"We could do like Putin; you sit down there and I sit here," jokes Tim Walbert as we enter the boardroom at Horizon Therapeutics's new start-of-the-art offices on Dublin's St Stephen's Green. The table, set up to seat 30 people, would certainly have satisfied the increasingly paranoid Russian leader but we settle to cluster at one end.
Horizon's new offices are certainly a statement by a company that expects to be a global player in making drugs for rare diseases over the next decade.
It is a subject close to Walbert's heart. He was in college in the US when he first started feeling the effects of what turned out to be a rare autoimmune disease. It took 10 years and visits to more than 100 doctors before he finally got an accurate diagnosis.
Walbert, Horizon's CEO, has spent the last 19 years on a drug called Humira, which he helped develop and commercialise in a previous role at the drugmaker now called Abbvie. His younger son has the same condition.
But that wasn’t where Horizon started. When Walbert joined as founding chief executive in 2008, Horizon was focused on inflammatory conditions. Then a private company, it grew largely by acquisition, picking up drugs that had a lower profile and modest sales of less than $200 million, and then growing revenues with strong marketing campaigns.
“Inflammation was opportunistic to take advantage of the market and create a business,” Walbert recalls. “Then, when you have a cash flow, you can do more of what you want to do.”
“We had four inflammation drugs. One we acquired while we were a private company, one we developed and then two we acquired – Vimovo and Pennsaid – after we went public in 2011. That allowed is to generate the business. We did well in that environment and used that cash flow to expand and diversify into areas we really liked.”
Rare diseases
It was that drive to diversify into rare diseases that first brought Horizon to Ireland by way of what was even then a controversial approach – corporate inversion.
In 2014, Horizon paid just shy of $600 million for a Dublin-headquartered business called Vidara Therapeutics. Vidara, a private business, had two years previously bought what was left of AGI Therapeutics, a listed specialty pharma set up by a team of former Elan Pharmaceutical executives
For sure, the move had tax advantages. Walbert noted at the time that it would lower Horizon’s corporate tax rate to around 20 per cent from the high 30s per cent that it was then paying as a US-incorporated business.
But, he insists, there was always much more substance to it than a mere tax play.
“If you look at a lot of those business [that arrived in Ireland by corporate inversion], it was just a tax combination. There were a lot of companies that were brass plates and not being committed,” he says.
“Whereas we got a medicine Actimmune, which has been an amazing medicine. It’s not a huge seller, it is a hundred something million dollar a year [drug], but that is eight years of a medicine doing it really well.”
More importantly, it was Horizon’s first rare disease drug.
“As we were looking to get into the rare-disease space. It was the first one available.”
International expansion
Horizon may have become an Irish company but its focus continued to be very much on the US market, which accounted for virtually all of its sales.
Walbert accepts that was the case but insists that the company is now very much focused on international expansion.
"Our plan has been to become a global company. We have had different businesses. We had several businesses in Europe that we got via acquisition, but they just didn't have the scale that we needed and we didn't have the right medicines that are highly innovative that can make a real difference in the rare-disease space," he says.
Several things have changed that picture.
One was the $3 billion acquisition last year of Viela Bio, which has rapidly accelerated the company's pipeline and focus on research and development.
“It gave us an on-market medicine, another really exciting rare-disease medicine but also a significant enhancement. We went into 2021 with around six or eight pipeline programmes to over 25 programmes, many of them in Phase III a or Phase II trials.”
The other was the decision to establish its first in-house manufacturing presence.
Manufacture
“It was always in our plan,” says Walbert but up to now the company has outsourced all its manufacture. That decision came back to bite them when the Covid-19 pandemic broke.
"Our lead medicine, Tepezza, was made on the same manufacturing line as Moderna's vaccine, " Walbert recalls. "So the US government came in and said, 'You are all going to be part of the bigger picture. Why don't you guys go sit on the sideline for a little while and we will focus on the vaccine?' Which we understood, you have to do the right thing.
“And so we had four months where we had to shut that down and all our patients had to stop taking that medicine.
