NovaBay(NBY)

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NovaBay(NBY) - 2019 Q3 - Quarterly Report
2019-11-07 21:11
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 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, 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: 001-33678 NOVABAY PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 68-0454536 (State or ot ...
NovaBay(NBY) - 2019 Q2 - Earnings Call Presentation
2019-08-09 03:25
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 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 June 30, 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: 001-33678 NOVABAY PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 68-0454536 (State or other j ...
NovaBay(NBY) - 2019 Q2 - Earnings Call Transcript
2019-08-09 03:05
Financial Data and Key Metrics Changes - For Q2 2019, net sales were $1.8 million, down from $2.8 million in the prior year period, primarily due to lower unit sales and a lower net selling price of Avenova [13] - Avenova sales were $1.6 million for the quarter, with a gross margin on net product revenue of 77%, compared to 83% for the same period last year [14][19] - Operating expenses decreased by 37% to $2.8 million from $4.4 million in the prior year period, reflecting a strategic shift in the U.S. commercial organization [15] Business Line Data and Key Metrics Changes - Avenova sales through the retail pharmacy channel were $1.3 million, accounting for 84% of total Avenova sales, while in-office direct channel sales were $209,000 [13] - Sales through the new Avenova Direct channel on Amazon.com contributed modestly, having launched in mid-June [14][11] - The partner pharmacy program accounted for 52% of all prescription Avenova units sold in Q2, up from 38% in Q1 [9] Market Data and Key Metrics Changes - The company expanded its partner pharmacy program to 16 partners, adding eight new partners since the beginning of the year [7] - The trend towards higher deductible health plans has necessitated increased usage of coupons and rebates to maintain Avenova's affordability [6] Company Strategy and Development Direction - The company is focused on making Avenova accessible and affordable while ensuring appropriate economics for NovaBay [12] - A new commercialization strategy aims to enhance patient experience and increase Avenova's accessibility [5] - The launch of CELLERX, a new topical solution, is planned for late 2019, targeting post-treatment care in aesthetic dermatology [26][28] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about Avenova's unique product positioning and its acceptance among medical professionals and patients [24] - The company expects to realize benefits from the reduction in force on operating expenses and anticipates a significant reduction in operating expenses from 2018 levels [23] - The outlook for 2019 net sales is projected to be in the range of $6 million to $8 million, with potential revisions as visibility improves [23] Other Important Information - The company reported a net loss of $2.5 million or $0.14 per share for Q2 2019, compared to a net loss of $1.6 million or $0.09 per share in Q2 2018 [19] - Cash and cash equivalents were $3.7 million as of June 30, 2019, with various funding activities completed throughout the year [22] Q&A Session Summary - There were no questions during the Q&A session, and the call concluded without further inquiries [32][34]
NovaBay(NBY) - 2019 Q2 - Quarterly Report
2019-08-07 10:53
[PART I - FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) [Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) This section presents NovaBay Pharmaceuticals' unaudited consolidated financial statements as of June 30, 2019, including Balance Sheets, Statements of Operations, Cash Flows, and Stockholders' Equity, with notes on new accounting standard adoptions Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2019 | December 31, 2018 | | :--- | :--- | :--- | | Cash and cash equivalents | $3,668 | $3,183 | | Total current assets | $7,496 | $8,608 | | Total assets | $9,870 | $9,361 | | Total current liabilities | $3,352 | $3,847 | | Total liabilities | $8,201 | $4,407 | | Total stockholders' equity | $1,669 | $4,954 | Consolidated Statements of Operations Highlights (in thousands, except per share data) | Metric | Three Months Ended June 30, 2019 | Three Months Ended June 30, 2018 | Six Months Ended June 30, 2019 | Six Months Ended June 30, 2018 | | :--- | :--- | :--- | :--- | :--- | | Product revenue, net | $1,789 | $2,794 | $3,239 | $5,728 | | Gross profit | $1,386 | $2,315 | $2,536 | $5,011 | | Operating loss | $(1,379) | $(2,083) | $(5,450) | $(4,451) | | Net loss | $(2,501) | $(1,589) | $(6,690) | $(3,739) | | Net loss per share (basic) | $(0.14) | $(0.09) | $(0.38) | $(0.22) | Consolidated