gedeon richter press presentation 2016m12 final · m12 2016 4 key events ii. 17 january 2017 –...
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M12 2016
Richter Group
Richter GroupInterim Report, M12 2016
Budapest, 6 February 2017
M12 2016
2
Summary – M12 2016
Consolidated sales: +6.1% (EUR), +6.7% (HUF)+ VraylarTM royalty+ Good growth in almost all regions− Sales decline in other CIS region and in the EU10
Profit for the period*: +16.8% (EUR), +17.5% (HUF)+ Excessive improvement in financial results+ Acquisition of Rxmidas – one-off reassessment at fair value+ Recordati milestone payment− Impact of RUB EUR exchange rate – 12.8% depreciation− Increase in S&M expenses− Expenses of product withdrawal of Lisvy®
2
*Net income attributable to owners linked to the parent
M12 2016
3
Key events I.
Teriparatide biosimilar product – Terrosa14 November 2016
− EMA-CHMP positive opinion recommending that marketing authorization be granted.
4 January 2017− European Commission (EC) granted approval
Pegfilgrastim19 December 2016
− withdrawal of Marketing Authorization Application (MAA) from the European Medicines Agency (EMA) for its biosimilar pegfilgrastim.
M12 2016
4
Key events II.
17 January 2017 – Ulipristal acetate− Venus II (phase III) clinical trials – positive results;− evaluating the efficacy and safety of ulipristal acetate in women with
abnormal bleeding due to uterine fibroids.
19 January 2017 – Levosert®
− distribution and supply agreement with Allergan to commercialize its levonorgestrel releasing Intrauterine System (IUS);
− in Western Europe and in other European countries under the trademark of Levosert®.
M12 2016
5
Consolidated financial highlights
*Net income attributable to owners of the parent
HUF Change % EUR Change %
Total revenues 389.7bn 6.7 1,251.2m 6.1
Profit from operations 56.0bn (16.0) 179.8m (16.5)
Profit for the period* 63.3bn 17.5 203.1m 16.8
EPS (diluted) 340 16.8 1.09 16.0
M12 2016
10%
6%
14%
9%
2%
22%
14%
7%2%
5% 4%
5%
6
Geographical composition of Group sales
6
M12 2015 M12 2016
Hungary
RussiaPoland
Romania
EU10
EU15USA
Other CIS
Ukraine
RoW
China
HungaryRussia
Poland
Romania
EU10
EU15USA
Other CIS
Ukraine
RoW
LatAm
Total: HUF 365.2bn
EUR 1,179.4m
Total: HUF 389.7bn
EUR 1,251.2m
+ 6.7% (HUF) + 6.1% (EUR)
China
LatAm
9%
6%
16%
4%
8%
21%
15%
6%6%
2%
5%
2%
M12 2016
7
P&L
HUFmM12 2016
Change %
EURmM12 2016
Change %
as % of total revenues
Total revenues 389,690 6.7 1,251.2 6.1
Gross profit 225,404 2.4 723.7 1.8 57.8
S&M expenses (107,213) 9.1 (344.2) 8.4 27.5
A&G expenses (20,159) 6.2 (64.7) 5.5 5.2
R&D expenses (35,081) 0.7 (112.7) 0.3 9.0
Other income and other expenses (6,941) 396.5 (22.3) 395.6 1.7
Profit from operations 56,010 (16.0) 179.8 (16.5) 14.4
Net financial income 8,658 n.a. 27.8 n.a. 2.2
Profit for the period* 63,271 17.5 203.1 16.8 16.2
*Profit attributable to owners of the parent
M12 2016
0%
10%
20%
30%
40%
50%
60%
0
50 000
100 000
150 000
200 000
250 000
Gross profit Gross margin
8
Decreasing gross profit, gross margin
+ VraylarTM royalty+ Increase of turnover in EU15
and in China
− Sales decline in other CIS− Weakening RUB exchange rate
against EUR and HUF (YoY) EUR RUB → 12.8%
− Increase of share in turnover ofW&R
− Esmya® and Bemfola®
amortization
HUFm57.8%60.4%
M12 2016
0%
5%
10%
15%
20%
25%
010 00020 00030 00040 00050 00060 00070 00080 000
Profit from operation Operating margin
9
Decreasing operating margin
HUFm
14.4%
18.3%
+ VraylarTM royalty+ Acquisition of Rxmidas – one-
off reassessment at fair value+ Recordati milestone payment+ Decreasing R&D expenditures
