ROVI Rocks!

Schizophrenia is a complex chronic disorder is associated with significant functional impairment and high personal and social costs. Likewise it is compounded by a high rate of comorbidities, such as cardiovascular diseases, leading to isolation and a progressive worsening of the condition.

On 24 May, World Schizophrenia Day, we at ROVI would like to shine a spotlight on people, their wellbeing, and the importance of continuing to construct increasingly humane, accessible and recovery-oriented care.

A reality that requires attention

The latest data, gathered in the Global Burden of Disease Study 2021, provide a clear picture of the scale of the challenge: over 23.2 million people all over the world live with schizophrenia, representing around 0.3% of the global population. Global prevalence stands at 293.8 cases per 100,000 inhabitants, with 332.5 cases per 100,000 inhabitants in Spain. Beyond the figures, one of the main challenges in managing schizophrenia continues to be maintaining good treatment adherence, a key factor in reducing relapses and hospital readmissions that impair patients’ functioning and quality of life.

Our commitment: to support, research and improve

At ROVI, we maintain a sustained commitment to the research and development of innovative solutions in the mental health field. Our ISM® technology forms part of this effort and has led to developments that are already available in various markets.

At the same time, we continue to work on new formulations in research, with the aim of further expanding the options available in the future. This commitment involves continuing to research, collaborating with healthcare professionals, and always placing patients at the centre of our work.

ROVI presents its financial results for the first quarter of 2026, a year in which the Company expects to resume a path of growth, supported by the key strategic decisions taken over recent years.

REVENUES

Total revenue stood at €154.7 million in the first quarter of 2026. ROVI booked operating revenue of 152.5 million euros, representing a 2% decrease on the first quarter of 2025 due to the behaviour of the heparin franchise. Notwithstanding, the contract manufacturing business (CDMO) recorded sales of 37.4 million euros, a 5% increase on the first quarter of 2025.

The sales of the specialty pharmaceutical business stood at €115.0 million in the first quarter of this year.

Sales of the low-molecular-weight heparin franchise dropped 13% to 58.9 million euros, due to a lower contribution from bemiparin, particularly in international sales, as a result of the high inventory levels held by partners.

Risperidone ISM stands out, with sales reaching 17.2 million euros, showing growth of 37% compared with the same quarter of 2025.

Solid performance of Neparvis®, with sales growing by 4% in the first quarter of this year.

Gross profit increased 5% to 95.0 million euros in the first quarter of 2026 compared with the first quarter of 2025, reflecting a 3.8 percentage point increase in the gross margin, which rose to 62.3%.

EBITDA stood at 20.3 million euros in the first quarter of 2026. This has led to a 6.3 percentage point reduction in the EBITDA margin to 13.3%. Net profit stood at 9.4 million euros.

R&D expenses rose 75% in the first quarter of 2026 compared with the same period of last year. This increase relates mainly to preparations for the phase III clinical trial of Letrozole SIE.

ROVI has updated its operating revenue guidance for 2026 . expecting them to continue to increase compared to 2025, although by a low- to mid-single-digit percentage. Factors taken into account for this revision include:

• Firstly, lower revenue forecast for 2026 under the prefilled syringe manufacturing agreement entered into with a global pharmaceutical company on 25 April 2024. The adjustment to the guidance is due, among other factors, to a delay in the initially expected commencement of routine manufacturing operations, which is awaiting the relevant regulatory authorization, as well as increased uncertainty regarding anticipated demand, without prejudice to the minimum contractual obligations assumed by the two parties; and

• Secondly, growing competitive pressure on pricing in the heparin franchise in the current context of increased regulatory and geopolitical uncertainty and greater volatility in supply and cost dynamics.

Laboratorios ROVI informed the National Securities Market Commission (CNMV) this Wednesday that the purchase agreement entered into between its subsidiary ROIS Phoenix Inc. and Bristol Myers Squibb (BMS) for the acquisition of a pharmaceutical manufacturing plant in Phoenix, Arizona (United States), has been completed.

As part of the transaction, the group has entered into a toll manufacturing agreement governing the terms under which ROIS Phoenix will continue to manufacture for BMS at the plant.

This transaction represents a strategic acquisition for ROVI and a key milestone towards achieving its vision of becoming one of the leading global manufacturers of high-value‑added injectables (pre-filled syringes, cartridges and vials).

Find here the information submitted to the CNMV earlier today.

ROVI announces its financial results for the full year 2025, an inflection point in which took strategic steps forward to reinforce its international reach and ensure the company’s long-term creation of sustainable value.

