UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): January 13, 2015 (January 13, 2015)
REGENERON PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
New York
(State or other jurisdiction
of incorporation)
| 000-19034 | 13-3444607 | |
| (Commission File Number) |
(I.R.S. Employer Identification No.) |
| 777 Old Saw Mill River Road, Tarrytown, New York | 10591-6707 | |
| (Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number, including area code: (914) 847-7000
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instructions A.2. below):
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
| Item 2.02. | Results of Operations and Financial Condition. |
On January 13, 2015, at the 33rd Annual J.P. Morgan Healthcare Conference in San Francisco, California, Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron Pharmaceuticals, Inc., is providing a corporate update. Dr. Schleifer’s presentation includes on page 26 information regarding the Company’s preliminary U.S. net sales of EYLEA® (aflibercept) Injection for the full year 2014. A copy of the presentation is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.
The information included or incorporated in this Item 2.02, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall such information and exhibit be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such a filing.
| Item 9.01. | Financial Statements and Exhibits |
| (d) | Exhibits. |
| 99.1 | Presentation by Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron Pharmaceuticals, Inc., at the 33rd Annual J.P. Morgan Healthcare Conference. | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| REGENERON PHARMACEUTICALS, INC. |
| /s/ Joseph J. LaRosa |
| Joseph J. LaRosa |
| Senior Vice President, General Counsel and Secretary |
Date: January 13, 2015
EXHIBIT INDEX
| Number |
Description | |
| 99.1 | Presentation by Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron Pharmaceuticals, Inc., at the 33rd Annual J.P. Morgan Healthcare Conference. | |
| Exhibit 99.1
|
JP Morgan Healthcare Conference
January 13, 2015
Leonard S. Schleifer, M.D., Ph.D.
President and Chief Executive Officer
1
|
|
NOTE REGARDING FORWARD-LOOKING STATEMENTS AND NON-GAAP FINANCIAL MEASURES
This presentation includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), 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 EYLEA®, Praluent™ (alirocumab), sarilumab, and dupilumab; 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®, Praluent™ (alirocumab), sarilumab, and dupilumab; 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 sales and the Company’s expectations regarding non-GAAP unreimbursed R&D, non-GAAP SG&A, cash tax payments, 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 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 ended December 31, 2013 and its Form 10-Q for the quarterly period ended September 30, 2014, 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 presentation uses non-GAAP unreimbursed R&D, non-GAAP SG&A, cash tax, and non-GAAP pre-tax income, which are financial measures that are not calculated in accordance with the U.S. Generally Accepted Accounting Principles (“GAAP”). Regeneron 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) estimate of income tax expense that is not payable in cash, as there is a significant difference between the Company’s effective tax rate and actual cash income taxes paid/payable due primarily to the utilization of net operating loss and tax credit carry-forwards, 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 expense reduced by R&D expense reimbursements from the Company’s collaboration partners. Non-GAAP pre-tax income represents GAAP pre-tax income less non-GAAP adjustments. 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.
2
|
|
For over 25 years, Regeneron’s vision has been to build an innovative company that consistently brings new medicines to patients with serious diseases.
