On November 2, 2023 Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company developing a first-in-class telomerase inhibitor, imetelstat, to treat hematologic malignancies, reported business highlights and financial results for the third quarter of 2023 (Press release, Geron, NOV 2, 2023, View Source [SID1234636762]).

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"This quarter, we continued to make important progress and build momentum along our planned path to develop and commercialize imetelstat, which is now the first telomerase inhibitor to be under review by both the FDA and EMA for potential regulatory approval," said John A. Scarlett, M.D., Chairman and Chief Executive Officer. "We see lower risk MDS as a very compelling commercial opportunity, with few durable treatment options and significant need for large patient segments such as patients without sideroblasts (RS-) and those with high transfusion burden. We believe, if approved, that imetelstat could play a meaningful role in this treatment landscape."

Dr. Scarlett continued, "We believe that we are in a strong position to execute upon a potential launch in the U.S., bolstered by an experienced leadership team and with our talented commercial and medical affairs leadership teams fully onboarded. Additionally, with approximately $382 million on the balance sheet as of the end of the quarter, and expected available resources, we have the financial resources to fund a potential successful launch in the U.S. and our planned operations through the end of Q3 2025."

Business Highlights

Received acceptance from the U.S. Food & Drug Administration (FDA) of the New Drug Application (NDA) submitted for imetelstat for the treatment of transfusion-dependent anemia in adult patients with low- to intermediate-1 risk myelodysplastic syndromes (MDS), or lower risk MDS, who have failed to respond, or have lost response to, or are ineligible for erythropoiesis-stimulating agents (ESAs). The FDA assigned a Prescription Drug User Fee Act (PDUFA) action date of June 16, 2024. In addition, the FDA informed the Company that it is currently planning to hold an advisory committee meeting as part of the NDA review.
Submitted the Marketing Authorization Application (MAA) for imetelstat in the same lower risk MDS indication as in the NDA and received validation from the European Medicines Agency (EMA) that the application is under regulatory review by the European Committee for Medicinal Products for Human Use (CHMP) under the centralized procedure. Review of the MAA is expected to be completed by the end of 2024.
Presented encore data and analyses from the IMerge Phase 3 clinical trial evaluating imetelstat in patients with lower risk MDS at the Society of Hematologic Oncology Annual Meeting. New analyses from this trial are also planned at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, on which a separate press release will be issued.
Escalated to the second dose cohort in the Phase 1 ImproveMF study evaluating imetelstat as a combination therapy with ruxolitinib in patients with frontline myelofibrosis (MF) following a unanimous decision by the study’s Safety Evaluation Team (SET), who reviewed the first cohort (3 patients) data and identified no dose-limiting toxicities.
Appointed Michelle Robertson as Executive Vice President, Chief Financial Officer and Treasurer, following Olivia Bloom’s retirement. Ms. Robertson brings to Geron over 30 years of financial and commercial operations experience. Prior to joining, she served as the Chief Financial Officer and Treasurer of Editas Medicine, a CRISPR genome editing company, where she raised $500M in capital over three years to support the company’s research transition into late-stage clinical development. Before that, she served as Chief Financial Officer of Momenta Pharmaceuticals, Inc. from 2018 until 2020, leading the finance team through a strategic restructure, before its acquisition by Johnson & Johnson. Prior to joining Momenta, Ms. Robertson held multiple finance and commercial operations roles of increasing responsibility.
Third Quarter 2023 Financial Results

As of September 30, 2023, the Company had $381.9 million in cash, cash equivalents, and marketable securities. In the third quarter of 2023, the Company received $28.3 million upon the cash exercise of outstanding warrants. As of September 30, 2023, warrants remaining outstanding are exercisable for potential future proceeds of $3.2 million. Based on the Company’s current operating plans and expectations regarding the timing of regulatory approval and commercialization of imetelstat in the United States (U.S.) in the first half of 2024, Geron projects that its existing financial resources, together with projected revenues from U.S. sales of imetelstat, proceeds from the exercise of outstanding warrants, and funding under the Company’s loan facility, will be sufficient to fund its projected operating requirements through the end of Q3 2025.

Revenues for the three and nine months ended September 30, 2023, were $164,000 and $214,000, respectively, compared to $297,000 and $493,000 for the comparable 2022 periods. Revenues in both years primarily reflect estimated royalties from sales of cell-based research products from the Company’s divested stem cell assets.

Total operating expenses for the three and nine months ended September 30, 2023, were $47.8 million and $139.9 million, respectively, compared to $40.2 million and $97.1 million for the comparable 2022 periods.

Research and development expenses for the three and nine months ended September 30, 2023, were $29.4 million and $92.1 million, respectively, compared to $24.6 million and $67.3 million for the comparable 2022 periods. The increase in research and development expenses for the three and nine months ended September 30, 2023, compared to the same periods in 2022 primarily reflects higher clinical trial costs related to supporting IMerge Phase 3 and IMpactMF, increased personnel-related expenses for additional headcount, higher consulting costs to support regulatory submissions and greater imetelstat manufacturing costs in preparation for potential commercialization in lower risk MDS.

General and administrative expenses for the three and nine months ended September 30, 2023, were $18.4 million and $47.7 million, respectively, compared to $15.6 million and $29.8 million for the comparable 2022 periods. The increase in general and administrative expenses for the three and nine months ended September 30, 2023, compared to the same periods in 2022, primarily reflects new costs for commercial preparatory activities and higher personnel-related expenses for additional headcount.

Interest income was $5.0 million and $13.6 million for the three and nine months ended September 30, 2023, respectively, compared to $852,000 and $1.3 million for the same periods in 2022. The increase in interest income for the three and nine months ended September 30, 2023, compared to the same periods in 2022, primarily reflects higher yields on the Company’s marketable securities as a result of rising interest rates, as well as a larger investment portfolio with the cash proceeds from the January 2023 public offering and warrant exercises in the first nine months of 2023.

Interest expense was $2.0 million and $6.0 million for the three and nine months ended September 30, 2023, respectively, compared to $1.8 million and $4.9 million for the same periods in 2022. The increase in interest expense for the three and nine months ended September 30, 2023, compared to the same periods in 2022, primarily reflects higher interest rates. Currently, the Company has $50.0 million in principal debt outstanding.

Projected 2023 Financial Guidance

For fiscal year 2023, under generally accepted accounting principles (GAAP), the Company continues to expect total expenses in the range of approximately $200 million to $210 million, which includes non-cash items such as stock-based compensation expense, amortization of debt discounts and issuance costs, and depreciation and amortization.

The fiscal year 2023 financial guidance reflects costs to support regulatory submissions with the FDA and EMA in 2023; continued support of ongoing clinical trials, IMerge Phase 3, IMpactMF, ImproveMF, and the investigator-led Impress trial, as well as preclinical studies in lymphoid malignancies and discovery research for a next generation telomerase inhibitor; manufacturing of commercial inventory of imetelstat; preparations for potential U.S. commercial launch of imetelstat in lower risk MDS; projected increases in headcount and interest payments on outstanding debt.

