Full Press Release Details
TARRYTOWN, N.Y., Feb. 11, 2014 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN)today announced financial results for the fourth quarter and full year 2013 and provided an update on development programs.
| Financial Highlights | ||||||||||||||||||
| ($ in millions, except per share data) | Three months endedDecember 31, | Year endedDecember 31, | ||||||||||||||||
| 2013 | 2012 | % Change | 2013 | 2012 | % Change | |||||||||||||
| EYLEA U.S. net product sales | $ | 402 | $ | 276 | 46% | $ | 1,409 | $ | 838 | 68% | ||||||||
| Total revenues | $ | 610 | $ | 415 | 47% | $ | 2,105 | $ | 1,378 | 53% | ||||||||
| Non-GAAP net income | $ | 259 | $ | 171 | 51% | $ | 935 | $ | 530 | 76% | ||||||||
| Non-GAAP net income per share -diluted | $ | 2.24 | $ | 1.47 | 52% | $ | 8.17 | $ | 4.66 | 75% | ||||||||
| GAAP net income | $ | 97 | $ | 470 | (79%) | $ | 424 | $ | 750 | (43%) | ||||||||
| GAAP net income per share - diluted | $ | 0.86 | $ | 4.08 | (79%) | $ | 3.81 | $ | 6.75 | (44%) | ||||||||
Financial Highlights
($ in millions, except per share data)
Three months ended
December 31,
Year ended
December 31,
% Change
% Change
EYLEA U.S. net product sales
$
402
$
276
46%
$
1,409
$
838
68%
Total revenues
$
610
$
415
47%
$
2,105
$
1,378
53%
Non-GAAP net income
$
259
$
171
51%
$
935
$
530
76%
Non-GAAP net income per share -
diluted
$
2.24
$
1.47
52%
$
8.17
$
4.66
75%
GAAP net income
$
97
$
470
(79%)
$
424
$
750
(43%)
GAAP net income per share - diluted
$
0.86
$
4.08
(79%)
$
3.81
$
6.75
(44%)
"We are pleased with our performance in 2013, with strong EYLEA sales growth globally and continued progress in our pipeline, as well as the launch of our new research initiative in the field of genomics through our Regeneron Genetics Center," said Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron. "Looking forward, in 2014 we expect EYLEA to continue to grow through demographic and geographic expansion, as well as potential approvals in new indications, such as diabetic macular edema. We also look forward to additional clinical data from our Phase 3 program for alirocumab for lowering LDL-cholesterol and Phase 2b data for dupilumab for atopic dermatitis (dupilumab is also being developed for asthma). In addition, we anticipate advancing clinical development of new antibodies, including our PDGFR-beta antibody and EYLEA combination product, which just commenced a Phase 1 study, and our CD20-CD3 bi-specific antibody, which is planned to enter clinical development later this year in immuno-oncology. EYLEA's continued growth, our advancing late-stage pipeline, and new R&D initiatives provide a strong foundation for the company's future."
Business Highlights
EYLEA®(aflibercept) Injection for Intravitreal Injection
• In the fourth quarter of 2013, net sales of EYLEA inthe United Stateswere$402 million, compared to$276 millionin the fourth quarter of 2012. For the full year 2013, net sales of EYLEA inthe United Stateswere$1.409 billion, compared to$838 millionfor the full year 2012.
• Bayer HealthCare commercializes EYLEA outsidethe United Statesfor the treatment of neovascular age-related macular degeneration (wet AMD) and macular edema following central retinal vein occlusion (CRVO). In the fourth quarter, net sales of EYLEA outside ofthe United States(1)were$184 millionand$472 millionfor the full year 2013, compared to$19 millionin both the fourth quarter and full year 2012. In the fourth quarter of 2013, Regeneron recognized$44 millionfrom its share of net profit from EYLEA sales outsidethe United States, after repayment of$15 millionin development expenses. For the full year 2013, Regeneron recognized$102 millionfrom its share of net profit from EYLEA sales outsidethe United States, after repayment of$58 millionin development expenses.
• During the fourth quarter of 2013, the Company submitted a supplemental BLA for U.S. regulatory approval of EYLEA in diabetic macular edema (DME); the target date for an FDA decision on the supplemental BLA isAugust 18, 2014. An application for marketing approval in the European Union for DME was also submitted in the fourth quarter of 2013.
• InFebruary 2014, the Company reported positive two year results from the Phase 3 VISTA-DME trial for the treatment of DME.
• InOctober 2013, the Company reported positive top-line results from the Phase 3 VIBRANT trial for the treatment of macular edema following branch retinal vein occlusion (BRVO). These results were presented during the annual meeting of the American Academy of Ophthalmology (AAO) held inNovember 2013inNew Orleans.
• An application for regulatory approval of EYLEA in myopic choroidal neovascularization (mCNV) was submitted inJapanin the fourth quarter of 2013.
