Shield Therapeutics Achieves Cash Flow Positivity and Record Revenue with ACCRUFeR® as US Market Leader in 2025

Shield Therapeutics 2025 results: record revenues, cash flow positive, and ACCRUFeR on top

Shield Therapeutics has posted its strongest year yet. Group revenue and other income reached $49.7 million in 2025, driven by ACCRUFeR – the company’s oral iron therapy – which delivered $45.8 million of US net product revenue, up 56% year on year. A key milestone landed in Q4 2025: positive net operating cash flow. Management now expects to deliver an operating profit in 2026.

The loss for 2025 narrowed to $17.7 million from $27.2 million in 2024, helped by both revenue growth and tighter operating costs. Cash at year end was $11.6 million, nudging up to $12.4 million by 31 March 2026, and the debt facility has been expanded to give more flexibility.

Headline numbers investors should know

Metric	2025	2024
Total revenue and other income	$49.7 million	$32.2 million
US ACCRUFeR net revenue	$45.8 million	$29.3 million
Ex-US royalties and milestones	$3.9 million	$2.9 million
US prescriptions dispensed	c.199,000	c.150,000
Average net selling price	$223	+21% vs 2024
Loss for the year	$17.7 million	$27.2 million
Cash and cash equivalents (year end)	$11.6 million	$6.5 million
Cost of sales	$26.7 million	$17.3 million
Selling, general and admin (SG&A)	$31.6 million	$36.0 million
Financial expense	$7.4 million	$3.9 million
Inventory	$9.2 million	$5.7 million
Senior secured facility	Up to $50 million, $22 million drawn	Not disclosed

ACCRUFeR becomes the #1 branded prescription oral iron in the US

This is the commercial engine. In 2025, ACCRUFeR became the top branded prescription oral iron in the US. Around 199,000 prescriptions were dispensed at an average net selling price of $223, up 21% on 2024. More than 15,000 prescribers wrote ACCRUFeR in the year, a 26% increase.

Two levers did the heavy lifting: a sharper US sales footprint and a bigger push in digital marketing. Notably, Shield reduced its “consignment” channel – subsidised scripts awaiting payer reimbursement – from 35% of dispensed prescriptions in 2024 to 22% in 2025. That mix shift supported the higher net price and better cash conversion.

Regulatory wins and international expansion broaden the runway

• FDA green light to treat adolescents aged 10 and over, extending ACCRUFeR’s US label.
• Launch in Canada via Kye Pharmaceuticals.
• Regulatory approval in the Republic of Korea by the MFDS, with a launch anticipated via Korea Pharma.
• China partner ASK submitted a marketing authorisation application to the NMPA in Q1 2026.
• Exclusive licence in Japan with Medleap Pharma, and a Phase II trial started in pulmonary arterial hypertension (PAH).

Outside the US, Shield booked $3.9 million of royalties and milestones, including $2.3 million from FeRACCRU sales in Europe through Norgine, led by Germany and the UK.

What moved the P&L: price, mix, and disciplined costs

Revenue stepped up strongly, but it is important to understand the cost structure. In the US, Shield shares 45% of ACCRUFeR revenue with Viatris, which sits in cost of sales, alongside manufacturing, shipping, and a 5% royalty to Vitra on net sales. That helps explain cost of sales of $26.7 million in 2025.

On the plus side, SG&A fell to $31.6 million from $36.0 million after a US sales force realignment. R&D spend was $1.8 million, mainly for the paediatric programme, with $0.3 million capitalised. Financial expense rose to $7.4 million, reflecting interest on the SWK loan, AOP milestone financing, and accounts receivable financing with Sallyport.

Cash, debt and flexibility: Q4 turned cash positive

Cash ended the year at $11.6 million, up from $6.5 million, with positive net operating cash flow in Q4 2025. Inventories increased to $9.2 million to support demand, and trade receivables were $24.3 million. The company also used $10.6 million of accounts receivable financing within other liabilities.

The senior secured debt has been amended and expanded to provide up to $50 million, including $15 million earmarked for potential M&A. As at 31 December 2025, $22 million was drawn. Management’s base case sees positive cash flow through 2026, and they outline levers to trim discretionary spend if needed. They also note potential access to royalty finance if required.

2026 outlook: growth, diversification, and a push to profitability

Management expects continued ACCRUFeR revenue growth in 2026, underpinned by the current sales team, marketing programmes, and better patient access. Seasonal patterns in US prescribing are expected to persist. Outside the US, Shield anticipates further momentum from partners in Europe, Canada, Korea, China, and Japan, with milestones and royalties improving the global mix.

The stated ambition is clear: achieve sustained profitability in 2026 and diversify revenue beyond adult iron deficiency/iron deficiency anaemia in the US. One macro watch-out flagged by the company is the risk of US tariffs on pharmaceuticals and active pharmaceutical ingredients, which could pressure costs and supply chains.

My take: momentum is real, but mind the financing and payor dynamics

This is a strong update. ACCRUFeR has won share, pricing is moving the right way as the consignment mix falls, and Q4 cash generation is an important proof point. The FDA’s adolescent label expansion and the international build-out add fresh growth vectors. The reduced SG&A shows management can flex costs without derailing revenue.

The flip side: 2025 still posted a $17.7 million loss and financial expense rose to $7.4 million. The US model carries a 45% revenue share with Viatris plus a 5% royalty to Vitra, so scaling volumes and net price will remain critical. Working capital is heavier, with inventories rising and receivables sizable, while the group is using accounts receivable financing. Debt capacity has increased to $50 million, which boosts flexibility, but investors should watch interest costs and covenant headroom as revenues scale.

What I will watch next

• Quarterly prescription growth and net selling price – especially the continued reduction in consignment scripts.
• Progress in adolescent uptake post-FDA label expansion.
• International catalysts – Korea launch timing, China NMPA review progress, and royalty/milestone contribution.
• Operating profit delivery in 2026 and the trajectory of financial expense.
• Working capital discipline – inventories and receivables conversion to cash.
• Any impact from US tariff policy on APIs or finished products.

AGM and investor engagement

The AGM is set for 2.00 pm BST on 18 June 2026 at Shield Therapeutics plc, Northern Design Centre, Baltic Business Quarter, Gateshead Quays, NE8 3DF. Shareholders attending should bring proof of shareholding, or a letter of representation if shares are held via a nominee. Shield has also launched a new interactive investor hub to centralise company content.

Bottom line

Shield Therapeutics exits 2025 with record revenue, the leading branded oral iron in the US, and Q4 cash flow positivity. The path to operating profit in 2026 looks credible if prescription momentum, net price, and partner royalties hold up. Keep an eye on financing costs and working capital, but the operational tide is moving in the right direction.