CRMD

Commercial Progress for DefendCat

• Signed a multi-year commercial supply agreement with an additional large U.S. dialysis organization (LDO), giving CoreMedix supply agreements with all five of the top U.S. dialysis providers.
• The new LDO will launch a Q3 2026 pilot of DefendCat, with potential for full utilization expansion in 2027; the pilot and its revenue are already included in 2026 guidance.
• Continues to make progress on Medicare Advantage contracting, a meaningful long-term growth avenue for DefendCat, though no 2026 contribution is assumed in guidance.
• Additional real-world evidence studies for DefendCat are expected to be published in Q4 2026, expanding the body of data supporting its clinical and pharmacoeconomic value.

Pipeline and Clinical Development

• Positive top-line Phase III RESPECT study results for RISEO (invasive fungal disease prophylaxis) met the primary endpoint of 90-day fungal-free survival non-inferiority versus standard of care, with a favorable safety profile.
• Working collaboratively with partner Mundi Pharma to submit the NDA for RISEO in Q3 2026, with FDA action expected in H1 2027 if the filing is accepted; full study data will be published at medical conferences in Q4 2026.
• Post-approval, CoreMedix will take ownership of the U.S. NDA and commercial rights for RISEO.
• Submitted a protocol amendment for the Phase III TPN indication study of DefendCat to narrow exclusion criteria and boost enrollment, with additional trial sites activated; study completion is expected in 2028.

Financial Performance

• The Melinta acquisition (closed August 2025) contributed a full quarter of operations in Q2 2026, driving year-over-year revenue and expense growth.
• Operating expenses totaled $34.2 million, up 87% from Q2 2025, driven by full-quarter Melinta operating costs; R&D expenses increased to $6.7 million from $2.4 million, while selling & marketing expenses rose to $12.4 million from $6.4 million.
• G&A expenses hit $15.1 million, up 59% year-over-year, including a $4.2 million reduction from expected insurance reimbursement of prior legal fees tied to securities litigation.

• Full-year 2026 consolidated revenue guidance is maintained at $325 million to $345 million, with DefendCat full-year revenue guidance held at $175 million to $195 million.
• Full-year 2026 adjusted EBITDA guidance is raised from the prior range to a new range of $125 million to $140 million.
• Full-year 2026 cash operating expense guidance (excluding non-cash charges) is maintained at $145 million to $155 million, which already includes planned pre-commercial investments for RISEO.
• July order volumes have aligned with the post-DAPA expiration forecast underlying current guidance, and new contract amendments with major customers for Q3/Q4 2026 pricing (and in some cases 2027 pricing/volume commitments) have improved visibility for the full year.
• Management will revisit guidance later in 2026 as more visibility into post-DAPA ordering patterns is obtained.

CORE Medix recorded Q2 2026 consolidated revenue of $101.9 million, up from $39.7 million in Q2 2025. The DefendCat segment generated $66.1 million in revenue, accounting for 64.9% of total consolidated revenue. The acquired Melinta portfolio contributed $35.8 million in revenue, representing 35.1% of total consolidated revenue. Adjusted EBITDA for the quarter was $58.7 million, up from $22.4 million in the year-ago quarter. Net income was $26.0 million in Q2 2026, compared to $19.8 million in Q2 2025. Ending cash and cash equivalents totaled $256.7 million at quarter end.

• Reimbursement transition following DAPA expiration creates uncertainty around long-term ordering and utilization patterns for DefendCat, with expected attrition among small dialysis providers.
• Regulatory timelines for RISEO approval are uncertain, and management has structured pre-commercial investments to preserve flexibility if timelines shift.
• Medicare Advantage contracting has lengthy cycles, and contributions from this channel are not yet guaranteed.
• Ongoing securities litigation creates ongoing legal cost exposure, though partial insurance reimbursement has been obtained for incurred fees.

Q: How will the new LDO agreement impact 2027 expectations, how long does ramp to steady state take, and is the pilot included in 2026 guidance?

A: Management notes the agreement was just signed, and the pilot is just launching. There are too many variables to provide 2027 guidance updates at this stage, with updates expected no earlier than late 2026 or early 2027. The pilot revenue is already included in existing 2026 guidance, and DefendCat is currently tracking to the mid-to-upper end of its 2026 revenue range.

Q: What volume trends have you seen in existing DefendCat channels post-DAPA expiration, and what is your outlook for potential ESRD payment increases?

A: July volumes have stabilized with large dialysis providers, in line with management expectations, while some attrition has occurred with very small providers, also as expected. Meaningful volume growth will depend on expansion of the new LDO pilot in 2027 and Medicare Advantage adoption. A final ESRD payment rule is expected in November, and management will adjust expectations once the rule is published.

Q: What is the size of the new LDO pilot, and what feedback have you received from prescribers on RISEO’s phase 3 data?

A: The pilot covers a couple hundred clinics, with no further details on scope available at this early stage. Full RISEO phase 3 data has not yet been published, so robust prescriber outreach and market research has not been conducted. Full data will be released at Q4 2026 medical conferences, after which substantive clinician discussions will begin.

Q: What explains the lower SG&A in the quarter, and were there any cost-cutting actions taken?

A: No deliberate cost actions were taken, and staffing for commercial expansion is ramping later in the year. SG&A was artificially reduced by a $4.2 million one-time credit from insurance reimbursement for prior legal fees tied to securities litigation, $2.7 million of which covered costs incurred in prior periods. Excluding this credit, the expense run rate is in line with expectations.