Orphazyme A/S (NASDAQ:ORPH) expects FY21 sales of DKK 35 million – DKK 37 million, compared to the previous guidance of DKK 30 million – DKK 40 million.
- It anticipates operating expenses of DKK 665 million – DKK 675 million, lower than the earlier outlook of DKK 700 million – DKK 720 million.
- On lower expenses, Orphaazyme forecasts a narrower operating loss of DKK (630) million – DKK (640) million, compared to previous guidance of DKK (670) million – DKK (700) million.
- Related: Orphazyme Stock Gains After FDA Update On Arimoclomol In Rare Neurodegenerative Disorder.
- The company attributed the revised outlook to increased visibility on net revenues from arimoclomol in the Early Access Program in France and lower-than-expected operating expenses.
- Orphazyme is awaiting an opinion from the CHMP on its European Marketing Authorization Application for arimoclomol during Q1 2022.
- "Furthermore, we continue to work with the FDA to determine a pathway to resubmission of our New Drug Application for arimoclomol in the United States as well as assessing different possibilities for obtaining additional funding to sustain operations," said Christophe Bourdon, CEO.
- The company expects the cash position as of December 31, 2021, to be no less than DKK 100 million.
- Price Action: ORPH shares are up 5.86% at $2.35 during the premarket session on the last check Wednesday.
