PAVmed(PAVM)
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PAVmed Provides Business Update and Reports Second Quarter 2025 Financial Results
Prnewswire· 2025-08-14 12:00
Core Insights - PAVmed Inc. has provided a business update highlighting its financial results and developments within its subsidiaries, Lucid Diagnostics and Veris Health, for the second quarter of 2025 [1][4] Financial Performance - Lucid Diagnostics recognized $1.2 million in revenue from 2,756 EsoGuard® tests processed in Q2 2025 [7] - The company strengthened its balance sheet with a public offering that netted approximately $16.1 million, extending its financial runway into 2026 [7] - PAVmed reported a net loss attributable to common stockholders of approximately $13.3 million for the three months ended June 30, 2025, translating to a loss of $(0.74) per diluted share [10] Business Developments - Lucid initiated patient testing under a new commercial insurance coverage policy from Highmark Blue Cross Blue Shield, effective May 26, 2025 [7] - Veris Health completed a $2.5 million direct equity financing, allowing it to fund the development of its implantable physiological monitor through FDA clearance [7] - Veris is advancing towards regulatory clearance for its implantable monitor and is integrating with The Ohio State's James Cancer Hospital for commercial deployment [7] Strategic Partnerships and Initiatives - PAVmed is actively evaluating new opportunities to leverage its platform and diversify its portfolio, including discussions with academic medical centers [7] - Lucid partnered with Hoag to launch a comprehensive EsoGuard esophageal precancer testing program [7] Conference Call Information - A conference call and webcast were scheduled for August 14, 2025, to discuss the business update and financial results [2][3]
PAVmed(PAVM) - 2025 Q2 - Quarterly Report
2025-08-14 00:04
[Part I - Financial Information](index=2&type=section&id=Part%20I%20-%20Financial%20Information) [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) Presents the unaudited condensed consolidated financial statements and notes for the periods ended June 30, 2025 and 2024 [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheets show a significant increase in total assets and a shift from a stockholders' deficit to positive equity Condensed Consolidated Balance Sheets (in thousands) | Asset/Liability Category | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets:** | | | | Cash | $4,004 | $1,185 | | Total current assets | $5,488 | $2,164 | | Equity method investment - at fair value | $35,998 | $25,637 | | Total assets | $43,893 | $30,660 | | **Liabilities, Mezzanine Equity and Stockholders' Equity (Deficit):** | | | | Senior Secured Convertible Notes - at fair value | $6,800 | $29,100 | | Total current liabilities | $10,506 | $35,446 | | Total liabilities | $12,474 | $37,693 | | Mezzanine Equity (Series C Convertible Preferred Stock) | $3,260 | — | | Total Stockholders' Equity (Deficit) | $28,159 | $(7,033) | | Total Liabilities, Mezzanine Equity and Stockholders' Equity (Deficit) | $43,893 | $30,660 | - Total assets increased by approximately **$13.2 million** from December 31, 2024, to June 30, 2025, primarily driven by a significant increase in the equity method investment and cash[8](index=8&type=chunk) - Total liabilities decreased substantially by approximately **$25.2 million**, mainly due to a reduction in Senior Secured Convertible Notes[8](index=8&type=chunk) - Stockholders' Equity (Deficit) shifted from a **deficit of $7.0 million to a positive equity of $28.2 million**, indicating a significant improvement in the company's financial position[8](index=8&type=chunk) [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The statements of operations reflect a significant revenue decrease but a shift to net income in H1 2025 due to deconsolidation effects Condensed Consolidated Statements of Operations (in thousands) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Revenue | $6 | $979 | $14 | $1,989 | | Total operating expenses | $4,721 | $14,663 | $10,174 | $29,711 | | Operating loss | $(4,715) | $(13,684) | $(10,160) | $(27,722) | | Management fee income | $3,150 | — | $6,300 | — | | Change in fair value - equity method investment | $(10,643) | — | $10,361 | — | | Net income (loss) attributable to PAVmed Inc | $(11,921) | $(10,827) | $7,047 | $(26,039) | | Net income (loss) attributable to PAVmed Inc common stockholders | $(13,308) | $(10,908) | $4,386 | $(33,696) | | Net income (loss) per share – basic | $(0.74) | $(1.19) | $0.27 | $(3.78) | | Net income (loss) per share – diluted | $(0.74) | $(1.19) | $0.13 | $(3.78) | - Revenue **significantly decreased** for both the three and six months ended June 30, 2025, compared to 2024, primarily due to the deconsolidation of Lucid Diagnostics' operating results[11](index=11&type=chunk)[208](index=208&type=chunk)[222](index=222&type=chunk) - Total operating expenses saw **substantial reductions** for both periods in 2025 compared to 2024, also largely attributable to the deconsolidation of Lucid Diagnostics[11](index=11&type=chunk)[209](index=209&type=chunk)[210](index=210&type=chunk)[211](index=211&type=chunk)[212](index=212&type=chunk)[223](index=223&type=chunk)[224](index=224&type=chunk)[225](index=225&type=chunk)[226](index=226&type=chunk) - The company reported a **net income attributable to PAVmed Inc of $7.0 million** for the six months ended June 30, 2025, a significant improvement from a **$26.0 million loss** in the prior year, driven by management fee income and a gain from the change in fair value of equity method investment[11](index=11&type=chunk)[229](index=229&type=chunk)[233](index=233&type=chunk) [Condensed Consolidated Statements of Changes in Stockholders' Equity (Deficit)](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Equity%20(Deficit)) Stockholders' equity improved significantly, moving from a deficit to a positive balance due to net income and stock issuances - PAVmed Inc's total stockholders' equity (deficit) improved from a **deficit of $(7,033) thousand** as of December 31, 2024, to a **positive $28,159 thousand** as of June 30, 2025[17](index=17&type=chunk)[18](index=18&type=chunk) - Key changes include the issuance of **Series C Convertible Preferred Stock** through debt exchange and unsecured debt cancellation, and an increase in additional paid-in capital[17](index=17&type=chunk)[18](index=18&type=chunk) - The company recognized **net income of $7,047 thousand** for the six months ended June 30, 2025, contributing to the equity improvement[17](index=17&type=chunk)[18](index=18&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=11&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash flows show significantly reduced cash use in operations and lower financing proceeds compared to the prior year Condensed Consolidated Statements of Cash Flows (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net income (loss) - before noncontrolling interest ("NCI") | $6,300 | $(33,426) | | Net cash flows used in operating activities | $(2,759) | $(24,765) | | Net cash flows used in investing activities | $(14) | $(45) | | Net cash flows provided by financing activities | $5,592 | $30,670 | | Net increase in cash | $2,819 | $5,860 | | Cash, end of period | $4,004 | $25,499 | - Net cash used in operating activities **significantly decreased from $(24.8) million in 2024 to $(2.8) million in 2025**, indicating improved operational efficiency or reduced burn rate[27](index=27&type=chunk) - Cash provided by financing activities **decreased from $30.7 million in 2024 to $5.6 million in 2025**, reflecting different financing strategies or needs[27](index=27&type=chunk) - The company ended the six months with **$4.0 million in