ROVI Rocks!

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.”

Churriana de la Vega hosted the 9th edition of the Churriana Integra Race, a benchmark event in the field of adapted sports in the province of Granada. Of course, Team ROVI Granada could not miss the competition, organised by the Granada Integra Foundation, which had more than 1,000 runners registered

A special route around the Air Base

This year, due to the works that prevented the normal circuit of previous editions, the Churriana Integra Race included in one of its sections the Armilla Air Base, being able to run through an area hitherto unexplored in the event and making this year a special occasion.

A celebration of sport and inclusion

The City Council of Churriana de la Vega and the Granada Integra Foundation wanted to close the event with a solidarity paella for all participants, demonstrating that sport brings people together and motivates us to get the best out of ourselves.

Don’t miss the video of the event!

ROVI lays the foundations for its future growth: it forecasts that its contract manufacturing business sales will double by 2030.

• ROVI forecasts that its 2024 operating revenue will be multiplied by between 1.5 and 1.8 in six years, driven primarily by an increase in its contract manufacturing business sales.
• The company will reinforce its current position as one of the major global leaders in the fill and finish of injectables after expanding its installed capacity.
• ROVI expects the specialty pharmaceutical division to grow annually by a low-single-digit percentage in the period from 2024 to 2030, with Okedi® as the primary growth driver.
• The company plans to commence the next phases of the clinical development of Letrozole SIE and three-monthly risperidone.

You can watch the presentation of the Capital Markets Day ROVI 2025 in this video.

Laboratorios Farmacéuticos ROVI announces the full-year results for 2024, a key year for setting the bases for ROVI’s future, focused on increasing our production capacities in the contract manufacturing business and reinforcing the company’s internationalisation with Risperidone ISM®.

In 2024, the company obtained operating revenue of 763.7 million euros; EBITDA of 207.4 million euros; and a net profit of 136.9 million euros.

The contract manufacturing business (CDMO) decreased 18% compared to 2023, dropping to 336.2 million, as a consequence of:

– lower revenue related to the manufacture of the COVID-19 vaccine compared with 2023, when ROVI booked higher revenue related to the production of the “pandemic” COVID-19 vaccine; and – lower revenue related to the activities carried out to prepare the plant for vaccine production under the agreement with Moderna.

Positive evolution of Okedi® (Risperidone ISM®), which had total sales of 28.8 million euros in 2024. Okedi® sales in 2024 doubled those of 2023.

Sales of the heparin franchise (low-molecular-weight heparins (LMWH) and other heparins) slightly decreased by 1% to 248.7 million euros in 2024, mainly due to lower orders from enoxaparin partners throughout the year.

In December 2024, for the fifth year running, ROVI improved its ESG risk rating awarded by Sustainalytics, achieving a low risk of 16.1, compared to 16.4 the previous year. The Company was placed fifth in the world ESG risk ranking from among the 424 companies evaluated in the pharmaceutical industry.

Financial donation of 250,000 euros for the reconstruction of damaged areas

We are pleased to announce that Laboratorios Farmacéuticos ROVI has made a donation of 250,000 euros to the solidarity account set up by the Generalitat Valenciana for the repair of damage and reconstruction of the areas affected by the DANA of 29th of October.

This contribution is part of the actions that the company carries out in emergency and humanitarian situations through the group’s Donations Committee. In this case, the funds will be used to repair the serious material damage caused in numerous urban and rural areas of the province of Valencia as a result of the intense rainfall and floods.

With this collaboration, we hope to contribute to a speedy recovery of the affected areas and the restoration of normal daily life.