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AP

ACURA PHARMACEUTICALS, INC (ACUR)·Q1 2021 Earnings Summary

Executive Summary

  • Q1 2021 delivered $0.64M total revenue and a net loss of $0.26M ($0.01 diluted EPS), with operating loss improving year over year; revenue declined vs Q1 2020 as license fees stepped down and prior-year G&A included a $0.67M impairment .
  • Sequentially, revenue rose vs Q4 2020 ($0.72M → $0.64M is actually down; correction: revenue fell sequentially), while net loss was comparable; operating loss held near flat (-$0.13M in Q4, -$0.15M in Q1) .
  • Liquidity tightened meaningfully: cash was approximately $0.2M as of May 14, 2021 and AD Pharma was delinquent on monthly license payments for January–May (aggregate $1.0M) plus ~$0.1M reimbursable LTX‑03 expenses, an event of default under the license agreement .
  • Key near-term catalysts: renegotiation of LTX‑03 NDA acceptance date (currently expected after July 31, 2021) and resolution of AD Pharma payment delinquencies; both directly impact funding and timeline risk .

What Went Well and What Went Wrong

What Went Well

  • Operating loss improved year over year to $0.15M vs $0.48M in Q1 2020, reflecting lower G&A (absence of prior-year impairment) despite lower license fees .
  • G&A expense fell to $0.39M from $1.19M in Q1 2020; prior-year included a one‑time $0.67M intangible impairment, removing a structural cost burden going forward .
  • Management reiterated intent to renegotiate the NDA filing acceptance date for LTX‑03 despite expecting acceptance after July 31, 2021, indicating continued commitment to the LIMITx program: “Acura intends to renegotiate the NDA filing acceptance date for LTX‑03, of which no assurance can be given.” .

What Went Wrong

  • Revenue declined year over year ($0.64M vs $1.09M) driven by lower license fees ($0.60M vs $1.05M); royalty revenue remained minimal ($32k vs $33k) .
  • Liquidity pressure: cash ~$0.2M and AD Pharma’s delinquent payments (Jan–May, $1.0M license + ~$0.1M reimbursable) created financing uncertainty and triggered an event of default risk under the license agreement .
  • Regulatory timeline risk rose: management expects LTX‑03 NDA acceptance “after July 31, 2021,” the contractual deadline at which AD Pharma can terminate and take ownership of IP absent an amendment to extend the date .

Financial Results

MetricQ3 2020Q4 2020Q1 2021
Revenue ($USD Thousands)$410 $718 $644
Diluted EPS ($USD)-$0.02 -$0.01 -$0.01
Net Income - (IS) ($USD Thousands)-$678 -$243 -$259
Operating Income ($USD Thousands)-$565 -$131 -$146
Net Income Margin %-165.4% -33.9% -40.3%
EBIT Margin %-137.8% -18.2% -22.7%

Segment revenue breakdown (reported components):

Revenue Component ($USD Thousands)Q3 2020Q4 2020Q1 2021
License fees – related party$300 $600 $600
Royalties$14 $28 $32
Collaboration – related party$96 $90 $12
Product sales$0 $0 $0

Key operating and liquidity KPIs:

KPIQ3 2020Q4 2020Q1 2021
R&D Expenses ($USD Thousands)$519 $430 $405
G&A Expenses ($USD Thousands)$456 $419 $385
Interest Expense ($USD Thousands)$113 $112 $113
Diluted Weighted Avg Shares (Thousands)32,336 32,319 32,464
Cash balance (point-in-time) ($USD Thousands)~$1,000 (Nov 12, 2020) ~$350 (Mar 30, 2021) ~200 (May 14, 2021)
AD Pharma License Payment Arrears ($USD Thousands)$0 (payments received Jun–Oct) $800 (Dec–Mar) + ~$100 reimbursable $1,000 (Jan–May) + ~$100 reimbursable
Convertible Debt to Related Party ($USD Thousands)$6,000 (noncurrent) $6,000 (current) $6,000 (current)

YoY reference (Q1 2020):

  • Q1 2020 revenue $1,091k; net loss $595k; diluted EPS -$0.02; R&D $387k; G&A $1,187k (includes $668k impairment) .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
LTX‑03 NDA acceptance deadlineThrough Jul 31, 2021Amended agreement required FDA acceptance by Jul 31, 2021 “Expected to occur after July 31, 2021”; Acura intends to renegotiate acceptance date Lowered/Delayed timeline; renegotiation needed
AD Pharma monthly license paymentsDec 2020–Jul 2021$200k/month through Jul 31, 2021 Delinquent for Dec–Mar (Q4 release) and Jan–May (Q1 release); management anticipated receipt by Apr 30, 2021 (Q4) but remained delinquent by May 14, 2021 (Q1) Deteriorated collection; event of default risk
Funding runway / cashQ1 2021~$350k cash as of Mar 30, 2021 ~$200k cash as of May 14, 2021 Lower cash, increased liquidity risk

No explicit quantitative guidance on revenues, margins, OpEx, OI&E, or tax rate was provided in these disclosures .

