Iterum Therapeutics plc (ITRM): Business Model Canvas [Dec-2025 Updated]

You're watching a development-stage biotech make its big pivot, and that's always a fascinating moment for an analyst like me. Iterum Therapeutics plc is now squarely focused on the commercial launch of ORLYNVAH™, the first oral penem antibiotic, relying heavily on EVERSANA for the U.S. push. Honestly, the numbers tell the story: with only $11.0 million in cash as of September 30, 2025, and Q3 revenue just hitting $0.4 million, the next few quarters are absolutely critical to hitting their $5 million to $15 million revenue guidance for 2026. Let's break down the entire Business Model Canvas to see exactly how they plan to turn this single, high-need product into a sustainable revenue stream.

Iterum Therapeutics plc (ITRM) - Canvas Business Model: Key Partnerships

You're looking at the core external relationships Iterum Therapeutics plc built to get ORLYNVAH™ from approval to the patient, which is a classic pharma commercialization strategy when cash is tight. These partnerships are essential because Iterum Therapeutics plc, despite launching a novel oral penem antibiotic, reported cash and cash equivalents of only $11.0 million as of September 30, 2025, with a projected cash runway into the second quarter of 2026.

Commercialization, Sales, and Logistics with EVERSANA

Iterum Therapeutics plc partnered with EVERSANA Life Science Services, LLC for the U.S. commercialization of ORLYNVAH™. This agreement, signed in June 2025, covers a comprehensive suite of services necessary for a market launch. The launch into the community market across targeted territories in seven states began in August 2025.

The services provided by EVERSANA are:

• Sales and commercial operations services in the United States
• Marketing support
• Logistics management
• Channel management
• Regulatory and medical affairs support

This outsourcing model allowed Iterum Therapeutics plc to focus resources on the drug itself while leveraging EVERSANA's established infrastructure to execute the launch quickly.

Commercial Manufacturing and Supply with ACS Dobfar S.p.A.

To ensure the physical supply of the product, Iterum Therapeutics plc entered into a Commercial Manufacturing and Supply Agreement with ACS Dobfar S.p.A. in July 2025. ACS Dobfar S.p.A. is responsible for manufacturing and supplying the ORLYNVAH™ bilayer tablets and/or the sulopenem etzadroxil bulk drug substance as required by Iterum Therapeutics International Limited (Iterum Ireland).

The financial structure of this supply chain relationship is based on specific metrics:

ACS Dobfar S.p.A. manages the procurement and qualification of materials, subject to instructions from Iterum Ireland regarding quantities and pricing.

Original Licensor Relationship with Pfizer Inc.

Pfizer Inc. remains a key financial partner as the original licensor under the Pfizer License Agreement from November 18, 2015, granting Iterum Therapeutics plc worldwide exclusive rights to sulopenem. This relationship involves significant contingent payments tied to the product's success.

Key financial obligations and terms related to Pfizer Inc. include:

• Regulatory Milestone Payment: A payment of $20.0 million was triggered by the FDA approval of ORLYNVAH™ on October 25, 2024.
• Payment Deferral Extension: The due date for the $20.0 million note was extended from October 2026 to October 25, 2029, as agreed in May 2025.
• Interest Rate Adjustment: The annual interest rate on the deferred amount increases from 8% to 10%, compounded daily, beginning on October 26, 2026.
• Sales Milestones: Potential future payments upon net sales ranging from $250.0 million to $1.0 billion for each product type.
• Royalties: Payments ranging from a single-digit to mid-teens percentage based on marginal net sales of each licensed product.

The extension was critical, allowing Iterum Therapeutics plc to strategically invest near-term capital into the ORLYNVAH™ launch instead of servicing the debt immediately.

Product Stocking and Distribution via Specialty Pharmacies

To ensure patient access following the August 2025 launch, Iterum Therapeutics plc established distribution channels through major players in the pharmaceutical supply chain. This is a crucial step, as the company reported Q3 2025 net product revenue of only $0.4 million against a GAAP net loss of $9.0 million, highlighting the need for rapid access expansion.

