Iterum Therapeutics' Q3 2025 Earnings Call: Contradictions Emerge on Sales Territory Coverage, Marketing Strategies, and Payer Coverage Expectations

Date of Call: November 14, 2025

Financials Results

• Revenue: $0.4M net product sales in Q3 2025 (included initial specialty pharmacy stocking)

Guidance:

• Full-year 2026 net product revenue expected to be $5M–$15M.
• Full-year 2026 total operating expenses estimated at $25M–$30M.
• Modest sales expected in Q4 2025.
• Cash and cash equivalents plus $2.6M ATM proceeds provide runway into Q2 2026.
• Company will likely need to raise additional capital and seek shareholder authorization to issue shares to continue commercialization.

Business Commentary:

* ORLYNVAH Launch and Prescription Growth: - Iterum Therapeutics reported more than 280 prescriptions for ORLYNVAH in just over two months since its launch on August 20, driven by 100 unique prescribers, with nearly half of those having prescribed to more than 1 patient. - The growth was driven by the change in healthcare provider behavior, emphasizing the need for frequent office visits and education about ORLYNVAH as a new alternative.

• Managed Care and Market Access:
• Iterum's coverage discussions are advancing well, with positive feedback from key stakeholders, and the company signed a rebate agreement with one of the top 3 Medicare Part D pharmacy benefit managers.

• This progress in managed care will likely lead to increased prescription fill rates, as payer decisions and coverage are being secured.

• Financial Performance and Guidance:

• The company generated $400,000 in net product sales for Q3 2025, with modest sales expected in Q4.
• For 2026, Iterum anticipates $5 million to $15 million in full-year net product revenue, with a cash runway into Q2 2026.

• Financial forecasts are based on continued commercialization efforts and anticipated payer coverage, which are key drivers for revenue growth.

• Patent Estate Expansion:

• Iterum was granted patents in China and Mexico, extending its patent coverage until 2041 and 2039, respectively.

• These patents are part of the company's strategy to strengthen its intellectual property position and protect its products.

• Commercialization and Field Operations:

• The field team was reduced to 10 representatives, with plans to augment with a combination of in-person and virtual reps, aiming for greater efficiency.
• This strategic change in the field organization is aimed at optimizing coverage and effectiveness in high prescribing geographies.
  

  Sentiment Analysis:

  Overall Tone: Neutral

  • Management highlighted early commercial traction ("more than 280 prescriptions" from "more than 100 unique prescribers") and progress on access (coverage reaching 16% of insured lives) but also disclosed widening losses (Q3 net loss $9.0M vs $6.1M prior year) and a cash runway only into Q2 2026, requiring additional financing.

Q&A:

• Question from Antonio Arce (WestPark Capital, Inc.): Do you intend to report launch metrics (patients, prescribers, reps, coverage) for the first few quarters, and how many physician details and sales regions will you continue?
  Response: Yes—will report prescriptions, physician counts and growth in early quarters; plan to effectively cover roughly 20 high-value territories using a reduced in‑person team plus supplemental resources.

• Question from Antonio Arce (WestPark Capital, Inc.): Can you give more color on the two drivers of 2026 sales guidance—payer coverage (currently 16% insured lives) and uptake—especially physician feedback on the oral profile and keeping patients at home?
  Response: Physician feedback is very positive—use cases include keeping high‑risk patients out of hospital and treating recurrent/resistant UTIs; coverage (PBM decisions) after the ~6‑month post‑launch period is expected to materially improve fill efficiency and drive uptake.

• Question from Jason Mccarthy (Maxim Group LLC, Research Division): Did I hear that PBM/formulary submissions were submitted and you expect decisions in February/1Q2026?
  Response: Bids have been submitted to the three large PBMs and major Medicare Part D plans; we hope decisions will come late this quarter and into Q1 to enable broader formulary access.

• Question from Jason Mccarthy (Maxim Group LLC, Research Division): Is there any EVERSANA strategy for advertising or social media to drive uptake?
  Response: We prioritized investment in the field organization initially; social media/advertising are being considered but will be deployed only if capital allocation and ROI justify it.

• Question from Jason Mccarthy (Maxim Group LLC, Research Division): Will you release data on patient types being treated (high‑risk, comorbidities)?
  Response: We won't provide detailed patient‑level data due to physician‑patient confidentiality; we will share anecdotal insights from prescribers collected via the salesforce.

• Question from Jason Mccarthy (Maxim Group LLC, Research Division): Do you expect demand for an oral penem beyond community UTI (broader infections)?
  Response: There is substantial inbound interest from clinicians outside targeted lists; company will supply on physician request but will only promote within the approved uncomplicated UTI indication.

• Question from Antonio Arce (WestPark Capital, Inc.): Please provide detail on augmenting the 10 in‑person reps with virtual reps and their capabilities to engage physicians.
  Response: Plan to combine in‑field and virtual reps to reach at least the original ~20 territories (potentially more); virtual reps are expected to be more efficient for scheduled outreach and produce strong performance per EVERSANA experience.

