Shield Therapeutics PlcLSE: STX

Annual Report and Accounts for the year ended 2024

· Issued by Shield Therapeutics Plc

Changing the Treatment Paradigm

For Patients with Iron Deficiency with or without Anemia

Contents

Strategic report Corporate governance

  • 22 Board of Directors

  • 24 Senior Executive Team

  • 26 Corporate governance report

  • 29 Audit and risk report

  • 31 Directors' remuneration report

  • 36 Directors' report

  • 38 Statement of Directors' responsibilities

Financial statements

  • 40 Independent auditor's report

  • 46 Consolidated statement of profit and loss and other comprehensive income

  • 47 Group balance sheet

  • 48 Company balance sheet

  • 49 Group statement of changes in equity

  • 50 Company statement of changes in equity

  • 51 Group statement of cash flows

  • 52 Company statement of cash flows

  • 53 Notes (forming part of the financial statements)

  • 74 Glossary

  • 74 Advisors

IFC

Why invest?

04

About us

05

Our journey

06

Chairman and Chief Executive Officer's

joint statement

07

Our blueprint for growth

08

Markets

11

Global partnerships

13

Business model

14

Stakeholder engagement

15

Our people and values

16

Chief Financial Officer's review

18

Principal risks and uncertainties

and risk management

Shield Therapeutics plc Annual report and accounts 2024 | Contents

For more information on our business and all our latest news and press releases, visit us at:www.shieldtherapeutics.com.

Follow Shield on social media

@ShieldTx

Shield Therapeutics plc

shieldtherapeutics

Why Invest?

Large global iron deficiency/iron deficiency anemia (ID/IDA) market ripe for discruption

  • • 40-60% of traditional oral irons often lead to discontinuation due to intolerable GI side effects or insufficient efficacy

  • • ~20 million iron deficient individuals in the U.S. with and without anemia

ACCRUFeR® set to become the oral iron treatment of choice

  • • Approved by the FDA,

    EMA, TGA, Swiss Medic and Health Canada as the only prescription oral iron indicated for the treatment of ID/IDA

  • • Highly tolerable proprietary oral formulation that offers a low side effect profile, distinguishing it from conventional iron treatments

Shield Therapeutics plc Annual report and accounts 2024 | Why Invest?

Poised to be cash flow positive by end of 2025

  • • A strengthened balance sheet with enough cash to get to turning cash flow positive by end of 2025

  • • Strong IP through 2035

  • • ACCRUFeR® peak revenue potential of $450M in the U.S.

About Us

Shield is a commercial stage pharmaceutical company with a focus on addressing iron deficiency with or without anemia, with our lead product ACCRUFeR®/FeRACCRU® (ferric maltol), a novel, stable, non-salt-based oral therapy.

Shield's proprietary lead product, ACCRUFeR®/ FeRACCRU®, has been approved for use in the U.S., the EU, the UK, Canada, Australia and Switzerland. The product has patent coverage until the mid-2030s. The Group launched ACCRUFeR® in the U.S. with an exclusive, multi-year collaboration agreement with Viatris Inc. FeRACCRU® is commercialised in the UK and European Union by Norgine B.V., that also have the marketing rights in Australia and New Zealand. Shield also has an exclusive licence agreement with Beijing Aosaikang Pharmaceutical Co., Ltd., for the development and commercialisation of ACCRUFeR®/FeRACCRU® in China, Hong Kong, Macau and Taiwan, with Korea Pharma Co., Ltd. for the Republic of Korea, and with Kye Pharmaceuticals Inc. for Canada.

Our Strategy

  • • Grow ACCRUFeR® net revenues in the U.S.

  • • Turn cash flow positive by the end of 2025

  • • Expand Global access to ACCRUFeR® through our partners across the world

2024 has been another strong year of growth for Shield, demonstrated by a significant increase in sales, net selling price, and the number of ACCRUFeR® prescriptions in the U.S. We continue to see rising demand for ACCRUFeR® both in the U.S. and across all our territories. Net sales, total prescriptions, and the net selling price of ACCRUFeR® are all showing positive trends.

Shield remains focused on increasing awareness of ACCRUFeR® amongst healthcare professionals in the U.S., expanding our geographic reach with international partners, and significantly enhancing the global availability of this well-tolerated and effective therapeutic option for the treatment of ID/IDA.

The solid financial foundation we have in place exiting 2024, empowers us to move forward with confidence, fully equipped to execute our strategy. With a stronger balance sheet, effective cost-saving measures, and a thriving presence in the U.S. market, we are well on our way toward achieving cash flow positivity by the end of 2025.

