Optimum’s hot topic: How do you turn a 10-person biotech into a $1.1 billion company sale in the space of seven years?

During the BIO-Europe conference in Stockholm, Optimum co-hosted a special reception featuring a fireside chat with Renée Aguiar-Lucander, former CEO of Calliditas, who led the Swedish company since 2017 until recently – taking it from small biotech to its $1.1 billion acquisition. Here, we tell the story of her remarkable seven-year journey with the firm. 

Back in 2017, Renée Aguiar-Lucander joined a small Stockholm-based biotech called Calliditas – then known as Pharmalink – as its new CEO.

With just 10 employees, the firm was investigating using a well-known asthma drug called budesonide for an entirely different purpose – to treat the rare kidney disease IgA Nephropathy (IgAN), also known as Berger disease.

The company had just convinced the US FDA to allow it to use an entirely new endpoint – measuring an important aspect of kidney health – to test its drug in a Phase 3 trial.

Spying an opportunity, Renée saw that the FDA’s decision could open up a much swifter clinical trial path to approval and commercialisation. They could develop the drug for the benefit of hundreds of thousands of people with IgAN, which affects around 4 in 10,000 people in Europe and for many patients results in end stage renal disease, requiring dialysis or transplantation.

While there are absolutely no guarantees on the road to biotech success, which is littered with potholes and dead-end diversions, Renée decided to run with it. Seven years later, Calliditas has just been sold for $1.1 billion to Japanese conglomerate Asahi Kasei.

During that whole time Optimum Strategic Communications has been a key partner of Calliditas, providing support to help raise its profile with potential investors and partners.

A strong communications strategy was implemented early on to position Renée as a biotech thought leader, with extensive media coverage, panel spots at key industry events, media engagements, and awards.

Renée explained that strong communications was one of her top priorities when she took the helm.

She said: “One of the biggest issues is, you need to communicate your story.

“I knew we were going to need to raise a significant amount of money …. but to be successful, you really do need a compelling and coherent story.”

Getting the story “really clear” also helped with another top priority – hiring the right people to build a successful company.

“When you are trying to get people, you need to communicate the vision and the mission: what’s the story and what’s the actual goal of this company?”

Renée has subsequently become recognised as one of the top CEOs in the biotech industry, winning accolades such as ‘Chief Executive of the Year’ at the 2021 European Mediscience Awards and ‘Women-Led Business of the Year’ at the 2023 LSX European Lifestars Awards.

Since 2017, Calliditas has flourished to become a fully integrated biopharma company, with a strong presence on both sides of the Atlantic: with R&D, regulatory and headquarter functions in Europe, and a strong commercial infrastructure in the US. It has also developed key commercial partnerships in Europe, China and Japan.

Renée’s first task was to set up a global Phase 3 trial to test its drug. For that, she needed to attract significant financing.

She drew upon her 12 years’ experience investing in life sciences – first for 3i Group and then for Omega Fund Management – and the knowledge that she had to communicate Calliditas’ growth story to a wide pool of potential investors, to take the company public on the Swedish Stock Exchange in 2018. It was one of the largest European IPOs that year. The same year, the first patients were enrolled in the pivotal Phase 3 ‘NeflgArd’ trial.

Two years later, Calliditas listed on the US’s NASDAQ exchange, raising $90m. During the process, Optimum worked closely with the management team to support its strategic communication efforts.

In due course, NeflgArd generated positive results, and, in December 2021, the FDA granted accelerated approval for TARPEYO^®, Calliditas’ budesonide-based drug for IgAN. Full approval by the FDA followed in December 2023, making TARPEYO® the first fully FDA-approved treatment for IgAN.

Meanwhile, Renée and her team worked to build up a strong in-house commercial infrastructure in the US, which now numbers more than 100 field-based staff. Calliditas also struck partnerships with Everest Medicines in 2019 to commercialise the drug in China, with STADA in 2021 to do so in Europe, and with Viatris Pharmacueticals in Japan in 2023. The drug is called Kinpeygo® in Europe and Nefecon® in China.

These efforts have paid off, with total company revenues growing from around $75m in 2022 to around $110m in 2023. The company now has some 250 staff worldwide.

Alongside its lead asset, Calliditas is also developing setanaxib, a NOX inhibitor. It is currently in Phase 2 clinical trials for the treatment of Alport Syndrome, with positive topline results having been reported in 2024 from Phase 2 studies in head and neck cancer and Primary Biliary Cholangitis.

Throughout its journey, Calliditas has recognised the importance of strong proactive communications to the market, consistently engaging with stakeholders through conference calls, industry events, by speaking to the media, and frequent updates on its website and social media platforms.

Renée’s leadership has been instrumental in transforming Calliditas into a global biopharma success story.