• Question from Antonio Arce (WestPark Capital, Inc.): Are you considering other marketing channels like medical journals or social media?
  Response: Yes—social media is viewed as potentially more effective than traditional journal ads; decisions will be driven by historical ROI and available capital, with current focus on field efforts.

Contradiction Point 1

Sales Territory Coverage

It involves changes in the company's strategy for sales territory coverage, which directly impacts the launch and market penetration of the product, potentially affecting profitability and growth expectations.

Will you report specific metrics for patients, prescribers, and reps in the first few quarters of the launch? Also, can you provide the number of physician details, sales regions, and reps? - Antonio Arce(WestPark Capital, Inc.)

2025Q3: We will report on prescriptions, growth, and number of physicians for transparency. Initially, we planned for 20 territories, but with the current change and supplemental resources, we will effectively cover at least 20, possibly more, territories more efficiently. - Corey Fishman(CEO)

Can you elaborate on the maturity of your conversations with potential commercial partners and whether there are any significant rate-limiting steps ahead of your launch this year? - Matthew Keller (H.C. Wainwright)

2025Q1: We're in the final stages of preparing for the commercial launch of ORLYNVAH in the fourth quarter of 2025. We have completed all necessary regulatory filings and are in final discussions with wholesalers and specialty pharmacies for product supply. We have also made product available to our specialty pharmacy channel partners as part of the preparations for the launch. - Corey Fishman(CEO)

Contradiction Point 2

Marketing and Advertising Strategy

It pertains to the company's approach to marketing and advertising, specifically the use of social media and other channels, which can influence market penetration and brand awareness.

Will the company launch advertising campaigns to boost adoption via social media? - Jason Mccarthy(Maxim Group LLC, Research Division)

2025Q3: We're considering optimizing our social media presence. At present, our focus is on field organization support. - Corey Fishman(CEO)

What are the capabilities and potential impact of using virtual efforts to augment the sales force? - Antonio Arce(WestPark Capital, Inc.)

2025Q2: We are committed to 20 territories, but we are now open to opportunities to cover more territories with virtual reps. - Corey Fishman(CEO)

Contradiction Point 3

Payer Coverage and Uptake Expectations

It involves the company's expectations regarding payer coverage and uptake for its product, which are critical for market success and revenue projections.

What are the key drivers of payer coverage and uptake for next year's net sales guidance, particularly related to the oral product profile and patient feedback? - Antonio Arce(WestPark Capital, Inc.)

2025Q3: Feedback from physicians is positive. Physicians appreciate the oral profile for treating those at risk and keeping patients at home. Access discussions are advancing. We anticipate formulary coverage decisions within the first quarter 2026, enhancing efficiency and increasing uptake. - Corey Fishman(CEO)

Can you provide feedback or details on your ongoing partner discussions, and what types of partners (e.g., pharma or financial entities) are you currently engaging with or seeking? - Wing Yip(HC Wainwright)

2024Q4: We are much more encouraged by the fact that the payers do have an interest in the therapy. So we are optimistic we can get formulary coverage, either through a partnership or through a strategic transaction on the commercial end. - Corey Fishman(CEO)

Contradiction Point 4

Sales Force Strategy and Territory Coverage

It involves the company's approach to sales force expansion and territory coverage, which directly impacts revenue growth and market penetration.

Will you report specific metrics on patients, prescribers, and reps for initial launch quarters? Can you also provide details on prescriber count, sales regions, and rep numbers? - Antonio Arce(WestPark Capital, Inc.)

2025Q3: We will report on prescriptions, growth, and number of physicians for transparency. Initially, we planned for 20 territories, but with the current change and supplemental resources, we will effectively cover at least 20, possibly more, territories more efficiently. - Corey Fishman(CEO)

How do you expect the sales force to evolve through 2025? - Michael Petusky(Jefferies)

2024Q4: We are not going to add sales representatives at this time. We are going to see how this progresses over the next quarter or 2 from a gross sales rep and then we'll probably reevaluate at that point. - Michael Shaw(CFO)

Contradiction Point 5

Marketing Strategies and Allocation of Resources

It highlights differences in the company's approach to marketing and resource allocation, which can impact product awareness and market penetration, potentially affecting sales and revenue projections.

Will there be advertising efforts to drive uptake through social media? - Jason McCarthy (Maxim Group LLC, Research Division)

2025Q3: We're considering optimizing our social media presence. Currently, our focus is on field organization support. If we raise more capital, we can explore these channels further. - Corey Fishman(CEO)

Can you discuss the maturity of conversations with potential commercial partners? Also, are there any rate-limiting steps expected before the launch later this year? - Matthew Keller (H.C. Wainwright)

2025Q1: There's really not a lot of color we can add on any commercial partner discussions. We are open to discussions with potential partners, but no concrete deals have been made yet. The market remains attractive, and we're focused on getting ORLYNVAH to patients and physicians. - Corey Fishman(CEO)