As we look ahead, our focus is crystal clear:

Shield Therapeutics plc Annual report and accounts 2024 | About us

Our Journey

Corporate history and milestones

2024

  • • 153% year-on-year growth in U.S. ACCRUFeR® revenues

  • • c.$31M in financings

  • • Health Canada approval

  • • Succesful pediatric trial (Phase 3) in ID/IDA

  • • Regulatory submission in South Korea and fully recruited Phase 3 trial in China

2023

  • • Launch of ACCRUFeR® in the U.S. with a 100 person sales force

  • • Growth capital of c.$49M + and $29M in equity raises and warrant conversion

  • • $20M credit facility with SWK Holdings, Inc

Shield Therapeutics plc Annual report and accounts 2024 | Our Journey

2022

  • • Agreement signed with Viatris to co-commercialise ACCRUFeR® in the U.S.

  • • Licence Agreement in Canada for ACCRUFeR® with Kye Pharmaceuticals

  • • Execution of convertible shareholder loan of $10M from AOP Health

2008

  • • Shield Therapeutics Limited formed and registered in the UK

2021

  • • Licence Agreement in Korea for ACCRUFeR® with Korea Pharma

Anders Lundstrom

Chief Executive Officer

Hans Peter Hasler

Non-Executive Chairman

Major step forward in 2024

As we reflect on Shield's performance during 2024, we are very proud of our teams' efforts in making significant progress towards achieving our strategic goal of positive cash flow by the end of 2025.

In 2024 Shield generated a total of $32.2M in net revenues (excluding other incomes), reflecting 146% growth over 2023 which was mainly driven by sales

growth in the U.S. market. The team worked hard to ensure that we strengthened our balance sheet by adding ~$31M in additional financing in 2024 and shortly post the year end resetting our operating cost base to put us in the best position to deliver against our core objective of being cash flow positive by end of 2025. In the U.S., ACCRUFeR® prescriptions nearly doubled while the average net selling price increased to $237 in Q4 2024, compared to $143 in Q4 2023. Additionally, 2024 saw a 153% year-over-year increase in net revenues from ACCRUFeR® reaching $29.3M.

Our partnership with Viatris in the U.S. has continued to progress steadily and successfully. Both organisations are strategically aligned and the commercialisation of ACCRUFeR® benefits from a strong collaboration and focused execution. Together, we remain steadfast in our commitment to making ACCRUFeR® the oral iron of choice in the U.S. Outside of the U.S. we were thrilled that in 2024 our partner in Canada, Kye Pharmaceuticals, was able to secure regulatory approval for ACCRUFeR® as a prescription drug for the treatment of adults with iron deficiency anemia (IDA) with Health Canada. This milestone makes Health Canada the fifth regulatory agency in the world, after the FDA (U.S.), EMA (EU), TGA (Australia), and Swiss Medic (Switzerland), addressing a significant unmet need for patients suffering from ID/IDA.

Similarly, our partner Korea Pharma, is working closely with the Korean Ministry of Food and Drug Safety (MFDS) to secure approval of ACCRUFeR® in South Korea, while our partner ASK Pharma has successfully completed recruitment of the Phase III confirmatory study in China in adult patients with inflammatory bowel disease (IBD) and IDA. We are also excited about the prospect of receiving a label expansion from the FDA and EMA

for pediatric patients with IDA based on successfully proving highly clinically relevant effectiveness in a pivotal trial in that patient population.

Royalty and milestone revenues accounted for $2.9M (2023: $1.5M) including $2.1M from FeRACCRU® sales in Europe by Norgine, with Germany and United Kingdom accounting for 67% and 21% respectively.

Therefore, whilst the U.S. market is the core near-term growth driver, we expect incremental revenues from other territories to become increasingly significant to the Group in the future.

We couldn't be prouder of the dedication, resilience, and performance shown by our team throughout 2024. The milestones we reached in 2024 not only highlight the strength of our team but also the growing demand and receptivity to ACCRUFeR® by patients and physicians across global markets.

Looking ahead - Our goal is to be a self-sustaining business by the end of 2025. The solid financial foundation we have in place exiting 2024, empowers us to move forward with confidence, fully equipped to execute our strategy. With a stronger balance sheet, effective cost-saving measures, and a thriving presence in the U.S. market, aiming at achieving cash flow positivity by the end of 2025. As we look ahead, our focus is crystal clear:

  • • Grow ACCRUFeR® net revenues

  • • Turn cash flow positive by the end of 2025

  • • Expand Global access to ACCRUFeR®

We are just getting started on our journey to making ACCRUFeR® the oral iron of choice.

