Full Press Release Details
TARRYTOWN, N.Y.,Feb. 10, 2015/PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) today announced financial results for the fourth quarter and full year 2014 and provided an update on development programs.
| Financial Highlights | |||||||||||||||
| ($ in millions, except per share data) | Three Months EndedDecember 31, | Year EndedDecember 31, | |||||||||||||
| 2014 | 2013 | % Change | 2014 | 2013 | % Change | ||||||||||
| EYLEA U.S. net product sales | $ | 518 | $ | 402 | 29% | $ | 1,736 | $ | 1,409 | 23% | |||||
| Total revenues | $ | 802 | $ | 610 | 31% | $ | 2,820 | $ | 2,105 | 34% | |||||
| Non-GAAP net income | $ | 328 | $ | 259 | 27% | $ | 1,175 | $ | 935 | 26% | |||||
| Non-GAAP net income per share - diluted | $ | 2.79 | $ | 2.24 | 25% | $ | 10.00 | $ | 8.17 | 22% | |||||
| GAAP net income | $ | 110 | $ | 97 | 13% | $ | 348 | $ | 424 | (18%) | |||||
| GAAP net income per share - diluted | $ | 0.96 | $ | 0.86 | 12% | $ | 3.07 | $ | 3.81 | (19%) | |||||
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
$
518
$
402
29%
$
1,736
$
1,409
23%
Total revenues
$
802
$
610
31%
$
2,820
$
2,105
34%
Non-GAAP net income
$
328
$
259
27%
$
1,175
$
935
26%
Non-GAAP net income per share - diluted
$
2.79
$
2.24
25%
$
10.00
$
8.17
22%
GAAP net income
$
110
$
97
13%
$
348
$
424
(18%)
GAAP net income per share - diluted
$
0.96
$
0.86
12%
$
3.07
$
3.81
(19%)
"In 2015, Regeneron continues on our mission to evolve into a company with multiple, commercially-important therapies for patients," said Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron. "We look forward to another strong year of EYLEA growth, driven by expanded use in diabetic macular edema, as well as the potential regulatory approval and U.S. launch of PRALUENT for hypercholesterolemia. Regeneron also continues to advance our innovative mid-to-late stage pipeline of antibodies for people with serious diseases including rheumatoid arthritis, atopic dermatitis, asthma, chronic pain, and a life-threatening infection."
Business Highlights
EYLEA®(aflibercept) Injection for Intravitreal Injection
• In the fourth quarter of 2014, net sales of EYLEA inthe United Statesincreased 29% to$518 millionfrom$402 millionin the fourth quarter of 2013. For the full year 2014, net sales of EYLEA inthe United Statesincreased 23% to$1.736 billionfrom$1.409 billionfor the full year 2013. Overall distributor inventory levels remained within the Company's one- to two-week targeted range.
• Bayer HealthCare commercializes EYLEA outsidethe United States. In the fourth quarter of 2014, net sales of EYLEA outside ofthe United States(1)were$297 million, compared to$184 millionin the fourth quarter of 2013. In the fourth quarter of 2014, Regeneron recognized$88 millionfrom its share of net profit from EYLEA sales outsidethe United States(after repayment of$14 millionin development expenses), compared to$44 millionin the fourth quarter of 2013 (after repayment of$15 millionin development expenses). For the full year 2014, net sales of EYLEA outside ofthe United States(1)were$1.039 billion, compared to$472 millionin 2013. For the full year 2014, Regeneron recognized$301 millionfrom its share of net profit from EYLEA sales outsidethe United States(after repayment of$57 millionin development expenses), compared to$102 millionin 2013 (after repayment of$58 millionin development expenses).