Distribution and Market Access Progress as of Late 2025:

Access remains broadly available via prior authorization and medical exception pathways while formal rebate contracting negotiations are ongoing. Finance: review the impact of the 10% Pfizer interest rate starting in late 2026 on the Q2 2026 cash runway projection by next Tuesday.

Iterum Therapeutics plc (ITRM) - Canvas Business Model: Key Activities

You're managing a company right at the critical inflection point: the transition from clinical-stage to commercial-stage with a newly approved, first-in-class oral antibiotic. The key activities here are all about execution under a tight financial clock, so every number matters.

Commercial launch and marketing of ORLYNVAH™ in the U.S.

The primary activity is driving the commercialization of ORLYNVAH™, the first oral penem antibiotic in the U.S. for uncomplicated urinary tract infections (uUTIs). Iterum Therapeutics plc launched ORLYNVAH™ in the U.S. community market in August 2025, initially targeting specific territories across seven states. This launch is being executed in partnership with EVERSANA Life Science Services, LLC, which provides the dedicated sales and marketing support. The initial results show the challenge of a new product ramp: Net product revenues for the third quarter of 2025 totaled $0.4 million, which included some initial stocking at specialty pharmacies. The company is aiming to capture a piece of the estimated $40M uUTI market. To support this, Selling, General and Administrative (SG&A) expenses hit $6.5 million in the third quarter of 2025 alone, contributing to total operating expenses of $8.1 million for that same period. Honestly, the initial revenue is small compared to the burn, which is typical for a launch, but it signals the start of revenue generation.

Securing formulary coverage and market access with PBMs and health plans

Market access is the next hurdle after the initial launch. Iterum Therapeutics plc's National Account Managers are actively engaging with the U.S. payer landscape, including the three largest pharmacy benefit managers (PBMs). As of the latest update in December 2025, ORLYNVAH™ access has grown to reach nearly 25% of insured lives in the U.S., which translates to more than 60 million insured lives. Currently, access is largely secured through prior authorization and medical exception pathways, which is standard for a new-to-market drug. A significant step was securing a signed rebate agreement with one of the top three Medicare Part D PBMs, which positions ORLYNVAH™ for inclusion on their Medicare Advantage Prescription Drug and Medicare Prescription Drug formularies, with coverage expected to start as early as Q1 2026. The company is committed to securing expanded access and long-term formulary positioning through Q1 2026.

Here are the key market access metrics as of late 2025:

Managing the outsourced manufacturing and supply chain

The company manages the manufacturing and supply chain through outsourced partners, focusing on product availability. The Cost of sales expenses for the first quarter of 2025 were $0.3 million; this figure primarily reflects the amortization related to the finite-lived intangible asset recognized for the regulatory milestone payment due to Pfizer upon ORLYNVAH™ FDA approval. For distribution, ORLYNVAH™ is now stocked at two major specialty distributors:

• McKesson
• Cencora (formerly AmerisourceBergen)

This dual stocking allows physicians to procure the product based on their practice preferences.

Ongoing capital raising to extend the cash runway into 2026

Liquidity is the most pressing constraint, driving continuous capital-raising activities. The company repaid its 6.500% Exchangeable Senior Subordinated Notes due 2025 in January 2025. To fund the commercialization, Iterum Therapeutics plc executed several financing rounds in 2025:

• April 2025 Registered Direct Offering: Gross proceeds of approximately $5 million.
• April 2025 At-the-Market (ATM) Offering: Approximately $1 million raised between April 1 and April 22, 2025.
• July/August 2025 ATM Offering: Net proceeds of $2.2 million raised.
• October/November 2025 ATM Offering: Net proceeds of $2.6 million raised.

Cash and cash equivalents stood at $11.0 million as of September 30, 2025. Factoring in the latest ATM proceeds, management projects this cash position will fund operations only into the second quarter of 2026 (Q2 2026). The estimated total operating expenses for the full year 2026 are projected to be between $25 million and $30 million, meaning more capital will be needed to sustain commercialization throughout 2026. Furthermore, a key financial obligation, a $20.0 million milestone payment to Pfizer Inc., has been deferred from October 2026 to October 25, 2029, which helps the near-term cash flow.

Here is a summary of the cash position and financing activities:

Finance: draft updated 13-week cash view incorporating Q4 2025 projections by Monday.

