PAVmed Inc. is a diversified commercial-stage medical technology company operating in the medical device, diagnostics, and digital health sectors. Its majority-owned subsidiary, Veris Health Inc., is a digital health company whose lead product is a digital cancer care platform with physiologic data collection, symptom reporting and telehealth functions, designed to improve personalized cancer care through remote patient monitoring. Veris has also been developing an implantable physiological monitor, designe ...

Financial Data and Key Metrics Changes - The cash balance at the end of Q1 2024 was $25.5 million, with an additional $11.6 million added from Lucid financing, resulting in pro forma cash of $37.1 million [12] - The average quarterly burn rate for the trailing four quarters was $11.7 million [12] - Non-GAAP loss for Q1 2024 was $8.6 million, reflecting a $2 million sequential improvement compared to Q4 2023 and a $2.5 million improvement year-over-year [16] - Total non-GAAP operating expenses for Q1 2024 were $12.6 million, showing a $2.2 million sequential improvement and a $2.4 million improvement year-over-year [16] Business Line Data and Key Metrics Changes - Lucid's revenue for Q1 2024 was approximately $1 million, flat compared to Q4 2023 but more than double the revenue from Q1 2023 [15] - EsoGuard test volume grew by 10% quarter-on-quarter, with 2,420 tests conducted in Q1 2024 [15][7] - Veris Health is focusing on large academic cancer centers, with a memorandum of understanding signed with Ohio State University for a pilot program involving 100 patients [9][18] Market Data and Key Metrics Changes - The average allowed amount for out-of-network claims was approximately $1,800, with 75% of claims adjudicated and about 46% resulting in allowable amounts [16][8] - The total addressable market for PortIO is estimated to be upwards of $3 billion, targeting patients with poor veins and those in renal failure [11] Company Strategy and Development Direction - The company is pursuing a strategy to drive shareholder value through independently financed subsidiaries like Lucid, Veris, and PMX PortIO, leveraging shared infrastructure [4][6] - The PMX incubator was launched to raise capital for individual products, with PortIO as the first target [6][10] - The focus is on securing coverage from regional plans in biomarker legislation states to enhance market access for EsoGuard [8] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about Lucid's progress and the upcoming MolDX presubmission meeting scheduled for July 17, 2024, to seek coverage for EsoGuard [4][8] - The company is actively seeking new independently financable technologies with large market opportunities [6] - Management highlighted the importance of capital raising efforts for advancing initiatives in Veris and the PMX incubator [12][31] Other Important Information - The company completed just under $30 million in a Series B preferred offering, strengthening its balance sheet [8] - The first-in-human study for PortIO showed excellent results with no complications [11] Q&A Session Summary Question: What are the milestones or expectations for the Ohio State MOU? - The pilot study aims to demonstrate feasibility with 100 patients, focusing on connecting patients to monitoring tools and providing data to physicians [19] Question: What does the total revenue opportunity look like for Ohio State? - The cancer center has 10,000 patients in infusion therapy, with potential recurring revenue of approximately $1,000 to $1,200 per patient per year [22] Question: How should we think about the opportunity of players like Ohio State? - There are several dozen centers on the target list, with about five in active engagement, including Ohio State [24] Question: How could strategic investments from venture arms be structured? - Investments from academic centers typically serve as a vote of confidence in the commercial potential of the partnership [25] Question: Can you discuss the fundraising environment for PortIO and PMX incubator initiatives? - The fundraising process is challenging but promising, with a focus on raising capital for PortIO first, followed by other projects like EsoCure and CarpX in parallel [31]

[PAVmed Q1 2024 Business Update and Financial Results](index=1&type=section&id=PAVmed%20Q1%202024%20Business%20Update%20and%20Financial%20Results) [Business Update](index=1&type=section&id=Business%20Update%20Highlights) PAVmed reported significant progress across its subsidiaries, focusing on driving value through Lucid, Veris, and the PMX Incubator - PAVmed's updated strategy is to drive shareholder value through its independently-financed subsidiaries (Lucid, Veris, and PMX Incubator) that utilize a shared infrastructure[4](index=4&type=chunk) [Lucid Diagnostics Highlights](index=1&type=section&id=Lucid%20Diagnostics%20Highlights) Lucid Diagnostics reported 124% YoY revenue growth, secured $29.8 million in financing, and advanced key clinical milestones | Metric | Value | Change (YoY) | | :--- | :--- | :--- | | Q1 2024 EsoGuard Revenue | $1.0 million | +124% vs Q1 2023 | - Strengthened its balance sheet by completing a **$29.8 million Series B Preferred Stock Offering**, providing runway through