Executive Summary

CARA reported Q1 2024 revenue of $2.14M (down 65% YoY) and a net loss of $30.7M ($0.56 per share), with cash and securities of $69.8M; management reaffirmed cash runway into 2026 .
Development focus intensified on notalgia paresthetica (NP): KOURAGE 1 Part A topline efficacy and safety now expected by end of Q2 2024, accelerated from the prior Q3 timing; this is the key near-term stock catalyst .
KORSUVA injection U.S. vials shipped grew sequentially to 111,720 in Q1, but with TDAPA expiration on March 31, 2024 and PPS bundling, management does not expect meaningful revenue contribution going forward .
Estimate comparisons unavailable: S&P Global consensus data could not be retrieved for CARA; as a result, we do not present vs-consensus beat/miss for Q1 2024 (S&P Global consensus unavailable via tool).

What Went Well and What Went Wrong

What Went Well

NP program ahead of schedule; KOURAGE 1 Part A topline moved up to end of Q2 2024 from Q3 2024, setting up earlier-than-expected data and dose selection for pivotal trials .
Strong interest from medical dermatology community and rapid enrollment underpin confidence in NP opportunity; CEO: “We now expect to report topline efficacy and safety results from KOURAGE 1 Part A by the end of the second quarter of 2024” .
Operating discipline: R&D expenses fell YoY to $22.0M (from $24.3M) as legacy programs were discontinued, partially offset by NP spend .

What Went Wrong

Revenues declined materially: $2.14M in Q1 2024 vs $6.17M in Q1 2023 due to lower collaborative and commercial supply revenue tied to KORSUVA; Net loss widened to $30.7M from $26.7M .
Restructuring expenses of $2.4M linked to strategic prioritization and workforce reduction pressured operating loss .
Post-TDAPA environment is a structural headwind for KORSUVA; management: dialysis organizations are expected to restrict access, and CARA does “not expect meaningful revenue contributions from KORSUVA going forward” .

Financial Results

Summary P&L metrics

Metric	Q1 2023	Q3 2023	Q4 2023	Q1 2024
Revenue ($M)	6.17	4.87	3.00	2.14
Net Loss ($M)	(26.67)	(28.03)	(32.34)	(30.70)
EPS (Basic & Diluted, $)	(0.49)	(0.52)	(0.59)	(0.56)
Operating Loss ($M)	(27.65)	(28.90)	(32.61)	(29.67)

Margins (derived)

Metric	Q1 2023	Q3 2023	Q4 2023	Q1 2024
Net Income Margin %	(432.5%)	(576.1%)	(1,076.8%)	(1,437.1%)
Operating Margin %	(448.5%)	(594.1%)	(1,085.5%)	(1,389.1%)

Note: Margins computed from reported revenue, operating loss, and net loss in cited documents.

Revenue composition

Revenue Type ($M)	Q3 2023	Q4 2023	Q1 2024
Collaborative revenue	2.47	2.31	0.79
Commercial supply revenue	1.25	0.00	0.64
Royalty revenue	0.17	0.00	0.00
License & milestone fees	0.91	0.00	0.00
Clinical compound revenue	0.07	0.00	0.08
Other revenue	0.00	0.70	0.62
Total revenue	4.87	3.00	2.14

Operating expenses (select lines)

Metric ($M)	Q1 2023	Q3 2023	Q4 2023	Q1 2024
Cost of goods sold	2.59	1.56	0.61	0.62
R&D	24.33	25.45	28.42	21.96
G&A	6.89	6.76	6.59	6.82
Restructuring	0.00	—	—	2.40

KPIs and balance sheet

KPI	Q3 2023	Q4 2023	Q1 2024
KORSUVA U.S. net sales ($M)	4.4	5.0	1.8
CARA collaborative revenue – KORSUVA ($M)	1.9	2.3	0.8
Vials shipped to clinics (units)	90,828	110,700	111,720
Cash, cash equivalents & marketable securities ($M)	83.3 (as of 9/30/23)	100.8 (as of 12/31/23)	69.8 (as of 3/31/24)

Estimate comparisons: S&P Global consensus unavailable via tool; no beat/miss presented.

