Sequenom presented a financial update and their plans for their T21 trisomy 21 noninvasive pre-natal test for fetal gene and chromosomal abnormalities. The Company plans to launch a CLIA LDT (lab developed test) by Q4 2011 and submit a PMA by late 2012. The Seroquel no prescription to buy T21 test will utilize the Illumina (ILMN) HiSeq 2000 next -generation sequencing platform which was recently launched by ILMN. The Fetal Nucleic Acid Technology utilized by SQNM test utilizes circulating cell-free maternal plasma to examine variances in genetic material of the fetus.
Sequenom received an FDA letter recently along with 13 other companies recently regarding improper marketing of LDT’s and the Company responded that it is marketing only to physicians and not to consumers.
Total revenue for Q2 grew 24% to $11.4M primarily MassARRAY DNA analysis system and related consumables. 11 systems were shipped in Q4 for basic and translational research use only, with a total of 350 systems placed worldwide. A Next Generation MassARRAY 4 mass spectrometry system was recently introduced for genetic analysis and validation of biomarkers. Losses for Q2 were $59.1M or $0.86 per share. Analyst forecasts for 2011 revenues are in the $60M range. All of the legal issues of the Company have been resolved so legal and admin costs should be reduced. The Company has $68M in Cash but will need more funding by late next year. A $150M shelf offering was filed today.