Cara Therapeutics Reports Fourth Quarter and Full Year 2021 Financial Results
KORSUVA™ (difelikefalin) injection
Initiation of Oral KORSUVA (difelikefalin) Phase 3 pruritus programs in non-dialysis dependent advanced chronic kidney disease and atopic dermatitis expected in 1Q 2022
Phase 3 programs to be highlighted in virtual R&D event on
Conference call today at
“Cara Therapeutics made excellent progress in 2021 executing on our strategic priorities, underscored by our first FDA approval -- KORSUVA™ (difelikefalin) injection, the first and only therapy approved for the treatment of pruritus associated with chronic kidney disease in adults undergoing hemodialysis,” said
Fourth Quarter and Recent Developments:
Leadership Appointment
In
KORSUVA Injection: Chronic Kidney Disease-Associated Pruritus: Hemodialysis
Following the
In
In
In
Oral KORSUVA (difelikefalin): Pruritus Associated with Non-Dialysis Dependent Advanced Chronic Kidney Disease
In
In
Oral KORSUVA (difelikefalin): Atopic Dermatitis
In
The Company expects to initiate a Phase 3 clinical program of Oral KORSUVA (difelikefalin) in AD patients in the first quarter of 2022. The Phase 3 program will be discussed during the virtual R&D event on
Oral KORSUVA (difelikefalin): Chronic Liver Disease-Associated Pruritus: Primary Biliary Cholangitis
The Company is currently conducting a Phase 2 clinical trial of Oral KORSUVA (difelikefalin) for the treatment of pruritus in patients with hepatic impairment due to primary biliary cholangitis (PBC). The trial is evaluating the safety and efficacy of Oral KORSUVA (difelikefalin) (1.0 mg tablet, twice daily) versus placebo for 16 weeks. The Company continues to screen patients in this ongoing Phase 2 trial and, primarily due to the ongoing effects of the COVID-19 pandemic on patient enrollment, now expects to report top-line data in the second half of 2022.
Oral KORSUVA (difelikefalin): Notalgia Paresthetica
The Company is evaluating the efficacy and safety of Oral KORSUVA (difelikefalin) for moderate-to-severe pruritus in approximately 120 subjects with notalgia paresthetica (NP) in a Phase 2 multicenter, randomized, double-blind, placebo-controlled 8-week trial. Subjects are randomized to receive Oral KORSUVA (difelikefalin) 2.0 mg twice daily versus placebo for 8 weeks, followed by a 4-week active extension period. The primary efficacy endpoint is the change from baseline in the weekly mean of the daily 24-hour WI-NRS score at week 8 of the treatment period. Secondary endpoints include change from baseline in itch-related quality of life scores and a change from baseline in itch-related sleep disturbance subscale at the end of week 8.
The Company expects to report top-line data from this trial in the second quarter of 2022.
COVID-19 Impacts and Business Operations
Due to the ongoing COVID-19 pandemic and in accordance with the FDA’s updated guidance for conducting clinical trials, the Company has implemented numerous clinical and operational measures to prioritize the health and safety of patients, employees and study investigators and minimize potential disruptions to its ongoing clinical trials. The Company is working closely with its clinical and commercial manufacturing partners to continue to ensure sufficient supply of KORSUVA is available for the commercial launch of KORSUVA injection and its ongoing and planned clinical trials.
