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, 2017
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 ] |
Emerging Growth [ ] |
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 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
[ ]
APPLICABLE TO CORPORATE ISSUERS:
66,837,021 shares of the issuers common stock, par value $.00001 per share, were issued and outstanding as of August 9, 2017.
1
IntelGenx Technologies Corp.
Form 10-Q
TABLE OF CONTENTS
2
IntelGenx Technologies Corp.
Consolidated Interim Financial Statements
June 30, 2017
(Expressed in U.S. Funds)
(Unaudited)
3
IntelGenx Technologies Corp.
Consolidated
Balance Sheet
(Expressed in Thousands of U.S. Dollars ($000s) Except
Share and Per Share Data)
(Unaudited)
June 30, | December 31, | |||||
2017 | 2016 | |||||
Assets | ||||||
Current | ||||||
Cash and cash equivalents | $ | 1,175 | $ | 612 | ||
Short-term investments | 1,639 | 3,884 | ||||
Accounts receivable | 367 | 1,044 | ||||
Prepaid expenses | 404 | 566 | ||||
Investment tax credits receivable | 213 | 246 | ||||
Total Current Assets | 3,798 | 6,352 | ||||
Leasehold Improvements and Equipment, net (note 4) | 6,034 | 5,730 | ||||
Security Deposits | 732 | 708 | ||||
Total Assets | $ | 10,564 | $ | 12,790 | ||
Liabilities | ||||||
Current | ||||||
Accounts payable and accrued liabilities | 452 | 897 | ||||
Current portion of long-term debt (note 7) | 728 | 704 | ||||
Deferred revenue (note 6) | 1,880 | 3,634 | ||||
Total Current Liabilities | 3,060 | 5,235 | ||||
Deferred lease obligations | 48 | 45 | ||||
Long-term debt (note 7) | 2,290 | 2,565 | ||||
Total Liabilities | 5,398 | 7,845 | ||||
Subsequent event (note 12) | ||||||
Shareholders' Equity | ||||||
Capital Stock, common shares, $0.00001 par
value; 100,000,000 shares authorized; 66,637,020 shares issued and outstanding (2016: 64,812,020 common shares) (note 8) |
1 | 1 | ||||
Additional Paid-in Capital (note 9) | 24,939 | 23,700 | ||||
Accumulated Deficit | (18,915 | ) | (17,737 | ) | ||
Accumulated Other Comprehensive Loss | (859 | ) | (1,019 | ) | ||
Total Shareholders Equity | 5,166 | 4,945 | ||||
$ | 10,564 | $ | 12,790 |
See accompanying notes
Approved on Behalf of the Board:
/s/ Bernd J.
Melchers
Director
/s/ Horst G.
Zerbe
Director
4
IntelGenx Technologies
Corp.
Consolidated Statement
of Shareholders' Equity
For the Period Ended June 30,
2017
(Expressed in Thousands of U.S. Dollars
($000s) 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, 2016 | 64,812,020 | $ | 1 | $ | 23,700 | $ | (17,737 | ) | $ | (1,019 | ) | $ | 4,945 | |||||
Foreign currency translation adjustment | - | - | - | - | 160 | 160 | ||||||||||||
Warrants exercised (note 9) | 1,690,000 | - | 954 | - | - | 954 | ||||||||||||
Options exercised (note 9) | 135,000 | - | 62 | - | - | 62 | ||||||||||||
Stock-based compensation (note 9) | - | - | 223 | - | - | 223 | ||||||||||||
Net loss for the period | - | - | - | (1,178 | ) | - | (1,178 | ) | ||||||||||
Balance June 30, 2017 | 66,637,020 | $ | 1 | $ | 24,939 | $ | (18,915 | ) | $ | (859 | ) | $ | 5,166 |
See accompanying notes
5
IntelGenx Technologies Corp.
Consolidated
Statement of Comprehensive Loss
(Expressed in Thousands of U.S.
