Full Press Release Details
Reports First Quarter 2023 Financial Results
- 1Q23 total revenue of $6.2M including
collaborative revenue of $2.8M from the Company's share of profit of KORSUVA (difelikefalin) injection -
- Acceleration in demand for KORSUVA
injection as evidenced by total vial sales more than doubling quarter to quarter -
- Three late-stage oral difelikefalin
clinical programs progressing with internal readout of Part A of KIND 1 AD trial on track for 4Q23 -
- Conference call today at 4:30 p.m. EDT
STAMFORD, Conn., May 15, 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 first quarter ended
"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
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:
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:
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
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
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