• InOctober 2014, the FDA approved EYLEA for the treatment of macular edema following retinal vein occlusion (RVO), which includes macular edema following branch retinal vein occlusion (BRVO) in addition to the previously-approved indication of macular edema following central retinal vein occlusion (CRVO). Bayer HealthCare has also submitted regulatory applications seeking marketing authorization in the European Union and Japanfor EYLEA for the treatment of macular edema following BRVO. InJanuary 2015, the European Committee for Medicinal Products for Human Use (CHMP) recommended EYLEA for approval for the treatment of visual impairment due to macular edema secondary to CRVO or BRVO.
• InOctober 2014, the Company announced that in the National Institutes of Health (NIH) sponsored, Diabetic Retinopathy Clinical Research Network comparative effectiveness study in patients with diabetic macular edema (DME), EYLEA demonstrated a significantly greater improvement in mean change in best-corrected visual acuity (BCVA) from baseline at 52 weeks compared to both bevacizumab (Avastin®) and ranibizumab injection (Lucentis®), the primary endpoint of the study. The independent, NIH-sponsored study was designed to determine if one of three different anti-VEGF therapies is superior to the others for the treatment of DME.
• InNovember 2014, the Japanese Ministry of Health, Labour and Welfare approved EYLEA for DME.
• InNovember 2014, the FDA accepted for priority review the supplemental biologics license application (sBLA) for EYLEA for the treatment of diabetic retinopathy in patients with DME, with a target action date ofMarch 30, 2015.
Pipeline ProgressRegeneron has fifteen fully human monoclonal antibodies generated using the Company'sVelocImmune®technology in clinical development, including five in collaboration with Sanofi. Highlights from the antibody pipeline include:
PRALUENT™(alirocumab) is the Company's antibody targeting PCSK9 to lower LDL-cholesterol (LDL-C). InJanuary 2015, the FDA accepted for priority review the BLA for PRALUENT, with a target action date ofJuly 24, 2015. In addition, the European Medicines Agency (EMA) recently accepted for review the Marketing Authorization Application (MAA) for PRALUENT.
InNovember 2014, the Company and Sanofi reported positive results from six Phase 3 ODYSSEY trials that showed that PRALUENT significantly reduced LDL-C, or "bad" cholesterol. All six trials, ODYSSEY LONG TERM, COMBO I, ALTERNATIVE, OPTIONS I, OPTIONS II, and HIGH FH, met their primary efficacy endpoint of a greater reduction in LDL-C at 24 weeks, versus either active comparator or placebo, which included standard-of-care therapy. Detailed results from these trials were presented as part of a special session on the ODYSSEY program at the American Heart Association (AHA) Scientific Sessions inChicago, IL. The companies had previously announced inJuly 2014that all six studies met their primary efficacy endpoints. Data from ten studies (ODYSSEY LONG TERM, FH I, FH II, HIGH FH, COMBO I, COMBO II, OPTIONS I, OPTIONS II, ALTERNATIVE, and MONO) formed the basis for the Company's initial global regulatory filings.
InJanuary 2015, the Company and Sanofi announced that the ODYSSEY CHOICE I and ODYSSEY CHOICE II studies met their primary efficacy endpoints. The trials compared the reduction from baseline in LDL-C at 24 weeks with PRALUENT versus placebo in patients with hypercholesterolemia. In these monthly dosing trials, the mean percent reduction in LDL-C from baseline was consistent with that seen in previous Phase 3 trials evaluating PRALUENT in every other week dosing.
The Phase 3 ODYSSEY program remains ongoing.
Sarilumab, the Company's antibody targeting IL-6R for rheumatoid arthritis, is currently under investigation in the global Phase 3 SARIL-RA program. The Phase 3 MONARCH study, which will be a head-to-head monotherapy study comparing sarilumab against adalimumab, was recently initiated. The Company and Sanofi plan to present new Phase 3 data in 2015 and submit a BLA inthe United Statesby the end of 2015.
