Corporate Development / Corporate Strategy

Corporate development is a necessary instrument to plan and develop the strategy of a company. Mostly, only larger size companies can afford to set aside professionals to form an independent Corporate Development and Strategy department. It should not be underestimated how important strategic planning is even for smaller size organizations. Every bakery shop owner will look around in his street whether there is already another shop that competes with him, before he makes such an investment. He will probably look around and assess the potential customer and their preferences. Will they primarily buy bread with small profit margins or do they prefer selected items such as cakes. Thus, without to much of thinking he is implementing forward-looking planning tools as also used in high-tech corporations to make the most optimal return on investment.

What sounds so simple and self-speaking is in high-tech corporations a very delicate exercise that can lead to painful decisions. Strategy is not only what you want to do, but also to determine what you are not doing! Choice-making is therefore an important requirement to obtain the highest possible gain from different available opportunities. To sustain corporate growth the choice-making process needs to be translated further down to your portfolio strategy, your budget, operational and marketing plans. An independent, external organization as Tytonis is able to do such corporate strategy planning and can guide you as part of your internal corporate team through this process.

Business Development

Business Development is implementing the corporate strategy into operational business. Here, the company gets exposed to the external world in order to communicate, interact and eventually corporate with e.g. other companies, universities, and other institutions. The business manager handles the deal-making process, including due diligence, contract negotiations (e.g. license, alliance, manufacturing, supply and other contractual arrangements), project-planning together with internal R&D functions, etc. Also financing, merger and acquisitions are important activities that belong to this category.

Tytonis and its independent network partners form a strong team that has done this work for many years in different successful companies. We have also the right networks both on the (bio)pharma business and R&D side in place, which is an extremely important factor to liaise successfully with a selected partner.

Licensing / Partnering

Licensing is one of many ways to get ownership to a technology or product by acquiring the part of the intellectual property for which the licensor has obtained an exclusive market position. Usually, this concerns a family of patents. A license is in other words nothing else than a merchandise based on IP matters.

Although, the term »license« is very popular among business executives, there are also other ways that can be attractive in order to participate in the technology or product of another partner. One is to form a risk/benefit sharing alliance in which both parties keep contributing actively to the success of a product. This makes usually sense when two companies have heterogeneous expertise and capabilities that may be needed to develop a successful commercial product. In particular, when two small or midsize companies come together each individual company can focus on its specific expertise and does not need to develop the same skills of the partner company.

Tytonis together with its independent partners can do all the related steps in licensing, including the value assessment, term sheet and license agreement negotiation, freedom-to-operate analysis, etc. The Tytonis team members are real deal-makers and can use all their creativity to respond adequately to the counter party to make a win-win deal happen.

Alliances Management

Once an alliance/joint venture deal has been closed the real work actually starts. Often your partner you are cooperating with has a very different company culture and way of working. This is often not visible during the deal negotiation process since the involved business executives work from a different background than the researchers that have to cooperate on a daily operational level. In this respect some members of the Tytonis network can guide you through different cooperation and communication tools so that the alliance/joint venture remains intact even in difficult situations.

Portfolio Management

Portfolio Management is the most crucial part to achieve with the most predictable degree of certainty your commercial success. What does portfolio management embrace? Essentially, the portfolio analysis leads to a ranking of projects into priority categories. This is a team effort, which should be done with different experts involved. The evaluation process includes the assessment of the medical need, commercial value and development/financial risk. Based on the ranking projects will be planned according to monitoring requirements. Development milestones are defined and the specifications that needs to be achieved to continue the project to the next phase. At the end the combination of projects in the portfolio shall result in a sufficiently high-cumulated probability value. In this case a non-successful project can be timely replaced with a back-up without risking the overall success probability of the company.

Tytonis has members that have the experience to perform such analysis. However, it is often a team effort that involves also the in-house expertise of our partner. We can guide you through this evaluation process so that you get the experience how to react timely to certain threads and unexpected outcomes.

Merger & Acquisitions

Merger & Acquisitions (M&A) often have a crucial impact of both company's organizations. Beside the access to technologies of another company, the human assets play an important role. Often companies have different cultures, especially when a smaller company is acquired by a larger one. The human work-force is a crucial part of the intangible assets which bears the know-how and experience that is only properly documented in the individual brains.

Tytonis has experience beyond the deal-making that can help to provide some advice how the human side can be taken optimal care of. In case of cultural changes we have ourselves external experts that can assist in the set-up of a change-management plan.

Due Diligence

Due Diligence is the evaluation process to assess the current value of a particular product, technology or even a whole business/company. Tytonis and its network partners is capable to conduct the entire evaluation involving the

• Intellectual Property (IP) Diligence including an expert analysis
  on the Freedom To Operate (FTO) position
• Commercial diligence
• Technology/Product Assessment and Valuation
• Contractual Diligence
• Competitive Analysis (SWOT)

Corporate Financing / Venture Capital

Corporate Financing is a service we offer based on experience with venture funds, dept financing and other alternative routes to get monetary funds to your company. We do due diligences for Venture Capital and other investors and vice versa we can support you in discussions with them. In addition we have several means to access US venture funds, in particular due to the presence of our US representative, who also works closely together with a US investment expert.

