WASHINGTON, Oct. 27, 2014 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA), today announced financial and operational results for the third quarter ended September 30, 2014.
“Our innovative approach to the commercialization of HETLIOZ® for Non-24 has yielded impressive third quarter revenue. We are developing a robust commercial engine that has just begun to access the Non-24 market in the U.S. by creating awareness leading to diagnosis and treatment,” said Mihael Polymeropoulos M.D., Vanda’s President and CEO. “The Named Patient Program launch in the EU and Canada under the HETLIOZAccess initiative furthers our commitment to patients with Non-24 worldwide.”
“Our commercial and clinical pipeline is also advancing with the recent launch of Fanapt® in Israel, the planned launch of Fanapt® in Mexico, the HETLIOZ® European Marketing Authorization Application, and development activities in pediatric Non-24, Smith-Magenis Syndrome, and chronic pruritus,” added Dr. Polymeropoulos.
Key Highlights:
HETLIOZ® (tasimelteon)
- HETLIOZ® U.S. sales grew to $5.2 million in the first full quarter since launch. HETLIOZ® is the first approved treatment for adults with Non-24-Hour Sleep-Wake Disorder (Non-24).
- Over 600 new patient prescriptions have been written for HETLIOZ® in the U.S.
- HETLIOZ® Marketing Authorization Application in the European Union (EU) was accepted by the European Medicines Agency (EMA) for review in June 2014; Vanda expects a regulatory decision in the third quarter of 2015.
- In September 2014, the HETLIOZAccess Named Patient Program launched in the EU and Canada. Vanda has launched the HETLIOZAccess program in geographic locations where HETLIOZ® is not yet approved but where the company is pursuing regulatory approvals.
Fanapt® (iloperidone)
- Fanapt® generated first ex-U.S. product revenue of $0.1 million. Fanapt® was launched in Israel by our distribution partner, Megapharm. Fanapt® is expected to launch later this year in Mexico by our distribution partner, Probiomed.
Clinical pipeline advances
- Non-24 pediatric population (tasimelteon). Vanda has initiated development activities for a pediatric formulation to be studied in pediatric patients with Non-24. Vanda has also initiated discussions with the U.S. Food and Drug Administration (FDA) and the EMA on clinical protocol designs for this indication.
- Smith-Magenis Syndrome (SMS) (tasimelteon). SMS is a rare genetic disorder caused by a deletion on chromosome 17 and estimated to affect approximately 1 in 20,000 people. One of the cardinal features is a disruption of the sleep-wake cycle. Vanda has initiated an observational study in patients with SMS in order to further characterize the circadian rhythm defect and its association with clinical symptoms. Results of this study are expected in the first half of 2015.
- Chronic Pruritus (VLY-686, tradipitant). Vanda’s Phase 2 study (2101), a double masked randomized study of tradipitant and placebo in patients with chronic pruritus in the context of atopic dermatitis, is ongoing in Germany. Results from this study are expected in the first half of 2015. In August of 2014, an Investigational New Drug application was filed with the FDA.
THIRD QUARTER 2014 REPORTED RESULTS
Total revenues for the third quarter of 2014 were $14.8 million, compared to $10.9 million for the second quarter of 2014 and $8.7 million for the third quarter of 2013. Net product revenues related to U.S. sales of HETLIOZ® in the third quarter of 2014 were $5.2 million as compared to $1.6 million in the second quarter of 2014.
Total operating expenses for the third quarter of 2014 were $16.2 million, compared to $32.5 million for the second quarter of 2014 and $14.1 million for the third quarter of 2013. Vanda recorded a net loss of $1.4 million for the third quarter of 2014, compared to a net loss of $21.6 million for the second quarter of 2014 and $5.4 million for the third quarter of 2013. Diluted net loss per share for the third quarter of 2014 was $0.04, compared to a net loss per share of $0.64 during the second quarter of 2014 and $0.17 for the third quarter of 2013.
Cash, cash equivalents and marketable securities were $56.1 million as of September 30, 2014.
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