ZALTRAP®(ziv-aflibercept) Injection for Intravenous Infusion
• ZALTRAP is currently approved in over 30 countries, includingthe United Statesand in the European Union, for treatment, in combination with 5-fluorouracil, leucovorin, irinotecan (FOLFIRI), of patients with metastatic colorectal cancer that is resistant to or has progressed following an oxaliplatin-containing regimen. Marketing authorization applications for ZALTRAP are currently under review by additional regulatory agencies outsidethe United States.
• ZALTRAP net product sales commenced inthe United StatesinAugust 2012and inEuropein the first quarter of 2013. In the fourth quarter of 2013, Sanofi's worldwide net sales of ZALTRAP were$20 million, compared to$23 millionin the fourth quarter of 2012. Sanofi's worldwide net sales of ZALTRAP were$70 millionfor the full year of 2013, compared to$32 millionfor the full year of 2012.
Monoclonal Antibodies
• Regeneron has fourteen fully human monoclonal antibodies based on the Company'sVelocImmune®technology in clinical development, including seven in collaboration with Sanofi.
• Alirocumab:Two trials of alirocumab dosed every four weeks, ODYSSEY CHOICE I and CHOICE II, were initiated during the fourth quarter of 2013 and the first quarter of 2014, respectively. All of the alirocumab trials in the ODYSSEY program with every two week dosing are fully enrolled with the exception of the 18,000 patient ODYSSEY OUTCOMES study. InOctober 2013, positive top-line results were reported from the Phase 3 ODYSSEY MONO trial. These were the first Phase 3 data to be reported from the PCSK9 inhibitor class of investigational drugs. Data from additional Phase 3 trials are expected to be available in mid-2014. Alirocumab, an antibody targeting PCSK9 to reduce LDL cholesterol, is being developed in collaboration with Sanofi.
• Sarilumab:InNovember 2013, it was announced that in the SARIL-RA-MOBILITY Phase 3 clinical trial in adult patients with active rheumatoid arthritis who were inadequate responders to methotrexate (MTX) therapy, sarilumab treatment in combination with MTX improved disease signs and symptoms as well as physical function, and inhibited progression of joint damage. Additionally, a Phase 2 study, SARIL-NIU-SATURN, in non-infectious uveitis was initiated in the fourth quarter of 2013. Sarilumab, the first fully-human monoclonal antibody to IL-6R, is being developed in collaboration with Sanofi.
• PDGFR-beta Antibody:InJanuary 2014, the Company entered into a license and collaboration agreement with Bayer HealthCare governing the joint development and commercialization outsidethe United Statesof an antibody product candidate (REGN2176) to Platelet Derived Growth Factor Receptor Beta (PDGFR-beta), including in combination with EYLEA, for the treatment of ocular diseases and disorders. InFebruary 2014, the Company initiated a Phase 1 trial of REGN2176 in combination with EYLEA for the treatment of wet AMD. Under the agreement, the Company will conduct the initial development of REGN2176 in combination with EYLEA through completion of the first proof-of-concept study, upon which Bayer HealthCare will have a right to opt-in to the collaboration for further development and commercialization. If Bayer HealthCare opts-in, they will have exclusive commercialization rights to the combination product outsidethe United Stateswhere they will share profits from sales equally with Regeneron. Withinthe United States, Regeneron has exclusive commercialization rights and will retain 100% of the profits from sales.
Human Genetics Initiative
• InJanuary 2014, the Company announced the launch of a new human genetics initiative via a wholly owned subsidiary, Regeneron Genetics Center LLC (RGC). RGC will perform sequencing and genotyping to generate de-identified genomic data. The objective of RGC is to expand the use of human genetics for discovering and validating genetic factors that cause or influence a range of diseases where there are major unmet medical needs. The hope is to improve all aspects of the drug discovery and development process. InJanuary 2014, the Company also announced that RGC and Geisinger Health System, one of the largest integrated health systems inthe United Statesserving approximately 3 million residents, entered into a research collaboration focused on studying the genetic determinants of human disease.
Fourth Quarter and Full Year 2013 Financial Results
Product Revenues:Net product sales were$406 millionin the fourth quarter and$1.426 billionfor the full year 2013, compared to$281 millionin the fourth quarter and$858 millionfor the full year 2012. EYLEA net product sales inthe United Stateswere$402 millionin the fourth quarter and$1.409 billionfor the full year 2013, compared to$276 millionin the fourth quarter and$838 millionfor the full year 2012. ARCALYST®net product sales were$4 millionin the fourth quarter and$17 millionfor the full year 2013, compared to$5 millionin the fourth quarter and$20 millionfor the full year 2012.