Dupilumab, the Company's antibody that blocks signaling of IL-4 and IL-13, is currently being studied in atopic dermatitis, asthma, chronic sinusitis with nasal polyps, and eosinophilic esophagitis. InOctober 2014, the LIBERTY AD CHRONOS Phase 3 study of dupilumab in atopic dermatitis was initiated and is currently enrolling patients. InNovember 2014, the FDA granted Breakthrough Therapy designation to dupilumab for the treatment of adults with moderate-to-severe atopic dermatitis who are not adequately controlled with topical prescription therapy and/or for whom these treatments are not appropriate.
InNovember 2014, the Company and Sanofi reported positive results from the interim analysis of a dose-ranging Phase 2b of dupilumab in adult patients with uncontrolled moderate-to-severe asthma. Full results of the trial will be presented at an upcoming scientific meeting.
A Phase 2 study of dupilumab in eosinophilic esophagitis was also recently initiated.
Fasinumab, an antibody targeting Nerve Growth Factor (NGF), is expected to re-enter clinical development during 2015.
REGN2222, an antibody targeting the respiratory syncytial virus (RSV), is expected to enter Phase 3 trials in 2015.
REGN2810, an antibody targeting PD-1, entered Phase 1 clinical development for the treatment of cancer in the first quarter of 2015.
Fourth Quarter and Full Year 2014 Financial Results
Product Revenues:Net product sales were$522 millionin the fourth quarter and$1.751 billionfor the full year 2014, compared to$406 millionin the fourth quarter and$1.426 billionfor the full year 2013. EYLEA net product sales inthe United Stateswere$518 millionin the fourth quarter and$1.736 billionfor the full year 2014, compared to$402 millionin the fourth quarter and$1.409 billionfor the full year 2013.
Total Revenues:Total revenues, which include product revenues described above, increased by 31% to$802 millionin the fourth quarter of 2014, compared to$610 millionin the fourth quarter of 2013. Total revenues also include collaboration revenues of$272 millionin the fourth quarter of 2014, compared to$197 millionin the fourth quarter of 2013. Full year 2014 total revenues increased by 34% to$2.820 billion, compared to$2.105 billionfor the full year 2013, and included collaboration revenues of$1.037 billionfor the full year 2014, compared to$650 millionfor the full year 2013. Collaboration revenues in the fourth quarter and full year 2014 increased primarily 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 2014 and 2013 also included$105 millionof sales milestone payments and$70 millionof milestone payments from Bayer HealthCare, respectively.
Refer to Table 4 for a summary of collaboration revenue.
Research and Development (R&D) Expenses:In 2014, GAAP R&D expenses were$352 millionin the fourth quarter and$1.271 billionfor the full year, compared to$268 millionin the fourth quarter and$860 millionfor full year 2013. The higher 2014 R&D expenses in the fourth quarter and full year were principally due to higher development costs primarily related to PRALUENT, dupilumab, sarilumab, and certain other, earlier-stage antibody product candidates, and higher headcount to support the Company's increased R&D activities. In 2014, GAAP R&D expenses also included the Company's 50% share, or$34 million, of the cost of purchasing a FDA priority review voucher. In addition, in 2014, R&D-related non-cash share-based compensation expense was$51 millionfor the fourth quarter and$184 millionfor the full year, compared to$34 millionin the fourth quarter and$117 millionfor the full year 2013.
Selling, General, and Administrative (SG&A) Expenses:In 2014, GAAP SG&A expenses were$144 millionin the fourth quarter and$505 millionfor the full year, compared to$82 millionin the fourth quarter and$329 millionfor full year 2013. The increases were primarily due to higher expenses associated with the Branded Prescription Drug Fee, higher headcount and headcount-related costs, higher legal costs primarily in connection with patent enforcement, and higher commercialization-related costs in connection with PRALUENT. In 2014, full year SG&A expenses included a$41 millionincremental charge related to the Branded Prescription Drug Fee, which was recorded in the third quarter of 2014, based on final regulations issued by the Internal Revenue Service (IRS) in July 2014. In 2014, SG&A-related non-cash share-based compensation expense was$30 millionfor the fourth quarter and$120 millionfor the full year, compared to$21 millionin the fourth quarter and$80 millionfor the full year 2013.