Statements of Cash Flows Highlights (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2019 | Six Months Ended June 30, 2018 | | :--- | :--- | :--- | | Net cash (used) in operating activities | $(5,000) | $(1,957) | | Net cash (used) by investing activities | $(19) | $(5) | | Net cash provided by financing activities | $5,504 | $5,597 | [Notes to Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) These notes detail accounting policies, financial components, and significant events, highlighting liquidity concerns, new accounting standard adoptions, debt financing, warrant liability, equity transactions, related party dealings, and a subsequent arbitration demand - The company's available funds as of June 30, 2019, are projected to be sufficient to fund operations only through the **third quarter of 2019**. This situation raises **substantial doubt** about the company's ability to continue as a going concern without securing additional financing[27](index=27&type=chunk) - On January 1, 2019, the company adopted the new lease accounting standard (ASU 2016-02), resulting in the recognition of operating lease right-of-use assets of **$2.24 million** and corresponding lease liabilities on the balance sheet[77](index=77&type=chunk)[78](index=78&type=chunk) - In February 2019, the company issued a **$1.0 million** promissory note to Pioneer Pharma (Hong Kong) Company Ltd., a related party. The note's maturity was later extended to July 2020 and the interest payment was increased[105](index=105&type=chunk)[106](index=106&type=chunk) - In March 2019, the company issued a **$2.215 million** Secured Convertible Promissory Note to Iliad Research and Trading, L.P. The note contains embedded derivative features (call and put options) that are bifurcated and accounted for as a liability at fair value, which was **$673 thousand** as of June 30, 2019[109](index=109&type=chunk)[115](index=115&type=chunk) - Subsequent to the quarter end, on July 29, 2019, former CFO and Interim CEO John McGovern made a demand for arbitration against the company for approximately **$370,000**, alleging constructive termination[192](index=192&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=45&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial results and condition, detailing a Q2 2019 strategic shift to reduce sales force and focus on a multi-channel sales strategy for Avenova, while reiterating going concern doubts due to limited funds - In Q2 2019, the company made a strategic shift by reducing its field sales representatives by about **75%** to significantly reduce operating expenses. This was a response to many national insurance payors stopping reimbursement for Avenova[199](index=199&type=chunk) - The company's new core business strategy focuses on increasing Avenova sales through four main channels: Avenova Direct (direct-to-consumer on Amazon.com), retail pharmacies, a Partner Pharmacy Program, and a buy-and-sell channel through eye care specialists[199](index=199&type=chunk) - Management states that cash and cash equivalents of **$3.7 million** as of June 30, 2019, are only sufficient to fund operations through the **third quarter of 2019**, raising **substantial doubt** about the company's ability to continue as a going concern[249](index=249&type=chunk) [Results of Operations](index=49&type=section&id=Results%20of%20Operations) This sub-section compares financial results for Q2 2019 and H1 2019 versus prior periods, showing a 36% YoY drop in Q2 net product revenue due to lower Avenova sales and insurance coverage, alongside reduced sales and marketing expenses Comparison of Results for the Three Months Ended June 30 (in thousands) | Metric | 2019 | 2018 | Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Product revenue, net | $1,789 | $2,794 | $(1,005) | (36%) | | Gross profit | $1,386 | $2,315 | $(929) | (40%) | | Sales and marketing | $1,535 | $2,977 | $(1,442) | (48%) | | Operating loss | $(1,379) | $(2,083) | $704 | (34%) | | Net loss | $(2,501) | $(1,589) | $(912) | 57% | Comparison of Results for the Six Months Ended June 30 (in thousands) | Metric | 2019 | 2018 | Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Product revenue, net | $3,239 | $5,728 | $(2,489) | (43%) | | Gross profit | $2,536 | $5,011 | $(2,475) | (49%) | | Sales and marketing | $5,066 | $6,373 | $(1,307) | (21%) | | Operating loss | $(5,450) | $(4,451) | $(999) | 22% | | Net loss | $(6,690) | $(3,739) | $(2,951) | 79% | [Financial Condition, Liquidity and Capital Resources](index=52&type=section&id=Financial%20Condition%2C%20Liquidity%20and%20Capital%20Resources) As of June 30, 2019, the company had $3.7 million in cash, sufficient only through Q3 2019, raising going concern doubts, with increased cash used in operations offset by $5.5 million from financing activities - Cash and cash equivalents were **$3.7 million** as of June 30, 2019, compared to **$3.2 million** as of December 31, 2018[249](index=249&type=chunk) - Net cash used in operating activities for the first six months of 2019 was **$5.0 million**, compared to **$2.0 million** for the same period in 2018. The increase was primarily due to a higher net loss and unfavorable changes in working capital[250](index=250&type=chunk) - Net cash provided by financing activities was **$5.5 million** for the first six months of 2019, mainly from proceeds from private placements, a related party promissory note, and a convertible note[252](index=252&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=56&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company identifies interest rate risk on cash and cash equivalents as its principal market risk, with no material exposure to foreign currency fluctuations due to its domestic U.S. market focus - The company's main market risk consists of **interest rate risk** on its cash and cash equivalents[269](index=269&type=chunk) - Due to a focus on the domestic U.S. market, the company does not have any material exposure to **foreign currency rate fluctuations**[269](index=269&type=chunk) [Controls and Procedures](index=56&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, evaluated the company's disclosure controls and procedures and concluded they were effective at a reasonable assurance level as of June 30, 2019. The report also states there were no changes in internal control over financial reporting during the quarter that materially affected, or are reasonably likely to materially affect, these controls - The Chief Executive Officer and Chief Financial Officer concluded that as of the end of the period, the company's disclosure controls and procedures were **effective at the reasonable assurance level**[272](index=272&type=chunk) - There were **no changes** in internal control over financial reporting during the quarter ended June 30, 2019, that have materially affected, or are reasonably likely to materially affect, internal controls[273](index=273&type=chunk) [PART II - OTHER INFORMATION](index=57&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) [Risk Factors](index=57&type=page&id=Item%201A.%20Risk%20Factors) Significant risks include substantial doubt about the company's ability to continue as a going concern, potential NYSE American delisting, heavy dependence on Avenova, intense competition, reliance on third-party manufacturers, and potential litigation - There is **substantial doubt** about the company's ability to continue as a going concern, as it has sustained operating losses and expects 2019 expenses to exceed revenues. Current funding may only be sufficient through **Q3 2019**[277](index=277&type=chunk) - The company is not in compliance with NYSE American's minimum stockholders' equity requirements and is subject to **delisting procedures** if its plan to regain compliance, which was accepted by the exchange, is not successful[279](index=279&type=chunk) - The company's future success is largely dependent on the successful commercialization of Avenova, which constituted approximately **98% of its revenue for 2018**[294](index=294&type=chunk) - The company relies on a limited number of pharmaceutical wholesalers (McKesson, Cardinal Health, AmerisourceBergen) for distribution and solely on Amazon.com for its Avenova Direct sales, making it **vulnerable to disruptions** in these relationships[312](index=312&type=chunk) - China Pioneer and Mr. Jian Ping Fu beneficially own approximately **25%** and **26%** of the company's common stock, respectively, giving them **significant influence** over corporate matters[283](index=283&type=chunk)[290](index=290&type=chunk) [Exhibits](index=75&type=section&id=Item%206.%20Exhibits) This section lists all the exhibits filed with or incorporated by reference into the 10-Q report. These include corporate governance documents, forms of warrants, various agreements (employment, lease, purchase, and financing), and officer certifications required by the SEC - The report includes exhibits such as the Amended and Restated Certificate of Incorporation, various warrant agreements, a Secured Convertible Promissory Note, a Common Stock Purchase Agreement, and officer certifications (31.1, 31.2, 32.1, 32.2)[353](index=353&type=chunk)[354](index=354&type=chunk)[355](index=355&type=chunk)
NovaBay(NBY) - 2019 Q1 - Quarterly Report
2019-05-15 19:03
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 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, 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: 001-33678 NOVABAY PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 68-0454536 (State or other ...
