Asset portfolio valuation of key asian markets
NEED: An emerging pharma client needed to obtain a valuation of its highly important drug candidates in key Asian markets before negotiating a major deal with a top-tier Chinese pharma company.
ASSIGNMENT: Monocl was hired to determine the risk-adjusted net present value for each of the client’s 4 preclinical and clinical assets. The valuation was performed using Monocl’s proprietary valuation software and established methodology for valuation of drug development programs. Firstly, Monocl estimated the incidence for each of the indications in the client’s 6 target product profiles. The incidence was calculated for each Asian country, accounting for each region’s ongoing vaccination programs and level of advancement of the healthcare systems. Secondly, Monocl estimated the probability for each of the assets to reach the market based on a large-scale study of historical data of market approvals within the same disease groups. Thirdly, Monocl forecasted R&D investments as well as future costs of goods and sales to determine profit margins together with the client. Based on the above, Monocl determined today’s aggregated net present value of the total portfolio assuming different timing of market approvals in different regions. The valuation served as foundation for the CEO and company Chair to negotiate a deal with one of the five biggest pharma companies in China.
Business plan development to raise clinical phase III financing
NEED: The CEO of an oncology company needed to attract 100+ MSEK in venture capital to fund its clinical phase II development in a new indication.
ASSIGNMENT: Monocl was brought in to ghost-write a business plan for the company’s new strategic direction to capture the interest of new investors. Market research was conducted in the new oncology indication to describe treatment algorithms, drug utilization patterns, competitive landscapes and patient epidemiology to support the business case. Monocl implemented data from the client’s earlier preclinical and clinical studies, development plans, budget and more to create a plan that was coherent with the company’s past activities. A detailed business plan was delivered to the company board, and was subsequently used to raise the needed capital.
Opportunity assessment and partnering preparation
NEED: A public company wanted to assess its opportunity in inlicensing assets in the immune checkpoint blocker field and wanted to position its cell therapeutic portfolio for partnering its technology with a leading player.
ASSIGNMENT: Monocl identified a number of relevant companies and leading research groups for high-level opportunity assessment. A review was provided of the presented clinical data together with competitive intelligence about each of the candidates and the key opinion leaders. Outcome of the report was used to develop the company’s strategic partnering plan and to create partnering communication material for targeted collaboration efforts at selected conferences. Monocl’s delivery was distributed through conference matchmakers and used to attract licensing partners and investments.
Company repositioning and development of new investment presentation
NEED: The CEO of a clinical phase II company needed to reposition the company’s existing business communication for development in a new indication.
ASSIGNMENT: Monocl led a number of workshops to determine the new strategic direction of the company together with the company management. An extensive communication strategy was developed to communicate the new target product profile along with a new scientific MOA rationale. Monocl established an investment presentation, tailoring it to fit in with the new strategy, upgraded the presentation’s graphical design and visual appearance, and crafted a credible storyline to use along with the investment presentation. Based on the main document, a series of confidential and non-confidential work packages as well as conference partnering folders were developed and delivered, which allowed the CEO and management to spend more time preparing for and initiating investor interactions.
Large scale assessment of the mitochondrial medicine space
NEED: The management of a public pharma company needed a high level opportunity assessment of all mitochondrial disorders.
ASSIGNMENT: Monocl prepared and conducted a workshop to determine the MOAs, targets and organelle components of high client relevance. An opportunity assessment was done on companies, key opinion leaders, orphan drug designations, financial deals and clinical trials to identify potential partners as well as the client’s competitive landscape. A large scale analysis – of reviews and published studies of patient case stories and clinical trials – revealed all molecules previously tested in various mitochondrial disorders together with their clinical results. The company management have subsequently implementented the content of the detailed dossier and executive summary presentation into its business plan, and used the delivery in various discussions with partners and investors.
Business opportunity and indication assessment in the dermatology space
NEED: A clinical stage pharma company needed to assess it business opportunity for its first topical drug.
ASSIGNMENT: Monocl performed a high level indication assessment of two large dermatology indications to determine the client’s strategic fit with current treatment algorithms, physician’s decision trees and prescription patterns on the target markets. Extensive reports were written for each of the indications where drug developing companies along with competitive intelligence about development pipelines, MOAs and recent financial deals were positioned in relation to the client’s envisioned TPP. To verify the strategic fit of the client’s envisioned TPP with the unmet clinical need, interviews were conducted with general physicians at primary wards, dermatologists and patient organizations. Based on the need assessment, competitive landcape and prescription norms, a solid foundation for a business plan could be crafted.
Decision support for developing immune modulation therapeutic
NEED: The CEO of a biotech platform technology company needed to assess the strategic fit of its technology in the complement inhibitor space.
