Revenues: $22,320 (+4%)
Earnings: $8,318 (+160)
R&D: $5,595 (+11%)
TOP SELLING DRUGS
It was big year of investments, alliances, and advancing assets for Lilly, along with a flurry of activity at the start of 2020, namely its COVID-19 efforts.
Through a series of major investments, Lilly is significantly expanding manufacturing capacity in the U.S., and its immunology pipeline. To keep up with increasing demand for current medicines, as well as provide additional manufacturing capacity for future medicines coming from its pipeline, Lilly is investing $400 million in its manufacturing facilities at its Lilly Technology Center campus in Indianapolis, IN, which will create approximately 100 new jobs.
Also, earlier this year, Lilly unveiled plans to invest more than $470 million and create more than 460 new jobs in Durham, NC with a new, state-of-the-art manufacturing facility for parenteral products and delivery devices. Lilly currently has seven manufacturing sites in the U.S., in Indiana, New Jersey and Puerto Rico.
Lastly, for approximately $1.1 billion in cash, Lilly recently acquired Dermira, Inc., a biopharmaceutical company dedicated to developing therapies for chronic skin conditions. The acquisition expands Lilly's immunology pipeline with the addition of lebrikizumab, a Phase III monoclonal antibody designed to bind IL-13 with high affinity that is being evaluated in moderate-to-severe atopic dermatitis.
Lebrikizumab was granted Fast Track designation from the U.S. FDA in December 2019. The acquisition also expands Lilly's portfolio of marketed dermatology medicines with the addition of QBREXZA (glycopyrronium) cloth, a medicated cloth approved by the FDA for the topical treatment of primary axillary hyperhidrosis (uncontrolled excessive underarm sweating).
Lilly won several key approvals for Lyumjev and expanded indications for top sellers CYRAMZA and Taltz. Lyumjev, a new rapid-acting insulin was approved by the FDA to improve glycemic control in adults with type 1 and type 2 diabetes. Lyumjev is a novel formulation of insulin lispro, developed to speed the absorption of insulin into the blood stream and reduce A1C levels. It works similar to how natural insulin works after meals in people without diabetes.
Lyumjev has been approved by regulatory authorities in several global markets, including Japan and the European Union in March 2020.
With its latest approval, CYRAMZA has now received six FDA approvals to treat certain types of lung, liver, stomach and colorectal cancers. The FDA approved CYRAMZA (ramucirumab) in combination with erlotinib for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations.
The approval is based on the Phase III RELAY trial in which CYRAMZA, a VEGF receptor 2 antagonist, in combination with erlotinib, demonstrated a statistically significant and clinically meaningful improvement in progression-free survival compared to placebo in combination with erlotinib (19.4 months compared to 12.4 months).
Fifty percent of people with NSCLC present with advanced or metastatic disease at diagnosis. The five-year survival rate for metastatic NSCLC patients is six percent. In the U.S., it is estimated that approximately 15 percent of people diagnosed with NSCLC have an EGFR mutation.
The FDA also approved Taltz injection for the treatment of active ankylosing spondylitis (AS), also known as radiographic axial spondyloarthritis (r-axSpA). This is the third indication for Taltz, which was first approved by the FDA in March 2016 for the treatment of moderate to severe plaque psoriasis, and then approved by the FDA in December 2017 for the treatment of adults with active psoriatic arthritis.
Additionally, Verzenio, indicated for the treatment of HR+, HER2- advanced or metastatic breast cancer, recently met the primary endpoint in a Phase III trial of invasive disease-free survival (IDFS), significantly decreasing the risk of breast cancer recurrence or death compared to standard adjuvant endocrine therapy alone. Verzenio is the only CDK4 & 6 inhibitor to demonstrate statistically significant improvement in invasive disease-free survival in this setting. Lilly will submit data from this trial to regulatory authorities around the world.
