UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
x | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended June 30, |
or
o | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to |
Commission File Number 001-33216
OCULUS INNOVATIVE SCIENCES,SONOMA PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
Delaware | 68-0423298 |
(State or other jurisdiction of incorporation or organization) | (I.R.S Employer Identification No.) |
1129 North McDowell Blvd.
Petaluma, CA 94954
(Address of principal executive offices) (Zip Code)
(707) 283-0550
Registrant’s telephone number, including area code
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 x No o
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted 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 and post such files). Yes x No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer”filer,” “smaller reporting company” and “smaller reporting“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 o No x
As of August 2, 20168, 2017 the number of shares outstanding of the registrant’s common stock, $0.0001 par value, was 4,200,776.4,307,963.
OCULUS INNOVATIVE SCIENCES,
SONOMA PHARMACEUTICALS, INC.
2 |
PART I — FINANCIAL INFORMATION
Item 1. | Financial Statements |
OCULUS INNOVATIVE SCIENCES,SONOMA PHARMACEUTICALS, INC. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets
(In thousands, except share and per share amounts)
June 30, | March 31, | June 30, | March 31, | |||||||||||||
2016 | 2016 | 2017 | 2017 | |||||||||||||
(Unaudited) | (Unaudited) | |||||||||||||||
ASSETS | ||||||||||||||||
Current assets: | ||||||||||||||||
Cash and cash equivalents | $ | 4,970 | $ | 7,469 | $ | 12,638 | $ | 17,461 | ||||||||
Accounts receivable, net | 2,593 | 2,274 | 2,741 | 2,108 | ||||||||||||
Inventories, net | 1,992 | 1,640 | 2,380 | 2,221 | ||||||||||||
Prepaid expenses and other current assets | 942 | 1,505 | 1,304 | 616 | ||||||||||||
Current portion of deferred consideration, net of discount | 250 | 237 | ||||||||||||||
Total current assets | 10,497 | 12,888 | 19,313 | 22,643 | ||||||||||||
Property and equipment, net | 764 | 850 | 1,496 | 1,239 | ||||||||||||
Deferred consideration, net of discount, less current portion | 1,517 | 1,497 | ||||||||||||||
Other assets | 59 | 65 | 95 | 80 | ||||||||||||
Total assets | $ | 11,320 | $ | 13,803 | $ | 22,421 | $ | 25,459 | ||||||||
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||||||||||
Current liabilities: | ||||||||||||||||
Accounts payable | $ | 1,368 | $ | 1,337 | $ | 774 | $ | 1,255 | ||||||||
Accrued expenses and other current liabilities | 1,442 | 1,526 | 1,546 | 1,302 | ||||||||||||
Deferred revenue | 656 | 574 | 285 | 345 | ||||||||||||
Deferred revenue Invekra | 152 | 176 | ||||||||||||||
Current portion of long-term debt | 66 | 114 | 87 | 123 | ||||||||||||
Current portion of capital leases | 139 | 74 | ||||||||||||||
Taxes payable | – | 13 | ||||||||||||||
Total current liabilities | 3,532 | 3,551 | 2,983 | 3,288 | ||||||||||||
Deferred revenue, less current portion | 38 | 112 | ||||||||||||||
Long-term deferred revenue Invekra | 538 | 527 | ||||||||||||||
Long-term debt, less current portion | 42 | 45 | ||||||||||||||
Long-term capital leases, less current portion | 252 | 168 | ||||||||||||||
Total liabilities | 3,570 | 3,663 | 3,815 | 4,028 | ||||||||||||
Commitments and Contingencies (Note 5) | ||||||||||||||||
Commitments and Contingencies (Note 6) | ||||||||||||||||
Stockholders’ Equity | ||||||||||||||||
Convertible preferred stock, $0.0001 par value; 714,286 shares authorized, none issued and outstanding at June 30, 2016 and March 31, 2016, respectively | – | – | ||||||||||||||
Common stock, $0.0001 par value; 12,000,000 shares authorized at June 30, 2016 and March 31, 2016, 4,200,756 (unaudited) and 4,196,873 shares issued and outstanding at June 30, 2016 and March 31, 2016, respectively (Note 6) | 1 | 1 | ||||||||||||||
Convertible preferred stock, $0.0001 par value; 714,286 shares authorized, none issued and outstanding at June 30, 2017 and March 31, 2017, respectively | – | – | ||||||||||||||
Common stock, $0.0001 par value; 12,000,000 shares authorized at June 30, 2017 and March 31, 2017, 4,307,062 and 4,289,322 shares issued and outstanding at June 30, 2017 and March 31, 2017, respectively | 1 | 1 | ||||||||||||||
Additional paid-in capital | 166,779 | 166,368 | 169,203 | 168,709 | ||||||||||||
Accumulated deficit | (154,943 | ) | (152,375 | ) | (146,620 | ) | (143,101 | ) | ||||||||
Accumulated other comprehensive loss | (4,087 | ) | (3,854 | ) | (3,978 | ) | (4,178 | ) | ||||||||
Total stockholders’ equity | 7,750 | 10,140 | 18,606 | 21,431 | ||||||||||||
Total liabilities and stockholders’ equity | $ | 11,320 | $ | 13,803 | $ | 22,421 | $ | 25,459 |
The accompanying footnotes are an integral part of these condensed consolidated financial statements.
3 |
SONOMA PHARMACEUTICALS, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Comprehensive Loss
(In thousands, except per share amounts)
(Unaudited)
Three Months Ended June 30, | ||||||||
2017 | 2016 | |||||||
Revenues | ||||||||
Product | $ | 3,603 | $ | 2,411 | ||||
Service | 232 | 227 | ||||||
Total revenues | 3,835 | 2,638 | ||||||
Cost of revenues | ||||||||
Product | 1,913 | 1,472 | ||||||
Service | 160 | 185 | ||||||
Total cost of revenues | 2,073 | 1,657 | ||||||
Gross profit | 1,762 | 981 | ||||||
Operating expenses | ||||||||
Research and development | 382 | 360 | ||||||
Selling, general and administrative | 4,763 | 4,130 | ||||||
Total operating expenses | 5,145 | 4,490 | ||||||
Loss from operations | (3,383 | ) | (3,509 | ) | ||||
Interest expense | (10 | ) | (1 | ) | ||||
Interest income | 53 | 1 | ||||||
Other (expense) income, net | (168 | ) | 3 | |||||
Loss from continuing operations before income taxes | (3,508 | ) | (3,506 | ) | ||||
Income tax benefit | – | 319 | ||||||
Loss from continuing operations | (3,508 | ) | (3,187 | ) | ||||
Income from discontinued operations (net of tax) (Note 4) | – | 619 | ||||||
Net loss | $ | (3,508 | ) | $ | (2,568 | ) | ||
Net loss per share: basic and diluted | ||||||||
Continuing operations | $ | (0.82 | ) | $ | (0.76 | ) | ||
Discontinued operations | – | 0.15 | ||||||
$ | (0.82 | ) | $ | (0.61 | ) | |||
Weighted-average number of shares used in per share calculations: basic and diluted | 4,294 | 4,198 | ||||||
Other comprehensive loss | ||||||||
Net loss | $ | (3,508 | ) | $ | (2,568 | ) | ||
Foreign currency translation adjustments | 200 | (233 | ) | |||||
Comprehensive loss | $ | (3,308 | ) | $ | (2,801 | ) |
The accompanying footnotes are an integral part of these condensed consolidated financial statements.
OCULUS INNOVATIVE SCIENCES,
SONOMA PHARMACEUTICALS, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Comprehensive LossCash Flows
(In thousands, except per share amounts)thousands)
(Unaudited)
Three Months Ended June 30, | ||||||||
2016 | 2015 | |||||||
Revenues | ||||||||
Product | $ | 3,509 | $ | 2,916 | ||||
Product licensing fees and royalties | 75 | 447 | ||||||
Service | 227 | 317 | ||||||
Total revenues | 3,811 | 3,680 | ||||||
Cost of revenues | ||||||||
Product | 1,707 | 1,516 | ||||||
Service | 185 | 291 | ||||||
Total cost of revenues | 1,892 | 1,807 | ||||||
Gross profit | 1,919 | 1,873 | ||||||
Operating expenses | ||||||||
Research and development | 360 | 467 | ||||||
Selling, general and administrative | 4,130 | 3,717 | ||||||
Total operating expenses | 4,490 | 4,184 | ||||||
Loss from operations | (2,571 | ) | (2,311 | ) | ||||
Interest expense | (1 | ) | – | |||||
Interest income | 1 | – | ||||||
Loss due to change in fair value of derivative liabilities | – | (59 | ) | |||||
Other income, net | 3 | 30 | ||||||
Net loss | (2,568 | ) | (2,340 | ) | ||||
Net loss per common share: basic and diluted | $ | (0.61 | ) | $ | (0.77 | ) | ||
Weighted-average number of shares used in common share calculations: | ||||||||
Basic and diluted | 4,198 | 3,034 | ||||||
Other comprehensive loss | ||||||||
Net loss | $ | (2,568 | ) | $ | (2,340 | ) | ||
Foreign currency translation adjustments | (233 | ) | (71 | ) | ||||
Comprehensive loss | $ | (2,801 | ) | $ | (2,411 | ) |
Three Months Ended June 30, | ||||||||
2017 | 2016 | |||||||
Cash flows from operating activities | ||||||||
Net loss from continuing operations | $ | (3,508 | ) | $ | (3,187 | ) | ||
Income from discontinued operations, net of tax | – | 619 | ||||||
Net loss | (3,508 | ) | (2,568 | ) | ||||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Depreciation and amortization | 109 | 61 | ||||||
Stock-based compensation | 438 | 411 | ||||||
Changes in operating assets and liabilities: | ||||||||
Accounts receivable | (592 | ) | (396 | ) | ||||
Inventories | (81 | ) | (410 | ) | ||||
Prepaid expenses and other current assets | (630 | ) | 538 | |||||
Accounts payable | (486 | ) | 55 | |||||
Accrued expenses and other current liabilities | 206 | (126 | ) | |||||
Deferred revenue | (90 | ) | 58 | |||||
Net cash used in operating activities | (4,634 | ) | (2,377 | ) | ||||
Cash flows from investing activities: | ||||||||
Purchases of property and equipment | (157 | ) | (14 | ) | ||||
Deposits | (14 | ) | 3 | |||||
Net cash used in investing activities | (171 | ) | (11 | ) | ||||
Cash flows from financing activities: | ||||||||
Proceeds from exercise of common stock purchase warrants | 45 | – | ||||||
Principal payments on capital leases | (31 | ) | – | |||||
Principal payments on long-term debt | (40 | ) | (48 | ) | ||||
Net cash used in financing activities | (26 | ) | (48 | ) | ||||
Effect of exchange rate on cash and cash equivalents | 8 | (63 | ) | |||||
Net decrease in cash and cash equivalents | (4,823 | ) | (2,499 | ) | ||||
Cash and cash equivalents, beginning of period | 17,461 | 7,469 | ||||||
Cash and cash equivalents, end of period | $ | 12,638 | $ | 4,970 | ||||
Supplemental disclosure of cash flow information: | ||||||||
Cash paid for interest | $ | 10 | $ | 1 | ||||
Non-cash operating and financing activities: | ||||||||
Automobiles financed using capital leases | $ | 180 | $ | – |
The accompanying footnotes are an integral part of these condensed consolidated financial statements.
