Theratechnologies Inc. (THTX): PESTLE Analysis [Nov-2025 Updated]

You're looking at Theratechnologies Inc. (THTX) and trying to map out its next 18 months. The simple truth is that while their established HIV treatments, Egrifta (tesamorelin) and Trogarzo (ibalizumab), provide a solid base-projected to bring in a combined revenue of around $100 million in fiscal year 2025-the real strategic tension is between the political headwind of US drug pricing reform and the defintely expensive, high-upside bet on their oncology pipeline. We need to see how macro forces like high interest rates and advancing drug delivery technology force their hand on capital allocation.

Theratechnologies Inc. (THTX) - PESTLE Analysis: Political factors

US government focus on drug price negotiation (e.g., Inflation Reduction Act impact)

The political climate in the US, particularly the focus on drug affordability, is a direct and immediate financial pressure point for Theratechnologies Inc. The Inflation Reduction Act (IRA) of 2022 is the key driver here, even if the company's drugs, EGRIFTA SV® and Trogarzo®, were not on the initial list for Medicare price negotiation.

The impact is already visible in the company's financials. In the second quarter of fiscal year 2025, sales of EGRIFTA SV® declined by 31.3% to $11.1 million compared to the same period in 2024. A significant portion of this drop was attributed to higher government chargebacks and rebates related to the IRA's provisions for the Medicare program, which includes new rebates enacted in late 2024. This isn't a negotiation on the list price, but a structural change to the rebate rules that cuts directly into net revenue.

The political risk is that this trend will continue. The second round of Medicare price negotiations for an additional 15 drugs is happening throughout 2025, with finalized prices expected by November 2025, to take effect in 2027. While the company's drugs have not been selected, the political momentum is toward expanding price controls, which could eventually include their products, especially as their combined franchises were valued at up to US$254 million in the acquisition deal by Future Pak. This is a clear headwind on future US revenue growth.

Regulatory harmonization between FDA and Health Canada affects market entry speed

As a Canadian-headquartered company with a major US market presence, Theratechnologies benefits from the ongoing regulatory harmonization between the US Food and Drug Administration (FDA) and Health Canada. This collaboration, often facilitated through initiatives like the Access Consortium, aims to streamline the approval process and reduce redundant review work.

The result is a tangible acceleration of market access. Joint review programs have been shown to reduce approval times by up to 40% for new active substances. For a specialty pharmaceutical company, this faster time-to-market is critical, as it extends the effective patent life and accelerates cash flow. Over 60% of new drug approvals in Canada now align closely with decisions made by the FDA and the European Medicines Agency (EMA).

However, the political/regulatory environment also imposes strict oversight, and harmonization means a problem in one jurisdiction quickly impacts the other. For example, the supply disruption for EGRIFTA SV® in Q1 2025 was triggered by a voluntary shutdown at a contract manufacturer's facility following an FDA inspection, which required the company to file a Prior Approval Supplement (PAS) to resume normal distribution. The Canadian regulatory environment is also tightening, with new amendments in 2025 focused on addressing drug shortages, which puts more pressure on manufacturers to maintain robust supply chains.

Geopolitical stability impacting global supply chain for raw materials

While Theratechnologies' primary products are biologics and peptides, the general geopolitical instability of 2025 still creates a high-risk environment for their outsourced supply chain. The core risk is concentration: specialty pharma companies often rely on a limited number of contract manufacturing organizations (CMOs) for key active pharmaceutical ingredients (APIs) and finished products.

The recent supply disruption for EGRIFTA SV® in Q1 2025, which cost the company an estimated $10 million to $12 million in lost revenue, underscores this vulnerability. While that specific event was regulatory/operational, the political backdrop of rising protectionism and trade controls globally means any future disruption from a geopolitically-sensitive region-whether due to trade disputes, resource nationalism, or political instability-could have a similar or worse financial impact. The global trend is a fivefold increase in export controls on critical materials over the past 15 years, a clear political risk for all pharma supply chains.

R&D tax credits and government grants influence research spending

Government incentives play a direct role in funding the company's research and development (R&D) pipeline, which is essential for long-term growth. As a Canadian company, Theratechnologies benefits significantly from Canadian federal non-refundable tax credits.

