Aug 20, 2026 earnings call — BLA resubmissions and manufacturing recovery
Company reaffirmed 2026 guidance of $650 million to $700 million revenue and $180 million to $220 million adjusted EBITDA.
Revenue $0.1B (est $0.1B) · EPS $-0.11 (est $-0.05) · Next-quarter revenue outlook $0.7B–$0.7B
Key quotes
"These investments allowed us to resubmit our US BLAs in June. And in July, the FDA formally closed the May surveillance inspection of our [ Alvotech ] facility with a VAI classification."
"AVT05 and AVT06 are now launched across more than 10 European markets, including the major markets of Germany, France, the U.K., Spain and Italy."
"The equity financing completed in June generated approximately $165 million in gross proceeds."
Analyst Q&A 5
Bio-Thera effect on Simponi and U.S.
Q (Christopher Uhde · SEB): He asked how the Bio-Thera news affects their Simponi biosimilar in Europe and beyond, including any tenders. He also asked which disclosed assets are not yet partnered for the U.S. and whether to update models now.
A: They said their partner Advance is expanding share, sitting slightly north of 15% and growing. They have built supply for the launch and are positioned through the rest of this year and into '27. Several pipeline assets remain in active licensing discussions and they expect milestone revenues to contribute for the remainder of '26 and into '27, with updates in Q3 and Q4.
"I think our partner has done well, certainly expanding market share, I think sitting slightly north of 15% at this point and growing." — Lisa Graver (CEO)
FDA resubmission status and Simponi launch
Q (Ashwani Verma · UBS): He asked whether the FDA has given any new communications or formally accepted the resubmitted applications, and whether any information requests remain. He also asked about confidence in a 4Q Simponi launch and whether the J&J patent lawsuit must be resolved to launch.
A: They said all BLAs were resubmitted as complete responses and the FDA issued acknowledgment letters and goal dates aligned with the 6-month clock upon resubmission. They would not comment on exact partner launch timing, but they expect a decision in the ongoing litigation in the fourth quarter, feel very strongly in their IP position, and said that would pave the way to launch with approval expected in the fourth quarter.
"we did get an acknowledgment letter for all of the submitted BLAs from the FDA that the application was submitted." — Joseph McClellan (COO)
AVT16 launch timing and R&D spend
Q (Arvid Necander · DNB Carnegie): He asked where they see the U.S. launch window for AVT16 after BLA acceptance. He also asked if they still stand by roughly $250 million total R&D spend for 2026 and about the Q3 step-up in expense versus capitalized development.
A: They said with the submission they are expecting an approval decision in early 2027 and feel comfortable in their IP position while working with partners to pursue a near-term launch; they are not currently involved in patent litigation. On R&D, they reported just over like $100 million in total R&D spend to date with roughly 50% capitalized, expect that trend to continue, and expect Q3 and Q4 R&D expense to be pretty evenly split.
"I do think with the submission, we are expecting an approval decision in early 2027." — Lisa Graver (CEO)
Drivers of guidance and submission timelines
Q (Glen Santangelo · Barclays): He asked how much of the second-half guidance is development milestones versus product revenue and for timing of submissions for EYLEA high dose (AVT29) and AVT80.
A: They said they are targeting a strong Q4 because Q2 production will become commercial product in Q4, and Q3 will still be impacted by the ramp-up; the second half is expected to be a mix of product revenue and licensing milestones, with milestones likely lumpy and heavier in Q4. Historically they have given a flavor of milestones around "$250 million a year"; EYLEA high dose in Europe is a 2026 event, the U.S. AVT29 clinical study is underway and anticipated to be a 2028 event, and AVT80 has been submitted in Europe with a U.S. submission expected very soon.
"So I would rather think about the year like we are targeting strong Q4." — Lisa Graver (CEO)
Fujifilm supply and the quarter provision
Q (Christopher Uhde · SEB): He asked for the status of the Fujifilm collaboration and whether the provision taken this quarter related to the CRLs.
A: They said the Fujifilm collaboration is progressing well and they expect to start to see product coming out of Fuji in the second half of '27, more towards the back half of '27, and are on track. On the provision, they said it relates to commercial and contractual matters, provisions can be required from time to time, and the underlying details remain commercially sensitive and confidential so they cannot elaborate.
"I think we have said previously, we expect to start to see product coming out of Fuji in the second half of '27, more towards the back half of '27." — Lisa Graver (CEO)