IntelGenx Technologies Corp. - Quarter Report: 2020 June (Form 10-Q)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
[X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended June 30, 2020
or
[ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from _________ to________
Commission File Number 000-31187
INTELGENX TECHNOLOGIES CORP.
(Exact name of small business issuer as specified in its charter)
Delaware | 87-0638336 |
(State or other jurisdiction of | (I.R.S. Employer Identification No.) |
incorporation or organization) |
6420 Abrams, Ville Saint Laurent, Quebec H4S 1Y2, Canada
(Address of principal executive offices)
(514) 331-7440
(Issuer's telephone number)
(Former Name, former Address, if changed since last report)
Indicate by checkmark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Yes [X] No [ ]
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", "non-accelerated filer" and "smaller reporting company" in Rule 12b-2 of the Exchange Act.
Large accelerated filer [ ] Accelerated filer [ ]
Non-accelerated filer [ ] (Do not check if a smaller reporting company) Smaller reporting company [X]
APPLICABLE ONLY TO ISSUERS INVOLVED IN BANKRUPTCY
PROCEEDS DURING THE PRECEDING FIVE YEARS
Indicate by check mark whether the registrant has filed all documents and reports required to be filed by Sections 12, 13, or 15(d) of the Securities Exchange Act of 1934 subsequent to the distribution of securities under a plan confirmed by a court.
Yes [ ] No [ ]
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [ ]
APPLICABLE TO CORPORATE ISSUERS:
110,259,653 shares of the issuer's common stock, par value $.00001 per share, were issued and outstanding as of August 12, 2020.
IntelGenx Technologies Corp.
Form 10-Q
TABLE OF CONTENTS
IntelGenx Technologies Corp.
Consolidated Interim Financial Statements
June 30, 2020
(Expressed in U.S. Funds)
(Unaudited)
Contents
IntelGenx Technologies Corp.
Consolidated Balance Sheet
(Expressed in Thousands of U.S. Dollars ($000's) Except Share and Per Share Data)
(Unaudited)
June 30, 2020 |
December 31, 2019 | |||||
Assets | ||||||
Current | ||||||
Cash | $ | 134 | $ | 1,332 | ||
Short-term investments | 2,953 | 580 | ||||
Accounts receivable | 380 | 381 | ||||
Prepaid expenses | 140 | 170 | ||||
Investment tax credits receivable | 467 | 375 | ||||
Inventory (note 4) | 370 | 382 | ||||
Total current assets | 4,444 | 3,220 | ||||
Leasehold improvements and equipment, net (note 5) | 5,794 | 6,365 | ||||
Security deposits | 720 | 752 | ||||
Operating lease right-of-use asset | 610 | 683 | ||||
Total assets | $ | 11,568 | $ | 11,020 | ||
Liabilities | ||||||
Current | ||||||
Accounts payable and accrued liabilities | 2,026 | 1,941 | ||||
Current portion of long-term debt (note 7) | 578 | 727 | ||||
Current portion of operating lease liability (note 13) | 138 | 137 | ||||
Convertible notes (note 9) | 1,364 | - | ||||
Convertible debentures (note 8) | - | 5,642 | ||||
Total current liabilities | 4,106 | 8,447 | ||||
Long-term debt (note 7) | 448 | 470 | ||||
Convertible debentures (note 8) | 5,089 | - | ||||
Convertible notes (note 9) | - | 1,255 | ||||
Operating lease liability (note 13) | 491 | 555 | ||||
Total liabilities | 10,134 | 10,727 | ||||
Shareholders' equity | ||||||
Capital Stock, common shares, $0.00001 par value; 200,000,000 shares authorized; 110,259,652 shares issued and outstanding (2019: 93,942,652 common shares) (note 10) | 1 | 1 | ||||
Additional paid-in capital (note 11) | 48,003 | 42,635 | ||||
Accumulated deficit | (45,614 | ) | (41,507 | ) | ||
Accumulated other comprehensive loss | (956 | ) | (836 | ) | ||
Total Shareholders' Equity | 1,434 | 293 | ||||
$ | 11,568 | $ | 11,020 |
See accompanying notes
Approved on Behalf of the Board:
/s/ Bernd J. Melchers Director /s/ Horst G. Zerbe Director
IntelGenx Technologies Corp.
Consolidated Statement of Shareholders' Equity
For the Period Ended June 30, 2020
(Expressed in Thousands of U.S. Dollars ($000's) Except Share and Per Share Data)
(Unaudited)
Accumulated | ||||||||||||||||||
Additional | Other | Total | ||||||||||||||||
Capital Stock | Paid-In | Accumulated | Comprehensive | Shareholders' | ||||||||||||||
Number | Amount | Capital | Deficit | Loss | Equity | |||||||||||||
Balance - December 31, 2019 | 93,942,652 | $ | 1 | $ | 42,635 | $ | (41,507 | ) | $ | (836 | ) | $ | 293 | |||||
Other comprehensive loss | - | - | - | - | (120 | ) | (120 | ) | ||||||||||
Common stock issued, net of transaction costs of $778 (note 11) | 16,317,000 | - | 3,912 | - | - | 3,912 | ||||||||||||
Warrants issued, net of transaction costs of $240 (note 11) | - | - | 1,207 | - | - | 1,207 | ||||||||||||
Agents' warrants issued (note 11) | - | - | 125 | - | - | 125 | ||||||||||||
Stock-based compensation (note 11) | - | - | 124 | - | - | 124 | ||||||||||||
Net loss for the period | - | - | - | (4,107 | ) | - | (4,107 | ) | ||||||||||
Balance - June 30, 2020 | 110,259,652 | $ | 1 | $ | 48,003 | $ | (45,614 | ) | $ | (956 | ) | $ | 1,434 |
See accompanying notes
IntelGenx Technologies Corp.
Consolidated Statement of Comprehensive Loss
(Expressed in Thousands of U.S. Dollars ($000's) Except Share and Per Share Data)
(Unaudited)
For the Three-Month Period | For the Six-Month Period | |||||||||||
Ended June 30, | Ended June 30, | |||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||
Revenues (note 12) | $ | 42 | $ | 197 | $ | 244 | $ | 613 | ||||
Total revenues | 42 | 197 | 244 | 613 | ||||||||
Expenses | ||||||||||||
Research and development expense | 602 | 1,182 | 1,452 | 2,042 | ||||||||
Selling, general and administrative expense | 1,016 | 1,181 | 2,340 | 2,885 | ||||||||
Depreciation of tangible assets | 175 | 172 | 354 | 343 | ||||||||
Total expenses | 1,793 | 2,535 | 4,146 | 5,270 | ||||||||
Operating loss | (1,751 | ) | (2,338 | ) | (3,902 | ) | (4,657 | ) | ||||
Finance and interest income (note 8) | 401 | 32 | 402 | 61 | ||||||||
Financing and interest expense | (300 | ) | (298 | ) | (607 | ) | (596 | ) | ||||
Net financing and interest income (expense) | 101 | (266 | ) | (205 | ) | (535 | ) | |||||
Net loss | (1,650 | ) | (2,604 | ) | (4,107 | ) | (5,192 | ) | ||||
Other comprehensive income (loss) | ||||||||||||
Foreign currency translation adjustment | 70 | 117 | (148 | ) | 340 | |||||||
Change in fair value | 247 | 8 | 28 | 32 | ||||||||
317 | 125 | (120 | ) | 372 | ||||||||
Comprehensive loss | $ | (1,333 | ) | $ | (2,479 | ) | $ | (4,227 | ) | $ | (4,820 | ) |
Basic and diluted weighted average number of shares outstanding | 110,259,652 | 93,527,473 | 102,908,037 | 93,523,329 | ||||||||
Basic and diluted loss per common share (note 15) | $ | (0.01 | ) | $ | (0.03 | ) | $ | (0.04 | ) | $ | (0.05 | ) |
See accompanying notes
IntelGenx Technologies Corp.