key reimbursement milestones[4](index=4&type=chunk)[5](index=5&type=chunk) - Secured a critical **MolDX pre-submission meeting for July 17, 2024**, to review data for technical assessment under its foundational LCD[8](index=8&type=chunk) - Published positive data from a landmark National Cancer Institute (NCI)-sponsored clinical validation study, strengthening clinical data for payor engagement[8](index=8&type=chunk) [Veris Health and PMX Incubator Highlights](index=2&type=section&id=Veris%20Health%20and%20PMX%20Incubator%20Highlights) Veris Health advanced its cancer care platform pilot while the PMX incubator actively seeks capital for its portfolio companies - Veris Health completed a Memorandum of Understanding (MOU) with The Ohio State's James Cancer Hospital to implement a pilot program for the Veris Cancer Care Platform[8](index=8&type=chunk) - Veris has a clear path to FDA clearance for its implantable monitor, which is **contingent on securing additional financing**[8](index=8&type=chunk) - The PMX incubator is **actively seeking to raise capital** for PortIO Corp. and other technologies including EsoCure and CarpX[8](index=8&type=chunk) [Financial Results](index=2&type=section&id=Financial%20Results) The company reported $1.0 million in Q1 revenue, a GAAP net loss of $22.8 million, and an improved non-GAAP adjusted loss of $8.6 million [Q1 2024 Key Financial Metrics](index=2&type=section&id=Q1%202024%20Key%20Financial%20Metrics) Q1 revenue more than doubled to $1.01 million YoY, operating expenses decreased, and the cash position strengthened to $25.5 million | Financial Metric (in thousands, except per-share) | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | Revenue | $1,010 | $446 | | Operating Expenses | $15,046 | $20,847 | | Net Loss Attributable to Common Stockholders | $(22,788) | $(18,005) | | Net Loss per Common Share | $(2.62) | $(2.78) | | Balance Sheet Item | As of Mar 31, 2024 | As of Dec 31, 2023 | | :--- | :--- | :--- | | Cash and Cash Equivalents | $25.5 million | $19.6 million | [Non-GAAP Financial Measures](index=2&type=section&id=PAVmed%20Non-GAAP%20Measures) The company uses non-GAAP measures to provide transparency, reporting an improved adjusted loss of $8.6 million for Q1 2024 - Management uses non-GAAP financial measures like EBITDA and non-GAAP adjusted loss to provide greater transparency and analyze underlying operational performance by excluding certain non-cash and financing-related expenses[7](index=7&type=chunk)[8](index=8&type=chunk) | Non-GAAP Reconciliation (in thousands, except per-share) | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | Net Loss | $(18,512) | $(22,214) | | **Non-GAAP Adjusted (Loss)** | **$(8,638)** | **$(11,169)** | | **Non-GAAP Adjusted (Loss) per Share** | **$(0.99)** | **$(1.73)** | | Operating Expense Reconciliation (in thousands) | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | Total Operating Expenses (GAAP) | $15,046 | $20,847 | | Stock-based compensation expense | $(1,882) | $(4,419) | | Depreciation and amortization expense | $(586) | $(727) | | **Net Operating Expenses (Non-GAAP)** | **$12,578** | **$14,988** | [About PAVmed and its Subsidiaries](index=5&type=section&id=About%20PAVmed%20and%20its%20Subsidiaries) PAVmed is a commercial-stage med-tech company with subsidiaries focused on esophageal cancer diagnostics and digital cancer care - PAVmed is a diversified commercial-stage medical technology company[12](index=12&type=chunk) - Its subsidiary, Lucid Diagnostics, markets the **EsoGuard Esophageal DNA Test** and **EsoCheck Esophageal Cell Collection Device** for early detection of esophageal precancer[12](index=12&type=chunk) - Its subsidiary, Veris Health, is a digital health company focused on personalized cancer care through **remote patient monitoring** with implantable sensors[12](index=12&type=chunk) [Forward-Looking Statements](index=5&type=section&id=Forward-Looking%20Statements) The press release contains forward-looking statements subject to inherent risks and uncertainties that could affect actual results - The press release includes forward-looking statements that involve risks and uncertainties and are not historical facts[16](index=16&type=chunk) - Potential risks include **stock price volatility, economic conditions, R&D uncertainties, regulatory hurdles, and market acceptance** of products[16](index=16&type=chunk)

The webcast will take place on Tuesday, May 14, 2024, at 8:30 AM and is accessible in the investor relations section of the Company's website at pavmed.com. Alternatively, to access the conference call by telephone, U.S.-based callers should dial 1-800-836-8184 and international listeners should dial 1-646-357-8785. All listeners should provide the operator with the conference call name "PAVmed Business Update" to join. Following the conclusion of the conference call, a replay will be available for 30 days ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q (Mark One) ☒ 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 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____ to _____ (Registrant's Telephone Number, Including Area Code) Securities registered pursuant to Section 12(b) of the Exchange Act: Commission File Number: ...

