Zacks_Analysts' Blog : Tagatose Development On-Track - Analyst Blog

Spherix (SPEX) reported financial results for the fourth quarter and full year 2009 on April 1, 2010. Total revenues for the fourth quarter were $0.3 million, in-line with our forecast. Revenues consisted of consulting fees from the company’s Health Sciences business. Total revenues for the full year 2009 were $1.4 million, up 32% from the full year 2008.



The Health Sciences business provides technical and regulatory consulting services to biotechnology and pharmaceutical companies, as well as providing technical support for the company’s own R&D activities. During 2009, Health Sciences provided services to a total of 12 companies. Revenue from the top 5 customers accounted for 19%, 16%, 14%, 12% and 11% of total revenues. No other customer of the Health Science business accounted for more than 10% of total revenues.



Net loss for the fourth quarter 2009 was $3.4 million, or -$0.21 per share. For the full year 2009, net loss totaled $9.1 million, or -$0.62 per share. Spherix exited 2009 with $9.4 million in cash and investments. We believe this is sufficient cash to fund operations through the completion of the ongoing phase III program testing D-tagatose as a treatment for type 2 diabetes.



Phase III Enrollment Completed



Enrollment has completed in the phase III NEET (Naturlose Efficacy Evaluation Trial) program in January 2010. Preliminary blinded data released by the company in November 2009 demonstrated a significant reduction in variability of HbA1c levels. The data also confirmed that the current protocol is sufficiently powered to achieve the statistical significance as per the primary endpoint of differences between control and D-tagatose in HbA1c.



The blinded analysis noted that the results of the secondary variables, LDL, HDL, triglycerides and BMI, are in agreement with that of the HbA1c results. The blinded interim analysis also looked at a summary of HbA1c "responders" (i.e., subjects achieving HbA1c target of <6.5%). The incidences of responders achieving an HbA1c target of <6.5% at 1, 2, 4 and 6 months of treatment were 4%, 13%, 19% and 18% respectively.  Because the trial is randomized 1:1 in terms of drug and placebo, approximately 50% of the patients received placebo.



Management’s goal is to complete the ongoing NEET program late 2010, and then file for U.S. FDA approval during the first half of 2011. We expect management to secure a commercialization partnership for D-tagatose around the NDA filing.



With a current market capitalization of only $21 million, we believe the shares are significantly undervalued. An effective and safe phase III type-2 diabetes drug is a highly coveted asset in the pharmaceutical industry, and D-tagatose looks like the real thing. In fact, we would not be surprised to see an outright acquisition by a larger organization instead of a licensing or commercialization partnership. We believe this could occur at a value of $60 million or higher, yielding a near-term fair-value target of $3.50 per share.
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