Consolidated Statement of Cash Flows
(Expressed in thousands of U.S. Dollars ($000's) Except Share and Per Share Data)
(Unaudited)
For the Three-Month Period | For the Six-Month Period | |||||||||||
Ended June 30, | Ended June 30, | |||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||
Funds (used) provided - | ||||||||||||
Operating activities | ||||||||||||
Net loss | $ | (1,650 | ) | $ | (2,604 | ) | $ | (4,107 | ) | $ | (5,192 | ) |
Depreciation of tangible assets | 175 | 172 | 354 | 343 | ||||||||
Stock-based compensation | 53 | 95 | 124 | 181 | ||||||||
Accretion expense | 147 | 124 | 293 | 244 | ||||||||
DSU expense | 32 | (98 | ) | (143 | ) | 112 | ||||||
Gain on debt extinguishment (note 8) | (401 | ) | - | (401 | ) | - | ||||||
Lease non-cash expense | 1 | 3 | 2 | 6 | ||||||||
(1,643 | ) | (2,308 | ) | (3,878 | ) | (4,306 | ) | |||||
Changes in non-cash items related to operations: | ||||||||||||
Accounts receivable | 45 | 208 | 1 | 349 | ||||||||
Prepaid expenses | 5 | 37 | 30 | 104 | ||||||||
Investment tax credits receivable | (53 | ) | (107 | ) | (92 | ) | (209 | ) | ||||
Inventory | (6 | ) | (6 | ) | ||||||||
Security deposits | (4 | ) | - | (4 | ) | - | ||||||
Accounts payable and accrued liabilities | 116 | (134 | ) | 241 | (635 | ) | ||||||
Net change in non-cash items related to operations | 103 | 4 | 170 | (391 | ) | |||||||
Net cash used in operating activities | (1,540 | ) | (2,304 | ) | (3,708 | ) | (4,697 | ) | ||||
Financing activities | ||||||||||||
Repayment of term loans | 45 | (178 | ) | (118 | ) | (337 | ) | |||||
Proceeds from exercise of warrants and stock options | - | - | - | 21 | ||||||||
Net proceeds from public offering | - | - | 5,564 | - | ||||||||
Transaction costs of public offering | - | - | (320 | ) | - | |||||||
Transaction costs of debt modification | (69 | ) | (69 | ) | ||||||||
Net cash (used in) provided by financing activities | (24 | ) | (178 | ) | 5,057 | (316 | ) | |||||
Investing activities | ||||||||||||
Additions to leasehold improvements and equipment | (24 | ) | (141 | ) | (81 | ) | (211 | ) | ||||
Redemption of short-term investments | 1,450 | 1,453 | 2,031 | 5,184 | ||||||||
Acquisition of short-term investments | - | - | (4,532 | ) | (1,469 | ) | ||||||
Net cash provided by (used in) investing activities | 1,426 | 1,312 | (2,582 | ) | 3,504 | |||||||
Decrease in cash | (138 | ) | (1,170 | ) | (1,233 | ) | (1,509 | ) | ||||
Effect of foreign exchange on cash | (83 | ) | 124 | 35 | 275 | |||||||
Cash | ||||||||||||
Beginning of period | 355 | 6,627 | 1,332 | 6,815 | ||||||||
End of period | $ | 134 | $ | 5,581 | $ | 134 | $ | 5,581 |
See accompanying notes
IntelGenx Technologies Corp. Notes to Consolidated Interim Financial Statements |
1. Basis of Presentation
The accompanying unaudited consolidated financial statements have been prepared in accordance with generally accepted accounting principles for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by generally accepted accounting principles for complete consolidated financial statements. In the opinion of management, all adjustments considered necessary for a fair presentation have been included. All such adjustments are of a normal and recurring nature.
These financial statements should be read in conjunction with the audited consolidated financial statements at December 31, 2019. Operating results for the six months ended June 30, 2020 are not necessarily indicative of the results that may be expected for the year ending December 31, 2020. The Company prepares its financial statements in accordance with accounting principles generally accepted in the United States ("U.S. GAAP"). This basis of accounting involves the application of accrual accounting and consequently, revenues and gains are recognized when earned, and expenses and losses are recognized when incurred.
The consolidated financial statements include the accounts of the Company and its subsidiary companies. On consolidation, all inter-entity transactions and balances have been eliminated.
The financial statements are expressed in U.S. funds.
Management has performed an evaluation of the Company's activities through the date and time these financial statements were issued and concluded that there are no additional significant events requiring recognition or disclosure.
2. Going Concern
The Company has financed its operations to date primarily through public offerings of its common stock, bank loans, royalty, up-front and milestone payments, license fees, proceeds from exercise of warrants and options, research and development revenues and the sale of U.S. royalty on future sales of Forfivo XL®. The Company has devoted substantially all of its resources to its drug development efforts, conducting clinical trials to further advance the product pipeline, the expansion of its facilities, protecting its intellectual property and general and administrative functions relating to these operations. The future success of the Company is dependent on its ability to develop its product pipeline and ultimately upon its ability to attain profitable operations. As of June 30, 2020, the Company had cash and short-term investments totaling approximately $3,087. The Company does not have sufficient existing cash and short-term investments to support operations for the next year following the issuance of these financial statements.
On March 11, 2020, the World Health Organization declared the outbreak of a novel coronavirus ("COVID-19") as a global pandemic, which continues to spread throughout Canada and around the world. On March 23, 2020, the government of Quebec ordered the closure of all non-essential businesses effective March 25, 2020. Because of the nature of its operations, the Company is only partially affected by this order. The Company is aware of the impact on its business as a result of COVID-19 but uncertain as to the extent of this impact on its consolidated
IntelGenx Technologies Corp. Notes to Consolidated Interim Financial Statements |
2. Going Concern (Cont'd)
financial statements. This partial disruption, even temporary, may impact our operations and overall business by delaying the progress of our research and development programs and production activities. There is uncertainty as to the duration and hence the potential impact. As a result, we are unable to estimate the potential impact on our business as of the date of this filing.
These conditions raise substantial doubt about the Company's ability to continue as a going concern. Management's plans to alleviate these conditions include pursuing one or more of the following steps to raise additional funding, none of which can be guaranteed or are entirely within the Company's control:
-
Raise funding through the possible sale of the Company's common stock, including public or private equity financings.
-
Raise funding through debt financing.
-
Continue to seek partners to advance product pipeline.
-
Initiate oral film manufacturing activities.
-
Initiate contract oral film manufacturing activities.
If the Company is unable to raise capital when needed or on attractive terms, or if it is unable to procure partnership arrangements to advance its programs, the Company would be forced to discontinue some of its operations. The current COVID-19 pandemic could continue to have a negative impact on the stock market, including trading prices of the Company's shares and its ability to raise new capital.
The accompanying consolidated interim financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. The accompanying consolidated interim financial statements do not include any adjustments or classifications that may result from the possible inability of the Company to continue as a going concern. Should the Company be unable to continue as a going concern, it may be unable to realize the carrying value of its assets and to meet its liabilities as they become due.
3. Significant Accounting Policies
Revenue Recognition
The Company may enter into licensing and collaboration agreements for product development, licensing, supply and manufacturing for its product pipeline. The terms of the agreements may include non-refundable signing and licensing fees, milestone payments and royalties on any product sales derived from collaborations. These contracts are analyzed to identify all performance obligations forming part of these contracts. The transaction price of the contract is then determined. The transaction price is allocated between all performance obligations on a residual standalone selling price basis. The stand-alone selling price is estimated based on the comparable market prices, expected cost plus margin and the Company's historical experience.
IntelGenx Technologies Corp. Notes to Consolidated Interim Financial Statements |
3. Significant Accounting Policies (Cont'd)
Revenue is measured based on a consideration specified in a contract with a customer, and excludes any sales incentives and amounts collected on behalf of third parties. The Company recognizes revenue when it satisfies a performance obligation by transferring control over a product or service to a customer.
Taxes assessed by a governmental authority that are both imposed on and concurrent with a specific revenue-producing transaction, that are collected by the Company from a customer, are excluded from revenue.
The following is a description of principal activities - separated by nature - from which the Company generates its revenue.
Research and Development Revenue
Revenues with corporate collaborators are recognized as the performance obligations are satisfied over time, and the related expenditures are incurred pursuant to the terms of the agreement.
Licensing and Collaboration Arrangements
Licenses are considered to be right-to-use licenses. As such, the Company recognizes the licenses revenues at a point in time, upon granting the licenses.
Milestone payments are considered variable consideration. As such, the Company estimates variable consideration at the most likely amount to which we expect to be entitled. The estimated amounts are included in the transaction price to the extent it is probable that a significant reversal of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is resolved. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such development milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect license, research and other revenues in the period during which the adjustment is recognized. The process of successfully achieving the criteria for the milestone payments is highly uncertain. Consequently, there is significant risk that the Company may not earn all of the milestone payments for each of its contracts.
Royalties are typically calculated as a percentage of net sales realized by the Company's licensees of its products (including their sub-licensees), as specifically defined in each agreement. The licensees' sales generally consist of revenues from product sales of the Company's product pipeline and net sales are determined by deducting the following: estimates for chargebacks, rebates, sales incentives and allowances, returns and losses and other customary deductions in each region where the Company has licensees. Revenues arising from royalties are considered variable consideration. As such, the Company estimates variable consideration at the most likely amount to which we expect to be entitled. The estimated amounts are included in the transaction price to the extent it is probable that a significant reversal of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is resolved.
IntelGenx Technologies Corp. Notes to Consolidated Interim Financial Statements |
3. Significant Accounting Policies (Cont'd)
Leasehold Improvements and Equipment
Leasehold improvements and equipment are recorded at cost. Provisions for depreciation are based on their estimated useful lives using the methods as follows:
On the declining balance method -
Laboratory and office equipment 20%
Computer equipment 30%
On the straight-line method -
Leasehold improvements over the lease term
Manufacturing equipment 5 - 10 years
Upon retirement or disposal, the cost of the asset disposed of and the related accumulated depreciation are removed from the accounts and any gain or loss is reflected in income. Expenditures for repair and maintenance are expensed as incurred.
Leases
Leases are classified as either finance leases or operating leases. A lease is classified as a finance lease if any one of the following criteria are met: the lease transfers ownership of the asset by the end of the lease term, the lease contains an option to purchase the asset that is reasonably certain to be exercised, the lease term is for a major part of the remaining useful life of the asset or the present value of the lease payments equals or exceeds substantially all of the fair value of the asset. A lease is classified as an operating lease if it does not meet any one of these criteria.