Earnings Call Themes & Trends

No Q1 2021 earnings call transcript was found for ACUR; therefore, call-specific themes and Q&A are unavailable [ListDocuments: none].

TopicPrevious Mentions (Q3 2020)Previous Mentions (Q4 2020)Current Period (Q1 2021)Trend
LTX‑03 NDA timelineAcceptance required by Jul 31, 2021 under amended agreement Still required; Acura notified revised timeline beyond Jul 31, 2021 and sought amendment Expects acceptance after Jul 31, 2021; intends to renegotiate Slipping; renegotiation increasingly critical
AD Pharma license paymentsPayments received Jun–Oct 2020 Delinquent Dec–Mar; anticipated cure by Apr 30, 2021 Delinquent Jan–May; event of default risk Deteriorating collections
Cash/liquidity~$1.0M (Nov 12, 2020) ~$0.35M (Mar 30, 2021) ~$0.2M (May 14, 2021) Declining cash, elevated funding risk
Royalty revenue$14k $28k $32k Modest improvement
R&D execution (LIMITx)Development ongoing; R&D $519k R&D $430k R&D $405k Stable activity, slightly lower spend

Management Commentary

  • “Acura currently expects the submission and FDA acceptance of the NDA for LTX‑03 to occur after July 31, 2021. Acura intends to renegotiate the NDA filing acceptance date for LTX‑03, of which no assurance can be given.”
  • “As of May 14, 2021, the Company had a cash balance of approximately $200 thousand.”
  • “AD Pharma is delinquent in remitting monthly license payments for January, 2021 thru May, 2021 which aggregates to $1.0 million and approximately $100 thousand of reimbursable LTX‑03 development expenses. Failure to make these payments is an event of default under the license agreement with AD Pharma.”
  • Prior disclosure: “AD Pharma is delinquent in the remittance of the required $200 thousand monthly license payments for December, 2020 thru March, 2021 as well as approximately $100 thousand of reimbursable LTX‑03 development expenses.”

Q&A Highlights

No Q1 2021 earnings call or Q&A transcript was available for ACUR in the document set reviewed [ListDocuments: none].

Estimates Context

S&P Global/Capital IQ consensus estimates for ACUR’s Q1 2021 EPS and revenue were unavailable via the estimates tool due to missing CIQ mapping for the ticker; as a result, comparisons to Wall Street consensus cannot be provided at this time. We will monitor for mapping updates or alternative consensus sources [GetEstimates error].

Key Takeaways for Investors

  • Revenue mix is heavily reliant on AD Pharma license fees; YoY decline to $0.64M reflects lower license fees vs prior year; royalty/collaboration remain small, highlighting revenue concentration risk .
  • Liquidity is strained (cash ~$0.2M) and delinquent license payments (aggregate $1.0M Jan–May plus ~$0.1M reimbursable) represent both financing risk and contractual default risk; resolution is a critical near-term catalyst .
  • Program timeline risk increased: management expects LTX‑03 NDA acceptance after Jul 31, 2021 and seeks to renegotiate the deadline; failure to amend could allow AD Pharma to terminate and take ownership of IP .
  • Operating discipline improved: operating loss narrowed YoY (-$0.15M vs -$0.48M) with lower G&A (absence of prior-year impairment), but sequential performance warrants caution given funding uncertainties .
  • With no available consensus estimates, price-discovery catalysts center on contractual developments (payment cure) and regulatory timeline updates rather than earnings beats/misses near term [GetEstimates error] .
  • Short-term trading implications: stock likely sensitive to any updates on payment receipt and NDA timeline amendment; liquidity and default language in filings could drive volatility .
  • Medium-term thesis hinges on LIMITx commercialization via AD Pharma; until funding stability and NDA acceptance timing are clarified, risk/reward skews to event-driven outcomes .