Executive Summary

Q4 2023 capped a transformative year: first mBôs surgical robot delivered to a global robotics distributor, introduction of mVision navigation, and acceleration of the regulatory path toward a 510(k) submission in H2 2024 .
The company reported FY 2023 revenue of $0.365M, largely reflecting initial commercialization activity, with FY net loss of $13.75M; cash ended at $13.59M, strengthening liquidity for Verification & Validation and the H2 2024 510(k) filing .
Management reiterated being “fully funded to anticipated 510(k) submission,” with V&V largely targeted for completion in H1 2024 and OUS clinical trials commencing in H2 2024 .
Wall Street consensus EPS and revenue for Q4 2023 from S&P Global were unavailable; quarterly financial line items were not disclosed in the 8-K press release, limiting beat/miss assessment. Expect stock narrative catalysts around FDA feedback, OUS trial initiation, and mVision development progress .

What Went Well and What Went Wrong

What Went Well

Delivered the first mBôs surgical robot to a major global robotics distributor, establishing a key commercialization and revenue milestone .
Introduced mVision navigation—aimed at eliminating cart-based tracking and reducing registration time and risks—positioning an upgradable pathway for mBôs and broadening product optionality .
Management’s tone: “We believe the modified system has very strong equivalence arguments… and the design modifications could even favorably improve the system’s performance,” and “we remain on target to largely complete verification and validation testing in H1 2024” .

What Went Wrong

Quarterly (Q4-specific) revenue/EPS/margins were not disclosed; only full-year financials provided, constraining near-term KPI granularity and estimate comparison .
Operating cash outflow rose to $(13.54)M in FY 2023 vs $(8.42)M in FY 2022 as R&D ramped from $5.38M to $10.59M, reflecting higher spend into V&V and software/robotics development .
Continued net losses (FY 2023: $(13.75)M) and dependence on regulatory clearance introduce execution and financing risk; management noted optionality via OUS trials but U.S. commercial timing remains contingent on FDA .

Financial Results

Note: The Q4 2023 8-K press release furnished full-year financial statements only (no Q4 breakout); comparisons below use FY and available quarterly updates.

Metric	FY 2022	FY 2023
Revenue ($USD Millions)	$0.000	$0.365
Research & Development ($USD Millions)	$5.385	$10.586
Marketing & Advertising ($USD Millions)	$2.744	$2.994
General & Administrative ($USD Millions)	$2.485	$4.053
Total Operating Expenses ($USD Millions)	$10.613	$17.633
Loss from Operations ($USD Millions)	$(10.613)	$(17.268)
Net Loss ($USD Millions)	$(13.691)	$(13.745)
Basic & Diluted Loss/Share ($USD)	$(1.42)	$(0.61)
Cash & Cash Equivalents ($USD Millions, year-end)	$10.469	$13.589
Operating Cash Flow ($USD Millions)	$(8.420)	$(13.543)

Metric	Q1 2023	Q1 2024
Research & Development ($USD Millions)	$1.940	$2.407
Marketing & Advertising ($USD Millions)	$1.133	$0.120
General & Administrative ($USD Millions)	$0.823	$1.084
Total Operating Expenses ($USD Millions)	$3.895	$3.610
Loss from Operations ($USD Millions)	$(3.895)	$(3.610)
Net Loss ($USD Millions)	$(3.858)	$(3.507)
Basic & Diluted Loss/Share ($USD)	$(0.40)	$(0.11)
Cash & Cash Equivalents ($USD Millions, period-end)	$7.719	$10.078
Operating Cash Flow ($USD Millions)	$(2.882)	$(3.651)

Segment breakdown: Not applicable. Company did not report segments in Q4 press release; focus on robotics and implants development .

KPIs (operational/financial):

Accounts Receivable ($USD Millions): $0.365 (FY 2023) .
Total Assets ($USD Millions): $13.690 (FY 2022), $16.579 (FY 2023) .
Total Liabilities ($USD Millions): $9.541 (FY 2022), $3.182 (FY 2023) .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
V&V Completion (mBôs System)	H1 2024	Targeted H1 completion	“Largely complete” in H1 2024	Maintained/clarified timeline
FDA 510(k) Submission (Semi-active modality)	H2 2024	Pursue 510(k) path in 2024	Accelerated to H2 2024 submission	Raised pace (accelerated)
OUS Clinical Trials (live-patient)	H2 2024	Pilot/launch outside U.S.	Commence OUS trials H2 2024	Maintained/specified start
Cash runway to 510(k)	Through H2 2024	N/A	“Fully funded to anticipated 510(k) submission”	New disclosure (runway)
Name Change	Effective May 15, 2024	Monogram Orthopaedics Inc.	Monogram Technologies Inc.; ticker unchanged (MGRM)	Corporate rebrand

