Full Press Release Details
Reports Third Quarter 2022 Financial Results
was $16.2M for 3Q22 including profit-sharing revenue of $7.4M from KORSUVA (difelikefalin) injection -
demand for KORSUVA injection driven by large dialysis organizations with ~180,000 vials shipped -
scheduled in 4Q22 to discuss potential pivotal program in notalgia paresthetica -
call today at 4:30 p.m. ET -
Nov. 7, 2022 - 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 third quarter ended September 30, 2022.
KORSUVA (difelikefalin) injection in the U.S. accelerated in the third quarter, reflecting the strong launch performance and our
product's value proposition for chronic kidney disease (CKD) patients undergoing hemodialysis who are suffering from pruritus,"
said Christopher Posner, President and Chief Executive Officer of Cara Therapeutics. "Positive momentum has also been building
internationally with the European launches in Austria and Germany, as well as approvals in Canada, Singapore and Switzerland during the
third quarter. In addition, we are pleased that our partner in Japan has submitted a New Drug Application for the approval of difelikefalin
injection, with a decision expected in the second half of 2023."
Mr. Posner continued,
"On the clinical development front, we continue to enroll patients in our two Phase 3 oral difelikefalin programs. We also look
forward to our meeting with the FDA to discuss a potential pivotal program in notalgia paresthetica. As a result of slow enrollment due
primarily to Covid-19, we made the strategic decision to discontinue our proof-of-concept Phase 2 study in pruritus associated with primary
biliary cholangitis (PBC). Although we did not observe anything in this study that would preclude us from moving forward in this indication,
we plan to focus our resources on maximizing the potential of our promising nephrology and dermatology franchises. With the strong traction
we achieved during the third quarter, we believe we are well positioned to drive long-term growth and establish Cara Therapeutics as
the leader in the treatment of chronic pruritus."
and Recent Developments:
Chronic Kidney Disease-Associated Pruritus: Hemodialysis
generated net sales of $16.2 million and the Company recorded profit-sharing revenue of $7.4 million in the third quarter of 2022. Wholesaler
shipments to dialysis centers increased from 1,812 vials in the second quarter of 2022 to 184,440 vials in the third quarter of 2022,
driven primarily by large dialysis organizations.
quarter of 2022, the Company's partner CSL Vifor commenced the European launch of Kapruvia starting with Austria and Germany.
In addition, KORSUVA was approved by Health Canada and the Health Sciences Authority in Singapore. It was also approved by the Swiss
Agency for Therapeutic Products under the brand name Kapruvia. Approval is expected in Australia within the coming months.
the Company's licensing partner Maruishi Pharmaceutical Co., Ltd. submitted a New Drug Application in Japan for the approval of
difelikefalin injection for the treatment of pruritus in hemodialysis patients. A final decision on the application is expected in the
second half of 2023.
Notalgia Paresthetica
Company's Phase 2 trial of oral difelikefalin for the treatment of moderate-to-severe pruritus in notalgia paresthetica (NP) were
presented during a late-breaking news session at the 31st European Academy of Dermatology and Venereology (EADV) Congress
in September 2022, as well as the Company's virtual NP event in September 2022. The data demonstrate that the onset of action with
oral difelikefalin is as early as Day 1 and the duration of effect is sustained throughout the active extension period to Week 12.
scheduled to meet with the U.S. Food and Drug Administration (FDA) this month to discuss next steps toward a potential pivotal program
for oral difelikefalin in NP.
Chronic Liver Disease-Associated Pruritus: Primary Biliary Cholangitis
Based on slow enrollment
due primarily to Covid-19, the Company made a strategic decision to discontinue and unblind the proof-of-concept Phase 2 clinical trial
of oral difelikefalin for the treatment of pruritus in patients with primary biliary cholangitis (PBC).
