[source: Shield Therapeutics]

Shield Therapeutics (STX ), a commercial stage pharmaceutical company, announced unaudited results for the 6 months ended 30 June 2022 (H1 2022)

Shield says it continues to focus on its three main commercial priorities: 1) increasing awareness of Accrufer, 2) generating clinical experience, and 3) expanding payor coverage.

Accrufer

Twelve months ago, the company launched its flagship product Accrufer, a novel therapy to treat iron deficiency and iron deficiency anaemia. Accrufer prescriptions accelerated in 2022 with 87% growth achieved in Q2 quarter-on-quarter, following equally strong Q1 growth. Half-on-half, prescriptions increased 350% in H1 2022 to 11,223, compared to 2,516 in H2 2021.

Women's health practitioners have so far written approximately 50% of Accrufer prescriptions to treat women with underlying diseases leading to iron deficiency and/or anaemia. This segment is growing rapidly, Shield said. The other c. 50% of prescriptions were written by general practitioners, with demand continuing to grow in that sector as well.

Accrufer in the US

Total US net revenue from Accrufer increased to £1.5m in H1 2022, compared to £0.1m in H2 2021, which was the first half-year following the product's launch. There were 1,050 new first-time prescribers of Accrufer in H1 2022, a five-fold increase in H1 2022, reflecting growing interest by healthcare providers.

Access to Accrufer has increased dramatically to 100 million or c. 40% of eligible lives, now having coverage for the treatment across both commercial and medicaid segments. Approximately 20 million in the US have anaemia, reflecting a large unmet medical need.

Shield also reported positive data from Accrufer in patients with Chronic Kidney Disease (AEGIS-CKD) as presented at the European Society of Medicine (ESMED). Additionally, the company reported Phase III paediatric studies in the US and UK progressing with 75% of sites active.

Feraccru in Europe

In Europe, where Accrufer is known under the brand name Feraccru, Shield reported Feraccru packs sold by partner Norgine increased 15% in H1 year-on-year, and 6% compared to H2 2021. The UK saw the largest increase in volume and now accounts for 20% of Feraccru packs sold in Europe. Royalty revenues from Norgnie amounted to £0.7m in H1 2022.

Accrufer in Canada

Shield's commercial partner KYE Pharmaceuticals submitted in March 2022 documentation for approval of Accrufer in the Canadian market. Approval is expected in mid-2023, and product launch is expected by end of 2023.

Greg Madison, CEO, summarised the results:

"Shield delivered a strong first half of 2022 and executed well across the Company's main commercial priorities. We are increasing awareness, developing new writers, growing prescriptions and expanding payor access, all with a small, motivated commercial footprint in the US. We continue to believe there is tremendous potential to disrupt the iron deficiency market that has lacked innovative new therapies that can offer the efficacy, tolerability and convenience as seen with Accrufer® in our clinical trials to individuals suffering from iron deficiency or iron deficiency anaemia. Based on our interim results and ongoing feedback from target prescribers, we are even more confident today about the potential for Accrufer® to become the oral iron treatment of choice."

 

View from Vox

In the twelve months since the launch of Accrufer in the US, Shield has developed and implemented its US commercial strategy, which has resulted in the sales growth detailed above. Sales in Europe are increasing as well, and expansion in Canada is expected next year.

Shield has successfully secured broad reimbursement coverage across commercial and medicaid segments in the US, substantially increased prescriber awareness, and extended its footprint through new commercial partnerships.

A US$10m shareholder loan will provide funding through the end of 2022. Shield says it continues to seek strategic partnerships and engage with 3rd parties regarding potential financing opportunities.

 

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