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, 2023.
“We are pleased to have closed our non-dilutive
financing transaction with HealthCare Royalty, which extends our
cash runway into 2025,” said Christopher Posner, President and
Chief Executive Officer of Cara Therapeutics. “This financing will
help us reach key clinical catalysts which we believe will validate
the potential of our oral difelikefalin pipeline.”
Mr. Posner continued, “We look forward to
releasing topline efficacy and safety data from Part A of our KIND
1 atopic dermatitis (AD) trial in December. Our other two
late-stage clinical programs for the treatment of pruritus
associated with advanced chronic kidney disease (CKD) and notalgia
paresthetica (NP) are on track for key data readouts in 2024. We
will continue to focus on maintaining a strong balance sheet and
delivering on our commitments across our wholly owned
pipeline.”
3Q23 and Recent Highlights
- Entered into Royalty Interest
Purchase and Sale Agreement with HealthCare Royalty (HCRx) for up
to $40 million, extending Cara’s cash runway into 2025
- Topline efficacy and safety data
from Part A of the KIND 1 Phase 3 program in pruritus associated
with AD expected in December 2023
- Enrollment on track in the KICK
Phase 3 program in pruritus associated with advanced CKD, with
topline results expected in 2H24
- Enrollment also on track in the
KOURAGE Phase 2/3 program in NP, with readout from Part A targeted
in 2H24 and final topline results for the program in 1H26
- Findings from the Neuropathic Itch
Patient Survey (NIRVE) were reported in an oral presentation at the
EADV Congress 2023
- Centers for Medicare & Medicaid
Services issued the CY 2024 End Stage Renal Disease Prospective
Payment System final rule
- Helen M. Boudreau was appointed to
the Company’s Board of Directors and will serve as Chair of the
Audit Committee
- Harrison M. Bains retired from the
Company’s Board of Directors
KORSUVA Injection U.S. Update:
3Q23
In the third quarter of 2023, KORSUVA injection
generated net sales of $4.4 million and the Company recorded
collaborative revenue of $1.9 million, which represented the
Company’s share of the profit from sales of KORSUVA injection.
Wholesalers shipped 90,828 vials to dialysis
centers during the third quarter of 2023. Vial orders increased 36%
quarter to quarter.
In October 2023, the Centers for Medicare &
Medicaid Services (CMS) issued a final rule for the End Stage Renal
Disease Prospective Payment System (ESRD PPS) for calendar year
2024, which confirmed the TDAPA period for KORSUVA injection until
March 31, 2024, and maintained the reimbursement methodology from
the June 2023 proposed rule.
Upcoming Meeting Activities
The Company expects to present at the following
upcoming investor conferences:
- Stifel Healthcare Conference,
November 15, 2023, at 10:55 a.m. EST
- Jefferies London Healthcare
Conference, November 16, 2023, at 8:00 a.m. GMT
- Piper Sandler Healthcare
Conference, November 29, 2023, at 4:30 p.m. EST
Third Quarter 2023 Financial
Results
Cash, cash equivalents and marketable securities
at September 30, 2023 totaled $83.3 million compared to $156.7
million at December 31, 2022. The decrease in the balance primarily
resulted from $74.7 million of cash used in operating
activities.
For the third quarter of 2023, net loss was
$28.0 million, or $(0.52) per basic and diluted share, compared to
net loss of $23.2 million, or $(0.43) per basic and diluted share,
for the same period in 2022.
Revenues: Total revenue was $4.9 million and
$10.8 million for the three months ended September 30, 2023 and
2022, respectively. Revenue consisted of:
- $1.9 million and $7.4 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 September 30, 2023 and 2022, respectively. In
addition, $0.5 million of collaborative revenue was recognized
during the three months ended September 30, 2023. This amount
relates to an allocated portion of the regulatory milestone payment
we earned in September 2023 from Maruishi Pharmaceuticals Co. Ltd,
or Maruishi, for the marketing approval in Japan for KORSUVA
injection;
- $1.3 million and $3.4 million of
commercial supply revenue related to sales of KORSUVA injection to
CSL Vifor during the three months ended September 30, 2023 and
2022, respectively;
- Approximately $167,000 of royalty
revenue related to our royalties on the net sales of Kapruvia in
Europe during the three months ended September 30, 2023. There was
no royalty revenue during the three months ended September 30,
2022; and
- $0.9 million of license and
milestone fees revenue related to the remaining allocated portion
of a regulatory milestone payment we earned in September 2023 from
Maruishi for the marketing approval in Japan for KORSUVA injection.
There was no license and milestone fees revenue during the three
months ended September 30, 2022.
Cost of Goods Sold: Cost of goods sold was $1.6
million and $3.1 million during the three months ended September
30, 2023 and 2022, respectively, related to commercial supply
revenue for KORSUVA injection sales to CSL Vifor.
Research and Development (R&D) Expenses:
R&D expenses were $25.5 million for the three months ended
September 30, 2023 compared to $24.7 million in the same period of
2022. The slightly 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. R&D expenses for the three
months ended September 30, 2022 included $5.0 million related to a
milestone payment due to Enteris Biopharma, Inc.
General and Administrative (G&A) Expenses:
G&A expenses were essentially flat at $6.8 million for the
three months ended September 30, 2023 compared to $6.9 million in
the same period of 2022.
Other Income, net: Other income, net was
approximately $866,000 for the three months ended September 30,
2023 compared to approximately $665,000 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 September 30,
2023.
Financial Guidance
Cara expects that our current unrestricted cash
and cash equivalents and available-for-sale marketable securities,
including the proceeds from our recently announced royalty
financing and the collaborative revenue from our share of the
profit from KORSUVA injection, will be sufficient to fund our
currently anticipated operating plan into 2025.
