Read the Conversation
EF: What is your agenda for Brazil, and what are your priorities for 2023?
GF: The company is actively working on restoring its operations to pre-pandemic levels, demonstrating our determination and resilience. Despite the Ministry of Health's view regarding purchasing products without registration, we see this year as an opportunity for growth and improvement. We are confident in our ability to navigate and adapt to these circumstances, benefiting local and multinational companies.
In Brazil, the demand for our products continues to rise as the population ages and medical diagnoses increase. Furthermore, we are delighted to share that a breakthrough genetic treatment for hemophilia has recently gained approval in the US and Europe. We aim to introduce this treatment to Brazil soon and are planning to work towards meeting the regulatory requirements.
Another focus area of our company lies in Primary immunodeficiency (PID). Diagnosis capabilities, particularly in Brazil, offer significant opportunities for improvement, for currently, less than 15 percent of PID patients are identified. In other countries, identification rates have reached up to 60%, so we are undertaking a project that leverages a commonly used and inexpensive blood test available nationwide to achieve this number. These tests cost less than two dollars per exam and can be assessed through a mathematical calculation called "Calculated Globulin." By monitoring the results and the ratio of these blood tests, we can identify warning signs below a specific threshold, prompting further investigation. We aim to make this valuable and affordable information accessible to improve diagnosis rates for diseases in Brazil. There is still work to be done, but our unwavering commitment and enthusiasm drive us forward in this endeavor.
EF: What part of your operations in Brazil excites you the most when you think about its impact and footprint?
GF: The field of immunodeficiency is a remarkable area that has consistently grown over the past 40 years, continually identifying new patients and pioneering new treatments for the population.
However, while immunology receives the company's largest therapeutic focus, we have a field dedicated to hematology, a growing therapeutic area for respiratory diseases, and recently expanded our range to transplant and cardiovascular medicine.
The cardiovascular sector is particularly noteworthy because it takes a distinct approach by targeting widespread conditions rather than rare diseases. Its emphasis lies in combating second heart attacks, a major cause of mortality in the healthcare system.
Furthermore, CSL Behring is making substantial investments in research and development (R&D). We recently had the privilege of participating in the clinical trial for a groundbreaking molecule where Brazil was the second-highest recruiter worldwide. The trial is set to conclude in 2024, and the product holds immense promise for our company's portfolio expansion.
EF: What could make Brazil more attractive for foreign investment?
GF: We need legislation that favors research and innovation to maintain competitiveness. During the pandemic, we were contacted by a clinical team running a trial for one of our molecules that was showing promising results for COVID treatment. We convinced them to bring the molecule to Brazil and take part in phase two trials. However, it took more than nine months to get the approval after we made the submission. At that time, the trial was already closed in Italy. -These conditions do not help us attract more investments to the country.
Clear and effective legislation is essential for us. This applies to transparency in sanitary legislation and registered product importation. Our investments are focused on the next ten years; therefore, we need certainty in our operations.
EF: Could you elaborate on how you have formed strategic partnerships to push innovation and access to your products in Brazil?
GF: CSL is, quoting our previous CEO, "the biggest biotech nobody knows." We are a low-profile company but one of the largest biotech firms by market value.
However, we engage with outside partners, especially through Sindusfarma. We are members of that syndicate and cooperate with the American Chamber and the Australian Embassy to create opportunities to be a socially responsible partner in the country.
When we were created in 1916, we were a public company. We have a very strong DNA in terms of public health, and that is what we try to focus our attention on. We transform the lives of our patients, bring in high-quality products, and focus on areas where we can make a difference. That is the biggest partnership of all: stay with the patients at the end of the health funnel.
EF: What do you think other companies can learn from CSL Behring?
GF: We decided to return to what is fundamental: focusing on the patient's real needs. Sometimes, companies become overly enthusiastic about a product or a novel approach, but we must pause and consider if it truly benefits the patients.
With this approach, CSL Behring has been involved in the field of hemophilia for many years and was the pioneer in recognizing it as a "therapeutic area." A few years ago, we introduced a long-term recombinant treatment that significantly improved the lives of numerous patients.