OCULUS INNOVATIVE SCIENCES, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Cash Flows
(In thousands)
(Unaudited)
Three Months Ended June 30, | ||||||||
2016 | 2015 | |||||||
(In thousands) | ||||||||
Cash flows from operating activities | ||||||||
Net loss | $ | (2,568 | ) | $ | (2,340 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Depreciation and amortization | 61 | 62 | ||||||
Stock-based compensation | 411 | 412 | ||||||
Service provider expenses settled with common stock | – | 107 | ||||||
Loss due to change in fair value of derivative liabilities | – | 59 | ||||||
Foreign currency transaction gain | (12 | ) | (9 | ) | ||||
Changes in operating assets and liabilities: | ||||||||
Accounts receivable, net | (384 | ) | (1,052 | ) | ||||
Inventories, net | (410 | ) | (82 | ) | ||||
Prepaid expenses and other current assets | 538 | 84 | ||||||
Accounts payable | 55 | 284 | ||||||
Accrued expenses and other current liabilities | (126 | ) | 265 | |||||
Deferred revenue | 58 | (375 | ) | |||||
Net cash used in operating activities | (2,377 | ) | (2,585 | ) | ||||
Cash flows from investing activities: | ||||||||
Purchases of property and equipment | (14 | ) | (148 | ) | ||||
Proceeds from sale of long-term investment | – | 4,538 | ||||||
Long-term deposits | 3 | (12 | ) | |||||
Net cash (used in) provided by investing activities | (11 | ) | 4,378 | |||||
Cash flows from financing activities: | ||||||||
Proceeds from issuance of common stock, net of offering costs | – | 879 | ||||||
Principal payments on long-term debt | (48 | ) | (52 | ) | ||||
Net cash (used in) provided by financing activities | (48 | ) | 827 | |||||
Effect of exchange rate on cash and cash equivalents | (63 | ) | (4 | ) | ||||
Net (decrease) increase in cash and cash equivalents | (2,499 | ) | 2,616 | |||||
Cash and cash equivalents, beginning of period | 7,469 | 6,136 | ||||||
Cash and cash equivalents, end of period | $ | 4,970 | $ | 8,752 | ||||
Supplemental disclosure of cash flow information: | ||||||||
Cash paid for interest | $ | 1 | $ | – | ||||
Non-cash operating and financing activities: | ||||||||
Issuance of common stock to settle obligation | $ | – | $ | 96 |
The accompanying footnotes are an integral part of these condensed consolidated financial statements.
5 |
OCULUS INNOVATIVE SCIENCES,
SONOMA PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Note 1. | Organization and Recent Developments |
Organization
Sonoma Pharmaceuticals, Inc., formerly known as Oculus Innovative Sciences, Inc., (the “Company”) was incorporated under the laws of the State of California in April 1999 and was reincorporated under the laws of the State of Delaware in December 2006. The Company’s principal office is located in Petaluma, California. The Company is a specialty pharmaceutical company that develops and markets solutions for the treatment of dermatological conditions and advanced tissue care. The Company’s products, which are sold throughout the United States and 39 countries around the world, have improved patient outcomes for more than five million patients globally by reducing infections, itch, pain, scarring, odor and harmful inflammatory responses.
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements as of June 30, 20162017 and for the three months then ended have been prepared in accordance with the accounting principles generally accepted in the United States of America for interim financial information and pursuant to the instructions to Form 10-Q and Article 8 of Regulation S-X of the Securities and Exchange Commission (“SEC”) and on the same basis as the Company prepares its annual audited consolidated financial statements. The condensed consolidated balance sheet as of June 30, 20162017 and the condensed consolidated statements of comprehensive loss and cash flows for the three months ended June 30, 20162017 and 20152016 are unaudited, but include all adjustments, consisting only of normal recurring adjustments, which the Company considers necessary for a fair presentation of the consolidated financial position, operating results and cash flows for the periods presented. The results for the three months ended June 30, 20162017 are not necessarily indicative of results to be expected for the year ending March 31, 20172018 or for any future interim period. The condensed consolidated balance sheet at March 31, 20162017 has been derived from audited consolidated financial statements. These unaudited condensed consolidated financial statements of the Company have been prepared in accordance with U.S. Generally Accepted Accounting Principles (“GAAP”) for interim financial information. Accordingly, they do not include all of the information and notes required by GAAP for complete financial statements. The accompanying condensed consolidated financial statements should be read in conjunction with the consolidated financial statements for the year ended March 31, 2016,2017, and notes thereto included in the Company’s annual report on Form 10-K, which was filed with the SEC on June 21, 2016.
Reverse Stock Split
Effective as of the open of business on June 24, 2016, the Company effected a reverse stock split of its common stock, par value $0.0001 per share. Every 5 shares of common stock were reclassified and combined into one share of common stock. No fractional shares were issued as a result of the reverse stock split. Instead, stockholders entitled to receive fractional shares received cash in the amount equal to the closing price per share of the Company’s common stock as reported on the NASDAQ Capital Market as of 5:00 p.m. Eastern Time on June 24, 2016, multiplied by the fraction of one share owned by the stockholder. The reverse stock split reduced the number of shares of the Company’s common stock outstanding from 21,004,857 to 4,200,756. The total number of authorized shares of common stock was also proportionally decreased by a ratio of 1:5 and the par value per share of the common stock continued to be $0.0001.
All common shares and per share amounts contained in the condensed consolidated financial statements have been retroactively adjusted to reflect a 1 for 5 reverse stock split.28, 2017.
Note 2. | Liquidityand Financial Condition |
The Company reported a net loss of $2,568,000$3,508,000 for the three months ended June 30, 2016.2017. At June 30, 20162017 and March 31, 2016,2017, the Company’s accumulated deficit amounted to $154,943,000$146,620,000 and $152,375,000,$143,101,000, respectively. The Company had working capital of $6,965,000$16,330,000 and $9,337,000$19,355,000 as of June 30, 20162017 and March 31, 2016,2017, respectively. The Company expects to continue incurring losses for the foreseeable future and may need to raise additional capital to pursue its product development initiatives, penetrate markets for the sale of its products and continue as a going concern.products.
Management believesThe Company currently anticipates that the Company has access to additional capital resources through possible public or private equity offerings, debt financings, corporate collaborations or other means; however, the Company cannot provide any assurance that other new financingsits cash and cash equivalents will be available on commercially acceptable terms, if needed. If the economic climate in the U.S. deteriorates, the Company’s abilitysufficient to raise additionalmeet its working capital could be negatively impacted. If the Company is unablerequirements to secure additional capital, it may be required to curtailcontinue its sales and marketing and research and development initiatives and take additional measures to reduce costs in order to conserve its cash in amounts sufficient to sustain operations and meet its obligations. These measures could cause significant delays inefforts for at least 12 months from the Company’s efforts to commercialize its products, which is critical to the realizationdate of its business plan and the future operations of the Company. These matters raise substantial doubt about the Company’s ability to continue as a going concern. The accompanying condensed consolidated financial statements do not include any adjustments that may be necessary should the Company be unable to continue as a going concern.filing this report.
Note 3. | Summary of Significant Accounting Policies |
Use of Estimates
The preparation of condensed consolidated financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent liabilities at the dates of the condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting periods. Actual results could differ from these estimates. Significant estimates and assumptions include reserves and write-downs related to receivables and inventories, the recoverability of long-lived assets, the valuation allowance relating to the Company’s deferred tax assets, valuation of equity and derivative instruments, debt discounts, valuation of investments, determination of the relative selling prices of the components sold to Invekra, and the estimated amortization periods of upfront product licensing fees received from customers. Periodically, the Company evaluates and adjusts estimates accordingly. The allowance for doubtful accounts represents probable credit losses of $15,000$10,000 and $14,000 at June 30, 20162017 and March 31, 2016.2017, respectively. Additionally, at June 30, 20162017 and March 31, 20162017 the Company has allowances of $715,000$776,000 and $653,000,$672,000, respectively, related to potential discounts, returns, distributor fees and rebates. The allowances are included in Accounts Receivable, net in the accompanying condensed consolidated balance sheets.
6 |
Net Loss per Share
The Company computes basic net loss per share by dividing net loss per share available to common stockholders by the weighted average number of common shares outstanding for the period and excludes the effects of any potentially dilutive securities. Diluted earnings per share, if presented, would include the dilution that would occur upon the exercise or conversion of all potentially dilutive securities into common stock using the “treasury stock” and/or “if converted” methods as applicable. The following were excluded from the computation of diluted shares outstanding due to the losses for the three months ended June 30, 20162017 and 2015,2016, as they would have had an anti-dilutive impact on the Company’s net loss (all amounts are rounded to the nearest thousand).
June 30, | June 30, | |||||||||||||||
2016 | 2015 | 2017 | 2016 | |||||||||||||
Restricted stock units | 45,000 | – | ||||||||||||||
Options to purchase common stock | 754,000 | 596,000 | 1,353,000 | 754,000 | ||||||||||||
Warrants to purchase common stock | 1,468,000 | 1,548,000 | 1,333,000 | 1,468,000 | ||||||||||||
2,222,000 | 2,144,000 | 2,731,000 | 2,222,000 |
Common Stock Purchase Warrants and Other Derivative Financial Instruments
The Company classifies common stock purchase warrants and other free standing derivative financial instruments as equity if the contracts (i) require physical settlement or net-share settlement or (ii) give the Company a choice of net-cash settlement or settlement in its own shares (physical settlement or net-share settlement). The Company classifies any contracts that (i) require net-cash settlement (including a requirement to net cash settle the contract if an event occurs and if that event is outside the control of the Company), (ii) give the counterparty a choice of net cash settlement or settlement in shares (physical settlement or net-share settlement), or (iii) contain reset provisions as either an asset or a liability. The Company assesses classification of its freestanding derivatives at each reporting date to determine whether a change in classification between assets and liabilities is required. The Company determined that its freestanding derivatives, which principally consist of warrants to purchase common stock, satisfied the criteria for classification as equity instruments, other than certain warrants that contained reset provisions and certain warrants that required net-cash settlement that the Company classified as derivative liabilities.
Revenue Recognition and Accounts Receivable
The Company generates revenue from sales of its products to a customer base including hospitals, medical centers, doctors, pharmacies, distributors and wholesalers. The Company sells products directly to end users and to distributors. The Company also entered into agreements to license its technology and products.
The Company also provides regulatory compliance testing and quality assurance services to medical device and pharmaceutical companies.
The Company records revenue when (i) persuasive evidence of an arrangement exists, (ii) delivery has occurred, (iii) the fee is fixed or determinable, and (iv) collectability of the sale is reasonably assured.
The Company requires all product sales to be supported by evidence of a sale transaction that clearly indicates the selling price to the customer, shipping terms and payment terms. Evidence of an arrangement generally consists of a contract or purchase order approved by the customer. The Company has ongoing relationships with certain customers from which it customarily accepts orders by telephone in lieu of purchase orders.
The Company recognizes revenue at the time it receives confirmation that the goods were either tendered at their destination, when shipped “FOB destination,” or transferred to a shipping agent, when shipped “FOB shipping point.” Delivery to the customer is deemed to have occurred when the customer takes title to the product. Generally, title passes to the customer upon shipment, but could occur when the customer receives the product based on the terms of the agreement with the customer.