Total Revenues:Total revenues increased by 47% to$610 millionin the fourth quarter of 2013, compared to$415 millionin the fourth quarter of 2012. Total revenues include collaboration revenues of$197 millionin the fourth quarter of 2013, compared to$127 millionin the fourth quarter of 2012. Collaboration revenues primarily increased due to an increase in the Company's net profit from commercialization of EYLEA outside the United States. Collaboration revenues in the fourth quarter of 2013 also included$25 millionof milestone payments earned from Bayer HealthCare, compared to$10 millionin the fourth quarter 2012.
Total revenues increased by 53% to$2.105 billionfor the full year 2013, compared to$1.378 billionfor the full year 2012. Total revenues include collaboration revenues of$650 millionfor the full year 2013, compared to$494 millionfor the full year 2012. Collaboration revenues primarily increased due to an increase in the Company's net profit from commercialization of EYLEA outsidethe United Statesand higher reimbursement of the Company's development expenses under its antibody collaboration with Sanofi. Collaboration revenue for the full year 2013 included$70 millionof milestone payments from Bayer HealthCare in connection with the companies' EYLEA collaboration outsidethe United States, comprised of$25 millionin development milestones related to regulatory approvals of EYLEA and three$15 millionsales milestones. Collaboration revenue for the full year 2012 included a$50 millionmilestone payment from Sanofi and$25 millionof milestone payments from Bayer HealthCare in connection with regulatory approvals of ZALTRAP and EYLEA, respectively.
Refer to Table 4 for a summary of collaboration revenue.
Research and Development (R&D) Expenses:In 2013, GAAP R&D expenses were$268 millionin the fourth quarter and$860 millionfor the full year, compared to$181 millionin the fourth quarter and$626 millionfor full year 2012. The higher 2013 R&D expenses in the fourth quarter and full year were principally due to increased R&D activities, primarily related to the Company's antibody collaboration with Sanofi, higher R&D headcount, and higher non-cash share-based compensation expense. In 2013, R&D-related non-cash share-based compensation expense was$34 millionfor the fourth quarter and$117 millionfor the full year, compared to$18 millionin the fourth quarter and$54 millionfor the full year 2012.
Selling, General, and Administrative (SG&A) Expenses:In 2013, GAAP SG&A expenses were$82 millionin the fourth quarter and$329 millionfor the full year, compared to$58 millionin the fourth quarter and$211 millionfor full year 2012. The increases were primarily due to higher expenses in connection with commercialization of EYLEA and higher non-cash share-based compensation expense. In 2013, SG&A-related non-cash share-based compensation expense was$21 millionfor the fourth quarter and$80 millionfor the full year, compared to$12 millionin the fourth quarter and$39 millionfor the full year 2012.
Cost of Goods Sold (COGS):In 2013, GAAP COGS was$34 millionin the fourth quarter and$118 millionfor the full year, compared to$30 millionin the fourth quarter and$84 millionfor the full year 2012. The increase was due to higher U.S. EYLEA sales in 2013.
Cost of Collaboration Manufacturing:In 2013, GAAP cost of collaboration manufacturing was$14 millionin the fourth quarter and$37 millionfor the full year, compared to$1 millionin both the fourth quarter and full year of 2012. Cost of collaboration manufacturing increased primarily due to the launch of EYLEA outsidethe United Statesin the fourth quarter of 2012. Cost of collaboration manufacturing primarily consists of third-party royalties, as well as costs of producing commercial supplies of EYLEA for Bayer HealthCare and ZALTRAP for Sanofi.
Interest Expense:In 2013, GAAP interest expense was$12 millionin the fourth quarter and$46 millionfor the full year, compared to$11 millionin the fourth quarter and$45 millionfor the full year 2012. GAAP interest expense in 2013 and 2012 primarily includes interest associated with the Company's $400 million aggregate principal amount of 1.875% convertible senior notes, including amortization of the note discount and debt issuance costs, and interest associated with facility lease obligations.
Income Tax Expense (Benefit):In 2013, GAAP income tax expense was$101 millionin the fourth quarter and$289 millionfor the full year, compared to a GAAP income tax benefit of$336 millionin both the fourth quarter and full year 2012. The effective tax rate was 51.1% for the quarter and 40.5% for full year 2013.
In the fourth quarter of 2012, the Company recorded an income tax benefit attributable to the release of substantially all of the valuation allowance against the Company's deferred tax assets. Starting in 2013, the Company has recorded income taxes on GAAP income using an estimated effective tax rate. Non-GAAP net income excludes non-cash income tax expense and the release of the valuation allowance. The Company does not currently pay, or expect to pay in at least the next 12 months, significant cash income taxes.
Non-GAAP and GAAP Net Income:The Company reported non-GAAP net income of$259 million, or$2.62per basic share and$2.24per diluted share, in the fourth quarter of 2013, compared to non-GAAP net income of$171 million, or$1.79per basic share and$1.47per diluted share, in the fourth quarter of 2012. The Company reported non-GAAP net income of$935 million, or$9.55per basic share and$8.17per diluted share, for the full year 2013, compared to non-GAAP net income of$530 million, or$5.60per basic share and$4.66per diluted share, for the full year 2012.
