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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Regeneron Pharmaceuticals Inc | NASDAQ:REGN | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
-0.895 | -0.10% | 891.585 | 891.53 | 892.90 | 896.85 | 885.01 | 892.11 | 296,069 | 19:50:20 |
(Mark One)
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☒
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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For the quarterly period ended
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September 30, 2019
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OR
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☐
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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For the transition period from __________ to __________
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Commission File Number:
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0-19034
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New York
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13-3444607
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(State or other jurisdiction of incorporation or organization)
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(I.R.S. Employer Identification No.)
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777 Old Saw Mill River Road
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Tarrytown,
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New York
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10591-6707
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(Address of principal executive offices, including zip code)
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Title of each class
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Trading Symbol
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Name of each exchange on which registered
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Common Stock - par value $.001 per share
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REGN
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NASDAQ Global Select Market
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Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
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Yes
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No
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☐
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Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
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Yes
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☒
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No
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Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of "large accelerated filer", "accelerated filer", "smaller reporting company" and "emerging growth company" in Rule 12b-2 of the Exchange Act.
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Large accelerated filer
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☒
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Accelerated filer
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☐
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Non-accelerated filer
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☐
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Smaller reporting company
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☐
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Emerging growth company
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☐
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
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☐
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Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
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Yes
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☐
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No
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☒
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Class of Common Stock
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Number of Shares
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Class A Stock, $.001 par value
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1,848,970
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Common Stock, $.001 par value
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107,946,794
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Page Numbers
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"ARCALYST®", "EYLEA®", "Libtayo®" (in the United States), "Regeneron®", "Regeneron Genetics Center®", "Veloci-BiTM", "VelociGene®", "VelociMab®", "VelocImmune®", "VelociMouse®", "VelociSuite®", and "ZALTRAP®" are trademarks of Regeneron Pharmaceuticals, Inc. Trademarks and trade names of other companies appearing in this report are, to the knowledge of Regeneron Pharmaceuticals, Inc., the property of their respective owners.
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September 30,
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December 31,
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||||
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2019
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2018
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ASSETS
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|||||||
Current assets:
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||||
Cash and cash equivalents
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$
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1,384.8
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$
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1,467.7
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Marketable securities
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1,493.1
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1,342.2
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Accounts receivable - trade, net
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2,027.7
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1,723.7
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Accounts receivable from Sanofi
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345.4
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226.4
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Accounts receivable from Bayer
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286.9
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293.1
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Inventories
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1,344.3
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1,151.2
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Prepaid expenses and other current assets
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226.9
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243.3
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Total current assets
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7,109.1
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6,447.6
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Marketable securities
|
3,112.6
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1,755.0
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Property, plant, and equipment, net
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2,771.4
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2,575.8
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Deferred tax assets
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808.3
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|
828.7
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Other noncurrent assets
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137.9
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127.4
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Total assets
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$
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13,939.3
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$
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11,734.5
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LIABILITIES AND STOCKHOLDERS' EQUITY
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|||||||
Current liabilities:
|
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Accounts payable
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$
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335.6
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$
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218.2
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Accrued expenses and other current liabilities
|
821.1
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|
772.1
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Deferred revenue from Sanofi
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427.1
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246.7
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Deferred revenue - other
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181.6
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205.8
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Total current liabilities
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1,765.4
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1,442.8
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Finance lease liabilities
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712.7
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708.5
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Deferred revenue from Sanofi
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551.9
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279.3
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Deferred revenue - other
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131.9
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184.9
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Other noncurrent liabilities
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273.0
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361.7
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Total liabilities
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3,434.9
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2,977.2
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Stockholders' equity:
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Preferred Stock, $.01 par value; 30,000,000 shares authorized; issued and outstanding - none
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—
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—
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Class A Stock, convertible, $.001 par value; 40,000,000 shares authorized; shares issued and outstanding - 1,848,970 in 2019 and 1,911,354 in 2018
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—
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—
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Common Stock, $.001 par value; 320,000,000 shares authorized; shares issued - 112,039,746 in 2019 and 111,084,951 in 2018
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0.1
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0.1
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Additional paid-in capital
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4,388.4
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3,911.6
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Retained earnings
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6,587.8
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5,254.3
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Accumulated other comprehensive income (loss)
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16.5
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(12.3
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)
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Treasury Stock, at cost; 4,167,018 shares in 2019 and 3,990,021 shares in 2018
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(488.4
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)
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(396.4
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)
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Total stockholders' equity
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10,504.4
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8,757.3
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Total liabilities and stockholders' equity
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$
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13,939.3
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$
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11,734.5
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The accompanying notes are an integral part of the financial statements.
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Three Months Ended
September 30, |
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Nine Months Ended
September 30, |
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2019
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2018
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2019
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2018
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||||||||
Statements of Operations
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Revenues:
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Net product sales
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$
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1,238.3
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$
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1,025.5
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$
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3,548.0
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$
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3,009.8
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Sanofi collaboration revenue
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404.2
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256.3
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999.7
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683.5
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Bayer collaboration revenue
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302.8
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264.4
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868.0
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775.2
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Other revenue
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103.1
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117.3
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278.2
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314.5
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2,048.4
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1,663.5
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5,693.9
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4,783.0
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Expenses:
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Research and development
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663.4
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557.0
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2,353.5
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1,584.8
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Selling, general, and administrative
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419.9
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369.2
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1,248.0
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1,064.9
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Cost of goods sold
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115.9
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30.8
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253.8
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136.1
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Cost of collaboration and contract manufacturing
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110.7
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79.6
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304.5
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180.9
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1,309.9
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1,036.6
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4,159.8
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2,966.7
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Income from operations
|
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738.5
|
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|
626.9
|
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|
1,534.1
|
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1,816.3
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||||||||
Other income (expense):
|
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||||||||
Other income (expense), net
|
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37.8
|
|
|
16.4
|
|
|
28.7
|
|
|
81.8
|
|
||||
Interest expense
|
|
(7.8
|
)
|
|
(7.4
|
)
|
|
(23.5
|
)
|
|
(20.8
|
)
|
||||
|
|
30.0
|
|
|
9.0
|
|
|
5.2
|
|
|
61.0
|
|
||||
|
|
|
|
|
|
|
|
|
||||||||
Income before income taxes
|
|
768.5
|
|
|
635.9
|
|
|
1,539.3
|
|
|
1,877.3
|
|
||||
|
|
|
|
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|
|
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|
||||||||
Income tax expense
|
|
(98.9
|
)
|
|
(41.2
|
)
|
|
(215.5
|
)
|
|
(253.3
|
)
|
||||
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||||||||
Net income
|
|
$
|
669.6
|
|
|
$
|
594.7
|
|
|
$
|
1,323.8
|
|
|
$
|
1,624.0
|
|
|
|
|
|
|
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||||||||
Net income per share - basic
|
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$
|
6.12
|
|
|
$
|
5.50
|
|
|
$
|
12.12
|
|
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$
|
15.06
|
|
Net income per share - diluted
|
|
$
|
5.86
|
|
|
$
|
5.17
|
|
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$
|
11.54
|
|
|
$
|
14.14
|
|
|
|
|
|
|
|
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||||||||
Weighted average shares outstanding - basic
|
|
109.4
|
|
|
108.0
|
|
|
109.2
|
|
|
107.8
|
|
||||
Weighted average shares outstanding - diluted
|
|
114.2
|
|
|
115.1
|
|
|
114.7
|
|
|
114.8
|
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||||
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||||||||
Statements of Comprehensive Income
|
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Net income
|
|
$
|
669.6
|
|
|
$
|
594.7
|
|
|
$
|
1,323.8
|
|
|
$
|
1,624.0
|
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Other comprehensive income (loss), net of tax:
|
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||||||||
Unrealized gain (loss) on debt securities
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1.0
|
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0.7
|
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|
31.5
|
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(6.9
|
)
|
||||
Unrealized (loss) gain on cash flow hedges
|
|
(0.3
|
)
|
|
0.3
|
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(2.7
|
)
|
|
2.4
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|
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Comprehensive income
|
|
$
|
670.3
|
|
|
$
|
595.7
|
|
|
$
|
1,352.6
|
|
|
$
|
1,619.5
|
|
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The accompanying notes are an integral part of the financial statements.