Other Income (Expense):In 2014, GAAP other expense included a$23 millionloss on extinguishment of debt in the fourth quarter and$33 millionfor the full year, related to the conversion of$170 millionand$231 millionprincipal amount, respectively, of the$400 millionaggregate principal amount of the Company's 1.875% convertible senior notes.
Income Tax Expense:In 2014, GAAP income tax expense was$111 millionin the fourth quarter and$428 millionfor the full year, compared to$101 millionin the fourth quarter and$289 millionfor the full year 2013. In 2014, the effective tax rate was 50.2% for the fourth quarter and 55.1% for full year 2014, compared to 51.1% for the fourth quarter and 40.5% for the full year 2013. The effective tax rate for the full year 2014 was negatively impacted primarily by losses incurred in foreign jurisdictions with rates lower than the federal statutory rate, an increase in income tax expense in connection with uncertain tax positions, and the non-tax deductible Branded Prescription Drug Fee, partly offset by the 2014 federal tax credit for increased research activities. GAAP income tax expense in 2014 and 2013 was principally a non-cash expense, due primarily to the utilization of net operating loss and tax credit carryforwards, and deductions related to employee stock option exercises.
Non-GAAP and GAAP Net Income:The Company reported non-GAAP net income of$328 million, or$3.23per basic share and$2.79per diluted share, in the fourth quarter of 2014, compared to non-GAAP net income of$259 million, or$2.62per basic share and$2.24per diluted share, in the fourth quarter of 2013. The Company reported non-GAAP net income of$1.175 billion, or$11.68per basic share and$10.00per diluted share, for the full year 2014, compared to non-GAAP net income of$935 million, or$9.55per basic share and$8.17per diluted share, for the full year 2013.
The Company reported GAAP net income of$110 million, or$1.09per basic share and$0.96per diluted share, in the fourth quarter of 2014, compared to GAAP net income of$97 million, or$0.98per basic share and$0.86per diluted share, in the fourth quarter of 2013. The Company reported GAAP net income of$348 million, or$3.46per basic share and$3.07per diluted share, for the full year 2014, compared to GAAP net income of$424 million, or$4.33per basic share and$3.81per diluted share, for the full year 2013.
A reconciliation of the Company's GAAP to non-GAAP results is included in Table 3 of this press release.
2015 Financial Guidance(3)
The Company's full year 2015 financial guidance consists of the following components:
| EYLEA U.S. net product sales | 25% - 30% growth over 2014 |
| Non-GAAP unreimbursed R&D(2) | $525 million - $575 million |
| Non-GAAP SG&A(2) | $650 million - $725 million |
| Cash tax as a % of non-GAAP pre-tax income(2) | 10% - 20% |
| Capital expenditures | $650 million - $800 million |
EYLEA U.S. net product sales
25% - 30% growth over 2014
Non-GAAP unreimbursed R&D(2)
$525 million - $575 million
Non-GAAP SG&A(2)
$650 million - $725 million
Cash tax as a % of non-GAAP pre-tax income(2)
10% - 20%
Capital expenditures
$650 million - $800 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 LLC in countries other than Japan and sales by Santen Pharmaceutical Co., Ltd. in Japan under a co-promotion agreement with a Japanese subsidiary of Bayer HealthCare LLC. 