Baxter's FDA Review For Novum IQ Large Volume Pump Put On Hold, Lowers FY22 EPS Outlook - Boston Scientif

Baxter International Inc (NYSE:BAX) has posted Q1 revenue of $3.71 billion, beating the consensus of $3.68 billion, up 26% on a reported basis, 29% on a constant currency basis, and 3% on an operational basis.
Adjusted EPS of $0.93 increased 22%, ahead of the consensus of $0.80.
Baxter's newly acquired Hillrom businesses – Patient Support Systems, Front Line Care, and Surgical Solutions – contributed approximately $755 million to Q1 performance on a reported basis.
Related: FDA Issues Class I Recall To Baxter's Spectrum Infusion Pump.
The gross margin improved from 42% to 45%, and the operating margin expanded from 17% to 18%.
In March, the company submitted responses to FDA's additional information requests for its Novum IQ Large Volume Pump and related Dose IQ Safety Software.
In April, Baxter received an additional information request from the FDA that identified an issue. Hence, the 510(k) review has been placed on hold so that Baxter can respond accordingly.
Baxter currently expects to respond to FDA's additional information request within the calendar year. The company expects submission of responses to the FDA on the Novum IQ Syringe Pump filing in Q2 of 2022.
Outlook: Baxter expects FY22 sales growth of approximately 23% - 24% (previous range of 24% - 25%) on a reported basis and around 3% on an operational basis (earlier 4%).
It expects an adjusted EPS of $4.12 - $4.20, down from $4.25 - $4.35 anticipated previously, versus the consensus of $4.29.
For Q2 FY22, Baxter expects an adjusted EPS of $0.86 - $0.89 compared to the Wall Street estimate of $0.98.
The company forecasts sales growth of approximately 4% on an operational basis.
Price Action: BAX shares are trading 0.80% higher at $70.50 during the market session on the last check Thursday.

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