Supplement new drug application for Bijuva is submitted. Bijuva is the first and only FDA approved (on October 28 of 2018) hormone therapy of bio-identical estradiol in combination with bio-identical progesterone (P+E, 1 mg/100 mg) for the treatment of moderate to severe vasomotor symptoms due to menopause. The new drug application (NDA) prior-approval efficacy supplement was submitted to the U.S. Food and Drug Administration (FDA) for the lower dose (0.5 mg/100 mg) capsules of Bijuva. The company anticipates a decision by the FDA in Q4 2020. We think this will provide options and dose flexibility for patients.Commercial uptake continues to grow. The company has three commercial products, all launched within the past 1.5 years. The company is primarily focused on the first commercial product Imvexxy that reached $4.77 mm sales in Q3 2019, while Bijuva and Annovera reached $0.49mm and $0.40mm. We think the product uptake continues to grow for all of the company’s products. The company has had a good start with Annovera sales even with a non-full-scale launch. We expect a full-scale launch in Q1 2020. We recognize the pace of revenue ramp-up has been slower than the Street anticipated. However, we continue to believe the company’s products target a large commercial opportunity.Read More >>