Executive Summary / Key Takeaways

• Repligen Corporation ($RGEN) is demonstrating robust growth, with Q3 2025 organic revenue up 18%, driven by a diversified portfolio, strong customer engagement, and strategic acquisitions, significantly outpacing broader bioprocessing market trends.
• The company's core investment thesis is anchored in its highly differentiated bioprocessing technologies, particularly in filtration and process analytics, which offer tangible benefits like enhanced efficiency and real-time process control, creating a strong competitive moat.
• Strategic initiatives, including aggressive R&D in new modalities and Process Analytical Technology (PAT), targeted M&A (908 Devices, Tantti), and a focus on key accounts and Asian market expansion, are positioning Repligen for sustained above-market growth and a goal to double its size in the medium term.
• Despite macroeconomic uncertainties, including tariff discussions and volatility in specific new modality segments, Repligen's proactive mitigation strategies, strong order book, and expanding gross margins (52-53% guided for 2025) underscore its operational resilience and financial health.
• Investors should monitor Repligen's continued execution on its innovation roadmap, successful integration of acquired assets, and expansion into high-growth geographies and new modalities as key drivers for long-term value creation.

A Differentiated Approach to Bioprocessing Excellence

Repligen Corporation, established in 1981, has evolved into a global life sciences powerhouse, specializing in innovative bioprocessing technologies that enhance the efficiency and flexibility of biological drug manufacturing. The company's mission is to inspire advances in bioprocessing, serving as a trusted partner in the production of critical biologic drugs, including monoclonal antibodies, recombinant proteins, vaccines, and advanced cell and gene therapies. This commitment is particularly vital as the biologics market expands, placing increasing pressure on manufacturers to optimize production costs, capacity, quality, and time. Repligen addresses these challenges with a comprehensive suite of solutions spanning both upstream and downstream processes.

The bioprocessing industry, while experiencing a recovery, remains dynamic, with market growth estimated to be in the 8% to 12% range during normal periods. Repligen's strategy is to consistently outpace this market growth by approximately 5% over the medium term, a goal supported by its highly differentiated product portfolio and customer-centric approach. The company's strategic evolution has been marked by a series of targeted acquisitions and continuous product innovation, aimed at diversifying its offerings and strengthening its competitive standing.

Technological Leadership: The Core of Repligen's Moat

Repligen's competitive advantage is deeply rooted in its proprietary and highly differentiated technologies, which constitute an estimated 80% of its business. These innovations provide tangible benefits that directly address critical customer needs in biopharmaceutical manufacturing.

At the forefront of its technological prowess are its Filtration products, notably the XCell ATF (Alternating Tangential Flow) Cell Retention Systems. These filtration devices are crucial for upstream perfusion and cell culture processing, enabling customers to achieve higher cell densities and improved product yields. The KrosFlo tangential flow filtration (TFF) and tangential flow depth filtration (TFDF) systems, along with ProConnex TFDF flow paths, further enhance downstream biologic drug concentration and buffer exchange. The company's recent launch of the KrosFlow RS 10 RPM system, the first and only single-use TFF system for bench-scale GMP production with in-line, fully automated protein concentration measurements, exemplifies its commitment to advanced, integrated solutions. This system offers enhanced process control and scalability, critical for modern biomanufacturing.

In Chromatography, Repligen offers OPUS pre-packed chromatography columns, which are instrumental in the purification of biologics. These columns provide significant advantages in terms of speed, consistency, and reduced validation efforts, particularly for contract development and manufacturing organizations (CDMOs) who require rapid changeovers between different client projects. The AVIPure double-stranded RNA (dsRNA) resin, launched in December 2024 and utilizing beads from the Tantti acquisition, is a notable innovation. It is the first affinity resin capable of removing dsRNA impurities from transcribed RNA without requiring heat or solvents, offering a unique and efficient purification solution.

The Process Analytics franchise is a cornerstone of Repligen's digitization strategy. Products like the SoloVPE, FlowVPE, and FlowVPX slope spectroscopy systems provide rapid, at-line protein concentration measurements. The recently launched SoloVPE PLUS offers increased data collection speed and enhanced sensitivity and reproducibility with a streamlined workflow, driving a multi-year upgrade cycle across its sizable installed base. The acquisition of 908 Devices Inc. 's bioprocessing PAT portfolio in March 2025 further expanded Repligen's capabilities into upstream analytics for glucose, lactate, and biomass measurement. The in-line integration of CTech FlowVPX into downstream TFF systems provides real-time monitoring and process control, which are key enablers for continuous manufacturing. This technological integration is a significant differentiator, offering customers actionable insights to optimize development processes and improve manufacturing efficiencies.

