Learning From Three Decades of Breakthroughs in One of the World’s Most Successful and Innovative Life Sciences Organizations

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A keynote conversation with Lisa Conte, the founder and CEO of Jaguar Health, was a high point of the recent Sikich event for life sciences organizations, “Discovery to Delivery: Maneuvering the Milestones.” Looking back at the company’s inception over 30 years ago, its trajectory seems almost improbable. However, as Conte describes, one carefully considered, manageable step led to another. Here are some of the insights we gleaned from her remarks in building a  successful life sciences organization through innovation.

A pharmaceutical breakthrough from the rainforest

Jaguar Health, based in San Francisco, is a unique commercial stage pharmaceuticals company. It develops and commercializes gastrointestinal pharmaceuticals by working with substances found in plants typically found in rainforest zones and used by indigenous populations. Jaguar Health’s first commercialized product was Mytesi, the trade name for a botanical drug that comprises crofelemer. Mytesi provides patients living with HIV/AIDS and on antiretroviral therapy relief from noninfectious diarrhea.

In Jaguar Health’s initial research, crofelemer showed overwhelming potential for alleviating pathological conditions as the active ingredient in certain plants. Today, it is cultivated organically and sustainably, and harvested and exported under Fair Trade Certified conditions. Mytesi is the only FDA-approved oral drug that is also processed in line with FDA botanical guidance.

The view from Mt. Kilimanjaro

When Conte founded Jaguar Health, she was a venture capitalist on a quest for early-stage technologies. During a climb of Mount Kilimanjaro, she became aware that local people had used certain plant-based medicines for millennia. She realized that identifying the active ingredients in such traditional medications could lead to the development of highly efficacious and safe pharmaceuticals. Based on that insight, the company took off, and eventually underwent venture capital and mezzanine financing.

Looking back at the early days of Jaguar Health from her current vantage point, Conte points out that one practice that enabled the company’s success was pursuing the end goal of delivering unheard-of patient outcomes by means of clearly defined, transformative value moments. Securing seed funding, then initial venture funding, recruiting key employees, and identifying expert advisors were examples of such milestones.

Achieving FDA approval and going public—three times

The Jaguar Health team members saw that considering previous clinical trials and their outcomes had limited relevance for a company whose mission was to innovate pharmaceutical treatments. More productive was to obtain buy-in from the FDA on Jaguar Health’s specific trial design, enrollment criterial, endpoint definitions, relevant statistical measures, and the company’s unique patient focus. FDA stakeholders needed to understand that the Jaguar Health approach and its goal of normalizing bowel function was substantially different from conventional medications, which rely on the body’s constipation mechanism.

That strategy was successful: Jaguar Health completed the entire journey from discovery to FDA approval for Mytesi. Only approximately one in 2,000 life sciences companies achieve the same results. In preparing a phase 3 trial for a new pharmaceutical that is currently underway, Jaguar Health invested close to two years in working with the FDA to reach agreement regarding the success criteria for a new way of treating disease.

Jaguar Health went public three times on leading stock exchanges, including NASDAQ and the London Stock Exchange. The first IPO happened in 1993 and the most recent one in 2015. Conte emphasizes that sound legal guidance was instrumental in taking her company public. Jaguar Health has collaborated with the same outside corporate counsel throughout its existence. Also critical for the success of an IPO—and an important part of Conte’s work as the Jaguar Health CEO—is striking the right balance between retail and long-term, institutional shareholders.

Working within complex reimbursement and single-payer systems

The complex U.S. healthcare system with a large variety of reimbursement organizations is difficult to navigate for life sciences companies that aim to commercialize their products, make them available to patients, and ensure that patients receive reimbursement. Conte recommends that life sciences organizations enlist strong expertise in addressing this challenge. Today, Jaguar Health draws on such expert insight as early as possible as it develops pharmaceutical solutions for diarrhea related to cancer therapy.

Engaging within the single-payer healthcare systems in other regions can be far less complex, and stakeholders in single-payer systems tend to have a greater appreciation for the management of chronic conditions. For these reasons, Jaguar Health recently created a European subsidiary, which will focus on chronic and orphan diseases. Once again, the participation of a highly experienced life sciences executive will be critical in steering the process toward approvals and delivery.

Creating a successful organization based on key values

As a life sciences organization proceeds from discovery to development and on to commercialization, a strong company culture with shared values is as important in bringing people together as a sense of what a difference the success of their mission can make for patients. Key values at Jaguar Health include advancing science to take care of patients, running a successful, profitable business, and being responsible stewards of the environment.

The world took notice of Jaguar Health’s ways of achieving breakthrough results while maintaining high standards for corporate social responsibility. In the fall of 2021, Conte received the Pure Earth Impact Award as a high-visibility acknowledgment of her own and her company’s over 30 years of support for indigenous communities and the sustainable harvesting and commercialization of the first-ever plant-based medicine approved under FDA botanical guidance.

Why life sciences innovation needs to be global

Conte expects unceasing innovation at Jaguar Health and in the life sciences industry. One area she finds particularly inspiring is cancer research, where targeted therapy is advancing to allow patients to manage their chronic conditions or stay well through remission. She anticipates that Jaguar Health will make important contributions to this realm of supportive care, helping patients enjoy a high quality of life.

An insight brought home for Conte by the current pandemic is that life sciences companies need to follow a global strategy in achieving their goals. If that is not the case, their results will be limited to a certain population and may not be long-term effective. Jaguar Health will continue to innovate its business model and research to benefit people around the world.

Here to help

Sikich is proud of many long-standing relationships with life sciences clients in helping them along every step of the way to achieving their own success stories through innovation. We provide solutions such as NetSuite, Coupa, and Trackwise, optimized for industry requirements, and deliver a broad portfolio of services, from regulatory, quality and compliance, technology management, to cybersecurity and strategic consulting.

To explore how engaging with Sikich could help your life sciences organization, you can:

This publication contains general information only and Sikich is not, by means of this publication, rendering accounting, business, financial, investment, legal, tax, or any other professional advice or services. This publication is not a substitute for such professional advice or services, nor should you use it as a basis for any decision, action or omission that may affect you or your business. Before making any decision, taking any action or omitting an action that may affect you or your business, you should consult a qualified professional advisor. You acknowledge that Sikich shall not be responsible for any loss sustained by you or any person who relies on this publication.

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