Substantially all of the Company's operating leases are comprised of office space and property leases and the Company does not hold any finance leases.
For all leases at the lease commencement date, a right-of-use asset and a lease liability are recognized. The right-of-use asset represents the right to use the leased asset for the lease term. The lease liability represents the present value of the lease payments under the lease.
The right-of-use asset is initially measured at cost, which primarily comprises the initial amount of the lease liability, plus any initial costs incurred, consisting mainly of brokerage commissions, less any lease incentives received. All right-of-use assets are reviewed for impairment. The lease liability is initially measured the present value of the lease payments, discounted using the interest rate implicit in the lease or, if that rate cannot be readily determined, the Company's secured incremental borrowing rate for the same term as the underlying lease.
IntelGenx Technologies Corp. Notes to Consolidated Interim Financial Statements |
3. Significant Accounting Policies (Cont'd)
Leases (Cont'd)
In April 2020, the FASB issued a Staff Question-and-Answer ("Q&A") to clarify whether lease concessions related to the effects of COVID-19 require the application of the lease modification guidance under the new lease standard, which the Company adopted on January 1, 2019. Under the new leasing standard, an entity would have to determine, on a lease by lease basis, if a lease concession was the result of a new arrangement reached with the tenant, which would be accounted for under the lease modification framework, or if the lease concession was under the enforceable rights and obligations that existed in the original lease, which would be accounted for outside the lease modification framework. The Q&A provides entities with the option to elect to account for lease concessions as though the enforceable rights and obligations existed in the original lease as long as the total cash flows from the modified lease are substantially similar to the cash flows in the original lease. The Company has elected to use this option and, to the extent that a rent concession is granted as a deferral of payments but total payments are substantially the same, the Company will account for the concession as if no change has been made to the original lease
Lease payments included in the measurement of the lease liability comprise the following: the fixed noncancelable lease payments, payments for optional renewal periods where it is reasonably certain the renewal period will be exercised, and payments for early termination options unless it is reasonably certain the lease will not be terminated early.
Lease modifications result in remeasurement of the lease liability.
Lease expense for operating leases consists of the lease payments plus any initial direct costs, primarily brokerage commissions, and is recognized on a straight-line basis over the lease term. Included in lease expense are any variable lease payments incurred in the period that were not included in the initial lease liability.
The Company has elected not to recognize right-of-use assets and lease liabilities for short-tern leases that have a term of 12 months or less. The effect of short-term leases on our right-of-use asset and lease liability was not material.
Recent Accounting Pronouncements
ASU 2019-12 Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes
The FASB issued ASU 2019-12 which removes specific exceptions to the general principles in Topic 740 in Generally Accepted Accounting Principles (GAAP). It eliminates the need for an organization to analyze whether the following apply in a given period:
-Exception to the incremental approach for intraperiod tax allocation;
-Exceptions to accounting for basis differences when there are ownership changes in foreign investments; and
-Exception in interim period income tax accounting for year-to-date losses that exceed anticipated losses.
IntelGenx Technologies Corp. Notes to Consolidated Interim Financial Statements |
3. Significant Accounting Policies (Cont'd)
The ASU also improves financial statement preparers' application of income tax-related guidance and simplifies GAAP for:
-Franchise taxes that are partially based on income;
-Transactions with a government that result in a step up in the tax basis of goodwill;
-Separate financial statements of legal entities that are not subject to tax; and
-Enacted changes in tax laws in interim periods.
These amendments are effective for fiscal years beginning after December 15, 2020. The Company is currently evaluating the impact of this Statement on its consolidated financial statements.
4. Inventory
Inventory as at June 30, 2020 consisted of raw materials in the amount of $370 (2019: $382).
5. Leasehold Improvements and Equipment
June 30, 2020 |
December 31, 2019 |
|||||||||||
Accumulated | Net Carrying | Net Carrying | ||||||||||
Cost | Depreciation | Amount | Amount | |||||||||
Manufacturing equipment | $ | 4,496 | $ | 976 | $ | 3,520 | $ | 3,778 | ||||
Laboratory and office equipment | 1,307 | 873 | 434 | 498 | ||||||||
Computer equipment | 124 | 92 | 32 | 40 | ||||||||
Leasehold improvements | 3,185 | 1,377 | 1,808 | 2,049 | ||||||||
$ | 9,112 | $ | 3,318 | $ | 5,794 | $ | 6,365 |
From the balance of manufacturing equipment, an amount of $1,704 thousand (2019: $1,788 thousand) represents assets which are still under construction as at June 30, 2020 and are consequently not depreciated.
IntelGenx Technologies Corp. Notes to Consolidated Interim Financial Statements |
6. Bank Indebtedness
The Company's credit facility is subject to review annually and consists of an operating demand line of credit of up to CAD$250 thousand ($183 thousand) and corporate credits cards of up to CAD$75 thousand ($55 thousand) and $60 thousand, and foreign exchange contracts limited to CAD$425 thousand ($312 thousand). Borrowings under the operating demand line of credit bear interest at the Bank's prime lending rate plus 2%. The credit facility and term loan (see note 8) are secured by a first ranking movable hypothec on all present and future movable property of the Company for an amount of CAD$4,250,000 ($3,119,000) plus 20%, and a 50% guarantee by Export Development Canada, a Canadian Crown corporation export credit agency. The terms of the banking agreement require the Company to comply with certain debt service coverage and debt to net worth financial covenants on an annual basis at the end of the Company's fiscal year. As at June 30, 2020, the Company has not drawn on its credit facility.
7. Long-term Debt
The components of the Company's debt are as follows:
|
June 30, 2020 $ |
December 31, 2019 $ |
||||
Term loan facility | 867 | 1,005 | ||||
Secured loan | 159 | 192 | ||||
Total debt | 1,026 | 1,197 | ||||
Less: current portion | 578 | 727 | ||||
Total long-term debt | 448 | 470 |
The Company's term loan facility consists of a total of CAD$4 million ($2.94 million) bearing interest at the Bank's prime lending rate plus 2.50%, with monthly principal repayments of CAD$62 thousand ($45 thousand). In April 2020, as a result of the global pandemic, the lender granted the Company an automatic six-month moratorium of capital repayments. The loan is secured by a second ranking on all present and future property of the Company.The term loan is subject to the same security and financial covenants as the bank indebtedness (see note 7).
The secured loan has a principal balance authorized of CAD$1 million ($734 thousand) bearing interest at prime plus 7.3%, reimbursable in monthly principal payments of CAD$17 thousand ($12 thousand) from January 2017 to March 2021. In March 2020, as a result of the global pandemic, the lender granted the Company an automatic six-month moratorium of capital repayments. The loan is secured by a second ranking on all present and future property of the Company. The terms of the banking agreement require the Company to comply with certain debt service coverage and debt to net worth financial covenants on an annual basis at the end of the Company's fiscal year.
IntelGenx Technologies Corp. Notes to Consolidated Interim Financial Statements |
7. Long-term Debt (Cont'd)
Principal repayments due in each of the next three years are as follows:
2020 231 (CAD 315)
2021 635 (CAD 864)
2022 160 (CAD 218)
8. Convertible Debentures
On July 12, 2017, the Company closed its previously announced prospectus offering (the "Offering") of convertible unsecured subordinated debentures of the Corporation (the "Debentures") for gross aggregate proceeds of CAD$6,838,000 ($5,018,000). Pursuant to the Offering, the Corporation issued an aggregate principal amount of CAD$6,838,000 ($5,018,000) of Debentures at a price of CAD$1,000 ($734) per Debenture. The Debentures will mature on June 30, 2020 and bear interest at annual rate of 8% payable semi-annually on the last day of June and December of each year, commencing on December 31, 2017. The interest may be paid in common shares at the option of the Corporation. The Debentures will be convertible at the option of the holders at any time prior to the close of business on the earlier of June 30, 2020 and the business day immediately preceding the date specified by the Corporation for redemption of Debentures. The conversion price will be CAD$1.35 ($0.99) (the "Conversion Price") per common share of the Corporation ("Share"), being a conversion rate of approximately 740 Shares per CAD$1,000 ($734) principal amount of Debentures, subject to adjustment in certain events.
On August 8, 2017, the Company closed a second tranche of its prospectus Offering of convertible unsecured subordinated debentures of the Corporation for which a first closing took place on July 12, pursuant to which it had raised additional gross proceeds of CAD$762,000 ($559,000).
Together with the principal amount of CAD$6,838,000 ($5,018,000) of Debentures issued on July 12, 2017, the Company issued a total aggregate principal amount of CAD$7,600,000 ($5,577,000) of Debentures at a price of CAD$1,000 ($734) per Debenture.
On June 25, 2020, the debentureholders approved the extension of the maturity date of the convertible debentures from June 30, 2020 to June 30, 2022 and the conversion price was reduced from CAD$1.5 ($0.99) to CAD$0.50 ($0.37). This extension was accounted for as an extinguishment and the debenture were re-measured at fair value on June 30, 2020. This re-measurement resulted in a gain on extinguishment in the amount of CAD$547,000 ($401,000) recognized in finance and interest income.
