q4 & full year 2015 - biogen...
TRANSCRIPT
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Q4 & Full Year 2015Financial Results and Business Update
January 27, 2016
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Forward-Looking StatementsThis presentation contains forward-looking statements, including statements relating to: Biogen’s commercial business and prospects;investments in, and potential of, pipeline and collaboration programs; anticipated timing of data readouts; potential product approvals and timingof launches; 2016 full year guidance and other financial matters. These forward-looking statements may be accompanied by such words as“anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “potential,” “project,” “target,” “will” and other words andterms of similar meaning. You should not place undue reliance on these statements.
These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements,including: our dependence on sales from our principal products; failure to compete effectively due to significant product competition in themarkets for our products; difficulties in obtaining and maintaining adequate coverage, pricing and reimbursement for our products; risksassociated with current and potential future healthcare reforms; the occurrence of adverse safety events, restrictions on use with our products orproduct liability claims; failure to protect and enforce our data, intellectual property and other proprietary rights and the risks and uncertaintiesrelating to intellectual property claims and challenges; uncertainty of long-term success in developing, licensing or acquiring other productcandidates or additional indications for existing products; risks associated with clinical trials, including our ability to adequately manage clinicalactivities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may requireadditional information or further studies or may fail to approve or may delay approval of our drug candidates; the risk that positive results in aclinical trial may not be replicated in subsequent or confirmatory trials or success in early stage clinical trials may not be predictive of results inlater stage or large scale clinical trials or trials in other potential indications; problems with our manufacturing processes; our dependence oncollaborators and other third parties for the development and commercialization of products and other aspects of our business, which areoutside of our control; failure to manage our growth and execute our growth initiatives; failure to achieve the anticipated benefits and savingsfrom our corporate restructuring efforts; risks relating to technology failures or breaches; failure to comply with legal and regulatoryrequirements; risks related to indebtedness; the risks of doing business internationally, including currency exchange rate fluctuations; chargesand other costs relating to our properties; fluctuations in our effective tax rate; risks relating to investment in and expansion of manufacturingcapacity for future clinical and commercial requirements; the market, interest and credit risks associated with our portfolio of marketablesecurities; risks relating to our ability to repurchase stock, including at favorable prices; risks relating to access to capital and credit markets;environmental risks; risks relating to the sale and distribution by third parties of counterfeit versions of our products; risks relating to the use ofsocial media for our business; change in control provisions in certain of our collaboration agreements; and the other risks and uncertainties thatare described in the Risk Factors section of our most recent annual or quarterly report and in other reports we have filed with the SEC.
These statements are based on our current beliefs and expectations and speak only as of the date of this press release. We do not undertakeany obligation to publicly update any forward-looking statements.
Note regarding trademarks: ALPROLIX®, AVONEX®, BENEPALI®, ELOCTATM, ELOCTATE®, FUMADERMTM, PLEGRIDY®, RITUXAN®,TECFIDERA®, TYSABRI®, and ZINBRYTATM, as used in this presentation, are trademarks or registered trademarks of Biogen or itssubsidiaries. Other trademarks referenced in this presentation are the property of their respective owners.
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Q4 2015 Earnings Call Agenda
Introduction Matt CalistriInvestor Relations
Overview George Scangos, Ph.D.Chief Executive Officer
R&D Update Al Sandrock, M.D., Ph.D.EVP, Chief Medical Officer
Business Update Paul ClancyEVP, Chief Financial Officer
Closing Remarks George Scangos, Ph.D.Chief Executive Officer
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OverviewGeorge Scangos, Ph.D. Chief Executive Officer
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Recent Highlights
Financial Update• 11% growth in revenues and 23% growth in
non-GAAP diluted EPS year-over-year• In 2015, purchased 16.8 million shares of
common stock, completing our $5.0 billion share repurchase program
• Corporate restructuring largely complete
Commercial Update• Stable demand for TECFIDERA in the US
and continued growth ex-US• Most prescribed oral MS therapy
worldwide• Over 170,000 patients have been
treated with TECFIDERA globally in the clinical trial and post-marketing setting
• Strong adoption of ALPROLIX and ELOCTATE
A reconciliation of our GAAP to non-GAAP financial results is at the end of this presentation
R&D Progress• ELOCTA approved for hemophilia A in the EU• Meaningful business development activity in
2015: • Acquired Convergence Pharmaceuticals,
including raxatrigine for neuropathic pain• Licensed amiselimod (MT-1303) from
Mitsubishi Tanabe for inflammatory bowel disease
• Entered collaboration with AGTC for gene therapy in ophthalmic diseases
• BENEPALI approved as 1st etanercept biosimilar referencing Enbrel® in the EU
• In 2015, advanced mid- and late-stage pipeline: aducanumab, anti-LINGO, and nusinersen
• Recently initiated Phase 1 trials in ALS and Parkinson’s disease
• Continued to strengthen research capabilities
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R&D UpdateAl Sandrock, M.D., Ph.D.EVP and Chief Medical Officer
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Alzheimer’s Disease: Clinical Development Updates
Anticipated 2016 Data Readouts
• Safety data for titration arms of ongoing Phase 1b PRIME study of
aducanumab expected in second half of the year
• Interim safety data for small molecule BACE-1 inhibitor (E2609)
• Topline efficacy and safety data for additional monoclonal antibody
targeting amyloid beta (BAN2401)
Aducanumab Phase 3 Status
• Two ongoing Phase 3 studies, ENGAGE and EMERGE
• Factors affecting enrollment:
• Challenging to access patients with early Alzheimer’s disease
• Limited availability of PET and high screen failure rate
• Substantial interest likely due to Phase 1b data
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Anti-LINGO Phase 2 MS Study (SYNERGY) Endpoints
9HPT, 9-hole peg test; EDSS, Expanded Disability Status Scale; PASAT-3, 3-second Paced Auditory Serial Addition Test; T25FW, timed 25-foot walk. Cadavid D, et al. Poster presented at the Annual Meeting of the AAN, April 26–May 03, 2014. Poster P3.154; Hupperts RMM, et al. Poster presented at the Annual Cooperative Meeting of ENS and the EFNS, May 31–June 03, 2014. Poster EP1153.