As of September 30, 2023, the Company had 137 employees. The Company plans to grow to a total of approximately 160 employees by year-end 2023.

Conference Call

Geron will host a conference call at 9:00 am ET on Thursday, November 2, 2023 to discuss business updates and third quarter 2023 financial results.

A live webcast of the conference call and related presentation will be available on the Company’s website at www.geron.com/investors/events. An archive of the webcast will be available on the Company’s website for 30 days.

Participants may access the webcast by registering online using the following link, View Source

About Imetelstat

Imetelstat is a novel, first-in-class investigational telomerase inhibitor exclusively owned by Geron and being developed in hematologic malignancies. Data from non-clinical studies and clinical trials of imetelstat provide strong evidence that imetelstat targets telomerase to inhibit the uncontrolled proliferation of malignant stem and progenitor cells in myeloid hematologic malignancies, resulting in malignant cell apoptosis and suggesting potential disease-modifying activity. Imetelstat has been granted Fast Track designation by the U.S. Food and Drug Administration for both the treatment of adult patients with transfusion dependent anemia due to Low or Intermediate-1 risk MDS that is not associated with del(5q) who are refractory or resistant to an erythropoiesis stimulating agent, and for adult patients with Intermediate-2 or High-risk myelofibrosis (MF) whose disease has relapsed after or is refractory to janus associated kinase (JAK) inhibitor treatment. Imetelstat is currently not approved by any regulatory authority.

About IMerge Phase 3

The Phase 3 portion of the IMerge Phase 2/3 study is a double-blind, 2:1 randomized, placebo-controlled clinical trial to evaluate imetelstat in patients with IPSS Low or Intermediate-1 risk (lower risk) transfusion dependent MDS who were relapsed after, refractory to, or ineligible for, erythropoiesis stimulating agent (ESA) treatment, had not received prior treatment with either a HMA or lenalidomide and were non-del(5q). To be eligible for IMerge Phase 3, patients were required to be transfusion dependent, defined as requiring at least four units of packed red blood cells (RBCs), over an eight-week period during the 16 weeks prior to entry into the trial. The primary efficacy endpoint of IMerge Phase 3 is the rate of red blood cell transfusion independence (RBC-TI) lasting at least eight weeks, defined as the proportion of patients without any RBC transfusion for at least eight consecutive weeks since entry to the trial (8-week TI). Key secondary endpoints include the rate of RBC-TI lasting at least 24 weeks (24-week TI), the duration of TI and the rate of hematologic improvement erythroid (HI-E), which is defined under 2006 IWG criteria as a rise in hemoglobin of at least 1.5 g/dL above the pretreatment level for at least eight weeks or a reduction of at least four units of RBC transfusions over eight weeks compared with the prior RBC transfusion burden. A total of 178 patients were enrolled in IMerge Phase 3 across North America, Europe, Middle East and Asia.

About ImproveMF

IMproveMF is a single arm, open label, two-part Phase 1 study to evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of imetelstat in combination with ruxolitinib as a frontline treatment in patients with Intermediate-2 or High-risk MF (frontline MF). In both parts, patients will receive ruxolitinib followed by imetelstat, a dosing schedule that showed synergistic and additive effects of the two agents in preclinical experiments. Part 1 will enroll up to 20 frontline MF patients who, at the time of enrollment, have received an optimized dose of ruxolitinib, to which imetelstat treatment will be added at increasing dose levels based on safety and tolerability. The primary purpose of Part 1 is to identify a safe dose for treating frontline MF patients with a combination of imetelstat and ruxolitinib. If a safe dose is identified in Part 1, participants in Part 2 will be JAK inhibitor naïve and will receive treatment with ruxolitinib after screening and enrollment at a starting dose based on standard-of-care or local prescribing information. Treatment with single-agent ruxolitinib will continue for at least 12 weeks, including four consecutive weeks at a stable dose prior to the addition of imetelstat. Part 2 is designed to confirm the safety profile of imetelstat in combination with ruxolitinib and to evaluate for preliminary clinical activity of the combination.

On November 2, 2023 Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, reported the publication of abstracts from the IMerge Phase 3 clinical trial evaluating its first-in-class investigational telomerase inhibitor imetelstat in patients with lower risk myelodysplastic syndromes (MDS) (Press release, Geron, NOV 2, 2023, View Source [SID1234636761]). Four abstracts have been accepted for presentation at the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting taking place from December 9-12 in San Diego, California and virtually.

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"The 2023 ASH (Free ASH Whitepaper) abstracts present data and analyses from the IMerge Phase 3 clinical trial that reinforce the differentiated clinical profile of imetelstat in lower risk MDS, and specifically highlight that patients achieve TI irrespective of risk status based on classification systems, or specific poor prognostic mutation profiles. Of particular importance, the nearly 20% of imetelstat-treated patients who achieved one year or greater transfusion independence with accompanying hemoglobin rises of 5 g/dl and reduction of MDS-associated mutations speak to the potential of this novel therapy to provide clinical benefits to patients that have not been observed before in transfusion-dependent lower risk MDS," said Faye Feller, M.D., Geron’s Executive Vice President, Chief Medical Officer.

Imetelstat is currently under regulatory review by the U.S. Food and Drug Administration (FDA) and by the European Medicines Agency (EMA) for the treatment of transfusion dependent anemia in adult patients with lower risk MDS who have failed to respond or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESAs).

"The data from IMerge Phase 3 being presented at the ASH (Free ASH Whitepaper) annual meeting provides important insight into the breadth of effect of TI achieved with imetelstat across different risk subgroups and across the various underlying mutations associated with MDS, suggesting a broad use for imetelstat in patients eligible for the study, including in difficult-to-treat subgroups. Imetelstat also demonstrated efficacy among patients who were reclassified as higher risk using molecular international prognostic scoring system (IPSS-M)," said Rami S. Komrokji, M.D., Vice Chair, Malignant Hematology Department, Moffitt Cancer Center, one of the principal investigators of IMerge Phase 3 and ASH (Free ASH Whitepaper) presenter. "Additionally, our abstract showcasing a real-world data population level analysis of over 5,000 lower risk MDS patients adds to the significant literature suggesting a correlation between TI and improvement in survival. These data support the importance of TI to improve outcomes for patients with lower risk MDS."

Abstract #194: "Efficacy of Imetelstat in Achieving Red Blood Cell Transfusion Independence (RBC-TI) Across Different Risk Subgroups in Patients with Lower Risk Myelodysplastic Syndromes (LR MDS) Relapsed/Refractory (R/R) to Erythropoiesis Stimulating Agents (ESAs) in IMerge Phase 3 Study"

Oral Presentation on December 9, 2023, at 2:15 p.m. PT

This abstract evaluates TI rates in patients treated with imetelstat vs. placebo across different risk subgroups as defined by International Prognostic Scoring System (IPSS), revised IPSS (IPSS-R) or IPSS molecular (IPSS-M) risk profiles and shows that patients treated with imetelstat consistently had higher TI response rates than placebo regardless of risk classification. Further, in patients re-classified as high or very high risk using IPSS-M, TI response rates with imetelstat (and not placebo) were similar to TI response rates in lower risk subgroups. This analysis suggests imetelstat has clinical activity in lower risk MDS patients independent of risk categories.