cash**, an increase from the beginning of the period, despite lower financing proceeds compared to the prior year[27](index=27&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=12&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations for the line items and policies presented in the financial statements [Note 1 — The Company](index=12&type=section&id=Note%201%20%E2%80%94%20The%20Company) Outlines the company's multi-product life sciences business model and current strategic focus areas - PAVmed Inc is a multi-product life sciences company focused on innovating, developing, acquiring, and commercializing novel healthcare technologies[29](index=29&type=chunk) - The company's current strategy involves establishing distinct subsidiaries for each financed asset, allowing for tailored financing directly into each subsidiary[29](index=29&type=chunk) - Current focus areas include supporting **EsoGuard's commercial expansion** through Lucid Diagnostics, expanding access to the **Veris Cancer Care Platform**, developing an implantable physiological monitor through Veris Health, and advancing other assets via an incubator-type platform (PMX)[30](index=30&type=chunk) [Note 2 — Liquidity and Going Concern](index=12&type=section&id=Note%202%20%E2%80%94%20Liquidity%20and%20Going%20Concern) Recurring losses and a working capital deficiency raise substantial doubt about the company's ability to continue as a going concern - The Company generated **less than $0.1 million in revenue** and experienced recurring losses and negative cash flows from operating activities for the three and six months ended June 30, 2025[32](index=32&type=chunk) - As of June 30, 2025, the Company had a **working capital deficiency of approximately $5.0 million**, including $6.8 million in Senior Secured Convertible Notes classified as current liabilities and $4.0 million in cash[33](index=33&type=chunk) - These factors raise **substantial doubt about the Company's ability to continue as a going concern** within one year, necessitating increased revenues, cost control, and additional capital raises[34](index=34&type=chunk) [Note 3 — Summary of Significant Accounting Policies](index=13&type=section&id=Note%203%20%E2%80%94%20Summary%20of%20Significant%20Accounting%20Policies) Details the basis of presentation, consolidation principles, revenue recognition, and adoption of new accounting standards - The financial statements are prepared in accordance with **U.S. GAAP and SEC rules**, with all intercompany transactions eliminated in consolidation[37](index=37&type=chunk) - PAVmed has a controlling financial interest in Veris Health Inc, but **ceased to have a controlling interest in Lucid Diagnostics** as of September 10, 2024, now accounting for it using the equity method with the fair value option[37](index=37&type=chunk) - Revenue recognition follows **ASC 606**, with current revenue primarily from the Veris Cancer Care Platform, and previously from Lucid's EsoGuard tests[44](index=44&type=chunk) - The company adopted **ASU No 2023-09 (Income Taxes)** effective January 1, 2025, and is evaluating other ASUs for future impact[59](index=59&type=chunk)[60](index=60&type=chunk)[61](index=61&type=chunk) [Note 4 — Equity Method Investment](index=16&type=section&id=Note%204%20%E2%80%94%20Equity%20Method%20Investment) Explains the accounting for the Lucid Diagnostics investment and presents its summarized financial information - PAVmed accounts for its investment in Lucid Diagnostics as an **equity method investment with the fair value option** since September 10, 2024, due to loss of controlling interest but retention of significant influence[62](index=62&type=chunk) Lucid Diagnostics Summarized Financial Information (in thousands) | Metric | June 30, 2025 | | :--- | :--- | | Cash | $31,123 | | Total assets | $38,670 | | Total liabilities | $30,808 | | Shareholders' equity | $7,862 | | Revenue (Three Months Ended June 30, 2025) | $1,163 | | Net income (loss) attributable to common stockholders (Three Months Ended June 30, 2025) | $(7,888) | | Revenue (Six Months Ended June 30, 2025) | $1,991 | | Net income (loss) attributable to common stockholders (Six Months Ended June 30, 2025) | $(43,906) | - The fair value of PAVmed's investment in Lucid was **$36.0 million** at June 30, 2025, up from $25.6 million at December 31, 2024, resulting in an **unrealized gain of $10.4 million** for the six months ended June 30, 2025[64](index=64&type=chunk) - PAVmed recognized **$3.15 million and $6.3 million in management fee income** from Lucid for the three and six months ended June 30, 2025, respectively, following Lucid's deconsolidation[65](index=65&type=chunk) [Note 5 — Revenue from Contracts with Customers](index=17&type=section&id=Note%205%20%E2%80%94%20Revenue%20from%20Contracts%20with%20Customers) Revenue has decreased significantly following the deconsolidation of Lucid Diagnostics Revenue and Cost of Revenue (in thousands) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Revenue | < $0.1 | $979 | < $0.1 | $1,989 | | Cost of Revenue | $41 | $1,666 | $78 | $3,411 | - Revenue for the three and six months ended June 30, 2025, was **less than $0.1 million**, primarily from Veris Health Cancer Care Platform subscription revenue, a significant decrease from 2024 due to Lucid's deconsolidation[67](index=67&type=chunk) - Cost of revenue for the three and six months ended June 30, 2025, was also **less than $0.1 million**, mainly from Veris subscription revenue, down from $1.7 million and $3.4 million in 2024, respectively, due to Lucid's deconsolidation[68](index=68&type=chunk)[69](index=69&type=chunk) [Note 6 — Prepaid Expenses, Deposits, and Other Current Assets](index=17&type=section&id=Note%206%20%E2%80%94%20Prepaid%20Expenses%2C%20Deposits%2C%20and%20Other%20Current%20Assets) Details the components of prepaid expenses, which increased primarily due to higher advance payments and insurance Prepaid Expenses, Deposits, and Other Current Assets (in thousands) | Category | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Advanced payments to service providers and suppliers | $320 | $115 | | Prepaid insurance | $528 | $233 | | Deposits | $373 | $347 | | Veris Box supplies | $260 | $266 | | Total prepaid expenses, deposits and other current assets | $1,481 | $961 | - Total prepaid expenses, deposits, and other current assets **increased by $520 thousand** from December 31, 2024, to June 30, 2025, primarily due to higher advanced payments to service providers and prepaid insurance[70](index=70&type=chunk) [Note 7 — Leases](index=18&type=section&id=Note%207%20%E2%80%94%20Leases) Summarizes the company's operating lease liabilities and future payment obligations Future Lease Payments (in thousands) | Year | Amount | | :--- | :--- | | 2025 (remainder of year) | $357 | | 2026 | $724 | | 2027 | $594 | | 2028 | $471 | | 2029 | $481 | | Thereafter | $367 | | Total lease payments | $2,994 | | Less: imputed interest | $(484) | | Present value of lease liabilities | $2,510 | - The present value of lease liabilities as of June 30, 2025, was **$2.51 million**, with a weighted-average remaining lease term of 4.61 years and a weighted-average discount rate of 7.875%[71](index=71&type=chunk) - Operating lease right-of-use assets **decreased from $2.50 million** at December 31, 2024, to **$2.26 million** at June 30, 2025[71](index=71&type=chunk) [Note 8 — Commitment and Contingencies](index=18&type=section&id=Note%208%20%E2%80%94%20Commitment%20and%20Contingencies) The company is not aware of any pending legal proceedings likely to have a material impact on its financials - The Company may be subject to legal actions and claims in the ordinary course of business, including product liability, consumer, commercial, tax, and governmental