Eli Lilly & Co. (LLY) Misses Q1 EPS by 2c

Eli Lilly & Co. (NYSE: LLY) reported Q1 EPS of $0.83, $0.02 worse than the analyst estimate of $0.85. Revenue for the quarter came in at $4.87 billion versus the consensus estimate of $4.82 billion.

Key Events Over the Last Three Months

Commercial

• Following approval by the U.S. Food and Drug Administration (FDA), the company launched Taltz (ixekizumab) injection 80 mg/mL in the U.S. for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.
• In Europe, the company launched Cyramza® (ramucirumab) for locally advanced or metastatic non-small cell lung cancer (NSCLC) and for metastatic colorectal cancer (CRC).
• Also in Europe, following approval by the European Commission, the company launched Portrazza™ (necitumumab), in combination with gemcitabine and cisplatin, as the first biologic for the treatment of patients with locally advanced or metastatic epidermal growth factor receptor expressing squamous NSCLC who have not received prior chemotherapy for this condition.

Regulatory

• Following a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP), the European Commission approved Taltz for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy.
• The company submitted olaratumab to both the FDA and the EMA for soft tissue sarcoma.
• Elanco Animal Health announced the FDA approval of Imrestor™ (pegbovigrastim injection) for the reduction in the incidence of clinical mastitis in dairy cows. Imrestor is a non-antibiotic therapy, the first product of its kind for the dairy industry.

Clinical

• The primary endpoint for the EXPEDITION3 clinical trial, a Phase 3 study of solanezumab in people with mild Alzheimer's dementia, was changed from co-primary endpoints of cognition and function to a single primary endpoint of cognition. Functional outcomes will be evaluated as key secondary endpoints.
• In collaboration with AstraZeneca, the company announced:
  • AMARANTH, a Phase 2/3 study of AZD3293, an oral beta secretase cleaving enzyme (BACE) inhibitor currently in development as a potential treatment for early Alzheimer's disease, will continue to Phase 3 of the Phase 2/3 seamless trial.
  • A new Phase 3 trial for AZD3293, named DAYBREAK, will study the safety and efficacy of AZD3293 in people with mild Alzheimer's dementia. DAYBREAK will begin enrolling participants in the third quarter of 2016.
• The Boehringer Ingelheim Lilly Diabetes Alliance announced plans to conduct two outcome trials investigating the diabetes medicine Jardiance® (empagliflozin) for the treatment of people with chronic heart failure. The trials are targeted to begin within the next 12 months and are planned to enroll people with chronic heart failure both with and without type 2 diabetes.

Guidance:

The company now expects 2016 EPS to be in the range of $2.68 to $2.78 (reported) and $3.50 to $3.60 (non-GAAP), both reflecting a discrete tax benefit in the first quarter. The revised reported EPS also reflects the impact of the Venezuelan financial crisis, including the significant deterioration of the bolívar, which resulted in a first-quarter charge of $203.9 million.

*** The Street sees FY16 EPS of $3.54.

For earnings history and earnings-related data on Eli Lilly & Co. (LLY) click here.

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