Author: Anne Nielsen Academic Supervisor: Palle Nierhoff Number of characters with space: 127.984 MSc Finance and International Business BAVARIAN NORDIC A/S EXPANDED NET PRESENT VALUE AND SHARE PRICE Department of Economics and Business Administration, School of Business and Social Sciences, Aarhus University February 2013 I Executive Summary In this paper, the share price for Bavarian Nodic A/S is calcualted based on the expanded net present values (eNPV) of the company’s vaccine candidates PROSTVAC© and MVN-BN© RSV. The focus is on the calculation of real options since this is considered difficult by managers. In this paper, a six-step approach for the calculation of eNPV is developed. The six-step approach involves the calculation on the traditional NPV in step 1-3 and the calculation of real options in step 4-6. The calculation of real options is based on the project volatility from management estimates and simulation, the risk-neutral probability and binomial trees. The calculated eNPV of PROSTVAC© was different from the eNPV of MVA-BN© RSV. PROSTVAC© had an eNPV 956 DKK million and no RO value whereas MVA-BN© RSV had a lower eNPV of 35,25 DKK million. RSV had a static NPV of -4,81 DKK million and a real option value of 40,06 DKK million. This may illustrate that projects with higher uncertainty have higher RO values. In the binomial trees, which shows management actions, PROSTVACs© abandonment options should never be exercised whereas it could be beneficial to exercise MVA-BN© RSVs options in some circumstances before phase 3 development. From the eNPV of PROSTVAC© the share price for Bavarian Nordic A/S is calcultated. Jyske Bank estimates that PROSTVAC© constitutes 45% of their target share price of 80 DKK/share. Therefore, from the eNPV calculation, the value of PROSTVAC is 36,64 DKK per share. If PROSTVAC is worth 45% then Bavarian Nordic A/S share price is 81,41 DKK/share the 31st of December 2012. Investment companies rarely price projects in early development which is why Jyske Bank does not set a value on MVA-BN© RSV. From the eNPV calculation it is clear that RSV does have a significant value and this value should be included in the share price. The value of 35,25 DKK/million adds an extra 1,35 DKK/share to the above share price. Bavarian Nordic A/S shares were traded at 49,80 DKK/share on the 31st of December 2012 and therefore it can be recommended to buy Bavarian Nordic A/S shares if investors preferences towards risk is disregarded. II Contents 1. Introduction ............................................................................................................................. 1 1.1 Problem Statement .......................................................................................................... 2 1. 2 Delimitation ...................................................................................................................... 3 1. 3 Methodology .................................................................................................................... 5 1. 4 Structure ........................................................................................................................... 6 2. Bavarian Nordic A/S .............................................................................................................. 6 2. 1 Pipeline ............................................................................................................................. 6 3. The Biotechnology Industry .................................................................................................. 8 3. 1 Clinical Stages................................................................................................................. 8 3. 2 Patents ........................................................................................................................... 11 3. 3 Royalties......................................................................................................................... 11 3. 4 Milestones ...................................................................................................................... 12 3. 5 Sales Curve ................................................................................................................... 13 4. Real Option Theory .............................................................................................................. 13 4.1 Use of Real Options ...................................................................................................... 14 4. 2 Real Options VS. Financial Options .......................................................................... 15 4. 3 Types of Real Options: ................................................................................................ 16 4. 4 Real Option Criticism.................................................................................................... 18 5. Step-Wise Approach to Valuing Real Options ................................................................. 19 5. 1 Step 1: Identify and Calculate Base Variables ......................................................... 20 5. 2 Step 2: Strategic Analysis............................................................................................ 22 5. 3 Step 3: Forecasting and Net Present Value ............................................................. 23 5. 4 Step 4: Project Volatility ............................................................................................... 23 5. 4. 1 Management Estimates:...................................................................................... 24 5. 4. 2 Simulation .............................................................................................................. 25 5. 5 Step 5: Real Option Valuation .................................................................................... 26 5. 5. 1 Binomial Tree 1 – Value of Underlying Asset .................................................. 26 5. 5. 2 Binomial Tree 2 – Value of Real Option ........................................................... 27 III 5. 5. 3 Binomial Tree 3 – Management Options .......................................................... 29 5. 5. 4 Calculate Expanded Net Present Value ........................................................... 29 5. 6 Sensitivity Analysis ....................................................................................................... 29 6 Real Option Valuation........................................................................................................... 30 7. Valuation of PROSTVAC© .................................................................................................. 30 7. 1 Step 1: Calculate Base Variables ............................................................................... 31 7. 2 Step 2: Strategic Analysis............................................................................................ 32 7. 2. 1 External Analysis (PROSTVAC) ........................................................................ 32 7. 2. 2 Internal Analysis (Bavarian Nordic) ................................................................... 35 7. 2. 3 SWOT Analysis ..................................................................................................... 38 7. 3 Step 3: Forecast ............................................................................................................ 39 7. 4 Step 4: Project Volatility ............................................................................................... 40 7. 5 Step 5: Real Option Valuation .................................................................................... 42 7. 6 Step 6: Sensitivity Analysis ......................................................................................... 46 8. Valuation of MVA-BN© RSV ............................................................................................... 46 8. 1 Step 1 and 2: Base Variables & Strategic Analysis ................................................. 47 8. 2 Step 3: Forecast ............................................................................................................ 49 8. 3 Step 4: Project Volatility ............................................................................................... 50 8. 4 Step 5: Real Option Valuation .................................................................................... 52 8. 5 Step 6: Sensitivity Analysis ......................................................................................... 56 9. Share Price ........................................................................................................................... 58 10. Conclusion .......................................................................................................................... 59 Bibliography Appendix IV Table of Figures: Figure 1: Bavarian Nordic Pipeline 2012 ............................................................ 7 Figure 2: Overview of Clinical Phases .............................................................. 10 Figure 3: Sales Curve ....................................................................................... 13 Figure 4: Six-step Approach to Valuing the Expanded Net Present Value ....... 19 Figure 5: SWOT Analysis ................................................................................. 39 Figure 6: Step 4 - Simulation on Project Volatility for PROSTVAC ................... 42 Figure 7: Step 5 - Binomial Tree 1 - Underlying Value of PROSTVAC............. 43 Figure 8: Step 5 - Binomial Tree 2 - Abandonment Value of PROSTVAC ....... 44 Figure 9: Step 5 - Binomial Tree 3 - Management Actions for PROSTVAC ..... 45 Figure 10: Step 4 - Project Volatility for RSV .................................................... 51 Figure 11: Step 5 - Binomial Tree 1 - Underlying Value of RSV ....................... 53 Figure 12: Step 5 - Binomial Tree 2 - Value of Sequential Abandonment Option for RSV ............................................................................................................. 54 Figure 13: Step 5 - Binomial Tree 3 - Management Actions for RSV ............... 55 Figure 14: Tornado Diagram over Input Variables for RO Calculation ............. 57 Figure 15: Step 6 - Sensitivity Analysis: Strike Price and Project Volatility ....... 58 V 1. Introduction Bavarian Nordic A/S is a Danish biotech company that develop various vaccine treatments. Before a vaccine can be sold in the market, it must to go through different phases of development. These phases are very costly and have low success rates. Therefore, it is very important that managers make the right investment decisions before they decide whether to invest in a vaccine project or not. In the past, the net present value approach has be used as a tool to valuate such projects, but the net present value approach neglects the fact that managers can change the course of a project after the initial investment decision has been made. The net present value approach is a static approach which only should be applied in projects where there is no uncertainty. If there is uncertainty in a project it has been suggested to apply the expanded net present value approach. This approach acknowledge that managers may make decisions, which impact the project, after the initial investment decision. For instance, a manager may discontinue the development of a vaccine and sell the intellectual property rights because the phase results were bad. This management flexibility adds value to projects through real options. The extra value may change the investment decisions compared to the traditional net present value approach. Some managers, however, do not apply the expanded net present value approach because they argue it is too complicated to apply real options as a valuation tool. Therefore, it is necessary to develop an easy model for the calculation of the expanded net present value or more specific the value of real options. If managers apply the expanded net present value approach a company’s projects may increase in value and thereby maximize shareholder value. Bavarian Nordic A/S is developing a number of new vaccines and it is interesting to see if the calculation of the expanded net present value add value to these vaccine projects. Projects in Bavarian Nordic A/S go through many different phases of development and management flexibility is vital in such a small biotech company. Bavarian Nordic A/S is currently in phase 3 development of a vaccine against advanced prostate cancer (PROSTVAC ©) and has just started the development of a vaccine against respiratory syncytial 1 virus (MVA-BN RSV©). These vaccines are in different phases of development and the added value from flexibility may be very different between them. 1.1 Problem Statement Based on the calculation of the expanded net present value for Bavarian Nordic’s vaccine candidates PROSTVAC© and MVA-BN© RSV; what is Bavarian Nordic’s estimated share price the 31st of December 2012? The objective of this paper is to calculate Bavarian Nordic’s share price based on the eNPV. The calculation will reveal if the extra value from real options will increase Bavarian Nordic’s share price. In order to reach that objective a number of research questions will be answered. The first part of the research questions are concerned with an analysis of real options. In the second part of the research questions, questions related to the calculation of the expanded net present value are identified. The research questions in the third part are concerned with an analysis of Bavarian Nordic and the chosen vaccine candidates. The last part of the research questions focus on the sensitivity of variables and recommendations based on the calculations and final eNPV. Research questions related to the analysis of real options: What are real options? Should real options always be applied in a valuation? Do companies use real options as a valuation tool? Is the expanded net present value approach a better valuation tool than the traditional net present value approach? Research questions related to the calculation of the expanded net present value: How can managers use real option valuation as a decision making tool? How can the expanded net present value easily be calculated? 2 Is it possible to develop a model for the calculation of eNPV and can it be applied to case specific projects? Research questions related to Bavarian Nordic A/S and the two vaccine candidates: What are the strengths and weaknesses of Bavarian Nordic A/S? What are the opportunities and threats for PROSTVAC© and MVA-BN© RSV? Which industry specific factors are relevant for the calculation of eNPV for PROSTVAC© and MVA-BN© RSV? Research question related to the final expanded net present values and recommendations: Which project specific decisions should management make based on the real option valuation of PROSTVAC© and MVA-BN© RSV? Are there any difference in the real option value from projects in different phases of development? What will happen to the real option value if a variable changes? Can it be recommended to buy Bavarian Nordic’s shares? 1. 2 Delimitation In this paper, the focus will be on real options and how to calculate these. Therefore, it is assumed the reader has knowledge of the traditional valuation tools such as how to calculate the traditional NPV and the discounted cash flows. The valuation will be conducted on one of Bavarian Nordic A/S most important vaccine candidates PROSTVAC© and a lesser known vaccine candidate MVABN© RSV. These two vaccine candidates will in this paper be referred to as PROSTVAC and RSV. Bavarian Nordic A/S will be referred to as BAVA or Bavarian Nordic and the expanded net present value will be referred to as 3 eNPV. The two vaccine candidates are chosen in an expectation that they will reveal different result. No other vaccine candidates will be evaluated in this paper. There has been no contact with Bavarian Nordic A/S wherefore management estimates are based on the objective beliefs of the writer. It is assumed, the value of PROSTVAC constitutes 45% of Jyske Banks target value of 80 DKK. This estimate is given by senior share analyst, Frank Andersen, from Jyske Bank. RSV is given no value by Jyske Bank. The role of investor preferences towards risk is not a part of the analysis. Therefore, a recommendation on whether to but BAVAs shares will solely be based on the share price calculated from the eNPV. The calculations will be in DKK since this is the currency used in BAVAs financial reports. Most of the industry specific variables are estimated in USD and these will be converted into DKK using the exchange rate USD 5,62/DKK from the 31/12-2012. No data or articles published after the 13th of November 2012 will be used in this paper; except for important date specific inputs such as the exchange rate and the risk free rate which are from the 31st of December 2012. Further, the mail correspondence with Frank Andersen took place in December 2012. The data, in this paper, stems largely from secondary material such as Bavarian Nordic’s financial statements, articles found via the search engine Business Source Complete and data extracted from DataStream. It has been important to read the financial statements and articles with a critical view since these may be biased. Data from DataStream is considered unbiased. Further, articles on industry structure, vaccines specific information and clinical phases come from competitor and government web-pages, these may also be biased. The important books in this paper are Mun 2006 and Copeland & Antikarov 2003, these books area quite old but they are still considered to be some of the best for real option valuation. 4 1. 