The components of the convertible debentures subsequent to the extension are as follows:
June 30, 2020 |
|||
Face value of the convertible debentures | $ | 5,560 | |
Transaction costs | (69 | ) | |
Accretion | (402 | ) | |
Convertible debentures | $ | 5,089 |
IntelGenx Technologies Corp. Notes to Consolidated Interim Financial Statements |
8. Convertible Debentures (Cont'd)
The convertible debentures have been recorded as a liability. The accretion expense for the six-month period ended June 30, 2020 amounts to CAD$249,000 ($182,000), compared to CAD$213,000 ($160,000) for the comparative period in 2019.
The interest accrued on the convertible debentures for the six-month period ended June 30, 2020 amounts to CAD$303 thousand ($222 thousand) and is recorded in financing and interest expense. The interest on the convertible debentures for the six-month period ended June 30, 2019 amounted to CAD$303 thousand ($227 thousand).
9. Convertible Notes
On May 8, 2018, the Company closed its previously announced offering by way of private placement (the "Offering"). In connection with the Offering, the Company issued 320 units (the "Units") at a subscription price of $10,000 per Unit for gross proceeds of $3,200,000. A related party of the Company participated in the Offering and subscribed for an aggregate of two Units.
Each Unit is comprised of (i) 7,940 common shares of the Corporation ("Common Shares"), (ii) a $5,000 convertible 6% note (a "Note"), and (iii) 7,690 warrants to purchase common shares of the Corporation ("Warrants"). Each Note bears interest at a rate of 6% (payable quarterly, in arrears, with the first payment being due on September 1, 2018), matures on June 1, 2021 and is convertible into Common Shares at a conversion price of $0.80 per Common Share. Each Warrant entitles its holder to purchase one Common Share at a price of $0.80 per Common Share until June 1, 2021.
In connection with the Offering, the Company paid to the Agents a cash commission of approximately $157,800 in the aggregate and issued non-transferable agents' warrants to the Agents, entitling the Agents to purchase 243,275 common shares at a price of $0.80 per share until June 1, 2021. Management has determined the value of the agents' warrants to be $50,000.
The proceeds of the Units are attributed to liability and equity components based on the fair value of each component as follows:
Gross proceeds | Transaction costs | Net proceeds | |||||||
Common stock | $ | 1,627 | $ | 167 | $ | 1,460 | |||
Convertible notes | 1,086 | 111 | 975 | ||||||
Warrants | 487 | 50 | 437 | ||||||
$ | 3,200 | $ | 328 | $ | 2,872 |
The convertible notes have been recorded as a liability. Total transactions costs in the amount of $111 thousand were recorded against the liability. The accretion expense for the six-month period ended June 30, 2020 amounts to $109,000 (2019: $86,000).
IntelGenx Technologies Corp. Notes to Consolidated Interim Financial Statements |
9. Convertible Notes (Cont'd)
The components of the convertible notes are as follows:
June 30, 2020 |
December 31, 2019 | |||||
Attributed value of net proceeds to convertible notes | $ | 975 | $ | 975 | ||
Accretion | 389 | 280 | ||||
Convertible note | $ | 1,364 | $ | 1,255 |
The interest on the convertible notes for the six-month period ended June 30, 2020 amounts to $48 thousand and is recorded in financing and interest expense (2019: $48).
10. Capital Stock
June 30, 2020 |
December 31, 2019 | |||||
Authorized - | ||||||
200,000,000 common shares of $0.00001 par value | ||||||
20,000,000 preferred shares of $0.00001 par value | ||||||
Issued - | ||||||
110,259,652 (December 31, 2019 - 93,942,652) common shares | $ | 1 | $ | 1 |
11. Additional Paid-In Capital
Public Offering
On February 11, 2020, IntelGenx announced the closing of 16,317,000 units (the "Units") at a price of CAD$0.50 ($0.37) for gross proceeds of CAD$8,158,500 ($5,987,000).
Each Unit consists of one share of common stock of the Company and one warrant entitling the holder to purchase one share of common stock of the Company at an exercise price of CAD$0.75 ($0.55) per share. The Warrants are exercisable immediately and will expire on the third anniversary of the date of their issuance. Management has determined the value attributed to common stock is $3,912 thousand and $1,207 thousand for the warrants issued, resulting in an increase in additional paid-in-capital of $5,119 thousand.
In connection with the Offering, the Company paid to the Agents a cash commission of approximately CAD$763,000 ($560,000) in the aggregate and issued non-transferable agents' warrants to the Agents, entitling the Agents to purchase 1,142,190 common shares at a price of CAD$0.75 ($0.55) per share until February 11, 2023. Management has determined the value of the agents' warrants to be $125,000, resulting in an increase in additional paid-in-capital of $125,000.
IntelGenx Technologies Corp. Notes to Consolidated Interim Financial Statements |
11. Additional Paid-In Capital (Cont'd)
The proceeds of the Units are attributed to equity components based on the fair value of each component as follows:
Gross proceeds | Transaction costs | Net proceeds | |||||||
Common stock | $ | 4,690 | $ | 778 | $ | 3,912 | |||
Warrants | 1,447 | 240 | 1,207 | ||||||
$ | 6,137 | $ | 1,018 | $ | 5,119 |
Stock options
No options were granted during the six-month period ended June 30, 2020.
No stock options were exercised during the six-month period ended June 30, 2020.
On March 27, 2019, 100,000 options to purchase common stock were granted to an employee under the 2016 Stock Option Plan. The options have an exercise price of $0.69. The options granted vest over a period of 2 years at a rate of 25% every six months and expire 10 years after the grant date. The stock options were accounted for at their fair value, as determined by the Black-Scholes valuation model, of approximately $40 thousand.
During the six-month period ended June 30, 2019 a total of 50,000 stock options were exercised for 50,000 common shares having a par value of $0 thousand in aggregate, for cash consideration of $21 thousand, resulting in an increase in additional paid-in capital of $21 thousand.
Compensation expenses for stock-based compensation of $124 thousand and $181 thousand were recorded during the six-month periods ended June 30, 2020 and 2019, respectively. An amount of $100 thousand expensed in the six-month period ended June 30, 2020 relates to stock options granted to employees and an amount of $24 thousand relates to stock options granted to consultants. An amount of $157 thousand expensed in the six-month period ended June 30, 2019 relates to stock options granted to employees and directors and an amount of $24 thousand relates to stock options granted to a consultant. As at June 30, 2020, the Company has $33 thousand (2019 - $333 thousand) of unrecognized stock-based compensation.
Warrants
No warrants were exercised during the six-month periods ended June 30, 2020 and 2019.
Deferred Share Units ("DSUs")
On March 27, 2019, 271,740 DSUs have been granted under the DSU Plan.
No DSUs were granted in 2020.
Performance and Restricted Share Units ("PRSUs")
No PRSUs were granted during the six-month periods ended June 30, 2020 and 2019.
IntelGenx Technologies Corp. Notes to Consolidated Interim Financial Statements |
12. Revenues
The following table presents our revenues disaggregated by revenue source. Sales and usage-based taxes are excluded from revenues:
June 30, 2020 | June 30, 2019 | |||||
Research and development agreements | $ | 244 | $ | 613 | ||
The following table presents our revenues disaggregated by timing of recognition:
June 30, 2019 | June 30, 2018 | |||||
(in U.S. $ thousands) | ||||||
Product and services transferred at point in time | $ | 202 | $ | 371 | ||
Products and services transferred over time | 42 | 242 | ||||
$ | 244 | $ | 613 |
The following table presents our revenues disaggregated by geography, based on the billing addresses of our customers:
June 30, 2020 | June 30, 2019 | |||||
Europe | $ | 244 | 534 | |||
Canada | - | 79 | ||||
$ | 244 | $ | 613 |
Remaining performance obligations
As at June 30, 2020, the aggregate amount of the transaction price allocated to the remaining performance obligation is $1,020 representing research and development agreements, the majority of which is expected to be recognized in the next twelve months. The Company is also eligible to receive up to $4,093 in research and development milestone payments, approximately 60% of which is expected to be recognized in the next three years, with the remaining 40% expected in the two years following; up to $28,376 in commercial sales milestone payments which are wholly dependent on the marketing efforts of our development partners. In addition, the Company is entitled to receive royalties on potential sales.
IntelGenx Technologies Corp. Notes to Consolidated Interim Financial Statements |
13. Leases
Substantially all our operating lease right-of-use assets and operating lease liability represents leases for office space and property to conduct our business.
The operating lease expense for the six-month period ended June 30, 2020 included in general and administrative expenses is $48 thousand. The cash outflows from operating leases for the six-month period ended June 30, 2020 was $36 thousand.
During the three-month period ended June 30, 2020, the Company was granted a rent concession by the landlord due to the COVID-19 pandemic that resulted in a negative variable lease expense in the amount of $26 thousand.
The weighted average remaining lease term and the weighted average discount rate for operating leases at June 30, 2020 were 5.7 years and 10%, respectively.