The unblinded data showed no unexpected adverse events. However, the low number of patients (N=14) limits the ability to draw
a meaningful conclusion regarding the efficacy (WI-NRS change from baseline at 16 weeks: DFK -3.8 vs. placebo -3.0) of difelikefalin
in this patient population.
Pruritus Associated with Non-Dialysis Dependent Advanced Chronic Kidney Disease
of oral difelikefalin is enrolling patients with advanced CKD stages 4 or 5 with moderate-to-severe pruritus who are not on dialysis.
The Phase 3 program is comprised of two identical 12-week, double-blind, placebo-controlled studies, known as KICK 1 and KICK 2. The
Company expects to report topline results in the second half of 2024.
of oral difelikefalin as an adjunctive therapy to topical corticosteroids is enrolling atopic dermatitis (AD) patients with moderate-to-severe
pruritus. The program is comprised of two studies, known as KIND 1 (Part A and Part B) and KIND 2. At
the end of the KIND 1 Part A 12-week treatment period, the Company expects to have an internal data readout to inform the dose and sample
size to initiate KIND 1 Part B and KIND 2. KIND 1 Part B and KIND 2 are both double-blind, controlled, 12-week studies with patients
allowed to roll over to 52-week open-label safety extensions. The internal readout for KIND 1 Part A is expected in the second half of
2023 and topline results for both KIND 1 Part B and KIND 2 are expected in the first half of 2025.
the Company announced the appointment of Ryan Maynard as Chief Financial Officer.
the Company announced the appointment of Lisa von Moltke, M.D., to its Board of Directors.
to present at the following upcoming investment conferences:
Conference, November 15-16
Healthcare Conference, November 15-17
Evercore ISI Healthcare
Conference, November 29-December 1
Piper Sandler Healthcare
Conference, November 29-December 1
2022 Financial Results
Cash, cash equivalents
and marketable securities on September 30, 2022 totaled $179.5 million compared to $236.8 million at December 31, 2021. The decrease
in the balance primarily resulted from $55.2 million of cash used in operating activities.
For the third quarter
of 2022, net loss was $23.2 million, or $(0.43) per basic and diluted share, compared to net loss of $1.0 million, or ($0.02) per basic
and diluted share, for the same period in 2021.
Total revenue was $10.8 million and $20.3 million for the three months ended September 30, 2022 and 2021, respectively. Revenue consisted
Sold: Cost of goods sold of $3.1 million related to commercial supply revenue for KORSUVA injection sales to Vifor during the three
months ended September 30, 2022. There was no cost of goods sold during the three months ended September 30, 2021, as commercialization
of KORSUVA injection began in April 2022.
Development (R&D) Expenses: R&D expenses were $24.7 million for the three months ended September 30, 2022 compared to $15.5
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 consultant costs, and a $5.0 million milestone payment due to Enteris Biopharma, Inc. during the three months ended September
Administrative (G&A) Expenses: G&A expenses were $6.9 million for the three months ended September 30, 2022 compared to $5.9
million in the same period of 2021. The higher G&A expenses in 2022 were principally due to increases in accounting and auditing
fees and payroll related costs, partially offset by a decrease in stock-based compensation expense.
net: Other income, net was $0.7 million for the three months ended September 30, 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 the Company's
portfolio of investments during the three months ended September 30, 2022, and a decrease in net amortization expense of available-for-sale
securities during the three months ended September 30, 2022.
its current unrestricted cash and cash equivalents and available-for-sale marketable securities will be sufficient to fund its currently
anticipated operating plan into the first half of 2024. This guidance assumes KORSUVA revenue profit share contribution consistent with
what the Company has reported for the quarter ended September 30, 2022.
About 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 novel 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 initiated its Phase 3 programs for the treatment of pruritus in patients with non-dialysis dependent advanced chronic kidney
disease and atopic dermatitis. The Company has completed a Phase 2 proof-of-concept trial 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
contained in this press release regarding matters that are not historical facts are "forward-looking statements" within