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Laboratorios ROVI: The Hidden Spanish Pharma Champion That Helped Vaccinate the World
I. Introduction & Episode Roadmap
In the summer of 2020, as the world scrambled for salvation from a once-in-a-century pandemic, Moderna's executives faced a daunting challenge: how to manufacture hundreds of millions of vaccine doses for every country outside the United States. The mRNA technology was revolutionary, but biotechnology means nothing without manufacturing scale. The call went not to a pharmaceutical giant with a household name, but to a family-controlled Spanish company most global investors had never heard of: Laboratorios Farmacéuticos ROVI.
How did a 78-year-old family-owned Spanish pharmaceutical company become Moderna's critical manufacturing partner for vaccinating the world outside the United States?
The answer lies in a multi-generational story of patient capital, technical excellence, and the kind of strategic positioning that only family-controlled enterprises can achieve. Laboratorios Farmacéuticos ROVI is a chemical and pharmaceutical company incorporated in Madrid in 1946, and today it stands as a member of the prestigious IBEX 35 index—Spain's equivalent of the Dow Jones Industrial Average.
In 2024, the company's revenue was €763.7 million, with net profit of €136.9 million. The company currently trades at approximately €2.97 billion in market capitalization, making it a mid-cap by global pharma standards but a significant player in European specialty pharmaceuticals.
At the heart of this enterprise sits the López-Belmonte family, whose three-generation stewardship transformed a post-Civil War startup into a sophisticated dual-engine pharmaceutical operation. The López-Belmonte family, the principal shareholders of ROVI, hold their interest through their investment vehicle Norbel Inversiones, S.L., which is the direct holder of approximately 63.1% of ROVI's shares. Norbel Inversiones is equally owned by Juan López-Belmonte Encina, Iván López-Belmonte Encina and Javier López-Belmonte Encina, each of whom is a member of its Board of Directors.
This article explores ROVI through three key inflection points: the development of Bemiparin—a proprietary low-molecular-weight heparin that established the company's scientific credibility; the transformative Moderna COVID-19 vaccine manufacturing partnership that put ROVI on the global map; and the creation of the ISM® drug delivery platform culminating in Okedi®, a proprietary long-acting injectable antipsychotic that represents ROVI's future as an innovator rather than merely a manufacturer.
The themes that emerge are universal to long-term investors: the power of family capitalism in an industry dominated by quarterly earnings pressures, the strategic wisdom of building a dual-engine business model combining proprietary drugs and contract manufacturing, and perhaps most importantly—being prepared when opportunity knocks.
II. Founding & Early Years: Post-War Spanish Pharma (1946-1990s)
The Crucible of Civil War
The story of ROVI begins not in the gleaming laboratories of modern Madrid, but in the rubble of Albacete in 1939. The company was founded in the year 1939 under the name of PAN QuĂmica FarmacĂ©utica and was in 1946 when it transformed towards Laboratorios Rovi. Juan LĂłpez-Belmonte, the founding patriarch, had survived a city devastated by the Spanish Civil War—Albacete was bombed no fewer than ten times during the conflict. He made his way to Madrid with a vision: to build a pharmaceutical company that could serve the Spanish market during a period of profound economic isolation.
Spain under Franco's autarky policies presented both challenge and opportunity. The country was largely cut off from international trade, creating a protected market for domestic manufacturers willing to invest in local production capacity. For a young pharmaceutical entrepreneur, the barriers to entry were high—but so was the protection from foreign competition.
The company was incorporated on December 21st, 1946 and began operations focused on the production and marketing of high-quality therapeutic solutions. In its earliest years, ROVI concentrated on manufacturing conventional pharmaceuticals, building the foundational capabilities in formulation, quality control, and regulatory compliance that would prove essential decades later.
The Heparin Foundation: ROVI's DNA
What separated ROVI from dozens of other Spanish pharmaceutical startups of the era was a fateful strategic choice: specialization in heparin products. Heparin, derived from porcine intestinal mucosa, is one of the oldest anticoagulant drugs in medicine's arsenal. While seemingly unglamorous compared to the blockbuster small molecules that would later dominate pharmaceutical portfolios, heparin products required genuine scientific expertise—particularly in glycomics (the study of complex carbohydrates in biological systems).
ROVI established its heparin franchise in the 1950s, a commitment that would define the company's identity for the next seven decades. This early focus on anticoagulant products set the stage for the glycomics expertise that would eventually yield Bemiparin—one of the most scientifically sophisticated low-molecular-weight heparins ever developed.
The LĂłpez-Belmonte family guided the company through Spain's tumultuous economic transformation, from Franco-era autarky through the democratic transition and Spain's 1986 accession to the European Economic Community. Each phase brought new challenges: the end of protected markets meant foreign competition; European integration meant stringent regulatory harmonization; but it also meant access to vast new markets.
By the early 1990s, ROVI had established itself as a credible domestic pharmaceutical company with particular expertise in injectable formulations and anticoagulants. But the company remained essentially a Spanish operation—respected at home, unknown abroad. That was about to change.