This is a clear, quantifiable benefit to their bottom line. For the full fiscal year 2024 (ending November 30, 2024), the company recorded $1,488,000 in Canadian federal non-refundable tax credits against R&D expenses. This essentially subsidizes their innovation efforts.

In the US, the R&D tax policy is a major political swing factor. While R&D expenses for Q2 2025 decreased to $2.6 million due to the completion of the EGRIFTA WR™ formulation, the future cost of US R&D is highly dependent on political action. A potential reversal of the 2022 requirement to amortize (spread out) R&D expenses over five years, allowing for immediate deduction starting in July 2025, would provide a substantial, immediate cash flow benefit to their US operations. This policy change is defintely one to watch.

Political/Regulatory Factor	2025 Fiscal Year Impact & Value	Actionable Insight
Inflation Reduction Act (IRA)	Higher government chargebacks contributed to a 31.3% sales decline for EGRIFTA SV® in Q2 2025.	Actively model the financial impact of potential inclusion in future Medicare negotiation rounds (IPAY 2027 and beyond).
Canadian R&D Tax Credits	Recorded $1,488,000 in Canadian federal non-refundable tax credits for FY2024, directly reducing R&D costs.	Maximize utilization of the Scientific Research and Experimental Development (SR&ED) program and other provincial grants.
Regulatory Harmonization (FDA/Health Canada)	Joint review programs reduce approval times by up to 40%, accelerating cross-border market entry.	Structure future drug submissions for concurrent filing via the Access Consortium to capitalize on faster review times.
Supply Chain Vulnerability	Q1 2025 supply disruption for EGRIFTA SV® caused an estimated $10 million to $12 million loss in Q1 revenue, highlighting concentration risk.	Diversify contract manufacturing base to mitigate single-source failure risk from regulatory or geopolitical events.

Theratechnologies Inc. (THTX) - PESTLE Analysis: Economic factors

The economic landscape for Theratechnologies Inc. in 2025 is defined by a dichotomy: the company has successfully restructured its debt to mitigate the high-interest-rate environment, but it faces persistent pressure from US payer cost-control measures and currency volatility that directly impact its reported net sales.

High interest rates increase the cost of capital for pipeline development.

While the broader market contends with elevated interest rates, Theratechnologies has managed to reduce its immediate cost of capital through new credit facilities secured in late 2024. This strategic move freed up approximately $19 million in cash for 2025, which is crucial for funding research and development (R&D) and pipeline assets.

However, the cost of capital (WACC) remains a key risk for long-term pipeline financing. The company's total long-term debt stood at approximately $49.48 million as of February 28, 2025, comprising the TD Term Loan, TD Revolver, and IQ Term Loan. Despite the favorable terms of the new facilities, the company still incurred net finance costs of $1,471,000 in the first quarter of fiscal 2025, which included a $450,000 loss on financial instruments carried at fair value. This shows that while the interest expense on debt is lower, the overall finance costs are still a significant drain on cash flow that could otherwise be allocated to R&D, which amounted to $5,583,000 for the first six months of 2025.

Payer reimbursement rates for specialty drugs like Trogarzo remain a cost-control focus.

Payer pressure on specialty drug pricing is a constant headwind, especially for a niche product like Trogarzo (ibalizumab-uiyk). The US healthcare system's focus on cost-effectiveness, accelerated by the Inflation Reduction Act (IRA), translates into higher rebates and chargebacks for manufacturers.

For the six-month period ended May 31, 2025, Trogarzo net sales were $11,765,000, a 5.7% decrease year-over-year. A significant factor in this decline was the increase in government rebates and chargebacks, which negatively impacted sales by 4.7% in the first half of fiscal 2025. Furthermore, reimbursement policies from major payers, such as FepBlue, require strict Prior Authorization for Trogarzo to ensure its cost-effective use, adding administrative complexity and potential delays to patient access.

Here's the quick math on the reimbursement environment:

Metric (6 Months Ended May 31, 2025)	Amount (in thousands of USD)	Impact
Trogarzo Net Sales	$11,765	5.7% decrease vs. 2024 comparable period
Government Rebate/Chargeback Impact	N/A (Included in Net Sales)	-4.7% impact on sales in the period
Trogarzo Private Payer Reimbursement (per unit)	$78.8925 (as of July 2025)	Benchmark for cost-control focus

Currency fluctuations (USD/CAD) significantly affect reported revenue and costs.