Dollars ($000s) Except Share and Per Share Data)
(Unaudited)
For the Three-Month Period | For the Six-Month Period | |||||||||||
Ended June 30, | Ended June 30, | |||||||||||
2017 | 2016 | 2017 | 2016 | |||||||||
Revenues | ||||||||||||
Royalties | $ | - | $ | 672 | $ | - | $ | 1,051 | ||||
License and other revenue | 1,126 | - | 2,479 | 439 | ||||||||
Total Revenues | 1,126 | 672 | 2,479 | 1,490 | ||||||||
Expenses | ||||||||||||
Cost of royalty and license revenue | 89 | 66 | 181 | 131 | ||||||||
Research and development expense | 654 | 426 | 1,298 | 907 | ||||||||
Selling, general and administrative expense | 826 | 874 | 1,730 | 1,765 | ||||||||
Depreciation of tangible assets | 170 | 100 | 340 | 187 | ||||||||
Total Expenses | 1,739 | 1,466 | 3,549 | 2,990 | ||||||||
Operating loss | (613 | ) | (794 | ) | (1,070 | ) | (1,500 | ) | ||||
Interest income | 1 | - | 3 | - | ||||||||
Financing and Interest expense | (54 | ) | (46 | ) | (111 | ) | (86 | ) | ||||
Net Loss | (666 | ) | (840 | ) | (1,178 | ) | (1,586 | ) | ||||
Other Comprehensive Income | ||||||||||||
Foreign currency translation adjustment |
116 | 34 | 160 | 73 | ||||||||
Comprehensive Loss | $ | (550 | ) | $ | (806 | ) | $ | (1,018 | ) | $ | (1,513 | ) |
Basic and Diluted Weighted Average Number of Shares Outstanding | 65,493,394 | 63,615,255 | 65,399,853 | 63,615,255 | ||||||||
Basic and Diluted Loss Per Common Share (note 11) | $ | (0.01 | ) | $ | (0.01 | ) | $ | (0.02 | ) | $ | (0.02 | ) |
See accompanying notes
6
IntelGenx Technologies Corp.
Consolidated
Statement of Cash Flows
(Expressed in thousands of U.S. Dollars
($000s) Except Share and Per Share Data)
(Unaudited)
For the Three-Month Period | For the Six-Month Period | |||||||||||
Ended June 30, | Ended June 30, | |||||||||||
2017 | 2016 | 2017 | 2016 | |||||||||
Funds Provided (Used) - | ||||||||||||
Operating Activities | ||||||||||||
Net loss | $ | (666 | ) | $ | (840 | ) | $ | (1,178 | ) | $ | (1,586 | ) |
Amortization and depreciation | 170 | 100 | 340 | 187 | ||||||||
Stock-based compensation | 53 | 29 | 223 | 92 | ||||||||
(443 | ) | (711 | ) | (615 | ) | (1,307 | ) | |||||
Changes in assets and liabilities: | ||||||||||||
Accounts receivable | 61 | (260 | ) | 677 | 390 | |||||||
Prepaid expenses | 24 | (27 | ) | 162 | (39 | ) | ||||||
Investment tax credits receivable | (35 | ) | (24 | ) | 33 | (53 | ) | |||||
Security deposit | (18 | ) | (3 | ) | (24 | ) | (229 | ) | ||||
Accounts payable and accrued liabilities | (161 | ) | 422 | (445 | ) | (438 | ) | |||||
Deferred revenue | (870 | ) | - | (1,754 | ) | - | ||||||
Deferred lease obligations | 2 | 1 | 3 | 18 | ||||||||
Net change in assets and liabilities | (997 | ) | 109 | (1,348 | ) | (351 | ) | |||||
Net cash used by operating activities | (1,440 | ) | (602 | ) | (1,963 | ) | (1,658 | ) | ||||
Financing Activities | ||||||||||||
Issuance of term loans | - | 1,177 | - | 1,569 | ||||||||
Repayment of term loans | (251 | ) | (53 | ) | (354 | ) | (70 | ) | ||||
Proceeds from exercise of warrants and stock options | 679 | - | 1,016 | - | ||||||||
Net cash provided by financing activities | 428 | 1,124 | 662 | 1,499 | ||||||||
Investing Activities | ||||||||||||
Additions to property and equipment | (233 | ) | (1,554 | ) | (455 | ) | (1,844 | ) | ||||
Redemption of short-term investments | 2,025 | - | 2,325 | - | ||||||||
Net cash provided by (used in) investing activities | 1,792 | (1,554 |
) |
1,870 | (1,844 |
) | ||||||
Increase (Decrease) in Cash and Cash Equivalents | 780 | (1,032 | ) | 569 | (2,003 | ) | ||||||
Effect of Foreign Exchange on Cash and Cash Equivalents | 95 | 61 | (6 |