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 an ongoing 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 X (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, 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
receipt of potential milestone payments pursuant to the Purchase
and Sale Agreement with HealthCare Royalty 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 September 30, 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) |
|
|
|
|
|
September 30, |
|
December 31, |
|
|
2023 |
|
|
|
2022 |
|
|
|
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
62,875 |
|
|
$ |
63,741 |
|
Marketable securities |
|
15,666 |
|
|
|
81,658 |
|
Accounts receivable, net - related party |
|
3,351 |
|
|
|
3,260 |
|
Inventory, net |
|
3,266 |
|
|
|
2,383 |
|
Income tax receivable |
|
697 |
|
|
|
697 |
|
Other receivables |
|
1,682 |
|
|
|
496 |
|
Prepaid expenses |
|
12,658 |
|
|
|
16,267 |
|
Restricted cash |
|
408 |
|
|
|
408 |
|
Total current assets |
|
100,603 |
|
|
|
168,910 |
|
Operating lease right-of-use assets |
|
7,108 |
|
|
|
1,551 |
|
Marketable securities, non-current |
|
4,747 |
|
|
|
11,350 |
|
Property and equipment, net |
|
1,380 |
|
|
|
426 |
|
Restricted cash, non-current |
|
1,500 |
|
|
|
- |
|
Total assets |
$ |
115,338 |
|
|
$ |
182,237 |
|
|
|
|
|
Liabilities and
stockholders’ equity |
|
|
|
Current liabilities: |
|
|
|
Accounts payable and accrued expenses |
$ |
22,384 |
|
|
$ |
21,540 |
|
Operating lease liabilities, current |
|
497 |
|
|
|
1,918 |
|
Total current liabilities |
|
22,881 |
|
|
|
23,458 |
|
|
|
|
|
Operating lease liabilities, non-current |
|
6,815 |
|
|
|
- |
|
|
|
|
|
Commitments and
contingencies |
|
- |
|
|
|
- |
|
|
|
|
|
Stockholders’ equity: |
|
|
|
Preferred stock |
|
- |
|
|
|
- |
|
Common stock |
|
54 |
|
|
|
53 |
|
Additional paid-in capital |
|
738,435 |
|
|
|
726,630 |
|
Accumulated deficit |
|
(652,408 |
) |
|
|
(566,232 |
) |
Accumulated other comprehensive loss |
|
(439 |
) |
|
|
(1,672 |
) |
Total stockholders’
equity |
|
85,642 |
|
|
|
158,779 |
|
Total liabilities and
stockholders’ equity |
$ |
115,338 |
|
|
$ |
182,237 |
|
|
|
|
|
|
|
|
|
CARA THERAPEUTICS, INC. |
CONDENSED STATEMENTS OF OPERATIONS |
(amounts in thousands, except share and per share data) |
(unaudited) |
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
|
|
Revenue: |
|
|
|
|
|
|
|
Collaborative revenue |
$ |
2,471 |
|
|
$ |
7,443 |
|
|
$ |
10,631 |
|
|
$ |
15,446 |
|
Commercial supply revenue |
|
1,252 |
|
|
|
3,370 |
|
|
|
5,843 |
|
|
|
8,160 |
|
Royalty revenue |
|
167 |
|
|
|
- |
|
|
|
415 |
|
|
|
- |
|
License and milestone fees |
|
910 |
|
|
|
- |
|
|
|
910 |
|
|
|
15,000 |
|
Clinical compound revenue |
|
66 |
|
|
|
- |
|
|
|
165 |
|
|
|
- |
|
Total revenue |
|
4,866 |
|
|
|
10,813 |
|
|
|
17,964 |
|
|
|
38,606 |
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
Cost of goods sold |
|
1,558 |
|
|
|
3,055 |
|
|
|
5,566 |
|
|
|
5,136 |
|
Research and development |
|
25,451 |
|
|
|
24,691 |
|
|
|
80,095 |
|
|
|
65,869 |
|
General and administrative |
|
6,755 |
|
|
|
6,912 |
|
|
|
21,191 |
|
|
|
23,829 |
|
Total operating expenses |
|
33,764 |
|
|
|
34,658 |
|
|
|
106,852 |
|
|
|
94,834 |
|
Operating loss |
|
(28,898 |
) |
|
|
(23,845 |
) |
|
|
(88,888 |
) |
|
|
(56,228 |
) |
|
|
|
|
|
|
|
|
Other income, net |
|
866 |
|
|
|
665 |
|
|
|
2,712 |
|
|
|
1,093 |
|
Net loss |
$ |
(28,032 |
) |
|
$ |
(23,180 |
) |
|
$ |
(86,176 |
) |
|
$ |
(55,135 |
) |
|
|
|
|
|
|
|
|
Net loss per share: |
|
|
|
|
|
|
|
Basic and Diluted |
$ |
(0.52 |
) |
|
$ |
(0.43 |
) |
|
$ |
(1.59 |
) |
|
$ |
(1.03 |
) |
|
|
|
|
|
|
|
|
Weighted average shares: |
|
|
|
|
|
|
|
Basic and Diluted |
|
54,235,695 |
|
|
|
53,726,123 |
|
|
|
54,038,239 |
|
|
|
53,616,753 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
MEDIA CONTACT:Annie Spinetta6
Degrees973-768-2170aspinetta@6degreespr.com
INVESTOR CONTACT:Iris Francesconi, Ph.D.Cara
Therapeutics203-406-3700investor@caratherapeutics.com
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