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
first quarter ended March 31, 2023.
“The U.S. and global launches of KORSUVA®
(difelikefalin) injection / Kapruvia® gained momentum in the first
quarter of 2023. Trends in vial shipments indicate a significant
acceleration in demand, and feedback from providers and patients
continues to be positive,” said Christopher Posner, President and
Chief Executive Officer of Cara Therapeutics. “On the clinical
development front, our three ongoing late-stage oral difelikefalin
programs across our nephrology and dermatology franchises are
progressing well. We are acutely focused on the execution of our
clinical programs and committed to maximizing the potential of
difelikefalin to address the unmet need for an oral therapy to
treat moderate-to-severe chronic pruritus associated with advanced
chronic kidney disease, atopic dermatitis, and notalgia
paresthetica. Looking ahead, we expect the internal readout from
Part A of our KIND 1 atopic dermatitis trial in the fourth quarter
of 2023 and will continue to build on our positive momentum to
drive long-term growth.”
1Q23 and Recent Highlights
- Kapruvia launched in France,
Finland, the Netherlands, and Switzerland
- Enrollment continued in the KIND
Phase 3 program in atopic dermatitis 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 chronic kidney disease (CKD) with
topline results expected in 2H24
- Results from the KOMFORT Phase 2
trial of oral difelikefalin in notalgia paresthetica (NP) were
published in the New England Journal of Medicine
- Initiation of the KOURAGE Phase 2/3
program of oral difelikefalin for the treatment of
moderate-to-severe pruritus in patients with NP; internal readout
from Part A expected in 2H24 and final topline results for the
program expected in 1H26
- Results from the Phase 2 trial of
oral difelikefalin in CKD patients with moderate-to-severe pruritus
were published in the Journal of the American Academy of
Dermatology
- The Company released its inaugural
Environmental, Social, and Governance (ESG) report
KORSUVA Injection Launch Update:
1Q23
In the first quarter of 2023, KORSUVA injection
generated net sales of $5.7 million and the Company recorded
collaborative revenue of $2.8 million, which represented the
Company’s share of the profit from sales of KORSUVA injection.
Wholesalers shipped 45,720 vials to dialysis
centers, the majority of which were Fresenius clinics, during the
first quarter of 2023. Vial orders more than doubled quarter to
quarter, signifying an acceleration in patient demand.
In the first quarter of 2023, Kapruvia generated
$1.2 million in net sales and the Company recorded $125,000 in
royalty revenue associated with Kapruvia sales in Europe. Kapruvia
launched in four additional countries in Europe, namely France,
Finland, the Netherlands, and Switzerland. The Company expects
additional launches to commence over the next 12-18 months.
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 conferences:
- Jefferies Healthcare Conference,
June 7-9
- Stifel Boston Bus Tour, June
21
First Quarter 2023 Financial
Results
Cash, cash equivalents and marketable securities
at March 31, 2023 totaled $123.4 million compared to $156.7 million
at December 31, 2022. The decrease in the balance primarily
resulted from $34.6 million of cash used in operating
activities.
For the first quarter of 2023, net loss was
$26.7 million, or $(0.49) per basic and diluted share, compared to
net loss of $27.7 million, or ($0.52) per basic and diluted share,
for the same period in 2022.
Revenues: Total revenue was $6.2 million and
$4.8 million for the three months ended March 31, 2023 and 2022,
respectively. Revenue primarily consisted of:
- $2.8 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
March 31, 2023. There was no collaborative revenue during the three
months ended March 31, 2022.
- $3.2 million and $4.8 million of
commercial supply revenue related to sales of KORSUVA injection to
CSL Vifor during the three months ended March 31, 2023 and 2022,
respectively.
- Approximately $125,000 of royalty
revenue related to our royalties on the net sales of Kapruvia in
Europe and other countries during the three months ended March 31,
2023. There was no royalty revenue during the three months ended
March 31, 2022.
Cost of Goods Sold: Cost of goods sold was $2.6
million and $2.1 million for the three months ended March 31, 2023
and 2022, respectively, related to commercial supply revenue for
KORSUVA injection sales to CSL Vifor. There was no associated cost
of goods sold recorded for commercial supply revenue of $2.3
million in January 2022 as all inventory costs were incurred prior
to receipt of regulatory approval of KORSUVA injection, and
accordingly, were expensed as incurred.
Research and Development (R&D) Expenses:
R&D expenses were $24.3 million for the three months ended
March 31, 2023 compared to $21.3 million in the same period of
2022. The higher R&D expenses in 2023 were primarily due to
increases in direct clinical trial costs related to our three
late-stage development programs.
