Stock of Aurinia Pharmaceuticals Inc. AUPH-Q fell to a three-year low Thursday after the Victoria-based company cut its revenue forecast for this year and introduced tepid 2023 guidance for sales of its drug for a severe form of lupus.
The company, once Canada’s most valuable biotechnology company and one of the few here to successfully take a drug to market in years – said it was cutting guidance for 2022 for sales of its drug Lupkynis to between US$100-million and US$105-million. That was down from previous guidance of US$115-million to US$135-million. Aurinia said it also expected Lupkynis revenue of US$120-million to US$140-million in 2023.
Aurinia gained regulatory approval in early 2021 to sell Lupkynis in the U.S. for use in combination with immunosuppressive therapies to treat adults with lupus nephritis (LN), a variant of lupus that occurs when the immune system attacks the kidneys.
The stock was down 28 per cent in mid-afternoon trading Thursday to $5.45, falling to levels last seen in November, 2019, and more than 80 per cent off its 52-week high.
Chief executive officer Peter Greenleaf told analysts on an earnings call that the lower forecast stemmed from fewer patient starts – 374 – in the quarter ended Sept. 30, compared with 412 in the second quarter. He said the drop could have been due to a seasonal dip as patients and doctors went on holiday and the impact of Hurricane Ian on the US southeast – a key market.
“Our internal analysis leads us to believe that these market events are temporary, seasonal or event-driven in nature,” he said.
Aurinia is increasing sales efforts to compel nephrologists and rheumatologists to prescribe the drug and keep patients on it, and recently launched a marketing campaign aimed at patients. “There’s an element of market development that needs to happen” to increase prescription, use and awareness of the drug’s benefits, he said.
There were 1,354 patients on Lupkynis on Sept. 30; about half who start the drug still use it after 12 months. Aurinia booked US$25.5-million in product sales in the third quarter up from US$14.6-million in the same period in 2021.
Bloom Burton analyst David Martin said in an interview that in his conversations with nephrology and rheumatology experts “they definitely see the value of the drug and they see the need to treat these patients who have leaking kidneys, aggressively and fast.” But, he added, “there’s probably going to be more of an education process required at the community level than we had thought initially.” He cut his stock price target to US$10.50 from US$15.50.
Mr. Greenleaf noted Aurinia has $400-million in cash including US$30-million received from licensing partner Otsuka Pharmaceutical Co. Ltd. on Monday after the European Commission granted marketing authorization for Lupkynis to the Japanese company to treat adults with LN in Europe.
“We are well capitalized and we have a great drug that we believe will eventually become a profitable franchise,” he said.