“It is one of those situations. We bought that company right before the phase III trials of Tepezza. If we were creating it from scratch, we would want to have our own facility and control our own destiny rather than rely on someone else.
“So it was really a good opportunity for us as we are building out our pipeline with a number of medicines in late-stage trials. Let’s make sure we can manufacture them ourselves while also maintaining our partnerships for broader supply chain.”
In a fortuitous piece of timing, Horizon's Irish team had become aware that an advanced manufacturing site run by an Irish pharmaceuticals business, EirGen, and sited on IDA Ireland land in Waterford, was about to become available.
The bonus for Horizon is not just that it gets a modern manufacturing facility, which is currently being prepared for necessary approval from Irish, European and US authorities to manufacture several of its medicines, but also that the site is large enough to accommodate future expansion, which the company is already actively looking at.
First up, though, it is getting the plant ready for its current biologic products and two more candidates in its pipeline for which the company has high hopes.
The acquisition to the EirGen site brought 40 new hires into the business and the company expects to employ another 50 there over the next 18 months. It is also beefing up its Dublin operation, which has seen around 60 new hires during Covid and expects to grow by another 50 people in the coming year and a half.
Irish Open
But how to get the Horizon name out there? The company had, until then, been resolutely low-profile, rarely appearing in headlines and still focused predominantly on its US market.
Walbert decided the company needed a platform to get its message out to prospective hires and also to the politicians and healthcare market partners it deals with. An avid golfer, his first move was to sign former Ryder Cup captain and three-time major winner, Pádraig Harrington as a brand ambassador.
That led, more recently, to the landmark announcement that Horizon will sponsor the Irish Open over the next six years, starting with this year's event in Mount Juliet at the end of June, in a deal rumoured to be worth in the region of €50 million, though the company has not given any figure.
And in a neat piece of corporate symmetry, the event, with substantially increased prize money, will be played at the K Club in 2023, 2025 and 2027, running up to Ireland's next hosting of the Ryder Cup at Adare Manor that same year. When Walbert and his board first came over to Ireland following that 2014 acquisition of Vidara Therapeutics, its first board meeting was held at the K Club.
"When we looked at where we are going as a company, we've always looked for different ways to give back and we continue to try to find ways to engage in the Irish community. As part of its support for the Irish Open , the company has also signed a six-year charity partnership with the Make-a-Wish Foundation that will see Horizon match what the charity collects at each of the next six Opens.
“As we were looking at our broader strategy, acquiring the facility in Waterford, knowing that we are going to have to hire hundreds of people and really expand what we do here, it seemed like a perfect opportunity for a larger company to give back in a bigger way.
"We became large pretty quickly. In 2014, when we came, the first time I sat with the taoiseach, Enda Kenny, in September or October of that year, we said we are going to do 25 jobs. We are now one of the larger companies in Ireland and it was a great opportunity to say here we are and raise awareness as we are acquiring people."
Walbert says that what Horizon has found is that Ireland offers the “best access to talent in our industry in all of Europe and frankly outside the US”.
"Even versus our ability to hire in Chicago or some other markets, we found this is the best market and we can hire the best people faster here than anywhere. We wouldn't build a manufacturing facility anywhere else because we had the confidence that the people are here."
Patient access
Persuading health payers to give patients access to orphan drugs for rare diseases is always a struggle, and Ireland consistently ranks towards the bottom of European states in terms of the number of rare-disease therapies approved and the time it takes for them to come to market.
Walbert accepts it is an issue but not one unique to Ireland. And he understands the difficulties for both drug companies and for regulators.
“A lot of times they are difficult to diagnose and people don’t invest in them because they are very rare. But when you find something, it is pretty special. There are 7,000-plus rare diseases and, if look around the world, probably fewer than 5 or 6 per cent of them have treatments that are actually approved for them. For many of them, there are no treatment for these patients; they just do palliative care and hope.”