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, non-GAAP SG&A, and cash tax as a percentage of non-GAAP pre-tax income, 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) the incremental charge recorded in the third quarter of 2014 related to the issuance of the final IRS regulations that provide guidance on the annual fee imposed by the Patient Protection and Affordable Care Act (the final IRS regulations differed from the temporary regulations issued in 2011 which resulted in the recognition of a catch-up adjustment); (iii) 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; (iv) loss on extinguishment of debt, since this non-cash charge is based on factors that are not within the Company's control; and (v) income tax expense for 2013 and 2014, which was principally a non-cash expense, due primarily to the utilization of net operating loss and tax credit carry-forwards and deductions related to employee stock option exercises. Prospectively, the Company continues to expect a significant difference between the Company's effective tax rate and actual cash income taxes paid/payable. Consequently, GAAP income tax expense is not deemed useful in evaluating the Company's operating performance. 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 historical GAAP to non-GAAP results is included in Table 3 of this press release. |
| (3) | The Company's 2015 financial guidance does not assume the completion of any significant business development transactions not completed as of the date 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 LLC in countries other than Japan and sales by Santen Pharmaceutical Co., Ltd. in Japan under a co-promotion agreement with a Japanese subsidiary of Bayer HealthCare LLC. 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, non-GAAP SG&A, and cash tax as a percentage of non-GAAP pre-tax income, 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) the incremental charge recorded in the third quarter of 2014 related to the issuance of the final IRS regulations that provide guidance on the annual fee imposed by the Patient Protection and Affordable Care Act (the final IRS regulations differed from the temporary regulations issued in 2011 which resulted in the recognition of a catch-up adjustment); (iii) 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; (iv) loss on extinguishment of debt, since this non-cash charge is based on factors that are not within the Company's control; and (v) income tax expense for 2013 and 2014, which was principally a non-cash expense, due primarily to the utilization of net operating loss and tax credit carry-forwards and deductions related to employee stock option exercises. Prospectively, the Company continues to expect a significant difference between the Company's effective tax rate and actual cash income taxes paid/payable. Consequently, GAAP income tax expense is not deemed useful in evaluating the Company's operating performance. 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 historical GAAP to non-GAAP results is included in Table 3 of this press release.
(3)
The Company's 2015 financial guidance does not assume the completion of any significant business development transactions not completed as of the date of this press release.
Conference Call Information
Regeneron will host a conference call and simultaneous webcast to discuss its fourth quarter and full year 2014 financial and operating results onTuesday, February 10, 2015, 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, Inc.
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 commercializes 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. Several Regeneron programs are based on human genetics findings. 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 Pharmaceuticals, Inc. ("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; 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 in additional indications in relevant jurisdictions, PRALUENT, sarilumab, dupilumab, fasinumab, and REGN2222; 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 and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), such as the comparative effectiveness study in patients with DME discussed in this news release, on the 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, cash tax as a percentage of non-GAAP pre-tax income, and capital expenditures; the potential for any license or collaboration agreement, including Regeneron's agreements with Sanofi and Bayer HealthCare LLC, to be cancelled or terminated without any further product success; and risks associated with intellectual property of other parties 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, 2013and its Form 10-Q for the quarterly period endedSeptember 30, 2014. 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 historical non-GAAP financial measures.
