Analyst Conference Summary

conference date: July 31, 2023 @ 5:00 AM Pacific Time
for quarter ending: June 39, 2023 (Q2, second quarter 2023)

Forward-looking statements

Overview: Elahere revenue continues ramp.

Basic data (GAAP):

Revenue was $83.2 million, up 67% sequentially from $49.9 million, and up 486% from $14.2 million year-earlier.

Net income was negative $4.2 million, up sequentially from negative $41.0 million, and up from negative $62.0 million year-earlier.

Diluted EPS was negative $0.02, up sequentially from negative $0.16, and up from negative $0.24 year-earlier.

Guidance:

Updtated full year 2023 to op ex between $350 and $365 million. Revenue excluding Elahere is expected between $45 and $50 million. No Elehere revenue guidance. Existing cash ramp over two years.

Conference Highlights:

Mark Enyedy, CEO of ImmunoGen, said "This quarter we achieved a significant milestone for patients and our organization. With positive data from our confirmatory MIRASOL trial, Elahere is the first therapy to demonstrate an overall survival benefit versus chemotherapy in a Phase 3 trial in platinum-resistant ovarian cancer. These data further support the potential of Elahere to become the new standard of care for FRa-positive platinum-resistant disease. In parallel, through strong execution by our commercial team supported by robust engagement from medical affairs, we have accelerated the Elahere launch, more than doubling our Q1 results with increasing breadth and depth of adoption. We also progressed our broader development program to move Elahere into platinum-sensitive disease and position it as the combination agent of choice in ovarian cancer. Turning to our second pivotal program, PVEK, we presented an interim analysis from our CADENZA trial showing encouraging anti-tumor activity and durable responses in BPDCN and are pleased to share that we enrolled our last patient in the pivotal de novo frontline cohort at the end of the second quarter. We also advanced development with IMGC936 and IMGN151, our second-generation ADC targeting FRa. Looking ahead, we see continued momentum through the second half of the year with multiple data readouts and regulatory milestones, including efficacy results from PICCOLO with Elahere monotherapy in platinum-sensitive ovarian cancer and from the expansion cohorts with the PVEK/VEN/AZA triplet in frontline AML as well as the submissions of the MAA and sBLA for Elahere." Does not have data yet to predict Elahere sales.

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.

In Q4 2023 plans to submit an sBLA to convert accelerated approval of Elahere to full approval. On November 14, 2022, the FDA approved Elahere (mirvetuximab soravtansine-gynx) for platinum-resistant ovarian cancer. Strong top-line Mirasol trial results in June 2023, should support full FDA approval as well as an EU application in Q4 2023. Partner Huadong Medicine will apply in China. Early adoption is going well. Certifying more labs to test for FRa+ cancer. Insurance coverage is very good.

Revenue from Elahere was $77.4 million, up % sequentially from $29.5 million. $0 million was from license and milestones (from Vertex); $6 million was non-cash royalties; $0 million was from research support.

On March 1, 2023, Immunogen announced a global, multi-target license and option agreement granting Vertex Pharmaceuticals (VRTX) rights to conduct research using ImmunoGen's ADC technology to discover novel targeted conditioning agents for use with gene editing. Will receive a $15 million upfront payment and up to $337 million in potential option exercise fees, development and commercial milestones, plus tiered royalties, all on a per target basis.

In Q2 Immunogen announced a new non-dilutive credit facility with Pharmakon Advisors, LP for up to $175 million; $75 million was received upon execution, in Q2.

Immunogen completed dose escalation in the Phase 1 study of IMGC936 in multiple solid tumor types in 2022. Has initiated expansion cohorts in triple-negative breast cancer and non-small cell long cancer. Data will be shared in Q2 2023.

In Q1 2023 completed enrollemnt in PICCOLO, a single-arm study of mirvetuximab monotherapy in high FRa recurrent platinum-sensitive ovarian cancer, designed to support potential label expansion.

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

Cash and equivalents ended at $572 million, up sequentially from $201 million on cash raise. No long-term debt.

Operating expenses were $87 million consisting of: cost of sales $1 million; $50 million R&D; $36 million general and administrative. Income from operations negative $4 million. Non-cash interest expense of on future royalty $1 million. Other income $0 million. Income tax $1 million.

Q&A selective summary:

Elahere be used in 2-plus FRa expression levels? FRa high expression definition is at least 75% of tumor cells are at least 2-plus. 50% is medium expression, patients do about as well with Elahere as with chemotherapy. We are exploring lower levels in combo strategies. Mirv plus Bev gets good results in about 80% of patients. So we hope to expand the label to combos and lower FRa expression.

Combo use in claims? Yes, we are seeing that. Physicians are reporting a significant percentage of use is in combination.

Testing in house by academic centers? Over 20,000 tests now. We have 33 operational labs. Another 16 are in process. Testing has not been a barrier to treatment.

Landscape has evolved because of PARP inhibitor therapy. So hard to predict the hurdle for platinum-sensitive patients for Elahere. We don't really know what the benchmark is. ORR data in Picolo expected before this year's end.

Veneza (? venetoclax) is the standard of care for AML, but most combos failed because of excess toxicity. Our regimen was not too toxic. FDA wants us to combine with standard Veneza dose.

EU launch strategy? The one real difference is how and when bevacizumab or Avastin. The problem is in most subgroups it does not improve overall survival. Most EU patients start with single agent chemo. We will make presentations in Turkey and at ESMO this year.

IMGC936? We prioritized NSCLC, but ADAM9 is expressed in many solid tumors. We will be looking for overall response rate int the first data.

Break even goal, R&D spend plans? We have a lifecycle management program for Elahere and its successors. We have 3 broad classes of payloads. We are expanding our preclinical activity. We expect to invest heavily in the business as we expand globally. Our cash guidance is we have more than 2 years of cash runway.

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