Roundtable ‘rounds up’ keys for success

Strategies for successful U.S. market entry in health care and life science sectors

MICHAEL KLEINER
Business and Sports Editor
The Norwegian American

What do health-care, life-sciences, biotech, and pharmaceutical companies in Norway need to know before entering the U.S. market? What are the challenges, misconceptions, and regulations? How do they seek investors and protect intellectual property?

A March 31 virtual roundtable on “Strategies for Successful U.S. Market Entry,” attempted to answer these questions. AmCham Norway, WorldUpStart, Norwegian American Chamber of Commerce Philadelphia, Nordic Consulting, Innovation Norway, Eversana, Scan MedPartners, and Burkland Associates sponsored the event.

WorldUpStart is a Philadelphia-based company that has a virtual accelerator program. Co-host Frode Kjersem, managing director of Nordic Consulting and past president of NACC Philadelphia, noted that in two years, WorldUpStart has “graduated 48 international companies, and 16 have settled in the United States, four have had drugs approved by the FDA (Food and Drug Administration), and overall, companies raised $70 million.”

Karina Sotnik, CEO of WorldUpStart was the moderator.

 

Karina Sotnik: What are the typical misconceptions when it comes to companies entering the U.S. market, from an Innovation Norway perspective, with emphasis on life sciences?

 

Jannik Grodt Schmidt, head of Life Science USA, Innovation Norway 

Jannik Grodt Schmidt cited three key areas: First, is setting too low a goal when raising funds, making the company unattractive to investors.

“They come over to the United States with a low target and they don’t fit into the brackets,” said Schmidt. “They are trying to raise funds for A rounds so they don’t fit into venture capitalist mentality. They end up having to scramble to get their money from angel investors and family officers, which sometimes is more complicated. The tendency is not wanting to build companies at a fast pace. They end up getting outpaced by U.S. companies that are bolder and have high risk-taking behavior.”

Second, is underestimating the market complexities and cost of administering them.

“That cost goes from finding and engaging with your KOLs (key opinion leaders), managing regulatory environments, getting through market access processes, understanding proper reimbursement, and engaging with experts in the market, such as lawyers and consultants,” said Schmidt. “Hiring your talent here is way more complicated than in the European setting and costs way more money than you would ever expect,” said Schmidt.

His third point is culture. There are differences between America and the Nordics.

“We all watch Hollywood movies and think we know the American audience and the American business culture,” said Schmidt. “Once you’re here, you’ll find out it’s very different. Bring in U.S. salespeople and U.S. leadership as fast as possible and make it a good mix of American and Nordic employees running your endeavor.”

 

Sotnik: What is the biggest hurdle for startups and well-established pharma companies?

 

Mike Ryan, executive vice president, Europe, EVERSANA

Mike Ryan said companies overcomplicate the United States; are reticent in breaking into the American marketplace; may undertake activities in the wrong order; are committed more to the goal of selling the product and/or company, and they don’t commercialize.

“Often their fundraising will start in order to get clinical approval,” said Ryan. “At this juncture, getting clinical approval is no good until you actually start getting reimbursed and earning revenue from your product. Many people take a different path. ‘We’re going to sell the company or the product.’ I’d rather see companies develop the products and take them commercial. To be able to harness the enthusiasm and the drive that got the products to market authorization in the first instance and turn that into commercial, to me, makes absolute sense. Nobody understands a product better than the company that developed it.

“Eversana did a study and found companies tend to overthink and overspend when it comes to commercialization in the United States. Our evidence suggests that, on average, a company launching a product in the United States needs a war chest of about $345 million to build up and maintain capacity over a certain period of time. What we would like to get people thinking about is that you can build an infrastructure, but you can outsource a lot of work. For companies to harness their experience, develop themselves, then think about ways to bring on partners that can provide the services to commercialize while retaining the brand and ownership of that brand at the pharmaceutical company level.

“Biotech is the future of development–90% of drugs that are developed in oncology right now are developed by biotech companies. Not only do you need to think about getting the product through FDA approval in the United States but also the investment required to get it to market. I’m not saying you’re not going to end up selling your company or product and recouping your investment, but what I’m saying is that companies that take into account the effort and cost of commercialization ultimately will see considerably more success.

“Even if they do decide to exit, it creates a much bigger value proposition for the company. The United States is the largest market in the world, and there is no error focusing on that as your first key market entry point. The return on investment is extremely high.”

 

Sotnik: Intellectual property strategy has to figure in overall strategy for many businesses. Can you touch on strategies companies need to think about when it comes to IP issues when looking at the U.S. market?

 

Christopher Halliday, partner, DLA Piper

The stark intellectual property difference between the United States and Europe is that, in the United States, ownership resides with the inventor, whereas in Europe, it automatically reverts to the company or employer.

“Here we like to see executed assignments of intellectual property to the company,” said Christopher Halliday. “That means an actually signed assignment showing that the inventors have transferred their personal rights to the company. We’ve seen assignments that weren’t executed. That raises red flags and issues that need to be investigated further for the company.