III. Strategic Transformation: From Domestic Player to Integrated Pharma (1995-2007)
The CDMO Pivot: A Decision That Changed Everything
The year 1995 marked a watershed moment in ROVI's history. Founded in 1946, ROVI began offering contract manufacturing services in 1995, and continues to do so today. This strategic decision—to leverage manufacturing expertise beyond proprietary products—would prove transformative, eventually positioning ROVI for the Moderna partnership that catapulted it to global prominence.
The logic was elegant: ROVI had invested heavily in FDA-quality manufacturing capabilities for its own injectable products. These facilities sat idle much of the time, representing stranded capital. By offering contract manufacturing services to other pharmaceutical companies, ROVI could improve capacity utilization, generate additional revenue streams, and build relationships with major pharmaceutical players who might one day become customers for proprietary products—or partners in their own manufacturing challenges.
This wasn't merely opportunistic capacity-filling. The LĂłpez-Belmonte family understood something profound about the pharmaceutical industry's evolution: as molecules became more complex and regulatory requirements more stringent, many drug companies would prefer to outsource manufacturing rather than maintain expensive in-house capabilities. ROVI positioned itself as the partner of choice for companies seeking European manufacturing excellence.
The Biotechnology Shift
The late 1990s saw ROVI make another strategic pivot. The company recognized that the pharmaceutical industry's center of gravity was shifting toward biotechnology and biologics. Traditional small-molecule chemistry, while still important, was yielding to protein therapeutics, monoclonal antibodies, and other biologically-derived medicines.
By 2000, ROVI had initiated research and development projects laying groundwork for future expansion into biologics. This wasn't about abandoning the heparin franchise—quite the opposite. Low-molecular-weight heparins themselves represent a form of biologic complexity, derived from biological sources and requiring sophisticated manufacturing processes. ROVI's glycomics expertise positioned it well for this transition.
The Bemiparin Breakthrough: From Follower to Innovator
The culmination of decades of heparin expertise came in 2001. In 2001, ROVI obtained approval for the marketing of Bemiparin (Hibor®), an innovative second-generation low-molecular-weight heparin, in the leading European markets.
The significance of this achievement cannot be overstated. Bemiparin sodium is a new second-generation low molecular weight heparin (LMWH). Bemiparin has the lowest mean molecular weight (3600 Da), the longest half-life (5.3 h) and the largest antifactor Xa:antifactor IIa ratio (8:1) of all LMWHs. In pharmaceutical terms, this represented genuine innovation—not merely a me-too product, but a differentiated therapeutic with superior pharmacological properties.
Due to its excellent pharmacological profile—the second-generation LMWH with the lowest molecular weight, the longest half-life and the highest anti-Factor Xa/anti-Factor IIa activity ratio—it can be safely used in special categories of patients including children, elderly, patients with renal impairment and congestive heart failure.
The commercial strategy for Bemiparin reflected ROVI's integrated approach. Rather than attempting to build global sales infrastructure—an enormous capital commitment for a company of ROVI's size—the company pursued strategic partnerships. Due to ROVI's dedication and its strategy of encouraging international trade, Bemiparin has extended its presence to a total of 88 countries thanks to strategic alliances established with international partners.
This partnership model would become a template for ROVI's international expansion: develop innovative products with genuine clinical differentiation, manufacture them in-house at world-class facilities, and leverage partner networks for market access.
Manufacturing Division Reorganization (2006)
As both the proprietary pharmaceutical business and contract manufacturing operations grew, ROVI's management recognized the need for structural clarity. In January 2006, the Manufacturing Division of ROVI separated from the main group to create an injectable plant, thus forming an independent company named ROVI CM entirely focused on contract manufacturing and analysis.
This organizational restructuring served multiple purposes. It created clear accountability for each business line. It allowed contract manufacturing customers to work with a dedicated organization rather than competing for attention with proprietary products. And it positioned ROVI for eventual expansion of its CDMO capabilities—including relationships with major pharmaceutical companies that would bear fruit during the pandemic.
In 2006, ROVI also established a significant partnership with a major U.S. pharmaceutical company, gaining access to advanced technologies and further building its reputation as a reliable manufacturing partner.
The stage was set for ROVI's transformation from a respected Spanish pharmaceutical company to a pan-European player with global manufacturing credentials.
IV. The IPO & Building Scale (2007-2019)
Going Public While Staying Family
Having worked for the Company since 1994, Juan López-Belmonte Encina was appointed Managing Director in October 2001, becoming Chief Executive Officer in October 2007. The timing was not coincidental. ROVI's IPO date was October 26, 2007—the younger generation took the helm just as the company entered public markets.
The IPO decision reflected a delicate balance: accessing capital markets for growth while maintaining family control. Juan LĂłpez-Belmonte Encina is a shareholder of Norbel Inversiones, S.L., in which he owns a 33.33% interest (making him the controlling shareholder of the Company) and is Chairman and Chief Executive Officer of ROVI. With the family retaining over 63% ownership through Norbel Inversiones, ROVI could pursue long-term strategies without quarterly earnings pressure from activist shareholders.