| Contact Information: | ||
| Manisha Narasimhan, Ph.D. | Hala Mirza | |
| Investor Relations | Corporate Communications | |
| 914-847-5126 | 914-847-3422 | |
| [email protected] | [email protected] |
| TABLE 1 | ||||||
| REGENERON PHARMACEUTICALS, INC.CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited)(In thousands) | ||||||
| December 31, | ||||||
| 2014 | 2013 | |||||
| Assets: | ||||||
| Cash and marketable securities | $ | 1,360,634 | $ | 1,083,875 | ||
| Accounts receivable - trade, net | 739,379 | 787,071 | ||||
| Accounts receivable from Sanofi and Bayer HealthCare | 278,020 | 167,896 | ||||
| Inventories | 128,861 | 70,354 | ||||
| Deferred tax assets | 316,104 | 276,555 | ||||
| Property, plant, and equipment, net | 974,309 | 526,983 | ||||
| Other assets | 74,520 | 38,279 | ||||
| Total assets | $ | 3,871,827 | $ | 2,951,013 | ||
| Liabilities and stockholders' equity: | ||||||
| Accounts payable, accrued expenses, and other liabilities | $ | 620,137 | $ | 262,226 | ||
| Deferred revenue | 250,301 | 231,199 | ||||
| Facility lease obligations | 312,291 | 185,197 | ||||
| Convertible senior notes | 146,773 | 320,315 | ||||
| Stockholders' equity | 2,542,325 | 1,952,076 | ||||
| Total liabilities and stockholders' equity | $ | 3,871,827 | $ | 2,951,013 |
TABLE 1
REGENERON PHARMACEUTICALS, INC.CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited)(In thousands)
December 31,
Assets:
Cash and marketable securities
$
1,360,634
$
1,083,875
Accounts receivable - trade, net
739,379
787,071
Accounts receivable from Sanofi and Bayer HealthCare
278,020
167,896
Inventories
128,861
70,354
Deferred tax assets
316,104
276,555
Property, plant, and equipment, net
974,309
526,983
Other assets
74,520
38,279
Total assets
$
3,871,827
$
2,951,013
Liabilities and stockholders' equity:
Accounts payable, accrued expenses, and other liabilities
$
620,137
$
262,226
Deferred revenue
250,301
231,199
Facility lease obligations
312,291
185,197
Convertible senior notes
146,773
320,315
Stockholders' equity
2,542,325
1,952,076
Total liabilities and stockholders' equity
$
3,871,827
$
2,951,013
| TABLE 2 | |||||||||||
| REGENERON PHARMACEUTICALS, INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)(In thousands, except per share data) | |||||||||||
| Three Months EndedDecember 31, | Year EndedDecember 31, | ||||||||||
| 2014 | 2013 | 2014 | 2013 | ||||||||
| Revenues: | |||||||||||
| Net product sales | $ | 521,518 | $ | 406,088 | $ | 1,750,762 | $ | 1,425,839 | |||
| Sanofi collaboration revenue | 135,271 | 110,950 | 541,299 | 430,111 | |||||||
| Bayer HealthCare collaboration revenue | 137,095 | 85,695 | 495,555 | 220,289 | |||||||
| Technology licensing and other revenue | 8,445 | 7,679 | 31,941 | 28,506 | |||||||
| 802,329 | 610,412 | 2,819,557 | 2,104,745 | ||||||||
| Expenses: | |||||||||||
| Research and development | 351,745 | 268,140 | 1,271,353 | 859,947 | |||||||
| Selling, general, and administrative | 143,743 | 82,085 | 504,755 | 329,415 | |||||||
| Cost of goods sold | 37,957 | 34,491 | 129,030 | 118,048 | |||||||
| Cost of collaboration manufacturing | 21,517 | 13,623 | 75,988 | 37,307 | |||||||
| 554,962 | 398,339 | 1,981,126 | 1,344,717 | ||||||||
| Income from operations | 247,367 | 212,073 | 838,431 | 760,028 | |||||||
| Other income (expense): | |||||||||||