The selling prices of all goods are fixed, and agreed to with the customer, prior to shipment. Selling prices are generally based on established list prices. The right to return product is customarily based on the terms of the agreement with the customer. The Company estimates and accrues for potential returns and records this as a reduction of revenue in the same period the related revenue is recognized. Additionally, distribution fees are paid to certain wholesale distributors based on contractually determined rates. The Company estimates and accrues the fee on shipment to the respective wholesale distributors and recognizes the fee as a reduction of revenue in the same period the related revenue is recognized. The Company also offers cash discounts to certain customers, generally 2% of the sales price, as an incentive for prompt payment. The Company accounts for cash discounts by reducing accounts receivable by the prompt pay discount amount and recognizes the discount as a reduction of revenue in the same period the related revenue is recognized. Additionally, the Company participates in certain rebate programs which provide discounted prescriptions to qualified patients. The Company contracts with a third-party to administer the program. The Company estimates and accrues for future rebates based on historical data for rebate redemption rates and the historical value of redemptions. Rebates are recognized as a reduction of revenue in the same period the related revenue is recognized.
The Company evaluates the creditworthiness of new customers and monitors the creditworthiness of its existing customers to determine whether an event or changes in their financial circumstances would raise doubt as to the collectability of a sale at the time in which a sale is made. Payment terms on sales made in the United States are generally 30 days and are extended up to 90 days for initial product launches, payment terms internationally generally range from prepaid prior to shipment to 90 days.
In the event a sale is made to a customer under circumstances in which collectability is not reasonably assured, the Company either requires the customer to remit payment prior to shipment or defers recognition of the revenue until payment is received. The Company maintains a reserve for amounts which may not be collectible due to risk of credit losses.
7 |
In the event a sale is made to a customer under circumstances in which returns cannot be estimated, the Company defers recognition of the revenue until sell-through is confirmed.
Product license revenue is generated through agreements with strategic partners for the commercialization of Microcyn® products. The terms of the agreements sometimes include non-refundable upfront fees. The Company analyzes multiple element arrangements to determine whether the elements can be separated. Analysis is performed at the inception of the arrangement and as each product is delivered. If a product or service is not separable, the combined deliverables are accounted for as a single unit of accounting and recognized over the performance obligation period.
When appropriate, the Company defers recognition of non-refundable upfront fees. If the Company has continuing performance obligations then such up-front fees are deferred and recognized over the period of continuing involvement.
The Company recognizes royalty revenues from licensed products upon the sale of the related products.
Revenue from consulting contracts is recognized as services are provided. Revenue from testing contracts is recognized as tests are completed and a final report is sent to the customer.
The Company recognizes royalty revenues from licensed products upon the sale of the related products.
Revenue from consulting contracts is recognized as services are provided. Revenue from testing contracts is recognized as tests are completed and a final report is sent to the customer.
Inventories
Inventories are stated at the lower of cost, cost being determined on a standard cost basis (which approximates actual cost on a first-in, first-out basis), or market.
Due to changing market conditions, estimated future requirements, age of the inventories on hand and production of new products, the Company regularly reviews inventory quantities on hand and records a provision to write down excess and obsolete inventory to its estimated net realizable value. The Company recorded reserves to reduce the carrying amounts of inventories to their net realizable value in the amounts of $167,000$117,000 and $164,000$61,000 at June 30, 20162017 and March 31, 2016.2017, respectively.
Income TaxesReclassifications
The Company is requiredCertain prior period amounts have been reclassified for comparative purposes to determine the aggregate amount of income tax expense or loss based upon tax statutes in jurisdictions in which it conducts business. In making these estimates, the Company adjusts its results determined in accordance with generally accepted accounting principles for items that are treated differently by the applicable taxing authorities. Deferred tax assets and liabilities resulting from these differences are reflected on its balance sheet for temporary differences in loss and credit carryforwards that will reverse in subsequent years. The Company also establishes a valuation allowance against deferred tax assets when it is more likely than not that some or all of the deferred tax assets will not be realized. Valuation allowances are based, in part, on predictions that management must make asconform to the results in future periods. The outcome of events could differ over time which would require thatfiscal 2018 presentation. These reclassifications have no impact on the Company makes changes in its valuation allowance.
Company’s previously reported condensed consolidated net loss.
Financial Assets and Liabilities
Financial instruments, including cash and cash equivalents, accounts receivable, accounts payable and accrued expenses and other liabilities are carried at cost, which management believes approximates fair value due to the short-term nature of these instruments. The fair value of capital lease obligations and equipment loans approximates their carrying amounts as a market rate of interest is attached to their repayment. The Company measures the fair value of financial assets and liabilities based on the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. The Company maximizes the use of observable inputs and minimizes the use of unobservable inputs when measuring fair value. The Company uses three levels of inputs that may be used to measure fair value:
Level 1 – quoted prices in active markets for identical assets or liabilities
Level 2 – quoted prices for similar assets and liabilities in active markets; quoted prices for identical or similar instruments in markets that are not active; and model-derived valuations in which all significant inputs and significant value drivers are observable in active markets.
Level 3 – inputs that are unobservable (for example cash flow modeling inputs based on assumptions)
Level 3 liabilities are valued using unobservable inputs to the valuation methodology that are significant to the measurement of the fair value of the liabilities. For fair value measurements categorized within Level 3 of the fair value hierarchy, the Company’s accounting and finance department, who report to the Chief Financial Officer, determine its valuation policies and procedures. The development and determination of the unobservable inputs for Level 3 fair value measurements and fair value calculations are the responsibility of the Company’s accounting and finance department and are approved by the Chief Financial Officer.
Level 3 Valuation Techniques:
Level 3 financial liabilities consist of the derivative liabilities for which there is no current market for these securities such that the determination of fair value requires significant judgment or estimation. Changes in fair value measurements categorized within Level 3 of the fair value hierarchy are analyzed each period based on changes in estimates or assumptions and recorded as appropriate.
As of June 30, 2016 and March 31, 2016, there were no transfers in or out of Level 3 from other levels in the fair value hierarchy.
Subsequent Events
Management has evaluated subsequent events or transactions occurring through the date the condensed consolidated financial statements were issued (Note 11)12).
Adoption of Recent Accounting Standards
In March 2016 the FASB issued ASU No. 2016-09, Compensation-Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting. This update simplifies the accounting for employee share-based payment transactions, including the accounting for income taxes, forfeitures, and statutory tax withholding requirements, as well as classification in the statement of cash flows.
On April 1, 2017, the Company adopted ASU No. 2016-09. As a result of adopting ASU No. 2016-09, the Company has made an accounting policy election to account for forfeitures as they occur. This change has been applied on a modified retrospective basis, with no material impacts on the Company’s financial statements. The adoption of ASU No. 2016-09 also requires excess tax benefits and tax deficiencies be recorded in the income statement as opposed to additional paid-in capital when the awards vest or are settled and recognize all previously unrecognized excess tax benefits and tax deficiencies upon adoption as a cumulative-effect adjustment to retained earnings. As of April 1, 2017, the Company recognized excess tax benefit of approximately $533,000 as an increase to deferred tax assets. However, the entire amount was offset by a full valuation allowance. Accordingly, no cumulative-effect adjustment to retained earnings was recorded as of June 30, 2017.
8 |
Additionally, the adoption of ASU No. 2016-09 related to the accounting for minimum statutory withholding tax requirements and cash paid by an employer when directly withholding shares for tax-withholding purposes had no impact on the Company's current consolidated financial statements or on any prior period financial statements presented.
Recent Accounting PronouncementsStandards
In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2014-09,Revenue from Contracts with Customers, which supersedes the revenue recognition requirements in Topic 605,Revenue Recognition and requires entities to recognize revenue in a way that depicts the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. In August 2015, the FASB issued ASU 2015-14, which defers by one year the effective date of ASU 2014-09. Accordingly, this guidance is effective for interim and annual periods beginning after December 15, 2017 with early adoption permitted for interim and annual periods beginning after December 15, 2016. In March 2016, the FASB issued ASU 2016-08Principal versus Agent Considerations (Reporting Revenue Gross versus Net) , which finalizes its amendments to the guidance in the new revenue standard on assessing whether an entity is a principal or an agent in a revenue transaction. This conclusion impacts whether an entity reports revenue on a gross or net basis. In April 2016, the FASB issued ASU 2016-10Identifying Performance Obligations and Licensing, which finalizes its amendments to the guidance in the new revenue standard regarding the identification of performance obligations and accounting for the license of intellectual property. In May 2016, the FASB issued ASU 2016-12Narrow-Scope Improvements and Practical Expedients, which finalizes its amendments to the guidance in the new revenue standard on collectability, noncash consideration, presentation of sales tax, and transition. In December 2016, the FASB issued ASU 2016-20,Technical Corrections and Improvements to Topic 606, Revenue from Contracts with Customers, which continues the FASB’s ongoing project to issue technical corrections and improvements to clarify the codification or correct unintended applications of guidance. The amendments are intended to make the guidance more operable and lead to more consistent application. The amendments have the same effective date and transition requirements as the new revenue recognition standard. The Company will adopt the new standard on April 1, 2018 and currently plans to use the modified retrospective method. The majority of the Company’s business is ship and bill and, on that primary revenue stream, the Company does not expect significant differences. However, the Company’s analysis is preliminary and subject to change. The Company has not completed its assessment of multiple element arrangements and certain discount and trade promotion programs.
Accounting standards that have been issued or proposed by the Financial Accounting Standards Board, (“FASB”), SEC and/or other standards-setting bodies that do not require adoption until a future date are not expected to have a material impact on the condensed consolidated financial statements upon adoption.
Note 4. | Disposition of Latin American Operations |
Description of Sale to Invekra
On October 27, 2016, the Company, along with its Mexican subsidiary and manufacturer Oculus Technologies of Mexico, S.A. de C.V. (“OTM”), closed on an asset purchase agreement with Invekra, S.A.P.I de C.V. (“Invekra”), an affiliate of Laboratorios Sanfer S.A. de C.V., for the sale of certain of its Latin America assets. Specifically, the Company agreed to sell certain patents, patent applications, trademarks and territory rights for Mexico, the Caribbean and South America, excluding the sale of dermatology products in Brazil, as well as to build and deliver equipment that Invekra will use to produce its own product.
The aggregate purchase price that Invekra will pay for the assets is $22,000,000, of which $18,000,000 was paid upon closing, $1,500,000 was paid on March 16, 2017 upon the delivery of certain equipment, and $2,500,000 is to be paid in Mexican currency in quarterly installments over a period of ten years from closing as consideration for the provision of certain services and providing technical assistance, calculated as three percent on net sales of certain products in Latin America, excluding Mexico. Because the $2,500,000 is to be paid in foreign currency, the Company may receive more or less than $2,500,000 due to currency fluctuations. During the three months ended June 30, 2017, the Company recorded $39,000 of service revenue and $33,000 of interest income related to technical assistance.
In connection with the asset purchase agreement, the Company agreed to provide the technology, know-how and assistance to Invekra to enable Invekra to manufacture on its own the products as currently produced by the Company (“Technical Services Arrangement”), and continue to supply product to Invekra for a two year transition period from the Sale Date, subject to mutual extension (“Supply Agreement”). During the three months ended June 30, 2017, the Company reported $569,000 of Latin America product revenue related to the Supply Agreement with Invekra.