The generational transition brought fresh energy and international perspective. The three López-Belmonte brothers—Juan, Iván, and Javier—had each built international experience before returning to the family business. Iván López-Belmonte Encina began his professional career in the banking sector in 1998, working for Argentaria, S.A. in the United Kingdom as an analyst, and in the pharmaceutical sector with Medeva Pharma, also in the United Kingdom. Javier López-Belmonte Encina began his professional career in Germany, working in companies like Amersham, engaged in nuclear medicine, and Hexal AG, specialised in generics.
This international experience would prove invaluable as ROVI expanded beyond Spain.
Manufacturing Excellence: The FDA Milestone
The 2012 milestone marked a transformational moment for ROVI's contract manufacturing ambitions. In September 2012, the ROVI CM injectable plant in Madrid received FDA approval.
FDA approval for a European manufacturing facility is no small achievement. The U.S. Food and Drug Administration maintains some of the world's most stringent manufacturing standards, and approval requires demonstrating not just adequate facilities but comprehensive quality systems, documentation practices, and ongoing compliance capabilities. For a Spanish company seeking to serve global pharmaceutical clients, FDA approval represented essential table stakes.
This credential opened doors to partnerships with multinational pharmaceutical companies who required FDA-approved manufacturing for products destined for the U.S. market. It positioned ROVI as one of a select group of European CDMOs capable of serving the world's largest pharmaceutical market.
Capacity Expansion: San Sebastián de los Reyes
In 2015, ROVI acquired a new injectable plant in San Sebastián de los Reyes, Spain, increasing ROVI's vial and syringe manufacturing capacity.
The San Sebastián de los Reyes facility expanded ROVI's manufacturing footprint within the Madrid metropolitan area—creating a cluster of manufacturing sites that could share expertise, quality systems, and management attention while providing redundancy and additional capacity. This geographic concentration would prove strategically important: it enabled tight coordination during the COVID-19 vaccine manufacturing ramp-up while maintaining the quality oversight essential for pharmaceutical manufacturing.
By the mid-2010s, ROVI was positioning itself as "one of the world leaders" in prefilled syringe manufacturing—a high-value niche within the CDMO universe. Prefilled syringes represent the premium segment of injectable drug delivery: they require stringent sterility standards, sophisticated filling equipment, and comprehensive visual inspection systems. Pharmaceutical companies increasingly preferred prefilled syringes for their convenience and reduced medication errors.
The Enoxaparin Biosimilar: Competing with Goliath
On 7th of March, 2017, Laboratorios Farmacéuticos ROVI received the positive outcome of the marketing authorization application of a low molecular weight heparin (enoxaparin biosimilar) in twenty-six countries of the European Union.
This approval represented something remarkable: ROVI was taking on Sanofi's Lovenox (enoxaparin), one of the world's best-selling anticoagulant drugs. ROVI estimated that worldwide sales of enoxaparin reached $1.8 billion in 2016, and that the European market represented 63% of the total sales value.
ROVI was the first company to launch a biosimilar enoxaparin into Germany. Being first-to-market in Europe's largest pharmaceutical market was a significant commercial achievement—it demonstrated ROVI's scientific capabilities and regulatory expertise while positioning the company to capture market share as healthcare systems sought lower-cost alternatives to branded products.
The results conclusively showed that the enoxaparin manufactured by Rovi is equivalent to the reference enoxaparin in all primary and secondary PK/PD parameters, as required by the European Medicines Agency to grant marketing authorization to a biosimilar low molecular-weight heparin.
The enoxaparin biosimilar represented strategic depth in ROVI's heparin franchise: Bemiparin for differentiated positioning, biosimilar enoxaparin for cost-competitive positioning. Together, they established ROVI as a comprehensive player in the low-molecular-weight heparin space.
Consolidation: ROVI Pharma Industrial Services® (2019)
By 2019, ROVI's contract manufacturing operations had grown sufficiently complex that consolidation was necessary. ROVI unified all of its contract manufacturing plants to create ROVI Pharma Industrial Services®—a single brand representing the company's CDMO capabilities to potential customers.
This consolidation was more than branding. It represented operational integration: shared quality systems, coordinated capacity planning, unified customer interfaces. For pharmaceutical companies evaluating CDMO partners, a unified organization signaled professionalism and scale.
The timing proved prescient. Within months, the world would face a pandemic, and pharmaceutical companies would desperately seek manufacturing partners capable of rapid scale-up. ROVI had spent two decades preparing for a moment nobody could have predicted.
V. The Moderna Partnership: When Preparation Meets Opportunity (2020-2022)
The COVID-19 Call
July 2020. The world was in chaos. COVID-19 had killed hundreds of thousands and disrupted billions of lives. Moderna's mRNA vaccine candidate, mRNA-1273, had shown promising early results, but the company faced a daunting challenge: manufacturing at scale.