Anders Lundstorm

Hans Peter Hasler

Chief Executive Officer

Non-Executive Chairman

23 April 2025

23 April 2025

Shield Therapeutics plc Annual report and accounts 2024 | Chairman and Chief Executive Officer's joint statement

Shield Therapeutics plc Annual report and accounts 2024 | Our blueprint for growth

Iron deficiency with & without anemia (ID/IDA)

A highly prevalent and serious condition

  • • Significant impact on quality of life

  • • Symptoms include extreme fatigue, headache, vertigo, numbness in extremities, cognitive impairment

  • • Prevalence is highest in women of childbearing age and patients with inflammatory conditions1

  • • Caused by malnutrition, malabsorption, or bleeding

  • • Prominent in womens health (menorrhagia, pregnancy, uterine fibroids), inflammatory bowel disease (Crohn's disease, ulcerative collitis), chronic kidney disease

"

Side effects of oral iron worse than the symptoms of IDA."

Patient's comment

Universal problem: HCPs are struggling to treat IDA because patients can't tolerate the GI side effects of oral iron salts

Oral ferrous salts dissociate in the stomach. Unabsorbed iron (Fe+) generates reactive oxidative species (ROS), causing irritation and damage to the intestinal lining and gastrointestinal (GI) side effects.

upto

upto

70% 60%

of patients can experience GI related side effects2,3 including bloating, dark stool, nausea distention.

of patients will discontinue treatment with ferrous (iron) salts primarily due to GI adverse events and lack of effectiveness.4

The ACCRUFeR® opportunity: to become the oral iron treatment of choice

The iron deficiency, with or without anemia, market, is a large, diverse and highly fragmented market driven by multiple underlying conditions of ID/IDA. Over 500 thousand HCPs prescribe more than 10 million oral IRT TRXs per year. Most of this market is flooded with oral ferrous salt products that comprise 90% of the prescriptions written for this condition in the U.S. Over 90% of the prescriptions written for the oral iron salt market are prescribed by primary care and OB/GYN physicians. The conventional or traditional oral iron salt, mostly ferrous-based products, are known for their poor adherence and tolerability based on the gastrointestinal adverse effects.

These ferrous salts dissociate prior to intestinal uptake and the inefficient absorption of iron results in residual free iron in the gastrointestinal tract causing a high level of adverse events to oral iron treatments. These gastrointestinal adverse effects and

Significant window of opportunity exists

Iron replacement that patients will actually take. A well tolerated oral iron that effectively normalizes and maintains Hb, ferritin, and TSAT levels.7

lack of tolerability of the conventional or traditional iron products create an unsatisfactory cycle of switches and discontinuations that ranges from 40-60%.

Oral Iron >90% ferrous salts

1. Cappellini MD, Musallam KM, Taher AT. Iron deficiency anemia revisited. J Intern Med. 2020;287(2):153-170. doi:10.1111/joim.13004 2 DeLoughery TG. Safety of oral and intravenous iron. Acta Haematol. 2019;142(1):8-12. doi:10.1159/000496966 3. Tolkien Z, Stecher L, Mander AP, Pereira DIA, Powell JJ. Ferrous sulfate supplementation causes significant gastrointestinal side-e ects in adults: a systematic review and meta-analysis. PLoS One 4. Cancelo-Hidalgo MJ, et al. Curr Med Res Opin. 2013;29(4):291-303. 5 ACCRUFeR is dosed at 30mg BID, MOA = mechanism of action. 6 ACCRUFeR® (ferric maltol) [Prescribing Information]. Austin, TX: Shield Therapeutics, 2019. Revised 02/22. 7 Data from AEGIS 1 and 2 study.

ACCRUFeR® designed for efficacy and tolerability

Unique MOA (mechanism of action) Shields and Delivers Elemental Iron to the Small Intestine5, 6

ACCRUFeR® (ferric maltol) is a novel formulation of oral iron designed to treat iron deficiency with minimal gastrointestinal adverse reactions, as demonstrated during clinical trials. Unlike ferrous salts, which disassociate in the gut, ACCRUFeR® dissociates upon uptake in the GI tract, allowing it to deliver a low dose of elemental iron to prevent and even reverse IDA (for short and long-term management), without the intolerable GI side effects. Specifically, ACCRUFeR® was well tolerated with a less than 5% discontinuation rate, within the clinical trials that supported its regulatory approvals. As a result, ACCRUFeR® has the potential to play a major role in this undertreated high growth iron deficiency market.

Shield Therapeutics plc Annual report and accounts 2024 | Markets

Fe

IV Iron

Shield Therapeutics plc Annual report and accounts 2024 | Markets continued

While ID/IDA is vast, reaching patients is critical to the success of ACCRUFeR®

Total oral IRT ferrous salts Rx

+550K HCPs 1

Digital Marketing Eorts

~50K HCPs1, ~1.2M Patients 3

72% PCP (12% Women's Health, 7% Hem/Onc, 9% Other)

Current Field Force Eorts

~10K HCPs (60% PCP, 40% Women's Health) ~220K Patients 3

1. 2023 IQVIA Xponent PlanTrak + consignment (ACCRUFeR®, ferrous sulfate, integra, ferralet, proferrin, ironspan, slow Fe+, iron combo product, and other ferrous elemental irons).