The following table reconciles the undiscounted cash flows for the operating leases as at June 30, 2020 to the operating lease liabilities recorded on the balance sheet:
Operating Leases | |||
2020 Remainder | $ | 81 | |
2021 | 145 | ||
2022 | 148 | ||
2023 | 150 | ||
2024 | 154 | ||
Thereafter | 179 | ||
Total undiscounted lease payments | 857 | ||
Less: Interest | 228 | ||
Present value of lease liabilities | $ | 629 |
Current portion of operating lease liability $138
Operating lease liability $491
IntelGenx Technologies Corp. Notes to Consolidated Interim Financial Statements |
14. Related Party Transactions
Included in management salaries for the six-month period ended June 30, 2020 are $19 thousand (2019 - $40) for options granted to the Chief Executive Officer, $19 thousand (2019 - $27 thousand) for options granted to the President and Chief Financial Officer, $19 (2019 - $15) for options granted to the Vice President, Operations, $9 thousand (2019 - $17 thousand) for options granted to the Vice-President, Research and Development, $9 thousand (2019 - $17 thousand) for options granted to Vice-President, Business and Corporate Development under the 2016 Stock Option Plan.
Also included general and administrative expense for the six-month period ended June 30, 2020 are director fees of $116 thousand (2019 - $116 thousand) and DSU recovery of $143 thousand (2019: expense of $117).
The above related party transactions have been measured at the exchange amount which is the amount of the consideration established and agreed to by the related parties.
15. Basic and Diluted Loss Per Common Share
Basic and diluted loss per common share is calculated based on the weighted average number of shares outstanding during the period. The warrants, share-based compensation and convertible debenture and notes have been excluded from the calculation of diluted loss per share since they are anti-dilutive.
Item 2: Management's Discussion and Analysis of Financial Condition and Results of Operations
Introduction to Management's Discussion and Analysis
This Management's Discussion and Analysis of Financial Condition and Results of Operations ("MD&A") comments on our business operations, performance, financial position and other matters for the six-month period ended June 30, 2020 and 2019.
Unless otherwise indicated, all financial and statistical information included herein relates to continuing operations of the Company. Unless otherwise indicated or the context otherwise requires, the words, "IntelGenx, "Company", "we", "us", and "our" refer to IntelGenx Technologies Corp. and its subsidiaries, including IntelGenx Corp.
This MD&A should be read in conjunction with the accompanying unaudited Consolidated Interim Financial Statements and Notes thereto. We also encourage you to refer to the Company's MD&A for the year ended December 31, 2019. In preparing this MD&A, we have taken into account information available to us up to August 13, 2020, the date of this MD&A, unless otherwise indicated.
Additional information relating to the Company, including our Annual Report on Form 10-K for the fiscal year ended December 31, 2019 (the "2019 Form 10-K"), is available on SEDAR at www.sedar.com and on the U.S. Securities and Exchange Commission (the "SEC") website at www.sec.gov.
All dollar amounts are expressed in U.S. dollars, unless otherwise noted.
Concerning Forward-Looking Statements
Certain statements included or incorporated by reference in this MD&A constitute forward-looking statements within the meaning of applicable securities laws. All statements contained in this MD&A that are not clearly historical in nature are forward-looking, and the words "anticipate", "believe", "continue", "expect", "estimate", "intend", "may", "plan", "will", "shall" and other similar expressions are generally intended to identify forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. All forward-looking statements are based on our beliefs and assumptions based on information available at the time the assumption was made. These forward-looking statements are not based on historical facts but on management's expectations regarding future growth, results of operations, performance, future capital and other expenditures (including the amount, nature and sources of funding thereof), competitive advantages, business prospects and opportunities. Forward-looking statements involve significant known and unknown risks, uncertainties, assumptions and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from those implied by forward-looking statements. These factors should be considered carefully and you should not place undue reliance on the forward-looking statements. Although the forward-looking statements contained in this MD&A or incorporated by reference herein are based upon what management believes to be reasonable assumptions, there is no assurance that actual results will be consistent with these forward-looking statements. These forward-looking statements are made as of the date of this MD&A or as of the date specified in the documents incorporated by reference herein, as the case may be. We undertake no obligation to update any forward looking statements to reflect events or circumstances after the date on which such statements were made or to reflect the occurrence of unanticipated events, except as may be required by applicable securities laws. The factors set forth in Item 1A., "Risk Factors" of the 2019 Form 10-K, as well as any cautionary language in this MD&A, provide examples of risks, uncertainties and events that may cause our actual results to differ materially from the expectations we describe in our forward-looking statements. Before you invest in the common stock, you should be aware that the occurrence of the events described as risk factors and elsewhere in this report could have a material adverse effect on our business, operating results and financial condition.
Company Background
We are a drug delivery company established in 2003 and headquartered in Montreal, Quebec, Canada. Our focus is on the development of novel oral immediate-release and controlled-release products for the pharmaceutical market. More recently, we have made the strategic decision to enter the Canadian cannabis market with a non-prescription cannabis infused oral film expected to be launched in 2020. In addition we are offering partners a comprehensive portfolio of pharmaceutical services, including pharmaceutical R&D, clinical monitoring, regulatory support, tech transfer and manufacturing scale-up, and commercial manufacturing.
Our business strategy is to leverage our proprietary drug delivery technologies and develop pharmaceutical products with tangible benefits for patients, and once the viability of a product has been demonstrated, license the commercial rights to partners in the pharmaceutical industry. In certain cases, we rely upon partners in the pharmaceutical industry to fund the development of the licensed products, complete the regulatory approval process with the FDA or other regulatory agencies relating to the licensed products, and assume responsibility for marketing and distributing such products.
In addition, we may choose to pursue the development of certain products until the project reaches the marketing and distribution stage. We will assess the potential for successful development of a product and associated costs, and then determine at which stage it is most prudent to seek a partner, balancing such costs against the potential for additional returns earned by partnering later in the development process.
Our primary growth strategies is based on three pillars: (1) out licensing commercial rights of our existing pipeline products, (2) partnering on contract development and manufacturing projects leveraging our various technology platforms, and (3) expanding our current pipeline through:
- identifying lifecycle management opportunities for existing market leading pharmaceutical products,
- develop oral film products that provide tangible patient benefits,
- development of new drug delivery technologies
- entering the veterinary market with VetaFilm™
- repurposing existing drugs for new indications, and
- developing generic drugs where high technology barriers to entry exist in reproducing branded films.
We have established a state-of-the-art manufacturing facility for the future manufacture of our VersaFilm™ and VetaFilm™ products. We believe that this (1) represents a profitable business opportunity, (2) will reduce our dependency upon third-party contract manufacturers, thereby protecting our manufacturing process know-how and intellectual property, and (3) allows us to offer our development partners a full service from product conception through to supply of the finished product.
With our current manufacturing equipment, we are only able to manufacture products that do not contain flammable organic solvents. We initiated a project to expand the existing manufacturing facility, the timing of which will be dictated in part by the completion of agreements with our commercial partners.
Lifecycle Management Opportunities
We are seeking to position our delivery technologies as an opportunity for lifecycle management of products for which patent protection of the active ingredient is nearing expiration. While the patent for the underlying substance cannot be extended, patent protection can be obtained for a new and improved formulation by filing an application with the FDA under Section 505(b)(2) of the U.S. Federal Food, Drug and Cosmetic Act. Such applications, known as a "505(b)(2) NDA", are permitted for new drug products that incorporate previously approved active ingredients, even if the proposed new drug incorporates an approved active ingredient in a novel formulation or for a new indication. A 505(b)(2) NDA may include information regarding safety and efficacy of a proposed drug that comes from studies not conducted by or for the applicant. The first formulation for a respective active ingredient filed with the FDA under a 505(b)(2) application may qualify for up to three years of market exclusivity upon approval. Based upon a review of past partnerships between third party drug delivery companies and pharmaceutical companies, management believes that drug delivery companies which possess innovative technologies to develop these special dosage formulations present an attractive opportunity to pharmaceutical companies. Accordingly, we believe "505(b)(2) products" represent a viable business opportunity for us.
Product Opportunities that provide Tangible Patient Benefits
Our focus will be on developing oral film products leveraging our VersaFilm™ technology that provide tangible patient benefits versus existing drug delivery forms. Patients with difficulties swallowing medication, pediatrics or geriatrics may benefit from oral films due to the ease of use. Similarly, we are working on oral films to improve bio-availability and/or response time versus existing drugs and thereby reducing side effects.
Development of New Drug Delivery Technologies
The rapidly disintegrating film technology contained in our VersaFilm™, and our AdVersa® mucosal adhesive tablet, are two examples of our efforts to develop alternate technology platforms. As we work with various partners on different products, we seek opportunities to develop new proprietary technologies.
Repurposing Existing Drugs
We are working on the repurposing of already approved drugs for new indications using our VersaFilm™ film technology. This program represents a viable growth strategy for us as it will allow for reduced development costs, improved success rates and shorter approval times. We believe that through our repurposing program we will be able minimize the risk of developmental failure and create value for us and potential partners.