) |
234 | |||||||
Cash and Cash Equivalents | ||||||||||||
Beginning of Period | 300 | 2,067 | 612 | 2,865 | ||||||||
End of Period | $ | 1,175 | $ | 1,096 | $ | 1,175 | $ | 1,096 |
See accompanying notes
7
IntelGenx Technologies Corp.
Notes to
Consolidated Interim Financial Statements
June 30, 2017
(Expressed in U.S. Funds)
(Unaudited)
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, 2016. Operating results for the six months ended June 30, 2017 are not necessarily indicative of the results that may be expected for the year ending December 31, 2017. 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 Companys 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. |
Adoption of New Accounting Standards |
The FASB issued Update 2016-06, Derivatives and Hedging Contingent Put and Call Options in Debt Instruments, clarifying the requirements for assessing whether contingent call (put) options that can accelerate the payment of principal on debt instruments are clearly and closely related to their debt hosts. The amendments in this Update require an entity performing the assessment to assess the embedded call (put) options solely in accordance with the four-step decision sequence. For public business entities, the amendments in this Update are effective for fiscal years beginning after December 15, 2016, including interim periods within those fiscal years. The adoption of this statement did not have a material effect on the Companys financial position or results.
The FASB issued Update 2016-09, Compensation Stock Compensation Improvements to Employee Share-Based Payment Accounting, simplifying several aspects of the accounting for share-based payment transactions, including income tax consequences, classification of awards as either equity or liabilities, and classification on the statement of cash flows. For public business entities, the amendments in this Update are effective for fiscal years beginning after December 15, 2016, including interim periods within those fiscal years. The adoption of this statement did not have a material effect on the Companys financial position or results.
8
IntelGenx Technologies Corp.
Notes to
Consolidated Interim Financial Statements
June 30, 2017
(Expressed in U.S. Funds)
(Unaudited)
2. |
Adoption of New Accounting Standards (Cont'd) |
The FASB issued Update 2015-11, Inventory: Simplifying the Measurement of Inventory, aligning the measurement of inventory in GAAP with the measurement of inventory in International Financial Reporting Standards (IFRS). The amendments in this Update state that an entity should measure inventory within the scope of this update at the lower of cost and net realizable value. Net realizable value is the estimated selling prices in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation. For public business entities, the amendments in this Update are effective for fiscal years beginning after December 15, 2016, including interim periods within those fiscal years. The adoption of this statement did not have a material effect on the Companys financial position or results.
The FASB issued 2015-017, Income Taxes: Balance Sheet Classification of Deferred Taxes, which requires that deferred tax liabilities be classified as noncurrent in a classified statement of financial position. For public business entities, the amendments in this Update are effective for fiscal years beginning after December 15, 2016, including interim periods within those fiscal years. The adoption of this statement did not have a material effect on the Companys financial position or results.