“The investors want to know that you are the owner of the thing they are investing in. Here, even years down the road, someone can say ‘I’m the inventor of that technology and they never got the assignment.’ If true, that person is 100% owner of the intellectual property, particularly the patents, that you are holding out as an asset of your company. Now, the investment gets split, or you go belly up, so you want to get that nailed down as early as possible that the ownership rights in your intellectual property are set and explicitly retained in the company.”

 

Sotnik: Many speakers touched on how companies coming from the Nordics misunderstand how much money they need to raise. What are the other common misconceptions that you see (as an investor)?

 

Glen Gaddy, managing member of Robin Hood Ventures, Mid-Atlantic Angel Investor group

Glen Gaddy notes companies need to align expectations and outcomes; know their request of the investor; know what stages investors will consider investing; have a strong story and a roadmap to success.

“I invest at the earliest of stages,” said Gaddy. “Hopefully, they’ve gotten their intellectual property lined up, but they may not have much more than that. Then, we need the narrative, which needs to be really focused on the alignment of what you’re raising with, where it’s getting you, and the pathway to world domination. If coming to us is part of that, that’s what we need to hear.

“You’re going to create a sustainable business by being in the United States. We want to figure out how we can help with that. It’s money, expertise, connections, local knowledge. Investors want to be able to contribute to that because we want to be smart money, not just money. Getting to that place is going to be very important for any company coming to America.

“Coming to the right sources of capital as opposed to the rich sources of capital. It’s an important differentiation. Don’t talk to angels if you need to raise tens of millions of dollars. Don’t talk to VCs if you’re too early for them. Understanding where you are, what you’re asking for, and where you fit within the American investor community is paramount to not wasting a huge amount of time and resources.”

 

Sotnik: A lot of health-care and pharma companies misunderstand how to market their products in the United States. Can you give us a quick snapshot of what is the biggest difference between the health care in the United States and health care elsewhere, in terms of marketing?

 

Norris Turner, president & CEO, Turner Healthcare Quality Consulting

Norris Turner noted several pros and cons but also highlighted opportunity. First, the main difference is most of Europe has a single payer health insurance system which is unified, and America doesn’t, which creates a challenge in gaining traction in the market.

“In the United States, we often say, ‘look at the U.S. health-care system,’ but that’s a misnomer,” said Turner. “It’s not a system because it’s so decentralized, fragmented. That has both positives and negatives. When you have a single payer plan, and you blow it, then where do you go?

“There’s opportunity within the market this size, this complex, this decentralized around health care. There’s opportunity when you recognize you have to make strategic choices ‘I’m coming to the United States.’ Why? How’s that playing a role? Then when you’ve made that decision, you need to understand this market.”

Who better to start with than the people who will benefit most from your product?

“One of the places to start is with the patients, their journey, where the unmet need is for the patients themselves, their caregivers and the people who provide care,” said Turner. “Where are system level issues in terms of the types of treatments that are unaffordable? ‘I’m coming into a market like this so what does that mean for us versus people who are already playing a role in this?’ It allows you to start thinking about market segmentation. ‘Where are we going to go relative to where we’re not going to go? Where do we start versus where we’re building toward?’

“The United States is predominantly fee for service. There’s a service, there’s a payment for value and value has an equation to it, quality over cost. How is the intervention or technology you’re bringing impacting quality as measured versus cost and who are those stakeholders that’s impacting? It really allows you to understand the value you’re bringing to key buyers.

“Then knowing what motivates buying. What motivates them wanting to use your intervention versus what problems are you causing by bringing that intervention? If you’re causing a problem, causing disruption, how are you solving that while you’re also solving the problem you’re bringing, maybe in workflow, while you’re also bringing new level quality of care and improved outcomes.”

Turner also recommended connecting with innovation centers that are usually aligned with health systems or universities, to establish an anchor in the United States.

 

Sotnik: You help many companies enter the U.S. market. What would be your biggest insights and pitfalls to give to companies?

 

Arne Madsen, president, Scan MedPartners

Among the services his company provides “is finding a high value U.S. partner for the Scandinavian company that is looking for synergistic value to add to their portfolio products.” Companies spend time looking for distributors and rushing to reach IPO exit rather than “thinking about your commercial strategy…and investing in expertise.”

Sotnik: Companies come to United States and spend millions of dollars without reaching any significant milestones. As someone who provides financial expertise, what would be your recommendations?

 

Daniel Rosenbaum, consulting CFO, Burkland Associates

“From a financial standpoint, make sure that you’ve got enough cash runway to deal with unanticipated expenses…How many months of operating costs do you need to have? One thing that’s often underestimated is the speed with which other U.S. companies are competitors, and how they will react to your entry. It’s probably going to be faster than you think…it will impact the derivative difficulty in market entry, which means more expenses.

“It’s also hard to get your message out to your audience…be careful about underestimating your market expenses. The United States is also a fairly litigious business environment and that translates to expenses … The United States … has 50 different state tax structures or regulatory laws that impact where you incorporate, how you incorporate. All those things can have an impact later on.”

 

The next accelerator program starts Sept. 12. See worldupstart.com/online-program.

 

This article originally appeared in the May 27, 2022, issue of The Norwegian American. To subscribe, visit SUBSCRIBE or call us at (206) 784-4617.