Categories Analysis, Earnings, Health Care

Earnings Preview: Aurinia’s Q4 results pivot on AURORA trial updates

Shares of Aurinia Pharmaceuticals (NASDAQ: AUPH/TSX: AUP) rose 13% on February 25 when the US patent office extended the patent protection for voclosporin till 2037 in treating patients diagnosed with lupus nephritis. Investors cheered up the news as this would give the firm market exclusivity for nearly two decades once the drug gets approved and hits the market.

With the positive momentum, the biopharma firm is scheduled to report its fourth quarter 2018 results on March 19, after the market closes. Street expects Q4 loss to narrow by 8 cents to $0.14 over the prior year, while sales is expected to jump 33% over last year.

Last quarter, the company reported a loss of $18.3 million, which is an increase of $5.2 million over the prior year. Higher losses in the third quarter were mainly due to the revaluation of warrants.

Aurinia is a late-stage biopharma firm focusing on developing and launching drugs in the market for diseases where there is a huge unmet medical need. Currently, its lead product candidate voclosporin is in Phase III clinical trials for treating patients who are suffering from lupus nephritis (LN). Apart from LN, the company is also focused on developing voclosporin treating patients with focal segmental glomerulosclerosis (FSGS), and Dry Eye Syndrome (DES).

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The Phase III clinical trial for the treatment of LN is called AURORA, which is a 56-week trial. With the enrollment complete for the trial, the top-line results are expected in the Q4 of 2019. If all goes well, the company would file a new drug application in 2020 and slated for a launch in the US in 2021.

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Investors would be expecting more insights from the management on how the AURORA trial would be progressing when the management publishes its Q4 results. With huge unmet need, if voclosporin is approved, it has the potential to become a blockbuster drug for the firm. Upon approval, this would become the first drug to be approved for treating LN.

Aurinia is also proceeding with its Phase II trial for renal indication of FSGS. The interim data for the proof of concept showed positive results in January 2019. Based on this the company plans to advance the voclosporin ophthalmic solution for the treatment of DES. The company’s shares have lost nearly 9% in 2019 and have increased by 16% in the last 12 months.

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