Health behemoth CSL sheds $7b in value after heart drug fails trial

Australia’s biggest healthcare company has disappointed investors a day out from posting its half-year results after the development of one of its anticipated drugs failed to deliver in a late-stage trial.

On Monday, CSL announced that its CSL112 drug, developed for patients who have suffered from a heart attack to reduce the risk of another major adverse heart event, did not effectively deliver its desired result after 90 days.

Bill Mezzanotte said the study of CSL’s heart drug was the most ambitious in the company’s history.

CSL executive vice president Bill Mezzanotte said the study of the drug, which was in its third phase, was the most ambitious in the company’s history.

“We plan to apply [the enhanced capabilities we developed for this study] as well as our plasma protein platform to future unmet medical need in cardiovascular and metabolic conditions as well as those in our other strategic therapeutic areas,” he said.

The blood plasma treatments maker, which shed more than $7 billion of its value on Monday, is due to release its half-year results on Tuesday. Shares in the company were trading nearly 5 per cent lower following the trial results.

While CSL said there were no major safety or tolerability concerns with CSL112, it said there were no plans for a near-term regulatory filing, which is required for a product to receive approval for wider distribution.

UBS analyst Dr Laura Sutcliffe said she would be surprised to see any further development of the molecule in a wide population.

“If there is a compelling subgroup, perhaps further development with smaller or shorter studies is an option, but this is rarely the outcome at this stage,” she said. “CSL112 was the next major clinical catalyst for CSL, so at this point, the challenge for the company may be to signpost clearly how the equity story will develop.”

CSL said it had excluded any financial contribution from CSL112 in its forward-looking estimates and statements, and said it did not expect any material financial impact after the study ended.

Sutcliffe said UBS had not included CSL112 sales in its modelling of the biotech company. However, she said some on the buy side may have been on the fence and mindful of the potential of the drug.

“As such, we would not be surprised to see the shares wobble today, but we do not expect a change in fundamental views,” she said.

Mezzanotte said there remained substantial work to fully analyse and understand the data from the study, and to determine whether there was a development path ahead.

Harvard Medical School cardiologist C. Michael Gibson said he would continue to analyse the findings and share the full results from the study in coming months. The main results will be presented at the American College of Cardiology Scientific Sessions on April 6.

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