SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM10-Q
(Mark One)
☒ QUARTERLY REPORT PURSUANT TO SECTION13 OR 15(d)OF THE SECURITIES
EXCHANGE ACT OF 1934
For the quarterly period ended SeptemberJune 30, 2017
OR
☐ TRANSITION REPORT PURSUANT TO SECTION13 OR 15(d)OF THE SECURITIES EXCHANGE
ACT OF 1934
For the transition period from __________________to __________________
000-19879
(Commission file number)
BIOSPECIFICS TECHNOLOGIES CORP.
(Exact Name of Registrant as Specified in Its Charter)
| | |
Delaware | 11-3054851 | |
(State or Other Jurisdiction | (I.R.S. Employer | |
of Incorporation or Organization) | Identification No.) | |
| | |
2 Righter Parkway, Suite 200, Wilmington, DE19803 | ||
(Address of Principal Executive Offices) (Zip Code) | ||
| ||
302.842.8450 | ||
(Registrant’s Telephone Number, Including Area Code) | ||
Indicate by check mark whether the registrant: (1)has filed all reports required to be filed by Section13 or 15(d)of the Securities Exchange Act of 1934 during the preceding 12months (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 90days. Yes ☒ No ☐
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 Rule405 of Regulation S-T (§232.405 of this chapter) during the preceding 12months (or for such shorter period that the registrant was required to submit and post such files). Yes ☒ No ☐
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” and “smaller reporting company” in Rule12b-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 comply 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 Rule12b-2 of the Exchange Act).
Yes ☐ No ☒
Securities registered pursuant to Section 12(b) of the issuer’s classes of common stock, as of the latest practicable date:
Title of | Trading Symbol(s) | Name of each exchange on which registered |
Common Stock, | BSTC | The Nasdaq Capital Market |
As of August 7, 2020, there were 7,344,955 shares of Common Stock, par value $0.001 per share, outstanding.
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| PARTI– FINANCIAL INFORMATION | |
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Management’s Discussion and Analysis of Financial Condition and Results of Operations | 22 | |
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| PARTII– OTHER INFORMATION | |
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2
Introductory Comments– Terminology
Throughout this Quarterly Report on Form10-Q, the terms “BioSpecifics,” “Company,” “we,” “our,” and “us” refer to BioSpecifics Technologies Corp. and its subsidiary, Advance Biofactures Corp.
Throughout this Quarterly Report on Form10-Q, Endo Global Ventures, a Bermuda unlimited liability company, an affiliate of Endo International plc, and Endo International plc are referred to collectively as “Endo”.
This Quarterly Report on Form10-Q includes “forward-looking statements” within the meaning of, and made pursuant to the safe harbor provisions of, the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact, including statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, expected revenue growth, and the assumptions underlying or relating to such statements, are “forward-looking statements.” The forward-looking statements in this Quarterly Report on Form10-Q include statements concerning, among other things, (i)the continued commercialization of XIAFLEX to treat Dupuytren’s contractureopportunity for minimally invasive non-surgical treatment XIAFLEX® in several potential pipeline indications; (ii)whether and Peyronie’s disease; the continued marketing and commercialization of XIAFLEX to treat Dupuytren’s contracture and Peyronie’s disease in Europe, Eurasia, Japan, Canada and Australia; Endo’s ability to obtain required regulatory approvals; Endo’s ability to manufacture XIAFLEX at an acceptable cost, in a timely manner and with appropriate quality; successful development of XIAFLEX for additional indications; the ability to successfully develop, market and commercialize our drug candidates; the funding of research and development at medical institutions under agreements that are generally cancellable;
In some cases, these statements can be identified by forward-looking words such as "expect," "plan," "anticipate," "potential," "estimate," "can," "will," "continue," “believe,” “expect,” “anticipate,” “estimate,” “likely,” “may,” “will,” “can,” and “could,” the negative or plural of these words, and other similar expressions. These forward-looking statements are predictions based on ourthe Company’s current expectations and ourthe Company’s projections about future events and various assumptions. There can be no assurance that wethe Company will realize ourits expectations or that ourthe Company’s beliefs will prove correct. There are a number of important factors that could cause BioSpecifics’the Company’s actual results to differ materially from those indicated by such forward-looking statements, including, but not limited to: the timing of regulatory filings and action; the ability of Endo and its partners, Asahi Kasei Pharma Corporation, Actelion Ltd. and Swedish Orphan Biovitrum AB, to achieve theirits objectives for XIAFLEX in their applicable territories;® and Qwo™; the market for XIAFLEX® in, and timing, initiation, and outcome of clinical trials for, additional indications, thatwhich will determine the amount of milestone, royalty, mark-up on cost of goods sold, license, and sublicense income BioSpecificsthat the Company may receive; the potential of XIAFLEX® to be used in additional indications;
3
September 30, 2017 | December 31, 2016 | |||||||
| (unaudited) | (audited) | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 6,422,358 | $ | 4,763,364 | ||||
| Short term investments | 48,166,583 | 44,254,862 | ||||||
| Accounts receivable | 4,681,885 | 3,810,792 | ||||||
| Income tax receivable | 56,930 | 494,711 | ||||||
| Deferred royalty buy-down | 1,566,078 | 1,451,893 | ||||||
| Prepaid expenses and other current assets | 673,064 | 624,345 | ||||||
| Total current assets | 61,566,898 | 55,399,967 | ||||||
| Long-term investments | 6,717,196 | 3,771,380 | ||||||
| Deferred royalty buy-down – long term, net | 757,021 | 1,976,456 | ||||||
| Deferred tax assets, net | 2,992,001 | 3,290,122 | ||||||
| Patent costs, net | 227,868 | 258,355 | ||||||
| Total assets | $ | 72,260,984 | $ | 64,696,280 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued expenses | $ | 785,275 | $ | 738,649 | ||||
| Deferred revenue | 1,134,031 | 1,179,848 | ||||||
| Accrued liabilities of discontinued operations | 78,138 | 78,138 | ||||||
| Total current liabilities | 1,997,444 | 1,996,635 | ||||||
| Long-term deferred revenue | 5,555,743 | 6,417,702 | ||||||
| Stockholders’ equity: | ||||||||
| Series A Preferred stock, $.50 par value, 700,000 shares authorized; none outstanding | - | - | ||||||
| Common stock, $.001 par value; 10,000,000 shares authorized; 7,575,167 and 7,555,167 shares issued, 7,164,233 and 7,156,281 shares outstanding as of September 30, 2017 and December 31, 2016, respectively | 7,575 | 7,555 | ||||||
| Additional paid-in capital | 33,303,898 | 32,945,240 | ||||||
| Retained earnings | 39,294,524 | 30,610,849 | ||||||
| Treasury stock, 410,934 and 398,886 shares at cost as of September 30, 2017 and December 31, 2016, respectively | (7,898,200 | ) | (7,281,701 | ) | ||||
| Total stockholders’ equity | 64,707,797 | 56,281,943 | ||||||
| Total liabilities and stockholders’ equity | $ | 72,260,984 | $ | 64,696,280 | ||||
| | | | | | | |
| | June 30, | | December 31, | | ||
|
| 2020 |
| 2019 |
| ||
| | | (unaudited) | | | (audited) | |
Assets | | | | | | | |
Current assets: | | | | | | | |
Cash and cash equivalents | | $ | 16,871,522 | | $ | 4,999,183 | |
Short term investments | |
| 82,180,784 | |
| 84,239,918 | |
Accounts receivable | |
| 11,696,598 | |
| 19,065,919 | |
Prepaid expenses and other current assets | |
| 1,310,388 | |
| 966,456 | |
Total current assets | |
| 112,059,292 | |
| 109,271,476 | |
| | | | | | | |
Long-term investments | |
| 20,791,278 | |
| 16,569,024 | |
Property and equipment, net | | | 64,839 | | | — | |
Operating lease right-of-use asset | |
| 201,228 | |
| 239,491 | |
Patent costs, net | |
| 531,989 | |
| 573,277 | |
Other assets | | | 133,159 | | | — | |
Total assets | | $ | 133,781,785 | | $ | 126,653,268 | |
| | | | | | | |
Liabilities and stockholders' equity | |
|
| |
|
| |
Current liabilities: | |
|
| |
|
| |
Accounts payable and accrued expenses | | $ | 2,090,056 | | $ | 998,409 | |
Income tax payable | |
| 1,673,051 | |
| 354,984 | |
Current portion of lease obligation | |
| 78,560 | |
| 69,099 | |
Total current liabilities | |
| 3,841,667 | |
| 1,422,492 | |
| | | | | | | |
Lease obligation | |
| 126,822 | |
| 167,014 | |
Deferred tax liability, net | |
| 395,858 | |
| 572,660 | |
Total liabilities | | | 4,364,347 | | | 2,162,166 | |
| |
|
| |
|
| |
Commitments and Contingencies | | | | | | | |
| |
|
| |
|
| |
Stockholders' equity: | | | | | | | |
Preferred stock, $0.50 par value, 700,000 shares authorized (150,000 shares designated as Series A Convertible Redeemable Preferred Stock and 10,000 shares designated as Series C Junior Participating Preferred Stock); none outstanding | | | — | | | — | |
Common stock, $0.001 par value; 15,000,000 shares authorized; 7,826,180 and 7,813,230 shares issued, 7,344,955 and 7,339,578 shares outstanding as of June 30, 2020 and December 31, 2019, respectively | |
| 7,826 | |
| 7,813 | |
Additional paid-in capital | |
| 40,080,279 | |
| 39,355,797 | |
Retained earnings | |
| 101,261,129 | |
| 96,646,527 | |
Treasury stock, 481,225 and 473,652 shares at cost as of June 30, 2020 and December 31, 2019, respectively | |
| (11,931,796) | |
| (11,519,035) | |
Total stockholders' equity | |
| 129,417,438 | |
| 124,491,102 | |
Total liabilities and stockholders’ equity | | $ | 133,781,785 | | $ | 126,653,268 | |
See accompanying notes to condensed consolidated financial statements.
4
BioSpecifics Technologies Corp.
(unaudited)
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2017 | 2016 | 2017 | 2016 | |||||||||||||
| Revenues: | ||||||||||||||||
| Royalties | $ | 6,511,700 | $ | 6,119,815 | $ | 20,729,017 | $ | 18,843,273 | ||||||||
| Licensing revenues | 4,408 | 762,345 | 13,226 | 787,034 | ||||||||||||
| Total Revenues | 6,516,108 | 6,882,160 | 20,742,243 | 19,630,307 | ||||||||||||
| Costs and expenses: | ||||||||||||||||
| Research and development | 356,847 | 312,907 | 949,359 | 1,005,884 | ||||||||||||
| General and administrative | 2,175,501 | 1,843,368 | 6,916,501 | 5,909,785 | ||||||||||||
| Total Cost and Expenses | 2,532,348 | 2,156,275 | 7,865,860 | 6,915,669 | ||||||||||||
| Operating income | 3,983,760 | 4,725,885 | 12,876,383 | 12,714,638 | ||||||||||||
| Other income: | ||||||||||||||||
| Interest income | 193,462 | 80,674 | 436,210 | 200,704 | ||||||||||||
| Other income | 14,667 | 6,254 | 40,651 | 37,448 | ||||||||||||
| 208,129 | 86,928 | 476,861 | 238,152 | |||||||||||||
| Income before income tax expense | 4,191,889 | 4,812,813 | 13,353,244 | 12,952,790 | ||||||||||||
| Provision for income tax expense | (1,477,057 | ) | (1,759,220 | ) | (4,669,569 | ) | (4,497,359 | ) | ||||||||
| Net income | $ | 2,714,832 | $ | 3,053,593 | $ | 8,683,675 | $ | 8,455,431 | ||||||||
| Basic net income per share | $ | 0.38 | $ | 0.43 | $ | 1.21 | $ | 1.20 | ||||||||
| Diluted net income per share | $ | 0.37 | $ | 0.42 | $ | 1.19 | $ | 1.16 | ||||||||
| Shares used in computation of basic net income per share | 7,164,934 | 7,062,543 | 7,166,470 | 7,031,068 | ||||||||||||
| Shares used in computation of diluted net income per share | 7,314,609 | 7,280,375 | 7,325,602 | 7,277,780 | ||||||||||||
| | | | | | | | | | | | | |
| | Three Months Ended | | Six Months Ended | | ||||||||
| | June 30, | | June 30, | | ||||||||
|
| 2020 |
| 2019 |
| 2020 |
| 2019 |
| ||||
Revenues: | | | | | | | | | | | | | |
Royalties | | $ | 3,903,402 |
| $ | 8,852,986 | | $ | 13,572,069 | | $ | 16,982,127 | |
Total Revenues | | | 3,903,402 | |
| 8,852,986 | | | 13,572,069 | |
| 16,982,127 | |
| | | | | | | | | | | | | |
Costs and expenses: | |
|
| |
|
| |
|
| |
|
| |
Research and development | |
| 160,461 | |
| 161,321 | |
| 282,431 | |
| 310,857 | |
General and administrative | |
| 3,993,861 | |
| 1,728,125 | |
| 7,161,907 | |
| 4,635,284 | |
Restructuring charges | | | — | | | — | | | 1,146,045 | | | — | |
Total Costs and Expenses | |
| 4,154,322 | |
| 1,889,446 | |
| 8,590,383 | |
| 4,946,141 | |
Operating income | |
| (250,920) | |
| 6,963,540 | |
| 4,981,686 | |
| 12,035,986 | |
| | | | | | | | | | | | | |
Other income: | |
|
| |
|
| |
|
| |
|
| |
Interest income | |
| 390,888 | |
| 517,156 | |
| 870,597 | |
| 966,580 | |
| | | | | | | | | | | | | |
Income before income tax expense | |
| 139,968 | |
| 7,480,696 | |
| 5,852,283 | |
| 13,002,566 | |
Provision for income tax expense | |
| (24,172) | |
| (1,054,236) | |
| (1,237,681) | |
| (2,159,511) | |
Net income | | $ | 115,796 | | $ | 6,426,460 | | $ | 4,614,602 | | $ | 10,843,055 | |
| | | | | | | | | | | | | |
Basic net income per share | | $ | 0.02 | | $ | 0.88 | | $ | 0.63 | | $ | 1.49 | |
Diluted net income per share | | $ | 0.02 | | $ | 0.87 | | $ | 0.63 | | $ | 1.48 | |
| |
|
| |
|
| |
|
| |
|
| |
Shares used in computation of basic net income per share | |
| 7,337,460 | |
| 7,308,268 | |
| 7,337,564 | |
| 7,292,663 | |
Shares used in computation of diluted net income per share | |
| 7,361,764 | |
| 7,349,696 | |
| 7,361,256 | |
| 7,344,008 | |
See accompanying notes to condensed consolidated financial statements.
