Aug 13, 2026 earnings call — DefenCath growth and REZZAYO sNDA progress
Announced Q2 consolidated revenue of $101.9 million and reaffirmed 2026 revenue guidance of $325 million to $345 million.
Revenue $0.1B (est $0.1B) · EPS $0.29 (est $0.24) · Next-quarter revenue outlook $0.3B–$0.3B
Key quotes
"Today we also announced that we've signed a multi-year commercial supply agreement for DefenCath with an additional large dialysis organization, or LDO."
"The ReSPECT study met its primary endpoint for FDA of fungal-free survival at day 90, showing non-inferiority versus the standard antifungal regimen, or SAR, meeting the pre-specified non-inferiority margin."
"Second quarter 2026 consolidated revenue was $101.9 million, compared with $39.7 million in the second quarter of 2025."
Analyst Q&A 5
new LDO pilot impact on 2027
Q (Leerink): They asked how the new multi-year agreement with the LDO will affect 2027 expectations and how long a new site takes to reach steady production. The analyst also asked whether the LDO pilot is included in 2026 guidance.
A: They recently signed the agreement and the LDO is rolling out a pilot; management is waiting for more visibility and will comment on 2027 later (late this year or early next year). They do not currently see a reason to change guidance. The pilot revenue is within existing 2026 guidance and DefenCath is tracking to the mid-top part of its guidance.
"So we just recently signed that agreement and they're rolling out a pilot." — Joseph Todisco (CEO·CHAIR)
current volumes and ESRD rule impact
Q (Leonid Timashev · RBC): They asked about volume growth so far this quarter after the TDAPA period ended and whether the final ESRD rule could increase payments.
A: In July volumes stabilized with the larger players and there was some attrition among the very small players. Management said DefenCath volume growth will likely need meaningful adoption by a new LDO or Medicare Advantage contracting to move materially. The final ESRD proposed rule differed from expectations; they expect comments and the final rule in November and will adjust then.
"I think to really see volume growth in DefenCath, one of two things can happen." — Joseph Todisco (CEO·CHAIR)
pilot size and REZZAYO feedback
Q (Jason Butler · Citizens): They asked the size or scope of the new LDO pilot and what feedback prescribers are giving on REZZAYO prophylaxis since the Phase III results, and whether that supports a label expansion.
A: For the pilot they shifted initial orders and currently think it covers a couple hundred clinics, but they are not giving more detail yet. For REZZAYO the full data set is not yet released, so they have not done robust market research; they expect publication later in the fourth quarter at one or more medical conferences and will have more substantive discussions with clinicians after the data is available.
"Yes, look, right now the size and scope of the pilot, we've shifted initial order." — Joseph Todisco (CEO·CHAIR)
why LDO signed now; REZZAYO label timing
Q (Serge Belanger · Needham & Company): They asked why the LDO decided to sign now after the product was available for two years and what to expect from the FDA labeling process for REZZAYO, including whether it could cover a broad patient population.
A: Management said they cannot speak to the LDO's motivations for timing, but noted they have built real-world evidence and are pleased the LDO is starting implementation of DefenCath. On REZZAYO, labeling is a label review issue and after coming out of the pre-NDA meeting they do not yet have visibility on what the final label will be.
"I really can't speak to the motivations of the company in terms of timing." — Joseph Todisco (CEO·CHAIR)
SG&A, expense changes, and sales actions
Q (Brandon Folkes · H.C. Wainwright): They asked about SG&A in the quarter, whether any actions were taken on sales and marketing (especially for DefenCath or Melinta), and for color on expense discipline.
A: Management said they did not take deliberate actions and are slightly light on expenses as some staffing will come later in the year. They disclosed a reduction of G&A for $4.2 million in the quarter driven by insurance deductible and reimbursement for litigation costs, of which $2.7 million was primarily incurred in Q1 of 2026; this reimbursement effectively eliminated those litigation fees in Q2 and would make the run rate roughly $2.7 million higher without the reversal. They confirmed no actions have been taken on the DefenCath sales and marketing infrastructure.
"It essentially eliminated those litigation legal fees that we had incurred in Q1 and in Q2 during the second quarter." — Susan Blum (CFO)