Iterum Therapeutics plc (ITRM) - Canvas Business Model: Key Resources

You're looking at the core assets Iterum Therapeutics plc has to drive the commercialization of ORLYNVAH™, which is a pivotal moment for the company. These resources are what you need to focus on when assessing their near-term viability.

The most tangible asset right now is the FDA-approved oral penem antibiotic, ORLYNVAH™ (sulopenem). This product is the entire revenue engine, having launched in the United States in August 2025 for the treatment of uncomplicated urinary tract infections (uUTIs) in adult women who have limited or no alternative oral antibacterial treatment options. This approval makes ORLYNVAH™ the only Food and Drug Administration (FDA) approved oral penem antibiotic in the U.S..

This product also benefits from regulatory advantages that are critical Key Resources in the pharmaceutical space:

• Qualified Infectious Disease Product (QIDP) designation received for both oral and IV formulations of sulopenem across seven indications.
• Fast Track designation also granted for both oral and IV formulations in the same seven indications.

Next, let's look at the shield protecting that product: the Intellectual Property. You need to know how long Iterum Therapeutics plc has exclusivity, and honestly, the patent estate looks solid for the near term.

Finally, the financial resource-the fuel for the commercial engine. As of September 30, 2025, Iterum Therapeutics plc reported $11.0 million in cash and equivalents. This is the hard number you need to track against burn rate. To be fair, management noted that this figure, combined with approximately $2.6 million in net proceeds raised from an at-the-market offering between October 1, 2025, and November 13, 2025, is projected to fund operations only into the second quarter of 2026. That gives them a tight window to scale revenue, so this cash balance is definitely a resource under pressure.

Finance: draft 13-week cash view by Friday.

Iterum Therapeutics plc (ITRM) - Canvas Business Model: Value Propositions

The core value proposition for Iterum Therapeutics plc centers on delivering a novel, effective oral treatment option where current standards are failing due to resistance.

First and only FDA-approved oral penem antibiotic in the U.S.

• The U.S. Food and Drug Administration (FDA) approved ORLYNVAH™ (oral sulopenem) in October 2024.
• ORLYNVAH™ is the first oral penem available in the United States.
• A patent covering the bilayer tablet is projected to expire in December 2039 in Mexico, absent extensions.

Treatment for uUTIs in adult women with limited or no oral alternatives

The opportunity is substantial, addressing a high-prevalence condition with limited innovation.

• The uUTI indication has over 30 million infections annually in the U.S.
• The addressable U.S. market for the current label is estimated at roughly $500 million.
• Net realized pricing is expected to land around $1,500-$2,000 per treatment course.
• In the third quarter of 2025, Iterum Therapeutics generated net product sales of $400,000.
• The global uncomplicated urinary tract infection treatment market was valued at $7.7 billion in 2025.

Addresses rising antimicrobial resistance to common generic treatments

The product is specifically positioned against the backdrop of growing resistance, which limits the utility of established generics.

• In the REASSURE trial, 9.2% of patients in the primary population had a baseline pathogen resistant to three or more classes of antibiotics.
• The company believes there is tremendous value in sulopenem due to rising resistance to all currently prescribed oral antibiotics.
• The company received 510(k) clearance for its 2 µg Antimicrobial Susceptibility Test Disc to support targeted therapy.

Superior efficacy to amoxicillin/clavulanate in the REASSURE trial

Clinical data from the Phase 3 REASSURE trial demonstrated a clear benefit over the comparator, Augmentin® (amoxicillin/clavulanate).

Here's the quick math on the overall response at the test-of-cure visit in the microbiological-modified-intent-to-treat susceptible population:

Oral sulopenem showed overall success in 61.7% of patients compared to 55.0% for Augmentin®, demonstrating statistically significant superiority.

Finance: draft 2026 operating expense forecast range by Friday.

Iterum Therapeutics plc (ITRM) - Canvas Business Model: Customer Relationships

You're launching a novel oral antibiotic, ORLYNVAH™, into a market that hasn't seen a new branded option in over 25 years. The customer relationship strategy for Iterum Therapeutics plc centers on direct, targeted engagement across the prescribing and access ecosystem.