The Company reported GAAP net income of$97 million, or$0.98per basic share and$0.86per diluted share, in the fourth quarter of 2013, compared to GAAP net income of$470 million, or$4.92per basic share and$4.08per diluted share, in the fourth quarter of 2012. The Company reported GAAP net income of$424 million, or$4.33per basic share and$3.81per diluted share, for the full year 2013, compared to GAAP net income of$750 million, or$7.92per basic share and$6.75per diluted share, for the full year 2012. The decrease in both fourth quarter and full year 2013 GAAP net income resulted primarily from (i) the non-cash tax benefit of$336 millionrecorded in the fourth quarter of 2012 primarily related to the Company's release of substantially all of the valuation allowance associated with its deferred tax assets, (ii) the Company's recognition of an income tax provision commencing in 2013, and (iii) higher operating expenses in 2013. These changes were partly offset by higher revenues, primarily driven by higher EYLEA sales withinthe United Statesby the Company and outsidethe United Statesby Bayer HealthCare(1).
Cash Position:AtDecember 31, 2013, cash and marketable securities totaled$1.084 billion, compared to$588 million(including$8 millionof restricted cash and marketable securities) atDecember 31, 2012.
2014 Financial Guidance
The Company's full year 2014 financial guidance consists of the following components:
| EYLEA U.S. net product sales | $1.7 billion - $1.8 billion |
| Non-GAAP unreimbursed R&D(2) | $425 million - $475 million |
| Non-GAAP SG&A(2) | $330 million - $380 million |
| Capital expenditures | $350 million - $425 million |
EYLEA U.S. net product sales
$1.7 billion - $1.8 billion
Non-GAAP unreimbursed R&D(2)
$425 million - $475 million
Non-GAAP SG&A(2)
$330 million - $380 million
Capital expenditures
$350 million - $425 million
| (1) | Regeneron records net product sales of EYLEA in the United States. Outside the United States, EYLEA net product sales comprise sales by Bayer HealthCare in countries other than Japan and sales by Santen Pharmaceuticals in Japan under a co-promotion agreement with a Japanese subsidiary of Bayer HealthCare. The Company recognizes its share of the profits (including a percentage on sales in Japan) from EYLEA sales outside the United States within "Bayer HealthCare collaboration revenue" in its Statements of Operations. |
| (2) | This press release uses non-GAAP net income, non-GAAP net income per share, non-GAAP unreimbursed R&D, and non-GAAP SG&A, which are financial measures that are not calculated in accordance with U.S. Generally Accepted Accounting Principles ("GAAP"). The Company believes that the presentation of these non-GAAP measures is useful to investors because they exclude, as applicable, (i) non-cash share-based compensation expense which fluctuates from period to period based on factors that are not within the Company's control, such as the Company's stock price on the dates share-based grants are issued, (ii) non-cash interest expense related to the Company's convertible senior notes since this is not deemed useful in evaluating the Company's operating performance, (iii) non-cash income tax expense, since the Company does not currently pay, or expect to pay in the near future, significant cash income taxes due primarily to the utilization of net operating loss and tax credit carry-forwards; therefore, non-cash income tax expense is not deemed useful in evaluating the Company's operating performance, and (iv) a non-cash tax benefit as a result of releasing substantially all of the valuation allowance associated with the Company's deferred tax assets. Non-GAAP unreimbursed R&D represents non-GAAP R&D expenses reduced by R&D expense reimbursements from the Company's collaboration partners. Management uses these non-GAAP measures for planning, budgeting, forecasting, assessing historical performance, and making financial and operational decisions, and also provides forecasts to investors on this basis. However, there are limitations in the use of these and other non-GAAP financial measures as they exclude certain expenses that are recurring in nature. Furthermore, the Company's non-GAAP financial measures may not be comparable with non-GAAP information provided by other companies. Any non-GAAP financial measure presented by Regeneron should be considered supplemental to, and not a substitute for, measures of financial performance prepared in accordance with GAAP. A reconciliation of the Company's GAAP to non-GAAP results is included in Table 3 of this press release. |
(1)
Regeneron records net product sales of EYLEA in the United States. Outside the United States, EYLEA net product sales comprise sales by Bayer HealthCare in countries other than Japan and sales by Santen Pharmaceuticals in Japan under a co-promotion agreement with a Japanese subsidiary of Bayer HealthCare. The Company recognizes its share of the profits (including a percentage on sales in Japan) from EYLEA sales outside the United States within "Bayer HealthCare collaboration revenue" in its Statements of Operations.
