Executive Summary

Q3 2023 net loss narrowed to $7.93M ($0.57 EPS) on total revenue of $0.18M; cash and equivalents rose to $35.0M, with runway into Q3 2024 .
TRV045 delivered statistically significant CNS target engagement and dose-dependent analgesic effects in Phase 1 proof-of-concept studies, with favorable safety; NIH seizure prevention readout is expected shortly and partnering discussions are active .
OLINVYK U.S. commercialization remains challenging, but clinical outcomes data (VOLITION/ARTEMIS) highlighted potential health economic benefits; company received $15M non-dilutive tranche triggered by first commercial sale in China .
S&P Global consensus estimates were unavailable for TRVN; beats/misses to Wall Street forecasts cannot be assessed at this time.*

What Went Well and What Went Wrong

What Went Well

Proof-of-concept success for TRV045: “statistically significant, dose-dependent treatment effect” in a validated capsaicin-induced neuropathic pain model and significant EEG spectral changes indicating CNS target engagement .
Strengthened balance sheet: receipt of $15M tranche under the ex-US royalty-based financing, contributing to cash of $35.0M and runway into Q3 2024 .
Management conviction and flexibility on partnerships: “We’re flexible as it relates to partners and partnerships… looking for the best way to advance TRV045 in patients” .

What Went Wrong

U.S. OLINVYK commercial business remains difficult: “Our U.S. OLINVYK commercial business remains challenging” .
Revenue volatility: Q3 total revenue fell to $0.18M from $3.02M in Q2 due to lower license/royalty revenue timing .
Limited visibility on near-term U.S. OLINVYK trajectory; management is “efficiently deploying resources” and reassessing best path forward .

Financial Results

P&L and Cash (USD Millions)

Metric	Q1 2023	Q2 2023	Q3 2023
Total Revenue ($M)	$0.006	$3.021	$0.180
Net Loss ($M)	$(7.819)	$(8.012)	$(7.930)
Diluted EPS ($)	$(0.81)	$(0.69)	$(0.57)
Cost of Goods Sold ($M)	$0.127	$0.088	$0.175
SG&A ($M)	$6.089	$5.138	$4.572
R&D ($M)	$3.909	$3.991	$4.260
Cash & Equivalents ($M)	$27.436	$28.097	$34.952

YoY reference: Q3 2023 vs Q3 2022 net loss improved from $(15.295)M to $(7.930)M; total revenue improved from $(0.438)M to $0.180M (prior-year negative driven by adjustments/returns) .

Revenue Components (USD Millions)

Component	Q1 2023	Q2 2023	Q3 2023
Product Revenue ($M)	$0.006	$0.021	$0.001
License & Royalty Revenue ($M)	$0.000	$3.000	$0.179

KPIs and Operational Highlights

KPI	Q1 2023	Q2 2023	Q3 2023
VOLITION GI Complete Response (%)	52.2% (initial topline)	—	—
ARTEMIS Length of Stay Reduction (days)	—	~1.4 days saved vs matched IV opioids	~1.4 days saved (presented at ASA)
R-Bridge Tranche Received ($M)	—	Anticipated $15M in 3Q	$15M received

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Cash Runway	Company	“into 2024” (post-Q2)	“into Q3 2024” (post-Q3)	Raised/extended specificity

No revenue/EPS/OpEx guidance was provided in Q3 materials .

Earnings Call Themes & Trends

Topic	Previous Mentions (Q1 & Q2)	Current Period (Q3)	Trend
TRV045 clinical progress	Q1: Two POC studies enrolling; topline in 3Q 2023 . Q2: TMS study database lock; POC data expected 3Q .	Reported POC results with significant CNS target engagement and dose-dependent analgesia; advancing formulation and tox for Phase 2 .	Positive progression; de-risking mechanism and PD.
OLINVYK commercialization	Q1: Additional outcomes/respiratory data anticipated mid-2023 . Q2: VOLITION respiratory data expected; ARTEMIS EMR outcomes shared .	U.S. business challenging; presented respiratory/HECON-related abstracts at ASA; contracting strategy continues .	Mixed: data generation positive; commercialization remains headwind.
Financing and liquidity	Q1: $3M Nhwa milestone; $15M tranche expected on first sale . Q2: Anticipated $15M tranche in 3Q .	$15M tranche received; cash $35.0M; runway into Q3 2024 .	Strengthened; improved runway.
NIH epilepsy data	Q1: Collaboration underway . Q2: TMS POC database lock; NIH program ongoing .	Expect readout shortly on seizure prevention model (potential disease-modifying profile) .	Near-term catalyst imminent.
Partnering strategy	Limited prior detail.	Flexible approach; considering indication-specific or broader partnerships; active discussions .	Increasing business development activity.

Management Commentary

Strategic focus: “We’re pleased to report a quarter of significant milestones achieved… TRV045’s unique mechanism of action and CNS target engagement… favorable safety tolerability profile” .
OLINVYK reality: “Our U.S. OLINVYK commercial business remains challenging. We’re efficiently deploying resources and pursuing our contracting strategy…” .
Liquidity: “Net loss was $7.9 million or $0.57 per share… We finished the quarter with $35 million… which we believe will fund our operations into the third quarter of 2024” .
TRV045 differentiation: “No evidence of lymphopenia… favorable safety and tolerability profile… especially well suited… chronic neuropathic pain and epilepsy” .
Partnering posture: “We’re flexible as it relates to partners… partners potentially interested in both epilepsy and pain” .

Q&A Highlights

Partnership scope: Management is open to indication-specific or broader partnerships; separate partners for pain vs. epilepsy are possible depending on commercial/logistical considerations .
Formulation work: Objective to reduce food effect and increase “headroom” on plasma exposure to enable robust Phase 2 dose-ranging; animal studies show 4–5x brain-to-plasma penetration, supporting CNS engagement .
NIH data gating: Expected NIH seizure prevention readout is additive to the story but “not a gating item” for partnership decisions .

Estimates Context

S&P Global consensus estimates for TRVN were unavailable; therefore, comparisons to Wall Street expectations (revenue/EPS/EBITDA, etc.) cannot be made at this time.*
Given micro-cap biotech coverage variability, analysts may need to recalibrate models post-POC readouts and financing update; absence of guidance limits near-term precision .

Key Takeaways for Investors

TRV045 de-risking: Statistically significant CNS target engagement and analgesic signals, alongside clean safety, advance the Phase 2 readiness narrative; upcoming NIH readout is a near-term catalyst .
Balance sheet improved: $15M tranche received and cash of $35.0M extend runway into Q3 2024, reducing financing overhang in the near term .
OLINVYK U.S. headwinds persist: While real-world outcomes suggest potential cost and clinical benefits, commercialization remains difficult; ex-China royalties and R-Bridge help offset variability .
Business development optionality: Management’s flexibility on partnerships (pain vs. epilepsy, regional/global) broadens paths to Phase 2 execution and risk-sharing .
Expense discipline: SG&A down sequentially and YoY; net loss narrowed materially YoY, aided by 2022 cost savings .
Modeling caution: With no S&P Global estimates and limited guidance, focus models on cash runway, TRV045 development timelines, and potential BD milestones; stock likely to trade on clinical/partnering headlines .
Near-term catalysts: NIH seizure prevention data, formulation optimization progress, and any partnering disclosures are the primary potential stock movers .

* S&P Global consensus estimates unavailable for TRVN at the time of analysis; values typically retrieved from S&P Global.

TREVENA INC (TRVN)·Q3 2023 Earnings Summary