Regeneron Pharmaceuticals, Inc.
REGENERON PHARMACEUTICALS INC (Form: 10-Q, Received: 05/03/2013 10:21:06)



UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 10-Q
 
(Mark One)
 
 
(X)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 
 
 
 
 
 
 
For the quarterly period ended   March 31, 2013
 
 
 
 
 

OR
 
 
 
 
 
 
( )
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 
 
 
 
 
 
 
For the transition period from __________ to __________
 
 

 
Commission File Number  
0-19034
 
REGENERON PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
New York
 
13-3444607
(State or other jurisdiction of
 
(I.R.S. Employer Identification No.)
incorporation or organization)
 
 
 
 
 
777 Old Saw Mill River Road, Tarrytown, New York
 
10591-6707
(Address of principal executive offices)
 
(Zip Code)
 
 
 
(914) 847-7000
(Registrant’s telephone number, including area code)

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.
Yes 
X

No 
 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted 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 and post such files).
Yes 
X

No 
 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer”, “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer
X   
 
Accelerated filer

Non-accelerated filer
 
(Do not check if a smaller reporting company)
Smaller reporting company


Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Yes 
 

No 
X
 
Number of shares outstanding of each of the registrant’s classes of common stock as of April 17, 2013:
Class of Common Stock
 
Number of Shares
Class A Stock, $0.001 par value
 
2,058,057
Common Stock, $0.001 par value
 
95,908,088



Table of Contents

REGENERON PHARMACEUTICALS, INC.
QUARTERLY REPORT ON FORM 10-Q
TABLE OF CONTENTS

 
 
 
 
Page Numbers
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
"ARCALYST ® ", "EYLEA ® ", "ZALTRAP ® , “VelocImmune ® , “VelociGene ® , ”VelociMouse ® , “VelociMab ® , and “VelociSuite  are trademarks of Regeneron Pharmaceuticals, Inc. All other trademarks in this Form 10-Q are the property of their respective owners.



2


Table of Contents

PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
REGENERON PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited)
(In thousands, except share data)
 
March 31,
 
December 31,
 
2013
 
2012
ASSETS
Current assets:
 
 
 
Cash and cash equivalents
$
180,362

 
$
230,276

Marketable securities
127,348

 
77,819

Accounts receivable - trade, net
703,857

 
593,207

Accounts receivable from Sanofi
98,781

 
99,913

Deferred tax assets
99,632

 
148,134

Prepaid expenses and other current assets
97,142

 
56,663

Total current assets
1,307,122

 
1,206,012

 
 
 
 
Restricted cash and marketable securities
8,494

 
8,186

Marketable securities
346,607

 
271,230

Property, plant, and equipment, at cost, net of accumulated depreciation and amortization
392,378

 
379,940

Deferred tax assets
201,319

 
192,022

Other assets
20,078

 
23,100

Total assets
$
2,275,998

 
$
2,080,490

LIABILITIES and STOCKHOLDERS' EQUITY
Current liabilities:
 
 
 
Accounts payable and accrued expenses
$
145,413

 
$
111,345

Deferred revenue from Sanofi, current portion
15,967

 
17,022

Deferred revenue - other, current portion
34,391

 
33,809

Facility lease obligations, current portion
1,473

 
1,374

Total current liabilities
197,244

 
163,550

 
 
 
 
Deferred revenue from Sanofi
76,909

 
76,520

Deferred revenue - other
125,436

 
131,822

Facility lease obligations
159,007

 
159,436

Convertible senior notes
302,268

 
296,518

Other long term liabilities
8,786

 
7,259

Total liabilities
869,650

 
835,105

 
 
 
 
Commitments and contingencies


 


 
 
 
 
Stockholders' equity:
 
 
 
Preferred stock, $.01 par value; 30,000,000 shares authorized; issued and outstanding - none


 


Class A Stock, convertible, $.001 par value; 40,000,000 shares authorized; shares issued and outstanding - 2,058,057 at March 31, 2013 and 2,069,187 at December 31, 2012
2

 
2

Common Stock, $.001 par value; 160,000,000 shares authorized; shares issued and outstanding - 95,650,666 at March 31, 2013 and 95,223,525 at December 31, 2012
95

 
95

Additional paid-in capital
1,826,075

 
1,763,508

Accumulated deficit
(418,180
)
 
(517,054
)
Accumulated other comprehensive loss
(1,644
)
 
(1,166
)
Total stockholders' equity
1,406,348

 
1,245,385

Total liabilities and stockholders' equity
$
2,275,998

 
$
2,080,490

The accompanying notes are an integral part of the financial statements.

3


Table of Contents

REGENERON PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (Unaudited)
(In thousands, except per share data)
 
 
Three months ended March 31,
 
 
2013
 
2012
Statements of Operations
 
 
 
 
Revenues:
 
 
 
 
Net product sales
 
$
318,740

 
$
127,931

Sanofi collaboration revenue
 
99,273

 
85,005

Bayer HealthCare collaboration revenue
 
14,907

 
12,483

Technology licensing
 
5,893

 
5,893

Other revenue
 
851

 
477

 
 
439,664

 
231,789

 
 
 
 
 
Expenses:
 
 
 
 
Research and development
 
180,299

 
138,862

Selling, general, and administrative
 
77,260

 
58,428

Cost of goods sold
 
29,055

 
12,298

 
 
286,614

 
209,588

 
 
 
 
 
Income from operations
 
153,050

 
22,201

 
 
 
 
 
Other income (expense):
 
 
 
 
Investment income
 
456

 
610

Interest expense
 
(11,675
)
 
(11,160
)
 
 
(11,219
)
 
(10,550
)
 
 
 
 
 
Income before income taxes
 
141,831

 
11,651

 
 
 
 
 
Income tax expense
 
(42,957
)
 

 
 
 
 
 
Net income
 
$
98,874

 
$
11,651

 
 
 
 
 
Net income per share - basic
 
$
1.02

 
$
0.12

Net income per share - diluted
 
$
0.90

 
$
0.11

 
 
 
 
 
Weighted average shares outstanding - basic
 
96,878

 
93,446

Weighted average shares outstanding - diluted
 
109,369

 
107,734

 
 
 
 
 
Statements of Comprehensive Income
 
 
 
 
Net income
 
$
98,874

 
$
11,651

Other comprehensive (loss) income:
 
 
 
 
Unrealized (loss) gain on marketable securities, net of tax
 
(478
)
 
525

Comprehensive income
 
$
98,396

 
$
12,176

 
 
 
 
 
The accompanying notes are an integral part of the financial statements.



4


REGENERON PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (Unaudited)
For the Three Months Ended March 31, 2013 and 2012
(In thousands)
 
 
Class A Stock
 
Common Stock
 
Additional Paid-in Capital
 
Accumulated Deficit
 
Accumulated Other Comprehensive Income (Loss)
 
Total Stockholders' Equity
 
 
Shares
 
Amount
 
Shares
 
Amount
 
 
 
 
Balance, December 31, 2012
 
2,069

 
$
2

 
95,223

 
$
95

 
$
1,763,508

 
$
(517,054
)
 
$
(1,166
)
 
$
1,245,385

Issuance of Common Stock in connection with exercise of stock options
 
 
 
 
 
396

 

 
9,804

 
 
 
 
 
9,804

Common Stock tendered upon exercise of stock options in connection with employee tax obligations
 
 
 
 
 
(17
)
 

 
(3,085
)
 
 
 
 
 
(3,085
)
Issuance of Common Stock in connection with Company 401(k) Savings Plan contribution
 
 
 
 
 
38

 
 
 

 
 
 
 
 

Conversion of Class A Stock to Common Stock
 
(11
)
 
 
 
11

 
 
 
 
 
 
 
 
 
 
Stock-based compensation charges
 
 
 
 
 
 
 
 
 
53,555

 
 
 
 
 
53,555

Excess tax benefit from stock-based compensation
 
 
 
 
 
 
 
 
 
2,293

 
 
 
 
 
2,293

Net income
 
 
 
 
 
 
 
 
 
 
 
98,874

 
 
 
98,874

Other comprehensive loss, net of tax
 
 
 
 
 
 
 
 
 
 
 
 
 
(478
)
 
(478
)
Balance, March 31, 2013
 
2,058

 
$
2


95,651


$
95


$
1,826,075


$
(418,180
)

$
(1,644
)

$
1,406,348

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Balance, December 31, 2011
 
2,109

 
$
2

 
90,692

 
$
91

 
$
1,754,824

 
$
(1,267,323
)
 
$
(1,862
)
 
$
(49,078
)
Issuance of Common Stock in connection with exercise of stock options
 
 
 
 
 
2,662

 
2

 
31,744

 
 
 
 
 
31,746

Common Stock tendered upon exercise of stock options in connection with employee tax obligations
 
 
 
 
 
(469
)
 

 
(49,078
)
 
 
 
 
 
(49,078
)
Issuance of Common Stock in connection with Company 401(k) Savings Plan contribution
 
 
 
 
 
64

 
 
 

 
 
 
 
 

Conversion of Class A Stock to Common Stock
 
(20
)
 
 
 
20

 
 
 
 
 
 
 
 
 

Stock-based compensation charges
 
 
 
 
 
 
 
 
 
23,448

 
 
 
 
 
23,448

Net income
 
 
 
 
 
 
 
 
 
 
 
11,651

 
 
 
11,651

Other comprehensive income
 
 
 
 
 
 
 
 
 
 
 
 
 
525

 
525

Balance, March 31, 2012
 
2,089

 
$
2


92,969


$
93


$
1,760,938


$
(1,255,672
)

$
(1,337
)

$
(30,786
)
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The accompanying notes are an integral part of the financial statements.


5


REGENERON PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited)
(In thousands)
 
 
Three months ended March 31,
 
 
2013
 
2012
Cash flows from operating activities:
 
 
 
 
Net income
 
$
98,874

 
$
11,651

Adjustments to reconcile net income to net cash provided by (used in) operating activities:
 
 
 
 
Depreciation and amortization
 
9,407

 
8,416

Non-cash compensation expense
 
53,030

 
23,244

Non-cash interest expense
 
5,781

 
5,543

Other non-cash charges and expenses, net
 
7,174

 
2,494

Deferred taxes
 
39,525

 

Changes in assets and liabilities:
 
 
 
 
Increase in Sanofi and trade accounts receivable
 
(109,518
)
 
(135,312
)
Increase in prepaid expenses and other assets
 
(43,660
)
 
(6,661
)
Decrease in deferred revenue
 
(6,470
)
 
(9,126
)
Increase in accounts payable, accrued expenses, and other liabilities
 
32,105

 
12,710

Total adjustments
 
(12,626
)
 
(98,692
)
Net cash provided by (used in) operating activities
 
86,248

 
(87,041
)
 
 
 
 
 
Cash flows from investing activities:
 
 
 
 
Purchases of marketable securities
 
(180,922
)
 
(48,569
)
Sales or maturities of marketable securities
 
54,754

 
75,853

Increase in restricted cash and marketable securities
 
(314
)
 
(463
)
Capital expenditures
 
(21,203
)
 
(11,055
)
Net cash (used in) provided by investing activities
 
(147,685
)
 
15,766

 
 
 
 
 
Cash flows from financing activities:
 
 
 
 
Payments in connection with facility and capital lease obligations
 
(649
)
 
(500
)
Proceeds from issuance of Common Stock
 
12,964

 
31,828

Payments in connection with Common Stock tendered for employee tax obligations
 
(3,085
)
 
(49,078
)
Excess tax benefit from stock-based compensation
 
2,293

 

Net cash provided by (used in) financing activities
 
11,523

 
(17,750
)
 
 
 
 
 
Net decrease in cash and cash equivalents
 
(49,914
)
 
(89,025
)
 
 
 
 
 
Cash and cash equivalents at beginning of period
 
230,276

 
483,610

 
 
 
 
 
Cash and cash equivalents at end of period
 
$
180,362

 
$
394,585

 
 
 
 
 
The accompanying notes are an integral part of the financial statements.


