Attached files

file filename
EX-32.1 - EX-32.1 - BioPharmX Corpbpmx-20181031ex321c53792.htm
EX-31.2 - EX-31.2 - BioPharmX Corpbpmx-20181031ex312d2b6e9.htm
EX-31.1 - EX-31.1 - BioPharmX Corpbpmx-20181031ex3113fbbf8.htm
EX-4.1 - EX-4.1 - BioPharmX Corpbpmx-20181031ex4146fa4ab.htm

 

 

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 October 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 No. 001-37411

 

BIOPHARMX CORPORATION

(Exact name of registrant as specified in its charter)

 

 

 

 

Delaware

 

59-3843182

(State or Other Jurisdiction of Incorporation or Organization)

 

(I.R.S. Employer Identification No.)

 

 

 

1505 Adams Drive, Suite D, Menlo Park, California

 

94025

(Address of principal executive offices)

 

(Zip Code)

 

Registrant’s telephone number, including area code: 650-889-5020

 

Indicate by checkmark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒  No ☐

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒  No ☐

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

 

 

 

Large accelerated filer  ☐

 

Accelerated filer  ☐

Non-accelerated filer  ☐

 

Smaller reporting company  ☒

 

 

Emerging growth company  ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

 

As of November 30, 2018, there were outstanding 212,815,296 shares of the registrant’s common stock, $0.001 par value.

 

 

 

 


 

BIOPHARMX CORPORATION

 

Form 10-Q

 

Table of Contents

 

 

 

 

PART I  — Financial Information

 

    

    

 

Item 1 

Condensed Consolidated Financial Statements (unaudited)

3

 

Condensed Consolidated Balance Sheets as of October 31, 2018 and January 31, 2018

3

 

Condensed Consolidated Statement of Operations and Comprehensive Loss for the three and nine months ended October 31, 2018 and 2017

4

 

Condensed Consolidated Statement of Cash Flows for the nine months ended October 31, 2018 and 2017

5

 

Notes to Condensed Consolidated Financial Statements

6

Item 2 

Management’s Discussion and Analysis of Financial Condition and Results of Operations

17

Item 3 

Qualitative and Quantitative Disclosures About Market Risk

22

Item 4 

Controls and Procedures

22

 

 

 

PART II  — Other Information

 

 

 

 

Item 1 

Legal Proceedings

22

Item 1A 

Risk Factors

22

Item 2 

Unregistered Sales of Equity Securities and Use of Proceeds

57

Item 3 

Defaults Upon Senior Securities

57

Item 4 

Mine Safety Disclosures

57

Item 5 

Other Information

58

Item 6 

Exhibits

58

 

 

 

SIGNATURES 

61

 

 

2


 

PART I

 

FINANCIAL INFORMATION

 

ITEM 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

 

BioPharmX Corporation

Condensed Consolidated Balance Sheets (unaudited)

(in thousands, except share and per share data)

 

 

 

 

 

 

 

 

 

 

 

 

 

October 31, 

 

January 31, 

 

 

    

2018

    

2018

 

Assets

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

3,018

 

$

7,576

 

Accounts receivable, net

 

 

 4

 

 

 7

 

Inventories

 

 

10

 

 

10

 

Prepaid expenses and other current assets

 

 

548

 

 

388

 

Total current assets

 

 

3,580

 

 

7,981

 

 

 

 

 

 

 

 

 

Property and equipment, net

 

 

135

 

 

109

 

Total assets

 

$

3,715

 

$

8,090

 

 

 

 

 

 

 

 

 

Liabilities and Stockholders' Equity

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

Accounts payable

 

$

1,387

 

$

1,376

 

Accrued expenses and other current liabilities

 

 

1,670

 

 

1,603

 

Total current liabilities

 

 

3,057

 

 

2,979

 

 

 

 

 

 

 

 

 

Long-term liabilities:

 

 

 

 

 

 

 

Long-term liabilities

 

 

67

 

 

39

 

Total liabilities

 

 

3,124

 

 

3,018

 

 

 

 

 

 

 

 

 

Commitments and contingencies (Note 5)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

 

Series A convertible preferred stock, $0.001 par value; 10,000,000 shares authorized; none issued and outstanding as of October 31, 2018 and January 31, 2018

 

 

 —

 

 

 —

 

Common stock, $0.001 par value; 450,000,000 shares authorized; 191,648,630 and 160,062,509 shares issued and outstanding as of October 31, 2018 and January 31, 2018, respectively

 

 

192

 

 

160

 

Additional paid-in capital

 

 

74,877

 

 

66,190

 

Accumulated deficit

 

 

(74,478)

 

 

(61,278)

 

Total stockholders' equity

 

 

591

 

 

5,072

 

 

 

 

 

 

 

 

 

Total liabilities and stockholders' equity

 

$

3,715

 

$

8,090

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

3


 

BioPharmX Corporation

Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited)

(in thousands, except share and per share data)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three months ended

 

Nine months ended

 

 

 

October 31, 

 

October 31, 

 

 

 

2018

 

2017

 

2018

 

2017

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Revenues, net

 

$

10

 

$

18

 

$

52

 

$

54

 

Cost of goods sold

 

 

60

 

 

 8

 

 

80

 

 

28

 

Gross margin

 

 

(50)

 

 

10

 

 

(28)

 

 

26

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

2,228

 

 

2,111

 

 

7,285

 

 

7,465

 

Sales and marketing

 

 

550

 

 

546

 

 

1,717

 

 

1,929

 

General and administrative

 

 

1,624

 

 

1,088

 

 

4,252

 

 

3,671

 

Total operating expenses

 

 

4,402

 

 

3,745

 

 

13,254

 

 

13,065

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Loss from operations

 

 

(4,452)

 

 

(3,735)

 

 

(13,282)

 

 

(13,039)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Change in fair value of warrant liability

 

 

42

 

 

169

 

 

(1)

 

 

330

 

Other income and expense, net

 

 

20

 

 

(148)

 

 

83

 

 

(142)

 

Loss before provision for income taxes

 

 

(4,390)

 

 

(3,714)

 

 

(13,200)

 

 

(12,851)

 

Provision for income taxes

 

 

 —

 

 

 —

 

 

 2

 

 

 1

 

Net loss and comprehensive loss

 

$

(4,390)

 

$

(3,714)

 

$

(13,202)

 

$

(12,852)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted net loss per share

 

$

(0.02)

 

$

(0.05)

 

$

(0.07)

 

$

(0.17)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Shares used in computing basic and diluted net loss per share

 

 

191,360,000

 

 

79,659,000

 

 

187,551,000

 

 

73,977,000

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

4


 

BioPharmX Corporation

Condensed Consolidated Statements of Cash Flows (unaudited)

(in thousands)

 

 

 

 

 

 

 

 

 

 

 

Nine months ended

 

 

 

October 31, 

 

 

 

2018

 

2017

 

Cash flows from operating activities:

    

 

 

    

 

 

 

Net loss

 

