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Monogram Orthopaedics (MGRM) - 2023 Q4 - Earnings Call Transcript
2024-03-22 03:50
Monogram Orthopaedics, Inc. (NASDAQ:MGRM) Q4 2023 Earnings Conference Call March 21, 2024 5:00 PM ET Company Participants Benjamin Sexson - CEO Noel Knape - CFO Doug Unis - Founder and CMO Kamran Shamaei - CTO Conference Call Participants Benjamin Sexson Okay, great. Thanks Greg. Well, good afternoon, everybody. We really appreciate you joining us today for this Update Call. I want to try and lay a couple of ground rules from the start. We're going to be really collaborative on this. You're going to be able ...
Monogram Orthopaedics (MGRM) - 2023 Q4 - Earnings Call Presentation
2024-03-22 01:58
ity monogram FY 2023 Investor Call NASDAQ: M G R M 2 Although Monogram believes that the expectations reflected in this presentation are based on reasonable assumptions, there are a number of risks and uncertainties that could cause actual results to differ materially from such forward-looking statements. 3 • Detailed Regulatory Strategy Review • mBôs Features December 31, 2023 Select Information: • Highly variable cost structure • Expect sufficient access to cash through 510k approval • mBôs is a Class II ...
Monogram Orthopaedics (MGRM) - 2023 Q4 - Annual Results
2024-03-15 12:30
[Operational and Strategic Highlights](index=1&type=section&id=Operational%20and%20Strategic%20Highlights) [Key Operational Highlights](index=1&type=section&id=Key%20Operational%20Highlights) Monogram Orthopaedics made significant operational strides in 2023-2024, securing 510(k) funding, delivering its first mBôs robot, and introducing mVision technology - The company is **fully funded** and **on track for its 510(k) submission** to the FDA in the **second half of 2024**, with Verification and Validation testing anticipated to be completed as early as the **first half of 2024**[4](index=4&type=chunk)[5](index=5&type=chunk) - Achieved a key revenue milestone by delivering the **first mBôs surgical robot** to a major global robotics distributor, marking its **first sale**[3](index=3&type=chunk)[4](index=4&type=chunk)[9](index=9&type=chunk) - Introduced **mVision technology**, a new approach to surgical registration and tracking, which is being developed as a potential standalone product or for future integration into the mBôs system[4](index=4&type=chunk)[8](index=8&type=chunk) - The company is proceeding with an **OUS clinical trial** to generate data that can support its U.S. 510(k) submission, if required by the FDA, or be used for post-launch marketing[4](index=4&type=chunk)[7](index=7&type=chunk) [Management Commentary](index=1&type=section&id=Management%20Commentary) Management emphasized 2023 as a transformative year, advancing mBôs commercialization, proactively modifying design for FDA equivalence, and targeting capital-efficient international growth - CEO Ben Sexson highlighted **2023 as a transformative first year** as a public company, focusing on advancing the mBôs product launch and developing the next-gen product pipeline[3](index=3&type=chunk) - The company has **preemptively made design changes**, primarily related to foot pedal control, to address potential FDA technical equivalence concerns and **possibly obviate the need for a clinical trial**[6](index=6&type=chunk) - The new **mVision navigation solution** is designed to **eliminate cart-based tracking**, **reduce surgical time**, and minimize risks such as pin site fracture and infection[8](index=8&type=chunk) - Management views the **international market as an attractive, capital-efficient opportunity** to scale without the significant SG&A costs associated with implant sales in the U.S[9](index=9&type=chunk) [Upcoming 2024 Milestones](index=3&type=section&id=Upcoming%202024%20Milestones) Monogram's 2024 milestones include completing mBôs system verification and validation, submitting its 510(k) application to the FDA, and commencing OUS live-patient surgical trials - Largely complete mBôs system verification and validation – **H1 2024**[17](index=17&type=chunk) - Submit semi-active modality 510(k) application to FDA – **H2 2024**[17](index=17&type=chunk) - Commence OUS live-patient surgery trials – **H2 2024**[17](index=17&type=chunk) [Full Year 2023 Financial Results](index=3&type=section&id=Full%20Year%202023%20Financial%20Results) [Financial Performance Summary](index=3&type=section&id=Financial%20Performance%20Summary) Monogram's 2023 net loss remained stable at $13.74 million despite increased R&D expenses, aided by a positive change in warrant liability fair value, with year-end cash at $13.6 million Financial Performance Summary | Metric | FY 2023 | FY 2022 | | :--- | :--- | :--- | | Research & Development Expenses ($) | $10.6 million | $5.4 million | | General & Administrative Expense ($) | $4.0 million | $2.5 million | | Net Loss ($) | $13.74 million | $13.69 million | | Cash and cash equivalents (Year-End) ($) | $13.6 million | $10.4 million | - The increase in R&D expenses was primarily due to development of the **sagittal