Executive Summary

Monogram reported no revenue for FY 2024 and remains pre-commercial; annual operating expenses decreased 13% to $15.3M, while net loss allocable to common shareholders was $14.97M and basic/diluted loss per share was $(0.46) . Cash and equivalents ended at $15.7M, down from $16.6M at Q3 but up year-over-year from $13.6M .
Regulatory progress: the company completed all supplemental testing and submitted a formal response to the FDA’s Additional Information Request; management “does not currently anticipate further requests,” with next communication expected to be a clearance decision for the mBôs TKA System .
India OUS clinical trial preparations advanced (robot shipped; investigator meeting held); initial live surgeries are targeted ~2–3 months post clearance, with 102 patients planned across three Shalby hospitals; expected enrollment pace to be measured initially (1–2 surgeries/day) with a three-month follow-up protocol .
Operating discipline: CFO reiterated a monthly cash burn rate trending under $1.2M (~$1.1M), with no traditional debt and a flexible cost structure (27 FTE; variable outsourced engineering), although Q2 2025 will include notable capital outlays for IEC compliance panels, a robot cart, and testing .
S&P Global Wall Street consensus data for Q4 2024 and FY 2024 was not available to us at this time; therefore, estimate comparisons are not included (we attempted retrieval, but access limits were hit).

What Went Well and What Went Wrong

What Went Well

Completed all supplemental testing and submitted the formal response to the FDA AIR; management does not anticipate further requests, framing the next communication as a potential clearance decision for the mBôs TKA System: “Assuming a favorable decision... the next communication... is anticipated to be a clearance decision...” .
Advanced OUS clinical trial readiness: robot shipped to India; investigator meeting conducted in Ahmedabad with principal investigators and surgeons; collaboration with Reliance Life Sciences and Shalby to manage regulatory submission and multicenter enrollment .
Strengthened balance sheet via an upsized and oversubscribed $13M offering; management and related parties also purchased ~$1M of MGRM shares in the open market, signaling confidence .

What Went Wrong

Full-year net loss increased versus 2023, with management noting 2023 benefited from a non-recurring warrant liability fair value change that did not repeat in 2024; reported net loss was $16.3M versus $13.7M in 2023 (disclosure differs from statement of operations figures, see “Financial Results” for reconciliation note) .
Q3 2024 quarterly net loss widened to $(5.0)M compared to $(1.0)M in Q3 2023, driven primarily by elevated marketing spend associated with the capital raise and the absence of a prior-period warrant liability gain .
S&P Global consensus estimates for Q4/FY were unavailable to us due to access limits, restricting explicit beat/miss analysis (we attempted multiple queries but hit daily limits).

Financial Results

Annual P&L and Liquidity (FY 2023 → FY 2024)

Metric	FY 2023	FY 2024
Revenue ($USD)	$365,000	$0
Research & Development ($USD)	$10,586,000	$8,777,000
Marketing & Advertising ($USD)	$2,994,000	$2,108,000
General & Administrative ($USD)	$4,053,000	$4,412,000
Total Operating Expenses ($USD)	$17,633,000	$15,297,000
Loss from Operations ($USD)	$(17,268,000)	$(15,297,000)
Change in FV of Warrant Liability ($USD)	$3,089,000	$0
Interest and Other, net ($USD)	$434,000	$482,000
Net Loss ($USD)	$(13,745,000)	$(14,815,000)
Net Loss Allocable to Common ($USD)	$(13,745,000)	$(14,966,000)
Basic & Diluted LPS ($USD)	$(0.61)	$(0.46)
Cash & Equivalents (End of Year, $USD)	$13,589,000	$15,658,000

Note: The press release text referenced “Net loss was $16.3M” for FY 2024, while the statement of operations shows net loss $(14.815)M and net loss allocable to common $(14.966)M; management attributed YoY variance partly to the non-recurring 2023 warrant liability fair value change .

Quarterly Snapshot (Q3 2023 → Q3 2024)

Metric	Q3 2023	Q3 2024
Research & Development ($USD)	$2,664,542	$2,214,729
Marketing & Advertising ($USD)	$32,220	$1,838,937
General & Administrative ($USD)	$1,060,270	$1,093,456
Net Loss ($USD)	$(995,660)	$(5,034,501)
Basic & Diluted LPS ($USD)	$(0.03)	$(0.16)
Cash & Equivalents (Period-End, $USD)	$14,875,476	$16,565,142

Liquidity Trend (Balance Sheet)

Metric	Dec 31, 2023	Sep 30, 2024	Dec 31, 2024
Cash & Equivalents ($USD)	$13,589,028	$16,565,142	$15,658,000
Total Assets ($USD)	$16,579,008	$20,222,266	$17,763,000
Total Liabilities ($USD)	$3,181,942	$2,808,121	$1,747,000
Total Stockholders’ Equity ($USD)	$13,397,066	$17,414,145	$16,016,000

KPIs (Operating Discipline and Readiness)

KPI	Q3 2024	Q4 2024
Monthly Cash Burn (approx.)	~$1.2M run-rate	Under $1.2M, ~$1.1M
FTE Headcount	27	27
Debt	No traditional debt	No traditional debt
Trial Budget (India OUS)	~$1.2M total (included in run-rate planning)	~$1.2M included; incremental ~$100k/month average

No revenue or margin metrics are presented for Q4 2024 specifically in the filings; the company is pre-revenue and did not report quarterly revenue for Q4 2024 .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
FDA 510(k) – mBôs TKA (semi-active)	2024–2025	Q3: Issue-specific meeting by Dec-2024; working plan to address AIR within allotted period	Q4: Formal AIR response submitted; management does not anticipate further requests; next FDA communication expected to be a clearance decision	Maintained trajectory; clarity improved
India OUS Clinical Trial (fully autonomous)	2025	Q3: Application submitted; plan for 102 patients at 3 Shalby sites	Q4: Robot shipped; investigator meeting held; post-clearance first surgeries targeted ~2–3 months; initial pace 1–2/day, 3-month follow-up	Execution milestones achieved
Monthly Cash Burn	2024–2025	~$1.2M/month	Trending under $1.2M; ~$1.1M; variable cost structure; no traditional debt	Lowered modestly
Capital Outlays (tooling/panels; robot cart; testing)	Q2 2025	Not previously specified	Expect significant outlays for IEC 60601-compliant panels, additional robot cart, and aggressive testing for V&V	New specific outlays disclosed

No explicit revenue/EPS/margin guidance was provided; management emphasized regulatory milestones and commercialization readiness .