5
BioSpecifics Technologies Corp.
Condensed Consolidated Statements of Stockholders’ Equity
| | | | | | | | | | | | | | | | | |
|
| |
| | |
| Additional |
| | |
| | |
| Stockholders’ | ||
| | Common Stock | | Paid in | | Retained | | Treasury | | Equity | |||||||
| | Shares |
| Amount | | Capital | | Earnings | | Stock | | Total | |||||
Balances - December 31, 2019 | | 7,813,230 | | $ | 7,813 | | $ | 39,355,797 | | $ | 96,646,527 | | $ | (11,519,035) | | $ | 124,491,102 |
Issuance of common stock upon vesting of restricted stock units |
| 11,450 | |
| 11 | |
| (11) | |
| — | |
| — | |
| — |
Issuance of common stock upon stock option exercise |
| 1,500 | |
| 2 | |
| 61,723 | |
| — | |
| — | |
| 61,725 |
Stock compensation expense |
| — | |
| — | |
| 662,770 | |
| — | |
| — | |
| 662,770 |
Repurchases of common stock |
| — | |
| — | |
| — | |
| — | |
| (412,761) | |
| (412,761) |
Net income |
| — | |
| — | |
| — | |
| 4,614,602 | |
| — | |
| 4,614,602 |
Balances - June 30, 2020 |
| 7,826,180 | | $ | 7,826 | | $ | 40,080,279 | | $ | 101,261,129 | | $ | (11,931,796) | | $ | 129,417,438 |
| | | | | | | | | | | | | | | | | |
|
| |
| | |
| Additional |
| | |
| | |
| Stockholders’ | ||
| | Common Stock | | Paid in | | Retained | | Treasury | | Equity | |||||||
| | Shares |
| Amount | | Capital | | Earnings | | Stock | | Total | |||||
Balances - March 31, 2020 | | 7,815,230 | | $ | 7,815 | | $ | 39,856,101 | | $ | 101,145,333 | | $ | (11,740,066) | | $ | 129,269,183 |
Issuance of common stock upon vesting of restricted stock units |
| 9,450 | |
| 9 | |
| (9) | |
| — | |
| — | |
| — |
Issuance of common stock upon stock option exercise |
| 1,500 | |
| 2 | |
| 61,723 | |
| — | |
| — | |
| 61,725 |
Stock compensation expense |
| — | |
| — | |
| 162,464 | |
| — | |
| — | |
| 162,464 |
Repurchases of common stock |
| — | |
| — | |
| — | |
| — | |
| (191,730) | |
| (191,730) |
Net income |
| — | |
| — | |
| — | |
| 115,796 | |
| — | |
| 115,796 |
Balances - June 30, 2020 |
| 7,826,180 | | $ | 7,826 | | $ | 40,080,279 | | $ | 101,261,129 | | $ | (11,931,796) | | $ | 129,417,438 |
| | | | | | | | | | | | | | | | | |
|
| |
| | |
| Additional |
| | |
| | |
| Stockholders’ | ||
| | Common Stock | | Paid in | | Retained | | Treasury | | Equity | |||||||
| | Shares |
| Amount | | Capital | | Earnings | | Stock | | Total | |||||
Balances - December 31, 2018 | | 7,738,167 | | $ | 7,738 | | $ | 36,302,446 | | $ | 72,176,719 | | $ | (10,898,383) | | $ | 97,588,520 |
Issuance of common stock upon stock option exercise |
| 58,063 | | | 58 | |
| 1,736,888 | |
| — | |
| — | |
| 1,736,946 |
Stock compensation expense |
| — | |
| — | |
| 260,466 | |
| — | |
| — | |
| 260,466 |
Repurchases of common stock |
| — | |
| — | |
| — | |
| — | |
| (118,566) | |
| (118,566) |
Net income |
| — | |
| — | |
| — | |
| 10,843,055 | |
| — | |
| 10,843,055 |
Balances - June 30, 2019 |
| 7,796,230 | | $ | 7,796 | | $ | 38,299,800 | | $ | 83,019,774 | | $ | (11,016,949) | | $ | 110,310,421 |
6
| | | | | | | | | | | | | | | | | |
|
| |
| | |
| Additional |
| | |
| | |
| Stockholders’ | ||
| | Common Stock | | Paid in | | Retained | | Treasury | | Equity | |||||||
| | Shares |
| Amount | | Capital | | Earnings | | Stock | | Total | |||||
Balances - March 31, 2019 | | 7,740,167 | | $ | 7,740 | | $ | 36,502,652 | | $ | 76,593,314 | | $ | (10,898,383) | | $ | 102,205,323 |
Issuance of common stock upon stock option exercise |
| 56,063 | |
| 56 | |
| 1,678,470 | |
| — | |
| — | |
| 1,678,526 |
Stock compensation expense |
| — | |
| — | |
| 118,678 | |
| — | |
| — | |
| 118,678 |
Repurchases of common stock |
| — | |
| — | |
| — | |
| — | |
| (118,566) | |
| (118,566) |
Net income |
| — | |
| — | |
| — | |
| 6,426,460 | |
| — | |
| 6,426,460 |
Balances - June 30, 2019 |
| 7,796,230 | | $ | 7,796 | | $ | 38,299,800 | | $ | 83,019,774 | | $ | (11,016,949) | | $ | 110,310,421 |
See accompanying notes to condensed consolidated financial statements.
7
(unaudited)
Nine Months Ended September 30, | ||||||||
| Cash flows from operating activities: | 2017 | 2016 | ||||||
| Net income | $ | 8,683,675 | $ | 8,455,431 | ||||
| Adjustments to reconcile net income to net cash provided by operating activities: | ||||||||
| Amortization | 1,632,823 | 1,215,814 | ||||||
| Stock-based compensation expense | 100,428 | 100,428 | ||||||
| Deferred tax expense | 298,121 | (2,747,864 | ) | |||||
| Changes in operating assets and liabilities: | ||||||||
| Accounts receivable | (871,093 | ) | (1,298,832 | ) | ||||
| Income tax receivable | 437,781 | 916,843 | ||||||
| Prepaid expenses and other current assets | (48,719 | ) | (170,591 | ) | ||||
| Patent costs | - | (23,341 | ) | |||||
| Accounts payable and accrued expenses | 46,626 | 380,858 | ||||||
| Income taxes payable | - | 279,333 | ||||||
| Deferred revenue | (907,776 | ) | 7,667,163 | |||||
| Net cash provided by operating activities | 9,371,866 | 14,775,242 | ||||||
| Cash flows from investing activities: | ||||||||
| Maturity of marketable investments | 43,579,082 | 32,548,040 | ||||||
| Purchases of marketable investments | (50,933,705 | ) | (47,568,734 | ) | ||||
| Net cash used in investing activities | (7,354,623 | ) | (15,020,694 | ) | ||||
| Cash flows from financing activities: | ||||||||
| Proceeds from stock option exercises | 258,250 | 529,300 | ||||||
| Payments for repurchase of common stock | (616,499 | ) | (898,025 | ) | ||||
| Excess tax benefits from share-based payment arrangements | - | 224,047 | ||||||
| Net cash used in financing activities | (358,249 | ) | (144,678 | ) | ||||
| Increase (decrease) in cash and cash equivalents | 1,658,994 | (390,130 | ) | |||||
| Cash and cash equivalents at beginning of year | 4,763,364 | 5,137,875 | ||||||
| Cash and cash equivalents at end of period | $ | 6,422,358 | $ | 4,747,745 | ||||
| Supplemental disclosures of cash flow information: | ||||||||
| Cash paid during the period for: | ||||||||
| Interest | - | - | ||||||
| Taxes | $ | 4,410,000 | $ | 5,825,000 | ||||
| | | | | | |
| | Six Months Ended | ||||
| | June 30, | ||||
|
| 2020 |
| 2019 | ||
Cash flows from operating activities: | | | | | | |
Net income | | $ | 4,614,602 | | $ | 10,843,055 |
Adjustments to reconcile net income to net cash provided by operating activities: | |
|
| |
|
|
Depreciation and amortization | | | 45,919 | | | 228,135 |
Stock-based compensation expense | |
| 662,770 | |
| 260,466 |
Deferred tax expense (benefit) | |
| (176,802) | |
| 159,459 |
Non-cash lease expense | |
| 38,263 | |
| — |
(Accretion) amortization of bond (discount) premium | | | 370,193 | | | (77,499) |
Changes in operating assets and liabilities: | |
|
| |
|
|
Accounts receivable | |
| 7,369,321 | |
| (210,949) |
Income tax payable | |
| 1,318,067 | |
| 173,690 |
Prepaid expenses and other assets | |
| (477,091) | |
| (365,423) |
Patent costs | |
| — | |
| (92,582) |
Accounts payable, accrued expenses and lease obligation | |
| 1,060,916 | |
| (1,087,775) |
Net cash provided by operating activities | |
| 14,826,158 | |
| 9,830,577 |
| | | | | | |
Cash flows from investing activities: | |
|
| |
|
|
Purchases of property and equipment | | | (69,470) | | | — |
Maturities of marketable investments | |
| 60,592,693 | |
| 42,451,229 |
Purchases of marketable investments | |
| (63,126,006) | |
| (53,104,080) |
Net cash used in investing activities | |
| (2,602,783) | |
| (10,652,851) |
| | | | | | |
Cash flows from financing activities: | |
|
| |
|
|
Proceeds from stock option exercises | |
| 61,725 | |
| 1,736,946 |
Payments for repurchase of common stock | |
| (412,761) | |
| (118,566) |
Net cash (used in) provided by financing activities | |
| (351,036) | |
| 1,618,380 |
| | | | | | |
Increase in cash and cash equivalents | |
| 11,872,339 | |
| 796,106 |
Cash and cash equivalents at beginning of year | |
| 4,999,183 | |
| 13,176,452 |
Cash and cash equivalents at end of period | | $ | 16,871,522 | | $ | 13,972,558 |
| | | | | | |
Supplemental disclosures of cash flow information: | |
|
| |
|
|
Cash paid during the period for: | |
|
| |
|
|
Taxes | | $ | 124,256 | | $ | 1,826,362 |
See accompanying notes to condensed consolidated financial statements.
8
BIOSPECIFICS TECHNOLOGIES CORP.
June 30, 2017
(Unaudited)
| 1. | ORGANIZATION AND DESCRIPTION OF BUSINESS |
We are a biopharmaceutical company involved in the development of an injectable collagenase clostridium histolyticum (“CCH”) for multiple indications. We maintain intellectual property with respect to injectable CCH that treats, among other indications, Dupuytren’s contracture (“DC”), Peyronie’s disease (“PD”), cellulite, frozen shoulder syndrome, plantar fibromatosis, and uterine fibroids. Injectable CCH currently have a developmentis approved and marketed in the U.S. under the trademark XIAFLEX® for the treatment of both DC and PD. We generate revenue primarily from our license agreement (the “License Agreement”) with Endo, Global Ventures, a Bermuda unlimited liability company (“Endo Global Ventures”), an affiliate of Endo International plc (“Endo”), for injectable collagenase for marketed indicationsunder which we receive license, sublicense income, royalties, milestones, and indications in development. Endo assumed this agreement when Endo acquired Auxilium Pharmaceuticals, Inc. (“Auxilium”) on January 29, 2015 (the “Acquisition”). Injectable collagenase clostridium histolyticum is marketed as XIAFLEX® (or Xiapex® in Europe).
Endo has opted-in to the following indications: frozen shoulder, cellulite, canine lipoma, lateral hip fat, plantar fibromatosis and human lipoma. Endo exercised, with our consent, an early opt-infiled a biologics license application for lateral hip fat and plantar fibromatosis in November 2015. Endo opted-in for human lipoma in July 2016. We manage the development of XIAFLEX for uterine fibroids and initiate the development of XIAFLEX in new potential indications, not licensed by Endo.
We have developed injectable CCH for 12 clinical indications to date. Under our license agreement with Swedish Orphan Biovitrum AB (“Sobi”), pursuant to which Sobi has marketing rights for Xiapex for Dupuytren’s contracture and Peyronie’s disease in Europe and certain Eurasian countries. In addition, Endo, has an agreement with Asahi Kasei Pharma Corporation (“Asahi”) pursuant to which AsahiEndo has the right to commercialize XIAFLEXfurther develop CCH for frozen shoulder and plantar fibromatosis, as well as certain other licensed indications. Endo has a right to opt-in for use of CCH in the treatment of Dupuytren’s contractureuterine fibroids.
On August 31, 2011, we entered into the Second Amended and Peyronie’s diseaseRestated Development and License Agreement (as amended, the “License Agreement”) with Auxilium Pharmaceuticals, Inc. (“Auxilium”), an entity that was acquired by Endo in Japan.2015. The License Agreement originally was entered into in June 2004 to obtain exclusive worldwide rights to develop, market, and sell certain products containing our enzyme CCH, which Endo markets for approved indications under the trademark XIAFLEX®. Endo’s licensed rights concern the development and commercialization of products, other than dermal formulations labeled for topical administration. Currently, Endo’s licensed rights cover the indications of DC, PD, cellulite, frozen shoulder, plantar fibromatosis, and other potential indications. We and Endo may further expand the License Agreement to cover other indications as they are developed.
On February 26, 2019, we entered into the Second Amendment to the Second Amended and Restated Development and License Agreement (the “Second Amendment”) (effective as of January 1, 2019) to amend certain provisions of the License Agreement to, among other things, require Endo to provide timely estimates of royalties to assist us in complying with our financial reporting obligations. Pursuant to the terms of the Second Amendment, we have consented to the assignment of the License Agreement by Endo Global Ventures to Endo Global Aesthetics Limited, an Irish private company and an affiliate of Endo Global Ventures that is indirectly wholly-owned by Endo.