• Acquisition of a manufacturing facility for injectable pharmaceuticals in Phoenix, Arizona (USA) to Bristol Myers Squibb and a Toll Manufacturing Agreement, which regulates the conditions under which ROIS Phoenix Inc. will continue to manufacture for BMS at the facility.

• ROVI will also collaborate with Roche for the manufacture of a new medicine, currently in the clinical development phase, from it’s metabolic and cardiovascular portfolio.

Total revenue in 2025 was 756.1 million euros, a 1% decrease on 2024. ROVI booked operating revenue of 743.5 million euros, representing a 3% decrease on 2024, due to the behaviour of the contract development and manufacturing business (CDMO).

In addition, the contract manufacturing business (CDMO) booked sales of 269.5 million euros.

Notwithstanding, sales of the specialty pharmaceutical business rose 11% to 473.9 million euros this year.

Risperidone ISM® continues its strong growth reaching total sales of 56.7 million euros. This represents a 97% increase over sales registered on 2024.

Sales of the heparin franchise, which includes low-molecular-weight heparins and other heparins, increased 7% to 266.8 million euros, due to the increase in orders from international partners. The main contributor to the division’s growth was enoxaparin, sales of which rose 9% to 157.7 million euros as a result of an increase in orders from partners during 2025. Bemiparin sales increased by 4% in 2025 in comparison to 2024.

Gross profit increased 3% to 494.7 million euros in 2025, reflecting an increase of the gross margin of 3.9 percentage points to 66.5% in 2025.

Likewise, in 2025 EBITDA increased to 216.2 million euros, reflecting a 1.9 percentage point rise in the EBITDA margin, which reached 29.1% in 2025.

Net profit rose 3% to 140.4million euros..

For 2026, ROVI expects operating revenue to increase by between a high single-digit and low double-digit percentage.

ROVI announces its financial results for the first nine months of 2025, a period in which it took strategic steps forward to reinforce its global reach and accelerate its growth.

One of the most significant milestones was the acquisition of a manufacturing facility for injectable pharmaceuticals in Phoenix (USA) from Bristol Myers Squibb (BMS), which positions ROVI as a global industrial player with direct presence in the United States market. In addition, as part of the transaction, a Toll Manufacturing Agreement has been signed with BMS, which regulates the conditions for continuing with the manufacture of its products at this facility.

Likewise, ROVI has announced that it will collaborate with Roche in the manufacture of a new medicine, currently in the clinical development phase, from Roche’s metabolic and cardiovascular portfolio.

ROVI booked operating revenue of 525.1 million euros, representing a 7% decrease on the first nine months of 2024, due to the behaviour of the contract manufacturing business.

Notwithstanding, sales of the specialty pharmaceutical business rose 10% to 343.4 million euros in the first nine months of the year.

Risperidone ISM® maintained its positive evolution, reaching total sales of 41.0 million euros in the first nine months of the year. This represents a 102% increase on the first nine months of 2024.

Sales of the heparin franchise, which includes low-molecular-weight heparins and other heparins, increased 7% to 189.8 million euros due to the increase in orders from international partners. The main contributor to the division’s growth was the enoxaparin biosimilar, sales of which rose 11% to 112.8 million euros in the first nine months of 2025 as a result of an increase in orders from partners during the period.

In addition, the contract manufacturing business (CDMO) booked sales of 181.7 million euros.

In the first nine months of 2025, the gross margin increased by 3.5 percentage points compared to the same period of 2024, reaching 67.1%.

Likewise, in the first nine months of 2025, EBITDA decreased 11% to 149.5 million euros.

Net profit was 97.7 million euros.

For 2025, ROVI expects operating revenue to decrease by a mid-single-digit percentage.

For 2026, ROVI expects its operating revenue to increase by between a high single-digit and low double-digit percentage compared to 2025.

This estimate is based on a number of factors whose evolution is difficult to predict, such as:

– Limited visibility of the evolution of the demand and production associated with the 2026 vaccination campaign,

– The potential revenue from the manufacturing agreement signed with Bristol Myers Squibb (still in the process of signature) as part of the transaction announced on 29 September 2025, and

– Revenues derived from other agreements related to contract manufacturing activities.

We are pleased to introduce ROIS, a new brand identity that continues the transformation of our third-party manufacturing activity (CDMO). This evolution strengthens our leadership and drives us to keep creating value for both our business and our clients.

ROIS represents the natural evolution of ROVI Pharma Industrial Services. It embodies a new image that reflects a path of sustained growth, consolidating our position as a global CDMO while clearly projecting our future vision: to be a company that continuously expands its capabilities while remaining a trusted partner to the world’s leading pharmaceutical companies.

