financial results presentation q3 fy2010. pocari sweat showed particularly solid growth due partly...
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Financial Results PresentationQ3 FY2010
(Fiscal Year Ending March 31, 2011)
February 15, 2011Atsumasa MakiseSenior Managing DirectorOtsuka Holdings Co., Ltd.
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Topics
Q3 YTD Consolidated Financial Results
Q3 YTD Sales by Business Segment
Q3 YTD Business Segment Analysis
Q3 YTD Pharmaceutical Segment Analysis
Abilify Sales Evolution
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1
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3
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Overview of Abilify Contract Extension
Q3 YTD Nutraceutical Segment Analysis
Q3 YTD Net Income: Change from PY
Consolidated Balance Sheet
FY2010 Forecast
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1. Q3 YTD Consolidated Financial Results(100 million yen)
FY2009 Actual FY2010 Actual Change %
Net Sales 8,175 8,381 207 2.5%
Cost of Sales 2,676 2,820 144 5.4%
SG&A Expenses 4,589 4,591 1 0.0%
Operating Income 909 971 61 6.7%
Ordinary Income 991 1,031 40 4.1%
Income Before Tax 958 1,047 89 9.3%
Net Income 655 694 39 6.0%
R&D Expenses 1,048 1,220 172 16.4%
Earnings Per Share (Yen) 140.07 144.04 - -
Effect of appreciation of the Yen: Net Sales -300, Operating Income -35, Net Income -60
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2. Q3 YTD Sales by Business Segment
【FY2009】Net Sales 8,175
【FY2010】Net Sales 8,381
Pharmaceuticals5,453
(65.1%)
Nutraceuticals2,003
(23.9%)
ConsumerProducts
373(4.4%)
Others552
(6.6%)
Pharmaceuticals5,341
(65.3%)
Nutraceuticals1,907
(23.3%)
ConsumerProducts
415(5.1%)
Others511
(6.3%)
*Parentheses represent component ratio
(100 million yen)
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3. Q3 YTD Business Segment Analysis
Net Sales Segment (operating) income
+112(+2.1%)
+99(+5.1%)
-43(-10.2%)
+40(+5.1%)
+207(+2.5%)
-99(-8.7%)
+115(+217.6%)
+59(-%)
+17(+62.0%)
-31(-%)
+61(+6.7%)
FY2009 FY2010 Change
Pharma 5,341 5,453 112
NC 1,921 2,020 99
Consumer 421 378 (43)
Others 780 820 40
Eliminations (289) (290) (1)
Consolidation 8,175 8,381 207
Operating incomeratio (%)
FY2009 FY2010 Change
Pharma 1,141 1,042 (99)
NC 53 168 115
Consumer (70) (11) 59
Others 27 44 17
Eliminations (241) (273) (31)
Consolidation 909 971 61
FY2009 FY2010
21.4 19.1
2.8 8.3
(16.6) (2.8)
3.5 5.4
― ―
11.1 11.6
FY2010 8,381 FY2010 971*Parentheses represent % increase
FY2009 8,175 FY2009 909
Pharmaceuticals
Consumer Products
Others
Nutraceuticals
Eliminations -1(-%)
(100 million yen) (100 million yen)
(100 million yen)
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4. Q3 YTD Pharmaceutical Segment Analysis
Abilify
Oncology
FY2009 5,341
FY2010 5,453
+59(+10.7%)
Net Sales
+77(+2.9%)
+112(+2.1%)
Clinical Nutrition
Mucosta
Pletal
Others
+10(+1.3%)
+9(+2.3%)
+15(+2.2%)
