Vivus 4Q16 – Qsymia revenue down 11% YOY to $48.5 million for full year; Sales fall 21% YOY to $11 million in 4Q16 – March 20, 2017

Vivus recently provided a despondent 4Q16 and year-end update in a call led by CEO Mr. Mark Ori. You can listen to a replay of the webcast here.

Qsymia (phentermine/topiramate extended-release) sales totaled $11 million for 4Q16 and $48.5 million for the full year 2016, which represents 21% year-over-year (YOY) decline and 11% YOY decline, respectively. Sequentially, 4Q16 revenue fell 10% from $12.3 million in 3Q16. According to the company’s news release, ~100,000 prescriptions of the obesity drug were dispensed in 4Q16 – this marks a 24% YOY drop in Qsymia volume, compared to ~132,000 prescriptions in 4Q15. In all of 2016, ~442,000 Qsymia prescriptions were dispensed, which is 22% YOY lower than the ~566,000 prescriptions dispensed in 2015. These numbers largely match the story we’ve been hearing on Qsymia throughout 2016 (see our coverage from 1Q16, 2Q16, and 3Q16), in that ongoing commercial challenges and are affecting both volume and sales. It also matches the story that this compound has just never taken off. It’s a tough market for obesity medicines in general, given stigma surrounding obesity (rather than recognition of the chronic condition as a treatable, biological disease), and given patient/provider reluctance to consider pharmacotherapy as a viable treatment option. Reimbursement prospects also continue to be extremely poor. We believe it will be challenging to address satisfactorily these obstacles to increase accessibility to Qsymia and other similar obesity drugs, including Orexigen’s Contrave (naltrexone/bupropion extended-release) and Arena/Eisai’s Belviq (lorcaserin). Novo Nordisk’s Saxenda (liraglutide 3.0 mg) has had quite the opposite kind of launch and market experience – Novo Nordisk has not only attracted some self-pay patients but it also has been able to achieve real success for patients on the reimbursment front. And, things are only improving for Saxenda, which is likely at least some of the reason for the further decline of Qsymia. We’d love to see concerted efforts from all the manufacturers in this area to tackle stigma and improve reimbursement further. We do continue to believe that Qsymia with the right combination can do well in some percentage of patients, as can Contrave and Belviq. However, in this environment, we also understand that further investment will be hard to garner. That is unfortunate, since the field needs novel approaches more than ever and the likely long-term ROI could be very strong.

• Sales of all obesity products have been on the decline in 2016, with the exception of Saxenda. In 3Q16, Saxenda alone experienced sales growth, and is the only reason the class grew even marginally, up 2% YOY and 1% sequentially. Qsymia, Contrave, and Belviq all experienced YOY decline individually, and pooled revenue from these three therapies fell 19% YOY. So far, this trend holds true for 4Q16 as well – Saxenda revenue more than tripled YOY and rose 29% sequentially, in contrast to Qsymia’s 21% YOY sales decline. We’ll be back with a complete pooled analysis of obesity products after Orexigen reports on March 28. Importantly, we don’t see success in this class as depending on competition (not at all!). Rather, it’s at least in part about making obesity medicines accessible and affordable for the high number of people who could benefit from a chronic weight loss therapy, because there is a staggering rate of US and global obesity that goes entirely untreated. It also is in part understanding more about the molecular qualities of certain compounds affecting appetite and targeting obesity and convincing HCPs of their safety.

-- by Payal Marathe, Abigail Dove, and Kelly Close