Oct 28, 2026 earnings call — TUDRIQEV commercial launch progress
Over 15 institutions have written 1 or more TUDRIQEV prescriptions in less than 20 business days.
EPS $-0.54 (est $-0.78)
Key quotes
"We have had proactive engagement with more than 70% of our initial 200 target accounts, reflecting real interest in TUDRIQEV and our team's ability to reach priority customers."
"We are ready to meet the demand with more than a year of inventory on hand produced at our in-house manufacturing facility."
"In terms of securing coverage, TUDRIQEV was very rapidly listed in the NCCN guidelines as a Category 2A recommendation."
Analyst Q&A 7
launch gating factors and early metrics
Q (Evan Seigerman · BMO): He asked what factors control the pace of the launch and what metrics (patients or accounts) to model next year.
A: Management said the launch is going very well and customers are quickly getting TUDRIQEV on formulary. They view the launch as a funnel: engaging melanoma treaters, operationalizing workflows, getting accounts to order and identify patients. They noted closer to 20 accounts have ordered and begun treating, and they will report accounts-on-formulary and accounts that wrote a first script rather than patient counts until cohorts complete 8 or more cycles.
"So we think about the cadence of are we engaging with the right melanoma treaters, is our team able to execute and help facilities operationalize workflows?" — Michelle DiNapoli
time to dosing, holdups, and early volume questions
Q (Allison Bratzel · Piper Sandler): She asked how many have actually administered a dose, typical time from prescription to first injection, main holdups, and whether early patient volume or tumor burden matches IGNYTE.
A: Management said distribution supports next-day delivery and accounts are dosing patients quickly after ordering. They gave examples of orders on Friday dosed Tuesday or orders on Monday dosed Tuesday, and said interventional radiologists are receptive and best practice is to schedule the eight cycles with IR when appropriate. On pricing/volume it's too early to conclude, though they believe IGNYTE was representative and will monitor real-world use.
"So we have seen accounts when they order, they are administering to their patients pretty quickly." — Michelle DiNapoli
readiness of 140 target sites and steps to start
Q (Leerink Partners): He asked for a breakdown of readiness among the 140 engaged institutions, the critical steps for an institution to start ordering, any surprises, and how the commercial team fixes issues.
A: They said each institution differs but often the first step is getting TUDRIQEV on formulary, which can sometimes be bypassed when patients need treatment. The commercial team partners with sites to set up workflows involving pharmacy, oncology and interventional radiology so treatments proceed smoothly. They have an operational excellence team and have held more than 50 cross-functional meetings to establish workflows.
"But often, the first step is getting the TUDRIQEV on formulary, so there is access within the institution." — Michelle DiNapoli
sales force staffing and remaining hires
Q (Anupam Rama · JPMorgan): He asked what the sales force looked like before approval, where it is now, and what hires or deployment remain in coming weeks.
A: They said they have rebuilt the commercial team quickly and have 23 account management positions in place plus an operational excellence team that is almost fully in place. They have penetrated over 70% of target accounts and the sales team will focus on completing training and continuing account engagements. There are a couple of internal roles remaining to hire but nothing major on the field-sales side.
"Specifically for the sales force, we have all -- we have 23 account management positions that are in place and an operational excellence team that is almost fully in place." — Michelle DiNapoli
superficial vs image-guided use and formulary limits
Q (Jiale Song · Jefferies): He asked whether treated patients are superficial or visceral, whether formularies limit reimbursed volume, and if the rollout timing to the next waves can be accelerated.
A: They said they are seeing both superficial and image-guided injections and are encouraging image-guided use; payers have not restricted retreatment. They are not seeing formulary volume restrictions and some published policies allow doses up to 24 doses and support the label including 8 cycles and retreatment. Their priority is the top 200 accounts (about 30% of melanoma patients treated nationally) and they may accelerate into a next wave of 250 accounts (another 20%) when ready.
"So the short answer is no, we're not seeing any restrictions on formulary in terms of usage." — Michelle DiNapoli
volume differences by superficial vs deep injections
Q (Mubeen Mosaheb · Cantor): He asked what proportion receive superficial versus deep injections and how that affects treatment volume.
A: Management said it's too early to comment on volume differences by lesion type and location during this launch. They noted that in IGNYTE deep injections such as lung and liver tended to have higher volume, but real-world patterns can vary by patient and it's premature to generalize now.
"Again, it's too early to comment on volume differences by lesion type and lesion location." — Sushil Patel (CEO)
which centers adopted and clinical positioning
Q (Romy O'Connor · Kempen): He asked whether the 15+ prescribing institutions are mostly large academic centers or also regional centers, and how physicians are positioning TUDRIQEV in practice.
A: They said the initial 15 accounts are mostly academic and hospital-based centers as expected, with some regional centers adopting quickly; these are generally higher-volume melanoma centers and some community centers have already treated patients. On positioning, the label is broad for patients who progressed on PD-1-based therapy, and physicians appear willing to use TUDRIQEV both earlier and later depending on patient need.
"So to your question around characterization of our top -- initial treaters in the 15 accounts, these are mostly within our expectations." — Michelle DiNapoli