3 Methodology There are many variables which have to be estimated for the calculation of the eNPV. Many of these variables are impossible to identify without having contact to the respective company. Therefore, it is possible to use estimates based on historic studies. Since projects are unique these historic estimates should, if possible, not be used. Given that there are no certain estimates from BAVA these base variables will be used, even if this make the project less unique. The historic estimates are based on numbers from the biotechnology and pharmaceutical industries. It is argued that it is necessary to conduct a strategic analysis in order to identify company specific strategies for the forecast. In this paper, an internal analysis based on Porter’s Value Chain framework (on company level), and an external analysis on factors of market attractiveness will be conducted. The internal and external analysis will be combined in a SWOT matrix. There are many other ways a strategic analysis can be conducted, for instance with a PEST or resource based analysis. It is up to the managers to evaluate which model is the best. The focus is on how to calculate the expanded net present value (eNPV), the calculation of traditional NPV is not that important, but the calculation of the option premium is quite important since this has proved to be difficult for managers. There are different approaches to the calculation of option values. In this paper, the risk neutral probabilities together with binomial trees are applied. One important assumption that is used in the real option calculation is the market asset disclaimer assumption (MAD), this assumption states that the value of the underlying asset without flexibility (static NPV) is the best unbiased estimate of the market value of the project. It is impossible to find identical projects for valuation and therefore this assumption is necessary. The project volatility is estimated in a Monte Carlo simulation where the input assumptions are based on management estimates. Instead of using management subjective estimates, one could use historic data if they existed. 5 1. 4 Structure This paper begins with an introduction to Bavarian Nordic and the biotechnology industry in which BAVA operates. From general assumptions about the biotech industry, variables for future calculations are identified The paper continues with a brief discussion of real options in paragraph 4; what are real options? Are they applied by companies? And what do critics say about real options. In paragraph 5, a six-step approach to valuing real options through the eNPV is introduced. This approach will be applied in the valuation of the expanded net present value of PROSTVAC and RSV in the latter parts. Paragraph 6 is a short introduction the next two paragraphs where the actual eNPVs of PROSTVAC and RSV will be calculated with the help of the six-step approach. In paragraph 9, Bavarian Nordic’s share price is estimated and it can be seen how much value each of the vaccine candidates contribute to BAVAS share price. Paragraph 10 concludes. 2. Bavarian Nordic A/S Bavarian Nordic A/S was founded in 1994 by Asger Aamund, who is the current chairman on the board of directors. Bavarian Nordic A/S also known as BAVA is a vaccine-focused biotechnology company which develops and produces vaccines for the treatment and preventions of life-threatening diseases such as smallpox, prostate cancer and respiratory syncytial virus. BAVA is listed on NASDAQ QMX Copenhagen and has more than 450 employees. The company’s primary operations are in Denmark, United States, Singapore and Germany (Bavarian Nordic, 2012a). 2. 1 Pipeline BAVA has a very promising pipeline with two vaccines in phase 3 development; IMVAMUNE© and PROSTVAC. BAVA has no vaccines approved for the market yet, nevertheless, IMVAMUNE© can be sold because it is considered an 6 emergency vaccine. BAVAs total costs for R&D and production are quite high and that compared with the low revenue has resulted in negative net profits for the last five years. Currently, BAVA is producing and selling IMVAMUNE© a (vaccine against smallpox) to the US Strategic National Stockpile even though the U.S. Food and Drug Administration (FDA) has not approved it for commercialization, but since it is considered an emergency vaccine it may be sold before approval. BAVA has a contract to deliver 14 million doses of IMVAMUNE© in 2012-2013, these deliveries increased the production significantly for 2010 and 2011 (Bavarian Nordic, 2011a). Another important candidate for FDA approval is PROSTVAC, PROSTVAC is a vaccine candidate against advanced prostate cancer. PROSTVAC reached phase 3 in November 2011. Both PROSTVAC© and IMVAMUNE© are in late phase development and therefore BAVAs R&D costs are quite high. If the two products are approved for commercialization then there are great sales prospects. BAVAs pipeline is divided in two divisions; the cancer division which has six projects in the pipeline and the infectious diseases division which have four products in the pipeline. Figure 1: Bavarian Nordic Pipeline 2012 Source: Bavarian Nordic Report Q2 2012 7 Since BAVA has begun production of IMVAMUNE© (emergency use) and PROSTVAC© has reached phase 3 development, it can be argued that BAVA is turning into a pharmaceutical company. Biotech companies are often characterized as companies with high R&D expenses, operate with a loss for a period, receive milestone payments from partners and do not have the resources to commercialize a product. Pharmaceutical companies, on the contrary, have lower R&D expenses (but still large), they already manufacture and sell drugs, therefore their sales and marketing expenses are high (Ferrara, 2011). Even though Bavarian Nordic may be in the process of turning into a pharmaceutical company, it may still take many years to receive FDA approvals and develop marketing and sales departments. Therefore, in this paper, Bavarian Nordic will be treated like a biotechnology company. 3. The Biotechnology Industry As mentioned above, BAVA is a biotechnology company. Biotech companies within the development of new drugs have to go through different phases of development in order to launch the drugs on the market. The road to market approval is time consuming, cost extensive and approval success rates are low. The different phases of development will be introduced below. 3. 1 Clinical Stages The major market for Bavarian Nordic is in the USA, therefore, the relevant approval process goes through the U.S. Food and Drug Administration (FDA). Europe has a corresponding approval structure which is through the European Medicine Controls Agency (EMEA). Generally, if a company receives FDA approval in the USA then it will also get it in Europe. It is the FDAs responsibility to protect the public safety (not approving bad drugs), but also not to delay innovative drugs unnecessarily. 8 There are several phases the company must go through in order to get FDA approval, namely preclinical tests on animals and clinical tests on humans. Therefore, the company must be very patient and have enough capital to go through the phases. The following paragraph is based on the study conducted by DiMasi and Grabowski 2007 (cost estimates) and the e-book by Bogdan and Villiger 2008 (time estimates and success rates). Preclinical trials: the compound (drug) is tested in animals to see if it can be applied to a living organism and whether it causes toxicity. On average, preclinical trials takes 10-12 months to complete and the average cost for the preclinical trials, are 59,88 USD million. Clinical trials – phase 1: a small group of human volunteers (20-80) are tested to evaluate safety, dose range and side effects. Before the testing of humans can begin, the FDA requires an ‘Investigational new drug application’ (IND) to be filed, if the application is approved, then human testing can begin. The cost in phase 1 is low compared to the cost in other phases because testing only involves a limited number of volunteers. The average cost for this phase is 32,28 USD million. The probability of entering into phase 1 is according to DiMasi 100% (in reality, not all drugs enter phase 1, many are discontinued in preclinical stages, but these drugs are not included in DiMasi’s study) and the probability of phase 1 success is 83,7%. Clinical trials – phase 2: here a group of about 100-300 people with the disease is tested. Phase 2 can be divided into; 2a: where the aim is to define the dose and 2b: where the aim is to prove the effectiveness of the drug. The average estimated costs are 37,69 USD million and the success rate for phase 2 projects is only 56,3%. Clinical trials – phase 3: the drug is tested on 500-20.000 patients in order to confirm the effectiveness of the treatment. The costs are much larger than in the other phases because of the large number of patients. The costs are estimated to be 96,09 USD million and the probability of success is a little higher than the phase 2 success rate, the success rate for phase 3 projects are 64,2%. 9 Approval phase: if the clinical phases are successful then the company will file for a Biologic License Application (BLA). FDA evaluates the data and then rejects or approves the drug. It takes on average a little more than one year to review the data and the costs are 3 USD million. The approval success rate is not evaluated by DiMasi & Grabowski 2007, therefore it is necessary to turn to one of DiMasi’s older studies where the approval success rates for different therapeutic classes were analyzed. The approval rate for immunology (same therapeutic class as PROSTVAC) was 81,6% whereas the approval success rate for respiratory (same therapeutic class as RSV) was lower with 76,9%. Since the data is quite old it may not reflect the approval success rates today (Bodgan & Villinger, 2008, p.16). An overview of the phases, costs, success rates and time estimates can be seen below. The estimates will be used as variables in the valuation, if no other, more certain, estimates can be found. Figure 2: Overview of Clinical Phases FDA Costs ($ million) Time (months) Probability of Success (%) Preclinical 59,9 10 - 12 100 Phase 1 32,3 18 - 22 83,7 Phase 2 37,7 24 - 28 56,3 Phase 3 96,1 28 - 32 64,2 BLA Approval 3 16 - 20 81,6/76,9 Source: own construction. Based on DiMasi & Grawbowski 2007 and Bogdan & Villinger 2008 10 3. 2 Patents The most important assets in biotechnology companies are their intellectual property (IP). It is very important to protect the IPs since these will form the basis for future revenue. Therefore, companies should patent protect their assets. A patent gives the holder the exclusive rights for a period of 20 years. After the 20 years it is possible to apply for a patent extension, the patent extension is usually for an extra five years with the exception that the product may only be patented and on the market for a maximum of 14 years (FDA, 2009). Usually, companies apply for patents when the product under development is in the preclinical phase. When the product has come through the clinical phases, the remaining patent period is often no more than ten years. 3. 3 Royalties Biotechnology companies often lack the knowledge, expertise and capacity to introduce their products to the market. Therefore, these companies are often interested in forming an alliance with a partner who can be in charge of the commercialization. The partner will pay the biotech company a royalty rate for the rights of the asset. A royalty is a user-based payment and allows the licensee the right of the asset. There are many different ways in which the partner agreement can be set up and biotech companies use the partner agreement as an important strategic tool; maybe access to different markets are important or maybe it is important to keep production in-house. There are many factors which can affect the royalty rates and these depend largely upon; stage of development, strength and scope of intellectual property rights, exclusivity of rights etc. (Finch, 2001). Evidence from surveys has shown that royalties paid by larger pharmaceutical companies can be very different and royalties in the range of 5% to 70% has previously been paid. Further, evidence has shown that companies typically pay a royalty rate based on sales. It can be argued that a royalty rate based on sales is not appropriate because the costs related to the product is rarely known in advance. Therefore, a royalty rate based on a profit measure may be better. Nevertheless, in this paper, the 11 royalty rate is based on sales since this is the most common way to set royalty rates. Royalty rates often depend on the stage of development at the time of agreement. Early stage royalties are often low, which reflects the risk associated with the asset. If the royalty agreement is made in late stage development, the royalty rate will often be larger, which illustrates the decreased risk. Most royalty rates often lie in the range of 5% to 15%. Royalties rates given for products in phase 3 development lies in the range of 10% to 20% (Finch, 2001). The royalty rate in the paper will therefore be 15% and based on sales. 3. 4 Milestones Milestones are one-time payments paid by the licensee to the licensor and are triggered when the project reaches a certain milestone. A milestone may be paid for the completion of phases, filing of patents and receiving positive results. In that context, milestone payments reflect the diminishing risk associated with the project. The amount and frequency of milestone payments are very different between projects and phases. In this paper, I will not include milestones in the forecast because of the high insecurity related to the amount and frequency of payments. This will make the forecasts a bit conservative because it is expected that BAVA will receive milestone payments when they find a partner (from the financial statements it is clear that BAVA expects to receive milestone payments from a partnering agreement for PROSTVAC and these payments should be used to finance other projects (Prospectus, 2011, p. 25)). In connection with that, milestone payments may also go the other way; BAVA can make an agreement to pay milestones to a partner, for instance, when the product has been safely commercialized or when the sales reaches a certain point. By not including milestones, I follow the approach applied by Jefferies, a global investment bank, which also disregards milestone payments for PROSTVAC (Jefferies, 2012). 12 3. 5 Sales Curve In order to undertake a forecast for the NPV calculation, it is important to include a sales curve or penetration rate for the new product. Sales curves can be very hard to estimate for new products because the market size and sales are uncertain. The calculation of sales curves is not a part of this thesis wherefore I use the sales curve suggested by Bogdan & Villiger 2010. The sales curve can been seen below. The sales curve illustrates that new products will start with little sales and thereafter increase until it reaches 100% just before patent expiry. After patent expiry the sales will flatten out over approximately nine years (Bogdan & Villiger, 2010, p. 109-111). Figure 3: Sales Curve Year Market share Year Market share 1 5% 12 100% 2 19% 13 99% 3 36% 14 97% 4 51% 15 95% 5 64% 16 72% 6 75% 17 53% 7 84% 18 37% 8 91% 19 24% 9 96% 20 13% 10 99% 21 6% 11 100% 22 1% Source: Own Construction. Based on Bogdan & Villiger 2010. 4. Real Option Theory Traditionally, the net present value (NPV) approach has been used to decide on investment decisions; if the NPV was positive managers should undertake the investment, it the NPV was negative, the investment should not be decided upon. However, the traditional NPV approach has limitations. The traditional NPV approach assumes that future cash flows are certain and the course of the project cannot change after the investment decision. This means that managers have a passive role. If there is uncertainty in a project, the traditional NPV will not reveal the correct value of the project. Uncertainty 13 adds value to a project because active managers can change the course of a project, for instance, managers may choose to abandon a project and thereby save future costs. The extra value come from a company’s real options, these options can be very different both in types and in value. In order to incorporate the value of real options in the investment decision, the expanded net present value approach can be applied. The equation for the expanded net present (eNPV) value can be seen below (Trigeorgis, 2005). 𝐸𝑥𝑝𝑎𝑛𝑑𝑒𝑑 𝑁𝑃𝑉 = 𝑆𝑡𝑎𝑡𝑖𝑐 𝑁𝑃𝑉 + 𝑂𝑝𝑡𝑖𝑜𝑛 𝑝𝑟𝑒𝑚𝑖𝑢𝑚 Equation 1 From the above equation it can be seen that the traditional NPV approach is also applied in the eNPV but an element is added – the option premium which can be identified as the value of flexibility or real option value. The value of flexibility comes from the fact that managers can change the course of a project after the investment decision, based on NPV, has been made. The focus of this paper will be to calculate the option premium, this can be done with a real option valuation. An introduction to real options is presented in the below paragraphs, here types, definitions, calculations and critique of real options will shortly be discussed. 4.1 Use of Real Options It is generally accepted that real options can be a valuable tool for a company’s strategy and investment decisions, but many companies have been slow to implement the use of real options. In the mid-1990s Triantis argued that the use of RO valuation was ready to increase significantly, this however has not been the case (Copeland, 2003). In a survey, conducted by Block in 2007, it was found that only 14,3% of the responding managers used real options. The study was conducted on 279 Fortune 1000 companies. The study revealed large differences in the use of real options between industries. Companies engaged in new product introduction (often biotech and pharmaceutical companies) are 14 the most frequent users of real options, 36,2% of these companies applied real options. At the other end of the spectra were companies engaged in foreign investments, here only 9,6% of managers applied real options (Block, 2007). According to the survey there are different reasons why companies do not use real options The primary reasons for not applying real options were: lack of management support (42,7%), DCF is the proven method (25,6%), requires too much sophistication (19,5%), real options encourage risk taking (12,2%). However, 43,5% of the respondents stated that there was a good chance they would use real options in the future. In conclusion, there is still a majority of companies which apply the traditional NPV approach, these companies could benefit (maximize shareholder value) by applying the eNPV approach (Baker, Dutta, & Saadi, 2011). 4. 