6


REGENERON PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
(Unless otherwise noted, dollars in thousands, except per share data)


1. Interim Financial Statements
The interim Condensed Consolidated Financial Statements of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”) have been prepared in accordance with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all information and disclosures necessary for a presentation of the Company’s financial position, results of operations, and cash flows in conformity with accounting principles generally accepted in the United States of America. In the opinion of management, these financial statements reflect all normal recurring adjustments and accruals necessary for a fair statement of the Company’s financial position, results of operations, and cash flows for such periods. The results of operations for any interim periods are not necessarily indicative of the results for the full year. The December 31, 2012 Condensed Consolidated Balance Sheet data were derived from audited financial statements, but do not include all disclosures required by accounting principles generally accepted in the United States of America. These financial statements should be read in conjunction with the financial statements and notes thereto contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2012.
Certain reclassifications have been made to prior period amounts to conform with the current period’s presentation.

2. Net Product Sales
EYLEA ® net product sales totaled $313.9 million and $123.5 million for the three months ended March 31, 2013 and 2012, respectively. In November 2011, the Company received marketing approval from the U.S. Food and Drug Administration ("FDA") for EYLEA (aflibercept) Injection for the treatment of neovascular age-related macular degeneration ("wet AMD"). In September 2012, the Company received marketing approval from the FDA for EYLEA for the treatment of macular edema following central retinal vein occlusion ("CRVO"). In addition, ARCALYST ® net product sales totaled $4.8 million and $4.4 million for the three months ended March 31, 2013 and 2012, respectively.
For the three months ended March 31, 2013 and 2012, the Company recorded 77% and 81% , respectively, of its total gross product revenue from sales to Besse Medical, a subsidiary of AmerisourceBergen Corporation.
Revenue from product sales is recorded net of applicable provisions for rebates and chargebacks under governmental programs (including Medicaid), distribution-related fees, prompt pay discounts, product returns, and other sales-related deductions. The following table summarizes the provisions, and credits/payments, for these sales-related deductions during the three months ended March 31, 2013.
 
Rebates &
Chargebacks
 
Distribution-
Related
Fees
 
Other Sales-
Related
Deductions
 
Total
Balance as of December 31, 2012
$
2,983

 
$
15,298

 
$
545

 
$
18,826

Provision related to current period sales
5,537

 
13,916

 
208

 
19,661

Credits/payments
(4,844
)
 
(11,521
)
 
(218
)
 
(16,583
)
Balance as of March 31, 2013
$
3,676

 
$
17,693

 
$
535

 
$
21,904


3. Collaboration Revenue
Sanofi Collaboration Revenue
The collaboration revenue the Company earned from Sanofi, as detailed below, consisted primarily of reimbursement for research and development expenses that the Company incurred, recognition of the Company's share of losses in connection with Sanofi's commercialization of ZALTRAP ® , and recognition of revenue related to non-refundable up-front payments.


7


REGENERON PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
(Unless otherwise noted, dollars in thousands, except per share data)

 
 
Three months ended March 31,
Sanofi Collaboration Revenue:
 
2013
 
2012
ZALTRAP:
 
 
 
 
Regeneron's share of losses in connection with commercialization of ZALTRAP
 
$
(7,789
)
 
$
(3,705
)
Reimbursement of Regeneron research and development and other expenses
 
2,563

 
2,820

Recognition of deferred revenue related to up-front payments
 
1,384

 
2,483

Total ZALTRAP
 
(3,842
)
 
1,598

Antibody:
 
 
 
 
Reimbursement of Regeneron research and development expenses
 
100,554

 
80,855

Recognition of deferred revenue related to up-front and other payments
 
2,162

 
2,153

Recognition of revenue related to VelociGene  agreement
 
399

 
399

Total Antibody
 
103,115

 
83,407

Total Sanofi collaboration revenue
 
$
99,273

 
$
85,005

Sanofi commenced sales of ZALTRAP(ziv-aflibercept) Injection for Intravenous Infusion, in combination with 5-fluorouracil, leucovorin, irinotecan ("FOLFIRI"), for patients with metastatic colorectal cancer (“mCRC”) that is resistant to or has progressed following an oxaliplatin-containing regimen, in the United States in the third quarter of 2012 and in certain countries in Europe in the first quarter of 2013. The Company and Sanofi globally collaborate on the development and commercialization of ZALTRAP. Under the terms of the companies' September 2003 collaboration agreement, as amended, Regeneron and Sanofi share co-promotion rights and profits and losses on sales of ZALTRAP outside of Japan. In Japan, the Company is entitled to a royalty on sales of ZALTRAP.
Bayer HealthCare Collaboration Revenue
Bayer HealthCare commenced sales of EYLEA for the treatment of wet AMD in the fourth quarter of 2012 following receipt of regulatory approvals in the European Union and other regions. The Company and Bayer HealthCare globally collaborate on the development and commercialization of EYLEA outside of the United States.
The collaboration revenue the Company earned from Bayer HealthCare is detailed below:
 
 
Three months ended March 31,
Bayer HealthCare Collaboration Revenue
 
2013
 
2012
Regeneron's net profit in connection with commercialization of EYLEA outside the United States
 
$
6,362

 
 
Cost-sharing of Regeneron EYLEA development expenses
 
5,971

 
$
10,506

Reimbursement of other Regeneron EYLEA expenses
 
597

 
 
Recognition of deferred revenue related to up-front and other milestone payments
 
1,977

 
1,977

 
 
$
14,907

 
$
12,483


8



REGENERON PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
(Unless otherwise noted, dollars in thousands, except per share data)


4. Net Income Per Share
The Company’s basic net income per share amounts have been computed by dividing net income by the weighted average number of shares of Common Stock and Class A Stock outstanding. Net income per share is presented on a combined basis, inclusive of Common Stock and Class A Stock outstanding, as each class of stock has equivalent economic rights. Diluted net income per share includes the potential dilutive effect of other securities as if such securities were converted or exercised during the period, when the effect is dilutive. The calculations of basic and diluted net income per share are as follows:
 
 
Three Months Ended March 31,
 
 
2013
 
2012
Net income - basic and diluted
 
$
98,874

 
$
11,651

 
 
 
 
 
(Shares in thousands)
 
 
 
 
Weighted average shares - basic
 
96,878

 
93,446

Effect of dilutive securities:
 
 
 
 
Stock options
 
10,276

 
13,630

Restricted stock
 
325

 
658

Warrants
 
1,890

 


Dilutive potential shares
 
12,491

 
14,288

Weighted average shares - diluted
 
109,369

 
107,734

 
 
 
 
 
Net income per share - basic
 
$
1.02

 
$
0.12

Net income per share - diluted
 
$
0.90

 
$
0.11


Shares which have been excluded from the March 31, 2013 and 2012 diluted per share amounts because their effect would have been antidilutive, include the following:
 
 
Three Months Ended March 31,
(Shares in thousands)
 
2013
 
2012
Stock options
 
3,868

 
89

Convertible senior notes
 
4,761

 
4,761

Warrants
 


 
4,761



5. Marketable Securities
Marketable securities at March 31, 2013 and December 31, 2012 consist of debt and equity securities. The Company also held restricted marketable securities at both March 31, 2013 and December 31, 2012, which consisted of debt securities, as detailed below, that collateralize letters of credit and lease obligations.

9



REGENERON PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
(Unless otherwise noted, dollars in thousands, except per share data)

The following tables summarize the amortized cost basis of debt and equity securities included in marketable securities, the aggregate fair value of those securities, and gross unrealized gains and losses on those securities at March 31, 2013 and December 31, 2012.
 
 
Amortized
 
Unrealized
 
Fair
At March 31, 2013
 
Cost Basis
 
Gains
 
Losses
 
Value
Unrestricted
 
 
 
 
 
 
 
 
U.S. government and government agency obligations
 
$
305,402

 
$
568

 
$
(3
)
 
$
305,967

Corporate bonds
 
123,015

 
3

 
(148
)
 
122,870

Commercial paper
 
25,172

 


 


 
25,172

Municipal bonds
 
17,159

 
6

 
(4
)
 
17,161

     Equity securities
 
4,044

 


 
(1,259
)
 
2,785

 
 
474,792

 
577

 
(1,414
)
 
473,955

Restricted
 
 
 
 
 
 
 
 
U.S. government obligations
 
8,350

 
9

 
(1
)
 
8,358

 
 
$
483,142

 
$
586

 
$
(1,415
)
 
$
482,313

At December 31, 2012
 
 
 
 
 
 
 
 
Unrestricted
 
 
 
 
 
 
 
 
U.S. government and government agency obligations
 
$
327,502

 
$
661

 
$
(17
)
 
$
328,146

Municipal bonds
 
17,542

 


 
(32
)
 
17,510

Equity securities
 
4,044

 

 
(651
)
 
3,393

 
 
349,088

 
661

 
(700
)
 
349,049

Restricted
 
 
 
 
 
 
 
 
U.S. government obligations
 
5,902

 
9

 
(2
)
 
5,909

 
 
$
354,990

 
$
670

 
$
(702
)
 
$
354,958

The Company classifies its debt securities based on their contractual maturity dates. The debt securities listed at March 31, 2013 mature at various dates through January 2016. The fair values of debt security investments by contractual maturity as of March 31, 2013 and December 31, 2012 consist of the following:
 
 
March 31,
 
December 31,
 
 
2013
 
2012
Unrestricted
 
 
 
 
Maturities within one year
 
$
127,349

 
$
77,819

Maturities after one year through five years
 
343,821

 
267,837

 
 
471,170

 
345,656

Restricted
 
 
 
 
Maturities within one year
 
6,868

 
2,781

Maturities after one year through five years
 
1,490

 
3,128

 
 
8,358

 
5,909

 
 
$
479,528

 
$
351,565


10



REGENERON PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
(Unless otherwise noted, dollars in thousands, except per share data)

The following table shows the fair value of the Company’s marketable securities that have unrealized losses and that are deemed to be only temporarily impaired, aggregated by investment category and length of time that the individual securities have been in a continuous unrealized loss position, at March 31, 2013 and December 31, 2012.
 
