Shield Therapeutics PLC (AIM:STX, OTCQX:SHIEF) confirmed it is fully funded to cash flow break even by the end of next year as it updated on the commercial, financial and operational progress it made in 2022.
It reported substantial sales traction for its drug Accrufer/Feraccru, a breakthrough oral iron therapy, as revenues grew to £8.5mln in the 12 months ended December, up from £1.5mln in 2021.
In December, Shield signed an exclusive multi-year agreement with Viatris, a global healthcare company, to co-commercialise Accrufer.
Shield received a one-time payment of US$5mln from Viatris and is eligible to receive up to US$30mln in sales milestones. The company aims to have its field sales team of 100 serving 12,000 healthcare professionals.
As of December 2022, Accrufer had annual sales volume of 25,200 prescriptions, a nearly 12-fold increase from 2,152 prescriptions in 2021, and an increase of 97% in the second half of 2022 compared with the first half.
In the fourth quarter alone, Accrufer had prescription volumes of 9,324, which represented 37% of the annual prescription volume and a quarter-over-quarter increase of 26%.
The group is fully funded having added £30mln to its coffers recently via a placing of new shares, an upfront payment from Viatris and additional borrowing.
"Completion of the Viatris collaborative sales agreement in December 2022 has set Accrufer up for strong 2023 growth in prescriptions and product sales,” said chief executive Greg Madison.
“We are thrilled to be working with Viatris to bring Accrufer to more patients suffering from ID/IDA in the US.
“I am pleased to report that the collaboration is off to a great start and hiring and training is well underway to put the expanded sales team in place.
“We are pleased to expand our commercial footprint with Viatris' well-established prescriber relationships, best-in-class digital marketing, direct-to-patient capabilities, and extensive market access experience."
In the US, about 20 million people suffer from anaemia, including iron deficiency and iron deficiency with anaemia, creating a large yet under-served market for Accrufer.
The therapy has the potential to meet an important unmet medical need as the first and only FDA-approved oral iron to treat iron deficiency with or without anaemia, regardless of the cause.