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Issue: 06 2016 UPharma Consulting is a professional consulting company, operating in the Life Sciences sector. We deliver best global practices in market knowledge, people management, marketing and strategy in the CIS/CEE.

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MACROECONOMIC ENVIRONMENT Table: Key Macroeconomic

2015

Indicators in Ukraine

May

(May 2015-May 2016)

Jun

Jul

Aug

2016

Sep

Oct

Nov

Dec

Jan

Feb

Mar

Apr

May

3.10

2.88

MACROECONOMIC INDICATORS GDP (US$ bn)

Q2

Q3

Q4

Q1

20.795

25.552

25.588

17.655

growth, % y-o-y

-35%

-26%

Export of Goods (US$ bn)

2.94

3.09

growth, % y-o-y

-41%

-30%

Import of Goods (US$ bn)

2.63

growth, % y-o-y

-46%

Industrial Production Sales (US$ bn)

5.65

growth, % y-o-y

Retail Turnover of Enterprises (US$ bn) growth, % y-o-y

Unemployment Rate (%) Average Salary (US$)

-38%

1.94

3.15

2.76 -37%

3.35

-34%

-22%

-22%

2.98

3.88

-34%

5.79

5.71

-35%

-2%

5.42

-33%

1.83

-17%

3.09

1.94

-23%

1.88

-41%

3.24 -30%

5.72 -20%

1.86

3.23 -23%

3.22 - 27%

6.29 -21%

2.04 -31%

3.13

0%

3.36

2.04

3.08

2.99

-11%

-31%

3%

-13%

1%

2.23

2.68

3.35

3.05

-21%

3.07

3.12

-27%

-32%

-26%

-6%

5.92

6.37

4.93

4.93

-19%

1.80

-17%

2.01

-18%

1.60 -19%

8%

1.50 4%

5%

5.41 -2%

1.64 2%

7%

5.17 -12%

1.76 6%

-2%

2.69 2%

5.39 -5%

1.59

-35%

-38%

-32%

-38%

-33%

-29%

1.8

1.7

1.6

1.6

1.5

1.5

1.6

1.9

1.9

1.9

1.7

1.6

1.6

-18%

193

202

202

194

199

207

193

223

180

174

187

191

198

OFFICIAL CURRENCY EXCHANGE RATE UAH / USD UAH / EUR

20.9

21.2

21.8

21.6

21.8

21.8

23.3

23.4

24.3

26.4

26.4

25.6

25.2

23.3

23.8

23.9

24.0

24.5

24.6

25.1

25.4

26.3

29.3

29.2

29.1

28.5

9.01

13.79

12.2

11.7

15.77

8.31

14.17

PHARMACEUTI CAL INDUSTRY INDICATORS Export of Pharma Products (mio USD)

13.00

15.36

13.85

growth, % y-o-y

-39%

-39%

-6%

-54%

Import of Pharma Products (mio USD)

84.2

115.0

106.5

93.3

growth, % y-o-y

-60%

-44%

-47%

Pharma Retail Sales, values (mio USD)

193.0

177.7

172.6

-47%

177.1

-47%

121.1

-37%

147.1

13.33

15.54

13.90

-52%

-28%

-30%

11%

16%

3%

141.3

142.1

103.7

145.0

125.1

130.0

-31%

-28%

-24%

-42%

15%

27%

21%

25%

193.2

206.3

196.6

212.3

198.9

176.0

187.3

178.1

growth, % y-o-y

-28%

-29%

-32%

-24%

-28%

-26%

-20%

-18%

-17%

-1%

-5%

-1%

Pharma Retail Sales, volumes (mio units)

124.5

118.4

119.5

122.5

126.7

130.2

129.0

136.4

133.6

126.8

133.8

125.2

growth, % y-o-y

WACP (USD)

-11%

1.47

-9%

1.52

-10%

1.48

-8%

1.45

-11%

1.52

-5%

1.58

-4%

1.52

-5%

1.56

1%

1.49

-12%

1.39

-5%

1.40

2%

1.42

growth, % y-o-y

-23%

-21%

-23%

-18%

-19%

-22%

-18%

-14%

-23%

-23%

13%

1%

CPI of Ukraine Pharmaceutical Products CPI Local Companies share, values (%) Local Companies share, volumes (%)

