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CHF Solutions (CHFS) Presents At Ladenburg Thalmann Healthcare Conference - Slideshow
2019-09-25 17:24
Financial Highlights - CHF Solutions had approximately 27 million common shares outstanding with a market cap of approximately $6 million as of September 16, 2019 [6] - The company experienced 9 consecutive quarters of double-digit revenue growth [6] - Year 2018 revenue grew 41% compared to 2017 [6] - Q2 2019 revenue was up 53% from Q2 2018 and 38% from Q1 2019 [6] - As of June 30, 2019, CHF Solutions had $74 million in cash on hand and no debt [6] Aquadex FlexFlow System - Aquadex FlexFlow removes 40% more fluid than conventional diuretic drug therapy [24] - Aquadex FlexFlow is associated with a 53% reduction in the risk of heart failure rehospitalization at 90 days compared to diuretics [24] Market Opportunity - The addressable US market segments for Aquadex FlexFlow total over $2 billion annually [80] - The company estimates a $950 million market opportunity in critical care, $900 million in heart failure, and $115 million in pediatrics [32] - There are over 6 million people in the US suffering from heart failure [36]
Nuwellis(NUWE) - 2019 Q2 - Quarterly Report
2019-08-08 21:00
[PART I—FINANCIAL INFORMATION](index=4&type=section&id=PART%20I%E2%80%94FINANCIAL%20INFORMATION) [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) For the six months ended June 30, 2019, CHF Solutions reported a net loss of $9.2 million on net sales of $2.9 million, with a 'going concern' uncertainty due to a history of losses and an accumulated deficit of $208.5 million [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2019, total assets increased to $11.4 million from $8.8 million at year-end 2018, primarily due to a rise in cash and cash equivalents, while stockholders' equity grew to $8.4 million Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2019 | December 31, 2018 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $7,402 | $5,480 | | Total current assets | $10,302 | $8,127 | | **Total Assets** | **$11,428** | **$8,776** | | **Liabilities & Equity** | | | | Total current liabilities | $2,637 | $2,840 | | Total liabilities | $2,994 | $2,840 | | Total stockholders' equity | $8,434 | $5,936 | | **Total Liabilities and Stockholders' Equity** | **$11,428** | **$8,776** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company's net sales grew to $1.7 million for Q2 2019 and $2.9 million for the first six months of 2019, but net loss widened to $4.4 million for the quarter and $9.2 million for the six-month period, driven by increased research and development expenses Statement of Operations Summary (in thousands, except per share data) | Metric | Q2 2019 | Q2 2018 | H1 2019 | H1 2018 | | :--- | :--- | :--- | :--- | :--- | | Net sales | $1,677 | $1,099 | $2,892 | $2,136 | | Loss from operations | $(4,428) | $(4,179) | $(9,153) | $(8,533) | | Net loss | $(4,430) | $(4,181) | $(9,157) | $(8,535) | | Basic and diluted loss per share | $(1.93) | $(13.03) | $(8.82) | $(28.03) | [Condensed Consolidated Statements of Stockholders' Equity](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Equity) Stockholders' equity increased from $5.9 million at the end of 2018 to $8.4 million by June 30, 2019, primarily driven by $11.0 million from common and preferred stock issuance, offsetting the net loss - The primary driver for the increase in stockholders' equity during the first half of 2019 was the issuance of common and preferred stock, which provided **$10,959 thousand** in capital, net of costs[19](index=19&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the six months ended June 30, 2019, net cash used in operating activities was $8.9 million, offset by $11.0 million from financing activities, resulting in a $1.9 million increase in cash and cash equivalents Cash Flow Summary for the Six Months Ended June 30 (in thousands) | Cash Flow Activity | 2019 | 2018 | | :--- | :--- | :--- | | Net cash used in operating activities | $(8,874) | $(8,478) | | Net cash used in investing activities | $(158) | $(121) | | Net cash provided by financing activities | $10,959 | $0 | | **Net increase (decrease) in cash** | **$1,922** | **$(8,600)** | | **Cash and cash equivalents - end of period** | **$7,402** | **$6,995** | [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's focus on the Aquadex FlexFlow® system and disclose a significant 'going concern' risk due to an accumulated deficit of $208.5 million and recurring