Regeneron (REGN) Tops Q4 EPS by $1.06, Revenues Beat; Offers FY19 Financial Guidance
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Regeneron (NASDAQ: REGN) reported Q4 EPS of $6.84, $1.06 better than the analyst estimate of $5.78. Revenue for the quarter came in at $1.93 billion versus the consensus estimate of $1.71 billion.
- Fourth quarter 2018 revenues were $1.93 billion, an increase of 22%
- Fourth quarter 2018 EYLEA® (aflibercept) Injection U.S. net sales increased 11% to $1.08 billion versus fourth quarter 2017
- Fourth quarter 2018 Libtayo® (cemiplimab-rwlc) Injection U.S. net sales were $15 million in the first three months of launch
- Fourth quarter revenues include a $149 million cumulative catch-up adjustment primarily related to the modification of the Sanofi Immuno-oncology Discovery and Development Agreement
- Fourth quarter 2018 EYLEA net sales outside the United States, which are recorded by the Company\'s collaborator Bayer, increased 14% to $724 million
- Fourth quarter 2018 Dupixent® (dupilumab) Injection global net sales, which are recorded by the Company\'s collaborator Sanofi, were $319 million
- Fourth quarter 2018 GAAP diluted EPS was $7.15; fourth quarter non-GAAP diluted EPS was $6.84; full year 2018 GAAP diluted EPS was $21.29; full year non-GAAP diluted EPS was $22.84
"2018 was marked by the diversification of our product revenue streams as well as exciting advances across our commercial and development portfolio," said Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron. "In 2019, we plan to strengthen EYLEA\'s U.S. market leadership position with a potential approval in diabetic retinopathy. With the fourth quarter U.S. approval of Dupixent in asthma, and the potential 2019 approvals in adolescent atopic dermatitis and chronic rhinosinusitis with nasal polyposis in the U.S. and asthma in the EU, Dupixent continues to deliver on its potential as a pipeline in a product. Libtayo, our first approved immuno-oncology therapy, has begun its launch in advanced cutaneous squamous cell carcinoma and we continue to investigate multiple other potential indications, both as monotherapy and in combination. This year we plan to initiate two potentially pivotal lymphoma studies with our most advanced bispecific antibody, CD20xCD3, and to advance two innovative co-stimulatory bispecific antibodies into human clinical studies."
2019 Financial Guidance
The Company's full year 2019 financial guidance consists of the following components:
GAAP Sanofi collaboration revenue: Sanofi
reimbursement of Regeneron
$510 million–$560 million
GAAP Unreimbursed R&D(5)
$1.855 billion–$2.000 billion
Non-GAAP Unreimbursed R&D(2)(4)
$1.590 billion–$1.710 billion
$1.700 billion–$1.830 billion
$1.500 billion–$1.600 billion
GAAP effective tax rate
$410 million–$490 million
For earnings history and earnings-related data on Regeneron (REGN) click here.
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