3
|
|
NOW IS OUR TIME AND IT’S JUST BEGINNING
4
|
|
A CLEAR PATH FORWARD
GENERATE
MAJOR SUBMISSIONS AND/OR APPROVALS YEAR AFTER YEAR
TRANSFORM
THE MANAGEMENT OF SERIOUS DISEASES: HEART DISEASE, RA, ATOPIC DERMATITIS, ASTHMA AND OTHERS
SUPPORT
EYLEA AS THE RETINAL THERAPY OF CHOICE & MAINTAIN LEADERSHIP IN RETINAL DISEASE
INVEST
IN THE NEXT WAVES OF INNOVATION FOR PATIENTS IN NEED
5
|
|
AND THE ENGINE TO MAKE IT A REALITY…
UNMATCHED
PIPELINE
CULTURE OF INNOVATION
PEOPLE
SCIENCE & TECH
PROWESS
6
|
|
AND THE ENGINE TO MAKE IT A REALITY…
PIPELINE
17 antibodies across multiple therapeutic areas
3 in late stage
CULTURE OF INNOVATION
PEOPLE
SCIENCE & TECH
PROWESS
7
|
|
AND THE ENGINE TO MAKE IT A REALITY…
PIPELINE
17 antibodies across multiple therapeutic areas
3 in late stage
PEOPLE
SCIENCE Top Employer for 3 years
#5 Most Innovative Company (Forbes)
Rapidly growing Commercial team
SCIENCE & TECH
PROWESS
8
|
|
AND THE ENGINE TO MAKE IT A REALITY…
PIPELINE
17 antibodies across multiple
therapeutic areas
3 in late stage
PEOPLE
SCIENCE Top Employer for 3 years
#5 Most Innovative Company (Forbes)
Rapidly growing Commercial team
PROWESS
VelocImmune® Industrial
Regeneron Operations Genetics Center & Supply
Bi-specifics
9
|
|
LATE STAGE PIPELINE: MULTIPLE POTENTIAL REGULATORY SUBMISSIONS/APPROVALS ADDRESSING SERIOUS DISEASES
PRALUENT™
(alirocumab)
SARILUMAB
DUPILUMAB
PRALUENT, sarilumab and dupilumab are being developed in collaboration with Sanofi
10
|
|
UNMET NEED REMAINS HIGH IN CV DISEASE
CV disease causes 17.3M deaths per year1 17.3M
Significant driver of U.S. economic costs2 $315B
LDL-C contributes to 60% of coronary heart 60% disease and 40% of all ischemic stroke3
24M high-risk patients fail to reach LDL-C goals4 24M
(1) WHO. http://who.int/mediacentre/factsheets/fs317/en/ (EU, East Mediterranean, the Americas, SE Asia, West Pacific, Africa). (2) NHLBI. http://www.nhlbi.nih.gov/about/documents/factbook/2012/chapter4.htm.
(3) WHO. http://www.who.int/whr/2002/en/whr02_en.pdf?ua=1. (4) U.S. NHANES, Market Scan, IMS and Sanofi estimates.
11
|
|
PRALUENT™: SIGNIFICANT AND CONSISTENT LDL-C REDUCTION ACROSS ALL 10 PIVOTAL TRIALS
LDL-C Change from Baseline at 24 Weeks Dosing Mean Baseline Study Q2W LDL-C (mg/dL) alirocumab Comparator
HIGH FH 150 mg 198 46% 7% placebo
FH I 75/150 mg(1) 145 49% 9% placebo
HeFH
FH II 75/150 mg(1) 134 49% 3% placebo
On top of max tolerated statin doses
LONG TERM 150 mg 122 61% 1% placebo
COMBO I 75/150 mg(1) 102 48% 2% placebo
COMBO II 75/150 mg(1) 108 51% 21% ezetimibe
High
CV Risk 21-23% ezetimibe OPTION I 75/150 mg(1) 105 44-54% 5% statin x2
21% statin switch On top of regular statin doses
(1) 11-14% ezetimibe OPTION II 75/150 mg 111 36-51% 16% statin switch
Statin Intolerant ALTERNATIVE 75/150 mg(1) 191 45% 15% ezetimibe
Not receiving statins Moderate (1)
MONO 75/150 mg 140 48% 16% ezetimibe
CV Risk
(1) Per protocol dose increase to 150 mg possible based on pre-specified LDL-C levels.
Primary efficacy endpoint met in all 10 reported trials
12
|
|
PRALUENT™: SIGNIFICANT AND CONSISTENT LDL-C REDUCTION ACROSS ALL 10 PIVOTAL TRIALS
alirocumab
46% 49% 49% 61% 48% 51%
44-54% 36-51% 45%
48%
(1) Per protocol dose increase to 150 mg possible based on pre-specified LDL-C levels.