Moderna and ROVI first collaborated in July 2020 for commercial fill-finish manufacturing of Moderna's mRNA COVID-19 vaccine candidate at ROVI's Spain facility.
The partnership announcement revealed how ROVI's decades of preparation had positioned it for this moment. US-based biotechnology firm Moderna partnered with European pharmaceutical company Laboratorios Farmacéuticos Rovi for finish-fill manufacturing of its Covid-19 vaccine candidate, mRNA-1273.
Moderna's choice wasn't random. Juan Andres, Moderna's Chief Technology Operations and Quality Officer, knew ROVI from previous experience—the companies had worked together before. His comments at the announcement revealed the depth of confidence: "ROVI's experience as a global manufacturer of drug product and expertise in fill-finish will be an important partnership for us to establish dedicated supply chains that can meet the needs of different countries and regions. I am delighted to be working with ROVI again."
The phrase "working with ROVI again" underscored something important: relationships matter in pharmaceutical manufacturing. Quality-sensitive pharmaceutical companies don't simply search for the lowest bidder—they seek partners with proven track records, established quality systems, and demonstrated reliability. ROVI's decades of investment in manufacturing excellence had built precisely the reputation needed when crisis struck.
The Scale of the Operation
As part of the agreement, ROVI will provide vial filling and packaging capacity by procuring a new production line and equipment for compounding, filling, automatic visual inspection and labelling to support production of hundreds of millions of doses of the vaccine candidate, intended in principle to supply markets outside of the U.S.
The scale was staggering. ROVI committed to installing entirely new production lines at its Madrid facility—during a global pandemic that disrupted supply chains and made equipment procurement enormously challenging. The company hired additional staff, modified facilities, and built entirely new capabilities in a matter of months.
ROVI will be responsible for large-scale, commercial fill-finish manufacturing of the vaccine product at its facility in Madrid, Spain.
The geographic scope was equally impressive: ROVI would manufacture Moderna vaccines for essentially the entire world outside the United States. Every vial of Spikevax administered in Europe, Asia, Latin America, and beyond during the pandemic's critical early phase passed through ROVI's Spanish facilities.
Moderna and its partners increased capacity globally and supplied over 500 million doses of Moderna's COVID-19 vaccine.
Five hundred million doses. For a company that had been essentially unknown outside pharmaceutical circles, this represented a transformation in scale, visibility, and strategic importance.
The 10-Year Strategic Partnership (2022)
The pandemic partnership quickly evolved into something more permanent. The manufacturing relationship between Rovi and Moderna is built on a 10-year partnership the two firms formed in 2022.
This new agreement, which has a term of ten years, includes a series of investments expected to allow the manufacturing capacity to increase across ROVI's facilities in Madrid, Spain. In addition to producing Moderna's COVID-19 vaccine, ROVI's platform could also be utilized to service future Moderna mRNA vaccine candidates.
The 10-year term was significant. In an industry where contract manufacturing relationships often span individual products or limited time periods, a decade-long commitment signaled strategic alignment. Moderna was betting that ROVI would remain its primary European manufacturing partner through multiple product generations—including future mRNA vaccines for influenza, RSV, CMV, and other indications.
"ROVI has been a pivotal partner in supporting the manufacturing of our COVID-19 mRNA vaccine for countries outside of the U.S., and this long-term agreement expands our partnership and allows for further scale-up for future mRNA medicines."
FDA Approvals for U.S. Market
The Moderna relationship eventually expanded to include the U.S. market itself. In September 2023, the U.S. Food and Drug Administration (FDA) approved ROVI's injectables manufacturing plants in Madrid, San Sebastián de los Reyes and Alcalá de Henares for the fill-and-finish of syringes with the Moderna mRNA COVID-19 vaccine.
Furthermore, in January 2024, the FDA approved ROVI's active substance manufacturing plant in Granada. This approval authorises Moderna to market the vaccine manufactured by ROVI in the United States.
These FDA approvals represented the culmination of years of investment in manufacturing quality. ROVI had achieved something rare for a European CDMO: comprehensive FDA clearance across its entire manufacturing network, enabling it to produce vaccines for the world's largest and most demanding pharmaceutical market.
The Moderna partnership transformed ROVI's financial profile, competitive position, and strategic options. But it also created a challenge: what happens when pandemic-era demand normalizes?
VI. The ISM® Platform & Okedi®: Proprietary Innovation (2016-Present)
Developing the ISM® Drug Delivery Technology
While the Moderna partnership captured headlines, ROVI had been quietly building something potentially more valuable: a proprietary drug delivery technology platform capable of generating multiple products across therapeutic areas.
The ISM® technology platform, patented by Laboratorios Farmacéuticos Rovi, is a new technology developed to release injected drugs, which allows sustained release throughout the dosing period. It is based on forming a solid and stable polymeric matrix system that in situ entraps microparticles of the active ingredient.