158.4 159.5 41.5 77.6

157.5 153.5 41.7 77.9

155.3 151.8 41.8 78.4

152.8 149.4 41.4 78.2

151.9 145.8 41.4 76.5

146.4 142.1 41.4 75.7

138.1 146.6 41.7 75.8

134.6 143.3 40.9 76.7

131.9 140.3 42.3 75.6

126.9 132.7 42.9 76.5

113.5 120.9 42.7 76.5

108.4 109.8 42.3 76.7

9%

110.4 31%

177.6 -8%

123.6 -1%

1.44 -2%

107.3 107.5 42.9 77.2

Description of the indicators: MACROECONOMIC INDICATORS

GDP (Gross Domestic Product) is an aggregate measure of production equal to the sum of the gross values added of all resident, institutional units engaged in production (plus any taxes, and minus any subsidies, on products not included in the value of their outputs) calculated in current prices. Converted from UAH to USD in accordance with an average official NBU exchange rate in the corresponding period. Hereinafter: excluding the temporarily occupied territory of the Autonomous Republic of Crimea and City of Sevastopol, as well as the part of zone of the antiterrorist operation. Source: State Statistics Service of Ukraine. Export of Goods is a sale of goods by Ukrainian subjects of foreign economic activities to foreign subjects of foreign economic activities (including non-cash payment) with or without exportation of these goods through the customs border of Ukraine, including the re-export of goods. Initially calculated in USD. Source: State Statistics Service of Ukraine. Import of Goods is a purchase (including non-cash payment) of goods by Ukrainian subjects of foreign economic activities in foreign subjects of economic activities with or without the importation of these goods into the territory of Ukraine, including the purchase of goods for domestic consumption by establishments and organizations of Ukraine located abroad. Initially calculated in USD. Source: State Statistics Service of Ukraine. Industrial Production Sales is the value of industrial goods, which are actually shipped in the period, as indicated in documents decorated as the basis for calculating with the buyer (customer), regardless of income payments for them. Converted from UAH to USD in accordance with an average official NBU exchange rate in the corresponding period. Source: State Statistics Service of Ukraine. Retail Turnover of Enterprises is the value of consumer goods sold via retail trade and restaurants to the population by all operating enterprises. It also includes direct retail sales by industrial, transport and other non-trade enterprises. In addition, retail turnover includes retail sales of food products to departments, organizations and enterprises to provide meals to the people they serve (at sanatoria, children’s care institutions, hospitals, etc.). Reflected in current prices. Converted from UAH to USD in accordance with an average official NBU exchange rate in the corresponding period. Source: State Statistics Service of Ukraine. Unemployment Rate is a ratio (percent) of the unemployed registered at the State Employment Service to the average annual population of working age. Source: State Statistics Service of Ukraine.

Average Salary is an average value of remuneration in cash and in kind paid to employees for time worked or work done. Converted from UAH to USD in accordance with an average official NBU exchange rate in the corresponding period. Source: State Statistics Service of Ukraine. Official Currency Exchange Rate is the rate established by the National Bank of Ukraine under which Ukrainian national currency – UAH (Ukrainian hryvnia) will be exchanged for foreign currency (USD or EUR). Calculated as average value in the corresponding period. Source: National Bank of Ukraine. PHARMACEUTICAL INDUSTRY INDICATORS