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
KOURAGE 1 Part A topline timing (NP)	2024	Q3 2024 (Q4’23 update)	End of Q2 2024	Accelerated
Cash runway	Multi-year	Into 2025 (Q3’23)	Into 2026 (Q4’23 and Q1’24)	Extended
KORSUVA U.S. revenue outlook	2024+	Reduced expectations post CMS rule (Q3’23)	“Do not expect meaningful revenue contributions…going forward” (Q4’23 call)	Lowered

Earnings Call Themes & Trends

Topic	Previous Mentions (Q3 2023, Q4 2023)	Current Period (Q1 2024)	Trend
NP (KOURAGE) timing and design	Part A readout targeted 2H24; Part A not powered; dose selection to drive Phase 3 (Q3 call)	Timing accelerated to end of Q2 2024; 214 pts enrolled; pathways to pivotals outlined	Positive acceleration
KORSUVA U.S. reimbursement	CMS ESRD PPS final rule criticized; post-TDAPA headwinds expected (Q3 call)	TDAPA expired 3/31/24; reimbursed via PPS bundle; mgmt sees minimal contribution	Deteriorating economics
Cash runway / financing	Royalty financing to extend into 2025 (Q3 call)	Runway into 2026 reaffirmed	Improved
AD (KIND) program	KIND 1 Part A planned mid-December; enriched itch-dominant design details (Q3 call)	Not a focus of Q1 release; main emphasis shifted to NP	Deprioritized in comms
Partnership strategy	Ex-U.S. partnering for oral DFK considered; development focus retained (Q3 call)	Asset unencumbered; continue internal NP development (Q4 call)	Optionality maintained

Note: No Q1 2024 earnings call transcript was available in our document set; current period insights reflect the Q1 2024 8-K press release.

Management Commentary

“Our notalgia paresthetica (NP) pivotal clinical program is progressing ahead of schedule and we now expect to report topline efficacy and safety results from KOURAGE 1 Part A by the end of the second quarter of 2024.” — Christopher Posner, CEO .
“Final topline results from the first pivotal study are expected by the end of 2025 with the second pivotal study results in early 2026.” .
On KORSUVA outlook: “We anticipate that dialysis organizations will modify current treatment protocols and significantly restrict access to KORSUVA… we do not expect meaningful revenue contributions from KORSUVA going forward.” .
Financial discipline: “The lower R&D expenses in 2024 were primarily due to decreases… partially offset by increases related to the oral difelikefalin NP program.” .

Q&A Highlights

No Q1 2024 earnings call transcript was found. Selected Q4 2023 Q&A themes (most recent available):

NP Phase 3 sizing and dose selection will be informed by Part A; aim to take a single dose forward (simplicity), acknowledging placebo rates may be higher with 3:1 randomization and broader site mix .
Safety disclosure plans: topline will include typical safety summaries; 2 mg BID safety expected consistent with prior studies, with potential tolerability benefits at lower doses .
Commercial stance: KORSUVA access expected to be restricted post-TDAPA; CSL Vifor’s promotion to be limited given diminished potential .
Strategy: Remain a development-focused company; oral DFK ex-U.S. partnership optionality, but NP development continues internally within runway .

Estimates Context

S&P Global consensus estimates for Q1 2024 EPS and revenue were unavailable via our tool for CARA. As a result, we cannot present beat/miss vs consensus for this quarter (S&P Global consensus unavailable).

Key Takeaways for Investors

The NP program is the core value driver; accelerated KOURAGE 1 Part A topline by end of Q2 2024 is the critical near-term catalyst likely to shape trajectory and partnering optionality .
Structural reimbursement headwinds effectively remove KORSUVA as a material U.S. contributor; investment case hinges on oral difelikefalin in NP (and optionality in AD/CKD) .
Cash runway into 2026 provides sufficient capital to reach multiple NP value inflections (Part A topline, pivotal initiation) without near-term financing, reducing dilution risk through mid-2026 .
Q1 P&L reflects the transition to a development-led model: minimal revenue, heavy but managed R&D spend, and one-time restructuring costs; monitor quarterly cash burn (Q1 operating cash use was $30.5M) vs runway .
Watch for potential discrepancies between narrative and reported tables in transcripts (e.g., Q4 “$7.5M” other revenue verbal remark vs $0.7M in the 8-K table, likely a transcription error), with 8-K tables as the anchor .
Next 3–12 months: NP Part A data (Q2), pivotal start logistics and dose selection, and clarity on timing for pivotal readouts (end-2025/early-2026) will frame medium-term thesis and any partnering discussions .

Appendix: Additional Detail (KORSUVA metrics and cash)

KORSUVA vials shipped rose sequentially Q3→Q4→Q1 (90,828 → 110,700 → 111,720), but revenue decoupled due to inventory reallocation and bundling transition; management foresees minimal revenue ahead .
Cash, cash equivalents and marketable securities declined to $69.8M at March 31, 2024 from $100.8M at year-end, driven primarily by $30.5M operating cash use; runway guided into 2026 .

Cara Therapeutics, Inc. (CARA)·Q1 2024 Earnings Summary