(2)
This press release uses non-GAAP net income, non-GAAP net income per share, non-GAAP unreimbursed R&D, and non-GAAP SG&A, which are financial measures that are not calculated in accordance with U.S. Generally Accepted Accounting Principles ("GAAP"). The Company believes that the presentation of these non-GAAP measures is useful to investors because they exclude, as applicable, (i) non-cash share-based compensation expense which fluctuates from period to period based on factors that are not within the Company's control, such as the Company's stock price on the dates share-based grants are issued, (ii) non-cash interest expense related to the Company's convertible senior notes since this is not deemed useful in evaluating the Company's operating performance, (iii) non-cash income tax expense, since the Company does not currently pay, or expect to pay in the near future, significant cash income taxes due primarily to the utilization of net operating loss and tax credit carry-forwards; therefore, non-cash income tax expense is not deemed useful in evaluating the Company's operating performance, and (iv) a non-cash tax benefit as a result of releasing substantially all of the valuation allowance associated with the Company's deferred tax assets. Non-GAAP unreimbursed R&D represents non-GAAP R&D expenses reduced by R&D expense reimbursements from the Company's collaboration partners. Management uses these non-GAAP measures for planning, budgeting, forecasting, assessing historical performance, and making financial and operational decisions, and also provides forecasts to investors on this basis. However, there are limitations in the use of these and other non-GAAP financial measures as they exclude certain expenses that are recurring in nature. Furthermore, the Company's non-GAAP financial measures may not be comparable with non-GAAP information provided by other companies. Any non-GAAP financial measure presented by Regeneron should be considered supplemental to, and not a substitute for, measures of financial performance prepared in accordance with GAAP. A reconciliation of the Company's GAAP to non-GAAP results is included in Table 3 of this press release.
Conference Call Information
Regeneron will host a conference call and simultaneous webcast to discuss its fourth quarter and full year 2013 financial and operating results onTuesday, February 11, 2014, at8:30 AM. To access this call, dial (888) 660-6127 (U.S.) or (973) 890-8355 (International). A link to the webcast may be accessed from the 'Events and Presentations' page of Regeneron's website atwww.regeneron.com. A replay of the conference call and webcast will be archived on the Company's website and will be available for 30 days.
About Regeneron Pharmaceuticals
Regeneron is a leading science-based biopharmaceutical company based inTarrytown, New Yorkthat discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron markets medicines for eye diseases, colorectal cancer, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including hypercholesterolemia, oncology, rheumatoid arthritis, asthma, and atopic dermatitis. For additional information about the company, please visitwww.regeneron.com.
Forward-Looking Statement
This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron, and actual events or results may differ materially from these forward-looking statements. Words such as "anticipate," "expect," "intend," "plan," "believe," "seek," "estimate," variations of such words and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of Regeneron's products, product candidates, and research and clinical programs now underway or planned, including without limitation Regeneron's human genetics initiative; unforeseen safety issues resulting from the administration of products and product candidates in patients, including serious complications or side effects in connection with the use of Regeneron's product candidates in clinical trials; the likelihood and timing of possible regulatory approval and commercial launch of Regeneron's late-stage product candidates and new indications for marketed products, including without limitation EYLEA®for the treatment of diabetic macular edema and macular edema following branch retinal vein occlusion, alirocumab, sarilumab, dupilumab, REGN2176, and CD20-CD3 bi-specific antibody; ongoing regulatory obligations and oversight impacting Regeneron's research and clinical programs and business, including those relating to patient privacy; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron's ability to continue to develop or commercialize Regeneron's products and product candidates; competing drugs and product candidates that may be superior to Regeneron's products and product candidates; uncertainty of market acceptance and commercial success of Regeneron's products and product candidates; the ability of Regeneron to manufacture and manage supply chains for multiple products and product candidates; coverage and reimbursement determinations by third-party payers, including Medicare and Medicaid; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its sales or other financial projections or guidance and changes to the assumptions underlying those projections or guidance, including without limitation those relating to EYLEA U.S. net product sales, non-GAAP unreimbursed R&D, non-GAAP SG&A, capital expenditures, and income tax obligations; the potential for any license or collaboration agreement, including Regeneron's agreements with Sanofi and Bayer HealthCare, to be cancelled or terminated without any further product success; and risks associated with third party intellectual property and pending or future litigation relating thereto. A more complete description of these and other material risks can be found in Regeneron's filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the fiscal year endedDecember 31, 2012and its Form 10-Q for the quarterly period endedSeptember 30, 2013, in each case including in the sections thereof captioned "Item 1A. Risk Factors." Any forward-looking statements are made based on management's current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update publicly any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.