Earnings Call Themes & Trends

Topic	Previous Mentions (Q-2 and Q-1)	Current Period (Q4 2023)	Trend
Regulatory path to 510(k)	Q3 2023: verification progressing; prepared for IDE if needed; export clearance for OUS pilot	Accelerated 510(k) in H2 2024; V&V largely complete in H1 2024; design changes (foot pedal) to address equivalence concerns	Momentum improving; clearer timeline
OUS commercialization	Q3 2023: global distributor pilot program set; ship on/ ahead of schedule pending approvals	First mBôs robot delivered to large global robotics distributor; OUS trials planned H2 2024	Execution milestones achieved
mVision navigation	Q3 2023: markerless tracking concept in pipeline	Introduced mVision to streamline registration/tracking; reduce surgical time/risks; upgradable path	From concept to product intro
R&D intensity	Q3 context: ramping software/robot prototype verification	FY 2023 R&D doubled YoY to $10.59M; Q1 2024 R&D $2.41M	Elevated spend continuing
Corporate identity/AI positioning	N/A	Post-Q4 (May): name change to Monogram Technologies, highlighting AI-driven robotics	Broader tech positioning

Management Commentary

“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.” — CEO Ben Sexson .
“Design changes related primarily to foot pedal control… could address the FDA’s cited technical equivalence concerns and potentially obviate the need for a clinical trial.” — CEO Ben Sexson .
“We recently announced mVision… designed to eliminate cart-based tracking and streamline registration and tracking… minimize pin site fracture and infection… and significantly reduce surgical time.” — CEO Ben Sexson .

Q&A Highlights

Management hosted a business update call on March 21, 2024, featuring CEO, CFO, CTO, and CMO; format emphasized openness and direct engagement; replay information shared via IR .
Prepared remarks focused on V&V progress, FDA interactions, and commercialization roadmap; management reiterated confidence in equivalence arguments and OUS trials optionality .
Specific Q&A transcript details are limited in public archives; Seeking Alpha and InsiderMonkey hosted call content, but full text access varies .

Estimates Context

S&P Global consensus EPS and revenue for Q4 2023 were unavailable due to access limits; the company did not disclose Q4-specific revenue/EPS/margins in the 8-K press release, preventing beat/miss analysis versus Street .
Given pre-revenue status and concentrated coverage, near-term estimate updates likely hinge on clarity of FDA pathway (clinical trial requirement vs. equivalence) and timing of OUS trials; watch for revisions post milestones .

Key Takeaways for Investors

Regulatory timeline clarity is improving; V&V largely completed in H1 2024 and targeted H2 2024 510(k) submission are near-term catalysts that can drive narrative and liquidity outlook .
Initial commercialization markers (first robot sale, A/R of $0.365M) validate interest; broader revenue inflection remains contingent on clearance and OUS deployment .
Elevated R&D to $10.59M and FY operating cash burn of $(13.54)M reflect aggressive execution; cash of $13.59M year-end and disclosure of runway through 510(k) mitigate immediate financing risk but watch burn trajectory .
mVision navigation could be a differentiator—reducing OR time and risks—and offers standalone/integrated monetization paths; upgrades to mBôs expand TAM and pricing leverage .
Name change to Monogram Technologies underscores AI/robotics positioning, potentially broadening investor appeal and strategic optionality beyond orthopedics over time .
Trading setup: headlines around FDA feedback (equivalence vs. clinical data), OUS trial initiation, and V&V completion timing will be the primary swing drivers; limited quarterly disclosures increase binary feel around milestone events .
Absent Q4-specific line items and Street estimates, anchor diligence on execution milestones, cash runway disclosures, and subsequent quarter updates (Q1 2024 trends show net loss improvement and cash of $10.1M) .

Additional context documents reviewed:

Q1 2024 8-K press release and financials (for trend analysis) .
Q3 2023 letter to stockholders and updated presentation (technology, OUS strategy, verification progress) .
Pro-Dex supply agreement and warrant exercise (manufacturing and supply chain framework for end effectors) .

Notes:

Prior two quarters’ earnings press releases (Q3 and Q2 2023) were not available in the document catalog; Q3 2023 context was derived from the October 20, 2023 8-K materials .
Wall Street consensus (S&P Global) for Q4 2023 was unavailable at time of analysis; company did not furnish Q4 line-item financials in its press release .

Monogram Technologies Inc. (MGRM)·Q4 2023 Earnings Summary