Amphastar slides as company provides CRL update alongside earnings

Shares of Amphastar (AMPH) are under pressure after the company reported second quarter results and discussed the complete response letter for its AMP-002 ANDA filing as well as the CRL for its AMP-015 ANDA. RESULTS: Amphastar reported net revenues of $123.5M for the second quarter and adjusted EPS of 39c, with consensus at $127.48M and 40c, respectively. CRL UPDATE: During Amphastar’s earnings conference call, the company said, according to a call transcript: “Regarding our regulatory efforts, I would like to bring our discussion towards our AMP-002 ANDA filing, to which we received a CRL last month. We believe the issues raised are addressable and will be fully responded to this quarter. Therefore, we anticipate the GDUFA action date for this filing in the first quarter of 2022. While this news is certainly not one we would have liked to receive, we remain confident with AMP-002’s future commercial prospects as it remains without any generic… To our AMP-015 ANDA filing, teriparatide, and the CRL received in June, we anticipate filing our response in the fourth quarter this year. Likewise, we remain confident that the inquiries made for this filing are entirely achievable.” PRICE ACTION: In Tuesday afternoon trading, shares of Amphastar have dropped nearly 16% to $31.86.

Related posts

Advisors in Focus- January 6, 2021

Gavin Maguire

Advisors in Focus- February 15, 2021

Gavin Maguire

Advisors in Focus- February 22, 2021

Gavin Maguire

Advisors in Focus- February 28, 2021

Gavin Maguire

Advisors in Focus- March 18, 2021

Gavin Maguire

Advisors in Focus- March 21, 2021

Gavin Maguire