9 |
The Company will provide product under the Supply Agreement at a reduced price from its current price list, while Invekra builds its own manufacturing line. At the conclusion of the transition period, the Company will cease to be a supplier of product to Invekra. The Company is uncertain as to the duration of the transition period or when Invekra will complete the build out of its manufacturing line. Pursuant to the Supply Agreement, the Company is subject to a potential penalty for failure to supply the products for a consecutive period of six months. The penalty, if triggered, will require the Company to make a one-time payment of $2,000,000 to Invekra. The penalty decreases by 12.5% each quarter of the term of the supply period. The Company does not expect to incur this penalty.
Discontinued operations
The Company determined that the sale of its Latin American operations to Invekra qualified as a sale of a component of its business and, as such, all such activity prior to consummation of the sale is required to be included in discontinued operations on the Company’s statement of operations. This includes the direct labor and materials for the product delivered to Invekra, the revenue on the sales to Invekra and the gain on the sale to Invekra, net of tax.
The operations of its Latin American business included in discontinued operations is summarized as follows:
Three Months Ended June 30, | ||||||||
2017 | 2016 | |||||||
Revenues | $ | – | $ | 1,173,000 | ||||
Cost of revenues | – | 235,000 | ||||||
Income from discontinued operations before tax | – | 938,000 | ||||||
Income tax expense | – | (319,000 | ) | |||||
Income from discontinued operations, net of tax | $ | – | $ | 619,000 |
Note | Condensed Consolidated Balance Sheets |
Inventories, net
Inventories, net consist of the following:
June 30, | March 31, | June 30, | March 31, | |||||||||||||
2016 | 2016 | 2017 | 2017 | |||||||||||||
Raw materials | $ | 1,218,000 | $ | 1,104,000 | $ | 1,459,000 | $ | 1,480,000 | ||||||||
Finished goods | 774,000 | 536,000 | 921,000 | 741,000 | ||||||||||||
$ | 1,992,000 | $ | 1,640,000 | $ | 2,380,000 | $ | 2,221,000 |
Note | Commitments and Contingencies |
Legal Matters
The Company, on occasion, may be involved in legal matters arising in the ordinary course of its business including matters involving proprietary technology. While management believes that such matters are currently insignificant, matters arising in the ordinary course of business for which the Company is or could become involved in litigation may have a material adverse effect on its business and financial condition or results of operations.comprehensive income (loss).
Employment Agreements
As of June 30, 20162017, the Company had employment agreements in place with foursix of its key executives. The agreements provide, among other things, for the payment of ninetwelve to twenty-foureighteen months of severance compensation for terminations under certain circumstances. With respect to these agreements, at June 30, 2016, the2017, aggregated annual salaries would be $1,167,000 and potential severance payments to these key executives would be $1,194,000 and aggregated annual salaries would be $944,000$1,417,000 if triggered.
10 |
Note | Stockholders’ Equity |
Authorized Capital
The Company is authorized to issue up to 12,000,000 shares of common stock with a par value of $0.0001 per share and 714,286 shares of convertible preferred stock with a par value of $0.0001 per share.
Note | Stock-Based Compensation |
Performance Based Awards Program
On April 1, 2017, the Company adopted ASU 2016-09 and, as a result, made a company-wide accounting policy change with respect to accounting for forfeitures. The Company’s Compensation Committee approvedCompany applied a short-term performance based bonus programmodified retrospective approach for fiscal 2016 with predetermined objectives related to revenue and expense targets. In the event the fiscal 2016 objectives were met, eighty-percentadoption of the options would have vested on June 30, 2016. On August 21, 2015, certain executivesnew policy and senior managers were granted an aggregate of 75,500 stock options in connectionaccordingly recorded a $11,000 increase to opening accumulated deficit at April 1, 2017. In accordance with this program. The stock options have an exercise price of $5.80 and expire ten years from the date of grant. At March 31, 2016, it was determined targets were met related to 50,400 stock options which vested on June 30, 2016. At March 31, 2016, 10,000 stock options expired due to targets that were not met. The vestingadoption of the remaining 15,100 stock options was at the discretion of the Company’s Compensation Committee to be determined during the three months ended June 30, 2016. The Company’s Compensation Committee determined 14,772 of the 15,100 discretionary stock options would vest at June 30, 2016.
The Company also approved a long-term market-based stock option bonus program for senior managers. Vesting of the stock options granted as part of this program is contingent upon the achievement of four separate target stock prices. The market-based options vest based on the 30 trading day trailing average of the stock price of the Company’s common stock with options vesting in 25% increments at each of the target stock prices. On the last day of each quarter, the chief executive officer and/or chief financial officer will determine if any of the target stock prices have been met by evaluating the period between the quarter end date and the grant date of the option. In the event that a target stock price has been met, the senior manager will be notified that such options have vested. At the end of five years from the date of the grant, if the stock target prices have not been met, then the unvested portion of the option will expire. On August 21, 2015, certain senior managers were granted an aggregate of 23,750 stock options in connection with this program. The stock options have an exercise price of $5.80 and if they vest will expire ten years from the date of grant. None of these options vested as of June 30, 2016.
Stock-Based Compensation
The Company issues service, performance and market-based stock options to employees and non-employees. The Company estimates the fair value of service and performance stock option awards using the Black-Scholes option pricing model. The Company estimates the fair value of market-based stock option awards using a Monte-Carlo simulation. Compensation expense for stock option awards is amortized on a straight-line basis over the awards’ vesting period. Compensation expense includes the impact of an estimate for forfeitures for all stock options.
The expected term of the stock options represents the average period the stock options are expected to remain outstanding and is based on the expected term calculated using the approach prescribed by the Securities and Exchange Commission's Staff Accounting Bulletin No. 110 for “plain vanilla” options. The expected stock price volatility for the Company’s stock options was determined by using an average of the historical volatilities ofaccounting policy, the Company and its industry peers. The Company will continue to analyze the stock price volatility and expected term assumptions as more data for the Company’s common stock and exercise patterns become available. The risk-free interest rate assumption is based on the U.S. Treasury instruments whose term was consistent with the expected term of the Company’s stock options. The expected dividend assumption is based on the Company’s history and expectation of dividend payouts. The Companyno longer estimates forfeitures based on historical experience and no longer reduces compensation expense accordingly. The estimated forfeiture rates used duringbased on the three months ended June 30, 2016 ranged from 4.65% to 4.71%. The estimated forfeiture rates used duringexpected forfeitures. Beginning April 1, 2017, the three months ended June 30, 2015 ranged from 0.85% to 1.81%.Company will record forfeitures as they occur and will reduce compensation cost at the time of forfeiture.
The Company estimatedweighted average grant date fair values of options granted during the fair valueperiod of employeeJune 30, 2017 and non-employee stock options using the Black-Scholes option pricing model. The fair value of employee stock options is being amortized on a straight-line basis over the requisite service periods of the respective awards. The fair value of employee stock options2016 was estimated using the following weighted-average assumptions:$6.06 and $3.71, respectively.
Three Months Ended June 30, | ||||||||
2016 | 2015 | |||||||
Expected Term | 7.45 yrs | 8.96 yrs | ||||||
Risk-free interest rate | 1.40% | 2.18% | ||||||
Dividend yield | 0.00% | 0.00% | ||||||
Volatility | 92.4% | 86.0% | ||||||
Fair value of options granted | $ | 3.46 | $ | 5.50 |
Share-based awards compensation expense is as follows:
Three Months Ended June 30, | Three Months Ended June 30, | |||||||||||||||
2016 | 2015 | 2017 | 2016 | |||||||||||||
Cost of revenues | $ | 68,000 | $ | 55,000 | $ | 44,000 | $ | 68,000 | ||||||||
Research and development | 64,000 | 73,000 | 45,000 | 64,000 | ||||||||||||
Selling, general and administrative | 279,000 | 284,000 | 349,000 | 279,000 | ||||||||||||
Total stock-based compensation | $ | 411,000 | $ | 412,000 | $ | 438,000 | $ | 411,000 |
At June 30, 2016,2017, there were unrecognized compensation costs of $1,377,000$3,150,000 related to stock options which areis expected to be recognized over a weighted-average amortization period of 1.302.62 years.
No income tax benefit has been recognized relating to stock-based compensation expense and no tax benefits have been realized from exercised stock options.
Stock-Based Award Activity
Stock-based awards outstanding at June 30,On April 1, 2017, pursuant to “evergreen” provisions in the 2011 Plan and the 2016 underPlan, the various plans arenumber of shares authorized for issuance in the 2011 Plan increased by 643,383 shares and the number of shares authorized for issuance in the 2016 Plan increased by 343,137 shares.
Stock options award activity is as follows:
Number of Shares | Weighted- Average Exercise Price | Weighted- Average Contractual Term | Aggregate Intrinsic Value | |||||||||||||
Outstanding at April 1, 2017 | 899,000 | $ | 17.87 | |||||||||||||
Options granted | 483,000 | 6.93 | ||||||||||||||
Options forfeited | (22,000 | ) | 6.68 | |||||||||||||
Options expired | (7,000 | ) | 234.45 | |||||||||||||
Outstanding at June 30, 2017 | 1,353,000 | $ | 12.99 | 8.12 | $ | 525,000 | ||||||||||
Exercisable at June 30, 2017 | 723,000 | $ | 18.57 | 6.91 | $ | 336,000 |
11 |
Stock options award activity is as follows:
Number of Shares | Weighted- Average Exercise Price | Weighted- Average Contractual Term | Aggregate Intrinsic Value | |||||||||||||
Outstanding at April 1, 2016 | 753,000 | $ | 21.47 | |||||||||||||
Options granted | 16,000 | 4.65 | ||||||||||||||
Options exercised | – | – | ||||||||||||||
Options forfeited | (1,000 | ) | 19.14 | |||||||||||||
Options expired | (14,000 | ) | 17.81 | |||||||||||||
Outstanding at June 30, 2016 | 754,000 | $ | 21.18 | 7.69 | $ | – | ||||||||||
Exercisable at June 30, 2016 | 504,000 | $ | 26.81 | 7.15 | $ | – |
The aggregate intrinsic value of stock options is calculated as the difference between the exercise price of the underlying stock options and the fair value of the Company’s common stock, or $4.01$6.62 per share at June 30, 2016.2017.
Restricted stock award activity is as follows:
| Number of Shares | Weighted Average Award Date Fair Value per Share | ||||||
Unvested restricted stock awards outstanding at April 1, 2016 | – | $ | – | |||||
Restricted stock awards granted | 4,000 | 4.85 | ||||||
Restricted stock awards vested | (4,000 | ) | 4.85 | |||||
Restricted stock awards forfeited | – | – | ||||||
Unvested restricted stock awards outstanding at June 30, 2016 | – | $ | – |
Number of Shares | Weighted Average Award Date Fair Value per Share | |||||||
Unvested restricted stock awards outstanding at April 1, 2017 | 34,000 | $ | 7.27 | |||||
Restricted stock awards granted | 20,000 | 6.89 | ||||||
Restricted stock awards vested | (9,000 | ) | 6.83 | |||||
Unvested restricted stock awards outstanding at June 30, 2017 | 45,000 | $ | 7.19 |
Restricted stock awards were issued to non-employee directors for services in the year endedAt June 30, 2016.
