Executive Summary

Q2 2025 showed strong strategic progress but heavier spend: collaboration revenue rose to $3.85M (+88% YoY; +145% QoQ), while net loss per share widened to -$1.21 as R&D and G&A scaled for late-stage programs and commercialization readiness .
Estimates context: RNA beat revenue consensus ($3.85M vs $1.61M*) but missed EPS (−$1.21 vs −$0.96*); 15 EPS and 11 revenue estimates tracked*, and target price consensus stood at $74*; highlight the narrative—topline beat driven by collaboration revenue recognition; EPS miss reflects accelerated spend as programs advance. Values retrieved from S&P Global.
Regulatory momentum and catalysts: FDA alignment on accelerated and full approval pathways for del-brax (FSHD), positive FORTITUDE dose-escalation topline, and initiation of the global Phase 3 FORWARD study; del-zota (DMD44) received FDA Breakthrough Therapy designation; HARBOR (DM1) completed enrollment .
Balance sheet and readiness: ~$1.2B cash and equivalents at 6/30 with an additional $185.5M raised post-quarter via ATM; runway to mid-2027 supports three potential BLAs over ~12 months and first potential U.S. launch in 2026 .
Commercial manufacturing infrastructure: Lonza Manufacturing Services Agreement with ~$620M minimum batch commitments from 2026–2028 underpins scale-up for anticipated launches; a potential stock reaction catalyst as it signals readiness and spend visibility .

What Went Well and What Went Wrong

What Went Well

FDA alignment on accelerated and full approval pathways for del-brax; initiated global Phase 3 FORWARD study, reinforcing a credible path to approval and commercial readiness .
Positive topline FORTITUDE dose-escalation data for del-brax showed consistent improvement vs placebo across functional mobility, strength, PROs, and rapid, significant biomarker reductions; favorable long-term safety and tolerability .
FDA Breakthrough Therapy designation for del-zota (DMD44), keeping the BLA submission timeline on track for year-end 2025 and strengthening the regulatory case for expedited review .

Management quote: “We have confirmed with the FDA that the accelerated approval pathway is open for del-brax.” — Sarah Boyce, President & CEO .
Management quote: “Avidity continues to operate from a position of financial strength… potentially three successive launches starting in 2026.” — Mike MacLean, CFO .

What Went Wrong

EPS missed Wall Street consensus as operating spend accelerated: R&D rose to $138.1M (vs $63.9M YoY), and G&A rose to $36.9M (vs $20.7M YoY), widening net loss as programs transition toward registrational and commercial phases .
Cash decreased QoQ with heightened investment (cash and equivalents fell from $1.38B at Q1 to ~$1.18B at Q2) despite subsequent ATM proceeds; underscores capital intensity of late-stage execution .
Earnings call transcript was not available in our document set, limiting formal Q&A visibility; however, management conducted program-focused webcasts during June around del-brax data and regulatory alignment .

Financial Results

Key P&L and Balance Sheet Metrics (USD Millions unless noted)

Metric	Q4 2024	Q1 2025	Q2 2025
Collaboration Revenue ($)	$2.973	$1.573	$3.847
Research & Development ($)	$95.625	$99.490	$138.125
General & Administrative ($)	$28.338	$33.600	$36.864
Total Operating Expenses ($)	$123.963	$133.090	$174.989
Other Income, net ($)	$18.733	$15.744	$13.827
Net Loss ($)	$(102.257)	$(115.773)	$(157.315)
Net Loss per Share (EPS)	$(0.80)	$(0.90)	$(1.21)
Weighted-Average Shares (MM)	128.497	129.232	129.622
Cash & Equivalents ($)	$1,501.497	$1,379.877	$1,183.144

Note: Q2 2025 post-quarter ATM net proceeds: $185.5M .

YoY Comparisons (Q2 2025 vs Q2 2024)

Metric	Q2 2024	Q2 2025
Collaboration Revenue ($)	$2.045	$3.847
Research & Development ($)	$63.940	$138.125
General & Administrative ($)	$20.731	$36.864
Net Loss per Share (EPS)	$(0.65)	$(1.21)

Estimates vs Actuals (Q2 2025)

Metric	Consensus*	Actual
Revenue ($)	$1.606M*	$3.847M
EPS ($)	$(0.958)*	$(1.21)
EPS - # of Estimates	15*	—
Revenue - # of Estimates	11*	—
Target Price Consensus Mean ($)	$74*	$74*

Bold highlights: Revenue beat; EPS miss. Values retrieved from S&P Global.

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
del-zota (DMD44) BLA submission	Year-end 2025	Planned YE 2025	On track for planned BLA YE 2025	Maintained
del-brax (FSHD) accelerated approval path	2025–2026	Expected regulatory alignment in Q2 2025	FDA alignment achieved; AA path open; global Phase 3 FORWARD initiated	Raised/Confirmed
del-brax FORTITUDE topline (dose-escalation)	Q2 2025	Planned Q2 topline	Reported positive topline data	Delivered
del-brax FORTITUDE biomarker cohort topline	Q2 2026	Cohort enrolled (Q1)	Topline anticipated Q2 2026	Maintained
del-brax BLA (accelerated approval)	H2 2026	Path evaluation ongoing	Planned BLA submission H2 2026	Raised/Specified
del-desiran (DM1) HARBOR enrollment	Mid-2025	On track to complete mid-2025	Enrollment completed	Achieved
del-desiran marketing applications	H2 2026+	Planned submissions 2026	Marketing submissions starting H2 2026 (U.S., EU, Japan)	Maintained/Expanded
Cash runway	Through mid-2027	Into mid-2027	Sufficient to fund operations to mid-2027 (incl. ATM)	Maintained

Earnings Call Themes & Trends

Note: A Q2 2025 earnings call transcript was not available in our document set. Program-focused investor webcasts were held June 9 around del-brax data and regulatory alignment .