Financial Data and Key Metrics Changes - Quarterly revenue increased by 33% compared to the prior quarter, indicating strong growth momentum [5][39] - Non-GAAP loss for the year was $42 million, with a quarterly average loss of $10.5 million, and the fourth quarter loss was $10.6 million, consistent with the annual average [46][44] - Cash balance at the end of the quarter was $19.6 million, reflecting a sequential burn of $11.8 million, with a 31% reduction in quarterly burn rate since the beginning of 2023 [44][38] Business Line Data and Key Metrics Changes - Lucid Diagnostics recognized revenue of $1,040,000 for the fourth quarter, representing a 33% increase over the third quarter, with test volume at 2,200 tests [39][10] - Veris Health is shifting its strategy to target large academic and regional cancer centers, which is expected to enhance its financeability [26][34] - The PMX incubator was launched to develop and commercialize existing medtech portfolio technologies, starting with PortIO, EsoCure, and CarpX [15][4] Market Data and Key Metrics Changes - The estimated market opportunity for the technologies being developed is approximately $500 million, excluding the dialysis population [16] - The reimbursement landscape is improving, with about 82% of claims adjudicated, and 46% of those resulting in an allowable amount by insurance companies [20][41] Company Strategy and Development Direction - The company is focusing on driving shareholder value through independently financed subsidiaries, similar to Lucid, leveraging shared infrastructure [24][27] - The strategy includes seeking groundbreaking independently financeable technologies with large market opportunities [28][4] - The company aims to replicate Lucid's success by engaging with large academic cancer centers and establishing long-term commercial partnerships [34][26] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, highlighting the potential for revenue growth through direct contracting and improved reimbursement processes [32][50] - The company is actively pursuing financing opportunities for its subsidiaries and believes it has a clear path to FDA clearance for its implantable monitor [6][35] - Management acknowledged the challenges in the reimbursement landscape but remains committed to enhancing long-term shareholder value [3][24] Other Important Information - The company has raised $18.1 million in preferred stock financing, strengthening Lucid's balance sheet [10] - The PMX incubator is a wholly owned subsidiary of PAVmed, aimed at securing financing for individual products [67][80] Q&A Session Summary Question: Can you provide additional commentary on the biomarker legislation? - Management noted that 15 states have some form of biomarker legislation, which varies by state, and they are starting to gain traction in this area [47][48] Question: How should we think about the potential revenue contribution from Veris in '24 and '25? - Management indicated that while there are longer lead times with large strategic accounts, the revenue opportunity is substantial due to the larger patient populations [58][60] Question: What is the status of the incubator and financial commitments? - The incubator is wholly owned by PAVmed, and the plan is to secure individual financing for each product without diluting PAVmed's majority stake [67][71]

Part I [Business](index=5&type=section&id=Item%201.%20Business) PAVmed Inc. commercializes healthcare technologies through subsidiaries, focusing on EsoGuard, Veris Health, and other products via an incubator [Background and Overview](index=5&type=section&id=Background%20and%20Overview) PAVmed is a multi-product life sciences company, leveraging a subsidiary structure for tailored financing and advancing EsoGuard, Veris Health, and incubator products - **PAVmed's corporate structure** allows for flexible financing, favoring **subsidiary-specific financing**[16](index=16&type=chunk) - The company's multi-fold focus includes **commercializing Lucid Diagnostics' EsoGuard**, seeking **partnerships for the Veris Health platform**, and advancing other products through an **incubator model**[17](index=17&type=chunk) [EsoGuard and EsoCheck](index=5&type=section&id=EsoGuard%20and%20EsoCheck) Lucid Diagnostics' EsoGuard and EsoCheck are noninvasive tests for early esophageal precancer detection, focusing on commercialization, reimbursement, and regulatory compliance EsoGuard Market Opportunity | Metric | Value | | :--- | :--- | | Target Patient Population (U.S.) | **30 million individuals** | | Total Addressable Market (U.S.) | **~$60 billion** | | Basis of Calculation | **30M patients** at **Medicare payment** of **$1,938** | - **Commercialization efforts** for **EsoGuard** are pursued through multiple channels: - A network of physical **Lucid Test Centers** - A satellite test center program, including a Mobile Testing Unit, to perform procedures in physician offices - On-site testing events with organizations like the San Antonio Fire