In a regular situation, a hemophilia patient needs to inject up to three times per week. With our new product, this treatment is only needed every 14 to 21 days, giving the patient a new quality of life. Moreover, we are working on a genetic treatment that aims to eradicate the disease.
EF: Considering your experience in emerging markets, what is their importance, and how do you see them evolving in the future?
GF: It is important to realize that the largest population is in emerging markets. Of the eight billion people in the world, 70 percent are concentrated only in India, China, Africa, and Latin America.
We need to pay more attention to these regions and mind the important question of affordability and access.
Since emerging markets have their own specifics, we must pay attention to diverse healthcare needs, as the pharmaceutical industry tends to concentrate heavily on specific areas. It is crucial to shift our focus beyond cancer and address other types of diseases and ensure that we can cater to a broad range of patients, not just those located in the US or Europe.
EF: How access and affordability be improved in Brazil’s health sector?
GF: We are very fortunate in Brazil and have this during the pandemic. SUS is probably one of the biggest and best public services in healthcare. It could still be improved by better organization and funding, but it already has many great programs. For example, the HIV and hemophilia programs in Brazil are some of the best in the world.
In addition to the public sector, Brazil has a very strong private sector managed by the ANS, which continues to grow. There is a noticeable trend of consolidation in that particular industry segment. Brazil is witnessing the formation of larger conglomerates, and this trend is expected to become even more prominent in the years ahead. I anticipate significant market changes affecting both the private and public sectors as the issue of healthcare access persists. There are many opportunities for conducting profitable business while ensuring patient population access. I am very optimistic about the country's prospects in the coming years.
EF: Could you please give us some insights into the plasma-derived products segment and how it influences your portfolio?
GF: The plasma sector in Brazil is a growing market. It is the biggest one in Latin America. However, there is still a lot of uncertainty in the market, especially related to product availability.
There is ongoing discourse surrounding the concept of self-sufficiency in the market. Recently, a public hearing was held in the Senate to discuss plasma collection in Brazil and how private companies like CLS Behring can contribute to this cause.
The estimated demand for immunoglobulins in Brazil is approximately 6 tons, yet local production by Hemobras, if they become fully productive, will only be able to reach around 2.4 tons at maximum capacity. This highlights a significant obstacle to achieving self-sufficiency. Currently, 70 percent of plasma collected worldwide comes from the United States, and Brazil remains a net importer of immunoglobulins due to the lack of local production.
It is crucial to understand the plasma market to address the issue of self-sufficiency and adequately serve patients. As for now, less than only 15 percent of patients in Brazil are identified. If this number were to double, the demand for immunoglobulins would rise to 12 tons, presenting a significant challenge. Various discussions are taking place to explore opportunities for growth from a business perspective. However, patients face uncertainties and challenges as a result of their experiences during the pandemic.
During a public hearing, a patient who served as the president of a patient association eloquently conveyed the senators' perspective, saying, "Do you remember how uncertain you felt at the beginning of COVID, not knowing if you could go out and get infected by the virus? Well, that's exactly how we feel every single day because we cannot go out without the product, without the protection of immunoglobulin. We are susceptible to every bacteria or virus." This patient's powerful statement highlights the immense challenges and suffering faced by patients, underscoring the need for a more serious approach to address their situation.
In the next ten years, we are still going to be a majority plasma-derived product company. CSL Behring's portfolio comprises up to 95 percent plasma-derived products. Other products, such as recombinants and genetic treatments, until now only make up a small portion. However, our portfolio continues to grow in that segment.
EF: CSL Behring has more than 54 years in Brazil. What are some of the key milestones you would like to celebrate, and what is your mission for the future?
GF: As the company is coming out of the pandemic, it continues to grow and serve our patients and employees. Covid brought a lot of tension and uncertainty, yet we navigated through it very calmly. We focused on what was important: We maintained the health of our internal group, served the patients that needed us, and ensured the survival of the business. Our biggest goal is to continue to grow because, by doing so, we can serve more patients.