As a Canadian-domiciled company reporting in U.S. dollars, Theratechnologies is exposed to translation risk (the impact of currency changes on reported financial results). The US dollar has been strong; specifically, the USD appreciated by a full 7.3% against the Canadian dollar (CAD) from the start of 2024 to early 2025.

Since the majority of the company's revenue from its commercial products, Trogarzo and EGRIFTA SV, is generated in the US (USD), a strengthening USD generally translates to a favorable conversion when Canadian dollar-denominated operating expenses are translated into the US dollar reporting currency. However, this volatility adds a layer of uncertainty to financial forecasting, especially with the average USD/CAD exchange rate for 2025 hovering around 1.3994 CAD per USD.

Competition from large-cap pharma limits pricing power in HIV treatment.

Trogarzo targets a highly specialized, niche patient population-heavily treatment-experienced adults with multidrug-resistant HIV-1 infection. While this niche offers a high-value proposition, the broader HIV market is dominated by large-cap pharmaceutical companies with deep pockets for R&D, marketing, and payer negotiations. This competition limits Theratechnologies' ability to aggressively raise prices or expand market share easily.

The impact of new competitors is already clear in the 2025 results:

• Trogarzo unit sales in Q1 2025 were down 17.5% year-over-year, primarily due to the entry of new competitors in the market.
• Despite this, the company managed a 3.0% higher selling price for Trogarzo in Q2 2025, which, combined with higher unit sales (+11.0%), led to a Q2 net sales increase of 13.4% to $6,598,000.

The competitive pressure is less about direct price war and more about market access and unit volume erosion, forcing the company to rely on its niche positioning and the premium price it can command for a therapy of last resort. The acquisition by an affiliate of Future Pak, expected to close in Q4 2025, highlights the strategic value of these niche assets but also confirms the need for a larger financial and operational partner to navigate these economic pressures.

Theratechnologies Inc. (THTX) - PESTLE Analysis: Social factors

Strong patient advocacy groups for HIV/AIDS influence treatment access and policy.

You need to understand that HIV/AIDS patient advocacy groups aren't just charities; they are powerful, defintely organized political forces. They directly influence drug pricing negotiations, access programs, and regulatory policy, which impacts Theratechnologies' core products like Egrifta SV (for HIV-associated lipodystrophy) and Trogarzo (a treatment for multi-drug resistant HIV-1). Their pressure ensures that access remains a priority, often pushing for broader coverage and lower out-of-pocket costs, which can squeeze pharmaceutical margins.

For instance, these groups have been instrumental in maintaining the 340B Drug Pricing Program, a crucial channel for drug distribution that affects your net sales. Honestly, if a new policy were to restrict 340B, it would immediately impact the sales volume of your HIV portfolio. The sales of Trogarzo, for example, depend heavily on its inclusion in state AIDS Drug Assistance Programs (ADAPs). You must continuously engage with these organizations; they are your gatekeepers to the patient community.

• Advocacy drives formulary inclusion for new therapies.
• They lobby for continued federal funding like the Ryan White CARE Act.
• Their influence can accelerate or delay drug approval pathways.

Increasing public awareness of non-alcoholic steatohepatitis (NASH) drives pipeline interest.

The growing public and medical community awareness of Non-Alcoholic Steatohepatitis (NASH), a severe form of fatty liver disease, is a massive social tailwind for Theratechnologies' pipeline. People are realizing that NASH is a silent epidemic, often linked to the rising rates of obesity and Type 2 diabetes. This awareness translates directly into patient demand and, critically, investor interest in companies developing treatments.

The estimated patient population for NASH in the US is huge, potentially over 16 million people, with a significant portion progressing to advanced fibrosis. This massive, underserved market makes your NASH pipeline candidates, like the one based on the tesamorelin peptide, highly valuable. The social shift toward preventative health and early diagnosis means that when a treatment is approved, the uptake will be rapid. It's a classic case of demand outstripping supply right now.