Export of Pharma Products is an export of goods related to the group “Pharmaceutical products” under the Ukrainian Classification of Goods for Foreign Economic Activities. Initially calculated in USD. Source: State Statistics Service of Ukraine. Import of Pharma Products is an import of goods related to the group “Pharmaceutical products” under the Ukrainian Classification of Goods for Foreign Economic Activities. Initially calculated in USD. Source: State Statistics Service of Ukraine. Pharma Retail Sales are retail sales of different product categories of “pharmacy basket” (drugs, medical devices, cosmetics and food supplements) in values and volumes. Converted from UAH to USD in accordance with an average official NBU exchange rate in the corresponding period. Source: Morion. WACP (Weighted average cost of a pack) is a ratio of pharma retail sales in values to pharma retail sales in volumes. CPI (Consumer price index) is an indicator of changes at the time of prices and tariffs for commodities and services being purchased by the population for unproductive consumption calculated to corresponding month of previous year. Source: State Statistics Service of Ukraine. Pharma Products CPI is a Consumer price index of “Pharmaceutical products, medical products, appliances and equipment” group calculated to corresponding month of previous year. Source: State Statistics Service of Ukraine. Local Companies Share is the share (percent) of sales related to Ukrainian companies in overall pharma retail sales in values and volumes. Source: Morion

Ukrainian Pharmaceutical Market Monthly: June 2016


Page 3

220

200

193.0 177.7

180

172.6

133.6

124.5

129.0

122.5 118.4

140

120

126.7

177.6

126.8

125.2

123.6

Pharma Retail Sales 2016

May

Jun

Jul

Aug

Sep

Oct

Nov

Dec

Jan

Feb

Mar

100

Apr

12

6

Industrial production

8

5.65

5.80

5.71

5.43

0

4.93

4.93

5.17

5.39

2.5

2.0 1.94

1.83

1.94

2.04 1.88

1.86

2.01 1.80

Retail turnover of enterprises

3

1.60

1.50

1.64

1.76 1.59

1.5

1

Industrial Production Sales & Retail Turnover of Enterprises Surplus 2015

0

May

Jun

Jul

Aug

Sep

Oct

Nov

Dec

Jun

Jul

Aug

158.4

157.5

155.3

152.8

Feb

Mar

0.0

Apr

40 20

151.9

Oct

Nov

Dec

2016 Jan

Feb

Mar

May

May

146.6

143.3

140.3

140

132.7 120.9 109.8

30 25

0

Apr

160 146.4

CPI of Ukraine

25.5

24.9

20.9

21.2

26.1

25.9

26.1

21.8

21.6

21.8

15

UAH / € 24.6

25.1

23.3 21.8 UAH / $

25.4

26.3

23.4

24.3

29.3

29.2

26.4

26.4

29.1

25.6

120 107.5 28.5

25.2

20

2015

0

May

Jun

Jul

Aug

Sep

Oct

Nov

80

40

vs. Consumer Price Index

5

100

60

Official Currency Exchange Rates

10

0.5

2016 Jan

Sep

80 60

40

20

1.0 2

14.2

8.3

35

5 4

May

120 100

13.9

13.3

2015

45

5.41

15.5

11.7

Ukraine's International Trade in Pharma Production

3.0

5.92

5.72

13.8

12.2

9.0

4

May

6.37

6.29

103.7

13.9

13.0

110.4

Export

50

7

125.1 15.8

15.4

140

130.0

142.1

Import

93.3 84.3

130

110

2015

122.2

160

145.0

141.3

106.6

16

120

100

115.0

140

133.8

Volumes (mio units)

119.5

20 178.1

176.0

136.4 130.2

160

150 187.3

Values (mio USD)

177.1

147.1

24 198.9

196.6

193.2

160

212.3

206.3

Dec

2016 Jan

Feb

Mar

0

Apr

May

KEY ECONOMIC EVENTS »» »» »» »» »» »» »» »» »»

