Theravance Biopharma, Inc. (TBPH): PESTLE Analysis [Nov-2025 Updated]

You need to know if Theravance Biopharma, Inc.'s (TBPH) financial foundation can withstand the regulatory and market shifts defining the biopharma sector right now. The short answer is yes, but the path is narrow. The company has a strong position, reporting $333 million in cash with no debt as of Q3 2025, plus a steady royalty floor from YUPELRI, which hit a record $71.4 million in U.S. net sales for the quarter. That cash buffer is defintely critical because the entire valuation hinges on the Phase 3 ampreloxetine data in early 2026, which is highly sensitive to external pressures like the US Inflation Reduction Act (IRA) and payer reimbursement scrutiny. You can't just look at the pipeline; you must map the macro-environment to the catalyst. Let's break down the Political, Economic, Sociological, Technological, Legal, and Environmental (PESTLE) factors that will either accelerate or derail TBPH's strategy.

Theravance Biopharma, Inc. (TBPH) - PESTLE Analysis: Political factors

US Inflation Reduction Act (IRA) drug price negotiation risk for future assets

The US Inflation Reduction Act (IRA) of 2022 fundamentally reshaped the pricing landscape for Theravance Biopharma, Inc. (TBPH) and the entire biopharma sector. The core risk is the Medicare Drug Price Negotiation Program, which allows the Centers for Medicare & Medicaid Services (CMS) to negotiate the price of high-cost, single-source drugs.

This policy creates a clear R&D disincentive, especially for small-molecule drugs, which face negotiation after only nine years on the market, compared to 13 years for biologics. This shortens the period of peak commercial return, forcing companies to launch faster and reach maximum sales sooner. For the first round of negotiations, which concluded in 2024, the CMS secured price cuts ranging from 38% to 79% for the selected drugs, with the new prices taking effect in January 2026. This is a defintely a tough precedent.

The second list of 15 drugs for negotiation was selected on February 1, 2025, with negotiated prices becoming effective in 2027. While TBPH's current portfolio may not be immediately targeted due to market size or time on market, any future blockbuster asset-particularly a small molecule-faces a guaranteed revenue cliff after nine years. This shifts the internal calculus for pipeline prioritization, favoring biologics or drugs with very specific, non-Medicare-dominant patient populations.

Increased scrutiny on Orphan Drug designation benefits

The political landscape around Orphan Drug designation (ODD) benefits has seen a significant, recent shift that is actually favorable to rare disease developers. Initially, the IRA's narrow exclusion for ODDs (only protecting those with a single rare disease indication) had created a chilling effect, discouraging companies like TBPH from pursuing additional indications for a drug.

However, the passage of the 'One Big Beautiful Bill Act' (OBBBA) in July 2025 amended the IRA. This new law expanded the Orphan Drug Exclusion, meaning a drug with multiple Orphan Drug designations is now completely exempt from Medicare price negotiations, provided it is not approved for any non-orphan use. This change is a strong incentive for TBPH to continue investing in the rare disease space, which represents a $190 billion opportunity in the US Orphan Designated Drugs Market in 2025. It protects the long-term pricing power for rare disease assets.

Global trade tensions impacting supply chain logistics for manufacturing

Geopolitical tensions and the resulting trade policies are directly increasing the cost and complexity of the biopharma supply chain. Since late 2024 and through 2025, the US government has implemented new tariff regimes that impact the global movement of active pharmaceutical ingredients (APIs), excipients, and manufacturing equipment.

The uncertainty is the real killer here. For example, a 10% baseline tariff on imports from numerous countries, effective April 5, 2025, and a 55% consolidated tariff on Chinese imports effective June 11, 2025, raise the cost of goods sold (COGS). While certain finished pharmaceuticals may be exempt, the raw materials and intermediates are often caught in the crossfire. A comprehensive 25% tariff on pharmaceutical imports, if fully implemented, is projected to increase U.S. drug prices by almost $51 billion annually.

This forces a strategic re-evaluation of sourcing and manufacturing footprint for TBPH, pushing for greater supply chain resilience through diversification or reshoring. The industry is grappling with:

• Increased COGS due to tariffs on raw materials and equipment.
• Logistical delays and increased customs complexity.
• Need to reduce concentration risk from key API sources like China and India.