matters[72](index=72&type=chunk) - As of the reporting date, the Company is **not aware of any pending legal or other proceedings** reasonably likely to have a material impact on its business, financial position, results of operations, or cash flows[72](index=72&type=chunk) [Note 9 — Financial Instruments Fair Value Measurements](index=19&type=section&id=Note%209%20%E2%80%94%20Financial%20Instruments%20Fair%20Value%20Measurements) Presents the fair value hierarchy for assets and liabilities, including the Lucid investment and convertible notes Fair Value Measurement on a Recurring Basis (in thousands) | Category | June 30, 2025 (Total) | December 31, 2024 (Total) | | :--- | :--- | :--- | | **Assets:** | | | | Investment in Lucid Diagnostics, Inc common stock | $35,998 | $25,637 | | **Liabilities:** | | | | Senior Secured Convertible Note - September 2022 | $6,800 | $8,800 | | Senior Secured Convertible Note - April 2022 | — | $20,300 | | Total liabilities at fair value | $6,800 | $29,100 | - The investment in Lucid Diagnostics common stock is classified as **Level 1 fair value**, based on quoted market prices[73](index=73&type=chunk) - Senior Secured Convertible Notes are classified as **Level 3 liabilities**, with fair values determined using Monte Carlo simulations and other valuation models[76](index=76&type=chunk)[78](index=78&type=chunk) - The April 2022 Senior Convertible Note was **fully satisfied** by June 30, 2025, while the September 2022 Senior Convertible Note's fair value decreased from $8.8 million to $6.8 million[73](index=73&type=chunk)[74](index=74&type=chunk) [Note 10 — Debt](index=21&type=section&id=Note%2010%20%E2%80%94%20Debt) Details the terms, covenants, and recent modifications of the company's outstanding senior convertible notes Senior Convertible Notes Outstanding (in thousands) | Note | Maturity Date | Stated Interest Rate | Conversion Price per Share | Principal Outstanding (June 30, 2025) | Fair Value (June 30, 2025) | | :--- | :--- | :--- | :--- | :--- | :--- | | September 2022 Senior Convertible Note | Dec 31, 2025 | 7.875% | $1.068 | $6,579 | $6,800 | - The April 2022 Senior Convertible Note was **fully satisfied in January 2025** through a debt exchange, and the September 2022 Senior Convertible Note's conversion price was reset to $1.068 and maturity extended to December 31, 2025[82](index=82&type=chunk)[87](index=87&type=chunk)[90](index=90&type=chunk) - The Company is subject to financial covenants, including **minimum cash of $8.0 million**, which were **waived through December 31, 2025**[84](index=84&type=chunk)[90](index=90&type=chunk) - Debt extinguishment losses were **less than $0.1 million** for the six months ended June 30, 2025, significantly lower than $1.1 million in the prior year[92](index=92&type=chunk)[231](index=231&type=chunk)[235](index=235&type=chunk) [Note 11 — Stock-Based Compensation](index=24&type=section&id=Note%2011%20%E2%80%94%20Stock-Based%20Compensation) Summarizes stock option activity and the significant decrease in stock-based compensation expense post-deconsolidation PAVmed Stock Options Summary | Metric | Number of Stock Options (June 30, 2025) | Weighted Average Exercise Price (June 30, 2025) | | :--- | :--- | :--- | | Outstanding stock options | 822,143 | $19.44 | | Vested and exercisable stock options | 596,926 | $25.96 | - PAVmed granted **255,000 stock options** in the six months ended June 30, 2025, and accepted voluntary forfeiture of approximately **494,202 options** with higher exercise prices in January 2025[97](index=97&type=chunk)[99](index=99&type=chunk) Consolidated Stock-Based Compensation Expense (in thousands) | Expense Category | Three Months Ended June 30, 2025 | Six Months Ended June 30, 2025 | | :--- | :--- | :--- | | Cost of revenue | $0 | $0 | | Sales and marketing expenses | $1 | $46 | | General and administrative expenses | $148 | $944 | | Research and development expenses | $13 | $102 | | Total stock-based compensation expense | $162 | $1,092 | - Total consolidated stock-based compensation expense **decreased significantly** from $1,904 thousand (3 months) and $3,786 thousand (6 months) in 2024 to $162 thousand and $1,092 thousand in 2025, respectively, primarily due to Lucid's deconsolidation[104](index=104&type=chunk) [Note 12 — Preferred Stock](index=27&type=section&id=Note%2012%20%E2%80%94%20Preferred%20Stock) Outlines the terms of Series B and Series C Preferred Stock, including recent issuances, conversions, and dividend accruals - As of June 30, 2025, there were **1,469,969 shares of PAVmed Series B Convertible Preferred Stock outstanding**, with dividends of $88 thousand and $175 thousand earned for the three and six months ended June 30, 2025, respectively[110](index=110&type=chunk)[113](index=113&type=chunk) - PAVmed **Series C Convertible Preferred Stock was issued** through a $22.3 million debt exchange and a $2.6 million unsecured debt cancellation in January 2025, with a stated value of $1,000 per share and a 7.875% annual dividend rate[86](index=86&type=chunk)[88](index=88&type=chunk)[118](index=118&type=chunk) - The Series C Preferred Stock conversion price was **temporarily reduced to $0.40 per share** through September 30, 2025, and the company recognized deemed dividend charges totaling $818 thousand in Q2 2025[129](index=129&type=chunk)[131](index=131&type=chunk)[136](index=136&type=chunk) - A portion of Series C Preferred Stock ($1.26 million) was **reclassified to mezzanine equity** due to a substantive redemption feature[132](index=132&type=chunk) [Note 13 — Common Stock and Common Stock Purchase Warrants](index=31&type=section&id=Note%2013%20%E2%80%94%20Common%20Stock%20and%20Common%20Stock%20Purchase%20Warrants) Describes recent common stock issuances, warrant activity, and the company's status with Nasdaq listing requirements - PAVmed **regained compliance with Nasdaq's $2.5 million stockholders' equity requirement** in February 2025 but received a notice for non-compliance with the $1 bid price rule in January 2025, with an extension until January 19, 2026[142](index=142&type=chunk)[143](index=143&type=chunk) - In the six months ended June 30, 2025, the company issued **401,303 common shares** for debt repayments, **1,216,565 shares** through its ATM facility for $0.8 million net proceeds, and **3,840,094 shares** from Series C Preferred Stock conversions[139](index=139&type=chunk)[144](index=144&type=chunk) - A February 2025 offering generated **$2.37 million gross proceeds** from selling 2,574,350 common shares and pre-funded warrants to purchase 756,734 shares[147](index=147&type=chunk)[149](index=149&type=chunk) - All **Series Z Warrants**, representing the right to purchase 795,830 shares, **expired on April 30, 2025**[150](index=150&type=chunk) [Note 14 — Noncontrolling Interest](index=33&type=section&id=Note%2014%20%E2%80%94%20Noncontrolling%20Interest) Explains the accounting for the noncontrolling interest in the consolidated subsidiary, Veris Health Noncontrolling Interest (NCI) Equity (in thousands) | Category | June 30, 2025 | | :--- | :--- | | NCI – equity - December 31, 2024 | $(4,538) | | Net loss attributable to NCI | $(747) | | Impact of subsidiary equity transactions | $(7,928) | | Veris Health issuance of common stock for settlement of vendor service agreement | $104 | | Veris Offerings | $3,438 | | Stock-based compensation expense - Veris Health 2021 Equity Plan | $300 | | NCI – equity – June 30, 2025 | $(9,371) | - PAVmed **lost controlling financial interest in Lucid Diagnostics** on September 10, 2024, reducing its voting interest to less than 50.0%, but retains significant influence[153](index=153&type=chunk) - Veris Health is a **consolidated majority-owned subsidiary**, with PAVmed holding a 59.49% majority-interest