How Intra-Cellular surprised Wall Street by breaking character

For drug companies, predicting how much money a product will make is a risky endeavor. If the estimate ends up being far off, then investors may question how well a developer understands its own business or the markets in which it operates. That’s especially true when the prediction is too high.

Analysts on Wall Street were therefore surprised last month to hear Intra-Cellular Therapies, which never much entertained this guessing game, say that its brain-rebalancing drug Caplyta would reach $5 billion in annual sales sometime in the next decade. This year alone, the New Jersey-based company expects $665 million to $685 million in net product sales from Caplyta.

“We kept getting asked,” said Sharon Mates, Intra-Cellular’s founder and CEO. “So we said, ‘Okay, why not tell you? Here it is.’”

Intra-Cellular’s stock price has subsequently risen by 13%, adding to a steady incline that, over the past five years, took shares from less than $10 apiece to above $85.

Known scientifically as lumateperone, Caplyta is already approved to treat schizophrenia and bipolar depression, and could be cleared for major depressive disorder as early as next year. Intra-Cellular licensed the drug from Bristol Myers Squibb in 2005, just a few years after the company formed and right as big pharma really started backing away from neuroscience and psychiatry. Now, the company has about 530 sales reps and plans to expand again in preparation for the move into major depression.

Mates spoke to BioPharma Dive about how her company scored a rare win in a notoriously tough research field, and how it intends to deliver on that lofty sales goal.

The following conversation has been edited and condensed for clarity.

BIOPHARMA DIVE: How did you first identify lumateperone as a potential medicine and then build a company around it?

SHARON MATES: I met Paul Greengard. He had just won his Nobel Prize and wanted to start a company based not just on cell surface receptors, but on downstream processing — what happens after the cell surface, how these signals come together, how they integrate.

The first thing I did was hire chemists, biologists. Some of our chemists knew chemists at Bristol, where they had stopped their neuroscience programs. The mantra in those days was you have to keep pushing the dose higher and higher until you get all these movement disturbances, and then you go back down. We showed through intracellular signaling … why you don’t need to have that profile. That’s how development started.

Given the mechanism of action, we thought lumateperone’s first indication would be schizophrenia. [But our research also found] we were effectively able to treat [schizophrenia patients’] depression. That’s what started us down mood disorders, which includes bipolar and major depressive disorder.

We received our first approval in December of 2019 and were preparing to launch the drug in 2020. We were going to fly everybody — 500-plus people — out to Arizona for our sales and launch meeting. Two weeks before, people were coming back from a Biogen meeting, all very sick. We said, “What are we doing here? We’re not sending all these people only for everybody to get sick and come back. We’re going to go virtual.”

We may have been, if not the first, one of the first to do a 100% virtual launch in pharmaceuticals. And remember, this was a challenging time for everybody, let alone a company that had never launched a product before.

Two years later, we received our first label expansion for bipolar depression. We were going to 43,000 healthcare providers before. We just late this year increased, so that we’re … addressing over 70,000. And we’ll expand again, anticipating approval in MDD next year.

Intra-Cellular formed around the time big pharma really began stepping back from psychiatry and neuroscience. How difficult was it to get investor buy-in?

It wasn’t easy in the beginning. Everybody was walking away, or had already walked away from neuroscience. But to me, that’s the time to get into something if you have conviction and believe in it. We knew there were patients [in need], and we thought we could develop better medicines.

We were very lucky. We were able to do several rounds of financing. Then we went public in 2014. Now we rely on our revenue base.

Do you think it would be harder for a young psychiatry company to follow Intra-Cellular’s trajectory today?

No, it’s just different. Other than lumateperone, all the compounds that we’re bringing forward, we discovered.

Today, most companies, they’re bringing in molecules from other companies that have already had substantial amounts of research go into them. They’re much further along than a structure on a piece of paper, which, when I went in … that’s what it was. They had done a few preclinical experiments. But it was really, really early.

Why have you tested your drug in this order in mood disorders? Why did you go for something like bipolar depression before a larger indication like MDD?

It’s a good question.

Every one of these drugs that has gone into mood disorders, they did start out in schizophrenia. And the reason is to give you some sense of where your dosing lies. There was one company, Memory Pharmaceuticals, that had a drug with a different mechanism of action. They thought they could go directly for bipolar. They did, and they failed. The company basically was destroyed, and they sold to Roche for $50 million.

I don’t even know whatever came of the molecule, but now there are companies with different mechanisms of action looking to not be in schizophrenia. That’s probably because schizophrenia is the smallest market of all these indications. There are about 2.6 million patients, bipolar is four to five times that size, and MDD is even larger.

Schizophrenia is absolutely an entry point, but one that is important. There’s a huge unmet need in all of these disorders. That’s historically why everybody started in schizophrenia, to understand the lay of the land.

An analyst once told me specialty neurology isn’t a very challenging category to launch a drug in, since the need for additional treatments is high and prescribers are often open to trying new things. Would you agree?

It’s true psychiatry is a prescribed area. But psychiatrists spend more time with their patients. Primary care doctors — you’re lucky if they’re spending eight minutes per patient these days. So it depends.

In every area, you have rapid adopters who, the minute a drug gets approved, want to give it to people. Then you have those on the other end of the spectrum, who say, “No, I’m going to wait two to three years until a lot of people have tried it.” And then you’ve got the middle, who are those doctors who’ll give it to one or two patients, see how they do, then increase to three or four, then keep increasing.

I’m not sure I would put this in any different category, other than it’s a prescribed group of caregivers who understand the need to be trying new medicines.

One question we used to get was, “Now you have an approved drug, but why do you think you can compete in the marketplace against the big guys?” And we said, “because we believe the product speaks for itself, and the efficacy, safety and tolerability demonstrate the attributes of the molecule over other molecules.”

As long as we can hire talented people, build a good team and have an equal share of voice in the marketplace — which means keep up with the DTC, keep up with the streaming — then the product speaks for itself. If you watch television, you see our ads and Vraylar ads and Rexulti ads. We’re all there.

That conviction raised eyebrows recently, when Intra-Cellular said Caplyta could be a $5 billion drug. Why offer a projection like that, since it puts a magnifying glass on execution?

What we said is we think, over the next 10 years, it’s a $5 billion opportunity for us. That means we think it actually could be bigger over more time.

Why did we do that now? You’ve probably heard we’re a pretty conservative company. Before we had conviction in our revenue guidance, we didn’t give revenue guidance, even though we kept getting told by Wall Street, “where’s your revenue guidance?” Once we had been in the marketplace, we could see where we were going. We could do our projections. We were comfortable giving revenue guidance, and for this year, we’re $665 million to $685 million.

From day one, we’ve gotten, “What’s your market opportunity? Or, what’s your peak sales?” As we built our base and our forecasts, we let the public know because we think that’s very important to our investors as well as to the general public.

At least some large drugmakers appear interested in neuroscience again and are investing. Does your company get more inbounds about partnerships and deals now? Is big pharma knocking down your door?

From day one, we have talked to people about partnerships. My mission is to go about building a company, and our team’s mission is to do the same. We will always do what’s in the best interest of our shareholders.

I think great companies, they’re bought, they’re not sold. We’re spending our time building our company. However, we always entertain inbound offers, and that includes different kinds of partnerships, different strategic options. We look at all of them, and we’ll continue to do so.

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