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$150 Million


At-the-market Offering

Versartis is an endocrine-focused biopharmaceutical company initially developing its novel long-acting recombinant human growth hormone, Somavaratan (VRS-317), for growth hormone deficiency, or GHD, an orphan disease. A key limitation to current recombinant human growth hormone, or rhGH, products is that they impose the burden of daily injections over multiple years, often resulting in poor compliance, which in turn can lead to suboptimal treatment outcomes in GHD patients. Despite this limitation, global annual sales from marketed rhGH products were over $3 billion in 2015. Somavaratan is intended to reduce the burden of daily treatment by requiring significantly fewer injections, potentially improving compliance and, therefore, treatment outcomes. The Company's first targeted indication for Somavaratan is pediatric GHD, which represents an approximately $1.5 billion existing market opportunity. The Company’s Phase 3 VELOCITY study of Somavaratan in pre-pubertal children with GHD was initiated in early 2015 following positive results from the Phase 2 study. The VELOCITY program will employ semi-monthly dosing with a height velocity endpoint relative to daily GHD therapy. Building off of the clean safety and efficacy profile achieved in the Phase 2 study, a higher dose level of Somavaratan will be administered. In January 2015 the Company announced positive safety and efficacy results from the Phase 2 extension trial, after having presented positive results from the initial Phase 2 trial in 2014. This consistently positive data de-risks the Phase 3 efficacy trial. Topline VELOCITY data is expected in 3Q 2017 with an expected year-end 2018 FDA approval and launch. The Company had a meeting with the Japanese regulatory authority in September during which they received approval to switch the Phase 2 trial in pediatric GHD to a Phase 3 trial.