2 Real Options VS. Financial Options The theory on real options stems from the theory of financial options. The difference between financial options and real options is that the underlying asset for a financial option is an intangible asset traded in the market whereas the underlying asset a for real option is a tangible asset such as a project or business unit and the asset is not traded in the market. Both types of options give the right, but not the obligation, to take an action (Berk, 2011). Generally there are two types of options: call and put options. The owner of a call option has the right to buy the asset at a specific price (exercise price) for a specific time period. The owner of a put option has the right to sell the asset within a specific time period (Mun, 2006 p. 349). Often real options are nontradable, this means, there is no liquid market for the asset as there is for financial options. Since there is no market for real options they can be quite difficult to valuate compared to financial options. Further, there is a difference between American options and European options; American options can be exercised at any time within a given time period whereas European options only can be exercised at maturity. 15 If the owner of an American call option finds that the price of the underlying is higher than the exercise price (i.e. the exercise price is lower than the strike price) then the option should be exercised and the option will be “in the money”. If, on the other hand, the value of the underlying is lower than the exercise price, the option will be “out of the money” (Mun, 2006, p.350). 4. 3 Types of Real Options: There are many different types of real options and some of the most commonly used will be described with examples below. As mentioned above, management can make decisions which have an impact on the project after the investment decision has been made, but before the end of the project. A flexible management can make decisions to defer, expand, abandon a project etc. Real options: - The option to abandon: suppose a pharmaceutical company is uncertain about the development of a new drug; it may not be approved by the FDA. Therefore, the company can create a strategic abandonment option for a 10 year time period. If the project is abandoned within the 10 year timeframe, the company can sell its intellectual property rights to another pharmaceutical company and save the cost for further development (Mun, 2006, p. 163). This kind of option in an American put option (the right to sell). - The option to expand: suppose a biotech company is developing a new drug, if the drug is approved by the FDA, management has an option to expand production by building a new building. Or management may decide to expand the use of a drug, for instance by making a pill for a drug that is currently injected with needles. Such an option is an American call option; it can be exercised at any time within the given time period. It gives the holder of the option, the right, but not the obligation to expand. If the cost of expanding is lower than the estimated profitability of expanding, then the option will be exercised. 16 - The option to wait (defer): if uncertainties are large, management can defer investments until the uncertainties have decreased. For instance, management may defer a sale because the price may or may not increase within five years. The management owns an American call option; if the expected profit is higher than the cost of the option, the option is in the money and will be exercised. - The option to contract: suppose a small biotech company is going into the clinical phases of development, the company may not have enough capital to undertake the clinical tests themselves; therefore management may decide to enter into an agreement/contract with another company to undertake the development. The management can during the agreed time period use the option to outsource the clinical test part. Since the option give the right, but not the obligation to sell off some of the capacity, it is an American put option (Copeland 2003, p. 135). - Sequential compound option: is a more advanced option. The value of sequential compound options are contingent upon other options; for instance, in a project with multiple phases, success depend on the success of previous phases. Sequential compound options are often used in connection with R&D projects. Sequential compound options can consist of different option types such as options to expand, abandon, defer etc. The phase/stage 2 option depends therefore on the previous phase/stage 1 option (Mun, 2006, p. 421). In order to value real options it is assumed that the management is competent, this means, managers act in the interest of the shareholders and the company through the maximization of wealth and minimization of risk and losses (Mun, 2006, p. 31). If a real option valuation should be successful, five requirements must be satisfied (Mun, 2006, p.38): A financial model must exist 17 Uncertainties must exist. If there are no uncertainties then there are no real options Uncertainties must affect decisions when the firm is actively managing the project and these uncertainties must affect the results of the financial model Management must have strategic flexibility or options to make midcourse corrections when actively managing the projects Management must be smart enough and credible enough to execute options when it becomes optimal to do so If these requirements are not satisfied, then it will be unnecessary to conduct a real option valuation. 4. 4 Real Option Criticism Real option valuation is not thoroughly approved as the best valuation tool, some of the criticism regarding real option valuation has the do with management actions and the assumption of constant variables. The criticism regarding constant variables is based on the fact the many of the input variables used in the real option valuation are not constant during the life of the project. For instance, project volatility may change quite often because the input variables use to calculate this measure may change. A change in project volatility can have a large impact on the RO value. Further, skeptics argue that managers will choose projects with high risks because these have higher volatilities and thereby higher option values. Other people in favor of RO argues that the criticism is incorrect because managers should hedge negative risk if they have projects with high volatility. It can also be discussed if managers can exercise the option at the right time (for American options). 18 5. Step-Wise Approach to Valuing Real Options As can be seen from above real option valuation is not widely applied by companies; some managers argue that it requires too much sophistication and real option valuation is only an exercise for academics. I argue, that the calculation of real options can be fairly easy if good model exists. In order to make the real option valuation easier both Mun 2006 and Copeland & Anitkarov 2003 suggest managers use a step-wise approach to valuing their real options. The step-wise approach will in time make the valuation of real options as easy as the calculation of the traditional NPV. Mun and Copeland/Antikarov’s approaches and steps are a bit different, for instance Mun suggest an eight-step approach whereas Copeland/Antikarov suggest a fourstep approach. Both agree on using the risk-neutral probabilities because it is easier than applying the replication portfolio approach. The two approaches will in theory give the same result. Below I will develop a six-step approach based on the risk neutral probabilities. The step-wise approach is similar to the four-step approach suggested by Copeland/Antikarov. An overview of the six-step approach can been seen below. Figure 4: Six-step Approach to Valuing the Expanded Net Present Value Step 1 Identify and calculate base variables Step 2 Conduct strategic analysis Step 3 Set up project forecast Step 4 Calculate project volatility Step 5 Real option valuation Step 6 Sensitivity analysis • • • • • Beta WACC Risk free rate Return on equity Debt level • Internal analysis • External analysis • SWOT • Industry variables • Project specific variables • Net Present Value • Tornado diagram • Management estiamates and implicit volatility • Monte Carlo simulation of variables --> project volatility • • • • • • • Identify real options Calculate up and down movements Binomial tree 1 Calculate risk neutral probabilities Binomial tree 2 Binomial tree 3 Final eNPV • Sensitivity analysis on RO input variables Source: Own Construction 19 The first part (step 1-3) are based on the calculation of the traditional NPV, the second part (step 4-6) are concerned with the valuation of the real options and final eNPV. As can be seen from the figure, step 5, is the most important step for the calculation of RO. The calculation of RO is based on two important assumptions: The first, is the market asset disclaimer assumption (MAD). This assumption states that for the asset under valuation, one can assume that the present value of the asset (without flexibility) can be used as the underlying risky asset. This assumption means that the traditional NPV is the best unbiased estimate of the project value (Copeland & Antikarov, 2003, p.94-95). If the MAD assumption was not used, it would be necessary to find the replication portfolio in order to conduct the valuation (which is quite difficult because real options are unique and not traded on the market). The second assumption is that prices or cash flows follow a random walk, which means that uncertainties can be simulated for instance with the use of Monte Carlo techniques (Copeland & Antikarov, 2003, p. 219). 5. 1 Step 1: Identify and Calculate Base Variables In step 1, the base variables for the forecast in step 3 are identified and calculated. The goal is to calculate the weighted average cost of capital (WACC) because WACC will be used as the project discount rate. Before WACC can be estimated one must calculate or find a number of other input variables, for instance: beta, the risk free rate, return on equity, and debt level. WACC will be used to discount the project cash flows. It can be argued that WACC is not the most appropriate discount rate since the risk of the company is rarely the same as the risk of the project (Arnold & Crack, 2004). The solution to that could be to use the opportunity cost of capital. In this paper, however, I will use WACC because the valuation will be conducted on PROSTVAC a vaccine that is estimated to be worth 45% of BAVAs share price, therefore, much of the company risk will be the same as the project risk. An assumption when applying 20 WACC is that the capital structure of the firm doesn’t change – this is a strong assumption. WACC is defined as: 𝑊𝐴𝐶𝐶 = 𝑅𝐸 ∗ 𝐸 𝑉 𝐷 + (1 + 𝑇) ∗ 𝑅𝐷 ∗ 𝑉 Equation 2 Where: RE = Return on equity RD = Return on debt V = Market value of the company E = Market value of equity D = Market value of debt T = Corporate tax rate In the equation RE is unknown (the other inputs can be found in BAVAs financial statements) and has to be determined with the help of the Capital Asset Pricing Model (CAPM). RE = β * (RM – RF) + RF Equation 3 Where: RE = Return on equity β = Covariance with the market portfolio (reflects market risk also called systematic risk) RM = Market return RF = Risk free rate 21 The unknown variables in this equation are β, RM and RF and these will be determined below. Beta can be calculated as the covariance with the market portfolio: β= 𝐶𝑜𝑣 (𝑅𝐴 ,𝑅𝑀 ) Equation 4 𝑉𝑎𝑟 (𝑅𝑀) Where: RA = Rate of return from asset RM = Market return The forecasts for both PROSTVAC and RSV will have a timeframe for more than ten years. This timeframe should be reflected in the beta estimate. Since BAVA may be in the process of turning into a pharmaceutical company with lesser risk, it can be argued that BAVAs beta will move towards the market average. To incorporate the lower company risk Bloomberg’s adjusted beta formula will be used to calculate BAVAs beta (Hiller, 2008, p.159-160). 𝐴𝑑𝑗𝑢𝑠𝑡𝑒𝑑 𝑏𝑒𝑡𝑎 = 0,66 ∗ 𝑅𝑎𝑤 𝑏𝑒𝑡𝑎 + 0,34 Equation 5 If beta equals 1, the company follows the market. If beta is 0 then there is no correlation with the market. If beta is greater than one, the company’s return will vary more than the market return. For instance, if the market decreases with one, the company will decrease with more than one. It is also possible the beta can be negative; this means that the company is inversely correlated with the market. 5. 2 Step 2: Strategic Analysis For managers it is important to be aware of the company’s strategic options because it increases the value of the company. In order to identify the strategic 22 options, management can conduct a strategic analysis; the analysis should consist of an internal and external analysis and conclude with a SWOT analysis to cover all aspects of the company. There are a number of ways to conduct a strategic analysis and a company should choose the one that fits their company the best. 5. 3 Step 3: Forecasting and Net Present Value By applying the inputs from the above steps, it is now possible to set up a forecast for the project. From the forecast the traditional NPV should be calculated. It is important to notice that the forecast will be used as a mean to conduct a real option valuation and therefore past events (investments) are not considered relevant for the forecast. If past events were considered to be relevant, it would be possible that a tax benefit should be included in the forecast. Biotechnology companies often experience huge losses prior to the launch of their products; the tax credit from this loss can be realized when the company increases the revenue. Another consideration for the forecast is which measure of profit to include. In this paper, the net operating profit less adjusted taxes (NOPLAT) will be applied as the profit measure. Another measure of profit is the free cash flows (FCF). The calculation of FCF involves calculations of depreciation, net working capital and provisions. These inputs are more appropriate on a company level and therefore the FCF is not used as a profit measure. The corporate tax rate is set to 25% which corresponds to the Danish corporate tax rate. 5. 4 Step 4: Project Volatility Step 4 is the first step in the second part of the six-step approach. The focus in the second part was to calculate the RO value. The project volatility is an important estimate used later in the RO valuation. 23 Volatility is a measure of the variation in variables over time. Volatility adds value to RO projects because managers can change the course of the project. There are two approaches to estimating the consolidated volatility: the historical and the subjective approach. From the consolidated approach it is possible to get a single estimate of volatility from many uncertainties (Copeland & Antikarov, 2003, p.244). If there are no historical data for the project it is better to use the subjective approach i.e. the subjective estimates of management is used. The first part in estimating the volatility is to identify variables of uncertainty from the forecast. A good way to do this is to make a tornado diagram. Tornado diagrams are graphic illustrations which show how much a difference of for instance +/- 25% (in a variable) will impact the NPV. The most uncertain variables will be at the top and the variables with low uncertainty will be at the bottom thus it looks like a tornado. 5. 4. 1 Management Estimates: If there are no historical data available, which often is the case with real options, management can provide estimates of the inputs needed to calculate the implicit volatility. More specifically, management must provide estimates of the highest (and lowest) values of the variable under consideration, with 95% confidence. Further, a growth rate of the variable must be determined. This growth rate, ri, is based on the assumption that the uncertainty (from variables) follows a Geometric Brownian Motion. The assumption of Geometric Brownian Motion means that the value of the variable in the next period, Vt+1, is equal to the value in the previous period, Vt, multiplied by the growth factor. A further assumption from the Geometric Brownian Motion is that there is no autocorrelation at the beginning (Copeland & Antikarov, 2003, p. 260). The implicit volatility can be calculated using the following formula: 𝑢𝑝𝑝𝑒𝑟 𝜎𝑢𝑝𝑝𝑒𝑟 = 𝑉 ln( 𝑇 𝑉0 𝑙𝑜𝑤𝑒𝑟 )− ∑𝑛 𝑖=1 𝑟𝑖 2√𝑇 , 𝜎𝑙𝑜𝑤𝑒𝑟 = 𝑉𝑇 ∑𝑛 𝑖=1 𝑟𝑖 − ln( 𝑉0 2√𝑇 ) Equations 6 Where 𝑉𝑇𝑙𝑜𝑤𝑒𝑟 is the value of the variable in period T with 95% confidence and r i is the growth rate. 24 5. 4. 2 Simulation Once the uncertain variables have been identified and the corresponding implicit volatility has been calculated, the project volatility can be estimated using a Monte Carlo simulation – a simulation will give a more reliable result. The Monte Carlo simulation can be run with the help of an Excel add-in called Crystal Ball or some other simulation software, in this paper Crystal Ball will be applied. First, in Crystal Ball, the probability distribution for the uncertain variables has to be selected. There are many different probability distributions for instance: normal, triangular, uniform, lognormal and beta. Since I use the Geometric Brownian Motion assumption and the fact that prices will never go negative, the lognormal distribution is chosen. The lognormal distribution requires two more inputs; the mean value, which can be found in the forecast as the first value in the variable, and the implicit volatility for the variable. The goal of the simulation is to forecast the percentage change in the return of the project from one time period to the next. The variable for the percentage change will be called z. The formula for z is: 𝑃𝑉 𝑧 = ln(𝑃𝑉1 ) Equation 7 0 To calculate z, the value of PV0 must be held constant while the simulation is run (Copeland & Antikarov, 2003, p. 249). After the Monte Carlo simulation for z the statistics for z can be seen. It is in this statics the project volatility is shown as the standard deviation. Biotech projects often have volatilities above 50% because of the high uncertainty. If a project volatility was estimated to be 0 it would imply that there is no uncertainty in the project and the RO value would be zero, therefore the traditional NPV analysis can be seen as a special case of the real option analysis (Bogdan & Villiger, 2010, p. 101). When the project volatility has been estimated the final part of the real option valuation can begin. 25 5. 5 Step 5: Real Option Valuation In this step the final eNPV is calculated, but before that calculation the value of the real option must be estimated. The real option value is estimated with the help of binomial trees, up/down movements and the risk neutral probability. 5. 5. 