Executive Summary

Q1 2025 net product revenue was $2.214M, down 37% sequentially vs Q4 2024 ($3.5M) and down 6% year over year vs Q1 2024 ($2.351M) as specialty pharmacy inventory normalization weighed on invoiced sales despite higher Mytesi dispensed prescriptions .
EPS missed Wall Street consensus: Primary EPS was -$16.70 vs -$10.82 consensus*; revenue was $2.214M vs $2.82M consensus*, reflecting weaker sell-in dynamics and higher OpEx from Gelclair launch and legal costs .
Operating loss widened to -$9.421M (vs -$8.215M a year ago) on increased Sales & Marketing and G&A, partly offset by lower R&D after OnTarget trial completion .
Strategic catalysts: FDA Type C meeting in Q2 2025 to discuss statistically significant OnTarget breast cancer subgroup results, and initial rare-disease POC data showing crofelemer reduced total parenteral nutrition (TPN) in MVID and pediatric SBS-IF patients (up to 27% and 12.5%), potentially enabling expedited regulatory pathways .

Estimates disclaimer: Values retrieved from S&P Global.

What Went Well and What Went Wrong

Mytesi dispensed prescriptions increased ~1.8% YoY despite revenue decline, indicating underlying demand resilience: “Mytesi prescription volume increased by approximately 1.8% in Q1 2025 over Q1 2024” .
Rare disease proof-of-concept: crofelemer reduced TPN by up to 27% (MVID) and 12.5% (pediatric SBS-IF), viewed by management as “groundbreaking” with potential to modify disease progression and support non-dilutive partnering .
Lower interest expense/benefit from FVO accounting shift: interest expense moved to ~$56K of income from $611K expense YoY, improving below-the-line items .

Sequential revenue decline driven by Q4 channel stocking: management cited “increased sales and higher distribution chain inventory levels in Q4 2024” leading to fewer purchases in Q1 2025 .
Operating leverage worsened: Loss from operations rose to -$9.421M (+15% YoY) on higher Sales & Marketing (Gelclair launch) and G&A (legal) despite lower R&D post-OnTarget .
Non-GAAP Recurring EBITDA loss widened to -$9.740M (vs -$8.778M), reflecting core profitability pressure even excluding non-recurring items .

Metric	Q3 2024	Q4 2024	Q1 2025
Total net revenue ($USD Millions)	$3.1	$3.5	$2.214
Revenue Consensus Mean ($USD Millions)*	—	—	$2.82*
Beat/Miss vs Consensus*	—	—	Miss (-$0.61M)*

Estimates disclaimer: Values retrieved from S&P Global.

Metric	Q1 2024	Q1 2025
Net loss per share, basic & diluted ($USD)	-$87.12	-$16.70
Primary EPS Consensus Mean ($USD)*	—	-$10.82*
Beat/Miss vs Consensus*	—	Miss (-$5.88)*

Estimates disclaimer: Values retrieved from S&P Global.

Metric ($USD Millions unless noted)	Q3 2024	Q1 2024	Q1 2025
Loss from operations	-$7.3	-$8.215	-$9.421
Net loss attributable to common stockholders	-$9.9	-$9.226	-$10.465
Non-GAAP Recurring EBITDA	-$8.2	-$8.778	-$9.740
Cost of product revenue	—	$0.4	$0.5

Component/KPI	Q3 2024	Q4 2024	Q1 2024	Q1 2025
License revenue recognized ($USD)	$0.042M	$0.042M	$0	$0.0425M
Deferred license revenue ($USD)	$0.765M	$0.7M	—	$0.7M
Mytesi Rx volume YoY change (%)	+2.7%	+9.4%	—	+1.8%
Mytesi Rx volume QoQ change (%)	+10.9%	+3.4%	—	-13.5%
Neonorm revenue	Minimal	—	Minimal	Minimal

Metric	Period	Previous Guidance	Current Guidance	Change
Financial guidance (revenue/EPS/margins)	FY/Q1 2025	Not provided	Not provided	Maintained (no formal guidance)
Clinical/regulatory milestones	Q2–2026	POC/IIT and Phase 2 timelines discussed	FDA Type C meeting in Q2 2025; POC results throughout 2025; Phase 2 results 1H 2026	Reiterated timeline

Topic	Previous Mentions (Q3 2024)	Current Period (Q1 2025)	Trend
OnTarget breast cancer subgroup	Accepted SABCS poster; planning FDA engagement	FDA Type C meeting in Q2 2025 to discuss responder analysis and pathway using Mytesi formulation	Advancing toward regulatory dialogue
Rare diseases (MVID, SBS-IF)	Phase 2 initiations; IITs starting in US/EU/MENA	POC data: TPN reduction up to 27% (MVID) and 12.5% (pediatric SBS-IF); additional POC expected through 2025	Positive clinical signal momentum
Commercial launch (Gelclair)	US launch initiated; oncology supportive care focus	Elevated Sales & Marketing spend tied to launch	Commercial investment phase
Channel dynamics	—	Q4 stocking drove Q1 sell-in softness	Normalization
Business development/funding	Non-dilutive licensing/partnering goal	Management emphasizes catalysts to drive non-dilutive dollars	Ongoing

“While our net revenue decreased in Q1 2025 versus Q4 2024, this was mostly driven by increased sales and higher distribution chain inventory levels in the fourth quarter of 2024, which resulted in fewer purchases in Q1 2025.”
On rare disease POC: “These results are groundbreaking… opportunity to modify disease progression… reduction in TPN” .
FDA engagement: “The FDA has granted… a Type C meeting… to discuss the responder analysis… in breast cancer” .
CFO summary: “Loss from operations increased… to $9.4 million… Net loss… increased… to $10.4 million” .

The Q1 investor webcast consisted of prepared remarks and a replay of a fireside chat; no traditional analyst Q&A session was conducted on this call .
Key clarifications embedded in prepared remarks addressed inventory dynamics, regulatory plans for cancer supportive care, and non-dilutive partnering intentions .

Revenue: Actual $2.214M vs Wall Street consensus $2.82M* → Miss; sequential decline tied to Q4 channel stocking normalization despite underlying Rx volume growth .
EPS: Actual -$16.70 vs consensus -$10.82* → Miss; higher Sales & Marketing (Gelclair) and G&A (legal) increased OpEx .

Estimates disclaimer: Values retrieved from S&P Global.

Near-term regulatory catalyst: FDA Type C meeting in Q2 2025 on OnTarget breast cancer subgroup may reframe the Mytesi label expansion path and is a potential stock catalyst .
Rare-disease optionality: Early POC evidence of TPN reduction in MVID/SBS-IF supports expedited pathways and potential non-dilutive licensing activity in orphan indications through 2025 .
Core demand intact: Mytesi dispensed prescriptions grew YoY; Q1 revenue shortfall primarily reflects Q4 sell-in dynamics, not end-user demand contraction .
Profitability pressure: Operating loss and non-GAAP recurring EBITDA worsened; expect elevated OpEx while Gelclair scales and legal costs persist .
Balance sheet/structure: 8-K disclosed exchanges reducing royalty obligations ($466K common-share exchange; $550K via Series L Preferred), with restrictive covenants and voting caps—important for future financing flexibility and share issuance limits .
Trading implications: Watch for FDA meeting outcomes and additional POC readouts; revenue normalization vs Q4 stocking suggests potential sequential recovery, but OpEx mix and limited estimate coverage (single analyst) heighten volatility .