Here you go, Jon:
[EDIT] Adams quote gives you the jist: <<"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." >> [END EDIT]
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(TM) 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(R) in the U.S.) in Japan -- Submitted Marketing Authorization Application (MAA) for LUNIVIA(R) brand eszopiclone (marketed as LUNESTA in the U.S.) for the treatment of insomnia in the European Union (EU)
MARLBOROUGH, Mass., Jul 27, 2007 (BUSINESS WIRE) -- 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(R) 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(R) 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(R) 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(R) brand desloratadine, sanofi-aventis' ALLEGRA(R) brand fexofenadine HCl and UCB's XYZAL(R)/XUSAL(TM) 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.
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