Under the License Agreement, Endo is currently distributing XIAFLEXresponsible, at its own cost and expense, for developing the formulation and finished dosage form of products and arranging for the clinical supply of products. Endo has the option to license development and marketing rights to these indications based on a full analysis of the data from the clinical trials, which would transfer responsibility for the future development costs to Endo and trigger opt-in payments and potential future milestone and royalty payments to us.
The License Agreement extends, on a country-by-country and product-by-product basis, for the longer of the patent life, the expiration of any regulatory exclusivity period or twelve years from the effective date. Either party may terminate the License Agreement as a result of the other party’s breach or bankruptcy.
Endo must pay us on a country-by-country and product-by-product basis a specified percentage, which typically is in Canada through Paladin Labs Inc, the low double digits, of net sales for products covered by the License Agreement. This royalty applies to net sales by Endo or its sublicensees. Endo also is obligated to pay a percentage of any future regulatory or commercial milestone payments received from such sublicensees. In addition, Endo and its affiliates pay us an operating company of Endo. In December 2016, Endo entered intoamount equal to a new out-licensing agreement with Actelion, pursuant to which Actelion obtained marketing and commercial rights for XIAFLEX in Australia and New Zealand.
9
certain cost of goods related to supply of XIAFLEX® (which mark-up is capped at a specified percentage of the cost of goods of XIAFLEX®) for products sold by Endo and its affiliates.
Endo had previously collaborated with partners to commercialize XIAFLEX® and Xiapex® outside of the United States; however, Endo is in the process of terminating third party partnership agreements for markets outside of the United States, which will reduce the amount of royalty revenues received by us. We do not believe that this reduction will have a material effect on our future consolidated statements of operations.
| 2. | SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES |
Except as detailed below, there have been no material changes to the Company’s significant accounting policies during the sixmonths ended June 30, 2020, as compared to the significant accounting policies disclosed in Note2 of the Consolidated Financial Statements in the Company’s 2019 Annual Report.
Basis of Presentation
The accompanying condensed consolidated financial statements are unaudited, but include all adjustments (consisting only of normal, recurring adjustments) whichthat we consider necessary for a fair presentation of our financial position at such dates and the operating results and cash flows for those periods. Although we believe that the disclosures in our financial statements are adequate to make the information presented not misleading, certain information normally included in financial statements prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) has been condensed or omitted pursuant to the rulesand regulations of the Securities and Exchange Commission (the “SEC”(“SEC”) for quarterly reporting.
The information included in this Quarterly Report on Form10-Q should be read in conjunction with the risk factors discussed herein and in “Part PartI, Item1A. Risk Factors”Factors in our Quarterly Reports on Form 10Q for the periods ended March 31, 2017 and June 30, 20172019 Annual Report filed with the SEC on May 10, 2017 and August 9, 2017, respectively,March16, 2020 and our Annualsubsequent filings and reports, including, without limitation, our Quarterly Report on Form 10-K10-Q for the yearquarter ended December March31, 2016 filed with the SEC on March 16, 2017.
Principles of Consolidation
The condensed consolidated financial statements include the accounts of the CompanyBioSpecifics and its subsidiary, Advance Biofactures Corp. All intercompany balances and transactions have been eliminated.
Risks and Uncertainties
We are subject to risks and uncertainties as a result of the global COVID-19 pandemic. While we expect that COVID-19 will impact our business to some degree, the significance and duration of the impact on our business cannot be determined at this time due to numerous uncertainties, including the ultimate geographic spread of the disease, the duration of the outbreak, travel restrictions and business closures, the effectiveness of actions taken to contain the disease, and other unforeseeable consequences.
Critical Accounting Policies, Estimates and Assumptions
The preparation of condensed consolidated financial statements in conformity with U.S. GAAP requires the use of management’s estimates and assumptions that affect the amounts reported in the condensed consolidated financial statements and accompanying notes. The Company makes certain assumptions and estimates for its deferred taxrevenues, income taxes, and third party royalties. We base our estimates on historical experience, and other relevant data including interim data provided by Endo and on various other assumptions that we believe are reasonable, the results of which form the basis for making judgments about the carrying values of assets, liabilities, and deferred royalty buy-down.the amount of revenues and expenses. Actual results may differ from these estimates under different assumptions or conditions. For further details, see notes “Revenue Recognition,” “Provision for Income Taxes”Taxes,” and “Third-Party RoyaltiesRoyalties.”
Revenue Recognition
Under Accounting Standards Codification (“ASC”) Topic 606, “Revenue from Contracts with Customers” (“ASC 606”), we recognize revenues when our customer obtains control of promised goods or services, in an amount that reflects the consideration which we expect to receive in exchange for those goods or services. We recognize revenues following the five step model prescribed under ASC 606: (i) identify contract(s) with a customer; (ii) identify the performance
10
obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenues when (or as) we satisfy the performance obligation(s).
Revenues, and their respective treatment for financial reporting purposes under ASC 606 and our license agreement with Endo, are as follows:
Royalty Buy-Down.” Actual/ Mark-Up on Cost of Goods Sold
We receive royalty revenues on net sales and mark-up on cost of goods sold revenue in the U.S. under our License Agreement with Endo. These are presented in “Royalties” in our consolidated statements of income. We do not have future performance obligations under this revenue stream. In accordance with ASC 606, we record these revenues based on estimates of the net sales that occurred during the relevant period. The relevant period estimates of these royalties are based on data provided by Endo and analysis of historical royalties and mark-up on cost of goods sold revenue that have been paid to us, adjusted for any changes in facts and circumstances, as appropriate. Differences between actual and estimated royalty revenues are adjusted for in the period in which they become known. The royalties payable by Endo to us are subject to set-off for certain patent costs.
Licensing Revenue
We include revenue recognized from upfront licensing, sublicensing, and milestone payments in “License Revenues” in our consolidated statements of income.
The Company recognizes licensing revenues generated through development and/or commercialization agreements. The terms of these agreements typically include payment to the Company of one or more of the following: nonrefundable, upfront license fees; sublicensing; development and commercial milestone payments; development activities; and royalties on net sales of licensed products. Each of these types of payments results may differin licensing revenues except for revenues from royalties on net sales of licensed products and the mark-up of cost of goods sold revenues which are classified as royalty revenues. Revenue is recognized upon satisfaction of a performance obligation by transferring control of a good or service to the customer.
For each development and/or commercialization agreement that result in revenues, the Company identifies all performance obligations, aside from those estimates.that are immaterial, which may include a license to intellectual property and know-how, development activities, and/or transition activities. In order to determine the transaction price, in addition to any upfront payment, the Company estimates the amount of variable consideration at the outset of the contract either utilizing the expected value or most likely amount method, depending on the facts and circumstances relative to the contract. The Company constrains (reduces) the estimates of variable consideration such that it is probable that a significant reversal of previously recognized revenue will not occur throughout the life of the contract. When determining if variable consideration should be constrained, management considers whether there are factors outside the Company’s control that could result in a significant reversal of revenue. In making these assessments, the Company considers the likelihood and magnitude of a potential reversal of revenue. These estimates are re-assessed each reporting period as required.
If a license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from nonrefundable, upfront license fees based on the relative standalone selling price prescribed to the license compared to the total value of the arrangement. The revenue is recognized when the license is transferred to the collaborator and the collaborator is able to use and benefit from the license. For licenses that are not distinct from other obligations identified in the arrangement, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time. If the combined performance obligation is satisfied over time, the Company applies an appropriate method of measuring progress for purposes of recognizing revenue from nonrefundable, upfront license fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition.
Development and Regulatory Milestone Payments
Depending on facts and circumstances, the Company may conclude that it is appropriate to include the milestone, representing variable consideration, in the estimated total transaction price, or that it is appropriate to fully constrain the milestone. The Company may include revenues from certain milestones in the total transaction price in a reporting period before the milestone is achieved if the Company concludes that achievement of the milestone is probable and that recognition of revenue related to the milestone will not result in a significant reversal in amounts recognized in future
11
periods. The Company records a corresponding contract asset when this conclusion is reached. Milestone payments that have not been included in the transaction price to date are fully constrained. The Company re-evaluates the probability of achievement of such development milestones and any related constraint each reporting period. The Company adjusts its estimate of the total transaction price, including the amount of revenue that it has recorded, if necessary.
Recent Accounting Pronouncements
Accounting Pronouncements Adopted
We adopted ASU No. 2018-13, Fair Value Measurement - Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement as of January 1, 2020. This standard modifies certain disclosure requirements on fair value measurements. The adoption of this guidance did not have a material impact on the Company’s consolidated financial statements and related disclosures.
Accounting Pronouncements Not Yet Adopted
In June 2016, FASB issued ASU 2016-13, Financial Instruments - Credit Losses. The amendment revises the impairment model to utilize an expected loss methodology in place of the currently used incurred loss methodology, which will result in more timely recognition of losses on financial instruments, including, but not limited to, available for sale debt securities and accounts receivable. The Company is required to adopt this standard starting in the first quarter of fiscal year 2023. Early adoption is permitted. We are currently evaluating the impact of the adoption of this standard on our consolidated financial statements and related disclosures.
In December 2019, the FASB issued ASU No. 2019-12, Income Taxes - Simplifying the Accounting for Income Taxes. This standard removes certain exceptions to the general principles of ASC 740 and improves consistent application of and simplifies U.S. GAAP for other areas of Topic 740 by clarifying and amending existing guidance. The Company is required to adopt this standard starting in the first quarter of fiscal year 2021. Early adoption is permitted. We are currently evaluating the impact of the adoption of this standard on our consolidated financial statements and related disclosures.
Cash, Cash Equivalents, and Investments
Cash equivalents include only securities having a maturity of three months90 days or less at the time of purchase. Investments are stated on an amortized cost basis. The Company limits its credit risk associated with cash, cash equivalents, and investments by placing its investments with banks it believes are highly creditworthy and with highly rated money market funds, certificates of deposit, commercial paper, U.S. government agency bonds, municipal bonds, and corporate and municipal bonds. All investments are classified as held to maturity. As of SeptemberJune 30, 20172020, and December31, 2016,2019, the aggregate fair valueamortized cost of these cash, cash equivalents and investments was $61.3$103.0 million and $52.8$100.8 million, respectively.
Fair Value Measurements
Management believes that the carrying amounts of the Company’s financial instruments, including cash, cash equivalents, held to maturityheld-to-maturity investments, accounts receivable, accounts payable, and accrued expenses approximate fair value due to the short-term natureduration of those instruments. As of SeptemberJune 30, 20172020, and December31, 2016,2019, there were no0 recorded unrealized gains or losses on our investments as they are held to maturity. classified as held-to-maturity. As of SeptemberJune 30, 2017,2020, and December31, 2019, amortized cost basis of the investments approximated their fair value. At September For three and six months June 30, 2017 and December 31, 2016,2020, the amortized premiumnet amount included in interest income due to the amortization of bond discounts/premiums was $497,000$266,000 and $610,000,$400,000, respectively. For the three and six months ended June 30, 2019, the net amount included in interest income due to the amortization of bond discounts/premiums was $32,000 and $82,000, respectively. At June 30, 2020 and December 31, 2019, the remaining unamortized net premium / (net discount) was $341,000 and $285,000, respectively.
12
The following table presents the Company’s schedule of maturities at SeptemberJune 30, 20172020 and December31, 2016:
Maturities as of September 30, 2017 | Maturities as of December 31, 2016 | |||||||||||||||
1 Year or Less | Greater than 1 Year | 1 Year or Less | Greater than 1 Year | |||||||||||||
| Municipal bonds | $ | 1,460,078 | $ | - | $ | 6,967,954 | $ | 586,074 | ||||||||
| Corporate bonds | 43,880,944 | 6,472,487 | 30,418,120 | 2,936,287 | ||||||||||||
| Certificates of deposit | 2,825,561 | 244,709 | 6,868,788 | 249,019 | ||||||||||||
| Total | $ | 48,166,583 | $ | 6,717,196 | $ | 44,254,862 | $ | 3,771,380 | ||||||||
| | | | | | | | | | | | | |
| | Maturities as of | | Maturities as of | | ||||||||
| | June 30, 2020 | | December 31, 2019 | | ||||||||
|
| 1 Year or Less |
| Greater than 1 Year |
| 1 Year or Less |
| Greater than 1 Year | | ||||
Municipal bonds | | $ | 10,468,782 | | $ | 2,292,620 | | $ | 11,341,249 | | $ | — | |
Government agency bonds | |
| 3,415,943 | |
| 3,500,000 | |
| 11,950,738 | |
| 6,231,804 | |
US Treasury bonds | | | 6,016,914 | | | — | | | — | | | — | |
Corporate bonds | |
| 57,296,635 | |
| 13,924,557 | |
| 57,321,784 | |
| 6,675,958 | |
Certificates of deposit | |
| 4,982,510 | |
| 1,074,101 | |
| 3,626,147 | |
| 3,661,262 | |
Total | | $ | 82,180,784 | | $ | 20,791,278 | | $ | 84,239,918 | | $ | 16,569,024 | |
The authoritative literature for fair value measurements established a three-tier fair value hierarchy, which prioritizes the inputs in measuring fair value. These tiers are as follows: Level 1, defined as observable inputs such as quoted market prices in active markets; Level 2, defined as inputs other than the quoted prices in active markets that are either directly or indirectly observable; and Level 3, defined as significant unobservable inputs (entity developed assumptions) in which little or no market data exists.
