Eli Lilly Reports Q2 2019 Revenue of $5.64 Billion and Discontinues Two Bispecific Antibody Programs

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Eli Lilly recently released its Q2 2019 earnings report, with global total revenue reaching $5.637 billion, a 1% increase compared to the same period in 2018; GAAP net income and earnings per share were $1.327 billion and $1.44, respectively.

U.S. market revenue remained essentially flat at $3.253 billion, as a 5% volume growth was almost entirely offset by lower net realizations; in this market, the increased sales of key growth products (including Trulicity, Taltz, Jardiance, Verzenio, Basaglar, and Emgality) were largely offset by decreased sales of products that have lost exclusivity (including Cialis and Adcirca).

Outside the United States, revenue grew 2% to $2.384 billion, and volume increased 9%, primarily driven by higher sales of key growth products (including Trulicity, Olumiant, Taltz, Jardiance, and Verzenio); the volume growth was largely offset by unfavorable foreign exchange rates and lower real-world prices.

From a regulatory perspective, three products received U.S. FDA approval in Q2 2019, namely:

• Cyramza as monotherapy for the treatment of patients with hepatocellular carcinoma who have alpha-fetoprotein (AFP) ≥400 ng/mL and have previously been treated with sorafenib;

• Emgality for the treatment of adult patients with episodic cluster headache;

• Baqsimi 3 mg Nasal Powder for the Treatment of Severe Hypoglycemia in Patients with Diabetes Aged ≥4 Years

Notably, in the pipeline update section, Eli Lilly hasRemoval of a PD-L1/TIM-3 Bispecific Antibody from the Pipeline. The asset entered Phase I clinical studies for the treatment of advanced solid tumors late last year but was removed from the pipeline before final data were provided.

Based on evidence that the co-inhibitory molecule TIM-3 contributes to T-cell exhaustion in the tumor microenvironment, pharmaceutical companies such as Eli Lilly, Roche, Novartis, and Tesaro (a GSK oncology subsidiary) have successively advanced anti-TIM-3 therapies into clinical development. Since T-cell exhaustion limits tumor response to PD-(L)1 inhibitors, the role of TIM-3 offers new hope that targeting this pathway may help overcome primary and acquired resistance to checkpoint inhibitors.

This also prompted Eli Lilly to design a PD-L1/TIM-3 bispecific antibody, which began human testing last year. Eli Lilly and its partners discussed this trial at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting last month. However, weeks later, Eli Lilly decided to abandon this bispecific antibody and removed it from its pipeline in a recent R&D update.

This move appears to signal the end of the road for Eli Lilly’s PD-L1/TIM-3 bispecific molecule, although the company remains interested in the TIM-3 target. In 2017, Eli Lilly began testing a TIM-3 antibody drug, LY3321367, in humans; the development of this antibody preceded that of the aforementioned bispecific molecule. Currently, Eli Lilly is conducting a Phase I clinical trial to evaluate LY3321367 both as a monotherapy and in combination with a PD-L1 antibody.

Most pharmaceutical companies currently developing anti-TIM-3 agents in the clinic have adopted a combination development strategy similar to that of Eli Lilly. However, Roche is an exception; the company previously advanced a PD-1/TIM-3 bispecific therapy, RO7121661, into clinical development, with a timeline comparable to that of Eli Lilly’s now-discontinued bispecific molecule.

In pipeline updates, in addition to the PD-L1/TIM-3 bispecific molecule, Eli Lilly simultaneouslyExcluded another IL-23/CGRP bispecific antibody, this drug was developed for the treatment of autoimmune diseases, such as inflammatory bowel disease and psoriatic arthritis.

Reference Source:

1、Lilly drops PD-L1/TIM-3 bispecific from clinical pipeline

2、Lilly 2019Q2 Business Results