Here's the quick math: high prevalence plus high unmet need equals a multi-billion dollar market opportunity. What this estimate hides, though, is the complexity of patient diagnosis and staging, which is a social and medical hurdle you still need to clear.

Patient adherence programs are crucial for maintaining sales of injectable therapies.

Your main products, Egrifta SV and Trogarzo, are injectable therapies. Trogarzo, specifically, is an intravenous (IV) infusion, which is a significant barrier to patient adherence (sticking to the treatment schedule). Injectable drugs require a higher level of patient commitment, plus support from healthcare providers, so adherence programs are not just a nice-to-have; they are a direct driver of recurring revenue.

If onboarding takes 14+ days or if the patient support system is weak, churn risk rises immediately. You must invest heavily in nurse support, co-pay assistance, and patient education to keep adherence rates high. For the 2025 fiscal year, maintaining adherence for Trogarzo is critical, as a drop of even 5 percentage points in patient compliance could translate into a substantial loss in recurring revenue. This is all about making the patient experience as seamless as possible.

Shifting demographics in target markets affect disease prevalence.

The demographics in your key markets, especially the US, are constantly shifting, and this directly impacts the prevalence of both HIV and NASH. For HIV, the disease burden is disproportionately affecting specific demographic groups, particularly older individuals and certain racial/ethnic minorities. As the HIV-positive population ages, the prevalence of comorbidities like lipodystrophy (treated by Egrifta SV) increases.

Also, the rise in NASH is tied to the aging population and the increasing prevalence of metabolic syndrome. The US population over 65 is growing, and this age group has a higher incidence of Type 2 diabetes and obesity, the main drivers of NASH. This demographic trend means the addressable market for your NASH pipeline is expanding organically every year.

To be fair, while the overall HIV prevalence is stable, the aging demographic means a growing need for long-term management of chronic complications, which is a clear opportunity for Theratechnologies. You need to map your sales and marketing efforts to these specific demographic clusters.

Social Factor Metric	Relevance to THTX	Impact on Business
HIV Patient Advocacy Power	High influence on drug access and pricing.	Directly affects 340B participation and net sales of Trogarzo/Egrifta SV.
NASH Patient Population US	Estimated over 16 million people.	Creates a massive, growing addressable market for the NASH pipeline.
Injectable Therapy Adherence Rate	Crucial for recurring revenue from Trogarzo.	Low adherence means high patient churn and lost sales.
US Population Aged 65+ Growth	Higher incidence of HIV comorbidities and NASH drivers.	Expands the target market for both Egrifta SV and the NASH pipeline.

Theratechnologies Inc. (THTX) - PESTLE Analysis: Technological factors

Advancements in drug delivery systems (e.g., long-acting injectables) create competitive threats.

The biggest near-term technological threat to Theratechnologies isn't a new molecule, but a new way to deliver medicine: long-acting injectables (LAIs). You see this shift most clearly in the HIV market, where convenience is now a core competitive factor. The global HIV drugs market is expected to reach $53.5 billion by 2034, and LAIs are driving that growth by simplifying patient adherence.

For example, Gilead Sciences received FDA approval for injectable lenacapavir (Yeytuo) for HIV prevention in June 2025, offering a twice-yearly injection. That's a massive leap in convenience over a daily pill or even Theratechnologies' bi-weekly Trogarzo. To be fair, Theratechnologies is fighting back with its own drug delivery improvements. They secured FDA approval to administer the Trogarzo maintenance dose as a 30-second intravenous (IV) push, which is a huge clinical improvement over the original 30-minute infusion. Plus, the new EGRIFTA WR™ formulation, approved in March 2025, improves patient life by allowing for room-temperature storage and a single vial, but it's still a daily injection.

Here's the quick map of the technological battleground:

• LAI Market: Twice-yearly injectable lenacapavir (Gilead) sets a new standard.
• THTX Response: Trogarzo IV push cuts administration time to 30 seconds.
• THTX Response: EGRIFTA WR™ (F8) improves convenience with room-temperature storage.

Patent expirations on existing drugs drive need for new formulations or indications.

Patent protection is the lifeblood of a biopharma company, and technology is the only way to extend it. Theratechnologies has executed a successful lifecycle management strategy for its flagship HIV lipodystrophy product, EGRIFTA SV. The older formulation was facing eventual generic pressure, but the company successfully developed and secured approval for a new, proprietary formulation.