Department - A Direct Contracting Strategic Initiative (DCSI) targeting self-insured employers and unions - An **EsoGuard Telemedicine Program** for direct-to-consumer marketing[32](index=32&type=chunk)[33](index=33&type=chunk)[34](index=34&type=chunk) - **CMS** granted **EsoGuard** a final **Medicare payment determination** of **$1,938.01**, effective January **1**, **2021**. However, a final Local Coverage Determination (LCD) for **reimbursement** is still pending, with the company planning to submit for a Technical Assessment[24](index=24&type=chunk)[38](index=38&type=chunk)[39](index=39&type=chunk) - The **FDA** has proposed a policy to phase out its general enforcement discretion for **Laboratory Developed Tests (LDTs)** like **EsoGuard**. The company anticipates finalizing its response by April **2024** and believes it can meet the new requirements without a **material commercial impact**[51](index=51&type=chunk)[52](index=52&type=chunk) [Veris Platform](index=13&type=section&id=Veris%20Platform) Veris Health's digital cancer care platform facilitates remote patient monitoring, pursuing strategic partnerships and a recurring-revenue SaaS model - The **Veris Platform** is a digital cancer care solution for **remote patient monitoring**, designed to detect early signs of complications and improve outcomes for cancer patients[61](index=61&type=chunk) - The **total addressable U.S. market** for the **Veris Platform** is estimated to exceed **$2 billion**, based on cancer prevalence and the current SaaS business model[63](index=63&type=chunk) - The **commercialization strategy** focuses on **strategic partnerships** with leading academic oncology systems and a **recurring-revenue SaaS model** where institutions pay monthly fees per patient[64](index=64&type=chunk) [Incubator Program](index=14&type=section&id=Incubator%20Program) PAVmed launched PMX, a wholly-owned incubator, to develop and commercialize PortIO, EsoCure, and CarpX through independent subsidiary financing - **PAVmed** launched a **wholly-owned incubator**, **PMX**, in a joint venture with Hatch Medical to advance development and **commercialization** of its PortIO, EsoCure, and CarpX technologies[69](index=69&type=chunk)[87](index=87&type=chunk) - The strategy involves assigning the technologies to **PMX** and then seeking independent financing for separate subsidiaries to develop each product with the goal of engaging a **strategic partner** for acquisition or distribution[70](index=70&type=chunk)[88](index=88&type=chunk) - **CarpX**, a device for treating carpal tunnel syndrome, has already received **FDA 510(k) marketing clearance** in April **2020** and European CE Mark Certification in May **2021**[76](index=76&type=chunk) [Recent Developments](index=16&type=section&id=Recent%20Developments) Recent corporate activities include a reverse stock split, special dividend of Lucid shares, Nasdaq compliance issues, and a significant Series B preferred stock offering by Lucid - On December **7**, **2023**, the company implemented a **1-for-15 reverse stock split** to regain **compliance** with **Nasdaq's $1 minimum bid price requirement**[79](index=79&type=chunk)[80](index=80&type=chunk) - On February **15**, **2024**, **PAVmed** distributed approximately **3.3 million shares** of **Lucid Diagnostics common stock** to its shareholders as a **special dividend**[83](index=83&type=chunk) - On March **7**, **2024**, the company received a notice from **Nasdaq** for its **market value** of listed securities (MVLS) falling below the **$35 million minimum**, with **180 days** (until September **3**, **2024**) to regain **compliance**[86](index=86&type=chunk) - On March **13**, **2024**, subsidiary **Lucid Diagnostics** raised aggregate gross proceeds of **$18.16 million** through a **Series B Convertible Preferred Stock offering** and exchange[91](index=91&type=chunk)[92](index=92&type=chunk) [Risk Factors](index=31&type=page&id=Item%201A.%20Risk%20Factors) The company faces substantial risks including financial instability, going concern doubts, Nasdaq delisting risk, intense competition, and regulatory hurdles for product reimbursement [Risks Related to Financial Position and Capital Resources](index=34&type=section&id=Risks%20Related%20to%20Financial%20Position%20and%20Capital%20Resources) Critical financial risks include recurring operating losses, substantial doubt about going concern, high dependency on subsidiary capital, and Nasdaq delisting risk - The company has concluded there is **substantial doubt** about its ability to continue as a **going concern**, and its **independent registered public accounting firm's report** contains an explanatory paragraph expressing the same concern[162](index=162&type=chunk) - Due to difficulties raising **capital** directly, **PAVmed** is highly **dependent** on its subsidiaries, particularly **Lucid Diagnostics**, to raise funds for their own operations and to fund **PAVmed's operations** through intercompany