Sales and marketing 25,075 18,738 67,625 54,362
General and administrative and
patent costs 4,413 5,324 15,021 15,281
Total operating expenses 86,469 59,030 236,873 175,123
Loss from operations (53,005) (50,081) (134,462) (124,890)
Other income (expense):
Interest income 5,229 11,683 21,013 30,872
Interest expense (11,017) (12,467) (33,772) (35,286)
Other income (expenses),
net(A) 48 70 1,022 (7,336)
Gain on sale of subsidiary
stock(B) 23,113 - 23,113 -
Equity in investee gain
(loss)(C) (812) 4,490 (812) 3,501
Total other income (expense) 16,561 3,776 10,564 (8,249)
Net loss before minority
interest (36,444) (46,305) (123,898) (133,139)
Minority interest in subsidiary - 1,079 2,152 2,568
Net loss $(36,444) $(45,226) $(121,746) $(130,571)
Basic and diluted net loss per
common share $(0.47) $(0.62) $(1.57) $(1.80)
Shares used in computing basic
and diluted
net loss per common share: 77,866 73,334 77,390 72,435
(A) Includes $7,497 in expenses relating to prepaid interest and fees
for the conversion of 6 1/4% convertible debentures for the nine months
ended September 30, 2000.
(B) Represents Sepracor's gain on the sale of 2.6 million shares of
BioSphere Medical Inc. stock for the three and nine months ended
September 30, 2001.
(C) Represents Sepracor's portion of HemaSure Inc. losses and a gain of
$5,000 resulting from the removal of a HemaSure loan guarantee for the
three and nine months ended September 30, 2000 and Sepracor's portion
of BioSphere Medical Inc. losses for the three and nine months ended
September 30, 2001.
Sepracor Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
(in thousands) September 30, December 31,
2001 2000
ASSETS
Cash, short and long-term
investments $479,231 $634,479
Accounts receivable, net 20,699 14,756
Inventory, net 7,078 5,998
Property, plant and equipment,
net 24,436 22,676
Investment in Versicor 24,243 13,746
Other assets(A) 73,026 59,303
Total assets $628,713 $750,958
LIABILITIES AND STOCKHOLDERS'
EQUITY (DEFICIT)
Accounts payable and accrued
expenses $77,075 $96,225
Other liabilities 16,330 8,288
Debt payable 2,197 1,242
Convertible subordinated
debentures(B) 759,960 852,818
Minority interest in subsidiary - 7,059
Total stockholders' equity
(deficit) (226,849) (214,674)
Total liabilities and
stockholders' equity
(deficit) $628,713 $750,958 |
