Victoria, BC’s Aurinia is currently focused on developing voclosporin to treat lupus nephritis, dry eye syndrome and FSGS. The stock virtually doubled overnight in December with news from an AURORA Phase 3 trial for lupus nephritis (LN) which showed voclosporin to significantly improve renal response rates in patients after one year of treatment.
That was followed up by a February 25 pre-NDA meeting with the US FDA which accepted a rolling submission for voclosporin with the filing expected to be completed by the end of Q2 and a final decision from the FDA in early 2021.
Aurinia released its fourth quarter and full year 2019 results last Thursday.
“Beyond the impact voclosporin could bring to those living with LN, we continue to evaluate voclosporin in additional indications, including the rare kidney disease, FSGS, as well as for the potential management of dry eye syndrome,” Chief Medical Officer Neil Solomons said. “During the second half of
2020, we anticipate reporting new data from both of these development programs, consisting of interim data from the exploratory Phase 2 FSGS study and results from the Phase 2/3 AUDREY DES trial evaluating 3 concentrations of VOS compared to vehicle alone.”
On the quarterly results — $0.0 million in revenue and a net loss of $76.5 million or $0.78 per share — Uddin said at this stage the financials are less important than clinical progress.
Nonetheless, the net loss was bigger than his forecast of negative $11.8 million or negative $0.12 per share. The analyst said the difference was composed of higher operating expenses and two non-cash items of $55.2 million in total. Uddin noted that AUPH finished the year with zero debt and $306 million in cash, enough to fund the company into 2021 when voclosporin should launch.
The increased operating expenses raised Uddin’s estimates, where he is now calling for fiscal 2020 revenue and fully diluted EPS of $0.1 million and negative $0.68 per share.
In his report to clients on Friday, Uddin mused about a possible takeout of Aurinia.
“AUPH recently expanded its commercial team with five key hires in the anticipation of the voclosporin launch – which begs the question were there any bids to buy the company?” Uddin said.
“We are maintaining our ‘SPECULATIVE BUY’ rating but reducing our target price from $24.00 to $22.00 after factoring in the December equity financing (US$192 million at $15.00/share) and revising our operating expense estimates. Our valuation is based on applying a new 35x P/E to our new 2021 EPS estimate of $0.63 per share. We are using a high multiple due to the assumption that voclosporin would be a major new product launch in early 2021,” Uddin wrote.
As of publication date, the analyst’s $22.00 target represented a projected one-year return of 17 per cent.
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