Executive Summary

Q4 2023 total revenue was $3.00M, down sequentially from $4.87M in Q3 and down year-over-year from $3.26M; GAAP net loss was $32.34M ($(0.59) per share) versus $(28.03)M ($(0.52)) in Q3 and $(30.34)M ($(0.56)) in Q4 2022 .
Management sharpened strategy to prioritize oral difelikefalin for notalgia paresthetica (NP), completed KOURAGE 1 Part A enrollment ahead of schedule (214 patients), with topline efficacy/safety now guided for Q3 2024; cash runway extended into 2026 via prioritization and HCR royalty financing .
KORSUVA injection net sales were $5.0M in Q4; wholesalers shipped 110.7K vials (+22% q/q), but reallocation within Fresenius limited incremental revenue; post-TDAPA reimbursement in the ESRD PPS bundle is expected to significantly restrict access, and management does not expect meaningful KORSUVA revenue going forward .
Wall Street consensus (S&P Global) for Q4 2023 EPS and revenue was unavailable; no beat/miss assessment can be made. Management commentary and reimbursement changes are the near-term stock catalysts, with KOURAGE 1 Part A data in Q3 2024 the key event .

What Went Well and What Went Wrong

What Went Well

Completed KOURAGE 1 Part A dose-finding enrollment ahead of schedule (214 patients); topline efficacy/safety now expected in Q3 2024, accelerating NP program visibility .
Strategy shift to NP with cash runway extended into 2026 via clinical prioritization and HCR royalty financing; “puts us on the path to significant near-term value creation” .
KORSUVA demand indicators strong: 110.7K vials shipped in Q4 (+22% q/q), reflecting clinical value despite distribution dynamics; “continued growth in demand” .

Quote: “We have prioritized the program with the highest likelihood of clinical and commercial success, oral difelikefalin for notalgia paresthetica… Focusing all our resources on NP extends our cash runway into 2026” .

What Went Wrong

Revenue and EPS deteriorated sequentially: revenue fell to $3.00M in Q4 from $4.87M in Q3; net loss widened to $(32.34)M from $(28.03)M; R&D remained elevated at $28.42M .
TDAPA expiry on March 31, 2024 and ESRD PPS bundle reimbursement expected to “significantly restrict access to KORSUVA” with limited revenue contributions going forward, raising U.S. commercial headwinds .
Cash and marketable securities declined to $100.8M at 12/31/23 (from $156.7M at 12/31/22), driven by $92.1M cash used in operating activities in 2023, underscoring ongoing funding needs absent NP success .

Financial Results

Summary P&L and EPS (USD)

Metric	Q2 2023	Q3 2023	Q4 2023
Total Revenue ($USD Millions)	$6.93	$4.87	$3.00
Operating Loss ($USD Millions)	$(32.34)	$(28.90)	$(32.61)
Net Loss ($USD Millions)	$(31.48)	$(28.03)	$(32.34)
EPS (Basic & Diluted) ($USD)	$(0.58)	$(0.52)	$(0.59)

Operating Expense and COGS (USD)

Metric	Q2 2023	Q3 2023	Q4 2023
Cost of Goods Sold ($USD Millions)	$1.42	$1.56	$0.61
Research & Development ($USD Millions)	$30.31	$25.45	$28.42
General & Administrative ($USD Millions)	$7.55	$6.76	$6.59

Revenue Components (USD)

Component	Q2 2023	Q3 2023	Q4 2023
Collaborative Revenue ($USD Millions)	$5.41	$2.47	$2.31
Commercial Supply Revenue ($USD Millions)	$1.40	$1.25	$0.00
License & Milestone Fees ($USD Millions)	$0.00	$0.91	$0.91 (FY allocation; none in Q4)
Royalty Revenue ($USD Millions)	$0.12	$0.17	$0.00
Other Revenue ($USD Millions)	$0.00	$0.00	$0.70

Note: The earnings call referenced $7.5M “other revenue”; the 8-K financial statements report $0.7M; we anchor to the 8-K .

KORSUVA Injection KPIs

KPI	Q2 2023	Q3 2023	Q4 2023
KORSUVA Net Sales ($USD Millions)	$11.40	$4.40	$5.00
Vials Shipped (Units)	66,852	90,828	110,700
q/q Vial Growth (%)	+46%	+36%	+22%

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Cash Runway	Multi-year	Into 2025 (post-HCR financing)	Into 2026 (prioritization + HCR)	Raised
KOURAGE 1 Part A Topline (NP)	2024	2H24 targeted	Q3 2024 expected	Clarified (maintained timeframe)
KORSUVA Reimbursement	Post-3/31/24	TDAPA through 3/31/24	ESRD PPS bundle post-3/31/24; access likely significantly restricted	Implemented (headwind)
KOURAGE Pivotal Results	2025–2026	1H26 final topline expected	First pivotal topline by YE 2025; second in early 2026	Pulled forward first study timing