Of note, Verzenio is Lilly's first solid oral dosage form to be made using a faster, more efficient continuous manufacturing process, and Lilly is among the first companies to use this technology.
In September, Lilly and Thermo Fisher Scientific partnered for the development of a companion diagnostic that will use the FDA-approved, next-generation sequencing-based Oncomine Dx Target Test to identify certain non-small cell lung cancer (NSCLC) and thyroid cancer patients who may be treated with Lilly's investigational therapy, LOXO-292. Specifically, the test would be used with patients whose tumors harbor a rearranged during transfection (RET) alteration. RET variants are found in about two percent of NSCLC, about 60 percent of medullary thyroid cancer (MTC) and up to approximately 20 percent of other thyroid cancers.
LOXO-292 is a highly selective and potent oral RET inhibitor being studied by Lilly in a Phase 1/2 trial for the treatment of advanced cancers that harbor the RET kinase.
More recently, Lilly entered an exclusive global licensing and research collaboration with Sitryx, a biopharma company focused on regulating cell metabolism to develop disease-modifying therapeutics in immuno-oncology and immuno-inflammation. The collaboration will study up to four preclinical targets identified by Sitryx that could lead to potential new medicines for autoimmune diseases.
Sitryx gets $50 million upfront and Lilly will make a $10 million equity investment in Sitryx. Sitryx will be eligible to receive potential development milestones up to $820 million, as well as potential commercialization milestones and royalties.
Lilly has an exclusive, worldwide license to develop and commercialize up to four immunometabolism targeted therapeutics, including Sitryx's two lead projects.
In June, Lilly initiated a Phase III study to evaluate the efficacy and safety of baricitinib, an oral JAK1/JAK2 inhibitor licensed from Incyte, in hospitalized COVID-19 patients. Baricitinib, marketed as OLUMIANT, is approved in 70 countries as a treatment for adults with moderately to severely active rheumatoid arthritis (RA). The study, being conducted in the U.S., Europe and Latin America, includes patients hospitalized with SARS-CoV-2 infection who have at least one elevated marker of inflammation but do not require invasive mechanical ventilation. Data is expected in the next few months.
In COVID-19 infection, increased disease severity can be associated with a hyperinflammatory state. Through JAK1 and JAK2 inhibition, baricitinib may reduce the cytokine storm associated with the complications of this infection. In addition, baricitinib may have a role in inhibiting the host cell proteins that assist in viral reproduction.
In May, Lilly partnered with Junshi Biosciences to co-develop therapeutic antibodies for the potential prevention and treatment of COVID-19.
The investigational medicine, JS016, is being co-developed by Junshi Biosciences and Lilly, with Junshi Biosciences leading development in Greater China. Lilly has exclusive rights in the rest of the world and a Phase I study in the U.S. is underway to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of JS016 in healthy participants who have not been diagnosed with COVID-19. This is Lilly's second neutralizing antibody to start clinical trials, following LY-CoV555 that recently entered Phase I and is currently being tested in hospitalized COVID-19 patients.
Lilly is planning a clinical development program which includes a portfolio of monotherapy and combination antibody regimens in order to understand which provide the best efficacy and tolerability in patients. These cocktails will include JS016, LY-CoV555, as well as additional antibodies currently in preclinical development.
The investigational medicine, LY-CoV555, is the first to emerge from the collaboration between Lilly and AbCellera to create antibody therapies for the prevention and treatment of COVID-19. Lilly scientists rapidly developed the antibody in just three months after AbCellera and the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases (NIAID) identified it from a blood sample taken from one of the first U.S. patients who recovered from COVID-19. LY-CoV555 is the first potential new medicine specifically designed to attack SARS-CoV-2.
Lilly is also advancing LY3127804, an investigational selective monoclonal antibody against Angiopoietin 2 (Ang2), to Phase II testing in pneumonia patients hospitalized with COVID-19 who are at a higher risk of progressing to acute respiratory distress syndrome (ARDS).