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Class A Stock
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Common Stock
|
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Additional Paid-in Capital
|
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Retained Earnings
|
|
Accumulated Other Comprehensive Income (Loss)
|
|
Treasury Stock
|
|
Total Stockholders' Equity
|
||||||||||||||||||||||
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Shares
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Amount
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Shares
|
|
Amount
|
|
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Shares
|
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Amount
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||||||||||||||||||||
Balance, December 31, 2018
|
|
1.9
|
|
|
—
|
|
|
111.1
|
|
|
$
|
0.1
|
|
|
$
|
3,911.6
|
|
|
$
|
5,254.3
|
|
|
$
|
(12.3
|
)
|
|
(4.0
|
)
|
|
$
|
(396.4
|
)
|
|
$
|
8,757.3
|
|
Issuance of Common Stock in connection with exercise of stock options
|
|
—
|
|
|
—
|
|
|
0.6
|
|
|
—
|
|
|
140.9
|
|
|
—
|
|
|
—
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|
|
—
|
|
|
—
|
|
|
140.9
|
|
||||||
Common Stock tendered upon exercise of stock options and vesting of restricted stock for employee tax obligations
|
|
—
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|
—
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|
|
—
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—
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(10.7
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)
|
|
—
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|
—
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—
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|
—
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(10.7
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)
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||||||
Issuance/distribution of Common Stock in connection with 401(k) Savings Plan
|
|
—
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—
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—
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—
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4.3
|
|
|
—
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—
|
|
|
0.1
|
|
|
6.2
|
|
|
10.5
|
|
||||||
Repurchases of Common Stock from Sanofi
|
|
—
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|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(0.1
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)
|
|
(54.0
|
)
|
|
(54.0
|
)
|
||||||
Stock-based compensation charges
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
114.8
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
114.8
|
|
||||||
Adjustment upon adoption of new accounting standard
|
|
—
|
|
|
—
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|
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—
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|
|
—
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—
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|
|
9.7
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—
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|
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—
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—
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|
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9.7
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|
||||||
Net income
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—
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—
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—
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—
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—
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461.1
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—
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—
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—
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461.1
|
|
||||||
Other comprehensive gain, net of tax
|
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—
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—
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—
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—
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—
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|
|
—
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15.1
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—
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|
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—
|
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|
15.1
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|
||||||
Balance, March 31, 2019
|
|
1.9
|
|
|
—
|
|
|
111.7
|
|
|
0.1
|
|
|
4,160.9
|
|
|
5,725.1
|
|
|
2.8
|
|
|
(4.0
|
)
|
|
(444.2
|
)
|
|
9,444.7
|
|
||||||
Issuance of Common Stock in connection with exercise of stock options
|
|
—
|
|
|
—
|
|
|
0.3
|
|
|
—
|
|
|
13.9
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
13.9
|
|
||||||
Common Stock tendered upon exercise of stock options and vesting of restricted stock for employee tax obligations
|
|
—
|
|
|
—
|
|
|
(0.1
|
)
|
|
—
|
|
|
(29.7
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(29.7
|
)
|
||||||
Issuance/distribution of Common Stock in connection with 401(k) Savings Plan
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
9.3
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
2.4
|
|
|
11.7
|
|
||||||
Stock-based compensation charges
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
109.2
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
109.2
|
|
||||||
Net income
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
193.1
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
193.1
|
|
||||||
Other comprehensive gain, net of tax
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
13.0
|
|
|
—
|
|
|
—
|
|
|
13.0
|
|
||||||
Balance, June 30, 2019
|
|
1.9
|
|
|
—
|
|
|
111.9
|
|
|
0.1
|
|
|
4,263.6
|
|
|
5,918.2
|
|
|
15.8
|
|
|
(4.0
|
)
|
|
(441.8
|
)
|
|
9,755.9
|
|
||||||
Issuance of Common Stock in connection with exercise of stock options
|
|
—
|
|
|
—
|
|
|
0.1
|
|
|
—
|
|
|
8.3
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
8.3
|
|
||||||
Common Stock tendered upon exercise of stock options and vesting of restricted stock for employee tax obligations
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(0.1
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(0.1
|
)
|
||||||
Issuance/distribution of Common Stock in connection with 401(k) Savings Plan
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
3.9
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
2.1
|
|
|
6.0
|
|
||||||
Repurchases of Common Stock from Sanofi
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(0.2
|
)
|
|
(48.7
|
)
|
|
(48.7
|
)
|
||||||
Conversion of Class A Stock to Common Stock
|
|
(0.1
|
)
|
|
—
|
|
|
0.1
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Stock-based compensation charges
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
112.7
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
112.7
|
|
||||||
Net income
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
669.6
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
669.6
|
|
||||||
Other comprehensive gain, net of tax
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
0.7
|
|
|
—
|
|
|
—
|
|
|
0.7
|
|
||||||
Balance, September 30, 2019
|
|
1.8
|
|
|
—
|
|
|
112.1
|
|
|
$
|
0.1
|
|
|
$
|
4,388.4
|
|
|
$
|
6,587.8
|
|
|
$
|
16.5
|
|
|
(4.2
|
)
|
|
$
|
(488.4
|
)
|
|
$
|
10,504.4
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended
September 30, |
||||||
|
|
2019
|
|
2018
|
||||
Cash flows from operating activities:
|
|
|
|
|
||||
Net income
|
|
$
|
1,323.8
|
|
|
$
|
1,624.0
|
|
Adjustments to reconcile net income to net cash provided by operating activities:
|
|
|
|
|
||||
Depreciation and amortization
|
|
156.0
|
|
|
105.4
|
|
||
Non-cash compensation expense
|
|
330.8
|
|
|
300.7
|
|
||
Other non-cash items, net
|
|
113.2
|
|
|
(82.7
|
)
|
||
Deferred taxes
|
|
(110.0
|
)
|
|
(33.5
|
)
|
||
Changes in assets and liabilities:
|
|
|
|
|
||||
Increase in Sanofi, Bayer, and trade accounts receivable
|
|
(460.9
|
)
|
|
(228.6
|
)
|
||
Increase in inventories
|
|
(227.2
|
)
|
|
(281.6
|
)
|
||
Decrease (increase) in prepaid expenses and other assets
|
|
21.2
|
|
|
(87.8
|
)
|
||
Increase (decrease) in deferred revenue
|
|
375.8
|
|
|
(29.5
|
)
|
||
Increase in accounts payable, accrued expenses, and other liabilities
|
|
119.9
|
|
|
179.9
|
|
||
Total adjustments
|
|
318.8
|
|
|
(157.7
|
)
|
||
Net cash provided by operating activities
|
|
1,642.6
|
|
|
1,466.3
|
|
||
|
|
|
|
|
||||
Cash flows from investing activities:
|
|
|
|
|
||||
Purchases of marketable and other securities
|
|
(2,834.9
|
)
|
|
(1,533.6
|
)
|
||
Sales or maturities of marketable securities
|
|
1,306.4
|
|
|
644.1
|
|
||
Capital expenditures
|
|
(290.6
|
)
|
|
(297.6
|
)
|
||
Other
|
|
—
|
|
|
(10.0
|
)
|
||
Net cash used in investing activities
|
|
(1,819.1
|
)
|
|
(1,197.1
|
)
|
||
|
|
|
|
|
||||
Cash flows from financing activities:
|
|
|
|
|
||||
Proceeds from issuance of Common Stock
|
|
163.5
|
|
|
87.4
|
|
||
Payments in connection with Common Stock tendered for employee tax obligations
|
|
(40.5
|
)
|
|
(77.1
|
)
|
||
Repurchases of Common Stock
|
|
(29.4
|
)
|
|
(4.4
|
)
|
||
Net cash provided by financing activities
|
|
93.6
|
|
|
5.9
|
|
||
|
|
|
|
|
||||
Net (decrease) increase in cash, cash equivalents, and restricted cash
|
|
(82.9
|
)
|
|
275.1
|
|
||
|
|
|
|
|
||||
Cash, cash equivalents, and restricted cash at beginning of period
|
|
1,480.2
|
|
|
825.2
|
|
||
|
|
|
|
|
||||
Cash, cash equivalents, and restricted cash at end of period
|
|
$
|
1,397.3
|
|
|
$
|
1,100.3
|
|
|
|
|
|
|
||||
The accompanying notes are an integral part of the financial statements.
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
Net Product Sales in the United States
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
EYLEA®
|
|
$
|
1,187.7
|
|
|
$
|
1,021.8
|
|
|
$
|
3,422.1
|
|
|
$
|
2,997.8
|
|
Libtayo®
|
|
47.6
|
|
|
—
|
|
|
115.2
|
|
|
—
|
|
||||
ARCALYST®
|
|
3.0
|
|
|
3.7
|
|
|
10.7
|
|
|
12.0
|
|
||||
|
|
$
|
1,238.3
|
|
|
$
|
1,025.5
|
|
|
$
|
3,548.0
|
|
|
$
|
3,009.8
|
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||
Besse Medical, a subsidiary of AmerisourceBergen Corporation
|
|
57
|
%
|
|
57
|
%
|
|
57
|
%
|
|
56
|
%
|
McKesson Corporation
|
|
34
|
%
|
|
36
|
%
|
|
33
|
%
|
|
37
|
%
|
|
Rebates, Chargebacks, and Discounts
|
|
Distribution-Related Fees
|
|
Other Sales-Related Deductions
|
|
Total
|
||||||||
Balance as of December 31, 2018
|
$
|
41.1
|
|
|
$
|
42.0
|
|
|
$
|
8.3
|
|
|
$
|
91.4
|
|
Provisions
|
301.0
|
|
|
177.3
|
|
|
46.0
|
|
|
524.3
|
|
||||
Credits/payments
|
(265.8
|
)
|
|
(172.5
|
)
|
|
(40.7
|
)
|
|
(479.0
|
)
|
||||
Balance as of September 30, 2019
|
$
|
76.3
|
|
|
$
|
46.8
|
|
|
$
|
13.6
|
|
|
$
|
136.7
|
|
|
|
|
|
|
|
|
|
||||||||
Balance as of December 31, 2017
|
$
|
29.9
|
|
|
$
|
34.1
|
|
|
$
|
21.3
|
|
|
$
|
85.3
|
|
Provisions
|
159.1
|
|
|
155.5
|
|
|
29.7
|
|
|
344.3
|
|
||||
Credits/payments
|
(145.9
|
)
|
|
(150.9
|
)
|
|
(35.7
|
)
|
|
(332.5
|
)
|
||||
Balance as of September 30, 2018
|
$
|
43.1
|
|
|
$
|
38.7
|
|
|
$
|
15.3
|
|
|
$
|
97.1
|
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
Sanofi Collaboration Revenue
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Antibody:
|
|
|
|
|
|
|
|
|
||||||||
Reimbursement of Regeneron research and development expenses
|
|
$
|
60.2
|
|
|
$
|
76.2
|
|
|
$
|
216.5
|
|
|
$
|
201.0
|
|
Reimbursement of Regeneron commercialization-related expenses
|
|
111.6
|
|
|
103.7
|
|
|
349.3
|
|
|
292.8
|
|
||||
Reimbursement for Regeneron's manufacturing of commercial supplies
|
|
78.5
|
|
|
40.3
|
|
|
133.3
|
|
|
94.4
|
|
||||
Regeneron's share of profits (losses) in connection with commercialization of antibodies
|
|
94.2
|
|
|
(38.9
|
)
|
|
105.2
|
|
|
(182.6
|
)
|
||||
Other
|
|
4.8
|
|
|
(7.2
|
)
|
|
(0.6
|
)
|
|
(12.3
|
)
|
||||
Total Antibody
|
|
349.3
|
|
|
174.1
|
|
|
803.7
|
|
|
393.3
|
|
||||
Immuno-oncology:
|
|
|
|
|
|
|
|
|
||||||||
Reimbursement of Regeneron research and development expenses
|
|
38.0
|
|
|
74.8
|
|
|
120.9
|
|
|
225.7
|
|
||||
Reimbursement of Regeneron commercialization-related expenses
|
|
3.0
|
|
|
3.2
|
|
|
7.0
|
|
|
6.5
|
|
||||
Amounts recognized in connection with up-front payments received
|
|
18.5
|
|
|
7.9
|
|
|
73.8
|
|
|
65.2
|
|
||||
Other
|
|
(4.6
|
)
|
|
(3.7
|
)
|
|
(5.7
|
)
|
|
(7.2
|
)
|
||||
Total Immuno-oncology
|
|
54.9
|
|
|
82.2
|
|
|
196.0
|
|
|
290.2
|
|
||||
|
|
$
|
404.2
|
|
|
$
|
256.3
|
|
|
$
|
999.7
|
|
|
$
|
683.5
|
|
|
|
September 30,
|
|
December 31,
|
||||
|
|
2019
|
|
2018
|
||||
Accounts receivable
|
|
$
|
332.5
|
|
|
$
|
138.2
|
|
Deferred revenue
|
|
$
|
377.0
|
|
|
$
|
236.1
|
|
|
|
Nine Months Ended
September 30, 2019 |
||
Increase due to shipments of commercial supplies to Sanofi
|
|
$
|
294.3
|
|
Revenue recognized that was included in deferred revenue at the beginning of the period
|
|
$
|
(159.0
|
)
|
|
|
September 30,
|
|
December 31,
|
||||
|
|
2019
|
|
2018
|
||||
Accounts receivable
|
|
$
|
8.2
|
|
|
$
|
77.9
|
|
Deferred revenue
|
|
$
|
602.0
|
|
|
$
|
289.9
|
|
|
|
Nine Months Ended
September 30, 2019 |
||
Increase as a result of payment received from Sanofi in connection with the Amended IO Discovery Agreement
|
|
$
|
415.9
|
|
Revenue recognized that was included in deferred revenue at the beginning of the period
|
|
$
|
(73.8
|
)
|
Revenue recognized that was added to deferred revenue during the period
|
|
$
|
(37.9
|
)
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
Bayer EYLEA Collaboration Revenue
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Regeneron's net profit in connection with commercialization of EYLEA outside the United States
|
|
$
|
275.0
|
|
|
$
|
243.2
|
|
|
$
|
793.3
|
|
|
$
|
721.5
|
|
Reimbursement of Regeneron EYLEA development expenses
|
|
5.0
|
|
|
1.7
|
|
|
15.6
|
|
|
8.8
|
|
||||
Other
|
|
22.8
|
|
|
20.7
|
|
|
59.1
|
|
|
45.4
|
|
||||
|
|
$
|
302.8
|
|
|
$
|
265.6
|
|
|
$
|
868.0
|
|
|
$
|
775.7
|
|
|
|
September 30,
|
|
December 31,
|
||||
|
|
2019
|
|
2018
|
||||
Accounts receivable (recorded within Prepaid expenses and other current assets)
|
|
$
|
36.0
|
|
|
$
|
28.8
|
|
Deferred revenue
|
|
$
|
127.8
|
|
|
$
|
194.5
|
|
|
|
Nine Months Ended
September 30, 2019 |
||
Revenue recognized that was included in deferred revenue at the beginning of the period
|
|
$
|
(68.7
|
)
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Net income - basic and diluted
|
|
$
|
669.6
|
|
|
$
|
594.7
|
|
|
$
|
1,323.8
|
|
|
$
|
1,624.0
|
|
|
|
|
|
|
|
|
|
|
||||||||
(Shares in millions)
|
|
|
|
|
|
|
|
|
||||||||
Weighted average shares - basic
|
|
109.4
|
|
|
108.0
|
|
|
109.2
|
|
|
107.8
|
|
||||
Effect of dilutive securities:
|
|
|
|
|
|
|
|
|
||||||||
Stock options
|
|
4.8
|
|
|
7.1
|
|
|
5.5
|
|
|
7.0
|
|
||||
Weighted average shares - diluted
|
|
114.2
|
|
|
115.1
|
|
|
114.7
|
|
|
114.8
|
|
||||
|
|
|
|
|
|
|
|
|
||||||||
Net income per share - basic
|
|
$
|
6.12
|
|
|
$
|
5.50
|
|
|
$
|
12.12
|
|
|
$
|
15.06
|
|
Net income per share - diluted
|
|
$
|
5.86
|
|
|
$
|
5.17
|
|
|
$
|
11.54
|
|
|
$
|
14.14
|
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||
(Shares in millions)
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||
Stock options
|
|
18.3
|
|
|
14.4
|
|
|
18.2
|
|
|
14.8
|
|
Restricted stock
|
|
0.4
|
|
|
—
|
|
|
0.4
|
|
|
0.1
|
|
|
|
Amortized
|
|
Unrealized
|
|
Fair
|
||||||||||
As of September 30, 2019
|
|
Cost Basis
|
|
Gains
|
|
Losses
|
|
Value
|
||||||||
Corporate bonds
|
|
$
|
3,880.6
|
|
|
$
|
27.0
|
|
|
$
|
(0.6
|
)
|
|
$
|
3,907.0
|
|
U.S. government and government agency obligations
|
|
65.9
|
|
|
0.2
|
|
|
(0.1
|
)
|
|
66.0
|
|
||||
Sovereign bonds
|
|
26.9
|
|
|
0.5
|
|
|
—
|
|
|
27.4
|
|
||||
Commercial paper
|
|
108.8
|
|
|
—
|
|
|
—
|
|
|
108.8
|
|
||||
Certificates of deposit
|
|
66.7
|
|
|
0.1
|
|
|
—
|
|
|
66.8
|
|
||||
|
|
$
|
4,148.9
|
|
|
$
|
27.8
|
|
|
$
|
(0.7
|
)
|
|
$
|
4,176.0
|
|
|
|
|
|
|
|
|
|
|
||||||||
As of December 31, 2018
|
|
|
|
|
|
|
|
|
||||||||
Corporate bonds
|
|
$
|
2,734.8
|
|
|
$
|
1.0
|
|
|
$
|
(17.4
|
)
|
|
$
|
2,718.4
|
|
U.S. government and government agency obligations
|
|
110.4
|
|
|
—
|
|
|
(1.0
|
)
|
|
109.4
|
|
||||
Sovereign bonds
|
|
7.6
|
|
|
—
|
|
|
—
|
|
|
7.6
|
|
||||
Commercial paper
|
|
113.8
|
|
|
—
|
|
|
—
|
|
|
113.8
|
|
||||
Certificates of deposit
|
|
60.0
|
|
|
—
|
|
|
—
|
|
|
60.0
|
|
||||
|
|
$
|
3,026.6
|
|
|
$
|
1.0
|
|
|
$
|
(18.4
|
)
|
|
$
|
3,009.2
|
|
|
|
September 30,
|
|
December 31,
|
||||
|
|
2019
|
|
2018
|
||||
Maturities within one year
|
|
$
|
1,493.1
|
|
|
$
|
1,342.2
|
|
Maturities after one year through five years
|
|
2,682.9
|
|
|
1,667.0
|
|
||
|
|
$
|
4,176.0
|
|
|
$
|
3,009.2
|
|
|
Less than 12 Months
|
|
12 Months or Greater
|
|
Total
|
||||||||||||||||||
As of September 30, 2019
|
Fair Value
|
|
Unrealized Loss
|
|
Fair Value
|
|
Unrealized Loss
|
|
Fair Value
|
|
Unrealized Loss
|
||||||||||||
Corporate bonds
|
$
|
294.8
|
|
|
$
|
(0.3
|
)
|
|
$
|
216.3
|
|
|
$
|
(0.3
|
)
|
|
$
|
511.1
|
|
|
$
|
(0.6
|
)
|
U.S. government and government agency obligations
|
18.5
|
|
|
(0.1
|
)
|
|
19.5
|
|
|
—
|
|
|
38.0
|
|
|
(0.1
|
)
|
||||||
|
$
|
313.3
|
|
|
$
|
(0.4
|
)
|
|
$
|
235.8
|
|
|
$
|
(0.3
|
)
|
|
$
|
549.1
|
|
|
$
|
(0.7
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
As of December 31, 2018
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Corporate bonds