Physical FunctionCognitive FunctionDisability
Timedwalking (T25FW)
Upper limbfunction (9HPT)
Information processinglearning and memory
(PASAT-3)
Disability progression (EDSS)
Change in brain volumes
Change in magnetization transfer
Change in lesion diffusivity
Diffusion Tensor Imaging
MagnetizationTransfer RatioBrain Atrophy
Com
posi
te P
rimar
y En
dpoi
ntIm
agin
g En
dpoi
nts
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Nusinersen for Spinal Muscular Atrophy (SMA)
Development Status
• Phase 3 CHERISH study in children: target
enrollment complete
• Phase 3 ENDEAR study in infants: enrollment
completion anticipated in 1H:16
• Data for both programs anticipated in 1H:17
• Collaboration with Ionis Pharmaceuticals
(formerly Isis Pharmaceuticals)
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New Hemophilia Data Presented at ASH Conference
• New data presented demonstrating that ELOCTATE
and ALPROLIX may effectively manage target joint
bleeding and maintain low annualized bleeding rates
in people with severe hemophilia A and B
• 3rd party data* from three children with inhibitors
showed successful immune tolerance induction using
ELOCTATE
• Time to anti-FVIII tolerance was 4-12 weeks,
significantly shorter than current standard of care
• No adverse effects
*Malec L.M., et al., “Immune Tolerance Induction Using rFVIIIFc (Eloctate)” poster
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Biogen Is Advancing ALS Drug Development
• Initiated a Phase 1/2 clinical study of IONIS-SOD1Rx (BIIB067) in patients with ALS in December 2015
• Superoxide Dismutase 1 (SOD1) is the second most common familial form of ALS, accounting for ~2% of cases
• SOD1 antisense oligonucleotide developed in collaboration with Ionis Pharmaceuticals
• ALS is a progressive, fatal neurodegenerative disorder with death typically within 2-5 years from diagnosis
• High unmet need for a therapy that provides functional benefit and extends survival
* IONIS-SOD1Rx (BIIB067) is being developed in collaboration with Ionis Pharmaceuticals. Program is currently in development and not approved
Survival in SOD1-G93A Rat
Biogen’s approach: Pursuing validated, genetically
identified targets
First Patient Dosed January 2016
First Patient Dosed January 2016
SOD1 ASO
PBS
SOD1 ASOPBS
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Deep PipelinePHASE I PHASE II PHASE III FILED
ZINBRYTA* Multiple Sclerosis
Multiple SclerosisAnti-LINGO
Inflammatory Bowel DiseaseAmiselimod (MT-1303)*
Primary Progressive & Relapsing Multiple SclerosisOcrelizumab*
Front-Line Indolent Non Hodgkin’s LymphomaGAZYVA*
Acute Ischemic StrokeTYSABRI
Front-Line Diffuse Large B-Cell LymphomaGAZYVA*
Alzheimer’s DiseaseE2609*
Alzheimer's DiseaseBAN2401*
Trigeminal NeuralgiaRaxatrigine (CNV1014802)
Multiple SclerosisBIIB061
IONIS-DMPKRx* Myotonic Dystrophy
Dapirolizumab pegol* SLE†
Anti-BDCA2 SLE†
X-linked Juvenile RetinoschisisXLRS gene therapy*
Anti-alpha-synuclein Parkinson’s Disease
PHASE I PHASE II PHASE III FILED
* Collaboration programs † Systematic Lupus Erthematosus # Amyotrophic Lateral Sclerosis
Alzheimer's DiseaseAducanumab (BIIB037)*
Spinal Muscular AtrophyNusinersen (IONIS-SMNRx)*
BIIB063 Sjogren’s Syndrome
BENEPALI (etanercept)* Multiple Immunology Indications in Europe
Multiple Immunology Indications in EuropeBiosimilar infliximab*
Idiopathic Pulmonary FibrosisBG00011 (STX-100)
Multiple Immunology Indications in EuropeBiosimilar adalimumab*
SOD1-ALS#IONIS-SOD1Rx (BIIB067)*