ownership (83.9% on an as-converted basis)[155](index=155&type=chunk) - Veris Health completed a June 2025 offering, selling 1,800,000 common shares and warrants for **$2.5 million gross proceeds**, to fund development of its implantable physiological monitor[156](index=156&type=chunk)[157](index=157&type=chunk) [Note 15 — Net Income (Loss) Per Share](index=34&type=section&id=Note%2015%20%E2%80%94%20Net%20Income%20(Loss)%20Per%20Share) Provides the calculation of basic and diluted net income (loss) per share, showing a shift from loss to profit Net Income (Loss) Per Share Attributable to PAVmed Inc Common Stockholders | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Net income (loss) per share – basic | $(0.74) | $(1.19) | $0.27 | $(3.78) | | Net income (loss) per share – diluted | $(0.74) | $(1.19) | $0.13 | $(3.78) | | Weighted average common shares outstanding, basic | 18,084,653 | 9,152,819 | 15,992,034 | 8,923,862 | | Weighted average common shares outstanding, diluted | 18,084,653 | 9,152,819 | 54,272,962 | 8,923,862 | - Basic and diluted EPS for the six months ended June 30, 2025, were **$0.27 and $0.13**, respectively, a significant improvement from losses of $(3.78) in the prior year[160](index=160&type=chunk) - For periods with net losses (Q2 2025, Q2 2024, H1 2024), common stock equivalents were **excluded from diluted EPS calculation** as their inclusion would be anti-dilutive[162](index=162&type=chunk) [Note 16 — Segment Information](index=35&type=section&id=Note%2016%20%E2%80%94%20Segment%20Information) The company operates as a single reportable segment with revenues concentrated in the United States - PAVmed operates as a **single operating segment**, with its Chief Executive Officer serving as the Chief Operating Decision Maker (CODM)[164](index=164&type=chunk)[165](index=165&type=chunk) - The company's business activities are managed on a consolidated basis, and revenues are concentrated in the **United States**[164](index=164&type=chunk)[166](index=166&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=36&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Analyzes financial condition and results of operations, focusing on Lucid's deconsolidation, recent developments, and liquidity [FORWARD-LOOKING STATEMENTS](index=36&type=section&id=FORWARD-LOOKING%20STATEMENTS) Warns that the report contains forward-looking statements subject to significant risks and uncertainties - The report contains **forward-looking statements** regarding future results, financial position, business strategy, and operational objectives, which involve substantial risks and uncertainties[171](index=171&type=chunk) - Key risk factors include limited operating history, ability to generate revenue, regulatory approval, market acceptance, and **additional financing needs**[174](index=174&type=chunk) [Overview](index=37&type=section&id=Overview) Reiterates the company's multi-product life sciences strategy and current areas of strategic focus - PAVmed is a multi-product life sciences company focused on innovative healthcare technologies, utilizing a corporate structure with **distinct subsidiaries for each financed asset**[175](index=175&type=chunk) - Current strategic focus includes supporting Lucid Diagnostics' **EsoGuard**, expanding Veris Health's **Cancer Care Platform**, and advancing other products through an incubator-type platform (PMX)[176](index=176&type=chunk) [Recent Developments](index=37&type=section&id=Recent%20Developments) Summarizes recent business and financing activities across the company and its key subsidiaries [Business](index=37&type=section&id=Business) Highlights recent clinical, regulatory, and commercial milestones for the Lucid Diagnostics' EsoGuard test - Lucid Diagnostics submitted a clinical evidence package to MolDx in November 2024 for **Medicare coverage reconsideration of EsoGuard**, with a CAC Meeting scheduled for September 4, 2025[177](index=177&type=chunk)[178](index=178&type=chunk) - Lucid was added to the **Russell 2000® and 3000® Indexes** on June 27, 2025, and launched a comprehensive esophageal precancer testing program with Hoag using EsoGuard[179](index=179&type=chunk)[181](index=181&type=chunk) - **NCCN Clinical Practice Guidelines** updated in March 2025 to reference non-endoscopic biomarker testing, such as EsoGuard, as an acceptable alternative for BE screening[182](index=182&type=chunk) - Lucid published its fifth peer-reviewed clinical utility manuscript showing a **2.4-fold increase in BE detection** with EsoGuard triage, and Highmark Blue Cross Blue Shield issued a positive coverage policy for EsoGuard in New York[183](index=183&type=chunk)[185](index=185&type=chunk) - Lucid announced an **$8 million NIH R01 grant** in February 2025 for a five-year clinical study evaluating EsoCheck and EsoGuard[186](index=186&type=chunk) [Financing](index=39&type=section&id=Financing) Summarizes recent capital raising activities at the PAVmed, Veris Health, and Lucid Diagnostics levels - Veris Health completed a June 2025 offering, raising approximately **$2.5 million in gross proceeds** to fund development of its implantable physiological monitor[188](index=188&type=chunk) - PAVmed and Veris completed a February 2025 offering, generating **$2.37 million in gross proceeds** from the sale of PAVmed common stock and pre-funded warrants, and Veris common stock[190](index=190&type=chunk) - PAVmed entered into a new **At-The-Market (ATM) Sales Agreement** with Maxim Group LLC in April 2025, allowing for sales of up to $2.88 million in common stock[192](index=192&type=chunk)[193](index=193&type=chunk) - Lucid Diagnostics completed a CMPO in April 2025, raising approximately **$16.2 million net**, and an RDO in March 2025, raising approximately **$14.9 million net**[195](index=195&type=chunk)[196](index=196&type=chunk) [Results of Operations](index=40&type=section&id=Results%20of%20Operations) Provides a comparative analysis of operating results, detailing the impact of Lucid Diagnostics' deconsolidation [Overview](index=40&type=section&id=Overview) Explains the expected impact of Lucid's deconsolidation on revenue and operating expense line items - Revenue is now primarily from the **Veris Health Cancer Care Platform**, shifting from Lucid's EsoGuard tests after its deconsolidation on September 10, 2024[198](index=198&type=chunk) - **Operating expenses are expected to decrease** due to Lucid's deconsolidation, as its expenses are no longer consolidated[199](index=199&type=chunk)[201](index=201&type=chunk)[203](index=203&type=chunk)[204](index=204&type=chunk) - Other income and expense, net, primarily includes **management fee income from Lucid** and changes in fair value of convertible notes[205](index=205&type=chunk) [The three months ended June 30, 2025 as compared to three months ended June 30, 2024](index=41&type=section&id=The%20three%20months%20ended%20June%2030%2C%202025%20as%20compared%20to%20three%20months%20ended%20June%2030%2C%202024) Compares Q2 2025 results to Q2 2024, showing decreased revenue and expenses due to Lucid's deconsolidation Key Financial Changes (Three Months Ended June 30, 2025 vs 2024) (in millions) | Metric | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | Revenue | < $0.1 | $1.0 | $(0.9) | | Cost of revenue | < $0.1 | $1.7 | $(1.6) | | Sales and marketing expenses | $0.2 | $4.2 | $(4.0) | | General and administrative expenses | $3.7 | $7.0 | $(3.3) | | Research and development expenses | $0.8 | $1.6 | $(0.8) | | Amortization of acquired intangible assets | $0 | $0.1 | $(0.1) | | Management fee income | $3.2 | $0 | $3.2 | | Change in fair value of convertible debt | $0.2 (expense) | $0.6 (expense) | $(0.4) | | Change in fair value of Equity Method Investment | $(10.6) (loss) | $0 | $(10.6) | | Loss on Debt