3. |
Significant Accounting Policies |
ASU 2017-09 Stock Compensation (Topic 718) Scope of Modification Accounting
In May 2016, the FASB issued ASU 2017-09 which provides guidance on determining which changes to the terms and conditions of share-based payment awards require an entity to apply modification accounting under Topic 718. The statement is effective for annual periods beginning after December 15, 2017. Early adoption is permitted in any interim or annual period for which financial statements have not yet been issued. The Company is currently evaluating the impact of this Statement on its consolidated financial statements.
ASU 2016-18 Statement of Cash Flows (Topic 230) Restricted Cash
In November 2016, the FASB issued ASU 2016-18 which requires that the statement of cash flows explain the change during the period in the total cash, cash equivalents, and amounts generally described as restricted or restricted cash equivalents. The statement is effective for annual periods beginning after December 15, 2017, and interim periods within those annual periods. Early adoption is permitted in any interim or annual period and should be applied on a retrospective basis. The Company is currently evaluating the impact of this Statement on its consolidated financial statements.
ASU 2016-15 Statement of Cash Flows (Topic 230) Classification of Certain Cash Receipts and Cash Payments
In August 2016, the FASB issued ASU 2016-15 which clarifies how certain cash receipts and payments are to be presented in the Statement of cash flows. The statement is effective for annual periods beginning after December 15, 2017, and interim periods within those annual periods. Early adoption is permitted in any interim or annual period, with any adjustments reflected as of the beginning of the fiscal year of adoption. The Company is currently evaluating the impact of this Statement on its consolidated financial statements.
9
IntelGenx Technologies Corp.
Notes to
Consolidated Interim Financial Statements
June 30, 2017
(Expressed in U.S. Funds)
(Unaudited)
3. |
Significant Accounting Policies (Contd) |
ASU 2016-01 Financial Instruments Overall (Subtopic 825-10) Recognition and Measurement of Financial Assets and Financial Liabilities
In January 2016, the FASB issued ASU 2016-01, which will significantly change practice for all entities. The targeted amendments to existing guidance are expected to include:
1. |
Equity investments that do not result in consolidation and are not accounted for under the equity method would be measured at fair value through net income, unless they qualify for the proposed practicability exception for investments that do not have readily determinable fair values. | |
2. |
Changes in instrument-specific credit risk for financial liabilities that are measured under the fair value option would be recognized in other comprehensive income. | |
3. |
Entities would make the assessment of the realizability of a deferred tax asset (DTA) related to an available- for-sale (AFS) debt security in combination with the entitys other DTAs. The guidance would eliminate one method that is currently acceptable for assessing the realizability of DTAs related to AFS debt securities. That is, an entity would no longer be able to consider its intent and ability to hold debt securities with unrealized losses until recovery. | |
4. |
Disclosure of the fair value of financial instruments measured at amortized cost would no longer be required for entities that are not public business entities. |
For public business entities, the amendments in this Update are effective for fiscal years beginning after December 15, 2017, including interim periods within those fiscal years. The Company is currently evaluating the impact of this Statement on its consolidated financial statements.
ASU 2017-04 Intangibles Goodwill and Other (Topic 350) Simplifying the Test for Goodwill Impairment
The FASB issued ASU 2017-04 which eliminates Step 2 from the goodwill impairment test and eliminates the requirements for any reporting unit with a zero or negative carrying amount to perform a qualitative assessment. These amendments are effective for a public business entity for fiscal years beginning after December 15, 2019. Early adoption is permitted in any interim or annual period and should be applied on a retrospective basis. The Company is currently evaluating the impact of this Statement on its consolidated financial statements.
10
IntelGenx Technologies Corp.
Notes to
Consolidated Interim Financial Statements
June 30, 2017
(Expressed in U.S. Funds)
(Unaudited)
3. |
Significant Accounting Policies (Contd) |
ASU 2017-01 - Business Combinations (Topic 805) - Clarifying the Definition of a Business
The FASB issued ASU 2017-01 which clarifies the definition of a business and is intended to help companies evaluate whether transactions should be accounted for as acquisitions (or disposals) of assets or businesses. These amendments are effective for a public business entity for fiscal years beginning after December 15, 2017, including interim periods within those fiscal years. Early adoption is permitted under certain circumstances and should be applied on a prospective basis. The Company is currently evaluating the impact of this Statement on its consolidated financial statements.