13
|
|
PRALUENT™: SIGNIFICANT AND CONSISTENT LDL-C REDUCTION ACROSS ALL 10 PIVOTAL TRIALS
alirocumab
46%
49%
Largest registration program to date Evaluation 49% of 75mg and 150mg Q2W as well 14 trials with ³23,500 patients as monthly 61% options Primary endpoint evaluated at 24 weeks Post-hoc data on lower rate of adjudicated major CV 48% events in LONG TERM trial
Double-blind design (6, 12, 18 and 24 months)
³4,500 patient 51% years exposure
44-54% 36-51% 45%
48%
(1) Per protocol dose increase to 150 mg possible based on pre-specified LDL-C levels.
14
|
|
PRALUENT™: SAFETY PROFILE FROM ODYSSEY LONG TERM
% of Patients with Treatment Emergent Adverse Events of Interest
alirocumab Placebo
(n=1550) (n=788)
General allergic reaction events 9.0 9.0 Treatment emergent local injection site reactions 5.8 4.3 Myalgia 4.9 3.0 Neurological events2 4.2 3.9 All cardiovascular events1 4.0 4.4 Ophthalmological events2 2.5 1.9 Neurocognitive disorders2 1.2 0.5 ALT increase 1.1 0.5 CPK increase 0.5 0.5 AST increase 0.2 0
All patients on background of maximally tolerated statin ± other lipid-lowering therapy Safety Analysis (at least 52 weeks for all patients continuing treatment, including 607 patients overall who completed W78 visit) (1) Confirmed by adjudication. Adjudicated CV events include all CV AEs positively adjudicated. The adjudication categories are the following: CHD death, non-fatal MI, fatal and non-fatal ischemic stroke, unstable angina requiring hospitalization, congestive heart failure requiring hospitalization, ischemia driven coronary revascularization procedure [PCI, CABG].
(2) Company MedDRA Queries (CMQ).
15
|
|
PRALUENT™: CRITICAL LAUNCH PREPAREDNESS UNDERWAY
2015 PRIORITIES
U.S. & EU Regulatory Review
FDA Priority Review expected
Invest for Successful Launch in 2H15
Manufacturing scale-up; commercial/ field force expansion
Present Monthly Dosing Results
CHOICE I and CHOICE II data
16
|
|
SARILUMAB IN RHEUMATOID ARTHRITIS:
GROWING OPPORTUNITY; BROAD DEVELOPMENT PROGRAM
RA affects up to 70M people worldwide1 Unmet need exists as patients cycle through multiple treatments Biologic monotherapy is an important and growing market segment2
~2,500 RA patients targeted in SARIL-RA program
STUDY DESIGN n
MOBILITY sarilumab + MTX, MTX IR patients 1,197
TARGET sarilumab + DMARD, Anti-TNF IR patients 546
sarilumab + MTX, Anti-TNF IR patients
ASCERTAIN ® 200
Safety calibrator vs. Actemra
sarilumab monotherapy, DMARD-
ONE 120
IR/inappropriate patients (open-label)
sarilumab + DMARD,
EASY 200
Auto-injector real-life use
sarilumab monotherapy vs. Humira®,, MTX-
MONARCH 340
IR or MTX- inappropriate patients
sarilumab + DMARD or monotherapy long-
EXTEND 2,000 term extension study (open-label)*
(1)World Health Organization. http://www.who.int/chp/topics/rheumatic/en/.
(2) Ann Rheum Dis. 2013 Dec;72(12):1897-904.
*Patients must have been in a previous sarilumab study
17
|
|
SARILUMAB: PHASE 3 RESULTS
SHOW STRONG EFFICACY AT BOTH DOSES
ACR RESPONSE AT ACR RESPONSE AT WEEK 24 WEEK 52
ACR
ACHIEVING (n=398)
% (n=400) (n=399)
* p<0.0001 vs. placebo
SARIL-RA-MOBILITY Change from Baseline in mTSS
Placebo + MTX mTSS 3
IN 2.5 mTSS: Sarilumab Modified 2 70% Total Sharp 150 mg + MTX
Score BASELINE 1.5
FROM 1 90%
0.5 Sarilumab CHANGE 0 200 mg + MTX
0 13 26 36 52 Week
* p<0.0001 vs. placebo
Sarilumab had a higher incidence of AEs leading to withdrawal; the most frequent AEs occurring more often in the sarilumab groups included neutropenia, upper respiratory tract infection, increased alanine aminotransferase, injection site erythema, urinary tract infection and nasopharyngitis. An increase in mean LDL-C and transaminases was observed.
