Eli Lilly Posts Strong Q4 Growth, Plans to Continue Trajectory in 2020

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During the final quarter of the year, Eli Lilly saw several regulatory wins, including the approval of Trijardy XR (empagliflozin/linagliptin/metformin hydrochloride extended release tablets) to lower blood sugar in adults with type 2 diabetes. The U.S. Food and Drug Administration also granted priority review for the New Drug Application for selpercatinib for the treatment of patients with advanced RET fusion-positive non-small cell lung cancer (NSCLC), RET-mutant medullary thyroid cancer, and RET fusion-positive thyroid cancer.

In its clinical development programs, Eli Lilly also saw some important results. This morning, the company and its development partner Incyte announced that baricitinib met the primary endpoint in two Phase III studies for atopic dermatitis. Lilly recently submitted baricitinib for regulatory review in Europe as a treatment for patients with moderate to severe atopic dermatitis and plans to submit for approval in the U.S. and Japan in 2020, the company said. Eli Lilly and Boehringer Ingelheim announced results from two Phase III clinical trials related to functional endpoints with Jardiance in adults with chronic heart failure with reduced and preserved ejection fraction. In both trials, there was no significant change from baseline to week 12 in exercise ability with Jardiance versus placebo, as measured by the six-minute walk test which was the primary endpoint of the studies.

Also during the fourth quarter, Eli Lilly struck a deal to acquire California-based Dermira, Inc. in an all-cash deal for $1.1 billion. The acquisition will allow Eli Lilly to expand its immunology pipeline with a late-stage treatment for atopic dermatitis. When Lilly struck the deal, it was focused on two assets, lebrikizumab, a novel, investigational, monoclonal antibody designed to bind IL-13, which is believed to be a driver of signs and symptoms of atopic dermatitis. That therapy is currently in two Phase III trials for the treatment of moderate-to-severe atopic dermatitis in adolescent and adult patients, ages 12 years and older. The other asset is Qbrexza (glycopyrronium) cloth, a medicated cloth approved by the FDA for the topical treatment of primary axillary hyperhidrosis (uncontrolled excessive underarm sweating).

The company also announced plans to provide lower-cost options for some of its insulin products, including Humalog Mix75/25 KwikPen and Humalog Junior KwikPen. Both insulins will have 50 percent lower list prices compared to the branded versions and will be available by mid-April. These insulins are identical molecules to the branded versions and may be substituted at the pharmacy counter, Eli Lilly said in its announcement.

Also in the fourth quarter, Eli Lilly forged an agreement to integrate DexCom, Inc. products into Lilly’s personalized diabetes management system, currently in development to advance the treatment of diabetes. Lilly will use Dexcom’s continuous glucose monitoring devices in both the pen- and pump-based platforms of the system being designed to help improve diabetes management.