Q2 results--here's the full report. Also thought Xopenex sales were surprisingly robust, subject to caveats already noted. I've been skeptical of SEPR's ability as a small company to market drugs on its own, as well as of the marketability of some of SEPR's drugs, such as Xopenex, which don't eliminate a fatal defect in the parent drug (the Seldane/ Allegra model). But I wonder if the marketing model isn't changing, as patients gather information themselves over the internet. Originally, prescription drugs were sold to doctors, who made decisions for their patients, then Claritin showed the power of a direct-to-consumer marketing model for certain indications. Now, with the internet, people can seek out new medications themselves, and ask for them from their physician. So pronouncements by the medical establishment (The Medical Letter) may not be as significant as before. Just a thought.
biz.yahoo.com
>>Sepracor Announces Second Quarter 1999 Financial Results
MARLBOROUGH, Mass., July 23 /PRNewswire/ -- Sepracor Inc. (Nasdaq: SEPR - news) today announced its consolidated financial results for the second quarter of 1999. For the three months ended June 30, 1999, Sepracor's consolidated revenues from continuing operations were $5.0 million, of which revenues from Xopenex(TM) were $4.2 million, and the net loss applicable to common shares was $36.6 million, or $1.11 per share. These consolidated results compare with consolidated revenues from continuing operations of $0.6 million, and a net loss applicable to common shares of $17.6 million, or $0.63 per share for the three months ended June 30, 1998.
For the six months ended June 30, 1999, Sepracor's consolidated revenues from continuing operations were $7.7 million, and the net loss applicable to common shares was $66.9 million, or $2.04 per share. This compares with consolidated revenues from continuing operations of $7.5 million, and a net loss applicable to common shares of $29.5 million, or $1.05 per share, for the six months ended June 30, 1998. Financial results for the three and six month periods ended June 30, 1999 and 1998 have been reclassified to record discontinued operations of BioSphere Medical, Inc. (formerly BioSepra Inc.), a subsidiary of Sepracor.
As of June 30, 1999, Sepracor had approximately $434 million in consolidated cash, cash equivalents and marketable securities.
Corporate News
Sepracor launched its first directly-marketed drug, Xopenex (levalbuterol HCl) inhalation solution, in two dosage strengths for use with a nebulizer in late April. The drug is sold through Sepracor's respiratory sales force to pulmonologists, allergists, pediatricians, and primary care physicians. Sepracor is also developing Xopenex for use in several additional delivery systems including syrup, tablet, dry-powder inhaler and metered-dose inhaler.
Also in the quarter, Sepracor announced a licensing agreement with UCB Farchim SA, an affiliate of UCB, relating to levocetirizine, an isomer of ZYRTEC® (racemic cetirizine) for the treatment of allergies. ZYRTEC, discovered and marketed by UCB, is Europe's leading antihistamine with sales of approximately $250 million in 1998.
Under the terms of the agreement, Sepracor has exclusively licensed to UCB all of Sepracor's issued patents and pending patent applications regarding levocetirizine in Europe and other countries. Sepracor has retained rights to this compound in the United States and Japan. UCB will begin to pay Sepracor royalties upon first product sale, and royalties will escalate upon achievement of sales volume milestones. UCB has announced that it intends to file a marketing authorization application (MAA), the European equivalent of a new drug application (NDA), for levocetirizine in early 2000. Levocetirizine is currently in Phase III clinical trials in Europe.
In May, Sepracor announced that Johnson & Johnson elected not to exercise its option to co-promote norastemizole, a nonsedating antihistamine being developed for seasonal and perennial allergic rhinitis. Sepracor will continue to fund clinical development and marketing of the drug, which is currently in Phase III clinical trials. Under the terms of the agreement between Sepracor and Johnson & Johnson, Sepracor has worldwide rights to all Johnson & Johnson intellectual property covering norastemizole, including the right to reference data from the astemizole New Drug Application (NDA), for Sepracor's norastemizole NDA filing. In exchange, Johnson & Johnson will receive a royalty on Sepracor's product sales.
Clinical News
Sepracor announced the results of a Phase IIA, 49-patient single-dose study comparing four doses of (R,R)-formoterol with the marketed dose of Ventolin® and placebo. (R,R)-Formoterol demonstrated an immediate increase in FEV1(1) after administration at all doses tested, with comparable peak FEV1 improvement comparable to Ventolin and 24-hour bronchodilation at the higher doses tested.
(R,R)-Formoterol is the single-isomer form of Novartis' Foradil® and Yamanouchi's Atock®. (R,R)-Formoterol is a long-acting bronchodilator that has the potential for long duration coupled with rapid onset of action. This combination of benefits should make the ICE candidate an attractive entry in the long-acting bronchodilator market, which had 1998 worldwide sales of approximately $1 billion. (R,R)-Formoterol has the potential to be the first once-a-day long acting bronchodilator and is expected to be sold through Sepracor's respiratory sales force.<<
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