$

(13,202)

 

$

(12,852)

 

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

 

Stock-based compensation expense

 

 

1,757

 

 

1,416

 

Expense related to modification of warrants

 

 

 

 

151

 

Depreciation expense

 

 

48

 

 

38

 

Change in fair value of warrant liability

 

 

 1

 

 

(330)

 

Changes in assets and liabilities:

 

 

 

 

 

 

 

Accounts receivable

 

 

 3

 

 

(4)

 

Inventories

 

 

 

 

23

 

Prepaid expenses and other assets

 

 

(160)

 

 

(289)

 

Accounts payable

 

 

11

 

 

(545)

 

Accrued expenses and other liabilities

 

 

49

 

 

528

 

Net cash used in operating activities

 

 

(11,493)

 

 

(11,864)

 

Cash flows from investing activities:

 

 

 

 

 

 

 

Purchases of property and equipment

 

 

(13)

 

 

(41)

 

Net cash used in investing activities

 

 

(13)

 

 

(41)

 

Cash flows from financing activities:

 

 

 

 

 

 

 

Proceeds from the issuance of common stock, preferred stock and warrants, net of issuance costs

 

 

 —

 

 

6,355

 

Proceeds from exercises of common stock warrants

 

 

6,961

 

 

615

 

Proceeds from exercises of stock options

 

 

 1

 

 

10

 

Payments on capital lease obligation

 

 

(14)

 

 

 —

 

Net cash provided by financing activities

 

 

6,948

 

 

6,980

 

Net decrease in cash and cash equivalents

 

 

(4,558)

 

 

(4,925)

 

Cash and cash equivalents as of beginning of period

 

 

7,576

 

 

6,501

 

Cash and cash equivalents as of end of period

 

$

3,018

 

$

1,576

 

 

 

 

 

 

 

 

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

5


 

BIOPHARMX CORPORATION

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)

1. DESCRIPTION OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Description of Business

BioPharmX Corporation (the “Company”) is incorporated under the laws of the state of Delaware and originally incorporated on August 30, 2010 in Nevada under the name Thompson Designs, Inc. The Company has one wholly-owned subsidiary, BioPharmX, Inc., a Nevada corporation. The Company is a specialty pharmaceutical company focused on utilizing its proprietary drug delivery technologies to develop and commercialize novel prescription products that address large markets in dermatology. The Company’s objective is to develop products that treat health or age-related conditions that (1) are not presently being addressed or treated at all or (2) are currently treated with drug therapies or drug delivery approaches that are suboptimal. The Company’s strategy is designed to bring new products to market by identifying optimal delivery mechanisms and/or alternative applications for United States Food and Drug Administration (FDA) approved active pharmaceutical ingredients and biological materials, while, in appropriate circumstances, reducing the time, cost and risk typically associated with new product development by repurposing drugs with demonstrated safety profiles and, when applicable, taking advantage of the regulatory approval pathway under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act. The Company believes these approaches may reduce drug development risk and could reduce the time and resources it spends during development.  Its current platform technologies include innovative delivery mechanisms for antibiotics, biologic materials and molecular iodine (I2).

Since the Company’s inception, substantially all of the Company’s efforts have been devoted to developing its product candidates, including conducting preclinical and clinical trials, and providing general and administrative support for its operations. The Company has financed its operations primarily through the sale of equity and convertible notes. 

Basis of Presentation and Principles of Consolidation

These unaudited interim condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (GAAP) and applicable rules and regulations of the Securities and Exchange Commission (SEC) regarding interim financial reporting. Certain information and note disclosures normally included in the consolidated financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. Accordingly, these unaudited interim condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and notes thereto contained in the Company’s Annual Report on Form 10-K for the year ended January 31, 2018, filed on April 26, 2018. The condensed consolidated balance sheet as of January 31, 2018, included herein, was derived from the audited consolidated financial statements as of that date.

The unaudited interim condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary and have been prepared on the same basis as the audited consolidated financial statements and include all adjustments, consisting only of normal recurring adjustments, necessary for the fair presentation of the Company’s statement of financial position as of October 31, 2018 and January 31, 2018, and the Company’s results of operations for the three and nine months ended October 31, 2018 and 2017 and its cash flows for the nine months ended October 31, 2018 and 2017.  The results for the three and nine months ended October 31, 2018 are not necessarily indicative of the results to be expected for the year ending January 31, 2019 or any future period.

Use of Estimates

The preparation of financial statements in accordance with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenues and expenses recognized during the reported period. Actual results could differ from those estimates.

6


 

Inventories

Inventories are stated at the lower of cost or net realizable value. Cost is determined using the standard cost method which approximates actual cost on a first-in, first-out basis. The Company regularly reviews inventory quantities in consideration of actual loss experiences, projected future demand and remaining shelf life to record a provision for inventory, which may have become obsolete or are in excess of anticipated demand or net realizable value. If future demand or market conditions for the products are less favorable than forecasted, the Company may be required to record additional write-downs, which would negatively affect its results of operations in the period when the write-downs were recorded.

The Company must order components for its products and build inventory in advance of product shipments. The Company has a purchase commitment relating to the manufacturing of VI2OLET finished product (iodine supplement tablets) and is non-cancelable as detailed in Note 5. The Company assesses its purchase commitment based on demand forecasts and establishes a liability for quantities deemed in excess of these forecasts.

Impairment of Long-Lived Assets

The Company reviews long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset might not be recoverable. When such an event occurs, management determines whether there has been an impairment by comparing the anticipated undiscounted future net cash flows to the related asset’s carrying value. If an asset is considered impaired, the asset is written down to fair value, which is determined based either on discounted cash flows or appraised value, depending on the nature of the asset. The Company did not identify any impairment losses for the three or nine months ended October 31, 2018.

Advertising Expenses

The Company expenses the costs of advertising, including promotional expenses, as incurred. Advertising expenses were approximately $5,000 and $4,000 for the three months ended October 31, 2018 and 2017, respectively, and approximately $9,000 and $23,000 for the nine months ended October 31, 2018 and 2017, respectively.

Net Loss per Share

Basic net loss per share is calculated based on the weighted-average number of shares of the Company’s common stock outstanding during the period. The weighted-average shares outstanding for the three and nine months ended October 31, 2018 and 2017 excludes 193,333 shares of unvested restricted common stock. Diluted net loss per share attributable to common stockholders is calculated based on the weighted-average number of shares of the Company’s common stock outstanding and other dilutive securities outstanding during the period.

As of October 31, 2018 and 2017, approximately 190,102,000 and 58,382,000 of potentially dilutive securities, respectively, were excluded from the computation of diluted net loss per share because their effect on net loss per share would be anti-dilutive.

Warrant Liability

The Company accounts for certain of its warrants as derivative liabilities based on provisions relating to cash settlement options.  The Company recorded a liability for the fair value of the warrants at the time of issuance, and at each reporting date the warrants are revalued to the instrument’s fair value. The fair value of the warrants are estimated using the Black-Scholes pricing model. This liability is subject to fair value re-measurement until the warrants are exercised or expired, and any change in fair value is recognized as other income or expense in the condensed consolidated statements of operations and comprehensive loss.