The new EGRIFTA WR™ (F8 formulation) was approved by the FDA on March 25, 2025, and is patent protected in the U.S. until 2033. This eight-year extension is defintely a win, effectively resetting the generic clock for their most important revenue stream. What this estimate hides, however, is that a patent for tesamorelin related to the use in treating mild cognitive impairment is still scheduled to expire in 2025, which could allow for generic competition in that specific, though non-core, indication.

Use of Artificial Intelligence (AI) in oncology target identification speeds up R&D.

The oncology space, where Theratechnologies is positioning its pipeline asset TH-1902, is being revolutionized by Artificial Intelligence (AI). AI algorithms are now capable of integrating vast multi-omics data (genomics, proteomics) to identify novel therapeutic targets and predict protein structures in a fraction of the time traditional methods require. Some AI workflows have been shown to generate a new drug candidate in as little as ~30 days, vastly accelerating the discovery timeline.

For Theratechnologies, which has a smaller R&D budget compared to Big Pharma, adopting AI in its oncology platform (which uses the SORT1+ technology) is not optional; it's a necessity to keep pace. While the company has not publicly disclosed a specific 2025 AI partnership or spending figure, the industry trend mandates that they must integrate these tools to efficiently screen for new indications or optimize their existing peptide-drug conjugate platform. You need to assume that if they aren't using AI, their oncology R&D efforts will be structurally slower and less capital-efficient than their competitors.

Biosimilar and generic competition for similar classes of drugs is a constant threat.

The threat of biosimilars (for biologics like Trogarzo) and generics (for small molecules) is a permanent technological factor that directly impacts revenue. This isn't a future risk; it's a current reality. In the first quarter of Fiscal 2025, Trogarzo sales amounted to $5,167,000, representing a 22.4% decrease from the same period in 2024. The company attributed this drop mostly to lower unit sales (-17.5%) due to the entry of new competitors in the multidrug-resistant HIV market.

This competition is only intensifying. In the broader market, new oncology biosimilars launching in 2025 are already showing Average Sales Price (ASP) discounts of 50-70% versus their reference products. This sets a clear precedent for the future financial pressure on any biologic, including Trogarzo, once its market exclusivity expires (which is around 2030). The table below summarizes the core competitive dynamics driven by technology:

Product / Platform	Technological Threat	2025 Impact & Mitigation
EGRIFTA SV / WR™	Long-Acting Injectables (LAIs)	LAIs like lenacapavir (twice-yearly) are superior in convenience. THTX mitigated patent risk with F8 approval (patent to 2033).
Trogarzo	New Competitors & Future Biosimilars	Q1 2025 sales down 22.4% due to new competitors. THTX improved administration to 30-second IV push. Market exclusivity runs until ~2030.
Oncology Pipeline (TH-1902)	AI-Accelerated R&D by Competitors	Industry AI cuts drug discovery time to ~30 days. THTX must adopt AI to keep its oncology R&D costs and timelines competitive.

Theratechnologies Inc. (THTX) - PESTLE Analysis: Legal factors

You're looking at Theratechnologies Inc. (THTX) in 2025, and the legal landscape isn't just a compliance checklist; it's a direct determinant of future revenue and corporate structure. The biggest legal factor this year is the acquisition by Future Pak, but the long-term value rests entirely on maintaining exclusivity for your core products against generic challengers.

Maintaining patent exclusivity for Egrifta and Trogarzo is critical for revenue protection

Patent and regulatory exclusivity is the bedrock of any specialty pharmaceutical company. For Theratechnologies, protecting the US sales of EGRIFTA SV® (tesamorelin for injection) and Trogarzo (ibalizumab-uiyk) is paramount, especially since the European commercial rights for Trogarzo were returned to TaiMed Biologics, Inc., and the EMA subsequently withdrew its marketing approval. Losing exclusivity means immediate, sharp revenue declines, so this is a top-tier risk.

The company has taken clear action to extend the life cycle of its flagship product. The current EGRIFTA SV® formulation's market exclusivity in the United States has expired, but the new, improved F8 formulation of tesamorelin is protected by patent until 2033. That's a defintely strong defense. Trogarzo, a biologic, benefits from the Biologics Price Competition and Innovation Act (BPCIA) in the US, which grants a 12-year market exclusivity period from its initial approval date, which is expected to run until March 2030.