-59(-19.9%)
Sales
R&D ExpensesSales Promotion Expenses
Cost of Sales
FY2009 1,141+112
+106
-126
+161
-99(-8.7%)
Segment (operating) income
FY2010 1,042
Other Expenses +70
Japan
Others
North America
FY2009 5,341
FY2010 5,453
-24(-1.0%)
+55(+2.3%)
Net Sales by Market
+82(+16.5%)
+112(+2.1%)
(100 million yen)
(100 million yen)
FY2009 FY2010 ChangeAbilify 2,681 2,758 77Oncology 554 613 59Clinical Nutrition 721 731 10Pletal 403 412 9Mucosta 295 236 -59Others 688 703 15Total 5,341 5,453 112
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【YTD】 (100 million yen)
Product 2008 2009 Change 2Q 2009 2Q 2010 Change 3Q 2009 3Q 2010 Change
Anti-psychotic agentAbilify 2,971 3,745 26.1% 1,879 1,902 1.2% 2,681 2,758 2.9%
North America 2,372 3,056 28.8% 1,518 1,524 0.4% 2,180 2,140 -1.8%(Million USD) (2,606) (3,303) 26.8% (1,574) (1,723) 9.4% (2,405) (2,553) 6.1%
Japan 132 187 41.7% 88 110 25.5% 142 173 22.5%Others 467 502 7.5% 272 267 -1.8% 359 444 23.8%
5. Abilify Sales Evolution
2010 North America Abilify Sales by Quarter
$Mil
2010 U.S. atypical anti-psychotics prescription market
(growth versus previous year)
Total market
Abilify
Other products total
2009 Net sales2010 Net salesGrowth rate
Source: Wolter Kluwer, pharmacy data, 2010 Dec
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As a result of the extension of the Co-promotion agreement with BMS, Otsuka’s Abilify profit structure in the US has improved from 2010
6. Overview of Abilify Contract Extension with BMS
2009 2010Otsuka Net Sales 100% 100%BMS profit share 65% 58%Otsuka profit margin 35% 42%
Abilify Sales and Profit Share Year US Net Sales Otsuka Group BMS2009 35.0% 65.0%2010 42.0% 58.0%2011 46.5% 53.5%2012 48.5% 51.5%
$0-$2.7 billion 50% 50%80% 20%93% 7%98% 2%99% 1%
2013 -2015/4
80% 20%
In addition to the above, Otsuka will be responsible for 30% of the U.S. expenses related to the commercialization of Abilify from 2010 to 2012 and 50% for 2013 and beyond. $4.0-$4.2 billion
In excess of $4.2 billion
$3.7-$4.0 billion
$2.7-$3.2 billion
$3.2-$3.7 billion
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7. Q3 YTD Nutraceutical Segment Analysis
Functional Beverages(3 core products)
Others
FY2009 1,921
FY2010 2,020
Net Sales
(+12.1%)
+99 (+5.1%)
(-1.5%)
Sales
Advertising expSales promotion exp
COGS
FY2009 53
+99+40
-39
+115 (217.6%)
Segment (operating) income
FY2010 168
-12
Other exp -6
FY2009 1,921
FY2010 2,020
+1 (+0.2%)
Net Sales by Market
-11 (-2.5%)
+109 (+9.4%)Japan
Others
North America
【Japan】 3 core functional beverages all showed positive
growth. Pocari Sweat showed particularly solid growth due partly to the hot summer.
SOYJOY and Calorie Mate recorded decreased sales.
【Overseas】 Functional foods, which consist of Nature Made,
N&S products and others, showed positive sales growth in local currency terms. However, yen-based sales showed negative growth as a result of the foreign exchange impact.
