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1PHARMACEUTICAL SCIENCES
ОЦ1НКА ВАРТОСТ1 1НВЕСТИЦ1Й В РОЗРОБЦ1 ТА ВИКОРИСТАНН1 НОВИХ
Л1КАРСЬКИХ ЗАСОБ1В
Самборський О.С.
1вано-Франювський нацюнальний медичний утверситет, кандидат фармацевтичних наук, доцент (м. 1вано-Франювськ)
Слободянюк М.М.
Нацюнальний фармацевтичний унiверситет (м. Харюв), доктор фармацевтичних наук, професор
Малий В.В.
Нацюнальний фармацевтичний ymiверситет (м. Харюв), доктор фармацевтичних наук, професор, завiдувач кафедри
Байгуш Ю.В.
1вано-Франювський нацiональний медичний утверситет,
асистент (м. 1вано-Франювськ)
ASSESSMENT OF INVESTMENTS VALUE IN THE DEVELOPMENT AND USE OF NEW
MEDICINES
Samborskyi O.S.
Candidate of Pharmacy (Ph. D.), associate professor of the Department of Organization and Economics of
Pharmacy and Drug Technology, Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine
Slobodyanyuk M.M.
Doctor of Pharmacy, Professor of the Department of Pharmaceutical Marketing and Management, National University of Pharmacy, Kharkov, Ukraine
Malyi V. V.
Doctor of Pharmacy, Professor, Head of Department of Pharmaceutical Marketing and Management, National University of Pharmacy, city of Kharkiv, Ukraine.
Baygush Yu.V.
Assistant of the Department of Organization and Economics of Pharmacy and Drug Technology, Ivano-
Frankivsk National Medical University, Ivano-Frankivsk, Ukraine
Анотащя
Статтю присвячено дослщженню в обласп шновацшно-швестицшно! дiяльностi процесу розробок та використання генеричних лшарських 3a^6ÍB нових поколшь. Висвилено питання оцшки економiчноl ефективносп швестицшних вкладень та 1х привабливостг Узагальнено методолопчш принципи та мето-дичш тдходи до оцшки змши вартосп швестицш у чай. На основi матерiалiв проведених дослвджень оргашзацшно-технолопчного процесу розробки лжарських засобiв видiлено складовi та ix групи. Визна-чено структуру та черговють iнвестицiйниx вкладень, опрацьовано дисконтованi суми протягом шве-стицiйного процесу. Обгрунтовано необxiднiсть значного шдвищення обсягiв продажу нового лтарського засобу у першi три роки комерцiйного використання для бшьш швидкого та повного повернення дискон-товано! суми iнвестицiйниx вкладень.
Abstract
The article is devoted to the research of developments and use of new generation generic medicines in the innovative investment activity sphere. We have outlined the problem of assessment of investments economic efficiency and their attractiveness. We have summarized methodological principles and methodical approaches to the assessment of investments value changes in time. Based on the investigations of organizational and technological process of new medicines development, we have singled out the components and their groups. We have determined the structure and investments priority, worked out discounted amounts during the investment process. We have motivated the necessity to significantly increase the sale volume of new medicines during the first three years of commercial use for faster and complete return of the investments discounted amount.
Ключов1 слова: ефективнють, оцшка швестицш, вартють фшанйв, управлшня фшансами, ризики, розробка лшв, швестицп, шновацп, фармащя
Keywords: efficiency, investments assessment, finances value, finances management, risks, medicines development, investments, innovations, pharmacy
Setting of the problem. Regular increase of the millions (for generic and hybrid medicines), a signifi-new medicines developments value to tens of millions cant prolongation of development terms up to 10-15 and billiard US dollars (for original) and hundreds of and 3-6 years correspondingly, a high level of risks and
at high intensity of such research, there is an urgent problem as to the investments transparency and saving of money. More important role is given to the problem of qualified management, project budgeting formation and rational management of organizational and technological process of new generation medicines development and use [10,14,17, 20,21,].
The investment project is developed using uncertainty regarding the costs, price, profitability and the new medicine sale volume, the project time limits, etc. that means high risks. The limited resources management optimization, especially financial, is an important strategic and the company tactful activity. Involvement of big financial resources, individual and external, investors, shareholders or creditors, requires use of the business management concept based on the value approach (Value Based Management), which in turn requires efficient methods of projects and business assessment. Investments assessment is based on the fact that profit from investments to such a project must be higher or equal to the profit, which we can have from making investments to other projects (for example, bank deposits or guaranteed public securities). It is worth mentioning that it is influenced by many factors, among which is inflation, level of risk, profit rate, which lead to the invested money depreciation. Therefore, discounted amounts of investments are important components in project budgeting. Organizational and technological process of development and use of a new medicine includes both an innovative base and expertise and public registration, organization of production and issue of a new medicine, market stage of medical implementation and commercial assistance [17,21,19, 22]. And almost all stages require significant investments in time. The beginning of the invested finances return starts from the beginning of commercial use of such medicines.