Here's the quick math on core product exclusivity in the critical US market:

Product	Active Ingredient	US Exclusivity Type	US Exclusivity/Patent Expiration
EGRIFTA SV® (F8 Formulation)	Tesamorelin	Patent Protection	2033
Trogarzo	Ibalizumab-uiyk	BPCIA Market Exclusivity	March 2030

Strict FDA and EMA (European Medicines Agency) requirements for new drug approvals

The regulatory path is always a bottleneck, and 2025 has provided a concrete example of the sheer compliance burden. The company's sBLA (Supplemental Biologics License Application) for the new F8 formulation of tesamorelin had a PDUFA (Prescription Drug User Fee Act) goal date of March 25, 2025. That date sets the timeline for market entry, and any delay directly impacts revenue forecasts.

Also, a temporary supply disruption for EGRIFTA SV® in late 2024/early 2025, caused by an unexpected voluntary shutdown at a contract manufacturer following an FDA inspection, forced the company to file a Prior Approval Supplement (PAS) on December 18, 2024. This is a perfect illustration that regulatory risk extends beyond just initial approval; it includes the entire, complex manufacturing supply chain.

Ongoing litigation risks related to intellectual property or product liability

While specific, high-stakes IP litigation isn't currently public, the single largest legal event of 2025 was the corporate transaction: the acquisition of Theratechnologies by an affiliate of Future Pak, LLC. This was a massive legal undertaking requiring shareholder and court approvals, with the final order from the Superior Court of Québec (Commercial Division) received on September 16, 2025. The total potential equity value of the transaction is approximately US $254 million, including up to US $65 million in Contingent Value Rights (CVRs) tied to the future performance of the EGRIFTA and Trogarzo franchises.

This process itself generated significant legal costs. For the first six months of Fiscal 2025 (ended May 31, 2025), General and Administrative expenses saw a large increase, driven by $1,359,000 in professional fees incurred specifically with respect to the sale process. That's a clear, non-negotiable cost of a major corporate legal event.

Data privacy regulations (e.g., HIPAA) govern patient data handling

As a biopharmaceutical company marketing products in the US, compliance with the Health Insurance Portability and Accountability Act (HIPAA) is non-negotiable. HIPAA governs the privacy and security of Protected Health Information (PHI) related to commercial operations, patient support programs (like THERA Patient Support®), and clinical trials. The legal risk here is significant: HIPAA fines can reach up to $1.9 million per calendar year for certain violation categories.

In 2025, the trend is toward stricter enforcement and mandatory security measures, notably the increased expectation for encryption of all ePHI (electronic Protected Health Information). Furthermore, state-level regulations add complexity. For example, the company must adhere to the California Health & Safety Code, which sets an annual, aggregate dollar limit of $1,500.00 for certain promotional spending on individual healthcare providers in California. You must invest in continuous monitoring and training to manage this complex, multi-jurisdictional compliance burden.

• HIPAA fines can reach $1.9 million annually.
• California state law limits certain HCP spending to $1,500.00.
• Mandatory encryption of ePHI is a rising 2025 compliance cost.

Theratechnologies Inc. (THTX) - PESTLE Analysis: Environmental factors

Increasing pressure from investors for comprehensive Environmental, Social, and Governance (ESG) reporting.

You need to recognize that ESG reporting is no longer a soft-skill narrative; it is a financial imperative in 2025. Investors are demanding structured, auditable data, not just high-level intentions. The shift is toward tangible impact metrics, and institutional capital is increasingly conditioned on verifiable environmental performance. For a commercial-stage company like Theratechnologies, with Q1 2025 revenue of $19,047,000, the pressure is coming from generalist funds and the due diligence requirements of potential acquirors, like the affiliate of Future Pak, LLC.

The core risk here is exclusion from sustainable finance opportunities and a lower valuation multiple. In 2025, ESG criteria are reported to influence 66% of strategic sourcing decisions by major corporations, which impacts your contract manufacturing relationships. You must move quickly to adopt a recognized framework, like the International Sustainability Standards Board (ISSB) or the Global Reporting Initiative (GRI), to benchmark your performance.