Revenue Recognition

Effective February 1, 2018, the Company adopted Financial Accounting Standards Board (FASB) Accounting Standards Codification Topic 606, Revenue from Contracts with Customers (ASC 606), using the modified retrospective transition method.  The cumulative effect of the initial application of ASC 606 of approximately $2,000 was recognized as an adjustment to accumulated deficit and a decrease to deferred revenue as of February 1, 2018.  The adoption of ASC 606 did not have a material impact on the Company’s condensed consolidated balance sheet, statement of operations and

7


 

comprehensive loss for the three or nine months ended October 31, 2018 and statement of cash flows for the nine months ended October 31, 2018. 

Revenue recognized to date is from the sale of VI2OLET, an iodine dietary supplement. Revenue is recognized when control is transferred to the customer, which is typically upon shipment.  There are no significant post-shipment obligations.  Revenue is recognized at the transaction price, which includes estimates of variable consideration for reserves related to estimated product returns, pricing discounts or other concessions.  These estimates are based on estimates of the amount earned or to be claimed on the related sales and are based on historical information and current contractual requirements.

The Company continually evaluates whether the revenue generating activities and advanced payment arrangements with customers result in the recognition of contract assets or liabilities. No such assets existed as of October 31, 2018 or February 1, 2018.  Separately, accounts receivable, net, represent receivables from contracts with customers. As of October 31, 2018 and February 1, 2018, deferred revenue was immaterial. The Company applies the practical expedient to make adjustments for a significant financing component unnecessary if, at contract inception, the Company does not expect the period between customer payment and transfer of control of the promised goods or services to the customer to exceed one year. During the three and nine months ended October 31, 2018, the Company did not have any contracts for the sale of its products with its customers with a significant financing component. The Company has elected the practical expedient to recognize the incremental costs of obtaining a contract as an expense when incurred if the amortization period of the asset that the Company otherwise would have recognized is one year or less. During the three and nine months ended October 31, 2018, the Company expensed the incremental costs of obtaining the contract as an expense when incurred as the amortization period was one year or less. Shipping costs billed to customers are recorded as revenue. Shipping and handling expense related to costs incurred to deliver product are recognized within cost of goods sold. The Company accounts for shipping and handling activities that occur after control has transferred as a fulfillment cost as opposed to a separate performance obligation, and the costs of shipping and handling are recognized concurrently with the related revenue.

Summary of Significant Accounting Policies

These unaudited interim condensed consolidated financial statements and accompanying notes should be read in conjunction with the Company’s annual consolidated financial statements and notes thereto contained in the Annual Report on Form 10-K for the fiscal year ended January 31, 2018. There have been no significant changes in the Company’s significant accounting policies for the three and nine months ended October 31, 2018, except for the adoption of ASC 606 as discussed above, as compared to the significant accounting policies described in the Annual Report on Form 10-K for the fiscal year ended January 31, 2018.

Recent Accounting Pronouncements

In February 2016, the FASB issued Accounting Standards Update 2016-02, Leases,  and in July 2018, Accounting Standards Update 2018-11, Targeted Improvements,  which requires entities to recognize assets and liabilities for leases with lease terms greater than twelve months. The new guidance also requires quantitative and qualitative disclosures regarding the amount, timing and uncertainty of cash flows arising from leases. The standard is effective for annual and interim periods beginning after December 15, 2018, with early adoption permitted upon issuance. The Company is in the process of evaluating the impact of adoption of this standard on its condensed consolidated financial statements.

In June 2018, the FASB issued Accounting Standards Update 2018-07, Improvements to Nonemployee Share-Based Payment Accounting, which simplifies the accounting for share-based payments to nonemployees by aligning it with the accounting for share-based payments to employees, with certain exceptions.  The amendment is effective for annual and interim periods beginning after December 15, 2018, with early adoption permitted.  The Company is in the process of evaluating the impact of adoption of this amendment on its condensed consolidated financial statements.

              The Company has reviewed other recent accounting pronouncements and concluded they are either not applicable to the business or no material effect is expected on the condensed consolidated financial statements as a result of future adoption.

8


 

2. GOING CONCERN

The accompanying condensed consolidated financial statements have been prepared assuming the Company will continue as a going concern and will continue to conduct operations for the foreseeable future and realize assets and discharge liabilities in the ordinary course of operations. As of October 31, 2018, the Company had cash and cash equivalents of $3.0 million and working capital of $0.5 million. 

The Company has incurred recurring losses and negative cash flows from operations since inception and has funded its operating losses through the sale of common stock, preferred stock, warrants to purchase common stock and the issuance of convertible notes. The Company incurred a net loss of $4.4 million and $3.7 million for the three months ended October 31, 2018 and 2017, respectively, and a net loss of $13.2 million and $12.9 million for the nine months ended October 31, 2018 and 2017, respectively.  The Company had an accumulated deficit of $74.5 million as of October 31, 2018. 

The Company has a limited operating history and its prospects are subject to risks, expenses and uncertainties frequently encountered by companies in its industry. The Company continues its research and development efforts for its product candidates, which will require significant funding. If the Company is unable to obtain additional financing in the future or research and development efforts require higher than anticipated capital, there may be a negative impact on the financial viability of the Company.  The Company plans to increase working capital by managing its cash flows and expenses and either entering into a strategic partnership or raising additional capital through private or public equity or debt financing. There can be no assurance that such financing or partnerships will be available or on terms which are favorable to the Company. While management of the Company believes that it has a plan to fund ongoing operations, there is no assurance that its plan will be successfully implemented. Failure to generate sufficient cash flows from operations, raise additional capital through one or more financings, enter into a strategic partnership or reduce certain discretionary spending could have a material adverse effect on the Company’s ability to achieve its intended business objectives. These factors raise substantial doubt about the Company’s ability to continue as a going concern. The condensed consolidated financial statements do not contain any adjustments that might result from the resolution of any of the above uncertainties.

3. FAIR VALUE MEASUREMENTS

The Company recognizes and discloses the fair value of its assets and liabilities using a hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The hierarchy gives the highest priority to valuations based upon unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to valuations based upon unobservable inputs that are significant to the valuation (Level 3 measurements). Each level of input has different levels of subjectivity and difficulty involved in determining fair value.

·

Level 1—Inputs used to measure fair value are unadjusted quoted prices that are available in active markets for the identical assets or liabilities as of the reporting date.

 

·

Level 2— Observable inputs other than quoted prices included in Level 1, such as quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the asset or liability.

 

·

Level 3— Unobservable inputs to the valuation methodology that are significant to the measurement of the fair value of the assets or liabilities.

As of October 31, 2018 and January 31, 2018, the Company held $2.5 million and $7.1 million, respectively, in money market funds, which are classified as Level 1 within the fair value hierarchy. No unrealized gains or losses are recorded in connection with these amounts. 