Earnings Call Themes & Trends

Topic	Previous Mentions (Q-2 and Q-1)	Current Period (Q4 2024)	Trend
FDA 510(k) progress	Q3: AIR received; issue-specific FDA meeting targeted for Dec-2024; plan to address 15 comments and testing	AIR response submitted; next comm anticipated to be clearance decision; clock restarted Feb 26	Progressed; higher confidence
India OUS trial	Q3: OUS trial planned with Shalby; 102 patients; CRO Reliance Life Sciences; robot import/training prep	Robot shipped; investigator meeting completed; clearance pending; initial enrollment pace outlined	Operational execution advancing
Cutting performance/technology	Q3: First fully autonomous saw-based cutting objective; value proposition vs Mako	New end effector achieves ~2:47 blade-in-bone time; ~300% feed rate increase; ~1.1 mm RMSE and <1° alignment in cadavers (non-clinical claims)	Technical capability improved
Cash/burn and balance sheet	Q3: $16.5M cash; ~$1.2M monthly burn; flexible cost structure	$15.7M year-end cash; burn ~ $1.1M; no debt; capital outlays upcoming	Slightly lower burn; preparing capex
Commercialization path	Q3: 2025–2026 launch timing depends on regulatory outcomes; multi-application roadmap	Plan to upgrade the submitted system to new end effector post-clearance; initial US launch measured; likely need additional capital	Pragmatic launch pacing

Management Commentary

“We have now completed all supplemental testing and submitted our formal response to the FDA regarding the AIR, and do not currently anticipate further requests for information... next communication... anticipated to be a clearance decision for the mBôs TKA System” — CEO Ben Sexson .
“We’re going to be releasing the higher feed rate... almost a 300% increase... cut times significantly reduced... RMSE ~1.1 mm; alignment less than a degree in cadavers” — CEO .
“We have a strong balance sheet... monthly cash burn around $1.2M... oversubscribed $13M raise... no traditional debt” — CFO Noel Knape .
“From the day we get [India] clearance to the first surgery... about two months... 102 patients... initial measured pace (1–2/day)... three-month follow-up” — CEO .

Q&A Highlights

India trial timeline: clearance to first surgery ~2–3 months; enrollment paced methodically, initially 1–2 surgeries/day; 102-patient protocol with three-month follow-up .
US path: strategy to upgrade the submitted semi-active system to the new end effector via additional filing steps post-clearance to enhance competitiveness; autonomy remains a key differentiator .
Cash burn: trending under $1.2M/month (~$1.1M), inclusive of India trial budget averaging ~$100k/month over the year; variable cost structure supports flexibility .
Capital outlays: Q2 2025 expected spending for IEC-compliant panels, another robot cart, and additional testing for fully autonomous V&V .
FDA process: AIR is a one-time event; next communication expected to be clearance decision per dialogue with CRO and reviewer; no impacts anticipated from federal budget cuts to the device branch at this time .

Estimates Context

We attempted to retrieve S&P Global consensus estimates for Q4 2024, FY 2024, and prior quarters, but access was restricted due to daily request limits; therefore, explicit beat/miss analysis versus Wall Street consensus is not included at this time.
Given the company’s pre-revenue status and lack of disclosed Q4 2024 quarterly EPS in filings, estimate comparisons would be less informative for operations-driven milestones.

Key Takeaways for Investors

Regulatory inflection: formal AIR response submitted; management expects the next FDA communication to be a clearance decision for mBôs TKA; OUS trial readiness underscores path to clinical validation of the fully autonomous system .
Technology credibility: materially faster cutting with the new end effector and promising non-clinical accuracy metrics could reduce surgeon time-to-adoption and improve competitive positioning versus current market leaders .
Operating discipline with sufficient runway: year-end cash $15.7M and burn ~ $1.1M/month support near-term milestones; variable cost structure and no traditional debt provide flexibility, though Q2 2025 will see higher capex/test spend .
Launch pacing and capital needs: US commercialization will be measured post-clearance to preserve first-impression quality; management indicated likely need for additional capital to scale sales/marketing and working capital for broader rollout .
India as early commercialization vector: post-trial clearance could open a large cost-sensitive market via Shalby partnership, potentially enabling faster OUS scaling while US accounts are seeded .
Narrative drivers for the stock near-term: FDA decision timing, India regulatory clearance, demonstration of autonomous cutting performance in clinical settings, and disciplined cash burn will likely dominate sentiment .
Disclosures: Full-year net loss in the press release differs from statement figures; investors should track reconciliations in forthcoming 10-K/Q filings for clarity .

Sources

Q4 2024 8-K and Exhibit 99.1 press release and financial statements:
Q4 2024 earnings call transcript:
Q3 2024 8-K press release and financials:
Q3 2024 earnings call transcript:

Monogram Technologies Inc. (MGRM)·Q4 2024 Earnings Summary