This press release and/or the financial results attached to this press release include amounts that are considered "non-GAAP financial measures" under SEC rules. As required, Regeneron has provided reconciliations of these measures.
| Contact Information: | ||
| Manisha Narasimhan, Ph.D. | Peter Dworkin | |
| Investor Relations | Corporate Communications | |
| 914-847-5126 | 914-847-7640 | |
| [email protected] | [email protected] |
| TABLE 1 | ||||||||
| REGENERON PHARMACEUTICALS, INC. | ||||||||
| CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) | ||||||||
| (In thousands) | ||||||||
| December 31, | ||||||||
| 2013 | 2012 | |||||||
| Assets: | ||||||||
| Cash, restricted cash, and marketable securities | $ | 1,083,875 | $ | 587,511 | ||||
| Accounts receivable - trade, net | 787,071 | 593,207 | ||||||
| Accounts receivable from Sanofi | 104,707 | 99,913 | ||||||
| Deferred tax assets | 276,555 | 340,156 | ||||||
| Property, plant, and equipment, net | 526,983 | 379,940 | ||||||
| Other assets | 171,822 | 79,763 | ||||||
| Total assets | $ | 2,951,013 | $ | 2,080,490 | ||||
| Liabilities and stockholders' equity: | ||||||||
| Accounts payable, accrued expenses, and other liabilities | $ | 262,226 | $ | 118,604 | ||||
| Deferred revenue | 231,199 | 259,173 | ||||||
| Facility lease obligations | 185,197 | 160,810 | ||||||
| Convertible senior notes | 320,315 | 296,518 | ||||||
| Stockholders' equity | 1,952,076 | 1,245,385 | ||||||
| Total liabilities and stockholders' equity | $ | 2,951,013 | $ | 2,080,490 |
TABLE 1
REGENERON PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited)
(In thousands)
December 31,
Assets:
Cash, restricted cash, and marketable securities
$
1,083,875
$
587,511
Accounts receivable - trade, net
787,071
593,207
Accounts receivable from Sanofi
104,707
99,913
Deferred tax assets
276,555
340,156
Property, plant, and equipment, net
526,983
379,940
Other assets
171,822
79,763
Total assets
$
2,951,013
$
2,080,490
Liabilities and stockholders' equity:
Accounts payable, accrued expenses, and other liabilities
$
262,226
$
118,604
Deferred revenue
231,199
259,173
Facility lease obligations
185,197
160,810
Convertible senior notes
320,315
296,518
Stockholders' equity
1,952,076
1,245,385
Total liabilities and stockholders' equity
$
2,951,013
$
2,080,490
| TABLE 2 | ||||||||||||||||
| REGENERON PHARMACEUTICALS, INC. | ||||||||||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) | ||||||||||||||||
| (In thousands, except per share data) | ||||||||||||||||
| Three months endedDecember 31, | Year endedDecember 31, | |||||||||||||||
| 2013 | 2012 | 2013 | 2012 | |||||||||||||
| Revenues: | ||||||||||||||||
| Net product sales | $ | 406,088 | $ | 281,471 | $ | 1,425,839 | $ | 858,093 | ||||||||
| Sanofi collaboration revenue | 110,950 | 104,779 | 430,111 | 423,814 | ||||||||||||
| Bayer HealthCare collaboration revenue | 85,695 | 21,791 | 220,289 | 70,099 | ||||||||||||
| Technology licensing and other revenue | 7,679 | 6,561 | 28,506 | 26,471 | ||||||||||||
| 610,412 | 414,602 | 2,104,745 | 1,378,477 | |||||||||||||
| Expenses: | ||||||||||||||||
| Research and development | 268,140 | 181,024 | 859,947 | 625,554 | ||||||||||||
| Selling, general, and administrative | 82,085 | 57,739 | 329,415 | 210,755 | ||||||||||||
| Cost of goods sold | 34,491 | 29,641 | 118,048 | 83,927 | ||||||||||||
| Cost of collaboration manufacturing | 13,623 | 528 | 37,307 | 528 | ||||||||||||
| 398,339 | 268,932 | 1,344,717 | 920,764 | |||||||||||||
| Income from operations | 212,073 | 145,670 | 760,028 | 457,713 | ||||||||||||
| Other income (expense): | ||||||||||||||||
| Investment (expense) income | (2,259) | 384 | (231) | 2,012 | ||||||||||||