Expected 2022 Milestones:
- Initiate Oral KORSUVA (difelikefalin) Phase 3 clinical program in pruritus associated with advanced CKD in the first quarter of 2022
- Initiate Oral KORSUVA (difelikefalin) Phase 3 clinical program in AD in the first quarter of 2022
- Launch KORSUVA injection in the
U.S. inApril 2022 - EMA decision on Kapruvia® (difelikefalin) in the second quarter of 2022
- Report Oral KORSUVA (difelikefalin) Phase 2 top-line data in NP in the second quarter of 2022
- Report Oral KORSUVA (difelikefalin) Phase 2 top-line data in PBC in the second half of 2022
Upcoming Meeting Activities:
The Company expects to make presentations at the following upcoming conferences:
American Academy of Dermatology Annual Meeting,March 25-29, 2022 National Kidney Foundation Spring Clinical Meeting,April 6-10, 2022 - Needham 21st Annual Healthcare Conference,
April 11-14, 2022
Virtual R&D Event
As previously announced, the Company will be hosting a virtual R&D event at
Christopher Posner , President & Chief Executive Officer and Director ofCara Therapeutics Joana Goncalves , MD, Chief Medical Officer ofCara Therapeutics Brian Kim , MD, MTR, Icahn School of Medicine atMount Sinai, NY Jonathan Silverberg , MD, PhD, MPH,George Washington University School of Medicine and Health Sciences
A live audio webcast of the presentation and accompanying slides will be accessible under “Events & Presentations” in the News & Investors section of the Company’s website at www.CaraTherapeutics.com. A replay of the webcast will be archived on the Company’s website following the presentation.
Fourth Quarter and Full Year 2021 Financial Results
Cash, cash equivalents and marketable securities at
For the fourth quarter of 2021, net loss was
Revenues: Total revenue was
$112.1 million of license and milestone fees revenue for the three months endedDecember 31, 2020 , of which$111.6 million related to the license agreement with Vifor and$0.5 million related to the license agreement with VFMCRP. There was no license and milestone fees revenue for the three months endedDecember 31, 2021 .$0.7 million of commercial supply revenue related to our sales of KORSUVA injection to Vifor Pharma for the three months endedDecember 31, 2021 . There was no commercial supply revenue for the same period in 2020.
Research and Development (R&D) Expenses: R&D expenses were
General and Administrative (G&A) Expenses: G&A expenses were
Other Income, net: Other income, net was
For the full year ended
Revenues: Total revenue was
$20.0 million of license and milestone fees revenue for the year endedDecember 31, 2021 was related to milestone payments we earned upon the regulatory approval of KORSUVA injection inAugust 2021 from (1)$15 million from VFMCRP and (2)$5 million from Vifor (the$5 million related to premium paid by Vifor for their$50 million stock purchase). We recognized$134.4 million of license and milestone fees revenue for the year endedDecember 31, 2020 , of which$111.6 million related to the license agreement with Vifor,$22.3 million related to the license agreement with VFMCRP, and$0.6 million related to the achievement of a milestone related to our license agreement with Chong Kun Dang Pharmaceutical Corp.$1.9 million of revenue for the year endedDecember 31, 2021 that we earned inJanuary 2021 from Maruishi’s first initiation of a Phase 3 trial for uremic pruritus inJapan under the Maruishi Agreement.$0.7 million of commercial supply revenue related to our sales of KORSUVA injection to Vifor for the year endedDecember 31, 2021 . There was no commercial supply revenue for the year endedDecember 31, 2020 .
Research and Development (R&D) Expenses: R&D expenses were
General and Administrative (G&A) Expenses: G&A expenses were
Other Income, net: Other income, net was approximately
Financial Guidance
Based on timing expectations and projected costs for current clinical development plans, Cara expects that its existing unrestricted cash and cash equivalents and available-for-sale marketable securities as of
Conference Call
Cara management will host a conference call today at
To participate in the conference call, please dial (855) 445-2816 (domestic) or (484) 756-4300 (international) and refer to conference ID 1891805. A live webcast of the call can be accessed under "Events and Presentations" in the News & Investors section of the Company's website at www.CaraTherapeutics.com.
An archived webcast recording will be available on the Cara website beginning approximately two hours after the call.