Approved in EUApproved in EU
Rituxan-Refractory Indolent Non Hodgkin’s LymphomaGAZYVA*
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Business UpdatePaul ClancyEVP, Chief Financial Officer
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2015 Financial Performance
$13.83
$17.01
2014 2015
+23%
$12.37
$15.34
2014 2015
+24%
Diluted EPS ($)
Non-GAAPGAAP
A reconciliation of our GAAP to non-GAAP financial results is at the end of this presentation
Total
$9.7
$10.8
2014 2015
+11%
$8.2
$9.2
2014 2015
+12%
Revenues ($B)
Product
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Q4 2015 Highlights• Revenue vs. Q3 2015 and Q4 2014
• US revenue benefitted by approximately $30 million versus Q3 2015 due to increase in wholesaler inventory
• Positive leading indicators for TECFIDERA marketing campaign; full impact to be assessed in Q2
• European label updated in December 2015
• In US, 14 shipping weeks in Q4 2014 and 13 in all other quarters shown
• FX, offset by hedging, weakened Q4 2015 TECFIDERA revenue by approximately $6 million versus Q4 2014 and FY 2015 revenue by approximately $27 million versus 2014
Global TECFIDERA Performance
Note: Numbers may not foot due to rounding
TECFIDERA Revenue ($M)
∆Q/Q ∆Y/YWW + 6% and + 8%US + 4% and + 6%ROW + 13% and + 20%
$743$648
$721 $754 $785
$173
$177$163
$183$208
$916
$825$883
$937$993
Q4-14 Q1-15 Q2-15 Q3-15 Q4-15
ROW
US
The Most Prescribed Oral MS Therapy Globally
The Most Prescribed Oral MS Therapy Globally
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Q4 2015 Highlights• Total Interferon
Revenue vs. Q3 2015 and Q4 2014
• In US, 14 shipping weeks in Q4 2014 and 13 in all other quarters shown
• FX, offset by hedging, weakened Q4 2015 interferon revenue by approximately $13 million versus Q4 2014 and FY 2015 revenue by approximately $88 million versus 2014
Global Interferon Performance
Interferon Revenues ($M)
∆Q/Q ∆Y/YWW (6%) and (5%)US (6%) and (4%)ROW (6%) and (6%)
$501 $479$405 $467 $440
$28 $40$50
$71 $67
$235 $214$211
$218$197
$13$22
$24
$29$36
$777 $755$690
$785$740
Q4-14 Q1-15 Q2-15 Q3-15 Q4-15
PLEG ROWAVX ROWPLEG USAVX US
Note: Numbers may not foot due to rounding
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Q4 2015 Highlights• Revenue vs. Q3 2015 and Q4 2014
• Continued trend of positive patient growth this quarter
• Physicians continue to choose this therapy for patients requiring high efficacy
• Well-understood safety profile after nearly 10 years on the market
• In US, 13 shipping weeks in all quarters shown
• FX, offset by hedging, weakened Q4 2015 TYSABRI revenue by approximately $13 million versus Q4 2014 and FY 2015 revenue by approximately $90 million versus 2014
Global TYSABRI Performance
TYSABRI Revenue ($M)
$266 $273 $269 $284 $278
$218 $190 $195 $196 $203
$484 $463 $463 $480 $481
Q4-14 Q1-15 Q2-15 Q3-15 Q4-15
ROW
US
∆Q/Q ∆Y/YWW + 0% and (1%)US (2%) and + 5%ROW + 4% and (7%)
Note: Numbers may not foot due to rounding
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Q4 2015 Highlights• Revenue vs. Q3 2015 and Q4 2014
• ELOCTA approved in the EU (to be commercialized by Sobi)
• ROW revenues primarily from Japan
ELOCTATE Performance
ELOCTATE Revenue ($M)
$37$53
$72$87
$96$0.4
$2
$4
$5
$37
$54
$74
$91$101
Q4-14 Q1-15 Q2-15 Q3-15 Q4-15
ROW
US
∆Q/Q ∆Y/YWW + 12% and + 175%US + 10% and + 160%ROW + 47% and NMF
Note: Numbers may not foot due to rounding
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Q4 2015 Highlights• Revenue vs. Q3 2015 and Q4 2014