Abstract #4603: "Impact of Mutational Status on Clinical Response to Imetelstat in Patients with Lower Risk Myelodysplastic Syndromes in the IMerge Phase 3 Study"

Poster Presentation on December 11, 2023, from 6-8 p.m. PT

This abstract evaluates the impact of MDS-associated mutations on clinical efficacy of imetelstat for the 165 of 178 patients for whom mutation data were available and shows that RBC-TI response rates in patients receiving imetelstat occurred regardless of the presence of baseline MDS associated mutations that have a poor prognosis (either specific mutations or multiple concurrent mutations). In patients with mutations associated with poor prognosis (TP53, ETV6, RUNX1, ASXL1, or EZH2), ≥8-week and ≥24-week, TI was observed in 31.8% and 9.1% of imetelstat-treated patients vs 0 on placebo. The 8-week TI rate for patients with 3 or more mutations was 55.6% with imetelstat compared to 14.3% with placebo. This analysis suggests clinical benefit of imetelstat across different molecularly defined subgroups and independent of the underlying molecular pattern.

Abstract #4605: "Durable Continuous Transfusion Independence (TI) With Imetelstat in IMerge Phase 3 for Patients with Heavily Transfused Non-Del(5q) Lower Risk Myelodysplastic Syndromes (LR MDS) Relapsed/Refractory (R/R) to or Ineligible for Erythropoiesis-Stimulating Agents (ESAs)"

Poster Presentation on December 11, 2023, from 6-8 p.m. PT

This abstract evaluates the 1-year TI responders in IMerge Phase 3, including 17.8% of imetelstat-treated patients (21/118; 95% CI, 11.4-25.9) and 1.7% of patients on placebo (1/60; 95% CI, 0-8.9). The median duration of TI for imetelstat ≥1-year TI responders was 123 weeks (95% CI, 80.4 to not evaluable); the median increase in hemoglobin during the longest TI interval was 5.18 g/dL (range, 2.67-13.76 g/dL) for the imetelstat group vs 1.67 g/dL for the placebo patient. Of the 18/21 imetelstat-treated 1-year TI responders for whom mutation data were available, 72.2% achieved ≥50% SF3B1 variant allele frequency (VAF) reduction, including 7 patients in whom there was complete elimination of MDS associated mutations. The abstract concludes that the long-term durable TI, robust increases in hemoglobin and meaningful reductions in mutational burden suggest imetelstat may have disease-modifying activity. Grade 3-4 thrombocytopenia and neutropenia occurred in 14 (67%) and 20 (95%) patients with ≥1-year TI, respectively, and the mean duration of grade 3/4 thrombocytopenia and neutropenia events was 2.25 and 1.78 weeks, respectively. 89% of grade 3/4 thrombocytopenia and 81% of grade 3/4 neutropenia was reduced to grade 1/2 within 4 weeks.

Abstract #2440: "Durable Transfusion Independence in Lower Risk Myelodysplastic Syndrome (LR MDS) Is Associated with Better Survival: A Population Level Analysis Based on a Large US Health Insurance Claims Database"

Poster Presentation on December 11, 2023, from 6-8 p.m. PT

This abstract describes a population level analysis of 5,662 lower risk MDS patients identified through Optum Clinformatics between October 2015 and June 2022. Among these patients, 35% and 49% were transfusion-dependent before first and second lines of therapy, respectively. The median overall survival from start of second line therapy was 23.4 months overall, and 37.9 months vs 9.3 months among responders becoming transfusion independent vs non-responders, respectively (P < .0001). Despite the currently available therapies, transfusion dependence after any line of therapy is associated with poorer outcomes. Achievement of durable TI was associated with improved survival, supporting the clinical benefit of achieving transfusion independence in lower risk MDS.

These abstracts are available on the ASH (Free ASH Whitepaper) 2023 Meeting website at View Source

About IMerge Phase 3

The Phase 3 portion of the IMerge Phase 2/3 study is a double-blind, 2:1 randomized, placebo-controlled clinical trial to evaluate imetelstat in patients with IPSS Low or Intermediate-1 risk (lower risk) transfusion dependent MDS who were relapsed after, refractory to, or ineligible for, erythropoiesis stimulating agent (ESA) treatment, had not received prior treatment with either a HMA or lenalidomide and were non-del(5q). To be eligible for IMerge Phase 3, patients were required to be transfusion dependent, defined as requiring at least four units of packed red blood cells (RBCs), over an eight-week period during the 16 weeks prior to entry into the trial. The primary efficacy endpoint of IMerge Phase 3 is the rate of red blood cell transfusion independence (RBC-TI) lasting at least eight weeks, defined as the proportion of patients without any RBC transfusion for at least eight consecutive weeks since entry to the trial (8-week TI). Key secondary endpoints include the rate of RBC-TI lasting at least 24 weeks (24-week TI), the duration of TI and the rate of hematologic improvement erythroid (HI-E), which is defined under 2006 IWG criteria as a rise in hemoglobin of at least 1.5 g/dL above the pretreatment level for at least eight weeks or a reduction of at least four units of RBC transfusions over eight weeks compared with the prior RBC transfusion burden. A total of 178 patients were enrolled in IMerge Phase 3 across North America, Europe, Middle East and Asia.

About Imetelstat

Imetelstat is a novel, first-in-class investigational telomerase inhibitor exclusively owned by Geron and being developed in hematologic malignancies. Data from non-clinical studies and clinical trials of imetelstat provide strong evidence that imetelstat targets telomerase to inhibit the uncontrolled proliferation of malignant stem and progenitor cells in myeloid hematologic malignancies resulting in malignant cell apoptosis and potential disease-modifying activity. Imetelstat has been granted Fast Track designation by the U.S. Food and Drug Administration for both the treatment of adult patients with transfusion dependent anemia due to Low or Intermediate-1 risk MDS that is not associated with del(5q) who are refractory or resistant to an erythropoiesis stimulating agent, and for adult patients with Intermediate-2 or High-risk myelofibrosis (MF) whose disease has relapsed after or is refractory to Janus associated kinase (JAK) inhibitor treatment. Imetelstat is currently not approved by any regulatory authority.

