TG Therapeutics (TGTX) Q1 FY26 earnings call: guidance and Q&A

What is the market opportunity for the subcutaneous product, and how does 12-week vs 8-week dosing impact share gain potential?

The subcutaneous segment represents about 35% of the CD20 market, which the company currently doesn't compete in, representing a new patient population. Both 8-week and 12-week dosing would be strong offerings, with 12-week being incrementally better, allowing competition across the entire CD20 landscape.

“As we mentioned, that segment represents about 35% of the CD20 market today. One, we do not compete in. And our perspective is this is expanding into a new patient population rather than shifting patients within our existing base.”

asked by Corinne Johnson · answered by Adam Waldman

What is the expected timing for ENHANCE and Phase I bioavailability data? Can you elaborate on stronger-than-anticipated persistence and the impact of DTC campaigns?

Exact timing for ENHANCE and Phase I bioavailability data is not available, but both are expected 'in the coming weeks'. Persistence is stronger than expected, particularly in the second year of treatment, supporting durability. DTC efforts are encouraging, increasing patient awareness and contributing to shared decision-making.

“In terms of timing, we don't have the exact timing. We just know that things are coming in soon. So we just basically thought we'd let people know that, that data was coming.”

asked by Lut Ming Cheng · answered by Michael Weiss

What is the cadence from subcu BRIUMVI Phase III data readout to filing, and how quickly would it become commercially available?

The target is for subcu BRIUMVI to be available in 2028. The company aims to file as soon as possible after Phase III completion, with additional studies needed for the filing package, including the auto-injector bridge. Approval is targeted for 2028, accounting for a typical 12-month review process.

“So our target is to have the subcu available sometime in 2028. In terms of the cadence of filing after the completion of that study, our goal is to get that filed as soon as we can.”

asked by Gregory Wiessner · answered by Michael Weiss

What would be the impact of remibrutinib's potential approval in MS on BRIUMVI and the CD20 class?

The company awaits product profiles for BTKs, noting past difficulties in demonstrating convincing clinical benefit over risk. While there's room for BTKs in certain patient populations (e.g., non-active secondary progressive MS) and the oral market, they are not expected to materially impact the CD20 class.

“But we don't think it's a drug class that will have a material impact on the CD20 class.”

asked by Cha Cha Yang · answered by Michael Weiss

What dosing profile does subcu BRIUMVI need to be meaningfully differentiated, considering competitors' longer interval work?

Both every two months and quarterly dosing would be strong offerings, with quarterly being incrementally better. The differentiation will come from BRIUMVI's molecule and convenience factors combined. The company expects to be highly competitive in the subcu marketplace, similar to its success in the IV space.

“And as Adam mentioned earlier, every two months or every three months will be a really strong offering. Again, it's BRIUMVI still loaded into the auto-injector, which means that all the differentiation that we have on the IV side, on the molecule itself will continue to exist as we go into the marketing effort on the subcu side.”

asked by Michael DiFiore · answered by Michael Weiss

What gives confidence in sustained growth for the rest of the year, and what are the expectations for operating expenses?

Confidence in sustained growth comes from Q1 performance driven by strong new patient starts and better persistence, with momentum continuing into Q2. The model has a growing recurring base and continued new patient demand. Full-year operating expenses (ex-stock-based comp) are still expected to be around $350 million, plus $100 million for specific manufacturing activities, despite Q1 being slightly higher.

“Q1 performance, as I mentioned, was driven by strength across all key drivers, including record number of new patient starts and better-than-expected persistence. I think we're seeing that momentum continue into Q2.”

asked by Emily Bodnar · answered by Adam Waldman

What is the plan for capital allocation between share buybacks and business development, and what are the gross-to-net discount expectations for the rest of the year?

The company remains highly selective and disciplined in BD efforts, willing to buy back shares if they are undervalued. They will continue share repurchases. Gross-to-net dynamics in Q1 were in line with expectations, and for the full year, it is expected to average around 65%.

“We've been clear. We view our stock as undervalued, and we're acting on that. This quarter alone, we repurchased $100 million of our stock.”

asked by Jennifer Kim · answered by Michael Weiss

Can you provide top-level insights on Azer-cel, what gives confidence in its advancement, and any expected data?

Azer-cel is still early, but the company is excited to be moving up in dose escalation. It's a logistically challenging study, but they are nearing the penultimate dose. Safety is paramount, followed by biomarkers of activity like B-cell deletion and oligoclonal bands. Updates are expected later this year, and the rationale for these drugs remains strong.

“Appreciate it. Yes, for Azer-cel, it's still early. We are excited to be moving up in the dose escalation, but it's a challenging study logistically to get to a point where we can open up enrollment.”

asked by William Wood · answered by Michael Weiss