Consumer inflation in Ukraine in May 2016 slowed to 0.1% from 3.5% in Apr 2016, the State Statistics Service reported. The y-o-y inflation growth in May 2016 amounted 7.5%. Cabinet of Ministers approved draft budget resolution for 2017, envisaging the deficit of up to 3% of GDP, government debt – up to 66% of GDP and average annual exchange rate of hryvnia at 27.2/USD. Brexit will not affect Ukrainian economy, while the country will not change its policy towards the integration into the EU, Ukraine’s authorities said. Ukrainian government intends by the year-end to settle legislative initiatives that would allow Ukraine to improve its positions in the Doing Business rating and enter the TOP-50 best counties in 2017 and the TOP-20 in 2018. In 2016 report, Ukraine was placed 83rd. Ukraine’s President reported macrofinancial stabilization in the country. Foreign exchange reserves are constantly growing without participation of foreign partners, which reflect guaranteed financial stabilization in the Ukrainian market, he said. The use of ProZorro system in public procurement, allowed saving UAH 1.5 bn for the state in 14 months, the Minister of Economic Development noted. The World Bank is ready to allocate additional USD 1 bn on programs in Ukraine, Ukrainian Prime Minister said. Agreed that the World Bank is to assist in developing a strategy for transport corridors and roads in Ukraine, assess what resources the strategy would require and determine where budgetary, credit or private funds should be attracted. American Congress approved the assignation of USD 663.5m to Ukraine in 2017 as financial aid. Industrial growth continued to slow down and reached 0.3% y-o-y in May compared to 3.5% y-o-y in April. Mining and machinery decreased -3.5% and 0/3% y-o-y respectively, while chemical output rose 8.4% y-o-y. In 5M2016, Ukraine’s industry increased 3.1% y-o-y.

Ukrainian Pharmaceutical Market Monthly: June 2016


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Page 5

MARKET & COMPANIES NEWS Red Star PJSC Will Conduct Private Placement Of Bonds Red Star pharmaceutical plant intends to hold private placement of bonds “A”-“J” series for UAH 30 mio. The corresponding decision was taken by the company’s Supervisory Body on Jun 2. 60% of funds raised the company plans to allocate for the reconstruction and modernization of tablet manufactory following the GMP requirements; 20% for modernization and equipment of the new laboratory; 20% will be invested in the development of new drugs. Red Star plant is one of the oldest pharmaceutical companies in Ukraine, which was founded in 1923 in Kharkov. The company’s facilities can produce 188 mio units per year. Red Star’s portfolio includes more than 90 brand names, 26% of them refer to medical cosmetics. Darnitsa Launches The Drug Against Arterial Hypertension On May 25-27 during the National Conference on arterial hypertension, Darnitsa pharmaceutical company presented its new drug Tiara Trio® (Valsartan + Amlodipine+ Hydrochlorothiazide). It is the first generic drug with such combination in Ukraine. Numerous comparative studies have shown that efficiency of triple therapy significantly exceeds the double combination therapy. It was confirmed balanced triple combination reduces the incidence of metabolic and clinical side effects that are often seen in

monotherapy. Darnitsa continues the expansion of its cardio portfolio, which contributes about 28% to the company’s overall revenues. Darnitsa Is Ready To Acquire 25% Of BCPP Pharmaceutical company Darnitsa publicly appealed Borshchahivskiy ChemicalPharmaceutical Plant (BCPP) with the proposition to acquire 25% of the company’s shares for UAH 80 ths per share. Darnitsa expects the transaction to cost UAH 207 mio. However, the acquirer will be accepting offers of BCPP shareholders until Aug 31 2016. On 16/06/2016, the Supervisory Board of BCPP unanimously decided to recommend the company’s shareholders not accept the proposal, as it significantly undervalues the fair value of the company, the BCPP’s Secretary of the Board said. On 23/06/2016, the Supervisory Board of BCPP convened the extraordinary general meeting of shareholders on a requirement of Darnitsa. Representatives of Darnitsa insisted on bringing the issue of the re-election of the Supervisory Board and changing the BCPP’s Statute to the agenda. In Mar 2015, Financial Company Kub, representing Darnitsa’s interests, acquired 29.95% of shares of BCPP on the auction for UAH 171.8 mio. In Jan 2016, the Antimonopoly Committee of Ukraine allowed Darnitsa to acquire 50% of BCPP’s shares. While, in Apr 2016, the Committee fined Darnitsa for the acquisition of 30% package of BCPP’s shares without corresponding permission.

