Clinical Data reports $2.0 million revenue for third quarter 2011

Feb 9 2011

Clinical Data, Inc. (NASDAQ: CLDA) today announced operational and financial results for the third fiscal quarter ended December 31, 2010. The Company received approval from the U.S. Food and Drug Administration (FDA) of Viibryd™ for the treatment of adults with major depressive disorder (MDD) on January 21, 2011. In addition, Phase III development of Stedivaze, the Company's coronary vasodilator for use in nuclear-SPECT myocardial perfusion imaging (MPI), is continuing with the initiation of a second Phase III trial anticipated in the second quarter of this calendar year.

“The recent FDA approval of Viibryd is a tremendous success for Clinical Data and we are eager to provide this first and only treatment that is a selective serotonin reuptake inhibitor and 5HT1A receptor partial agonist to patients with MDD”

"The recent FDA approval of Viibryd is a tremendous success for Clinical Data and we are eager to provide this first and only treatment that is a selective serotonin reuptake inhibitor and 5HT_1A receptor partial agonist to patients with MDD," said Drew Fromkin, Clinical Data's President and Chief Executive Officer. "Viibryd is a new and different antidepressant that will enter a $12 billion U.S. market, with potential for 11 years of market exclusivity."

Third Quarter Fiscal 2011 and Recent Highlights

• Obtained FDA approval of Viibryd™ for the treatment of adults with MDD, with the product expected to be available in U.S. pharmacies in the second quarter of this calendar year
• Obtained an issued patent for the most commercially viable polymorphic form of Viibryd (vilazodone HCl, Form IV), providing Viibryd exclusive protection in the U.S. for nearly three additional years. This issued patent will expire in 2022.
• Presented supportive data from clinical trials of Viibryd at major medical meetings, including: 1) two placebo-controlled Phase III clinical trials and a long-term safety study demonstrating Viibryd's therapeutic profile, 2) a Thorough QT Study, and 3) a bioavailability study
• Sold the Company's genetic and pharmacogenomic testing and biomarker development business for $15.6 million plus certain future accounts receivables, milestones and royalties, completing Clinical Data's transformation into a pharmaceutical company with a deep product pipeline
• Received notice of a $2.0 million milestone from Santen Pharmaceutical Co., Ltd. for their filing of an Investigational New Drug (IND) application with the FDA for Clinical Data's highly selective adenosine A_2A agonist, ATL313, for primary open angle glaucoma and ocular hypertension. Santen expects to begin clinical trials in early 2011.
• Obtained Orphan Drug Designation from the FDA for PRX-8066, a selective serotonin 2B (5-HT_2B) receptor antagonist, in Phase II development for pulmonary arterial hypertension (PAH)
• Received two grants totaling nearly $0.5 million for research and development efforts related to Viibryd and Stedivaze
• Reported a cash burn for the quarter of $4.7 million, which included $6.0 million related to a portion of the cash proceeds from the sale of the Company's genetic testing business, $1.5 million from the release of funds held in escrow from a previous transaction, and other items totaling approximately $1.0 million

Commenting on the Company's third quarter financial results, Mr. Fromkin added, "Our track record of fiscal discipline is evident again this quarter. By employing a strict cash management and resource prioritization approach, together with our proven ability to monetize non-core assets again this quarter, we reported a cash burn of under $5.0 million. This is a notable achievement when considering the increased expenses related to the commercial launch preparations for Viibryd and continued patient enrollment in our Phase III trial for Stedivaze."

Financial Results for the Three Months Ended December 31, 2010

Revenue for the three months ended December 31, 2010 was $2.0 million, all of which was related to a non-recurring milestone from Santen upon filing its IND for Clinical Data's ATL313 compound in development for glaucoma. The Company did not have any revenue during the three months ended December 31, 2009, after the financial statements were adjusted to reflect the genetic and biomarker development business as discontinued operations.

Research and development expenses were essentially flat at $8.9 million for the three months ended December 31, 2010, compared with $8.8 million for the three months ended December 31, 2009. Research and development efforts were primarily attributable to the commercialization activities for Viibryd in anticipation of FDA approval, which occurred in early 2011, and the ongoing Phase III ASPECT 1 trial for Stedivaze.

General and administrative expenses increased $0.6 million, or 20%, to $3.8 million for the three months ended December 31, 2010 from $3.2 million for the three months ended December 31, 2009.

Financial Results for the Nine Months Ended December 31, 2010

Revenue for the nine months ended December 31, 2010 was $4.0 million, attributed to two non-recurring $2.0 million milestones from Santen: 1) exercising their option to license ATL313 for further development of glaucoma treatments in May 2010, and 2) filing an IND with ATL313 for glaucoma in December 2010. The Company did not have any revenue during the nine months ended December 31, 2009, after the financial statements were adjusted to reflect the genetic and biomarker development business as discontinued operations.

Research and development expenses remained essentially flat at $27.4 million for the nine months ended December 31, 2010, compared to $27.2 million for the nine months ended December 31, 2009.

General and administrative expenses increased $1.3 million, or 11%, to $12.5 million for the nine months ended December 31, 2010, up from $11.2 million for the nine months ended December 31, 2009.

Cash and cash equivalents at December 31, 2010 were $42.3 million.