The product was launched in the US on 1 July, so the only impact it had on the company’s results for the first six months of the year was as an expense as the company prepared for the launch.
During the second quarter of 2021, the company built up a sales force and started to contact key prescribers. Due to the ongoing impact of the COVID pandemic and the emergence of the delta variant in the US, face-to-face contact with clinicians has been limited in the initial phase of launch but discussions are taking place with payers regarding formulary placement of Accrufer and will continue over the next several months.
The focus in the US will be on building awareness among healthcare providers, initiating prescriptions for appropriate patients to generate clinical experience and extending patient access through negotiations with payer groups.
Revenue in the first half of 2021 was GBP481,000, compared to GBP8.9mln the year before – a period in which the company received an GBP8.7mln upfront payment from licensing partner ASK Pharm.
The second half of this year should see the company recognise a GBP500,000 upfront payment from the Korea licensing deal announced last week.
The first half saw a loss before tax of GBP7.6mln versus a profit the year before of GBP2.7mln. After adjusting for non-cash items, the actual cash outflow from the first-half loss was GBP5.4mln.
Shield ended June with GBP22.6mln in cash, up from GBP2.9mln at the end of 2020, following its well-supported GBP27.7mln fundraising in March.
While attention in the second half of the year will be on the company’s bold move to go it alone in the US, in Europe, Feraccru sales are expected to continue to grow steadily in Germany, the UK, Scandinavia and Belgium while progress is made on pricing and reimbursement in other countries.
In China, ASK Pharm will start the Phase III study required for approval while Shield will start recruiting patients into the paediatric study.
“The first six months of 2021 have been a truly pivotal and exciting period for Shield which opens up the prospect of substantially greater shareholder value for investors,” said Greg Madison, the chief executive officer of Shield.
“In the second quarter a huge amount of planning and implementation was completed which allowed us to launch Accrufer on 1 July 2021 and I am pleased with progress to date. With Accrufer now available in the US, and Feraccru available in Europe, I am excited about the long-term prospects for our product(s) and Shield,” Madison said.