9


 

The fair value of the warrant liability was classified as a Level 3 liability, as the Company uses unobservable inputs to value it.  The table below presents the activity within Level 3 of the fair value hierarchy (in thousands):

 

 

 

 

    

Warrant Liability

Balance as of January 31, 2018

$

39

Change in fair value of warrants

 

66

Balance as of April 30, 2018

 

105

Change in fair value of warrants

 

(23)

Balance as of July 31, 2018

 

82

Change in fair value of warrants

 

(42)

Balance as of October 31, 2018

$

40

 

 

4. BALANCE SHEET DETAILS

 

 

 

 

 

 

 

 

 

 

 

October 31, 

 

January 31, 

 

   

    

2018

    

2018

 

   

 

(in thousands)

 

Inventories:

 

 

 

 

 

 

 

Work in process

 

$

4

 

$

 5

 

Finished goods

 

 

4

 

 

 1

 

Channel inventory

 

 

2

 

 

 4

 

   

 

$

10

 

$

10

 

 

 

 

5. COMMITMENTS AND CONTINGENCIES

Commitments

The following table summarizes the Company’s commitments as of October 31, 2018 (in thousands):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Fiscal years ending January 31,

 

 

    

Total

    

2019

    

2020

    

2021

    

2022

    

2023

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating lease

 

$

1,331

 

$

79

 

$

280

 

$

314

 

$

324

 

$

334

 

Purchase commitment

 

 

807

 

 

269

 

 

269

 

 

269

 

 

 —

 

 

 —

 

Total

 

$

2,138

 

$

348

 

$

549

 

$

583

 

$

324

 

$

334

 

 

On December 14, 2016, the Company signed a lease for 12,066 square feet of office and laboratory space in Menlo Park, California. In September 2017, the lease term was extended to December 2018 and the square footage increased to 12,203 square feet. On October 30, 2018, the Company signed a lease for 11,793 square feet of office and laboratory space in San Jose, California.  The Company expects to move into its new headquarters in December 2018. The future minimum lease payments for this new lease are included in the table above. Rent expense for the three months ended October 31, 2018 and 2017 was approximately $160,000 and $154,000, respectively. Rent expense for the nine months ended October 31, 2018 and 2017 was approximately $480,000 and $453,000, respectively.

The purchase commitment relates to the manufacturing of VI2OLET finished product (iodine supplement tablets) and is non-cancelable through the term of the contract. The Company assesses its purchase commitments based on demand forecasts and establishes a liability for quantities deemed in excess of these forecasts.  In November 2018, the Company divested the rights to develop, manufacture, market and sale VI2OLET.  The divestiture included the transfer of the fiscal year 2020 and 2021 purchase commitment obligations to the new owner.  See Note 9 for further details.

 The Company is party to an agreement with  a contract research organization (CRO) to conduct the Phase 2 clinical trial for  BPX04, a topical antibiotic for the treatment of rosacea. The actual amounts owed under the agreement and the timing of those obligations depend on various factors, including the rate of patient enrollment, any protocol amendments and other factors relating to the clinical trial.  As of October 31, 2018, the remaining liability under the

10


 

agreement, excluding any potential amendments to the agreement, was $1.0 million.  The Company can terminate the agreement at any time and any amounts incurred through the termination date would be due to the CRO.

 The Company recorded a capital lease obligation related to laboratory equipment in March 2018.  The leased asset value was approximately $61,000 and the corresponding current and long-term liabilities were recorded in accrued liabilities and other current liabilities and long-term liabilities, respectively. 

 

Legal Proceedings

 

The Company may become subject to legal proceedings, claims and litigation arising in the ordinary course of business. In addition, the Company may receive letters alleging infringement of patents or other intellectual property rights. The Company is not a party to any material legal proceeding, nor is it aware of any pending or threatened litigation that the Company believes is likely to have a material adverse effect on its business, results of operations, cash flows or financial condition should such litigation be resolved unfavorably. These claims, even if not meritorious, could result in the expenditure of significant financial resources and diversion of management efforts.

Indemnification

The Company enters into standard indemnification arrangements in the ordinary course of business. Pursuant to these arrangements, the Company indemnifies, holds harmless, and agrees to reimburse the indemnified parties for losses suffered or incurred by the indemnified party, in connection with any trade secret, copyright, patent or other intellectual property infringement claim by any third-party with respect to the Company’s technology. The term of these indemnification agreements is generally perpetual. The maximum potential amount of future payments the Company could be required to make under these agreements is not determinable because it involves claims that may be made against the Company in the future, but have not yet been made.

The Company has entered into indemnification agreements with its directors, officers and certain of its medical advisors that may require the Company to indemnify its directors, officers and such medical advisors against liabilities that may arise by reason of their status or service in these roles, other than liabilities arising from willful misconduct of the individual. The Company has not incurred costs to defend lawsuits or settle claims related to these indemnification agreements. No liability associated with such indemnifications has been recorded to date.

License Agreement

In March 2013, the Company entered into an amended and restated collaboration and license agreement with Iogen LLC, which provides the Company with a license to certain rights to label, market, and resell the finished inventory and ongoing manufacturing of the Iogen molecular iodine technology for future product formulation development and commercialization. New formulation patents developed by the Company will be solely owned by the Company. The agreement gives the Company a perpetual, fully paid-up, exclusive license to make, have made, use, sell and offer for sale and import products.

Pursuant to the terms of the license, the Company must pay:

·

a fee for the exclusive license to the IP.

 

·

30% of net profit associated with direct commercialization of an over-the-counter product or 30% of net royalties received from any sub-licensee.

 

·

a royalty of 3% of net sales for the first 24 months of commercialization and 2% of net sales thereafter for a prescription iodine tablet developed and commercialized under the license.

 

·

a royalty of 3% of net sales for the first 12 months of commercialization for other products developed and commercialized under the license and 2% of net sales thereafter until expiration of applicable patents covering such products and 1% thereafter.

 

11


 

·

a fixed royalty fee for the protection and indemnification of licensed intellectual property right (IP rights) for the prescription product developed, marketed and sold from newly developed formulations as long as the patents are valid and cover the prescription product.

 

·

a fixed royalty fee for the protection and indemnification of licensed IP rights for the other products utilizing the molecular iodine technology developed, marketed and sold from newly developed formulations as long as the patents are valid and cover the prescription product.

 

No royalties have been required to be accrued in accordance with the license agreement as of October 31, 2018.

 

6. CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY 

Common Stock

In April 2017, the Company issued 6,410,258 shares of common stock at a price per share of $0.78 resulting in net proceeds of $4.4 million and warrants to purchase 3,365,385 shares of common stock at an exercise price of $0.90 in a registered direct offering.

In July 2017, the Company issued 5,500,000 shares of common stock at a price per share of $0.36 resulting in net proceeds of $1.9 million in a registered direct offering. 