agreements[163](index=163&type=chunk)[164](index=164&type=chunk) - On March **7**, **2024**, the company received a notice from **Nasdaq** for its **market value** falling below the **$35 million minimum requirement**, giving it until September **3**, **2024**, to regain **compliance** or face **delisting**[166](index=166&type=chunk) [Risks Associated with Our Business](index=36&type=section&id=Risks%20Associated%20with%20Our%20Business) Operational risks include intense competition, market acceptance uncertainty, reliance on third-party manufacturers, and challenges in protecting intellectual property - The company faces **intense competition** from established medical device companies that have substantially greater financial, technical, marketing, and manufacturing resources[181](index=181&type=chunk) - The company relies on a **single laboratory facility** in Lake Forest, CA, for its **EsoGuard test**. Any damage, disruption, or capacity constraints at this facility could materially harm the business[194](index=194&type=chunk)[195](index=195&type=chunk) - The success of the new **incubator financing structure** is not guaranteed and may result in substantial direct costs without insulating the liabilities of its subsidiaries from each other or from **PAVmed**[198](index=198&type=chunk)[199](index=199&type=chunk) [Risks Associated with Healthcare Regulation, Billing and Reimbursement, and Product Safety and Effectiveness](index=49&type=section&id=Risks%20Associated%20with%20Healthcare%20Regulation%2C%20Billing%20and%20Reimbursement%2C%20and%20Product%20Safety%20and%20Effectiveness) Significant regulatory and reimbursement risks include securing adequate payment for EsoGuard and potential increased FDA oversight of Laboratory Developed Tests (LDTs) - The **commercial success of EsoGuard** is highly **dependent** on securing adequate **reimbursement** from third-party payors. While **CMS** has set a **payment rate**, a final **Medicare Local Coverage Determination (LCD)** has not yet been granted, creating uncertainty[227](index=227&type=chunk)[228](index=228&type=chunk) - The **FDA** has proposed a policy to phase out its general enforcement discretion for **LDTs**, which would subject **EsoGuard** to the same **regulatory approach** as other in-vitro diagnostics (IVDs). While the company is confident it can comply, failure to do so could materially impact its business[235](index=235&type=chunk)[236](index=236&type=chunk) - The company's ability to commercialize future products depends on obtaining **regulatory approvals** (e.g., **FDA 510(k)** or PMA), which requires expensive and time-consuming clinical trials with uncertain outcomes[237](index=237&type=chunk)[240](index=240&type=chunk) [Risks Associated with Ownership of Our Common Stock](index=57&type=section&id=Risks%20Associated%20with%20Ownership%20of%20Our%20Common%20Stock) Common stock ownership risks include significant dilution from outstanding securities, stock price volatility, no cash dividends, and high public company compliance costs - As of December **31**, **2023**, a significant number of **shares** are issuable upon the exercise or conversion of outstanding warrants, stock options, preferred stock, and convertible notes, which could lead to **substantial dilution** for existing stockholders[263](index=263&type=chunk)[264](index=264&type=chunk) - The company does not intend to pay any **cash dividends** in the foreseeable future, meaning any investment gains will rely solely on stock price appreciation[266](index=266&type=chunk) - The company and its subsidiary **Lucid Diagnostics** incur significant legal, accounting, and other **expenses** as **public companies**, requiring substantial management time for **compliance** with SEC and **Nasdaq regulations**[269](index=269&type=chunk) [Unresolved Staff Comments](index=63&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports no unresolved staff comments from the SEC - Not applicable[280](index=280&type=chunk) [Cybersecurity](index=64&type=section&id=Item%201C.%20Cybersecurity) The board's audit committee oversees cybersecurity risk, managed by a third-party vendor, with no material incidents reported to date - **Cybersecurity risk oversight** is administered by the **audit committee** of the board[281](index=281&type=chunk) - The company utilizes a **third-party vendor**, **CyberTeam**, to manage its **cybersecurity program**, which includes identifying, assessing, and mitigating risks[282](index=282&type=chunk)[284](index=284&type=chunk)[285](index=285&type=chunk) - The company is not currently aware of any **cybersecurity threats** or incidents that have had or are reasonably likely to have a **material effect** on the company[287](index=287&type=chunk) [Properties](index=64&type=section&id=Item%202.%20Properties) The company leases corporate headquarters, an R&D facility, a CLIA lab, an office, and multiple Lucid Test Centers across several U.S. states - The company leases its **corporate offices** in New York, an **R&D facility** in Massachusetts, a **CLIA lab** in California, an office in Pennsylvania, and multiple **Lucid Test Centers** across the U.S[288](index=288&type=chunk) [Legal Proceedings](index=64&type=section&id=Item%203.