Less than 12 Months
 
12 Months or Greater
 
Total
At March 31, 2013
Fair Value
 
Unrealized Loss
 
Fair Value
 
Unrealized Loss
 
Fair Value
 
Unrealized Loss
Unrestricted
 
 
 
 
 
 
 
 
 
 
 
U.S. government and government agency obligations
$
25,004

 
$
(3
)
 
 
 
 
 
$
25,004

 
$
(3
)
Corporate bonds
114,555

 
(148
)
 
 
 
 
 
114,555

 
(148
)
Municipal bonds
6,490

 
(4
)
 
 
 
 
 
6,490

 
(4
)
Equity security
 
 
 
 
$
2,786

 
$
(1,259
)
 
2,786

 
(1,259
)
 
146,049

 
(155
)
 
2,786

 
(1,259
)
 
148,835

 
(1,414
)
Restricted
 
 
 
 
 
 
 
 
 
 
 
U.S. government obligations
904

 
(1
)
 
 
 
 
 
904

 
(1
)
 
$
146,953

 
$
(156
)
 
$
2,786

 
$
(1,259
)
 
$
149,739

 
$
(1,415
)
 
 
 
 
 
 
 
 
 
 
 
 
At December 31, 2012
 
 
 
 
 
 
 
 
 
 
 
Unrestricted
 
 
 
 
 
 
 
 
 
 
 
U.S. government and government agency obligations
$
44,738

 
$
(17
)
 
 
 
 
 
$
44,738

 
$
(17
)
Municipal bonds
17,510

 
(32
)
 
 
 
 
 
17,510

 
(32
)
Equity security


 


 
$
3,393

 
$
(651
)
 
3,393

 
(651
)
 
62,248

 
(49
)
 
3,393

 
(651
)
 
65,641

 
(700
)
Restricted
 
 
 
 
 
 
 
 
 
 
 
U.S. government obligations
1,194

 
(2
)
 


 


 
1,194

 
(2
)
 
$
63,442

 
$
(51
)
 
$
3,393

 
$
(651
)
 
$
66,835

 
$
(702
)

Realized gains and losses are included as a component of investment income. For the three months ended March 31, 2013 and 2012, total realized gains and losses on sales of marketable securities were not material.


11



REGENERON PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
(Unless otherwise noted, dollars in thousands, except per share data)

6. Fair Value Measurements
The Company’s assets that are measured at fair value on a recurring basis , at March 31, 2013 and December 31, 2012, consist of the following:
 
 
 
Fair Value Measurements at Reporting Date Using
At March 31, 2013
Fair Value
 
Quoted Prices in
Active Markets
for Identical
Assets
(Level 1)
 
Significant Other
Observable Inputs
(Level 2)
Unrestricted
 
 
 
 
 
Available-for-sale marketable securities:
 
 
 
 
 
U.S. government and government agency obligations
$
305,967

 
 
 
$
305,967

Corporate bonds
122,870

 
 
 
122,870

Commercial paper
25,172

 
 
 
25,172

Municipal bonds
17,161

 
 
 
17,161

Equity security
2,785

 
$
2,785

 
 
 
473,955

 
2,785


471,170

Restricted
 
 
 
 
 
Available-for-sale marketable securities:
 
 
 
 
 
U.S. government obligations
8,358

 
 
 
8,358

 
$
482,313

 
$
2,785

 
$
479,528

 
 
 
 
 
 
At December 31, 2012
 
 
 
 
 
Unrestricted
 
 
 
 
 
Available-for-sale marketable securities:
 
 
 
 
 
U.S. government and government agency obligations
$
328,146

 
 
 
$
328,146

Municipal bonds
17,510

 
 
 
17,510

Equity security
3,393

 
$
3,393

 
 
 
349,049

 
3,393

 
345,656

Restricted
 
 
 
 
 
Available-for-sale marketable securities:
 
 
 
 
 
U.S. government obligations
5,909

 
 
 
5,909

 
$
354,958

 
$
3,393

 
$
351,565


Marketable securities included in Level 2 were valued using a market approach utilizing prices and other relevant information, such as interest rates, yield curves, prepayment speeds, loss severities, credit risks and default rates, generated by market transactions involving identical or comparable assets. The Company considers market liquidity in determining the fair value for these securities. The Company did no t record any charges for other-than-temporary impairment of its Level 2 marketable securities during the three months ended March 31, 2013 and 2012.

12



REGENERON PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
(Unless otherwise noted, dollars in thousands, except per share data)

There were no purchases, sales, or maturities of Level 3 marketable securities and no unrealized gains or losses related to Level 3 marketable securities for the three months ended March 31, 2013 and 2012. There were no transfers of marketable securities between Levels 1, 2, or 3 classifications during the three months ended March 31, 2013 and 2012.
As of March 31, 2013 and December 31, 2012, the Company had $400.0 million in aggregate principal amount of 1.875% convertible senior notes that will mature on October 1, 2016 unless earlier converted or repurchased. The fair value of the outstanding convertible senior notes was estimated to be $861.1 million and $843.2 million as of March 31, 2013 and December 31, 2012, respectively, and was determined based on Level 2 inputs.

7. Inventory
Inventories, which were included in prepaid expenses and other current assets in the Company's balance sheets, consist of the following:
 
March 31,
 
December 31,
 
2013
 
2012
Raw materials
$
6,315

 
$
4,862

Work in process
25,061

 
14,656

Finished goods
6,390

 
2,570

Deferred costs
6,211

 
6,550

 
$
43,977

 
$
28,638


Deferred costs represent the costs of product manufactured and shipped to the Company's collaborators for which recognition of revenue has been deferred.
As of March 31, 2013 and December 31, 2012, the inventory balance included reserves of $4.6 million and $3.6 million , respectively. For the three months ended March 31, 2013 and 2012, cost of goods sold included inventory write-downs and reserves totaling $3.2 million and $1.9 million , respectively.

8. Accounts Payable and Accrued Expenses
Accounts payable and accrued expenses consist of the following:
 
March 31,
 
December 31,
 
2013
 
2012
Accounts payable
$
24,729

 
$
38,934

Accrued payroll and related costs
32,385

 
19,987

Accrued clinical trial expense
18,197

 
10,985

Accrued sales-related charges, deductions, and royalties
47,735

 
21,870

Other accrued expenses and liabilities
22,367

 
19,569

 
$
145,413

 
$
111,345

With respect to non-cash investing activities in connection with the Company's Statements of Cash Flows, included in accounts payable and accrued expenses at March 31, 2013 and December 31, 2012 were $10.1 million and $8.6 million , respectively, of accrued capital expenditures. Included in accounts payable and accrued expenses at March 31, 2012 and December 31, 2011 were $5.8 million and $6.2 million , respectively, of accrued capital expenditures.


13



REGENERON PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
(Unless otherwise noted, dollars in thousands, except per share data)

9. Income Taxes

The Company is subject to U.S. federal, state, and foreign income taxes. The Company's effective tax rate for the three months ended March 31, 2013 was 30.3% , which included, as a discrete item, the impact of enacting The American Taxpayer Relief Act in January 2013. The American Taxpayer Relief Act included a provision to extend the income tax credit for increased research activities retroactively to the tax year ended December 31, 2012. As a result, the Company's 2012 research tax credit reduced its effective tax rate for the three months ended March 31, 2013 by 12.3% .

For the three months ended March 31, 2013, the Company recorded an income tax provision of $43.0 million . In addition, within other comprehensive income, the Company recognized a $0.3 million income tax benefit for the three months ended March 31, 2013, in connection with the change in the Company’s unrealized gain/(loss) on “available-for-sale” marketable securities.

Tax years subsequent to 2009 remain open to examination by federal tax authorities. In addition, New York state has commenced an examination of the Company's 2009, 2010, and 2011 tax years.

For the three months ended March 31, 2012, income tax expense relating to the Company's pre-tax income was fully offset by a reversal of a portion of the Company's valuation allowance. As of March 31, 2012, the Company continued to recognize a full valuation allowance against its net operating loss carry-forward and other deferred tax assets since the Company had an extended history of losses. In the fourth quarter of 2012, the Company recorded an income tax benefit attributable to the release of substantially all of the remaining valuation allowance against the Company's deferred tax assets. The decision to release this valuation allowance was made after the Company determined that it was more likely than not that these deferred tax assets would be realized.

10. Legal Matters
From time to time, the Company is a party to legal proceedings in the course of the Company’s business. The Company does not expect any such current ordinary course legal proceedings to have a material adverse effect on the Company’s business or financial condition. Costs associated with the Company’s involvement in legal proceedings are expensed as incurred.
Genentech Patent Litigation
The Company is aware of issued patents and pending patent applications owned by Genentech that claim certain chimeric VEGF receptors. The Company does not believe that ZALTRAP or EYLEA infringe any valid claim in these patents or patent applications. The Company is involved in five patent litigations with Genentech, two in the United States and three in Europe. In November 2010, the Company commenced a lawsuit against Genentech in the U.S. District Court for the Southern District of New York (the "Court"), seeking a declaratory judgment that no activities relating to the Company's VEGF Trap infringe any valid claim of certain Genentech patents referred to as the Davis-Smyth patents (the "First Davis-Smyth Case"). Genentech answered the complaint and asserted counterclaims that the Company's prior or planned activities relating to VEGF Trap have infringed or will infringe claims of four of the Davis-Smyth patents and requested a judgment against the Company for damages, including for willful infringement, and other relief as the Court deems appropriate.
On December 31, 2011, the Company entered into a Non-Exclusive License and Partial Settlement Agreement with Genentech (the "Genentech Agreement") that covers making, using, and selling EYLEA in the United States for the prevention and treatment of human eye diseases and disorders in the United States, and ends the litigation relating to those matters. Under the Genentech Agreement, the Company received a non-exclusive license to the Davis-Smyth patents, and certain other technology patents owned or co-owned by Genentech. The Genentech Agreement does not cover any non-U.S. patent rights or non-U.S. patent disputes, and does not cover any use of aflibercept other than for prevention and treatment of human eye diseases and disorders in the United States. The First Davis-Smyth Case is continuing with respect to matters not covered by the Genentech Agreement. The Genentech Agreement provides for the Company to make payments to Genentech based on U.S. sales of EYLEA through May 7, 2016, the date the Davis-Smyth patents expire. As required by the Genentech Agreement, in 2012, the Company made a lump-sum payment of $60.0 million when cumulative U.S. sales of EYLEA reached $400 million . The Company will also pay royalties of 4.75% on cumulative U.S. sales of EYLEA between $400 million and $3 billion and 5.5% on any cumulative U.S. sales of EYLEA over $3 billion . As a result of the Genentech Agreement, on January 17, 2012, Genentech filed a second amended answer and counterclaim in the First Davis-Smyth Case, in which it amended its counterclaims alleging infringement of four of the Davis-Smyth patents. On December 23, 2011, Genentech initiated a related case in the Court against Regeneron and Sanofi alleging infringement of four of the Davis-Smyth Patents by activities relating to VEGF Trap (but excluding EYLEA) (the "Second Davis-Smyth Case").