In November 2017, the Company issued 45,275,000 shares of common stock, pre-funded warrants to purchase 28,225,000 shares of common stock, and accompanying Series A common warrants to purchase 73,500,000 shares of common stock (Series A Warrants), and accompanying Series B common warrants to purchase 73,500,000 shares of common stock (Series B Warrants), resulting in net proceeds of $9.7 million. Each share of common stock and pre-funded warrant was sold together with a Series A Warrant to purchase one share of common stock and a Series B Warrant to purchase one share of common stock. The public offering price was $0.15 per share of common stock and accompanying Series A Warrant and Series B Warrant and $0.1490 per pre-funded warrant and accompanying Series A Warrant and Series B Warrant. The pre-funded warrants were issued and sold to purchasers in lieu of shares of common stock that would otherwise result in the purchaser's beneficial ownership exceeding 4.99% (or at the election of the purchaser, 9.99%) of the Company’s outstanding common stock immediately following the closing of the offering. The pre-funded warrants have a nominal exercise price of $0.001 per share and have been fully exercised. The Series A Warrants have an exercise price of $0.20 per share, are exercisable immediately and expire five years from the date of issuance. The Series B Warrants have an exercise price of $0.25 per share, are exercisable immediately and expire on the earlier of (1) the twenty-first trading day after the Company issues a press release announcing it has entered into a strategic licensing, collaboration, partnership or similar agreement for the commitment to fund its Phase 3 trials for BPX01, and (2) the eighteen month anniversary of issuance.

Series A Convertible Preferred Stock

Pursuant to the Certificate of Designation filed with the Secretary of State of the State of Delaware on November 22, 2016, 10,000 shares of Series A convertible preferred stock were designated.  In November 2016, the Company issued 1,515 shares of Series A convertible preferred stock (Preferred Stock), which included warrants to purchase 3,246,429 shares of common stock. The Preferred Stock had a purchase price of $1,000 per share and was convertible into common stock at a conversion rate of $0.35 per share.  The Preferred Stock contained a beneficial conversion feature valued at $0.1 million, which was recorded as a deemed dividend at the time of issuance, which was considered to be the earliest time of conversion. In January 2018, the Preferred Stock was converted into 4,328,571 shares of common stock.

Pursuant to the Certificate of Elimination filed with the Secretary of State of the State of Delaware on March 6, 2018, all shares of Series A convertible preferred stock previously designated were returned to the status of authorized but unissued shares of preferred stock, without designation as to series or rights, preferences, privileges or limitations.

12


 

Warrants

In the first quarter of fiscal year 2019, the Company received $7.0 million from the exercise of warrants to purchase common stock.  A summary of warrants outstanding warrants as of October 31, 2018 is as follows:

 

 

 

 

 

 

 

 

 

Total

 

Price per Share

 

Expiration Date

Warrants related to January 2014 agreement

 

289,505

 

$ 1.85

 

May 2019

Warrants related to May 2014 agreement

 

316,395

 

$2.035

 

May 2019

Warrants related to April to November 2014 financing

 

1,661,055

 

$ 3.70

 

April 2019 - November 2019

Warrants related to June 2015 financing

 

109,091

 

$ 2.75

 

June 2020

Warrants related to April 2016 financing

 

1,952,000

 

$ 1.20

 

April 2021

Warrants related to September 2016 financing (1)

 

1,286,501

 

$ 0.75

 

September 2021 to March 2022

Warrants related to November 2016 financing

 

30,406,061

 

$ 0.35

 

November 2022 to November 2024

Warrants related to November 2016 financing

 

895,450

 

$ 0.44

 

November 2022

Warrants related to November 2016 financing

 

198,214

 

$ 0.33

 

November 2022

Warrants related to April 2017 financing

 

801,282

 

$ 0.90

 

October 2022

Warrants related to October 2017 financing (2)

 

3,846,152

 

$ 0.30

 

October 2022

Warrants related to November 2017 financing

 

56,935,191

 

$ 0.20

 

November 2022

Warrants related to November 2017 financing (3)

 

60,088,727

 

$ 0.25

 

May 2019


(1)

In connection with the sale of common stock in September 2016, warrants to purchase 1,286,501 shares of common stock were issued at an exercise price of $0.75 per share.  These warrants included a cash settlement option requiring the Company to record a liability for the fair value of the warrants at the time of issuance and at each reporting period with any change in the fair value reported as other income or expense.  At the time of issuance, approximately $566,000 was recorded as a warrant liability.  To value the warrant liability, the Company used the Black-Scholes pricing model with the following assumptions: risk-free interest rate of 1.1%, contractual term of 5 years, expected volatility of 95.8% and a dividend rate of 0%.  As of October 31, 2018, the fair value of the warrant liability was approximately $40,000 and was included in long-term liabilities.

(2)

On October 23, 2017, the Company entered into agreements with certain of these warrant holders to permit their immediate exercise of 2,564,103 shares of common stock underlying the warrants at an exercise price per share of $0.24.  The Company recorded a charge for the incremental fair value of approximately $151,000 in the other expense line item in the condensed consolidated statement of operations and comprehensive loss. The fair value of the warrants exercised was computed as of the date of exercise using the following assumptions: risk-free interest rate of 2.03%, contractual term of 5 years, expected volatility of 83.9% and a dividend rate of 0%. In addition, these warrant holders were issued new warrants to purchase up to an aggregate of 3,846,152 shares of common stock at an exercise price per share of $0.30.

(3)

On November 20, 2018, the Company entered into agreements with certain of these warrant holders to cash exercise up to 26,666,666 shares of common stock underlying the warrants at an exercise price per share of $0.14.  See Note 9 for further details.

Equity Incentive Plan

On July 5, 2016, the Company adopted the 2016 Equity Incentive Plan (2016 Plan), which permits the Company to grant equity awards to directors, officers, employees and consultants. In connection with the adoption of the 2016 Plan, the Company ceased to grant equity awards under its 2014 Equity Incentive Plan (2014 Plan), which was adopted on January 23, 2014. All grants and awards under the 2014 Plan, including stock options previously issued under BioPharmX, Inc.’s 2011 Equity Incentive Plan that were substituted with stock options issued under the 2014 Plan, remain in effect in accordance with their terms. Stock options generally vest in one to four years and expire ten years from the date of grant.  In March 2017, the 2016 Plan was amended and the shares reserved for issuance were increased by 20,000,000 shares to a total of 24,000,000 shares of common stock.  In August 2018, the 2016 Plan was amended and the shares reserved for issuance were increased by 50,000,000 shares to a total of 74,000,000 shares of common stock. The 2014 Plan and 2016 Plan are referred to collectively as the “Plans.”