On November 2, 2023 Genmab A/S (Nasdaq: GMAB) reported that multiple abstracts evaluating epcoritamab (DuoBody-CD3xCD20), a T-cell engaging bispecific antibody administered subcutaneously, across a variety of treatment settings and hematologic malignancies have been accepted for presentation and publication at the 65thAnnual Meeting and Exposition of the American Society of Hematology (ASH) (Free ASH Whitepaper), being held in San Diego, California, and virtually, December 9-12 (Press release, Genmab, NOV 2, 2023, View Source [SID1234636760]). The presentations will include two oral and 11 poster presentations highlighting data from several trials evaluating the safety and efficacy of epcoritamab as a monotherapy or in combination for the treatment of patients with various lymphoma subtypes, across lines of therapy including relapsed/refractory (R/R) and newly diagnosed patients.

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Additionally, results from a phase 1/2 trial evaluating GEN3014 (HexaBody-CD38), an investigational novel human CD38 monoclonal antibody, in patients with R/R multiple myeloma (MM), will be presented.

All abstracts accepted for presentation have been published on the ASH (Free ASH Whitepaper) website.

"The breadth and depth of data accepted for presentation at this year’s American Society of Hematology (ASH) (Free ASH Whitepaper) meeting underline our dedication to comprehensive evaluation of our investigational medicines and reinforce our joint commitment with AbbVie to develop epcoritamab as a potential core therapy for B-cell malignancies," said Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer of Genmab.

2023 R&D Update and ASH (Free ASH Whitepaper) Data Review
On Tuesday, December 12, at 11:00 AM EST (5:00 PM CET/4:00 PM GMT), Genmab will host its 2023 R&D Update and ASH (Free ASH Whitepaper) Data Review. The event will be virtual and webcast live. Details, including the webcast link and registration will be available on www.genmab.com. This meeting is not an official program of the ASH (Free ASH Whitepaper) Annual Meeting.

Abstracts accepted for presentation at ASH (Free ASH Whitepaper):

Epcoritamab (DuoBody-CD3xCD20)

Abstract Number Abstract Title Type of Presentation Date/Time of Presentation
438 Subcutaneous Epcoritamab Plus Lenalidomide in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma from EPCORE NHL-5. Avivi, I et al. Oral Sunday, December 10,
9:30 – 11:00 AM PT
1655 Epcoritamab SC Monotherapy Drives Deep and Durable Responses in Patients with Relapsed or Refractory Follicular Lymphoma: Results from the EPCORE NHL-1 Dose Expansion Cohort. Linton KM et al. Poster Saturday, December 9, 5:30 – 7:30 PM PT
1729 CRS Mitigation Strategies: Preliminary Results from the DLBCL Optimization Arm A Cohort of EPCORE NHL-1. Vose J et al. Poster Saturday, December 9, 5:30 – 7:30 PM PT
3053 EPCORE FL-1: Phase 3 Trial of Subcutaneous Epcoritamab With Rituximab and Lenalidomide (R2) vs R2 Alone in Patients With Relapsed or Refractory Follicular Lymphoma. Falchi L et al. Poster Sunday, December 10, 6:00 – 8:00 PM PT
3092 Epcoritamab SC + GemOx Leads to High Complete Metabolic Response Rates in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma Ineligible for Autologous Stem Cell Transplant: Updated Results from EPCORE NHL-2. Brody J, et al. Poster Sunday, December 10, 6:00 – 8:00 PM PT

3135 Identification of Optimal Dosing Regimen for Subcutaneous Epcoritamab in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma. Li, T et al. Poster Sunday, December 10, 6:00 – 8:00 PM PT
4481 Population Pharmacokinetics of Subcutaneous Epcoritamab in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma. Li, T et al. Poster Monday, December 11, 6:00 – 8:00 PM PT
4457 Subcutaneous Epcoritamab + R-mini-CHOP in Patients with Previously Untreated Diffuse Large B-Cell Lymphoma Ineligible for Full-Dose Anthracycline: Results from the EPCORE NHL-2 Phase 1/2 Trial. Vermaat JS et al. Poster Monday, December 11, 6:00 – 8:00 PM PT

GEN3014 (HexaBody-CD38)

Abstract Number Abstract Title Type of Presentation Date/Time of Presentation
4757 GEN3014 (HexaBody-CD38) in Anti-CD38 mAb–Naive Patients with Relapsed/Refractory Multiple Myeloma: Preliminary Results from a Dose-Expansion Cohort of a Phase 1/2 Trial. Grosicki S, et al. Poster Monday, December 11, 6:00 – 8:00 PM PT
Outcomes Research

Abstract Number Abstract Title Type of Presentation Date/Time of Presentation
309 Effectiveness of Chemo-Immunotherapy (CIT) and Novel Therapies in Second or Later Line of Therapy (2L+) for Patients with Relapsed/Refractory (R/R) Aggressive Large B-cell Lymphoma (LBCL). Nastoupil L et al. Oral Saturday, December 9, 4:00 – 5:30 PM PT
1683 Real-World Response Rates Across Lines of Therapy Among Patients With Relapsed/Refractory Follicular Lymphoma. Philips T et al. Poster Saturday, December 9, 5:30 – 7:30 PM PT
1733 Efficacy of Subcutaneous Epcoritamab vs Tisa-cel in R/R LBCL CAR T-naive and CAR T-eligible Patients: An Indirect Comparison. Salles G et al. Poster Saturday, December 9, 5:30 – 7:30 PM PT
5089 Cost-Effectiveness of Epcoritamab in Relapsed or Refractory Diffuse Large B-Cell Lymphoma After At Least Two Lines of Therapy in The United States. Qu et al. Poster Monday, December 11, 6:00 – 8:00 PM PT
5158 Patterns of Care and Resource Use Among Elderly Relapsed/Refractory Follicular Lymphoma Patients: US Medicare Claims Analysis. Chawla SB, et al. Poster Monday, December 11, 6:00 – 8:00 PM PT
NA Practice Efficiency Associated with Epcoritamab for The Treatment of Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma from an Institutional Perspective. Lei M et al. Publication N/A
NA Estimating the Number of Relapsed/Refractory Follicular Lymphoma Patients on Therapy in the United States. Johnston K et al. Publication N/A
Discovery Research

Abstract Number Abstract Title Type of Presentation Date/Time of Presentation
NA Assessment of ultra-deep DIA mass spectrometry-based proteomics compared to flow cytometry and RNA-based methods for the discovery and validation of therapeutic targets in immune cells; Wah Au et al. Publication N/A
NA Unbiased Subtyping of AML: Unraveling Genomic and Transcriptomic Features for Precision Medicine and Targeted Therapies using Beat-AML and TCGA Data; Karagoz et al Publication N/A
The safety and efficacy of epcoritamab has not been established for these investigational uses. The safety and efficacy of HexaBody-CD38 has not been established.

About Large B-cell Lymphoma (LBCL)
LBCL is a fast-growing type of non-Hodgkin’s lymphoma (NHL), a cancer that develops in the lymphatic system and affects B-cell lymphocytes, a type of white blood cell. There are an estimated 150,000 new LBCL cases each year globally.1,2 There are several subtypes of LBCL, including diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B).