14



REGENERON PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
(Unless otherwise noted, dollars in thousands, except per share data)

As in the First Davis-Smyth Case, in the new complaint Genentech requests a judgment against the Company for damages, including for willful infringement, and other relief as the Court deems appropriate. On September 21, 2012, Genentech asserted two additional Davis-Smyth patents, and one additional application (which was allowed and issued as a patent on September 25, 2012) in both the First David-Smyth Case and the Second Davis-Smyth Case.
The Company believes Genentech's remaining claims in the First Davis Smyth Case and the Second Davis Smyth Case are without merit and intends to continue to defend against all of Genentech's remaining claims vigorously. As this litigation is at an early stage, at this time the Company is not able to predict the probability of the outcome or an estimate of loss, if any, related to these matters.
The Company has initiated patent-related actions against Genentech in Germany, the United Kingdom, and Italy relating in each case to a patent that expired on October 28, 2012. The Company may initiate other actions in other countries outside the United States, which could have similar or other adverse outcomes that would materially harm its business and which, irrespective of the outcomes, may also entail significant costs and expenses. In the United Kingdom, an adverse decision at first instance dated March 22, 2012 was appealed to the UK Court of Appeal. The Court of Appeal decision dated February 21, 2013 found the designation of European patent EP 1 238 986 in the United Kingdom to be valid and that potential acts relating to VEGF Trap-Eye in the United Kingdom before expiration of the patent on October 28, 2012 would infringe this patent. The Company has sought permission to appeal to the Supreme Court of the United Kingdom. A negative decision would result in an order requiring the Company to pay Genentech's recoverable legal costs.
11. Subsequent Events
In April 2013, the Company entered into a new lease agreement for additional laboratory and office space at its Tarrytown facility. The new facilities will include approximately 297,000 square feet of laboratory and office space in two new buildings to be constructed. The initial term of the lease, which is expected to commence in mid-2014, is 15 years and contains three renewal options to extend the terms of the lease by five years each. Construction of the new buildings is anticipated to begin in the second half of 2013 and to be completed in late 2015.
In April 2013, the Company also executed an early renewal of approximately 360,000 square feet of space that it currently leases at its Tarrytown facility. The early renewal extended the term of the lease from June 2024 to June 2029.
In May 2013, the Company acquired from Sanofi full exclusive rights to two families of novel antibodies invented at Regeneron and previously included in the Company's antibody collaboration with Sanofi. The Company acquired full rights to antibodies targeting the PDGF (platelet derived growth factor) family of receptors and ligands in ophthalmology and all other indications and to antibodies targeting the ANG2 (angiopoietin-2) receptor and ligand in ophthalmology. Antibodies to PDGF and ANG2 are currently in preclinical development for use in ophthalmology.

With respect to PDGF antibodies, the Company will pay Sanofi $10 million upfront, up to $40 million in development milestone payments, and royalties on any future sales. With respect to ANG2 antibodies in ophthalmology, the Company will pay Sanofi $10 million upfront, a potential $5 million development milestone payment, and royalties on any future sales.

15



ITEM 2.
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The discussion below contains forward-looking statements that involve risks and uncertainties relating to future events and the future financial performance of Regeneron Pharmaceuticals, Inc., and actual events or results may differ materially from these forward-looking statements. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of EYLEA ® , ZALTRAP ® , and ARCALYST ® and our product candidates, potential new indications for marketed products, and research and clinical programs now underway or planned; the likelihood and timing of possible regulatory approval and commercial launch of our late-stage product candidates and new indications for marketed products; determinations by regulatory and administrative governmental authorities which may delay or restrict our ability to continue to develop or commercialize EYLEA, ZALTRAP, and ARCALYST and other product and drug candidates and possible new indications for marketed products; the ability for us to manufacture and manage supply chains for multiple products and product candidates; competing drugs and product candidates that may be superior to EYLEA, ZALTRAP, and ARCALYST and our product and drug candidates and possible new indications for marketed products; uncertainty of market acceptance of EYLEA, ZALTRAP, and ARCALYST and our product and drug candidates and possible new indications for marketed products; coverage and reimbursement determinations by third-party payers, including Medicare and Medicaid; unforeseen safety issues resulting from the administration of products and product candidates in patients; unanticipated expenses; the costs of developing, producing, and selling products; the ability for us to meet any of our financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license or collaboration agreement, including our agreements with Sanofi and Bayer HealthCare LLC, to be canceled or terminated without any further product success; and risks associated with third-party intellectual property and pending or future litigation relating thereto. These statements are made by us based on management's current beliefs and judgment. In evaluating such statements, shareholders and potential investors should specifically consider the various factors identified under the caption “Risk Factors” which could cause actual events and results to differ materially from those indicated by such forward-looking statements. We do not undertake any obligation to update publicly any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required by law.
Overview
Regeneron Pharmaceuticals, Inc. is a fully integrated biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Our total revenues were $439.7 million in the first quarter of 2013, compared to $231.8 million in the first quarter of 2012. Our net income was $98.9 million , or $0.90 per diluted share, in the first quarter of 2013, compared to net income of $11.7 million , or $0.11 per diluted share, in the first quarter of 2012.
We currently have three marketed products:
EYLEA ® (aflibercept) Injection, known in the scientific literature as VEGF Trap-Eye, which is available in the United States for the treatment of neovascular age-related macular degeneration (wet AMD) and macular edema following central retinal vein occlusion (CRVO), and in the United Kingdom, Germany, Switzerland, Australia, Japan, and certain other countries for the treatment of wet AMD. We commenced sales of EYLEA for the treatment of wet AMD in November 2011 and for the treatment of macular edema following CRVO in September 2012, following receipt of regulatory approval in the United States. Bayer HealthCare commenced sales of EYLEA for the treatment of wet AMD in the fourth quarter of 2012 following receipt of regulatory approvals in the European Union (EU) and other regions. Bayer HealthCare has additional regulatory applications for EYLEA for the treatment of wet AMD pending in other countries. In addition, Bayer HealthCare has submitted applications for marketing authorization for EYLEA in Europe, Japan, and other countries for the treatment of macular edema following CRVO.

We are collaborating with Bayer HealthCare on the global development and commercialization of EYLEA outside the United States. Bayer HealthCare markets EYLEA outside the United States, where, for countries other than Japan, the companies share equally the profits and losses from sales of EYLEA. In Japan, we are entitled to a royalty on sales of EYLEA, as described below. We maintain exclusive rights to EYLEA in the United States and are entitled to all profits from any such sales.
 
Net product sales of EYLEA in the United States were $ 313.9 million in the first quarter of 2013 compared to $ 123.5 million in the first quarter of 2012. EYLEA net product sales outside of the United States, which are recorded by Bayer HealthCare, commenced in the fourth quarter of 2012, and were $64.8 million in the first quarter of 2013.

ZALTRAP ® (ziv-aflibercept) Injection for Intravenous Infusion, known in the scientific literature as VEGF Trap, which is available in the United States for treatment, in combination with 5-fluorouracil, leucovorin, irinotecan (FOLFIRI), of

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Table of Contents

patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin-containing regimen. In February 2013, the European Commission (EC) granted marketing authorization in the European Union for ZALTRAP 25mg/ml concentrate for solution for infusion in combination with FOLFIRI chemotherapy in adults with mCRC that is resistant to or has progressed after an oxaliplatin-containing regimen. Regulatory applications for marketing authorization of ZALTRAP for the treatment of previously treated mCRC patients in other countries have also been submitted and are currently under review by the respective regulatory agencies.

We and Sanofi globally collaborate on the development and commercialization of ZALTRAP, and share profits and losses from commercialization of ZALTRAP, except for Japan, where we are entitled to a royalty on sales of ZALTRAP, as described below. ZALTRAP net product sales, which are recorded by Sanofi, commenced in the United States in August 2012 and in Europe in the first quarter of 2013, and were $ 14.1 million in the first quarter of 2013.

ARCALYST ® (rilonacept) Injection for Subcutaneous Use, which is available in the United States for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Auto-inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS), in adults and children 12 and older. CAPS are a group of rare, inherited, auto-inflammatory conditions characterized by life-long, recurrent symptoms of rash, fever/chills, joint pain, eye redness/pain, and fatigue. Intermittent, disruptive exacerbations or flares can be triggered at any time by exposure to cooling temperatures, stress, exercise, or other unknown stimuli.

Net product sales of ARCALYST totaled $ 4.8 million in the first quarter of 2013, compared to $ 4.4 million in the first quarter of 2012.
We have 13 product candidates in clinical development, all of which were discovered in our research laboratories. Our Trap-based clinical programs are:
EYLEA, which is in clinical trials for the treatment of diabetic macular edema (DME), macular edema following branch retinal vein occlusion (BRVO), and, in Asia, choroidal neovascularization of the retina as a result of pathologic myopia (mCNV), in collaboration with Bayer HealthCare; and
ZALTRAP, which is being studied in combination with our angiopoietin-2 inhibitor (nesvacumab) in oncology in collaboration with Sanofi.
Our antibody-based clinical programs include eleven fully human monoclonal antibodies. The following six are being developed in collaboration with Sanofi:
Sarilumab (REGN88), an antibody to the interleukin-6 receptor (IL-6R), which is being developed in rheumatoid arthritis;
Alirocumab (REGN727), an antibody to Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9), which is being developed for low-density lipoprotein (LDL) cholesterol reduction;
Dupilumab (REGN668), an antibody to the interleukin-4 receptor (IL-4R), which is being developed in atopic dermatitis and allergic asthma;
Enoticumab (REGN421), an antibody to Delta-like ligand-4 (Dll4), a novel angiogenesis target, which is being developed in oncology;
Nesvacumab (REGN910), an antibody to angiopoietin-2 (ANG2), another novel angiogenesis target, which is being developed in oncology; and
REGN1033, an antibody to myostatin (GDF8), which is being developed in metabolic disorders.
In addition, we are developing the following five antibodies independently:
REGN1400, an antibody to ErbB3, which is being developed in oncology;
REGN846, an antibody in clinical development against an undisclosed target, which is being developed in atopic dermatitis;
REGN1154, an antibody in clinical development against an undisclosed target;
REGN1500, an antibody in clinical development against an undisclosed target; and
Fasinumab (REGN475), an antibody to Nerve Growth Factor (NGF), which is being developed for the treatment of pain and which is currently on clinical hold by the U.S. Food and Drug Administration (FDA).
Our core business strategy is to maintain a strong foundation in basic scientific research and discovery-enabling technologies, and to combine that foundation with our clinical development, manufacturing, and commercial capabilities. Our long-term objective is to build a successful, integrated, multi-product biopharmaceutical company that provides patients and medical professionals with innovative options for preventing and treating human diseases.
We believe that our ability to develop product candidates is enhanced by the application of our VelociSuite TM technology platforms. Our discovery platforms are designed to identify specific proteins of therapeutic interest for a particular disease or cell

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type and validate these targets through high-throughput production of genetically modified mice using our VelociGene ® technology to understand the role of these proteins in normal physiology, as well as in models of disease. Our human monoclonal antibody technology ( VelocImmune ® ) and cell line expression technologies ( VelociMab ® ) may then be utilized to discover and produce new product candidates directed against the disease target. Our antibody product candidates currently in clinical trials were developed using VelocImmune . Under the terms of our antibody collaboration with Sanofi, which was expanded during 2009, we plan to advance a total of 20 to 30 candidates into clinical development over the life of the agreement. We continue to invest in the development of enabling technologies to assist in our efforts to identify, develop, manufacture, and commercialize new product candidates.