These technological differentiators contribute directly to Repligen's competitive moat by offering solutions that are often superior in performance, ease of use, or integration compared to alternatives. For investors, this translates into stronger customer loyalty, potential for premium pricing, and a sustained pipeline of recurring consumable sales driven by equipment placements. The company's R&D investments, such as the partnership with Novasign to integrate machine learning and modeling into filtration systems for digital twin capabilities, aim to significantly reduce process development time and cost, supporting more efficient and reliable scale-up for customers.

Competitive Landscape and Strategic Positioning

Repligen operates in a competitive bioprocessing market alongside larger, more diversified players such as Thermo Fisher Scientific (TMO), Danaher Corporation (DHR), and Agilent Technologies (A). While these competitors possess greater scale and broader portfolios, Repligen strategically carves out its niche through specialized innovation and agility.

Thermo Fisher Scientific, a global leader in scientific instrumentation, offers a wide array of bioprocessing solutions. Repligen's specialized filtration systems and Protein A ligands provide targeted tools for biologics purification, often noted for their ease of integration. While TMO benefits from an extensive global distribution network, Repligen's focus allows for deeper specialization and potentially faster innovation in niche applications.

Danaher Corporation, with its strong life sciences presence through subsidiaries like Pall Corporation, directly competes in filtration and chromatography. Repligen's OPUS columns and advanced filtration systems are generally viewed as providing solutions with notably more targeted efficiency for biologics applications. DHR's strength lies in its integrated systems and the Danaher Business System's operational efficiencies. However, Repligen's nimbleness allows for better adaptability to emerging needs in drug manufacturing, particularly in new modalities.

Agilent Technologies, focused on analytical instruments, overlaps with Repligen's process analytics. Repligen's SoloVPE systems are perceived to offer qualitative advantages in ease of use and materially faster setup times for biologics-specific process monitoring. While Agilent benefits from a broader array of analytical tools, Repligen's specialized focus can lead to stronger positioning in biologics-specific applications.

Repligen's strategy to integrate its PAT capabilities directly into its systems, as seen with CTech FlowVPX, provides a significant competitive advantage. Customers who previously purchased hardware from competitors are now seeking Repligen's PAT technologies, highlighting the disruptive nature of its integrated solutions. The company's smaller market share in hardware also means it has a greater runway for growth by gaining market share with its differentiated products.

Indirect competitors, including automation providers and AI-driven drug discovery platforms, pose a long-term threat by offering alternative process optimization solutions. However, Repligen's focus on integrating digital capabilities, such as its partnership with Novasign for digital twins, demonstrates a proactive approach to leveraging these trends rather than being disrupted by them.

Financial Performance and Operational Momentum

Repligen has demonstrated impressive financial and operational momentum, particularly in 2025, building on a year of strategic adjustments in 2024.

For the nine months ended September 30, 2025, total revenue reached $540.3 million, an increase of 15.7% over the same period in 2024. Product revenue, the primary driver, grew 15.7% to $540.2 million. In Q3 2025 alone, total revenue was $188.8 million, marking an outstanding 18% organic growth. This growth was widespread, with all franchises achieving double-digit growth and both biopharma and CDMO customers growing over 20%. Geographically, Asia Pacific was a standout with approximately 50% growth, while the Americas grew 20% and EMEA low double digits. Consumable demand remained robust, growing over 20%, and capital equipment also saw strong growth exceeding 20% in Q3 2025.

Profitability has shown significant expansion. The adjusted gross margin for the nine months ended September 30, 2025, was 52.3%, up from 50.5% in the prior year period. In Q3 2025, the adjusted gross margin reached 53.3%, an increase of 260 basis points year-over-year and 210 basis points sequentially. This improvement was primarily driven by volume leverage, strategic pricing, manufacturing productivity, and an improved product mix. Adjusted income from operations for Q3 2025 was $27 million, up 16% year-over-year on a reported basis, and approximately 20% excluding the impact of foreign currency and M&A. The adjusted operating margin for Q3 2025 was 14.2%, while the adjusted EBITDA margin was 19%.

The company's strategic acquisitions, such as 908 Devices , contributed $2.9 million in Q3 2025 and $6.9 million year-to-date in revenue. Research and development (R&D) expenses increased by 46% in Q3 2025 and 30.2% year-to-date, reflecting increased investment in innovation, partly due to these acquisitions. Selling, general and administrative (SG&A) costs saw a slight decrease in Q3 2025 due to a one-time stock-based compensation expense in the prior year, but increased year-to-date due to investments in personnel and professional services to support growth.