Government funding priorities shifting toward pandemic preparedness

Post-COVID-19, US government funding priorities have demonstrably shifted toward creating a more robust and responsive public health infrastructure, which impacts the R&D funding environment. This shift prioritizes platform technologies and medical countermeasures (MCMs) that can be rapidly scaled for a future pandemic.

While this is a boon for companies focused on infectious diseases or platform technologies, it can draw federal research dollars away from other therapeutic areas. For fiscal year 2025 (FY 2025), there was a specific request for $15 million in funding for the FDA's proposed Emerging Pathogens Preparedness Program. This shows a clear, albeit relatively small, financial commitment to building regulatory expertise and facilitating MCM development, which could offer partnership opportunities for biopharma companies with relevant technologies.

The goal is to move from a reactive to a proactive state:

• Sustaining an innovation ecosystem for rapid R&D of MCMs.
• Building regulatory expertise at the FDA's Center for Biologics Evaluation and Research (CBER).
• Investing in flexible, scalable manufacturing capacity.

Theravance Biopharma, Inc. (TBPH) - PESTLE Analysis: Economic factors

High interest rate environment increasing cost of capital for R&D financing.

You might think a high-interest-rate environment is a death knell for a biotech company that needs capital, but Theravance Biopharma is in a defintely unique position. While the broader biopharma sector's internal rate of return for R&D investment has fallen to 4.1%, which is well below the current cost of capital, TBPH is largely insulated from this direct pressure. They have a strong balance sheet with approximately $333 million in cash and, crucially, no debt as of the third quarter of 2025. This means they aren't scrambling to refinance or secure high-interest loans for their core operations or R&D.

Still, the high cost of capital affects their strategic decisions. It makes external financing (like a new equity raise) more dilutive and increases the hurdle rate for any new R&D project or acquisition they consider. Their projected R&D expenses for 2025 (excluding share-based compensation) are between $32 million and $38 million, a manageable figure that is internally funded. The real impact is on the valuation of their future pipeline, like ampreloxetine, where a higher discount rate shrinks the net present value (NPV) of potential future revenue.

Payer pressure on pricing and reimbursement, especially for new drugs.

The US drug pricing landscape is under immense pressure in 2025, and this is a significant macro-economic risk for any company with a new drug in the pipeline. The Inflation Reduction Act (IRA) is the biggest driver, with Medicare price negotiation for high-cost drugs set to begin in 2026. Furthermore, a May 2025 executive order aimed to cut prescription drug prices by up to 90% by aligning them with prices in other developed nations via a Most-Favored Nation (MFN) drug pricing model.

For TBPH, this pressure is a direct threat to the potential commercial success of their late-stage candidate, ampreloxetine, if approved. Payers are shifting toward value-based pricing, where reimbursement is tied to clinical outcomes, not just usage. This forces companies to prove exceptional clinical benefit just to maintain a reasonable price. The environment is pushing for:

• Faster adoption of biosimilars and generics.
• Increased scrutiny on specialty drug costs, which are projected to account for 60% of total drug spending by the end of 2025.
• Tougher negotiations with Pharmacy Benefit Managers (PBMs).

This means the pricing power for any new drug is shrinking. You need a truly differentiated product to command a premium.

Strong US dollar potentially decreasing international royalty revenue value.

A strong US dollar (USD) typically hurts companies with significant international sales, as foreign currency revenue translates into fewer USD. For TBPH, this risk is mitigated by their current revenue mix, which is heavily weighted toward US-based sales and USD-denominated payments.

The primary revenue stream, YUPELRI, is a US-focused profit-sharing arrangement. While they did sell their royalty interest in TRELEGY ELLIPTA for a strategic monetization of $225 million in Q2 2025, they retained the right to receive certain contingent milestone payments. These milestones, while based on global net sales of TRELEGY, are paid in USD from Royalty Pharma. The currency risk is therefore primarily a risk to the size of the underlying global sales, not a direct translation risk on their books for the core revenue base.

Royalty stream from YUPELRI providing a steady, but capped, revenue floor.

The YUPELRI (revefenacin) collaboration with Viatris provides a crucial, predictable revenue floor. This is structured as a profit and loss sharing arrangement, not a traditional royalty, where TBPH receives a 35% share of the US net sales. This stream is the financial backbone supporting their R&D efforts.