No income tax benefit has been2017, there were unrecognized compensation costs of $241,000 related to restricted stock which is expected to be recognized relating to stock-based compensation expense and no tax benefits have been realized from exercised stock options.over a weighted-average amortization period of 1.67 years.
The Company did not capitalize any cost associated with stock-based compensation.
The Company issues new shares of common stock upon exercise of stock options or release of restricted stock awards.
The Company issues new shares of common stock upon exercise of stock based awards.
Note | Income Taxes |
The Company has completed a study to assess whether a change in control has occurred or whether there have been multiple changes of control since the Company’s formation. The Company determined, based on the results of the study, no change in control occurred for purposes of Internal Revenue Code section 382. The Company, after considering all available evidence, fully reserved its deferred tax assets since it is more likely than not, such benefits, will not be realized in future periods. The Company incurred losses for both financial reporting and income tax purposes for the year ended March 31, 2016.2017. Accordingly, the Company is continuing to fully reserve for its deferred tax assets. The Company will continue to evaluate its deferred tax assets to determine whether any changes in circumstances could affect the realization of their future benefit. If it is determined in future periods that portions of the Company’s deferred income tax assets satisfy the realization standards, the valuation allowance will be reduced accordingly.
As a result of certain realization requirements of Accounting Standards Codification Topic 718, the Company’s deferred tax assets and liabilities do not include certain deferred tax assets at June 30, 20162017 that arose directly from tax deductions related to equity compensation in excess of compensation recognized for financial reporting purposes. Equity will be increased by approximately $533,000 if and when such deferred tax assets are ultimately realized.
Note | Segment and Geographic Information |
The Company generates product revenues from wound care products thatwhich are sold into the human and animal healthcare markets, and the Company generates service revenues from laboratory testing services which are provided to medical device manufacturers.
The Additionally, the Company operates a single segment business for product revenues, which consists of three geographical sales territories as follows:provides technical services to Invekra.
Three Months Ended June 30, | ||||||||
2016 | 2015 | |||||||
United States | $ | 1,373,000 | $ | 787,000 | ||||
Latin America | 1,098,000 | 1,558,000 | ||||||
Europe and Rest of the World | 1,038,000 | 571,000 | ||||||
3,509,000 | 2,916,000 | |||||||
Product license fees and royalties | 75,000 | 447,000 | ||||||
Total | $ | 3,584,000 | $ | 3,363,000 |
The following table shows the Company’s product license fees and royalties revenues by partner:geographic region:
Three Months Ended June 30, | ||||||||
Product license fees and royalties | 2016 | 2015 | ||||||
Exeltis | $ | – | $ | 54,000 | ||||
Innovacyn | – | 20,000 | ||||||
Laboratorios Sanfer, S.A. de C.V. | 75,000 | 373,000 | ||||||
Total product license fees and royalties | $ | 75,000 | $ | 447,000 |
Three Months Ended June 30, | ||||||||||||||||
2017 | 2016 | $ Change | % Change | |||||||||||||
United States | $ | 1,859,000 | $ | 1,373,000 | $ | 486,000 | 35% | |||||||||
Latin America | 569,000 | – | 569,000 | 100% | ||||||||||||
Europe and Rest of the World | 1,175,000 | 1,038,000 | 137,000 | 13% | ||||||||||||
Total | $ | 3,603,000 | $ | 2,411,000 | $ | 1,192,000 | 49% |
12 |
In connection with the Company’s sale of its Latin American business to Invekra, product revenues were reclassified from continuing operations to discontinued operations as follows:
Three Months Ended June 30, | ||||||||
2017 | 2016 | |||||||
Product revenues | $ | – | $ | 1,098,000 | ||||
Product license fees and royalties | – | 75,000 | ||||||
Total product related revenues | $ | – | $ | 1,173,000 |
The Company’s service revenues amounted to $227,000$232,000 and $317,000$227,000 for the three months ended June 30, 2017 and 2016, and 2015, respectively. During the three months ended June 30, 2017, the Company recorded service revenue related to technical services provided to Invekra in the amount of amount of $39,000.
Note | Significant Customer Concentrations |
For the three months ended June 30, 2016,2017, one customer represented 29%18% of net revenue, one customer represented 16% of net revenue, one customer represented 12% of net revenue and one customer represented 11% of net revenue. For the three months ended June 30, 2015,2016, one customer represented 53%29% of net revenue.
At June 30, 2016,2017, one customer represented 41%, and three customers eachone customer represented 11%16% of the net accounts receivable balance. At March 31, 2016,2017, one customer represented 33%26%, one customer represented 12%, and one customer represented 10% of the net accounts receivable balance.
Note | Subsequent Events |
On July 26, 2016,In August 2017, the Company entered into a new employmentservices agreement with Jim Schutz, its President and Chief Executive Officerpursuant to update his agreements and responsibilities.which the Company agreed to issue shares of common stock valued at $34,650 to the services provider in two equal tranches. The termsfirst tranche of 2,570 shares of common stock was issued on July 27, 2017 valued at $6.74 per share. The Company agreed to issue the new employment agreement provide for a continued annual base salary of $250,000 or such other amount as the Board of Directors may set. In addition, Mr. Schutz is eligible to receive an annual bonus, the payment, type and amount of which issecond tranche in the sole discretion of the Compensation Committee. Mr. Schutz also receives certain benefits, such as participation in our health and welfare plans, vacation and reimbursement of expenses.late August 2017.
13 |
Item 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations |
The following discussion of our financial condition and results ofoperations should be read in conjunction with the condensed consolidatedfinancial statements and notes to those statements included elsewhere in thisQuarterly Report on Form 10-Q as of June 30, 20162017 and our auditedconsolidated financial statements for the year ended March 31, 20162017 included inour Annual Report on Form 10-K, filed with the Securities and ExchangeCommission on June 21, 2016.28, 2017.
This report contains forward-looking statements within the meaning of thePrivate Securities Litigation Reform Act of 1995. When used in this report, thewords “anticipates,“anticipate,” “suggests,“suggest,” “estimates,”“plans,“estimate,” “projects,“plan,” “project,” “continue,” “ongoing,” “potential,” “expect,” “predict,”“believe, “believe,” “intend,” “may,” “will,” “should,” “could,” “would,” “proposal,” and similarexpressions are intended to identify forward-looking statements.
Forward-looking statements are subject to risks and uncertainties thatcould cause our actual results to differ materially from those projected. Theserisks and uncertainties include, but are not limited to the risks described inour Annual Report on Form 10-K including: our ability to become profitable; the impact of the Invekra transaction on our business and results of operations; the vulnerability of our Petaluma facility to extreme weather events; the impact of seasonality on our sales; the progress andtiming of our development programs and regulatory approvals for our products; thebenefits and effectiveness of our products; the ability of our products to meetexisting or future regulatory standards; the progress and timing of clinical trialsand physician studies; our expectations related to the use of our cash reserves; ourexpectations and capabilities relating to the sales and marketing of our currentproducts and our product candidates; our ability to gain sufficient reimbursement from third-party payors; our ability to compete with other companies thatare developing or selling products that are competitive with our products; theestablishment of strategic partnerships for the development or sale of products; the risk our research and development efforts do not lead to new products; thetiming of commercializing our products; ourability to penetrate markets through our sales force, distribution network,andstrategic business partners to gain a foothold in the market and generate attractive margins; the expansion of oursales force and distribution network; the ability to attain specified revenue goalswithin a specified time frame, if at all, or to reduce costs; the outcome ofdiscussions with the U.S. Food and Drug Administration, or FDA, and other regulatory agencies; the content and timing ofsubmissions to, and decisions made by, the FDA and other regulatory agencies,including demonstrating to the satisfaction of the FDA the safety and efficacy of ourproducts; our ability to manufacture sufficient amounts of our product candidatesfor clinical trials and products for commercialization activities; our ability toprotect our intellectual property and operate our business without infringing on theintellectual property of others; our ability to continue to expand our intellectualproperty portfolio; our expectations about the outcome of litigation andcontroversies with third parties; the risk we may need to indemnify our distributors or other third parties; risks attendant with conducting a significant portion of our business outside the United States; our ability to comply with complex federal and state fraud and abuse laws, including state and federal anti-kickback laws; risks associated with changes to health care laws; our ability to attract and retain qualifieddirectors, officers and employees; our expectations relating to the concentration ofour revenue from international sales; our ability to expand to and commercializeproducts in markets outside the wound care market; and the impact of theSarbanes-Oxley Act of 2002 and any future changes in accounting regulations orpractices in general with respect to public companies. These forward-looking statements speak only as ofthe date hereof. We expressly disclaim any obligation or undertaking to releasepublicly any updates or revisions to any forward-looking statements containedherein to reflect any change in our expectations with regard thereto or anychange in events, conditions or circumstances on which any such statement isbased, except as required by law.
Our Business
We are a specialty pharmaceutical company dedicated to identifying, developing and commercializing unique, affordable differentiated therapies to improve the livesmillions of patients living with dermatologic diseases orchronic skin conditions. OurWe believe our products, which are sold throughout the United States and internationally, have improved patient outcomes for more than five million patients globally by treating and reducing certain topical skin diseases including acne, atopic dermatitis, scarring, infections, itch, pain and harmful inflammatory responses.
We currently focusare focused on the development and commercialization of therapeutic solutions in medical dermatology to treat or reduce skin conditions, such as acne, atopic dermatitis and scarring. These diseases impact millions of patients worldwide and can have significant, multi-dimensional effects on patients’ quality of life, including their physical, functional and emotional well-being.
Since our founding in 1999, we built our business by developing and promoting products via partnerships for multiple therapeutic indications, with a primary focus on advanced tissue care. Starting in 2013, with a new Board of Directors and new management team, we pivoted to focus on one specialty pharmaceutical area, medical dermatology, and created our own sales force in the United States to promote our unique, affordable, differentiated prescription dermatology products.
14 |
Some of our key products in the United States are:
· | Celacyn®, a prescription hypochlorous acid based scar management gel clinically proven to soften and flatten raised scars while reducing redness and discoloration. |
· | Ceramax™ Skin Barrier Cream helps manage dry itchy skin, minor skin irritations, rashes, and inflammation caused by various skin conditions. |
· | Mondoxyne™, a prescription oral tetracycline antibiotic used for the treatment of certain bacterial infections, including acne. |
· | Alevicyn™, a prescription hypochlorous acid based atopic dermatitis product line clinically proven to reduce pruritus (itch) and pain associated with various dermatoses. |
· |
· | Microcyn® |
Our key product outside the United States is:
· | Microcyn® orMicrodacyn60® (sold under a variety of brand names), a line of products based on electrically charged oxychlorine small molecules designed to target a wide range of pathogens including viruses, fungi, spores and bacteria, including antibiotic-resistant strains. |
To date,As of July 31, 2017, we have obtained 1417 clearances from the U.S. Food and Drug Administration, or FDA, that permit us to sell our products as medical devices for Section 510(k) of the Federal Food, Drug and Cosmetic Act in the United States.
Outside the United Sates,States, we sell products for dermatological and advanced tissue care with a European Conformity marking (known as Conformité Européenne or CE) covering 25 of our products, 14 approvals from the Mexican Ministry of Health, and various approvals in Central America, China, Southeast Asia, South Korea, India, Australia, New Zealand, and the Middle East.