| Investment and other income (expense) | 2,952 | (2,259) | 8,157 | (231) | |||||||
| Interest expense | (6,350) | (11,661) | (37,372) | (46,437) | |||||||
| Loss on extinguishment of debt | (22,682) | — | (33,469) | — | |||||||
| (26,080) | (13,920) | (62,684) | (46,668) | ||||||||
| Income before income taxes | 221,287 | 198,153 | 775,747 | 713,360 | |||||||
| Income tax expense | (111,111) | (101,347) | (427,673) | (288,998) | |||||||
| Net income | $ | 110,176 | $ | 96,806 | $ | 348,074 | $ | 424,362 | |||
| Net income per share - basic | $ | 1.09 | $ | 0.98 | $ | 3.46 | $ | 4.33 | |||
| Net income per share - diluted | $ | 0.96 | $ | 0.86 | $ | 3.07 | $ | 3.81 | |||
| Weighted average shares outstanding - basic | 101,467 | 98,862 | 100,612 | 97,917 | |||||||
| Weighted average shares outstanding - diluted | 114,246 | 112,557 | 113,413 | 111,290 |
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
$
521,518
$
406,088
$
1,750,762
$
1,425,839
Sanofi collaboration revenue
135,271
110,950
541,299
430,111
Bayer HealthCare collaboration revenue
137,095
85,695
495,555
220,289
Technology licensing and other revenue
8,445
7,679
31,941
28,506
802,329
610,412
2,819,557
2,104,745
Expenses:
Research and development
351,745
268,140
1,271,353
859,947
Selling, general, and administrative
143,743
82,085
504,755
329,415
Cost of goods sold
37,957
34,491
129,030
118,048
Cost of collaboration manufacturing
21,517
13,623
75,988
37,307
554,962
398,339
1,981,126
1,344,717
Income from operations
247,367
212,073
838,431
760,028
Other income (expense):
Investment and other income (expense)
2,952
(2,259)
8,157
(231)
Interest expense
(6,350)
(11,661)
(37,372)
(46,437)
Loss on extinguishment of debt
(22,682)
—
(33,469)
—
(26,080)
(13,920)
(62,684)
(46,668)
Income before income taxes
221,287
198,153
775,747
713,360
Income tax expense
(111,111)
(101,347)
(427,673)
(288,998)
Net income
$
110,176
$
96,806
$
348,074
$
424,362
Net income per share - basic
$
1.09
$
0.98
$
3.46
$
4.33
Net income per share - diluted
$
0.96
$
0.86
$
3.07
$
3.81
Weighted average shares outstanding - basic
101,467
98,862
100,612
97,917
Weighted average shares outstanding - diluted
114,246
112,557
113,413
111,290
| 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, | ||||||||||
| 2014 | 2013 | 2014 | 2013 | ||||||||
| GAAP net income | $ | 110,176 | $ | 96,806 | $ | 348,074 | $ | 424,362 | |||
| Adjustments: | |||||||||||
| R&D: Non-cash share-based compensation expense | 51,180 | 33,779 | 184,347 | 116,520 | |||||||
| SG&A: Non-cash share-based compensation expense | 29,531 | 20,722 | 120,203 | 79,966 | |||||||
| SG&A: Branded Prescription Drug Fee incremental charge | — | — | 40,600 | — | |||||||
| COGS: Non-cash share-based compensation expense | 744 | 681 | 2,688 | 1,913 | |||||||
| Interest expense: Non-cash interest related to convertible senior notes | 2,375 | 5,841 | 17,821 | 22,980 | |||||||
| Other expense: Loss on extinguishment of debt | 22,682 | — | 33,469 | — | |||||||
| Income tax expense | 111,111 | 101,347 | 427,673 | 288,998 | |||||||
| Non-GAAP net income | $ | 327,799 | $ | 259,176 | $ | 1,174,875 | $ | 934,739 | |||
| Non-GAAP net income per share - basic | $ | 3.23 | $ | 2.62 | $ | 11.68 | $ | 9.55 | |||
| Non-GAAP net income per share - diluted(a) | $ | 2.79 | $ | 2.24 | $ | 10.00 | $ | 8.17 | |||
| Shares used in calculating: | |||||||||||
| Non-GAAP net income per share - basic | 101,467 | 98,862 | 100,612 | 97,917 | |||||||
| Non-GAAP net income per share - diluted(b) | 117,825 | 116,740 | 117,966 | 115,343 |
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
$
110,176
$
96,806
$
348,074
$
424,362
Adjustments:
R&D: Non-cash share-based compensation expense
51,180
33,779
184,347
116,520
SG&A: Non-cash share-based compensation expense
29,531
20,722
120,203
79,966
SG&A: Branded Prescription Drug Fee incremental charge
—
