Aurinia Pharmaceuticals loss narrowed in Q1; AURORA trial on track

Aurinia Pharmaceuticals (NASDAQ:AUPH / TSX:AUP) narrowed its loss in the first quarter. Post the Q1 results, stock rose 2% in the after-market trading. The company’s stock has lost 11% this year after touching a new 52-week high of $7.85 in January 2019.

The late-stage biopharma firm reaffirmed that AURORA Phase III trial update is on track, which is good news for investors. Last month, Peter Greenleaf took over as CEO from Richard Glickman who retired in November 2018.

Q1 Performance

For the first quarter, the company reduced its loss to $12.4 million compared to $15.5 million in the prior year. Loss per share stood at $0.14, reduction of $0.04 from last year. Analysts were expecting a loss of $0.15 per share.

Revenue of $30,000 was flat year-over-year. However, this is lower than the $50,000 expected by the street. The company ended the quarter with cash and cash equivalents of $140.4 million over $117.9 million in the prior year period. Research and development expenses rose 19% due to the ongoing clinical trials.

Focus on Unmet Medical Need

Aurinia is focused on developing and launching drugs in the market for diseases where there is a huge unmet medical need. Along those lines, the company is currently conducting trials for patients who are suffering from lupus nephritis (LN).

The company is also focused on developing voclosporin in treating patients with focal segmental glomerulosclerosis (FSGS), and Dry Eye Syndrome (DES) indications.

Trial Updates

The lead product candidate voclosporin is in Phase III clinical trials now (AURORA) and the results are expected in the fourth quarter of 2019. If all goes well, new drug application will be filed in 2020 and the drug is slated for the US launch by early 2021.

Since there is a huge unmet need in the LN space, analysts expect voclosporin to become a blockbuster drug ($1 billion in sales per year). If approved by the FDA, this is the first drug to get the nod for treating LN patients.

Phase II trials are ongoing for renal indication of FSGS, which was started in June 2018. The interim data for the proof of concept showed positive results in January 2019. FSGS is a rare disease which affects kidneys, if not treated would lead to kidney damage and renal failure. Patient enrollment is expected to take 1 year.

In July 2018, Aurinia started Phase II trials for treating DES patients with voclosporin ophthalmic solution (VOS). The Phase 2a trial done against Restasis from Allergan were mixed. Aurinia plans to start Phase II/III trials by late 2019 to get the nod from FDA for DES. It’s worth noting that there are 16 million people who are impacted by DES just in the US, which shows there is huge potential for VOS to become a blockbuster drug.

Last quarter, the biopharma firm reported a loss of $0.17 per share compared to $0.04 loss per share in the prior year. Revenue dropped to $29 million from $30 million in the prior-year quarter.

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