• ROW revenues primarily from Japan
• ALPROLIX filed for marketing authorization in EU
ALPROLIX Performance
ALPROLIX Revenue ($M)
$37 $41$49
$59 $60
$4$2
$5
$7$11
$40$43
$54
$66$71
Q4-14 Q1-15 Q2-15 Q3-15 Q4-15
ROW
US
∆Q/Q ∆Y/YWW + 9% and + 77%US + 2% and + 64%ROW + 63% and + 202%
Note: Numbers may not foot due to rounding
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$19 $21 $14 $17 $17
$286 $310 $323 $320 $317$305 $331 $338 $337 $334
$872$956 $986 $959 $947
Q4-14 Q1-15 Q2-15 Q3-15 Q4-15ROW Royalty BIIB US Profit Share BIIB Revenue US Net Sales
RITUXAN and GAZYVA Performance
RITUXAN and GAZYVA Results ($M)
Note: In collaboration with Roche and Genentech. Numbers may not foot due to rounding. 1 BIIB US profit share = US profit share + expense reimbursement
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Q4 2015 HighlightsRevenue vs. Q3 2015 and Q4 2014
∆Q/Q ∆Y/YUS Net Sales (1%) and + 9%US Profit Share1 (1%) and + 11%ROW Royalty (2%) and (9%)BIIB Revenue (1%) and + 10%
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$ in Millions Q4 2014
Q3 2015
Q4 2015
Q/Q
Y/Y
FY 2014
FY 2015
FY/FY
Cost of Sales1 $297 $310 $332 (7%) (12%) $1,171 $1,240 (6%)
% of Total Revenues 11% 11% 12% 12% 12%
Non-GAAP R&D Expenses2 $499 $520 $542 (4%) (9%) $1,888 $2,013 (7%)
% of Total Revenues 19% 19% 19% 19% 19%
Non-GAAP SG&A Expenses3 $573 $478 $583 (22%) (2%) $2,191 $2,113 4%
% of Total Revenues 22% 17% 21% 23% 20%
Amortization of Acquired Intangibles4 $6 $4 $5 (14%) 22% $17 $17 (3%)
Gain on Sale of Rights (BENLYSTA) $5 $0 $0 NMF (100%) $17 $0 (100%)
Q4 & FY 2015 Financial Results Summary
Note: Numbers may not foot due to rounding. Percent changes represented as favorable & (unfavorable).1 For all periods there were no adjustments between GAAP and non-GAAP cost of sales.2 For Q4’14 GAAP R&D expense was $500 million and 19% of Total Revenues, non-GAAP R&D expense excludes $1 million in stock option expense. For Q3‘15 and Q4’15 there were no adjustments between GAAP and non-GAAP R&D expense. For FY‘14 GAAP R&D expense was $1,893 million and 20% of Total Revenues, non-GAAP R&D expense excludes $6 million in stock option expense. For FY‘15 there were no adjustments between GAAP and non-GAAP R&D expense.3 For Q4'14 GAAP SG&A expense was $574 million and 22% of Total Revenues, non-GAAP SG&A expense excludes $1 million in stock option expense . For Q3’15 and Q4’15 there were no adjustments between GAAP and non-GAAP SG&A expense. For FY’14 GAAP SG&A expense was $2,232 million and 23% of Total Revenues, non-GAAP SG&A expense excludes $6 million in stock option expense and a $35 million donation to the Biogen Foundation. For FY’15 there were no adjustments between GAAP and non-GAAP SG&A expense.4 For Q4’14 GAAP Amortization was $107 million, non-GAAP Amortization excludes $101 million of amortization related to acquired intangible assets. For Q3’15 GAAP Amortization was $98 million, non-GAAP Amortization excludes $94 million of amortization related to acquired intangible assets. For Q4’15 GAAP Amortization was $97 million, non-GAAP Amortization excludes $92 million of amortization related to acquired intangible assets. For FY’14 GAAP Amortization was $490 million, non-GAAP Amortization excludes $473 million of amortization related to acquired intangible assets. For FY’15 GAAP Amortization was $383 million, non-GAAP Amortization excludes $365 million of amortization related to acquired intangible assets.
