3 variables of Xcopri ahead of US release

SK Biopharm announces launch of Xcopri in the 2nd quarter

The key is how the direct sales strategy affects conservative prescription trends

SK Biopharm's most anticipated product, Xcopri (Cenobamate) is making its debut soon in the US.

 

SK Biopharm aims to release the US in the second quarter There are three major variables that will determine Xcopri's success of the US market.

 

Its competitive effect with existing leading products such as 'Vimpat', conservative prescription trends, and direct sales influence.

 

It is very optimistic on the stock market.

 

It is expected to increase from about ₩30 billion in 2020, the first year of launch, to ₩155.1 billion in 2021 and ₩257.5 billion by 2022.

 

◆Seizure suppression effect is better than ₩1.5 trillion 'Vimpat' First is a competitive drug.

 

When Xcopri is released, it is expected to compete with UCB's Vimpat.

 

Vimpat has annual sales of ₩1.5 trillion in the US market.

 

Vimpat is classified as a third generation epilepsy treatment.

 

It is prescribed for intractable patients who do not improve with existing primary and secondary treatments.

 

This intractable patient is estimated to be around 30% of the total.

 

Currently, there are about 3.33 million people with epilepsy in the United States.

 

Arithmically, more than 1 million people use third-generation drugs.

 

In clinical trials, the efficacy and effectiveness of Xcopri have been shown to be ahead.

 

Xcopri has demonstrated superior seizure suppression effects in its control trial with Vimpat.

 

The median frequency of seizures in Xcopri was 55% in Study 013·17.

 

Given that 20~40% of competing drugs, including Vimpat, Xcopri is competitive enough as a new drug.

 

In addition, complete seizure loss effect that was not found in other products is also observed.

 

In the relevant trials, 28% of the treated groups had a complete seizure loss.

 

In addition, the expansion of indications in 2023 is another factor that adds expectations.

 

Xcopri currently has indications for partial seizures only.

 

The successful completion of clinical trials for ongoing systemic seizures is expected to increase indications as early as 2023.

 

SK Biopharm

◆Conservative trends, how much will change Second is the uniqueness of the US market.

 

Efficacy itself has a comparative advantage, but it may not lead directly to earnings.

 

Like South Korea, US physicians are said to be conservative in changing prescriptions.

 

It is predicted that it will be hard to skip the proven effects and safety based on 10 years of experience.

 

The US healthcare system, which is built around private insurance, will also be a factor.

 

According to how each insurer evaluates Xcopri, it will affect the doctor's prescription to some extent.

 

The key is the drug price.

 

Depending on the price of Xcopri, private insurers are expected to evaluate the value of Xcopri differently.

 

◆Direct sales, ‘like a double-edged sword’ Third is the sales distribution network.

 

SK Biopharm has declared direct entry into the US for the first time among the domestic pharmaceutical industry.

 

The company intends to have a local distribution network without a sales contract.

 

SK Biopharm's direct sales are attributed to the disease characteristics of epilepsy.

 

There are not many patients, and the doctors who care for them are more limited.

 

In fact, there are between 12,000 and 14,000 neurologists who deal with epilepsy in the United States.

 

As few doctors prescribe most prescriptions, SK Biopharm expects to build a sales network that closely marks them.

 

It is pointed out that this direct sales strategy is like a double-edged sword.

 

It is clear that direct sales can maximize profit margins.

 

But it is also true how strange new drug companies will be in the conservative US healthcare system.

 

A pharmaceutical industry official said, "It is difficult to predict the results because it is the first time a Korean pharmaceutical company is directly challenged in the United States.

 

It depends on how quickly the doctor's prescription pattern for Vimpat, which has been used in the past 10 years, is quickly converted to Xcopri".

 

It is very optimistic on the stock market.

 

In a recent report, Yuanta Securities expects sales to exceed ₩1 trillion in 2023, the fourth year in the US.