|
$
|
1,482.6
|
|
|
$
|
(6.1
|
)
|
|
$
|
801.6
|
|
|
$
|
(11.3
|
)
|
|
$
|
2,284.2
|
|
|
$
|
(17.4
|
)
|
U.S. government and government agency obligations
|
—
|
|
|
—
|
|
|
99.1
|
|
|
(1.0
|
)
|
|
99.1
|
|
|
(1.0
|
)
|
||||||
|
$
|
1,482.6
|
|
|
$
|
(6.1
|
)
|
|
$
|
900.7
|
|
|
$
|
(12.3
|
)
|
|
$
|
2,383.3
|
|
|
$
|
(18.4
|
)
|
|
|
|
Fair Value Measurements at Reporting Date Using
|
||||||||
As of September 30, 2019
|
Fair Value
|
|
Quoted Prices in
Active Markets
for Identical
Assets
(Level 1)
|
|
Significant Other
Observable Inputs
(Level 2)
|
||||||
Available-for-sale debt securities:
|
|
|
|
|
|
||||||
Corporate bonds
|
$
|
3,907.0
|
|
|
—
|
|
|
$
|
3,907.0
|
|
|
U.S. government and government agency obligations
|
66.0
|
|
|
—
|
|
|
66.0
|
|
|||
Sovereign bonds
|
27.4
|
|
|
—
|
|
|
27.4
|
|
|||
Commercial paper
|
108.8
|
|
|
—
|
|
|
108.8
|
|
|||
Certificates of deposit
|
66.8
|
|
|
—
|
|
|
66.8
|
|
|||
Equity securities (unrestricted)
|
46.9
|
|
|
$
|
46.9
|
|
|
—
|
|
||
Equity securities (restricted)
|
382.8
|
|
|
49.3
|
|
|
333.5
|
|
|||
|
$
|
4,605.7
|
|
|
$
|
96.2
|
|
|
$
|
4,509.5
|
|
|
|
|
|
|
|
||||||
As of December 31, 2018
|
|
|
|
|
|
||||||
Available-for-sale debt securities:
|
|
|
|
|
|
||||||
Corporate bonds
|
$
|
2,718.4
|
|
|
—
|
|
|
$
|
2,718.4
|
|
|
U.S. government and government agency obligations
|
109.4
|
|
|
—
|
|
|
109.4
|
|
|||
Sovereign bonds
|
7.6
|
|
|
—
|
|
|
7.6
|
|
|||
Commercial paper
|
113.8
|
|
|
—
|
|
|
113.8
|
|
|||
Certificates of deposit
|
60.0
|
|
|
—
|
|
|
60.0
|
|
|||
Equity securities (unrestricted)
|
43.6
|
|
|
$
|
43.6
|
|
|
—
|
|
||
Equity securities (restricted)
|
44.4
|
|
|
—
|
|
|
44.4
|
|
|||
|
$
|
3,097.2
|
|
|
$
|
43.6
|
|
|
$
|
3,053.6
|
|
|
September 30,
|
|
December 31,
|
||||
|
2019
|
|
2018
|
||||
Raw materials
|
$
|
229.0
|
|
|
$
|
226.8
|
|
Work-in-process
|
633.5
|
|
|
571.1
|
|
||
Finished goods
|
49.4
|
|
|
24.4
|
|
||
Deferred costs
|
432.4
|
|
|
328.9
|
|
||
|
$
|
1,344.3
|
|
|
$
|
1,151.2
|
|
|
|
Three Months Ended
September 30, 2019 |
|
Nine Months Ended
September 30, 2019 |
||||
Amortization of right-of-use assets
|
|
$
|
3.6
|
|
|
$
|
10.8
|
|
Interest on lease liabilities
|
|
6.9
|
|
|
21.4
|
|
||
|
|
$
|
10.5
|
|
|
$
|
32.2
|
|
|
|
September 30,
|
|
|
|
2019
|
|
Remaining lease term (in years)
|
|
2.42
|
|
Discount rate
|
|
2.89
|
%
|
|
|
Operating Leases
|
|
Finance Leases
|
||||
2019
|
|
$
|
1.9
|
|
|
$
|
5.7
|
|
2020
|
|
8.0
|
|
|
21.2
|
|
||
2021
|
|
6.6
|
|
|
20.1
|
|
||
2022
|
|
3.3
|
|
|
725.0
|
|
||
2023
|
|
2.0
|
|
|
—
|
|
||
2024
|
|
2.3
|
|
|
—
|
|
||
Thereafter
|
|
4.3
|
|
|
—
|
|
||
Total undiscounted lease payments
|
|
28.4
|
|
|
772.0
|
|
||
Imputed interest
|
|
(3.1
|
)
|
|
(53.2
|
)
|
||
Debt financing costs
|
|
—
|
|
|
(6.1
|
)
|
||
Total lease liabilities
|
|
$
|
25.3
|
|
|
$
|
712.7
|
|
|
|
Operating Leases
|
|
Capital and Facility Lease Obligations
|
||||
2019
|
|
$
|
10.4
|
|
|
$
|
26.4
|
|
2020
|
|
3.8
|
|
|
28.4
|
|
||
2021
|
|
3.4
|
|
|
27.9
|
|
||
2022
|
|
2.2
|
|
|
7.0
|
|
||
2023
|
|
1.5
|
|
|
—
|
|
||
Thereafter
|
|
4.1
|
|
|
—
|
|
||
|
|
$
|
25.4
|
|
|
$
|
89.7
|
|
|
|
September 30,
|
|
September 30,
|
||||
|
|
2019
|
|
2018
|
||||
Cash and cash equivalents
|
|
$
|
1,384.8
|
|
|
$
|
1,087.8
|
|
Restricted cash included in Other noncurrent assets
|
|
12.5
|
|
|
12.5
|
|
||
Total cash, cash equivalents, and restricted cash shown in the Condensed Consolidated Statement of Cash Flows
|
|
$
|
1,397.3
|
|
|
$
|
1,100.3
|
|
ITEM 2.
|
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
(In millions, except per share data)
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Revenues
|
|
$
|
2,048.4
|
|
|
$
|
1,663.5
|
|
|
$
|
5,693.9
|
|
|
$
|
4,783.0
|
|
Net income
|
|
$
|
669.6
|
|
|
$
|
594.7
|
|
|
$
|
1,323.8
|
|
|
$
|
1,624.0
|
|
Net income per share - diluted
|
|
$
|
5.86
|
|
|
$
|
5.17
|
|
|
$
|
11.54
|
|
|
$
|
14.14
|
|
Product
|
|
Disease Area(1)
|
|
Territory
|
||||||
|
|
U.S.
|
|
EU
|
|
Japan
|
|
ROW(6)
|
||
EYLEA (aflibercept) Injection(2)
|
-
|
Neovascular age-related macular degeneration (wet AMD)
|
|
a
|
|
a
|
|
a
|
|
a
|
-
|
Diabetic macular edema (DME)
|
|
a
|
|
a
|
|
a
|
|
a
|
|
-
|
Macular edema following retinal vein occlusion (RVO), which includes macular edema following central retinal vein occlusion (CRVO) and macular edema following branch retinal vein occlusion (BRVO)
|
|
a
|
|
a
|
|
a
|
|
a
|
|
-
|
Myopic choroidal neovascularization (mCNV)
|
|
|
|
a
|
|
a
|
|
a
|
|
-
|
Diabetic retinopathy
|
|
a
|
|
|
|
|
|
|
|
Dupixent (dupilumab) Injection(3)
|
-
|
Atopic dermatitis (in adults)
|
|
a
|
|
a
|
|
a
|
|
a
|
-
|
Atopic dermatitis (in adolescents)
|
|
a
|
|
a
|
|
|
|
a
|
|
-
|
Asthma (in adults and adolescents)
|
|
a
|
|
a
|
|
a
|
|
a
|
|
-
|
Chronic rhinosinusitis with nasal polyposis (CRSwNP)
|
|
a
|
|
a
|
|
|
|
|
|
Praluent (alirocumab) Injection(3)
|
-
|
LDL-lowering in heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD) (in adults)
|
|
a
|
|
a
|
|
a
|
|
a
|
-
|
Cardiovascular risk reduction in patients with established cardiovascular disease
|
|
a
|
|
a
|
|
|
|
a
|
|
Kevzara (sarilumab) Solution for Subcutaneous Injection(3)
|
-
|
Rheumatoid arthritis (RA) (in adults)
|
|
a
|
|
a
|
|
a
|
|
a
|
Libtayo (cemiplimab) Injection(3)(4)
|
-
|
Metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC)
|
|
a
|
|
a
|
|
|
|
a
|
ARCALYST® (rilonacept) Injection for Subcutaneous Use
|
-
|
Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Auto-inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS)
|
|
a
|
|
|
|
|
|
|
ZALTRAP® (ziv-aflibercept) Injection for Intravenous Infusion(5)
|
-
|
Metastatic colorectal cancer (mCRC)
|
|
a
|
|
a
|
|
a
|
|
a
|
|
|
|
|
|
|
|
||||
(1) Refer to label information in each territory for specific indication
|
||||||||||
(2) In collaboration with Bayer (outside the United States)
|
||||||||||
(3) In collaboration with Sanofi
|
||||||||||
(4) Marketed as Libtayo (cemiplimab-rwlc) Injection in the United States
|
||||||||||
(5) Pursuant to a 2015 amended and restated ZALTRAP agreement, Sanofi is solely responsible for the development and commercialization of ZALTRAP, and Sanofi pays us a percentage of aggregate net sales of ZALTRAP
|
||||||||||
(6) Rest of world. Checkmark in this column indicates that the product has received marketing approval in at least one country outside of the United States, European Union (EU), or Japan
|
Clinical Program
|
|
Phase 1
|
|
Phase 2
|
|
Phase 3
|
|
Regulatory Review(i)
|
EYLEA
|
|
|
-
|
High-dose formulation in wet AMD
|
-
|
Retinopathy of prematurity (ROP)(c)
|
|
|
Dupixent (dupilumab)(a)
Antibody to IL-4R alpha subunit
|
|
|
-
|
Grass allergy
|
-
|
Atopic dermatitis in pediatrics (6–11 years of age)(d)
|
-
|
Auto-injector for 300 mg dose (U.S., EU, and Japan)
|
|
|
-
|
Peanut allergy
|
|
|
|||
|
|
|
|
-
|
Atopic dermatitis in pediatrics (6 months–5 years of age) (Phase 2/3)(d)
|
-
|
CRSwNP (Japan)
|
|
|
|
|
|
-
|
Asthma in pediatrics (6–11 years of age)
|
|
|
|
|
|
|
|
-
|
Eosinophilic esophagitis (EOE)(c)
|
|
|
|
|
|
|
|
-
|
Chronic obstructive pulmonary disease (COPD)
|
|
|
|
Praluent (alirocumab)(a)
Antibody to PCSK9
|
|
|
|
|
-
|
Homozygous familial hypercholesterolemia (HoFH)(c) in adults and pediatrics
|
|
|
|
|
|
|
-
|
HeFH in pediatrics
|
|
|
|
Kevzara (sarilumab)(a)
Antibody to IL-6R
|
|
|
-
|
Polyarticular-course juvenile idiopathic arthritis (pcJIA)
|
-
|
Polymyalgia rheumatica (PMR)
|
|
|
|
|
-
|
Systemic juvenile idiopathic arthritis (sJIA)
|
-
|
Giant cell arteritis (GCA)
|
|
|
|
Libtayo (cemiplimab)(a)(h)
Antibody to PD-1
|
-
|
Solid tumors and advanced hematologic malignancies
|
-
|
Basal cell carcinoma (BCC) (potentially pivotal study)
|
-
|
First-line non-small cell lung cancer (NSCLC)
|
|
|
|
-
|
Metastatic or locally advanced CSCC(d)
|
-
|
Second-line cervical cancer(e)
|
|
|
||
|
|
|
|
|
-
|
Adjuvant CSCC
|
|
|
Fasinumab(b)(f) (REGN475)
Antibody to NGF
|
|
|
|
|
-
|
Osteoarthritis pain of the knee or hip(e)
|
|
|
Evinacumab(f) (REGN1500)
Antibody to ANGPTL3
|
|
|
-
|
Refractory hypercholesterolemia (both HeFH and non-FH)
|
-
|
HoFH(c)(d)
|
|
|
|
|
-
|
Severe hypertriglyceridemia
|
|
|
|
|
|
REGN1979
Bispecific antibody targeting CD20 and CD3
|
-
|
Certain B-cell malignancies(c)
(on partial clinical hold pending FDA review of protocol amendment)
|
-
|
Relapsed/refractory follicular lymphoma (FL)
|
|
|
|
|
REGN-EB3(g) (REGN3470-3471-3479)
Multi-antibody therapy to Ebola virus infection (Ebola)
|
|
|
|
|
|
|
-
|
Ebola (U.S.)(c)(d)(j)
|
|
|
|
|
|
|
|
|
|
Clinical Program (continued)
|
|
Phase 1
|
|
Phase 2
|
|
Phase 3
|
|
Regulatory Review(i)
|
Garetosmab(f) (REGN2477)
Antibody to Activin A
|
|
|
-
|
Fibrodysplasia ossificans progressiva (FOP)(c)(e) (potentially pivotal study)
|
|
|
|
|
REGN3500(a)
Antibody to IL-33. Studied as monotherapy and in combination with Dupixent.