High-touch engagement with targeted physicians via a contract sales force

Iterum Therapeutics plc initiated the U.S. commercial launch of ORLYNVAH™ in August 2025, focusing on targeted territories across seven states. The company uses a contract sales force model, with representatives contracted by and dedicated to Iterum via EVERSANA Life Science Services, LLC to engage with target physicians. This engagement has started to translate into prescriptions being written. To manage costs while maintaining reach, the in-person field team was adjusted, moving from 20 representatives to 10 representatives, with virtual sales efforts being added to cover target geographies.

Physician adoption signals are emerging:

• Over 100 unique prescribers generated prescriptions through November 12.
• Over 280 Orlynda prescriptions were generated through November 12.
• Nearly 50% of prescribers wrote more than one prescription, which management noted as a key adoption signal.

The initial commercial focus is on physicians who have shown interest in learning about ORLYNVAH™ and its recommended patient profiles. Also, Iterum Therapeutics plc has received inbound inquiries from non-target physicians seeking information on the product and access options.

Direct engagement with national, regional, and state health plans for formulary access

Securing favorable formulary positioning is defintely a critical relationship focus for Iterum Therapeutics plc. National Account Managers are actively engaging with key stakeholders across the U.S. payer landscape, presenting ORLYNVAH™'s value proposition. This engagement includes discussions with the three largest pharmacy benefit managers (PBMs) serving health plans. As of the third quarter of 2025, ORLYNVAH™ was covered for 16% of insured lives. The current access mechanism relies on prior authorization and medical exception pathways, which is standard for a new-to-market product.

The company has made significant progress toward formal formulary inclusion:

Formal committee reviews and rebate contracting negotiations are ongoing, with the aim to secure expanded access and long-term formulary positioning through the first quarter of 2026.

Patient support programs to manage access and affordability (implied by launch)

To help patients navigate the initial access hurdles, Iterum Therapeutics plc has established a co-pay support program designed to defray out-of-pocket costs for appropriate commercially insured patients. This program is a temporary measure while the company works toward optimizing broader coverage. The company's intention is to work with insurance carriers, including Medicare plans, to help optimize the adjudication process and reduce patient out-of-pocket exposure over time. Furthermore, ORLYNVAH™ is stocked at distributors like McKesson and Cencora, which allows certain physicians to procure the product directly, consistent with their practice preferences.

Initial net product sales for the third quarter of 2025 were $400,000, which included some stocking at the specialty pharmacy.

Iterum Therapeutics plc (ITRM) - Canvas Business Model: Channels

You're looking at how Iterum Therapeutics plc gets its product, ORLYNVAH™, into the hands of the right prescribers and patients following its August 2025 launch. The channel strategy is heavily reliant on a third-party partner for the sales force and a multi-pronged approach for distribution and access.

Targeted Sales Force (via EVERSANA)

Iterum Therapeutics plc entered a Product Commercialization Agreement with EVERSANA Life Science Services, LLC, for U.S. commercial operations, including sales. This structure is designed to leverage EVERSANA's existing infrastructure to support the ORLYNVAH™ market introduction. The initial focus is on high-prescribing physicians in specific geographic areas.

Here's the quick math on the dedicated sales force deployed through EVERSANA:

What this estimate hides is the ongoing shift to a more cost-effective, augmented sales model, which is a direct response to financial planning constraints.

Specialty Pharmacies for Product Distribution and Stocking

Product distribution is managed through specialty channels to ensure ORLYNVAH™ is available to prescribers and patients. This channel is critical for optimizing speed to therapy, which includes handling managed care requirements like prior authorizations and facilitating delivery options.

• Distribution is secured through specialty distributors McKesson and Cencora (formerly AmerisourceBergen).
• Initial stocking at specialty pharmacies contributed to the first reported product revenue of $0.4 million in the third quarter of 2025.
• The selected specialty pharmacy supports delivery options including local pharmacy pickup, courier services, and overnight shipments.

Payer Negotiations and Formulary Placement with Pharmacy Benefit Managers (PBMs)

Securing favorable formulary placement is an ongoing effort to improve patient access and reduce out-of-pocket costs. Iterum Therapeutics plc is actively engaging with state, regional, and national health plans, including the three largest Pharmacy Benefit Managers (PBMs).

