Q&A - Q1 2026 Trading Update Webinar
Below is a summary of the key investor questions addressed during the webinar, together with additional questions submitted by investors that were not addressed live during the session.
Incase you missed the webinar: https://shieldtherapeutics.com/webinars/YeNdZP-q1-trading-update
What is the impact of the new New York Medicaid prior authorisation requirements for ACCRUFeR®?
Management discussed the introduction of prior authorisation (PA) requirements for ACCRUFeR®prescriptions within New York Medicaid from 23 April 2026.
Shield noted that this development was not unexpected and that similar PA requirements already exist across many states for branded products. The Company confirmed that it is actively engaging with New York Medicaid to better understand approval criteria and to help educate healthcare providers on the updated process.
Management also stated that commercial opportunities in New York remain significant, and that the sales organisation has already intensified its focus on commercial prescribers within the state.
At this stage, Shield said it is too early to quantify the financial impact.
How does Shield plan to accelerate future sales growth and what is the long-term revenue opportunity for ACCRUFeR®?
Management reiterated that increasing awareness among both patients and healthcare providers remains the primary driver of future growth.
The company continues to focus on:
Digital marketing initiatives
Sales force optimisation
Expansion within key prescribing states
Increasing physician and patient awareness
Shield also reaffirmed its belief that ACCRUFeR® has peak annual revenue potential of approximately $450 million.
How has April trading performed so far?
Management referenced publicly available prescription data indicating approximately 22% growth in April 2026 compared with the same period in January 2026.
What is happening with the CFO transition?
Santosh Shanbhag confirmed he will step down as CFO effective 1 June 2026 to pursue a leadership opportunity within an oncology-focused pharmaceutical company.
Management thanked Santosh for his contribution to the company’s operational and financial progress over recent years.
What proportion of ACCRUFeR® sales are commercial versus Medicaid?
Management stated that approximately two-thirds of total prescription volume currently comes from the commercial channel, while Medicaid represents approximately 25–30%.
Shield also noted that it does not publicly disclose pricing differences between individual reimbursement channels.
Is Shield still actively pursuing acquisitions or additional products?
Management confirmed that expanding the portfolio through an additional product or acquisition remains a key strategic priority.
Shield stated that its existing infrastructure could support additional products and that the Company continues to evaluate opportunities, particularly late-stage Phase III assets approaching FDA approval.
How does management view the potential impact of the New York Medicaid changes on future growth?
Management reiterated that it is too early to quantify the financial impact of the New York Medicaid prior authorisation changes.
Shield also confirmed it continues to pursue opportunities to add a second product to the commercial platform.
Why does management believe the New York prior authorisation changes are significant?
Management clarified that the key change implemented in New York Medicaid was the introduction of a formal prior authorisation process.
Shield stated that it continues to work through the exact approval requirements and documentation needed for successful prescription approvals.
What is limiting faster sales growth in the US market?
Management stated that awareness remains the biggest limiting factor to accelerating growth in the US market.
The company continues to optimise both marketing and sales initiatives and believes additional awareness and future investment can support further growth acceleration over time.
Does Shield offer employee share incentive programmes?
Management confirmed that employees already participate in share option programmes as part of their individual remuneration packages.
Has the conflict in Iran impacted ACCRUFeR® manufacturing or supply chains?
Management confirmed there is currently no impact on Shield’s supply chain, manufacturing operations or API sourcing arising from the conflict in Iran.
Are current broker forecasts still considered realistic?
Shield reiterated that it does not provide formal revenue guidance but stated that current broker forecasts appear reasonable based on publicly available information.
What mitigation plans has Shield already implemented regarding New York Medicaid?
Management stated that the company had anticipated the possibility of tighter Medicaid controls and had already implemented mitigation strategies, including increasing focus on commercial prescribing opportunities.
How is Shield using AI within the business?
Management stated that AI is being used to:
Improve understanding of customer behaviour
Enhance digital marketing targeting
Optimise commercial activities
Improve efficiency across the organisation
Why did prescriptions decline during Q1 and is this expected to recover?
Management noted that Q1 seasonality related to insurance deductible resets and prior authorisation renewals has been consistent historically.
Shield also stated that March showed a rebound in prescription performance and referenced positive April prescription trends.
What is the status of the pediatric launch for ACCRUFeR®?
Management confirmed:
The pediatric label expansion was approved in December 2025
Sales force training took place during Q1 2026
The formal commercial launch began on 1 April 2026
Shield also confirmed that pediatric prescriptions are now being generated in the US market.
Questions submitted but not addressed live during the webinar
Should investors have concerns regarding the non-US business given the limited update provided during Q1?
The vast majority of Shield's revenues are generated through sales of ACCRUFeR® in the Unites States. Our quarterly trading updates are hence primarily focused on US performance unless there is a material revenue generating Ex-US milestone event. The Q1 2026 trading update included an update on the receipt of the $7.9M milestone from ASK, our partner in China. This resulted in Group net revenues of c.$18M that included c.$9.9M in ACCRUFeR® revenues in the US, $7.9M milestone related revenues from ASK, and c$0.7M royalty-related revenues from our Ex-US partners, Norgine and KYE Pharmaceuticals. The royalty-related revenues are consistent with prior period trends and expectations.
Additionally, we are excited to see that the international business is moving forward with real momentum:
KYE Pharmaceuticals launched ACCRUFeR® in Canada in March 2025, making it the only prescription oral iron indicated for IDA in that market.
ASK Pharma in China announced the filing, and acceptance by the Chinese National Medical Products Administration (‘NMPA’), of a Marketing Authorisation Application (‘MAA’) for ACCRUFeR® for the treatment of adults with Iron Deficiency by its licensing partner, Beijing Aosaikang Pharmaceutical Co. Ltd ('ASK Pharm'). This followed the successful completion and outcome of a Phase 3 efficacy and safety clinical study in Chinese adults with iron deficiency anemia (‘IDA’) and inflammatory bowel disease who are intolerant to oral ferrous products. The study demonstrated clinically and statistically relevant efficacy and good tolerance in Chinese adults.
In Europe our pediatric filing has been accepted by the EMA, triggering a milestone payment from Norgine and opening a meaningful new patient population. FeRACCRU® will now be indicated for the treatment of iron deficiency in adult and pediatric patients 12 years of age and older.
VITAL-NET in Japan, initiated a Phase II Clinical Trial for ACCRUFeR® (Ferric Maltol) for the Treatment of Pulmonary Arterial Hypertension (PAH) in Japan.
Korea Pharma received Marketing Authorisation by Korean Ministry of Food and Drug Safety (MFDS) for ACCRUFeR®
0
likes
•
0
questions
•
0
company answers
Ask a question
Your question will be visible to everyone.
Investor Q&As
Start the conversation
Ask Shield Therapeutics a question about this update.