Anika Therapeutics, Inc. (ANIK) Q2 2025 Earnings Summary

Executive Summary

Q2 2025 revenue of $28.22M decreased 8% YoY but was above S&P Global consensus ($27.03M); diluted EPS from continuing operations was -$0.33 and matched consensus, as adjusted EPS from continuing operations was -$0.13. The beat was driven by 41% growth in Regenerative Solutions (Integrity) and a rebound in US OA pricing, while OEM revenue fell on lower J&J pricing .*
Gross margin fell to 51% due to a one-time $3.0M inventory obsolescence/scrap charge from temporary production yield issues; management expects H2 gross margin recovery to 58–59% as yields normalize .
FY25 guidance maintained: Commercial revenue $47–$49.5M; OEM revenue $62–$65M; adjusted EBITDA -3% to +3%. Long-term commercial growth for 2026–2027 was lowered to +10–20% (from +20–30%) with Hyalofast launch timing now 2027 and ~$3M initial sales assumed .
Hyalofast pivotal trial missed co-primary endpoints but hit key secondary endpoints (KOOS Sports/Quality of Life/Total KOOS); company will file final PMA module in H2 2025 under Breakthrough Device Designation. Narrative around Hyalofast and 2026–27 growth is a likely stock reaction catalyst .

What Went Well and What Went Wrong

What Went Well

Integrity outperformance: Regenerative Solutions revenue up 41% YoY; Integrity has exceeded full-year 2024 performance and is on track to more than double in 2025. “Integrity procedures grew for the fifth consecutive quarter…on track to significantly outpace…soft tissue augmentation market” .
Operational normalization: Production yield issues resolved and output restored; international backlog expected to be recovered in Q3, supporting margin recovery in H2 2025 (58–59%) .
Cost control: Operating expenses down 17% YoY; SG&A reductions and headcount actions underpin maintained FY25 adjusted EBITDA guidance despite OEM pricing pressure .

What Went Wrong

Gross margin compression: GM fell to 51% (from 67% YoY Q2 2024), driven by $3.0M scrap/obsolescence charges and lower Monovisc/Orthovisc pricing at J&J .
OEM channel weakness: OEM revenue declined 13% YoY on lower US OA pricing; management expects a more pronounced pricing decline in H2 2025 before normalization in 2026 .
Hyalofast coprimary miss: Pivotal U.S. trial missed pre-specified co-primary endpoints (KOOS Pain, IKDC Function), prompting a 12-month extension to commercial timeline and lower 2026–27 growth guidance .

Financial Results

Headline Metrics (GAAP unless noted)

Metric	Q4 2024	Q1 2025	Q2 2025
Revenue ($USD)	$30.60M	$26.17M	$28.22M
Diluted EPS - Continuing Ops ($)	-$0.17	-$0.28	-$0.33
Gross Margin (%)	56%	56%	51%
Operating Expenses ($USD)	$17.8M	$19.0M	$18.5M
Adjusted EBITDA ($USD)	$3.59M	$0.13M	-$0.19M
Cash Balance ($USD)	$55.6M	$53.4M	$53.2M
Cash from Operations ($USD)	$1.6M provided	-$0.1M used	-$0.2M used

Notes:

Q2 gross margin includes $3.0M obsolescence/scrap charges from lower yields .

Segment Breakdown (Revenue)

Segment	Q4 2024	Q1 2025	Q2 2025
OEM Channel ($USD)	$19.67M	$14.91M	$16.34M
Commercial Channel ($USD)	$10.93M	$11.26M	$11.88M
Total Revenue ($USD)	$30.60M	$26.17M	$28.22M

Q2 2025 vs Wall Street Consensus

Metric	Consensus	Actual	Surprise
Revenue ($USD)	$27.03M*	$28.22M	+$1.19M; +4.4% (beat)
Primary EPS ($)	-$0.13*	-$0.13	In line

Estimates: Primary EPS Consensus Mean and Revenue Consensus Mean; # of estimates were 1 (EPS) and 3 (Revenue).*
Values retrieved from S&P Global.

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Commercial Channel Revenue ($)	FY 2025	$47–$49.5M	$47–$49.5M	Maintained
OEM Channel Revenue ($)	FY 2025	$64–$68.5M, “towards lower end” → updated to $62–$65M	$62–$65M	Lowered in Q1; Maintained in Q2
Adjusted EBITDA (margin)	FY 2025	8–10%	-3% to +3%	Lowered in Q1; Maintained in Q2
Commercial Growth (%)	FY 2026–2027	+20% to +30%	+10% to +20% (Hyalofast launch now 2027)	Lowered
Hyalofast launch timing	U.S.	2026 expected	2027 expected; ~$3M initial sales	Delayed
Gross Margin outlook (%)	H2 2025	N/A	58–59% target in H2	New quantitative outlook