Extinguishment | $0 | $0.8 | $(0.8) | - **Significant decreases in revenue and operating expenses** are primarily due to Lucid's deconsolidation from PAVmed's operating results[208](index=208&type=chunk)[209](index=209&type=chunk)[210](index=210&type=chunk)[211](index=211&type=chunk)[212](index=212&type=chunk) - Management fee income increased by **$3.2 million** due to Lucid's deconsolidation, while a **$10.6 million unrealized loss** was recognized on the equity method investment in Lucid[215](index=215&type=chunk)[220](index=220&type=chunk) [The six months ended June 30, 2025 as compared to six months ended June 30, 2024](index=43&type=section&id=The%20six%20months%20ended%20June%2030%2C%202025%20as%20compared%20to%20six%20months%20ended%20June%2030%2C%202024) Compares H1 2025 results to H1 2024, highlighting a shift to net income driven by deconsolidation effects Key Financial Changes (Six Months Ended June 30, 2025 vs 2024) (in millions) | Metric | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | Revenue | < $0.1 | $2.0 | $(1.9) | | Cost of revenue | < $0.1 | $3.4 | $(3.3) | | Sales and marketing expenses | $0.5 | $8.6 | $(8.1) | | General and administrative expenses | $8.1 | $13.7 | $(5.6) | | Research and development expenses | $1.6 | $3.6 | $(2.0) | | Amortization of acquired intangible assets | $0 | $0.5 | $(0.5) | | Management fee income | $6.3 | $0 | $6.3 | | Change in fair value of convertible debt | $0.3 (expense) | $2.7 (expense) | $(2.4) | | Change in fair value of Equity Method Investment | $10.4 (gain) | $0 | $10.4 | | Loss on Debt Extinguishment | < $0.1 | $1.1 | $(1.0) | | Deemed Dividend on Lucid Series A and Series A-1 Convertible Preferred Stock Exchange Offer | $0 | $7.5 | $(7.5) | - Similar to the quarterly trend, the six-month period shows **substantial decreases in revenue and operating expenses** due to Lucid's deconsolidation[222](index=222&type=chunk)[223](index=223&type=chunk)[224](index=224&type=chunk)[225](index=225&type=chunk)[226](index=226&type=chunk) - Management fee income increased by **$6.3 million**, and an **unrealized gain of $10.4 million** was recognized on the equity method investment in Lucid[229](index=229&type=chunk)[233](index=233&type=chunk) - Debt extinguishment losses **decreased significantly from $1.1 million in 2024 to less than $0.1 million in 2025**[231](index=231&type=chunk) [Liquidity and Capital Resources](index=45&type=section&id=Liquidity%20and%20Capital%20Resources) Discusses the company's financing strategy, cash position, and the going concern uncertainty due to recurring losses - The company's financing strategy focuses on obtaining capital directly into subsidiaries (Lucid, Veris) but retains flexibility to raise capital at the PAVmed level[236](index=236&type=chunk) - PAVmed experienced net income of $6.3 million before noncontrolling interests and used **$2.8 million cash in operations** for the six months ended June 30, 2025, ending with **$4.0 million cash on hand**[237](index=237&type=chunk) - The company expects continued recurring losses and negative cash flows, necessitating additional capital, which raises **substantial doubt about its going concern ability**[237](index=237&type=chunk) - Key financing activities in H1 2025 included issuing shares via ATM for **$0.8 million net proceeds** and a February offering for **$2.37 million gross proceeds**[240](index=240&type=chunk) - The September 2022 Senior Convertible Note's maturity was **extended to December 31, 2025**, and its financial covenants were waived until that date[239](index=239&type=chunk)[241](index=241&type=chunk) - Veris Health raised approximately **$2.5 million in gross proceeds** from a June 2025 offering of common stock and warrants to fund its implantable physiological monitor development[262](index=262&type=chunk) [Critical Accounting Estimates](index=49&type=section&id=Critical%20Accounting%20Estimates) Confirms no material changes to critical accounting estimates related to fair value, stock compensation, and taxes - The preparation of financial statements requires management to make estimates and assumptions, particularly regarding **fair value of debt obligations** and **stock-based equity awards**[43](index=43&type=chunk)[265](index=265&type=chunk) - There have been **no material changes** to the critical accounting estimates in the three months ended June 30, 2025, as disclosed in the Annual Report on Form 10-K for the year ended December 31, 2024[265](index=265&type=chunk) [Item 4. Controls and Procedures](index=45&type=section&id=Item%204.%20Controls%20and%20Procedures) Details the evaluation of disclosure controls and procedures and changes to internal controls over financial reporting [Evaluation of Disclosure Controls and Procedures](index=49&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of the end of the reporting period - Management, including the principal executive and financial officers, concluded that the company's disclosure controls and procedures were **effective as of June 30, 2025**[266](index=266&type=chunk) - These controls provide **reasonable assurance** that required information is recorded, processed, summarized, and reported within SEC specified time periods[266](index=266&type=chunk) [Changes to Internal Controls Over Financial Reporting](index=49&type=section&id=Changes%20to%20Internal%20Controls%20Over%20Financial%20Reporting) Reports no material changes to internal control over financial reporting during the most recent fiscal quarter - There have been **no material changes** to internal control over financial reporting during the fiscal quarter ended June 30, 2025[267](index=267&type=chunk) [Part II - Other Information](index=50&type=section&id=Part%20II%20-%20Other%20Information) [Item 1. Legal Proceedings](index=50&type=section&id=Item%201.%20Legal%20Proceedings) Addresses potential legal actions and claims the company may face during the ordinary course of business - The Company may be subject to various legal actions and claims, including product liability, consumer, commercial, tax, and governmental matters[269](index=269&type=chunk) - As of the reporting date, the Company is **not aware of any pending legal or other proceedings** that are reasonably likely to have a material impact on its business, financial position, results of operations, or cash flows[269](index=269&type=chunk) [Item 5. Other Information](index=50&type=section&id=Item%205.%20Other%20Information) Confirms no directors or officers adopted or terminated Rule 10b5-1 trading arrangements during the quarter - No directors or officers adopted or terminated a **"Rule 10b5-1 trading arrangement"** or "non-Rule 10b5-1 trading arrangement" during the fiscal quarter ended June 30, 2025[273](index=273&type=chunk) [Item 6. Exhibits](index=50&type=section&id=Item%206.%20Exhibits) Lists all exhibits filed as part of the Quarterly Report on Form 10-Q - The Exhibit Index includes the Sales Agreement (ATM Facility), the Sixth Amended and Restated 2014 Long-Term Incentive Equity Plan, and various certifications (e g, Section 302 and 906 of Sarbanes-Oxley Act)[281](index=281&type=chunk)
PAVmed(PAVM) - 2025 Q2 - Earnings Call Transcript
2025-08-13 13:30