As of SeptemberJune 30, 2017,2020, the Company held certain investments that are required to be measured at fair value on a recurring basis. The following tables present the Company’s fair value hierarchy for these financial assets as of SeptemberJune 30, 20172020 and December31, 2016:2019:
| | | | | | | | | | | | | | |
June 30, 2020 |
| Type of Instrument |
| Fair Value |
| Level 1 |
| Level 2 |
| Level 3 | ||||
Cash equivalents | | Institutional Money Market | | $ | 8,058,112 | | $ | 8,058,112 | | $ | — | | $ | — |
Investments | | Certificates of Deposit | | | 6,056,611 | | | 6,056,611 | | | — | | | — |
Cash equivalents | | Municipal Bonds | | | 2,248,333 | | | | | | 2,248,333 | | | |
Investments | | Municipal Bonds | | | 12,761,402 | | | — | | | 12,761,402 | | | — |
Investments |
| Government Agency Bonds |
| | 6,915,943 |
| | — |
| | 6,915,943 |
| | — |
Investments |
| US Treasury Bonds |
| | 6,016,914 |
| | — |
| | 6,016,914 |
| | — |
Investments | | Corporate Bonds | | | 71,221,192 | | | — | | | 71,221,192 | | | — |
| | | | | | | | | | | | | | |
December 31, 2019 |
| Type of Instrument |
| Fair Value |
| Level 1 |
| Level 2 |
| Level 3 | ||||
Cash equivalents | | Institutional Money Market | | $ | 950,658 | | $ | 950,658 | | $ | — | | $ | — |
Investments | | Certificates of Deposit | | | 7,287,409 | | | 7,287,409 | | | — | | | — |
Investments |
| Municipal Bonds |
| | 11,341,249 |
| | — |
| | 11,341,249 |
| | — |
Investments | | Government Agency Bonds | | | 18,182,542 | | | — | | | 18,182,542 | | | — |
Investments |
| Corporate Bonds |
| | 63,997,742 |
| | — |
| | 63,997,742 |
| | — |
13
September 30, 2017 | Type of Instrument | Fair Value | Level 1 | Level 2 | Level 3 | ||||||||||||
| Cash equivalents | Institutional Money Market | $ | 3,565,530 | $ | 3,565,530 | $ | - | $ | - | ||||||||
| Investments | Municipal Bonds | 1,460,078 | - | 1,460,078 | - | ||||||||||||
| Investments | Corporate Bonds | 50,353,431 | - | 50,353,431 | - | ||||||||||||
| Investments | Certificates of Deposit | 3,070,270 | 3,070,270 | - | - | ||||||||||||
December 31, 2016 | Type of Instrument | Fair Value | Level 1 | Level 2 | Level 3 | ||||||||||||
| Cash equivalents | Institutional Money Market | $ | 2,290,331 | $ | 2,290,331 | $ | - | $ | - | ||||||||
| Investments | Municipal Bonds | 7,554,028 | - | 7,554,028 | - | ||||||||||||
| Investments | Corporate Bonds | 33,354,407 | - | 33,354,407 | - | ||||||||||||
| Investments | Certificates of Deposit | 7,117,807 | 7,117,807 | - | - | ||||||||||||
Concentration of Credit Risk and Major Customers
The Company maintains bank account balances, which, at times, may exceed insured limits. The Company has not experienced any losses with these accounts and believes that it is not exposed to any significant credit risk on cash.
The Company maintains investments in FDIC insured certificates of deposits, municipal bonds, and corporate bonds.
The Company is currently dependent on one1 customer, Endo, whowhich generates almost all itsthe Company’s revenues. For the three and nine monthsthree-and six month periods ended SeptemberJune 30, 2017,2020, licensing, sublicensing, milestones, and royalty revenues under the License Agreement with Endo were approximately $6.5$3.9 million and $20.7$13.6 million, respectively and for the three and ninesix months ended SeptemberJune 30, 2016, the2019, licensing, sublicensing, milestones and royalty revenues under the License Agreement with Endo were approximately $6.9$8.9 million and $19.6$17.0 million, respectively.
At SeptemberJune 30, 20172020 and December31, 2016,2019, our accounts receivable balances from Endo were $4.7$11.7 million and $3.8$19.1 million, respectively.
Treasury Stock
The Company accounts for treasury stock under the cost method and includes treasury stock as a component of stockholders’ equity. For the ninesix months ended SeptemberJune 30, 2017,2020, we repurchased 12,0487,573 shares at an average price of $51.17 as compared to$54.50. For the repurchase of 24,020six months ended June 30, 2019, there were 2,048 shares repurchased at an average price of $37.39$57.89. The stock repurchase program terminated in the corresponding 2016 period.
Receivables and Doubtful Accounts
Trade accounts receivable are stated at the amount the Company expects to collect. We may maintain allowances for doubtful accounts for estimated losses resulting from the inability of our customers to make required payments. We consider the following factors when determining the collectability of specific customer accounts: customer credit-worthiness, past transaction history with the customer, current economic industry trends, and changes in customer payment terms. Our accounts receivable balance is typically due from Endo, our onesingle large specialty pharmaceutical customer. Endo has historically paid timely and has been a financially stable organization. Due to the nature of the accounts receivable balance, we believe the risk of doubtful accounts is minimal.minimal and therefore no allowance is recorded. If the financial condition of our customerEndo were to deteriorate, adversely affecting its ability to make payments, additional allowances would be required. We may provide for estimated uncollectible amounts through a charge to earnings and a credit to a valuation allowance. Balances that remain outstanding after we have used reasonable collection efforts are written off through a charge to the valuation allowance and a credit to accounts receivable. At SeptemberJune 30, 20172020 and December31, 20162019, our accounts receivable balance was $4.7$11.7 million and $3.8$19.1 million, respectively, and was from one1 customer, Endo.
Third-Party Royalties
We have entered into licensing and royalty agreements with third parties and agreed to pay certain royalties on net sales of products for specific indications. The royalty rates differ from agreement to agreement and, in certain cases, have been redacted with the permission of the SEC.agreement. No assumptions should be made that any disclosed royalty rate payable to a particular third party is the same or similar with respect to any royalty rate payable to any other third parties. We accrue third-party royalty expenses on net sales reported to us by Endo. Third-party royalty costs are generally expensed under general and administrative in the quarter that Endo provides the written reports and related information to us; that is, generally one quarter following the quarter in which the underlyingnet sales by Endohave occurred. For the three and ninethree-and six month periods ended SeptemberJune 30, 2017,2020, third-party royalty expenses were $0.4$0.1 million and $1.4$0.2 million, respectively. For the three and ninesix month periods ended SeptemberJune 30, 2016,2019, third-party royalty expenses were $0.4$0.2 million and $1.2$0.6 million, respectively. OurAs of June 30, 2019, we have no further third-party royalty expense under general and administrative expenses may increase if net sales by Endo and its partners for XIAFLEX and Xiapex increase and potential new indications for XIAFLEX and Xiapex are approved, marketed and sold.
Royalty Buy-Down
On March31, 2012, we entered into an amendment to our existing agreement with Dr.Martin K. Gelbard, dated August27, 2008, related to our future royalty obligations in connection with Peyronie’s disease.PD. The amendment enables us to buy down a portion of our future royalty obligations in exchange for an initial cash payment of $1.5 million and five5 additional cash payments of $600,000, fourall of which have been paid as of September 30, 2017. We are currently making the payments to buy down the future royaltyJanuary1, 2018. Royalty obligations which royalty obligations terminateterminated five years after the first commercial sale, which occurred in January2014. Accordingly, we ceased paying royalties in February2019. The Company amortizes long-term contracts with finite lives in a manner that reflects the pattern in which the economic benefits of the assets are consumed or otherwise used up. Dr.Gelbard’s agreement is amortized based on an income
14
forecast method by estimating sales of XIAFLEXXIAFLEX® and XiapexXiapex® for Peyronie’s diseasePD on an annual basis as measured by the proportion of the total estimated sales over the five year period. For the three and ninesix months ended SeptemberJune 30, 2017,2019 we amortized approximately $0.4 million0 and $1.1$0.2 million related to this agreement, respectively, related to this agreement and $0.2 millionis recorded as part of general and $0.7 million for the three and nine months ended September 30, 2016, respectively.administrative expenses. As of Septemberboth June 30, 20172020 and December31, 2016, the2019, there were no remaining capitalized balances were approximately $2.3 million and $3.4 million, respectively. We perform an evaluation of the recoverability of the carrying valueoutstanding related to determine if facts and circumstances indicate that the carrying value of the assets may be impaired and if any adjustment is warranted. As of September 30, 2017, there was no indicator that an impairment existed.
Research and Development Expenses
R&D expenses
include, but are not limited to, internal costs, such as salaries and benefits, costs of materials, lab expense, facility costs, and overhead. R&D expenses also consist ofClinical Trial Expenses
Our cost accruals for clinical trials are based on estimates of the services received and efforts expended pursuant to contracts with various clinical trial centers and clinical research consultants.organizations. In the normal course of business, we contract with third parties to perform various clinical trial activities in the ongoing development of potential drugs. The financial terms of these agreements are subject to negotiation and vary from contract to contract and may result in uneven payment flows. Payments under the contracts depend on factors such as the achievement of certain events, the successful enrollment of patients, the completion of portions of the clinical trial, or similar conditions. The objective of our accrual policy is to match the recording of expenses in our financial statements to the actual cost of services received and efforts expended. As such, expenses related to each patient enrolled in a clinical trial are recognized ratably beginning upon entry into the trial and over the course of the patient’s continued participation in the trial. In the event of early termination of a clinical trial, we accrue an amount based on our estimate of the remaining non-cancelable obligations associated with the winding down of the clinical trial. Our estimates and assumptions could differ significantly from the amounts that may actually be incurred.
Stock-Based Compensation
ASC 718, Compensation - Stock Compensation (“ASC 718”), requires the recognition of compensation expense, using a fair-value based method, for costs related to all stock optionsawards including stock options and common stock issued to our employees and directors under our stock plans. ASC 718 requires companies to estimate the fair value of stock option awards on the date of grant using an option-pricing model. The fair value of each service-based restricted stock unit granted is estimated on the day of grant based on the closing price of the Company’s common stock. The value of the portion of the award that is ultimately expected to vest is recognized as expense on a straight-line basis over the requisite service periods in our condensed consolidated statements of operations.
Under ASC 718, we estimate the fair valueCompany’s 2019 Omnibus Incentive Compensation Plan (the “Plan”), grants to employees, key advisors, on non-employee directors may consist of our employeeincentive stock optionoptions, non-qualified stock options, stock appreciation rights, restricted stock, restricted stock units, other stock-based awards, ator cash awards. As of June 30, 2020, options to purchase 232,187 shares of common stock and 4,036 restricted stock awards were outstanding under the Plan, and a total of 1,098,612 shares remained available for grant under the Plan. Grants under the Plan vest over periods ranging from one to four years and expire ten years from date of grant using the Black-Scholes option-pricing model, which requires the usegrant.
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2019 Omnibus Incentive Compensation Plan (2019 Plan)
Restricted Stock Awards
A summary of the expected volatility of the market price of ourrestricted stock and the expected term of an award. When establishing an estimate of the expected term of an option award, we consider the vesting period for the award, our recent historical experience of employee stock option exercises (including forfeitures) and the expected volatility of our common stock. As required under the accounting rules, we review our estimates at each grant date and, as a result, the valuation assumptions that we use to value employee stock-based awards granted in future periods may change. No stock options were grantedactivity during the ninesix months ended SeptemberJune 30, 2017 and 2016.
| | | | | |
|
| |
| Weighted- | |
| | | | Average Grant | |
| | | | Date Fair Value | |
| | Restricted Stock | | Per Share | |
Nonvested at December 31, 2019 |
| 10,450 | | $ | 60.47 |
Issued |
| 5,036 | |
| 55.71 |
Vested |
| (11,450) | |
| 59.60 |
Forfeited |
| — | |
| — |
Nonvested at June 30, 2020 |
| 4,036 | | $ | 57.00 |
Stock-based compensation expense related to restricted stock awards recognized in general and administrative expenses expense was approximately $33,000$193,000 and $100,000$337,000 for eachthe three month and ninesix month periods ended SeptemberJune 30, 20172020, respectively, and approximately $33,000 and $100,0000 for the three and nine monthssix month periods ended SeptemberJune 30, 2016, respectively.
As of June 30, 2020, there was $181,000 of total unrecognized compensation cost related to non-vested share-based compensation arrangements related to restricted stock. This cost is expected to be recognized over the vesting periods of the restricted stock, with a weighted-average period of 1.00 year.
Stock Option Activity
For the sixmonths ended June 30, 2020, we granted a total of 182,000 stock options with a weighted average grant date fair value of $61.37 per share.
The assumptions used in the valuation of stock options granted during the sixmonths ended June 30, 2020 were as follows:
| | | | |
|
| | Six Months Ended |
|
| | | June 30, 2020 | |
Risk-free interest rate |
| | 0.34% - 1.61% |
|
Expected term of option |
| | 5.5 - 6.25 years |
|
Expected stock price volatility |
| | 39.5% - 41.5% |
|
Expected dividend yield | | $ | 0.0 | |
A summary of our stock option activity during the ninesix months ended SeptemberJune 30, 20172020 is presented below:
| Shares | Weighted Average Exercise Price | Weighted Average Remaining Contractual Term | Aggregate Intrinsic Value | |||||||||||||
| Outstanding at December 31, 2016 | 297,000 | $ | 20.14 | 3.10 | $ | 10,561,380 | ||||||||||
| Grants | - | - | - | - | ||||||||||||
| Exercised | (20,000 | ) | 12.91 | - | - | |||||||||||
| Forfeitures or expirations | - | - | - | - | ||||||||||||
| Outstanding at September 30, 2017 | 277,000 | $ | 20.66 | 2.49 | $ | 7,162,770 | ||||||||||
| Exercisable at September 30, 2017 | 242,000 | $ | 18.90 | 2.20 | $ | 6,683,370 | ||||||||||
| | | | | | | | | | |
|
| |
| | |
| Weighted |
| | |
| | | | Weighted | | Average | | Aggregate | ||
| | | | Average | | Remaining | | Intrinsic | ||
| | Shares | | Exercise Price | | Contractual Term | | Value | ||
Outstanding at December 31, 2019 |
| 189,187 |
| $ | 46.79 |
| 8.62 |
| $ | 1,920,684 |
Grants |
| 182,000 |
| | 61.37 |
| — |
| | — |
Exercised |
| (1,500) |
| | 41.15 |
| — |
| | — |
Forfeited |
| (137,500) |
| | 55.79 |
| — |
| | — |
Outstanding at June 30, 2020 |
| 232,187 |
| $ | 56.02 |
| 8.12 |
| $ | 1,222,261 |
Exercisable at June 30, 2020 |
| 52,687 | | $ | 39.70 |
| 2.50 | | $ | 1,136,761 |
During the nine monthssix-month periods ended SeptemberJune 30, 20172020 and 2016,2019, the Company received $0.3$0.1 million and $0.5$1.7 million, respectively, from stock options exercised by option holders.
Aggregate intrinsic value represents the total pre-tax intrinsic value based on the closing price of our common stock of $46.52$61.28 on SeptemberJune 30, 2017,2020, which would have been received by the option holders had all option holders exercised their options as of that date. We have approximately $169,000$4.3 million in unrecognized compensation cost related to stock options outstanding as of SeptemberJune 30, 2017,2020, which we expect to recognize over the next 1.58.1 years.