The product's performance in 2025 has been strong, with an all-time high in net sales. Here's the quick math on the near-term revenue floor and growth:

The growth trajectory is clear: the company is on track to achieve a $25 million sales milestone in 2025, which is triggered when annual US net sales of YUPELRI reach $250 million. This collaboration revenue provides the stability needed to fund the pivotal Phase 3 CYPRESS study for ampreloxetine, which is their primary focus.

Theravance Biopharma, Inc. (TBPH) - PESTLE Analysis: Social factors

Growing demand for respiratory and nephrology treatments due to aging populations

You can defintely see the social impact of an aging U.S. population reflected in Theravance Biopharma's core business. The rising prevalence of chronic conditions, especially Chronic Obstructive Pulmonary Disease (COPD) and Chronic Kidney Disease (CKD), creates a massive, durable market opportunity. For instance, 34% of U.S. adults aged 65 and above are affected by CKD, and overall, 93.0% of older adults (65+) had one or more chronic conditions in 2023. That's a huge segment of the population needing long-term, effective management.

This demographic reality directly fuels the demand for the company's approved product, YUPELRI (revefenacin) for COPD. The market demand is strong: U.S. net sales for YUPELRI hit an all-time high of $71.4 million in Q3 2025, representing a 15% year-over-year increase, with customer demand up 6% year-over-year. The need for convenient, once-daily treatments like YUPELRI becomes more critical as patient complexity and co-morbidities increase with age. It's a clear map of social demographics to commercial success.

Increased public awareness and scrutiny of pharmaceutical pricing practices

The social pressure on drug pricing is intense, and it's a constant headwind for every pharmaceutical company, including Theravance Biopharma. In 2025, the scrutiny on the entire supply chain-especially Pharmacy Benefit Managers (PBMs)-remains high, with pharmacy-related costs now consuming over 25% of employers' U.S. health care budgets. This forces payers and employers to demand more value for every dollar spent, pushing back on high list prices.

The ongoing implementation of the Inflation Reduction Act (IRA) drug negotiation program, which is kicking off its second year of negotiations, signals a permanent shift toward government-mandated price controls in the Medicare space. This environment means that while YUPELRI has strong demand, its commercial success is highly dependent on favorable net pricing and formulary access, which is constantly under threat from cost-containment measures. You have to be smart about pricing and access from day one.

Patient advocacy groups influencing clinical trial design and access programs

In the rare disease space, patient advocacy groups wield significant power, and this is crucial for Theravance Biopharma's pipeline asset, ampreloxetine, for symptomatic neurogenic orthostatic hypotension (nOH) in Multiple System Atrophy (MSA) patients. This is a devastating, rare condition affecting approximately 40,000 patients in the U.S. alone.

Because the patient population is so small and the unmet need is so high, advocacy groups directly influence the FDA and the company to focus on endpoints that truly matter to patients, like the ability to perform daily activities. The company's focus on demonstrating clinically meaningful and durable symptom improvement without worsening supine hypertension, as highlighted in their 2025 presentations, shows they are prioritizing patient-reported outcomes (PROs) and safety profiles that resonate with these groups. They completed enrollment in the pivotal Phase 3 CYPRESS study in Q3 2025, and the topline readout is on track for Q1 2026. This is a high-stakes, patient-driven catalyst.

Shift toward value-based healthcare models demanding proven patient outcomes

The entire U.S. healthcare system is moving away from fee-for-service (FFS) and toward value-based care (VBC), which means reimbursement is increasingly tied to demonstrable patient outcomes, not just the volume of prescriptions. With U.S. healthcare spending exceeding 17% of GDP in 2023, payers-from Medicare to large employers-are demanding proof that a drug actually improves a patient's quality of life and reduces downstream costs like hospitalizations.

For Theravance Biopharma, this shift is both a risk and an opportunity. The opportunity is clear: YUPELRI's success in the hospital channel, with doses up 29% year-over-year, suggests its nebulized, once-daily format is providing value in an acute setting, potentially reducing readmissions for COPD exacerbations. On the pipeline side, ampreloxetine's goal of achieving durable symptom improvement in nOH is a perfect VBC metric. If the drug can truly improve a patient's daily functioning (measured by the Orthostatic Hypotension Daily Activity Scale or OHDAS), it will be well-positioned for favorable formulary placement, because it delivers a clear, measurable outcome.