“The biggest challenge with rare diseases – and I have one and it means something to an individual – is education. The traditional way of measuring outcomes in terms of quality of life and value for money don’t work in rare diseases – they also don’t work in most cancers. I think the way to improve this is to continue to educate: educate the government, educate everyone involved. And then understand the consequences, because while you or I may have one rare disease, when you aggregate 7,000 of them together, it becomes an important group of people who live here and have to bring value to society.”
However, he also acknowledges that much remains to be learned, including form the patients taking the medicines his company makes.
“Companies may think they came out with a great advance but it is still not going to change the lives of some of these patients. So you have to be realistic in how you approach them. It may be the first medicine approved for them but it may only make this much difference,” he says, as he holds thumb and forefinger close together.
“So you have to be really sensitive and work with the patient and the advocacy groups that represent them, because they are very critical,” he says.
That extends to clinical trials. Horizon has trials ongoing around the world but, right now, the focus is on patients on trials of the company's pipeline drugs in Ukraine and Belarus.
“We have some impacted there and we have been able to successfully manage most of those patients and continue to treat them,”, he says. “I think you have to give the patient the opportunity, if they want, to stop being in the trial. But the hardest part is making sure the people who want to get treated, get the medicine and make sure they are doing okay. it has been such a devastating situation.
“We’re not starting new trials [in Ukraine] but what you are seeing every multinational do is if they want to continue the trials to get the medicine to them.”
The company has also donated through the Irish Red Cross and some of its staff, including former its former country leader, have taken in Ukrainian families that have arrived in Ireland.
Office team
Even touring the company’s sparkling new office, it is clear that Walbert and his team work to connect with their employees. He got involved personally in the design of the new Dublin office, and the company ensured staff had a major say in how their work areas, where everyone has desks that can be used seated or standing up and where space is generous, were designed and even in the naming of its conference rooms, which focus on Irish lakes and scientists connected with some of the conditions their products treat.
Open and recreational space is available throughout the building, with everything from a “tech bar” where you can meet the tech-support team and play pool or table tennis while they sort out your laptop, to a yoga/mediation space that can double up as a mothers’ room.
“I think it is something everyone cares about individually, because everyone played a part in what ultimately came out,” says Walbert.
There are now 130 people on-site in Stephen’s Green, with capacity for around 206, well shy of the 500 the building was touted as being able to accommodate when it was being marketed. Horizon is determined not to compromise on the open design, but it can already see the need for more space.
“The first thing we did when we came over in October, as this building was just finished, was walk next door and say, ‘Hmm, I wonder can we get more space here?’ because really we are going to outgrow this with our employee growth. The first meeting I had here was really to see whether there was more space near that we could expand to. We are growing faster than we can keep up with.”
The same is true in Waterford, where the company is already eyeing up the potential for the next phase of expansion of the new manufacturing site.
Looking forward 10 years, Walbert sees a dynamic, growing business even more connected with its Irish base.
“I think in that period, we would become a very well-established global company in all the major markets, with our pipeline coming through very nicely and this continuing to be our main hub. I would hope that what we are doing in Waterford is just the beginning of our manufacturing presence. And that this would continue to be the centre of all that, but we would be very global in nature instead of being predominantly US. We are now starting that process.”
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CV
Name: Tim Walbert
Position: Chief executive and chairman of rare disease specialists Horizon Therapeutics
Age: 55
Why is he in the news?: Horizon announced earlier this year that it will sponsor the Irish Open Golf for the next six years and the company has this week formally opened its new global HQ in Dublin's St Stephen's Green.
Family: married with three children, two boys and a girl – and four dogs.
Interests: Golf, unsurprisingly, and coaching. "I coached my kids in every sport they play – soccer, football, baseball, basketball. So it is either the kids, golf and work."
Something you might expect: His interest in rare and autoimmune diseases stems from his own 10-year battle to be diagnosed with a lifelong condition, which also afflicts his younger son.
Something that might surprise: He played a central role in design and look of both the company's new Dublin headquarters and US headquarters building – everything from furniture to branding to landscaping.