13


 

The following table summarizes the Company’s stock option awards under the Plans:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted

 

 

 

 

 

 

 

 

 

 

 

 

Average

 

Remaining

 

Aggregate

 

 

 

Available for

 

 

 

Exercise

 

Contractual

 

Intrinsic

 

 

    

Grant

    

Shares

    

Prices

    

Life

    

Value

 

 

 

 

 

 

 

 

 

 

 

 

(in thousands)

 

Balance as of February 1, 2018

 

1,884,878

 

24,724,663

 

$

0.41

 

9.17

 

$

304

 

Exercised

 

 —

 

(10,140)

 

$

0.13

 

 

 

 

 

 

Cancelled and expired under the 2014 Plan

 

 —

 

(73,750)

 

$

0.73

 

 

 

 

 

 

Cancelled under the 2016 Plan

 

376,969

 

(376,969)

 

$

0.35

 

 

 

 

 

 

Balance as of April 30, 2018

 

2,261,847

 

24,263,804

 

$

0.41

 

8.91

 

$

1,300

 

Exercised

 

 —

 

(5,556)

 

$

0.10

 

 

 

 

 

 

Cancelled and expired under the 2014 Plan

 

 —

 

(49,188)

 

$

0.95

 

 

 

 

 

 

Cancelled under the 2016 Plan

 

116,763

 

(116,763)

 

$

0.35

 

 

 

 

 

 

Balance as of July 31, 2018

 

2,378,610

 

24,092,297

 

$

0.41

 

8.67

 

$

982

 

Shares authorized for issuance

 

50,000,000

 

 —

 

 

 

 

 

 

 

 

 

Granted

 

(10,444,000)

 

10,444,000

 

$

0.21

 

 

 

 

 

 

Exercised

 

 —

 

(262,500)

 

$

0.10

 

 

 

 

 

 

Cancelled and expired under the 2014 Plan

 

 —

 

(73,709)

 

$

0.91

 

 

 

 

 

 

Cancelled under the 2016 Plan

 

4,083,587

 

(4,083,587)

 

$

0.26

 

 

 

 

 

 

Balance as of October 31, 2018

 

46,018,197

 

30,116,501

 

$

0.36

 

7.81

 

$

507

 

Vested and exercisable

 

 

 

12,149,662

 

$

0.51

 

5.50

 

$

234

 

Vested and expected to vest

 

 

 

28,583,682

 

$

0.37

 

7.72

 

$

490

 

Inducement Grants

The Company has also awarded inducement option grants to purchase common stock to new employees outside of the 2016 Plan as permitted under Section 711(a) of the NYSE American Company Guide. Such options vest at the rate of 25% of the shares on the first anniversary of the commencement of such employee’s employment with the Company, and then one forty-eighth (1/48) of the shares monthly thereafter subject to such employee’s continued service.  The following table summarizes the Company’s inducement grant stock option awards:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted

 

 

 

 

 

 

 

 

 

 

Average

 

Remaining

 

 

 

 

 

 

 

 

Exercise

 

Contractual

 

Aggregate

 

 

    

Shares

    

Prices

    

Life

    

Intrinsic Value

 

 

 

 

 

 

 

 

 

 

(in thousands)

 

Balance as of February 1, 2018

 

660,000

 

$

1.44

 

7.72

 

$

 —

 

Granted

 

400,000

 

$

0.19

 

 —

 

$

 —

 

Balance as of April 30, 2018 and July 31, 2018

 

1,060,000

 

$

0.97

 

8.09

 

$

4

 

Cancelled

 

(53,855)

 

$

1.67

 

 —

 

$

 —

 

Balance as of October 31, 2018

 

1,006,145

 

$

0.93

 

6.67

 

$

 —

 

Vested and exercisable

 

487,395

 

$

1.44

 

4.45

 

$

 —

 

Vested and expected to vest

 

970,103

 

$

0.95

 

6.59

 

$

 —

 

 

 

 

14


 

The following table summarizes significant ranges of outstanding and exercisable options as of October 31, 2018:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Options Outstanding

 

Options Vested and Exercisable

 

 

 

 

 

Weighted

 

 

 

 

 

 

 

 

 

 

 

 

 

Average

 

Weighted

 

 

 

Weighted

 

 

 

 

 

Remaining

 

Average

 

Number

 

Average

 

 

 

Number

 

Contractual

 

Exercise

 

Vested and

 

Exercise

 

Range of Exercise Prices

    

Outstanding

    

Life (in Years)

    

Prices

    

Exercisable

    

Prices

 

$0.10 - $0.16

 

8,249,863

 

7.69

 

$

0.11

 

3,541,540

 

$

0.10

 

$0.17 - $0.35

 

12,965,729

 

9.00

 

$

0.22

 

2,214,574

 

$

0.23

 

$0.36 - $0.65

 

3,810,189

 

5.96

 

$

0.53

 

2,737,123

 

$

0.54

 

$0.66 - $1.09

 

4,595,720

 

6.71

 

$

0.77

 

2,800,095

 

$

0.78

 

$1.10 - $1.85

 

1,401,145

 

5.47

 

$

1.68

 

1,243,725

 

$

1.69

 

$1.86 - $3.00

 

100,000

 

6.50

 

$

3.00

 

100,000

 

$

3.00

 

 

 

31,122,646

 

7.78

 

$

0.38

 

12,637,057

 

$

0.55

 

The total intrinsic value of stock options exercised during the three and nine months ended October 31, 2018 was approximately $24,000 and $26,000, respectively.  The total intrinsic value of stock options exercised during the nine months ended October 31, 2017 was approximately $4,000.  There were no stock options exercised during the three months ended October 31, 2017.  

7. STOCK-BASED COMPENSATION

The following table summarizes the stock-based compensation expenses included in the condensed consolidated statement of operations and comprehensive loss (in thousands):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

For the three months ended

 

For the nine months ended

 

 

 

October 31, 

 

October 31, 

 

 

    

2018

    

2017

    

2018

    

2017

 

Research and development

 

$

166

 

$

131

 

$

525

 

$

397

 

Sales and marketing

 

 

114

 

 

98

 

 

355

 

 

289

 

General and administrative

 

 

438

 

 

236

 

 

877

 

 

730

 

Total

 

$

718

 

$

465

 

$

1,757

 

$

1,416

 

The Company estimates the fair value of stock options granted using the Black-Scholes pricing model. This model also requires subjective assumptions, including future stock price volatility and expected time to exercise, which greatly affect the calculated values. For employee grants, the fair value is amortized on a straight-line basis over the requisite service periods of the awards, which is generally the vesting period. As of October 31, 2018, total compensation costs related to unvested, but not yet recognized, stock-based awards was $3.0 million, net of estimated forfeitures. This cost will be amortized on a straight-line basis over a weighted average remaining period of 2.71  years and will be adjusted for subsequent changes in estimated forfeitures.