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Stock-based compensation expense related to stock options recognized in general and administrative expenses was a credit of $31,000 for the three months ended June 30, 2020 and $136,000 for the six month period ended June 30, 2020, and $119,000 and $260,000 for the three and six month periods ended June 30, 2019, respectively. The credit for the three months ended June 30, 2020 was the result of the reversal of $200,000 of previously recognized stock compensation expense due to forfeitures that occurred during the period. In addition, stock compensation expense related to restructuring associated with the acceleration of vesting of certain stock options and restricted stock units was $190,000 for the three months ended March 31, 2020 (see Note 7).
Property and Equipment
Property and equipment are stated at cost, less accumulated depreciation. Machinery and equipment, furniture and fixtures, andautos are depreciated on a straight-line basis over their estimated useful lives of five to ten years. Leasehold improvements are amortized over the lesser of their estimated useful lives or the remaining life of the lease. At eachJune 30, 2020, total property and equipment consisted of September 30, 2017furniture and fixtures of $65,000 with an expected useful life of five years. At December 31, 2016,2019, all property and equipment were fully depreciated.
Comprehensive Income
For each of the three and nine monthsix-month periods ended SeptemberJune 30, 20172020 and 2016,2019, we had no0 components of other comprehensive income other than net income itself.
Provision for Income Taxes
We use the asset and liabilitiesliability method of accounting for income taxes, as set forth in ASC 740-10-25-2. Under this method, deferred income taxes, when required, are recognized basedprovided on the expected future tax consequences, using current tax rates,basis of temporary differencesthe difference between the financial statement carrying amountsreporting and the income tax basis of assets and liabilities.liabilities at the statutory rates enacted for future periods when the differences are expected to reverse. A valuation allowance is applied against any net deferred tax asset if, based on the weighted available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized.
The Company recognizes a tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination by taxing authorities, based on the technical merits of the position. The tax benefits recognized in the consolidated financial statements from such position are measured based on the largest benefit that has a greater than 50% likelihood of being realized upon the ultimate settlement. As of SeptemberJune 30, 20172020 and December31, 2016,2019, the Company has not0t recorded any unrecognized tax benefits.
Commitments and Contingencies
We determine if an arrangement includes a lease at inception. Right-of-use lease assets and lease liabilities are recognized based on the Company entered intopresent value of the future minimum lease payments over the lease term at the commencement date. The right-of-use lease asset includes any lease payments made and excludes lease incentives. Incremental borrowing rate is used in determining the present value of future payments. We apply a portfolio approach to the property leases to apply an agreementincremental borrowing rate to leases with similar lease terms. The lease terms may include options to extend or terminate the Landlordlease. We recognize the options to extend the termlease as part of the right-of-use lease toassets and lease liabilities only if it is reasonably certain that the Headquartersoption would be exercised. Lease expense for an additional one year period (the “Extended Lease Agreement”). The one year extension will endminimum lease payments is recognized on November 30, 2018. Pursuant toa straight-line basis over the Extended Lease Agreement, the base rent is $11,165 per month and the Company may cancel thenon-cancelable lease with three months’ prior written notice to the Landlord at any time during the term. The Extended Lease Agreement was filed withadoption of the SECnew standard as Exhibit 10.1 to the Company’s Quarterly Report on Form 10Q on November 9, 2017.
In December 2019, we recorded a right-of-use lease asset of $243,000, a short-term lease liability of $76,000, and a long-term lease liability of $167,000 associated with the lease of our new headquarters in Wilmington, Delaware.
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The following table summarizes the maturity of the Company’s lease obligations on an undiscounted cash flow basis and a reconciliation to the operating lease liabilities recognized on our balance sheet as of June 30, 2020 and December 31, 2019:
| | | | | | |
|
| June 30, 2020 |
| December 31, 2019 | ||
2020 |
| $ | 41,210 | | $ | 75,352 |
2021 |
| | 84,893 | | | 84,893 |
2022 |
| | 87,428 | | | 87,428 |
Total lease payments |
| | 213,531 | | | 247,673 |
Less: interest |
| | (8,149) | | | (11,560) |
Total lease obligation | | $ | 205,382 | | $ | 236,113 |
On January7, 2020, the Company provided three months’ notice to 35 Wilbur Street Associates, LLC of the Company’s intent to terminate the lease agreement for our former corporate headquarters, located at 35 Wilbur St., Lynbrook, New York 11563. Accordingly, the lease terminated on April7, 2020. As the lease provided the Company the option to cancel the lease by giving threemonths’ prior written notice, the Company did not incur any termination penalties.
Total operating lease expenses amounted to $23,000 and $80,000 for the three and ninesix month period ended June 30, 2020 and $34,000 and $67,000 for the three and six months period ended SeptemberJune 30, 2017.
The recent outbreak of this guidance may resultthe novel coronavirus (COVID-19) resulted in a different patterndecrease in revenues of recognition than under current us GAAP. We plan53% from the second quarter of 2020 as compared to adopt this guidance effective January 1, 2018, as required. We understandthe second quarter of 2019. Since XIAFLEX® is used primarily in elective procedures, which have been curtailed during the outbreak, and based on public statements made by Endo, the Company believes that the adoptionCOVID-19 outbreak may have a material adverse effect on its business and financial results until the easing of ASC 606,the restrictions that have been imposed as a result of the outbreak.
On June 12, 2020, the Company filed an arbitration demand against the Research Foundation of the State University of New York for and particularlyon behalf of Stony Brook University (“Research Foundation”) seeking a declaration that one of its former employees is a co-inventor of the standards enhanced useResearch Foundation’s patent for the treatment of management estimates,cellulite (U.S. Patent No. 10,123,959, which has an expiration date of February 7, 2027), and challenging the potentialResearch Foundation’s prospective rights to materially impact our revenue recognition process, opening balances and related disclosures. We areroyalties under the Cellulite License Agreement dated August 23, 2007, which is described in the processCompany’s most recent annual report on Form 10-K. This is a private and confidential arbitration administered by the American Arbitration Association. On July 9, 2020, the Research Foundation filed a response, denying the allegations of completing the analysisdemand and making a counterclaim alleging principally that the Company is in breach of ASC 606’s impactits obligations under the Cellulite License Agreement. The Company has responded to the counterclaim, denying the allegations and requesting judgment in its favor on our royaltyall claims. However, should the Research Foundation prevail in this arbitration, it could have a material adverse effect on the Company’s future financial results. See “Subsequent Events” (Note 8) for disclosure concerning FDA approval and licensing revenuepostponement of commercial launch of the cellulite indication.
Stockholders’ Equity
At the Company’s annual meeting of stockholders held on June 12, 2020 (the “2020 Annual Meeting”), the stockholders approved an amendment to the Company’s Certificate of Incorporation, as amended, to increase the authorized number of shares of common stock from 10,000,000 shares to 15,000,000 shares.
On April 10, 2020, the Board approved an amendment to the Company's Rights Agreement, dated as of May 14, 2002 and expectamended June 19, 2003, February 3, 2011, March 5, 2014, May 27, 2016, and May 11, 2018 (the “Original Rights Agreement”), by and between the Company and Worldwide Stock Transfer, LLC (successor in interest to complete this processOTC Corporate Transfer Service Company), as rights agent (the “Rights Agent”). The amendment, which was subsequently executed on that date by the Company and the Original Rights Agent, changes the Final Expiration Date (as defined in the fourth quarterOriginal Rights Agreement) of 2017.
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Also, on April 10, 2020, the Board approved and disclosure requirementsadopted a Rights Agreement, dated as of April 10, 2020 (the “Rights Agreement”), by and between the Company and the Rights Agent. Pursuant to the Rights Agreement, the Board declared a dividend of 1 preferred share purchase right (each, a “Right”) for financial instruments. All equity investments in unconsolidated entities (other than those accounted for undereach outstanding share of common stock, par value $0.001, of the equity methodCompany (each, a “Common Share" and, collectively, the “Common Shares”). The Rights are distributable to stockholders of accounting) will generally be measured at fair value with changes in fair value recognized through earnings. There will no longer be an available-for-sale classification (changes in fair value reported in other comprehensive income (loss) for equity securities with readily determinable fair values)record as of the close of business on April 21, 2020 (the “Record Date”). In addition, the FASB clarified the need for a valuation allowance on deferred tax assets resulting from unrealized losses on available-for-sale debt securities. In general, the new guidance will require modified retrospective application to all outstanding instruments, with a cumulative effect adjustment recorded to opening retained earnings. This guidanceNaN Right also will be effective for us on January 1, 2018. We are currently evaluatingissued together with each Common Share issued by the expected impactCompany after April 21, 2020, but before the Distribution Date (as defined in the Rights Agreement) (or the earlier redemption or expiration of the Rights) and, in certain circumstances, after the Distribution Date.
Generally, the Rights Agreement works by causing substantial dilution to any person or group that acquires beneficial ownership of 20 percent (20%) or more of the standard could have on our consolidated financial statementsCommon Shares without the approval of the Board. As a result, the overall effect of the Rights Agreement and related disclosure but we dothe issuance of the Rights may be to render more difficult or discourage a merger, tender or exchange offer or other business combination involving the Company that is not currently haveapproved by the Board. The Rights Agreement is not intended to interfere with any available-for-sale equity investments.
A proposal to ratify the new guidance, lessees will be required to recognizeadoption by the following for all leases (withBoard of the exception of short-term leases)Rights Agreement was approved by the stockholders at the lease commencement date: a lease liability, which is a lessee’s obligation to make lease payments arising from a lease, measured on a discounted basis; and a right-of-use asset, which is an asset that represents the lessee’s right to use, or control the use of, a specified asset for the lease term. Under the new guidance, lessor accounting is largely unchanged. Certain targeted improvements were made to align, where necessary, lessor accounting with the lessee accounting model and Topic 606,
| 3. | NET INCOME PER SHARE |
In accordance with Accounting Standards CodificationASC 260, Earnings Per Share, basic net income per share amount is computed using the weighted-average number of shares of common stock outstanding during the periods presented, while diluted net income per share is computed using the sum of the weighted-average number of common and common equivalent shares outstanding. Common equivalent shares used in the computation of diluted earnings per share result from the assumed exercise of stock options and restricted stock awards using the treasury stock method.
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2017 | 2016 | 2017 | 2016 | |||||||||||||
| Stock options | 20,000 | 20,000 | 20,000 | 20,000 | ||||||||||||
| 4. | ACCOUNTS PAYABLE AND ACCRUED EXPENSES |
Accounts payable and accrued expenses consisted of the following:
| | | | | | | |
| | June 30, | | December 31, | | ||
|
| 2020 |
| 2019 |
| ||
Trade accounts payable | | $ | 346,270 | | $ | 197,077 | |
Accrued legal and other professional fees | |
| 883,069 | |
| 330,787 | |
Accrued payroll, severance, and related costs | |
| 638,089 | |
| 209,330 | |
Third-party royalties | |
| 62,000 | |
| 228,000 | |
Restructuring accrual | | | 59,678 | | | — | |
Other accruals | |
| 100,950 | |
| 33,215 | |
Total | | $ | 2,090,056 | | $ | 998,409 | |
| 5. | |
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September 30, 2017 | December 31, 2016 | |||||||
| Trade accounts payable | $ | 218,020 | $ | 505,098 | ||||
| Accrued legal and other professional fees | 233,240 | 51,000 | ||||||
| Accrued payroll and related costs | 244,045 | 182,551 | ||||||
| Other accruals | 89,970 | - | ||||||
| Total | $ | 785,275 | $ | 738,649 | ||||
| 5. | PATENT COSTS |
We amortize intangible assets with definite lives on a straight-line basis over their remaining estimated useful lives, ranging from two to ten years, and review for impairment on a quarterly basis and when events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable. We analyze our intangible assets, specifically,As of June30, 2020 and December31, 2019, 0 impairment existed, and no adjustments were warranted.
NaN costs were capitalized patent costs, on an annual basis for any indicator that an impairment exist.
September 30, 2017 | December 31, 2016 | |||||||
| Patents | $ | 720,601 | $ | 720,601 | ||||
| Accumulated amortization | (492,733 | ) | (462,246 | ) | ||||
| $ | 227,868 | $ | 258,355 | |||||
| | | | | | | |
| | June 30, | | December 31, | | ||
|
| 2020 | | 2019 | | ||
Patents | | $ | 1,272,625 |
| $ | 1,272,625 | |
Accumulated amortization | |
| (740,636) | |
| (699,348) | |
| | $ | 531,989 | | $ | 573,277 | |
The amortization expense for patents for the three and ninesix months ended SeptemberJune 30, 20172020 was approximately $10,200 $20,000 and $30,500,$41,000 respectively, and for the three and ninesix months ended SeptemberJune 30, 20162019 was approximately $10,300 $24,000 and $29,600,$43,000, respectively. The estimated aggregate amortization expense for the remaining three sixmonths of 20172020 and each of theyears below is approximately as follows:
| | | |
July 1, 2020 – December 31, 2020 |
| $ | 41,300 |
2021 | |
| 65,400 |
2022 | |
| 65,400 |
2023 | |
| 65,400 |
2024 | |
| 65,400 |
Thereafter | |
| 229,100 |
| 6. | |
| October 1, 2017 - December 31, 2017 | $ | 10,200 | ||
| 2018 | 40,600 | |||
| 2019 | 40,600 | |||
| 2020 | 28,600 | |||
| 2021 | 16,600 | |||
| Thereafter | 91,300 |
Our deferred tax liabilities and deferred tax assets are impacted by events and transactions arising in the ordinary course of business, R&D activities, vesting of nonqualified options and other items. The provision for income taxes we consider all available information, including operating results, ongoingis based on an estimated effective tax planning,rate derived from our consolidated earnings before taxes, adjusted for nondeductible expenses and forecasts of future taxable income.other permanent differences for the fiscal year. The significant components of the Company’s deferred tax assets consist of stock-based compensation and deferred revenues. For the three and nine months ended September 30, 2017, the provision for income taxes for the three and six month periods ended June 30, 2020 was $1.5$24,000 and $1.2 million, respectively, and for the three and six month periods ended June 31, 2019 was $1.1 million and $4.7$2.2 million, respectively. As of September June30, 20172020 and December31, 2016,2019, our remainingnet deferred tax assetsliabilities were approximately $3.0$0.4 and $0.6 million, respectively.