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$ in Millions Q4 2014
Q3 2015
Q4 2015
Q/Q
Y/Y
FY 2014
FY 2015
FY/FY
Other Income (Expense), Net1 ($9) ($15) ($82) (435%) (842%) ($26) ($124) (380%)
Non-GAAP Tax Rate2 24% 24% 23% 25% 24%
Equity in Loss of Investee, Net of Tax3 $0 $7 $0 100% 100% $15 $13 17%
Net Income (Loss) Attributable to Non Controlling Interest
($1) $54 ($3) 105% 230% $7 $46 (581%)
Non-GAAP Net Income Attributable to Biogen4,5 $966 $1,042 $995 (5%) 3% $3,281 $3,932 20%
Weighted Average Diluted Shares Used in Calculating Diluted EPS
236 233 221 5% 7% 237 231 3%
Non-GAAP EPS4,5 $4.09 $4.48 $4.50 1% 10% $13.83 $17.01 23%
Q4 & FY 2015 Financial Results Summary
Note: Numbers may not foot due to rounding. Percent changes represented as favorable & (unfavorable).1 For all periods other income (expense), net there were no adjustments between GAAP and non-GAAP. 2 GAAP tax rates were 23%, 24%, and 24% in Q4’14, Q3'15, and Q4’15, respectively. GAAP tax rates were 25% and 24% in FY’14 and FY’15, respectively. The difference between the GAAP and non-GAAP tax rate for all periods is a result of the cumulative effects of the reconciliation that can be found at the end of this presentation and the footnotes to the prior slide of this presentation.3 Represents our share of the results of operations related to our investment in Samsung Bioepis.4 GAAP diluted EPS were $3.74, $4.15, and $3.77 in Q4’14, Q3'15, and Q4’15, respectively. GAAP diluted EPS were $12.37 and $15.34 in FY’14 and FY’15, respectively. GAAP net income attributable to Biogen Inc. was $883 million, $966 million and $832 million in Q4’14, Q3'15, and Q4’15, respectively. GAAP net income attributable to Biogen Inc. was $2,935 million and $3,547 million in FY’14 and FY’15, respectively. Please refer to the end of this presentation for the most directly comparable GAAP net income attributable to Biogen Inc. and diluted GAAP EPS, with a reconciliation to the non-GAAP net income attributable to Biogen Inc. and diluted non-GAAP EPS.5 Q4’15 and FY’15 GAAP results include the impact of a $93 million pretax charge for employee severance and R&D program termination costs in connection with the cost reduction initiative announced in October 2015.
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2016 Full Year Financial GuidanceExpense ratios apply to both GAAP and Non-GAAP 2016 Full Year Guidance. FY 2016 Guidance Assumptions
RevenuesApproximately
$11.1 to $11.3 billion
• Relatively stable demand for TECFIDERA in the US and continued growth in Europe
• Continued growth for ELOCTATE and moderating patient adds for ALPROLIX
• Current spot rates for FX• ~ $170 million in hedge gains in 2015 makes year
over year comparison less favorable
R&D Expense(as a % of revenues)
19 to 20% • Includes $100 million for BD and investments in a number of mid- and late-stage programs
SG&A Expense(as a % of revenues)
17 to 18% • Headcount reduction and termination of pipeline
programs announced in October 2015• Plan to reduce fees and services expenses
Non-GAAP EPSExpected between $18.30 and $18.60 • Share stabilization and 219 million weighted
average diluted sharesGAAP EPS Expected between $16.85 and $17.15
Biogen may incur charges, realize gains or experience other events in 2016 that could cause actual results to vary from this guidance. In 2016, Biogen plans to provide one update to its annual financial guidance, which is expected to be provided in connection with its second quarter earnings release. This approach is intended to synchronize our guidance with internal business planning processes and to ensure a continued focus on long-term value creation.A reconciliation of our GAAP to non-GAAP financial results is at the end of this presentation
• Anticipate paying $1.2 billion in CVR payments to Fumapharm• Capital expenditures for the year are expected to be between $800 to $850 million• For our MS therapies, plan assumes a constant number of shipping weeks of 13 for each of the 4 quarters in 2016
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Closing RemarksGeorge Scangos, Ph.D. Chief Executive Officer
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• Continued focus on commercial execution
• Long-term value creation expected to come from pipeline
• Multiple upcoming potential value drivers:– Insight into impact of TECFIDERA marketing campaign in Q2:16– Phase 2 for anti-LINGO-1 in MS expected mid-2016– Phase 2 for BAN2401 and E2609 expected in 2016– Phase 3 for nusinersen expected 1H:17– Phase 1b titration data for aducanumab expected 2H:16– BENEPALI launch expected in 2016– Approval of infliximab biosimilar and ZINBRYTA expected 1H:16
Biogen: Creating Value in 2016
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Questions & Answers
