198 0 Kommentare Orphazyme accelerates arimoclomol pre-launch activities and updates financial outlook for 2020 - Seite 2

Full-year 2020 anticipated operating loss	DKKm	USDm^*
Previous guidance	(500) – (550)	(80) – (88)
New guidance	(625) – (650)	(96) – (104)

Cash position at December 31, 2020	DKKm	USDm^*
Previous guidance	>300	>48
New guidance	>700	>111

^*USD figures are for reference only; FX rate 1 DKK / 0.16 USD.

Year to date, operating expenses have tracked in line with the Company’s previous guidance of an operating loss of DKK 500 – 550M. Following the successful global offering, the company has decided to accelerate its pre-launch activities during the fourth quarter in preparation for potential approval of arimoclomol in the U.S. and will further invest in its Early Access Programs, additional API manufacturing, regulatory affairs, and clinical safety activities. Orphazyme also expects continued costs through year-end for the on-going trials in sporadic Inclusion Body Myositis and Amyotrophic Lateral Sclerosis in order to provide home nursing and direct to patient distribution due to the COVID-19 pandemic. In addition, the Company intends to increase investment in its NME program of next generation HSP amplifiers and will incur additional operational costs in Q4 2020 associated with the U.S. listing. As a result, the operating loss is expected to be in the range of DKK 625M to DKK 650M (USD 96M to USD 104M), for the fiscal year ending December 31, 2020.

Orphazyme expects to finish 2020 with cash of DKK >700M (USD >111M). This compares to previous guidance of DKK >300M (USD >48M) and includes net proceeds to date from the Company’s recent global offering.

In September 2020, the FDA accepted Orphazyme’s New Drug Application for arimoclomol for NPC, with Priority Review. The FDA set a target action date of March 17, 2021 under the Prescription Drug User Fee Act, or PDUFA, for completion of its review of the NDA. Orphazyme continues to expect to submit a Marketing Authorization Application, or MAA, to the European Medicines Agency in the second half of 2020.

For additional information, please contact