+99 (+5.1%)
(100 million yen)
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8. Q3 YTD Net Income: Change from Previous Year
Operating Income
Equity in earnings
Gain on change in equity interest
Others
Loss on transfer of business
Net Income655
Net Income694
+61 (+6.7%)
+39
【Factors】
Co-promotion extensionCurrent period portion of payment received for the extension of the US portion of the Abilify co-promotion agreement
Foreign exchange lossForeign exchange loss as a result of the appreciation of the yen
Gain on change in equity interest
Increase in equity interest as a result of the IPO of the equity method affiliate, Microport Scientific
Loss on transfer of business
Loss related to the transfer of the Agri-Techno business
Non-operating
Extra-ordinary
Income
taxes
Others
Income taxes
Minority interest
Co-promotion extension
-14 (-23.3%)
+55 (-%)
-4 (-11.5%)
+56 (-%)
+19 (-%)
+12 (+37.9%)
+45 (+15.2%)
+5 (+72.6%)
<Change>971
Foreign exchange loss +58(+551.6%)-69
46
55
29
56
-19
-20
340
13
<FY2010>(100 million yen)
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9. Consolidated Balance Sheet
0
2,000
4,000
6,000
8,000
10,000
12,000
14,000
2008/03 2009/03
16,000
(100 million yen) March 31, 201014,584
December 31, 201015,692 (+1,108)
Factors:・Increase in Current Assets (+1,367) ・・・Cash and deposits +428, Marketable securities +732・Decrease in Current Liabilities(-757) ・・・Short-term borrowings -207, Income taxes payable -302・Increase in Net Assets (+2,093) ・・・IPO +1,623, Net Income +694
Fixed Assets43.4%(6,809)
CurrentAssets56.6%(8,882)
73.8%(11,578)
15.0%(2,361)
11.2%(1,753)
Current Liabilities -757
Fixed Liabilities-229
Total Net Assets +2,093
+1,367
-259Fixed Assets48.5%(7,068)
Current Assets51.5%(7,515)
65.0%(9,485)
21.4%(3,118)
13.6%(1,981)
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10. FY2010 Forecast
(100 million yen)
Change %
Net Sales 10,843 11,380 537 5.0%
Operating Income 985 1,200 215 21.9%
Ordinary Income 1,091 1,290 199 18.3%
Net Income 674 797 123 18.2%
Earnings Per Share (Yen) 143.50 159.28 - -Dividends Per Share (Yen) 12.50 28.00 - -
Year-On-YearFY2009Actual
FY2010Forecast
R&D Pipeline Update and Overview of New Pharmaceutical Products
February 15, 2011Katsuya Yamasaki, Ph.D.Managing Director (Board Member)Otsuka Holdings Co., Ltd.
Agenda
R&D Pipeline in Pharmaceuticals
Update on Development Pipeline
Topics on Development Projects
Overview of New Products Launched in FY2010
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1
2
3
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Number of Development Projects (as of Jan. 31, 2011 )
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Areas No. of Compounds P II P III NDA Filing Total
CNS 4 3 8 1 12
Oncology 12 10 6 1 17
Cardiovascular 1 0 2 1 3
Others 10 5 4 2 11
Diagnostics 3 0 0 3 3
Total 30 18 20 8 46
Note) Each development project is counted on the basis of the number of indication. The number of PI project in oncology is five.
Many development projects are ongoing in the top priority areas of central nervous system and oncology.
Agenda
R&D Pipeline in Pharmaceuticals
Update on Development Pipeline
Topics on Development Projects
Overview of New Products Launched in FY2010
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1
2
3
4
Update on Development Pipeline Since September 2010
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Area P II P III NDA Filing ApprovalJapan OCV-101
Pancreatic Cancer
TSU-68Gastric
CancerColorectal
Cancer
E KeppraEpilepsy (Partial
Seizures in Children) Epilepsy
(Generalized Seizures)
Rebamipide Eye DropsDry EyeSubmitted on Oct. 20,
2010
AripiprazoleBipolar DisorderSubmitted on Jan. 24,
2011
E KeppraEpilepsy (Partial seizures in
adults)Launched on Sep. 17, 2010
AbraxaneBreast CancerLaunched on Sep. 24, 2010
SamscaCardiac Edema (Heart Failure)Approved on Oct. 27, 2010Launched on Dec. 14, 2010
US SativexCancer Pain
Asia TSU-68Hepatocellular
Carcinoma
The following chart shows the development status of primary projects. Three products have been launched in Japan.
