Eli Lilly is feeling pretty secure these days. As its branded meds turn in strong growth and the company touts a “long IP runway," the drugmaker is gearing up for some big launches over the next year and a half, CEO David Ricks told investors Thursday.
Overall, Lilly grew revenue 15% to around $7.8 billion in 2022’s first quarter, or 10% after taking Alimta and COVID-19 antibody sales out of the equation, the company noted in a release.
Lilly credited its growth to its stable of key drugs including diabetes med Trulicity, breast cancer drug Verzenio and Jardiance, which recently widened its cardiovascular reach with an approval to curb the risk of cardiovascular death and hospitalization in adults with heart failure.
There remains a “long IP runway for many of these products,” Ricks said on the company’s earnings call, noting that less than 10% of the company’s 2022 revenue is exposed to patent expirations in the next five years.
Meanwhile, Lilly is on track to potentially launch five new medicines over the next 18 months, the CEO pointed out. One of those is the closely watched Alzheimer’s prospect donanemab.
After the Centers for Medicare & Medicaid Services’ (CMS) restrictive coverage decision on Biogen’s Aduhelm—and other amyloid-targeting antibodies like it—Lilly shares patient and caregiver disappointment, Daniel Skovronsky, M.D., Ph.D., the company’s chief scientific and medical officer, said Thursday.
Despite that potential reimbursement hurdle, Lilly is moving ahead with its initial submission to the FDA, Lilly’s top scientist added.
“We intend to complete our initial submission yet in Q2 enabling a potential regulatory decision in early 2023,” he said.
Should Lilly’s donanemab studiy yield positive data, the company will “advocate for CMS to reconsider outright coverage,” Skovronsky said.
“It’s inconceivable to us that once substantial evidence of clinical benefit has been established for any Alzheimer’s medicine, people with the disease won’t have access to it,” he added.
Aside from its revenue figures, Lilly had positive pipeline news to report Thursday. In the late-stage SURMOUNT 1 trial, tirzepatide helped trigger average weight reductions from 16% at the low, 5-mg dose, to 22.5% at the high, 15-mg dose, Lilly said Thursday.
“We’re looking forward to reviewing the data with the FDA and discussing the potential for an expedited path forward for this indication,” Skovronsky said. If approved in obesity, the dual GIP/GLP-1 drug would compete with Novo Nordisk’s Wegovy.
Lilly represents “one of the strongest expansion stories in Pharma,” Cantor Fitzgerald mused in a note to clients Thursday. The team predicts Lilly is on the cusp of a “period of earnings estimate growth through 2030, bolstered by multiple pipeline readouts, as well of launches of its first-in-class/best-in-class compounds” like donanemab for Alzheimer’s and tirzepatide in weight loss.
For the full year, Lilly now expects to rake in between $28.8 billion and $29.3 billion. It upped its previous guidance by $1 billion, courtesy of its COVID antibody bebtelovimab sale to the U.S. last quarter.
Looking forward, the company expects any additional COVID-19 antibody sales to be “limited” in the second quarter, Lilly’s chief financial officer Anat Ashkenazi said on the call.
Meanwhile, Lilly is facing new competition to lung cancer blockbuster Alimta after Eagle Pharmaceuticals launched the first generic competitor in February. Lilly expects “broad generic entry” in May to spur “significant erosion” of the drug’s U.S. sales, Ashkenazi said.