• Measure patient outcomes: Focus on data that shows reduced hospitalizations.
• Demonstrate cost-effectiveness: Prove the drug saves money long-term.
• Align with payers: Use real-world evidence to support value claims.

Theravance Biopharma, Inc. (TBPH) - PESTLE Analysis: Technological factors

Rapid advancements in precision medicine and biomarker identification

The entire biopharma landscape is shifting toward precision medicine, which means developing drugs that target specific genetic or molecular markers (biomarkers). Theravance Biopharma is defintely playing in this space, focusing on niche, high-need areas like neurogenic orthostatic hypotension (nOH) in Multiple System Atrophy (MSA) with its investigational drug, ampreloxetine. This focus is a strategic technological choice because it allows for smaller, more targeted clinical trials, which saves time and money.

This approach requires sophisticated biomarker identification tools and genetic sequencing capabilities to stratify patient populations effectively. For a company like Theravance Biopharma, which has guided its 2025 R&D costs to be between $32 million and $38 million, this means a significant portion of that budget must be allocated to high-tech data analysis and partnerships to find those precise patient groups. The ability to identify the right patients early is what makes or breaks a drug for a rare disease.

Increased use of Artificial Intelligence (AI) in drug discovery and trial optimization

You can't talk about drug development in 2025 without mentioning Artificial Intelligence (AI). This technology is no longer a futuristic concept; it's a tool that is fundamentally changing the economics of R&D. The global AI in Drug Discovery market is valued at approximately $6.93 billion in 2025, and it's growing fast.

For Theravance Biopharma, AI presents a massive opportunity to accelerate its pipeline, especially in optimizing clinical trials for its late-stage assets. Honestly, AI can reduce the overall drug discovery cost by up to 40% and cut development timelines from five years down to as little as 12 to 18 months. That's a game-changer for a biotech with a focused pipeline like theirs. They need to be using AI for:

• Predicting compound efficacy and toxicity.
• Optimizing patient selection for clinical trials.
• Creating synthetic control arms (digital twin generators) to reduce patient numbers.

Need for robust data security and protection against cyber threats (HIPAA compliance)

As Theravance Biopharma collects and processes clinical trial data, they are a covered entity under the Health Insurance Portability and Accountability Act (HIPAA), and the compliance burden is only getting heavier. The biggest risk here is financial and operational disruption. The average cost of a successful cyberattack on a pharmaceutical company is about $5.1 million per incident, and the average cost to recover from a ransomware attack can be as high as $10.1 million.

What this means is that their IT and compliance investment needs to be significant to protect their intellectual property (IP) and patient data (electronic Protected Health Information, or ePHI). The 2025 HIPAA updates are making security controls mandatory, not optional, which requires clear action:

• Mandatory encryption of all ePHI, both at rest and in transit.
• Required Multi-Factor Authentication (MFA) for all ePHI access points.
• More stringent requirements for conducting and documenting risk analyses.

The risk is real, and the cost of a breach could easily wipe out a significant portion of their available cash of $333 million. That's the quick math on why cybersecurity is a strategic, not just an IT, priority.

Manufacturing process innovation to reduce costs and improve scalability

While Theravance Biopharma's primary commercial product, YUPELRI (revefenacin), is partnered with Viatris, and their pipeline is focused on specialty drugs, the need for efficient manufacturing remains a core technological factor. Manufacturing innovation, like the shift to Continuous Manufacturing (CM) from traditional batch processing, is crucial for reducing Cost of Goods Sold (COGS) and improving supply chain resilience.

For specialty drugs like ampreloxetine, which targets a rare disease, the manufacturing process must be highly scalable, but also flexible enough for smaller initial production runs. The key technological opportunity here is adopting process analytical technology (PAT) to ensure quality and consistency. This table maps the challenge and opportunity based on their current focus:

They have to ensure that their early-stage process development is robust, because a failure in manufacturing scale-up can delay a launch by years, regardless of how good the clinical data is.

Theravance Biopharma, Inc. (TBPH) - PESTLE Analysis: Legal factors

Ongoing intellectual property (IP) litigation risks for key drug patents.

The core of a biopharma company's valuation rests on its intellectual property (IP) protection, and for Theravance Biopharma, Inc., this means defending its patents for YUPELRI® (revefenacin) inhalation solution. You should know that the legal landscape here is a constant, high-stakes battle against generic manufacturers filing Abbreviated New Drug Applications (ANDA) under the Hatch-Waxman Act.