:Oncology:CNS:Others
Agenda
R&D Pipeline in Pharmaceuticals
Update on Development Pipeline
Topics on Development Projects
Overview of New Products Launched in FY2010
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1
2
3
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TSU-68 SativexIndication Hepatocellular Carcinoma (after TACE) Cancer PainName of Study SPRAYStage P II P II
Location of Study Japan GlobalConference /Journal
ASCO, Chicago, Jun. 4-8, 2010 The Japan Society ofHepatology ,Yokohama, Oct. 13-14, 2010
GW Pharmaceuticals, News Release, Mar. 23, 2010
URL http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=74&abstractID=43074
http://www.gwpharm.com/Phase%20IIb%20Cancer%20Pain%20Trial%20Data.aspx
Tolvaptan Rebamipide (Eye Drops)Indication Polycystic Kidney Disease Dry EyeName of Study TEMPOStage P II (Open-label) P IIbLocation of Study US JapanConference/Journal
ASN RW, Denver, Nov. 16-21, 2010 ARVO Fort Lauderdale, May. 2-6, 2010
URL http://www.asn-online.org/education_and_meetings/ http://abstracts.iovs.org/cgi/content/abstract/46/5/2037
Main Clinical Trial Results (FY2010)
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Agenda
R&D Pipeline in Pharmaceuticals
Update on Development Pipeline
Topics on Development Projects
Overview of New Products Launched in FY2010
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1
2
3
4
75.3
56.851.5
73.3
44.5 40.4
0
20
40
60
80
100
Acute (0~24hrs)
Delayed (24~120hrs)
Total(0~120hrs)
Aloxi group(n=555)Control group(n=559)
Com
plet
e R
espo
nse
Rat
e ***p<0.001
******
%
Aloxi:5-HT3 Receptor Antagonist
Palonosetron Hydrochloride Prevention of acute and delayed
nausea and vomiting induced by cancer chemotherapy
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Generic Name・Indication Example of Clinical Trial Results
Comments Date Approved : Jan. 20, 2010 (Japan) Date Launched : Apr. 22, 2010 (Japan) Cumulative Sales : Approx. 2.8B yen
(in Japan, as of Dec.31, 2010) Currently approved in more than 60 countries worldwide
5-HT3 Receptor Antagonist Persistent antiemetic effect with
a single administration before cancer chemotherapy (cisplatin, etc.)
Also effective in delayed nausea and vomiting (PROTECT Trial)
Recommended by NCCN and JSCO* guidelines (May, 2010)
*JSCO (Japan Society of Clinical Oncology)
Mechanisms of Action・Features
Effective in both acute and delayed nausea and vomiting. Aloxi has gained the largest market share in eight months since its launch.
Saito.M. et al : Lancet Oncol.,10 115 (2009)
Abraxane:Anticancer Agent (nanoparticle)
Nanoparticle Albumin-bound Paclitaxel
Breast Cancer
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Generic Name・Indication Example of Clinical Trial Results
Comments Date Approved : Jul. 23, 2010 (Japan) Date Launched : Sep. 24, 2010 (Japan) Cumulative Sales : Approx. 0.5B yen
(in Japan, as of Dec.31, 2010) NSCLC(PⅢ), Gastric Cancer(PⅡ): Ongoing Approved in 41 countries worldwide (as of July, 2010) All-Case surveillance has been completed on Feb. 14,
2011.
Polyoxyethylated castor oil (Cremophor)-free nanoparticlealbumin-bound paclitaxelformulation
Infusion time is 30 minutes
Mechanism of Action・Features
PR 21.0%
PR 10.7%
24.0%
11.1%
CR:0.4%
CR:3.0%
Gradishar, W.J. et al.: J Clin Oncol, 23(31), 7794(2005)
Novel formulation makes higher-dose taxane therapy possible with greater safety.
Administration of Abraxane in patients with metastatic breast cancer showed high response rate, compared with other solvent-based paclitaxel.