About Diffuse Large B-cell Lymphoma (DLBCL)
DLBCL is the most common type of NHL worldwide, accounting for approximately 30 percent of all NHL cases and comprising an estimated 30,400 U.S. cases in 2022. DLBCL can arise in lymph nodes as well as in organs outside of the lymphatic system, occurs more commonly in the elderly and is slightly more prevalent in men.1,3 DLBCL is a fast-growing type of NHL, a cancer that develops in the lymphatic system and affects B-cell lymphocytes, a type of white blood cell. For many people living with DLBCL, their cancer either relapses, which means it may return after treatment, or becomes refractory, meaning it does not respond to treatment. Although new therapies have become available, treatment management can remain a challenge.1,4

About Follicular Lymphoma (FL)
FL is typically an indolent (or slow growing) form of NHL that arises from B-lymphocytes.5 FL is the second most common form of NHL overall, accounting for 20-30 percent of all NHL cases, and represents 10-20 percent of all lymphomas in the western world.6,7 Although FL is an indolent lymphoma, it is considered incurable with conventional therapy.8,9

About Epcoritamab
Epcoritamab (approved as EPKINLY) is an IgG1-bispecific antibody created using Genmab’s proprietary DuoBody technology and administered subcutaneously. Genmab’s DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response towards target cell types. EPKINLY is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T-cell mediated killing of CD20+ cells.10

EPKINLY (also known as TEPKINLY in certain countries) has received regulatory approval in various indications and conditions in the U.S., Japan, the European Union, the United Kingdom and Canada. In the U.S., epcoritamab was added to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines) as a treatment option for diffuse large B-cell lymphoma (DLBCL).

Genmab and AbbVie continue to evaluate the use of epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. This includes three ongoing phase 3, open-label, randomized trials including a trial evaluating epcoritamab as a monotherapy in patients with R/R DLBCL (NCT: 04628494) compared to investigators choice chemotherapy, a phase 3 trial evaluating epcoritamab in combination with R-CHOP in adult participants with newly diagnosed DLBCL (NCT: 05578976), and a phase 3, open-label clinical trial evaluating epcoritamab in combination with rituximab and lenalidomide in patients with R/R FL (NCT: 05409066). Epcoritamab is not approved to treat newly diagnosed patients with DLBCL or FL. The safety and efficacy of epcoritamab has not been established for these investigational uses. Please visit clinicaltrials.gov for more information.

EPKINLY (epcoritamab-bysp) U.S. IMPORTANT SAFETY INFORMATION

Important Warnings—EPKINLY can cause serious side effects, including:

Cytokine release syndrome (CRS), which is common during treatment with EPKINLY and can be serious or life-threatening. To help reduce your risk of CRS, you may receive other medicines before receiving EPKINLY and you will also be given smaller doses of EPKINLY for the first 2 doses (called "step-up" dosing). Your first full dose of EPKINLY will be given on day 15 of your first cycle of treatment and you should be hospitalized for 24 hours after due to risk of CRS and neurologic problems. If your dose of EPKINLY is delayed for any reason, you may need to repeat the step-up dosing schedule.
Neurologic problems that can be life-threatening and lead to death. Neurologic problems may happen days or weeks after you receive EPKINLY.
Tell your healthcare provider or get medical help right away if you develop a fever of 100.4°F (38°C) or higher; dizziness or lightheadedness; trouble breathing; chills; fast heartbeat; feeling anxious; headache; confusion; shaking (tremors); problems with balance and movement, such as trouble walking; trouble speaking or writing; confusion and disorientation; drowsiness, tiredness or lack of energy; muscle weakness; seizures; or memory loss. These may be symptoms of CRS or neurologic problems. Do not drive or use heavy machinery or do other dangerous activities if you have any symptoms that impair consciousness until your symptoms go away.

EPKINLY can cause other serious side effects, including:

Infections that may lead to death. Tell your healthcare provider right away if you develop any symptoms of infection during treatment, including fever of 100.4°F (38°C) or higher, cough, chest pain, tiredness, shortness of breath, painful rash, sore throat, pain during urination, or feeling weak or generally unwell.
Low blood cell counts are common during treatment with EPKINLY and can be serious or severe. Your healthcare provider will check your blood cell counts during treatment. EPKINLY may cause low blood cell counts, including low white blood cells (neutropenia), which can increase your risk for infection; low red blood cells (anemia), which can cause tiredness and shortness of breath; and low platelets (thrombocytopenia), which can cause bruising or bleeding problems.
Your healthcare provider will monitor you for symptoms of CRS, neurologic problems, infections, and low blood cell counts during treatment with EPKINLY. Your healthcare provider may temporarily stop or completely stop treatment with EPKINLY if you develop certain side effects.

Before you receive EPKINLY, tell your healthcare provider about all your medical conditions, including if you have an infection, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. If you receive EPKINLY while pregnant, it may harm your unborn baby. If you are a female who can become pregnant, your healthcare provider should do a pregnancy test before you start treatment with EPKINLY and you should use effective birth control (contraception) during treatment and for 4 months after your last dose of EPKINLY. Tell your healthcare provider if you become pregnant or think that you may be pregnant during treatment with EPKINLY. Do not breastfeed during treatment with EPKINLY and for 4 months after your last dose of EPKINLY.

The most common side effects of EPKINLY include CRS, tiredness, muscle and bone pain, injection site reactions, fever, stomach-area (abdominal) pain, nausea, and diarrhea. These are not all the possible side effects of EPKINLY. Call your doctor for medical advice about side effects.

You are encouraged to report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch or to Genmab US, Inc. at 1-855-4GENMAB (1-855-443-6622).

Please see Medication Guide, including Important Warnings.

On November 2, 2023 Foghorn Therapeutics Inc. (Nasdaq: FHTX), a clinical-stage biotechnology company pioneering a new class of medicines that treat serious diseases by correcting abnormal gene expression, reported a financial and corporate update in conjunction with the Company’s 10-Q filing for the quarter ended September 30, 2023 (Press release, Foghorn Therapeutics, NOV 2, 2023, View Source [SID1234636759]). With an initial focus in oncology, Foghorn’s Gene Traffic Control Platform and resulting broad pipeline have the potential to transform the lives of people suffering from a wide spectrum of diseases.

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"During the third quarter, we continued to enroll patients in our FHD-286 combination study in AML and expect to have data in the second half of 2024. Based on the mutation agnostic differentiation effect observed in our single-agent escalation study, we believe FHD-286 has the potential to be a first-in-class broad-based differentiation therapeutic in AML," said Adrian Gottschalk, President and Chief Executive Officer of Foghorn. "We also made important progress with our Loxo@Lilly collaboration transitioning the BRM Selective inhibitor program to them."