Valuation Assumptions

During the nine months ended October 31, 2018, the grant date fair value of stock options granted was $0.12 per share. The following assumptions were used to calculate the estimated fair value of awards granted for the periods ended:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

For the three months ended

 

 

For the nine months ended

 

 

 

 

October 31, 

 

 

October 31, 

 

 

 

    

2018

    

 

2018

    

2017

 

    

Expected volatility

 

78.8% - 91.0%

 

 

78.8% - 91.0%

 

95.5% - 96.8%

 

 

Expected term in years

 

4.0 - 8.6

 

 

4.0 - 8.6

 

6.0 - 9.6

 

 

Risk-free interest rate

 

2.72% - 3.10%

 

 

2.72% - 3.10%

 

1.80% - 2.35%

 

 

Expected dividend yield

 

 —

 

 

 —

 

 —

 

 

15


 

Expected Term

The expected term represents the period that the Company’s stock-based awards are expected to be outstanding. For awards granted subject only to service vesting requirements, the Company utilizes the simplified method for estimating the expected term of the stock-based award, instead of historical exercise data.

Expected Volatility

The Company uses the historical volatility of the price of shares of common stock of selected public companies, including the Company’s stock price, in the biotechnology sector due to its limited trading history.

Risk-Free Interest Rate

The Company bases the risk-free interest rate used in the Black-Scholes pricing model upon the implied yield curve currently available on U.S. Treasury zero-coupon issues with a remaining term equal to the expected term used as the assumption in the model.

Expected Dividend

The Company has never paid dividends on its shares of common stock and currently does not intend to do so and, accordingly, the dividend yield percentage is zero for all periods.

8. INCOME TAXES

The Company evaluates its ability to recover deferred tax assets, in full or in part, by considering all available positive and negative evidence, including past operating results and its forecast of future taxable income on a jurisdictional basis. The Company bases its estimate of current and deferred taxes on the tax laws and rates that are currently in effect in the appropriate jurisdiction. Changes in laws or rates may affect the tax provision as well as the amount of deferred tax assets or liabilities.

Current tax laws impose substantial restrictions on the utilization of net operating loss and credit carry-forwards in the event of an “ownership change,” as defined by the Internal Revenue Code. If there should be an ownership change, the Company’s ability to utilize its carry-forwards could be limited. The Company has not conducted a formal net operating loss carryforward analysis.

As of October 31, 2018 and January 31, 2018, the Company has not recorded any liability for unrecognized tax benefits related to uncertain tax positions. The 2010 to 2018 tax years remain open for examination by the federal and state authorities.

9. SUBSEQUENT EVENTS

On November 20, 2018, the Company entered into agreements with holders of certain of its warrants to purchase common stock with an exercise price per share of $0.25 originally issued on November 24, 2017 (Existing Warrants), whereby the holders and the Company agreed that the holders would cash exercise up to 26,666,666 shares of common stock underlying such Existing Warrants at a reduced price of $0.14, and the Company would issue new warrants to such holders to purchase up to an aggregate of 26,666,666 shares of common stock (New Warrants), with such New Warrants to be issued on a share-for-share basis in an amount equal to the number of shares underlying Existing Warrants that are cash exercised by February 28, 2019. The New Warrants are exercisable after the six-month anniversary of their issuance and terminate on the 30-month anniversary following their issuance. The New Warrants have an exercise price per share of $0.164.

On November 27, 2018, the Company entered into an asset purchase agreement to divest the rights to develop, manufacture, market and sell its molecular iodine technology, including the dietary supplement product, VI2OLET (Purchase Agreement).  The Purchase Agreement includes the sale of all tangible and intangible assets related to VI2OLET, including but not limited to existing customer and vendor arrangements, in exchange for 3% royalty payments on net revenues exceeding $1.0 million.  In addition, after January 1, 2020, the purchaser may be relieved of its obligations to pay royalties to the Company by making a lump-sum payment to the Company.  Under the Purchase

16


 

Agreement, the Company will remain liable for any liabilities incurred prior to December 31, 2018, with the purchaser assuming responsibility for all liabilities thereafter. The purchase commitment obligations relating to the manufacturing of VI2OLET finished product incurred after December 31, 2018 are included in the vendor arrangements assigned under the Purchase Agreement.  Upon the effectiveness of the Purchase Agreement, each of the Company’s prior collaboration, license, colocation and supply agreements related to VI2OLET were terminated or will be assigned to the purchaser.

 

ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

This Quarterly Report on Form 10-Q and other written reports and oral statements made from time to time by the Company may contain so-called “forward-looking statements,” all of which are subject to risks and uncertainties. One can identify these forward-looking statements by their use of words such as “expect,” “plan,” “will,” “may,” “anticipate,” “believe,” “estimate,” “should,” “intend,” “forecast,” “project” the negative or plural of these words, and other comparable terminology. One can identify them by the fact that they do not relate strictly to historical or current facts. These statements are likely to address the Company’s growth strategy, financial results and product and development programs. One must carefully consider any such statement and should understand that many factors could cause actual results to differ from the Company’s forward-looking statements. These factors include inaccurate assumptions and a broad variety of other risks and uncertainties, including some that are known and some that are not. No forward-looking statement can be guaranteed and actual future results may vary materially. The Company does not assume the obligation to update any forward-looking statement. One should carefully evaluate such statements in light of factors described in the Company’s filings with the SEC, especially the Company’s Annual Report on Form 10-K and the Company’s Quarterly Reports on Form 10-Q. In various filings, the Company has identified important factors that could cause actual results to differ from expected or historic results. One should understand that it is not possible to predict or identify all such factors. Consequently, the reader should not consider any such list to be a complete list of all potential risks or uncertainties.

The following discussion is presented on a consolidated basis and analyzes our financial condition and results of operations for the three and nine months ended October 31,  2018 and 2017. Unless the context indicates or suggests otherwise, reference to “we”, “our”, “us” and the “Company” in this section refers to the consolidated operations of BioPharmX Corporation, as defined in Note 1 —Description of Business.

The following Management’s Discussion and Analysis of Financial Condition and Results of Operations, or MD&A, is intended to help the reader understand our results of operations and financial condition. MD&A is provided as a supplement to, and should be read in conjunction with, our financial statements and the accompanying notes to the financial statements and other disclosures included in this Quarterly Report on Form 10-Q. Our financial statements have been prepared in accordance with U.S. generally accepted accounting principles and are presented in U.S. dollars.

Overview

We are a specialty pharmaceutical company focused on utilizing our proprietary drug delivery technologies to develop and commercialize novel prescription, products that address large markets in dermatology. Our objective is to develop products that treat health or age‑related conditions that: (1) are not presently being addressed or treated or (2) are currently treated with drug therapies or drug delivery approaches that are sub‑optimal. Our strategy is designed to bring new products to market by identifying optimal delivery mechanisms and/or alternative applications for United States Food and Drug Administration, or FDA, approved active pharmaceutical ingredients, or APIs, and biological materials, while, in appropriate circumstances, reducing the time, cost and risk typically associated with new product development by repurposing drugs with demonstrated safety profiles and, when applicable, taking advantage of the regulatory approval pathway under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. Section 505(b)(2) permits an applicant for a new product, such as a new or improved formulation or a new use of an approved product, to rely in part on literature and/or the FDA’s findings of safety and/or effectiveness for a similar previously‑approved product. We believe these approaches may reduce drug development risk and could reduce the time and resources we spend during development. Our current platform technologies include innovative delivery mechanisms for antibiotics, biologic materials and molecular iodine (I2).

