The Benefits And Risks Of An LLC Business Model In Biotech
By Abbas Kazimi
In the rapidly evolving world of life sciences, companies are constantly seeking ways to optimize their business structures to better navigate the complex landscape of drug development and financing. Traditional models, such as C-corporations, have long been the standard, offering clear pathways for public offerings and investor engagement. However, in recent years, a growing number of companies are exploring alternative structures that offer greater flexibility and adaptability — qualities that are increasingly crucial in today’s market.
One such alternative is the limited liability company (LLC) structure. Although not as commonly discussed as other business models, the LLC offers unique advantages, particularly in how it manages ownership and IP. It also presents certain challenges that companies must consider carefully before adopting this model. In this article, we’ll explore the pros and cons of the LLC structure in biotech, comparing it to other models and highlighting how companies like Nimbus Therapeutics have leveraged its benefits.
Advantages Of The LLC Model In Drug Development
Flexibility In Deal Structures And Targeted Investments
One of the most compelling advantages of the LLC model is its inherent flexibility, particularly in how deals are structured and investments are targeted. In the traditional corporate model, acquiring a biotech company often means acquiring the entire entity, including all its assets, liabilities, and ongoing programs. This can be a daunting prospect for both buyers and sellers, especially when a company’s value is concentrated in a single asset or program.
The LLC structure, however, allows for more tailored transactions and investments. Life sciences companies operating under this model can structure deals that enable partners to acquire individual assets rather than the whole company. Furthermore, by establishing individual development programs as separate subsidiaries, each with its own secured rights and intellectual property, companies can attract investors interested in specific assets rather than the entire portfolio.
For example, Nimbus Therapeutics has executed several high-profile deals under its LLC structure. In 2016, Gilead Sciences acquired Nimbus’ acetyl-CoA carboxylase (ACC) inhibitor for the treatment of fatty liver disease for $1.2 billion. More recently, in 2023, Takeda purchased Nimbus’ tyrosine kinase 2 (TYK2) inhibitor program for the treatment of psoriasis in a $6 billion deal. In both instances, the flexibility of the LLC model allowed Nimbus to sell specific programs and their associated IP without relinquishing control over the company or its other promising development programs.
Additionally, Nimbus operates its hematopoietic protein kinase 1 (HPK1) program for advanced solid tumors as a fully owned subsidiary, with its Investigational New Drug (IND) application filed under the subsidiary's name. This structure creates unique opportunities: if Nimbus encounters investors specifically interested in oncology assets, it could potentially discuss financing the HPK1 subsidiary independently, bringing in new investors while determining how Nimbus LLC can continue supporting the program.
This flexibility extends to a variety of deal structures, including licensing agreements, option deals, and outright acquisitions. By enabling more granular transactions and targeted investments, the LLC model can make it easier for companies to align their business strategy with their partners’ needs and investors’ interests, ultimately fostering stronger and more mutually beneficial collaborations.
Clear Ownership And IP Management
In the biotech industry, where intellectual property is often a company’s most valuable asset, clear ownership is crucial. The LLC model offers distinct advantages in this area. Under an LLC structure, each development program can be treated as an independent asset with its own clear-cut ownership. This simplifies the process of selling or licensing a program, as there is no need for complicated negotiations over shared IP, which are common in more traditional corporate structures.
This clarity is particularly appealing to potential partners and investors who may be wary of the complexities often associated with IP ownership in the life sciences sector. For instance, when a development program is spun off into a subsidiary or separate entity, questions about who owns the underlying IP can arise, potentially complicating negotiations and delaying deals. In contrast, the LLC structure ensures that the ownership of each program’s IP is clearly defined, making it easier to execute transactions without the risk of IP entanglements.
Moreover, selling an asset within an LLC structure typically involves fewer disruptions to the company’s operations. Because each program is managed as an independent entity, changes related to staffing or facilities are minimized, allowing the company to maintain continuity and focus on its remaining programs.
