Praluent Stay Not Enough To Save Regeneron

A soft fourth quarter from Regeneron (NASDAQ:REGN), marked by weaker than expected Praluent and Eylea sales, has put the company on the back foot again. It had been celebrating a stay against the injunction handed to its rival Amgen (NASDAQ:AMGN) in January – but the latest sales figures suggest that Praluent is already falling behind Repatha.

Amgen’s PCSK9 inhibitor booked $58m in Q4, compared with $41m in the same period for Praluent. The emergency stay, pending appeal, removes the worst-case scenario for Regeneron: that Praluent would be forced off the market by February 21. But its PCSK9 troubles seem far from over.

Even so, bullish comments on two expected new launches this year in the form of Dupixent and sarilumab must have done the trick, as Regeneron’s share price edged higher this morning.

The PCSK9 appeal could take four to 10 months, Amgen has said. In the meantime, the company will try to push its advantage with Repatha – namely, a positive cardiovascular outcomes study result (Fourier love all around as Repatha improves outcomes, February 3, 2017).

No one knows just how good the data are yet – all will be revealed at the American College of Cardiology meeting in Washington on March 17 – but Regeneron is some way behind as it is not expecting to complete its Odyssey Outcomes trial until the end of the year.

As for the appeal, Regeneron chief executive Len Schleifer still seems confident in prevailing, maintaining during the earnings call that Amgen’s asserted patent claims are invalid. However, investors are likely to be more cautious about Regeneron and Sanofi’s (NYSE:SNY) chances, Leerink analysts noted.

Eyes down

Meanwhile, disappointing sales of Eylea, which Regeneron had preannounced at January’s JP Morgan meeting, look set to continue. The company’s 2017 guidance forecasts single digit percentage growth over last year, implying sales of $3.36-3.62bn, below EvaluatePharma consensus of $3.65bn.

Mr. Schleifer would not give more specific figures for Eylea, listing the errors that can impact forecasting, but he did acknowledge that the guidance was “rather broad”. He added: “I think there’s growth still to be had in new indications, and growth outside the US with Bayer.”

Regeneron put the lackluster guidance down to a normal slowing in sales for a maturing product, but efforts to breathe new life into Eylea have not gone as smoothly as hoped. A co-formulation with the anti-PDGF therapy rinucumab failed to show a benefit in phase II in wet age-related macular degeneration last year (Regeneron failure is one in the eye for Ophthotech, October 3, 2016).

The group has already pivoted to REGN910-3, a co-formulation with nesvacumab, which targets angiopoietin-2, which is set for phase II read outs in diabetic macular edema and AMD this year. Regeneron also highlighted non-proliferative diabetic retinopathy as the next growth driver for Eylea; results from the phase III Panorama trial are due early next year.

Mr. Schleifer concluded: “We know how important Eylea is, so we’re going to defend and try to extend that.” However, with two of its big marketed therapies disappointing, the pressure is now on upcoming products like Dupixent and sarilumab to deliver.

Project

Trial

ID

REGN910-3

Ruby

Onyx

NCT02712008

NCT02713204

Eylea

Panorama

NCT02718326

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