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Msg  35803 of 36616  at  1/23/2021 8:32:21 AM  by

minxmrphd


 In response to msg 35801 by  dartgator
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Re: FDA approves AUPH

 from BIOTECH on twitter:
 
RBC $AUPH FDA approval of voclosporin for active LN
Impact: Positive
First impression
Our take - We expect a positive share price reaction given that Aurinia’s
sole product, voclosporin (brand name LUPKYNIS), is now FDA approved
for the treatment of active lupus nephritis (LN) in adults. Overall, the
FDA product label is essentially in line with our expectations, including
the approval for active LN and potential extended exclusivity. Pricing
was not disclosed. We note that there was potential for approval in all
LN rather than active LN, and the label includes a black box warning,
both of which may be viewed as disappointing by investors but offset
by potential incremental exclusivity. We reiterate our view that Aurinia is
well-positioned to gain market share in this underpenetrated therapeutic
area, with only one other drug FDA-approved for the treatment of
LN (BENLYSTA, approved in Dec. 2020), robust Ph. III data, a sizeable
cash position, and an experienced commercialization team in place. We
compare key voclosporin label items vs. our expectations below.
• Approved for treatment of active LN. This is consistent with our
forecasts which assume an addressable active LN patient population of
~40K/year.
• Label with dosing data likely extends IP runway due to 2037 patent.
An existing patent and added exclusivity give voclosporin exclusivity to
late 2027. Importantly, the FDA product label incorporated a US patent
related to the eGFR dosing used in Aurinia's AURA and AURORA trials,
potentially extending exclusivity through 2037. Our forecasts and US
$20 price target for Aurinia reflect a risk-weighted approach based on
potential for LOE beyond 2027.
• The label includes a black box warning of "Increased risk for
developing malignancies and serious infections with LUPKYNIS or other
immunosuppressants that may lead to hospitalization or death". We
note that this is consistent with many other immunosuppressants.
Aurinia's release did not include details on potential pricing. We
currently assume an annual price of $55K/patient, vs. the company's
previously disclosed potential range of $45-90K. An ICER Draft Evidence
Report published Jan. 22, 2021 assumed average pricing of ~$32K for
voclosporin "based on analysts' estimates" vs. BENLYSTA at ~$42K. We
note that eGFR dosing of voclosporin, which we believe could potentially
apply to ~50% of patients, could result in daily doses of 2/3 or 1/3 of the
starting dose, which would decrease the average price per patient. Our
latest estimates for Aurinia include US product revenues of $110MM in
2021, assuming initial 5% penetration (vs. RBCe 30% peak US penetration)
of a 40K addressable patient population in active LN, at $55K/patient;
lowering this to ~$32K/patient would decrease our US sales estimate
to ~$64MM, similar to the FactSet consensus average of ~$62MM. As

such, pending clarity on pricing from management, we currently believe
consensus appears achievable, and we see upside potential vs. our 5%
penetration assumption with lower pricing. We note that our published
2021 total revenue estimate of $192MM included an assumed $75MM
licensing payment (whereas Aurinia received $50MM in Dec. 2020,
discussed below) and other revenue. For 2022, we currently estimate
product sales of $238MM (consensus $219MM).
Well-positioned to execute on the voclosporin launch. We believe Aurinia
has ample cash to fund the launch and ramp-up of voclosporin. The
company had cash of $421MM as of Q3/20, and in December announced
an EU/Japan licensing agreement with an upfront payment of $50MM
and potential milestone payments of up to $50MM (likely to be largely
received in 2022) upon regulatory approval in these regions. In addition,
Aurinia has built an experienced commercialization team and prepared for
a launch amid COVID-19, including virtual tactics.
Conference call: Monday, Jan. 25 at 8:30am ET. Dial-in: 1-877-407-9170; 


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35816 Re: FDA approves AUPH sling5 7 1/25/2021 12:31:07 PM








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