The ISM® technology, a long-acting technology, is currently exclusive to ROVI and is patent protected until 2033.
The technology addresses a fundamental challenge in treating chronic psychiatric conditions: patient adherence. Many patients with schizophrenia and other chronic mental illnesses struggle to take daily oral medications consistently. Missed doses can lead to symptom recurrence, hospitalization, and worse long-term outcomes. Long-acting injectables (LAIs) address this problem by providing weeks or months of medication from a single injection.
However, existing LAI formulations often required loading doses or oral supplementation at the start of treatment—creating complexity and delaying therapeutic effect. Against this background, a second-generation LAI—one without safety or tolerability issues that achieves therapeutic levels for 1 month without the need for an injectable loading dose or oral supplementation at the start of treatment—could address the shortcomings shown by other similar antipsychotics and improve adherence.
ROVI's ISM® technology promised exactly this: immediate therapeutic levels from the first injection, sustained release over the dosing period, and no need for supplemental oral medication.
Risperidone ISM® Clinical Development
In 2016, ROVI made significant progress developing the first candidate using its ISM® technology. The phase II clinical trial of Risperidone ISM®, "PRISMA-2", concluded successfully and the favourable final results were presented on 13 March, 2016 at the 24th European Congress of Psychiatry.
The clinical development of Risperidone ISM® continued with recruitment for the Phase III study, PRISMA-3, which commenced in the United States in May 2017.
The choice of risperidone as the first ISM® product was strategically astute. Risperidone is a well-established antipsychotic with decades of clinical use—physicians are familiar with its efficacy and safety profile. By reformulating an established molecule rather than developing an entirely new drug, ROVI could potentially follow the FDA's 505(b)(2) regulatory pathway, reducing development time and costs compared to new chemical entity development.
European Approval: Okedi® (2022)
The European Commission authorized the marketing of Okedi® (Risperidone ISM®) for the treatment of schizophrenia in adults for whom tolerability and effectiveness has been established with oral risperidone.
Risperidone ISM® is a prolonged-release injectable antipsychotic developed and patented by ROVI for the treatment of schizophrenia in adults since, as of the first injection, it provides immediate and sustained plasmatic drug levels and does not require loading doses or supplementation with oral risperidone.
The approval validated years of R&D investment and confirmed the ISM® platform's potential. In 2022, the product was launched in Germany, the United Kingdom and Spain and, in 2023, in Portugal, Italy, Austria, Greece and Serbia.
U.S. Approval and Strategic Decision: Risvan® (2024)
In April 2024, the FDA authorized the marketing of Risvan® (Risperidone ISM®) for the treatment of schizophrenia in adults.
The U.S. approval represented the culmination of a challenging regulatory journey that included multiple complete response letters and manufacturing inspections. But what came next surprised many investors.
ROVI announced that Risvan® (Risperidone ISM®), a product indicated for the treatment of schizophrenia in adults, will not be marketed in the United States, following an assessment of the uncertainties and opportunities associated to this launch.
ROVI decided not to proceed with the launch of Risvan in the United States due to market uncertainties and lack of a reliable partner.
This decision, while initially disappointing to investors, revealed strategic discipline. The U.S. psychiatric market is notoriously competitive, with established products from major pharmaceutical companies backed by extensive sales forces. ROVI, despite securing FDA approval, concluded that the commercial investment required for successful U.S. launch exceeded the risk-adjusted return potential.
Instead, the company chose to focus resources on European development, where Okedi® was gaining traction and where ROVI's existing commercial infrastructure provided competitive advantage. ROVI has, therefore, chosen to focus on the European development of Okedi® and expects this product to reach global potential sales of between 100 and 200 million euros in upcoming years.
Commercial Traction
The Okedi® commercial performance has exceeded expectations. Positive evolution of Okedi® (Risperidone ISM®), sales of which increased 126% compared to the first nine months of 2023, totalling 20.3 million euros.
Positive evolution of Okedi® (Risperidone ISM®), which had total sales of €41.0 million in the first nine months of 2025. Okedi® sales increased 102% in 9M 2025 vs 9M 2024, and 81% in Q3 2025 vs Q3 2024.
The triple-digit growth rates indicate genuine market acceptance. For investors, Okedi® represents something valuable: a high-margin proprietary product with significant growth runway, developed from a platform technology that can potentially yield additional products.
The ISM® pipeline continues to advance. ROVI's R&D efforts continue, with focus on its proprietary ISM technology, which centres on developing novel, long-acting formulations of approved drugs. Assets include Risperidone ISM and Letrozole ISM (Phase I breast cancer).
VII. Modern Era: Navigating Post-COVID Transition (2023-Present)
The Post-Pandemic Adjustment
Every pandemic-era winner faces the same challenge: normalizing growth when extraordinary circumstances end. For ROVI, this meant navigating declining COVID-19 vaccine demand while building new growth drivers.
Operating revenue in the first half of 2024 was 329.3 million euros, a 14% decrease on the first half of 2023, mainly due to the performance of the CDMO business.
