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
second quarter ended June 30, 2023.
“In the second quarter of 2023, the
commercialization of KORSUVA® (difelikefalin) injection in the U.S.
and Kapruvia® in countries around the world continued to make
meaningful progress. We believe the increased vial shipments and
reorder rates in the U.S., as well as the positive feedback from
providers and patients globally, confirm the significant need for
an anti-pruritic treatment for chronic kidney disease (CKD)
patients,” said Christopher Posner, President and Chief Executive
Officer of Cara Therapeutics. “In June, CMS issued the CY2024 ESRD
PPS proposed rule, providing clarity around the reimbursement of
KORSUVA injection post its TDAPA period. While we were pleased that
CMS included additional funding outside the bundle rate in the
proposed rule, we will continue to work with CMS on refining the
reimbursement methodology ahead of the release of the final rule,
which is expected in the fourth quarter of 2023.”
Mr. Posner continued, “On the development front,
we are pleased with the progress of our late-stage oral
difelikefalin programs for pruritus associated with atopic
dermatitis (AD), advanced CKD and notalgia paresthetica (NP). All
three trials are enrolling patients and the internal readout from
Part A of our KIND Phase 3 program in AD is expected in the fourth
quarter of 2023. As the key driver of our long-term value, we are
focused on advancing the development of oral difelikefalin in our
nephrology and medical dermatology franchises and remain steadfast
in our commitment to establishing Cara Therapeutics as the leader
in the treatment of chronic pruritus.”
2Q23 and Recent Highlights
- England’s National Institute for
Health and Care Excellence (NICE) recommended Kapruvia® for the
treatment of moderate-to-severe chronic kidney disease-associated
pruritus (CKD-aP) in adult patients on hemodialysis
- Enrollment continued in the KIND
Phase 3 program in AD with the internal readout from Part A
expected in 4Q23 and final topline results for the program expected
in 1H25
- Enrollment continued in the KICK
Phase 3 program in advanced CKD with topline results expected in
2H24
- KOURAGE Phase 2/3 program of oral
difelikefalin for the treatment of moderate-to-severe pruritus in
patients with NP is ongoing; internal readout from Part A is
expected in 2H24 with final topline results for the program
expected in 1H26
KORSUVA Injection Launch Update:
2Q23
United States
In the second quarter of 2023, KORSUVA injection
generated net sales of $11.4 million and the Company recorded
collaborative revenue of $5.4 million, which represented the
Company’s share of the profit from sales of KORSUVA injection.
Wholesalers shipped 66,852 vials to dialysis
centers, the majority of which were Fresenius clinics, during the
second quarter of 2023. Vial orders increased 46% quarter to
quarter, indicating an acceleration in patient demand.
In June 2023, the Centers for Medicare &
Medicaid Services (CMS) issued a proposed rule for the End Stage
Renal Disease Prospective Payment System (ESRD PPS) for calendar
year 2024, which addresses the reimbursement of KORSUVA injection
after its Transitional Drug Add-On Payment Adjustment (TDAPA)
period. The final rule is expected in the fourth quarter of
2023.
International
In the second quarter of 2023, Kapruvia
generated $1.2 million in net sales and the Company recorded
$123,000 in royalty revenue associated with Kapruvia sales in
Europe.
Seven EU countries have launched Kapruvia to
date, and the Company expects additional launches to commence over
the coming months. In May 2023, England’s NICE recommended Kapruvia
for the treatment of moderate-to-severe CKD-aP in adult patients on
hemodialysis.
The Company continues to expect its licensing
partner Maruishi Pharmaceutical Co., Ltd. to receive a regulatory
decision from the Pharmaceuticals and Medical Devices Agency (PMDA)
in Japan in the second half of 2023.
Upcoming Meeting Activities
The Company expects to present at the following
upcoming investor conferences:
- Canaccord Genuity 43rd Annual
Growth Conference, August 7-10
- Stifel Biotech Summer Summit,
August 14-15
- H.C. Wainwright Global Investment
Conference, September 11-13
Second Quarter 2023 Financial
Results
Cash, cash equivalents and marketable securities
at June 30, 2023 totaled $101.7 million compared to $156.7 million
at December 31, 2022. The decrease in the balance primarily
resulted from $55.1 million of cash used in operating
activities.
For the second quarter of 2023, net loss was
$31.5 million, or $(0.58) per basic and diluted share, compared to
net loss of $4.2 million, or $(0.08) per basic and diluted share,
for the same period in 2022.