Generic Drugs with High Barriers to Entry
We plan to pursue the development of generic drugs that have certain barriers to entry, e.g., where product development and manufacturing is complex and can limit the number of potential entrants into the generic market. We plan to pursue such projects only if the number of potential competitors is deemed relatively insignificant.
Most recent key developments
On April 06, 2020, the Company announced various initiatives aimed at helping the Company address, and satisfactorily respond to, the Complete Response Letter that it received on March 27, 2020 from the U.S. Food and Drug Administration regarding its resubmitted 505(b)(2) New Drug Application for RIZAPORT® VersaFilm®, as well as maintain IntelGenx's financial stability in light of the current market environment and the challenges posed by the global COVID-19 pandemic. In order to address these issues, the Board and Management of the Company decided to launch an aggressive performance improvement program that would focus on: (1) generating near-term revenue; (2) reducing staff headcount and implementing other measures to preserve the Company's resources and extend its cash runway; (3) implementing organizational changes to strengthen various parts of IntelGenx's business, including regulatory affairs and manufacturing operations; (4) comprehensively and satisfactorily responding to the CRL; (5) undertaking steps to accelerate the launch of RIZAPORT® in Spain and, subsequently, in other European countries; and (6), to the extent possible, working to mitigate the impact of the COVID-19 pandemic on the Company's employees, customers and other stakeholders
On June 08, 2020, the Company received its cannabis micro-processing license from Health Canada for its Montreal facility, in accordance with the Cannabis Act and Cannabis Regulations. This license enables the Company to commence working towards commercial production of its cannabis-infused VersaFilm®.
On June 10, 2020, the Company announced that Health Canada had authorized the sale of IntelGenx's hand sanitizer product, both in liquid and gel formulations, which will be manufactured using excess capacity at the Company's Health Canada-certified cGMP manufacturing facility in Montreal. Health Canada has implemented an interim expedited licensing approach in response to increasing demand for hand sanitizers due to the COVID-19 pandemic. The Agency issued IntelGenx's hand sanitizer liquid and gel formulations Natural Product Numbers 80100846 and 80101130, respectively, which permit product distribution to healthcare and commercial settings across Canada. The Company currently expects product shipments to commence in Q3-2020. At this time, the Company does not expect to generate significant revenues from this program.
On June 25, 2020, the Company announced that the holders of its 8.0% convertible unsecured subordinated debentures due on June 30, 2020, originally issued on July 12, 2017 and August 8, 2017 had approved the proposed amendments to the Debentures at the convened meeting of debenture holders. As a result, the maturity date of the CDN$7,577,000 principal amount Debentures has been extended from June 30, 2020 to June 30, 2022 and the conversion price has been reduced from CDN$1.35 to CDN$0.50. The changes became effective on June 30, 2020.
Following the end of the quarter, more specifically on July 07, 2020, the Company announced that it had entered into a feasibility agreement with Cybin Corp., Canada's premier mushroom life sciences company focused on advancing psychedelic and nutraceutical-based products derived from fungi, for the development of an orally-dissolving film for the delivery of pharmaceutical-grade psilocybin.
Following the end of the quarter, more specifically on July 20, 2020, the Company announced that it and Tilray, Inc. had amended the exclusivity terms of their November 2018 license, development and supply agreement to allow for IntelGenx's co-development and commercialization of CBD products with additional partners. In consideration, IntelGenx shall pay a royalty to Tilray on all CBD products sold pursuant to this amendment. All other terms of the Agreement, including those pertaining to Tilray's exclusive, worldwide marketing and distribution rights for non-CBD cannabis-infused VersaFilm®, remain unchanged.
All amounts are expressed in thousands of U.S. dollars unless otherwise stated.
Currency rate fluctuations
Our operating currency is Canadian dollars, while our reporting currency is U.S. dollars. Accordingly, our results of operations and balance sheet position have been affected by currency rate fluctuations. In summary, our financial statements for the six-month period ended June 30, 2020 report an accumulated other comprehensive loss due to foreign currency translation adjustments of $956 primarily due to the fluctuations in the rates used to prepare our financial statements, $148 of which negatively impacted our comprehensive loss for the six-month period ended June 30, 2020. The following Management Discussion and Analysis takes this into consideration whenever material.
Reconciliation of Comprehensive Loss to Adjusted Earnings (Loss) before Interest, Taxes, Depreciation and Amortization (Adjusted EBITDA (Loss))
Adjusted EBITDA is a non-US GAAP financial measure. A reconciliation of the Adjusted EBITDA is presented in the table below. The Company uses adjusted financial measures to assess its operating performance. Securities regulations require that companies caution readers that earnings and other measures adjusted to a basis other than US-GAAP do not have standardized meanings and are unlikely to be comparable to similar measures used by other companies. Accordingly, they should not be considered in isolation. The Company uses Adjusted EBITDA to measure its performance from one period to the next without the variation caused by certain adjustments that could potentially distort the analysis of trends in our operating performance, and because the Company believes it provides meaningful information on the Company's financial condition and operating results.
IntelGenx obtains its Adjusted EBITDA measurement by adding / (deducting) to comprehensive loss, finance income and costs, depreciation and amortization, income taxes and foreign currency translation adjustment incurred during the period. IntelGenx also excludes the effects of certain non-monetary transactions recorded, such as share-based compensation, for its Adjusted EBITDA calculation. The Company believes it is useful to exclude these items as they are either non-cash expenses, items that cannot be influenced by management in the short term, or items that do not impact core operating performance. Excluding these items does not imply they are necessarily nonrecurring. Share-based compensation costs are a component of employee and consultant's remuneration and can vary significantly with changes in the market price of the Company's shares. Foreign currency translation adjustments are a component of other comprehensive income and can vary significantly with currency fluctuations from one period to another. In addition, other items that do not impact core operating performance of the Company may vary significantly from one period to another. As such, Adjusted EBITDA provides improved continuity with respect to the comparison of the Company's operating results over a period of time. Our method for calculating Adjusted EBITDA may differ from that used by other corporations.
Reconciliation of Non-US GAAP Financial Information
Three-month period | Six-month period | |||||||||||
ended June 30, | ended June 30, | |||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||
$ | $ | $ | $ | |||||||||
Comprehensive loss | (1,333 | ) | (2,479 | ) | (4,227 | ) | (4,820 | ) | ||||
Add (deduct): | ||||||||||||
Depreciation | 175 | 172 | 354 | 343 | ||||||||
Finance costs | 300 | 298 | 607 | 596 | ||||||||
Finance income | (401 | ) | (32 | ) | (402 | ) | (61 | ) | ||||
Share-based compensation | 53 | 95 | 124 | 181 | ||||||||
Other comprehensive (income) loss | (317 | ) | (125 | ) | 120 | (372 | ) | |||||
Adjusted EBITDA Loss | (1,523 | ) | (2,071 | ) | (3,424 | ) | (((4,133 | ) |
Adjusted Earnings (Loss) before Interest, Taxes, Depreciation and Amortization (Adjusted EBITDA (Loss))
Adjusted EBITDA (Loss) improved by $548 for the three-month period ended June 30, 2020 to ($1,523) compared to ($2,071) for the three-month period ended June 30, 2019. The improvement in Adjusted EBITDA (Loss) of $548 for the three-month period ended June 30, 2020 is mainly attributable to a decrease in R&D expenses of $573 before consideration of stock-based compensation and a decrease in SG&A expenses of $130 before consideration of stock-based compensation, offset by a decrease in revenues of $155.
Adjusted EBITDA (Loss) improved by $709 for the six-month period ended June 30, 2020 to ($3,424) compared to ($4,133) for the six-month period ended June 30, 2019. The improvement in Adjusted EBITDA (Loss) of $709 for the six-month period ended June 30, 2020 is mainly attributable to a decrease in R&D expenses of $580 before consideration of stock-based compensation and a decrease in SG&A expenses of $498 before consideration of stock-based compensation, offset by an decrease in revenues of $369.
Results of operations for the three-month and six-month periods ended June 30, 2020 compared with the three-month and six-month periods ended June 30, 2019.
Three-month period ended June 30, | Six-month period ended June 30, | |||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||
Revenue | $ | 42 | $ | 197 | $ | 244 | 613 | |||||
Research and Development Expenses | 602 | 1,182 | 1,452 | 2,042 | ||||||||
Selling, General and Administrative Expenses | 1,016 | 1,181 | 2,340 | 2,885 | ||||||||
Depreciation of tangible assets | 175 | 172 | 354 | 343 | ||||||||
Operating loss | (1,751 | ) | (2,338 | ) | (3,902 | ) | (4,657 | ) | ||||
Net loss | (1,650 | ) | (2,604 | ) | (4,107 | ) | (5,192 | ) | ||||
Comprehensive loss | (1,333 | ) | (2,479 | ) | (4,227 | ) | (4,820 | ) |
Revenue
Total revenues for the three-month period ended June 30, 2020 amounted to $42, representing a decrease of $155 or 79% compared to $197 for the three-month period ended June 30, 2019. Total revenues for the six-month period ended June 30, 2020 amounted to $244, representing a decrease of $369 or 60% compared to $613 for the six-month period ended June 30, 2019. The decrease for the three-month period ended June 30, 2020 compared to the last year's corresponding period is mainly attributable to a decrease in R&D revenues of $155. The decrease for the six-month period ended June 30, 2020 compared to the last year's corresponding period is mainly attributable to a decrease in R&D milestones revenues of $369.