NovaBay(NBY) - 2018 Q4 - Annual Report
2019-03-29 18:01
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2018 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 001-33678 NOVABAY PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 68-0454536 (State or other jurisd ...
NovaBay(NBY) - 2018 Q4 - Earnings Call Transcript
2019-03-29 00:05
Financial Data and Key Metrics Changes - For Q4 2018, net sales were $3.6 million, down from $6.3 million in the prior year, primarily due to low insurance reimbursement and a reduction in non-Avenova sales by $1.3 million [22][25] - The operating loss for Q4 2018 was $1.6 million, compared to an operating income of $392,000 in Q4 2017 [25] - The net loss for Q4 2018 was $1.3 million or $0.07 per share, compared to a net income of $793,000 or $0.02 per diluted share in Q4 2017 [25] - For the full year 2018, net sales were $12.5 million, down from $18.2 million in 2017, with a net loss of $6.5 million or $0.39 per share, compared to a net loss of $7.4 million or $0.48 per share in 2017 [26][27] Business Line Data and Key Metrics Changes - Avenova sales in the retail pharmacy channel for Q4 2018 were $3.3 million, accounting for 92% of total sales, while in-office direct channel sales were $282,000 [23] - Gross margin on net product revenue for Q4 2018 improved to 88% from 85% in the prior year, mainly due to product mix [24] Market Data and Key Metrics Changes - The company identified 15 profitable territories that generated 95% of Avenova prescriptions over the trailing six-month period, indicating a focused sales strategy [14][15] Company Strategy and Development Direction - The company announced a shift in its US commercial strategy, including changes in executive management and restructuring of the sales organization to support cost management and long-term profitable growth [6][12] - The focus is on maintaining access to Avenova for eye care professionals and patients while reducing reliance on rebates and coupons [19] - The company plans to explore new distribution channels to potentially increase overall unit volume [30] Management's Comments on Operating Environment and Future Outlook - Management acknowledged challenges due to changes in the reimbursement environment, which are expected to negatively impact revenues in 2019 [13] - The company expects revenues for 2019 to be in the range of $6 million to $8 million, with a conservative estimate and potential upside from strategic initiatives [29] - Cost savings related to the reduction in force are expected to be $3.6 million over 2019, with a significant reduction in operating expenses anticipated [30] Other Important Information - The company received $2 million from a promissory note and has a commitment for an additional $3 million from an institutional fund [20] - Cash and cash equivalents were reported at $3.2 million as of December 31, 2018 [27] Q&A Session Summary Question: Could you reiterate your projected operating expenses in 2019? - Management expects operating expenses to be significantly lower than in 2018 [35] Question: What about selling and marketing expenses and G&A expenses? - G&A expenses might drop slightly, but selling and marketing expenses are expected to decrease significantly, with a minimum reduction of 30% [36] Question: At what revenue level do you expect to achieve breakeven? - Management indicated that breakeven is a corporate objective, but due to uncertainties in the reimbursement landscape, they do not have a fixed projection yet [37] Question: Will there be any more operational changes expected near-term? - Management stated that they are done with reductions in the field sales force and are focused on improving operational excellence [40] Question: Is there a timeline for bringing a permanent CEO or CFO? - Management indicated that this question is best answered by the Board, with no immediate plans [41] Question: What would make you comfortable to start the hiring process again for sales reps? - Management stated that hiring would resume once breakeven is reached and costs are stabilized [44]