|
|
|
-
|
Asthma
|
|
|
|
|
|
|
-
|
COPD
|
|
|
|
|
|
|
|
-
|
Atopic dermatitis
|
|
|
|
|
|
REGN1908-1909(f)
Multi-antibody therapy to Feld1
|
|
|
-
|
Cat allergy
|
|
|
|
|
Pozelimab(f) (REGN3918)
Antibody to C5
|
|
|
-
|
Paroxysmal nocturnal hemoglobinuria (PNH)(c)
|
|
|
|
|
REGN5069
Antibody to GFRα3
|
|
|
-
|
Osteoarthritis pain of the knee
|
|
|
|
|
REGN3048-3051(g)
Multi-antibody therapy to Middle East Respiratory Syndrome (MERS) virus
|
-
|
MERS virus infection
|
|
|
|
|
|
|
REGN3767(f)
Antibody to LAG-3
|
-
|
Solid tumors and advanced hematologic malignancies
|
|
|
|
|
|
|
REGN4461
Agonist antibody to leptin receptor (LEPR)
|
-
|
Lipodystrophy and obesity
|
|
|
|
|
|
|
REGN4018(a)
Bispecific antibody targeting MUC16 and CD3
|
-
|
Platinum-resistant ovarian cancer
|
|
|
|
|
|
|
REGN4659(f)
Antibody to CTLA4
|
-
|
Advanced NSCLC
|
|
|
|
|
|
|
REGN5458(a)
Bispecific antibody targeting BCMA and CD3
|
-
|
Multiple myeloma
|
|
|
|
|
|
|
REGN5459(a)
Bispecific antibody targeting BCMA and CD3
|
-
|
Multiple myeloma
|
|
|
|
|
|
|
REGN5713-5714-5715
Antibody to Betv1
|
-
|
Birch allergy
|
|
|
|
|
|
|
REGN5678
Bispecific antibody targeting PSMA and CD28
|
-
|
Prostate cancer
|
|
|
|
|
|
|
REGN5093
Bispecific antibody targeting two distinct MET epitopes
|
-
|
MET-altered advanced NSCLC
|
|
|
|
|
|
|
Note: For purposes of the table above, a program is classified in Phase 1, 2, or 3 clinical development after recruiting for the corresponding study or studies has commenced
|
||||
(a) In collaboration with Sanofi
|
||||
(b) In collaboration with Teva and Mitsubishi Tanabe Pharma
|
||||
(c) FDA granted orphan drug designation
|
||||
(d) FDA granted Breakthrough Therapy designation
|
||||
(e) FDA granted Fast Track designation
|
||||
(f) Sanofi did not opt-in to or elected not to continue to co-develop the product candidate. Under the terms of our agreement, Sanofi is entitled to receive royalties on any future sales of the product candidate.
|
||||
(g) Sanofi did not opt-in to the product candidate. Under the terms of our agreement, Sanofi is entitled to receive royalties on any future sales of the product candidate. We and the Biomedical Advanced Research Development Authority (BARDA) of the U.S. Department of Health and Human Services (HHS) are parties to agreements whereby HHS provides certain funding to support research, development, and manufacturing of these antibodies.
|
||||
(h) Studied as monotherapy and in combination with other antibodies and treatments
|
||||
(i) Information in this column relates to U.S., EU, and Japan regulatory submissions only
|
||||
(j) Included as part of the Extension Phase of a trial coordinated by World Health Organization
|
Clinical Program
|
|
2019 Events to Date
|
|
2019–2020 Milestones
(next 12 months)
|
EYLEA
|
-
|
Approved by FDA for the treatment of diabetic retinopathy
|
-
|
Initiate Phase 3 studies of a high-dose formulation of aflibercept in wet AMD and DME
|
-
|
Approved by FDA for pre-filled syringe
|
|
||
-
|
Initiated Phase 3 study in ROP
|
|
|
|
-
|
Initiated Phase 2 study using a high-dose formulation of aflibercept in wet AMD
|
|
|
|
Dupixent (dupilumab; IL-4R Antibody)
|
-
|
Approved by FDA and European Commission (EC) for expanded atopic dermatitis indication in adolescent patients (12–17 years of age)
|
-
|
Submit supplemental Biologics License Application (sBLA) and Marketing Authorization Application (MAA) for expanded atopic dermatitis indication in pediatric patients (6–11 years of age)
|
|
-
|
Reported that Phase 3 study in pediatric patients (6–11 years of age) with severe atopic dermatitis met its primary and secondary endpoints
|
-
|
Japan decision on application for CRSwNP
|
|
|
-
|
FDA decision (target action date of March 20, 2020) and final EU decision on applications for 300 mg auto-injector
|
|
|
-
|
Approved by EC for treatment of asthma in adults and adolescents
|
-
|
Resubmit sBLA for 200 mg auto-injector
|
|
-
|
Approved by FDA and EC for CRSwNP
|
-
|
Present results from Phase 2a trial in grass allergy at medical meeting
|
|
-
|
Submitted regulatory application in Japan for CRSwNP
|
-
|
Initiate Phase 3 study in pediatric patients with EOE
|
|
-
|
EMA's Committee for Medicinal Products for Human Use (CHMP) recommended approval for 300 mg auto-injector
|
-
|
Initiate Phase 3 studies in bullous pemphigoid, prurigo nodularis, chronic spontaneous urticaria, and additional type 2 inflammatory diseases
|
|
-
|
Submitted sBLA for 300 mg auto-injector
|
|
|
|
-
|
EU approval for 200 mg auto-injector
|
|
|
|
-
|
FDA issued Complete Response Letter (CRL) regarding the sBLA for 200 mg auto-injector
|
|
|
|
-
|
Initiated Phase 3 study in COPD
|
|
|
|
-
|
Completed Phase 2a trial in grass allergy
|
|
|
|
|
|
|
|
Clinical Program (continued)
|
|
2019 Events to Date
|
|
Select 2019–2020 Milestones
(next 12 months) |
Praluent (alirocumab; PCSK9 Antibody)
|
-
|
Approved by EC for a new indication to reduce cardiovascular risk in adults with established ASCVD
|
-
|
Report results from Phase 3 study in HoFH
|
|
-
|
Approved by FDA for a new indication to reduce the risk of heart attack, stroke and unstable angina requiring hospitalization in adults with established CV disease
|
|
|
|
-
|
Approved by FDA for the treatment of adults with primary hyperlipidemia (including HeFH) to reduce low-density lipoprotein cholesterol (LDL-C)
|
|
|
Libtayo (cemiplimab; PD-1 Antibody)
|
-
|
Conditionally approved by EC for treatment of advanced CSCC
|
-
|
Continue patient enrollment in NSCLC and various other studies
|
|
-
|
Initiated Phase 3 adjuvant study in CSCC
|
-
|
Report results from Phase 2 study in BCC
|
|
-
|
An independent data monitoring committee conducted an interim analysis for overall survival in a Phase 3 NSCLC trial, and recommended the trial continue as planned
|
-
|
Initiate Phase 2 neoadjuvant study in CSCC
|
Fasinumab (NGF Antibody)
|
-
|
Completed patient enrollment in Phase 3 efficacy studies and Phase 3 long-term safety study in osteoarthritis pain
|
-
|
Report results from Phase 3 studies
|
Evinacumab (ANGPTL3 Antibody)
|
-
|
Reported positive top-line results from Phase 3 trial in HoFH
|
-
|
Submit BLA and MAA for HoFH
|
REGN1979 (CD20 and CD3 Antibody)
|
-
|
Reported updated data from Phase 1 study in patients with relapsed or refractory B-cell non-Hodgkin lymphoma
|
-
|
Initiate potentially pivotal Phase 2 program in aggressive non-Hodgkin lymphoma
|
|
-
|
Began recruiting patients in Phase 2 study in relapsed/refractory FL
|
|
|
REGN-EB3 (Multi-antibody therapy to Ebola)
|
-
|
Included in randomized controlled trial coordinated by World Health Organization in the Democratic Republic of Congo (DRC)
|
-
|
Complete rolling BLA submission for Ebola
|
|
-
|
Investigational trial in the DRC was stopped early based on data showing that REGN-EB3 was superior to ZMapp in preventing death
|
|
|
|
-
|
FDA granted Breakthrough Therapy designation for the treatment of Ebola
|
|
|
|
-
|
Commenced rolling BLA submission for Ebola
|
|
|
Garetosmab (Activin A Antibody)
|
|
|
-
|
