Eli Lilly expects both sales and drug development costs to rise next year as part of an ambitious annual plan it laid out Tuesday that foresees clinical progress and regulatory action for new drugs in obesity, diabetes, Alzheimer’s and autoimmune diseases.
The Indianapolis-based drugmaker forecasts 6% higher sales over 2022, as well as a 15% jump in R&D expenses. Gross profit as a percent of sales will tick higher, to 77% in 2023 as COVID-19 antibody revenue declines, Lilly said.
Per-share profits will see an increase of 18% to between $7.65 and $7.85, however.
Wall Street analysts said the expected research and development spending total was greater than they had forecast while per-share earnings were below expectations.
Lilly’s 2023 guidance outlines plans to advance five new drugs into late-stage clinical study and shepherd four into regulatory review, while two already approved diabetes drugs, Mounjaro and Jardiance, could gain expanded uses. Chief among the new drugs is the Alzheimer’s disease medicine donanemab, on which Lilly expects a Food and Drug Administration approval decision next year.
Depending on the FDA’s views on donanemab and Eisai and Biogen’s competitng drug lecanemab, there could be as many as three new drugs aimed at slowing cognitive decline in people with Alzheimer’s disease approved by the end of 2023.
Lilly’s major pipeline announcements show it’s planning a big challenge to its metabolic disease rival Novo Nordisk. Mounjaro, an injectable dual-acting glucose-lowering drug, gained approval in 2022 to take on the Danish company’s Ozempic, and Lilly expects regulatory review and action in 2023 on Mounjaro for weight management in obesity to take on Novo’s Wegovy and Saxenda.
Meanwhile, Lilly is also advancing into Phase 3 studies an oral glucose-lowering drug called orforglipron that would take on Novo’s Rybelsus. In Phase 2 studies, the experimental treatment lowered blood sugar by up to 2% and weight by up to 10% in diabetic people after 26 weeks, and in non-diabetic obesity patients the weight loss was up to 15% after 36 weeks.
The obesity data disclosed Tuesday suggests that the weight-loss benefit accumulates over time, Evercore ISI analyst Umer Raffat wrote in a note to clients. Lilly had previously released 12-week data showing the drug helped diabetic patients lose 6% of their body weight, which is a similar amount as the injectable drugs, Raffat wrote.
“If [Lilly] is successful in the development of its [orforglipron], we think the company could solidify its leadership in diabetes and chronic weight management,” Cantor Fitzgerald analyst Louise Chen wrote in a note to clients.
A second metabolic disease candidate, called retatrutide, is headed for Phase 3 study in chronic weight management. In Phase 2 study in people with obesity, retatrutide reduced weight by as much as 24% after 48 weeks.
Other regulatory approval decisions expected by Lilly are in autoimmune disease and cancer. In atopic dermatitis, lebrikizumab is facing review and could be on the market to take on Sanofi and Regeneron’s Dupixent and Leo Pharma’s Adbry, while in ulcerative colitis, approval of mirikizumab could allow Lilly to take on Johnson & Johnson’s Stelara.
In cancer, pirtobrutinib could gain approval in mantle cell lymphoma.