%20Legal%20Proceedings) The company is not aware of any pending legal proceedings likely to have a material impact on its business or financial position - The company is not aware of any pending **legal proceedings** that are reasonably likely to have a **material impact** on the company[289](index=289&type=chunk) [Mine Safety Disclosures](index=65&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[291](index=291&type=chunk) Part II [Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=66&type=section&id=Item%205.%20Market%20for%20Registrant%E2%80%99s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock and Series Z Warrants trade on Nasdaq, facing delisting risk, with no cash dividends planned but a recent Lucid stock special dividend - The company's **common stock** and **Series Z Warrants** trade on the **Nasdaq Capital Market**, but on March **7**, **2024**, the company received a notice of non-compliance for failing to meet the **minimum market value** of **$35 million**[292](index=292&type=chunk) - The company has not paid **cash dividends** and does not plan to in the foreseeable future. However, on February **15**, **2024**, it paid a **special dividend** of **Lucid Diagnostics common stock** to its shareholders[294](index=294&type=chunk)[297](index=297&type=chunk) - The **Series B Convertible Preferred Stock accrues dividends** at a rate of **8% per annum**, which are cumulative and payable at the company's election in cash, **common stock**, or additional preferred stock[299](index=299&type=chunk) [Reserved](index=67&type=section&id=Item%206.%20%5BReserved%5D) This item is reserved [Management’s Discussion and Analysis of Financial Condition and Results of Operations](index=68&type=section&id=Item%207.%20Management%E2%80%99s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses increased revenue from EsoGuard sales, reduced operating losses, critical liquidity concerns, and recent financing activities at the subsidiary level [Results of Operations](index=73&type=section&id=Results%20of%20Operations) Revenue increased significantly to $2.5 million in 2023, improving operating loss to $68.8 million due to decreased general and administrative and R&D expenses Comparison of Operations (2023 vs. 2022) | Financial Metric (in millions) | 2023 | 2022 | | :--- | :--- | :--- | | **Revenue** | **$2.5** | **$0.4** | | Cost of **revenue** | **$6.4** | **$3.6** | | Sales and marketing | **$17.6** | **$19.3** | | General and administrative | **$30.9** | **$41.4** | | Research and development | **$14.3** | **$25.3** | | **Operating loss** | **($68.8)** | **($91.1)** | - The **$10.5 million decrease** in general and administrative **expenses** was principally related to an **$8.1 million decrease** in **stock-based compensation** and a **$3.5 million decrease** in third-party professional fees[343](index=343&type=chunk) - The **$11.0 million decrease** in research and development **expenses** was primarily due to a **$10.1 million decrease** in development costs, particularly in clinical trial activities[344](index=344&type=chunk) [Liquidity and Capital Resources](index=76&type=section&id=Liquidity%20and%20Capital%20Resources) The company faces substantial doubt about going concern, with $19.6 million cash at year-end, relying on subsidiary capital raises and recent debt amendments for operations - The company's **recurring losses** and negative **cash flows** raise **substantial doubt** about its ability to continue as a **going concern** beyond March **2025**[349](index=349&type=chunk)[350](index=350&type=chunk) Cash Position and Burn Rate | Metric (in millions) | 2023 | 2022 | | :--- | :--- | :--- | | **Cash at year-end** | **$19.6** | **$39.7** | | **Net cash used in operations** | **($52.0)** | **($71.0)** | | **Net cash from financing** | **$31.2** | **$38.2** | - The company amended its **Senior Secured Convertible Notes** to extend maturity dates to **2025** and obtained a waiver for non-compliance with financial covenants through August **31**, **2024**, in exchange for a **$2.0 million fee**[323](index=323&type=chunk)[353](index=353&type=chunk)[354](index=354&type=chunk) - In **2023**, **PAVmed** raised approximately **$1.8 million** through its at-the-market (ATM) facility. Its subsidiary, Lucid, raised funds through its own committed equity and ATM facilities[328](index=328&type=chunk)[329](index=329&type=chunk)[330](index=330&type=chunk) [Critical Accounting Policies and Estimates](index=81&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) Key accounting policies include Revenue Recognition (estimating variable consideration), Fair Value Option for convertible notes (complex valuation), and Stock-Based Compensation (Black-Scholes model estimates) - For **revenue recognition**, the company estimates variable