Research and development ("R&D") expenses
R&D expenses for the three-month period ended June 30, 2020 amounted to $602, representing a decrease of $580 or 49%, compared to $1,182 for the three-month period ended June 30, 2019. R&D expenses for the six-month period ended June 30, 2020 amounted to $1,452, representing a decrease of $590 or 29%, compared to $2,042 for the six-month period ended June 30, 2019.
The decrease in R&D expenses for the three-month period ended June 30, 2020 is mainly attributable to a decrease in study costs of $307, lab supplies of $200, salary expenses of $53 as well as a decrease in patent costs of $48, offset by a decrease in R&D investment tax credits of 57. The decrease in R&D expenses for the six-month period ended June 30, 2020 is mainly attributable decrease in study costs of $341, analytical costs of $116, lab supplies of $63, salary expenses of $48, patent costs of $44, consulting fees of $28 as well as a decrease in scale-up costs of $20, offset by a decrease in R&D investment tax credits of 78.
In the three-month period ended June 30, 2020 we recorded estimated Research and Development Tax Credits of $37, compared with $94 that was recorded in the same period of the previous year. In the six-month period ended June 30, 2020 we recorded estimated Research and Development Tax Credits of $110, compared with $188 that was recorded in the same period of the previous year.
Selling, general and administrative ("SG&A") expenses
SG&A expenses for the three-month period ended June 30, 2020 amounted to $1,016, representing a decrease of $165 or 14%, compared to $1,181 for the three-month period ended June 30, 2019. SG&A expenses for the six-month period ended June 30, 2020 amounted to $2,340 representing a decrease of $545 or 19%, compared to $2,885 for the six-month period ended June 30, 2019.
The decrease in SG&A expenses for the three-month period ended June 30, 2020 is mainly attributable to the decreases in the variation of the foreign exchange expense due to the depreciation of the CA dollar vs the US currency of $147, investor relations expenses of $58 and rent expense of $48 due to the Canadian government rent relief program related to the COVID-19 pandemic, offset by increases in insurance expense of $90. The decrease in SG&A expenses for the six-month period ended June 30, 2020 is mainly attributable to decreases in salaries and compensation expenses of $244 (mainly attributable to the revaluation of DSUs and the fact that there were no new DSUs granted in 2020), investor related expenses of $191, the variation of the foreign exchange expense due to the depreciation of the CA dollar vs the US currency of $134, business development expenses of $33, rent expense of $32 due to the Canadian government rent relief program related to the COVID-19 pandemic, offset by increases in insurance expense of $134.
Depreciation of tangible assets
In the three-month period ended June 30, 2020 we recorded an expense of $175 for the depreciation of tangible assets, compared with an expense of $172 for the same period of the previous year. In the six-month period ended June 30, 2020 we recorded an expense of $354 for the depreciation of tangible assets, compared with an expense of $343 for the same period of the previous year.
Share-based compensation expense, warrants and stock-based payments
Share-based compensation warrants and share-based payments expense for the three-month period ended June 30, 2020 amounted to $53 compared to $95 for the three-month period ended June 30, 2019. Share-based compensation warrants and share-based payments expense for the six-month period ended June 30, 2020 amounted to $124 compared to $181 for the six-month period ended June 30, 2019.
We expensed approximately $41 in the three-month period ended June 30, 2020 for options granted to our employees in 2018 and 2019 under the 2016 Stock Option Plan and approximately $12 for options granted to a consultant in 2018, compared with $83 and $12, respectively that was expensed in the same period of the previous year.
We expensed approximately $100 in the six-month period ended June 30, 2020 for options granted to our employees in 2018 and 2019 under the 2016 Stock Option Plan and approximately $24 for options granted to a consultant in 2018, compared with $157 and $24, respectively that was expensed in the same period of the previous year.
There remains approximately $33 in stock-based compensation to be expensed in fiscal 2020 and 2021, of which $20 relates to the issuance of options to our employees during 2018 to 2019 and $13 relates to the issuance of options to a consultant in 2018. We anticipate the issuance of additional options and warrants in the future, which will continue to result in stock-based compensation expense.
Key items from the balance sheet
June 30, 2020 | December 31, 2019 | Increase/ (Decrease) |
Percentage Increase/ (Decrease) | |||||||||
Current Assets | $ | 4,444 | $ | 3,220 | $ | 1,224 | 38% | |||||
Leasehold improvements and Equipment, net | 5,794 | 6,365 | (571 | ) | (9%) | |||||||
Security Deposits | 720 | 752 | (32 | ) | (4%) | |||||||
Operating lease right-of-use asset | 610 | 683 | (73 | ) | (11%) | |||||||
Current Liabilities | 2,742 | 2,805 | (63 | ) | (2%) | |||||||
Long-term debt | 448 | 470 | (22 | ) | (5%) | |||||||
Convertible debentures | 5,089 | 5,642 | (553 | ) | (10%) | |||||||
Convertible notes | 1,364 | 1,255 | 109 | 9% | ||||||||
Operating lease liability | 491 | 555 | (64 | ) | (12%) | |||||||
Capital Stock | 1 | 1 | 0 | 0% | ||||||||
Additional Paid-in-Capital | 48,003 | 42,635 | 5,368 | 13% |
Going Concern
The Company has financed its operations to date primarily through public offerings of its common stock, convertible debentures, convertible notes, bank loans, royalty, up-front and milestone payments, license fees, proceeds from exercise of warrants and options, research and development revenues and the sale of U.S. royalty on future sales of Forfivo XL®. The Company has devoted substantially all of its resources to its drug development efforts, conducting clinical trials to further advance the product pipeline, the expansion of its facilities, protecting its intellectual property and general and administrative functions relating to these operations. The future success of the Company is dependent on its ability to develop its product pipeline and ultimately upon its ability to attain profitable operations. As of June 30, 2020, the Company had cash and short-term investments totaling approximately $3,087. The Company does not have sufficient existing cash and short-term investments to support operations for the next year following the issuance of these financial statements.
On March 11, 2020, the World Health Organization declared the outbreak of a novel coronavirus ("COVID-19") as a global pandemic, which continues to spread throughout Canada and around the world. On March 23, 2020, the government of Quebec ordered the closure of all non-essential businesses effective March 25, 2020. Because of the nature of its operations, the Company is only partially affected by this order. The Company is aware of the impact on its business as a result of COVID-19 but uncertain as to the extent of this impact on its consolidated financial statements. This partial disruption, even temporary, may impact our operations and overall business by delaying the progress of our research and development programs and production activities. There is uncertainty as to the duration and hence the potential impact. As a result, we are unable to estimate the potential impact on our business as of the date of this filing.
These conditions raise substantial doubt about the Company's ability to continue as a going concern. Management's plans to alleviate these conditions include pursuing one or more of the following steps to raise additional funding, none of which can be guaranteed or are entirely within the Company's control:
- Raise funding through the possible sale of the Company's common stock, including public or private equity financings.
- Raise funding through debt financing.
- Continue to seek partners to advance product pipeline.
- Initiate oral film manufacturing activities.
- Initiate contract oral film manufacturing activities.
If the Company is unable to raise capital when needed or on attractive terms, or if it is unable to procure partnership arrangements to advance its programs, the Company would be forced to discontinue some of its operations.. The current COVID-19 pandemic could continue to have a negative impact on the stock market, including trading prices of the Company's shares and its ability to raise new capital.
The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. The accompanying financial statements do not include any adjustments or classifications that may result from the possible inability of the Company to continue as a going concern. Should the Company be unable to continue as a going concern, it may be unable to realize the carrying value of its assets and to meet its liabilities as they become due.
Current assets
Current assets totaled $4,444 as at June 30, 2020 compared with $3,220 at December 31, 2019. The increase of $1,224 is mainly attributable to increases in short-term investments of $2,373 and investment tax credits receivable of $92, offset by a decrease in cash of $1,198 and prepaid expenses of $30.
Cash
Cash totaled $134 as at June 30, 2020 representing a decrease of $1,198 compared with the balance of $1,332 as at December 31, 2019. The decrease in cash on hand relates to net cash used in operating activities of $3,708 and cash used in investing activities of $2,582, offset by net cash provided by financing activities of $5,057.
Accounts receivable
Accounts receivable totaled $380 as at June 30, 2020 representing a decrease of $1 compared with the balance of $381 as at December 31, 2019.
Prepaid expenses
As at June 30, 2020 prepaid expenses totaled $140 compared with $170 as of December 31, 2019. The decrease in prepaid expenses is attributable to the expensing of advance payments made in December 2019 related to services to be provided in the remainder of the year.
Investment tax credits receivable
R&D investment tax credits receivable totaled approximately $467 as at June 30, 2020 compared with $375 as at December 31, 2019. The increase is attributable to the accrual estimated and recorded for the first half of 2020 and the fact that the 2019 amounts were not yet received..