—
40,600
—
COGS: Non-cash share-based compensation expense
744
681
2,688
1,913
Interest expense: Non-cash interest related to convertible senior notes
2,375
5,841
17,821
22,980
Other expense: Loss on extinguishment of debt
22,682
—
33,469
—
Income tax expense
111,111
101,347
427,673
288,998
Non-GAAP net income
$
327,799
$
259,176
$
1,174,875
$
934,739
Non-GAAP net income per share - basic
$
3.23
$
2.62
$
11.68
$
9.55
Non-GAAP net income per share - diluted(a)
$
2.79
$
2.24
$
10.00
$
8.17
Shares used in calculating:
Non-GAAP net income per share - basic
101,467
98,862
100,612
97,917
Non-GAAP net income per share - diluted(b)
117,825
116,740
117,966
115,343
| (a) | For diluted non-GAAP net income per share calculations, excludes $0.6 million and $1.8 million, respectively, of interest expense for the three-month periods ended December 31, 2014 and 2013, and $5.0 million and $7.2 million, respectively, of interest expense for the years ended December 31, 2014 and 2013, 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 $0.6 million and $1.8 million, respectively, of interest expense for the three-month periods ended December 31, 2014 and 2013, and $5.0 million and $7.2 million, respectively, of interest expense for the years ended December 31, 2014 and 2013, 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, | ||||||||||
| 2014 | 2013 | 2014 | 2013 | ||||||||
| Sanofi collaboration revenue: | |||||||||||
| Regeneron's share of losses in connection with commercialization of ZALTRAP® | — | $ | (8,229) | $ | (4,715) | $ | (30,810) | ||||
| Regeneron's share of losses in connection with commercialization of antibodies | $ | (24,253) | — | (41,378) | — | ||||||
| Reimbursement of Regeneron research and development expenses | 143,664 | 111,831 | 552,567 | 459,128 | |||||||
| Reimbursement of Regeneron commercialization-related expenses | 12,417 | 1,868 | 19,480 | 1,868 | |||||||
| Up-front payments to Sanofi for acquisition of rights related to two antibodies | — | — | — | (20,000) | |||||||
| Other | 3,443 | 5,480 | 15,345 | 19,925 | |||||||
| Total Sanofi collaboration revenue | 135,271 | 110,950 | 541,299 | 430,111 | |||||||
| Bayer HealthCare collaboration revenue: | |||||||||||
| Regeneron's net profit in connection with commercialization of EYLEA outsidethe United States | 88,011 | 44,308 | 301,302 | 101,494 | |||||||
| Sales and development milestones | 30,000 | 25,000 | 105,000 | 70,000 | |||||||
| Cost-sharing of Regeneron development expenses | (1,661) | 6,963 | 26,231 | 20,905 | |||||||
| Other | 20,745 | 9,424 | 63,022 | 27,890 | |||||||
| Total Bayer HealthCare collaboration revenue | 137,095 | 85,695 | 495,555 | 220,289 | |||||||
| Total collaboration revenue | $ | 272,366 | $ | 196,645 | $ | 1,036,854 | $ | 650,400 |
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 with commercialization of ZALTRAP®
—
$
(8,229)
$
(4,715)
$
(30,810)
Regeneron's share of losses in connection with commercialization of antibodies
$
(24,253)
—
(41,378)
—
Reimbursement of Regeneron research and development expenses
143,664
111,831
552,567
459,128
Reimbursement of Regeneron commercialization-related expenses
12,417
1,868
19,480
1,868
Up-front payments to Sanofi for acquisition of rights related to two antibodies
—
—
—
(20,000)
Other
3,443
5,480
15,345
19,925
Total Sanofi collaboration revenue
135,271
110,950
541,299
430,111
Bayer HealthCare collaboration revenue:
Regeneron's net profit in connection with commercialization of EYLEA outsidethe United States
88,011
44,308
301,302
101,494
Sales and development milestones
30,000
25,000
105,000
70,000
Cost-sharing of Regeneron development expenses
(1,661)
6,963
26,231
20,905
Other
20,745
9,424
63,022
27,890
Total Bayer HealthCare collaboration revenue
137,095
85,695
495,555
220,289
Total collaboration revenue
$
272,366
$
196,645
$
1,036,854
$
650,400