1 Binomial Tree 1 – Value of Underlying Asset There are different approaches to estimating the value of an option. The most applied methods are closed-form solutions, partial-differential equations, and binomial lattices (Mun, 2006, p. 123). A common approach for valuing real options is by applying binomial trees because they are easy to implement and explain. Closed-form solutions such as the Black-Scholes model are difficult to explain and use complicated mathematics. There are two approaches to solving a binomial lattice; the two methods give the same result: Market-replicating portfolios: assumes there are a number of traded assets in the market which can be replicated and match the project payout policy. This is often the case for financial options. Risk-neutral probability: the idea with the risk-neutral probability is to risk-adjust the probabilities on the expected cash flows. When the cash flows are risk adjusted it is possible to discount them with the risk free rate. Compared to the market replicating portfolio this approach is not as risky because it does not use a risky set of cash flows (Mun, 2006, p. 128). In option models which apply the risk-neutral probability there is a minimum requirement of at least two binomial lattices; one showing the value of the underlying asset and the other showing the value of the option. The lattice for the underlying asset starts with the traditional NPV at time zero without technological uncertainty (a discussion on the role of uncertainty can be seen in paragraph 5.5.2.1). The value of the underlying asset is then multiplied with the up and down factors from left to right making the branches on the binomial tree recombining. 26 The risk-neutral probability (p) and the up (u) and down (d) factors are calculated from the below formulas: 𝑢 = 𝑒 𝜎√∆𝑡 𝑑 = 𝑒 −𝜎√∆𝑡 = 1 𝑝= 𝑢 𝑟 ∆𝑡 𝑒 𝑓∗ −𝑑 𝑢−𝑑 Equations 8 T= time to expiration σ = volatility rf = risk free rate ΔT = time steps The risk-neutral probability is not the probability of increasing stock prices. Rather, it is a number that illustrates how the actual probability should be adjusted to keep the share price the same in a risk-neutral world (Berk, 2011). 5. 5. 2 Binomial Tree 2 – Value of Real Option After the first lattice which shows the value of the underlying asset, a second lattice for the value of the option has to be made. To calculate the value of the option one should use a process called backward induction. Backward induction means that the value of the option is calculated backwards i.e. the nodes at the end of the lattice (terminal nodes) are calculated first – from right to left (Mun, 2006, p. 165). The value of an abandonment option at the terminal node (which is a put option – see paragraph 4.3) is thus calculated as the max of zero and the cost which can be saved by abandoning the project less the value of the underlying asset multiplied with the technological risk. If the value is positive, management will abandon the project (the put option is in the money). If the value is zero, the management will continue with the project. The values at the intermediate nodes can be calculated as: 27 𝑉𝑎𝑙𝑢𝑒 𝑜𝑓 𝑖𝑛𝑡𝑒𝑟𝑚𝑒𝑑𝑖𝑎𝑡𝑒 𝑛𝑜𝑑𝑒𝑡 = 𝑀𝑎𝑥(0; ( 𝑝∗𝑈𝑝 𝑚𝑜𝑣𝑒𝑚𝑒𝑛𝑡𝑡+1 +(1−𝑝)∗𝐷𝑜𝑤𝑛 𝑚𝑜𝑣𝑒𝑚𝑒𝑛𝑡𝑡+1 𝐷𝑖𝑠𝑐𝑜𝑢𝑛𝑡 𝑓𝑎𝑐𝑡𝑜𝑟 ) Equation 9 From equation 9, it is seen that the value of the intermediate node is the discounted value of the up and down movements from the previous period multiplied with p and 1-p respectively. This calculation assumes that the option is a European option because European options can only be exercised at the end of expiration. The inputs for the second lattice are: values from the first lattice, the risk neutral probability, a discount factor and the technological uncertainty. Since technological uncertainty has been kept separate from the calculation of the value of the underlying asset it is possible to discount the value of the option with a discount factor based on the risk free rate. 5. 5. 2. 1 Uncertainties In biotech projects there are two types of uncertainties, these different types of uncertainties must be kept separate in order to get a correct RO valuation – this is called the separation approach (Copeland & Antikarov, 2003, p. 221). The two types of uncertainties derives from market and technological factors. Market uncertainty is characterized by factors that are known today but will become more diffuse through time; market uncertainty can for instance be the price. Technological uncertainty is diffuse now but will resolve in time. For instance, a biotech company may have a 70% probability of FDA drug approval today, but the probability will be less diffuse in a few years. Since the technological risk is independent of the market, it can be discounted with the risk-free rate (Copeland & Antikarov, 2003, p. 271 + 276). Whereas the market risk should be discounted with a project specific discount rate, in this paper WACC was suggested to be the best discount rate. Therefore, the present value of the underlying asset, S_0, at the beginning of binomial tree 1 is the traditional NPV, without R&D costs and technological risk. In binomial tree 2, technological risk will be added by multiplying it with the real 28 option value. When only the technological risk is added, the RO value should be discounted with the risk free rate. 5. 5. 3 Binomial Tree 3 – Management Options The third binomial tree is not really a part of the real option valuation, it is included in this paper because it illustrates how managers should act. For instance, if an abandonment option shows a positive value, managers should exercise the option, if, on the contrary, the value is zero, managers should hold the option. 5. 5. 4 Calculate Expanded Net Present Value Now the values of the real option and the static NPV have been estimated, the final eNPV can thus be calculated by adding the option premium with the static NPV. If the option has no value than eNPV will equal NPV. 5. 6 Sensitivity Analysis After the RO analysis it is important to evaluate how the input variables such as the project volatility and strike price influence on RO value. A sensitivity analysis can be used to analyze what will happen to the RO value if a variable change with 5%, 10% or 15%. It is also possible to set up a two or three factor model where it is possible to see what will happen to the RO value if there is a five percent increase in one variable and a 20 percent decrease in another variable. Therefore, the final RO value should be seen as matrix of values since input variables may change over time. The sensitivity analysis will be conducted on the RO value since ROs are the focus in this paper. It is, however, also possible to conduct a sensitivity analysis on the variables for the traditional NPV. A limit to this RO sensitivity analysis is that it is not possible to see where the change comes from. For instance, it is possible to analyze what will happen if the project volatility change 5% but the analysis does show where the 5% change stems from. A change in project volatility may come from changed assumptions in one or more of the forecast variables. 29 For managers, the change in a project’s RO value is important because the RO value can be a significant factor in the investment decision. Therefore, a sensitivity analysis on the share price is irrelevant in this case. 6 Real Option Valuation Now the steps for valuing real options have been explained it is time to apply them to two real cases. The first case is a vaccine candidate against advanced prostate cancer called PROSTVAC, PROSTVAC is in phase 3 development. PROSTVAC is estimated to constitute 45% of the value of BAVAs target share price of 80 DKK. The estimate comes from senior investor in Jyske Bank, Frank Andersen (the short e-mail correspondence can be seen in appendix 2). The second vaccine is RSV which is in the preclinical phase of development. Following the argumentation in paragraph 4, the hypothesis is that RSV will have a higher RO value than PROSTVAC because there are more uncertainty related to RSV than PROSTVAC. 7. Valuation of PROSTVAC© PROSTVAC is an immunotherapeutic vaccine candidate for the treatment of advanced prostate cancer. Immunotherapeutic treatments use the body’s own immune system to fight the cancer. PROSTVAC is currently in phase 3 clinical trials where it is going to be tested in 1200 patients from more than 20 countries (Bavarian Nordic, 2011a). PROSTVAC has been developed in collaboration with the National Cancer Institute (NCI) of the United States. There are many different ways to treat prostate cancer and often the treatment consists of a combination of different treatments. PROSTVAC will be an off-the-shelf vaccine; it should be taken seven times over a five months period (Investor Presentation, 2011). Tests have shown that on average patients live 8,5 months longer when they use PROSTVAC compared to placebo. Further, the risk of death is reduced with 44% compared to placebo. 30 7. 1 Step 1: Calculate Base Variables In order to calculate WACC, the expected return on equity, RE, must be estimated. One of the inputs needed to calculate return on equity is the market return. The market return can be found with the help of a market benchmark, I have chosen to use the MSCI World Index. MSCI also have a benchmark for Denmark, but the Danish market is heavily weighted with Maersk and Novo Nordisk wherefore it is considered not to fully reflect the market. The time frame for estimating the variables have been set to three years. However, according to theory, a five-year time frame should be applied. If a five-year time frame is applied in this paper, the market return will be negative. The reason for the negative market return is the economic crisis which begun a little more than five years ago. In other publications it has been suggested to use the historical market premium (between 5-7%) to overcome this problem (McKinsey, Inc., Koller, Goedhart, & Wessels, 2010). With a three year time frame (26/10-2009 to 26/10-2012) the market return is estimated to be 6,77% (see CD-ROM). The calculations of beta can also be seen in the CD-ROM. The adjusted beta is estimated to 1,22 which means that BAVA is more volatile than the market. The risk free rate for a 10-year government bond was 1,76% on the 31st of December 2012 (U.S. Department of the Treasury, 2012). In a perfect world one should use a government bond with different maturity for each year of cash flow, since this can be very comprehensive, an approximation is often used (McKinsey et al., 2010). The risk free rate should be in the same currency as the company’s cash flows in order to incorporate inflation. It can be discussed whether the Danish or the US government bond should be applied. I use the US bond because most of the income will come from the sales in the US. Biotech firms are often financed 100% with equity, therefore RE = WACC. The reason why biotech companies are equity financed is that banks will require a high interest rate on loans since they cannot be sure whether the development will be successful or not. For biotech companies it is cheaper to get equity finance. Bavarian Nordic is also a 100% equity financed: 31 From BAVAs annual report in 2011 it can be seen that BAVA had borrowings of 99 DKK million, this amount dropped to 96,2 DKK million in 2012. Since BAVAs net debt can be calculated as borrowing less cash and other financial assets it is clear that BAVA has a large negative net debt which implies that BAVA is in essence 100% equity financed (the calculations are not shown, the numbers are found in BAVAs annual report for 2011). Therefore, the WACC used for further calculations will be WACC = 1,76%+1,22*(6,77%-1,76%) = 7,90%. Since BAVA disclose a lot of information about PROSTVAC it is possible to include more accurate base variables than the base variables identified as industry specific. The time frame for PROSTVAC and phase 3 testing is a little more than four years: the enrolment of PROSTVAC in the phase 3 study was in November 2011 and the estimated completion date for the phase 3 study is in the second half of 2015 (Health, 2012). In order to allow for a little delay in the phase 3 study it is assumed that phase 3 testing will end in December 2015. Therefore, the total testing time for PROSTVAC in phase 3 will be 50 months which is more than the average testing time seen in paragraph 3.1. Further, BAVA estimates the cost of phase 3 will be $150 USD million. 7. 2 Step 2: Strategic Analysis In the following I will conduct an external analysis for PROSTVAC and an internal analysis for BAVA. The internal analysis will be based on Porters Value Chain Framework and the analysis will be made on company level since an internal analysis for both assets (PROSTVAC and RSV) will overlap. Further, a SWOT analysis will be included in order to identify the strengths, weaknesses, opportunities and threats, these observations will be important for strategic and forecasting reasons. 7. 2. 1 External Analysis (PROSTVAC) The external analysis will be based on factors of market attractiveness, such as market potential, customer characteristics and the competitive environment. 32 Porters 5 Forces is not used as a method for analyzing PROSTVACs external environment because the model gives a static overview of the current industry situation. For the purpose of setting up a forecast for PROSTVAC an overview of the current industry situation is not appropriate. Market Potential: In the U.S., prostate cancer is the second most common cancer in American men. The American Cancer Society estimates that there will be 241,740 new cases of diagnosed prostate cancer in 2012 (American Cancer Society, 2012) and on the world level 780,000 men will be diagnosed with prostate cancer (Bavarian Nordic, 2011b) (Prospectus, 2011, p. 49). During the recent years the number of people diagnosed with prostate cancer has increased, this doesn’t necessarily mean that more people develop prostate cancer, it may also mean that tools for detecting prostate cancer have improved. According to cancer.dk the risk of developing prostate cancer has increased with 8,2% during the last 10 years (Kræftens Bekæmpelse, 2012). BAVA, on the contrary, expects the growth to be closer to 2% (Investor Presentation, 2011). PROSTVAC is for the treatment of people with advanced prostate cancer, on average almost 14% of the people diagnosed with prostate cancer will be suitable for treatment. This calculation is based on the average number of US men diagnosed with prostate cancer each year (214.730) and the people suitable for treatment with Provenge© (30.000) (Beasley, 2012). Provenge© is an FDA accepted competitor to PROSTVAC and it is assumed that PROSTVAC will have the same customer base. Therefore people suitable for treatment are: (30.000*100)/214.730 = 13,97% The price for PROSTVAC is not certain yet, it depends on the price-strategy BAVA choose in the future; managers at BAVA can either set a high price (but below Provenge©) and receive a high profit. Or they can set a low price so they can increase their market share fast. There is no doubt that PROSTVACs costs will be a lot lower than $60.000USD which is the cost for Provenge © – the selling price is $93.000 USD (Baghdadi, 2010). Even if BAVA was to sell PROSTVAC at a price of 40.000 – 50.000 USD they would still have a very high profit margin (Investor Presentation, 2011). Jyske Bank estimates the future 33 price for PROSTVAC to be around 60.000 DKK (Jyske Bank, 2010) other people guess that the costs for producing PROSTVAC is 1/6 of the production cost for Provenge©. Given these statements the cost for producing PROSTVAC is assumed to be 10.000 USD and if BAVA applies the same mark-up as Provenge© (approx. 35%) the selling price for PROSTVAC will be $13.500 USD per treatment. Customer Characteristics: The customers for PROSTVAC will be private and public hospitals. Most of the customers are located in high-income countries and will therefore be able to pay for the treatment. The customers do not have a large bargaining power because they are many and small. This is in contrast to the customers of IMVAMUNE (Bavarian Nordics successful smallpox vaccine), here the customers are government and organizations which need to stockpile a large quantity of the vaccine in order to prevent a bio attack. Competitive Environment: The development of immunotherapeutic cancer treatments is quite new; therefore there are a limited number of competitors. Currently there is only one vaccine in the market, Provenge© developed by Dendreon. Provenge© was approved in April 2010 and there has been huge expectations for sales, the sales has, however, not been nearly as good as expected. This may be due to the high price; a treatment which consists of 3 treatments in a month costs $93.000 and extends life for four months. Expected net revenue for Provenge© was $350-400 million in 2011 but the net revenue was in fact $213,5 million (Dendreon, 2011). Both Dendreon and BAVAs share prices fell after that announcement, the reason was that the market size might be lower than assumed by Dendreon. As an alternative to immunotherapy, Johnson and Johnson has developed a pill called Zytiga. Zytiga works by interrupting the androgen-making process (androgen feeds the tumor) (Zytiga, 2012). Zytiga is to be taken once a month for 8 months and the total cost is $40.000 which is a lot cheaper than Provenge (Forbes, 2012). A new product that was approved by the FDA in July 2012 is Xtandi which also interrupts the androgen-making process. Studies show that patients live on 34 average 4,8 months longer compared to placebo drugs. Xtandi should be taken on a daily basis for a month and the total cost is $7450 (Pollack, 2012). Both Progenics Pharmaceuticals and BioSante Pharmaceuticals (GVAX Prostate) have treatments for prostate cancer under development and is currently in phase 2. Another treatment that was developed by Onyvax has been suspended. In conclusion, there are a number of competitors in the market, which offers different treatments for prostate cancer patients in the advanced stage. Since PROSTVAC will be cheaper and has shown fewer side effects than Provenge, it is expected that BAVA will gain market share from Provenge©. The other two competitors, Zytiga and Xtandi, can pose a threat if they show better results than immunotherapy. The treatments under development will not be considered as a threat to PROSTVAC© because they still need to be fully developed and that will take years. If one should place PROSTVAC in the Boston Consulting Group matrix (BCG matrix), then it would be a STAR; there are huge growth opportunities and the possibility of gaining a large market share is possible because PROSTVAC is a superior product compared to all of the other products on the market or under development. 