Report results from Phase 2 study in FOP
|
REGN3500 (IL-33 Antibody)
|
-
|
Reported that the Phase 2 study in asthma met its primary and key secondary endpoints
|
-
|
Initiate Phase 2b study in asthma
|
|
|
-
|
Report results from Phase 2 study in COPD
|
|
|
|
|
-
|
Report results from Phase 2 study in atopic dermatitis
|
REGN1908-1909 (Feld1 Antibody)
|
-
|
Initiated Phase 2 study in cat allergic asthmatics
|
-
|
Report results from Phase 2 study in cat allergic asthmatics
|
Pozelimab (C5 Antibody)
|
-
|
Initiated Phase 2 study in PNH
|
-
|
Report interim results from Phase 2 study in PNH
|
REGN5069 (GFRα3 Antibody)
|
-
|
Initiated Phase 2 study in osteoarthritis pain
|
|
|
|
|
|
|
|
Clinical Program (continued)
|
|
2019 Events to Date
|
|
Select 2019–2020 Milestones
(next 12 months) |
REGN3048-3051 (Multiple-antibody therapy to MERS)
|
|
|
-
|
Complete Phase 1 study in healthy volunteers
|
REGN4461 (LEPR Agonist Antibody)
|
|
|
-
|
Initiate Phase 2 study in generalized lipodystrophy
|
REGN5458 (BCMA and CD3 Antibody)
|
-
|
Initiated Phase 1 study in multiple myeloma
|
-
|
Report interim results from Phase 1 study in multiple myeloma
|
REGN5459 (BCMA and CD3 Antibody)
|
-
|
Initiated Phase 1 study in multiple myeloma
|
|
|
REGN5713-5714-5715 (Betv1 Antibody)
|
-
|
Initiated Phase 1 study in birch allergy
|
|
|
REGN5678 (PSMA and CD28 Antibody)
|
-
|
Initiated Phase 1 study in prostate cancer
|
|
|
REGN5093 (MET Antibody)
|
-
|
Initiated Phase 1 study in MET-altered advanced NSCLC
|
|
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
(In millions, except per share data)
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Revenues
|
|
$
|
2,048.4
|
|
|
$
|
1,663.5
|
|
|
$
|
5,693.9
|
|
|
$
|
4,783.0
|
|
Operating expenses
|
|
(1,309.9
|
)
|
|
(1,036.6
|
)
|
|
(4,159.8
|
)
|
|
(2,966.7
|
)
|
||||
Income from operations
|
|
738.5
|
|
|
626.9
|
|
|
1,534.1
|
|
|
1,816.3
|
|
||||
Other income (expense), net
|
|
30.0
|
|
|
9.0
|
|
|
5.2
|
|
|
61.0
|
|
||||
Income before income taxes
|
|
768.5
|
|
|
635.9
|
|
|
1,539.3
|
|
|
1,877.3
|
|
||||
Income tax expense
|
|
(98.9
|
)
|
|
(41.2
|
)
|
|
(215.5
|
)
|
|
(253.3
|
)
|
||||
Net income
|
|
$
|
669.6
|
|
|
$
|
594.7
|
|
|
$
|
1,323.8
|
|
|
$
|
1,624.0
|
|
|
|
|
|
|
|
|
|
|
||||||||
Net income per share - diluted
|
|
$
|
5.86
|
|
|
$
|
5.17
|
|
|
$
|
11.54
|
|
|
$
|
14.14
|
|
|
|
Three Months Ended
September 30, |
|
Increase
|
|
Nine Months Ended
September 30, |
|
Increase
|
||||||||||||||||
(In millions)
|
|
2019
|
|
2018
|
|
(Decrease)
|
|
2019
|
|
2018
|
|
(Decrease)
|
||||||||||||
Net product sales in the United States:
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
EYLEA
|
|
$
|
1,187.7
|
|
|
$
|
1,021.8
|
|
|
$
|
165.9
|
|
|
$
|
3,422.1
|
|
|
$
|
2,997.8
|
|
|
$
|
424.3
|
|
Libtayo
|
|
47.6
|
|
|
—
|
|
|
47.6
|
|
|
115.2
|
|
|
—
|
|
|
115.2
|
|
||||||
ARCALYST
|
|
3.0
|
|
|
3.7
|
|
|
(0.7
|
)
|
|
10.7
|
|
|
12.0
|
|
|
(1.3
|
)
|
||||||
Sanofi and Bayer collaboration revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Sanofi
|
|
404.2
|
|
|
256.3
|
|
|
147.9
|
|
|
999.7
|
|
|
683.5
|
|
|
316.2
|
|
||||||
Bayer
|
|
302.8
|
|
|
264.4
|
|
|
38.4
|
|
|
868.0
|
|
|
775.2
|
|
|
92.8
|
|
||||||
Other revenue
|
|
103.1
|
|
|
117.3
|
|
|
(14.2
|
)
|
|
278.2
|
|
|
314.5
|
|
|
(36.3
|
)
|
||||||
Total revenues
|
|
$
|
2,048.4
|
|
|
$
|
1,663.5
|
|
|
$
|
384.9
|
|
|
$
|
5,693.9
|
|
|
$
|
4,783.0
|
|
|
$
|
910.9
|
|
(In millions)
|
Rebates, Chargebacks, and Discounts
|
|
Distribution-Related Fees
|
|
Other Sales-Related Deductions
|
|
Total
|
||||||||
Balance as of December 31, 2018
|
$
|
41.1
|
|
|
$
|
42.0
|
|
|
$
|
8.3
|
|
|
$
|
91.4
|
|
Provisions
|
78.6
|
|
|
52.8
|
|
|
16.1
|
|
|
147.5
|
|
||||
Credits/payments
|
(60.8
|
)
|
|
(47.9
|
)
|
|
(0.4
|
)
|
|
(109.1
|
)
|
||||
Balance as of March 31, 2019
|
58.9
|
|
|
46.9
|
|
|
24.0
|
|
|
129.8
|
|
||||
Provisions
|
106.5
|
|
|
61.2
|
|
|
17.2
|
|
|
184.9
|
|
||||
Credits/payments
|
(78.7
|
)
|
|
(40.0
|
)
|
|
(30.5
|
)
|
|
(149.2
|
)
|
||||
Balance as of June 30, 2019
|
86.7
|
|
|
68.1
|
|
|
10.7
|
|
|
165.5
|
|
||||
Provisions
|
115.9
|
|
|
63.3
|
|
|
12.7
|
|
|
191.9
|
|
||||
Credits/payments
|
(126.3
|
)
|
|
(84.6
|
)
|
|
(9.8
|
)
|
|
(220.7
|
)
|
||||
Balance as of September 30, 2019
|
$
|
76.3
|
|
|
$
|
46.8
|
|
|
$
|
13.6
|
|
|
$
|
136.7
|
|
|
|
|
|
|
|
|
|
||||||||
Balance as of December 31, 2017
|
$
|
29.9
|
|
|
$
|
34.1
|
|
|
$
|
21.3
|
|
|
$
|
85.3
|
|
Provisions
|
48.5
|
|
|
51.7
|
|
|
11.2
|
|
|
111.4
|
|
||||
Credits/payments
|
(30.7
|
)
|
|
(42.0
|
)
|
|
(14.7
|
)
|
|
(87.4
|
)
|
||||
Balance as of March 31, 2018
|
47.7
|
|
|
43.8
|
|
|
17.8
|
|
|
109.3
|
|
||||
Provisions
|
49.2
|
|
|
50.4
|
|
|
8.7
|
|
|
108.3
|
|
||||
Credits/payments
|
(60.4
|
)
|
|
(56.5
|
)
|
|
(9.7
|
)
|
|
(126.6
|
)
|
||||
Balance as of June 30, 2018
|
36.5
|
|
|
37.7
|
|
|
16.8
|
|
|
91.0
|
|
||||
Provisions
|
61.4
|
|
|
53.4
|
|
|
9.8
|
|
|
124.6
|
|
||||
Credits/payments
|
(54.8
|
)
|
|
(52.4
|
)
|
|
(11.3
|
)
|
|
(118.5
|
)
|
||||
Balance as of September 30, 2018
|
$
|
43.1
|
|
|
$
|
38.7
|
|
|
$
|
15.3
|
|
|
$
|
97.1
|
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
(In millions)
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Antibody:
|
|
|
|
|
|
|
|
|
||||||||
Reimbursement of Regeneron research and development expenses - License and Collaboration Agreement
|
|
$
|
60.2
|
|
|
$
|
76.2
|
|
|
$
|
216.5
|
|
|
$
|
201.0
|
|
Reimbursement of Regeneron commercialization-related expenses(1)
|
|
111.6
|
|
|
103.7
|
|
|
349.3
|
|
|
292.8
|
|
||||
Reimbursement for Regeneron's manufacturing of commercial supplies(2)
|
|
78.5
|
|
|
40.3
|
|
|
133.3
|
|
|
94.4
|
|
||||
Regeneron's share of profits (losses) in connection with commercialization of antibodies
|
|
94.2
|
|
|
(38.9
|
)
|
|
105.2
|
|
|
(182.6
|
)
|
||||
Other
|
|
4.8
|
|
|
(7.2
|
)
|
|
(0.6
|
)
|
|
(12.3
|
)
|
||||
Total Antibody
|
|
349.3
|
|
|
174.1
|
|
|
803.7
|
|
|
393.3
|
|
||||
Immuno-oncology:
|
|
|
|
|
|
|
|
|
||||||||
Reimbursement of Regeneron research and development expenses - Discovery Agreement
|
|
12.9
|
|
|
34.7
|
|
|
37.8
|
|
|
108.4
|
|
||||
Reimbursement of Regeneron research and development expenses - License and Collaboration Agreement
|
|
25.1
|
|
|
40.1
|
|
|
83.1
|
|
|
117.3
|
|
||||
Reimbursement of Regeneron commercialization-related expenses(1)
|
|
3.0
|
|
|
3.2
|
|
|
7.0
|
|
|
6.5
|
|
||||
Amounts recognized in connection with up-front payments received
|
|
18.5
|
|
|
7.9
|
|
|
73.8
|
|
|
65.2
|
|
||||
Other
|
|
(4.6
|
)
|
|
(3.7
|
)
|
|
(5.7
|
)
|
|
(7.2
|
)
|
||||
Total Immuno-oncology
|
|
54.9
|
|
|
82.2
|
|
|
196.0
|
|
|
290.2
|
|
||||
Total Sanofi collaboration revenue
|
|
$
|
404.2
|
|
|
$
|
256.3
|
|
|
$
|
999.7
|
|
|
$
|
683.5
|
|
|
|
|
|
|
|
|
|
|
||||||||
(1) The corresponding commercialization-related costs incurred by us are recorded within Selling, general and administrative expense.
|
||||||||||||||||
(2) The corresponding costs incurred by us in connection with such production is recorded within Cost of collaboration and contract manufacturing.