Analysis of resent research and publications. In economic literature, much attention is given to the investments assessment, their significant depreciation in long-term projects, motivated methods of investments assessment and determination of their efficiency [5,7,8, 15, 21, 19,22]. At the same time, scientific developments in pharmacy, especially in long-term technological process of development and use of the new medicine is not enough, they reveal some problems and their solutions [1,2,4,9-12,13].
The goals of the article. The profound theoretical summary of methodological principles and methodical approaches to the innovative budgets assessment, determination of investments efficiency taking into account term of their use.
Unsolved issues, which are part of general problem.
Publications analysis and innovative practical pharmacy requirements shows that traditional approaches to the realization of projects aimed at the development and use of new generation medicines do not meet the requirements of the market and investors [3,5,7,9,23].
Today in pharmacy they do not make an efficiency assessment of investments use, which in turn restrains attractiveness of such an innovative process. Analysis
The scientific heritage No 15 (15),2017 of developments budgets, determination of terms of the investments return taking into account time of their use is an urgent requirement nowadays.
The goal of this research is to summarize methodical approaches as to the determination of the value of investments change in time, to work out a methodology of the investments composition determination for the development of new generation generic medicines and calculation of discounted investments amount.
The key results of the research and their discussion. Analysis of publications shows escalation of value management in Ukraine. Among the key problems it is worth mentioning conflicts between shareholders and management, shareholders and creditors, problems of choosing between allotting limited resources to investments and dividends, choosing high priority investments, etc. [7,15,20,21,16,18]. Extremely limited resources, low sale volume of medicines and low purchasing ability strengthen the problem of investment projects efficiency, investments attractiveness [1,3,4,7]. A guarantee of higher profit for investments to the new medicines development, shorter period of time for their payback becomes a basis for the investment attractiveness assessment [3,9,13,21].
For economic assessment of the investment project they use a number of methods, among which are the following: a method of the obtained effect calculation, a method of the investments payback term determination, a method of the investment project profitability internal norm determination, a method of investments profitability index calculation, a method of investments efficiency coefficient calculation, a method of the obtained effect calculation. A capital value is a profit, which must be obtained from investments so that they could justify themselves from investor's view point and could be presented as an interest rate of invested capital [5,15, 21-23].
The fundamental criterion of investments attractiveness to a project is a time of returning the invested capital or a pay-back period. Classically, one can state that the faster the project can pay back the invested capital, the sooner it can bring profit and the bigger will be its general size.
Efficiency assessment of real investment projects is based on the peculiarity of methodological principles (performance, objectivity, complexity, resources lack, alternative value, consistency, unlimited needs), as the most general, which do not depend on the peculiarity of a specific investment project and methodical (insufficient information, disparity of multi-temporal costs and results, dynamics, peculiarity of project, differences in the interests of the participants), which are connected with a specific project.
We have determined that the economic efficiency assessment of the investment project is based on the augmentation operation and the discounting operation. The future value of the invested money depends on the investments amount, a period of using the investments, an interest rate, an inflation level, a simple or complicated interest rate, etc. Herewith, the operation of augmentation is a process of the future value of invested money determination till the end of the determined pe-
riod of time or only the beginning amount (a simple interest rate), or periodically we add the profit obtained (a complicated interest rate). Moreover, we single out two types of investments optimization: dimensional and temporary.
As the experience shows, in order to determine project efficiency and finances, one should make a complex investments assessment, motivation of costs and results achieved. There are two approaches to the economic efficiency assessment: do not taking into account the time factor, when equal amount of income gained in different time is considered to be of the same value, and taking into account the time factor, when methods of economic efficiency assessment are divided into static and dynamic methods of discounting. A discounting term of payback will show a time period, in which investor's profit taking into account the time factor will meet the investment costs taking into account risk, inflation and rate of income. Such an indicator is considered to be the best criterion of investments assessment [7,8,15].
Investment needs, as a general amount of investments, are divided by the companies into three groups: direct investments (basic and current), as active balance
sheet item, related investments (investment to the objects connected territorially or functionally with a direct object), scientific research investment. All range of investment needs should be submitted in the form of a special plan or schedule of investments flow.
Based on the analysis of new generation generic medicines developments, we have determined that innovative pharmaceutical production has a big social importance, and in the innovative process medicines, as a special product, require big financial investments, the process of development itself is characterized by a significant duration, intensity of research and complexity of work, peculiarity of complex chemical, technological, pharmaceutical, medical, economic and other investigations [1, 3-6,18, 22]. We have summarized that the amount of investments for the development and use of a new medicine in Ukraine is approximately 1 million UAH (38,5 thousand US dollars).