ASSIGNMENT: Monocl was engaged to gather competitive intelligence about inhibitors developed against characterized targets in the immunological cascade to identify development opportunities were the client would have a competitive edge. A shortlist of potential licensees was crafted based on identified drug candidates with technical disadvantages (e.g. short half life, molecule size, cost of goods, etc.) that the client’s technology would be able to address. The CEO presented the outcome to his board and subsequently used it as a foundation for the company’s collaboration strategy in this space.
Opportunity analysis of orphan indications in acute kidney injuries
NEED: A public biotech company wanted to understand the orphan drug designations (ODDs) opportunities that existed in the acute kidney injury (AKI) space.
ASSIGNMENT: Monocl was engaged to provide the management and Board of Directors with a foundation of strategic considerations about orphan designations in the major regions and to scout for the company’s orphan opportunities in the AKI field. Rare diseases as related to kidney diseases and AKI were mapped alongside with competing players holding ODDs in the space. A selection of orphan drug strategies were presented for the selected identified rare diseases together with high-level reported prevalence data in the key region of interest. The outcome was used to prioritize between the identified orphan opportunities and to create a shortlist of those with the highest fit with the company’s business.
Briefing package of allogeneic stem cell company
NEED: The CEO of a stem cell platform company needed to create a briefing package of its offering for investors in its next financing round.
ASSIGNMENT: Monocl was engaged to position the company’s communication strategy, conduct market research to build the business case and to package the information in a comprehensive prospectus. To position the company against other allogeneic and autologous competitors, an envisioned TPP was developed and insights were gathered to build an attractive investment case. Through benchmark studies and client workshops, the foundation was laid out for a credible development and commercial strategy. The project outcome was subsequently used to pitch for private investors and the client is now preparing for a potential initial public offering.
Partner and opportunity analysis for non-antibiotic treatment of infectious disease
NEED: The CEO of an infectious disease company was facing competition from a newly approved antibiotic and needed to better understand the market opportunities and threats of non-antibiotic treatments in its targeted indication.
ASSIGNMENT: Monocl was contracted to identify a potential partner for the client with a strategic fit. A workshop was held with the client to determine partnering strategy and partner characteristics of interest. Potential partners were mapped based on this strategy with interest within the indication or the client’s product type. A large scale opportunity analysis led to a prioritized list of unmet clinical needs that none of the market approved treatments address today. Three of these unmet clinical needs could readily be implemented into the target product profile by modifying the study design of the next clinical trial. To understand the client’s indirect competition, various non-antibiotic alternatives were analyzed based on published study results and ongoing clinical trials. In the end, the client was able to integrate the strategic insights into its plans and start negotiations with a potential partner.
Investment negotiation support to value phase II asset in lung cancer
NEED: The management of an oncology company with an ongoing clinical phase II trial needed an independent valuation base for one of its key assets for a meeting with an interested venture capitalist.
ASSIGNMENT: Monocl conducted strategic workshops with the management and gathered relevant source data to conduct a thorough valuation of the clinical asset.A number of market assumptions were made in consultation with the client and a number of workshop discussions led to consensus around the target TPP to be valued. Based on an extensive epidemiology analysis in the client’s targeted regions (EU28+3, China and the US), a projection of the number of the eligible patients according to the TPP was made. Benchmark analyses were then made to estimate relevant pricing, R&D costs as well as the expected pre-market and market related miscellaneous costs. Overhead costs, of the client’s most likely big pharma partner, were modeled to calculate the most likely net income from royalty payments. Lastly, risk-adjustments were made based on clinical data to estimate the likelihood of approval for the current development stage in the specific indication to model a net present value for the oncology type. To model a likely deal value, 500+ recent oncology deals were analyzed based on client specific characteristics – resulting in estimated ranges for typical upfront payments, milestone amounts (and types) and royalty percentages. The two resulting scenarios were close and helped the CEO convince the venture capitalist about the value of the company’s drug.
Deal support for divestiture of preclinical Hepatitis asset
NEED: The COO of a small pharma company had started to receive licensing term sheets for an asset that Monocl had helped value and was interested in comparing differently structured term sheets based on the valuation.
ASSIGNMENT: Monocl consulted the client about its ideal deal outcome and the type of terms the client was interested in negotiating further. Based on this input, Monocl created a management tool for comparing different term sheets. The model provided negotiation flexibility in how to structure the deal regarding geographies, R&D milestones, commercial achievements, sales targets, etc, with a dynamic re-calculation of the total deal value based on the target patient population. In the end, the client choose the deal partner with the most attractive profile and offer, which turned out to be one of the largest preclinical deals in the area. In addition to scoring a great deal, the model also enabled the company management to perceive its deal strategy in a higher perspective and think more strategically about how much of an asset’s value to capture when deciding to divest anything in its portfolio.