18
|
|
SARILUMAB: CRITICAL YEAR WITH MAJOR PHASE 3 READOUTS
2015 PRIORITIES
Report Results from 3 Phase 3 Trials
TNF-IR and monotherapy populations
Complete U.S. Submission by Year End
19
|
|
DUPILUMAB: A FIRST-IN-CLASS IL4/IL13 INHIBITOR WITH POTENTIAL FOR IMPORTANT ALLERGIC DISEASES
Moderate-to-Severe Asthma
Up to 300M WW affected1 10-20% uncontrolled despite existing therapies2
Moderate-to-Severe Atopic Dermatitis (AD)
>5M affected in U.S. & EU3 Widespread lesions; intense itching Sleep & other lifestyle disturbance 40% uncontrolled w/ topicals4
Chronic Sinusitis with Nasal Polyps (CSwNP)
Long-term nasal symptoms Loss of sense of smell Facial pain Approx. 200K U.S. patients have sinus surgery annually for nasal polyps5
(1) WHO. http://www.who.int/gard/publications/chronic_respiratory_diseases.pdf. (2) Am J Respir Crit Care Med. 2004 Oct;170(8):836-844.6.
(3) Adapted from White Book on Allergy. http://www.worldallergy.org/UserFiles/file/WAO-White-Book-on-Allergy.pdf. (4) Allergy Asthma Proc. 2012 May-Jun;33(3):227-34.
(5) MEDSTAT and IHCIS Database, and Internal Analysis.
20
|
|
DUPILUMAB: A FIRST-IN-CLASS IL4/IL13 INHIBITOR WITH POTENTIAL FOR IMPORTANT ALLERGIC DISEASES
Moderate-to-Severe Asthma
Up to 300M WW affected1 10-20% uncontrolled despite existing therapies2
Moderate-to-Severe Atopic Dermatitis (AD)
Breakthrough Therapy Designation
Chronic Sinusitis with Nasal Polyps (CSwNP)
Long-term nasal symptoms Loss of sense of smell Facial pain Approx. 200K U.S. patients have sinus surgery annually for nasal polyps5
(1) WHO. http://www.who.int/gard/publications/chronic_respiratory_diseases.pdf.
(2) Am J Respir Crit Care Med. 2004 Oct;170(8):836-844.6.
(3) Adapted from White Book on Allergy. http://www.worldallergy.org/UserFiles/file/WAO-White-Book-on-Allergy.pdf.
(4) Allergy Asthma Proc. 2012 May-Jun;33(3):227-34.
(5) MEDSTAT and IHCIS Database, and Internal Analysis.
