Executive Summary

Q1 2024 had no product revenue and a narrower net loss of $3.51M ($0.11 loss per share), driven by higher R&D as the company advanced Verification & Validation and introduced mVision; cash ended at $10.10M, down from $13.59M at year-end .
Management reiterated an accelerated regulatory timeline: Verification & Validation largely complete in Q2 2024 and a 510(k) submission targeted for H2 2024, with constructive FDA feedback on test protocols and the OUS clinical trial plan .
The company engaged a CRO to support clinical activities outside the U.S. and highlighted mVision as a novel tracking solution in development, expanding optionality for commercialization and post-launch marketing .
S&P Global consensus estimates were unavailable through our data tool at this time; therefore, we cannot quantify beats/misses vs Wall Street in this report (see Estimates Context) [GetEstimates error log].

What Went Well and What Went Wrong

What Went Well

Accelerated commercial timeline with Verification & Validation expected largely complete in Q2 2024 and 510(k) submission planned for H2 2024; CEO: “we took the initiative to accelerate our commercial timeline by making key modifications to our strategy” .
Constructive FDA engagement: management believes the testing plan is sufficient to support a strong 510(k) submission; “communications with the FDA… have been productive” and feedback integrated into plans .
mVision introduced as a novel registration/tracking approach, being developed as standalone and/or integrable into mBôs, potentially minimizing surgical footprint and time; management emphasized mVision’s potential to advance standard of care .

What Went Wrong

No product revenue recognized in Q1 2024, limiting near-term financial visibility; product revenue remained $0 in both Q1 2023 and Q1 2024 .
Cash declined by $3.51M during the quarter to $10.10M, reflecting operating cash burn as the company invested in Verification & Validation and regulatory preparation .
Continued net losses (though improved YoY): Q1 2024 net loss of $3.51M vs $3.86M in Q1 2023; marketing spend was sharply lower YoY, indicating constrained commercial readiness while regulatory milestones are prioritized .

Financial Results

Income Statement and Key Metrics (YoY Comparison)

Metric	Q1 2023	Q1 2024
Revenue ($USD Millions)	$0.00	$0.00
Research & Development ($USD Millions)	$1.94	$2.41
Marketing & Advertising ($USD Millions)	$1.13	$0.12
General & Administrative ($USD Millions)	$0.82	$1.08
Total Operating Expenses ($USD Millions)	$3.90	$3.61
Net Loss ($USD Millions)	$3.86	$3.51
Diluted EPS ($USD)	$(0.40)	$(0.11)

Balance Sheet/Cash (Prior Quarter vs Current Quarter)

Metric	Dec 31, 2023	Mar 31, 2024
Cash and Equivalents ($USD Millions)	$13.59	$10.08
Total Assets ($USD Millions)	$16.58	$12.54
Total Stockholders’ Equity ($USD Millions)	$13.40	$10.23

Estimates vs Actuals (Q1 2024)

Metric	Consensus (S&P Global)	Actual
Revenue ($USD Millions)	N/A (unavailable)	$0.00
Primary EPS ($USD)	N/A (unavailable)	$(0.11)

Note: S&P Global consensus estimates were unavailable through our data tool at this time; beats/misses cannot be assessed.

Segment Breakdown

Not applicable; the company did not report segment revenues in Q1 2024 .

KPIs (Operational)

KPI	Q4 2023	Q1 2024	Notes
Verification & Validation status	In verification; completion as early as H1 2024	Expected largely complete Q2 2024	On track; reflects accelerated timeline .
Regulatory engagement	Multiple formal FDA communications; design changes to address technical equivalence	FDA feedback on test protocols and OUS trial plan; constructive posture	Supports 510(k) filing in H2 2024 .
mVision technology	Introduced	Further development; standalone/integration path	Navigation approach to streamline registration/tracking .
Clinical/CRO	Preparing OUS trials	Engaged CRO for OUS activities	Enables international trial execution .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Verification & Validation completion	H1 2024	“Largely complete H1 2024”	“Expected to be largely complete in Q2 2024”	Maintained (more specific timing)
510(k) submission timing	H2 2024	“On track for H2 2024”	“Accelerated for second half of 2024”	Maintained (reinforced/accelerated language)
OUS live-patient trials	H2 2024	“Commence H2 2024”	“Progress towards OUS live-patient surgery trials”	Maintained
Funding to submission	2024	“Fully funded to anticipated 510(k) submission”	Not updated in Q1 release	N/A

No quantitative guidance on revenue, margins, OpEx, OI&E, tax rate, or dividends was provided in these materials -.