Darnitsa retained 3rd position on Ukrainian pharmaceutical market in 2015, while BCPP climbed four positions y-o-y to 16th position. Ukrainian Market Of Clinical Trials Reached USD 300 mio The value of Ukrainian market of clinical trials in 2015 reached USD 300 mio, while the number of participants of drug testing is about 50-60 ths people per year, the estimates of Pharmaxi company say. According to the State Expert Center, in 2015 the number of positive conclusions for clinical trials conduction in Ukraine amounted 202, which is 25% less than a year before (269). This was mainly caused by the reduction of the number of international trials, which was only partially offset by local pharmaceutical manufacturers. “In 2015, the number of II phase trials decreased four times, while I phase trails nearly have not been conducted,” the director of Pharmaxi Yuriy Lebed said. “This drop in the number of new projects leads to increased competition and causes market participants to reduce prices for services as well as look for ways to optimize costs. “Ukraine uses only 10-15% of its potential. The number of clinical trials per capita is very low ��� 0.61,” Mr. Lebed concluded. Currently, 40 CRO companies are operating in Ukraine; 15-20% of the market related to local enterprises. In 2014, the biggest CRO companies by net income were Quintiles (UAH 217 mio), InnoPharm/PPD (UAH 100 mio) and PSI Ukraine (UAH 98 mio).

Ukrainian Pharmaceutical Market Monthly: June 2016


Page 6

REGULATORY UPDATES Provided by

In addition, there is no mechanism for prices declaration for original native products.

Back To Reference Pricing For Medicinal Products

The package of documents required for submission should include the declaration, statement on prices level and power of attorney. For foreign manufacturers the declaration currency shall be Ukrainian hryvnya. The term for documents processing shall take 25 business days.

Specializing ministry developed and published for public consideration the Draft Resolution of CMU «On Reference Pricing for Medicinal Products». The document has been developed under the instruction of the Government. Therewith, the CMU actions plan by 30.09.2016 envisages the new pricing principals implementation aimed at reducing budget expenses at tenders up to 30%. The CMU Draft Resolution foresees that since 01.08.2016 the declaration shall be fulfilled under the new procedure, and all wholesale-retail prices declared under currently acting procedure should be re-declared by 01.10.2016. It is provided, that MOH of Ukraine should establish a standing commission on medicinal products prices regulation, which shall decide on the relevance of wholesale-retail prices’ level of declared medicinal product and on the possibility of its inclusion into the register of wholesaleretail prices. Commission shall be composed of the representatives of Ministry of Economic Development, Ministry of Social Policy and Ministry of Finance of Ukraine. Wholesale-retail prices for original foreign medicinal products are proposed to be designated according to the minimal price (and not according to arithmetic average as previously) of one of the reference countries (country of first registration, Bulgaria, Moldova, Poland, Slovakia, Check Republic, Latvia, Hungary, Serbia).

Public Health Committee Put Off Consideration Of Bill On Public Health Policy On 15/06/2016, Parliamentary Committee on Public Heath decided to put off consideration of the Draft Law #2409a on the basics of public health policy in order to modify it. The working group will have to offer a new version of some articles of the document to resolve contradiction with the Constitution by end of July. The Draft Law was registered in July 2015 as an alternative to the one prepared by the MOH. The initiator of the document Oleg Musiy considered it as one of two basic and fundamental ones for the reformation of Ukraine’s healthcare system. He expected the Draft Law #2409a to be approved in the first reading in May-June. Public Health Committee Put Off Consideration Of Bill On Autonomization Of Hospitals Parliamentary Committee on Public Heath postponed the consideration in the second reading of the Draft Law #2309a-d aimed to improve the healthcare legislation to provide autonomization to medical

institutions in Ukraine. Committee Members failed to agree on a number of amendments, which proposed a working group to finalize the Draft Law. The Head of the Committee proposed to postpone the consideration of the document to the next session. The Draft Law was registered in Dec 2015 and approve in the first reading on 21/04/2016. In summer 2015, the Parliamentary Committee rejected the Draft Law #2309 developed by the MOH having seen the risk of privatization of healthcare facilities. According to exMinister of Healthcare Alexander Kvitashvili approval of the Draft Law is fundamental to start reformation of healthcare system in Ukraine. EBA Urges To Amend Tax Code The European Business Association (EBA) urges Ukrainian Parliament to approve amendments to the Tax Code (Draft Law #3180) to regulate the problems of drugs and medical devices VAT taxation. First problem is taxation of drugs with standard 20% VAT rate instead of preferential 7% rate when the date of a registration certificate expired and the next certificate is not received yet. Second problem is when a medical device referred to other classification code at customs and, therefore, the preferential 7% VAT rate does not apply. The approval of the Draft Law #3180 is expected to enhance economic accessibility of certain drugs and medical devices and increase the attractiveness of local market for foreign manufacturers of high-tech medical products.