7. 2. 2 Internal Analysis (Bavarian Nordic) The internal analysis on BAVA will be conducted by applying Porter’s Value Chain framework. The value chain framework was suggested by Michael Porter and the goal is to undertake an assessment of the overall added value of the business. Normally, the strategic analysis should be conducted on product level because it is important to identify how each part of the organization contributes to the whole organization (Lynch, 2009). Even though I analyze two of Bavarian Nordic’s products, I will conduct the value chain analysis on company level. The reason for this is that BAVA has no project specific estimations in their financial statements. In connection with that, BAVA is still a relatively small company wherefore, some product and support activities may be done for both products 35 at the same time. The analysis will however have focus on PROSTVAC and RSV. Primary Activities: The value chain is composed of primary activities and support activities. The primary activities are: Inbound logistics, operations, outbound logistics, marketing & sales and service. Since BAVA does not sell its products on a commercial scale (except for IMVAMUNE which is not that relevant for this report) outbound logistics, marketing and sales are not a part of BAVAs value chain and are therefore considered a weakness. Instead I will focus on inbound logistics, operations and the support activities. Inbound logistics/procurement: Suppliers are very important for BAVA and BAVA strives to have at least two suppliers for critical commodities. BAVA estimates that if a supplier of a critical commodity fails to deliver, it will delay production with 3-6 months (Prospectus, 2011, p.22). BAVA must eliminate the possibility of supplier failure by continually searching for possible partners. Depending on the role of suppliers this can either be a strength or weakness. Currently it is something in between; BAVA have the needed suppliers but they are still vulnerable if a supplier fails to deliver. Operations: the development of PROSTVAC takes place at BN ImmunoTherapeutics located in California, USA. The current production of PROSTVAC takes place at IDT Biologika in Germany. IDT Biologika is not large enough to produce PROSTVAC on a commercial scale and since BAVA is inexperienced in production, it is very important to find a partner which has enough production capacity. Support activities: Firm infrastructure: here the role of management and the board, legal capabilities and the financial resources will be analyzed: Owners and management: the chairman of the board is Asger Aamund, Aamund founded BAVA in 1994. Aamund has great experience in the Danish 36 biotech sector where he has been involved in, among others, Ferrosan and NeuroSearch. Asger Aamund is also the chairman of A.J. Aamund which has an ownership share of more than five percent in BAVA. A.J. Aamund is in financial trouble and had a deficit of 297 DKK million in 2011. Nordea Bank will protect A.J. Aamund for the rest of 2012 (Frovst, 2012). Therefore, Aamund is very dependent on the success of BAVA (increase in share price) if A.J. Aamund should survive in the near future. Asger Aamund has often been considered to be a good profile for BAVA but his good reputation has decreased after the financial trouble with A.J Aamund. The rest of the board is also very experienced in the pharmaceutical and biotechnological sector. The current CEO is Anders Hedegaard, Hedegaard joined BAVA in 2007 and has experience from Alk-Abello A/S and Novo Nordisk. The competences of the board and management is considered a strength for Bavarian Nordic. Legal capabilities: in the biotech industry it is very important a company can develop and protect its assets. One way to do this is to apply for patents and other intellectual property rights. BAVA is very competent in this area and it has patent portfolio of more than 750 patents and 350 applications for patents (Prospectus, 2011, p. 70). BAVA is very concerned about protecting existing rights; in 2005 BAVA filed a lawsuit against Acambis, a competitor they accused of stealing company secrets about the MVA-BN technology used for smallpox. The lawsuit was settled in 2007 (Bavarian Nordic, 2007). Another dispute concerning MVA-BN was with Oxford BioMedica this was settled in 2010 (Prospectus, 2011, p. 35). Financial resources: BAVA cannot finance its R&D and operations from product sales. Therefore, BAVA have had a number of share emissions to increase capital, the latest in 2011. The capital raised in 2011 was used to finance phase 3 development for PROSTVAC. BAVA expected to find a partner that would finance and pay milestones for PROSTVAC before phase 3 trials. A partner was not found and BAVA had to finance PROSTVACs phase 3 trials themselves thus the share emission. Now BAVA expects to find a partner for the commercialization of PROSTVAC but so far no partner has been found. 37 BAVA expects a partner to pay milestone and royalties, the milestones are important because they should to finance BAVAs other vaccine developments. BAVA is lacking capital and may have to postpone the development of their vaccines (Prospectus, 2011, p. 9). Lack of financial resources is certainly a weakness of BAVA. Human resource management: one of the most important resources in BAVA is their employees. In order to attract the best employees, BAVA offers flexible working hours (important for the work-life balance), a competitive salary package, good retirement, insurance and international experience (Bavarian Nordic, 2012b). At the time of writing, BAVA has more than 450 employees and only four vacancies which may imply that employees are happy to work at BAVA. Technology development: BAVA owns the patent rights to the MVA-BN (Modified Vaccinia Ankara – Bavarian Nordic) platform. MVA-BN is used in most of BAVAs development programs and have proven to be very successful. Further, BAVA is also interested in in-licensing for the development of anticancer, infectious disease products and technologies. Technology development is an important strength of BAVA and should continue to be a focus area for future success. In conclusion, BAVA has its strengths in the technological development, board of directors, employees, legal capabilities and management. BAVA lacks financial resources and may have to postpone development activities if a partner for PROSTVAC is not found. Operations is also an area that needs attention, so far with a smaller production there are no problems, but if BAVA experience success with their vaccines production facilities may turn into a weakness. 7. 2. 3 SWOT Analysis The SWOT analysis, which can be seen below, give managers a good overview of strategic factors, such as strengths, weaknesses, opportunities and threats. Management should identify ways in which to combine the identified factors and 38 improve them. For instance, management could find a partner for the production of PROSTVAC thereby removing the current weakness ‘lack of large scale production facilities’ and reducing the future cost of PROSTVAC. Figure 5: SWOT Analysis STRENGTHS (company level) WEAKNESS (company level) Management very experienced Financial capacity within biotech & pharma Distribution Large patent portfolio Sales & marketing Skilled employees Supplier relations Legal knowledge Large scale production facilities Technology & intellectual property rights OPPORTUNITIES THREATHS PROSTVAC PROSTVAC Attractive market No partner agreement High profitability Competing products New treatment therapy Lower prices Low costs RSV RSV High profitability High costs Attractive market No partner agreement Few competitors Few years on the market Source: Own Construction 7. 3 Step 3: Forecast Based on the inputs from step 1 and 2 it is possible to set up a forecast for PROSTVAC, the forecast begins in 2013 where PROSTVAC is in phase 3 development (appendix 3). Since phase 3 development is estimated take up to 50 months, the annual R&D costs are 202 DKK million (843,73 DKK million 39 /50*12). In the forecast, it is assumed that BAVA will receive a patent extension of five years due to the long development time. The patent for PROSTVAC was received in 2004 and will expire at the end of 2023 where the patent extension begins. PROSTVAC is expected to be ready for commercialization in 2017. After patent expiry BAVA will continue to sell PROSTVAC but the sales will slowly decrease (see paragraph 3.5). BAVA is very keen on finding a partner for the commercialization of PROSTVAC and that combined with the fact that BAVA has limited financial resources, it is assumed BAVA will find a partner which pays a royalty. The royalty rate is set to 15% of sales because that is an appropriate rate (see paragraph 3.3). No milestone payments are included because these are very uncertain. Jefferies, an investment banker company, also ignore potential milestones in their valuation of PROSTVAC. It should, however, be mentioned that BAVA expects a future partner to pay milestones (can be seen in the annual reports) but so far it is far from certain that they will receive any. BAVAs market share for PROSTVAC is assumed to be 35%. This illustrates that PROSTVAC is a superior product which decreases the risk of death, extends life and is a lot cheaper than competing products. The corporate tax rate is 25% and the tech. risk is based on the findings in paragraph 3.1 The static NPV with technological uncertainty is 956 DKK million. According to this estimate, managers should continue the development of PROSTVAC because NPV is high and positive. Even though PROSTVAC is in late state development there is still a little uncertainty involved, this uncertainty may add more value to PROSTVAC and therefore a real option analysis should be conducted. It is, however, expected that the RO value will be very low or 0 because PROSTVAC already is in phase 3 development. 7. 4 Step 4: Project Volatility In order to identify the uncertain variables, a tornado diagram has been made in Excel (see appendix 5). The variables chosen for the tornado diagram are: 40 people suitable for treatment, royalty rate, price, BAVA market share and growth. Other inputs such as WACC and technologic risk etc. will not be evaluated here but in stage 6 where the sensitivity on the RO value will be analyzed. From the tornado diagram it can be seen that the number of people with prostate cancer is not that volatile compared to the other variables. None of the variables will push the NPV below 600 DKK mill which is a good sign. The variables of uncertainty will be used to estimate the project volatility. The project volatility is based on the implicit volatilities from the above variables of uncertainty. The implicit volatilities are based on subjective management estimates because there are no historical data available (see appendix 6). The implicit volatilities are based on the lower estimate of management. The implicit volatilities are in the range of 8,73% and 54,93% the highest implicit volatility comes from the royalty rate. The royalty rate is high because it is assumed that an agreement on the royalty rate only can be made once which means that there is no growth rate. The lowest volatility is based on the variable with number of people with prostate cancer, this low volatility was expected because the variable is quite certain and the growth rate is low. Next, the estimated implicit volatilities are used in the spreadsheet for simulation. For the Monte Carlo Simulation the variables of uncertainty must be defined. All variables are defined as lognormal distribution, the standard deviation is the implicit volatility and the mean value is the first number in the forecast variable. In the simulation spreadsheet, assumption variables are green and the decision variable is blue (see appendix 7). In order to run the simulation a few changes must be applied to the spreadsheet; first, a variable called z(return) is included as the decision variable, this variable illustrates the difference between the NPV in period t=0 and t=1. The difference can be interpreted as the percentage change in the return from one time period to the next. Second, R&D costs are not included in the spreadsheet, this has been done in order to avoid negative numbers for the z value. 41 By running the simulation 50.000 times we see that the project volatility is 55,80% (seen as the standard deviation in the statistics below). The volatility is high but in accordance with the expectations from paragraph 5.4.2. Figure 6: Step 4 - Simulation on Project Volatility for PROSTVAC Source: Own construction 7. 5 Step 5: Real Option Valuation There are a number of real options that can be included in the valuation of PROSTVAC. First, it is uncertain that PROSTVAC will get a phase 3 approval since it is still under development. If the results from PROSTVAC turns out to be bad managers can choose to abandon the development of PROSTVAC and thereby save the costs for the BLA. This is an abandonment option where the management has the option but not the obligation to abandon the project (a put option), where the exercise price will be the cost of BLA. Further, if the results for PROSTVAC are bad the management can choose to sell the patent rights to a competitor; this option is also an abandonment option. In the forecast, it has been assumed that BAVA will find a partner for the production and commercialization of PROSTVAC, but this could also have been included in the valuation as an option: BAVA could invest and build production facilities themselves instead of finding a partner; this would be a call option. 42 The real option valued in this case is the option to abandon the project before approval (BLA), which means, if the results for phase 3 are not satisfactory BAVA can abandon the project and save the BLA cost. An option of the salvage value has not been included since it is very doubtful that BAVA will sell the patents rights because BAVA expect to use the patents for other research. Binomial Tree 1: The first step in the RO calculation is to estimate the underlying value of the asset. In order to do that the up and down movements must be calculated 𝑢 = 𝑒 𝜎√∆𝑡 = 𝑒 55,80%√0,25 = 1,3218 The up factor, u, is: Where the volatility is the project volatility, delta t is the number of sub periods in a year – here four sub periods are used. The larger the number of sub periods the more accurate the binomial tree will be, four sub periods have been chosen because they correspond to four quarters in a year. The down factor, d, is 1/1,3218 = 0,7564. The NPV value with no technological uncertainty is 2.666 DKK million and will be used at the start of the binomial tree. The binomial tree is constructed by adding the up and down values to the value of the underlying asset moving from left to right. Figure 7: Step 5 - Binomial Tree 1 - Underlying Value of PROSTVAC STEP 5: BINOMIAL TREE 1 - VALUE OF UNDERLYING ASSET Phase 3 2014 2013 q1 2666 q2 3524 2017 q3 4658 2666 1526 Input Value of underlying asset (s_0) Duration of subperiod, years ΔT Yearly volatility, σ Factor up, u Factor down, d q4 q1 6157 3524 2017 1154 8138 4658 2666 1526 873 BLA 2016 2015 q2 q3 q4 q1 q2 q3 q4 q1 10757 6157 3524 2017 1154 661 14219 8138 4658 2666 1526 873 500 18795 10757 6157 3524 2017 1154 661 378 24843 14219 8138 4658 2666 1526 873 500 286 32838 18795 10757 6157 3524 2017 1154 661 378 216 43405 24843 14219 8138 4658 2666 1526 873 500 286 164 57373 32838 18795 10757 6157 3524 2017 1154 661 378 216 124 75836 43405 24843 14219 8138 4658 2666 1526 873 500 286 164 94 2666 0,25 55,80% 1,321807 0,75654 Source: Own Construction 43 q2 100241 57373 32838 18795 10757 6157 3524 2017 1154 661 378 216 124 71 q3 132500 75836 43405 24843 14219 8138 4658 2666 1526 873 500 286 164 94 54 q4 175139 100241 57373 32838 18795 10757 6157 3524 2017 1154 661 378 216 124 71 41 As can be seen from the above figure, the value of the underlying asset can be very different dependent on the development of PROSTVAC. The option expires just before market commercialization where it was assumed that BAVA has found a partner. In binomial tree 2 the value of the abandonment option will be calculated. Binomial Tree 2: The inputs needed for the second binomial tree is the discount factor, exercise price, risk neutral probability and technological probabilities. The risk neutral probability is calculated as follows: 𝑝= 𝑒 𝑟𝑓∗ ∆𝑡 − 𝑑 𝑒 1,76%∗0,25 − 0,7565399 = = 0,4385 𝑢−𝑑 1,3218 − 0,7565399 Where u and d are already know from binomial tree 1, the risk free rate was 1,76% and the number of sub periods was four. The value of the abandonment option is calculated using backward induction see paragraph 5.5.2 The value in top right corner (Q4, 2016) is calculated as the max of zero and exercise price less the strike price multiplied with the technological risk, since BAVA cannot save any cost from not entering the market, the value is zero: Max (0,0-175139)*81,6% = 0. Figure 8: Step 5 - Binomial Tree 2 - Abandonment Value of PROSTVAC STEP 5: BINOMIAL TREE 2 - VALUE OF ABANDONMENT OPTION Phase 3 2013 2014 q1 q2 q3 q4 q1 q2 q3 0 0 0 0 0 0 Input Yearly risk free rate delta t Risk neutral probability Exercise price, abandon BLA Tech risk phase 3 Tech risk BLA Discount factor Exercise price, abandon market 0 0 0 0 0 0 0 0 0 1,76% 0,25 0,4385 16,87 64,20% 81,60% 1,00441 0 0 0 0 0 0 0 q4 0 0 0 0 0 0 0 q1 0 0 0 0 0 0 0 0 Source: Own construction 44 q2 0 0 0 0 0 0 0 0 0 2015 q3 0 0 0 0 0 0 0 0 0 0 q4 0 0 0 0 0 0 0 0 0 0 0 q1 0 0 0 0 0 0 0 0 0 0 0 0 q2 0 0 0 0 0 0 0 0 0 0 0 0 0 BLA 2016 q3 0 0 0 0 0 0 0 0 0 0 0 0 0 0 q4 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Discounting the values from right to left reveals no real option value for PROSTVAC at all. In the calculations, I have assumed that we use a European option, which means, that the holder of the option can only exercise it at the expiration date. This means that BAVA, we entering phase 3, already has made the commitment to spend 150 USD million. In reality, however, BAVA may have the option re-evaluate the project every year and decide on whether they should continue or not. Even if this was the case, the real option would have no value because the value of the underlying asset is always higher than the cost that could have been saved. The real option value of 0 was almost expected because PROSTVAC is in late stage development. The only cost that could have been saved (assuming a European option) was 16,87 DKK million by not entering BLA. Binomial Tree 3: Management can use the above real option valuation to make decisions: If the value of the option is higher than zero, the managers should exercise the option because the exercise price would be higher than the strike price i.e. the value of the cost savings would be greater than the value of the underlying asset. From the below figure it can be seen that managers should choose to hold the option in all circumstances. Figure 9: Step 5 - Binomial Tree 3 - Management Actions for PROSTVAC STEP 5: BINOMIAL TREE 3 - MANAGEMENT ACTIONS q1 q2 2013 q3 q4 q1 q2 Phase 3 2014 q3 q4 q1 Source: Own Construction 45 q2 2015 q3 q4 hold hold hold hold hold hold hold hold hold hold hold hold q1 q2 BLA 2016 q3 q4 hold hold hold hold hold hold hold hold hold hold hold hold hold hold hold hold Expanded Net Present Value of PROSTVAC The value of PROSTVAC from the traditional NPV was 956 DKK million. The RO valuation revealed no extra value to the project and therefore the expanded net present value for PROSTVAC is 956 DKK million. 