Earnings Call Themes & Trends

Topic	Previous Mentions (Q-2 and Q-1)	Current Period (Q4 2023)	Trend
NP Program Focus	KOURAGE Part A enrollment on track; readout 2H24	Prioritization to NP; Part A enrollment completed; topline Q3 2024	Strengthening focus
KORSUVA Demand vs Revenue	Strong increases in vials (+46% Q2; +36% Q3)	+22% q/q vials, but reallocation limited revenue; minimal future revenue expected	Demand OK, revenue headwind
Reimbursement (TDAPA/PPS)	Proposed rule (Q2); Final rule confirms TDAPA through 3/31/24 (Q3)	Post-TDAPA bundle; significant access restriction expected	Negative regulatory shift
Financing and Runway	HCR up to $40M extends runway into 2025	HCR proceeds recorded; runway into 2026; liability and imputed interest recognized	Improved liquidity duration
Clinical Readouts (AD/CKD)	KIND 1 Part A topline Dec 2023; CKD topline 2H24	Strategic emphasis moved to NP; AD/CKD deprioritized implicitly via focus	Portfolio refocus

Management Commentary

“We have prioritized the program with the highest likelihood of clinical and commercial success, oral difelikefalin for notalgia paresthetica… Focusing all our resources on NP extends our cash runway into 2026” – CEO Christopher Posner .
“In the fourth quarter 2023, we saw a strong quarter-to-quarter demand growth of 22%… However… we anticipate dialysis organizations will… significantly restrict access to KORSUVA. As a result, we do not expect meaningful revenue contributions from KORSUVA going forward.” – CEO .
“We were able to bring forward the value of our ex U.S.A. and Japan royalties… recorded as a long-term liability… Royalties… recorded as noncash other revenue… we also recorded noncash imputed interest.” – CFO Ryan Maynard .

Q&A Highlights

Dose selection and study size: Part A is not powered for significance; aim is dose separation and benefit-risk to select a single dose for a simpler pivotal program; size will depend on Part A outcomes .
Placebo expectations: Slightly higher placebo response anticipated versus prior due to 3:1 randomization, more sites, and greater awareness; design otherwise similar to COMFORT .
Safety: Topline will include adverse events and discontinuations; highest dose (2 mg BID) expected to mirror prior acceptable profile; lower doses may improve tolerability .
Partnering: Asset is unencumbered; with runway into 2026, intent is to continue development internally rather than late-stage partnering at this time .
Dosing regimen: BID remains appropriate given PK and renal excretion; once-daily not planned .

Estimates Context

S&P Global consensus estimates for Q4 2023 EPS and revenue were unavailable for CARA at the time of this review; therefore, formal beat/miss cannot be assessed. Management’s guidance implies KORSUVA U.S. revenue expectations should be reduced due to ESRD PPS reimbursement dynamics post-TDAPA, while NP timelines are firming with Q3 2024 topline for KOURAGE 1 Part A .

Actuals vs Consensus (Q4 2023)

Metric	Consensus	Actual	Beat/Miss
Revenue ($USD Millions)	N/A (S&P Global unavailable)	$3.00	N/A
EPS ($USD)	N/A (S&P Global unavailable)	$(0.59)	N/A

Key Takeaways for Investors

NP is now the core value driver: completed Part A enrollment and Q3 2024 topline are the pivotal next catalyst; success could establish first and only oral therapy in an underserved neuropathic pruritus market .
Liquidity extended: prioritization and HCR financing extend cash runway into 2026, covering NP milestones; HCR accounted as long-term liability with noncash interest .
U.S. KORSUVA outlook negative: ESRD PPS bundle post-TDAPA likely restricts access and revenue; investors should recalibrate commercial expectations accordingly .
Demand vs revenue divergence: vial growth remains healthy, but inventory reallocation and reimbursement mechanics cap revenue recognition—focus modeling on collaborative revenue rather than vials .
Near-term trading setup: stock likely to trade on NP program momentum and any updates from the March NP KOL event and Q3 topline; downside risk tied to NP efficacy/tolerability or delays .
Watch opex discipline: R&D spend remains high; prioritization aims to streamline spend into NP while preserving runway .
Note transcript-to-8K discrepancies: rely on 8-K for financials (e.g., other revenue $0.7M vs $7.5M mentioned on the call; cash/marketable securities $100.8M at YE vs misstatement) .

Discrepancy Notes

The earnings call cited $7.5M in “other revenue” for Q4, but the 8-K reports $0.7M; total revenue reconciles to $3.00M per 8-K. We anchor to the 8-K .
The call’s cash figure appears misstated; 8-K reports cash, cash equivalents and marketable securities of $100.8M as of 12/31/23 .

Cara Therapeutics, Inc. (CARA)·Q4 2023 Earnings Summary