losses, alongside a March 2019 public offering that raised $12.4 million - The company is a medical device firm focused on the Aquadex FlexFlow® system for aquapheresis therapy, having acquired the business from Baxter in 2016[23](index=23&type=chunk)[24](index=24&type=chunk) - The financial statements were prepared on a going concern basis, but the company's accumulated deficit of **$208.5 million** and history of losses raise substantial doubt about its ability to continue as a going concern for the next twelve months[28](index=28&type=chunk) - In March 2019, the company closed a public offering of common stock, Series G convertible preferred stock, and warrants, raising gross proceeds of **$12.4 million**[49](index=49&type=chunk) - A contingent consideration liability from the Aquadex acquisition, valued at **$126,000** at the end of 2018, was reduced to **$0** as of June 30, 2019, as the likelihood of payment was deemed remote[33](index=33&type=chunk)[58](index=58&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=15&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management attributes the 52.6% year-over-year revenue growth for Q2 2019 to commercialization strategy and in-house manufacturing, while operating expenses increased, and liquidity improved by an $11.0 million capital raise, though 'going concern' risk remains [Results of Operations](index=18&type=section&id=Results%20of%20Operations) For Q2 2019, net sales increased 52.6% to $1.7 million, and gross margin improved due to in-house manufacturing, but operating expenses, particularly R&D, rose significantly due to product enhancement initiatives Net Sales Comparison (in thousands) | Period | 2019 | 2018 | Increase | % Change | | :--- | :--- | :--- | :--- | :--- | | **Three Months Ended June 30** | $1,677 | $1,099 | $578 | 52.6% | | **Six Months Ended June 30** | $2,892 | $2,136 | $756 | 35.4% | - Gross margins improved in 2019 due to the transition to selling internally manufactured inventory, moving away from higher-cost inventory purchased from Baxter under a previous manufacturing agreement[98](index=98&type=chunk)[106](index=106&type=chunk) - Research and development expenses more than doubled in Q2 2019 versus Q2 2018, reflecting investments to improve the Aquadex system, including software updates and catheter enhancements[96](index=96&type=chunk)[101](index=101&type=chunk) [Liquidity and Capital Resources](index=21&type=section&id=Liquidity%20and%20Capital%20Resources) The company's liquidity is primarily sourced from a March 2019 public offering that provided $11.0 million in net proceeds, resulting in $7.4 million in cash and cash equivalents as of June 30, 2019, with management acknowledging potential future financing needs - The company closed a public offering on March 12, 2019, for net proceeds of approximately **$11.0 million**, which is a primary source of its current liquidity[112](index=112&type=chunk) - As of June 30, 2019, the company had cash and cash equivalents of **$7.4 million**, compared to **$5.5 million** at the end of 2018[114](index=114&type=chunk) - Net cash used in operating activities was **$8.9 million** for the first six months of 2019, reflecting the company's net loss for the period[115](index=115&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=23&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company has determined that this section is not applicable, indicating it does not have material exposure to market risks such as interest rate or foreign currency fluctuations - Not applicable[122](index=122&type=chunk) [Item 4. Controls and Procedures](index=23&type=section&id=Item%204.%20Controls%20and%20Procedures) As of June 30, 2019, the company's CEO and CFO concluded that disclosure controls and procedures were effective, with no material changes in internal control over financial reporting during the quarter - Management concluded that the company's disclosure controls and procedures were effective as of June 30, 2019[125](index=125&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that have materially affected, or are reasonably likely to materially affect, internal controls[126](index=126&type=chunk) [PART II—OTHER INFORMATION](index=23&type=section&id=PART%20II%E2%80%94OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=23&type=section&id=Item%201.%20Legal%20Proceedings) The company reports that it is not currently involved in any material legal proceedings - The company is not currently subject to any material legal proceedings[128](index=128&type=chunk) [Item 1A. Risk Factors](index=23&type=section&id=Item%201A.