Analyst Conference Summary

conference date: November 2, 2023 @ 5:00 AM Pacific Time
for quarter ending: September 30, 2023 (Q3, third quarter 2023)

Forward-looking statements

Overview: Elahere revenue continues ramp nicely, resulting in a turn to net income.

Basic data (GAAP):

Revenue was $113 million, up 36% sequentially from $83.2 million, and up 653% from $15 million year-earlier.

Net income was $30.7 million, up sequentially from negative $4.2 million, and up from negative $77.8 million year-earlier.

Diluted EPS was $0.10, up sequentially from negative $0.02, and up from negative $0.31 year-earlier.

Guidance:

Unchanged.

Conference Highlights:

Mark Enyedy, CEO of ImmunoGen, said "Elahere is tracking towards one of the most successful first product launches in oncology in a decade. We also made important progress in our effort to bring Elahere to eligible patients around the world with the acceptance of the MAA by the EMA and the NDA by the NMPA, and the establishment of a collaboration with Takeda to deliver Elahere in Japan. In addition, we advanced the Elahere development program and are pleased to report that our PICCOLO trial in platinum-sensitive ovarian cancer has met the primary endpoint of objective response rate based on an interim efficacy assessment. With a number of patients remaining on treatment and longer follow-up required to establish mature response durability of Elahere in this patient population, we anticipate an ORR of at least 48% when we report full data in mid-2024. Turning to our second pivotal program, PVEK, we continue to advance our 802 study and look forward to reporting data from our PVEK/VEN/AZA triplet in frontline AML at ASH in December. We also continued to monitor the NSCLC cohort with IMGC936 and advanced dose escalation with IMGN151, our second-generation ADC targeting FRa. We look forward to a strong finish to the year and a productive 2024 with the continued growth of Elahere, important new data for our programs, and geographic expansion in Europe and China."

In Q3 2023 PICCOLO, a single-arm study of mirvetuximab monotherapy in high FRa recurrent platinum-sensitive ovarian cancer, designed to support potential label expansion, met its primary endpoint, ORR. Full data should be presented in mid-2024.

In Q4 2023 to submitted an sBLA to convert accelerated approval of Elahere to full approval. The application for ovarian cancer was accepted by the EMA. Partner Huadong Medicine applied in Q3 2023 in China. Early adoption is going well. Insurance coverage is very good.

Takeda Pharmaceutical took an exclusive license to market Elahere in Japan. Imunogen received a $23 million updrong payment and could receive up to $135 million in milestones plus royalties.

Revenue from Elahere was $105.2 million, up 36% sequentially from $77.4 million. $0 million was from license and milestones (from Vertex); $7.4 million was non-cash royalties; $0.9 million was from research support.

In Q3 2023 Imunogen entered a multi-target license and option agreement with ImmunoBiochem Corporation to develop next-generation ADCs.

Immunogen completed dose escalation in the Phase 1 study of IMGC936 in multiple solid tumor types in 2022. Partnered with Macrogenics. Non-small cell lung cancer expansion cohort could report data in 2024.

In Q2 2023 Immunogen presented an interim analysis from the Phase 2 CADENZA trial of pivekimab sunirine (pivekimab or PVEK) in patients with frontline and relapsed/refractory (R/R) blastic plasmacytoid dendritic cell neoplasm (BPDCN) at the European Hematology Association (EHA) 2023 Congress. Also completed enrollment in that trial in the quarter. Will present more AML data in December 2023.

IMGN151, a next generation anti-folate alpha (FRa) molecule enrolled its first Phase 1 patient in January 2023 and continues dose escalation in ovarian and endometrial cancers.

Cash and equivalents ended at $606 million, up sequentially from $572 million on cash raise. $72 million loan debt.

Operating expenses were $87 million consisting of: cost of sales $2 million; $48 million R&D; $38 million general and administrative. Income from operations $26 million. Non-cash interest expense of on future royalty $1 million. Other income $5 million. Income tax benefit $1 million.

Q&A selective summary:

Elahere with Avastin share v. total Elahere use? Seeing growth in both mono and combined therapy.

Treatment share in platinum resistant ovarian? Don't have specific data. Seeing good trends in monotherapy. Moved from 4th line to earlier lines of therapy. Still high unmet need, selling into both academic and community settings.

Piccolo data? The data is very good. Competition ORR in monotherapy is high single to low double digits, combo therapy ORR from high 20s to high 30s. We expect to show at least a 48% ORR.

ADAM9? ADAM9 is broadly expressed. We will share any data we get.

We expect continued growth, but on an over $100 million per quarter base, the slope will not be as steep as in prior quarters.

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