| Interest expense | (11,661) | (11,495) | (46,437) | (45,304) | ||||||||||||
| (13,920) | (11,111) | (46,668) | (43,292) | |||||||||||||
| Income before income taxes | 198,153 | 134,559 | 713,360 | 414,421 | ||||||||||||
| Income tax (expense) benefit | (101,347) | 335,848 | (288,998) | 335,848 | ||||||||||||
| Net income | $ | 96,806 | $ | 470,407 | $ | 424,362 | $ | 750,269 | ||||||||
| Net income per share - basic | $ | 0.98 | $ | 4.92 | $ | 4.33 | $ | 7.92 | ||||||||
| Net income per share - diluted | $ | 0.86 | $ | 4.08 | $ | 3.81 | $ | 6.75 | ||||||||
| Weighted average shares outstanding - basic | 98,862 | 95,691 | 97,917 | 94,685 | ||||||||||||
| Weighted average shares outstanding - diluted | 112,557 | 117,237 | 111,290 | 115,382 |
TABLE 2
REGENERON PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)
(In thousands, except per share data)
Three months ended
December 31,
Year ended
December 31,
Revenues:
Net product sales
$
406,088
$
281,471
$
1,425,839
$
858,093
Sanofi collaboration revenue
110,950
104,779
430,111
423,814
Bayer HealthCare collaboration revenue
85,695
21,791
220,289
70,099
Technology licensing and other revenue
7,679
6,561
28,506
26,471
610,412
414,602
2,104,745
1,378,477
Expenses:
Research and development
268,140
181,024
859,947
625,554
Selling, general, and administrative
82,085
57,739
329,415
210,755
Cost of goods sold
34,491
29,641
118,048
83,927
Cost of collaboration manufacturing
13,623
528
37,307
528
398,339
268,932
1,344,717
920,764
Income from operations
212,073
145,670
760,028
457,713
Other income (expense):
Investment (expense) income
(2,259)
384
(231)
2,012
Interest expense
(11,661)
(11,495)
(46,437)
(45,304)
(13,920)
(11,111)
(46,668)
(43,292)
Income before income taxes
198,153
134,559
713,360
414,421
Income tax (expense) benefit
(101,347)
335,848
(288,998)
335,848
Net income
$
96,806
$
470,407
$
424,362
$
750,269
Net income per share - basic
$
0.98
$
4.92
$
4.33
$
7.92
Net income per share - diluted
$
0.86
$
4.08
$
3.81
$
6.75
Weighted average shares outstanding - basic
98,862
95,691
97,917
94,685
Weighted average shares outstanding - diluted
112,557
117,237
111,290
115,382
| TABLE 3 | ||||||||||||||||
| REGENERON PHARMACEUTICALS, INC. | ||||||||||||||||
| RECONCILIATION OF GAAP NET INCOME TO NON-GAAP NET INCOME (Unaudited) | ||||||||||||||||
| (In thousands, except per share data) | ||||||||||||||||
| Three months endedDecember 31, | Year endedDecember 31, | |||||||||||||||
| 2013 | 2012 | 2013 | 2012 | |||||||||||||
| GAAP net income | $ | 96,806 | $ | 470,407 | $ | 424,362 | $ | 750,269 | ||||||||
| Adjustments: | ||||||||||||||||
| R&D: Non-cash share-based compensation expense | 33,779 | 18,498 | 116,520 | 53,833 | ||||||||||||
| SG&A: Non-cash share-based compensation expense | 20,722 | 11,851 | 79,966 | 39,249 | ||||||||||||
| COGS: Non-cash share-based compensation expense | 681 | 422 | 1,913 | 1,075 | ||||||||||||
| Interest expense: Non-cash interest related to convertiblesenior notes | 5,841 | 5,591 | 22,980 | 21,623 | ||||||||||||
| Income taxes: Non-cash income tax expense | 101,347 | 4,308 | 288,998 | 4,308 | ||||||||||||
| Income taxes: Release of valuation allowance | — | (340,156) | — | (340,156) | ||||||||||||
| Non-GAAP net income | $ | 259,176 | $ | 170,921 | $ | 934,739 | $ | 530,201 | ||||||||
| Non-GAAP net income per share - basic | $ | 2.62 | $ | 1.79 | $ | 9.55 | $ | 5.60 | ||||||||
| Non-GAAP net income per share - diluted(a) | $ | 2.24 | $ | 1.47 | $ | 8.17 | $ | 4.66 | ||||||||
| Shares used in calculating: | ||||||||||||||||
| Non-GAAP net income per share - basic | 98,862 | 95,691 | 97,917 | 94,685 | ||||||||||||
| Non-GAAP net income per share - diluted(b) | 116,740 | 117,237 | 115,343 | 115,382 | ||||||||||||
TABLE 3
REGENERON PHARMACEUTICALS, INC.