2. Q1 2025 ACCRUFeR® targets. 3. Patients taking Oral Iron Salts and have GI Side Effects estimated to be ~45%-50% based on HCP and patient quant 2024.

A market ripe for disruption

~20m

12m

Patients with anemia (actively diagnosed and treated) Prescriptions per year (majority OTC iron)

$2.3bn

1 in 5

U.S. market opportunity for iron deficiency U.S. women of childbearing age are at risk of iron deficiency

Shield Therapeutics plc Annual report and accounts 2024 | Markets continued

Global partnerships

Deals include upfront payments, milestones & double-digit royalties

Market

~20M patients with anemia

12M prescriptions per year

$2.3BN U.S. market opportunity

1 in 5 U.S. women of childbearing age are at risk of iron deficiency The European IDA therapy market generated approximately $1.38BN in 2022 and is projected to reach $2.34BN by 2030

6-7% of people living in Canada with ID

~2% of the population classified as having IDA

ACCRUFeR® is approved as a prescription medicine in Canada for adults with IDA who are unresponsive or intolerant to other oral iron preparations

There are an estimated 5.2M people in the Republic of Korea with iron deficiency and iron deficiency anemia in need of novel treatment options China has the world's largest population affected by iron deficiency anemia, with an estimated prevalence of 15%. Anemia affects 6.1% of children and teenagers, and pregnant women have a prevalence ranging from 10.0% to 35.2%.(source CSL Vifor)

Shield will continue to evaluate further partnerships in selected geographies.

Shield Therapeutics plc Annual report and accounts 2024 | Global partnerships

Why patients and writers choose ACCRUFeR®

Unmet need and unsatisfied market

Other available oral iron treatments have a high degree of gastrointestinal related adverse events that compromise the patient's ability to stay on these medications.

Effectiveness with tolerability

Due to its unique maltol formulation, ACCRUFeR® effectively treats iron deficiency with a lower dose of iron and results in <5% individual adverse reactions and treatment discontinuations.

Acceptable cost to patients

ACCRUFeR® covered across ~70% of lives in the U.S.

Our resources

FDA and EMA-approved potential best-in-class therapy

ONLY FDA-approved oral iron therapy for iron deficiency with and without anemia.

Collaborative commercial

partnership in the U.S. and Canada

U.S. commercial partnership with Viatris doubles sales, marketing, and market access impact. Launch in Canada following approval by Health Canada.

Dedicated and committed global licence partners

Dedicated global licence partners to make ACCRUFeR®/FeRACCRU® available to even more patients around the world.

Experienced and solution-driven team of professionals

Team of highly skilled, deeply experienced and diverse employees drives the overall performance of the business. We continue to invest in our people by hiring new talent that can lend leadership and support to our mission.

How we create value

Making ACCRUFeR® the oral iron of choice:

Shield Therapeutics plc Annual report and accounts 2024

Shield Therapeutics plc Annual report and accounts 2024 | Business model

What we do

Drive U.S. prescription demand

In partnership with our commercial partner, Viatris, we have a sales force of 80 sales representatives that prioritise 10,000 high prescribing providers within Women's Health, Primary Care, and other specialties in order to raise awareness and drive prescriptions of ACCRUFeR®. We have increased our digital marketing outreach and have prioritised awareness of patients through social media engagement and other mediums of digital media.

Optimise prescription distribution channels

We have expanded our pharmacy

networks that support and fill ACCRUFeR®

prescriptions to enable a seamless patient

experience. We have partnered with the

leading digital concierge distribution

company that has a mission to work with

pharma companies to offer transparent

low prices, free home delivery, and

unmatched provider and patient support.

Along with this digital distribution

company partnership, we have enabled a

select network of retail pharmacies that

offer quality, alternative pharmacy options

for our customers.

Manage life cycle of our product

We continue to invest in our product and have initiated a clinical study in the U.S. and the UK to evaluate the tolerability, safety and efficacy of ferric maltol oral suspension versus ferrous sulfate oral liquid in children and adolescents aged 2 to 17 years with iron deficiency anemia, with a single-arm study in infants aged one month to less than two years.

Support global licence partner

We are working closely with our global licence partner to support its efforts to obtain regulatory approval for ACCRUFeR®/FeRACCRU® and, in the case of Europe and the UK, assist our partner Norgine with the execution of its commercialisation plan.