Operating revenue in 2024 was 763.7 million euros, a 7.9% decrease on 2023, mainly due to the performance of the contract development and manufacturing business ("CDMO").
This division generated lower revenues from the manufacture of the COVID-19 vaccine in comparison to 2023, when ROVI had booked higher income related to the production of the "pandemic" COVID-19 vaccine.
The pandemic-to-endemic transition created genuine revenue headwinds. COVID-19 vaccination moved from emergency mass campaigns to routine seasonal immunization, reducing demand significantly. ROVI's challenge: replace pandemic-era revenues with sustainable growth drivers.
Diversification Strategy
ROVI responded with aggressive diversification of its CDMO client base. In April 2024, ROVI's subsidiary ROIS entered into an agreement to support the manufacture of pre-filled syringes for a global pharmaceutical company. Under the terms of the agreement, ROIS will provide a high-speed production line at its San Sebastián de los Reyes facility in Madrid, with an estimated annual capacity of 100 million units. Commercial production is expected to commence in 2026, and as from 2027, ROVI's CDMO division expects to have a positive revenue impact with an increase ranging between 20% and 45% over 2023 sales.
The company also secured a significant new partnership. On 21 October 2025, ROVI announced that its subsidiary ROVI Pharma Industrial Services will collaborate with F. Hoffmann-La Roche Ltd. for the manufacture of a new medicine, currently in clinical development, from Roche's metabolic and cardiovascular portfolio.
For 2030, ROVI estimates that the Roche agreement will contribute with a minimum increase of between 20% and 25% in CDMO business sales vs 2024 figure.
Meanwhile, the specialty pharmaceutical business demonstrated resilience. Sales of the specialty pharmaceutical business increased 2% to 427.5 million euros, compared to 420.2 million euros in 2023.
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.
2030 Vision
At its March 2025 Capital Markets Day, ROVI unveiled ambitious long-term guidance. The company expects its Contract Development and Manufacturing Organization (CDMO) revenue to hit approximately €700 million by 2030, accounting for 51% to 61% of the group's operating revenues.
With this capacity, the company forecasts that its CDMO business sales will double by 2030, reaching around 700 million euros, with an estimated capacity utilisation ratio of between 70% and 75%.
Thus, ROVI becomes one of the world leaders with the largest capacities in the manufacture of high-value-added injectables (prefilled syringes, vials and cartridges).
Margins are expected to remain robust, with EBITDA post-R&D margins forecasted between 43% and 47.4%, after accounting for average R&D expenses of €40 million to €60 million per year from 2025 to 2030.
The guidance implies significant revenue growth: ROVI has announced a revenue forecast for FY30E of 1.5-1.8 times FY24 levels, translating to approximately €1,146 million to €1,375 million.
Analysts at Jefferies commented on the guidance, noting that "the midpoint of Operating Revenue guidance gives a FY24-FY30E sales Compound Annual Growth Rate (CAGR) of 8.6%."
Strategic Review and CDMO Decision
In late 2024, ROVI conducted a strategic review of its CDMO business. ROVI has been evaluating strategic options for its assets including a potential sale of a stake in its third-party contract development and manufacturing ('CDMO') business. The process attracted offers from both investment funds and industrial companies who presented several proposals for the CDMO business.
However, ROVI's Board of Directors has concluded that, given the strength, momentum and prospects of this business, the best way to maximize value for shareholders at this time is to continue executing on the Company's standalone strategic plan, with the interest of the CDMO business best served and developed under the current group structure.
This decision revealed management confidence in the CDMO business's long-term value—and family ownership's ability to resist pressure for short-term monetization.
VIII. Playbook: Business & Strategy Lessons
Key Strategic Insights
1. Family Capitalism Advantage
Multi-generational ownership enabled long-term bets that public-market pressure would have foreclosed. The ISM® technology took over eight years from concept to European approval—a timeline few quarterly-earnings-focused companies would tolerate. The López-Belmonte family's 63%+ ownership stake insulated management from activist pressure, enabling patient capital deployment.
2. Dual Engine Model
ROVI's combination of proprietary drug development (Bemiparin, Okedi®) with CDMO services creates strategic synergy. Manufacturing excellence built for proprietary products attracts contract manufacturing customers. Revenue from contract manufacturing funds R&D investment in proprietary products. Each business reinforces the other.
3. Preparation Meets Opportunity
The Moderna partnership didn't emerge from nowhere. Decades of investment in FDA-approved manufacturing facilities, prefilled syringe expertise, and quality systems positioned ROVI when Moderna needed a European partner urgently. Companies that invest during calm periods capture opportunities during crises.
4. Vertical Integration
ROVI has invested in vertical integration of its entire value chain, from production of active pharmaceutical ingredients (at its Granada facility for Bemiparin and the Moderna vaccine API) to fill-finish manufacturing and packaging. This integration provides quality control, cost efficiency, and flexibility that purely outsourced models cannot match.