17


 

The product candidates in our current portfolio target significant market opportunities and include three clinical‑stage product candidates, BPX01, a topical antibiotic for the treatment of inflammatory lesions of acne based on a unique formulation of minocycline, BPX04, a topical antibiotic for the treatment of rosacea, and BPX03, a molecular iodine (I2) tablet for the treatment of benign breast pain associated with fibrocystic breast condition, or FBC, and cyclic mastalgia, as well as one development‑stage product candidate, BPX02, an injectable product utilizing biological materials for aesthetic dermatology applications. We presented comprehensive BPX01 Phase 2b clinical data for the treatment of acne and received positive FDA feedback regarding our BPX01 Phase 3 clinical trial plans. We are considering strategic partnership alternatives to fund our Phase 3 clinical program in this indication. We expect to begin a Phase 3 clinical trial, should we raise the necessary additional capital or enter into a strategic partnership to fund the trial. Our 12-week feasibility study of BPX04 for the treatment of rosacea assessed tolerability in 30 subjects.  No unexpected adverse reactions and no serious adverse events were observed of BPX04 for this indication. The Phase 2 study for BPX04 for the treatment of inflammatory lesions for papulopustular rosacea uses the 1% minocycline concentration.  The first patient was enrolled in October 2018. The molecular iodine project includes a marketed over-the-counter, or OTC, dietary supplement version, or VI2OLET, for the alleviation of symptoms of FBC, as well as an investigational prescription drug version for the treatment of moderate to severe, periodic breast pain associated with FBC and cyclic mastalgia.

Critical Accounting Policies

Our financial statements and related public financial information are based on the application of accounting principles generally accepted in the United States, or GAAP. GAAP requires the use of estimates, assumptions, judgments and subjective interpretations of accounting principles that have an impact on the assets, liabilities, revenues and expense amounts reported. These estimates can also affect supplemental information contained in our external disclosures including information regarding contingencies, risk and financial condition. We believe our use of estimates and underlying accounting assumptions adhere to GAAP and are consistently applied. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances. Actual results may differ materially from these estimates under different assumptions or conditions. We continue to monitor significant estimates made during the preparation of our condensed consolidated financial statements.

On February 1, 2018, we adopted Accounting Standards Update 2014-09, Revenue from Contracts with Customers (Topic 606), or ASC 606, using the modified retrospective transition method.  The cumulative effect of the initial application of ASC 606 of approximately $2,000 was recognized as an adjustment to accumulated deficit and an decrease to deferred revenue as of February 1, 2018.  The adoption of ASC 606 did not have a material impact on our condensed consolidated balance sheet, statement of operations and comprehensive loss for the three and nine months ended October 31, 2018 and statement of cash flows for the nine months ended October 31, 2018.

Our significant accounting policies are summarized in Note 1 of our audited consolidated financial statements, which are included in our Annual Report on Form 10-K for the year ended January 31, 2018. While all of these significant accounting policies impact our financial condition and results of operations, we view the revenue recognition, inventories, warrant liability and stock-based compensation policies as critical. Policies determined to be critical are those policies that have the most significant impact on our financial statements and require management to use a greater degree of judgment and estimates. Actual results may differ from those estimates. Our management believes that given current facts and circumstances, it is unlikely that applying any other reasonable judgments or estimate methodologies would cause an effect on our results of operations, financial position or liquidity for the periods presented in this report.

Going Concern

The accompanying condensed consolidated financial statements have been prepared assuming we will continue as a going concern, meaning we will continue in operation for the foreseeable future and will be able to realize assets and discharge liabilities in the ordinary course of operations. As of October 31, 2018, we had cash and cash equivalents of $3.0 million and a working capital of $0.5 million.

We have incurred recurring losses and negative cash flows from operations since inception and have funded our operating losses through the sale of common stock in public and private offerings and the issuance of convertible notes, Series A convertible preferred stock and warrants. We incurred a net loss of $4.4 million and $3.7 million for the three months ended October  31, 2018 and 2017, respectively, and a net loss of $13.2 million and $12.9 million for the nine months ended October 31, 2018, respectively.  We had an accumulated deficit of $74.5 million as of October 31, 2018. 

18


 

We have a limited operating history and our prospects are subject to risks, expenses and uncertainties frequently encountered by companies in our industry. To date, we have generated a de minimis amount of revenue from the sale of VI2OLET, our iodine dietary supplement. We continue our research and development efforts for our product candidates, which will require significant funding. If we are unable to obtain additional financing in the near‑term or research and development efforts require higher than anticipated capital, there may be a negative impact on our financial viability. We plan to increase working capital by managing our cash flows and expenses and either entering into a strategic partnership or raising additional capital through private or public equity or debt financing. Risks include, but are not limited to, the uncertainty of availability of additional financing and the uncertainty of achieving future profitability.  We may also raise additional funds through the issuance of equity securities. We have an effective shelf registration statement on file with the SEC to allow us to sell up to approximately $79.0 million of our securities from time to time prior to February 2019, subject to regulatory limitations. For example, pursuant to General Instruction I.B.6 of Form S-3, in no event will we sell securities pursuant to the shelf registration statement with a value of more than one third of the aggregate market value of our common stock held by non-affiliates in any 12 month period, so long as the aggregate market value of our common stock held by non-affiliates is less than $75.0 million. There can be no assurance that such financing will be available or on terms which are favorable to us. While our management believes that we have a plan to fund ongoing operations, there is no assurance that our plan will be successfully implemented. Failure to generate sufficient cash flows from operations, raise additional capital through one or more financings, enter into a strategic partnership or reduce certain discretionary spending could have a material adverse effect on our ability to achieve our intended business objectives. These factors raise substantial doubt about our ability to continue as a going concern. The condensed consolidated financial statements do not contain any adjustments that might result from the resolution of any of the above uncertainties.

Results of Operations

Three and nine months ended October 31, 2018 and 2017

Revenue

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three months ended October 31, 

 

Nine months ended October 31, 

 

2018

    

2017

    

Change

    

%

    

2018

    

2017

    

Change

    

%

 

($ in thousands)

 

 

 

($ in thousands)

 

 

 

$

10

 

$

18

 

$

(8)

 

(44)

%

$

52

 

$

54

 

$

(2)

 

(4)

%

We recognize revenue when control is transferred to the customer, which is typically upon shipment, net of reserves for product returns, pricing discounts or other concessions. Revenue in the third quarter and first nine months of fiscal year 2019 compared to the prior year periods decreased due to less unit shipments.  In November 2018, we sold the VI2OLET product, therefore we do not expect to recognize material revenues in the future from this product.    

Cost of Goods Sold

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three months ended October 31, 

 

Nine months ended October 31, 

 

2018

    

2017

    

Change

    

%

    

2018

    

2017

    

Change

    

%