7. 6 Step 6: Sensitivity Analysis From above we see that the eNPV of PROSTVAC was estimated to 956 DKK million and it was clear that the real options had no value. The above estimate, however, does not take into consideration what will happen if one of the input variables changes. A change in one variable can have a huge impact on the RO value. In order to see which input variables have the most impact on the RO value, the data for a tornado diagram can be seen appendix in 8. From the diagram it is clear that none of the variables will have an impact on the RO value if they change with +/-25%. Even if the volatility increases with 25% (higher volatility, higher RO value) and the strike price decreases with 25% the RO value will still be 0 (lower strike price, higher RO value). Therefore, managers need not to worry about a 25% change in the variables. One could choose to make a tornado diagram of +/-50% changes but it is quite unrealistic that variables will change that much in four years. 8. Valuation of MVA-BN© RSV Respiratory syncytial virus (RSV) is a virus that causes respiratory tract infections in both children and adults. RSV is the main reason for serious infections in children under the age of two. RSV is often the triggering cause of asthmatic bronchitis (Jensen, 2007) In elderly people, respiratory syncytial virus infections may cause severe cases of pneumonia. Each year 64 million people suffer from respiratory syncytial virus infections and the infections causes approximately 160.000 deaths (Bavarian Nordic, n.a.). 46 Bavarian Nordic is in the process of developing a new vaccine against respiratory syncytial virus infections. The MVA-BN© RSV vaccine candidate is based on the MVA-BN© platform, the earlier MVA-BN© vaccines (against measles) has proved to be well tolerated in children of the age of six months to five years old. The vaccine candidate is currently in the preclinical phase but an IND is expected to be handed to the FDA at the beginning of 2013 and it is expected that phase 1 development will start in 2013. 8. 1 Step 1 and 2: Base Variables & Strategic Analysis The base variables calculated in step 1 for PROSTVAC will also be used as base variables in the valuation of RSV, the argumentation for this was given in paragraph 5.1. WACC was estimated to be 7,90% and the 10-year risk free rate for a US Government bond was 1,76%. Since the development and sales of PROSTVAC will take place in the US, the US government bond was used. It may be argued that the risk free rate for RSV should be the Danish risk free rate since the current activities regarding RSV takes place in Denmark. But BAVA usually aim their products at the US market (get FDA approval) first and therefore most of the future cash flow is expected to be in US dollars even though the production may take place in Denmark. Since the base variables are calculated, the next step in the valuation of RSV, is to conduct an external analysis (the internal analysis for BAVA was conducted in 7.2.2). In paragraph 7.2.1 it was argued that the external analysis should be conducted based on factors of market attractiveness, the same argumentation applies for the external analysis of RSV. The factors are: market potential, customer characteristic and competitive environment. Market Potential: There is a large unmet market for prophylactic vaccines against respiratory syncytial virus: on average, children will at least get the infection once before they turn 2 years old. Further, half of the children will experience a recurrence of the infection. From the summary of a report called Respiratory Syncytial Virus (RSV) Prophylactic – Pipeline Assessment and Market Forecast to 2019 it is estimated that the global RSV prophylactic market to be worth $798.8 million in 2011 and the Compound Annual Growth Rate is 47 3,3% for the next eight years. Therefore, the market for prophylactic RSV in 2019 is estimated to reach more than one billion USD (ASDReports, 2012). Customer characteristics: Since the majority of infections happen in children, the customers or decision makers for the purchase of RSV vaccines will be hospitals and medical clinics. Marketing efforts should be aimed at these smaller buyers. BAVA is not used to market their products to small decision makers (compared to countries and governments as decision makers as is the case for IMVAMUNE) and BAVA has to make a decision on whether to market the RSV vaccine themselves or find a partner. The same rationale can be applied to the distribution; currently BAVA only deliver large amounts of IMVAMUNE to the US and Canada. When the customers for RSV vaccines are hospitals and medical clinics there will be many deliveries and the requested quantity of vaccines will be low. This will require BAVA to invest in distribution systems or find a partner for it. Competitive environment: Currently, there are no approved vaccines for the treatment of RSV. The only drug that has been approved by the FDA is Synagis (Palivizumab) which is for the prevention of Lower Respiratory Tract (LRT) caused by RSV – i.e. it is only for children with a high risk of RSV. Synagis was approved in 1998 and the patent expires in 2015. The costs for Synagis are high (a shot of Synagis cost around $1000 in Denmark and a child requires one shot every month in winter season (Medicin.dk, 2012)) and therefore most of the treatment with Synagis will take place in high income countries. There are a number of RSV development projects most of them (76% of the total pipeline of 21) are in the preclinical and discovery stages. No RSV drugs under development has reached phase 3 illustrating the difficulty of developing such a vaccine. There are two project in phase two development; RSV-604 developed by Novartis and ALN-RSV01 developed by Alnylam (Olszewska & Openshaw, 2009). These may be future competitors but there is still a lot of insecurity about the development of a drug for the prevention (not necessarily a vaccine) of RSV. Due to the fact that many RSV compounds have been discontinued and the difficulty of developing such a drug, it is reasonable to believe that BAVA 48 can acquire a large market share if their product receive FDA approval – the competition is low and the profitability will be high. In conclusion, it is very difficult to develop a RSV vaccine and many companies have a history of discontinued projects. Currently, the competition for being the firsts company with an FDA approved drug for the prevention of RSV is fierce and an approval will first be relevant in more than five years (only phase two development projects). If BAVA develops a FDA approved RSV vaccine the potential market share will be large due to few competitors and a growing market. An approved RSV vaccine can be identified as a STAR in the Boston-Consulting-Group matrix (BCG matrix). Stars are characterized with high market shares in industries with high growth rates. Stars can become CASH COWS if the growth slows but the market share is obtained. If BAVA is one of the first companies to develop an effective vaccine against RSV it is possible that the vaccine will become a cash cow in the future. 8. 2 Step 3: Forecast A large part of the input for the forecast is based on assumptions since it is very difficult to know what the future will look like. As can be seen in appendix 9 the forecasted period start in January 2013, BLA approval is expected in 2019 and market launch is expected the following year. The RSV vaccine is based on the MVA-BN© technology and the patents for this technology are given from 2004 to now (Prospectus, 2011, p. 71). From the forecast it can be seen that RSV will be in the market for ten years (including patent extension). The short time in the market will have an impact on the sale of RSV which will never reach 100%. These few years on the market may scare a potential partner because it will lower their profits. Therefore, a partner may pay BAVA a low royalty rate. On the other side, BAVA may apply for new and more important patents related to RSV and thereby extending the time in the market. The forecast ends in 2039 where RSV will have no sales. The market size and growth rate was identified in the strategic analysis. The market size was assumed to be high and in the forecast it is assumed to be 49 35%. The 35% illustrates a large market share but it also illustrates that there will be other competitors in the market. The royalty rate is set to 15% this implies that it is expected BAVA will find a partner for the commercialization and distribution of RSV since these factors have been identified as a weakness. The 15% may also illustrate that BAVA will find a partner in later stages of development because the higher the risk, the lower the royalty rate (see paragraph 3.3). Milestone payments are shown as an entry in the forecast but no amount has been added, as with PROSTVAC milestones are expected but will not be included. The development of RSV is quite new and only limited information from BAVA is available, therefore, the base variables identified in paragraph 3 will be applied in the forecast. No costs are included in 2013 because it is assumed that BAVA already has made the obligation to invest the money. The cumulative probability of the RSV vaccine to get FDA approval is only 23,3%. The probability weighted traditional NPV the 31st of December 2012 has been estimated to -4,81 DKK million. From the negative NPV managers may decide to discontinue the development of RSV. This decisions should, however, not be made without an real option valuation for RSV. The value of real options may increase the eNPV suggesting that development should continue. 8. 3 Step 4: Project Volatility In order to identify the uncertain variables a tornado diagram has been constructed (see appendix 11). A change in one variable with +/- 25% can have a large impact on the static NPV. For instance, a 25% increase in the market share will increase the NPV to 54,80 DKK million, whereas a 25% decrease in the market share will give a negative NPV of -64,43 DKK million. From these estimates it is clear that changes in the forecasted values can have a huge impact on the NPV. In order to incorporate this uncertainty in the RO valuation, management estimates with 95% confidence level have been conducted and the implicit volatilities have been calculated (see appendix 12). These implicit volatilities are the base for the project volatility. 50 The project volatility of RSV is expected to be higher than the volatility for PROSTVAC because RSV is in early stage development. The implied volatilities (based on lower estimates) are: market share 22,93%, market growth 34,29% and royalty rate 54,93%. The estimated implicit volatilities are quite high compared to PROSTVAC and this illustrates the higher level of uncertainty. After the implied volatilities have been calculated they are used as inputs for the assumption variables in the Monte Carlo simulation. Again, assumption variables follow a lognormal distribution and the return variable z is calculated. R&D costs are not included in the simulation spreadsheet because this will give negative z values in the simulation. The simulation spreadsheet can be seen in appendix 13. By running the simulation 50.000 times we get a project volatility of 51,71% which is lower than the project volatility for PROSTVAC. The result of the simulation can be seen in the figure below. Even though the implicit volatilities were higher for RSV than PROSTVAC, PROSTVAC has a higher project volatility, this is because more variables of uncertainty were included in PROSTVAC. Figure 10: Step 4 - Project Volatility for RSV Source: Own Construction – Monte Carlo simulation 51 8. 4 Step 5: Real Option Valuation It is possible to identify many options for the RSV project; finding a partner for distribution and commercialization versus make investments and do it themselves, stop and sell the patent rights, partnership for the clinical trials tests etc. As before, the option valuated here is abandonment options. There are a number of abandonment options in the RSV project thus making it a sequential compound option; the second option depends on the first option. The options for RSV are: Option 1: Abandon the RSV project before initiating phase 2 – saving the cost of 212 DKK million. Option 2: Abandon the RSV project before initiating phase 3 (given that option 1 has not been exercised) – saving a total cost of 541 DKK million Option 3: Abandon the RSV project before applying for BLA (given that option 2 has not been exercised) – save 17 DKK million in BLA costs An option 4 can be considered: abandon market after BLA approval since I have assumed that BAVA will find a partner there is in reality no cost to be saved therefore the market phase should always be initialized. If BAVA wants to undertake the production and distribution themselves it is possible to extend this analysis with an option to finding a partner versus do it themselves. Binomial Tree 1: To estimate the underlying value of the asset one must calculate the up and down movements. The inputs needed are: the project volatility, value of the underlying asset and the sub periods. The larger the number of sub periods the more accurate the binomial tree will be. The up factor, u, is 𝑢 = 𝑒 𝜎√∆𝑡 = 𝑒 51,71%√0,25 = 1,295 The down factor can be calculated as 1/u which gives a down factor of 0,7722. The value of the underlying asset was 1025 DKK million with no technological 52 risk. Now the first binomial tree can be constructed be multiplying the value of the underlying asset with the up and down factors. Figure 11: Step 5 - Binomial Tree 1 - Underlying Value of RSV STEP 5: BINOMIAL TREE 1 - VALUE OF UNDERLYING ASSET Phase 1 2013 q1 q2 q3 q4 q1 1025 1327 1719 2226 2883 791 1025 1327 1719 611 791 1025 472 611 364 Input Value of underlying asset (s_0) Duration of subperiod, years ΔT Yearly volatility, σ Factor up, u factor down, d 2014 q2 3733 2226 1327 791 472 281 q3 4835 2883 1719 1025 611 364 217 q4 6262 3733 2226 1327 791 472 281 168 q1 8109 4835 2883 1719 1025 611 364 217 130 Phase 2 2015 q2 q3 10502 13600 6262 8109 3733 4835 2226 2883 1327 1719 791 1025 472 611 281 364 168 217 100 130 77 q4 17613 10502 6262 3733 2226 1327 791 472 281 168 100 60 q1 22809 13600 8109 4835 2883 1719 1025 611 364 217 130 77 46 2016 q2 29539 17613 10502 6262 3733 2226 1327 791 472 281 168 100 60 36 1025 0,25 51,71% 1,2950509 0,7721704 q3 38255 22809 13600 8109 4835 2883 1719 1025 611 364 217 130 77 46 27 q4 49542 29539 17613 10502 6262 3733 2226 1327 791 472 281 168 100 60 36 21 q1 64160 38255 22809 13600 8109 4835 2883 1719 1025 611 364 217 130 77 46 27 16 Phase 3 2017 q2 q3 83090 107606 49542 64160 29539 38255 17613 22809 10502 13600 6262 8109 3733 4835 2226 2883 1327 1719 791 1025 472 611 281 364 168 217 100 130 60 77 36 46 21 27 13 16 10 BLA 2018 q4 139355 83090 49542 29539 17613 10502 6262 3733 2226 1327 791 472 281 168 100 60 36 21 13 8 q1 180472 107606 64160 38255 22809 13600 8109 4835 2883 1719 1025 611 364 217 130 77 46 27 16 10 6 q2 233721 139355 83090 49542 29539 17613 10502 6262 3733 2226 1327 791 472 281 168 100 60 36 21 13 8 4 q3 302680 180472 107606 64160 38255 22809 13600 8109 4835 2883 1719 1025 611 364 217 130 77 46 27 16 10 6 3 q4 391986 233721 139355 83090 49542 29539 17613 10502 6262 3733 2226 1327 791 472 281 168 100 60 36 21 13 8 4 3 q1 507642 302680 180472 107606 64160 38255 22809 13600 8109 4835 2883 1719 1025 611 364 217 130 77 46 27 16 10 6 3 2 2019 q2 q3 q4 657422 851395 1102600 391986 507642 657422 233721 302680 391986 139355 180472 233721 83090 107606 139355 49542 64160 83090 29539 38255 49542 17613 22809 29539 10502 13600 17613 6262 8109 10502 3733 4835 6262 2226 2883 3733 1327 1719 2226 791 1025 1327 472 611 791 281 364 472 168 217 281 100 130 168 60 77 100 36 46 60 21 27 36 13 16 21 8 10 13 4 6 8 3 3 4 2 2 3 1 2 1 Source: Own Construction The last abandonment option expires just before market commercialization after that there are no more options. When all the values of the underlying asset have been calculated the value of the sequential abandonment option can be estimated. Binomial Tree 2: The inputs needed for the calculation of the abandonment option are; the discount factor, risk neutral probability, exercise prices for the different phases and the tech. risk for the different phase. First the risk neutral probability is calculated 𝑒 𝑟𝑓∗ ∆𝑡 − 𝑑 𝑒 1,76%∗0,25 − 0,7722 𝑝= = = 0,4441 𝑢−𝑑 1,295 − 0,7722 The discount factor is calculated based on the risk free rate and sub periods. The discount factor is e1,76%*0,25 = 1,00441 53 Figure 12: Step 5 - Binomial Tree 2 - Value of Sequential Abandonment Option for RSV STEP 5: BINOMIAL TREE 2 - ABANDONMENT OPTION Phase 1 2013 q1 q2 q3 q4 q1 40,06 25 13 6 2 53 34 19 9 68 46 28 86 62 106 Input Yearly risk free rate Delta t Discount factor Risk neutral probability Exercise price, abandon BLA Exercise price, abandon phase 3 Exercise price, abandon phase 2 Exercise price, abandon market Tech risk BLA Tech risk phase 3 Tech risk phase 2 Tech risk phase 1 Phase 2 2015 2014 q2 q3 0 3 14 39 80 128 q4 0 1 6 25 65 121 178 q1 0 0 1 10 37 88 149 203 q2 0 0 0 2 16 54 115 178 225 Phase 3 2016 q3 0 0 0 0 4 25 77 146 205 243 q4 0 0 0 0 0 7 40 107 178 227 257 q1 0 0 0 0 0 0 12 64 143 207 245 268 q2 0 0 0 0 0 0 0 21 98 181 230 260 277 1,76% 0,25 1,00 0,4441536 17 541 212 0 76,90% 64,20% 56,30% 83,70% BLA 2017 q3 0 0 0 0 0 0 0 0 39 146 210 248 271 284 q4 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 q1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 2 q2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 3 2018 q3 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 4 q4 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 2 5 q1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 3 6 q2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2 4 7 2019 q3 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 3 6 8 q4 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 5 7 9 q1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 q2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 q3 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 q4 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Source: Own Construction The values at the end of each phase have been calculated as the max of 0 and the exercise price less the strike price multiplied with the technological risk. The 0 in the top right corner can be calculated as MAX (0, (0-1.102.600)*76,9%) = 0 here the exercise price is zero because BAVA cannot save any cost after the BLA approval (a partner will pay for the commercialization). Moving to the left and phase 3 – if BAVA experience bad phase 3 result they can choose not to apply for BLA and thereby save approx. 