In a key development this year, Theravance Biopharma, along with its partner Mylan, reached a Settlement Agreement with Eugia Pharma Specialties Ltd. on June 5, 2025. This agreement resolves the litigation with Eugia, but it also sets a firm date for generic entry. Eugia is granted a royalty-free license to manufacture and market its generic YUPELRI® in the U.S. beginning on April 23, 2039. This date provides a clear runway for the branded drug's exclusivity, which is a positive for long-term revenue visibility.

Still, the IP risk isn't fully mitigated. Litigation remains pending against two other ANDA filers: Cipla Limited and Mankind Pharma Ltd. The outcome of these ongoing cases will defintely shape the final patent expiry landscape for YUPELRI®, a product that generated an implied $25.0 million in net sales for Theravance Biopharma in the third quarter of 2025 alone.

Strict Food and Drug Administration (FDA) requirements for Phase 3 trial success.

The FDA's regulatory path is the single biggest gatekeeper for any drug's commercial success. For Theravance Biopharma's pipeline, the focus is squarely on ampreloxetine, the investigational treatment for symptomatic neurogenic orthostatic hypotension (nOH) in patients with Multiple System Atrophy (MSA). The legal and regulatory hurdle here is the successful completion of the pivotal Phase 3 CYPRESS study.

The company successfully completed enrollment in the open-label portion of the CYPRESS trial in August 2025. This is a critical milestone, but the true regulatory risk remains the top-line data readout, which is anticipated in Q1 2026. If the data is supportive, the company plans to request priority FDA review for its New Drug Application (NDA), which could shorten the review time from the standard 10 months to 6 months.

Here's the quick math on the investment required to clear this regulatory hurdle: Theravance Biopharma's full-year 2025 guidance for Research & Development (R&D) expenses (excluding share-based compensation) is between $32 million and $38 million. This substantial spend underscores the cost of maintaining the scientific rigor and regulatory compliance required for a successful Phase 3 program.

Global data privacy regulations (e.g., GDPR) impacting clinical trial data management.

Operating clinical trials internationally means you are subject to a patchwork of global data privacy laws, which adds complexity and cost to data management. Theravance Biopharma is explicitly obligated to comply with the EU's General Data Protection Regulation (GDPR) and the UK GDPR, plus a growing list of U.S. State Privacy Laws like those in California, Colorado, and Virginia.

To manage this, the company must ensure that the health data of clinical trial participants is handled with the highest level of security. They primarily use pseudonymized Personal Data from their Clinical Sites. This means the data they receive for analysis is stripped of direct identifiers, a key technical and organizational measure required by GDPR.

The financial risk of non-compliance is staggering. A serious breach of GDPR can lead to administrative fines of up to 4% of a company's global annual revenue or €20 million, whichever is higher. This is a constant operational risk that requires continuous investment in data governance and cybersecurity infrastructure.

Anti-trust enforcement focused on pharmaceutical mergers and acquisitions.

The U.S. Department of Justice (DOJ) and the Federal Trade Commission (FTC) have intensified their scrutiny of the life sciences sector in 2025, particularly focusing on how companies maintain market exclusivity.

A direct example of this scrutiny is the YUPELRI® patent settlement with Eugia Pharma Specialties Ltd. The agreement is legally required to be submitted to the DOJ and FTC for review. This review process is specifically designed to catch so-called 'pay-for-delay' settlements, where a brand-name company pays a generic competitor to delay its market entry, which regulators view as anti-competitive behavior.

This heightened enforcement environment impacts not just patent settlements but also M&A activity. While Theravance Biopharma has not announced a major acquisition this year, the general environment for the biopharma industry is one of increased regulatory risk, especially for deals involving pipeline assets (often referred to as 'killer acquisitions') or those that could lead to a dominant market share.

The table below summarizes the key legal and regulatory risks and their associated financial or operational impact as of 2025.

Theravance Biopharma, Inc. (TBPH) - PESTLE Analysis: Environmental factors

You're looking at Theravance Biopharma, Inc. (TBPH) and the environmental calculus is shifting quickly for biopharma, even for a company focused on R&D like this one. While Theravance Biopharma is smaller than the giants, the industry's new regulatory landscape and investor pressure mean their environmental footprint-or lack thereof-is now a material risk. The key takeaway is that the industry's average carbon intensity is high, and Theravance Biopharma's focus on respiratory and neurologic medicines directly intersects with climate-driven health crises.