Valuation

Valuation is the process that leads to a particular commercial assessment that allows to assign a value, e.g. in US$ to it. If you have once sold a car you know that two major factors determine the value:

• the value based on the prize of the individual components of a car,
  e.g. the motor, wheels, an expensive radio, etc., and
• the market value (one model is more preferred than another one)

In other words, the material value and the market are the important factors that need to be evaluated. The latter is often assessed based on benchmarking and retrospective analysis, whereas the material value of a technology or IP-based product is often calculated by net-present values (NPV's), option models, etc. All of these methods, including benchmarking are approximations of the real commercial value of a product that is still in development and has a risk to fail. In this case valuations can be an important tool in the portfolio management even before a product is considered for out-licensing. What product specifications do I need to have a successful valuable product? How much development efforts and costs are justified to balance the financial development risk with the expected revenues? How is the product positioned compared to other competitor products? This later question requires a thorough and diligent SWOT (Strong-Weak-Opportunity-Thread) analysis.

In outlicensing we usually assess the value from the perspective of both the licensee and the licensor. The models we preferably use are based on double-sided, risk adjusted, respectively weight-adjusted NPV's. In addition Monte-Carlo simulation or option-based value models can be used as well.

Marketing / Sales

Marketing is not just taking the phone and promoting your product or technology you wish to partner. Successful and efficient marketing needs to be planned in a tailor-made fashion according to the needs of the product and your company. This involves the preparation of a marketing plan in which all activities are balanced to the available budget to achieve optimal success. It should also not be underestimated the involvement of a good communication expert who can help you that your marketing efforts result in a corporate image that is in line with your corporate identity.

Legal / IP

The business experts in our team have negotiated successfully many different agreements and are capable to lead a negotiation in the best interest of our partner. Moreover, we are supported by a very experienced legal counsel who has worked both in Europe and in the US. Ann-Kathrin Klink has more than 10 year experience in the legal field covering license, manufacturing & supply as well as alliance/joint venture agreements. Together, we can support you in the most optimal way in your contractual needs.

Patents (Filing, Freedom to Operate Analysis, IP Strategy)

In the technology business patents are almost unavoidable. However, the secret of success goes beyond the technicality of writing and filing a patent. Many more questions need get answered first. Is your patent indeed defendable? How is the dependency to other patents, is there freedom-to-operate once you want to exploit the patent? When should you file for a patent and when you should keep your proprietary know-how as a trade secret?

For these and other related questions the expertise within the P@W team we can deliver profound expertise not only in the area of filing and defending patents but can also advise you in the technology assessment and development strategy.

Project Management

Every successful project depends on an experienced manager. In particular when time lines and budgets are tight the experienced project manager can react appropriately in case of unexpected event.

Most of the P@W members have such experience from different synergistic backgrounds and can advise you from the back office, but also can join as a member of your in-house team. We can assist you in setting-up the planning as well as to improve the efficacy of your intended development program in terms of development costs and time by coordinating and implementing the operational activities including supply chains.

Clinical Trial Management

Clinical Trial Management is a costly exercise, once a suitable product has been developed that can be tested in humans. Early on advise, e.g. to assess the financial risk and time lines in the business planning, as well as planning the needed preclinical and toxicology studies before entering the clinical phase can save significant time and money. In this process we can assist in preparing the investigator brochure and also arrange the meeting with regulatory bodies to validate the intended development activities.

Quality Assurance

Quality Assurance becomes relevant as soon as the project moves from the research activity towards development stage. In order to justify the application of a new product in patients the underlying data must be in place following the quality/documentation requirements of the regulatory authorities. An important question in particular for smaller sized companies is: »How much quality regulations do I need to apply at which stage of development«?

Within our network team we have qualified persons and expertise to set-up and monitor the required quality requirements in your organization according to the requirements of your product development plan. Our key philosophy is »as much as needed at the right stage of development« and to avoid by all means an oversized quality management that turns your company in a non-flexible and non-efficient organization.

Regulatory / Registration

Already at an early stage of development of a project, e.g. during the switch from preclinical to clinical phase, regulatory considerations become more and more important. Within the P@W team we have members with profound experience concerning communication and filings with the EMEA, FDA and also the Japanese and Korean regulatory agency. We strongly recommend that regulatory advice should be added early on in the development and business planning process in order to assess - among others - the right territorial filing strategy for your particular product and communicate timely with regulatory agencies together with an experienced person in the field. Moreover, this will allow for optimized budget/time planning of upcoming »go - no go« milestone events and the related assessments for your product portfolio strategy.

Communication Strategy / Corporate Design

How to make your company visible to the external world? This is something that requires a good preparation. As anyone who goes out of the house thinks about his own personal style and clothing each corporation needs to present itself appropriately to achieve the desired image. How much imaging do I need at which time and at which costs? Which media are appropriate for my business?

Since we think that there is no business without the right imaging we have asked Thomas Diller to join our team. His experiences in life-sciences and health care guarantees that he understands your business and can help you proficiently to communicate your corporate messages to the external world.