Clinical Programs:
1. EYLEA - Ophthalmologic Diseases
Vascular Endothelial Growth Factor (VEGF) is a naturally occurring protein in the body. Its normal role in a healthy organism is to trigger formation of new blood vessels (angiogenesis) supporting the growth of the body's tissues and organs. However, in certain diseases, such as wet AMD, it is also associated with the growth of abnormal new blood vessels in the eye, which exhibit abnormal increased permeability that leads to edema. Scarring and loss of fine-resolution central vision often results. In CRVO and BRVO, a blockage occurs in the main blood vessel that transports deoxygenated blood away from the retina. VEGF levels are elevated in response, contributing to macular edema. For clinically significant DME, VEGF-mediated leakage of fluid from blood vessels in the eye results in interference with vision.
EYLEA is a recombinant fusion protein, consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 and formulated as an iso-osmotic solution for intravitreal administration. EYLEA acts as a soluble decoy receptor that binds VEGF-A and placental growth factor (PlGF) and thereby can inhibit the binding and activation of these cognate VEGF receptors. EYLEA is specially purified and contains iso-osmotic buffer concentrations, allowing for injection into the eye.
We, together with our ex-U.S. collaborator Bayer HealthCare, are evaluating EYLEA in Phase 3 programs in patients with DME, macular edema following BRVO, and, in Asia, mCNV of the retina as a result of pathologic myopia. Wet AMD, diabetic retinopathy (which includes DME), and retinal vein occlusion are three of the leading causes of adult blindness in the developed world. In these conditions, severe visual loss is caused by neovascular proliferation and/or retinal edema.
In the second quarter of 2011, we and Bayer HealthCare initiated Phase 3 studies to evaluate the safety and efficacy of EYLEA in DME. We are conducting one of these studies, VISTA-DME, in the United States. Bayer HealthCare is conducting the second study, VIVID-DME, in Europe, Japan, and Australia. Both the VISTA-DME and VIVID-DME trials are fully enrolled. An additional Phase 3 safety study in Japan (VIVID-Japan) was initiated in the first quarter of 2012 and is required for approval in Japan. In February 2013, we and Bayer HealthCare also initiated another Phase 3 study to evaluate the efficacy and safety of EYLEA in DME in Russia, China, and other Asian countries (VIVID EAST-DME).
In the first quarter of 2011, we and Bayer HealthCare initiated a Phase 3 trial in Asia in collaboration with the Singapore Eye Research Institute (SERI) investigating the efficacy and safety of EYLEA in patients with mCNV of the retina as a result of pathologic myopia (MYRROR). This study is fully enrolled.
In the fourth quarter of 2011, we and Bayer HealthCare initiated a Phase 3 trial in China evaluating the efficacy and safety of EYLEA in wet AMD (SIGHT). The trial is expected to include approximately 300 patients.
In the second quarter of 2012, we initiated a multinational study of EYLEA in patients with macular edema following BRVO (VIBRANT). This study is fully enrolled.
In the fourth quarter of 2012, we initiated a study to fulfill a post-marketing requirement by the FDA, RE-VIEW, which will evaluate the effect of EYLEA on corneal endothelium.
2. ZALTRAP (ziv-aflibercept) - Oncology
ZALTRAP is a fusion protein that is designed to bind all forms of VEGF-A, VEGF-B, and P1GF, and prevent their interaction with cell surface receptors. VEGF-A (and to a lesser degree, P1GF) is required for the growth of new blood vessels (a process known as angiogenesis) that are needed for tumors to grow.
During the third quarter of 2012, we and Sanofi initiated a Phase 1b study of a combination of ZALTRAP and our angiopoietin-2 inhibitor (nesvacumab) in patients with advanced solid malignancies.

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3. Sarilumab (REGN88; IL-6R Antibody) for inflammatory diseases
IL-6 is a key cytokine involved in the pathogenesis of rheumatoid arthritis, causing inflammation and joint destruction. A therapeutic antibody to IL-6R, ACTEMRA ® (tocilizumab), a registered trademark of Chugai Seiyaku Kabushiki Kaisha, has been approved for the treatment of rheumatoid arthritis.
Sarilumab is a fully human monoclonal antibody to IL-6R generated using our VelocImmune technology. In July 2011, we and Sanofi announced that in the Phase 2b stage of the SARIL-RA-MOBILITY trial in rheumatoid arthritis (RA), patients treated with sarilumab in combination with a standard RA treatment, methotrexate (MTX), achieved a significant and clinically meaningful improvement in signs and symptoms of moderate-to-severe RA compared to patients treated with MTX alone. The primary endpoint of the study was the proportion of patients achieving at least a 20% improvement in RA symptoms (ACR20) after 12 weeks.
The Phase 2/3 SARIL-RA-MOBILITY study in patients with RA is fully enrolled. This trial will assess the improvement in signs and symptoms at 24 weeks and sarilumab's effect on radiographic progression at one year. In addition, we and Sanofi have initiated an additional Phase 3 study, SARIL-RA-TARGET, which is a randomized, double-blind, placebo-controlled study evaluating sarilumab in combination with non-biologic, disease-modifying anti-rheumatic drugs (DMARDs) in moderate-to-severe active RA patients with inadequate response to, or who are intolerant of, one or more tumor necrosis factor alpha (TNF-alpha) inhibitors. Patients who complete SARIL-RA-MOBILITY and SARIL-RA-TARGET are offered enrollment into the ongoing SARIL-RA EXTEND, which is an open-label, long-term safety study of sarilumab.
4. Alirocumab (REGN727; PCSK9 Antibody) for LDL cholesterol reduction
Elevated LDL cholesterol (“bad cholesterol”) level is a validated risk factor leading to cardiovascular disease. Statins are a class of drugs that lower LDL through inhibition of HMG-CoA, an enzyme regulating the early and rate-limiting step in cholesterol biosynthesis. PCSK9 is a secreted protein that plays a key role in modulating LDL cholesterol levels in the body. PCSK9 binds to and induces the destruction of the LDL receptor, thereby interfering with cellular uptake and increasing circulating levels of LDL cholesterol. In a landmark study published in the New England Journal of Medicine in March 2006, patients with lower than normal PCSK9 levels due to a genetic abnormality not only had significantly lower levels of LDL cholesterol, but also a significant reduction in the risk of coronary heart disease. We used our VelocImmune technology to generate a fully human monoclonal antibody inhibitor of PCSK9, called alirocumab, that is intended to lower LDL cholesterol.
Alirocumab has been studied in three Phase 2 clinical studies, two in patients with primary hypercholesterolemia and one in patients with heterozygous familial hypercholesterolemia (heFH). In the Phase 2 studies, alirocumab significantly reduced LDL-cholesterol from baseline up to 72% on top of standard of care statin therapy. Consistent and robust reductions in other lipid parameters, including a reduction in lipoprotein-a (Lp(a)) were also observed. Lp(a) is another form of bad cholesterol which is believed to be a risk factor for coronary heart disease and strokes when elevated. In the Phase 2 program, injection site reactions were the most common adverse events with alirocumab, and were rare. Rare cases of hypersensitivity reaction were also reported. Serious adverse events (SAEs) were reported in 1.8% of patients (5/275) in the active treatment arms and 2.6% of patients (2/77) in the placebo groups.
We and Sanofi initiated the global Phase 3 ODYSSEY program for alirocumab in June 2012. The ODYSSEY program will enroll more than 22,000 patients. This includes over ten clinical trials evaluating the effect of alirocumab on lowering LDL cholesterol. The 18,000 patient ODYSSEY OUTCOMES trial, assessing reduction in serious cardiovascular events, and several other trials in the ODYSSEY program, are currently enrolling patients. LDL cholesterol levels is expected to be the primary efficacy endpoint for initial regulatory filings. The studies will be conducted in clinical centers around the world including the United States, Canada, Western and Eastern Europe, South America, Australia, and Asia. Furthermore, the ODYSSEY-MONO1 trial is evaluating the efficacy and safety of alirocumab versus ezetimibe in patients with primary hypercholesterolemia. We expect to report initial results from the Phase 3 ODYSSEY-MONO1 trial in the second half of 2013.
5. Dupilumab (REGN668; IL-4R Antibody) for allergic and immune conditions
IL-4R is required for signaling by the cytokines IL-4 and IL-13. Both of these cytokines are critical mediators of immune response, which, in turn, drives the formation of Immunoglobulin E (IgE) antibodies and the development of allergic responses, as well as the atopic state that underlies atopic dermatitis and allergic asthma.
Dupilumab is a fully human monoclonal antibody generated using our VelocImmune technology that is designed to bind to IL-4R. Dupilumab demonstrated positive proof of concept in patients with atopic dermatitis and allergic asthma. Data from two Phase 1b trials in atopic dermatitis was presented at the American Academy of Dermatology annual meeting in March 2013. Data from a Phase 2a trial in allergic asthma will be presented at the American Thoracic Society in May 2013. We and Sanofi plan to initiate Phase 2b studies with dupilumab in asthma and atopic dermatitis in 2013.