Engaging with Stakeholders

Our stakeholders are critical to our success and help to shape our strategy. We actively engage with our stakeholders on a regular basis to ensure that we are managing expectations and promoting trust and transparency across all of our activities with a view to promoting mutually beneficial relationships.

Duty to promote the success of the Group

Shield's objective is to progress shareholder value through the continuing development and commercialisation of ACCRUFeR®/ FeRACCRU® with a focus on patients around the world who suffer from iron deficiency, with or without anemia. This year, the Group has accomplished important milestones in achieving its objective to making ACCRUFeR® the oral iron of choice. The operational and financial reviews within this Annual Report discuss these milestones in more detail.

Stakeholder engagement

The Board recognises its responsibility to take into consideration the needs and concerns of Shield's key stakeholders as part of its decision-making process. This table illustrates how the

Group engages with its stakeholders.

Patients and Health Care Professionals (HCPs)

Key areas of focus:

  • • Sales representatives solicit feedback on their interactions with HCPs

  • • Medical Affairs engages and educates key opinion leaders and healthcare professionals

  • • Monitoring of internal and external data reports, e.g. repeat and new subscribers

Our response

  • • Understanding needs of patients and HCPs

  • • Patient and HCP experience

  • • Maintain high standard of product offering

Investors

  • • Issuance of regular business and trading updates

  • • Availability of meaningful information on corporate websitewww.shieldtherapeutics.com

  • • Periodic analyst and investor meetings by CEO and CFO

  • • Availability of Directors and senior management team throughout the year

  • • Reliable, timely and transparent information

  • • Access to key decision makers of the business

Section 172 statement on the discharge of Directors' duties

In compliance with the Companies Act 2006, the Board is required to act in accordance with a set of general duties. During the year ended 31 December 2024, the Board considers that it has individually and collectively acted in a way it considers, in good faith, would be most likely to promote the success of the Group for the benefit of its shareholders as a whole having regard to the six matters listed in Section 172(1)(a) to (f) of the Companies Act 2006. In order to achieve long-term success for the benefit of all shareholders, the Board recognises the importance of building and maintaining relationships with key stakeholders as well as considering the likely consequences of its decisions in the long term. Please see page 36 for further Section 172 statement.

Global licence partners

  • • Direct engagement by senior members of management team and key partners and suppliers

  • • Regular business reviews with global licence partners

  • • Regulatory approval of our lead product in the jurisdictions of our licence partners is critical to advance the reach of our product

  • • Successful commercialisation by licence partners upon regulatory approval provides additional revenue streams to the Group

Shield Therapeutics plc Annual report and accounts 2024 | Stakeholder engagement

Our people

  • • Hiring and retaining top talent

  • • Culture of performance

  • • Operating as a global team

  • • Flexible work arrangement

  • • Competitive pay and benefits package

  • • Retention

  • • Investment in training

Our people and values

Strong, reliable, and essential to everything we do.

Empowerment

We develop an open and trusting environment that requires accountability and responsibility at all levels.

Will to succeed

Results oriented environment that values resiliency in overcoming challenges. Encourage a 'learning culture' that celebrates success and learns from failures.

"

I am privileged to lead a dedicated and high-performing team of specialty sales representatives here at Shield. Our team exemplifies a commitment to excellence, where accountability and growth are central to our success. At Shield, we foster an environment that prioritises collaboration, adaptability, and continuous improvement, enabling us to achieve exceptional outcomes."

Nikki D. Caesar

Regional Sales Manager

Collaboration

Our success is driven by teamwork, trust, transparency and our ability to work together to find the optimal solutions.

Shield Therapeutics plc Annual report and accounts 2024 | Our people and values

Agility

While moving with a clear purpose, we want to prepare for the unexpected and adapt quickly to change and the changing environment.

Revenue

In 2024, total revenue (excluding other income) reached $32.2M, up from $13.1M in 2023. This includes $29.3M (2023: $11.6M) in net product revenue from ACCRUFeR® sales in the U.S., with c.150,000 prescriptions (2023: c.77,000 prescriptions). A significant portion of 2023 and 2024 prescription sales were subsidised through patient assistance programs, resulting in a net average sales price of $184 in 2024 (2023: $137). By the end of Q4 2024, the net average sales price had increased to $237.

Additionally, royalty and milestone revenues accounted for $2.9M (2023: $1.5M) including $2.1M from FeRACCRU® sales in Europe by Norgine, with Germany and United Kingdom accounting for 67% and 21% respectively. Milestone payments accounted for $0.8M from our Canadian, Korean and prospective Japanese partners.