Our Strategy
Our strategy is to in-license, acquire, develop and commercialize unique, affordable and differentiated therapies that we believe advance the standard of care for patients with dermatological diseases. The key components of our strategy are to:
· | Expand our Internal U.S. Sales Force: We continue to hire additional experienced sales people who have established relationships with dermatologists in their |
· | Develop and Launch New Dermatology Products: We currently sell |
· | In-License and Acquire New Product Candidates: Since beginning our turn-around strategy in 2013, we have executed multiple transactions resulting in adding new products and product |
· | Create a Competitive Pricing Strategy: We have and will continue to develop a unique product pricing strategy, which we believe solves many of the challenges associated with the prescription dermatology market’s current pricing and rebate programs. |
· | Develop a Pharmaceutical Line: We plan to acquire or develop pharmaceutical products with affordable clinical trials to increase our market presence and create innovator patent protection. |
15 |
Our plan is to evolve into a leading dermatology company, providing innovative and cost-effective solutions to patients, while generating strong, consistent revenue growth and maximizing long-term shareholder value.
Additional Information
Investors and others should note that we announce material financial information using our company website (www.oculusis.com)(www.sonomapharma.com), our investor relations website (ir.oculusis.com)(ir.sonomapharma.com), SEC filings, press releases, public conference calls and webcasts. Information about Oculus, our business, and our results of operations may also be announced by posts on the following social media channels:
The information that we post on these social media channels could be deemed to be material information. Therefore, we encourage investors, the media, and others interested in Oculus to review the information that we post on these social media channels. These social media channels may be updated from time to time on Oculus’ investor relations website. The information on, or accessible through, our websites and social media channels is not incorporated by reference in this Quarterly Report on Form 10-Q.
Comparison of the Three Months Ended June 30, 20162017 and 20152016
Results of Continuing Operations
Revenues
Total revenues for the three months ended June 30, 20162017 of $3,811,000$3,835,000 increased by $131,000$1,197,000 or 4%45%, as compared to $3,680,000$2,638,000 for the three months ended June 30, 2015.2016. Product revenues for the three months ended June 30, 2016 of $3,509,000$3,603,000 increased by $593,000$1,192,000 or 20%49% when compared to the same period in the prior year. This increase was the result of strong growth in the United States, Europe, andthe Rest of the World partially offset by a decline inand Latin America due to the 19% decline in the peso and a robust quarter last year. Product licensing fees and royalties of $75,000 decreased $372,000, largely related to a reduction in the amortization of upfront payments from Laboratorios Sanfer, S.A. de C.V.America.
Product revenues in the United States for the three months ended June 30, 20162017 of $1,373,000,$1,859,000, increased by $586,000,$486,000, or 74%35%, when compared to the same period in the prior year. This increase was mostly the result of higher sales of our dermatology and animal health products. We currently haveacute care products, partly offset by a directdecline in sales force team of 20 focused on dermatology and a strong product portfolio of seven products, for the treatment of atopic dermatitis, scar management, surgical procedures, an oral anti-infective for severe acne and Ceramax, which utilizes a “state of the art” skin repair technology. In addition, sales$145,000 related to a newour animal health care partner increased during the period compared to the prior year. In the quarter ended June 30, 2016, our animal health products sold in the U.S. accounted for approximately 10% of product revenue. Going forward, while we expect that sales of U.S. animal health product will continue to grow, we expect sales of our product lines in the dermatology space to grow faster and thus, we expect the percentage of animal sales as a part of overall sales to decrease. Management has determined that our core focus will be prescription dermatology sales. Compared to our prescription dermatology sales, animal health product gross margins are lower because we need to work with partners, wholesalers and retailers before getting the product to the end consumer. We believe focusing on higher margin products utilizing an internal sales force allows us to better control and grow our future results rather than relying on external partners for marketing and sales. However, we will continue to explore and invest in partner relationships when we believe they provide an opportunity to grow sales and contribute to our goal to become profitable.
products.
Product revenue in Europe and the Rest of the World for the three months ended June 30, 20162017 of $1,038,000,$1,175,000, increased by $467,000,$137,000, or 82%13%, as compared to the same period in the prior year, with increases in Europe, Asia, Middle East, Europe, Hong Kong, Singapore, partly offset by decreases in a China and India. Revenue
As a result of the asset purchase agreement and arrangement we entered into on October 27, 2016 with Invekra, going forward, we expect our revenues in EuropeLatin America to decrease significantly. Pursuant to the arrangement, going forward we will receive a royalty of 3% on all Latin American net revenues excluding Mexico, with a minimum payment of $250,000 per year for the next ten years, to be paid quarterly in Mexican pesos. Additionally, while Invekra sets up their manufacturing, we will continue to supply Invekra with product at a reduced price. During the three months ended June 30, 2016, increased 56% in U.S. dollars, when compared to the same period last year primarily due to the launch2017, we reported $569,000 of new products and expansion of the customer base.
Product revenue in Latin America for the three months ended June 30, 2016 was $1,098,000, down $460,000 or 30%, when comparedproduct revenue related to the same period in the prior year. This decrease was caused by a 19% decline in the peso from the same period in the prior year, as well as higher sales during the three months ended June 30, 2015 due to stocking by our new Latin American partner, Sanfer, to fill their expansive pharmacy store network. When we announced our strategy to develop our own internal sales force, we were, in part, reacting to the dependence we have on our partners to generate sales for us in certain of our products lines in certain territories. While we believe revenues in Latin America will rebound, and we will work with our partner in that region to accomplish a return to previous revenue levels, our primary focus will continue to be driving revenues with our own internal sales force in the dermatology space.
Invekra.
The following table shows our product revenues by geographic region:
Three months ended June 30, | Three Months Ended June 30, | |||||||||||||||||||||||||||||||
2016 | 2015 | $ Change | % Change | 2017 | 2016 | $ Change | % Change | |||||||||||||||||||||||||
United States | $ | 1,373,000 | $ | 787,000 | $ | 586,000 | 74% | $ | 1,859,000 | $ | 1,373,000 | $ | 486,000 | 35% | ||||||||||||||||||
Latin America | 1,098,000 | 1,558,000 | (460,000 | ) | (30% | ) | 569,000 | – | 569,000 | 100% | ||||||||||||||||||||||
Europe and Rest of the World | 1,038,000 | 571,000 | 467,000 | 82% | 1,175,000 | 1,038,000 | 137,000 | 13% | ||||||||||||||||||||||||
3,509,000 | 2,916,000 | 593,000 | 20% | |||||||||||||||||||||||||||||
Product license fees and royalties | 75,000 | 447,000 | (372,000 | ) | (83% | ) | ||||||||||||||||||||||||||
Total | $ | 3,584,000 | $ | 3,363,000 | $ | 221,000 | 7% | $ | 3,603,000 | $ | 2,411,000 | $ | 1,192,000 | 49% |
In the three months ended June 30, 2016,connection with our sale of our Latin American business to Invekra, product license feesrevenues and royalties revenue declined primarily as a resultcost of a decrease in the amortization of upfront payments from Laboratorios Sanfer, S.A. de C.V.
The following table shows our product license fees and royalties revenue by partner:
Three Months Ended June 30, | ||||||||||||||||
Product license fees and royalties | 2016 | 2015 | $ Change | % Change | ||||||||||||
Exeltis | $ | – | $ | 54,000 | $ | (54,000 | ) | (100% | ) | |||||||
Innovacyn | – | 20,000 | (20,000 | ) | (100% | ) | ||||||||||
Laboratorios Sanfer, S.A. de C.V. | 75,000 | 373,000 | (298,000 | ) | (80% | ) | ||||||||||
Total product license fees and royalties | $ | 75,000 | $ | 447,000 | $ | (372,000 | ) | (83% | ) |
Service revenues for the three months ended June 30, 2016 of $227,000 decreased by $90,000 when compared to $317,000reported in the prior period. This decrease was dueperiod were reclassified from continuing operations to a decrease in the number of tests and services provided by our lab services business.discontinued operations as follows:
Three Months Ended June 30, | ||||||||
2017 | 2016 | |||||||
Product revenues | $ | – | $ | 1,098,000 | ||||
Product license fees and royalties | – | 75,000 | ||||||
Total product related revenues | – | 1,173,000 | ||||||
Cost of revenues | – | 235,000 | ||||||
Gross profit | $ | – | $ | 938,000 |
16 |
Service revenues for the three months ended June 30, 2017 of $232,000 increased by $5,000 when compared to $227,000 in the prior period. The increase in service revenues was related to technical services provided to Invekra in the amount of amount of $39,000 offset by a $34,000 decrease in our lab services business.
Gross Profit
For the three months ended June 30, 2016,2017, we reported total revenues of $3,835,000 and total cost of revenues of $2,073,000, resulting in total gross profit of $1,919,000$1,762,000 or 50%46% of total revenues, compared to a gross profit of $1,873,000,$981,000 or 51%37% of total revenues, for the same period in the prior year. The decline in gross profit was primarily due to the decline in our license fees and royalties revenue of $372,000.
For the three months ended June 30, 2016, we reported product gross profit of $1,802,000, or 51%, compared to product gross profit of $1,400,000, or 48%, for the same period in the prior year. The increase in product gross profit was primarily due to the reclassification, in the prior period, of Latin America product and license revenue and related variable cost of goods sold from continuing operations to product mix from higher sales ofdiscontinued operations. Additionally, as our stronger margin dermatology products which have higher margins.revenue increases, we expect our margins to improve.
For the three months ended June 30, 2016,2017, we reported product revenues of $3,603,000 and cost of product revenues of $1,913,000, resulting in product gross profit of $1,690,000, or 47% of product revenues, compared to product gross profit of $939,000, or 39% of product revenues, for the same period in the prior year. The increase in gross profit was primarily due to the reclassification, in the prior period, of Latin America product and related variable cost of goods sold from continuing operations to discontinued operations. Additionally, as dermatology product revenues increase as an overall percentage of our product revenues, we expect our margins will improve due to higher gross margins associated with our dermatology products.
For the three months ended June 30, 2017, we reported service revenues of $232,000 and cost of service revenues of $160,000, resulting in service gross profit of $72,000, or 31% of service revenues, compared to service gross profit of $42,000, or 19%, compared to of service gross profit of $26,000, or 8%,revenues, for the same period in the prior year. The increase in service gross profit was primarily related to higher service revenue in the current period and the mix of tests and services performed.
Research and Development Expense
We reported research and development expenseexpenses of $360,000$382,000 for the three months ended June 30, 2016, a decrease2017, an increase of $107,000,$22,000, or 23%6%, when compared to the same period in the prior year. The decreaseincrease is largely due to a decreasean increase in development milestone payments and license fees related to a dermatology product.spending on product development.
Selling, General and Administrative Expense
We reported selling, general and administrative expenses of $4,130,000$4,763,000 for the three months ended June 30, 2016,2017, an increase of $413,000,$633,000, or 11%15%, when compared to the same period in the prior year. The increase for the three months ended June 30, 20162017 was primarily due to higher sales and marketing expenses of $532,000 primarily related to the addition of our directgrowing dermatology sales force in the United States and the launch of new dermatology products, partly offset by lower expenses in Mexico and Europe and lower stock compensation charges.
