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Monogram Orthopaedics (MGRM) - 2024 Q1 - Quarterly Report
2024-05-13 23:08
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, 2024 Or Monogram Orthopaedics Inc. (Exact name of registrant as specified in its charter) 3913 Todd Lane, Austin, TX 78744 (Address of principal executive offices) (Zip Code) (512) 399-2656 (Registrant's telephone number, including area code) N/A (Former name, former address and f ...
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 ...