21
|
|
DUPILUMAB: POSITIVE PHASE 2 RESULTS ACROSS 3 KEY DISEASES
ATOPIC DERMATITIS PHASE 2B (n=380): MEAN PERCENT CHANGE IN EASI/ITCHING
EASI SCORE OVER 16 WEEKS REDUCTION IN ITCHING AT 16 WEEKS
0 2 4 6 8 10 12 14 16 0
Pbo 300m 300mg
Placebo g QW
-25
Q2W
(n=61) (n=64) (n=63)
-50
300mg Q2W Pruritus
11% 53% 60%
-75 NRS
5-D
300mg QW
-100 Pruritus 9% 35% 44% p<0.0001 vs. placebo at Week 16 Score p<0.0001 vs. placebo for all parameters All other time points p<0.05 vs. placebo
CSwNP PHASE 2A STUDY (n=60): REDUCTION IN NASAL POLYPS
Mean change +/- SE NASAL POLYP SCORE (NPS)
0.5 0.0 -0.5 -1.0 -1.5
-2.0 Placebo -2.5 Dupilumab
-3.0 Baseline 4 8 12 16 Week
ASTHMA PHASE 2B (n=776):
MEAN IMPROVEMENT IN LUNG FUNCTION (FEV1)
500 25.9%(1) 25.8%(2)
400
(1)
18.0% FEV1=forced
17.7%(1)
300 expiratory volume 10.4% volume over
200
6.2% one second
FEV1 100 0
High Eosinophils Population Overall Population
Placebo 200mg Q2W 300mg Q2W (1) p<0.001 vs. placebo
(2) p<0.01 vs. placebo
ASTHMA PHASE 2B (n=776):
ANNUALIZED RATE OF SEVERE EXACERBATION EVENTS
1 0.8 0.6
0.4 -64%(1) (2) (3)
-67%
-75%(1) -67% 0.2
0 (1) p<0.05 vs. placebo
High Eosinophils Population Overall Population (2) p<0.01 vs. placebo
Placebo 200mg Q2W 300mg Q2W (3) p<0.001 vs. placebo
22
|
|
DUPILUMAB: BALANCED ADVERSE EVENT PROFILE IN PHASE 2 STUDIES TO DATE
ATOPIC DERMATITIS PHASE 2B: ASTHMA PHASE 2B: PHASE 2A CSwNP:
MOST COMMON AEs MOST COMMON AEs TOP-LINE COMMON AEs
Nasopharyngitis: Injection site reaction: Injection site reactions,
18-23% vs. 21% placebo 13-25% vs. 12% placebo nasopharyngitis, oropharyngeal
Headache: respiratory infection: pain, epistaxis, headache and Upper
12-15% vs. 8% placebo 10-13% vs. 13% placebo dizziness
Injection site reaction:
5-10% vs. 3% placebo Headache:
5-10% vs. 8% placebo
Nasopharyngitis:
3-10% vs. 6% placebo
Bronchitis:
5-8% vs. 8% placebo
23
|
|
DUPILUMAB: ADVANCE BROAD DEVELOPMENT PROGRAM
2015 PRIORITIES
Execute Phase 3 Adult AD Program; Initiate Pediatric AD Program
Launch Phase 3 in Asthma
Plan Phase 3 in Chronic Sinusitis with Nasal Polyps
Launch Eosinophilic Esophagitis Development Program
24
|
|
SUPPORT EYLEA® AS THE RETINAL THERAPY OF CHOICE; MAINTAIN LEADERSHIP IN RETINAL DISEASE
®
EYLEA will continue to drive top-line growth, supported by a growing body of clinical evidence
25
|
|
EYLEA®: POSITIONED FOR CONTINUED GROWTH EYLEA® CONTINUED GROWTH U.S. NET SALES Now approved for major retinal diseases in U.S. & EU NIH-sponsored PROTOCOL T study should support DME growth Granted Breakthrough Therapy designation by U.S. FDA for treatment of diabetic retinopathy in patients with DME $2,000 ~$1.735B* $1,800 $1,600 $1.41B $1,400 MM $1,200 $ $1,000 $838 $800 $600 $400 $200 $25 $0 2011† 2012 2013 2014 † *2014 unaudited, preliminary numbers EYLEA approved in November 2011 26 REGENERON NOW IS OUR TIME AND IT’S JUST BEGINNING
|
|
ADVANCING NEXT-GENERATION RETINAL THERAPIES
PDGFR-B inhibitor/EYLEA co-formulation moving to Phase 2 in 2015
Regeneron owns 100% U.S. commercial rights
ANG2 inhibitor/EYLEA co-formulation in Phase 1 AVALANCHE Biotech collaboration
27
|
|