− Impact of RUB EUR exchangerate – 12.8% depreciation
− Increase in sales and marketing expenses
− Expenses linked to product withdrawal of Lisvy®
− Bemfola® amortization costs
M12 2016
10
Sales in the Pharmaceutical segment*
* 89% of turnover originates from outside of Hungary
10
Sales development – contradictory impacts+ growth in almost all regions
+ increasing ESMYA® sales
+ sizeable contribution – cariprazine royalty
− decreasing overall OC sales
− decline: EU10, other CIS
Successful product launches
M12 2016
Hungary
Stable pharmaceutical market
Sales increase: 2.8% in HUF
Success of products launched in recent years
HUFbn
*Turnover of the pharmaceutical segment
11
0
10
20
30
40
Turnover *
M12 2016
EU – composition of sales*
EU15− strengthening our position
in key Western-European markets
− own Women’s Healthcaresales and marketing network
Poland, Romania, EU10− well established in the region for
decades− own specialized sales network*Turnover of the pharmaceutical segment
12
51%
49%
M12 2016
EU15
*Turnover of the pharmaceutical segment
11.2% sales increase in EUR
Richter’s own S&M network
Women’s Healthcare products: ESMYA®, Bemfola®, Richter OC portfolio, acquired OCs
Decline in oral contraceptivemarket
EURm
13
020406080
100120140160180200
Turnover*
M12 2016
Poland, Romania, EU10
Increasing generic competitionPrice erosion
Poland: – 6.9% increase in PLN– strong flu epidemic –
Groprinosin sales increase
Romania:– increasing sales levels
(+8.8% in RON)– base period: low level of
wholesale stock
EURm
*Turnover of the pharmaceutical segment
14
0
50
100
150
200
Turnover*
Poland Romania EU10
M12 2016
CIS
Sales decline (-0.9% in EUR)
Russia− RUB devaluation (YoY)− slowdown of Russian economy
(but positive prospects in 2017)
Ukraine− political uncertainty− UAH devaluation− decreasing purchasing power
EURm
*Turnover of the pharmaceutical segment
15
0
100
200
300
400
500
Turnover*
Russia Ukraine Other CIS
M12 2016
Russia
Sales increase in RUB(+12.8% in RUB; 0.0% in EUR)February 2016 – An average 4% price increase related to thewhole portfolioIncrease in volumeWeakening of EUR RUB exchange rate in M12 2016: 12.8% (YoY)On going consolidation in thewholesale market
EURm
*Turnover of the pharmaceutical segment16
RUBm
0
100
200
300
400
Turnover*
10000
12000
14000
16000
18000
20000
Turnover*
M12 2016
Ukraine, Other republics
Ukraine− sales increase (USD +11.2%)− low sales level in the base
period− political and economic
turmoil− UAH devaluation
USD UAH: 17.3% (YoY)
Other republics− 8.0% decrease (EUR)
(-8.3% in USD)− devaluation of Kazakh Tenge
EUR KZT: 73.3% (YoY)− uncertain economic and
FOREX environment
USDm
*Turnover of the pharmaceutical segment
17
0
50
100
150
200
Turnover*
Ukraine Other CIS
M12 2016
USA
Sales increase (+3.2% in USD)
Cariprazine (VraylarTM) royaltyincome: USD 17.3m
Sales level of emergency contraceptives still significantSubstantial decrease of revenues resulting from profit sharing agreementsSignificant proportion of Women’s Healthcare – 64%
USDm
*Turnover of the pharmaceutical segment
18
0
40
80
120
160
Turnover*
M12 2016
China
19
Sales in M12 2016: EUR 69.4m
Dynamically expanding pharmaceutical market
From 2016 GR Rxmidas 100% Richter owned
Sales network personnel: 232
Higher sales level of Cavinton and Escapelle
M12 2016
Latin America
20
Sales* in M12 2016: USD 20.7mRegional presence:− Brazil− Mexico− Colombia− Ecuador− Bolivia− Peru− Chile
Women’s Healthcare products in focusGradual launch of ESMYA®
*Turnover of the pharmaceutical segment
Mediplus N.V.