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BiogenAppendix
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Q4 & FY 2015 Financial Results Summary: Revenues 1 of 2
$ in Millions Q4 2014
Q3 2015
Q4 2015
Q/Q
Y/Y
FY 2014
FY 2015
FY/FY
TECFIDERA US $743 $754 $785 4% 6% $2,427 $2,908 20%
TECFIDERA ROW $173 $183 $208 13% 20% $483 $730 51%
Total TECFIDERA Sales1 $916 $937 $993 6% 8% $2,909 $3,638 25%
AVONEX US $501 $467 $440 (6%) (12%) $1,957 $1,790 (9%)
AVONEX ROW $235 $218 $197 (9%) (16%) $1,056 $840 (20%)
Total AVONEX Sales1 $736 $685 $637 (7%) (13%) $3,013 $2,630 (13%)
PLEGRIDY US $28 $71 $67 (6%) 139% $28 $227 716%
PLEGRIDY ROW $13 $29 $36 23% 171% $17 $111 569%
Total PLEGRIDY Sales1 $41 $100 $103 3% 150% $44 $338 661%
Total Interferon Sales $777 $785 $740 (6%) (5%) $3,058 $2,969 (3%)
TYSABRI US $266 $284 $278 (2%) 5% $1,025 $1,103 8%
TYSABRI ROW $218 $196 $203 4% (7%) $934 $783 (16%)
Total TYSABRI Sales1 $484 $480 $481 0% (1%) $1,959 $1,886 (4%)
FAMPYRA $19 $21 $28 31% 49% $80 $90 12%
Total MS Sales $2,195 $2,223 $2,241 1% 2% $8,006 $8,583 7%
Numbers may not foot due to rounding. Percent changes represented as favorable & (unfavorable).For all periods, there were no adjustments between GAAP and non-GAAP revenues.1 Net of Hedge
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Q4 & FY 2015 Financial Results Summary: Revenues 2 of 2
$ in Millions Q4 2014
Q3 2015
Q4 2015
Q/Q
Y/Y
FY 2014 FY 2015
FY/FY
ELOCTATE US $37 $87 $96 10% 160% $58 $308 428%
ELOCTATE ROW $0 $4 $5 47% NMF $0 $11 NMF
Total ELOCTATE Sales $37 $91 $101 12% 175% $58 $320 447%
ALPROLIX US $37 $59 $60 2% 64% $72 $209 190%
ALPROLIX ROW $4 $7 $11 63% 202% $4 $26 544%
Total ALPROLIX Sales $40 $66 $71 9% 77% $76 $234 208%
Total Hemophilia Sales $77 $156 $172 10% 123% $134 $554 312%
FUMADERM Sales $14 $12 $13 1% (12%) $63 $51 (18%)
Total Product Sales $2,287 $2,392 $2,426 1% 6% $8,203 $9,188 12%
RITUXAN/GAZYVA US Profit Share1 $286 $320 $317 (1%) 11% $1,117 $1,270 14%
RITUXAN ROW Royalty $19 $17 $17 (2%) (9%) $78 $69 (11%)
Unconsolidated Joint Business Revenue (RITUXAN & GAZYVA) $305 $337 $334 (1%) 10% $1,195 $1,339 12%
Corporate Partner Revenues $18 $40 $69 74% 290% $128 $189 48%
Royalties $31 $9 $10 13% (68%) $177 $48 (73%)
Total Revenues $2,641 $2,778 $2,839 2% 8% $9,703 $10,764 11%
Numbers may not foot due to rounding. Percent changes represented as favorable & (unfavorable).For all periods, there were no adjustments between GAAP and non-GAAP revenues1 US Profit Share = US Profit Share + Expense Reimbursement
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Neurology Late Stage Programs - MS
Molecule ZINBRYTA1 OCRELIZUMAB2
Trial Name DECIDE OPERA I OPERA II ORATORIO
Phase Phase III Phase III Phase III Phase III
Indication RMS RMS RMS PPMS
Administration SC Injection IV/Infusion IV/Infusion IV/Infusion
Target Enrollment 1,800 800 800 630
Design
Active comparator
trial versus Ifn β 1-A
Active comparator trial
vs. Ifn β 1-A (Rebif)
Active comparator trial
vs. Ifn β 1-A (Rebif)
Placebo comparator
Primary Endpoint
ARR at 2-3 years
ARR at 96 Weeks
ARR at 96 Weeks
Time to sustained disability
progression
StatusFiled in US, EU, Canada, & Switzerland
Data presented at ECTRIMS
2015
Data presented at ECTRIMS
2015
Data presented at ECTRIMS
2015
1 Collaboration with AbbVie Biotherapeutics.2 Genentech has responsibility for, and is funding 100% of, the further development of ocrelizumab in multiple sclerosis and will be responsible for commercialization.
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Neurology Late Stage Programs - Continued
Molecule Aducanumab1 ISIS-SMNRx2 ISIS-SMNRx
2
Trial Name ENGAGE EMERGE ENDEAR CHERISH
Phase Phase III Phase III Phase III Phase III
Indication
Early Alzheimer’s Disease
(MMSE 24-30 /PET Screened)
Early Alzheimer’s Disease
(MMSE 24-30 /PET Screened)
Infantile-onset Spinal Muscular Atrophy
(SMA)
Later-onset Spinal Muscular Atrophy
(SMA)
Administration Monthly IV/Infusion Monthly IV/Infusion Intrathecal Injection Intrathecal Injection
Target Enrollment 1350 1350 110 120
Design
3 mg/kg, 6 mg/kg, and placebo for ApoE4 carriers
6 mg/kg, 10 mg/kg, and placebo for
ApoE4 non-carriersAll arms include
titration
3 mg/kg, 6 mg/kg, and placebo for ApoE4 carriers
6 mg/kg, 10 mg/kg, and placebo for
ApoE4 non-carriersAll arms include
titration
12mg intrathecalinjection versus sham
procedure
12mg intrathecalinjection versus sham
procedure
Primary EndpointCDR sum of boxes at
18 monthsCDR sum of boxes at
18 monthsTime to death or
permanent ventilationHammersmith
Functional Motor Scale-Expanded (HFMSE)
Status Currently enrolling Currently enrolling Currently enrollingTarget enrollment
completed January 2016
1 Eisai has the right to opt-in to jointly develop and commercialize aducanumab.2 Collaboration with Ionis Pharmaceuticals.
