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To breakeven based on a quarterly expense run rate of $32M, or report $0.00 EPS, they need to sell K-IV in the US to cover ~12,000 patients (based on administration of 3 vials/week, 12 week quarters at $150). This would be the baseline to help immunize the fluctuating and variability of the milestone payments.
This is achievable given the US CKD-Ap population of 150,000-200,000
Second Quarter and Recent Developments:
KORSUVA Injection: Chronic Kidney Disease-Associated Pruritus: Hemodialysis
In April 2022, the Company and its commercial partner, Vifor, launched KORSUVA (difelikefalin) injection in the U.S. for the treatment of moderate-to-severe pruritus associated with chronic kidney disease (CKD) in adults undergoing hemodialysis. KORSUVA injection generated net sales of $16.8 million in the second quarter of 2022, translating into $8 million in profit-sharing revenue for Cara. Wholesalers shipped 1,812 vials driven by independent and midsize dialysis organizations.
In the second quarter, the Company received the $15 million regulatory milestone payment triggered by the April 2022 European Commission approval of Kapruvia® (difelikefalin) for the treatment of moderate-to-severe pruritus associated with CKD in adult hemodialysis patients. Also in April 2022, Kapruvia was approved in the UK. The Company expects the commercial launches of Kapruvia to commence in certain European markets in the second half of 2022.
Second Quarter 2022 Financial Results
Cash, cash equivalents and marketable securities at June 30, 2022 totaled $204.7 million compared to $236.8 million at December 31, 2021. The decrease in the balance primarily resulted from $30.0 million of cash used in operating activities.
For the second quarter of 2022, net loss was $4.2 million, or $(0.08) per basic and diluted share, compared to net loss of $30.7 million, or ($0.61) per basic and diluted share, for the same period in 2021.
Revenues: Total revenue was $23.0 million for the three months ended June 30, 2022. There was no revenue during the same period of 2021. Revenue consisted of:
$15.0 million of license and milestone fees revenue, related to the regulatory milestone payment for the approval of Kapruvia by the European Commission in April 2022 during the three months ended June 30, 2022; and
$8.0 million of collaborative revenue, related to the profit-sharing revenue from Vifor’s sales of KORSUVA injection to third parties during the three months ended June 30, 2022.
Up big in premarket!!!
I had expected -$0.03 with the $15M milestone payment from the ACSS nations but this remains outstanding.
Overall a good quarter.
$$$
Additionally, the 1,812 vials distributed is also the equivalent to K-IV administration to a mere 50 patients which is low. I suspect that this may have been a test/launch at a single dialysis center.