Cost of sales

The cost of sales for 2024 totaled $17.3M, compared to $9.0M in 2023. This includes the manufacturing and shipping costs for prescriptions sold in the U.S., finished packs supplied to Norgine for sale in Europe, and a 5% royalty on net sales payable to Vitra Pharmaceuticals Limited ("Vitra") who are the original owners of the intellectual property behind ACCRUFeR®/FeRACCRU®.

Selling, general and administrative expenses

Selling, general and administrative expenses were $36.0M in 2024 (2023: $38.0M). The decrease was driven primarily due to the restructuring of the ACCRUFeR® sales force announced in Q4 2024. The share based payment charge to the income statement was $0.9M in 2023 and 2024.

Research and development

The Group spent $4.3M (2023: $4.5M) on research and development. Of that total spend, $2.4M (2023: $2.7M) have been capitalised as additions to intangible assets, as management deemed that it is probable that these costs will generate future economic benefits. The balance of $1.9M (2023: $1.8M) was expensed in the current year. Research and development expenditure is predominantly related to the ongoing pediatric study.

Financial income

Financial income of $0.3M was reported in 2024 (2023: $0.5M). This income was generated primarily through interest received from treasury bank account interest.

Financial expense

Financial expense of $3.9M was reported in 2024 (2023: $1.6M). The expense was primarily related to interest charged on the shareholder loan and later the long-term loan with SWK Holdings alongside the AOP milestone financing put in place during 2024 (see Note 26 for further details).

Balance sheet

As of 31 December 2024, cash stood at $6.5M, down from $13.9M on 31 December 2023. As at 31 March 2025 cash and cash equivalents were $10.5M reflecting the close of the equity financing just post the year end.

Intangible assets increased to $18.2M as of 31 December 2024, up from $16.9M in 2023. This includes capitalised development costs for FeRACCRU®, such as the ongoing pediatric pharmacokinetic study, and costs related to FeRACCRU® patents and trademarks, which were incurred to strengthen the Group's intellectual property.

Inventories grew to $5.7M (31 December 2023: $3.2M), reflecting the Group's efforts to build inventory in response to growing demand in the U.S. market.

Trade and other receivables as of 31 December 2024 were $25.0M, up from $13.5M at 31 December 2023. This increase is due to higher trading volumes in the U.S., alongside $10.0M owed by AOP from the equity placing on 29 December 2024, which was paid on 3 January 2025.

The current tax asset stood at $0.3M at 31 December 2024, down from $0.6M in 2023. This relates to the expected R&D tax credit claim for the 2024 and 2023 financial years.

Non-current liabilities include a long-term loan from SWK Holdings for $19.8M and milestone financing from AOP for $6.4M. Both loans are accounted for using an effective interest rate method in line with IFRS 9.

Trade and other payables were $23.2M as of 31 December 2024, compared to $12.7M at 31 December 2023. This increase is primarily due to the growth in trading volumes in the U.S. Other liabilities were $9.2M (2023: $0.8M) which included $9.0M (2023: $Nil) of accounts receivable financing with Sallyport Commercial Finance. Lease liabilities decreased from $0.4M in 2023 to $0.2M in 2024.

Cash flow

Net cash outflow in 2024 was $7.5M, decreasing the cash on hand from $13.9M at 31 December 2023 to $6.5M at 31 December 2024. Net cash outflows from operating activities was $6.8M, comprised of $27.2M loss for the year, adjusted for non-cash items of $6.6M (including depreciation and amortisation of $1.4M, share-based payments of $0.9M, net financial expense of $3.7M and income tax of $0.6M) and a net decrease in the Group's working capital of $13.8M.

Net cash outflows from investing activities of $2.2M are the result of capitalised development expenditure of $2.4M and financial income of $0.3M.

Net cash inflows from financing activities of $1.4M are attributable to $5.7M received in relation to the AOP milestone monetisation agreement, interest paid of $3.9M, payment of lease liabilities of $0.2M, proceeds from equity raise of $0.1M and legal fees paid in relation to the equity raise of $0.2M.

Going concern

At 31 December 2024, the Group held $6.5M in cash. The Group's unaudited cash balance at 31 March 2025 was $10.5M.

Since year end the Group has received $10.0M from AOP in relation to the pre-year end equity placing.

The forecasts show that the Group's monthly cash flows start to turn positive by the end of 2025 and and the Group has sufficient cash to allow the business to continue in operations for at least 12 months from the date of approval of the Financial Statements. The Directors have considered scenarios in which sales revenues fall below base case forecasts. In these circumstances mitigating actions such as reduction of discretionary marketing, general and administrative, and production related expenditure combined with the reliance on the full $15.0M accounts receivable facility could be taken to preserve cash. The Directors also believe that other forms of finance, such as royalty finance are likely to be available to the Group.

Based on the above factors, the Directors believe that it remains appropriate to prepare the financial statements on a going concern basis.