RECONCILIATION OF GAAP NET INCOME TO NON-GAAP NET INCOME (Unaudited)
(In thousands, except per share data)
Three months ended
December 31,
Year ended
December 31,
GAAP net income
$
96,806
$
470,407
$
424,362
$
750,269
Adjustments:
R&D: Non-cash share-based compensation expense
33,779
18,498
116,520
53,833
SG&A: Non-cash share-based compensation expense
20,722
11,851
79,966
39,249
COGS: Non-cash share-based compensation expense
681
422
1,913
1,075
Interest expense: Non-cash interest related to convertiblesenior notes
5,841
5,591
22,980
21,623
Income taxes: Non-cash income tax expense
101,347
4,308
288,998
4,308
Income taxes: Release of valuation allowance
—
(340,156)
—
(340,156)
Non-GAAP net income
$
259,176
$
170,921
$
934,739
$
530,201
Non-GAAP net income per share - basic
$
2.62
$
1.79
$
9.55
$
5.60
Non-GAAP net income per share - diluted(a)
$
2.24
$
1.47
$
8.17
$
4.66
Shares used in calculating:
Non-GAAP net income per share - basic
98,862
95,691
97,917
94,685
Non-GAAP net income per share - diluted(b)
116,740
117,237
115,343
115,382
| (a) | For diluted non-GAAP net income per share calculations, excludes $1.8 million and $1.9 million, respectively, of interest expense for the three month periods ended December 31, 2013 and 2012, and $7.2 million and $7.5 million, respectively, of interest expense for the years ended December 31, 2013 and 2012, related to the contractual coupon interest rate on the Company's 1.875% convertible senior notes, since these securities were dilutive. |
| (b) | Weighted average shares outstanding includes the dilutive effect, if any, of employee stock options, restricted stock awards, convertible senior notes, and warrants. |
(a)
For diluted non-GAAP net income per share calculations, excludes $1.8 million and $1.9 million, respectively, of interest expense for the three month periods ended December 31, 2013 and 2012, and $7.2 million and $7.5 million, respectively, of interest expense for the years ended December 31, 2013 and 2012, related to the contractual coupon interest rate on the Company's 1.875% convertible senior notes, since these securities were dilutive.
(b)
Weighted average shares outstanding includes the dilutive effect, if any, of employee stock options, restricted stock awards, convertible senior notes, and warrants.
| TABLE 4 | ||||||||||||||||
| REGENERON PHARMACEUTICALS, INC. | ||||||||||||||||
| COLLABORATION REVENUE (Unaudited) | ||||||||||||||||
| (In thousands) | ||||||||||||||||
| Three months endedDecember 31, | Year endedDecember 31, | |||||||||||||||
| 2013 | 2012 | 2013 | 2012 | |||||||||||||
| Sanofi collaboration revenue: | ||||||||||||||||
| Regeneron's share of losses in connection withcommercialization of ZALTRAP | $ | (8,229) | $ | (6,109) | $ | (30,810) | $ | (25,634) | ||||||||
| Substantive milestones and up-front payments | — | — | (20,000) | 50,000 | ||||||||||||
| Reimbursement of Regeneron research and developmentexpenses | 111,831 | 103,435 | 459,128 | 375,947 | ||||||||||||
| Other | 7,348 | 7,453 | 21,793 | 23,501 | ||||||||||||
| Total Sanofi collaboration revenue | 110,950 | 104,779 | 430,111 | 423,814 | ||||||||||||
| Bayer HealthCare collaboration revenue: | ||||||||||||||||
| Regeneron's net profit in connection with commercializationof EYLEA outside the United States | 44,308 | — | 101,494 | — | ||||||||||||
| Sales and substantive development milestones | 25,000 | 10,000 | 70,000 | 25,000 | ||||||||||||
| Cost-sharing of Regeneron EYLEA development expenses | 6,963 | 9,210 | 20,905 | 34,892 | ||||||||||||
| Other | 9,424 | 2,581 | 27,890 | 10,207 | ||||||||||||
| Total Bayer HealthCare collaboration revenue | 85,695 | 21,791 | 220,289 | 70,099 | ||||||||||||
| Total collaboration revenue | $ | 196,645 | $ | 126,570 | $ | 650,400 | $ | 493,913 |
TABLE 4
REGENERON PHARMACEUTICALS, INC.
COLLABORATION REVENUE (Unaudited)
(In thousands)
Three months ended
December 31,
Year ended
December 31,
Sanofi collaboration revenue:
Regeneron's share of losses in connection withcommercialization of ZALTRAP
$
(8,229)
$
(6,109)
$
(30,810)
$
(25,634)
Substantive milestones and up-front payments
—
—
(20,000)
50,000
Reimbursement of Regeneron research and developmentexpenses
111,831
103,435
459,128
375,947
Other
7,348
7,453
21,793
23,501
Total Sanofi collaboration revenue
110,950
104,779
430,111
423,814
Bayer HealthCare collaboration revenue:
Regeneron's net profit in connection with commercializationof EYLEA outside the United States
44,308
—
101,494
—
Sales and substantive development milestones
25,000
10,000
70,000
25,000
Cost-sharing of Regeneron EYLEA development expenses
6,963
9,210
20,905
34,892
Other
9,424
2,581
27,890
10,207
Total Bayer HealthCare collaboration revenue
85,695
21,791
220,289
70,099
Total collaboration revenue
$
196,645
$
126,570
$
650,400
$
493,913