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
(In millions)
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Regeneron's net profit in connection with commercialization of EYLEA outside the United States
|
|
$
|
275.0
|
|
|
$
|
243.2
|
|
|
$
|
793.3
|
|
|
$
|
721.5
|
|
Reimbursement of Regeneron development expenses
|
|
5.0
|
|
|
0.5
|
|
|
15.6
|
|
|
8.3
|
|
||||
Other
|
|
22.8
|
|
|
20.7
|
|
|
59.1
|
|
|
45.4
|
|
||||
Total Bayer collaboration revenue
|
|
$
|
302.8
|
|
|
$
|
264.4
|
|
|
$
|
868.0
|
|
|
$
|
775.2
|
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
(In millions)
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
EYLEA net product sales outside the United States
|
|
$
|
730.2
|
|
|
$
|
654.6
|
|
|
$
|
2,114.9
|
|
|
$
|
1,944.5
|
|
Regeneron's share of collaboration profit from sales outside the United States
|
|
$
|
289.2
|
|
|
$
|
256.7
|
|
|
$
|
835.5
|
|
|
$
|
761.1
|
|
Reimbursement of development expenses incurred by Bayer in accordance with Regeneron's payment obligation
|
|
(14.2
|
)
|
|
(13.5
|
)
|
|
(42.2
|
)
|
|
(39.6
|
)
|
||||
Regeneron's net profit in connection with commercialization of EYLEA outside the United States
|
|
$
|
275.0
|
|
|
$
|
243.2
|
|
|
$
|
793.3
|
|
|
$
|
721.5
|
|
|
|
|
|
|
|
|
|
|
||||||||
Regeneron's net profit as a percentage of EYLEA net product sales outside the United States
|
|
38
|
%
|
|
37
|
%
|
|
38
|
%
|
|
37
|
%
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
(In millions)
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Teva collaboration revenue:
|
|
|
|
|
|
|
|
|
||||||||
Reimbursement of Regeneron research and development expenses
|
|
$
|
34.2
|
|
|
$
|
27.6
|
|
|
$
|
102.9
|
|
|
$
|
101.1
|
|
Other
|
|
23.2
|
|
|
41.5
|
|
|
69.3
|
|
|
95.5
|
|
||||
Total Teva collaboration revenue
|
|
57.4
|
|
|
69.1
|
|
|
172.2
|
|
|
196.6
|
|
||||
Other revenue
|
|
45.7
|
|
|
48.2
|
|
|
106.0
|
|
|
117.9
|
|
||||
Total other revenue
|
|
$
|
103.1
|
|
|
$
|
117.3
|
|
|
$
|
278.2
|
|
|
$
|
314.5
|
|
•
|
Recognition of a portion of deferred revenue from up-front and other payments received from MTPC in connection with our fasinumab collaboration.
|
•
|
Sanofi's reimbursement for manufacturing commercial supplies of ZALTRAP and a percentage of aggregate net sales of ZALTRAP under the terms of the Amended ZALTRAP Agreement.
|
•
|
Royalties in connection with a June 2009 agreement with Novartis, under which we receive royalties on worldwide sales of Novartis' Ilaris® (canakinumab). The royalty rates in the agreement start at 4% and reach 15% when annual sales exceed $1.5 billion, and we are entitled to royalties until Novartis ceases sale of products subject to royalty.
|
•
|
Recognition of revenue in connection with our agreements with BARDA related to REGN-EB3 for the treatment of Ebola.
|
•
|
Recognition of revenue in connection with sequencing of samples by the Regeneron Genetics Center® (RGC) for its customers.
|
|
|
Three Months Ended
September 30, |
|
Increase
|
|
Nine Months Ended
September 30, |
|
Increase
|
||||||||||||||||
(In millions, except headcount data)
|
|
2019
|
|
2018
|
|
(Decrease)
|
|
2019
|
|
2018
|
|
(Decrease)
|
||||||||||||
Research and development
|
|
$
|
663.4
|
|
|
$
|
557.0
|
|
|
$
|
106.4
|
|
|
$
|
2,353.5
|
|
|
$
|
1,584.8
|
|
|
$
|
768.7
|
|
Selling, general, and administrative
|
|
419.9
|
|
|
369.2
|
|
|
50.7
|
|
|
1,248.0
|
|
|
1,064.9
|
|
|
183.1
|
|
||||||
Cost of goods sold(1)
|
|
115.9
|
|
|
30.8
|
|
|
85.1
|
|
|
253.8
|
|
|
136.1
|
|
|
117.7
|
|
||||||
Cost of collaboration and contract manufacturing(2)
|
|
110.7
|
|
|
79.6
|
|
|
31.1
|
|
|
304.5
|
|
|
180.9
|
|
|
123.6
|
|
||||||
Total operating expenses
|
|
$
|
1,309.9
|
|
|
$
|
1,036.6
|
|
|
$
|
273.3
|
|
|
$
|
4,159.8
|
|
|
$
|
2,966.7
|
|
|
$
|
1,193.1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Average headcount
|
|
7,925
|
|
|
7,147
|
|
|
778
|
|
|
7,674
|
|
|
6,763
|
|
|
911
|
|
||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
(1) Cost of goods sold includes costs in connection with producing commercial supplies for products that are sold by Regeneron in the United States (i.e., EYLEA, Libtayo, and ARCALYST) and any royalties we are obligated to pay on such sales, period costs for our Limerick manufacturing facility, and amounts we are obligated to pay to Sanofi for its share of Libtayo U.S. gross profits.
|
||||||||||||||||||||||||
(2) Cost of collaboration and contract manufacturing primarily includes costs we incur in connection with producing commercial drug supplies for Sanofi and Bayer.
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
(In millions, except effective tax rate)
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Income tax expense
|
|
$
|
98.9
|
|
|
$
|
41.2
|
|
|
$
|
215.5
|
|
|
$
|
253.3
|
|
Effective tax rate
|
|
12.9
|
%
|
|
6.5
|
%
|
|
14.0
|
%
|
|
13.5
|
%
|
|
September 30,
|
|
December 31,
|
|
Increase
|
||||||
(In millions)
|
2019
|
|
2018
|
|
(Decrease)
|
||||||
Financial assets:
|
|
|
|
|
|
||||||
Cash and cash equivalents
|
$
|
1,384.8
|
|
|
$
|
1,467.7
|
|
|
$
|
(82.9
|
)
|
Marketable securities - current
|
1,493.1
|
|
|
1,342.2
|
|
|
150.9
|
|
|||
Marketable securities - noncurrent
|
3,112.6
|
|
|
1,755.0
|
|
|
1,357.6
|
|
|||
|
$
|
5,990.5
|
|
|
$
|
4,564.9
|
|
|
$
|
1,425.6
|
|
|
|
|
|
|
|
||||||
Working capital:
|
|
|
|
|
|
||||||
Current assets
|
$
|
7,109.1
|
|
|
$
|
6,447.6
|
|
|
$
|
661.5
|
|
Current liabilities
|
1,765.4
|
|
|
1,442.8
|
|
|
322.6
|
|
|||
|
$
|
5,343.7
|
|
|
$
|
5,004.8
|
|
|
$
|
338.9
|
|
|
September 30,
|
|
September 30,
|
|
Increase
|
||||||
(In millions)
|
2019
|
|
2018
|
|
(Decrease)
|
||||||
Cash flows provided by operating activities
|
$
|
1,642.6
|
|
|
$
|
1,466.3
|
|
|
$
|
176.3
|
|
Cash flows used in investing activities
|
$
|
(1,819.1
|
)
|
|
$
|
(1,197.1
|
)
|
|
$
|
(622.0
|
)
|
Cash flows provided by financing activities
|
$
|
93.6
|
|
|
$
|
5.9
|
|
|
$
|
87.7
|
|
•
|
effectiveness of the commercial strategy in and outside the United States for the marketing of our products, including pricing strategy;
|
•
|
sufficient coverage of, and reimbursement for, our marketed products by third-party payers, including Medicare and Medicaid in the United States and other government and private payers in the United States and foreign jurisdictions, as well as U.S. and foreign payer restrictions on eligible patient populations and the reimbursement process (including drug price control measures that may be introduced in the United States by various federal and state authorities);
|
•
|
our ability and our collaborators' ability to maintain sales of our marketed products in the face of competitive products and to differentiate our marketed products from competitive products, including as applicable product candidates currently in clinical development; and, in the case of EYLEA, the existing and potential new competition for EYLEA (discussed further under "The commercial success of our products and product candidates is subject to strong competition - Marketed Products - EYLEA" below) and the willingness of retinal specialists and patients to switch from Lucentis® (ranibizumab) or off-label use of repackaged Avastin® (bevacizumab) to EYLEA or to start treatment with EYLEA;
|
•
|
serious complications or side effects in connection with the use of our marketed products, as discussed under "Risks Related to Maintaining Approval of Our Marketed Products and the Development and Obtaining Approval of Our Product Candidates and New Indications for Our Marketed Products - Serious complications or side effects in connection with the use of our products and in clinical trials for our product candidates and new indications for our marketed products could cause our regulatory approvals to be revoked or limited or lead to delay or discontinuation of development of our product candidates or new indications for our marketed products, which could severely harm our business, prospects, operating results, and financial condition" below;
|
•
|
maintaining and successfully monitoring commercial manufacturing arrangements for our marketed products with third parties who perform fill/finish or other steps in the manufacture of such products to ensure that they meet our standards and those of regulatory authorities, including the FDA, which extensively regulate and monitor pharmaceutical manufacturing facilities;
|
•
|
our ability to meet the demand for commercial supplies of our marketed products;
|
•
|
the outcome of the pending patent infringement proceedings relating to Dupixent and Praluent (described further in Note 11 to our Condensed Consolidated Financial Statements included in this report), as well as other risks relating to our marketed products associated with intellectual property of other parties and pending or future litigation relating thereto (as discussed under "Risks Related to Intellectual Property and Market Exclusivity" below);
|
•
|
the outcome of the pending government investigations described in Note 11 to our Condensed Consolidated Financial Statements included in this report;
|
•
|
the results of post-approval studies, whether conducted by us or by others and whether mandated by regulatory agencies or voluntary, and studies of other products that could implicate an entire class of products or are perceived to do so; and
|
•
|
the effect of existing and new health care laws and regulations currently being considered or implemented in the United States, including price reporting and other disclosure requirements of such laws and regulations and the potential impact of such requirements on physician prescribing practices and payer coverage.