To determine the volume of investments required we have singled out the components of investment needs. Having analyzed summarized data as to the investments structure and investment budget structure, we have determined that developments and investigations of new generation generic medicine last 1 year and 8 months (Table 1).
Table 1
Basic characteristics of investments in motivation of expediency and efficiency, development and implementation of new generation generic medicine
№ Name of indicator Period of investment, year Total
1st 2nd 3rd
1. Motivation of efficiency and expediency of the project, scientific and research works, public expertise and registration 226,9 214,1 441,0
1.1 Informational and patent research 8,8 8,8
1.2 Marketing research and analysis 56,2 56,2
1.3 Pharmaceutical development. Technological research. 34,7 37,6 72,3
1.4 Pharmaceutical development. Analytical research. 13,2 37,3 50,5
1.5 Pre-clinical research. 12,6 45,7 58,3
1.6 Organizational expert and public registration, including clinical approbation 101,4 93,5 194,9
2. Putting into production and realization 37,7 41,0 78,7
2.1 Organizational, technical technological and analytical works 29,6 31,7 61,3
2.2 Marketing research and commercial support 8,1 9,3 17,4
3. Investment to marketing communications 184,2 295,4 479,6
3.1 Active promotion campaign costs 130,4 207,6 338,0
3.2 One-time event costs 46,2 69,5 115,7
3.3 Supporting promotion costs 7,6 18,3 25,9
Total investments 264,6 439,3 295,4 999,3
Thus, from general amount of investments 441,0 thousand UAH (44,13%) are required to motivate expediency of the project and development of the medicine itself, 78,7 thousand UAH (7,88%) - for putting it into production, 479,6 thousand UAH (47,99%) - for active marketing as to the preparation of the market to faster increase of sale volume. Increase of sales during the first years will ensure a big capture of the market and faster return of investments. Generally speaking, such policy will ensure fast discounted in time return of
investments as well as getting regular profit. It is determined that investments are required irregularly: 1st year - 264,6 thousand UAH, 2nd year - 439,3 thousand UAH and 3rd year - 295,4 thousand UAH. It is worth mentioning that the beginning of returning the investments will be a commercial sale of the medicine and part of profit from such income. We should also take into account that the average term of storage of raw material in the storehouse is 24 calendar days, average delay of payment for raw material - 20 calendar days, average
duration of production - 8 calendar days, average storage of goods in the storehouse - 30 calendar days, and delay of payment for goods - 18 calendar days.
When processing the results, we have taken into account characteristics of investments amount change
according to the duration of implementation to the project and results of the investments discounting in time (discounting rate - 18%). (Table 2).
Table 2
Characteristics of investments changes to the development and use of new generation generic medicine
№ Period of investment, year Investments, UAH Discounted amount of investment, UAH Amount of discount, UAH
1. 1st 264600 264600 -
2. 2nd 703900 751528 47628
3. 3rd 999300 1182203 182903
4. 4th - 1394527 395227
From the results of calculation, during the fourth year the amount of investment (999,3 thousand UAH) is growing up to 1394,527 thousand UAH or will increase by 395,227 thousand UAH. Further analysis proves that at 100% of the medicine production profitability and sale at the market of a new medicine - approximately 50 thousand packs a year and allotting 50% of income, further return of the discounted investments amount will last no less than four years. Such results set a goal before management and marketing specialists to significantly increase volume of sale of the new medicine to pay back the investment as soon as possible.
Conclusions.
1. It was determined that big investments in the development of new medicines, a long period of time for their development raise an acute issue regarding transparency of budgets and saving of finances. The necessity to manage the budget reasonable is growing.
2. Economic efficiency of the product is becoming more important. For economic assessment of investment project, a set of different methods is used. As the value of the capital it is considered to be the profit gained from the investments to justify themselves from investor's view point and could be presented as an interest rate of invested capital.
3. The fundamental criterion of investments attractiveness to a project is a time of returning the invested capital or a pay-back period. We have underlined change of the investments value in time under the influence of inflation, risks and rates of income for investors.
4. We have worked out the model project determined on the basis of the new medicines investigations results. We have singled out the components of investments, determined the amount and involvement of investments in time.
5. Results of investments discounting required showed that they will be growing for three years by 395,227 thousand UAH. Complex processing of market and economic indicators show that the discounted investments can be paid back no less than in four years.
6. The delivered calculations prove the necessity to increase volume of the new medicine sale in order to pay off the whole amount of investment.
The results achieved, their discussion and methodical approach may be used further, when analyzing financial budgets and investments of different projects, when developing and using of new generation generic medicines.
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