AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) Q3 2019 Earnings Conference Call - Final Transcript

Nov 01, 2019 • 08:00 am ET

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AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) Q3 2019 Earnings Conference Call - Final Transcript

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Presentation
Executive
William K. Heiden

saw strong consistent execution from our commercial teams. Revenue has increased in each of the first 3 quarters of 2019 for all 3 of our commercial products: Feraheme the Makena subcutaneous auto-injector and Intrarosa. The growth is even more impressive on a year-over-year basis as laid out in our press release. We're pleased with the continued strong performance of Feraheme which is shown here on the left which posted record revenue of $44.2 million in the third quarter a 5% increase over prior quarter. Year-over-year Feraheme revenues grew 20%. Feraheme's average market share grew to 17.5% in the quarter.

Shown in the center of the slide Makena subcutaneous auto-injector revenues have stabilized around $40 million per quarter which is roughly where we predicted they would be. With 4 intramuscular generics in the market we're pleased that we've been able to capture and maintain nearly 2/3 of all FDA-approved hydroxyprogesterone caproate products. I know you all may have questions about the Makena franchise going forward following this week's advisory committee meeting and Julie will cover this in a moment. But it's important to remember that Makena remains on the market and available to eligible pregnant women. And finally on the right Intrarosa's net revenues grew to $5.6 million in the third quarter and the average TRx market share growing to 4.8% for the quarter.

I'm now going to turn the call over to Julie who can provide an update on Tuesday's FDA Advisory Committee Meeting.

Executive
Julie Krop, M.D

Thank you Bill. Since we first announced top line results from the study earlier this year we've been in ongoing discussions with the FDA to identify the appropriate path forward. On our Q2 call we shared with you that FDA recommended an Advisory Committee Meeting to better understand and interpret the results of the PROLONG study. Since that time we've been working closely with our publications committee to accelerate the publication of the PROLONG data ahead of the Advisory Committee Meeting as well as preparing for the meeting. Just a week ago on Friday October 25 the PROLONG study results were published in the American Journal of Perinatology. Dr. Sean Blackwell a Chair of the Department of Obstetrics and Gynecology and Reproductive Sciences at McGovern Medical School UTHealth in Houston was the lead author on the publication. And the publication lays out the author's perspective on the potential reasons behind PROLONG's results.

After reviewing the publication the American College of Obstetrics and Gynecologists and Society for Maternal-Fetal Medicine updated their guidelines reiterating their support for the use of Makena in this high-risk patient population. Earlier this week the Bone Reproductive and Urologic Drugs Advisory Committee met to better understand and interpret the PROLONG study results in the context of prior studies. In the meeting there was a lot of questions regarding the need for additional data and how to balance that with how to successfully conduct the U.S. study in the face of widespread use of 17P. Some members even felt the only way to get