consideration from insurance payers and constrains **revenue** until collection is probable, which may result in no **revenue** being recognized upon test delivery if historical experience is limited[368](index=368&type=chunk)[369](index=369&type=chunk) - The company has elected the **Fair Value Option (FVO)** for its **Senior Secured Convertible Notes**. This requires remeasuring the debt at **fair value** each period using complex models like Monte Carlo simulations, with changes in value reported in the statement of operations[371](index=371&type=chunk)[374](index=374&type=chunk) - **Stock-based compensation** is valued using the **Black-Scholes model**, which requires significant estimates for inputs such as expected stock price volatility and the expected term of the options[378](index=378&type=chunk)[380](index=380&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=85&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This item is not applicable to the company - Not applicable[389](index=389&type=chunk) [Financial Statements and Supplementary Data](index=86&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) The company's consolidated financial statements and independent auditor's report are included in the Annual Report starting on page F-1 - The company's **consolidated financial statements** and the **independent auditor's report** are included in the report[391](index=391&type=chunk) [Changes in and Disagreements With Accountants on Accounting and Financial Disclosure](index=86&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20With%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) The company reports no changes in or disagreements with its accountants on accounting and financial disclosure - None[392](index=392&type=chunk) [Controls and Procedures](index=86&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that disclosure controls and internal control over financial reporting were effective as of December 31, 2023, with no material changes - Management concluded that the company's **disclosure controls and procedures** were effective as of December **31**, **2023**[393](index=393&type=chunk) - Based on an evaluation using the COSO framework, management concluded that the company's **internal control over financial reporting** was effective as of December **31**, **2023**[396](index=396&type=chunk) [Other Information](index=86&type=section&id=Item%209B.%20Other%20Information) Material modifications include a 12-month extension of Series Z Warrants; no Rule 10b5-1 trading plans were adopted or terminated by directors or officers - The company extended the expiration date of its **Series Z Warrants** by **12 months** to April **30**, **2025**[401](index=401&type=chunk) [Disclosure Regarding Foreign Jurisdictions That Prevent Inspections](index=87&type=section&id=Item%209C.%20Disclosure%20Regarding%20Foreign%20Jurisdictions%20That%20Prevent%20Inspections) This item is not applicable to the company - Not applicable[403](index=403&type=chunk) Part III [Directors, Executive Officers and Corporate Governance](index=88&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) Information for this item will be incorporated by reference from the company's 2024 definitive proxy statement - Information is incorporated by reference from the **2024 Proxy Statement**[406](index=406&type=chunk) [Executive Compensation](index=88&type=section&id=Item%2011.%20Executive%20Compensation) Information for this item will be incorporated by reference from the company's 2024 definitive proxy statement - Information is incorporated by reference from the **2024 Proxy Statement**[407](index=407&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=88&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Information for this item will be incorporated by reference from the company's 2024 definitive proxy statement - Information is incorporated by reference from the **2024 Proxy Statement**[408](index=408&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=88&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) Information for this item will be incorporated by reference from the company's 2024 definitive proxy statement - Information is incorporated by reference from the **2024 Proxy Statement**[409](index=409&type=chunk) [Principal Accountant Fees and Services](index=88&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services) Information for this item will be incorporated by reference from the company's 2024 definitive proxy statement - Information is incorporated by reference from the **2024 Proxy Statement**[410](index=410&type=chunk) Part IV [Exhibits, Financial Statement Schedules](index=89&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section lists all financial statements, schedules, and exhibits filed with the Form 10-K, including those incorporated by reference - This section lists all **financial statements** and exhibits filed with the Form **10-K**[413](index=413&type=chunk)[414](index=414&type=chunk)[415](index=415&type=chunk) [Form 10-K Summary](index=90&type=section&id=Item%2016.