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MarketScreener Homepage  >  Equities  >  OTC Bulletin Board  >  Provectus Biopharmaceuticals, Inc.    PVCT

PROVECTUS BIOPHARMACEUTICALS, INC.

(PVCT)
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PROVECTUS BIOPHARMACEUTICALS : MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS. (form 10-Q)

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05/13/2019 | 12:42pm EDT

The following discussion is intended to assist in the understanding and assessment of significant changes and trends related to our results of operations and our financial condition together with our consolidated subsidiaries. This discussion and analysis should be read in conjunction with the accompanying unaudited financial statements and our Annual Report on Form 10-K for the year ended December 31, 2018 filed with the Securities and Exchange Commission ("SEC) on March 7, 2019 ("2018 Form 10-K"), which includes additional information about our critical accounting policies and practices and risk factors. Historical results and percentage relationships set forth in the statement of operations, including trends which might appear, are not necessarily indicative of future operations.

Overview of Core Technologies

Provectus is a clinical-stage biotechnology company developing a new class of drugs for oncology and dermatology based on halogenated xanthenes, such as Rose Bengal (4,5,6,7-tetrachloro-2',4',5',7'-tetraiodofluorescein). Intralesional PV-10, the first small molecule oncolytic immunotherapy, which can induce immunogenic cell death, is undergoing clinical study for adult solid tumor cancers, like melanoma and gastrointestinal cancers, and preclinical study for pediatric cancers. Topical PH-10 is undergoing clinical study for inflammatory dermatoses, like psoriasis and atopic dermatitis. For psoriasis, pathways significantly improved include published psoriasis transcriptomes and cellular responses mediated by IL-17, IL-22, and interferons.

Our approach to drug development comprises two related, complementary, clinical development program paths based on the features of our investigational drugs and their clinically rational applicability to different patient populations. In solid tumor cancers for adults, for example, we believe PV-10 has important implications as a single agent for earlier states of disease (i.e., locally advanced disease, or Stage III or earlier), while the combination of PV-10 with other classes of therapy or therapeutic agent (e.g., chemotherapy, immunotherapy, radiotherapy, targeted therapy) is more appropriate for more advanced disease states (i.e., widely metastatic disease, or Stage IV).



Results of Operations


Comparison of the Three Months Ended March 31, 2019 and March 31, 2018



Research and Development


Research and development expenses decreased by $905,732 from $1,943,063 for the three months ended March 31, 2018 to $1,037,331 for the three months ended March 31, 2019, a decrease of approximately 47% year-over-year. The decrease was due primarily to lower contractor costs of $896,205, insurance costs of $11,190, travel cost of $18,191, offset by an increase in payroll of $4,272, conference costs of $12,233, and other costs totaling $3,349.

Research and development costs of $1,037,331 for the three months ended March 31, 2019 included amortization of patents of $167,780, payroll of $149,475, conferences of $22,233, consulting and contract labor of $560,468, insurance of $64,529, lab supplies and pharmaceutical preparations of $17,232, travel cost of $23,379, rent and utilities of $24,415, depreciation expense of $2,162, and other costs of $5,658.

Research and development costs of $1,943,063 for the three months ended March 31, 2018 included patent amortization expense of $167,780, payroll of $139,423, conferences of $10,000, consulting and contract labor of $1,456,673, insurance of $75,719, lab supplies and pharmaceutical preparations of $21,285, travel of $41,570, rent and utilities of $17,859, depreciation expense of $2,162, and other costs of $10,592.



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General and Administrative



General and administrative expenses increased by $3,101, from $756,151 for the three months ended March 31, 2018 to $759,252 for the three months ended March 31, 2019, an increase of approximately .4% year-over-year. The increase was due primarily to (i) a $40,000 increase in directors' fees, which were accrued, (ii) an increase in accounting fees of $88,806, (iii) an increase in investor relations of $132,599 due to credits received in 2018 totaling $144,747, and other cost increases of $9,609, partially offset by (iv) decreased legal expenses of $179,813 due to wind down of lawsuits, (v) a decrease of $42,176 in finance expenses, (vi) decreased payroll expense of $20,122, and (vii) decreased travel cost of $25,802.




Other Income/(Expense)



Other income increased by $627,152 from $(200,398) for the three months ended March 31, 2018 to $426,754 for the three months ended March 31, 2019. In the quarter ended March 31, 2019, the matters with BHS and RSM were resolved pursuant to a settlement between these parties and the Company, the terms of which are confidential.

Interest expense increased by $128,006 from $206,567 for the three months ended March 31, 2018 to $334,573 for the three months ended March 31, 2019. The increase was due to the increased number of convertible notes payable relating to the PRH Notes.

Liquidity and Capital Resources

Our cash and cash equivalents were $1,767,900 at March 31, 2019, compared to $50,986 at December 31, 2018. The condensed consolidated financial statements and notes thereto included in this Quarterly Report on Form 10-Q have been prepared on a basis that contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. We have continuing net losses and negative cash flows from operating activities. In addition, we have an accumulated deficit of $228,264,121 as of March 31, 2019. These conditions raise substantial doubt about our ability to continue as a going concern for a period within one year from the date that the financial statements included elsewhere in this Quarterly Report on Form 10-Q are issued. Our financial statements do not include any adjustments to the amounts and classification of assets and liabilities that may be necessary should we be unable to continue as a going concern. Our ability to continue as a going concern depends on our ability to obtain additional financing as may be required to fund current operations.

Management's plans include selling our equity securities and obtaining other financing to fund our capital requirement and on-going operations, including the 2017 Financing; however, there can be no assurance we will be successful in these efforts. The financial statements do not include any adjustment that might be necessary if we are unable to continue as a going concern. Significant funds will be needed to continue and complete our ongoing and planned clinical trials.



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Access to Capital


Management plans to access capital resources through possible public or private equity offerings, including the 2017 Financing, exchange offers, debt financings, corporate collaborations or other means. If we are unable to raise sufficient capital through the 2017 Financing or otherwise, we will not be able to pay our obligations as they become due.

The primary business objective of management is to build the Company into a commercial-stage biotechnology company; however, we cannot assure you that management will be successful in implementing the Company's business plan of developing, licensing, and/or commercializing our prescription drug candidates. Moreover, even if we are successful in improving our current cash flow position, we nonetheless plan to seek additional funds to meet our current and long-term requirements in 2019 and beyond. We anticipate that these funds will otherwise come from the proceeds of private placement transactions, including the 2017 Financing, the exercise of existing warrants and outstanding stock options, or public offerings of debt or equity securities. While we believe that we have a reasonable basis for our expectation that we will be able to raise additional funds, we cannot assure you that we will be able to complete additional financing in a timely manner. In addition, any such financing may result in significant dilution to stockholders.



Critical Accounting Policies


For a description of our critical accounting policies, see Note 3 - Significant Accounting Policies in Part 1, Item 1 of this Quarterly Report on Form 10-Q.

Off-Balance Sheet Arrangements

We do not have any off-balance sheet arrangements, financings, or other relationships with unconsolidated entities or other persons, also known as special purpose entities ("SPEs").

© Edgar Online, source Glimpses

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Managers
NameTitle
Bruce Horowitz Director, Chief Executive & Operating Officer
Timothy C. Scott President
Edward V. Pershing Chairman
Heather Raines Chief Financial Officer
Eric A. Wachter Chief Technology Officer
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