Recent shifts in U.S. economic policy, including the imposition of tariffs on imported goods such as pharmaceuticals and active pharmaceutical ingredients (APIs), present ongoing risks and uncertainties for our business. These measures may lead to increased costs, supply chain disruptions, and margin pressure, particularly if alternative sourcing options are limited or similarly affected. The evolving nature of U.S. trade policy, including the potential for future tariffs or retaliatory actions by other countries, creates added unpredictability that may impact our operational planning and financial performance. We continue to monitor these developments and evaluate strategies to mitigate potential impacts.

Financial outlook

On the back of significant expansion of ACCRUFeR® in the U.S. in 2024, the Company is poised for a fresh wave of growth in ACCRUFeR® primarily driven by execution of an optimised sales force plan in close collaboration with our partner, Viatris Inc., increasing patient and physician awareness, and enhancing patient access. Globally, we see an oral iron market which has clear needs based on physician and patient feedback for a product that delivers both effectiveness and tolerability.

Contributions from our global partners including continued growth of FeRACCRU® by Norgine in EU, launch of ACCRUFeR® by Kye Pharmaceuticals in Canada, and the progression of the regulatory processes in Korea and China by Korea Pharma and ASK respectively will contribute to revenues through both royalties and milestones. Lastly, our efforts to be hyper focused on return on our investments across the company and strong working capital management are expected to allow us to be cash flow positive by the end of 2025. Despite the weather-related impact on Q1 2025 revenues, on the back of a solid performance in March 2025, we expect to see significant growth in 2025 as we continue to drive the business to become cash flow positive and fully self-sustaining.

Santosh Shanbhag

Chief Financial Officer 23 April 2025

Shield Therapeutics plc Annual report and accounts 2024 | Chief Financial Officer's review

Shield Therapeutics plc Annual report and accounts 2024 | Chief Financial Officer's review continued

Managing our key risks in light of the Group's strategy and objectives

Risk Management Framework

The Board is responsible for risk management and reviewing the internal controls systems. It ensures that the key risks are understood and appropriately managed in light of the Group's strategy and objectives, and that an effective internal risk management process, including internal controls, is in place to identify, assess, minimise and manage significant risks. The internal control systems are designed to manage rather than eliminate the risk of failure to achieve business objectives and can only provide reasonable and not absolute assurance against material misstatement or loss. The Audit Committee oversees risk management on behalf of the Board.

Identify

Assess

The Group highlights potential financial and non-financial risks that may impact on the business as part of the risk management procedures in the form of a Risk Register.

The Audit Committee periodically reviews the Risk Register and approves the addition or deletion of any risks, along with changes in the underlying risk assessment. There are ongoing processes for identifying, evaluating and mitigating the significant risks faced by the Group, which are reviewed on a regular basis.

Risk Description

Minimise

Manage

The review process involves a review of each area of the business to identify material risks and the controls in place to manage these risks. The process is led by the Chief Financial Officer, together with the senior managers with responsibility for specific controls, and overseen by the Audit Committee. Where any significant weakness or failing is identified, implementation of appropriate remedial action is completed following approval by the Audit Committee.

Change Potential impact and mitigation

The Group is dependent on one product for its short and medium-term success: ACCRUFeR®/ FeRACCRU® which has been out-licensed for commercialisation in a range of territories including Europe, China, Canada, Korea, Australia and New Zealand and marketed in the U.S. pursuant to the Viatris Partnership. The Company is heavily dependent upon sales of ACCRUFeR®/FeRACCRU® by its collaboration and licensing partners in those territories and the resultant revenues receivable by the Company. Further, regulatory approval is still required to be obtained for the product to be sold in China, Korea and this may not be obtained and the clinical trials required for such regulatory approval may not be successfully completed or may take materially longer than currently expected.

The Group is also dependent on the effective delivery of our commercial strategy for the marketing of ACCRUFeR®/FeRACCRU®, including our pricing strategy and the effectiveness of our efforts to obtain adequate third-party reimbursements.

This risk is mitigated by the Company employing a highly experienced commercial team to lead on the execution of commercial strategies to ensure the commercial success of ACCRUFeR®/FeRACCRU®.

The Group has incurred losses since its inception and near-term losses are expected to increase as a result of the commercialisation of ACCRUFeR® in the United States pursuant to the Viatris Collaboration Agreement. If ACCRUFeR®/FeRACCRU® is not successfully commercialised in the U.S., Europe, China, Canada, Korea and other markets, the Group is unlikely to become profitable or produce a reasonable return, or any return, on investment.

If the Group fails to generate sufficient revenues from its operations to fund its business objectives, additional financing will be required before it becomes self-sustaining, the terms of which may not be advantageous for existing shareholders and the Group.