cutting systems** and moving the **robot prototype into the verification phase**[12](index=12&type=chunk) - The 2023 net loss was positively impacted by a **$3.1 million change in the fair market value of warrant obligations**, whereas the 2022 result was negatively impacted by **$3.4 million** from the same item[14](index=14&type=chunk) [Consolidated Balance Sheets](index=5&type=section&id=Consolidated%20Balance%20Sheets) As of December 31, 2023, Monogram's balance sheet showed increased total assets to $16.6 million and a substantial decrease in total liabilities to $3.2 million, significantly improving stockholders' equity to $13.4 million Consolidated Balance Sheets | Metric | December 31, 2023 | December 31, 2022 | | :--- | :--- | :--- | | Cash and cash equivalents ($) | $13,589,028 | $10,468,645 | | Total Assets ($) | $16,579,008 | $13,690,063 | | Total Liabilities ($) | $3,181,942 | $9,540,886 | | Total Stockholders' Equity ($) | $13,397,066 | $4,149,176 | [Consolidated Statements of Operations](index=6&type=section&id=Consolidated%20Statements%20of%20Operations) Monogram reported its first revenue of $364,999 in 2023, with total operating expenses increasing to $17.6 million, yet net loss remained stable at $13.7 million due to warrant liability adjustments, improving loss per share to $0.61 Consolidated Statements of Operations | Metric | Year Ended Dec 31, 2023 | Year Ended Dec 31, 2022 | | :--- | :--- | :--- | | Revenue ($) | $364,999 | $0 | | Total Operating Expenses ($) | $17,633,028 | $10,613,147 | | Loss from Operations ($) | ($17,268,029) | ($10,613,147) | | Net Loss ($) | ($13,745,217) | ($13,690,947) | | Basic and Diluted Loss Per Share ($) | ($0.61) | ($1.42) | [Consolidated Statements of Cash Flows](index=7&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) In 2023, Monogram used $13.5 million in operating cash, offset by $16.7 million from financing activities, resulting in a net cash increase of $3.1 million and a year-end cash balance of $13.6 million Consolidated Statements of Cash Flows | Metric | Year Ended Dec 31, 2023 | Year Ended Dec 31, 2022 | | :--- | :--- | :--- | | Cash used in operating activities ($) | ($13,542,509) | ($8,419,553) | | Cash used in investing activities ($) | ($64,913) | ($241,203) | | Cash provided by financing activities ($) | $16,727,805 | $13,593,691 | | Net increase in cash ($) | $3,120,383 | $4,932,935 | | Cash and cash equivalents, end of year ($) | $13,589,028 | $10,468,645 | [Corporate Information](index=3&type=section&id=Corporate%20Information) [Business Update Conference Call](index=3&type=section&id=Business%20Update%20Conference%20Call) Monogram management will host a business update conference call on Thursday, March 21, 2024, at 5:00 p.m. Eastern Time, featuring key executives - The company will host a business update conference call on **Thursday, March 21, 2024, at 5:00 p.m. Eastern Time**[1](index=1&type=chunk)[18](index=18&type=chunk) - **Key executives** including the CEO, Chief Medical Officer, Chief Technology Officer, and Chief Financial Officer will host the call[16](index=16&type=chunk) [About Monogram Orthopaedics](index=4&type=section&id=About%20Monogram%20Orthopaedics) Monogram Orthopaedics is a medical technology company developing patient-optimized orthopedic implants through 3D printing, robotics, and imaging, currently awaiting FDA 510(k) clearance for its products - Monogram's long-term goal is to create **patient-optimized orthopedic implants** by linking **3D printing and robotics** with **advanced pre-operative imaging**[19](index=19&type=chunk) - The company has **not yet obtained FDA 510(k) clearance** for its robotic products, which is a necessary step for commercialization in the United States[19](index=19&type=chunk)
Monogram Orthopaedics (MGRM) - 2023 Q4 - Annual Report
2024-03-15 01:59
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-K ☒ Annual Report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the fiscal year ended December 31, 2023 ☐ Transition Report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to Commission file number 001-41707 Monogram Orthopaedics Inc. (Exact name of registrant as specified in its charter) Delaware 81-2349540 (State or Other Juris ...
Monogram Orthopaedics (MGRM) - 2023 Q3 - Quarterly Report
2023-11-08 11:24
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______________ to _____________ Commission file number: 001-41707 3913 Todd Lane, Austin, TX 78744 (Address of principal executive offices) (Zip Co ...
Monogram Orthopaedics (MGRM) - 2023 Q2 - Quarterly Report
2023-08-09 21:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______________ to _____________ Commission file number: 001-41707 Monogram Orthopaedics Inc. (Exact name of registrant as specified in its charter) 3913 ...
Monogram Orthopaedics (MGRM) - 2023 Q1 - Quarterly Report
2023-06-06 21:19
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______________ to _____________ Commission file number: 001-41707 Monogram Orthopaedics Inc. (Exact name of registrant as specified in its charter) 391 ...