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Hemophilia Late Stage Programs
Molecule ALPROLIX1 ELOCTATE1
Trial Name B-LONG KIDS B-LONG A-LONG KIDS A-LONG
Phase Phase III Phase III Phase III Phase III
Indication Hemophilia B Hemophilia B Hemophilia A Hemophilia A
Administration IV Infusion IV Infusion IV Infusion IV Infusion
Target Enrollment 123 ~20 ~150 ~50
Design
Weekly prophylaxisIndividualized interval
prophylaxisOn-demand treatment
Perioperative management
Prophylaxis regimen Individualized prophylaxis
Weekly prophylaxisOn-demand treatment
Perioperative management
Prophylaxis regimen
Key EndpointsInhibitor incidence
Annualized bleeding rate Response to treatment
Inhibitor incidenceAnnualized bleeding rate Response to treatment
Inhibitor incidenceAnnualized bleeding rate Response to treatment
Inhibitor incidenceAnnualized bleeding rate Response to treatment
Status
Study completeFDA approved
Filed in EUApproved in Japan
Study completeData released February
2015
Study completeFDA approvedApproved in EU
Approved in Japan
Study completeData released April 2014
1 Will be commercialized by Sobi in Europe, Russia, Turkey and certain countries in the Middle East
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Anti-CD20 Late Stage Programs
Molecule GAZYVA
Trial Name GOYA GADOLIN GALLIUM
Phase Phase III Phase III Phase III
IndicationFront-line Diffuse Large
B-cell lymphoma (DLBCL)
Rituxan-refractory indolent Non Hodgkin’s
Lymphoma (iNHL) w/maintenance
Front-line iNHL w/maintenance
Administration IV Infusion IV Infusion IV Infusion
Target Enrollment 1,418 411 1,401
Design
Arm A: GAZYVA plus CHOP
Arm B: RITUXAN plus CHOP
Arm A: GAZYVA plus Bendamustine followed
by GAZYVA maintenanceArm B: Bendamustine
Arm A: GAZYVA plus chemotherapy followed
by GAZYVA maintenanceArm B: RITUXAN plus chemotherapy followed
by RITUXAN maintenance
Primary Endpoint Progression-free survival Progression-free survival Progression-free survival
Status
Recruitment completed Q2 2014
Trial continues after interim analysis in 2015
Final data expected in 2016
Trial stopped at interim for efficacy Q1 2015
Data presented at ASCO 2015
Filed globally Q3 2015
Priority review granted by the FDA Q3 2015
Recruitment completed
Expect data in 2017
Note: In collaboration with, and operationalized by, Roche.
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Q4 and FY 2015 Impact of Foreign Exchange
ActualsFX / Hedge Impact
Favorable / (Unfavorable)
ActualsFX / Hedge Impact
Favorable / (Unfavorable)
Q4 2015 Versus Q4 2014
Versus Q3 2015 FY 2015 Versus FY 2014
Total Revenues $2,839 $(35)* $(0)# $10,764 $(227)^
Cost of Sales $332 $5 $3 $1,240 $24
Non-GAAP R&D Expenses $542 $7 $2 $2,013 $34
Non-GAAP SG&A Expenses $583 $19 $3 $2,113 $88
Note: Amounts are in ($) millions. See end of this presentation for a reconciliation of our GAAP to non-GAAP financial results. Numbers may not foot due to rounding.* Total Q4 2015 revenues excluding the $40 million gain from hedging were lower by $75 million in the current period versus a year ago due to foreign exchange rates. # Total Q4 2015 revenues excluding the $10 million gain from hedging were lower by $10 million in the current period versus prior quarter due to foreign exchange rates. ^ Total FY 2015 revenues excluding the $166 million gain from hedging were lower by $393 million in the current period versus prior year due to foreign exchange rates.
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Accounting Treatment for BiosimilarsOverall Samsung Bioepis Economics• Samsung Biologics originally contributed ~$250.0 million for an 85% stake in Samsung Bioepis and Biogen contributed
~$45.0 million for the remaining 15%. As of 12/31/15, Biogen’s ownership interest is ~9%.
• Option to increase ownership percentage up to 49.9%.
• Our share of results is currently accounted for under “Equity in Loss of Investee, Net of Tax” one quarter in arrears. During 2015, our share of losses exceeded the carrying value of our investment and we suspended recognizing additional losses unless we commit to providing additional funding.
• Biogen granted Samsung Bioepis exclusive license to use, develop, manufacture, and commercialize products using BIIB product-specific technology in exchange for single-digit royalties.