Topic	Previous Mentions (Q4 2024 & Q1 2025)	Current Period (Q2 2025)	Trend
Regulatory approvals (FSHD)	Anticipated alignment on AA path; Phase 3 design alignment expected	FDA alignment achieved; AA path open; FORWARD Phase 3 initiated	Accelerating
Clinical data (FSHD)	Early FORTITUDE signals and enrollment updates	Positive dose-escalation topline; consistent functional and biomarker improvements	Strengthening
DMD44 (del-zota)	EXPLORE44 topline in Q1; OLE enrollment completed; YE 2025 BLA timeline	FDA Breakthrough Therapy designation; BLA YE 2025 maintained	De-risking
DM1 (del-desiran)	HARBOR enrollment on track; MARINA-OLE long-term update planned	HARBOR enrollment completed; marketing submissions H2 2026	On track
Commercial readiness	Building global commercial infrastructure; cash into mid-2027	Lonza MSA for commercial supply; ~$620M commitments; runway affirmed	Scaling
Capital & liquidity	~$1.5B cash YE 2024; ~$1.38B Q1	~$1.18B Q2; $185.5M ATM post-quarter; runway to mid-2027	Adequate

Management Commentary

“Avidity continues to deliver on its leadership in RNA therapeutics as we prepare for three potential BLA submissions in a 12-month period with strong clinical data, regulatory progress, and operational execution.” — Sarah Boyce, President & CEO .
“As we move quickly toward potentially three successive launches starting in 2026, we continue to make meaningful progress in building our global infrastructure.” — Mike MacLean, CFO .
“Breakthrough Therapy designation further underscores the FDA’s appreciation for the significant potential of del-zota… we remain on track for our planned BLA submission at year end 2025.” — Steve Hughes, M.D., CMO .
“Del-brax data… show favorable safety and tolerability with early and consistent trends toward benefit vs placebo across multiple functional and PRO measures.” — Jeffrey M. Statland, M.D., FORTITUDE investigator .

Q&A Highlights

No Q2 2025 earnings call transcript was available in our document set; however, the company hosted a June 9 investor/analyst webcast focused on del-brax clinical data and U.S. accelerated approval pathway alignment .
Guidance clarifications in Q2 releases centered on del-brax AA path details, surrogate biomarker validation steps (KHDC1L), and FORWARD study design flexibility, elevating selected measures to primary endpoints if warranted .

Estimates Context

Q2 2025 revenue beat and EPS miss: Revenue $3.85M vs $1.61M consensus*; EPS −$1.21 vs −$0.96 consensus*; 11 revenue and 15 EPS estimates*, respectively. Values retrieved from S&P Global.
The revenue beat was driven by collaboration revenue recognition under the BMS partnership; the EPS miss reflects increased R&D and commercial infrastructure costs as programs transition to registrational stages .
Target price consensus mean $74* (11 estimates*), consistent with ongoing late-stage value inflection potential across three programs. Values retrieved from S&P Global.

Key Takeaways for Investors

Multiple near- and mid-term catalysts: del-zota BLA at YE 2025, del-brax FORTITUDE biomarker topline in Q2 2026 and accelerated BLA in H2 2026, DM1 HARBOR topline in Q2 2026 followed by global submissions .
Manufacturing readiness de-risks launch execution: Lonza MSA with ~$620M minimum commitments (2026–2028) signals scale-up and provides visibility into commercialization costs .
Balance sheet supports execution: ~$1.18B cash at Q2 plus $185.5M ATM post-quarter; runway to mid-2027 enables sequential launch preparations without near-term financing overhang .
Expense trajectory is a watch item: R&D and G&A are rising ahead of revenue as expected for a company entering registrational and precommercial phases; monitor spending discipline vs timeline milestones .
Regulatory narrative is favorable: FDA alignment on del-brax AA/full approval and BTD for del-zota reduce pathway uncertainty; KHDC1L surrogate endpoint validation remains a key risk to monitor .
Trading setup: Near-term sentiment drivers include further del-brax disclosure, EXPLORE44-OLE data in Q4 2025, and BLA acceptance milestones; setbacks on surrogate endpoint validation or safety could be stock-negative .
Strategic breadth: Three late-stage programs across FSHD, DMD44, and DM1 diversify clinical/regulatory outcomes and create multiple shots on goal for 2026 launches .

Values retrieved from S&P Global for consensus data; all company figures and milestones are cited from Avidity’s Q2 2025 8-K/press releases and prior quarter disclosures.

Avidity Biosciences, Inc. (RNA)·Q2 2025 Earnings Summary