Regeneron Reports First Quarter 2020 Financial and Operating Results – BioSpace

TARRYTOWN, N.Y., May 5, 2020 /PRNewswire/ --

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced financial results for the first quarter of 2020 and provided a business update.

"Over 30 years, the Regeneron team has built a science and technology engine uniquely suited to address the COVID-19 pandemic and we are applying our signature passion, innovation, and drive to advance solutions. Our novel antibody cocktail, REGN-COV2, which is specifically-designed for both prevention and treatment, is expected to begin human studies in June and we are working in parallel to have large-scale quantities available by late summer," said Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron. "Beyond our COVID-19 efforts, we maintain our commitment to the many other patients with serious diseases who are counting on us. In the first quarter, we saw continued growth with EYLEA, Dupixent, and Libtayo in the U.S. driven by underlying demand despite the impact of the pandemic. Moreover, we continue to advance our broad immuno-oncology platform, including the PD-1 inhibitor Libtayo, for which we plan regulatory submissions this year in both non-small cell lung cancer and basal cell carcinoma, based on recent promising late-stage results."

"We believe our recent revision to the accounting presentation better reflects the nature of revenues earned and costs incurred and simplifies our financial reporting," said Robert E. Landry, Executive Vice President, Finance and Chief Financial Officer of Regeneron. "We were also pleased to close the Praluent restructuring transaction with Sanofi, which we expect to be accretive beginning in the second quarter of 2020."

Financial Highlights

($ in millions, except per share data)

Q1 2020

Q1 2019

% Change

Total revenues(4)

$

1,828

$

1,373

33

%

GAAP net income

$

625

$

461

36

%

GAAP net income per share - diluted

$

5.43

$

3.99

36

%

Non-GAAP net income(1)

$

771

$

518

49

%

Non-GAAP net income per share - diluted(1)

$

6.60

$

4.45

48

%

Business Highlights

Key Pipeline Progress

Regeneron has more than 20 product candidates in clinical development, including five marketed products for which it is investigating additional indications. Updates from the clinical pipeline include:

EYLEA (aflibercept) Injection

Dupixent (dupilumab)

Oncology Program

Praluent (alirocumab)

Evinacumab, an antibody to ANGPTL3

Pozelimab, an antibody to C5

REGN-EB3, a multi-antibody therapy to Ebola virus infection

COVID-19 Update

Business Development Update

In December 2019, the Company and Sanofi also announced their intent to restructure their antibody collaboration for Kevzara. The companies continue to assess potential terms of this restructuring in light of the recently launched clinical programs evaluating Kevzara in patients hospitalized with COVID-19.

First Quarter 2020 Financial Results

Effective January 1, 2020, Regeneron has implemented changes in the presentation of its financial statements related to certain reimbursements and other payments for products developed and commercialized with collaborators. The Company made these changes in presentation to better reflect the nature of the Company's costs incurred and revenues earned pursuant to arrangements with collaborators and to enhance the comparability of Regeneron's financial statements with industry peers. The change in presentation has been applied retrospectively. See Note (4) below for further information.

Revenues

Total revenues increased by 33% to $1.828 billion in the first quarter of 2020, compared to $1.373 billion in the first quarter of 2019.

EYLEA net product sales in the United States were $1.172 billion in the first quarter of 2020, compared to $1.074 billion in the first quarter of 2019. Overall distributor inventory levels for EYLEA in the United States remained within the Company's one-to-two-week targeted range.

Total revenues also include Sanofi and Bayer collaboration revenues(2) of $528 million in the first quarter of 2020, compared to $246 million in the first quarter of 2019. Sanofi collaboration revenue in the first quarter of 2020 included the Company's share of profits from collaboration antibodies (Dupixent, Praluent, and Kevzara) of $171 million, while Sanofi collaboration revenue in the first quarter of 2019 included the Company's share of losses from collaboration antibodies of ($28) million. The change in the Company's share of profits (losses) from collaboration antibodies was primarily driven by higher Dupixent profits.

Refer to Table 4 for a summary of collaboration revenue.

Operating Expenses

GAAP

%Change

Non-GAAP(1)

%Change

($ in millions)

Q1 2020

Q1 2019

Q1 2020

Q1 2019

Research and development (R&D)

$

584

$

486

20

%

$

527

$

427

23

%

Selling, general, and administrative (SG&A)

$

367

$

291

26

%

$

307

$

242

27

%

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Regeneron Reports First Quarter 2020 Financial and Operating Results - BioSpace

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