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A big part of basic research that sometimes is overlooked is its translational part. Bringing the knowledge to the society is what will make an impact. Hormonic’s history is just starting, now we have to carry it to its full potential. Here we present the other side of new inventions, the roadmap that we will follow from now on to make Hormonic a reality.

entrepreneurship

Introduction
Hormonic Business Plan
Hormonic Business Model Canvas
References

Introduction

Hormonic’s potential to become a feasible device for treating thyroid hormonal imbalances has been proved. However, there is a long road ahead of us to bring Hormonic to reality. This will imply its arrival to the market, and therefore, to the final consumer.

In this page, you can find the roadmap that we will follow to develop the final version of the device and to overpass all the regulations, thus arriving to the potential users. The Business Plan, where all the future steps are detailed, and the Hormonic Business Model is detailed below. Moreover, the incomes, outcomes and other statistics about the enterprise are calculated to be aware of the return on investment that the company will have and the potential benefits. Enterpering is a vital experience in life but is not something easy, so developing all these potential tools will make our journey easier.

Hormonic Business Plan

Figure 1. Hormonic’s Business Plan for the coming years.

Experimental Phase

Pre-Clinical Phase

Clinical Phase

Experimental Phase

The Experimental Phase is crucial for the future of Hormonic and its arrival to the market, the real world. It will be starting at the end of 2020 and is intended to finalize at the end of the next year. In this phase, the final prototype will be generated and validated experimentally to demonstrate its feasibility. Moreover, an early competitive positioning and an indication prospect study is key to know how the device will be positioned and how the competence and other companies will affect our business.

A term-sheet with the university must be successfully done to have an exclusive license, and thus preventing idea exploitation by others. This is something really important as it will be our main value proposition. Furthermore, an early regulatory roadmap must be designed to take under consideration everything needed to overpass the controls. Patents must be done at the end of 2021 to protect the product.

In order to fulfill these objectives we need to raise money, this will be done via non-dilutive public grants (around $250.000 dollars) from our environment (CDTI, AGAUR, etc.).

Pre-Clinical Phase

Once the Experimental phase has been completed, the next step will be to start the animal trials, starting with small rodents. Animal trials are essential for any new invention, as it's necessary to prove the effectiveness in other mammals before starting trials with humans. Due to this, we must consider that several regulations must be passed to ensure that Hormonic is ready for advancing to the late stages.

Furthermore, we will need a powerful competitive positioning study, as Hormonic will be really close to the final device prototype, and we must have different value propositions with respect to the competence.

For doing all these, including all the patents fees that need to be paid, we will need to perform a seed round of around $1.5M of dollars. The money will be raised from a mixture of Public grants, tech transfer companies (Examples in our environment would be: Caudal, Genesis ventures…), Business angels and from the known triple F (family, friends and fools).

Clinical Phase

When the Pre-Clinical Phase is successfully completed, the next step is to start the clinical trials in humans. As the device is just another way of administering levothyroxine in the body, clinical trials should be shorter and easier to pass. In the late phases regulations are very strict and a lot of expenses will be designated to fulfill them.

A series A financing round should be done to raise all the money needed to pass the Clinical phase. We plan to raise approximately $5M of dollars from venture capital (Examples in our environment would be: Ysios, Caixa Capital Risc…).

Once the phase is completed, we will have the approval of the CE, and therefore, Hormonic will be ready for a market launch and, at the end, to become a reality.

Hormonic Business Model Canvas

Figure 2. Hormonic’s Business Model Canvas.

The Business Model is important as it describes how an organization creates, delivers and captures value. To generate the business model we have used the Business Model Canvas tool as it visually captures all the business strategy [1][2]. Regarding Hormonic’s Business Model Canvas, each block can be detailed independently.

The value proposition of our project is without any doubt the development of a system that is capable of restoring the disbalanced hormonal feedback in hypothyroidism patients. Moreover, it should also be considered that our proposal is based on telemedicine and a novel T3 sensor. This innovative treatment could help 40% of the current hypothyroidism patients who do not have a proper attachment to nowadays therapy.

The customer segments go from the potential end users, which of course are the patients, to the payers. This later group is composed by the insurance companies, public health systems or the private health sector. We can not forget the doctors, despite they are not going to purchase the device, they will also use it and prescribe it.

When it comes to the customer relationships, despite the fact that probably the device will not be acquired by patients until a later commercialization phase, it would be interesting to establish technical support for the management of the device (for both clinicians and patients). Of course having feedback and support from key opinion leaders (KOLs) is a crucial point.

The channels to use are diverse: academic publications like the Biosensors Journal or the Journal of Biochips and TissueChips, social media and webpage, sales representatives, tenders for public and private sector or congresses to establish relationships with doctors that may be interested in using the device and even recommending it later.

Two main revenue streams have to be considered, direct sales of the device and the rechargeable units of it (levothyroxine).

Furthermore, lots of key activities have been taken into account in the plan: patent protection, MVP development, industrialization and commercialisation, clinical validation, regulatory approval, fundraising, business development, market access management and company management.

The key resources of the company would be the patent, the clinical trials, the human capital, the contacts network and the capital (goods, cash...).

Some of the key partners to be considered are the investors, the distributors and the contract manufacturer organizations. Establishing contact with patient associations or external funding organizations, such as La Caixa Impulse or the FIPSE, should not be undervalued. Some other partners which we thought about are people from the marketing area, experts in the regulatory field (for instance for the CE marking) or a contract research organization.

Finally, lots of points could be included in the cost structure of the plan. We have tried to refer to the most relevant ones, which are the patent cost, distribution channels, production and personnel, research and development (R+D) and external contractors.

Costs & Revenue financial analysis and net present value

The incomes, outcomes and other statistics about the enterprise are calculated to be aware of the return on investment that the company will have and the potential benefits in ten years from now. In order to get these parameters, we performed a cost and revenue analysis to see Hormonic’s feasibility as a device. These kind of studies take into account the device market window and all the costs derived from releasing Hormonic into the market. It was done taking into account the European potential users, based on the disease’s prevalence of the 5% of the population, and from them, the 33% that have some kind of problems with the current treatment [3]. We estimate that only the 10% of those patients, the most affected ones, will be the main market window for Hormonic. As it can be seen in the graph (Fig.3), we would surpass the valley of death and we should have revenues in the 5th year from now. These future projections are very important when requesting investment, since it shows the stability of the start-up and its potential.

Figure 3. Costs & Revenues analysis for Hormonic.

Moreover, the net present value (NPV) of the start-up has been calculated. This parameter is the difference between the cash inflows and the cash outflows over a period of time, in this case starting from 2021 till 2030. Investors and market analyzers use this value number to decide on which projects they will invest in. As our NPV is positive and high (660646.8624) it means that Hormonic has a lot of potential to succeed in the market.

All the financial analysis and the NPV can be found in the following excel document:

References

[1] Osterwalder, Y. Pigneur. Business Model Generation, 1rst ed., John Wiley & Sons, 2010.

[2] Nielsen, C. and Lund, M. An introduction to business models, in Nielsen, C. & Lund M. (Eds.) The Basics of Business Models; 2014,1(1). Copenhagen: BookBoon.com/Ventus Publishing Aps

[3] Chiovato, L., Magri, F. & Carlé, A. Hypothyroidism in Context: Where We’ve Been and Where We’re Going. Adv Ther,2019, 36, 47–58. DOI:10.1007/s12325-019-01080-8