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6. Enoticumab (REGN421; Dll4 Antibody) for advanced malignancies
In many clinical settings, positively or negatively regulating blood vessel growth could have important therapeutic benefits, as could the repair of damaged and leaky vessels. VEGF was the first growth factor shown to be specific for blood vessels, by virtue of having its receptor primarily expressed on blood vessel cells. In the December 21, 2006 issue of the journal Nature , we reported data from a preclinical study demonstrating that blocking an important cell signaling molecule, known as Dll4, inhibited the growth of experimental tumors by interfering with their ability to produce a functional blood supply. The inhibition of tumor growth was seen in a variety of tumor types, including those that were resistant to blockade of VEGF, suggesting a novel anti-angiogenesis therapeutic approach. Moreover, inhibition of tumor growth is enhanced by the combination of Dll4 and VEGF blockade in many preclinical tumor models.
Enoticumab is a fully human monoclonal antibody to Dll4 generated using our VelocImmune technology, and is in Phase 1 clinical development.
7. Nesvacumab (REGN910; ANG2 Antibody) for oncology and ophthalmology
The angiopoietins, which were discovered at Regeneron, are ligands for the endothelial cell receptor Tie2 and are essential for vascular development and angiogenesis. Unlike other family members, angiopoietin-2 (ANG2) is strongly upregulated by endothelial cells at sites of angiogenesis and vascular remodeling, including tumors. Enhanced anti-tumor effects have been observed in preclinical models with combined blockade of both VEGF and ANG2.
Nesvacumab is a fully human monoclonal antibody generated using our VelocImmune technology that is designed to block ANG2. Nesvacumab is in Phase 1 clinical development in oncology. In addition, during the third quarter of 2012, we and Sanofi initiated a Phase 1b study evaluating nesvacumab in combination with ZALTRAP in patients with advanced solid malignancies.
In May 2013, we acquired from Sanofi full rights to antibodies targeting the ANG2 receptor and ligand in ophthalmology, as described below. We expect our ANG2 inhibitor to enter clinical development in ophthalmology in 2013.
8. REGN1033 (GDF8 Antibody)
In January 2012, we initiated a Phase 1 clinical study for REGN1033, a fully human monoclonal GDF8 antibody generated using our VelocImmune technology. Myostatin has been validated as a target to increase muscle mass and strength through genetic mutations in both animals and humans that abrogate its bioactivity.  
9. REGN1400 (ErbB3 Antibody) for oncology
REGN1400 is a fully human monoclonal antibody generated using our VelocImmune technology, against ErbB3. REGN1400 is in Phase 1 clinical development in oncology.
10. REGN846
REGN846 is a fully human monoclonal antibody generated using our VelocImmune technology, against an undisclosed target, and is being evaluated in a Phase 1b study in patients with atopic dermatitis. In July 2011, Sanofi elected not to continue co-development of REGN846, and Regeneron now has sole global rights to REGN846. Under the terms of our agreement, Sanofi remains obligated to fund agreed-upon REGN846 clinical costs through conclusion of a planned proof of concept trial and is entitled to receive a mid-single digit royalty on any future sales of REGN846.
11. REGN1154
REGN1154 is a fully human monoclonal antibody generated using our VelocImmune technology, against an undisclosed target. In March 2012, we initiated a Phase 1 clinical study in Australia. Sanofi decided not to opt-in to the REGN1154 program and we have sole global rights. Under the terms of our agreement, Sanofi is entitled to receive a mid-single digit royalty on any future sales of REGN1154.
12. REGN1500
REGN1500 is a fully human monoclonal antibody generated using our VelocImmune technology, against an undisclosed target. In December 2012, we initiated a Phase 1 clinical study. Sanofi decided not to opt-in to the REGN1500 program and we have sole global rights. Under the terms of our agreement, Sanofi is entitled to receive a mid-single digit royalty on any future sales of REGN1500.

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13. Fasinumab (REGN475; NGF Antibody) for pain (on clinical hold)
Fasinumab is a fully human monoclonal antibody to NGF, generated using our VelocImmune technology, which is designed to block pain sensitization in neurons. Preclinical experiments indicate that fasinumab specifically binds to and blocks NGF activity and does not bind to or block cell signaling for the closely related neurotrophins NT-3 and BDNF.
In December 2012, the FDA placed fasinumab and other investigational agents targeting NGF on clinical hold based on preclinical findings with other anti-NGF agents in development. Prior to the FDA clinical hold action, we were planning to initiate late-stage clinical trials with fasinumab. There are currently no ongoing trials with fasinumab that are either enrolling or treating patients.
Sanofi elected not to continue co-development of fasinumab, and we have sole global rights. Under the terms of our agreement, Sanofi is entitled to receive a mid-single digit royalty on any future sales of fasinumab.

Acquisition of Ophthalmology Development Programs from Sanofi
In May 2013, we acquired from Sanofi full exclusive rights to two families of novel antibodies invented at Regeneron and previously included in our antibody collaboration with Sanofi. We acquired full rights to antibodies targeting the PDGF (platelet derived growth factor) family of receptors and ligands in ophthalmology and all other indications and to antibodies targeting the ANG2 receptor and ligand in ophthalmology. Antibodies to PDGF and ANG2 are currently in preclinical development for use in ophthalmology.

With respect to PDGF antibodies, we will pay Sanofi $10 million upfront, up to $40 million in development milestone payments, and royalties on any future sales. With respect to ANG2 antibodies in ophthalmology, we will pay Sanofi $10 million upfront, a potential $5 million development milestone payment, and royalties on any future sales.

We and Sanofi will continue to develop antibodies to ANG2 outside of ophthalmology under our antibody collaboration agreement, including nesvacumab, as described above.

Research Programs
Our preclinical research programs are in the areas of oncology and angiogenesis, ophthalmology, metabolic and related diseases, muscle diseases and disorders, inflammation and immune diseases, bone and cartilage, pain, cardiovascular diseases, and infectious diseases.
Research and Development Technologies
Many proteins that are either on the surface of or secreted by cells play important roles in biology and disease. One way that a cell communicates with other cells is by releasing specific signaling proteins, either locally or into the bloodstream. These proteins have distinct functions and are classified into different “families” of molecules, such as peptide hormones, growth factors, and cytokines. All of these secreted (or signaling) proteins travel to and are recognized by another set of proteins, called “receptors,” which reside on the surface of responding cells. These secreted proteins impact many critical cellular and biological processes, causing diverse effects ranging from the regulation of growth of particular cell types to inflammation mediated by white blood cells. Secreted proteins can at times be overactive and thus result in a variety of diseases. In these disease settings, blocking the action of specific secreted proteins can have clinical benefit. In other cases, proteins on the cell-surface can mediate the interaction between cells, such as the processes that give rise to inflammation and autoimmunity.
Our scientists have developed two different technologies to design protein therapeutics to block the action of specific cell surface or secreted proteins. The first technology, termed the “Trap” technology, was used to generate our three approved products, EYLEA, ZALTRAP, and ARCALYST. These novel “Traps” are composed of fusions between two distinct receptor components and the constant region of an antibody molecule called the “Fc region,” resulting in high affinity product candidates. VelociSuite is our second technology platform; it is used for discovering, developing, and producing fully human monoclonal antibodies that can address both secreted and cell-surface targets.
VelociSuite. VelociSuite consists of VelocImmune, VelociGene, VelociMouse ® , and VelociMab . The VelocImmune mouse platform is utilized to produce fully human monoclonal antibodies. VelocImmune was generated by exploiting our VelociGene technology (see below), in a process in which six megabases of mouse immune gene loci were replaced, or “humanized,” with corresponding human immune gene loci. VelocImmune mice can be used to generate efficiently fully human monoclonal antibodies to targets of therapeutic interest. VelocImmune and our entire VelociSuite offer the potential to increase the speed and efficiency through which human monoclonal antibody therapeutics may be discovered and validated, thereby improving the overall efficiency

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of our early stage drug development activities. We are utilizing the VelocImmune technology to produce our next generation of drug candidates for preclinical and clinical development.
Our VelociGene platform allows custom and precise manipulation of very large sequences of DNA to produce highly customized alterations of a specified target gene, or genes, and accelerates the production of knock-out and transgenic expression models without using either positive/negative selection or isogenic DNA. In producing knock-out models, a color or fluorescent marker may be substituted in place of the actual gene sequence, allowing for high-resolution visualization of precisely where the gene is active in the body during normal body functioning as well as in disease processes. For the optimization of preclinical development and pharmacology programs, VelociGene offers the opportunity to humanize targets by replacing the mouse gene with the human homolog. Thus, VelociGene allows scientists to rapidly identify the physical and biological effects of deleting or over-expressing the target gene, as well as to characterize and test potential therapeutic molecules.
Our VelociMouse technology platform allows for the direct and immediate generation of genetically altered mice from embryonic stem cells (ES cells), thereby avoiding the lengthy process involved in generating and breeding knockout mice from chimeras. Mice generated through this method are normal and healthy and exhibit a 100% germ-line transmission. Furthermore, mice developed using our VelociMouse technology are suitable for direct phenotyping or other studies. We have also developed our VelociMab platform for the rapid screening of antibodies and rapid generation of expression cell lines for our Traps and our VelocImmune human monoclonal antibodies.

Collaboration Agreements
Collaborations with Sanofi
ZALTRAP . We and Sanofi globally collaborate on the development and commercialization of ZALTRAP. Under the terms of our September 2003 collaboration agreement, as amended, we and Sanofi share co-promotion rights and share profits and losses from commercialization of ZALTRAP outside of Japan. In Japan, we are entitled to a royalty of approximately 35% on sales of ZALTRAP, subject to certain potential adjustments.
Under the ZALTRAP collaboration agreement, as amended, agreed upon worldwide development expenses incurred by both companies during the term of the agreement are funded by Sanofi. If the collaboration becomes profitable, we will be obligated to reimburse Sanofi out of our share of ZALTRAP profits (including royalties on sales of ZALTRAP in Japan) for 50% of the development expenses that they funded. The reimbursement payment in any quarter will equal 5% of the then outstanding repayment obligation, but never more than our share of the ZALTRAP profits in the quarter unless we elect to reimburse Sanofi at a faster rate. As a result, we expect that, initially, our share of any ZALTRAP profits will be used to reimburse Sanofi for this repayment obligation.
Antibodies . In November 2007, we and Sanofi entered into a global, strategic collaboration to discover, develop, and commercialize fully human monoclonal antibodies. The collaboration is governed by a Discovery and Preclinical Development Agreement and a License and Collaboration Agreement. In connection with the execution of the discovery agreement in 2007, we received a non-refundable, up-front payment of $85.0 million from Sanofi. Pursuant to the collaboration, Sanofi is funding our research to identify and validate potential drug discovery targets and develop fully human monoclonal antibodies against these targets. We lead the design and conduct of research activities under the collaboration, including target identification and validation, antibody development, research and preclinical activities through filing of an Investigational New Drug Application (IND) or its equivalent, toxicology studies, and manufacture of preclinical and clinical supplies. 
For each drug candidate identified through discovery research under the discovery agreement, Sanofi has the option to license rights to the candidate under the license agreement. If it elects to do so, Sanofi will co-develop the drug candidate with us through product approval. Development costs for the drug candidate are shared between the companies, with Sanofi generally funding these costs up front, except that following receipt of the first positive Phase 3 trial results for a co-developed drug candidate, subsequent Phase 3 trial-related costs for that drug candidate are shared 80% by Sanofi and 20% by us. We are generally responsible for reimbursing Sanofi for half of the total development costs for all collaboration antibody products from our share of profits from commercialization of collaboration products to the extent they are sufficient for this purpose. However, we are not required to apply more than 10% of our share of the profits from collaboration products in any calendar quarter towards reimbursing Sanofi for these development costs.
Sanofi will lead commercialization activities for products developed under the license agreement, subject to our right to co-promote such products. The parties will equally share profits and losses from sales within the United States. The parties will share profits outside the United States on a sliding scale based on sales starting at 65% (Sanofi)/35% (us) and ending at 55% (Sanofi)/45% (us), and will share losses outside the United States at 55% (Sanofi)/45% (us). In addition to profit sharing, we are entitled to receive up to $250 million in sales milestone payments, with milestone payments commencing after aggregate annual sales outside the United States exceed $1.0 billion on a rolling 12-month basis.