Financial Data and Key Metrics Changes - Revenue for the second quarter was $1,200,000, reflecting a 40% increase from the first quarter and matching the previous quarterly high [9][39] - The cash balance at the end of the second quarter was $31,100,000, with a quarterly burn rate of $10,300,000, slightly better than the average burn rate of the previous four quarters [39][40] - Non-GAAP net loss for the second quarter was $9,900,000, which is an improvement of $1,200,000 sequentially [45] Business Line Data and Key Metrics Changes - EtherCAT test volume for the second quarter was 2,756 tests, within the target range of 2,500 to 3,000 tests per quarter [7] - The company invoiced nearly $7,000,000 for 2,756 tests, with revenue recognized at approximately $1,200,000, indicating a 40% sequential revenue increase and a 19% year-over-year increase [42][47] Market Data and Key Metrics Changes - The company is targeting a Medicare population that constitutes approximately 40% to 50% of the 30 million patients recommended for screening under existing guidelines [57] - Currently, the Medicare portion of testing is running in the 10% to 15% range, primarily due to a lack of targeted efforts [58] Company Strategy and Development Direction - The company is focused on securing Medicare coverage, which is seen as a critical milestone for accelerating commercialization efforts [6][36] - A Multi X Contractor Advisory Committee (CAC) meeting is scheduled for September 4, which is viewed as a significant step towards achieving a positive Medicare coverage policy outcome [12][19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming CAC meeting and the potential for a positive outcome regarding Medicare coverage [36][54] - The company is taking proactive steps to prepare for increased Medicare patient engagement once coverage is secured [36][59] Other Important Information - The company has strengthened its balance sheet with a public offering that netted $16,100,000 in proceeds, providing sufficient resources to ramp up commercial efforts after securing Medicare approval [15][39] - The publication of a pilot study in the American Journal of Gastroenterology highlighted the effectiveness of EsoGuard, which could expand the total addressable market significantly if similar results are replicated in ongoing studies [16][18] Q&A Session Summary Question: Insights on the multi-jurisdictional CAC meeting - Management indicated that the meeting is a positive sign of collaboration among Medicare contractors, suggesting they are in the late stages of the coverage determination process [52][53] Question: Percentage of business currently from Medicare - Currently, the Medicare portion of testing is around 10% to 15%, with plans to increase this significantly once Medicare coverage is secured [58][59] Question: Timing expectations post-CAC meeting - Management expects a draft LCD to be published relatively quickly after the CAC meeting, with a comment period following that [62][70]
PAVmed to Hold a Business Update Conference Call and Webcast on August 14, 2025
Prnewswire· 2025-07-31 12:01
Company Overview - PAVmed Inc. is a diversified commercial-stage medical technology company operating in the medical device, diagnostics, and digital health sectors [4] - The company has two subsidiaries: Lucid Diagnostics, which focuses on cancer prevention diagnostics, and Veris Health, which enhances personalized cancer care through remote patient monitoring [4] Upcoming Conference Call - PAVmed will host a business update conference call and webcast on August 14, 2025, at 8:30 AM ET [1] - The call will feature Lishan Aklog, M.D., the Chairman and CEO, providing an overview of the company's operations and growth strategy, along with Dennis McGrath, the President and CFO, discussing the second quarter 2025 financial results [1] Access Information - The webcast will be available on the investor relations section of the company's website [2] - U.S.-based callers can join the conference call by dialing 1-800-836-8184, while international listeners should dial 1-646-357-8785 [2] Replay Availability - A replay of the conference call will be available for 30 days on the investor relations section of the company's website [3]
PAVmed Subsidiary Veris Health Completes $2.5 Million Direct Equity Financing
Prnewswire· 2025-06-24 12:01
Core Insights - PAVmed Inc. completed a private placement equity financing for its subsidiary Veris Health, raising $2.5 million at a pre-money valuation of approximately $35 million [1][2][3] Group 1: Financing Details - Veris Health sold shares at $1.40 per share, with proceeds aimed at advancing its implantable physiological monitor through FDA clearance expected in 2026 [2][3] - The financing follows a previous $2.4 million round completed earlier in the year, indicating ongoing investor interest and confidence in Veris Health's potential [1][2] Group 2: Product and Technology - Veris Health focuses on personalized cancer care through remote patient monitoring using implantable biologic sensors and connected external devices [2][4] - The Veris Cancer Care Platform integrates remote physiological data collection, symptom reporting, telehealth capabilities, and electronic health record integration to enhance patient care [4][5] Group 3: Strategic Importance - The financing is seen as a significant milestone for both PAVmed and Veris, providing necessary capital to fund the development and commercialization of the implantable physiological monitor [3][4] - The monitor is expected to serve as a key differentiator in the market, enhancing personalized care in conjunction with the Veris Cancer Care Platform [3][5]
PAVmed Subsidiary, Veris Health, Enters into Strategic Partnership Agreement with The Ohio State University Comprehensive Cancer Center - James Cancer Hospital and Solove Research Institute
Prnewswire· 2025-06-03 12:31
Core Insights - Veris Health Inc. has established a strategic partnership with The Ohio State University Comprehensive Cancer Center (OSUCCC – James) following a successful pilot program of the Veris Cancer Care Platform™ [1][4] - The partnership aims to enhance personalized cancer care through remote patient monitoring and the development of the Veris Cancer Care Platform [2][3] Group 1: Partnership Details - The agreement includes a long-term, multi-project collaboration to further develop and commercialize the Veris Cancer Care Platform and its implantable physiologic monitor [2][3] - Key components of the partnership involve expanding commercial utilization across cancer care service lines, full electronic health record (EHR) integration, and launching a large clinical registry and clinical trial [3][4] Group 2: Platform Features - The Veris Cancer Care Platform offers remote physiological data collection, symptom reporting, telehealth capabilities, and EHR integration, aiming to improve personalized cancer care [4][5] - Patients enrolled in the platform receive a VerisBox™ with connected health care devices that transmit data to a cloud-based clinician portal, along with a patient smartphone app for symptom reporting and health tracking [5] Group 3: Company Background - PAVmed Inc. is a diversified commercial-stage medical technology company operating in medical devices, diagnostics, and digital health sectors, with Veris Health as its majority-owned subsidiary [7] - Veris Health focuses on enhancing personalized cancer care through innovative technologies, including the development of an implantable physiological monitor [7]
PAVmed(PAVM) - 2025 Q1 - Earnings Call Presentation
2025-05-15 19:52
