Executive Summary

Q3 2021 revenue was $0.27M, down 56% QoQ and 34% YoY, with operating loss of $0.53M and net loss of $0.26M ($0.00 diluted EPS); results benefited from $0.27M PPP loan forgiveness recognized in the quarter .
License fees from AD Pharma fell to $0.20M after monthly payments ended July 31, 2021, while royalties improved to $0.07M; mix shift and lower license fees drove the revenue decline .
Liquidity remains tight (cash ~$0.13M as of Nov 12, 2021), though the second PPP loan ($0.27M) was forgiven in October and will be recognized in Q4 2021, providing near‑term relief .
Regulatory/counterparty risk is elevated: if the LTX‑03 NDA is not accepted by the FDA by Feb 28, 2022, AD Pharma can terminate the agreement and take ownership of the IP—an explicit potential stock reaction catalyst around the deadline .

What Went Well and What Went Wrong

What Went Well
- Royalty revenue increased YoY to $0.07M in Q3 (from $0.01M), partially offsetting the step-down in license fees .
- Lower operating expenses YoY (R&D $0.39M→$0.39M vs $0.52M; G&A $0.46M→$0.42M) helped limit operating loss despite lower revenue .
- “The three and nine month 2021 results were positively affected by the SBA forgiveness in July of our 1st Loan under the Paycheck Protection Program of $269 thousand,” boosting reported net loss comparatives .
What Went Wrong
- Revenue declined sharply as AD Pharma’s monthly license payments ended July 31, 2021; Q3 license fees dropped to $0.20M vs $0.60M in Q2 and $0.30M in Q3 2020 .
- Liquidity remained constrained with cash of ~$0.13M as of Nov 12, 2021; prior disclosures highlighted delinquent AD Pharma license payments in 1H21, underscoring counterparty/collection risk .
- Regulatory milestone risk: failure to achieve FDA NDA acceptance for LTX‑03 by Feb 28, 2022 allows AD Pharma to terminate the agreement and take ownership of the IP .

Financial Results

Metric	Q3 2020	Q1 2021	Q2 2021	Q3 2021
Revenue ($M)	$0.41	$0.64	$0.61	$0.27
Operating Income (Loss) ($M)	$(0.57)	$(0.15)	$(0.30)	$(0.53)
Net Income (Loss) ($M)	$(0.68)	$(0.26)	$(0.39)	$(0.26)
Diluted EPS ($)	$(0.02)	$(0.01)	$(0.01)	$(0.00)
Operating Margin %	(137.8%)	(22.7%)	(48.9%)	(196.7%)
Net Income Margin %	(165.4%)	(40.2%)	(63.1%)	(97.0%)

Note: Margins are calculated from reported revenues and income figures in cited documents.

Revenue mix and components:

Revenue Component ($M)	Q3 2020	Q1 2021	Q2 2021	Q3 2021
License fees – related party	$0.30	$0.60	$0.60	$0.20
Royalties	$0.01	$0.03	$0.00	$0.07
Collaboration – related party	$0.10	$0.01	$0.01	$0.00
Total Revenues	$0.41	$0.64	$0.61	$0.27

Operating expense KPIs:

KPI ($M)	Q3 2020	Q1 2021	Q2 2021	Q3 2021
R&D Expense	$0.52	$0.41	$0.39	$0.39
G&A Expense	$0.46	$0.39	$0.52	$0.42

Liquidity and one‑offs:

Item	Q1 2021	Q2 2021	Q3 2021
Cash balance (date)	~$0.20M (May 14)	~$0.22M (Aug 13)	~$0.13M (Nov 12)
PPP loan forgiveness recognized	—	—	$0.27M (1st PPP)
PPP loan forgiveness expected (Q4 recognition)	—	—	$0.27M (2nd PPP)

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance/Update	Change
LTX‑03 NDA acceptance deadline	FDA acceptance date	July 31, 2021 (prior target)	Extended to Feb 28, 2022; if not accepted by then, AD Pharma may terminate and take IP	Extended; termination option reiterated
Financial guidance (rev/margins)	FY/Q4 2021	None disclosed	No formal financial guidance provided in releases	Maintained (no guidance)
One‑off income	Q4 2021	—	2nd PPP loan ($0.27M) forgiven in Oct; to be reflected in Q4 results	New item