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In November 2009, we and Sanofi amended these agreements to expand and extend our antibody collaboration. The goal of the expanded collaboration is to advance a total of 20 to 30 new antibody product candidates into clinical development from 2010 through 2017.
Under the amended discovery agreement, Sanofi agreed to fund up to $160 million per year of our antibody discovery activities over the period from 2010-2017, subject to a one-time option for Sanofi to adjust the maximum reimbursement amount down to $120 million per year commencing in 2014 if, over the prior two years, certain specified criteria were not satisfied. Sanofi has an option to extend the discovery program for up to an additional three years after 2017 for further antibody development and preclinical activities. Pursuant to the collaboration, Sanofi funded $30 million of agreed-upon costs we incurred to expand our manufacturing capacity at our Rensselaer, New York facilities.
In August 2008, we entered into an agreement with Sanofi, which extended through December 2012, to use our VelociGene platform to supply Sanofi with genetically modified mammalian models of gene function and disease. Under this agreement, Sanofi is paying us a total of $21.5 million for knock-out and transgenic models of gene function for target genes identified by Sanofi. These models are used by Sanofi for its internal research programs that are outside of the scope of our antibody collaboration.
Collaboration with Bayer HealthCare
In October 2006, we entered into a license and collaboration agreement with Bayer HealthCare for the global development and commercialization outside the United States of EYLEA. Under the agreement, we and Bayer HealthCare collaborate on, and share the costs of, the development of EYLEA through an integrated global plan. Bayer HealthCare markets EYLEA outside the United States, where, for countries other than Japan, the companies share equally in profits and losses from sales of EYLEA. In May 2012, Bayer HealthCare's Japanese subsidiary, Bayer Yakuhin, Ltd., and Santen Pharmaceutical Co., Ltd. entered into an agreement to co-promote EYLEA in Japan. In conjunction with this agreement, we and Bayer HealthCare amended our existing global license and collaboration agreement for EYLEA to convert the 50/50 profit share for Japan into a royalty agreement under which we are entitled to receive a tiered royalty of between 33.5% and 40.0% of EYLEA annual net sales in Japan. In certain specified circumstances, the Japan royalty may revert to a profit share arrangement.
We may also receive up to $25 million in additional milestone payments related to marketing approvals of EYLEA in other indications in major market countries outside the United States, and can earn up to $135 million in sales milestone payments if twelve-month sales of EYLEA outside the United States achieve certain specified levels starting at $200 million.
Commencing with the first commercial sale of EYLEA in a major market country outside the United States, we became obligated to reimburse Bayer HealthCare for 50% of the development costs that it has incurred under the agreement from our share of the collaboration profits (including royalties on sales of EYLEA in Japan). The reimbursement payment in any quarter will equal 5% of the then outstanding repayment obligation, but never more than our share of the collaboration profits in the quarter unless we elect to reimburse Bayer HealthCare at a faster rate. As a result, we expect that, initially, a portion of our share of EYLEA profits outside the United States will be used to reimburse Bayer HealthCare for this repayment obligation.

Within the United States, we retain exclusive commercialization rights to EYLEA and are entitled to all profits from any such sales.
License Agreement with Astellas
In March 2007, we entered into a six-year, non-exclusive license agreement with Astellas Pharma Inc. to allow Astellas to utilize our VelocImmune technology in its internal research programs to discover human monoclonal antibodies. In July 2010, the license agreement with Astellas was amended and extended through June 2023. Under the terms of the amended agreement, Astellas made a $165.0 million up-front payment to us in August 2010. In addition, Astellas will make a $130.0 million second payment to us in June 2018 unless the license agreement has been terminated prior to that date. Astellas has the right to terminate the agreement at any time by providing 90 days' advance written notice. Under certain limited circumstances, such as our material breach of the agreement, Astellas may terminate the agreement and receive a refund of a portion of its up-front payment or, if such termination occurs after June 2018, a portion of its second payment, to us under the July 2010 amendment to the agreement. We are entitled to receive a mid-single digit royalty on any future sales of antibody products discovered by Astellas using our VelocImmune technology.

Royalty Agreement with Novartis Pharma AG

Under a June 2009 agreement with Novartis (that replaced a previous collaboration and license agreement), we receive royalties on worldwide sales of Novartis' canakinumab, a fully human anti-interleukin-IL1ß antibody. The royalty rates in the agreement start at 4% and reach 15% when annual sales exceed $1.5 billion. Canakinumab is marketed for the treatment of CAPS and gouty arthritis, and is in earlier stage development for atherosclerosis and other inflammatory diseases. We are unable to predict whether these royalties will ever contribute materially to our results of operations or financial condition.

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General

Developing and commercializing new medicines entails significant risk and expense. Before significant revenues from the commercialization of our antibody candidates or new indications for our marketed products can be realized, we (or our collaborators) must overcome a number of hurdles which include successfully completing research and development and obtaining regulatory approval from the FDA and regulatory authorities in other countries. In addition, the biotechnology and pharmaceutical industries are rapidly evolving and highly competitive, and new developments may render our products and technologies uncompetitive or obsolete.

Beginning in the first quarter of 2012, we reported profitability; prior to that, we generally incurred net losses. Our ability to continue to generate profits and to generate positive cash flow from operations over the next several years depends significantly on our success in commercializing EYLEA. We expect to continue to incur substantial expenses related to our research and development activities, a significant portion of which we expect to be reimbursed by our collaborators. Also, our research and development activities outside our collaborations, the costs of which are not reimbursed, will expand and require additional resources. Our operating results may fluctuate from quarter to quarter and will depend on, among other factors, the net sales of our marketed products, the scope and progress of our research and development efforts, the timing of certain expenses, and the continuation of our collaborations with Sanofi and Bayer HealthCare, including our share of collaboration profits or losses, or royalties, from sales of commercialized products and the amount of reimbursement of our research and development expenses that we receive from collaborators. We cannot predict whether or when new products or new indications for our marketed products will receive regulatory approval or, if any such approval is received, whether we will be able to successfully commercialize such product(s) and whether or when they may become profitable.


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The planning, execution, and results of our clinical programs are significant factors that can affect our operating and financial results. In our clinical programs, key events in 2013 to date were, and plans for the next 12 months are, as follows:   
Trap-based Clinical Programs:
 
2013 Events to Date
 
2013-14 Plans (next 12 months)
      
EYLEA
     
 
Ÿ
Bayer HealthCare received regulatory approval for EYLEA in New Zealand, South Korea, and other countries for the treatment of patients with wet AMD and continued to pursue regulatory applications for marketing approval in other countries
Ÿ
Regulatory agency decisions on additional applications outside the United States for the treatment of wet AMD and macular edema following CRVO
Ÿ
Bayer HealthCare received regulatory approval for EYLEA in first country outside the United States for the treatment of patients with macular edema following CRVO and continued to pursue regulatory applications for marketing approval in other countries
Ÿ
Report one year primary endpoint (EU) results for VIVID-DME study
Ÿ
Completed enrollment of VIBRANT study in macular edema following BRVO
Ÿ
Report six month primary endpoint results for VIBRANT study in macular edema following BRVO
Ÿ
Initiated Phase 3 VIVID EAST-DME study in Russia, China, and other Asian countries
Ÿ
Report primary endpoint results for MYRROR study in myopic CNV
 
 
Ÿ
Report two year primary endpoint results for VISTA-DME study
 
ZALTRAP
 
 
Ÿ
European Commission granted marketing authorization in the European Union for ZALTRAP for patients with mCRC that is resistant to or has progressed following an oxaliplatin-containing regimen
Ÿ
Regulatory agency decisions outside the United States on additional applications for ZALTRAP in the treatment of previously treated mCRC patients


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      Antibody-based Clinical Programs:
 
     
2013 Events to Date
     
2013-14 Plans (next 12 months)
Sarilumab (IL-6R Antibody)
Ÿ
Continued enrollment in Phase 3 SARIL-RA program
Ÿ
Report initial results from SARIL-RA MOBILITY study

 
 
Ÿ
Initiate additional Phase 3 studies
Alirocumab (PCSK9 Antibody)
Ÿ
Continued patient enrollment in Phase 3 ODYSSEY trials
Ÿ
Continue enrollment of the Phase 3 ODYSSEY trials

 
 
Ÿ
Report initial results from Phase 3 ODYSSEY-MONO1 trial
Dupilumab (IL-4R Antibody)
Ÿ
Reported initial results for Phase 1b studies in atopic dermatitis
Ÿ
Present initial results from Phase 2a study in allergic asthma

 
 
Ÿ
Initiate Phase 2b trials in atopic dermatitis and allergic asthma
Enoticumab (Dll4 Antibody)
Ÿ
Continued patient enrollment in Phase 1 program
Ÿ
Complete patient enrollment in the expansion of the Phase 1 program
Nesvacumab (ANG2 Antibody)
Ÿ
Continued patient enrollment in Phase 1 program
  Ÿ
Complete patient enrollment in the Phase 1b program in advanced malignancies
 
 
 
Ÿ
Initiate clinical development in ophthalmology
REGN1033 (GDF8 Antibody)
Ÿ
Continued patient enrollment in Phase 1 program
Ÿ
Continue patient enrollment in Phase 1 program
REGN1400 (ErbB3 Antibody)
Ÿ
Continued patient enrollment in Phase 1 program
Ÿ
Continue patient enrollment in Phase 1 program
REGN846 (target not disclosed)
Ÿ
Continued patient treatment in
Phase 1b program in atopic dermatitis
 
 
REGN1154 (target not disclosed)
Ÿ
Continued patient enrollment in Phase 1 program
Ÿ
Continue patient enrollment in Phase 1 program
REGN1500 (target not disclosed)
Ÿ
Continued patient enrollment in Phase 1 program
Ÿ
Continue patient enrollment in Phase 1 program
Fasinumab (NGF Antibody)
  Ÿ
On clinical hold
Ÿ
Determine future development plan


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Results of Operations

Three Months Ended March 31, 2013 and 2012
Net Income
We reported net income of $98.9 million , or $0.90 per diluted share, for the first quarter of 2013, compared to $11.7 million , or $0.11 per diluted share, for the first quarter of 2012. The increase in net income resulted primarily from an increase in net product sales of EYLEA, which we launched in November 2011.
Revenues
Revenues for the three months ended March 31, 2013 and 2012 consist of the following:
(In millions)
2013
 
