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VVUS: Qsymia Receives Approval in Korea

08/06/2019
By John Vandermosten, CFA

NASDAQ:VVUS

Vivus (NASDAQ: VVUS) announced the approval of Qsymia in South Korea through the development efforts of partner Alvogen yesterday. The South Korean Ministry of Food and Drug Safety (MFDS) approved the drug as a safe and effective pharmaceutical. No additional safety or other post marketing studies are required as a condition of approval.

Vivus will receive a $2.5 million milestone from Alvogen as a result of the approval. An additional milestone is expected upon first sales, which we think will begin in 1Q:20. Over the next several months, sales and marketing training will take place to prepare the salesforce to commercialize Qsymia. Upon product sales, Vivus will receive royalties, the amount of which has not been publically disclosed.

The population of South Korea is approximately 52 million and the competitive market is similar to that in the United States with Belviq, Contrave and Saxenda all available in the country. Based on our review of comparable studies as discussed in our initiation, compared to approved peers Qsymia appears to be in a favorable position with the greatest weight loss vs. placebo among peers and a median adverse event rank.

The positive news regarding Qsymia in South Korea will add some cash to the balance sheet in the near term and contribute to revenues next year. Vivus’ global efforts to license its portfolio have been fruitful with approvals granted in the Middle East and Russia over the last year. We look forward to today’s earnings call for additional detail on the expansion of Qsymia and the rest of the portfolio.

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