Jose Antonio Moreno Toscano, CEO for the US affiliate of iconic French firm LFB shares the company’s journey in the US market and his insights for other European mid-caps looking to achieve success across the Atlantic.

 

Jose, could you please share the journey of LFB USA and the highlights since you took over as CEO in April 2018?

The presence of LFB in the US was established on the basis of our rPRO Technology™, which is a new and differentiated approach to protein production that avoids the limitations of conventional cell culture production methods. Through a robust expression platform using recombinant DNA technology, we have managed to develop a more natural, scalable and cost-effective process of protein production. LFB USA’s first product, ATryn®, was approved by the FDA in 2009 and it was actually marketed until around 2015 when major production issues raised at our contract manufacturing partner site.

When I joined in 2018, LFB USA was mostly an R&D and manufacturing company in the US and it has been a significant undertaking to transform the affiliate into a full pharma company.

A second rPRO Technology™ product, Sevenfact®, have been filed with the FDA for a ‘Biologic License Application’ (BLA). In October 2017, LFB had received a ‘Complete Response Letter’ (CRL) so it was a huge project to put everything together to answer all the questions from the FDA in the CRL. A joint force was set up with LFB teams from our HQ in France and the US to ensure we mobilised the needed expertise. It was a challenging but fantastic journey with a good outcome in the end.

The new chapter of LFB USA has now begun with the 1 April 2020 approval of Sevenfact®, our new recombinant coagulation Factor VIIa, for the treatment and control of bleeding episodes occurring in adults and adolescents 12 years of age and older with Hemophilia A or B with inhibitors. We are now ready to continue to fulfil our mission: to improve the lives of patients with our products. We will once again have close contact with doctors, patient associations and other stakeholders, which is an important milestone for any pharma company.

 

With the approval of SEVENFACT®, what can we expect in terms of the product launch moving forward?

In 2015, LFB had signed an agreement with a US privately-owned pharma company US WorldMeds to form a joint venture, which is called HEMA Biologics. HEMA Biologics acquired the commercial rights for Sevenfact® in the US and Canada. In terms of commercialization, we are therefore proceeding within the framework of this JV.

As you can imagine, we are currently in full launch preparations and it is an intense period. The first signals from the market have been very positive, and we are extremely excited to bring this product to patients. There is only one other product on the market so far for the treatment of bleeding episodes in patients with Hemophilia A or B with inhibitors, so we are happy to be able to offer to patients an alternative. In my eyes, this is the fulfilment of our vision and mission for patients as a pharma company.

We do anticipate a couple of challenges associated with the current COVID-19 global pandemic. For instance, many medical congresses have either been postponed or moved online but we are endeavouring to participate as much as we can. In addition, accessing doctors and forming relationships with them would be a little different, both for patients, who are reducing their visits to doctors and hospitals and for commercial sales teams, who are used to speaking to doctors and other healthcare practitioners face-to-face. Such interactions have been reduced in the short and possibly medium term.

However, I do not think we will have a lot of trouble from the pandemic because the initial market response has been positive. Through HEMA Biologics, we have been interacting with KOLs and patient associations for quite some time now in anticipation of Sevenfact®’s approval. We are in a good position in terms of the market launch. The objective now is about reinforcing those existing relationships.

Realistically, we are looking at a market launch at the end of the year or beginning of 2021. The Sevenfact®’s manufacturing stages are divided between the US and Europe. Some of these have been affected by COVID-19 so we want to ensure that we manage our supply chain in a careful and comprehensive manner. We are committed to bringing Sevenfact® to the US as soon as possible.

 

Looking beyond the launch of SEVENFACT®, what else do you envision for LFB USA?

With the recent FDA approval of our CMO for ATryn®, we will be also preparing for the next steps to bring ATryn back to the market.

On a medium and longer-term, one of my main tasks has been to select products from LFB’s global portfolio for the US market. The hardest part is always the decision to deselect certain products or projects because you have to adapt your portfolio to the capabilities of the company in terms of competences, resources, funding and time. My job is to select the products that could make the biggest difference in the US market. Sevenfact® was obviously the first one and there are more coming.

For instance, we see a significant opportunity for immunoglobulin. It is a USD 6 billion market where issues like supply shortages have come up in the last few years. LFB has products in this area already approved in Europe and we believe they can make a significant difference to patients in the US. There are really many possibilities in this space. Our work in the next two to three years is to accelerate the entry of these products.

 

After over 15 years in the US, what learnings have you taken away regarding the US market, particularly for European midcaps like LFB and ALK, where you spent 10 years previously?

Throughout that time, I have seen how US operations can be rolled out differently. For a typical pharma company, US revenues would range between 35 to 45 percent of global revenues and represents the most important single market. This is a very sensitive topic for European midcaps because while the US is the largest single market, taking the European bloc as a whole, Europe is bigger. The US market is not really a country market but a continental or regional market, and that is important to understand when a company set up US operations. It is not sensible to treat US affiliates or its management as a single country. The US is much bigger and more important to the global organization so there is a need to take into consideration the individuality and complexity of the US market. In addition, the working environment, management styles and cultures in the US and Europe are very different. Being able to recognize these points of difference is probably the single best advice I could give to any European company looking to roll out US operations.

I will also add that it is expensive to do business in the US. The cost of doing business in the US has risen faster over the past 15 years when compared to Europe. European companies need to adapt to this and accept that if you want to be part of the very attractive US market with high prices and high margins, you need to pay the price of higher costs as well.

Another hot topic for a European affiliate is being an attractive employer in the US. During my time, I have realized that there is a sweet spot to attract talent. European companies are mostly small- and medium-sized enterprises, which allow employees the opportunity to truly make a difference. In a big company, it is difficult for individuals not to feel that they are just a cog in the machine. At the same time, as I mentioned above, if the global organization is able to recognize the importance of the US affiliate and grant a little more autonomy in its management and operations, that increases the attractiveness of working for a European company. Employees can then feel like they are working on an affiliate with autonomy and responsibility for their work, and benefiting from the longer-term vision that European companies tend to have. US companies are much more focused on short-term quarterly results. Of course, compensation is also a significant aspect, and one that sometimes causes friction between the US and European teams, but if you can create this ‘sweet spot’ environment, then it is not difficult to attract talent.

 

A final message for our international audience?

I think firstly, regarding COVID-19, the positive effect is that it has motivated the entire pharma industry to try to find solutions and bring them to the market quickly: for example, LFB is part of an alliance of global plasma companies, COVIG-19 Plasma Alliance, who develop a hyperimmune immunoglobulin using plasma collected from convalescent COVID-19 patients to research potential remedies for COVID-19.

It has also improved the public perception of the industry, which has not been so good in the past few years – for good reasons in some cases, as sometimes companies have placed money ahead of patients. This crisis is a good opportunity for the whole industry to show that they know and believe that patients are the foundation and the entire reason for the existence of the industry.

For LFB, it has been a great last two years. At the end of the day, a company cannot advance without the commitment, efforts and dedication of its employees. LFB USA has an amazing team that works together to overcome barriers. Our successes with Sevenfact® and ATryn® shows what you can achieve when you work together. This has really encouraged me to work even harder and I am excited about how we can take LFB USA to the next level in the future.