• Current reimbursement coverage extends to nearly 25% of insured lives in the U.S..
• This coverage represents access for over 60 million people through various benefit designs.
• Specific current coverage includes California and New York State Medicaid programs, certain Veterans Affairs/Tricare affiliates, and parts of Blue Cross Blue Shield plans and Aetna.
• A rebate agreement has been signed with one of the top three Medicare Part D PBMs, positioning ORLYNVAH™ for inclusion on Medicare Advantage and Medicare Prescription Drug formularies starting in Q1 2026.
• Formal committee reviews and rebate contracting negotiations are ongoing, with long-term formulary positioning targeted for later in 2025 and into Q1 2026.
• Even while awaiting formal formulary decisions, approximately 40% of ORLYNVAH prescriptions have been filled after going through payer approval processes like prior authorization or medical exception.

Iterum Therapeutics plc (ITRM) - Canvas Business Model: Customer Segments

You're looking at the core groups Iterum Therapeutics plc targets with ORLYNVAH, their oral antibiotic for uncomplicated urinary tract infections (uUTIs). The market itself is substantial, reflecting a defintely high need for new options.

The uncomplicated UTI treatment market in the U.S. is estimated to be valued at $7.95 Bn in 2025, with projections showing it could reach $15.89 Bn by 2032, growing at a compound annual growth rate (CAGR) of 10.4% from 2025 to 2032. Another analysis suggests the market grew from $6.12 billion in 2024 to $6.78 billion in 2025 at a CAGR of 10.9%.

The specific customer segments Iterum Therapeutics plc focuses on are:

• Adult women with uncomplicated urinary tract infections (uUTIs)
• Patients with uUTIs caused by specific resistant Gram-negative bacteria

For the physicians, Iterum Therapeutics plc is targeting those who need an effective new oral agent, especially given the current prescribing landscape. It's important to note that over 60% of physicians are likely to prescribe penicillin and combinations to treat UTIs, while a significant percentage prescribe nitrofurans for uncomplicated infections in female patients.

• U.S. physicians who treat uUTIs and need new oral options

The final segment involves the gatekeepers to patient access, which is crucial for a company with a market capitalization of just $23.23 million as of December 2025. Securing formulary position directly impacts prescription volume for ORLYNVAH.

• Health plans and PBMs covering the U.S. uUTI market

As of early December 2025, ORLYNVAH has reimbursement coverage reaching nearly 25% of insured lives in the United States, which represents over 60 million people. This includes coverage under California and New York State Medicaid programs, certain Veterans Affairs/Tricare affiliates, and portions of Blue Cross Blue Shield plans and Aetna. Also, Iterum Therapeutics plc announced a signed rebate agreement with one of the top three Medicare Part D Pharmacy Benefit Managers, positioning ORLYNVAH for inclusion on Medicare Advantage Prescription Drug and Medicare Prescription Drug formularies, with coverage expected to begin as early as Q1 2026.

Iterum Therapeutics plc (ITRM) - Canvas Business Model: Cost Structure

You're looking at the expenses Iterum Therapeutics plc incurred to get ORLYNVAH™ to market and keep the lights on through the third quarter of 2025. The cost structure is heavily weighted toward commercial launch activities now that the product is approved and selling.

The Selling, General, and Administrative (SG&A) expenses, which were $6.49 million in Q3 2025, show a significant step-up from the prior year. Honestly, this jump directly reflects the costs associated with the August 2025 launch of ORLYNVAH™ in the United States. That's where the bulk of the spending is going right now.

Commercialization costs for the ORLYNVAH™ launch are a major driver here, largely channeled through the partnership with EVERSANA Life Science Services, LLC, which began in June 2025. EVERSANA is handling a lot of the heavy lifting for market access and sales execution. Their scope includes sales and commercial operations services, marketing, logistics, channel management, regulatory, and medical affairs support in the U.S. Iterum Therapeutics plc still retains responsibility for legal, regulatory, and manufacturing aspects, but EVERSANA is the exclusive provider for the agreed-upon commercialization services. This partnership is set to last until five years post-commercial launch.