M12 2016
15%
20%
38%
3%
6%
18%
Pharmaceutical sales by therapeutic areas
Muscle relaxants
Gastrointestinal
Other
Women’s Healthcare
Central nervous system
Cardiovascular
Total: EUR 1,039.7m
M12 2016
21
M12 2016
22%
4% 10%
39%
6%10%
4%
5%
22
Women’s Healthcare sales by region
CEEHungary
CIS
USA
RoW
EU15
Ex-Grünenthalportfolio
Total: HUF 124.6bnEUR 400.1m
EURm
22
China
LatAm
0
50
100
150
200
250
300
350
400
Gynaecological sales Non‐gynaecological sales
M12 2016
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Sales impact of Ex-Grünenthal portfolio and ESMYA®
Ex-Grünenthal portfolio sales: EUR 46.7m
ESMYA® sales: EUR 69.0m
Subtotal: EUR 115.7m
Women’s Healthcare sales
Ex-Grünenthalportfolio
ESMYA®
WH Total: EUR 400.1m
12%
17%
M12 2016
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Fertility – Bemfola®
innovative biosimilar product addressing female fertilitydeveloped as a biosimilar to Gonal-f®
recombinant-human Follicle Stimulating Hormone (r-hFSH) launch: Q2 2014currently commercialized in the EU, in Israel, in the Middle East and in AustraliaRichter acquired global marketing rights for the product (excluding the USA)
Sales in Q3-Q4 2016: EUR 10.6m*
*Included in consolidated turnover.
M12 2016
Levosert®
distribution and supply agreement with Allergan plclevonorgestrel releasing Intrauterine System (IUS) in Western Europe and in other European countries under the trademark of Levosert®
national marketing authorizations have been already granted in Western and Northern Europe and the product has been launched by Allergan in a number of these countriesproduct already marketed by Richter in most of the Central and Eastern European countries (Uteron Pharma, 2011)upfront payments, royalty:− upon signature of the contract− subsequent to the launch of the product – further sales related
royalties and milestone payments
25
M12 2016
staff
26
Sales network
0
200
400
600
800
1 000
1 200
1 400
1 600
1 800
2010 2011 2012 2013 2014 2015 2016CIS CEE Hungary EU15 China LatAm
M12 2016
27
Wholesale and retail
W&R sales contribution is 19% of total sales
76% of the W&R turnover originates in Romania
21.8% sales increase in EUR in Romania
27
M12 2016
25.25%
67.75%7.00%
28
Ownership structure
31 December 2016
Hungarian State Holding Company
Domestic investors International
investors
28
M12 2016
Thank you for your attention!
29
M12 2016
Appendix
Exchange rates
30
M12 2016
31
Evolution of currency exchange rates
HUF
260
280
300
320
340
EUR HUFUSD HUF
M12 2016
32
Evolution of currency exchange rates
EUR
60
70
80
90
100
EUR RUB
M12 2016
33
Evolution of currency exchange rates
HUF
3,25
3,50
3,75
4,00
4,25
4,50
4,75
5,00
HUF RUB
M12 2016
M12 2016 M9 2016 H1 2016 Q1 2016 M12 2015
EURHUF 311.46 312.23 312.67 311.98 309.67
USDHUF 281.26 279.64 279.95 283.12 279.16
RUBHUF 4.19 4.09 4.00 3.77 4.70
EURRUB 74.33 76.34 78.17 82.75 65.89
EURUSD 1.11 1.12 1.12 1.10 1.11
34
Exchange rates At period end
Average
31.12.2016 30.09.2016 30.06.2016 31.03.2016 31.12.2015
EURHUF 311.02 309.15 316.16 314.16 313.12
USDHUF 293.69 276.35 284.29 276.62 286.63
RUBHUF 4.78 4.36 4.43 4.09 3.88
EURRUB 65.07 70.91 71.73 76.81 80.70
EURUSD 1.06 1.12 1.11 1.14 1.09