Earnings Call Themes & Trends

Topic	Previous Mentions (Q4 2024 and Q1 2025)	Current Period (Q2 2025)	Trend
Hyalofast regulatory path	Filed 2nd PMA module; U.S. launch anticipated in 2026 ; on track to submit final module H2 2025; 2026 launch expected	Coprimary endpoints missed; secondary endpoints significant; final PMA module to be filed H2 2025; FDA Breakthrough pathway; commercial launch shifted to 2027	Timeline extended; regulatory risk highlighted
Cingal NDA	Type C feedback; final tox testing initiated; BE study design aligned	Progress on toxicity and BE preparations; BE study to start later this year; NDA filing after completion	Advancing per plan
Integrity adoption	>40% sequential growth Q4; >300 surgeries; strong U.S. launch	Regenerative Solutions +41%; Integrity exceeded FY24; on pace to more than double in 2025; 510(k) cleared new sizes	Strengthening and expanding SKUs
OEM pricing volatility (J&J)	OEM down 8% Q4; pricing stabilization steps	OEM down 13% YoY; Monovisc pricing stronger on timing of payer rebates; expected decline in Q3 then modest rebound in Q4; pricing normalization expected by 2026	Near-term pressure; medium-term normalization
Production yields/supply	N/A	Yield issues resolved; $3.0M scrap charge; backlog recovery expected Q3; no patient delivery impact	Resolved; operational improvement
Tariffs/macro	EBITDA guide impacted by recently announced tariffs	No incremental update beyond EBITDA guide maintenance	Stable assumptions
R&D execution	Integrity prospective study first patient enrolled Q4; EU MDR pathway	Integrity study enrollment underway; full site activation expected H2 2025	Continued execution

Management Commentary

“Regenerative Solutions revenue increasing 41% in the quarter driven by Integrity’s outperformance and continued strong International Hyalofast growth…we anticipate a more pronounced decline in pricing during the second half of 2025, with normalization expected as we enter 2026” — Cheryl Blanchard, CEO .
“While we are disappointed that the [Hyalofast] study did not meet its pre-specified co-primary endpoints, we are encouraged by statistically significant improvements in secondary endpoints…we plan to submit the final PMA module…later this year” — Cheryl Blanchard, CEO .
“Gross margins…second half will be slightly below [60%]. A lot of that is driven by…pricing dynamic for Johnson & Johnson on Monovisc and Orthovisc” — Steve Griffin, CFO .
“The primary driver [of GM decline] was a one-time, $3 million charge related to lower yields…excluding this, gross margin would have been above 60%” — Steve Griffin, CFO .

Q&A Highlights

Gross margin trajectory: Management expects H2 gross margin at 58–59% as one-time scrap charges lapse and despite pricing dynamics at J&J; Q2 gross margin ex-one-time would have been above 60% .
OEM/channel diversification: No new OEM partnerships disclosed; Cingal likely fits OEM channel; timing will be driven by value-maximizing distribution decisions .
Integrity TAM expansion: New 510(k)-cleared shapes enable Achilles/knee/hip applications; incremental adoption expected in 2026 with limited 2025 release .
Hyalofast approval basis: Confidence rests on secondary endpoints used in prior FDA approvals and robust international data; FDA encouraged a full data package submission under Breakthrough .
Cash/capacity: Operating cash flow controls improved; capacity investments continue to support Monovisc, Cingal, Integrity, and Hyalofast; no debt and strong liquidity .

Estimates Context

Q2 2025 S&P Global consensus: Revenue $27.03M* vs actual $28.22M (beat); EPS -$0.13* vs actual -$0.13 (in line). # of estimates: Revenue 3; EPS 1.*
Q1 2025 had misses (Revenue $28.07M* vs $26.17M; EPS $0.09* vs -$0.06), framing the Q2 improvement as operational normalization plus Integrity momentum.*
Forward estimates likely adjust for: H2 margin recovery, OEM pricing volatility (near-term down, normalization by 2026), and 12-month delay in Hyalofast U.S. launch shifting commercial growth down to +10–20% in 2026–27 .

Estimates marked with * are Values retrieved from S&P Global.

Key Takeaways for Investors

Q2 print was cleaner operationally with a revenue beat and EPS in line; H2 margin recovery to 58–59% is a near-term support, while OEM pricing remains the key headwind .
Integrity is the growth engine: five consecutive quarters of sequential growth and 41% Regenerative Solutions growth; new SKUs expand use cases, positioning for 2026 commercial upside .
Hyalofast trial outcome introduces regulatory uncertainty; however, secondary endpoints and extensive OUS data underpin the PMA strategy under Breakthrough—commercial impact now modeled from 2027 with ~$3M initial sales .
FY25 guidance intact despite Q2 margin pressure; cost reductions and disciplined OpEx management provide cushion for adjusted EBITDA range maintenance .
Watch J&J pricing cadence: Q3 pricing decline expected, modest rebound in Q4; 2026 normalization should ease margin/royalty pressure .
Near-term trading implication: sentiment will hinge on H2 gross margin progression and any regulatory updates on Hyalofast/Cingal; long-term thesis depends on Integrity adoption levels and successful U.S. pathways for Hyalofast and Cingal .
Liquidity solid (cash ~$53M, no debt), with capacity investments underway to scale core HA products—reduces financing risk during regulatory timelines .

S&P Global estimates used where indicated.