Revenues: Total revenue was $6.9 million and
$23.0 million for the three months ended June 30, 2023 and 2022,
respectively. Revenue primarily consisted of:
- $5.4 million and $8.0 million of
collaborative revenue related to our share of the profit from CSL
Vifor’s sales of KORSUVA injection to third parties during the
three months ended June 30, 2023 and 2022, respectively;
- $1.4 million of commercial supply
revenue related to sales of KORSUVA injection to CSL Vifor during
the three months ended June 30, 2023. There was no commercial
supply revenue during the three months ended June 30, 2022;
- Approximately $123,000 of royalty
revenue related to our royalties on the net sales of Kapruvia in
Europe during the three months ended June 30, 2023. There was no
royalty revenue during the three months ended June 30, 2022;
and
- There was no license and milestone
revenue during the three months ended June 30, 2023. We recorded
$15.0 million in milestone revenue related to the approval of
Kapruvia by the European Commission in April 2022 during the three
months ended June 30, 2022.
Cost of Goods Sold: Cost of goods sold was $1.4
million during the three months ended June 30, 2023, related to
commercial supply revenue for KORSUVA injection sales to CSL Vifor.
There was no associated cost of goods sold during the three months
ended June 30, 2022 as there was no commercial supply revenue from
CSL Vifor.
Research and Development (R&D) Expenses:
R&D expenses were $30.3 million for the three months ended June
30, 2023 compared to $19.9 million in the same period of 2022. The
higher R&D expenses in 2023 were primarily due to increases in
clinical trial costs related to our three late-stage development
programs partially offset by a decrease in stock-based compensation
expense.
General and Administrative (G&A) Expenses:
G&A expenses were essentially flat at $7.5 million for the
three months ended June 30, 2023 compared to $7.6 million in the
same period of 2022.
Other Income, net: Other income, net was
approximately $861,000 for the three months ended June 30, 2023
compared to approximately $266,000 in the same period of 2022. 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 June 30, 2023.
Financial Guidance
We expect 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 for at least the next 12 months.
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 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
Statements contained in this press release
regarding matters that are not historical facts are
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. Examples of these
forward-looking statements include statements concerning the
Company’s and its partners’ ongoing commercialization of and
ability to successfully commercialize KORSUVA injection and
Kapruvia, future revenue and profit share from sales of KORSUVA and
Kapruvia, planned future regulatory submissions and potential
future regulatory approvals, potential for post-TDAPA reimbursement
of KORSUVA and timing of final rules related thereto, future
product launches, the performance of the Company’s commercial
partners, including CSL Vifor, expected timing of the initiation,
enrollment and data readouts from the Company’s planned and ongoing
clinical trials, the potential results of ongoing clinical trials,
timing of future regulatory and development milestones for the
Company’s product candidates, the potential for the Company’s
product candidates to be alternatives in the therapeutic areas
investigated and the potential for oral difelikefalin to address
additional pruritic indications, the size and growth of the
potential markets for pruritus management, the Company’s
participation in certain conferences and the Company’s expected
cash reach. Because such statements are subject to risks and
uncertainties, actual results may differ materially from those
expressed or implied by such forward-looking statements. These
risks and uncertainties include the risks inherent in the launch of
new products, including that our commercial partners, including CSL
Vifor, may not perform as expected, risks inherent in the clinical
and regulatory development of pharmaceutical products, and the
risks described more fully in Cara Therapeutics’ filings with the
Securities and Exchange Commission, including the “Risk Factors”
section of the Company’s Annual Report on Form 10-K for the year
ending December 31, 2022 and its other documents subsequently filed
with or furnished to the Securities and Exchange Commission,
including its Form 10-Q for the quarter ended March 31, 2023. All
forward-looking statements contained in this press release speak
only as of the date on which they were made. Cara Therapeutics
undertakes no obligation to update such statements to reflect
events that occur or circumstances that exist after the date on
which they were made, except as required by law.