Leasehold improvements and equipment
As at June 30, 2020, the net book value of leasehold improvements and equipment amounted to $5,794, compared to $6,365 at December 31, 2019. In the six-month period ended June 30, 2020 additions to assets totaled $81 and mainly comprised of $58 for manufacturing equipment, $15 for leasehold improvements, $5 for computer equipment and $3 for lab and office equipment, offset by depreciation expense of $354 and variation of foreign exchange fluctuation.
Security deposit
A security deposit in the amount of CAD$300 ($220) in respect of an agreement to lease approximately 17,000 square feet in a property located at 6420 Abrams, St-Laurent, Quebec, Canada was recorded as at June 30, 2020. Security deposits in the amount of CAD$650 ($476) for the term loans, CAD$15 ($11) for utilities and CAD$5 ($4) for Cannabis license were also recorded as at June 30, 2020.
Accounts payable and accrued liabilities
Accounts payable and accrued liabilities totaled $2,026 as at June 30, 2020 compared with $1,941 as at December 31, 2019.
Long-term debt
Long-term debt totaled $1,026 as at June 30, 2020 (December 31, 2019 - $1,197). An amount of $867 is attributable to term loan from the lender secured by a first ranking movable hypothec on all present and future movable property of the Company and a 50% guarantee by Export Development Canada, a Canadian Crown corporation export credit agency. The reimbursement of the term loan started in September 2015 and should be fully reimbursed by October 2021. In April 2020, as a result of the global pandemic, the lender granted the Company an automatic three-month moratorium of debt repayment with a possible moratorium extension of an additional three-month.
An amount of $159 is attributable to a second loan secured by a second ranking on all present and future property of the Company reimbursable in monthly principal payments starting January 2018 to December 2021. In March 2020, as a result of the global pandemic, the lender granted the Company an automatic six-month moratorium of debt repayment
Convertible debentures
Convertible debentures totaled $5,089 as at June 30, 2020 as compared to $5,642 as at December 31, 2019. The Corporation issued a total aggregate principal amount of CAD$7,600,000 ($5,577,000) of debentures at a price of CAD$1,000 ($734) per debenture in July 2017 and August 2017. The convertible debentures have been recorded as a liability. On June 25, 2020, the debenture holders approved the extension of the maturity date of the convertible debentures from June 30, 2020 to June 30, 2022 and the conversion price was reduced from CAD$1.35 ($0.99) to CAD$0.50 ($0.37).
Total transactions costs (including CAD$94,000 ($69,000) related to the extension) in the amount of CAD$1,331,000 ($977,000) were recorded against the liability. The accretion expense for the six-month period ended June 30, 2020 amounts to CAD$249,000 ($182,000) ((CAD$213,000, (160,000) in 2019)). The interest on the convertible debentures as at June 30, 2020 amounts to CAD$303,000 ($222,000) compared to CAD$303,000 ($227,000) for the comparative period in 2019 and is recorded in Financing and interest expense. A gain on debt extinguishment based on its present value calculation was recognized in finance and interest income in the amount of $401 in June 2020 which will be accreted until June 30, 2022.
Convertible notes
Convertible notes totaled $1,364 as at June 30, 2020 as compared to $1,255 as at December 31, 2019. The convertible notes have been recorded as a liability. Total transactions costs in the amount of $111 thousand were recorded against the liability. The accretion expense for the six-month period ended June 30, 2020 amounts to $109 compared to $86 for the comparative period in 2019. The interest on the convertible notes for the six-month period ended June 30, 2020 amounts to $48 ($48 in 2019) and is recorded in Financing and interest expense.
Shareholders' equity
As at June 30, 2020 we had accumulated a deficit of $44,889 compared with an accumulated deficit of $41,507 as at December 31, 2019. Total assets amounted to $11,568 and shareholders' equity totaled $2,160 as at June 30, 2020, compared with total assets and shareholders' equity of $11,020 and $293 respectively, as at December 31, 2019.
Capital stock
As at June 30, 2020 capital stock amounted to $1.102 (December 31, 2019: $0.939). Capital stock is disclosed at its par value with the excess of proceeds shown in Additional Paid-in-Capital.
Additional paid-in-capital
Additional paid-in capital totaled $48,003 as at June 30, 2020, as compared to $42,635 as at December 31, 2019. Additional paid in capital increased by $5,368 from which $3,912 was the value of the common stock issued in the February 2020 public offering, $1,207 was the value of the warrants issued in the February 2020 public offering, $125 was the value attributed to the Agents' warrants in the February 2020 public offering transaction, and $124 from stock based compensation attributable to the amortization of stock options granted to employees and consultants.
Taxation
As at December 31, 2019, the date of our latest annual tax return, we had Canadian and provincial net operating losses of approximately $23,101 (December 31, 2018: $14,934) and $25,264 (December 31, 2018: $16,498) respectively, which may be applied against earnings of future years. Utilization of the net operating losses is subject to significant limitations imposed by the change in control provisions. Canadian and provincial losses will be expiring between 2026 and 2039. A portion of the net operating losses may expire before they can be utilized.
As at December 31, 2019, we had non-refundable tax credits of $2,486 thousand (2018: $1,981 thousand) of which $8 thousand is expiring in 2026, $10 thousand is expiring in 2027, $174 thousand is expiring in 2028, $152 thousand is expiring in 2029, $130 thousand is expiring in 2030, $138 thousand is expiring in 2031, $173 thousand is expiring in 2032, $115 thousand is expiring in 2033, $87 thousand expiring in 2034, $102 thousand is expiring in 2035, $141 thousand expiring in 2036, $270 thousand is expiring in 2037, $582 thousand expiring in 2038 and $404 thousand expiring in 2039 and undeducted research and development expenses of $14,282 thousand (2018: $10,663 thousand) with no expiration date.
The deferred tax benefit of these items was not recognized in the accounts as it has been fully provided for.
Key items from the statement of cash flows
June 30, 2020 | June 30, 2019 | Increase/ (Decrease) |
Percentage Increase/ (Decrease) | |||||||||
Operating Activities | $ | (3,708 | ) | $ | (4,697 | ) | $ | 989 | (21%) | |||
Financing Activities | 5,057 | (316 | ) | 5,373 | (1700%) | |||||||
Investing Activities | (2,582 | ) | 3,504 | (6,086 | ) | (174%) | ||||||
Cash - end of period | 134 | 5,581 | (5,447 | ) | (98%) |
Statement of cash flows
Net cash used in operating activities was $3,708 for the six-month period ended June 30, 2020, compared to $4,697 for the six-month period ended June 30, 2019. For the six-month period ended June 30, 2020, net cash used by operating activities consisted of a net loss of $4,107 (2019: $5,192) before depreciation, accretion expense, stock-based compensation, DSU expense, gain on debt extinguishment and lease non-cash expense in the amount of $229 (2019: $886) and an increase in non-cash operating elements of working capital of $170 (2019: $391 decrease).
The net cash provided by financing activities was $5,057 for the six-month period ended June 30, 2020, compared to net cash used in financing activities of $316 in the same period of the previous year.
An amount of $5,564 derives from the proceeds from public offering (2019: $Nil) and an amount of $Nil derives from proceeds from exercise of warrants and stock options (2019: $21) offset by repayment of term loans for an amount of $118 (2019: $337), the transaction costs related to the public offering of $320 (2019: $Nil) and the transaction costs related to the debt modification of $69 (2019: $Nil).
Net cash used investing activities amounted to $2,582 for the six-month period ended June 30, 2020 compared to net cash provided from investing activities of $3,504 in the same period of 2019. The net cash used investing activities for the six-month period ended June 30, 2020 relates to the acquisition of short-term investments of $4,532 (2019: $1,469) and the purchase of leasehold improvements and equipment of $81 (2019: $211), offset by the redemption of short-term investments of $2,031 (2019: $5,184).
The balance of cash as at June 30, 2020 amounted to $134, compared to $5,581 as at June 30, 2019.
Subsequent Events
None
Off-balance sheet arrangements
We have no off-balance sheet arrangements.
Item 3. Controls and Procedures.
As of the end of the period covered by this report, we carried out an evaluation, under the supervision and with the participation of management, including our chief executive officer and principal financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934. Based upon that evaluation, our chief executive officer and principal financial officer concluded that our disclosure controls and procedures are effective to cause the material information required to be disclosed by us in the reports that we file or submit under the Exchange Act to be recorded, processed, summarized and reported within the time periods specified in the SEC's rules and forms. There have been no significant changes in our internal controls or in other factors which could significantly affect internal controls subsequent to the date we carried out our evaluation.
PART II
Item 1. Legal Proceedings
This Item is not applicable
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
This Item is not applicable.
Item 3. Defaults Upon Senior Securities
This Item is not applicable.
Item 4. (Reserved)
Item 5. Other Information
This Item is not applicable.
Item 6. Exhibits
Certification of C.E.O. Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
SIGNATURES
In accordance with the requirements of the Securities Exchange Act of 1934, the Registrant caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
INTELGENX TECHNOLOGIES CORP.
Date: August 13, 2020 | By: /s/ Horst G. Zerbe |
Horst G. Zerbe | |
Chief Executive Officer and | |
Director | |
Date: August 13, 2020 | By: /s/ Andre Godin |
Andre Godin | |
Principal Accounting Officer | |