As noted above, OPTN is a specialty pharmaceutical company. More specifically. it is focused on developing products for patients treated by ear, nose and throat (ENT) and allergy specialists. Its lead product, XHANCE nasal spray, utilizes its proprietary Breath Powered exhalation delivery system, (EDS) to deliver a topically-acting and potent anti-inflammatory corticosteroid for the treatment of chronic rhinosinusitis with nasal polyp, and if approved, chronic rhinosinusitis without nasal polyps. Chronic rhinosinusitis is a serious nasal inflammatory disease that is currently treated using therapies, such as intranasal steroids that have significant limitations.
OPTN is off to a pretty good start. On September 18, 2017, the FDA approved its new drug application for XHANCE for the treatment of nasal polyps in patients 18 years of age or older. Consequently, it expects to launch XHANCE for the treatment of nasal polyps in 2Q18 with a dedicated sales force targeting a specialty prescriber base comprised of approximately 15,000 physicians in the United States. OPTN expects its sales force will initially consist of approximately 75 representatives. Furthermore, it plans to initiate additional clinical trials of XHANCE in 2H18 to seek a follow-on indication for the treatment of chronic sinusitis to broaden its market opportunity.
The company has conducted five clinical trials evaluating over 1,500 adult patients, including two randomized, double-blinded, placebo-controlled Phase 3 pivotal clinical trials in adults with nasal polyps and two supportive open-label Phase 3 clinical trials in adults with symptoms of chronic sinusitis with and without nasal polyps. In both Phase 3 pivotal clinical trials, patients treated with XHANCE experienced statistically significant reductions of both nasal congestion/obstruction symptoms and total polyp grade, which were the co-primary endpoints. Treatment benefits were also observed in all four defining symptoms of chronic rhinosinusitis, as well as in polyp elimination, quality of life, need for sinus surgery and patient global impression of change.
OPTN's initial target market for XHANCE will consist of ENT physicians, allergists and primary care physicians in the United States that most frequently prescribe INS. This group of approximately 5,000 primary care physicians accounts for approximately 25% of all INS prescriptions written by primary care physicians.
It believes the approximately 15,000 physicians in this specialty segment together treat an estimated 3.5 million U.S. patients with chronic rhinosinusitis, an estimated 1.2 million of whom have chronic rhinosinusitis with nasal polyps. Therefore, the total annual U.S. market opportunity for XHANCE in this specialty segment is over $3.4 billion, of which approximately one-third consists of patients with chronic rhinosinusitis with nasal polyps.
If the company is able to obtain approval for the follow-on indication of chronic sinusitis, it intends to broaden its commercialization efforts to target additional primary care physicians that it believes treat an additional estimated 6.25 million U.S. patients with chronic rhinosinusitis.
As a clinical stage company, there isn't too much in the way of financials yet. The company didn't generate any revenue over the first six months of the year. Operating loss for the six month period ended June 30, 2017 was ($15.6) million.On a pro forma basis, OPTN has $149.1 million in cash. OPTN believes with the proceeds from this offering, together with existing cash, it will have enough capital to last into 1Q19.