Financial Performance - PAVmed's Q1 2025 revenue and management fee income was $3158 thousand, a decrease of $352 thousand compared to $3510 thousand in Q1 2024[23] - The company's operating expenses decreased significantly from $15046 thousand in Q1 2024 to $5454 thousand in Q1 2025, a reduction of $9592 thousand[23] - Net income for Q1 2025 was $18623 thousand, a substantial improvement of $37135 thousand compared to a loss of $18512 thousand in Q1 2024[23] - PAVmed reported an EBITDA of $19007 thousand in Q1 2025, compared to a negative EBITDA of $14813 thousand in Q1 2024, an increase of $33820 thousand[23] - Non-GAAP adjusted loss improved by $7705 thousand, from a loss of $8615 thousand in Q1 2024 to a loss of $910 thousand in Q1 2025[23] - Non-GAAP adjusted loss per share improved from $(099) in Q1 2024 to $(007) in Q1 2025, an increase of $092[23] Balance Sheet - PAVmed's cash position increased by $1515 thousand, from $1185 thousand in 4Q24 to $2700 thousand in 1Q25[22] - Equity method investments in Lucid increased by $21004 thousand, from $25637 thousand in 4Q24 to $46641 thousand in 1Q25[22] - Senior secured convertible notes decreased by $22500 thousand, from $29100 thousand in 4Q24 to $6600 thousand in 1Q25[22] - Preferred shares outstanding were 24480 thousand in 1Q25[22] - Shares outstanding increased from 112 million to 168 million, an increase of 56 million shares[22] Business Updates - Lucid Diagnostics' EsoGuard revenue for Q1 2025 was $08 million, with a test volume of 3034[17] - PAVmed strengthened its balance sheet by netting approximately $161 million in proceeds from an underwritten public offering of common stock[17]
PAVmed(PAVM) - 2025 Q1 - Earnings Call Transcript
2025-05-15 13:32
Financial Data and Key Metrics Changes - The company reported a revenue of $800,000 for the last quarter, with a test volume of 3,034, which is at the upper end of the target range of 2,500 to 3,000 tests per quarter [9] - A significant balance sheet improvement was noted with a public offering netting $16,100,000, resulting in a pro forma cash position of $40,000,000 at the end of Q1, extending the runway well into 2026 [10] - The company achieved a large GAAP net income of $18,600,000 before non-controlling interest and preferred dividends, resulting in a positive primary EPS of $1.28 and a positive diluted EPS of $0.34 [22][23] Business Line Data and Key Metrics Changes - Lucid, the diagnostic subsidiary, is positioned to capitalize on a large clinical and market opportunity, with ongoing efforts to secure Medicare coverage [6][11] - Verus has restarted the development of a key implantable physiologic monitor, with favorable engagement from the FDA and a targeted filing for the first half of 2026 [12] - The incubator PMX is focusing on the PortIO implantable intraosseous device, with discussions ongoing with potential strategic partners [13] Market Data and Key Metrics Changes - The company is seeing momentum in new sales channels, particularly in concierge medicine and employer market contracts, which are expected to impact revenue in the second half of the year [10][11] - The company has a significant equity method investment balance of almost $47,000,000 reflecting a gain of $21,000,000 since year-end, representing an 82% increase in Lucid's stock price [18][19] Company Strategy and Development Direction - The company aims to diversify into the biopharma space, leveraging its infrastructure and management services model to pursue attractive biopharma assets [8][36] - The strategic vision includes expanding partnerships and exploring new opportunities while maintaining focus on existing subsidiaries like Lucid and Verus [53][54] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's positioning and ability to execute on strategic initiatives, highlighting the strong relationships with key cancer centers and the positive feedback from pilot programs [30][31] - The management team believes that the current market conditions will not hinder their ability to raise capital, citing successful recent financings [46][48] Other Important Information - The company has deconsolidated Lucid from its financial statements, which has impacted the historical understanding of its financials [16][21] - The company continues to explore additional assets and opportunities to diversify its portfolio, with a focus on maintaining operational independence among its subsidiaries [8][40] Q&A Session Summary Question: Feedback from the pilot program - Management received excellent feedback from the pilot program, meeting all pre-specified performance metrics and demonstrating clinical success [29][30] Question: Exclusive rights to the platform - There are no exclusive rights limiting broader commercialization; the agreement allows for a registry and initial implantable procedures at the cancer center [32][33] Question: Strategic rationale for biopharma expansion - The company is leveraging its infrastructure and management services to pursue biopharma opportunities, which align with its history of adapting to market needs [36][39] Question: Impact of market volatility on capital raising - Management indicated that market volatility has not affected their ability to raise capital, with successful recent financings demonstrating investor confidence [46][48]
PAVmed(PAVM) - 2025 Q1 - Earnings Call Transcript
2025-05-15 13:30
Financial Data and Key Metrics Changes - The company reported a net income of $18.6 million for the first quarter, resulting in a positive primary EPS of $1.28 and a positive diluted EPS of $0.34 [23][24]. - A significant liability reduction of approximately $25 million was achieved, primarily from a reduction in convertible notes and accrued expenses [19][20]. - The company ended the quarter with $40 million in pro forma cash, extending its runway well into 2026 [11]. Business Line Data and Key Metrics Changes - Lucid, the company's diagnostic subsidiary, reported revenue of $800,000 with a test volume of 3,034, meeting the target range [10]. - Verus has restarted the development of a key implantable physiologic monitor after securing financing [12][14]. - The incubator PMX is focused on advancing technologies, particularly the PortIO device, with ongoing discussions with strategic partners [8][14]. Market Data and Key Metrics Changes - The company is seeing momentum in new sales channels, particularly in concierge medicine and employer market contracts, which are expected to impact revenue in the second half of the year [11][12]. - The company is awaiting a response from the MolDX program regarding Medicare coverage for EsoGuard, which is anticipated to be imminent [12]. Company Strategy and Development Direction - The company aims to diversify into the biopharma space, leveraging its infrastructure and management services model to capitalize on early-stage assets in oncology and cardiometabolic areas [9][39]. - The strategic focus includes expanding partnerships and exploring new assets that fit within the shared services model [10][39]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's positioning and ability to execute its strategic vision, highlighting the potential value creation from Lucid and Verus [51][52]. - The company is optimistic about leveraging its model and infrastructure to pursue significant opportunities in the near future [52][53]. Other Important Information - The company has deconsolidated Lucid from its financial statements, which will affect year-over-year comparisons in the upcoming quarters [16][22]. - PAVmed remains the largest shareholder of Lucid, holding approximately 29% of the common shares outstanding [20]. Q&A Session Summary Question: Feedback from the pilot program - Management received excellent feedback from the pilot program, with all pre-specified performance metrics met and enthusiasm from academic medical centers [31][32]. Question: Exclusive rights to the platform - There are local rights for advancing the platform, but no exclusivity that limits broader commercialization efforts [34][35]. Question: Rationale for expanding into biopharma - The company is leveraging its adjusted corporate structure and management services to explore opportunities in biopharma, particularly in early-stage assets that require clinical research [39][40]. Question: Impact of market volatility on capital raising - Management indicated that market volatility has not significantly affected their ability to raise capital, with successful financing in the first quarter [47][48].