17 DKK million. From the results above it is clear that this option has almost no value because the savings are quite small. If we, on the other hand, stop the RSV project in phase 2 we can save the large phase 3 costs. At the end of phase 2, BAVA can choose to exercise the option, it would be a good idea to exercise the option if they are in one of the six lower nodes (at the end of phase two). The calculation for the 284 DKK million follows: Max (0, (540-36)*56,30%) = 284. Since we are valuing a European real option it can only be exercised at the end of the period, therefore the values to the left of q2 in 2016 are not that relevant - they are only relevant if their discounted value is larger than the value of the next abandonment option. This is the case for the value in q2 2014 phase 1: The exercise price less the strike price multiplied with the tech. risk is a negative number indicating that the option (Option 1) has no value (calculations not shown). Even though Option 1 has no value we still need to find the final value of the abandonment option, this is done by discounting the values from the previous option. For instance, in 2014 quarter 1 the value of 128 can be calculated as the 54 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 discounted value of the two previous up and down values: ((121*0,44415+178*(1-0,44415))/1,0041)*83,7% = 128 The RO value of the sequential abandonment option is estimated to 40,06 DKK million. The value of the real option should be added to the static NPV in order to include flexibility. RSV is an uncertain project and this uncertainty adds value to the final value. In contrast, we saw the abandonment option for PROSTVAC had no real option value, this was because the project was in a late stage development and no significant cost could be saved. The extra value from the option may change management decisions if they were uncertain about whether to continue or discontinue the RSV project. Binomial Tree 3: Managers can use the results from the second binomial tree to make decisions; if the value of the abandonment option is positive then the option should be exercised. From the third binomial tree it can be seen that the abandonment option should be exercised in the six most pessimistic outcomes when going from phase 2 to phase 3 and the option should also be exercised in the four most pessimistic outcomes of phase 3. Figure 13: Step 5 - Binomial Tree 3 - Management Actions for RSV STEP 5: BINOMIAL TREE 3 - MANAGEMENT ACTIONS FOR RSV Phase 1 2013 q1 q2 q3 q4 q1 Phase 2 2015 2014 q2 q3 hold hold hold hold hold hold q4 q1 q2 Phase 3 q3 q4 q1 2016 q2 hold hold hold hold hold hold hold hold abandon abandon abandon abandon abandon abandon Source: Own Construction 55 BLA 2017 q3 q4 q1 q2 2018 q3 q4 q1 q2 q3 hold hold hold hold hold hold hold hold hold hold hold hold hold hold hold hold hold hold hold abandon abandon abandon abandon 2019 q4 q1 q2 q3 q4 hold hold hold hold hold hold hold hold hold hold hold hold hold hold hold hold hold hold hold hold hold hold hold hold hold hold hold hold hold Expanded net present value of RSV The value from the traditional NPV with technological uncertainties was -4,81 DKK million and the value of flexibility from the abandonment options increases this value with 40,06 DKK million. The extended net present value (eNPV) for RSV the 31st of December 2012 was -4,81 + 40,06 = 35,25 DKK million. If the managers at BAVA had their doubts about whether to continue the development of RSV or not, the extra RO value may change the no-go decision to a go decision. The value of flexibility adds significant value to the RSV project. 8. 5 Step 6: Sensitivity Analysis Compared to PROSTVAC, RSV does have a RO value, the value is not large but it adds extra value to the project. Since the development of RSV will take another 7 years, managers may be very interested in a sensitivity analysis. The analysis will tell managers what will happen to the RO value if one of the variables changes. Managers should try to hedge against negative changes and improve the possibility of positive changes. In order to identify which variables have the largest impact on the RO value, a tornado diagram has been constructed (see below figure). From the tornado diagram, it can be seen that there are three variables which have a large effect on the RO value. These variables are phase 3 costs, project volatility and the underlying value of the asset (strike price). A +/- 25% change in the volatility will increase uncertainty and thereby the RO value. A 25% increase in the volatility will increase the RO value to 63,56 DKK million. A limit to the sensitivity analysis is that it does not show where the change in a variables stems from. A change in the volatility may come from a change in the market growth in the static NPV (a scenario analysis could have solved this problem). The technological risk is not relevant for phase 3 and BLA because the options corresponding to the risk have no value, whereas the risk for phase 2 can change the RO value. 56 Figure 14: Tornado Diagram over Input Variables for RO Calculation Source: Own construction Based on the above, it is clear that there are 3 drivers for the RO value. In order to see how two of these variables impact on each other and the RO value, a two factor sensitivity analysis has been constructed. The two variables used in the analysis are the volatility and the strike price. It is expected that the highest RO value will come from a +25 increase in volatility and a 25% decrease in the strike price. From the figure below it is clear that this is the case and the RO value has almost doubled now the RO value is 80,16 DKK million. The bold numbers in the figure illustrate that the RO values are based on the value of two options. Before, only option 2 had a value. Now when the volatility increases and the strike price decrease, option 1, begin to have RO value. Therefore the RO value of 80,16 DKK million are based on the value of option 1 (3,01 DKK million) and option 2 (77,15 DKK million). In the upper left corner the lowest RO values are shown, these values are based on a low volatility and a high strike price. The lowest RO value, from changes of +/- 25% in the two variables, is 11,47 DKK million. Even though the RO value is low, it still add extra value to the project and the eNPV will still be positive, indicating that mangers should continue the project. 57 Figure 15: Step 6 - Sensitivity Analysis: Strike Price and Project Volatility Two-factor model: Volatility & Strike price (percentage change) -25% -20% -15% -10% -5% 38,78% 41,37% 43,95% 46,54% 49,12% 11,47 14,74 18,02 21,3 24,57 12,94 16,16 19,38 22,61 25,83 14,41 17,57 20,75 23,92 27,09 15,88 18,99 22,11 25,23 28,43 17,35 20,41 23,47 26,99 31,88 18,82 21,82 25,75 30,55 35,32 20,28 24,7 29,41 34,1 38,77 23,86 48,47 33,08 37,66 42,21 27,74 32,25 36,74 41,21 45,66 31,63 36,02 40,41 44,77 49,1 35,51 39,8 44,07 48,32 52,55 0 51,71% 27,84 29,04 30,25 33,4 36,73 40,06 43,4 46,73 50,07 53,4 56,74 5% 54,30% 31,09 32,24 35,09 38,32 41,54 44,77 48 51,22 54,45 57,67 61,54 10% 56,88% 34,33 36,96 40,08 43,2 46,31 49,43 52,55 55,67 58,87 62,56 66,25 15% 59,47% 38,99 42 45,01 48,03 51,04 54,05 57,06 60,24 63,8 67,37 70,93 20% 62,05% 44,08 46,99 49,9 52,8 55,71 58,62 61,8 65,24 68,68 72,12 75,57 25% 64,64% 49,11 51,92 54,72 57,52 60,33 63,56 66,88 70,2 73,52 76,84 80,16 Volatility/S_0 1281,101 1229,857 1178,613 1127,369 1076,125 1025 973,6366 922,3926 871,1486 819,9045 768,6605 25% 20% 15% 10% 5% 0 -5% -10% -15% -20% -25% Source: Own Construction 9. Share Price The eNPV values of PROSTVAC and RSV revealed an important difference in the two projects; PROSTVAC had no RO value whereas RSV had. This difference stems largely from the fact that RSV can be discontinued before the initiation of phase 3 wherefore a significant amount can be saved. The eNPV value of PROSTVAC was estimated to 956 DKK million. Since it is assumed that PROSTVAC constitutes 45% of the total share price (appendix 2), the value of PROSTVAC is 36,64 DKK per share. The calculation: PROSTAVC eNPV divided by number of shares (956 DKK million/26,094361 million shares). The total share price for BAVA, based on PROSTVAC will then be 81,41 DKK/share which is quite close to Jyske Bank’s target share price of 80 DKK/Share. Many investment companies do not value projects in early stage development because the cumulative probability of success is very low. Despite the low probability of success, RSV still had a positive eNPV which should increase BAVAs share price. RSV had eNPV of 35,25 DKK million and that should increase the share price with 1,35 DKK/share. If investor acknowledge this extra value, BAVAs share price should be 82,76 DKK/share, if not, then the share price based solely on PROSTVAC was 81,41 DKK/share. On the 31st of December 2012, BAVAs shares were selling for 49,80 DKK/share, this is a large difference between the actual share price and the 58 estimated share price. One reason for this difference may be that investors are risk averse which means that investors prefer safe investments. 10. Conclusion In many companies, the traditional NPV approach is often applied as a decision making tool. However, the traditional NPV approach fails to incorporate the value of uncertainty wherefore it is suggested to apply the eNPV as a decision making tool. This tool, can with advantage, be applied for projects that go through different phases of development. In order to increase the use of real options as a part of the eNPV, a six-step model is developed and tested on two specific projects from Bavarian Nordic. The first three steps in the model are concerned with the inputs needed for the traditional NPV calculation. The last three steps are concerned with the calculation of real options. The selected cases were those of PROSTAVC and RSV, two vaccine candidates developed by Bavarian Nordic. The vaccine candidates were selected because they are in different phases of development. PROSTVAC, a vaccine treatment for late stage prostate cancer, showed promising prospects. The market for PROSTAVC is large and PROSTVAC is a superior product compared to its competitors. The probability of entering the market is high because it is in late phase development. The static NPV was estimated to 956 DKK million. Since PROSTVAC is yet to be approved by the FDA, uncertainties are still relevant. The project volatility was estimated to 55,8% based on management estimates. The high project volatility did however not influence the real option value, which was 0. The low RO value was expected because PROSTVAC is quite close to market approval and no significant cost can be saved. The eNPV for PROSTVAC was therefore the same as the traditional NPV. 59 BAVA is developing a vaccine treatment against respiratory syncytial virus, the vaccine is in early phase development and the project is very uncertain. Not a lot of information is available on RSV wherefore the generic industry variables form the basis for the NPV calculation. If RSV receives FDA approval, an attractive market with no competitors is waiting. The future development of RSV depends on the financial resources of BAVA. BAVA lacks financial resources and BAVA is seeking partners for both PROSTVAC and RSV, but so far no partner agreement has been agreed upon. The consequence of this, might be that the development of RSV will be postponed. The NPV for RSV was -4,81 DKK million suggesting that managers should discontinue the development. The value of the sequential abandonment option was 40,06 DKK million and the eNPV, from the six-step approach, was therefore 35,25 DKK million suggesting that managers should, in fact, continue the development of RSV. From the binomial tree on management actions it can be seen that in some circumstances before phase 3 development, it could be beneficial to exercise RSVs abandonment option. RSVs higher RO adds value to the share price. The share price based on the eNPVs of PROSTVAC and RSV is estimated to 82,76 DKK/share the 31st of December 2012. From this estimate PROSTVAC contributes with 36,64 DKK/share and RSV contributes with 1,35 DKK/share. 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About ZYTIGA© Retrieved 28/10, 2012, from http://www.zytiga.com/about_zytiga/ 64 APPENDIX Appendix 1: Abbreviations Appendix 2: Mail Correspondence with Frank Andersen Appendix 3: PROSTVAC – Static NPV Appendix 4: PROSTVAC – NPV no tech. risk and R&D cost Appendix 5: PROSTVAC – Tornado diagram Appendix 6: PROSTVAC – Management estimates Appendix 7: PROSTVAC – Spreadsheet for Monte Carlo simulation and project volatility Appendix 8: PROSTVAC – Tornado diagram and sensitivity analysis Appendix 9: RSV – Static NPV Appendix 10: RSV – NPV no tech. risk and no R&D cost Appendix 11: RSV – Tornado diagram Appendix 12: RSV – Management estimates Appendix 13: RSV – Spreadsheet for Monte Carlo simulation Appendix 1: Abbreviations BAVA: Bavarian Nordic A/S BCG: Boston Consulting Group BLA: Biologic License Application CAPM: Capital Asset Pricing Model DCF: Discounted Cash Flow eNPV: Expanded Net Present Value FDA: Food and Drug Administration (USA) EMEA: European Medicine Controls Agency IND: Investigational New Drug IP: Intellectual Property LRT: Lower Respiratory Tract NCI: National Cancer Institute NPV: Net Present Value MAD: Market Asset Disclaimer MVA-BN Modified Vaccina Ankara – Bavarian Nordic PEST: Analysis Political, Economic, Socio-cultural and Technological PV: Present Value R&D: Research and Development RO: Real Options ROA: Real Options Analysis RSV: Respiratory Syncytial Virus SWOT: Strengths, Weakness, Opportunities, Threats WACC: Weighted Average Cost of Capital Appendix 2: Mail correspondence with Frank Andersen Hej Anne Vores kursmål er vægtet af dels vores fair DCF værdi og dels et nyhedsrelateret element. Derfor er vores kursmål lavere end fair DCF værdi. Vi estimerer, at Prostvac udgør 45% af værdien. Venlig hilsen Frank Hørning Andersen Senior aktieanalytiker Analyse T +45 89 89 70 31 Vestergade 8 - 16 | 8600 Silkeborg CVR-nr. 17 61 66 17 Tag din økonomi med på farten - hent Jyske Mobilbank Fra: anne nielsen [mailto:[email protected]] Sendt: 11. december 2012 11:06 Til: Frank Hørning Andersen Emne: SV: Bavarian Nordic - info til speciale? Hej Frank, Mange tak for svar! Jeg har lige et tillægsspørgsmål jeg også håber at du vil svare på: Jeres kursmål for Bavarian Nordic er 80kr - hvor mange procent vil du mene Prostvac udgør af dette kursmål? (fra uofficielle kilder har jeg hørt at Prostvac udgør omkring 60% af aktiekursen, men synes det lyder lidt højt) Venlig hilsen Anne Fra: Frank Hørning Andersen <[email protected]> Til: 'anne nielsen' <[email protected]> Sendt: 14:16 mandag den 10. december 2012 Emne: SV: Bavarian Nordic - info til speciale? Hej Anne Fair DCF værdi på DKK 122 per aktie Værdi Prostvac DKK 55 per aktie Værdi IMVAMUNE DKK 50 per aktie Net cash DKK 17 per aktie Venlig hilsen Frank Hørning Andersen Senior aktieanalytiker Analyse T +45 89 89 70 31 Vestergade 8 - 16 | 8600 Silkeborg CVR-nr. 17 61 66 17 Tag din økonomi med på farten - hent Jyske Mobilbank Fra: anne nielsen [mailto:[email protected]] Sendt: 5. december 2012 19:38 Til: Frank Hørning Andersen Emne: Bavarian Nordic - info til speciale? Kære Frank, Mit navn er Anne og til daglig studere jeg Cand. Merc. in Finance & International Business på Handelshøjskolen i Aarhus. Jeg er i gang med at skrive speciale om real options og Bavarian Nordic. Mere konkret laver jeg en real options analyse af et par af deres assets. I den forbindelse vil jeg høre om du kan komme med et estimat af hvor meget PROSTVAC og (evt. MVA-BN RSV) udgør af en samlet værdiansættelse for Bavarian Nordic? Såfremt det ønskes kan estimaterne holdes fortrolige. Jeg ser frem til dit svar og hvis du har brug for mere information eller andet, må du endelig skrive tilbage. Med venlig hilsen Anne Nielsen Tlf: 28 49 83 58 E-mail: [email protected] Appendix 3: PROSTVAC – Static NPV STEP 3: FORECAST OF PROSTVAC Input variables WACC Tax rate 1US$ equals (exchange rate 31/12-2012) Phase 3 costs USD million (for 5 years) BLA cost USD million DKK USD USD 7,90% 25% 5,62 150,00 DKK 3,00 DKK t=time Year Phase 0 2012 843,73 16,87 1 2013 2 2014 3 3 2015 4 2016 BLA 5 2017 6 2018 7 2019 8 2020 9 2021 10 11 2022 2023 MARKET 12 2024 13 2025 14 2026 15 2027 16 2028 17 2029 18 2030 19 2031 20 2032 21 22 2033 2034 MARKET (no patent) 23 2035 24 2036 25 2037 26 2038 Probability of succes Culmulative probability 100,00% 100,00% 100% 100,00% 100% 100,00% 64,20% 64,20% 81,60% 52,39% 100% 52,39% 100% 52,39% 100% 52,39% 100% 52,39% 100% 52,39% 100% 52,39% 100% 52,39% 100% 52,39% 100% 52,39% 100% 52,39% 100% 52,39% 100% 52,39% 100% 52,39% 100% 52,39% 100% 52,39% 100% 52,39% 100% 52,39% 100% 52,39% 100% 52,39% 100% 52,39% 100% 52,39% Yearly number of people diagnosed with prostate cancer Growth (2%) People suitable for treatment (13,97%) 780.000 2% 14% 795.600 2% 14% 811.512 2% 14% 827.742 2% 14% 844.297 2% 14% 861.183 2% 14% 878.407 2% 14% 895.975 2% 14% 913.894 2% 14% 932.172 2% 14% 950.816 2% 14% 969.832 2% 14% 989.229 2% 14% 1.009.013 2% 14% 1.029.193 2% 14% 1.049.777 2% 14% 1.070.773 2% 14% 1.092.188 2% 14% 1.114.032 2% 14% 1.136.313 2% 14% 1.159.039 2% 14% 1.182.220 