About
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 ability to successfully commercialize KORSUVA injection, including the timing of the product launch, planned future regulatory submissions and potential future regulatory approvals, the Company’s ability to obtain and maintain coverage and adequate reimbursement for KORSUVA injection, the performance of our commercial partners, including Vifor Pharma, 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, the Company’s expected cash reach, and the potential impact of COVID-19 on the Company’s commercial launch, clinical development and regulatory timelines and plans. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in Cara Therapeutics’ filings with the
Financial tables follow
BALANCE SHEETS | |||||||
(in thousands) | |||||||
(unaudited) | |||||||
2021 | 2020 | ||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 13,453 | $ | 31,683 | |||
Marketable securities | 153,582 | 149,242 | |||||
Income tax receivable | 697 | 1,507 | |||||
Other receivables | 455 | 557 | |||||
Inventory, net | 2,584 | - | |||||
Prepaid expenses | 2,519 | 12,076 | |||||
Total current assets | 173,290 | 195,065 | |||||
Operating lease right-of-use assets | 2,973 | 4,279 | |||||
Marketable securities, non-current | 69,754 | 70,565 | |||||
Property and equipment, net | 631 | 840 | |||||
Restricted cash | 408 | 408 | |||||
Total assets | $ | 247,056 | $ | 271,157 | |||
Liabilities and stockholders’ equity | |||||||
Current liabilities: | |||||||
Accounts payable and accrued expenses | $ | 15,861 | $ | 16,881 | |||
Operating lease liabilities, current | 1,755 | 1,602 | |||||
Total current liabilities | 17,616 | 18,483 | |||||
Operating lease liabilities, non-current | 1,918 | 3,673 | |||||
Commitments and contingencies | - | - | |||||
Stockholders' equity: | |||||||
Preferred stock | - | - | |||||
Common stock | 53 | 50 | |||||
Additional paid-in capital | 708,585 | 641,195 | |||||
Accumulated deficit | (480,758 | ) | (392,317 | ) | |||
Accumulated other comprehensive (loss) income | (358 | ) | 73 | ||||
Total stockholders’ equity | 227,522 | 249,001 | |||||
Total liabilities and stockholders’ equity | $ | 247,056 | $ | 271,157 | |||
STATEMENTS OF OPERATIONS | |||||||||||||||
(amounts in thousands, except share and per share data) | |||||||||||||||
(unaudited) | |||||||||||||||
Three Months Ended |
Year Ended |
||||||||||||||
2021 | 2020 | 2021 | 2020 | ||||||||||||
Revenue: | |||||||||||||||
License and milestone fees | - | $ | 112,062 | $ | 21,223 | $ | 134,439 | ||||||||
Collaborative revenue | - | - | 706 | - | |||||||||||
Commercial supply revenue | 701 | - | 701 | - | |||||||||||
Clinical compound revenue | 120 | 27 | 398 | 643 | |||||||||||
Total revenue | 821 | 112,089 | 23,028 | 135,082 | |||||||||||
Operating expenses: | |||||||||||||||
Research and development | 22,831 | 27,140 | 82,701 | 107,851 | |||||||||||
General and administrative | 11,512 | 6,659 | 29,410 | 21,846 | |||||||||||
Total operating expenses | 34,343 | 33,799 | 112,111 | 129,697 | |||||||||||
Operating (loss) income | (33,522 | ) | 78,290 | (89,083 | ) | 5,385 | |||||||||
Other income, net | 140 | 364 | 642 | 2,334 | |||||||||||
(Loss) income before income tax benefit | (33,382 | ) | 78,654 | (88,441 | ) | 7,719 | |||||||||
Income tax benefit | - | 255 | - | 691 | |||||||||||
Net (loss) income | $ | (33,382 | ) | $ | 78,909 | $ | (88,441 | ) | $ | 8,410 | |||||
Net (loss) income per share: | |||||||||||||||
Basic | $ | (0.63 | ) | $ | 1.60 | $ | (1.74 | ) | $ | 0.18 | |||||
Diluted | $ | (0.63 | ) | $ | 1.59 | $ | (1.74 | ) | $ | 0.18 | |||||
Weighted average shares: | |||||||||||||||
Basic | 52,757,808 | 49,228,774 | 50,718,765 | 47,413,250 | |||||||||||
Diluted | 52,757,808 | 49,701,864 | 50,718,765 | 47,915,030 | |||||||||||
MEDIA CONTACT:
6 Degrees
973-768-2170
aspinetta@6degreespr.com
INVESTOR CONTACT:
203-406-3700
investor@caratherapeutics.com

Source: Cara Therapeutics, Inc.