• Biogen provides technical development, technology transfer, and manufacturing services and recognizes associated revenue under corporate partner revenue.
• Biogen to commercialize three anti-TNF biosimilars in Europe and in the case of one anti-TNF biosimilar, Japan.
• Upon commercialization, there will be a 50% profit share with Samsung Bioepis.
• Samsung Bioepis is eligible to receive an additional $75.0 million in milestones ($25.0 million upon EU approval of each anti-TNF).
Accounting for Anti-TNFs Biogen Is Commercializing
Samsung BioepisBiogen
50% of profit/loss recorded within OpEx
COGS & SG&A
Our share of overall Samsung Bioepis results recorded one quarter in arrears under “Equity in Income/Loss of Investee, Net of Tax”
Product Revenue
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GAAP to Non-GAAP ReconciliationUse of Non-GAAP Financial MeasuresWe supplement our consolidated financial statements presented on a GAAP basis by providing additional measures which may be considered “non-GAAP” financial measures under applicable SEC rules. We believe that the disclosure of these non-GAAP financial measures provides additional insight into the ongoing economics of our business and reflects how we manage our business internally, set operational goals and forms the basis of our management incentive programs. These non-GAAP financial measures are not in accordance with generally accepted accounting principles in the United States and should not be viewed in isolation or as a substitute for reported, or GAAP, net income attributable to Biogen Inc. and diluted earnings per share.
Our “Non-GAAP net income attributable to Biogen Inc.” and “Non-GAAPearnings per share - Diluted” financial measures exclude the following items from "GAAP net income attributable to Biogen Inc." and "GAAPearnings per share - Diluted":
1. Purchase accounting and merger-related adjustments.We exclude certain purchase accounting related items associated with the acquisition of businesses, assets and amounts in relation to the consolidation of variable interest entities for which we are the primary beneficiary. These adjustments include charges for in-process research and development, the amortization of certain acquired intangible assets and fair value remeasurement of our contingent consideration obligations.
2. Stock option expense recorded in accordance with theaccounting standard for share-based payments.
3. Other items.We evaluate other items on an individual basis, and consider both the quantitative and qualitative aspects of the item, including (i) its size and nature, (ii) whether or not it relates to our ongoing business operations, and (iii) whether or not we expect it to occur as part of our normal business on a regular basis. We also include an adjustment to reflect the related tax effect of all reconciling items within our reconciliation of our GAAP to Non-GAAP net income attributable to Biogen Inc.
2015 2014 2015 2014
GAAP earnings per share - Diluted 3.77$ 3.74$ 15.34$ 12.37$ Adjustments to GAAP net income attributable to Biogen Inc. (as detailed below) 0.74 0.35 1.67 1.46 Non-GAAP earnings per share - Diluted 4.50$ 4.09$ 17.01$ 13.83$
2015 2014 2015 2014
GAAP net income attributable to Biogen Inc. 831.6$ 883.5$ 3,547.0$ 2,934.8$ Adjustments:
Amortization of acquired intangible assets 92.0 101.4 365.3 472.9 (Gain) loss on fair value remeasurement of contingent consideration 24.6 7.3 30.5 (38.9) Restructuring charges 93.4 - 93.4 - SG&A: Stock option expense - 1.1 - 6.4 R&D: Stock option expense - 1.0 - 5.8 Donation to Biogen Foundation - - - 35.0 Income tax effect related to reconciling items (46.9) (28.7) (104.3) (134.9)
Non-GAAP net income attributable to Biogen Inc. 994.7$ 965.6$ 3,931.9$ 3,281.1$
2016 Full Year Guidance: GAAP to Non-GAAP Reconciliation
$ Shares Diluted EPS
Projected GAAP net income attributable to Biogen Inc. 3,722.0$ 218.8 17.01$ Adjustments:
Amortization of acquired intangible assets 350.0 (Gain) loss on fair value remeasurement of contingent consideration 20.0 Restructuring charges 10.0 Income tax effect related to reconciling items (65.0)
Projected Non-GAAP net income attributable to Biogen Inc. 4,037.0$ 218.8 18.45$
Numbers may not foot due to rounding.
An itemized reconciliation between projected net income attributable to Biogen Inc. and diluted earnings per share on a GAAP basis and on a Non-GAAP basis is as follows:
BIOGEN INC. AND SUBSIDIARIESGAAP TO NON-GAAP RECONCILIATION:
NET INCOME ATTRIBUTABLE TO BIOGEN INC. AND DILUTED EARNINGS PER SHARE(unaudited, in millions, except per share amounts)
For the Three MonthsEnded December 31,
An itemized reconciliation between net income attributable to Biogen Inc. on a GAAP basis and on a Non-GAAP basis is as follows:
For the Three Months
Ended December 31,
An itemized reconciliation between diluted earnings per share on a GAAP basis and on a Non-GAAP basis is as follows:
For the Twelve Months
Ended December 31,
For the Twelve MonthsEnded December 31,