The estimated effective tax rate for the three and $3.3 million, respectively.
The estimated effective tax rate for the three and ninesix months ended SeptemberJune 30, 2016,2019 was 14% and 17%, respectively, of pre-tax income reported in the provisionperiod, calculated based on the estimated annual effective rate anticipated for the year ending December 31, 2019 plus the effects, if any, of certain discrete items occurring in 2019.
On March 27, 2020, the Coronavirus Aid, Relief and Economic Security Act (“CARES Act”) was enacted in response to the COVID-19 pandemic. The CARES Act made various tax law changes including, among other things, (i) increasing the limitation under IRC Section 163(j) for 2019 and 2020 to permit additional expensing of interest, (ii) enacting a technical correction so that qualified improvement property can be immediately expensed under IRC Section 168(k) and (iii) making modifications to the federal net operating loss rules including permitting federal net operating losses incurred in 2018, 2019, and 2020 to be carried back to the five preceding taxable years in order to generate a refund of previously paid taxes. The income taxes was $1.8 million and $4.5 million, respectively.
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| 7. | RESTRUCTURING AND SEPARATION COSTS |
On January 7, 2020, we announced that we would be relocating our corporate headquarters from Lynbrook, New York to Wilmington, Delaware as of April 7, 2020. On January 6, 2020, in connection with this relocation, we notified 5 employees and 1 consultant that their services would no longer be required effective March 31, 2020. On March 23, 2020, the 5 employees and 1 consultant were given separation agreements detailing the termination benefits to which they would be entitled.
As a result, we recorded a one-time restructuring charge of $1.1 million in the first quarter of fiscal 2020. The restructuring charge is associated with $0.9 million of one-time termination benefits that we expect to pay out in cash over a period of six months and $0.2 million of one-time non-cash termination expenses associated with the acceleration of vesting of certain stock options and restricted stock units. The estimated liability for termination benefits was recorded at fair value during the first quarter of 2020 as a current liability in the consolidated balance sheet. These termination benefits consist of severance payments, reimbursement of benefits payments, and guaranteed consulting payments. Total charges and payments related to the restructuring plan recognized in the consolidated statement of operations are as follows:
| | | |
| | Six Months Ended | |
| | June 30, | |
|
| 2020 | |
Restructuring accrual, January 1, 2020 | | $ | — |
Termination costs | | | 1,070,024 |
Facility exit costs | | | 76,020 |
Payments | | | (895,934) |
Stock compensation expense charged to additional paid-in-capital | | | (190,432) |
Restructuring accrual, June 30, 2020 | | $ | 59,678 |
On April 6, 2020, the Company and Mr. J. Kevin Buchi mutually agreed that Mr. Buchi would step down as Chief Executive Officer and as a director of the Company, effective immediately. The Company and Mr. Buchi have entered into a separation agreement that details the termination benefits to which he is entitled. The Company recorded $0.6 million in separation costs related to this agreement in general and administrative expenses for the three and six months ended June 30, 2020. The remaining accrual of $0.5 million at June 30, 2020 is included in accounts payable and accrued expenses and will be paid out over the next 9 months.
8. SUBSEQUENT EVENTS
On July 6, the FDA granted approval of the cellulite indication, but Endo has postponed the commercial launch until the first half of 2021, citing the effects of the COVID-19 pandemic on the market for aesthetic treatments. The Company reiterates its policy stated in its most recent annual report on Form 10-K not to announce publicly royalty rates for potential future indications under development before commercialization. It is important to emphasize that in-licensing royalty rates vary from indication to indication and it should not be assumed that the in-licensing royalty rates for potential future indications will be the same as those for currently marketed indications.
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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with the condensed
Overview
We are a biopharmaceutical company involved in the development of an injectable collagenase clostridium histolyticum (“CCH”) for multiple indications. We currently have a development and license agreement (the “License Agreement”) with Endo Global Ventures, a Bermuda unlimited liability company (“Endo Global Ventures”), an affiliateCollagenases are naturally occurring enzymes responsible for the breakdown of Endo International plc (“Endo”), for injectable collagenase for marketed indications and indicationscollagen, which is the main structural protein in development. Endo assumed this agreement when Endo acquired Auxilium Pharmaceuticals, Inc. (“Auxilium”) on January 29, 2015 (the “Acquisition”). Injectable collagenase clostridium histolyticum is marketed as XIAFLEX® (or Xiapex®the extracellular matrix in Europe).
We maintain intellectual property with respect to the First Amendment, weinjectable CCH that treats, among other indications, Dupuytren’s contracture (“DC”), Peyronie’s disease (“PD”), cellulite, frozen shoulder syndrome, plantar fibromatosis, and Endo mutually agreed that in exchange for a $8.25 million lump sum payment, we will not receive future additional mark-up on cost of goods sold for sales by non-affiliated sublicensees of Endo outside of the U.S.; provided, however, that Endo will still be required to pay a mark-up on cost of goods sold for sales made in the “Endo Territory,” which includes sales madeuterine fibroids. Injectable CCH currently is marketed in the U.S. and sales made in any other country whereby our partner Endo sellsunder the product directly or through affiliated sublicensees. We received this $8.25 million lump sum payment in February 2016 and began recognizing this income over time based on sales by non-affiliated sublicensees of Endo outside of the U.S. according to our revenue recognition policy in the second quarter of 2016.
Endo filed a biologics license application for CCH for the treatment of cellulite with the FDA. On July 6, 2020, Endo announced that it received FDA approval of Qwo™ (collagenase clostridium histolyticum- aaes) for the treatment of moderate to severe cellulite in the buttocks of adult women. Endo anticipate Qwo™ to be available commercially in the U.S. starting in the first half of 2021. Endo dosed the first patient in a clinical trial in plantar fibromatosis in June 2020 and adhesive capsulitis, also known as frozen shoulder, in July 2020. Adhesive capsulitis is an inflammation and thickening of the shoulder capsule due to collagen which causes decreased motion in the shoulder. Plantar fibromatosis is a non-malignant thickening of the feet’s deep connective tissue or fascia. There are currently no FDA-approved pharmaceutical therapies available to treat either condition.
We have developed injectable CCH for 12 clinical indications to date. Under our license agreement with Endo, Endo has the right to further develop CCH for frozen shoulder and plantar fibromatosis, as well as certain other licensed indications. Endo has a right to opt-in for use of CCH in the treatment of uterine fibroids.
Second Quarter Highlights and Outlook
| ● | Royalty revenues from XIAFLEX for the quarter decreased by 56% primarily as a result of physician office closures and a decline in patients electing to be treated due to the COVID-19 pandemic. Endo expects revenues to begin to recover during the remainder of 2020 as physician and patient activities continue returning toward pre-COVID-19 levels. |
| ● | In July 2020, Qwo™ (collagenase clostridium histolyticum-aaes), the first and only U.S Food and Drug Administration (FDA)-approved injectable treatment for cellulite was approved by the FDA. Endo’s commercial launch is expected to occur in the first half of 2021. |
| ● | Endo dosed the first patient in a clinical trial in plantar fibromatosis in June 2020 and adhesive capsulitis, also known as frozen shoulder, in July 2020. Plantar fibromatosis is a non-malignant thickening of the feet's deep connective tissue or fascia that occurs in five to 11 percent of the adult population in the U.S. Adhesive capsulitis is an inflammation and thickening of the shoulder capsule due to collagen which causes decreased motion in the shoulder that occurs in two to five percent of the adult population in the U.S. There are currently no FDA-approved pharmaceutical therapies available to treat either condition. |
Impact of COVID-19
The outbreak of COVID-19 has adversely impacted the U.S. and global economies. Our revenues declined by 56% from the second quarter of 2020 as compared to the second quarter of 2019 as a result of royalties associated with lower net sales due to the impact of COVID-19, including, but not limited to the effect of significant office closures and less office visits for physician-administered products. Based on public disclosures made by Endo, we currently anticipate that
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revenues from our license agreement with Endo will begin to recover during the remainder of 2020 as patient activities return to pre-COVID-19 levels. We also currently expect full year 2020 revenues to decline compared to full-year 2019 revenues.
License Agreement with Endo
We generate revenue from one source, our license agreement with Endo (the “License Agreement”), under which we receive license, sublicense income, royalties, milestones, and mark-up on cost of goods sold payments related to the sale, regulatory submissions, and approval of XIAFLEX® as described above.
Under the License Agreement, Endo is responsible, at its own cost and expense, for developing the formulation and finished dosage form of products and arranging for the clinical supply of products. Endo has the option to license development and marketing rights to these indications based on a full analysis of the data from the clinical trials, which would transfer responsibility for the future development costs to Endo and trigger opt-in payments and potential future milestone and royalty payments to us.
Endo must pay us on a country-by-country and product-by-product basis a specified percentage, which typically is in the low double digits, of net sales for products covered by the License Agreement. This royalty applies to net sales by Endo or its sublicensees. Endo also is obligated to pay a percentage of any future regulatory or commercial milestone payments received from such sublicensees. In addition, Endo and its affiliates pay us an amount equal to a specified mark-up on certain cost of goods related to supply of XIAFLEX® (which mark-up is capped at a specified percentage of the cost of goods of XIAFLEX®) for products sold by Endo and its affiliates.
Endo had previously collaborated with partners to commercialize XIAFLEX® and Xiapex® outside of the United States; however, Endo is in the process of terminating third-party partnership agreements for markets outside of the United States, which will reduce the amount of royalty revenues received by us. We do not believe that this reduction will have a material effect on our future consolidated statements of operations.
Significant Risks
We are dependent to a significant extent on third parties, and our principal licensee, Endo, may not be able to continue successfully commercializing XIAFLEXXIAFLEX® for Dupuytren’s contractureDC and Peyronie’s disease,PD, successfully develop XIAFLEXXIAFLEX® for additional indications, obtain required regulatory approvals, manufacture XIAFLEXXIAFLEX® at an acceptable cost, in a timely manner and with appropriate quality, or successfully market products or maintain desired margins for products sold, and, as a result, we may not achieve sustained profitable operations.
The Company maintains bank account balances, which, at times, may exceed insured limits. The Company has not experienced any losses with these accounts and believes that it is not exposed to any significant credit risk on cash. The Company maintains its investment in FDIC insuredmoney market funds, certificates of deposits with several banks,deposit, commercial paper, U.S. government agency bonds, municipal bonds, and corporate bonds.
The Company is subject to risks and uncertainties as a result of the global COVID-19 pandemic. While we expect that COVID-19 will impact our business to some degree, the significance and duration of the impact on our business cannot be determined at this time due to numerous uncertainties, including the ultimate geographic spread of the disease, the duration of the outbreak, travel restrictions and business closures, the effectiveness of actions taken to contain the disease, and other unforeseeable consequences.
For more information regarding the risks facing the Company, please see the risk factors discussed under the heading “Risk Factors” under Part II, Item 1A of1A. herein, under Part 2II, Item 1A. of our Quarterly ReportsReport on Form 10Q10-Q for the periodsquarter ended March 31, 2017 June 30, 2017 filed with the SEC on May 10, 20172020, and filed with the SEC on August 9, 2017, respectively and under item 1AItem 1A. of Part 1 of our 2019 Annual Report on Form 10-K for the year ended December 31, 2016 filed with the SEC on March 16, 2017.
Critical Accounting Policies, Estimates and Assumptions
The preparation of condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. These estimates are based on historical experience, interim data provided by
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Endo, and on various other assumptions that we believe are reasonable under the circumstances. The financial information at SeptemberJune 30, 20172020 and for the three and nine monthssix month periods ended SeptemberJune 30 2017, 2020 and 20162019 is unaudited but includes all adjustments (consisting only of normal recurring adjustments) which, in the opinion of management, are necessary to state fairly the financial information set forth herein. The December 31, 20162019 balance sheet amounts and disclosures included herein have been derived from the Company’s December 31, 20162019 audited consolidated financial statements. The interim results are not necessarily indicative of results to be expected for the full fiscal year. These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements for the year ended December 31, 20162019 included in the Company’s 2019 Annual Report on Form 10-KReport.
As described in Note2to our accompanying Condensed Consolidated Financial Statements, there have been no significant changes to our critical accounting policies for the three and withsix month periods ended June 30, 2020, compared to the unaudited condensed consolidated financial statementscritical accounting policies disclosed in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our Quarterly Reports on Form 10-Q for the first and second quarter of 2017 filed with the SEC. While our significant accounting policies are described in more detail in the notes to our unaudited condensed consolidated financial statements, we believe the following accounting policies to be critical to the judgments and estimates used in the preparation of our unaudited condensed consolidated financial statements. Actual results have differed in the past, and may differ in the future, from our estimates and could impact our earnings in any period during which an adjustment is made.
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RESULTS OF OPERATIONS
THREEMONTHS ENDED JUNE30, 2020 COMPARED TO THREEMONTHS ENDED JUNE30, 2019
Revenues
We recognizegenerate revenue for delivered elements only when the fair values of undelivered elements are known, when the associated earnings process is complete and, to the extent the milestone amount relates to our performance obligation, when our licensee confirms that we have met the requirements under the terms of the agreement, and when payment is reasonably assured. Changes in the allocation of the contract value between various deliverable elements might impact the timing of revenue recognition, but in any event, would not change the total revenue recognized on the contract. For example, nonrefundable upfront product license fees for product candidates for which we are providing continuing services related to product development are deferred and recognized as revenue over the development period.
Royalties
Royalties consist of royalties and the mark-up on cost of goods sold under the License Agreement. Total royalty and mark-up on cost of goods sold for the three monththree-month period ended SeptemberJune 30, 20172020 were $6.5$3.9 million as compared to $6.1$8.9 million in the corresponding 20162019 period, an increaserepresenting a decrease of $0.4$4.9 million or 7%56%. This increaseThe decrease in royalties andtotal revenues for the mark-up on cost of goods soldquarterly period was primarily due to the increase inroyalties associated with lower net sales of XIAFLEX for the treatment of Peyronie’s disease and Dupuytren’s contracture partially offset by lower mark-up on cost of goods sold revenue.