%20Form%2010-K%20Summary) The company indicates that there is no Form 10-K summary - None[417](index=417&type=chunk) Financial Statements [Report of Independent Registered Public Accounting Firm](index=94&type=section&id=Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) The independent auditor's report expresses a fair opinion but includes substantial doubt about the company's going concern and identifies convertible notes valuation as a critical audit matter - The **auditor's report** includes an explanatory paragraph highlighting **substantial doubt** about the Company's ability to continue as a **going concern**[428](index=428&type=chunk) - The **valuation** of the company's **Senior Secured Convertible Notes** was identified as a **Critical Audit Matter** due to the complexity and high degree of subjectivity in the **valuation methodology**[433](index=433&type=chunk)[434](index=434&type=chunk) [Consolidated Financial Statements](index=96&type=section&id=Consolidated%20Financial%20Statements) The consolidated financial statements show decreased cash, increased liabilities, and an improved net loss for 2023, with cash used in operations offset by financing activities Consolidated Balance Sheet Highlights (in thousands) | Account | Dec 31, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | **Cash** | **$19,639** | **$39,744** | | Total Assets | **$33,119** | **$53,980** | | **Senior Secured Convertible Notes** - at **fair value** | **$44,200** | **$33,650** | | Total Liabilities | **$57,137** | **$43,046** | | Total Stockholders' Equity (Deficit) | **($24,018)** | **$10,934** | Consolidated Statement of Operations Highlights (in thousands) | Account | 2023 | 2022 | | :--- | :--- | :--- | | **Revenue** | **$2,452** | **$377** | | **Operating loss** | **($68,795)** | **($91,087)** | | **Net loss attributable to PAVmed Inc.** | **($64,175)** | **($88,983)** | | **Net loss per share** | **($9.16)** | **($15.03)** | Consolidated Cash Flow Highlights (in thousands) | Account | 2023 | 2022 | | :--- | :--- | :--- | | **Net cash used in operating activities** | **($52,036)** | **($70,985)** | | Net cash provided by (used in) investing activities | **$758** | **($4,740)** | | **Net cash provided by financing activities** | **$31,173** | **$38,211** | [Notes to Consolidated Financial Statements](index=103&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) Notes detail liquidity issues, going concern uncertainty, the 1-for-15 reverse stock split, federal NOL carryforwards, and a recent special dividend of Lucid Diagnostics stock - Note **2** confirms that factors such as **recurring losses**, negative **cash flow**, and the need to raise additional **capital** raise **substantial doubt** about the company's ability to continue as a **going concern** beyond March **2025**[452](index=452&type=chunk)[455](index=455&type=chunk) - A **1-for-15 reverse stock split** became effective on December **7**, **2023**. All share and per-share amounts in the **financial statements** have been retroactively adjusted to reflect this split[459](index=459&type=chunk)[460](index=460&type=chunk) - As of December **31**, **2023**, the company had approximately **$236.3 million** in federal **net operating loss (NOL) carryforwards** available to reduce future taxable income, though a full **valuation allowance** has been recorded against the resulting deferred tax assets[611](index=611&type=chunk) - Subsequent to year-end, on February **15**, **2024**, the company distributed **3,331,747 shares** of **Lucid Diagnostics common stock** to its shareholders as a **special dividend**[594](index=594&type=chunk)[602](index=602&type=chunk)

PAVmed Inc. (NASDAQ:PAVM) Q3 2023 Earnings Call Transcript November 15, 2023 8:30 AM ET Company Participants Michael Parks - Vice President of Investor Relations Lishan Aklog - Chairman and Chief Executive Officer Dennis McGrath - Executive Vice President and Chief Financial Officer Conference Call Participants Frank Takkinen - Lake Street Capital Markets Ed Woo - Ascendiant Capital Anthony Vendetti - Maxim Group Operator Good day, and welcome to the PAVmed Third Quarter 2023 Business Update Conference Call ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q (Mark One) ☒ 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: 001-37685 PAVMED INC. (Exact Name of Registrant as Specified in Its Charter) (State or Other Jurisdiction of (IRS Emp ...

PAVmed Inc. (NASDAQ:PAVM) Q2 2023 Earnings Conference Call August 16, 2023 8:30 AM ET Company Participants Michael Parks - Vice President of Investor Relations Lishan Aklog - Chairman and Chief Executive Officer Dennis McGrath - Executive Vice President and Chief Financial Officer Conference Call Participants Frank Takkinen - Lake Street Capital Markets Ed Woo - Ascendiant Capital Ross Osborn - Cantor Fitzgerald Anthony Vendetti - Maxim Group Operator Good day, and welcome to the PAVmed Second Quarter 2023 ...