Exit Points And Capital Cycling
In the biotech industry, a company’s success is often measured by its ability to generate returns for investors. Public markets have traditionally been the primary avenue for achieving this, with IPOs providing a lucrative exit strategy for early investors. However, the LLC model offers alternative pathways that can be equally, if not more, advantageous in certain circumstances.
One of the key benefits of the LLC structure is the ability to recycle capital through multiple transactions. When a development program is sold or licensed, the proceeds can be distributed to equity shareholders, providing a return on investment. This creates a cycle of capital returns that can be particularly attractive to investors looking for ongoing opportunities to reinvest in a company’s future growth or looking for other, external investment opportunities. Those experiences are real for Nimbus.
For example, after Nimbus’ successful sale of its TYK2 program to Takeda, the company distributed over $3.5 billion dollars to all equity holders of Nimbus Therapeutics, LLC (to date, Nimbus has returned over $4.1 billion dollars to all its equity holders). This ability to raise capital, invest across a diverse portfolio, return value to investors, and potentially reinvest capital on an ongoing basis can make the LLC model particularly appealing to private companies that are not yet ready to go public but still need to demonstrate financial returns to their investors.
Furthermore, the proven success of such transactions under the LLC model can make it easier for companies to access additional financing. Investors and partners are often more willing to engage with a company that has demonstrated a track record of successful exits, creating a virtuous cycle of investment and growth.
Potential Risks In The LLC Model
Not A One-Size-Fits-All Option
While the LLC model offers many advantages, it is not without its limitations. One of the primary challenges is that the LLC structure may not be suitable for every company, particularly those with complex or interconnected IP portfolios.
For companies that rely on a shared platform technology across multiple programs, the LLC model can introduce complications. If a single piece of IP supports several development programs, separating the IP from one program to facilitate a deal can be difficult and possibly limit the ability to generate value for a program. This can result in convoluted deal structures that are less attractive to potential partners and may ultimately reduce the company’s negotiating power as the company granting a license to the IP wants to protect the portfolio, and the partner accepting the IP wants to make sure all aspects of IP are carved out for their use.
In such cases, a more traditional corporate structure, where all programs and IP are housed under a single entity, may be more appropriate. This structure allows for a cleaner separation of IP and can simplify the process of selling or licensing individual programs.
Talent Flexibility
The dynamic and fluid nature of the LLC model, while advantageous in many respects, also can present challenges, particularly in managing talent. In a traditional corporate structure, employees often work on specific development programs within defined therapeutic areas, providing a sense of stability and continuity in their roles.
However, in an LLC, where programs can be sold or licensed at any time, employees may need to pivot quickly from one program to another. This can create a higher level of uncertainty and optionality in workflows and career paths. While some employees may thrive in this dynamic environment, others may find it challenging to adapt to the constant changes.
To succeed in an LLC model, companies must cultivate a workforce that is not only highly skilled but also highly adaptable, with a willingness to embrace new challenges and opportunities as they arise across a diverse portfolio that has multiple opportunities to impact human health.
Drug development is a high-risk, high-reward business, and the structure of a company can play a critical role in determining its success. The LLC model offers unique advantages, including flexibility in deal-making, clear IP ownership, and efficient capital recycling, making it an attractive option for many life sciences companies.
The LLC model is not without its risks, however. It requires careful consideration of the company’s IP portfolio, investment strategy, and talent management. Companies that choose this model must be prepared to navigate its complexities and ensure that it aligns with their long-term goals.
For those willing to embrace a non-traditional approach, the LLC model can be a powerful tool in advancing development programs and bringing new therapies to patients. As with any business decision, the key to success lies in determining the structure that best supports the company’s mission and objectives.
About The Author:
Abbas Kazimi is Chief Business Officer of Nimbus Therapeutics, LLC, a Boston-based biotechnology company focused on developing breakthrough medicines for patients through precision small molecule design.