2% 14% 1.205.864 2% 14% 1.229.981 2% 14% 1.254.581 2% 14% 1.279.673 2% 14% 0 0 0 0 35% 5% 35% 19% 35% 36% 35% 51% 35% 64% 35% 75% 35% 84% 35% 91% 35% 96% 35% 99% 35% 100% 35% 100% 35% 99% 35% 97% 35% 95% 35% 72% 35% 53% 35% 37% 35% 24% 35% 13% 35% 6% 35% 1% 0,08 2% 0,08 2% 0,08 2% 0,08 2% 0,08 2% 0,09 2% 0,09 2% 0,09 2% 0,09 2% 0,09 2% 0,10 2% 0,10 2% 0,10 2% 0,10 2% 0,10 2% 0,11 2% 0,11 2% 0,11 2% 0,11 2% 0,11 2% 0,12 2% 0,12 2% BAVA market share Penetration Price (DKK million) Price inflation (%) Revenue (DKK million) 161 638 1.257 1.853 2.420 2.950 3.438 3.875 4.253 4.563 4.795 4.989 5.138 5.238 5.337 4.208 3.223 2.341 1.580 890 427 74 Royalty share % of revenue Royalty (DKK million) Cost (phase 3 and BLA) (DKK million) 15% 24 15% 96 15% 189 15% 278 15% 363 15% 443 15% 516 15% 581 15% 638 15% 684 15% 719 15% 748 15% 771 15% 786 15% 801 15% 631 15% 483 15% 351 15% 237 15% 134 15% 64 15% 11 0 202 202 17 EBIT (DKK million) 0 -202 -202 -17 24 96 189 278 363 443 516 581 638 684 719 748 771 786 801 631 483 351 237 134 64 11 Tax (25%) (DKK million) 0 -51 -51 -4 6 24 47 69 91 111 129 145 159 171 180 187 193 196 200 158 121 88 59 33 16 3 NOPLAT (DKK million) NOPLAT probability weighted (DKK million) 0 0 -152 -152 -152 -152 -13 -8 18 10 72 38 141 74 208 109 272 143 332 174 387 203 436 228 478 251 513 269 539 283 561 294 578 303 589 309 600 315 473 248 363 190 263 138 178 93 100 52 48 25 8 4 0 -130 -121 -6 7 24 44 59 72 81 88 92 93 93 90 87 83 79 74 54 38 26 16 8 4 1 Present value probability weigthed (DKK million) Probability weigthed NPV p.31/12-2012 (DKK million) 956 Appendix 4: PROSTVAC – NPV no tech. risk and R&D cost Input variables WACC Tax rate 1US$ equals (exchange rate 31/12-2012) Phase 3 costs USD million (for 5 years) BLA cost USD million t=time Year Phase 7,90% 25% DKK 5,62 USD 150,00 DKK 843,73 USD 3,00 DKK 16,87 0 2012 Yearly number of people diagnosed with prostate cancer Growth (2%) People suitable for treatment (10%) BAVA market share Penetration 1 2013 2 2014 3 3 2015 4 2016 BLA 5 2017 EBIT (DKK million) Tax (25%) (DKK million) NOPLAT (DKK million) Present value (DKK million) NPV 31/12-2012 (DKK million) 2.666 8 2020 9 2021 10 2022 11 2023 MARKET 12 2024 13 2025 14 2026 15 2027 16 2028 17 2029 18 2030 19 2031 20 2032 21 22 2033 2034 MARKET (no patent) 23 2035 24 2036 25 2037 26 2038 795.600 2% 14% 811.512 2% 14% 827.742 2% 14% 844.297 2% 14% 861.183 2% 14% 878.407 2% 14% 895.975 2% 14% 913.894 2% 14% 932.172 2% 14% 950.816 2% 14% 969.832 2% 14% 989.229 2% 14% 1.009.013 2% 14% 1.029.193 2% 14% 1.049.777 2% 14% 1.070.773 2% 14% 1.092.188 2% 14% 1.114.032 2% 14% 1.136.313 2% 14% 1.159.039 2% 14% 1.182.220 2% 14% 1.205.864 2% 14% 1.229.981 2% 14% 1.254.581 2% 14% 1.279.673 2% 14% 0 0 0 0 35% 5% 35% 19% 35% 36% 35% 51% 35% 64% 35% 75% 35% 84% 35% 91% 35% 96% 35% 99% 35% 100% 35% 100% 35% 99% 35% 97% 35% 95% 35% 72% 35% 53% 35% 37% 35% 24% 35% 13% 35% 6% 35% 1% 0,09 2% 0,09 2% 0,09 2% 0,10 2% 0,10 2% 0,10 2% 0,10 2% 0,10 2% 0,11 2% 0,11 2% 0,11 2% 0,11 2% 0,11 2% 0,12 2% 0,12 2% 0,12 2% 0,12 2% 0,13 2% 0,13 2% 0,13 2% 0,13 2% 0,14 2% 0 Royalty share % of revenue Royalty (DKK million) 7 2019 780.000 2% 14% Price per treatment (DKK million) Price inflation (%) Revenue (DKK million) 6 2018 0 0 0 186 734 1.448 2.134 2.786 3.397 3.958 4.461 4.896 5.253 5.521 5.744 5.916 6.031 6.145 4.846 3.711 2.695 1.819 1.025 492 85 15% 28 15% 110 15% 217 15% 320 15% 418 15% 510 15% 594 15% 669 15% 734 15% 788 15% 828 15% 862 15% 887 15% 905 15% 922 15% 727 15% 557 15% 404 15% 273 15% 154 15% 74 15% 13 28 110 217 320 418 510 594 669 734 788 828 862 887 905 922 727 557 404 273 154 74 13 7 28 54 80 104 127 148 167 184 197 207 215 222 226 230 182 139 101 68 38 18 3 21 83 163 240 313 382 445 502 551 591 621 646 666 678 691 545 417 303 205 115 55 10 14 52 96 131 158 179 193 202 205 204 199 191 183 173 163 119 85 57 36 19 8 1 Appendix 5: PROSTVAC – Tornado diagram PROSTVAC; TORNADO DIAGRAM - UNCERTAIN VARIABLES Input PV -25% Base case PV 25% Growth 880 956 1.036 BAVA Market Share 652 956 1.259 Price 652 956 1.259 Royalty 652 956 1.259 People Suitable for Treatment 652 956 1.259 Appendix 6: PROSTVAC – Management Estimates 0 2012 MANAGEMENT ESTIMATES FOR UNCERTAIN VARIABLES 1 2013 2 2014 3 2015 4 2016 5 2017 6 2018 7 2019 8 2020 9 2021 10 2022 11 2023 12 2024 13 2025 14 2026 15 2027 16 2028 17 2029 18 2030 19 2031 20 2032 21 2033 22 2034 23 2035 24 2036 25 2037 26 2038 780.000 795.600 408.000 811.512 416.160 827.742 424.483 844.297 432.973 861.183 441.632 878.407 450.465 895.975 459.474 913.894 468.664 932.172 478.037 950.816 487.598 969.832 497.350 13,97% 5,00% 13,97% 5,00% 13,97% 5,00% 13,97% 5,00% 13,97% 5,00% 13,97% 5,00% 13,97% 5,00% 13,97% 5,00% 13,97% 5,00% 13,97% 5,00% 13,97% 5,00% 13,97% 5,00% 13,97% 5,00% 13,97% 5,00% 13,97% 5,00% 13,97% 5,00% 13,97% 5,00% 13,97% 5,00% 13,97% 5,00% 13,97% 5,00% 13,97% 5,00% 13,97% 5,00% 13,97% 5,00% 13,97% 5,00% 13,97% 5,00% 15% 15% 5% 15% 5% 15% 5% 15% 5% 15% 5% 15% 5% 15% 5% 15% 5% 15% 5% 15% 5% 15% 5% 15% 5% 15% 5% 15% 5% 15% 5% 15% 5% 15% 5% 15% 5% 15% 5% 15% 5% 15% 5% 0,09 0,09 0,05 0,09 0,05 0,10 0,05 0,10 0,05 0,10 0,05 0,10 0,05 0,10 0,05 0,11 0,05 0,11 0,05 0,11 0,05 0,11 0,06 0,11 0,06 0,12 0,06 0,12 0,06 0,12 0,06 0,12 0,06 0,13 0,06 0,13 0,06 0,13 0,07 0,13 0,07 0,14 0,07 35% 5% 35% 5% 35% 5% 35% 5% 35% 5% 35% 5% 35% 5% 35% 5% 35% 5% 35% 5% 35% 5% 35% 5% 35% 5% 35% 5% 35% 5% 35% 5% 35% 5% 35% 5% 35% 5% 35% 5% 35% 5% 35% 5% # of people with prostate cancer Input Growth (%) Base Case Lower estimate (95% confidence) 2% 780.000 400.000 Data Base case Lower estimate Result Volatility based on lower estimate (%) Absolute volatility 989.229 1.009.013 1.029.193 1.049.777 1.070.773 1.092.188 1.114.032 1.136.313 1.159.039 1.182.220 1.205.864 1.229.981 1.254.581 1.279.673 507.297 517.443 527.792 538.347 549.114 560.097 571.298 582.724 594.379 606.267 618.392 630.760 643.375 656.242 8,73% 68.132 People suitable for treatment Input Growth (%) Base case Lower estimate 0% 13,97% 5,00% Data Base case Lower estimate 13,97% Result Volatility based on lower estimate (%) Absolute volatility 10,08% 1,41% Royalty Input Growth (%) Base case Lower estimate 0,00% 15% 5% Data Base case Lower estimate 15% 5% Result Volatility based on lower estimate (%) Absolute volatility 54,93% 8,24% Price Input Growth (%) Base case Lower estimate 2% 0,09 0,045 Data Base Case Lower estimate Result Volatility based on lower estimate (%) Absolute volatility 9,77% 0,0088 Market share Input Growth (%) Base case Lower estimate Data Base case Lower estimate Result Volatility based on lower estimate Absolute volatility 0 35% 5% 35% 19,08% 0,0668 35% 5% 35% 5% 35% 5% Appendix 7: PROSTVAC – Spreadsheet for Monte Carlo Simulation and Project Volatility Input variables WACC Tax rate 1US$ equals (exchange rate 31/12-2012) Phase 3 costs USD million (for 5 years) BLA cost USD million t=time Year Phase DKK USD USD 7,90% 25% 5,62 150,00 DKK 3,00 DKK 0 2012 Probability of succes Culmulative probability Yearly number of people diagnosed with prostate cancer Growth (2%) People suitable for treatment (13,97%) BAVA market share Penetration 843,73 16,87 1 2013 2 2014 3 3 2015 4 2016 BLA 5 2017 6 2018 7 2019 8 2020 9 2021 10 2022 11 2023 MARKET 12 2024 13 2025 14 2026 15 2027 16 2028 17 2029 18 2030 19 2031 20 2032 21 22 2033 2034 MARKET (no patent) 23 2035 24 2036 25 2037 26 2038 100% 100% 100% 100% 100% 100% 64,20% 64,20% 81,60% 52,39% 100% 52,39% 100% 52,39% 100% 52,39% 100% 52,39% 100% 52,39% 100% 52,39% 100% 52,39% 100% 52,39% 100% 52,39% 100% 52,39% 100% 52,39% 100% 52,39% 100% 52,39% 100% 52,39% 100% 52,39% 100% 52,39% 100% 52,39% 100% 52,39% 100% 52,39% 100% 52,39% 100% 52,39% 780.000 2% 14% 795.600 2% 14% 811.512 2% 14% 827.742 2% 14% 944.297 2% 14% 861.183 2% 14% 878.407 2% 14% 895.975 2% 14% 913.894 2% 14% 932.172 2% 14% 950.816 2% 14% 969.832 2% 14% 989.229 2% 14% 1.009.013 2% 14% 1.029.193 2% 14% 1.049.777 2% 14% 1.070.773 2% 14% 1.092.188 2% 14% 1.114.032 2% 14% 1.136.313 2% 14% 1.159.039 2% 14% 1.182.220 2% 14% 1.205.864 2% 14% 1.229.981 2% 14% 1.254.581 2% 14% 1.279.673 2% 14% 0 0 0 0 35% 5% 35% 19% 35% 36% 35% 51% 35% 64% 35% 75% 35% 84% 35% 91% 35% 96% 35% 99% 35% 100% 35% 100% 35% 99% 35% 97% 35% 95% 35% 72% 35% 53% 35% 37% 35% 24% 35% 13% 35% 6% 35% 1% 0,1185 2% Price (DKK million) Price inflation (%) 0,0782 2% 0,0797 2% 0,0813 2% 0,0829 2% 0,0846 2% 0,0863 2% 0,088 2% 0,0898 2% 0,0916 2% 0,0934 2% 0,0953 2% 0,0972 2% 0,0991 2% 0,1011 2% 0,1031 2% 0,1052 2% 0,1073 2% 0,1094 2% 0,116 2% 0,1139 2% 0,1161 2% Revenue (DKK million) 161 713 1.257 1.852 2.419 2.950 3.437 3.875 4.253 4.562 4.796 4.989 5.137 5.237 5.335 4.208 3.223 2.340 1.641 890 427 74 Royalty share % of revenue Royalty (DKK million) Cost (phase 3 and BLA) (DKK million) 15% 24 15% 107 15% 189 15% 278 15% 363 15% 443 15% 515 15% 581 15% 638 15% 684 15% 719 15% 748 15% 770 15% 786 15% 800 15% 631 15% 483 15% 351 15% 246 15% 134 15% 64 15% 11 0 202 202 17 EBIT (DKK million) 0 -202 -202 -17 24 107 189 278 363 443 515 581 638 684 719 748 770 786 800 631 483 351 246 134 64 11 Tax (25%) (DKK million) 0 -51 -51 -4 6 27 47 69 91 111 129 145 159 171 180 187 193 196 200 158 121 88 62 33 16 3 NOPLAT (DKK million) NOPLAT probability weighted (DKK million) 0 0 0 0 0 0 0 0 18 10 80 42 141 74 208 109 272 143 332 174 387 203 436 228 478 251 513 269 540 283 561 294 578 303 589 309 600 314 473 248 363 190 263 138 185 97 100 52 48 25 8 4 7 7 27 29 44 47 59 64 72 78 81 88 88 95 92 99 93 101 93 100 90 97 87 94 83 90 79 85 74 80 54 58 38 42 26 28 17 18 8 9 4 4 1 1 PV t=0 PV t=1 NPV 31/12-2012 NPV 31/12-2013 1.216 1.312 z (return) 7,60% Appendix 8: PROSTVAC – Tornado Diagram and Sensitivity Analysis Tornado Diagram over RO Input Variables RO Value -25% Base S_0 0 0 Volatility 0 0 Risk free rate 0 0 Tech risk phase 3 0 0 Tech risk BLA 0 0 25% 0 0 0 0 0 Two-factor model: Volatility & Strike price (percentage change) -25% -20% -15% -10% Volatility/S_0 41,85% 44,64% 47,43% 50,22% -25% 2000 0 0 0 0 -20% 2133 0 0 0 0 -15% 2266 0 0 0 0 -10% 2399 0 0 0 0 -5% 2533 0 0 0 0 0% 2666 0 0 0 0 5% 2799 0 0 0 0 10% 2933 0 0 0 0 15% 3066 0 0 0 0 20% 3199 0 0 0 0 25% 3333 0 0 0 0 -5% 53,01% 0 0 0 0 0 0 0 0 0 0 0 0 55,80% 0 0 0 0 0 0 0 0 0 0 0 5% 58,59% 0 0 0 0 0 0 0 0 0 0 0 10% 61,38% 0 0 0 0 0 0 0 0 0 0 0 15% 64,17% 0 0 0 0 0 0 0 0 0 0 0 20% 66,96% 0 0 0 0 0 0 0 0 0 0 0 25% 69,75% 0 0 0 0 0 0 0 0 0 0 0 Appendix 9: RSV – Static NPV STEP 3: FORECAST FOR RSV Phases Preclinical phase 1 phase 2 phase 3 BLA Cost (mill USD) Cost (DKK mill) Exchange rate 59,9 336,93 5,62 32,2 181,12 Tax rate 37,7 212,06 25% 96,1 540,55 WACC 3 16,87 7,90% Time Year phase tech risk Cul. Probability 0 2012 RSV market (DKK mill) Market growth (%) Market share (%) Penetration Revenue Royalty (%) Royalty (DKK mill) 1 100% 100% 2 83,7% 83,7% 100% 83,7% 56,3% 47,1% 100% 47,1% 100% 47,1% 7 2019 BLA 64,20% 30,3% 4.935 3,30% 0% 5.098 3,30% 0% 5.266 3,30% 0% 5.440 3,30% 0% 5.620 3,30% 0% 5.805 3,30% 0% 5.997 3,30% 0% 2013 1 2 2014 3 2015 4 2016 5 2017 3 6 2018 8 2020 9 2021 10 2022 11 2023 12 13 2024 2025 MARKET 100% 100% 23,3% 23,3% 76,90% 23,3% 100% 23,3% 100% 23,3% 100% 23,3% 6.399 3,30% 35% 19% 426 6.610 3,30% 35% 36% 833 6.828 3,30% 35% 51% 1219 7.054 3,30% 35% 64% 1580 14 100% 23,3% 100% 23,3% 100% 23,3% 100% 23,3% 100% 23,3% 100% 23,3% 100% 23,3% 22 23 2034 2035 Market (no patent) 100% 100% 100% 23,3% 23,3% 23,3% 7.287 3,30% 35% 75% 1913 7.527 3,30% 35% 84% 2213 7.775 3,30% 35% 91% 2476 8.032 3,30% 35% 96% 2699 8.297 3,30% 35% 99% 2875 8.571 3,30% 35% 99% 2970 8.854 3,30% 35% 97% 3006 9.146 3,30% 35% 95% 3041 9.448 3,30% 35% 72% 2381 9.759 3,30% 35% 53% 1810 2026 15 2027 16 2028 17 2029 18 2030 19 2031 20 2032 21 2033 24 2036 25 2037 26 2038 27 2039 100% 23,3% 100% 23,3% 100% 23,3% 100% 23,3% 10.081 3,30% 35% 37% 1306 10.414 3,30% 35% 24% 875 10.758 3,30% 35% 13% 489 11.113 3,30% 35% 6% 233 11.480 3,30% 35% 1% 40 0 0 0 0 0 0 0 6.195 3,30% 35% 5% 108 0% 0 0% 0 0% 0 0% 0 0% 0 0% 0 0% 0 15% 16 15% 64 15% 125 15% 183 15% 237 15% 287 15% 332 15% 371 15% 405 15% 431 15% 445 15% 451 15% 456 15% 357 15% 272 15% 196 15% 131 15% 73 15% 35 15% 6 6 Milestone payments R&D Cost 0 106 106 180 180 180 17 EBIT (DKK mill) 0 -106 -106 -180 -180 -180 -17 16 64 125 183 237 287 332 371 405 431 445 451 456 357 272 196 131 73 35 Tax 25% (DKK mill) 0 -27 -27 -45 -45 -45 -4 4 16 31 46 59 72 83 93 101 108 111 113 114 89 68 49 33 18 9 2 NOPLAT (DKK mill) NOPLAT with tech risk (DKK mill) 0 0 -80 -67 -80 -67 -135 -64 -135 -64 -135 -64 -13 -4 12 3 48 11 94 22 137 32 178 41 215 50 249 58 279 65 304 71 323 75 334 78 338 79 342 80 268 62 204 47 147 34 98 23 55 13 26 6 5 1 0 -57 -53 -47 -44 -40 -2 2 6 10 14 17 19 20 21 21 21 20 19 17 13 9 6 4 2 1 0 Pressent value probability weighted NPV 31/12-2012 -4,81 Appendix 10: RSV – NPV no tech. risk and R&D cost Phases Preclinical phase phase 1 phase 2 phase 3 BLA Time Year phase RSV market (DKK mill) Market growth (%) Market share (%) Penetration Revenue Cost (mill USD) Cost (DKK mill) Exchange rate WACC 59,9 336,93 5,62 7,90% 32,2 181,12 37,7 212,06 96,1 540,55 3 16,87 0 2012 4777,05 1 2013 1 2 2014 2 5.098 3,30% 0% 4 2016 5.266 3,30% 0% 5 2017 3 5.440 3,30% 0% 6 2018 5.619 3,30% 0% 7 2019 BLA 5.804 3,30% 0% 8 2020 5.996 3,30% 0% 9 2021 10 2022 11 2023 12 13 2024 2025 MARKET 14 2026 15 2027 16 2028 17 2029 18 2030 19 2031 20 2032 21 2033 22 23 2034 2035 Market (no patent) 24 25 26 27 2036 2037 2038 2039 0 0 0 0 0 0 0 6.194 3,30% 35% 5% 108 0% 0 0% 0 0% 0 0% 0 0% 0 0% 0 0% 0 15% 16,26 15% 63,82 15% 124,92 15% 182,81 15% 236,98 15% 286,87 15% 331,90 15% 371,42 15% 404,76 15% 431,18 15% 445,41 15% 450,81 15% 456,09 15% 357,07 15% 271,52 15% 195,81 15% 131,20 15% 73,41 15% 35,00 15% 6,03 EBIT (DKK mill) 0 0 0 0 0 0 0 16 64 125 183 237 287 332 371 405 431 445 451 456 357 272 196 131 73 35 6 Tax 25% (DKK mill) 0 0 0 0 0 0 0 4 16 31 46 59 72 83 93 101 108 111 113 114 89 68 49 33 18 9 2 NOPLAT (DKK mill) 0 0 0 0 0 0 0 12 48 94 137 178 215 249 279 304 323 334 338 342 268 204 147 98 55 26 5 Pressent value 0 0 0 0 0 0 0 7 24 44 59 71 80 86 89 90 89 85 80 75 54 38 26 16 8 4 1 Royalty (%) Royalty (DKK mill) 4.935 3,30% 0% 3 2015 6.398 3,30% 35% 19% 425 6.609 3,30% 35% 36% 833 6.828 3,30% 35% 51% 1219 7.053 3,30% 35% 64% 1580 7.286 3,30% 35% 75% 1912 7.526 3,30% 35% 84% 2213 7.774 3,30% 35% 91% 2476 8.031 3,30% 35% 96% 2698 8.296 3,30% 35% 99% 2875 8.570 3,30% 35% 99% 2969 8.852 3,30% 35% 97% 3005 9.145 3,30% 35% 95% 3041 9.446 3,30% 35% 72% 2380 9.758 3,30% 35% 53% 1810 10.080 3,30% 35% 37% 1305 10.413 3,30% 35% 24% 875 10.756 3,30% 35% 13% 489 11.111 3,30% 35% 6% 233 11.478 3,30% 35% 1% 40 Milestone payments NPV 31/12-2012 1025 Appendix 11: RSV – Tornado diagram Input PV -25% Base PV +25% Market growth -31,99 -4,81 25,85 Royalty -64,43 -4,81 54,80 Market share -64,43 -4,81 54,80 Appendix 12: RSV – Management Estimates MANAGEMENT ESTIMATES FOR UNCERTAIN VARIABLES 0 2012 1 2013 2 2014 3 2015 4 2016 5 2017 6 2018 7 2019 8 2020 9 2021 10 2022 11 2023 12 2024 13 2025 14 2026 15 2027 16 2028 17 2029 18 2030 19 2031 20 2032 21 2033 22 2034 23 2035 35% 35% 5% 35% 5% 35% 5% 35% 5% 35% 5% 35% 5% 35% 5% 35% 5% 35% 5% 35% 5% 35% 5% 35% 5% 35% 5% 35% 5% 35% 5% 35% 5% 3,30% 0,10% 3,30% 0,10% 3,30% 0,10% 3,30% 0,10% 3,30% 0,10% 3,30% 0,10% 3,30% 0,10% 3,30% 0,10% 3,30% 0,10% 3,30% 0,10% 3,30% 0,10% 3,30% 0,10% 3,30% 0,10% 3,30% 0,10% 3,30% 0,10% 3,30% 0,10% 3,30% 0,10% 15% 15% 3% 15% 3% 15% 3% 15% 3% 15% 3% 15% 3% 15% 3% 15% 3% 15% 3% 15% 3% 15% 3% 15% 3% 15% 3% 15% 3% 15% 3% 15% 3% MARKET SHARE Input Growth Base case Lower estimate (95% confidence) 0% 35% 5% Data Base case Lower estimate Result Volatility based on lower estimate (%) Absolute volatility 24,32% 8,51% MARKET GROWTH Input Growth Base Case Lower estimate 0 3,30% 0,10% Data Base Case Lower estimate (95% confidence) 3,30% Result Volatility based on lower estimate (%) Absolute volatility 3,30% 0,10% 3,30% 0,10% 3,30% 0,10% 3,30% 0,10% 3,30% 0,10% 36,45% 1,20% ROYALTY Input Growth Base case Lower estimate (95% confidence) 0% 15% 3% Data Base case Lower estimate Result Volatility based on lower estimate Absolute volatility 80,47% 12,07% Appendix 13: RSV – Spreadsheet for Monte Carlo Simulation and Project Volatility Phases Preclinical phase 1 phase 2 phase 3 BLA Cost (mill USD) Cost (DKK mill) Exchange rate WACC 59,9 336,93 5,62 7,90% 32,2 181,12 37,7 212,06 96,1 540,55 3 16,87 Time Year phase tech risk Cul. Probability 0 2012 RSV market (DKK mill) Market growth (%) Market share (%) Penetration Revenue Royalty (%) Royalty (DKK mill) 1 2013 1 2 2014 100% 100% 2 83,7% 83,7% 3 2015 4 2016 100% 83,7% 56,3% 47,1% 5 2017 3 100% 47,1% 4.935 3,30% 0% 5.098 3,30% 0% 5.266 3,30% 0% 5.440 3,30% 0% 5.620 3,30% 0% 6 2018 100% 47,1% 7 2019 BLA 64,20% 30,3% 5.805 3,30% 0% 5.997 3,30% 0% 8 2020 9 2021 10 2022 11 2023 12 13 2024 2025 MARKET 100% 100% 23,3% 23,3% 76,90% 23,3% 100% 23,3% 100% 23,3% 100% 23,3% 6.399 3,30% 35% 19% 426 6.610 3,30% 35% 36% 833 6.828 3,30% 35% 51% 1219 7.054 3,30% 35% 64% 1580 14 2026 15 2027 16 2028 17 2029 18 2030 19 2031 20 2032 21 2033 100% 23,3% 100% 23,3% 100% 23,3% 100% 23,3% 100% 23,3% 100% 23,3% 100% 23,3% 22 23 2034 2035 MARKET(no patent) 100% 100% 100% 23,3% 23,3% 23,3% 24 2036 25 2037 26 2038 27 2039 100% 23,3% 100% 23,3% 100% 23,3% 100% 23,3% 7.287 3,30% 35% 75% 1913 7.527 3,30% 35% 84% 2213 7.775 3,30% 35% 91% 2476 8.032 3,30% 35% 96% 2699 8.297 3,30% 35% 99% 2875 8.571 3,30% 35% 99% 2970 8.854 3,30% 35% 97% 3006 9.146 3,30% 35% 95% 3041 9.448 3,30% 35% 72% 2381 9.759 3,30% 35% 53% 1810 10.081 3,30% 35% 37% 1306 10.414 3,30% 35% 24% 875 10.758 3,30% 35% 13% 489 11.113 3,30% 35% 6% 233 11.480 3,30% 35% 1% 40 0 0 0 0 0 0 0 6.195 3,30% 35% 5% 108 0% 0 0% 0 0% 0 0% 0 0% 0 0% 0 0% 0 15% 4 15% 64 15% 125 15% 183 15% 237 15% 287 15% 332 15% 371 15% 405 15% 431 15% 445 15% 451 15% 456 15% 357 15% 272 15% 196 15% 131 15% 73 15% 35 15% 6 Milestone payments R&D Cost 0 106 106 180 180 180 17 EBIT (DKK mill) 0 -106 -106 -180 -180 -180 -17 4 64 125 183 237 287 332 371 405 431 445 451 456 357 272 196 131 73 35 6 Tax 25% (DKK mill) 0 -27 -27 -45 -45 -45 -4 1 16 31 46 59 72 83 93 101 108 111 113 114 89 68 49 33 18 9 2 NOPLAT (DKK mill) NOPLAT with tech risk (DKK mill) 0 0 -80 -67 -80 -67 -135 -64 -135 -64 -135 -64 -13 -4 3 1 48 11 94 22 137 32 178 41 215 50 249 58 279 65 304 71 323 75 334 78 338 79 342 80 268 62 204 47 147 34 98 23 55 13 26 6 5 1 0 0 6 6 10 11 14 15 17 18 19 20 20 22 21 22 21 23 21 22 20 21 19 20 17 19 13 14 9 10 6 6 4 4 2 2 1 1 0 0 PV t = 0 PV t = 1 NPV 31/12-2012 NPV 31/12-2013 237 256 z (return) 7,60%
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