ASU 2016-16 Income Taxes (Topic 740) Intra-Entity Transfers of Assets Other Than Inventory
The FASB issued ASU 2016-16 and requires an entity to recognize the income tax consequences of an intra-entity transfer of an asset other than inventory when the transfer occurs. These amendments are effective for a public business entity for fiscal years beginning after December 15, 2017, including interim periods within those fiscal years. The amendments should be applied on a modified retrospective basis through a cumulative-effect adjustment directly to retained earnings as of the beginning of the period of adoption. The Company is currently evaluating the impact of this Statement on its consolidated financial statements.
ASU 2016-02: Leases (Topic 842) Section A
The FASB issued ASU 2016-02 to increase the transparency and comparability among organizations by recognizing lease assets and lease liabilities on the balance sheet and disclosing key information about leasing arrangements.
These amendments are effective for a public business entity for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years.
The Company is currently evaluating the impact of this Statement on its consolidated financial statements.
11
IntelGenx Technologies Corp.
Notes to
Consolidated Interim Financial Statements
June 30, 2017
(Expressed in U.S. Funds)
(Unaudited)
3. |
Significant Accounting Policies (Contd) |
Revenue from Contracts with Customers (Topic 606)
The FASB and IASB (the Boards) have issued converged standards on revenue recognition. ASU No. 2014-09 which affects any entity using U.S. GAAP that either enters into contracts with customers to transfer goods or services or enters into contracts for the transfer of nonfinancial assets unless those contracts are within the scope of other standards. This ASU will supersede the revenue recognition requirements in Topic 605, Revenue Recognition and most industry-specific guidance. The core principle of the guidance is that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. To achieve that core principle, an entity should apply the following steps:
| Step 1: Identify the contract(s) with a customer. | |
| Step 2: Identify the performance obligations in the contract. | |
| Step 3: Determine the transaction price. | |
| Step 4: Allocate the transaction price to the performance obligations in the contract. | |
| Step 5: Recognize revenue when (or as) the entity satisfies a performance obligation. |
In the year ended December 31, 2016, the FASB issued three new amendments related to Topic 606:
1. |
ASU 2016-08: Revenue from Contracts with Customers (Topic 606): Principal versus Agent Considerations (Reporting Revenue Gross versus Net) which was issued to add clarification to the implementation guidance on principle versus agent considerations. This amendment does not provide any changes to the previously issued ASU No. 2014-09 and is effective for the same reporting period which was deferred by one year in ASU 2015-14: Revenue From Contracts With Customers (Topic 606), Deferral of the Effective Date. | |
2. |
ASU 2016-10: Revenue from Contracts with Customers (Topic 606): Identifying Performance Obligations and Licensing which was issued to clarifying the following two aspects of topic 606; identifying performance obligations and the licensing implementation guidance. This amendment does not provide any changes to the previously issued ASU No. 2014-09 and is effective for the same reporting period which was deferred by one year in ASU 2015-14: Revenue From Contracts With Customers (Topic 606), Deferral of the Effective Date. | |
3. |
ASU 2016-11 Revenue Recognition (Topic 605) and Derivatives and Hedging (Topic 815): Rescission of SEC Guidance Because of Accounting Standards Updates 2014-09 and 2014-16 Pursuant to Staff Announcements at the March 3, 2016 EITF Meeting. With this amendment, the SEC Staff is rescinding the following SEC Staff Observer comments that are codified in Topic 605, Revenue Recognition, and Topic 932, Extractive ActivitiesOil and Gas, effective upon adoption of Topic 606. This amendment is effective immediately. |
12
IntelGenx Technologies Corp.