Research and Development (R&D) expenses for the third quarter of 2025 were $1.3 million. This is down from $3.1 million in Q3 2024, primarily because the costs for chemistry, manufacturing, and control (CMC) related to ORLYNVAH™ have shifted. Following the FDA approval in October 2024, costs incurred for manufacturing the drug product are now capitalized to inventory, which is standard practice, rather than being expensed immediately through R&D.

Here's a quick look at the key operating expense components for the third quarter of 2025:

Royalty payments to Pfizer Inc. on product sales are a direct cost tied to revenue generation. For the third quarter of 2025, the Cost of Sales expense, which primarily consisted of these royalty payments, was only $0.02 million, reflecting the initial net product revenues of $0.4 million for the quarter.

Regarding manufacturing and supply costs for the drug product, the accounting treatment changed post-approval. Costs incurred for the manufacture of ORLYNVAH™ tablets for commercial supply, under the agreement entered into in July 2025 with ACS Dobfar S.p.A, are now capitalized to inventory. This means the direct cost of goods sold (COGS) impact is seen in the Cost of Sales line item, which was minimal at $0.02 million in Q3 2025, while the inventory build-up itself is an asset on the balance sheet, not an immediate operating expense.

It's also worth noting the long-term financial commitment to Pfizer. While not a direct operating cost in Q3 2025, the $20 million regulatory milestone payment, which was deferred, now carries an increased annual interest rate of 10% starting October 26, 2026. You'll want to track that financing cost as it impacts future cash flow.

The cost structure breakdown shows a clear shift from development to commercial execution. You're seeing the price of entry for a US launch.

• SG&A increase driven by commercial team build-out and marketing spend.
• R&D costs are decreasing as development activities wind down.
• Cost of Sales is low initially, tied directly to minimal Q3 net product revenues of $0.4 million.
• Manufacturing costs are now flowing through inventory capitalization.

Finance: draft 13-week cash view by Friday.

Iterum Therapeutics plc (ITRM) - Canvas Business Model: Revenue Streams

You're looking at the very start of Iterum Therapeutics plc's commercial revenue generation, which is entirely dependent on the successful uptake of ORLYNVAH™ following its August 2025 U.S. launch. Honestly, the initial figures reflect a product just hitting the market, not one with established market share.

The primary revenue stream is the Net product sales of ORLYNVAH™ in the U.S. market. This is the sole recognized revenue source as of late 2025. The initial traction is what we need to watch closely, as the company's cash runway is tight, projected to last only into the second quarter of 2026 based on September 30, 2025 cash of $11.0 million plus $2.6 million in ATM proceeds.

The first concrete data point you have is the Initial net product revenue of $0.4 million reported in Q3 2025. This Q3 revenue, which came after the August launch, included some initial stocking at the specialty pharmacy locations. To put that in context against the burn rate, the GAAP net loss for that same quarter was $9.0 million. The cost of sales for that quarter was a minimal $0.02 million, which primarily covers royalty payments to Pfizer Inc..

Looking ahead, the company has set a clear, though ambitious, target for the next fiscal year. The Projected 2026 net product revenue guidance of $5 million to $15 million is based on continued commercial build-out and expected expansion of payer coverage. Management has noted that achieving this range will be done with a modest field organization relative to other antibiotic launches.

Here is a snapshot of the initial commercial performance metrics versus the 2026 projection:

The second area of potential, though not yet realized, revenue involves Future potential licensing or strategic transaction revenue for sulopenem rights. While the immediate focus is on U.S. ORLYNVAH™ sales, the intellectual property surrounding the compound provides a foundation for future value realization through partnerships or geographical licensing outside the current focus. The company has fortified this position with recent patent grants.

Key intellectual property milestones supporting future value include:

• Chinese patent for combination therapy expiring in March 2041.
• Mexican patent for bilayer tablet formulation expiring in December 2039.
• The sulopenem Susceptibility Disc received 510(k) clearance from the FDA.
• The company is advancing both oral and IV formulations of sulopenem.

You're tracking a pure-play commercial launch right now, so every prescription matters. The company has also deferred a $20.0 million Milestone Payment due to Pfizer Inc. from October 2026 to October 2029, which impacts near-term cash flow structure but isn't a direct revenue stream. Finance: draft 13-week cash view by Friday.