Repligen's liquidity remains strong, with cash and cash equivalents of $748.7 million as of September 30, 2025. Operating activities generated $91.7 million in cash for the nine months ended September 30, 2025. While investing activities consumed $89.7 million, primarily for acquisitions and capital expenditures, the company maintains that its current cash balances are sufficient to meet its needs for at least the next 24 months, absent significant acquisitions or debt conversions. Capital expenditures are expected to be down 20-25% versus 2024, returning to pre-COVID levels.

Strategic Outlook and Guidance for 2025

Repligen's management is confident in its updated 2025 financial guidance, which reflects the company's strong portfolio, commercial execution, and improving market conditions. The company is raising its 2025 revenue guidance to a range of $729 million to $737 million, an increase of $8 million at the midpoint from prior guidance. This update is primarily driven by $6 million from overall portfolio strength and $2 million from foreign currency benefits. This implies Q4 revenue growth in the low double digits organically, even while overcoming a 1% headwind from a specific gene therapy platform.

Franchise-specific growth expectations for 2025 (reported) are:

• Filtration: Approximately 10% (13.5% non-COVID growth).
• Chromatography: Approximately 25%.
• Proteins: 15% to 20%.
• Analytics: North of 30% (including the 908 bioprocessing acquisition).

Adjusted gross margins are projected to be in the range of 52% to 53% for the full year, representing 210 basis points of year-over-year margin expansion at the midpoint. This expansion is expected from volume leverage, pricing, and manufacturing productivity, partially offset by inflation and the lingering drag from 2024 COVID sales. Adjusted income from operations is guided to be between $98 million and $100 million, assuming a roughly 13.5% operating margin. Adjusted fully diluted earnings per share are expected to be between $1.65 and $1.68. The adjusted effective tax rate is now anticipated to be 21% to 22%, a point lower than previous guidance, benefiting from tax planning strategies.

Management's strategic priorities for 2025 include accelerating above-market growth, capitalizing on best-in-class innovation (e.g., SoloVPE PLUS, single-use mixers, new ligands/resins for new modalities), expanding margins, pursuing strategic M&A, and becoming "fit for growth" through investments in human resources tools and a project management office. The company is actively working towards having dual manufacturing capabilities for the vast majority of its portfolio by the end of 2026 to enhance supply chain resilience and capitalize on potential U.S. onshoring projects.

Risks and Challenges

Despite a compelling growth narrative, Repligen faces several risks and challenges. Macroeconomic uncertainties, including global geopolitical conflicts, supply chain disruptions, foreign currency fluctuations, and cost pressures, continue to make financial estimates challenging. While the company has implemented mitigation strategies like price increases and productivity improvements, these factors could still impact future performance.

Tariffs represent another area of uncertainty. While Repligen estimates a limited net impact on adjusted EPS, with potential for a slight revenue tailwind from surcharges and a modest headwind to margins, the volatility of the global trade environment necessitates continuous monitoring. The company's proactive approach to establishing dual manufacturing sites aims to mitigate these risks.

The new modalities market, while a strategic focus, can be volatile. A specific gene therapy platform is expected to be a 1% revenue headwind in 2025, and overall new modality demand is anticipated to be muted in the second half of the year. Repligen's diversification into cell therapy and antibody-drug conjugates (ADCs) aims to offset some of this segment-specific volatility. Furthermore, the health of the small biotech segment, which relies on funding trends, remains a concern, although it represents a smaller portion of Repligen's overall business.

Finally, Repligen has identified material weaknesses in its internal control over financial reporting as of September 30, 2025, related to revenue recognition, IT general controls, and business process-level controls. While the company is actively implementing remediation plans, the full effectiveness of these measures is still being evaluated.

Conclusion

Repligen Corporation is charting a compelling course for growth, driven by a powerful combination of innovative bioprocessing technologies, strategic acquisitions, and disciplined execution. The company's ability to deliver consistent organic growth, expand margins, and maintain a robust order book, even amidst a complex macroeconomic backdrop, underscores the strength of its underlying business and the relevance of its differentiated solutions. By focusing on key accounts, expanding its global footprint, and relentlessly investing in R&D, Repligen is not merely participating in the bioprocessing market but actively shaping its future, particularly through the digitization of workflows and advancements in new modalities.

The strategic emphasis on proprietary technologies, such as the SoloVPE PLUS and AVIPure dsRNA resin, coupled with the integration of PAT capabilities from acquisitions like 908 Devices (MASS), positions Repligen as a critical enabler of efficiency and innovation for its biopharmaceutical customers. While challenges such as market volatility in certain new modality segments and ongoing tariff uncertainties persist, Repligen's proactive management, strong balance sheet, and clear strategic roadmap provide a solid foundation. For discerning investors, Repligen represents a compelling opportunity to invest in a company poised for sustained above-market growth, driven by technological leadership and a clear vision for the future of biologic drug manufacturing.