Financial tables follow
|
CARA THERAPEUTICS, INC. |
CONDENSED BALANCE SHEETS |
(in thousands) |
(unaudited) |
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
|
2023 |
|
2022 |
|
|
|
Assets |
|
|
|
|
Current
assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
58,249 |
|
|
$ |
63,741 |
|
Marketable securities |
|
|
36,442 |
|
|
|
81,658 |
|
Accounts receivable, net - related party |
|
|
10,124 |
|
|
|
3,260 |
|
Inventory, net |
|
|
3,420 |
|
|
|
2,383 |
|
Income tax receivable |
|
|
697 |
|
|
|
697 |
|
Other receivables |
|
|
420 |
|
|
|
496 |
|
Prepaid expenses |
|
|
14,976 |
|
|
|
16,267 |
|
Restricted cash |
|
|
408 |
|
|
|
408 |
|
Total current
assets |
|
|
124,736 |
|
|
|
168,910 |
|
Operating lease right-of-use assets |
|
|
792 |
|
|
|
1,551 |
|
Marketable securities, non-current |
|
|
7,053 |
|
|
|
11,350 |
|
Property and equipment, net |
|
|
308 |
|
|
|
426 |
|
Restricted cash, non-current |
|
|
1,500 |
|
|
|
- |
|
Total assets |
|
$ |
134,389 |
|
|
$ |
182,237 |
|
|
|
|
|
|
Liabilities and stockholders’ equity |
|
|
|
|
Current
liabilities: |
|
|
|
|
Accounts payable and accrued expenses |
|
$ |
24,475 |
|
|
$ |
21,540 |
|
Operating lease liabilities, current |
|
|
982 |
|
|
|
1,918 |
|
Total current
liabilities |
|
|
25,457 |
|
|
|
23,458 |
|
|
|
|
|
|
Commitments and
contingencies |
|
|
- |
|
|
|
- |
|
|
|
|
|
|
Stockholders’
equity: |
|
|
|
|
Preferred stock |
|
|
- |
|
|
|
- |
|
Common stock |
|
|
54 |
|
|
|
53 |
|
Additional paid-in capital |
|
|
733,984 |
|
|
|
726,630 |
|
Accumulated deficit |
|
|
(624,376 |
) |
|
|
(566,232 |
) |
Accumulated other comprehensive loss |
|
|
(730 |
) |
|
|
(1,672 |
) |
Total
stockholders’ equity |
|
|
108,932 |
|
|
|
158,779 |
|
Total liabilities
and stockholders’ equity |
|
$ |
134,389 |
|
|
$ |
182,237 |
|
|
CARA THERAPEUTICS, INC. |
CONDENSED STATEMENTS OF OPERATIONS |
(amounts in thousands, except share and per share data) |
(unaudited) |
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
2023 |
|
2022 |
|
2023 |
|
2022 |
|
|
|
|
|
Revenue: |
|
|
|
|
|
|
|
|
Collaborative revenue |
|
$ |
5,410 |
|
|
$ |
8,003 |
|
|
$ |
8,160 |
|
|
$ |
8,003 |
|
Commercial supply revenue |
|
|
1,400 |
|
|
|
- |
|
|
|
4,591 |
|
|
|
4,790 |
|
Royalty revenue |
|
|
123 |
|
|
|
- |
|
|
|
248 |
|
|
|
- |
|
License and milestone fees |
|
|
- |
|
|
|
15,000 |
|
|
|
- |
|
|
|
15,000 |
|
Clinical compound revenue |
|
|
- |
|
|
|
- |
|
|
|
99 |
|
|
|
- |
|
Total revenue |
|
|
6,933 |
|
|
|
23,003 |
|
|
|
13,098 |
|
|
|
27,793 |
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Cost of goods sold |
|
|
1,418 |
|
|
|
- |
|
|
|
4,008 |
|
|
|
2,081 |
|
Research and development |
|
|
30,310 |
|
|
|
19,905 |
|
|
|
54,644 |
|
|
|
41,178 |
|
General and administrative |
|
|
7,545 |
|
|
|
7,570 |
|
|
|
14,436 |
|
|
|
16,917 |
|
Total operating
expenses |
|
|
39,273 |
|
|
|
27,475 |
|
|
|
73,088 |
|
|
|
60,176 |
|
Operating
loss |
|
|
(32,340 |
) |
|
|
(4,472 |
) |
|
|
(59,990 |
) |
|
|
(32,383 |
) |
|
|
|
|
|
|
|
|
|
Other income,
net |
|
|
861 |
|
|
|
266 |
|
|
|
1,846 |
|
|
|
428 |
|
Net loss |
|
|
(31,479 |
) |
|
|
(4,206 |
) |
|
|
(58,144 |
) |
|
|
(31,955 |
) |
|
|
|
|
|
|
|
|
|
Net loss per
share: |
|
|
|
|
|
|
|
|
Basic and
Diluted |
|
$ |
(0.58 |
) |
|
$ |
(0.08 |
) |
|
$ |
(1.08 |
) |
|
$ |
(0.60 |
) |
|
|
|
|
|
|
|
|
|
Weighted average
shares: |
|
|
|
|
|
|
|
|
Basic and
Diluted |
|
|
54,002,988 |
|
|
|
53,614,668 |
|
|
|
53,937,875 |
|
|
|
53,561,161 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
MEDIA CONTACT:Annie Spinetta6
Degrees973-768-2170aspinetta@6degreespr.com
INVESTOR CONTACT:Iris Francesconi, Ph.D.Cara
Therapeutics203-406-3700investor@caratherapeutics.com
Cara Therapeutics (NASDAQ:CARA)
과거 데이터 주식 차트
부터 4월(4) 2024 으로 5월(5) 2024
Cara Therapeutics (NASDAQ:CARA)
과거 데이터 주식 차트
부터 5월(5) 2023 으로 5월(5) 2024