Key Recent Updates and Upcoming Milestones

•FHD-286. FHD-286 is a potent, selective inhibitor of the BRG1 and BRM subunits of the BAF chromatin remodeling complex where dependency on BRG1/BRM is well-established preclinically with multiple tumor types, including acute myelogenous leukemia (AML)/myelodysplastic syndrome (MDS), non–small cell lung cancer (NSCLC) and prostate cancer.
◦AML Update. Foghorn commenced a Phase 1 study of FHD-286 in combination with decitabine or low-dose cytarabine (LDAC) in relapsed and/or refractory AML patients, with the first patient dosed during the third quarter of 2023. Data are expected in the second half of 2024.

•Differentiated Pipeline Advancement. Foghorn continues to expand its platform and pipeline. The Company anticipates the potential for six new investigational new drug (IND) applications in the next four years. The Company continues to progress programs for multiple targets that include chromatin remodeling complexes, transcription factors, helicases and other chromatin-related factors. These targets include Selective BRM* and wholly owned programs including CBP, EP300, and ARID1B, as well as other undisclosed targets, which combined could address more than 20 tumor types impacting more than 500,000 new patients annually.
◦Selective EP300 and Selective CBP programs. Foghorn presented new preclinical data for its EP300 and CBP selective degrader programs at Hanson Wade’s 6th Annual Targeted Protein Degradation Summit on October 31st.
•EP300 selective degraders showed potent cellular antiproliferation and in vivo tumor growth inhibition in an AR+ enzalutamide prostate in vivo model.
•CBP selective degraders demonstrated significant tumor growth inhibition in a colorectal cancer in vivo model. Antiproliferative effects were also observed for numerous cancer cell lines, including colorectal, gastric and bladder cancers.
•At preclinical efficacious doses, neither the EP300 nor the CBP selective degraders caused thrombocytopenia, commonly observed safety liability for dual CBP/EP300 inhibitors.

•Loxo@Lilly Collaboration. Foghorn continues to progress its strategic collaboration with Loxo@Lilly.
◦During Q3 2023, the Company transitioned the BRM Selective inhibitor program to Loxo@Lilly.

*In December 2021, Foghorn announced a strategic collaboration with Loxo@Lilly to create novel oncology medicines. The collaboration includes a co-development and co-commercialization agreement for Foghorn’s Selective BRM oncology program and an additional undisclosed oncology target. In addition, the collaboration includes three discovery programs using Foghorn’s proprietary Gene Traffic Control platform.

Third Quarter 2023 Financial Highlights

•Strong Balance Sheet and Cash Runway. As of September 30, 2023, the Company had $259.9 million in cash, cash equivalents and marketable securities, which provides cash runway into the first half of 2026.

•Collaboration Revenues. Collaboration revenue was $17.5 million for the three months ended September 30, 2023, compared to $6.6 million for the three months ended September 30, 2022. The increase year-over-year was primarily driven by revenue realized upon termination of the Merck collaboration.

•Research and Development Expenses. Research and development expenses were $26.3 million for the three months ended September 30, 2023, compared to $26.9 million for the three months ended September 30, 2022. This decrease was primarily due to costs associated with continued investment in R&D personnel and platform and early-stage research investments, modestly offset by a decline in clinical trial spend.

•General and Administrative Expenses. General and administrative expenses were $8.3 million for the three months ended September 30, 2023, compared to $8.0 million for the three months ended September 30, 2022. This increase was primarily due to an increase in investments to support the growing business which included increases in personnel-related costs and stock-based compensation expense.

•Net Loss. Net loss was $14.3 million for the three months ended September 30, 2023, compared to a net loss of $25.8 million for the three months ended September 30, 2022.

About FHD-286
FHD-286 is a highly potent, selective, allosteric, and orally available small-molecule, enzymatic inhibitor of BRG1 (SMARCA4) and BRM (SMARCA2), two highly similar proteins that are the ATPases, or the catalytic engines, of the BAF complex, one of the key regulators within the chromatin regulatory system. In pre-clinical studies, FHD-286 has shown anti-tumor activity across a broad range of malignancies including both hematologic and solid tumors.

About AML
Adult acute myeloid leukemia (AML) is a cancer of the blood and bone marrow and the most common type of acute leukemia in adults. AML is a diverse disease associated with multiple genetic mutations. It is diagnosed in about 20,000 people every year in the United States.

On November 2, 2023 Eli Lilly and Company (NYSE: LLY) reported its financial results for the third quarter of 2023 (Press release, Eli Lilly, NOV 2, 2023, View Source [SID1234636758]).

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"Lilly had another strong quarter in Q3 as Mounjaro and Verzenio continued to gain momentum," said David A. Ricks, Lilly’s chair and CEO. "Lilly executed on business development priorities in the third quarter, including multiple acquisitions that expand our already robust pipeline. We remain focused on growth and delivering new, innovative medicines that make life better for millions of patients around the globe."

Lilly has had numerous updates recently on key regulatory, clinical, business development and other events, including:

The U.S. Food and Drug Administration (FDA) approval of Omvoh (mirikizumab) for the treatment of adults with moderately to severely active ulcerative colitis;
FDA approval of Jardiance for the treatment of adults with chronic kidney disease;
Positive Phase 3 VIVID-1 results, which evaluated the safety and efficacy of mirikizumab for the treatment of adults with moderately to severely active Crohn’s disease;
Positive Phase 3 LIBRETTO-531 results, which showed that Retevmo demonstrated superior progression-free survival compared to approved multikinase inhibitors in RET-mutant medullary thyroid cancer;
Updated timing of expected FDA action on donanemab for the treatment of early symptomatic Alzheimer’s disease to Q1 2024;
The FDA’s issuance of a complete response letter for lebrikizumab for the treatment of moderate-to-severe atopic dermatitis based on inspection findings at a third-party manufacturer with no stated concerns about the clinical data package, safety or label;
Completion of the acquisitions of DICE Therapeutics, Inc., Versanis Bio, Inc., Emergence Therapeutics AG and Sigilon Therapeutics, Inc.;
The announcement of an agreement to acquire POINT Biopharma Global Inc. to expand oncology capabilities into radioligand therapies; and
The announcement of changes to the company’s executive leadership team.
For information on important public announcements, visit the news section of Lilly’s website.

Financial Results

$ in millions, except

per share data

Third Quarter

2023

2022

% Change

Revenue

$9,498.6

$6,941.6

37 %

Net income (loss) – Reported

(57.4)

1,451.7

NM

Earnings (loss) per share – Reported

(0.06)

1.61

NM

Net income – Non-GAAP

94.8

1,789.2

(95) %

Earnings per share – Non-GAAP

0.10

1.98

(95) %

A discussion of the non-GAAP financial measures is included below under "Reconciliation of GAAP Reported to Selected Non-GAAP Adjusted Information (Unaudited)."