General and Administrative (G&A) Expenses:
G&A expenses were $6.9 million for the three months ended March
31, 2023 compared to $9.3 million in the same period of 2022. The
lower G&A expenses in 2023 were primarily due to higher
stock-based compensation expense recorded during the three months
ended March 31, 2022 for the modification of our former CEO’s
equity awards, and certain performance-based restricted stock units
that vested during the first quarter of 2022.
Other Income, net: Other income, net was
approximately $985,000 for the three months ended March 31, 2023
compared to approximately $162,000 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 March 31, 2023, and an
increase in accretion income from our available-for-sale marketable
securities.
Financial Guidance
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 the second 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
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, 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, 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) |
|
|
March 31, |
|
December 31, |
|
|
|
2023 |
|
|
|
2022 |
|
Assets |
|
|
|
|
Current assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
47,391 |
|
|
$ |
63,741 |
|
Marketable securities |
|
|
66,892 |
|
|
|
81,658 |
|
Accounts receivable, net - related party |
|
|
6,066 |
|
|
|
3,260 |
|
Inventory, net |
|
|
3,515 |
|
|
|
2,383 |
|
Income tax receivable |
|
|
697 |
|
|
|
697 |
|
Other receivables |
|
|
495 |
|
|
|
496 |
|
Prepaid expenses |
|
|
17,195 |
|
|
|
16,267 |
|
Restricted cash |
|
|
408 |
|
|
|
408 |
|
Total current assets |
|
|
142,659 |
|
|
|
168,910 |
|
Operating lease right-of-use
assets |
|
|
1,175 |
|
|
|
1,551 |
|
Marketable securities, non-current |
|
|
9,074 |
|
|
|
11,350 |
|
Property and equipment,
net |
|
|
368 |
|
|
|
426 |
|
Total assets |
|
$ |
153,276 |
|
|
|
182,237 |
|
|
|
|
|
|
Liabilities and
stockholders’ equity |
|
|
|
|
Current liabilities: |
|
|
|
|
Accounts payable and accrued
expenses |
|
$ |
15,222 |
|
|
$ |
21,540 |
|
Operating lease liabilities,
current |
|
|
1,456 |
|
|
|
1,918 |
|
Total current liabilities |
|
|
16,678 |
|
|
|
23,458 |
|
|
|
|
|
|
Commitments and contingencies |
|
|
- |
|
|
|
- |
|
|
|
|
|
|
Stockholders' equity: |
|
|
|
|
Preferred stock |
|
|
- |
|
|
|
- |
|
Common stock |
|
|
54 |
|
|
|
53 |
|
Additional paid-in capital |
|
|
730,542 |
|
|
|
726,630 |
|
Accumulated deficit |
|
|
(592,897) |
|
|
|
(566,232) |
|
Accumulated other comprehensive loss |
|
|
(1,101) |
|
|
|
(1,672) |
|
Total stockholders’
equity |
|
|
136,598 |
|
|
|
158,779 |
|
Total liabilities and
stockholders’ equity |
|
$ |
153,276 |
|
|
$ |
182,237 |
|
CARA THERAPEUTICS, INC.CONDENSED
STATEMENTS OF OPERATIONS(amounts in thousands, except
share and per share data)(unaudited) |
|
|
Three Months Ended March 31, |
|
|
2023 |
|
2022 |
|
|
|
|
|
Revenue |
|
|
|
|
Collaborative revenue |
|
$ |
2,750 |
|
|
$ |
- |
|
Commercial supply revenue |
|
|
3,191 |
|
|
|
4,790 |
|
Royalty revenue |
|
|
125 |
|
|
|
- |
|
Clinical compound revenue |
|
|
99 |
|
|
|
- |
|
Total Revenue |
|
|
6,165 |
|
|
|
4,790 |
|
|
|
|
|
|
Operating Expenses |
|
|
|
|
Cost of goods sold |
|
|
2,590 |
|
|
|
2,081 |
|
Research and development |
|
|
24,334 |
|
|
|
21,273 |
|
General and administrative |
|
|
6,891 |
|
|
|
9,347 |
|
Total Operating Expenses |
|
|
33,815 |
|
|
|
32,701 |
|
Operating Loss |
|
|
(27,650) |
|
|
|
(27,911) |
|
|
|
|
|
|
Other income, net |
|
|
985 |
|
|
|
162 |
|
Net loss |
|
$ |
(26,665) |
|
|
$ |
(27,749) |
|
|
|
|
|
|
Net loss per share: |
|
|
|
|
Basic and diluted |
|
$ |
(0.49) |
|
|
$ |
(0.52) |
|
|
|
|
|
|
Weighted average shares: |
|
|
|
|
Basic and diluted |
|
|
53,872,038 |
|
|
|
53,507,060 |
|
|
|
|
|
|
|
|
|
|
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)
Historical Stock Chart
From Mar 2024 to Apr 2024
Cara Therapeutics (NASDAQ:CARA)
Historical Stock Chart
From Apr 2023 to Apr 2024