INVEST IN NEXT WAVES OF INNOVATION
To realize our vision, we must continually refuel the pipeline and advance science and technology innovation
28
|
|
A BROAD AND SUSTAINABLE PIPELINE
ANTIBODY CANDIDATES PHASE 1 PHASE 2 PHASE 3
PRALUENT™ (alirocumab) Hypercholesterolemia
Sarilumab (REGN88) Rheumatoid arthritis, non-infectious uveitis
Dupilumab (REGN668) Atopic dermatitis, asthma, chronic sinusitis with nasal polyps REGN1033 (GDF8) Skeletal muscle disorders Fasinumab (NGF) Pain (on partial clinical hold) REGN2176-3 (PDGFR+EYLEA) Retinal disease Nesvacumab (Ang2) Cancer (on partial clinical hold)
REGN2222 (RSV) RSV
REGN1400 (ERBB3) Cancer
REGN1500 (Angptl-3) CV & metabolic (on partial clinical hold) REGN1979 (CD20/CD3) Cancer REGN1908-1909 Allergic diseases REGN910-3 (Ang2+EYLEA) Retinal disease Enoticumab (REGN421—DII4) Cancer
REGN1154 (undisclosed target) Program partnered with Bayer ex-US
REGN1193 (undisclosed target)
Program partnered
REGN2810 (PD-1) Cancer (IND filed Q414) with Sanofi
29
|
|
ACCELERATING CLINICAL PROGRAMS: RSV, NGF
RSV ANTIBODY (PHASE 1)
MOST COMMON CAUSE OF BRONCHIOLITIS AND PNEUMONIA IN U.S. CHILDREN <11
Leading cause of infant hospitalization Phase 1 results expected in 2015 Potential for less frequent dosing
EXPECT TO MOVE TO PHASE 3 in 2015
FASINUMAB, NGF ANTIBODY (PHASE 2)
A NOVEL NON-OPIOID APPROACH TO ADDRESSING CHRONIC PAIN
Full clinical hold lifted in osteoarthritis (OA) based on positive pre-clinical data shared with FDA* Partnering efforts underway
HUMAN TRIALS EXPECTED TO RESUME in 2015
(1) Pediatrics 2010 Feb;125(2):342-9.
*Program on Partial Clinical Hold limiting duration of trials in OA to 16 weeks pending submission of further preclinical data in 1H15.
30
|
|
ADVANCING MULTIPLE APPROACHES IN IMMUNO-ONCOLOGY
IMMUNO-ONCOLOGY
Deep research and early development focus: bi-specifics, checkpoint inhibitors and ADCs Phase 1: CD20/CD3 bi-specific antibody for blood cancers IND Filed in Q414: anti-PD1 for cancer
BI-SPECIFICS CHECKPOINT INHIBITORS
KILLING
Tumor T-cell Cell
Adapted from NEJM 2012
31
|
|
RAPID PROGRESS WITH REGENERON GENETICS CENTER
Unprecedented Speed, Scale and Integration in Genetic Research
32
|
|
2015 FINANCIAL GUIDANCE1
Non-GAAP Unreimbursed R&D: $525MM—$575MM
Non-GAAP SG&A: $650MM—$725MM
This includes REGN incurred commercial-related expenses for Sanofi collaboration antibodies
Cash Tax2 as a % of Non-GAAP Pre-tax Income: 10%—20%
Capital Expenditures: $650MM—$800MM
1) The 2015 guidance does not assume the completion of any significant business development transactions not completed as of December 31, 2014.
2) Represents estimated income taxes that are payable in cash for the relevant period.
33
|
|
IMPORTANT DATA, REGULATORY AND
OPERATIONAL MILESTONES THROUGHOUT 2015
PRALUENT™ U.S. & EU regulatory review & launch Sarilumab Phase 3 readouts & U.S. submission Expansion of dupilumab Phase 3 program RSV, NGF, GDF8 antibodies clinical progress Protocol T DME publication; EYLEA® WW growth Continued operational expansion in U.S. and Ireland
34
|
|
NOW IS OUR TIME
AND IT’S JUST BEGNNING
35
|
|
END
36