To mitigate against this risk the Company maintains close monitoring of actual to budgeted results and explores alternative financing options if required. The goal is to become cash flow positive and become a self sustaining business by the end of 2025.

Risk Description

Change Potential impact and mitigation

The Company operates in a highly regulated environment. ACCRUFeR®/FeRACCRU®, along with any other products of the Company which may obtain regulatory approval, are subject to ongoing regulatory obligations. Regulatory authorities may impose significant restrictions on the indicated uses or marketing of ACCRUFeR®/FeRACCRU® or impose ongoing requirements for potentially costly post-approval studies or post-market surveillance. In addition, product manufacturers and their facilities are subject to continual review and periodic inspections by the EMA, the FDA and other regulatory authorities for compliance with good manufacturing practices and good pharmacovigilance practices. If the Company or a regulatory agency discovers previously unknown problems with ACCRUFeR®/FeRACCRU® or problems with a facility where ACCRUFeR®/FeRACCRU® is manufactured, a regulatory agency may impose restrictions relative to ACCRUFeR®/FeRACCRU® or the manufacturing facility, including requiring recall or withdrawal of ACCRUFeR®/FeRACCRU® from the market or suspension of manufacturing which could severely limit the Company's ability to generate revenues.

In order to mitigate this risk the Company maintains and operates suitable quality standards and practices and utilises third party regulatory consultants for expert advice. In addition, the Company regularly audits its key suppliers and manufacturers and works with its external stakeholders to ensure regulatory obligations are met.

The Company's business strategy utilises the expertise and resources of third parties in a number of areas including manufacturing and the conducting of clinical studies and the protection of the Group's intellectual property rights in various geographical locations. This strategy creates risks for the Company by placing critical aspects of the Company's business in the hands of third parties whom the Company must manage appropriately to fit in its best interest.

The Group is also currently reliant on two contract manufacturers for the manufacture of ACCRUFeR®/ FeRACCRU®, although it is currently in the process of engaging an alternative supplier for both drug substance and the completed product.

In order to mitigate this risk the Company holds substantial quantities of raw materials in order to mitigate any disruption to supply and has clearly defined agreements with its manufacturing and clinical partners to set out third party obligations.

The Company has been granted, or has in-licensed rights under, a number of key patent families for ACCRUFeR®/FeRACCRU® (or other proprietary rights), and patent applications are pending in multiple jurisdictions. The strength of patents in the pharmaceutical field involves complex legal and scientific questions and can be uncertain. Patents or other rights might not be granted under any pending or future applications filed or in-licensed by the Company and any claims allowed might not be sufficiently broad to protect the Group's technologies and products from competition. In addition, patents granted may be subjected to opposition or comparable proceedings lodged in various national and regional patent offices. These proceedings could result in the loss of a patent which has already been granted, or loss or reduction in the scope of one or more of the claims of the patent. Generic pharmaceutical manufacturers may successfully challenge some of the Company's patents and/or seek approval to market products which utilise the intellectual property involved in the development and manufacture of ACCRUFeR®/FeRACCRU®.

Competitors may also successfully design around key patents held by the Group, thereby avoiding a claim of infringement. Patents or other registrable rights might also be revoked for other reasons after grant. Competitors may have filed applications or been granted patents or obtained additional patents and proprietary rights that relate to and could be infringed by the Company's products. Any such failure to sufficiently protect the Company's proprietary intellectual property, resulting in additional competition from other third-party products could have a material adverse effect on the Company's business, prospects, financial condition and results of operations.

In order to mitigate this risk the Company employs a team of intellectual property experts who actively advise on the intellectual property portfolio, monitor global patent watches and assist to robustly strengthen and defend the portfolio.

The Company needs to attract and retain key personnel to conduct and grow its operations effectively. The Company's ability to compete in the highly competitive pharmaceutical industry depends upon its ability to attract and retain highly qualified employees. Many of the other pharmaceutical companies and academic institutions that it competes against for qualified personnel have greater financial and other resources and different risk profiles and a longer history in the industry than the Company does.

The Company might not be able to attract or retain these key persons on conditions that are economically acceptable. The inability of the Company to attract and retain these key persons could have a material adverse effect on its business, earnings, financial situation and prospects and its relationships with its suppliers and key commercialisation partners.

In order to mitigate this risk the Group endeavours to offer attractive benefits, remuneration and working environment to employees.

Approved by the Board and signed on its behalf by:

Hans Peter Hasler

Non-Executive Chairman 23 April 2025

Shield Therapeutics plc Annual report and accounts 2024 | Principal risk and uncertainties and risk management

Shield Therapeutics plc Annual report and accounts 2024 | Principal risk and uncertainties and risk management continued