Consensus $14.10. Raises FY19 revenue view to $22.0B-$22.9 from $21.8B-$22.9B, consensus $22.78B. “We continue to generate strong, volume-driven growth for our newer products, while effectively defending our mature products. We are also advancing a record number of first-in-class molecules targeting significant areas of unmet need through our pipeline,” said Robert Bradway, chairman and CEO.
Tuesday, April 30, 2019
Evolus reports Q1 EPS (40c), consensus (79c)
Total cash and cash equivalents and short-term investments were $133.7M as of March 31 compared to $93.2M as of December 31, 2018. “Evolus is well capitalized, our sales team is hired and trained, our head-to-head clinical data versus BOTOX(R) is published and we are now on the brink of launching the first new 900kDa neurotoxin to enter the United States in nearly 30 years,” said David Moatazedi, president and CEO. “We have delivered on all major company milestones, within our stated timelines, and we now set our sights on our goal of achieving the number two market position within 24 months of launch.”
Vertex reports Q1 EPS $1.03, consensus 98c
Reports Q1 revenue $858.4M, consensus $850.93M. The company said, “Our goal is to develop transformative medicines for all people with CF and other serious diseases and to ensure all eligible patients have access to these medicines as quickly as possible. We have made significant progress toward achieving this goal by rapidly advancing our triple combination regimens through late-stage development, and we remain on track to submit a New Drug Application for one of these medicines in the third quarter of 2019. We also continue to advance our earlier-stage programs targeting AAT, pain, FSGS and sickle cell disease. In the first quarter, we again delivered strong revenue and earnings growth, which further enhances our ability to make significant investments in internal and external innovation.” Reports Q1 KALYDECO revenue $244M vs. $250M last year, ORKAMBI revenue $293M vs. $354M last year, and SYMDEKO/SYMKEVI revenue $320M vs. $34M last year.
Vertex plans to submit triple combination NDA in Q3
The company said, “Final Phase 3 24-week data are expected in the second quarter of 2019 from the triple combination program. Vertex plans to utilize these data to choose the best triple combination regimen to submit for regulatory approvals globally. The company plans to submit a New Drug Application to the U.S. Food and Drug Administration in the third quarter of 2019 and a Marketing Authorization Application in Europe in the fourth quarter of 2019 for either the VX-659 or VX-445 triple combination regimen in people with CF who have two F508del mutations and in people with CF who have one F508del mutation and one minimal function mutation.” Vertex added, “The company has initiated a Phase 2 dose-ranging study evaluating the once-daily potentiator VX-561 as a monotherapy as requested by the FDA. The study is designed to evaluate multiple doses of VX-561 to support potential Phase 3 development of VX-561 in a once-daily triple combination regimen.”
AMN Healthcare to acquire Advanced Medical for $200M
AMN Healthcare announced a definitive agreement to acquire Advanced Medical Personnel Services. The purchase price is $200M, with up to an additional $20M to be paid based on Advanced’s 2019 financial performance. The acquisition is structured to allow AMN to realize tax benefits with an estimated net present value of $8M and is expected to be immediately accretive to AMN’s adjusted earnings per share. The acquisition, subject to regulatory approvals and customary closing conditions, is expected to close by early June.
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