We expect selling, general and administrative expenses to increase as we add people to our direct sales force.
Interest Expense
Interest expense was negligibleamounted to $10,000 and $1,000 for the three months ended June 30, 2017 and 2016, and 2015.respectively. The increase in interest expense relates primarily to capital leases.
Interest Income
Interest income was negligibleamounted to $53,000 and $1,000 for the three months ended June 30, 2017 and 2016, and 2015.
Lossrespectively. The increase is due to Change in Fair Valueinterest income earned on increased cash and cash equivalent balances over the prior period and $39,000 accretion of Derivative Liabilities
In connectioninterest income related to the technical service agreement with our December 9, 2013 and February 26, 2014 registered direct offerings we issued a series of common stock purchase warrants, which contain cash settlement provisions. During the quarter ended June 30, 2015, we recorded a loss due to an increase in the fair value of our derivative liabilities of $59,000, primarily due to an increase in our common stock price, partially offset by the decreasing contractual term of the warrants.Invekra.
Other (Expense) Income, Net
Other income,expense, net of $3,000$168,000 for the three months ended June 30, 2016, decreased $27,000,2017, increased $171,000, from $30,000$3,000 of other income, net for the same period in the prior year. The decreaseincrease in other income,expense, net during the three months ended June 30, 2017, relates primarily to foreign exchange losses and franchise tax payments.
Net Loss from Continuing Operations
Net loss from continuing operations for the three months ended June 30, 20162017 was primarily related to foreign exchange gains and losses.
Net Loss
Net loss for the three months ended June 30, 2016 was $2,568,000$3,508,000 compared to $2,340,000,a net loss from continuing operations of $3,187,000, for the same period in the prior year. The increase in net loss of $228,000 isfrom continuing operations primarily duerelates to an increase of $306,000additional spending in our operating expenses mostly related to our dermatology division, partly offset by an increase in gross profit.the current period on sale and marketing expenses.
17 |
Discontinued Operations, net of Tax
During the year ended March 31, 2017, we divested certain assets related to our Latin American business. On October 27, 2016, we closed on an asset purchase agreement with Invekra, S.A.P.I de C.V., an affiliate of Laboratorios Sanfer S.A. de C.V., for the sale of certain of our Latin America assets. We decided to divest our Latin American business, to focus on our U.S. dermatology business, resulting in a strategic shift that had a major effect on our operations and financial results. Therefore, the divested Latin American operations meet the criteria to be reported as discontinued operations.
The related assets, liabilities, results of operations and cash flows for our Latin American business are classified as discontinued operations for all periods presented.
Income from discontinued operations for the three months ended June 30, 2016 includes $938,000 of gross profit reclassified from continuing operations to discontinued operations during the period. Additionally, for the three months ended June 30, 2017, we recorded income tax expense related to the transaction in the amount of $319,000 and we recorded a $319,000 tax benefit resulting in no tax expense during the period.
The following summarizes operations of our Latin American business included in discontinued operations:
Three Months Ended June 30, | ||||||||
2017 | 2016 | |||||||
Revenues | $ | – | $ | 1,173,000 | ||||
Cost of revenues | – | 235,000 | ||||||
Income from discontinued operations before tax | – | 938,000 | ||||||
Income tax expense | – | (319,000 | ) | |||||
Income from discontinued operations, net of tax | $ | – | $ | 619,000 |
Liquidity and Capital Resources
We incurredreported a net loss of $2,568,000$3,508,000 for the three months ended June 30, 2016.2017. At June 30, 20162017 and March 31, 2016,2017, our accumulated deficit amounted to $154,943,000$146,620,000 and $152,375,000,$143,101,000, respectively. AtWe had working capital of $16,330,000 and $19,355,000 as of June 30, 20162017 and March 31, 2016,2017, respectively.
We currently anticipate that our cash and cash equivalents, including the proceeds from the sale to Invekra, will be sufficient to meet our working capital amounted to $6,965,000 and $9,337,000, respectively. We may raise additional capital from external sources in order to fund working capital and continue the longer term efforts contemplated under our business plan. We expectrequirements to continue incurring losses for the foreseeable futureour sales and may need to raise additional capital to pursue our product development initiatives, to penetrate markets for the sale of our productsmarketing and continue as a going concern. We cannot provide any assurances that we will be able to raise additional capital.
Management believes that we have access to capital resources through possible public or private equity offerings, debt financings, corporate collaborations or other means; however, we cannot provide any assurance that new financing will be available on commercially acceptable terms, if at all. If the economic climate in the U.S. deteriorates, our ability to raise additional capital could be negatively impacted. If we are unable to secure additional capital, we may be required to curtail our research and development initiatives and take additional measures to reduce costs in order to conserve our cash in amounts sufficient to sustain operations and meet our obligations. These measures could cause significant delays in our efforts to commercialize our products, which is critical tofor at least 12 months from the realizationdate of our business plan and our future operations. These matters raise substantial doubt about our ability to continue as a going concern.filing this report.
Sources of Liquidity
As of June 30, 20162017, we had cash and cash equivalents of $4,970,000.$12,638,000. Since our inception, substantially all of our operations have been financed through sales of equity securities. Other sources of financing that we have used to date include our revenues, as well as various loans.loans and the sale of certain Latin American assets to Invekra.
Since July 1, 2014,2015, substantially all of our operations have been financed through the following transactions:
· | proceeds of |
· | net proceeds of |
· | net proceeds of $2,994,000 received from an underwritten public offering on March 18, 2016; |
· | net proceeds of |
· | net proceeds of $18,639,000 received from the sale of certain Latin America assets to Invekra on October 27, 2016. |
18 |
Cash Flows
As of June 30, 2016,2017, we had cash and cash equivalents of $4,970,000,$12,638,000, compared to $7,469,000$17,461,000 as of March 31, 2016.2017.
Net cash used in operating activities during the three months ended June 30, 2017 was $4,634,000, primarily due to our net loss of $3,508,000 offset by stock compensation of $438,000 in the period. Additionally, we had increases in prepaid expenses of $659,000 and an increase in accounts receivable of $592,000.
Net cash used in operating activities during the three months ended June 30, 2016 was $2,377,000, primarily due to our net loss of $2,568,000 offset by stock compensation of $411,000 in the period.
Net cash used in operatinginvesting activities during thewas $171,000 for three months ended June 30, 2015 was $2,585,000,2017, primarily duerelated to our net lossthe purchase of $2,340,000 for the period and an increase in accounts receivable of $1,052,000 due to increased sales on payment terms, offset by an increase of $549,000 in accounts payable and accrued liabilitiesequipment.
Net cash used in investing activities was $11,000 for three months ended June 30, 2016, primarily related to the purchase of equipment.
Net cash provided by investingused in financing activities was $4,378,000$26,000 for the three months ended June 30, 2015, consisting2017 related to principal payments on debt and capital leases of $4,538,000 received$71,000 offset by proceeds from the saleexercise of 1,650,000 of our shares of Ruthigen common stock offset by $148,000 related to equipment purchases and $12,000 related to changes in long-term assets.purchase warrants of $45,000.
Net cash used in financing activities was $48,000 for the three months ended June 30, 2016 related to principal payments on debt.
Net cash provided by financing activities was $827,000 for the three months ended June 30, 2015 was primarily related to $879,000 of net proceeds received from At-the-Market Issuances of common stock which was offset by principal payments on debt in the amount of $52,000.
Operating Capital and Capital Expenditure Requirements
We incurredreported a net loss of $2,568,000$3,508,000 for the three months ended June 30, 2016.2017. At June 30, 20162017 and March 31, 2016,2017, our accumulated deficit amounted to $154,943,000$146,620,000 and $152,375,000,$143,101,000, respectively. AtWe had working capital of $16,330,000 and $19,355,000 as of June 30, 20162017 and March 31, 2016, our working capital amounted to $6,965,000 and $9,337,000,2017, respectively.
We may need to raise additional capital from external sources in order to continue the longer termlong-term efforts contemplated under our business plan. We expect to continue incurring losses for the foreseeable future and may need to raise additional capital to pursue our product development initiatives and to penetrate markets for the sale of our products.
Our future funding requirements will depend on many factors, including:
· |
· | the scope, rate of progress and cost of our research and development activities; |
· | future clinical trial results; |
· | the terms and timing of any collaborative, licensing and other arrangements that we may establish; |
· | the cost and timing of regulatory approvals; |
· | the cost and delays in product development as a result of any changes in regulatory oversight applicable to our products; |
· | the cost and timing of establishing sales, marketing and distribution capabilities; |
· | the effect of competing technological and market developments; |
· | the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; and |
· | the extent to which we acquire or invest in businesses, products and technologies. |
19 |
Use of Estimates
The preparation of consolidated financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent liabilities at the dates of the consolidated financial statements and the reported amounts of revenues and expenses during the reporting periods. Actual results could differ from these estimates. Significant estimates and assumptions include reserves and write-downs related to receivables and inventories, the recoverability of long-lived assets, the valuation allowance related to our deferred tax assets, valuation of equity and derivative instruments, debt discounts, valuation of investments and the estimated amortization periods of upfront product licensing fees received from customers.
Off-Balance Sheet Transactions
We currently have no off-balance sheet arrangements that have or are reasonably likely to have a current or future material effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources.
Item 3. | Quantitative and Qualitative Disclosures About Market Risk |
As a smaller reporting company, we are electing scaled disclosure reporting obligations and therefore are not required to provide the information required by this Item.
Item 4. | Controls and Procedures |
Evaluation of Disclosure Controls and Procedures
We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in the reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating our disclosure controls and procedures, our management recognized that disclosure controls and procedures, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the disclosure controls and procedures are met. Accordingly, our disclosure controls and procedures have been designed to meet reasonable assurance standards. Additionally, in designing disclosure controls and procedures, our management was necessarily required to apply its judgment in evaluating the cost-benefit relationship of possible disclosure controls and procedures. The design of any disclosure controls and procedures is also based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions.
We carried out an evaluation, under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of the end of the period covered by this report. Based upon this evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective as of June 30, 2016.2017.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting that occurred(as such term is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the three monthsquarter ended June 30, 20162017 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
20 |
Item 1. | Legal Proceedings |
On occasion, we may be involved in legal matters arising in the ordinary course of our business including matters involving proprietary technology. While management believes that such matters are currently insignificant, matters arising in the ordinary course of business for which we are or could become involved in litigation may have a material adverse effect on our business, financial condition or results of comprehensive loss.
Item 1A. | Risk Factors |
There have been no material changes from risk factors previously disclosed in our annual report on Form 10-K for the fiscal year ended March 31, 2016,2017, as filed with the SEC on June 21, 2016.28, 2017.
Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds |
We did not sell anyOn July 27, 2017, we issued 2,570 unregistered securities during the quarter ended June 30, 2016.shares of common stock to a service provider valued at $6.74 per share.
We relied on the Section 4(a)(2) exemption from securities registration under the federal securities laws for transactions not involving any public offering. No advertising or general solicitation was employed in offering the securities. The securities were issued to an accredited investor. The securities were offered for investment purposes only and not for the purpose of resale or distribution. The transfer thereof was appropriately restricted by us.
Item 3. | Default Upon Senior Securities |
We did not default upon any senior securities during the quarter ended June 30, 2016.2017.