Here's the quick math: the pharmaceutical sector produces over 48 tons of CO₂ equivalent for every $1 million in revenue generated, far outpacing the auto industry. With Theravance Biopharma reporting total revenue of $20.0 million in Q3 2025, their proportional environmental scrutiny is rising, even if they outsource much of their manufacturing.

Pressure from investors and regulators for sustainable drug manufacturing practices.

The days of ignoring environmental, social, and governance (ESG) factors are over; this is now a core due diligence item for investors. Major pharmaceutical companies are responding by spending an estimated $5.2 billion yearly on environmental programs, a 300% jump from 2020. This sets a new, high bar for the entire supply chain, including companies like Theravance Biopharma.

On the regulatory front, the European Union's Corporate Sustainability Reporting Directive (CSRD), which is effective from 2025, is a game-changer. It forces large companies to disclose extensive ESG impacts, including all scopes of emissions, and this pressure trickles down to US-based partners and suppliers. Honest to goodness, if your partners don't comply, you can't sell in those markets.

The table below summarizes the key 2025 regulatory drivers impacting Theravance Biopharma's commercial partners and, by extension, their own operations and supply chain for products like YUPELRI (revefenacin) inhalation solution.

Need to manage and dispose of hazardous biological and chemical waste safely.

Biopharma research and development (R&D) inherently generates hazardous waste (HW), and Theravance Biopharma's operations are no exception. While the company's Q3 2025 R&D expenses were a focused $8.1 million, the complexity of the waste stream remains a high-risk area. For instance, in 2022, the company's South San Francisco facility required an emergency permit from the California Department of Toxic Substances Control (DTSC) to chemically stabilize highly reactive compounds before off-site transport.

This isn't a minor administrative task; it's a critical safety and compliance function. The list of chemicals requiring stabilization-including Methyl Isobutyl Ketone, Acetaldehyde, and Borane THF-shows the high-acuity nature of their R&D waste. The EPA's Subpart P rules, which are seeing full state-level enforcement throughout 2025, are tightening standards for hazardous waste pharmaceuticals, especially banning the sewering (flushing down the drain) of any hazardous waste pharmaceuticals, which is a defintely a good thing.

• Stabilize volatile R&D compounds before transport.
• Comply with 365-day accumulation limits for non-creditable HW.
• Ensure third-party disposal partners (like Clean Harbors Environmental Services, as used previously) meet new 2025 standards.

Climate change impacting the geographic spread of infectious diseases.

This is a long-term strategic factor, but it directly impacts Theravance Biopharma's R&D pipeline. Climate change alters vector-borne disease patterns and exacerbates respiratory conditions due to air quality degradation. The World Health Organization (WHO) projects climate change will cause an additional 250,000 deaths every year between 2030 and 2050 from diseases like malaria, diarrhea, and heat stress.

For Theravance Biopharma, this presents a dual reality: a market opportunity and a mandate for R&D focus. Their existing product, YUPELRI, treats Chronic Obstructive Pulmonary Disease (COPD), a respiratory condition often worsened by environmental factors like pollution and heat. The company's focus on specialty respiratory and neurologic diseases means their research is inherently aligned with addressing climate-related health challenges, which is a strong point for ESG-minded investors.

Focus on reducing the carbon footprint of the global supply chain.

Theravance Biopharma, like many biotechs, relies on a complex network of contract manufacturing organizations (CMOs) and third-party logistics (3PL) providers. This means their Scope 3 emissions-the hardest to track-are the most significant. The industry trend for 2025 is to tackle this by moving toward green supply chain strategies.

Leading biopharma companies are setting ambitious targets: some aim for carbon neutrality in Scope 1 and 2 emissions by 2025, and net-zero value chains by 2040. Theravance Biopharma must ensure its partners for YUPELRI manufacturing and distribution are adopting practices such as:

• Using reusable cold chain packaging solutions to cut waste.
• Sourcing renewable energy for manufacturing sites.
• Implementing logistics optimization to reduce transport emissions.

What this estimate hides is that Theravance Biopharma's small size and focus on a few key products (YUPELRI, ampreloxetine) gives them less leverage over massive CMOs than a Pfizer or a Johnson & Johnson, making Scope 3 reduction a particularly tough challenge.