Q1 EPS: Confident in an FDA Approval by Nov 2026, Plus Robust Sales in 2027

研报英文原文证据摘录

Q1 EPS: Confident in an FDA Approval by Nov 2026, Plus Robust Sales in 2027

riggered a major BLA amendment.

FDA did not cite safety/efficacy/CMC issues (not an FDA data request). (2) BIIB's subQ Leqembi

PDUFA extension could be another recent example where the FDA necessitated an extension when

operating under a compressed review timeline. (3) In any case, our precedent analysis of PDUFA

extensions dating back to 2015 shows 80%+ of NDA/BLA extensions are ultimately approved

(N=142/176). (4) Even though CMC/manufacturing remains a technical risk (which accounts

for 50%+ of published CRLs), we think SVRA/Fujifilm should pass mid/late-cycle pre-approval

inspections (PAIs), since Fujifilm has already completed 3 upstream/downstream PPQ campaigns

and is a well-established drug supplier globally. (5) Recall, the Day 74 letter confirmed no AdCom

planned.

Molbreevi's sales trajectory should be favorable in 2027. (1) At the time of pot'l US approval (Nov

22, 2026), we expect SVRA to have a direct line-of-sight to significantly more than 1,000+ diagnosed

patients, reasonable since mgmt already cited ~1,000 as of Dec 2025 - driven by ICD10 codes

(claims data), SVRA's next-gen dried-blood spot (DBS) test in the US (launched March '25), and

an ongoing EAP program. (2) Although SVRA does not necessarily expect to capture all of these

patients in the first year, we do expect an initial bolus (US launch expected in early 2027). (3) Note

just capturing 150+ patients in Q1:27 means Molbreevi could meet 2027 cons of $60M+ (on a $400K

net price) - a fraction of 1,000 line-of-sight patients. (4) Also, new Phase III OLE data at ATS (May

17-20) can help educate the physician community ahead of the global launches.

Andrew Tsai * | Equity Analyst

(415) 229-1566 | atsai@jefferies.com