Earnings Call Themes & Trends

Topic	Previous Mentions (Q1, Q2)	Current Period (Q3 2021)	Trend
LTX‑03 NDA timeline	Q1: Expected submission/acceptance after July 31, 2021; intended to renegotiate date . Q2: Acceptance deadline extended to Feb 28, 2022 .	Termination option if NDA not accepted by Feb 28, 2022 reiterated .	Deadline extended; regulatory milestone critical
AD Pharma payments	Q1: AD Pharma delinquent Jan–May ($1.0M license + ~$0.10M expenses) . Q2: Delinquent May–July ($0.6M + ~$0.10M expenses) .	Monthly license payments ended Jul 31, 2021 per amendment .	Collection risk highlighted then subsides as payments end
Revenue mix	Q1–Q2: License fees $0.60M each; royalties minimal .	License fees dropped to $0.20M; royalties improved to $0.07M .	Mix shift away from license fees
PPP loans	Q2: 1st PPP forgiven in July .	1st PPP forgiveness recognized in Q3; 2nd PPP forgiven Oct (to be recognized Q4) .	One‑offs provide temporary relief
Operating expenses	Q1–Q2: R&D ~$0.39–$0.41M; G&A ~$0.39–$0.52M .	R&D $0.39M; G&A $0.42M .	Stable to modestly lower YoY

Management Commentary

Strategic and financial positioning
- “The three and nine month 2021 results were positively affected by the SBA forgiveness in July of our 1st Loan under the Paycheck Protection Program of $269 thousand.”
- “As of November 12, 2021, the Company had a cash balance of approximately $130 thousand.”
- Under the amended AD Pharma agreement: “The…payment…became $200,000 per month and ended on July 31, 2021… However, if the NDA application for LTX‑03 is not accepted by the FDA by February 28, 2022, AD Pharma has the option of terminating the Agreement and taking ownership of the intellectual property.”
Product/technology positioning
- On LIMITx/LTX‑03 overdose‑mitigation profile: in a human study, “formulations of LTX‑03…reduced the maximum blood level (Cmax) up to 34% when subjects were exposed to higher buffer ingredient levels.”

Q&A Highlights

No earnings call transcript was available in the company’s filing archive for Q3 2021; therefore, no Q&A highlights or guidance clarifications to report.

Estimates Context

S&P Global consensus estimates for ACUR were unavailable; as a result, we cannot benchmark Q3 2021 revenue or EPS against Street expectations at this time.

Key Takeaways for Investors

Revenue reset lower post‑July as AD Pharma monthly license payments ended; royalties are improving but currently insufficient to offset the step‑down—near‑term revenue visibility is limited absent LTX‑03 progress .
Liquidity is tight (cash ~$0.13M as of Nov 12), with temporary support from PPP forgiveness ($0.27M recognized in Q3; another ~$0.27M to be recognized in Q4), but structural funding needs remain .
The Feb 28, 2022 NDA acceptance deadline for LTX‑03 is a binary catalyst; failure risks loss of the AD Pharma agreement and transfer of IP, while success could restore a path to commercialization and milestone/royalty economics .
Operating discipline is evident (R&D/G&A trending lower YoY), but operating margins remain deeply negative given the revenue decline; additional cost actions or new funding may be required if timelines slip .
Prior disclosures of AD Pharma payment delinquencies underscore counterparty risk; while monthly payments have ended, any future milestones/royalties would still depend on partner execution and regulatory outcomes .
With no formal financial guidance and no observable Street consensus, positioning ahead of the regulatory milestone and monitoring cash runway should drive trading strategy into Q4/Q1.

References: Q3 2021 earnings press release and schedules (Form 8‑K, Nov 17, 2021) ; Q2 2021 press release (Form 8‑K, Aug 17, 2021) ; Q1 2021 press release (Form 8‑K, May 18, 2021) ; AD Pharma amendment press release (Form 8‑K, July 28, 2021) .

ACURA PHARMACEUTICALS, INC (ACUR)·Q3 2021 Earnings Summary