Research and Development Activities and Expenses
R&D expenses include, but are not limited to, internal costs, such as salaries and benefits, costs of materials, lab expenses, facility costs, and overhead. R&D expenses also consist of third partythird-party costs, such as medical professional fees, product costs used in clinical trials, consulting fees, and costs associated with clinical study arrangements. For the three month periods ended SeptemberJune 30, 20172020 and 2016,2019, R&D expenses were approximately $357,000$160,000 and $313,000, respectively and in each case, are primarily related to the development work associated with our clinical programs, preclinical and other R&D programs.
We manage the development of XIAFLEXXIAFLEX® for uterine fibroids and initiate the development of XIAFLEXXIAFLEX® in new potential indications, not licensed by Endo.
Three Months Ended September 30, 2017 | Three Months Ended September 30, 2016 | |||||||
Program | ||||||||
| Human Lipoma | $ | - | $ | 100,973 | ||||
| Uterine Fibroids | 129,276 | 18,762 | ||||||
| Pre-clinical/other research projects | 227,571 | 193,172 | ||||||
The successful development of drugs is inherently difficult and uncertain. Our business requires investments in R&D over many years, often for drug candidates that may fail during the R&D process. Even if the Company is able to successfully complete the development of our drug candidates, our long-term prospects depend upon our ability and the ability of our partners, particularly with respect to XIAFLEX and Xiapex,XIAFLEX®, to continue to commercialize these drug candidates.
There is significant uncertainty regarding our ability to successfully develop drug candidates in other indications. These risks include the uncertainty of:
| the nature, timing, and estimated costs of the efforts necessary to complete the development of our drug candidate projects; |
| the anticipated completion dates for |
| the scope, rate of progress, and cost of |
| the scope, rate of progress of |
| clinical trial results for |
| the cost of filing, prosecuting, defending, and enforcing any patent claims and other intellectual property rights relating to |
| the terms and timing of any strategic alliance, licensing, and other arrangements that we have or may establish in the future relating to our drug candidate projects; |
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| costs relating to future product opportunities; |
| ● | the cost and timing of regulatory approvals with respect to |
| the cost of establishing clinical supplies for our drug candidate projects. |
We believe that our current resources and liquidity are sufficient to advance our current clinical and R&D projects.
General and Administrative Expenses
General and administrative expenses consist primarily of salaries and other related costs for personnel, third-party royalty fees, amortization of deferred royalty buy-down, consultant costs, legal fees, investor relations, professional fees, and overhead costs. General and administrative expenses for the three monthsthree-month periods ended September June30, 20172020 and 20162019 were $2.2$4.0 million and $1.8$1.7 million, respectively. The increaseIncreases in general and administrative expenses was mainly due to thean increase in headcount and associated compensation costs, separation costs, legal fees, amortization of the deferred royalty buy-down,stock compensation expense, consulting fees, and third party royalties.
Other Income
Other income for the three months ended SeptemberJune 30, 20172020 was approximately $208,000$391,000 compared to $87,000$517,000 in the corresponding 20162019 period. Other income consists of interest earned on our investments. The decrease is due to lower returns on investments and product sales of collagenase for laboratory use.
Provision for Income Taxes
Our deferred tax liabilities and deferred tax assets are impacted by events and transactions arising in the ordinary course of business R&D activities, vesting of nonqualified options, deferred revenuesincluding stock-based compensation, revenue and other items. The provision for income taxes is based on an estimated effective tax rate derived from an estimate of condensed consolidated earnings before taxes, adjusted for nondeductible expenses and other permanent differences for the fiscal year.leases. For the three monththree-month period ended SeptemberJune 30, 2017,2020, our provision for income taxes was $1.5$24,000. Our deferred tax liabilities as of June 30, 2020 were $0.4 million. The estimated effective tax rate for the three months ended June 30, 2020 was 17% of pre-tax income reported in the period, calculated based on the estimated annual effective rate anticipated for the year ending December 31, 2020 plus the effects of certain discrete items occurring in 2020. For the three-month period ended June 30, 2019, our provision for income taxes was $1.1 million. Our deferred tax assets as of SeptemberJune 30, 20172019 were $3.0$0.2 million. ForOur effective tax rate for the three monthmonths ended June 30, 2019 was 14%. Our effective tax rate was also impacted by the discrete impact of current period ended September 30, 2016,stock option exercises which impacts the provision for income taxes was $1.8 million.
Net Income
For the three months ended SeptemberJune 30, 2017,2020, we recorded net income of $2.7$0.1 million, or $0.38$0.02 per basic common share and $0.37$0.02 per diluted common share, compared to a net income of $3.1$6.4 million, or $0.43$0.88 per basic common share and $0.42$0.87 per diluted common share, for the same period in 2016.
SIX MONTHS ENDED SEPTEMBERJUNE 30, 20172020 COMPARED TO NINESIX MONTHS ENDED SEPTEMBERJUNE 30, 2016
Revenues
We generate revenue primarily from royalties under the License Agreement and, to a lesser degree, licensing fees, sublicensing fees, and milestones.
Royalties
Royalties consist of royalties and the mark-up on cost of goods sold under the License Agreement. Total royalty and mark-up on cost of goods sold for the ninesix month period ended SeptemberJune 30, 20172020 were $20.7$13.6 million as compared to $18.8$17.0 million in the corresponding 20162019 period, an increaserepresenting a decrease of $1.9$3.4 million, or 10%20%. This increaseThe decrease in royalties and the mark-up on cost of goods soldtotal revenues was primarily due to the increase inroyalties associated with lower net sales of XIAFLEX for the treatment of Peyronie’s disease and Dupuytren’s contracture.
Research and Development Activities and Expenses
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R&D expenses include, but are not limited to, internal costs, such as salaries and benefits, costs of materials, lab expenses, facility costs and overhead. R&D expenses also consist of third party costs, such as medical professional fees, product costs used in clinical trials, consulting fees, and costs associated with clinical study arrangements. For the ninesix month periods ended SeptemberJune 30, 20172020 and 2016,2019, R&D expenses were approximately $0.9$0.3 million and $1.0$0.3 million, respectively, and in each case, are primarily related to the development work associated with our clinical, programs, preclinical and other R&D programs.
We manage the development of XIAFLEXXIAFLEX® for uterine fibroids and initiate the development of XIAFLEXXIAFLEX® in new potential indications, not licensed by Endo.
Nine Months Ended September 30, 2017 | Nine Months Ended September 30, 2016 | |||||||
Program | ||||||||
| Human Lipoma | $ | - | $ | 352,073 | ||||
| Uterine Fibroids | 357,409 | 111,782 | ||||||
| Pre-clinical/other research projects | 591,950 | 542,029 | ||||||
The successful development of drugs is inherently difficult and uncertain. Our business requires investments in R&D over many years, often for drug candidates that may fail during the R&D process. Even if the Company is able to successfully complete the development of our drug candidates, our long-term prospects depend upon our abilityand the ability of our partners, particularly with respect to XIAFLEX and Xiapex,XIAFLEX® to continue to commercialize these drug candidates.
There is significant uncertainty regarding our ability to successfully develop drug candidates in other indications. These risks include the uncertainty of:
| the nature, timing and estimated costs of the efforts necessary to complete the development of our drug candidate projects; |
| the anticipated completion dates for our drug candidate projects; |
| the scope, rate of progress and cost of our clinical trials that we are currently running or may commence in the future with respect to our drug candidate projects; |
| the scope, rate of progress of our preclinical studies and other R&D activities related to our drug candidate projects; |
| clinical trial results for our drug candidate projects; |
| the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights relating to our drug candidate projects; |
| the terms and timing of any strategic alliance, licensing and other arrangements that we have or may establish in the future relating to our drug candidate projects; |
| the cost and timing of regulatory approvals with respect to our drug candidate projects; and |
| the cost of establishing clinical supplies for our drug candidate projects. |
We believe that our current resources and liquidity are sufficient to advance our current clinical and R&D projects.
General and Administrative Expenses
General and administrative expenses consist primarily of salaries and other related costs for personnel, third-party royalty fees, amortization of deferred royalty buy-down, consultant costs, legal fees, investor relations, professional fees and overhead costs. General and administrative expenses for the ninesix months ended SeptemberJune 30, 20172020 and 20162019 were $6.9$7.2 million and $5.9$4.6 million, respectively. The increase in general and administrative expenses was mainly due to the increased third party patent and legal fees, amortization of the deferred royalty buy-down, third party royalties,an increase in headcount and consultingassociated payroll costs, separation costs, stock compensation expense and directors fees, partially offset by lower investor relations.third party royalties associated with XIAFLEX®.
Restructuring Charges
On January 7, 2020, we announced that we would be relocating our corporate headquarters from Lynbrook, New York to Wilmington, Delaware as of April 7, 2020. On January 6, 2020, in connection with the relocation, we notified five employees and one consultant that their services would no longer be required effective March 31, 2020. On March 23, 2020, the five employees and one consultant were given separation agreements detailing the termination benefits to which they would be entitled. As a result, we recorded a one-time restructuring charge of $1.1 million in the first quarter of fiscal 2020. The restructuring charge is primarily associated with $0.9 million of one-time termination benefits that we expect
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to pay out in cash over the six- month period beginning April 2020 and $0.2 million of one-time non-cash termination expenses associated with the acceleration of vesting of certain stock options and restricted stock units.
Other Income
Other income for the ninesix months ended SeptemberJune 30, 20172020 was approximately $477,000$0.9 million compared to $238,000$1.0 million in the corresponding 20162019 period. Other income consists of interest earned on our investments and product sales of collagenase for laboratory use.
Provision for Income Taxes
Our deferred tax liabilities and deferred tax assets are impacted by events and transactions arising in the ordinary course of business R&D activities, vesting of nonqualified options, deferred revenuesincluding stock-based compensation, revenue and other items. The provision for income taxes is based on an estimated effective tax rate derived from an estimate of condensed consolidated earnings before taxes, adjusted for nondeductible expenses and other permanent differences for the fiscal year.leases. For the ninesix month period ended SeptemberJune 30, 2017,2020, our provision for income taxes was $4.7$1.2 million. Our taxes payabledeferred tax liabilities as of SeptemberJune 30, 20172020 were reduced by $28,000 due to$0.4 million. The estimated effective tax rate for the windfall associated withsix months ended June 30, 2020 was 21% of pre-tax income reported in the disqualified saleperiod, calculated based on the estimated annual effective tax rate anticipated for the year ending December 31, 2020 plus the effects of incentive stock options andcertain discrete items occurring in 2020. For the exercise of nonqualified options.six month period ended June 30, 2019, our provision for income taxes was $2.2 million. Our deferred tax assets as of SeptemberJune 30, 20172019 were $3.0$0.2 million. The estimated effective tax rate for the three months ended June 30, 2019 was 17% of pre-tax income reported in the period, calculated based on the estimated annual effective tax rate anticipated for the year ending December 31, 2019 plus the effects of certain discrete items occurring in 2019 including current period stock option exercises.
Net Income
For the nine month period ended September 30, 2016, the provision for income taxes was $4.5 million.
Liquidity and Capital Resources
To date, we have financed our operations primarily through product sales, licensing revenues and royalties under agreements with third parties and sales of our common stock.
At SeptemberJune 30, 20172020 and December 31, 2016,2019, we had cash and cash equivalents and investments in the aggregate of approximately $61.3$119.8 million and $52.8$105.8 million, respectively. We currently anticipate that our available funds and cash flow from operations will be sufficient to meet our operational cash needs for at least the next 12 months from the date of this filing.
On June 26, 2020, we filed a shelf registration statement on Form S-3, which we subsequently amended on July 15, 2020, relating to the sale, from time to time, in one or more transactions, of up to $200,000,000 of common stock, preferred stock, debt securities, warrants, and units (the “Shelf Registration Statement”). The Shelf Registration Statement was declared effective on July 17, 2020. As of July 31, 2020, $200,000,000 remained available for issuance under the Shelf Registration Statement. As set forth in the Shelf Registration Statement, the Company expects to use a substantial portion of the net proceeds from the sale of securities under the Shelf Registration Statement for general corporate purposes; the Company, however, has not allocated the net proceeds for specific purposes.
Net cash provided by operating activities for the ninesix months ended SeptemberJune 30, 2017 and 20162020 was $9.4 million and $14.8 million respectively.as compared to $9.8 million in the 2019 period. Net cash provided by operating activities in the 20172020 period was primarily attributable to our net income plus a reduction in accounts receivable of $8.7$7.4 million and increases in accounts payable, accrued expenses and lease obligation of $1.1 million and an increase in operating assets and liabilitiesincome taxes payable of $1.3 million of which $0.9 million was related to an increase in accounts receivable due to sales of XIAFLEX.million. Non-cash items included amortization, stock-based compensation expense, and deferred taxes which was reduced by adjustmentsused to reconcile net income to net cash provided by operating activities of $2.0 million.$0.9 million included amortization of patent costs and bond premiums and discounts, deferred tax benefits, and stock-based compensation expense. Net cash provided by operating activities in the 20162019 period was primarily attributable to our net income partially offset by a reduction in accounts payable and accrued expenses of $8.5$1.1 million and an increase in operating assets and liabilitiesprepaid expenses of $7.8 million of which $7.7 million was related to the First Amendment with Endo for mark-up on cost of goods sold for sales by non-affiliated sublicensees of Endo outside of the U.S.$0.4 million. Non-cash items included amortization, stock-based compensation expense, and deferred taxes which was reduced by adjustmentsused to reconcile net income to net cash provided by operating activities of $1.4 million.
Net cash used byin investing activities for the ninesix months ended SeptemberJune 30, 20172020 was $7.4$2.6 million as compared $15.0to net cash used in investing activities of $10.7 million for the corresponding 20162019 period. The net cash used in investing activities in the 2017
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2020 period reflects the investment of $63.1 million and the maturing of $43.6 million and investment of $50.9$60.6 million in marketable securities. The net cash used in investing activities in the 20162019 period reflects the investment of $53.1 million and the maturing of $32.5 million and investment of $47.6$42.5 million in marketable securities.
Net cash used in financing activities for the ninesix months ended SeptemberJune 30, 20172020 was approximately $358,000$0.4 million as compared to approximately $145,000net cash provided by financing activities of $1.6 million in the corresponding 20162019 period. In the 20172020 period, net cash used in financing activities was mainly due to the repurchase of approximately $616,000 of our common stock under our stock repurchase program partially offset the proceeds received from stock option exercises of approximately $258,000. In the 2016 period, net cash used in financing activities was mainly due to the repurchase of $898,000$0.4 million of our common stock under our stock repurchase program partially offset by proceeds received from stock option exercises of approximately $529,000 and$62,000. In the excess tax benefits related2019 period, net cash provided by financing activities was due to share-based paymentsproceeds received from stock option exercises of $224,000.
