Eli Lilly and Company LLY boasts a diversified product profile including a solid lineup of new successful drugs. It also has a dependable pipeline as it navigates through challenges like patent expirations of several drugs and rising pricing pressure on its U.S. diabetes franchise.
Its revenue growth is being driven by higher demand for drugs like Trulicity, Taltz, and others. Its key growth products (like Trulicity, Taltz etc.) grew 20% and contributed nearly 67% to total revenues, excluding revenues from COVID-19 antibodies.
Importantly, Lilly expects to launch five new medicines by 2023 end, which could serve as catalysts to driving its top-line growth through the decade.
Of these five, Mounjaro (tirzepatide), a dual GIP and GLP-1 receptor agonist (GIP/GLP-1 RA), was approved by the FDA in May. The drug showed impressive blood sugar reductions and weight loss in type II diabetes patients in phase III studies. Mounjaro recorded $16.0 million in sales in the first quarter of 2022.
Regulatory applications for tirzepatide for type II diabetes are under review in Europe and Japan. The company also initiated a cardiovascular outcome study for tirzepatide in June 2020. Tirzepatide is also in phase III studies for obesity, obstructive sleep apnea and heart failure with preserved ejection fraction and phase II in NASH.
Mounjaro is Lilly’s first of potentially five new medicines it plans to launch by the end of 2023.
Other two important candidates for which Lilly has filed regulatory application seeking accelerated approval from the FDA are donanemab and pirtobrutinib, in Alzheimer's disease and mantle cell lymphoma indications, respectively. The filings have been granted priority review designation by the FDA. Regulatory applications seeking approval of mirikizumab for ulcerative colitis are under review in the United States and Europe while a new drug application for lebrikizumab for atopic dermatitis is expected to be filed later this year.
Of all the five candidates, Mounjaro and donanemab have multibillion dollar sales potential.
Regarding, donanemab, Lilly has filed for accelerated approval pathway based on data from TRAILBLAZER-ALZ and expects a potential regulatory decision in early 2023. It expects a data readout from the TRAILBLAZER-ALZ 2 confirmatory phase III study on donanemab in 2023. If the data from this study is positive, it will become easier to meet the high level of evidence criteria set forth by The Centers for Medicare & Medicaid Services (“CMS”) in the final National Coverage Determination (NCD) decision released in April for the class of anti-amyloid antibodies approved by the FDA like Biogen’s BIIB Aduhelm.
Per the final NCD decision, Medicare said it will cover FDA-approved drugs like Biogen’s Aduhelm only for patients enrolled in CMS-approved studies. The final NCD decision basically denies all Medicare beneficiaries access to Aduhelm, which will reduce future demand for the drug to a minimal level. As a result of the NCD decision, Biogen decided to substantially wind down commercial operations for Aduhelm, retaining only minimal resources to manage patients’ access programs. The final NCD decision may also limit coverage for Lilly’s donanemab and Biogen/Eisai’s another Alzheimer’s candidate lecanemab, which may be approved by the FDA in the future.
Lilly has its share of issues like generic competition for several drugs, rising pricing pressure in the United States mainly on key drug, Trulicity, and price cuts in some international markets like China, Japan and Europe.
Its key drug Alimta’s vitamin regimen patent expired worldwide in June 2021 and generics were launched in Europe and Japan, hurting sales significantly. In the United States, per a settlement with Eagle Pharmaceuticals EGRX, Eagle launched its generic on a limited basis in February 2022 with an unlimited entry starting in April 2022. From second-quarter 2022 onward, Alimta sales have declined rapidly with multi-source generic entrants following the loss of patent exclusivity in the United States. Alimta sales are likely to erode rapidly in the remaining quarters of 2022.
However, Lilly is hopeful that its key products like Trulicity, Taltz, Jardiance and others and thereafter the new products discussed above will keep the driving the company’s sales.
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