Third-Quarter Reported Results

In Q3 2023, worldwide revenue was $9.50 billion, an increase of 37% compared with Q3 2022, driven by increases of 31% in volume, 6% due to higher realized prices, and 1% from the favorable impact of foreign exchange rates. The volume increase was primarily driven by $1.42 billion from the sale of rights for the olanzapine portfolio (Zyprexa), and volume growth from Verzenio, Mounjaro, Jardiance, Taltz and Trulicity, partially offset by the absence of COVID-19 antibodies revenue in 2023. Excluding revenue from the olanzapine portfolio and the $386.6 million of COVID-19 antibodies sales in 2022, revenue in Q3 2023 increased 24%. New Products contributed $1.44 billion to revenue in Q3 2023. Growth Products revenue increased 12% to $4.96 billion in Q3 2023. Higher realized prices were primarily driven by Mounjaro savings card dynamics, partially offset by Trulicity.

Revenue in the U.S. increased 21% to $5.37 billion, driven by a 13% increase in realized prices and a 9% increase in volume. The higher realized prices in the U.S. were driven by Mounjaro savings card dynamics, partially offset by lower realized prices for Trulicity. When excluding Mounjaro, U.S. price declined high-single digits for the quarter. The increase in U.S. volume was driven by Mounjaro, Verzenio, Trulicity, Jardiance and Taltz, partially offset by the absence of revenue from COVID-19 antibodies in 2023. Excluding revenue from the olanzapine portfolio and COVID-19 antibodies, U.S. revenue increased 32%.

Revenue outside the U.S. increased 64% to $4.13 billion, driven by a 69% increase in volume and a 2% increase from the favorable impact of foreign exchange rates, partially offset by a 7% decrease due to lower realized prices. The increase in volume outside the U.S. was largely driven by the sale of rights for the olanzapine portfolio, as well as increased volume for Verzenio, Jardiance and Taltz. The lower realized prices were primarily driven by a new supply arrangement associated with the sale of rights for the olanzapine portfolio. Excluding revenue from the olanzapine portfolio, revenue outside the U.S. increased 10%.

Gross margin increased 42% to $7.64 billion in Q3 2023. Gross margin as a percent of revenue was 80.4%, an increase of 3.1 percentage points. The increase in gross margin percent was primarily driven by the sale of rights for the olanzapine portfolio and the absence of COVID-19 antibodies sales in Q3 2023, as well as higher realized prices, partially offset by increased manufacturing expenses related to labor costs and investments in capacity expansion.

In Q3 2023, research and development expenses increased 34% to $2.41 billion, or 25% of revenue, primarily driven by higher development expenses for late-stage assets and additional investments in early-stage research.

Marketing, selling and administrative expenses increased 12% to $1.80 billion in Q3 2023, primarily driven by costs associated with launches of new products and indications, as well as compensation and benefits costs.

In Q3 2023, the company recognized acquired in-process research and development (IPR&D) charges of $2.98 billion, compared with $62.4 million in Q3 2022. The Q3 2023 charges primarily related to the acquisitions of DICE Therapeutics, Inc., Versanis Bio, Inc. and Emergence Therapeutics AG.

There were no asset impairment, restructuring and other special charges recognized in Q3 2023. In Q3 2022, the company recognized asset impairment, restructuring and other special charges of $206.5 million.

Other income (expense) was $23.2 million of expense in Q3 2023 compared with $111.0 million of expense in Q3 2022. The decrease in expense was primarily driven by lower net losses on investments in equity securities in Q3 2023 compared with Q3 2022.

The effective tax rate was 113.4% in Q3 2023 compared with 7.3% in Q3 2022. The higher effective tax rate for Q3 2023 was primarily driven by the non-deductible acquired IPR&D charges.

In Q3 2023, net income (loss) and earnings (loss) per share were $(57.4) million and $(0.06), respectively, compared with net income of $1.45 billion and earnings per share (EPS) of $1.61 in Q3 2022. EPS in Q3 2023 was inclusive of an increase of $1.22 of EPS associated with the sale of rights for the olanzapine portfolio, as well as a decrease of $3.29 from acquired IPR&D charges, compared with a decrease of $0.06 from acquired IPR&D charges in Q3 2022.

Third-Quarter Non-GAAP Measures

On a non-GAAP basis, Q3 2023 gross margin increased 41% to $7.76 billion. Gross margin as a percent of revenue was 81.7%, an increase of 2.7 percentage points. The increase in gross margin percent was primarily driven by the sale of rights for the olanzapine portfolio and the absence of COVID-19 antibodies sales in Q3 2023, as well as higher realized prices, partially offset by increased manufacturing expenses related to labor costs and investments in capacity expansion.

The effective tax rate on a non-GAAP basis was 84.6% in Q3 2023 compared with 10.7% in Q3 2022. The higher effective tax rate for Q3 2023 reflected the non-deductible acquired IPR&D charges.

On a non-GAAP basis, Q3 2023 net income and EPS were $94.8 million and $0.10, respectively, compared with $1.79 billion and $1.98 in Q3 2022. Non-GAAP EPS in Q3 2023 was inclusive of an increase of $1.22 of EPS associated with the sale of rights for the olanzapine portfolio, as well as a decrease of $3.29 from acquired IPR&D charges, compared with a decrease of $0.06 from acquired IPR&D charges in Q3 2022.

For further detail on non-GAAP measures, see the reconciliation below as well as the "Reconciliation of GAAP Reported to Selected Non-GAAP Adjusted Information (Unaudited)" table later in this press release.

Third Quarter

2023

2022

% Change

Earnings (loss) per share (reported)

$(0.06)

$1.61

NM

Asset impairment, restructuring and other
special charges

—

.17

Amortization of intangible assets

.11

.11

Net losses on investments in equity securities

.06

.09

Earnings per share (non-GAAP)

$0.10

$1.98

(95) %

Numbers may not add due to rounding.

Acquired IPR&D

3.29

.06

NM

Selected Revenue Highlights

(Dollars in millions)

Third Quarter

Year-to-Date

Selected Products

2023

2022

% Change

2023

2022

% Change

Trulicity

$1,673.6

$1,850.4

(10) %

$5,463.2

$5,503.5

(1) %

Mounjaro

1,409.3

187.3

NM

2,957.5

203.2

NM

Verzenio

1,040.2

617.7

68 %

2,717.9

1,675.6

62 %

Taltz

744.2

679.9

9 %

1,975.0

1,774.2

11 %

Jardiance(a)

700.8

573.3

22 %

1,946.6

1,453.7

34 %

Humalog(b)

395.4

447.0

(12) %

1,296.8

1,512.3

(14) %

Cyramza

224.1

232.1

(3) %

721.1

693.6

4 %

Olumiant(c)

231.4

182.9

27 %

679.2

624.7

9 %

Emgality

168.5

168.5

0 %

492.2

475.2

4 %

Tyvyt

115.1

76.8

50 %

279.7

235.8

19 %

Retevmo

63.4

40.5

56 %

180.2

127.3

42 %

Alimta

53.5

119.4

(55) %

172.6

691.1

(75) %

COVID-19 antibodies(d)