Here's the quick math on your estimated carbon footprint, based on industry benchmarks:

Metric	Value (Fiscal Q1 2025)	Source/Benchmark
Q1 2025 Consolidated Revenue	$19,047,000	Theratechnologies Financials
Pharma Industry GHG Intensity	48.55 tCO2e per $1M revenue	Industry Benchmark
Estimated Q1 2025 CO2e Emissions	~925.03 metric tons of CO2e	Derived Estimate (19.047 48.55)

This estimate of 925.03 metric tons of CO2e for just one quarter highlights a material risk that must be quantified and managed, particularly in your Scope 3 (supply chain) emissions, which are often the largest for biopharma companies.

Safe disposal regulations for injectable drug waste and medical devices.

Your products, EGRIFTA SV® and Trogarzo®, are injectable therapies, meaning their administration generates sharps and pharmaceutical waste at the patient and healthcare facility level. This puts Theratechnologies directly in the crosshairs of tightening US Environmental Protection Agency (EPA) regulations.

Specifically, the EPA's 40 CFR Part 266 Subpart P rule for hazardous waste pharmaceuticals is seeing widespread enforcement in many states as of early 2025. The most critical action is the nationwide ban on the sewering (flushing down the drain) of all hazardous waste pharmaceuticals, regardless of generator status. This is not a suggestion; it's a legal obligation.

What this means for you is a need for robust, documented take-back or disposal programs for your products' used syringes and vials, especially as they enter the home-use market. If your current specialty pharmacy network partner, RxCrossroads, does not have a fully compliant, audited process for managing this waste, the liability falls back to Theratechnologies. You need to ensure compliance with the following key requirements:

• Ban on sewering of all hazardous pharmaceutical waste.
• Clear standards for when a container is considered RCRA empty.
• Proper segregation and storage protocols for non-creditable hazardous waste.

Failure to comply with Subpart P can result in significant fines and reputational damage. It's a compliance issue that directly impacts your cost of goods sold (COGS) and distribution strategy.

Managing the carbon footprint of global manufacturing and distribution networks.

Your business model relies on contract manufacturing organizations (CMOs) and a global distribution network, which means your largest environmental risk is in your Scope 3 emissions-the emissions of your suppliers. The industry is under pressure to cut its emissions intensity by 59% from 2015 levels by 2025 to align with the Paris Agreement goals. This pressure is being passed down the supply chain.

The acquisition by an affiliate of Future Pak, a contract manufacturer, packager, and distributor, presents both a risk and a clear opportunity. If Future Pak has not already integrated advanced sustainability practices, Theratechnologies will inherit a significant carbon liability.

The industry trend is toward green chemistry and more efficient processes. For example, continuous manufacturing, which is being adopted by contract development and manufacturing organizations (CDMOs), can deliver up to a 35% reduction in energy usage and up to 90% fewer chemical byproducts compared to traditional batch processes. You should be requiring your CMOs to report their emissions data through platforms like Manufacture 2030 to gain visibility into your Scope 3 risk.

Sustainable sourcing of chemical components for drug synthesis.

The move toward Green Chemistry is a major trend in 2025, focusing on designing chemical products and processes that reduce or eliminate hazardous substances. This is especially relevant for the synthesis of your active pharmaceutical ingredients (APIs) for EGRIFTA SV® (tesamorelin) and Trogarzo® (ibalizumab).

The market for sustainable bioprocessing materials is seeing massive growth, with North America holding a 46.5% market revenue share in 2024, driven by demand for eco-friendly alternatives. Companies are actively substituting hazardous solvents for biodegradable alternatives derived from biomass. Your supply chain resilience is now tied to your sustainability. Near-shoring initiatives are bringing about 30% of API production back to North America and Europe, which cuts down on long-haul transportation emissions and mitigates geopolitical risk.

You need to audit your API and excipient suppliers against a clear set of green chemistry principles. This is not just about being a good corporate citizen; it is about securing your supply chain against future regulatory shifts and resource constraints. The cost of a supply disruption, like the temporary EGRIFTA SV® shortage in Q1 2025, far outweighs the investment in sustainable sourcing.