Building a Forever Biotech in This Market

This post was originally published by Halloran Consulting Group.

Building a biotech company is not for the faint of heart. It requires scientific expertise, business and organizational focus, and advanced knowledge of product development and commercialization to harness to formulate the company and secure fundraising to sustain growth. No one founder holds all the expertise within each of these functional areas, but rather, it’s the company comprised of team members with varied skillsets and expertise that results in cross-functional talent that contributes to a biotech’s ability to survive, scale, and thrive – to build a forever biotech – that sustains product development and fundraising complexities.

We’ve observed through our own varied experiences and conversations with successful biotech founders that there is a commonality with their success and that is the ability to be grounded in the following growth strategies from the onset:

  • Building a business model around a core asset
  • Raising sustainable capital
  • Developing a pipeline from a single core asset

In this blog post, we will build upon these three strategies to serve as a framework to build a forever biotech. It’s not going to be easy, but it can be manageable.

Building a Business Model Around a Core Asset

A biotech founder, first and foremost, must believe in their product and that it’s addressing an unmet need for patients. Assuming there’s excitement around the product, for example, let’s say a biotech has a small molecule therapeutic with strong efficacy data via a mouse model, and effective pharmacokinetics properties in a therapeutic area with a high unmet medical need, where should they begin if they want to get their therapeutic into a clinical trial?

Beginning with an internal Integrated Development Plan (IDP) is essential because it provides a roadmap for a biotech company that defines the steps necessary to support entry into the clinic, particularly for early stages companies, and even more, how to support the product through later stages of development like commercialization. This plan is essentially an internal tool to streamline development strategy, highlight efficient development pathways, and optimize the speed and efficiency of product development.

The plan is then broken down by activities and functional areas across clinical development, regulatory, chemistry, manufacturing, and controls (CMC), and non-clinical development team members. The goal of the IDP is to accelerate progress and become fully prepared to implement the plan so the company can continue to reach milestone success and reach its next phase of growth.

The following key elements should be included in the IDP:

  • Target Product Profile (TPP)
  • Non-clinical, safety, and toxicology data
  • Regulatory interactions, submissions, and designations
  • Clinical trial design, i.e., duration and cost
  • CMC considerations
  • Assumptions, risks, and opportunitiesIdeally, the IDP is kicked-off by the Program Manager to confirm alignment on the scope of the plan, ensure deliverables, and provide key timelines to all those cross-functional team members to build their business model around a core asset.

Once that plan is kicked-off, there are more complex questions to consider if that biotech wants to scale and grow, such as ‘how do you develop a pipeline from a single core asset?’ It’s been shared with industry colleagues that “companies that are built on a platform are still here!” Let’s explore.

But to grow and scale, companies will need to attract investors.

Raising Sustainable Capital

Funding sources for a biotech are varied, especially due to the proliferation of biotech and life science companies over the past decade. However, a lack of access to reliable and sustainable capital sources is often a key reason that new or emerging biotechs often fail before reaching their potential. The challenge is this – there is no blueprint! There is no one-size-fits-all solution for capital formation and the options are vast. Moving beyond the traditional ‘family and friends’ funded biotechs, here is a non-exhaustive, but comprehensive list of funding sources.

