Biogen (BIIB) Q2 FY26 earnings call: guidance and Q&A

How is the high-dose SPINRAZA ramp progressing compared to expectations, what conversion metrics are being observed, and how significant are switchbacks from other therapies to overall volumes?

High-dose SPINRAZA is exceeding the original launch in start forms and grads in its first 13 weeks, driven by patient demand and urgency. The majority of patients are transitioning from the lower dose, but new starts (including babies) and switchbacks from oral therapies are also occurring, particularly in ex-U.S. markets like Germany. The convenience of 2 loading doses versus 4 for the original SPINRAZA is also a factor.

“SPINRAZA high dose is exceeding the original launch of SPINRAZA in both start forms and grads in the first 13 weeks of launch, and we are growing every single week.”

asked by Chris Schott · answered by Alisha Alaimo

What separation versus placebo in lupus trials would be considered clinically meaningful and differentiated, and what is the dose of the BTK inhibitor going forward?

Biogen is confident in its lupus trial design (TOPAZ 1 and 2 for SLE) which incorporates learnings from prior trials to manage placebo responses and patient heterogeneity. They will not speculate on specific separation but will look at the totality of data including SRI4, BICLA, and patient-reported outcomes. For the BTK inhibitor (BIIB091), the dose has not been disclosed, and the company is evaluating next steps given the competitive RRMS market and external inflections in the BTK landscape.

“Our primary endpoint is [ SRI4 ]. However, we have a key secondary endpoint in [indiscernible] and we have multiple patient-reported outcomes. So we'll really be looking at the totality of the data, including [Audio Gap] and we'll be presenting 52-week data at EADV this fall, so we remain confident in that data set as well.”

asked by Umer Raffat · answered by Priya Singhal

What are the underlying dynamics driving SYFOVRI's performance, such as new patient starts and durability, and what growth should be expected?

SYFOVRI had its strongest quarter since launch, with June being the best month in the brand's history. Growth is attributed to a reduction in free drug programs by half, improved HCP sentiment due to 5-year long-term data, and an increase in new writers and patient numbers. Future growth drivers include a planned direct-to-consumer (DTC) campaign, the launch of a prefilled syringe to improve workflow, and educating patients/physicians to improve persistency after the first injection.

“And in the month of June, the month of June was the best month in the brand's history.”

asked by Marc Godman · answered by Alisha Alaimo

How is the BTK inhibitor BIIB091 expected to be differentiated, and what are the considerations regarding its safety profile?

BIIB091, a peripheral, non-covalent BTK inhibitor, showed compelling efficacy in a Phase II trial for RRMS. However, Biogen is evaluating next steps due to the highly competitive RRMS market and external inflections in the BTK landscape. The decision involves prioritizing assets based on scientific data, value, opportunity, and capital allocation, rather than solely on efficacy or safety, which were not detailed.

“Overall, we see that it could perform really well in RRMS, but I think it's another very important example of how we prioritize assets in our portfolio where we look at the scientific data, but we marry it up with the value and the opportunity in terms of totality and really capital allocation.”

asked by Salveen Richter · answered by Priya Singhal

What is the initial demand and interest for subcutaneous LEQEMBI IQLIK induction, and what are the latest views on access dynamics and timelines?

Initial demand for LEQEMBI IQLIK induction, which will be available by the end of August, has been observed with physicians already writing scripts. Eisai is working with payers on Part D access for next year, but medical exceptions for the IV product have shown a high approval rate. The subcutaneous option is expected to accelerate the market by addressing patient reluctance to IV infusions and improving workflow for IDNs and hospitals.

“And so we've had -- as of yesterday, several physicians have already written scripts. And so we're not really counting that yet in our expectations until the product is actually readily available for the market.”

asked by Brian Abrahams · answered by Alisha Alaimo

Why is the $2 billion opportunity for felzartamab in AMR not reflected in Biogen's current valuation, and what data is needed to convince investors?

The AMR opportunity is likely undervalued due to a tendency to focus on lead products and the lack of analogs for conditions with no existing treatment. Felzartamab's Phase II data showed an 80% resolution of AMR, and there is a huge unmet need, with the only alternative being a second kidney transplant. The company believes the upcoming Phase III data in H1 2027 will demonstrate the product's potential and address investor skepticism.

“But 1,000 patients. And if you took even the Otsuka price for iGame 350,000 you're getting somewhere between a $3 billion and $4 billion market. And when you consider that the Phase II data showed an 80% resolution of AMR in an open label in a small study and obviously something we have to repeat in a Phase II. But there is no product approved for AMR today.”

asked by Evan Seigerman · answered by Christopher Viehbacher