|
•
|
changes in the FDA and foreign regulatory processes for new therapeutics that may delay or prevent the approval of any of our current or future product candidates;
|
•
|
new laws, regulations, or judicial decisions related to healthcare availability or the payment for healthcare products and services, including prescription drugs, that would make it more difficult for us to market and sell products once they are approved by the FDA or foreign regulatory agencies;
|
•
|
changes in FDA and foreign regulations that may require additional safety monitoring prior to or after the introduction of new products to market, which could materially increase our costs of doing business; and
|
•
|
changes in FDA and foreign cGMPs that may make it more difficult and costly for us to maintain regulatory compliance and/or manufacture our marketed product and product candidates in accordance with cGMPs.
|
•
|
unfamiliar foreign laws or regulatory requirements or unexpected changes to those laws or requirements;
|
•
|
other laws and regulatory requirements to which our business activities abroad are subject, such as the FCPA and the U.K. Bribery Act (discussed in greater detail above under "Risks from the improper conduct of employees, agents, contractors, or collaborators could adversely affect our reputation and our business, prospects, operating results, and financial condition");
|
•
|
changes in the political or economic condition of a specific country or region;
|
•
|
fluctuations in the value of foreign currency versus the U.S. dollar;
|
•
|
tariffs, trade protection measures, import or export licensing requirements, trade embargoes, and sanctions (including those administered by the Office of Foreign Assets Control of the U.S. Department of the Treasury), and other trade barriers;
|
•
|
difficulties in attracting and retaining qualified personnel; and
|
•
|
cultural differences in the conduct of business.
|
•
|
net product sales of our marketed products (as recorded by us or our collaborators), in particular EYLEA, Dupixent, and Libtayo, as well as our overall operating results;
|
•
|
if any of our product candidates or our new indications for our marketed products receive regulatory approval, net product sales of, and profits from, these product candidates and new indications;
|
•
|
market acceptance of, and the market share for, our marketed products, especially EYLEA, Dupixent, and Libtayo;
|
•
|
whether our net product sales and net profits underperform, meet, or exceed the expectations of investors or analysts;
|
•
|
announcement of actions by the FDA or foreign regulatory authorities or their respective advisory committees regarding our, or our collaborators', or our competitors', currently pending or future application(s) for regulatory approval of product candidate(s) or new indications for marketed products;
|
•
|
announcement of submission of an application for regulatory approval of one or more of our, or our competitors', product candidates or new indications for marketed products;
|
•
|
progress, delays, or results in clinical trials of our or our competitors' product candidates or new indications for marketed products;
|
•
|
announcement of technological innovations or product candidates by us or competitors;
|
•
|
claims by others that our products or technologies infringe their patents;
|
•
|
challenges by others to our patents in the EPO and in the USPTO;
|
•
|
public concern as to the safety or effectiveness of any of our marketed products or product candidates or new indications for our marketed products;
|
•
|
pricing or reimbursement actions, decisions, or recommendations by government authorities, insurers, or other organizations (such as health maintenance organizations and pharmacy benefit management companies) affecting the coverage, reimbursement, or use of any of our marketed products or competitors' products;
|
•
|
our ability to raise additional capital as needed on favorable terms;
|
•
|
developments in our relationships with collaborators or key customers;
|
•
|
developments in the biotechnology industry or in government regulation of healthcare, including those relating to compounding (i.e., a practice in which a pharmacist, a physician, or, in the case of an outsourcing facility, a person under the supervision of a pharmacist, combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient);
|
•
|
large sales of our Common Stock by our executive officers, directors, or significant shareholders;
|
•
|
changes in tax rates, laws, or interpretation of tax laws;
|
•
|
arrivals and departures of key personnel;
|
•
|
general market conditions;
|
•
|
our ability to repurchase our Common Stock under any share repurchase program on favorable terms or at all;
|
•
|
trading activity that results from the rebalancing of stock indices in which our Common Stock is included, or the inclusion or exclusion of our Common Stock from such indices;
|
•
|
other factors identified in these "Risk Factors"; and
|
•
|
the perception by the investment community or our shareholders of any of the foregoing factors.
|
•
|
our current executive officers and directors beneficially owned 9.5% of our outstanding shares of Common Stock, assuming conversion of their Class A Stock into Common Stock and the exercise of all options held by such persons which are exercisable within 60 days of September 30, 2019, and 20.3% of the combined voting power of our outstanding shares of Common Stock and Class A Stock, assuming the exercise of all options held by such persons which are exercisable within 60 days of September 30, 2019; and
|
•
|
our five largest shareholders (including our largest shareholder Sanofi) plus Dr. Schleifer, our Chief Executive Officer, beneficially owned approximately 44.8% of our outstanding shares of Common Stock, assuming, in the case of our Chief Executive Officer, the conversion of his Class A Stock into Common Stock and the exercise of all options held by him which are exercisable within 60 days of September 30, 2019. In addition, these five shareholders plus our Chief Executive Officer held approximately 51.1% of the combined voting power of our outstanding shares of Common Stock and Class A Stock, assuming the exercise of all options held by our Chief Executive Officer which are exercisable within 60 days of September 30, 2019.
|
•
|
authorization to issue "blank check" preferred stock, which is preferred stock that can be created and issued by the board of directors without prior shareholder approval, with rights senior to those of our Common Stock and Class A Stock;
|
•
|
a staggered board of directors, so that it would take three successive annual shareholder meetings to replace all of our directors;
|
•
|
a requirement that removal of directors may only be effected for cause and only upon the affirmative vote of at least eighty percent (80%) of the outstanding shares entitled to vote for directors, as well as a requirement that any vacancy on the board of directors may be filled only by the remaining directors;
|
•
|
a provision whereby any action required or permitted to be taken at any meeting of shareholders may be taken without a meeting, only if, prior to such action, all of our shareholders consent, the effect of which is to require that shareholder action may only be taken at a duly convened meeting;
|
•
|
a requirement that any shareholder seeking to bring business before an annual meeting of shareholders must provide timely notice of this intention in writing and meet various other requirements; and
|
•
|
under the New York Business Corporation Law, in addition to certain restrictions which may apply to "business combinations" involving our Company and an "interested shareholder," a plan of merger or consolidation of our Company must be approved by two-thirds of the votes of all outstanding shares entitled to vote thereon. See the risk factor above captioned "Our existing shareholders may be able to exert significant influence over matters requiring shareholder approval and over our management."
|
Period
|
|
Total Number of Shares (or Units) Purchased
|
|
Average Price Paid per Share (or Unit)
|
|
Total Number of Shares (or Units) Purchased as Part of Publicly Announced Plans or Programs
|
|
Maximum Number (or Approximate Dollar Value) of Shares (or Units) that May Yet Be Purchased Under the Plans or Programs
|
|||||
|
|
|
|
|
|
|
|
|
|||||
9/1/2019–9/30/2019
|
|
172,904
|
|
|
$
|
281.15
|
|
|
—
|
|
|
—
|
|
Exhibit Number
|
|
Description
|
31.1
|
|
|
31.2
|
|
|
32
|
|
|
101
|
|
Interactive Data Files pursuant to Rule 405 of Regulation S-T formatted in Inline Extensible Business Reporting Language ("Inline XBRL"): (i) the Registrant's Condensed Consolidated Balance Sheets as of September 30, 2019 and December 31, 2018; (ii) the Registrant's Condensed Consolidated Statements of Operations and Comprehensive Income for the three and nine months ended September 30, 2019 and 2018; (iii) the Registrant's Condensed Consolidated Statements of Stockholders’ Equity for the three and nine months ended September 30, 2019 and 2018; (iv) the Registrant's Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2019 and 2018; and (v) the notes to the Registrant's Condensed Consolidated Financial Statements.
|
104
|
|
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).
|
|
|
|
REGENERON PHARMACEUTICALS, INC.
|
|
|
|
|
|
|
|
|
Date:
|
November 5, 2019
|
|
By:
|
/s/ Robert E. Landry
|
|
|
|
|
|
|
|
|
|
|
|
Robert E. Landry
|
|
|
|
|
|
Executive Vice President, Finance and
|
|
|
|
|
|
Chief Financial Officer
|
|
|
|
|
|
(Duly Authorized Officer)
|
|
1 Year Regeneron Pharmaceuticals Chart |
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