Ukrainian Pharmaceutical Market Monthly: June 2016


Page 7

HEALTHCARE NEWS MOH Intends To Develop A State Program For Import-Substituting Industries The MOH started the process of development of the Concept of State program for imports substitution in Ukraine aimed to increase the share of drugs produced by local companies on the Ukrainian pharmaceutical market by supporting local producers in the development of import-substituting manufacturing of medicines and medical devices. “Today the domestic pharmaceutical industry is quite powerful and has all possibilities for the production of quality drugs,” the acting Head of the MOH said. “Thus, development and improvement of the competitiveness of the local pharmaceutical market, which would provide patients with affordable and quality drugs, is a strategic goal for the MOH.” MOH Will Enhance Cooperation With The WB In Healthcare Reforming The MOH of Ukraine intends to intensify cooperation with the World Bank (WB) within the joint project “Improving healthcare at the service of the people,” which have been implementing in nine regions of Ukraine since 2015. The parties agreed on a tight schedule of meetings and involvement of the WB’s representatives in the working groups on the principal directions of the reformation. In Mar 2015, the WB approved the credit for USD 214.7 mio for the implementation of the project aimed to the development of medical infrastructure and improvement of the quality of medical services. The project is

designed for five years and will be implemented in Vinnytsia, Volyn, Dnipropetrovsk, Zakarpattia, Zaporizhia, Lviv, Poltava and Rivne regions. Kyiv Intends To Provide More Authorities To Healthcare Facilities Kyiv government intends to expand the authorities of medical institutions on the part of the administration of financial resources and implement the project of healthcare system reformation, the Mayor of the capital Vitali Klitschko said. “Our goal is to create the efficient system of medical care, provide the access to medical services and provide normal working conditions for doctors,” the Mayor said. “This will be achieved through decentralization and provision to head physicians of opportunities to use budgetary funds for the purchase of drugs, equipment and paying salaries to physicians.” Pilot Project For Reimbursement Of Drugs Against Hypertension To Be Improved The MOH created the working group aiming to improve the pilot project for reimbursement of drugs against hypertension, which was realizing in Ukraine from 2012 to 2014. The group was headed by the Deputy Minister of Health Roman Ilyk. In 2014, UAH 117.8 mio were allocated for the project; the percentage of prescriptions for which a partial refund of the costs was carried out amounted 70.5% of all prescriptions. In 2014, 61.7% of 9 mio patients registered with arterial hypertension in Ukraine were involved in the project.

MOH Wants To Develop A Concept For Import-Substituting Industries’ Support MOH of Ukraine announced the intention to develop the concept of the state program for import-substituting industries’ development to increase the share of local drugs and medical devices on the pharmaceutical market. The development of the concept will involve the representatives of public, professional environment, the pharmaceutical market. The terms of the concept’s development are not indicated. “Today domestic pharmaceutical industry is powerful enough and has all opportunities for the manufacturing of quality drugs,” the press service of the Ministry noted. In 2015, the share of local products on the retail pharmaceutical market amounted 77% in volumes and 41% in values. On hospital market, local producers held 49% in values and 89% in volumes. Kyiv Will Present Pilot Project On E-Health By The Summer End By the end of summer 2016, Kyiv government intends to present the first pilot project on e-health to be realized in Podilskyi District of the capital, the Deputy Head of Kyiv State Administration Mykola Povorosnik said at the conference “Development of healthcare system of Kyiv.” The system will contain all information on all appointments and diagnoses of a patient. Moreover, Kyiv plans the implementation of the project on first-aid development, Mr. Povorosnik added.

Ukrainian Pharmaceutical Market Monthly: June 2016


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Upharmacia - June 2016