Notes to
Consolidated Interim Financial Statements
June 30, 2017
(Expressed in U.S. Funds)
(Unaudited)
3. |
Significant Accounting Policies (Contd) |
Public business entities, certain not-for-profit entities, and certain employee benefit plans should apply the guidance in Update 2014-09 to annual reporting periods beginning after December 15, 2017, including interim reporting periods within that reporting period. Earlier application is permitted only as of annual reporting periods beginning after December 15, 2016, including interim reporting periods within that reporting period.
This ASU is to be applied retrospectively, with certain practical expedients allowed. The Company is currently evaluating the impact of this Statement on its consolidated financial statements.
4. |
Leasehold Improvements and Equipment |
As at June 30, 2017 no depreciation has been recorded on manufacturing equipment in the amount of $450 as the equipment is not ready for use.
5. |
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 and corporate credits cards of up to CAD$75 thousand. Borrowings under the operating demand line of credit bear interest at the Banks prime lending rate plus 2%. The credit facility and term loan (see note 7) are 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 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 Companys fiscal year. As at June 30, 2017, the Company has not drawn on its credit facility.
6. |
Deferred Revenue |
On August 5, 2016, the Company sold its U.S. royalty on future sales of Forfivo XL® to SWK Holdings Corporation for $6 million. Under the terms of the agreement, SWK paid IntelGenx $6 million at closing. In return for, (i) 100% of any and all royalties or similar royalty amounts received on or after April 1, 2016, (ii) 100% of the $2 million milestone payment upon Edgemont reaching annual net sales of $15 million, and (iii) 35% of all potential future milestone payments.
The deferred revenue represents the remaining, unrecognized portion of the payment received for the royalty on future sales in the amount of $6 million less the Q2 royalties recognized in the second quarter of 2016 in the amount of $352 thousand. The deferred revenue will be recognized as other revenue on a straight-line basis until December 31, 2017.
13
IntelGenx Technologies Corp.
Notes to
Consolidated Interim Financial Statements
June 30, 2017
(Expressed in U.S. Funds)
(Unaudited)
6. |
Deferred Revenue (contd) |
10% of the proceeds were paid to our former development partner, Cary Pharmaceuticals Inc. This amount is included in prepaid expenses and will be recognized as cost of royalty, license and other revenue on a straight-line basis until December 31, 2017
7. |
Long-term debt |
The components of the Companys debt are as follows:
June 30, 2017 | December 31, 2016 | ||||||
$ | $ | ||||||
(in U.S. $ thousands) | |||||||
Term loan facility | 2,440 | 2,636 | |||||
Secured loan | 578 | 633 | |||||
Total debt | 3,018 | 3,269 | |||||
Less: current portion | 728 | 704 | |||||
Total long-term debt | 2,290 | 2,565 |
The Companys term loan facility consists of a total of CAD$4 million bearing interest at the Banks prime lending rate plus 2.50% . The term loan is subject to the same security and financial covenants as the bank indebtedness (see note 5).
The secured loan has a principal balance authorized of CAD$1 million bearing interest at prime plus 7.3%, reimbursable in monthly principal payments of CAD$17 thousand from January 2017 to March 2021. 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 Companys fiscal year.
Principal repayments due in each of the next five years are as follows:
2017 | $ |
364 (CAD 472) |
|
2018 |
728 (CAD 945) |
||
2019 |
728 (CAD 945) |
||
2020 |
728 (CAD 945) |
||
2021 |
470 (CAD 610) |
14
IntelGenx Technologies Corp.