2012
Net product sales
$
318.7

 
$
127.9

Collaboration revenue:
 
 
 
Sanofi
99.3

 
85.0

Bayer HealthCare
14.9

 
12.5

Total collaboration revenue
114.2

 
97.5

Technology licensing revenue
5.9

 
5.9

Other revenue
0.9

 
0.5

Total revenue
$
439.7

 
$
231.8


Net Product Sales
Net product sales consist of U.S. sales of EYLEA and ARCALYST. In November 2011, we received marketing approval from the FDA for EYLEA for the treatment of wet AMD, at which time product sales commenced. In addition, in September 2012, we received marketing approval from the FDA for EYLEA for the treatment of macular edema following CRVO. For the three months ended March 31, 2013 and 2012, we recognized EYLEA net product sales of $313.9 million and $123.5 million , respectively. For the three months ended March 31, 2013 and 2012, we also recognized ARCALYST net product sales of $4.8 million and $4.4 million , respectively.
For the three months ended March 31, 2013 and 2012, we recorded 77% and 81% , respectively, of our total gross product revenue from sales to Besse Medical, a subsidiary of AmerisourceBergen Corporation.
We record product sales net of allowances and accruals for rebates and chargebacks under governmental programs (including Medicaid), distribution-related fees, prompt pay discounts, product returns, and other sales-related deductions. The following table summarizes the provisions, and credits/payments, for sales-related deductions for the three months ended March 31, 2013 and 2012.
(In millions)
Rebates & Chargebacks
 
Distribution-Related Fees
 
Other Sales-Related Deductions
 
Total
Balance as of December 31, 2012
$
3.0

 
$
15.3

 
$
0.5

 
$
18.8

Provision related to current period sales
5.5

 
13.9

 
0.2

 
19.6

Credits/payments
(4.8
)
 
(11.5
)
 
(0.2
)
 
(16.5
)
Balance as of March 31, 2013
$
3.7

 
$
17.7

 
$
0.5

 
$
21.9

 
 
 
 
 
 
 
 
Balance as of December 31, 2011
$
0.6

 
$
1.5

 
$
0.2

 
$
2.3

Provision related to current period sales
2.4

 
7.0

 
0.7

 
10.1

Credits/payments
(0.2
)
 
(3.0
)
 
(0.4
)
 
(3.6
)
Balance as of March 31, 2012
$
2.8

 
$
5.5

 
$
0.5

 
$
8.8


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Sanofi Collaboration Revenue
The collaboration revenue we earned from Sanofi, as detailed below, consisted primarily of reimbursement for research and development expenses that we incurred, recognition of our share of losses in connection with Sanofi's commercialization of ZALTRAP, and recognition of revenue related to non-refundable up-front payments.
Sanofi Collaboration Revenue
 
Three months ended
March 31,
(In millions)
 
2013
 
2012
ZALTRAP:
 
 
 
 
Regeneron's share of losses in connection with commercialization of ZALTRAP
 
$
(7.8
)
 
$
(3.7
)
Reimbursement of Regeneron research and development and other expenses
 
2.5

 
2.8

Recognition of deferred revenue related to up-front payments
 
1.4

 
2.5

Total ZALTRAP
 
(3.9
)
 
1.6

Antibody:
 
 
 
 
Reimbursement of Regeneron research and development expenses
 
100.6

 
80.8

Recognition of deferred revenue related to up-front and other payments
 
2.2

 
2.2

Recognition of revenue related to VelociGene  agreement
 
0.4

 
0.4

Total Antibody
 
103.2

 
83.4

Total Sanofi collaboration revenue
 
$
99.3

 
$
85.0


Sanofi commenced sales of ZALTRAP (ziv-aflibercept) Injection for Intravenous Infusion, in combination with FOLFIRI, for patients with mCRC that is resistant to or has progressed following an oxaliplatin-containing regimen, in the United States in the third quarter of 2012 and in certain countries in Europe in the first quarter of 2013. Regeneron's share of the loss in connection with commercialization of ZALTRAP, as shown in the table below, represents our 50% share of ZALTRAP net product sales less cost of goods sold and shared commercialization and other expenses.
Regeneron's share of losses in connection with commercialization of ZALTRAP
 
Three months ended March 31,
(In millions)
 
2013
 
2012
Net product sales recorded by Sanofi
 
$
14.1

 
 
Regeneron's share of collaboration losses
 
(7.8
)
 
$
(3.7
)

Our share of the loss increased in the first quarter of 2013, compared to the first quarter of 2012, as higher costs in connection with launching ZALTRAP were partly offset by net product sales. Sanofi provides us with an estimate of our share of the profit or loss from commercialization of ZALTRAP for the most recent fiscal quarter. Sanofi's estimates of net products sales and related expenses for such quarter are reconciled to their actual net product sales and related expenses in the subsequent fiscal quarter, and our portion of the profit or loss is adjusted accordingly, as necessary.

Recognition of deferred revenue related to the ZALTRAP up-front payments from Sanofi decreased in the first quarter of 2013, compared to the same period of 2012, due to lengthening the estimated performance period over which this deferred revenue is being recognized, effective in the first quarter of 2013. In connection with recognition of deferred revenue related to ZALTRAP, as of March 31, 2013, $10.1 million of the original $105.0 million of up-front payments was deferred and will be recognized as revenue in future periods.
In the first quarter of 2013, Sanofi's reimbursement of our antibody expenses consisted of $44.8 million under our discovery agreement and $55.8 million of development costs under our license agreement, compared to $44.6 million and $36.2 million, respectively, in the first quarter of 2012. The higher reimbursement of development costs in the first quarter of 2013, compared to the same period of 2012, was primarily due to increased development activities for alirocumab.

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As it relates to recognition of deferred revenue, in connection with the November 2009 amendment of the discovery agreement, Sanofi has funded $30 million of agreed-upon costs incurred by us to expand our manufacturing capacity at our Rensselaer, New York facilities. Revenue related to such funding from Sanofi was deferred and is being recognized as collaboration revenue prospectively over the related performance period in conjunction with the recognition of the original $85.0 million up-front payment. As of March 31, 2013, $67.0 million of the up-front and other payments was deferred and will be recognized as revenue in future periods.
Bayer HealthCare Collaboration Revenue
The collaboration revenue we earned from Bayer HealthCare, as detailed below, consisted primarily of recognition of our share of profits in connection with commercialization of EYLEA outside the United States, cost-sharing of Regeneron EYLEA development expenses, and recognition of revenue related to a non-refundable $75.0 million up-front payment received in 2006 and a $20.0 million milestone payment received in 2007 (which, for the purpose of revenue recognition, was not considered substantive).
Bayer HealthCare Collaboration Revenue
 
Three months ended
March 31,
(In millions)
 
2013
 
2012
Regeneron's net profit in connection with commercialization of EYLEA outside the United States
 
$
6.4

 
 
Cost-sharing of Regeneron EYLEA development expenses
 
6.0

 
$
10.5

Reimbursement of other Regeneron EYLEA expenses
 
0.5

 
 
Recognition of deferred revenue related to up-front and other milestone payments
 
2.0

 
2.0

Total Bayer HealthCare collaboration revenue
 
$
14.9

 
$
12.5


Bayer HealthCare commenced sales of EYLEA for the treatment of wet AMD in the fourth quarter of 2012 following receipt of regulatory approvals in the European Union and other regions. Regeneron's net profit in connection with commercialization of EYLEA outside the United States is summarized below.
Regeneron's Net Profit from EYLEA Sales Outside the United States
 
Three months ended
(In millions)
 
March 31, 2013
Net product sales outside the United States recorded by Bayer HealthCare
 
$
64.8

Regeneron's share of collaboration profit from sales outside the United States
 
19.6

Reimbursement of EYLEA development expenses incurred by Bayer HealthCare in accordance with Regeneron's payment obligation
 
(13.2
)
Regeneron's net profit in connection with commercialization of EYLEA outside the United States
 
$
6.4

Our share of the profit and the Japan royalties we earned from commercialization of EYLEA outside the United States were partly offset by our contractual obligation to reimburse Bayer HealthCare for a portion of the agreed-upon development expenses previously incurred by Bayer HealthCare. Bayer HealthCare provides us with an estimate of our share of the profit or loss from commercialization of EYLEA outside the United States for the most recent fiscal quarter. Bayer HealthCare's estimates of net product sales and related expenses for such quarter are reconciled to their actual net product sales and related expenses in the subsequent fiscal quarter, and our portion of the profit or loss is adjusted accordingly, as necessary.

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Cost-sharing of our global EYLEA development expenses with Bayer HealthCare decreased in the first quarter of 2013 compared to the same period in 2012. In the first quarter of 2013, we incurred lower costs in connection with regulatory activities and our EYLEA clinical studies in wet AMD.
As of March 31, 2013, $27.7 million of the up-front and 2007 milestone payments was deferred and will be recognized as revenue in future periods.
Technology Licensing Revenue
In connection with the amendment and extension of our VelocImmune license agreement with Astellas, in August 2010, we received a $165.0 million up-front payment, which was deferred upon receipt and is being recognized as revenue ratably over a seven-year period beginning in June 2011. In the first quarter of both 2013 and 2012, we recognized $5.9 million of technology licensing revenue related to this agreement. As of March 31, 2013, $122.2 million of the August 2010 technology licensing payment received from Astellas was deferred and will be recognized as revenue in future periods.
Other Revenue
Under a June 2009 agreement with Novartis, we receive royalties on worldwide sales of Novartis' canakinumab. In the first quarter of 2013 and 2012, other revenue included $0.8 million and $0.5 million, respectively, of royalties from Novartis.
Expenses
Total operating expenses increased to $286.6 million in the first quarter of 2013 from $209.6 million in the first quarter of 2012. Our average headcount in the first quarter of 2013 increased to 1,996 from 1,729 in the same period of 2012, principally in connection with expanding our research and development, and commercialization, activities.
Operating expenses in the first quarter of 2013 and 2012 included a total of $53.0 million and $23.2 million , respectively, of non-cash compensation expense related to employee stock option and restricted stock awards (Non-cash Compensation Expense). The increase in total Non-cash Compensation Expense in the first quarter of 2013 was primarily attributable to the higher fair market value of our Common Stock on the date of our annual employee option grants made in December 2012 compared to recent prior years.

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Research and Development Expenses
Research and development expenses increased to $180.3 million in the first quarter of 2013 from $138.9 million in the same period of 2012. The following table summarizes the major categories of our research and development expenses for the three months ended March 31, 2013 and 2012:
Research and Development Expenses
 
Three months ended March 31,
 
Increase
(In millions)
 
2013
 
2012
 
(Decrease)
Payroll and benefits (1)
 
$
69.1

 
$
51.4