AIM ImmunoTech Inc. (AIM)·Q1 2017 Earnings Summary

Executive Summary

• Q1 2017 delivered minimal revenue ($0.084M) and a net loss of $(2.821)M, with diluted EPS of $(0.11); revenue rose year over year versus $0.039M in Q1 2016, but losses persisted .
• Liquidity tightened: cash fell to $0.776M and marketable securities to $2.973M; current assets were $5.190M at quarter-end .
• Strategic progress: the European Early Access Program (EAP) for Ampligen was extended to pancreatic cancer (50 approved patients), a new batch shipped in January, and “first sales” cash receipts occurred; the company reinitiated the U.S. cost-recovery program at a higher FDA‑approved price .
• Capital pathway: a term sheet (March 29) for a secured funding line up to $4M was discussed on the April 7 call; the two‑year mortgage facility was executed in May (post‑Q1), intended to fund production and sales (particularly Ampligen) .
• Manufacturing overhang remains a stock narrative driver: Alferon production is on hold pending revalidation and FDA pre‑approval inspection despite flood-related repairs being completed; commercial sales cannot resume until new batches are manufactured and released .

What Went Well and What Went Wrong

What Went Well

• “We consummated our first sales, money actually being received for the very first shipment of recently manufactured Ampligen in our international programs,” and reinitiated the U.S. cost‑recovery program at an FDA‑approved higher price .
• EAP expansion: Netherlands authorities approved up to 50 pancreatic cancer patients; shipment was received January 26, enabling program progress .
• Full‑year 2016 expense discipline: net loss decreased ~51% YoY to $7.502M (from $15.230M in 2015), positioning the company to preserve capital while pursuing commercialization .

What Went Wrong

• Continued operating and net losses in Q1 2017: operating loss $(3.241)M and net loss $(2.821)M, reflecting limited revenue scale and ongoing R&D and production costs .
• Liquidity pressure: cash declined to $0.776M; current liabilities increased to $2.636M, underscoring reliance on external financing .
• Manufacturing and regulatory hurdles: Alferon manufacturing remains on hold pending FDA pre‑approval inspection; Ampligen still requires additional FDA‑requested clinical and nonclinical steps before potential U.S. approval .

Financial Results

Income Statement (Q1 year-over-year)

Balance Sheet/Liquidity (Quarter-end)

Context from Prior Quarters (Aggregated Reporting)

Segment breakdown: Not applicable; company does not report operating segments .

KPIs:

• Redeemable warrants liability: $1,279K at Q1 2017 (Level 3 fair value) .
• Assets held for sale: $764K for underutilized building adjacent to NJ facility .

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• “Authorities in the Netherlands have approved up to 50 patients for treatment in the Early Access Program for pancreatic cancer, including a funding mechanism to remunerate us for the use of Ampligen… we consummated our first sales, money actually being received for the very first shipment” .
• “We expect to continue our discussions with the FDA… to finalize a protocol… based on the FDA’s interest in new therapeutic options for ME/CFS” (with caution that outcomes are uncertain) .
• “We are moving forward… on the sale of [the] lot and building adjacent to our manufacturing facility” and working to monetize underutilized assets .
• “Entered into a term sheet on March 29 with a funding company to obtain a 2‑year funding line of up to $4 million… [for] production and sales of our products, specifically Ampligen” .

Q&A Highlights

• The company solicited stockholder questions in advance; the available April 7 call transcript reflects prepared remarks rather than a detailed Q&A record .
• Management clarified intent to use the funding line for scaling Ampligen production and sales and reiterated the plan to finalize an FDA path for ME/CFS subject to regulatory dialogue .

Estimates Context

• Wall Street consensus (S&P Global) for Q1 2017 EPS and revenue was unavailable via our S&P Global feed at the time of retrieval (daily limit exceeded). As a result, we cannot benchmark reported results to consensus for this quarter [GetEstimates error].

Key Takeaways for Investors

• Near‑term revenue contribution remains limited; Q1 2017 revenue was $0.084M as the EAP and cost‑recovery programs begin to monetize but are not yet scale drivers .
• Liquidity tightness and reliance on external financing heighten execution risk; the $4M secured mortgage line (closed in May) is a bridge to support production and sales, but it carries high interest cost and maturity in 24 months .
• Regulatory progress in the U.S. (Ampligen for ME/CFS) remains the core value unlock; management is pursuing protocol alignment with FDA, but additional clinical/nonclinical work is expected before potential approval .
• Manufacturing and regulatory readiness for Alferon are prerequisites to resume U.S. sales; repairs are complete, yet production is on hold pending revalidation and FDA pre‑approval inspection, with uncertainty on timing .
• Strategic optionality via EAP expansion (including pancreatic cancer) and Argentina approval (ME/CFS) provides interim access channels and proof points; first sales and shipments reflect early monetization outside the U.S. .
• Equity dilution risk persists given low cash and ongoing losses; recent equity raise (~$875K net in Feb) and warrants add to capital structure complexity; further capital will likely be needed absent a step‑up in sales .
• Trading implications: headlines around EAP sales/expansion and funding line completion can catalyze sentiment; conversely, delays in manufacturing revalidation or FDA protocol could pressure shares given liquidity constraints .