Earnings Call Themes & Trends

Topic	Previous Mentions (Q-2: Q4 2023)	Previous Mentions (Q-1: Q3 2023)	Current Period (Q1 2024)	Trend
Regulatory path/FDA	Design modifications (e.g., foot pedal control) to strengthen equivalence; constructive FDA dialogue	Not found in our document set	FDA feedback deemed constructive on verification plan and OUS protocol; integrating feedback; V&V robust	Advancing constructively
OUS clinical trial strategy	Moving forward with OUS trials; leverage OUS data as needed	Not found in our document set	Engaged CRO; positive FDA posture toward OUS data	Execution readiness
mVision tech	Introduced; aims to reduce arrays and surgical footprint -	Not found in our document set	Technology development ongoing; standalone/integration options	Building capability
Commercialization timeline	Verification and validation largely complete H1; 510(k) H2; funded to submission -	Not found in our document set	Verification & Validation largely complete Q2; 510(k) in H2; accelerated messaging	On track/accelerating
Market dynamics/press-fit & robotics	Not discussed in Q4 press release	Not found in our document set	Call commentary on Stryker’s high robotic utilization and press-fit knee share; synergy thesis for press-fit + robotics	Framing adoption thesis

Note: We did not locate Q3 2023 materials in the document catalog; “Previous Mentions (Q-1)” reflects this limitation.

Management Commentary

“Our team has worked tirelessly to advance Monogram toward the critical milestone of a 510(k) submission. The inherent value of our mBôs surgical robot, our mVision technology, and our underlying IP is gaining increasing recognition within both the orthopedic and robotics industries.” — Ben Sexson, CEO .
“Based on the FDA’s feedback, we believe our proposed testing plan is sufficient for evaluating the safety and effectiveness of our robotic system, supporting a strong 510(k) submission… Verification and Validation… largely complete by the end of Q2 2024.” — Ben Sexson, CEO .
Prior quarter framing: “We think it could be possible to complete all Verification and Validation testing as early as the first half of 2024 with a 510(k) submission without clinical data in the second half of 2024.” — Ben Sexson, CEO .

Q&A Highlights

FDA feedback and testing plans: management emphasized robust Verification & Validation plans and constructive FDA input, with the team integrating feedback into protocols .
OUS clinical trial protocol: management indicated the FDA provided fair and constructive feedback, with no objections to the proposed OUS plan; the company will share the final protocol at the appropriate time .
Market context: detailed commentary on the synergy between robotics and press-fit implants, citing high robotic utilization rates and press-fit share at leading competitors (e.g., Stryker), supporting Monogram’s thesis on adoption trends .
Logistics: call announced for May 22 at 4:30 p.m. ET (StreamYard) .

Estimates Context

We attempted to retrieve S&P Global consensus estimates for Q1 2024 revenue and EPS, but the data was unavailable through our tool at this time (daily request limit exceeded). As a result, we cannot assess beats/misses vs Wall Street for this quarter in this report [GetEstimates error log].
Given the absence of recognized revenue and the company’s pre-clearance status, near-term estimates are likely focused on cash runway, OpEx trajectory, and regulatory milestones rather than meaningful P&L contributions; future consensus revisions may hinge on regulatory progress and OUS trial timing -.

Key Takeaways for Investors

The narrative is a regulatory and technology execution story: constructive FDA interactions, Verification & Validation nearing completion, and a targeted H2 2024 510(k) submission remain the core catalysts for shares .
No revenue yet; the company is investing in R&D and regulatory readiness, with Q1 net loss improving YoY and cash declining to $10.10M; monitor cash runway versus milestone timelines .
mVision could enhance differentiation by reducing surgical footprint and registration complexity; integrated or standalone deployment adds commercialization optionality .
OUS trials and CRO engagement provide a path to clinical validation and potential post-launch marketing leverage; positive FDA posture toward OUS data is supportive .
Competitive framing (robotics and press-fit synergy) underscores potential adoption tailwinds once cleared; management’s emphasis on market dynamics aligns with long-term thesis .
Near-term trading implications: stock moves likely tied to incremental FDA feedback, completion of key human factors/accuracy labs, and any clarity on submission timing; absence of revenue keeps P&L catalysts muted .
Medium-term: value inflection hinges on 510(k) clearance, OUS trial execution, and the pace of mVision development; funding to submission was previously asserted, but continued monitoring of liquidity is prudent .

Sources: Q1 2024 8-K and Exhibit 99.1, including financial statements and management commentary -; FY 2023 8-K and Exhibit 99.1 for prior-period context -; MarketBeat call summary/audio and SeekingAlpha link for Q1 2024 earnings call commentary ; Accesswire/BioSpace regulatory update and press coverage .

Monogram Technologies Inc. (MGRM)·Q1 2024 Earnings Summary