Delays in US FDA approvals for respiratory products
FLOVENT 44 approval is pending; any delay could impact Q4 US revenue growth.
Glenmark Pharmaceuticals · Material risks, their source context, and severity in the latest available quarter.
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Risk intelligence
FLOVENT 44 approval is pending; any delay could impact Q4 US revenue growth.
Analyst questioned the quantum of currency benefit; management could not quantify, indicating potential overstatement of organic growth.
Excluding out-licensing income, gross margin was lower at 65% due to product mix; recovery depends on new approvals.
Despite progress, working capital days remain a focus; any slippage could impact cash flow targets.