The launch of this new brand identity coincides with the announcement of an agreement to acquire a state-of-the-art facility for the manufacturing and packaging of injectable medicines in Phoenix, Arizona (United States). This milestone marks a significant step forward for the company, enabling direct manufacturing for pharmaceutical and biotechnology partners in one of the world’s most important markets, the United States.

“Our transformation into ROIS reflects both our present situation and our future. We are proud of our legacy and excited about what lies ahead: growing, investing, and expanding our capacity to meet the needs of our partners worldwide,” explained Javier López-Belmonte, Vice Chairman of the Board & Chief Financial Officer at ROVI.

A new brand for a new era

The ROIS brand signals the next stage in the company’s evolution. ROVI Pharma Industrial Services has built a reputation as a trusted partner for injectable development and manufacturing, and the rebrand reflects its continued investment in capacity, technology and service.

“Our transformation into ROIS reflects where we are today and where we are headed,” said López-Belmonte. “We are proud of our legacy and excited about our future — growing, investing, and expanding capacity to meet our partners’ needs worldwide.”

Significant US manufacturing capability

The Phoenix facility comprises approximately 34,000 m² on an ~80,000 m² site and has benefited from ~$100m CAPEX since 2021. The site includes a cytotoxic/high-potent (OEB5) area and holds regulatory approvals from FDA, EMA and Japanese authorities. ROIS plans to install an Optima pre-filled syringe (PFS) isolator line in 2027, projected to add ~65–70 million PFS capacity annually once operational. The US facility is equipped for commercial-scale sterile fill-finish and packaging across vials, PFS and cartridges.

With this expansion, ROIS will:

Increase global capacity and flexibility for injectable development and production.
Provide direct US-based manufacturing for pharmaceutical and biotech partners.
Reinforce its commitment to innovation and investment in advanced facilities and equipment.
The rebrand and US expansion underline ROIS’s vision to be a partner of choice for injectable medicines worldwide, underpinned by continued investment in people, technology and infrastructure.

“This acquisition is a strategic step in building ROIS as a global CDMO for high-value injectables,” added López-Belmonte. “The Phoenix site adds significant sterile fill-finish and high-potent capability, enabling us to better serve partners on US soil while continuing to invest across our network.”

For more information, visit www.roiscdmo.com.

ROVI has entered into an Asset Purchase Agreement with Bristol Myers Squibb (BMS) for the acquisition of a drug manufacturing facility located in Phoenix, Arizona (United Stated of America). Transaction is done by ROIS Phoenix Inc., a wholly owned subsidiary of ROVI Pharma Industrial Services, S.A.U.

Furthermore, ROIS Phoenix has entered into a Toll Manufacturing Agreement with BMS, which regulates the conditions under it will continue to manufacture products for BMS at the Facility. The agreement has an initial term of five years from the closing of the Transaction and provides for a minimum payment of 50 million dollars for each year of the contract.

This Wednesday, Laboratorios Farmacéuticos Rovi, S.A. held its Ordinary General Shareholders’ Meeting, at which all the items on the agenda were approved, including the annual accounts for 2024 and the shareholder remuneration via dividend. Specifically, the Meeting, which reached a quorum on the first call, approved the distribution of a dividend of 0.9351 euros per share entitled to receive it, equivalent to a maximum of 47,910,561.05 euros, charged to the 2024 profit, representing a pay-out of 35% of ROVI’s consolidated net profit.

The 2025 General Shareholders’ Meeting was attended by 397 shareholders, both present and represented, holding a total of 44,104,081 shares, accounting for 86.081% of the Company’s share capital. The strong support received at the Meeting reflects the shareholders’ confidence in the current management team and the Company’s long-term growth strategy, with special focus on internationalisation, driving the contract manufacturing business (CDMO) forward and promoting innovation and the development of own products using the ISM® technology, such as Okedi® (Risperidone ISM®).

Mr Juan López-Belmonte Encina said: “2024 was a key year of transition in laying the foundations for our future. We focused on strengthening our capacity in the contract manufacturing area to address the imbalance between the growing demand and the limited supply of production capacities for injectables. The expansion of our production capacities places us in a favourable position to meet global market needs. Furthermore, Risperidone ISM® showed efficacy in treating schizophrenia with positive results that are reflected in an improvement in the patients’ quality of life. We are continuing to invest in research and development, taking advantage of the capabilities of our ISM® technology to provide innovative solutions that drive the well-being of society forward and help medicine to advance.”