Full Press Release Details
Announces Fourth Quarter and Full Year 2022 Financial Results
total revenue was $3.3 million including collaborative revenue of $1.1 million from the Company's share of profit of KORSUVA (difelikefalin) injection; FY22 revenue was $41.9 million including collaborative revenue of $16.6 million -
momentum across first four EU launches; Global rollout to accelerate with most EU countries launching in 2023 -
- Phase 2/3 clinical program of oral difelikefalin
in NP initiated in 2023; NDD CKD and AD programs tracking to expectations with internal readout from KIND 1 Part A expected in 2H23 -
- Conference call today at 4:30 p.m. EST
STAMFORD, Conn., Mar. 6, 2023 - Cara
Therapeutics, Inc. (Nasdaq: CARA), a commercial-stage biopharmaceutical company leading a new treatment paradigm to improve the lives
of patients suffering from pruritus, today announced financial results and operational highlights for the fourth quarter and full year
ended December 31, 2022.
"As the U.S. launch of KORSUVA (difelikefalin)
injection continues to progress, we are encouraged by the positive feedback from providers and patients. During the fourth quarter of
2022, we saw both new clinic and repeat orders driving product uptake, bolstering our confidence in KORSUVA's long-term potential,"
said Christopher Posner, President and Chief Executive Officer of Cara Therapeutics. "The rollout of Kapruvia in Europe has
continued to gain momentum and we look forward to the acceleration of global launches throughout 2023. In addition, we continue to expect
a regulatory decision from the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan in the second half of 2023."
Mr. Posner continued, "With the recent initiation
of our Phase 2/3 clinical program of oral difelikefalin for moderate-to-severe pruritus in patients with notalgia paresthetica (NP), we
now have three ongoing late-stage programs. As we focus on maximizing the potential of difelikefalin for the treatment of chronic pruritus
associated with multiple indications, we are confident that our pipeline in a product together with our strong financial foundation will
drive long-term growth across our nephrology and dermatology franchises and create significant value for our shareholders."
2022 and Recent Highlights
KORSUVA Injection Launch Update: 4Q22 &
In the fourth quarter of 2022, KORSUVA injection
generated net sales of $2.3 million and the Company recorded collaborative revenue of $1.1 million, which represented the Company's
share of the profit from sales of KORSUVA injection. The Company also recorded $72,000 in royalty revenue associated with Kapruvia sales
in Europe. For the full year 2022, KORSUVA injection generated net sales of $35.3 million and the Company recorded collaborative revenue
In the fourth quarter of 2022, wholesalers shipped
20,844 vials to dialysis centers following initial inventory building in the third quarter of 2022, predominantly at Fresenius clinics.
For the full year 2022, wholesalers shipped 207,096 vials to dialysis centers.
The Company expects launches in countries in Europe
to continue in 2023, following launches of Kapruvia in Austria, Germany, and Sweden during the fourth quarter of 2022.
With the approval of Kapruvia in Australia in
the fourth quarter of 2022, all four Access Consortium countries have approved the product. The Company expects launches to commence in
Canada, Singapore, Switzerland, and Australia over the next 12-18 months. The product is approved under the brand name KORSUVA in Canada
In Japan, the Company continues to expect its
licensing partner Maruishi Pharmaceutical Co., Ltd. to receive a regulatory decision from the PMDA in the second half of 2023.
Upcoming Meeting Activities
The Company expects to present at the following
upcoming conferences:
Fourth Quarter and Full Year 2022 Financial
Cash, cash equivalents and marketable securities
at December 31, 2022 totaled $156.7 million compared to $236.8 million at December 31, 2021. The decrease in the balance primarily resulted
from $78.7 million of cash used in operating activities.
For the fourth quarter of 2022, net loss was $30.3
million, or $(0.56) per basic and diluted share, compared to net loss of $33.4 million, or $(0.63) per basic and diluted share, for the
same period in 2021.
