Vericel Corp (NASDAQ:VCEL) expects to report a drop of 23% in Q2 2020 revenues to $20 million. Net revenues of MACI and Epicel, the two products of Vericel, expect to decline by 27% and 8% to $15 million and $5 million in Q2 2020 compared to Q2 2019.
Reschedules 70% of MACI cases
Vericel increased net revenues in June 2020 compared to the previous year though it suffered a drop in May and April sales this year. The company rescheduled around 70% of the MACI cases from H1 2020 because of an ongoing coronavirus crisis.
Vericel, Nick Colangelo said the company staged a smart recovery in Q2 for MACI because of easing restrictions nationwide on elective surgeries. Though uncertainties remain, the company expects to post better growth in Q3 2020.
Seeks FDA nod to cure severe thermal burns with Nexobird
Vericel submitted a BLA (Biological License Application) seeking the US FDA’s approval to treat thermal burns in patients using Nexobird. Proteolytic enzyme concentrates enriched in Bromelain will be applied in adults to remove eschar.
BLA submission is based on Phase 3 clinical trial of Nexobird in adults who suffered 30% of the body area with thermal burns (full-thickness or particle thickness). The drug met the primary endpoint in the study in completely removing eschar with reduced blood loss.
Nexobird approved in the EU
Nexobird got approved in the EU and other international markets. In the US, Europe, and other markets worldwide, the drug is designated as an OB (orphan biologic). Biologics and drugs that offer effective and safe treatment or prevent rare disorders and diseases are given orphan status.
Vericel holds exclusive commercial rights for Nexobird in North America. BARDA (Biomedical Advanced Research and Development Authority) in the US provides technical support and funding to MediWound Ltd that engages in developing Nexobird.
Nick said the company achieved an important milestone in submitting BLA along with the partner MediWound for Nexobird. The innovative formulation will help several patients, who suffer from thermal burns, every year to eliminate eschar. Vericel, along with its partner, will work with the US FDA for quick approval for marketing Nexobird in the US.