5. Strategic Focus: Knowing When NOT to Enter
The decision not to commercialize Risvan® in the United States—despite securing FDA approval—demonstrated strategic discipline. Rather than pursuing every available market, ROVI concentrated resources where competitive advantage was greatest. This is the opposite of the "growth at any cost" mentality that destroys value.
6. Geographic Concentration
ROVI's Madrid-area manufacturing cluster—facilities in Madrid, San Sebastián de los Reyes, Alcalá de Henares, and Granada—enables operational efficiency, quality oversight, and management attention that geographically dispersed operations cannot achieve.
IX. Porter's 5 Forces & Hamilton's 7 Powers Analysis
Porter's 5 Forces Analysis
| Force | Assessment | Details |
|---|---|---|
| Threat of New Entrants | LOW | High barriers: FDA approvals require years of preparation and hundreds of millions in facility investment. Technical expertise in sterile injectables takes decades to develop. Relationships with pharmaceutical customers require proven track records. |
| Supplier Power | MODERATE | Specialized raw materials (particularly heparin from porcine sources) create some dependency, but ROVI's vertical integration into active ingredient manufacturing (Granada facility) reduces exposure. |
| Buyer Power | MODERATE-HIGH | Large pharmaceutical clients like Moderna have significant negotiating leverage, but switching costs are high once production is validated. Pharmaceutical companies are reluctant to change manufacturing partners given regulatory and quality implications. |
| Threat of Substitutes | LOW-MODERATE | Injectable drugs face some substitution risk from oral alternatives, but biologics and biosimilars inherently require injectable delivery. mRNA vaccines specifically require specialized manufacturing that oral delivery cannot address. |
| Competitive Rivalry | MODERATE | The global pharmaceutical CDMO market size was evaluated at USD 184.90 billion in 2024. Competition from Catalent, Lonza, Recipharm exists, but ROVI has carved a defensible niche in prefilled syringes with FDA-approved European manufacturing. |
Hamilton's 7 Powers Analysis
| Power | Presence | Evidence |
|---|---|---|
| Scale Economies | âś… STRONG | ROVI expects to substantially increase its high-value-added injectables capacity, targeting 625-810 million prefilled syringes and 140-180 million vials by 2030. Scale provides cost advantages in a capital-intensive industry. |
| Network Effects | ⚠️ WEAK | Limited network effects in pharmaceutical manufacturing—each customer relationship is essentially bilateral. |
| Counter-Positioning | âś… MODERATE | Family ownership enables patience and long-term thinking that quarterly-focused public CDMOs cannot match. The integrated pharma + CDMO model is rare among competitors. |
| Switching Costs | ✅ STRONG | Once a pharmaceutical company validates a manufacturing facility, switching requires new regulatory filings, validation batches, and quality audits—creating high switching costs for established customers. |
| Branding | ⚠️ WEAK | Limited branding power in a B2B manufacturing context. Reputation matters but doesn't command premium pricing. |
| Cornered Resource | ⚠️ MODERATE | ISM® technology patents provide exclusivity until 2033, but platform technologies can potentially be worked around. |
| Process Power | âś… STRONG | Decades of experience in glycomics, heparin manufacturing, and sterile injectables create process knowledge that competitors cannot easily replicate. |
Competitive Comparison
In December 2024, Novo Holdings closed a USD 16.5 billion Catalent deal, creating the world's largest CDMO platform. This transaction—Novo Nordisk's parent company acquiring Catalent—reshapes the CDMO competitive landscape.
Rovi CEO Juan LĂłpez-Belmonte sees Novo Nordisk's acquisition of Catalent as a "tremendous opportunity" for his company to win more customers.
The logic is compelling: pharmaceutical companies that previously used Catalent may now view it as conflicted given Novo Nordisk ownership, creating opportunities for independent CDMOs like ROVI to capture displaced business.
Industry Dynamics
According to market projections, the pharmaceutical CDMO sector is expected to grow from USD 156.62 billion in 2024 to USD 315.08 billion by 2034, reflecting a CAGR of 7.24%.
The global pharmaceutical contract development and manufacturing organization market is expected to grow at a compound annual growth rate of 7.38% from 2025 to 2033 to reach USD 293.6 billion by 2033.
The CDMO industry benefits from structural tailwinds: pharmaceutical companies increasingly outsourcing manufacturing to focus on R&D and commercialization; growing complexity of biologic and specialty drugs requiring specialized manufacturing capabilities; regulatory requirements favoring established, high-quality manufacturers.
X. Bull Case, Bear Case & Investment Considerations
The Bull Case
1. CDMO Growth Accelerates Post-COVID Transition ROVI's 2030 guidance implies CDMO revenue approximately doubling from 2024 levels to €700 million. New contracts with major pharmaceutical companies (including Roche), FDA approvals across all facilities, and the Catalent-Novo Nordisk transaction creating market opportunities could drive outperformance.
2. Okedi® Exceeds Commercial Expectations Triple-digit year-over-year growth rates suggest genuine market acceptance. If Okedi® captures significant European LAI market share and ROVI successfully expands to additional markets, the €100-200 million revenue potential could prove conservative.
