Revenues: $24,556 (+7%)
Earnings: $3,232 (NM)
R&D: $5,307 (-1%)
TOP SELLING DRUGS
Ascending the ranks, Eli Lilly’s products are performing well and key late stage assets are advancing. Despite generic competition for one of the company’s best-selling products, Cialis, and slipping sales for flagship insulin products Humalog and Humulin, and other established brands, Forteo, Cymbalta, and Erbitux, revenues for the year were up 7%. Burgeoning sales of psoriasis and psoriatic arthritis drug Taltz, up 68% for the year, and diabetes products Trulicity, Basaglar, and Jardiance, up 58%, 85%, and 47%, respectively, helped to offset established product declines.
Also, newly launched breast cancer drug Verzenio is off to good start, and Emgality, approved in September for migraine prevention, and more recently for preventing episodic cluster headaches, offers tremendous potential with estimated peak annual sales of approximately $700 million. Lilly’s numerous late stage assets include another promising migraine drug, lasmiditan, pending approval, and, in addition to expanded indications for top sellers, such Alimta, promising new candidates include mirikizumab, an immunology therapy being studied in Crohn’s disease, and tanezumab being studied in osteoarthritic, back, and cancer pain.
Additionally, broadening its oncology portfolio, the pending $8 billion acquisition of Loxo Oncology will provide Lilly entry into precision medicine with approved and investigational medicines.
In addition to the pending acquisition of Loxo Oncology, Lilly has recently made several strategic moves, including the divestiture of its Animal health business, Elanco, which raised $1.5 billion in its stock market debut, and the sale of antibiotic assets in China for $375 million.
The Loxo Oncology acquisition was the largest in a series of strategic transactions to expand its oncology pipeline with externally sourced, first-in-class therapies. Loxo’s pipeline of targeted medicines is focused on cancers that are uniquely dependent on single gene abnormalities that can be detected by genomic testing.
Among its assets, LOXO-292, an oral RET inhibitor that has been granted Breakthrough Therapy designation by the FDA for three indications, has an initial potential launch in 2020. RET fusions and mutations occur across multiple tumor types, including certain lung and thyroid cancers as well as a subset of other cancers.
Also, Vitrakvi, an oral TRK inhibitor developed and commercialized in collaboration with Bayer, was recently approved by the FDA. Vitrakvi is the first treatment that targets a specific genetic abnormality to receive a tumor-agnostic indication at the time of initial approval. LOXO-195, a follow-on TRK inhibitor is also being studied by Loxo and Bayer for acquired resistance to TRK inhibition, and has a potential launch in 2022.
This past March, Elanco Animal Health became a fully independent company. The spin-off is intended to provide a greater focus on Lilly’s human pharmaceuticals business, which the company is heavily investing in.
Lilly recently sold the rights in China for two legacy antibiotics, Ceclor and Vancocin, as well as a manufacturing facility in Suzhou, to Eddingpharm, a China-based specialty pharmaceutical company, in a transaction valued at $375 million.
Thanks to a recent head-to-head study, Talz is performing even better than expected. Talz surpassed Humira in reducing PsA disease activity by half and completely clearing patient skin after 24 weeks, according to data from a Phase IIIB/IV study. Thirty-six percent of the 234 trial patients treated with Taltz achieved both markers at 24 weeks, compared to 28% of Humira patients. Taltz also achieved its secondary endpoints of matching Humira in disease activity and surpassing it in clearing skin.
Representing a significant approval for Lilly, Emgality injection was approved by the FDA for the treatment of episodic cluster headache in adults. Emgality is an innovative therapeutic approach for this neurologic disease and the first and only calcitonin gene-related peptide antibody approved by the FDA for two distinct headache disorders. Emgality was first approved by the FDA in September 2018 for the preventive treatment of migraine.
Also, Cyramza received approval from the FDA as a single agent for the treatment of patients with hepatocellular carcinoma (HCC), marking the fifth FDA approval for Cyramza. Importantly, the FDA has also removed the boxed warning from the labeling, which should boost sales further.
Additionally, the FDA approved a new indication for top seller Alimta in combination with Merck’s Keytruda for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer, with no EGFR or ALK genomic tumor aberrations.
From its pain portfolio, Lilly and Pfizer achieved positive results from a Phase III study evaluating tanezumab in moderate-to-severe chronic low back pain, meeting the primary endpoint demonstrating a statistically significant improvement in pain. Furthermore, Lilly has acquired several pain assets, gaining rights to CNTX-0290 from Centrexion Therapeutics for $47.5 million upfront and as much as $575 million in potential development milestones. CNTX-0290 is a small molecule somatostatin receptor type 4 (SSTR4) agonist currently in Phase I testing as a potential non-opioid treatment for chronic pain conditions.
Lilly also acquired all assets related to Hydra Biosciences’ program of TRPA1 antagonists, currently being studied for the potential treatment of chronic pain syndromes.
Lilly has not given up on its diabetes therapeutic endeavors. Lilly bolstered its diabetes portfolio with Chugai’s oral GLP-1 agonist, OWL833, a Phase I-ready asset being studied in type 2 diabetes. Also, Lilly and Boehringer recently submitted a NDA for the fixed-dose combination tablet of empagliflozin, linagliptin and metformin extended release for type 2 diabetes.
Lilly has several immunology alliances underway leveraging platform technologies of partner companies. A global alliance with Avidity aims to develop new medicines in immunology and other indications leveraging Avidity’s technology platform to potentially overcome barriers to the delivery of oligonucleotides and target genetic drivers of disease.
A research collaboration leveraging Aduro’s cGAS-STING Pathway Inhibitor program aims to develop immunotherapies for autoimmune and other inflammatory diseases. Additionally, an agreement with AC Immune will research tau aggregation inhibitor small molecules for the potential treatment of Alzheimer’s disease and other neurodegenerative diseases leveraging AC Immune’s Morphomer platform technology.