Revenues: Total revenue was $3.3 million
and $0.8 million for the three months ended December 31, 2022 and 2021, respectively. Revenue primarily consisted of:
Cost of Goods Sold: Cost of goods sold
of $2.1 million related to commercial supply revenue for KORSUVA injection sales to CSL Vifor during the three months ended December 31,
2022. There was no cost of goods sold during the three months ended December 31, 2021, as commercialization of KORSUVA injection began
Research and Development (R&D) Expenses:
R&D expenses were $26.0 million for the three months ended December 31, 2022 compared to $22.8 million in the same period of 2021.
The higher R&D expenses in 2022 were principally due to increases in direct clinical trial costs and related consultants' costs,
and increases in payroll and related costs. R&D expenses in the three months ended December 31, 2021 included a $5.0 million milestone
paid to Enteris Biopharma, Inc., or Enteris.
General and Administrative (G&A) Expenses:
G&A expenses were $6.4 million for the three months ended December 31, 2022 compared to $11.5 million in the same period of 2021.
The lower G&A expenses in 2022 were principally due to a decrease in stock-based compensation expense as a result of expense relating
to the modification of our former CEO's equity awards during the three months ended December 31, 2021.
Other Income, net: Other income, net was
$1.0 million for the three months ended December 31, 2022 compared to $0.1 million in the same period of 2021. The increase in other income,
net was primarily due to an increase in interest income resulting from a higher yield on our portfolio of investments during the three
months ended December 31, 2022.
For the full year ended December 31, 2022, net
loss was $85.5 million, or $(1.59) per basic and diluted share, compared to net loss of $88.4 million, or $(1.74) per basic and diluted
share for the full year ended December 31, 2021.
Revenues: Total revenue was $41.9 million
and $23.0 million for the full years ended December 31, 2022 and 2021, respectively. Revenue primarily consisted of:
Cost of Goods Sold: Cost of goods sold
of $7.3 million related to commercial supply revenue for KORSUVA injection sales to CSL Vifor during the year ended December 31, 2022.
There was no cost of goods sold during the year ended December 31, 2021, as commercialization of KORSUVA injection began in April 2022.
Research and Development (R&D) Expenses:
R&D expenses were $91.9 million for the full year ended December 31, 2022 compared to $82.7 million for the full year ended December
31, 2021. The higher R&D expenses in 2022 were principally due to increases in direct clinical trial costs and related consultant
costs, payroll and related costs, and travel costs. R&D expenses in the year ended December 31, 2022 and 2021 included milestones
of $5.0 million and $15.0 million, respectively, earned by Enteris.
General and Administrative (G&A) Expenses:
G&A expenses were $30.3 million for the full year ended December 31, 2022 compared to $29.4 million for the full year ended December
31, 2021. The increase in 2022 was primarily due to increases in payroll and related costs, accounting and auditing fees, and consultants'
costs, partially offset by decreases in stock-based compensation expense as a result of expense relating to the modification of our former
CEO's equity awards during the year ended December 31, 2021.
Other Income, net: Other income, net was
$2.1 million for the full year ended December 31, 2022 compared to $0.6 million for the full year ended December 31, 2021. The increase
in other income, net was primarily due to an increase in interest income resulting from a higher yield on our portfolio of investments
during the year ended December 31, 2022, and a decrease in net amortization expense of available-for-sale marketable securities during
the year ended December 31, 2022.
Cara expects that our current unrestricted cash
and cash equivalents and available-for-sale marketable securities, including collaborative revenue from our share of the profit from KORSUVA
injection, will be sufficient to fund our currently anticipated operating plan into at least the first half of 2024.
About Cara Therapeutics
Cara Therapeutics is a commercial-stage biopharmaceutical
company leading a new treatment paradigm to improve the lives of patients suffering from pruritus. The Company's KORSUVA (difelikefalin)
injection is the first and only FDA-approved treatment for moderate-to-severe pruritus associated with chronic kidney disease in adults
undergoing hemodialysis. The Company is developing an oral formulation of difelikefalin and has Phase 3 programs ongoing for the treatment
of pruritus in patients with non-dialysis dependent advanced chronic kidney disease and atopic dermatitis. In addition, the Company has
initiated a Phase 2/3 program of oral difelikefalin for the treatment of moderate-to-severe pruritus in patients with notalgia paresthetica.
For more information, visit www.CaraTherapeutics.com and follow the company on Twitter, LinkedIn and Instagram.
Forward-looking Statements