3. ISM® Pipeline Value Not Reflected The ISM® platform has proven its value with Okedi®. The ISM technology is patent protected until 2033. Additional products from this platform—including Letrozole LEBE for breast cancer—represent option value not fully reflected in current valuations.
4. Family Ownership Enables Long-Term Value Creation With 63%+ family ownership, ROVI can pursue multi-year strategies without activist pressure. This governance structure is increasingly rare and valuable in pharmaceutical industry facing short-term earnings pressure.
The Bear Case
1. Moderna Dependency Risk The Moderna relationship, while transformative, creates concentration risk. If COVID-19 vaccination demand continues declining, or if Moderna's future mRNA pipeline underperforms, ROVI's CDMO revenues could face sustained pressure.
2. CDMO Overcapacity Risk The pandemic triggered massive CDMO capacity expansion industry-wide. If demand normalizes below expanded capacity, pricing pressure could compress margins across the sector, including for ROVI.
3. Risvan/Okedi® Competitive Pressure The schizophrenia market is crowded with so many companies working in the domain. Established products from Johnson & Johnson, Otsuka, and others with larger sales forces could limit Okedi®'s market penetration.
4. Family Governance Double-Edged Sword While family ownership enables long-term thinking, it can also insulate management from accountability. With majority family control, minority shareholders have limited recourse if strategy proves misguided.
Key KPIs to Monitor
For long-term fundamental investors, three metrics warrant particular attention:
1. Okedi® Sales Growth & Market Share This metric captures both commercial execution and ISM® platform validation. Sustained triple-digit growth rates would indicate strong market acceptance; deceleration below 50% annual growth would suggest competitive pressure limiting penetration.
2. Non-Moderna CDMO Revenue This metric isolates CDMO diversification progress from COVID-19 vaccine volatility. Growth in non-Moderna CDMO revenues demonstrates commercial capability and reduces concentration risk. ROVI's guidance for 20-45% CDMO growth from 2027 from new contracts provides a benchmark.
3. Gross Margin Trajectory Gross margin was 62.7% in 2024, an increase of 3.7 percentage points on 2023. Margin expansion indicates favorable product mix (more Okedi®, higher-value CDMO contracts) and operational efficiency. Margin compression would signal competitive pressure or unfavorable mix shift.
Regulatory & Accounting Considerations
Regulatory Overhang: ROVI operates in a heavily regulated industry where FDA and EMA compliance is essential. Any manufacturing quality issues could result in warning letters, production shutdowns, or customer losses. The January 2024 FDA approval of the Granada facility was positive, but ongoing compliance requires continuous attention.
Revenue Recognition: CDMO contracts often involve upfront payments, milestone payments, and production-based payments that can create revenue lumpiness. Investors should focus on trends over multiple quarters rather than individual quarter fluctuations.
R&D Capitalization: Pharmaceutical companies sometimes capitalize development costs that should arguably be expensed. ROVI's R&D accounting warrants attention, though the company's conservative family ownership suggests aggressive accounting is unlikely.
XI. Conclusion: A Family Business at an Inflection Point
The story of Laboratorios Farmacéuticos ROVI is, at its core, a story about the compounding power of patient capital and strategic consistency across generations.
When Juan LĂłpez-Belmonte founded PAN QuĂmica FarmacĂ©utica in the aftermath of Spain's Civil War, he could not have imagined that his creation would one day help vaccinate the world against a global pandemic. Yet the capabilities that enabled that moment—expertise in injectable formulations, commitment to manufacturing excellence, willingness to invest for long-term competitive advantage—were planted in those earliest years.
Three generations later, the López-Belmonte family controls a company with €2.97 billion in market capitalization, FDA-approved manufacturing facilities across Spain, proprietary drug delivery technology protected until 2033, and relationships with some of the world's most important pharmaceutical companies.
ROVI now stands at an inflection point. The pandemic-era tailwinds have faded, replaced by the harder work of diversifying customer relationships, growing Okedi® sales, and advancing the ISM® pipeline. The 2030 guidance—1.5-1.8x 2024 revenues—represents management's confidence in this transition.
For investors, ROVI offers something increasingly rare: a profitable, growing pharmaceutical company with genuine competitive advantages, controlled by owners whose time horizon extends across generations rather than quarters. The family's decision to retain majority ownership despite market value exceeding €2 billion speaks to commitment that transcends financial engineering.
As CEO Juan LĂłpez-Belmonte characterized 2025: "a transition year in which the company continues to invest, laying the foundation for sustainable growth and value creation in the years ahead."
The question for investors is whether that foundation—built over nearly eight decades of family stewardship—will support the next chapter of growth. If history is any guide, betting against the López-Belmonte family's ability to position ROVI for long-term success would be unwise.
Note: This analysis is for informational purposes only and does not constitute investment advice. Investors should conduct their own due diligence before making any investment decisions.
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