■Response Rate
Abraxane Group (n=229)
Other Solvent-based Paclitaxel Group (n=225)
Abraxane Particle
Serum Albumin
Paclitaxel
Approx. 130nm
E Keppra:Antiepileptic Agent
Levetiracetam An add-on therapy in the treatment of
partial seizures, with or without secondary generalization, in adult patients with epilepsy, who have not shown sufficient response to other antiepileptic drugs.
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Generic Name・Indication Overseas Post-Marketing Surveillance
Comments Date Approved :Jul. 23, 2010 (Japan) Date Launched : Sep. 17, 2010 (Japan) Approved in more than 95 countries worldwide Epilepsy (Partial Seizures in Children) (PIII),
(Generalized Seizures) (PIII) : Ongoing in Japan
Levetiracetam and related analogs showed a rank order of affinity for SV2A which correlated with the potency of their antiseizure activity
No drug-drug interaction Possible to start from efficacious
dose with no need for TDM Low dropout rate due to fewer side
effects Excellent safety profile
The KEEPER Trial Results in Epilepsy Patients with Partial Seizures
High response rate and low withdrawal rate have been highly evaluated both in and outside Japan.
Mechanism of Action・Features
Perc
ent o
f Pat
ient
s(%
)
Disappearance of partial seizures (12 weeks)
More than 50% reduction in the frequency of partial seizures
Samsca:Aquaretic Agent
Tolvaptan Volume overload in heart failure when
adequate response is not obtained with other diuretics (e.g., loop diuretics)
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Generic Name・Indication
Comments Date Approved : Oct. 27, 2010 (Japan) Date Launched : Dec.14, 2010 Approved and Launched in 10 countries worldwide Total World Sales:2.9B yen(FY2010 US・EU・JPN)
Nonpeptide vasopressin V2 -receptor antagonist
By inhibiting vasopressin’s effects at the V2 -receptor, Samsca increases the excretion of free water without an accompanying increase in electrolyte excretion No significant decrease in serum
electrolytes No clinically significant impact on
renal function
World's First Aquaretic Agent for the Treatment of Volume Overload in Patients with Heart Failure
Mechanism of Action・Features
Example of Clinical Trial Results
Mea
n ur
ine
volu
me
Time since start of administration
1 2 3 4 5 6 7Baseline
(mL)
1,000
1,500
2,000
2,500
3,000
3,500
4,000
day
Mean±S.D.
LOCF*
Conventional diuretics+PlaceboConventional diuretics+Samsca15mg
12
(day)
2,000
1,500
1,000
500
0
-500
1 2 3 4 5 6 7 1 2 3 4 5 6 7
Conventional diuretics+Samsca15mg (n=53)
Conventional diuretics+Placebo (n=57)
Mean±S.D.
(mL)
(day)
Urine Volume Fluid Intake
Amou
nt o
f cha
nge
Masatake Fukunami (Osaka University):Company Data, A Double-Blind, Placebo-Controlled Study, 2008
Change in daily urine volume and fluid intake in CHF patients (Japan: PIII )
Subjects: Congestive heart failure (CHF) Patients* with extracellular volume expansiondespite the use of conventional diuretics.
*Patients between the ages of 20 and 85.N=110 (Samsca Group n=53, Placebo group n=57)
Mean±S.D.
Time since start of administration
-1.5
-1
-0.5
0
0.5
-2
-2.5Baseline 1 2 3 4 5 6 7 LOCF# (day)
(kg)
Conventional diuretics+PlaceboConventional diuretics+Samsca 15mg
Primary EndpointP<0.0001(t -test)
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Body weight change in CHF patients (Japan: PIII )Adding Samsca to conventional diuretics (at a daily dosage equivalent to 40 mg or more of furosemide, or more than two diuretic agents) showed clinically-significant body weight loss when compared with placebo group.
Bod
y W
eigh
t Los
s (A
mou
nt o
f cha
nge)
Masatake Fukunami (Osaka University):Company Data, A Double-Blind, Placebo-Controlled Study, 2008