Fourth Quarter 2012 Financial Results
- Acceptance by the EMA for review of the MAA filings for vintafolide and etarfolatide in platinum-resistant ovarian cancer
- Trial enrollment on track for the Phase 3 PROCEED trial in platinum-resistant ovarian cancer and the Phase 2b TARGET trial in second line NSCLC
- The option to add 100 additional patients to the PROCEED study to support overall survival analysis
- A fourth vintafolide clinical study in folate receptor-positive triple negative breast cancer
- On schedule to file two investigational new drug applications (INDs) in the next 12 months: a folate-targeted SMDC incorporating tubulysin as the drug payload and a prostate-specific membrane antigen (PSMA) targeted SMDC for prostate cancer
Endocyte reported a net loss of $0.8 million, or $0.02 per basic and diluted share for the fourth quarter of 2012, compared to a net loss of $10.8 million, or $0.30 per basic and diluted share, for the same period in 2011.
Revenue was $14.5 million for the fourth quarter of 2012 associated with the collaboration with Merck. Of this revenue, $13.5 million related to the amortization of (1) the $120.0 million upfront license payment; (2) a $5.0 million milestone payment received for the MAA filing during the fourth quarter and (3) $9.5 million in reimbursable research and development expenditures incurred prior to the fourth quarter of 2012. The remaining $1.0 million of revenue related to amortization of reimbursable research and development expenditures incurred during the fourth quarter of 2012. The amortization for both the upfront license fee and ongoing research and development services are recognized as revenue ratably over a performance period that began at the closing date of the agreement, April 27, 2012, and will conclude at the end of 2014.
Research and development expenses were $10.5 million for the fourth quarter of 2012, compared to $7.8 million for the same period in 2011. The increase was driven by an increase in clinical trial expenses, development costs of the preclinical pipeline and compensation expense, partially offset by a decrease in manufacturing costs related to process and method validations for Endocyte's lead candidate's vintafolide and etarfolatide. Merck funds manufacturing costs for vintafolide, along with a portion of the PROCEED trial and all of the TARGET trial costs, under the companies' collaboration agreement. Adjusted research and development expenses were $6.4 million for the fourth quarter of 2012, net of the $4.1 million current period expenses reimbursable by Merck referred to above.