  • Traditional Non-Dilutive Funding
  • This includes traditional bank loans or lines of credit. When a company has the balance sheet and/or assets to secure bank financing, this type of funding is attractive because it does not require the founder to surrender any ownership or control of their company in exchange for funds, i.e., non-dilutive.
  • Non-Traditional, Non-Dilutive Funding
  • This includes revenue royalty financing arrangements whereby investors are entitled to receive a certain percentage of a company’s revenue generated from their products. In this type of financing, royalty arrangements do not dilute the ownership percentages of founders, but they allow the company to raise capital without the drawbacks of borrowing money, i.e., non-traditional.
  • Angel Investors
  • “Angel” investments are typically made in the development-to-early stage of a company. These investments are made by individuals or groups of investors, and in exchange for their investment, angel investors will require a percentage of ownership of the company, a certain level of control over the decision-making, or some combination of both.
  • Venture Capital
  • These investments are typically made after the startup stage. Venture funding for biotechs typically comes from venture capital firms and their investments are typically high-dollar investments that are made with the expectation of high returns within a defined period of time, and most often require the founder to give up a certain percentage of ownership and control of the business to the venture capital firm.
  • Federal and State Government Grants and Awards
  • Many US federal agencies provide grants to early-stage companies and startups, and while these grants typically do not require founders to surrender ownership or control of their company, they often contain strict requirements with respect to the number of employees, ownership, and control, which may impact the potential to enter into certain strategic partnerships or ventures in the future while using the funds.
  • Crowdfunding
  • In 2015, the Security Exchange Commission (SEC) adopted rules providing an exemption from SEC registration requirements to companies seeking to raise capital from the public through the use of ‘crowdfunding.’ This type of funding is a relatively recent method of acquiring capital through debt or equity through small investments from a large number of investors. However, there is a limit to what companies may raise and by whom for a period of time, and can only be acquired through a registered broker-dealer or a registered funding portal.
  • Strategic Transactions and Outsourcing
  • At times, an easy way to obtain funding is for a company, typically early-to-middle-stage biotechs, to align itself with another company that already has sufficient capital to be a source of funding. These transactions and outsourcing take many forms, such as joint ventures, mergers, or partnerships with similarly situated or larger biotech companies. The company seeking funding should be prepared to surrender some degree of autonomy in exchange for access to capital.
  • Initial Public Offering (IPO)
  • Mid-to-late stage biotechs with additional capital needs may also choose to conduct an IPO of their capital securities in the form of issued common stock. In addition, an IPO can raise the public profile of a company, potentially leading to an increase in that company’s market share.
  • For the early-stage biotechs, some funding options are more appropriate than others, but we’ve found that investor partner compatibility is crucial for success. For example, if you go the strategic transaction route, can your partner develop your asset faster and better? If you’re going the venture capital route, are their skills and mindset complimentary to yours? And in all scenarios, do you appreciate the way each potential investor behaves in the negotiation process? The answers to these questions matter because the partnership dynamics – the relationship – between the company and investors will determine the path ahead for the company.

    Now let’s throw in another dynamic, which is the broad life science downturn in the market, and access to capital isn’t as easy as it was two years ago. This puts biotechs in a position to be even more critical with their future investment choices and the existing capital they hold to sustain their organization.

    Small, private biotechs need to make tough decisions to survive, like reducing budgets and timelines where appropriate, staying focused and aligned on their IDP, and ensuring the right talent so that they have more of a chance to develop their core asset faster to harness the capital that is right for them for future growth.

    As companies design their investment pitch strategy, the following considerations are critical in this tight financial market:

    • Who is your team, and will they make a positive impact?
    • What story do you need to tell about your data, both pre-clinical and clinical?
    • Will your product make a difference?This won’t be an easy path ahead, but if you pitch to more types of investors, practice patience, trim costs where appropriate, and ultimately choose the right choice for your organization, your early-stage biotech may have a better chance of thriving.

    Developing a Pipeline from a Single Core Asset

    Once more funding is secured, biotech leaders may evaluate creating a product pipeline from a single core asset. This process helps to de-risk a company from relying on a single asset and potentially staring at failure with nothing else in the pipeline. But where should companies start in this approach?

    A company’s pipeline is also what investors typically are looking for. For example, what pipeline will be required for a company to grow and mature in the business? How many products will it take to win in the marketplace?

    We recommend starting with competitive intelligence analysis of the market needs. Competitive intelligence is a continuous process that occurs throughout early and late-stage development and encompasses the entire development lifecycle. How to leverage all this information is a major component of this exercise, and the information gathered is from insights on patient-centric recruitment strategies and trial design, trending clinical strategies as well as clinical and regulatory precedence, accessible regulatory pathways, special designations, decentralized and data-driven technologies, and macroeconomic data affecting the entire industry. All this information is essential because it can serve as insight into how a company’s pipeline can win in the marketplace and shape development strategies.

    Learn how Halloran Consulting Group takes a personalized and integrated approach to help companies like yours through every stage of clinical development strategy. Please contact our team to have a conversation.