Clinical Data Completes Strategic Transition to Pharmaceutical Company with PDUFA Date for Vilazodone

Strategic Insights -

Clinical Data, Inc. has signed a definitive asset purchase agreement with Transgenomic, Inc. to sell its genetic and pharmacogenomic testing and biomarker development business for approximately $15.4 million. This sale completes Clinical Data's transformation to a pharmaceutical company, focusing on advancing its late-stage therapeutic programs, including vilazodone, a new treatment for Major Depressive Disorder.

Key Takeaways:

  • Clinical Data sold its genetic and pharmacogenomic testing and biomarker development business to Transgenomic, Inc. for approximately $15.4 million.
  • The sale includes $6 million in cash, a three-year promissory note for $8.5 million bearing interest at 10%, and a one-year promissory note for $932,000 bearing interest at 6.5%.
  • Clinical Data will receive a percentage of accounts receivables collected by Transgenomic after the closing, as well as milestones and royalty payments on the development and commercialization of multiple new pharmacogenomic diagnostic products.
  • The transaction will complete Clinical Data's transformation to a pharmaceutical company with a deep product pipeline, including two late-stage compounds, vilazodone and Stedivaze.
  • A New Drug Application for vilazodone was accepted for review by the U.S. Food and Drug Administration (FDA) on May 21, 2010, with a currently assigned PDUFA date of January 22, 2011.
  • Clinical Data's commercial team will focus exclusively on the launch of vilazodone, subject to the successful completion of FDA review.
  • The sale will reduce Clinical Data's cash consumption from non-core assets and enable the company to fully focus on advancing its late-stage therapeutic programs.

Statistics:

  • $15.4 million: the approximate sale price of Clinical Data's genetic and pharmacogenomic testing and biomarker development business to Transgenomic, Inc.
  • $6 million: the cash portion of the sale.
  • $8.5 million: the three-year promissory note bearing interest at 10%.
  • $932,000: the one-year promissory note bearing interest at 6.5%.
  • 18 months: the timeframe for collecting accounts receivables, estimated to be as high as $1.8 million.
  • Up to $500,000: the milestones in cash or Transgenomic's stock upon the commercial launch of two pharmacogenomic tests.
  • $1.8 million: the estimated accounts receivables to be collected over the first 18 months.

Sources:

  • Clinical Data, Inc. Press Release, May 25, 2010 (emphasis on the asset sale to Transgenomic, Inc.)
  • Clinical Data, Inc. Form 8-K filing with the U.S. Securities and Exchange Commission, May 25, 2010 (providing details on the asset sale)
  • Clinical Data, Inc. Annual Report on Form 10-K for the fiscal year ended March 31, 2010 (background information on the company's operations and financials)