PAVmed(PAVM) - 2025 Q1 - Quarterly Results
2025-05-15 12:25
[Business Update and Financial Results](index=1&type=section&id=Business%20Update%20and%20Financial%20Results) The company reports strategic business advancements and Q1 2025 financial performance, including key non-GAAP reconciliations [Business Update Highlights](index=1&type=section&id=Business%20Update%20Highlights) PAVmed stabilized its finances, enabling its subsidiaries to pursue key milestones and supporting expansion into biopharma - PAVmed is leveraging its infrastructure to expand into the biopharma sector by evaluating clinical and late preclinical-stage assets for a potential new subsidiary[5](index=5&type=chunk) - Lucid Diagnostics secured approximately **$30.6 million** from stock offerings, ending Q1 2025 with over **$40 million in pro forma cash**, extending its operational runway past key reimbursement milestones[1](index=1&type=chunk)[8](index=8&type=chunk) - Veris Health completed a financing round in Q1 2025, enabling it to resume the development of its implantable physiological monitor and launch a commercial partnership with a major cancer center[1](index=1&type=chunk)[8](index=8&type=chunk) Lucid Diagnostics Q1 2025 Operational Highlights | Metric | Value | | :--- | :--- | | EsoGuard Test Revenue | $0.8 million | | EsoGuard Tests Processed | 3,034 | [Financial Results](index=2&type=section&id=Financial%20Results) The company reported a significant GAAP net income for Q1 2025 driven by non-cash items, alongside a much smaller non-GAAP adjusted loss PAVmed Q1 2025 Key Financial Metrics | Metric | Q1 2025 Value | | :--- | :--- | | GAAP Net Income Attributable to Common Stockholders | $17.7 million | | GAAP Diluted EPS | $0.34 | | Non-GAAP Adjusted Loss | $(0.9) million | | Non-GAAP Adjusted Loss Per Share | $(0.07) | | Cash and Cash Equivalents (as of Mar 31, 2025) | $2.7 million | - Due to deconsolidation effective September 10, 2024, EsoGuard-related revenues are no longer consolidated; PAVmed's management service income from Lucid, totaling **$3.2 million**, is now recorded under Other Income[8](index=8&type=chunk) - Total operating expenses for Q1 2025 were approximately **$5.5 million**, which includes **$1.0 million** in stock-based compensation[8](index=8&type=chunk) [PAVmed Non-GAAP Measures](index=3&type=section&id=PAVmed%20Non-GAAP%20Measures) The company uses non-GAAP measures like EBITDA and adjusted loss to provide greater transparency into its core operational performance - Management provides non-GAAP financial measures, including EBITDA and non-GAAP adjusted loss, to offer greater transparency for analyzing financial performance and operational decision-making[9](index=9&type=chunk) - Non-GAAP adjusted loss further adjusts EBITDA by excluding items like **stock-based compensation**, loss on issuance of convertible securities, and periodic changes in fair value of convertible securities[9](index=9&type=chunk) - The purpose of these non-GAAP measures is to help investors understand the impact of non-cash charges and to enhance the comparability of financial results against prior periods[9](index=9&type=chunk) [Condensed Consolidated Statement of Operations (Unaudited)](index=4&type=section&id=Condensed%20Consolidated%20Statement%20of%20Operations%20(Unaudited)) Q1 2025 operations show a shift to net income driven by other income, with a significantly narrowed non-GAAP adjusted loss year-over-year Condensed Consolidated Statement of Operations (in thousands) | | For the three months ended March 31, | | :--- | :---: | :---: | | | **2025** | **2024** | | Revenue | $8 | $1,010 | | Operating expenses | $5,454 | $15,046 | | Other (Income) Expense | $(24,069) | $4,476 | | Net (Income) Loss | $(18,623) | $18,512 | | Net income (loss) attributable to common stockholders | $17,695 | $(22,788) | Reconciliation to Non-GAAP Adjusted Loss (in thousands) | | For the three months ended March 31, | | :--- | :---: | :---: | | | **2025** | **2024** | | Net income (loss) as reported | $18,968 | $(15,212) | | Adjustments (Depreciation, Interest, etc) | $39 | $400 | | EBITDA | $19,007 | $(14,813) | | Other non-cash/financing adjustments | $(19,917) | $6,198 | | **Non-GAAP adjusted (loss)** | **$(910)** | **$(8,615)** | [Reconciliation of GAAP Operating Expenses to Non-GAAP Net Operating Expenses](index=5&type=section&id=Reconciliation%20of%20GAAP%20Operating%20Expenses%20to%20Non-GAAP%20Net%20Operating%20Expenses) This reconciliation adjusts GAAP operating expenses to non-GAAP net operating expenses by removing non-cash items like stock-based compensation GAAP to Non-GAAP Operating Expense Reconciliation (in thousands) | | For the three months ended March 31, | | :--- | :---: | :---: | | | **2025** | **2024** | | Total operating expenses (GAAP) | $5,454 | $15,046 | | Depreciation and amortization expense | $(43) | $(586) | | Operating expenses issued in stock | $(50) | $(23) | | Stock-based compensation expense | $(930) | $(1,882) | | **Net operating expenses (Non-GAAP)** | **$4,431** | **$12,555** | [About PAVmed and its Subsidiaries](index=5&type=section&id=About%20PAVmed%20and%20its%20Subsidiaries) PAVmed Inc is a commercial-stage medical technology company with operations in medical devices, diagnostics, and digital health - PAVmed is a diversified commercial-stage medical technology company[13](index=13&type=chunk) - Subsidiary **Lucid Diagnostics (NASDAQ: LUCD)** markets the EsoGuard DNA Test and EsoCheck Device for early detection of esophageal precancer[13](index=13&type=chunk) - Subsidiary **Veris Health** is a digital health company focused on personalized cancer care via remote patient monitoring and is developing an implantable physiological monitor[13](index=13&type=chunk) [Forward-Looking Statements](index=6&type=section&id=Forward-Looking%20Statements) This report contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially - The press release contains forward-looking statements that are not historical facts and are subject to risks and uncertainties[17](index=17&type=chunk) - Key risks include **stock price volatility**, **R&D uncertainties**, **regulatory approval challenges**, market acceptance, and the ability to raise additional capital[17](index=17&type=chunk) - The company disclaims any obligation to update forward-looking statements and refers readers to its Annual Report on Form 10-K and Quarterly Reports on Form 10-Q for a full description of risks[17](index=17&type=chunk)