Off-Balance Sheet Arrangements
We do not have any off-balance sheet arrangements as defined in Item 303(a)(4) of Regulation S-K.
Not applicable.
Item4. Controls and long-term obligations. We consider investments that, when purchased, have a remaining maturity of three months or less to be cash equivalents.
Evaluation of Disclosure Controls and Procedures
We maintain disclosure controls and procedures as of the end of the period covered by this Quarterly Report on Form 10-Q. Based on that evaluation, Thomas L. Wegman, in his capacity as the sole named executive officer of the Company, the Company’s Principal Executive Officer and the Company’s Principal Financial Officer, concluded that the Company’s disclosure controls and procedures are effectivedesigned to ensureprovide reasonable assurance that information required to be disclosed by it in our reports the Company files or submits under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms, of the SEC, and that such material information is accumulated and communicated to the Company’s management of the Company (“Management”), including its Principal Executive Officerour principal executive officer and Principal Financial Officer,our principal financial officer, as appropriate, to allow timely decisions regarding required disclosure. Because ofIn designing and evaluating the inherent limitations in all control systems,disclosure controls and procedures, Management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives,objectives.
The Company, under the supervision and management necessarily is required to applywith the participation of our principal executive officer and principal financial officer, evaluated the effectiveness of its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Furthermore, the Company’sdisclosure controls and procedures can(as defined in Rules 13a-15(e) or 15d-15(e) under the Exchange Act) as of the end of the period covered by this Quarterly Report. Based on that evaluation, our principal executive officer and principal financial officer concluded, as of the end of the period covered by this Quarterly Report, that the Company’s disclosure controls and procedures were effective in the timely and accurate recording, processing, summarizing, and reporting of material financial and non-financial information within the time periods specified within the SEC’s rules and forms. Our principal executive officer and principal financial officer also concluded that our disclosure controls and procedures were effective to ensure that information required to be circumvented bydisclosed in the individual acts of some persons, by collusion of tworeports that we file or more people or by management override of such control,submit under the Exchange Act is accumulated and misstatements duecommunicated to error or fraud may occurour Management, including our principal executive officer and not be detected on aprincipal financial officer, to allow timely basis.
Changes in Internal Controls
There were no changes in our internal controlscontrol over financial reporting (as defined in Rules 13a–15(f) and 15d–15(f) under the Exchange Act) that occurred during the quarterthree months ended SeptemberJune 30, 20172020 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
PARTII: OTHER INFORMATION
Item1. Legal Proceedings
On June12, 2020, the Company filed an arbitration demand against the Research Foundation of the State University of New York for and on behalf of Stony Brook University (“Research Foundation”) seeking a declaration that one of its former employees is a co-investor of the Research Foundation’s patent for the treatment of cellulite (U.S. Patent No. 10,123,959, which has an expiration date of February7, 2027), and challenging the Research Foundation’s prospective
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rights to royalties under the Cellulite License Agreement dated August23, 2007, which is described in the Company’s 2019 Annual Report. This is a private and confidential arbitration administered by the American Arbitration Association. On July9, 2020, the Research Foundation filed a response denying the allegations of the demand and making a counterclaim alleging principally that the Company is in breach of its obligations under the Cellulite License Agreement. The Company has responded to the counterclaim, denying the allegations and requesting judgment in its favor on all claims. However, should the Research Foundation prevail in this arbitration, it could have a material adverse effect on the Company’s future financial results. See Note 8, “Subsequent Events,” for disclosure concerning FDA approval and postponement of commercial launch of the cellulite indication.
Item1A. Risk Factors
Our business may be adversely affected by the ongoing coronavirus pandemic.
COVID-19 has resulted in global business and economic disruption and extreme volatility in the financial markets as many jurisdictions have placed restrictions on travel and non-essential business operations and implemented social distancing, shelter-in-place, quarantine, and other similar measures for their residents to contain the spread of the virus. The extent to which the coronavirus impacts our operations will depend on future developments, which are highly uncertain and cannot be predicted at this time, and include the duration, severity, and scope of the outbreak and the actions taken to contain or treat the coronavirus outbreak.
The continued spread of COVID-19 globally could materially and adversely impact our operations including without limitation, future clinical trial operations, regulatory approval and the timing thereof, the operations of our collaboration partners, travel, and employee health and availability which may have a material and adverse effect on our business, financial condition, and results of operations. Specifically, depending upon the length and severity of the pandemic, COVID-19 could impact:
| Our future clinical trial plans, specifically with respect to uterine fibroids; |
| Endo’s development programs for the CCH treatment of plantar fibromatosis and adhesive capsulitis; |
| Endo’s commercialization and launch of CCH treatment for cellulite which has already been postponed until 2021 because of the pandemic; and |
| ● | Endo’s ability to manufacture, market, and sell XIAFLEX® with respect to DC and PD. |
In addition, a recession, depression or other sustained adverse market event could materially and adversely affect the financial markets, our business, the value of our common stock and our royalty streams. The coronavirus pandemic continues to rapidly evolve. The ultimate impact of the coronavirus pandemic on us is highly uncertain and subject to change and will depend on future developments, which cannot be accurately predicted.
COVID-19 could materially and adversely affect Endo’s business, which in turn would impact our business.
As we are dependent upon revenue from Endo, Endo’s operating success or failure has a significant impact on our potential royalty stream and other payment rights. Accordingly, the following impacts of COVID-19 on Endo’s business, could materially affect our business.
In response to public health directives and orders, Endo has implemented alternative working practices and work-from-home requirements for appropriate employees, as well as social distancing, modified schedules, shift rotation, and other similar policies at its manufacturing facilities. Endo launched a hybrid approach selling model as of June 1, 2020 for its field employees, which allows virtual and/or live engagement with healthcare providers and other customers. Endo has also suspended international and domestic travel. The effects of COVID-19, including these public health directives and orders, have had an impact on Endo’s business and may in the future materially disrupt its business (including its manufacturing and supply chain operations by significantly reducing its output), negatively impacting its productivity, and delaying its product development programs.
COVID-19 may have significant impacts on third-party arrangements, including those with Endo’s manufacturing, supply chain, and distribution partners, information technology and other service providers and business partners. For example, there may be significant disruptions in the ability of any or all of Endo’s third-party providers to meet their obligations to Endo on a timely basis, or at all, which may be caused by their own financial or operational difficulties, including any
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closures of their facilities pursuant to a governmental order or otherwise. Due to these disruptions and other factors, including changes in Endo’s workforce availability, Endo’s ability to meet its obligations to third-party distribution partners may be negatively impacted. As a result, Endo has delivered, and in the future Endo or its third-party providers may deliver, notices of the occurrence of a force majeure or similar event under certain of its third-party contracts, which could result in prolonged commercial disputes and ultimately legal proceedings to enforce contractual performance and/or recover losses. Further, the publicity of any such dispute could harm Endo’s reputation and make the negotiation of any replacement contracts more difficult and costly, thereby prolonging the effects of any resulting disruption in Endo’s operations. Such disruptions could be acute with respect to certain of its raw material suppliers where Endo may not have readily accessible alternatives or alternatives may take longer to source than usual. Any of these disruptions could harm Endo’s ability to manufacture XIAFLEX®.
Endo has experienced, and expects to continue to experience, changes in customer demand as the COVID-19 pandemic evolves. The current economic crisis and rising unemployment rates resulting from COVID-19 have the potential to significantly reduce individual disposable income and depress consumer confidence, which could limit the ability of some consumers to purchase certain pharmaceutical products and reduce consumer spend on certain medical procedures in both the short- and medium-term. Additionally, as part of the measures to address COVID-19, certain healthcare providers are not currently performing various medical procedures, including those that use XIAFLEX®. For example, during the last two weeks of the first quarter of 2020 and continuing into the second quarter of 2020, XIAFLEX® began experiencing significantly decreased sales volumes due to reduced physician office activity and patient office visits compared to prior year because of the COVID-19 pandemic.
Additionally, Endo’s product development programs have been, and may continue to be, adversely affected by the global pandemic and the prioritization of production during this pandemic. The public health directives in response to COVID-19 requiring social distancing and restricting non-essential business operations have in certain cases caused and may continue to cause delays, increased costs, and additional challenges in Endo’s product development programs, including obtaining adequate patient enrollment and successfully bringing product candidates to market. In addition, Endo may face additional challenges receiving regulatory approvals as previously scheduled dates or anticipated deadlines for action by the FDA on its applications and products in development could be subject to delays beyond Endo’s control as regulators such as the FDA focus on COVID-19. For example, as a result of COVID-19 and its impact on medical aesthetics physician office closures and consumer spending, Endo has moved the anticipated product launch of Qwo™ to the first half of 2021. In addition, Endo has assessed, and expects to continue to assess, the timeline for the development and commercialization of other products, which could include CCH treatment for frozen shoulder and plantar fibromatosis.
The magnitude of the effect of COVID-19 on Endo’s business will depend, in part, on the length and severity of the restrictions (including the effects of recent “re-opening” actions and plans following a recent slowdown of the virus infection rate in certain countries and localities) and other limitations on Endo’s ability to conduct its business in the ordinary course. The extent, length and consequences of the pandemic are uncertain and impossible to predict, but could be material.
In addition to the other information contained elsewhere in this Quarterly Report on Form10-Q, you should carefully consider the risk factors discussed in “PartI, Item1A. Risk Factors” in our Quarterly Reports on Form 10Q for the periods ended March 31, 20172019 Annual Report and June 30, 2017 filed with the SEC on May 10, 2017 and August 9, 2017, respectively andunder Part II, Item 1A. of our AnnualQuarterly Report on Form 10-K10-Q for the yearquarter ended December March31, 2016 filed with the SEC on March 16, 2017,2020, which could materially affect our business, financial condition or future results.
Item2. Unregistered Sales of Equity Securities and Use of Proceeds
During the nine monthsix-month period ended SeptemberJune 30, 2017,2020, we did not issue any unregistered equityshares of securities.
Issuer Purchases of Equity Securities
On May23, 2019, the Company announced the authorization of a new stock repurchase program under which we can repurchase up to$4 millionof our outstanding common stock.Pursuant to the repurchase program, from time to time we repurchase stock through a broker in the open market, provided that the timing, actual number and price per share of the common stock to be purchased will be subject to market conditions, applicable legal requirements, including Rule10b-18 of the Exchange Act, and various other factors. The stock repurchase program terminated in May 2020.
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The following table presents a summary of share repurchases made by us during the quartersix months ended September June30, 2017.2020.
| | | | | | | | | | | ||
|
| |
| | |
| |
| Maximum | |||
| | | | | | | Total Number of | | Number (or | |||
| | | | | | | Shares | | Dollar Value) of | |||
| | Total Number | | Average | | Purchased as | | Shares that May | ||||
| | of Shares | | Price Paid | | Part of Publicly | | Yet be Purchased | ||||
Period | | Purchased (1) | | Per Share (2) | | Announced Plan |
| under the Plan (3) | ||||
Remaining balance as of December 31, 2019 | | |
| |
|
|
|
| $ | 3,379,349 | ||
January 1, 2020 – January 31, 2020 | | 1,709 | | $ | 56.66 |
| 13,096 |
| | 3,282,509 | ||
February 1, 2020 – February 29, 2020 | | 848 | | $ | 61.39 |
| 13,944 |
| | 3,230,446 | ||
March 1, 2020 – March 31, 2020 | | 1,510 | | $ | 47.77 |
| 15,454 | | | 3,158,318 | ||
April 1, 2020 – April 30, 2020 | | 2,677 | | $ | 53.93 |
| 18,131 | | | 3,013,957 | ||
May 1, 2020 – May 31, 2020 | | 829 | | $ | 57.14 |
| 18,960 | | $ | 2,966,587 | ||
Total | | 7,573 | | | | | | | | | ||
| Period | Total Number of Shares Purchased (2) | Average Price Paid Per Share (3) | Total Number of Shares Purchased as Part of Publicly Announced Plan | Maximum Number (or Dollar Value) of Shares that may yet be Purchased under the Plan | ||||||||||||
| $ | 144,328 | (1) | ||||||||||||||
| July 1, 2017 – July 31, 2017 | 1,555 | $ | 50.77 | 273,804 | 65,384 | |||||||||||
| August 1, 2017 – August 31, 2017 | 1,210 | 48.59 | 275,014 | 6,950 | ||||||||||||
| September 1, 2017 – September 30, 2017 | - | - | - | - | ||||||||||||
| (1) |
| The purchases were made in open-market transactions in compliance with Exchange Act Rule10b-18 or under the company’s 10b-18 plan. |
| (2) | Includes commissions paid, if any, related to the stock repurchase transactions. |
| (3) | On May23, 2019, we announced that our Board of Directors had authorized the repurchase of up to $4.0 million of our common stock under the stock repurchase program. This program terminated in May 2020. |
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3.1 | ||
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3.2 | ||
| | |
4.1 | ||
| | |
10.1 | ||
| | |
10.2 | ||
| | |
10.3 | ||
| | |
10.4 | ||
| | |
10.5* | Amendment to Letter Agreement, dated June 4, 2020, by and between the Company and Patrick Hutchison | |
| | |
10.6* | Employment Agreement, dated June 19, 2020, by and between the Company and Alex Monteith | |
| | |
31.1** | ||
| | |
31.2** | ||
| | |
32.1** | ||
| | |
101.INS | XBRL Instance Document – the | |
| | |
101.SCH | Inline XBRL Taxonomy Extension Schema | |
| | |
101.CAL | Inline XBRL Taxanomy Extension Calculation Linkbase Document | |
| | |
101.DEF | Inline XBRL Taxanomy Extension Definition Linkbase Document | |
| | |
101.LAB | Inline XBRL Taxonomy Extension Labels Linkbase Document | |
| | |
101.PRE | Inline XBRL Taxonomy Extension Presentation Linkbase Document | |
| | |
104 | Cover Page Interactive Data File (Embedded within the Inline XBRL document and | |
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.
| |
| BIOSPECIFICS TECHNOLOGIES CORP. |
| |
| |
Date: | /s/ |
| Joseph Truitt |
| Chief Executive Officer and Principal Executive Officer |
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