Item 4. | Mine Safety Disclosures |
Not applicable.
Item 5. | Other Information |
On July 26, 2016, we entered into a new employment agreement with Jim Schutz, our President and Chief Executive Officer to update his agreements and responsibilities. The terms of the new employment agreement provide for a continued annual base salary of $250,000 or such other amount as the Board of Directors may set. In addition, Mr. Schutz is eligible to receive an annual bonus, the payment, type and amount of which is in the sole discretion of the Compensation Committee. Mr. Schutz also receives certain benefits, such as participation in our health and welfare plans, vacation and reimbursement of expenses.None.
21 |
Item 6. | Exhibits |
Exhibit Index
Exhibit No. | Description |
3.1 | Restated Certificate of Incorporation of Oculus Innovative Sciences, Inc. |
3.2 | Certificate of Amendment of Restated Certificate of Incorporation of Oculus Innovative Sciences, Inc. |
3.3 | |
Certificate of Amendment of Restated Certificate of Incorporation of Oculus Innovative Sciences, Inc., as amended, | |
Certificate of Amendment of Restated Certificate of Incorporation of Oculus Innovative Sciences, Inc., as amended, | |
Certificate of Amendment of Restated Certificate of Incorporation of Oculus Innovative Sciences, Inc., as amended, | |
Certificate of Amendment of Restated Certificate of Incorporation of Oculus Innovative Sciences, Inc., as amended, | |
Certificate of Designation of Preferences, Rights and Limitations of Series A 0% Convertible Preferred Stock, filed with the Delaware Secretary of State on April 24, 2012 | |
4.1 | Specimen Common Stock Certificate(included as Exhibit 4.1 to the Company’s Annual Report on Form 10-K filed June 28, 2017, and incorporated herein by reference). |
Form of Underwriters Warrant to be issued to the Underwriters in connection with the March 2013 Offering | |
Warrant issued to Dawson James Securities, Inc., dated December 9, 2013 |
4.4 |
Form of Series A Common Stock Purchase Warrant for February 2014 offering | |
Form of Series B Common Stock Purchase Warrant for February 2014 offering | |
Warrant issued to Dawson James Securities, Inc., dated February 26, 2014 | |
Warrant Agreement, including Form of Warrant entered into by and between Oculus Innovative Sciences, Inc. and Computershare, Inc. and Computershare Trust Company, N.A., dated January 20, 2015 | |
Underwriters Warrant issued to Maxim Partners LLC on January 26, 2015 | |
Underwriters Warrant issued to Robert D. Keyser, Jr. on January 26, 2015 |
22 |
4.10 | Underwriters Warrant issued to R. Douglas Armstrong on January 26, 2015 |
Underwriters Warrant issued to Dawson James Securities, Inc. on January 26, 2015 | |
Underwriters Warrant issued to Dawson James Securities, Inc. on January 26, 2015 | |
Warrant Agreement, including Form of Warrant entered into by and between Oculus Innovative Sciences, Inc. and Computershare, Inc. and Computershare Trust Company, N.A., dated March 18, 2016 | |
Form of Warrant issued to Dawson James Securities, Inc. on March 31, 2016 | |
4.15 | Section 382 Rights Agreement, dated as of October 18, 2016, between Oculus Innovative Sciences, Inc. and Computershare Inc., which includes the Form of Certificate of Designation of Series B Preferred Stock as Exhibit A, the Form of Right Certificate as Exhibit B and the Summary of Rights to Purchase Preferred Stock as Exhibit C(included as Exhibit 4.1 to the Company’s Current Report on Form 8-K filed October 21, 2016, and incorporated herein by reference). |
10.1 | Form of Indemnification Agreement between Oculus Innovative Sciences, Inc. and its officers and directors |
10.2 | Office Lease Agreement, dated October 26, 1999, between Oculus Innovative Sciences, Inc. and RNM Lakeville, L.P. |
10.3 | Amendment No. 1 to Office Lease Agreement, dated September 15, 2000, between Oculus Innovative Sciences, Inc. and RNM Lakeville L.P. |
10.4 | Amendment No. 2 to Office Lease Agreement, dated July 29, 2005, between Oculus Innovative Sciences, Inc. and RNM Lakeville L.P. |
10.5 | Amendment No. 3 to Office Lease Agreement, dated August 23, 2006, between Oculus Innovative Sciences, Inc. and RNM Lakeville L.P. |
10.6 | Office Lease Agreement, dated May 18, 2006, between Oculus Technologies of Mexico, S.A. de C.V. and Antonio Sergio Arturo Fernandez Valenzuela (translated from Spanish) |
10.7 | Office Lease Agreement, dated July 2003, between Oculus Innovative Sciences, B.V. and Artikona Holding B.V. (translated from Dutch) |
10.8 | Form of Director Agreement |
10.9 | |
Amended and Restated Oculus Innovative Sciences, Inc. 2006 Stock Incentive Plan and related form stock option plan agreements | |
Amendment No. 4 to Office Lease Agreement, dated September 13, 2007, by and between Oculus Innovative Sciences, Inc. and RNM Lakeville L.P. | |
Amendment to Office Lease Agreement, effective February 15, 2008, by and between Oculus Innovative Sciences Netherlands B.V. and Artikona Holding B.V. (translated from Dutch) |
Amendment No. 5 to Office Lease Agreement by and between Oculus Innovative Sciences, Inc. and RNM Lakeville, LLC, dated May 18, 2009 | |
Amendment No. 6 to Office Lease Agreement by and between Oculus Innovative Sciences, Inc. and RNM Lakeville, L.P., dated April 26, 2011 | |
Oculus Innovative Sciences, Inc. 2011 Stock Incentive Plan |
Amendment No. 7 to Office Lease Agreement by and between Oculus Innovative Sciences, Inc. and 1125-1137 North McDowell, LLC, dated October 10, 2012 | |
|
Form of Securities Purchase Agreement by and between Oculus Innovative Sciences, Inc. and the Purchasers, dated February 21, 2014 | |
At-the-Market Issuance Sales Agreement, dated April 2, 2014, by and between Oculus Innovative Sciences, Inc. and MLV & Co. LLC | |
Lease Agreement by and between Oculus Innovative Sciences, Inc. and 2500 York, L.P., dated July 9, 2014 | |
Underwriting Agreement entered into by and between Oculus Innovative Sciences, Inc. and Maxim Group LLC as representative of the underwriters named on Schedule A thereto, dated January 20, 2015 | |
Sales Representation Contract, dated February 1, 2015, by and between Oculus Innovative Sciences, Inc. and SLA Brands, Inc. | |
Amendment No. 1 to Sales Representation Contract, dated November 6, 2015, by and between Oculus Innovative Sciences, Inc. and SLA Brands, Inc. | |
Underwriting Agreement entered into by and between Oculus Innovative Sciences, Inc. and Dawson James Securities, Inc. as representative of the underwriters named on Schedule 1 thereto, dated March 18, 2016 | |
Exclusive Sales and Distribution Agreement, dated November 6, 2015, by and between Oculus Innovative Sciences, Inc. and Manna Pro Products, LLC(included as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed March 23, 2016, and incorporated herein by reference). | |
10.24 | Employment Agreement by and between Oculus Innovative Sciences, Inc. and Jim Schutz, dated July 26, 2016 |
10.25† | Asset Purchase Agreement dated October 27, 2016, between Oculus Innovative Sciences, Inc. and Invekra, S.A.P.I de C.V.(included as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed October 31, 2016, and incorporated herein by reference). |
10.26† | Amendment Agreement to Acquisition Option dated October 27, 2016, by and between More Pharma Corporation S. de R.L. de C.V. and Oculus Technologies of Mexico, S.A. de C.V.(included as Exhibit 10.2 to the Company’s Current Report on Form 8-K filed October 31, 2016, and incorporated herein by reference). |
10.27 | Employment Agreement by and between Oculus Innovative Sciences, Inc. and Robert Miller, dated November 30, 2016(included as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed December 1, 2016, and incorporated herein by reference). |
10.28 | Employment Agreement by and between Oculus Innovative Sciences, Inc. and Bruce Thornton, dated November 30, 2016(included as Exhibit 10.2 to the Company’s Current Report on Form 8-K filed December 1, 2016, and incorporated herein by reference). |
10.29 | Employment Agreement by and between Oculus Innovative Sciences, Inc. and Robert Northey, dated November 30, 2016(included as Exhibit 10.3 to the Company’s Current Report on Form 8-K filed December 1, 2016, and incorporated herein by reference). |
10.30 | Employment Agreement by and between Oculus Innovative Sciences, Inc. and Jeffrey Day, dated November 30, 2016(included as Exhibit 10.4 to the Company’s Current Report on Form 8-K filed December 1, 2016, and incorporated herein by reference). |
10.31 | Employment Agreement by and between Sonoma Pharmaceuticals, Inc. and Marc Umscheid, dated December 31, 2016(included as Exhibit 10.97 to the Company’s Quarterly Report on Form 10-Q filed February 17, 2017, and incorporated herein by reference). |
10.32 | Master Vendor Agreement by and between Sonoma Pharmaceuticals, Inc. and PetSmart Home Office, Inc., dated November 21, 2016(included as Exhibit 10.32 to the Company’s Annual Report on Form 10-K filed on June 28, 2017, and incorporated herein by reference). |
10.33# | Distribution Agreement by and between Sonoma Pharmaceuticals, Inc. and G. Pohl-Boskamp GmbH & Co. KG, dated April 13, 2016(included as Exhibit 10.33 to the Company’s Annual Report on Form 10-K filed on June 28, 2017, and incorporated herein by reference). |
10.34 | Amendment No. 8 to Office Lease Agreement by the between Oculus Innovative Sciences, Inc. and SSCOP Properties LLC, dated June 23, 2016(included as Exhibit 10.34 to the Company’s Annual Report on Form 10-K on June 28, 2017, and incorporated herein by reference). |
14.1 | Code of Business Conduct(included as Exhibit 14.1 to the Company’s Current Report on Form 8-K filed on January 23, 2017, and incorporated herein by reference). |
31.1* | Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of |
31.2* | Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of |
32.1* | 2002. |
101.INS* | XBRL Instance Document. |
101.SCH* | XBRL Taxonomy Extension Schema. |
101.CAL* | XBRL Taxonomy Extension Calculation Linkbase. |
101.DEF* | XBRL Taxonomy Extension Definition Linkbase. |
101.LAB* | XBRL Taxonomy Extension Label Linkbase. |
101.PRE* | XBRL Taxonomy Extension Presentation Linkbase. |
* | Filed herewith. |
† | Confidential treatment has been granted with respect to certain portions of this agreement. |
# | Confidential treatment is being sought for portions of this agreement. |
Copies of above exhibits not contained herein are available to any stockholder, upon payment of a reasonable per page fee, upon written request to: Chief Financial Officer, Oculus Innovative Sciences,Sonoma Pharmaceuticals, Inc., 1129 N. McDowell Blvd., Petaluma, California 94954.
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
Date: August | By: | /s/ Jim Schutz |
Jim Schutz | ||
Chief Executive Officer | ||
(Principal Executive Officer) | ||
Date: August | By: | /s/ Robert Miller |
Robert Miller | ||
Chief Financial Officer | ||
(Principal Financial Officer and Principal Accounting Officer) |