%20Risk%20Factors) The company states there have been no material changes to the risk factors previously disclosed in its Annual Report on Form 10-K for the fiscal year ended December 31, 2018 - There are no material changes to the risk factors discussed in the Annual Report on Form 10-K for the fiscal year ended December 31, 2018[129](index=129&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=24&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) On May 30, 2019, the company granted a market-based warrant to a consultant for investor relations services, allowing the purchase of up to 100,000 shares of common stock at an exercise price of $3.18 per share under a registration exemption - On May 30, 2019, the company granted a market-based warrant to a consultant to acquire up to **100,000 shares** of common stock at an exercise price of **$3.18 per share** in exchange for investor relations services[131](index=131&type=chunk) [Item 5. Other Information](index=24&type=section&id=Item%205.%20Other%20Information) On May 23, 2019, the board of directors amended the New-Hire Equity Incentive Plan, increasing the aggregate number of shares available for issuance from 38,836 to 288,836 to aid in attracting qualified employees - The company amended its New-Hire Equity Incentive Plan to increase the number of shares of common stock available for issuance from **38,836** to **288,836**[134](index=134&type=chunk) [Item 6. Exhibits](index=24&type=section&id=Item%206.%20Exhibits) This section provides an index of all exhibits filed with the Form 10-Q, including corporate governance documents, warrants, certifications by the CEO and CFO, and XBRL data files - The report includes a list of filed exhibits, such as the Common Stock Purchase Warrant dated May 30, 2019, the Sixth Amendment to the New-Hire Equity Incentive Plan, and officer certifications required by the Sarbanes-Oxley Act[135](index=135&type=chunk)[138](index=138&type=chunk)
Nuwellis(NUWE) - 2019 Q2 - Earnings Call Transcript
2019-08-06 18:57
CHF Solutions, Inc. (CHFS) Q2 2019 Earnings Conference Call August 6, 2019 9:00 AM ET Company Participants Scott Gordon - Managing Director of CORE IR John Erb - Chairman and Chief Executive Officer Claudia Drayton - Chief Financial and Officer Nestor Jaramillo - Chief Commercial Officer Conference Call Participants Jeffrey Cohen - Ladenburg Thalmann Kyle Bauser - Dougherty & Company Operator Good morning, and welcome to the CHF Solutions Earnings Conference Call for the second quarter ended June 30, 2019. ...
Nuwellis(NUWE) - 2019 Q1 - Quarterly Report
2019-05-09 21:08
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10‑Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2019 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 001-35312 CHF SOLUTIONS, INC. (Exact Name of Registrant as Specified in its Charter) Delaware No. 68-0533453 (State or Ot ...
Nuwellis(NUWE) - 2019 Q1 - Earnings Call Transcript
2019-05-07 17:47
CHF Solutions, Inc. (CHFS) Q1 2019 Earnings Conference Call May 7, 2019 9:00 AM ET Company Participants John Marco - Managing Director, CORE IR John Erb - Chairman, CEO & President Claudia Drayton - CFO Conference Call Participants Jeffrey Cohen - Ladenburg Thalmann & Co. Kyle Bauser - Dougherty & Company Operator Good morning, and welcome to the CHF Solutions Earnings Conference Call for the first quarter ended March 31, 2019. [Operator Instructions]. Participants of this call are advised that audio of thi ...
Nuwellis(NUWE) - 2018 Q4 - Annual Report
2019-02-21 21:27
TABLE OF CONTENTS UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Fiscal Year Ended: December 31, 2018 o 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 001-35312 (952) 345-4200 (Registrant's telephone number, including area code) Securities registered pursuant to Section 12(b) of the ...
Nuwellis(NUWE) - 2018 Q4 - Earnings Call Transcript
2019-02-20 16:49
CHF Solutions, Inc. (CHFS) Q4 2018 Earnings Conference Call February 20, 2019 9:00 AM ET Company Participants Scott Gordon - President of CORE IR John Erb - Chief Executive Officer and President, Chairman of the Board Claudia Drayton - Chief Financial Officer Conference Call Participants Jeffrey Cohen - Ladenburg Thalmann Operator Good morning and welcome to the CHF Solutions??? Earnings Conference Call for the Fourth Quarter ending December 31, 2018. All participants will be in listen-only mode. [Operator ...