—

386.6

(100) %

—

1,985.5

(100) %

Total Revenue

9,498.6

6,941.6

37 %

24,770.7

21,239.6

17 %

(a) Jardiance includes Glyxambi, Synjardy and Trijardy XR

(b) Humalog includes Insulin Lispro

(c) Olumiant includes sales of baricitinib that were made pursuant to Emergency Use Authorization (EUA) or similar
regulatory authorizations

(d) COVID-19 antibodies include sales for bamlanivimab administered alone, for bamlanivimab and etesevimab
administered together, and for bebtelovimab, and were made pursuant to EUAs or similar regulatory authorizations

NM – not meaningful

Trulicity

For Q3 2023, worldwide Trulicity revenue decreased 10% compared with Q3 2022 to $1.67 billion. U.S. revenue decreased 11% to $1.26 billion, primarily driven by changes to estimates for rebates and discounts in both periods, as well as unfavorable segment mix and higher contracted rebates, partially offset by wholesaler buying patterns and increased demand. Revenue outside the U.S. decreased 4% to $414.6 million, driven by lower realized prices and decreased volume, partially offset by the favorable impact of foreign exchange rates. Volumes in international markets were affected by actions Lilly has taken to manage strong demand amid tight supply, including measures to minimize impact to existing patients.

Mounjaro

For Q3 2023, worldwide Mounjaro revenue was $1.41 billion. U.S. revenue was $1.28 billion reflecting higher realized prices due to decreased utilization of savings card programs as access continues to expand and increased demand. In Q3 2023, Lilly experienced intermittent delays fulfilling orders of certain Mounjaro doses given significant demand, which affected volume. Revenue outside the U.S. was $132.4 million.

Verzenio

For Q3 2023, worldwide Verzenio revenue increased 68% compared with Q3 2022 to $1.04 billion. U.S. revenue was $684.6 million, an increase of 65%, driven by increased demand and, to a lesser extent, higher realized prices. Revenue outside the U.S. was $355.7 million, an increase of 75%, driven by increased demand, partially offset by lower realized prices.

Taltz

For Q3 2023, worldwide Taltz revenue increased 9% compared with Q3 2022 to $744.2 million. U.S. revenue increased 3% to $509.3 million, driven by increased demand, largely offset by lower realized prices. Revenue outside the U.S. increased 26% to $234.9 million, driven by increased volume and, to a lesser extent, the favorable impact of foreign exchange rates, partially offset by lower realized prices.

Jardiance

For Q3 2023, worldwide Jardiance revenue increased 22% compared with Q3 2022 to $700.8 million. U.S. revenue was $415.9 million, an increase of 19%, primarily driven by increased demand. Revenue outside the U.S. was $284.8 million, an increase of 28%, driven by increased volume and, to a lesser extent, the favorable impact of foreign exchange rates.

Jardiance is part of the company’s alliance with Boehringer Ingelheim. Lilly reports as revenue royalties received on net sales of Jardiance.

Humalog

For Q3 2023, worldwide Humalog revenue decreased 12% compared with Q3 2022 to $395.4 million. U.S. revenue was $194.2 million, a decrease of 22%, driven by lower realized prices. Revenue outside the U.S. was $201.2 million, an increase of 1%.

Olumiant

For Q3 2023, worldwide Olumiant revenue increased 27% compared with Q3 2022 to $231.4 million. U.S. revenue increased to $65.7 million, driven by increased demand due to utilization for the treatment of alopecia areata, partially offset by lower realized prices. Revenue outside the U.S. was $165.7 million, an increase of 4%, driven by increased volume, partially offset by lower realized prices.

Emgality

For Q3 2023, worldwide Emgality revenue remained flat compared with Q3 2022 at $168.5 million. U.S. revenue increased 11% to $126.5 million, driven by increased demand, partially offset by lower realized prices. Revenue outside the U.S. decreased 23% to $42.1 million, driven by decreased volume resulting from customer buying patterns in Japan and lower realized prices.

2023 Financial Guidance

The company updated certain elements of its 2023 financial guidance on both a reported and non-GAAP basis.

Revenue guidance remains unchanged with the range of $33.4 to $33.9 billion.

Gross margin as a percent of revenue remains unchanged at approximately 78% on a reported basis and 80% on a non-GAAP basis, but is trending toward the higher end of this estimate.

Marketing, selling and administrative expenses guidance remains unchanged with the range of $7.2 to $7.4 billion, and research and development expenses guidance also remains unchanged with the range of $8.9 to $9.1 billion. Both expense categories are trending toward the top ends of these ranges.

Acquired IPR&D guidance increased by $2.98 billion to $3.18 billion, reflecting charges incurred through Q3 2023. Charges in Q3 2023 primarily related to the acquisitions of DICE Therapeutics, Inc., Versanis Bio, Inc. and Emergence Therapeutics AG.

Other income (expense) guidance has been updated to the range of $150 to $50 million of expense on a reported basis and remains unchanged on a non-GAAP basis with the range of $0 to $100 million of income. The update to the reported guidance reflects net losses on investments in equity securities incurred through Q3 2023.

The estimated effective tax rate increased to 19% to 20%, primarily driven by the non-deductible acquired IPR&D charges incurred in Q3 2023.

Based on these changes, EPS guidance decreased to the range of $5.95 to $6.15 on a reported basis and $6.50 to $6.70 on a non-GAAP basis. The company’s 2023 financial guidance reflects adjustments shown in the reconciliation table below.

2023

Expectations

Earnings per share (reported)

$5.95 to $6.15

Amortization of intangible assets

.44

Net losses on investments in equity securities

.12

Earnings per share (non-GAAP)

$6.50 to $6.70

Numbers may not add due to rounding

The following table summarizes the company’s updated 2023 financial guidance:

2023 Guidance(1)

Prior

Updated

Revenue

$33.4 to $33.9 billion

Unchanged

Gross Margin % of Revenue (reported)

Approx. 78%

Unchanged

Gross Margin % of Revenue (non-GAAP)

Approx. 80%

Unchanged

Marketing, Selling & Administrative

$7.2 to $7.4 billion

Unchanged

Research & Development

$8.9 to $9.1 billion

Unchanged

Acquired IPR&D

$202 million

$3.18 billion(2)

Other Income/(Expense) (reported)

$(75) to $25 million

$(150) to $(50) million

Other Income/(Expense) (non-GAAP)

$0 to $100 million

Unchanged

Tax Rate

14% to 15%

19% to 20%

Earnings per Share (reported)

$9.20 to $9.40

$5.95 to $6.15

Earnings per Share (non-GAAP)

$9.70 to $9.90

$6.50 to $6.70

(1) Non-GAAP guidance reflects adjustments presented in the earnings per share reconciliation table above.

(2) Guidance does not include acquired IPR&D either incurred, or that may potentially be incurred, after Q3 2023.

Webcast of Conference Call

As previously announced, investors and the general public can access a live webcast of the Q3 2023 financial results conference call through a link on Lilly’s website at investor.lilly.com/webcasts-and-presentations. The conference call will begin at 9 a.m. Eastern time today and will be available for replay via the website.