Notes to
Consolidated Interim Financial Statements
June 30, 2017
(Expressed in U.S. Funds)
(Unaudited)
8. |
Capital Stock |
June 30, | December 31, | ||||||
2017 | 2016 | ||||||
Authorized - | |||||||
100,000,000 common shares of $0.00001 par value | |||||||
20,000,000 preferred shares of $0.00001 par value | |||||||
Issued - | |||||||
66,637,020 (December 31, 2016 - 64,812,020) common shares | $ | 1 | $ | 1 |
9. |
Additional Paid-In Capital |
Stock options
During the six-month period ended June 30, 2017, on January 18, 2017, 300,000 options to purchase common stock were granted to non-employee directors under the 2016 Stock Option Plan. The options have an exercise price of $0.89. The options vest immediately 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 $114 thousand.
During the six-month period ended June 30, 2017 a total of 135,000 stock options were exercised for 135,000 common shares having a par value of $0 thousand in aggregate, for cash consideration of $62 thousand, resulting in an increase in additional paid-in capital of $62 thousand. No stock options were exercised during the six-month period ended June 30, 2016.
Compensation expenses for stock-based compensation of $223 thousand and $92 thousand were recorded during the six-month periods ended June 30, 2017 and 2016, respectively. An amount of $220 thousand expensed in the six-month period of 2017 relates to stock options granted to employees and directors and an amount of $3 thousand relates to stock options granted to a consultant. The entire amount expensed in the six-month period of 2016 relates to stock options granted to employees and directors. As at June 30, 2017, the Company has $188 thousand (2016 - $128 thousand) of unrecognized stock-based compensation.
Warrants
During the six-month period ended June 30, 2017 a total of 1,690,000 warrants were exercised for 1,690,000 common shares having a par value of $Nil in aggregate, for cash consideration of approximately $954 thousand, resulting in an increase in additional paid-in capital of approximately $954 thousand. No warrants were exercised during the six-month period ended June 30, 2016.
15
IntelGenx Technologies Corp.
Notes to
Consolidated Interim Financial Statements
June 30, 2017
(Expressed in U.S. Funds)
(Unaudited)
10. |
Related Party Transactions |
Included in management salaries are $Nil (2016 - $2 thousand) for options granted to the Chief Executive Officer, $30 thousand (2016 - $30 thousand) for options granted to the Chief Financial Officer, $3 thousand (2016 - $3 thousand) for options granted to the Vice President, Operations, $3 thousand (2016 - $2 thousand) for options granted to the Vice-President, Research and Development, $17 thousand (2016 - $Nil) for options granted to Vice-President, Business and Corporate Development and $Nil (2016 - $5 thousand) for options granted to the Vice President, Corporate Development under the 2016 Stock Option Plan and $124 thousand (2016 - $41 thousand) for options granted to non-employee directors.
Also included in management salaries are director fees of $136 thousand (2016 - $89 thousand).
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.
11. |
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 notes have been excluded from the calculation of diluted loss per share since they are anti-dilutive.
12. |
Subsequent Event |
On July 12, 2017, the Company announced that it had closed its previously announced prospectus offering (the Offering) of convertible unsecured subordinated debentures of the Corporation (the Debentures) for gross aggregate proceeds of CDN$6,838,000. Pursuant to the Offering, the Corporation issued an aggregate principal amount of CDN$6,838,000 of Debentures at a price of CDN$1,000 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 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 CDN$1.35 (the Conversion Price) per common share of the Corporation (Share), being a conversion rate of approximately 740 Shares per CDN$1,000 principal amount of Debentures, subject to adjustment in certain events.
On August 8, 2017, the Company announced that it had 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 CDN$762,000.
Together with the principal amount of CDN$6,838,000 of Debentures issued on July 12, 2017, the Corporation issued a total aggregate principal amount of CDN$7,600,000 of Debentures at a price of CDN$1,000 per Debenture.
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Item 2: Managements Discussion and Analysis of Financial Condition and Results of Operations Introduction to Managements Discussion and Analysis
This Managements 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 three-month and six-month periods ended June 30, 2017 and 2016.
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 Financial Statements and Notes thereto. We also encourage you to refer to the Companys MD&A for the year ended December 31, 2016. In preparing this MD&A, we have taken into account information available to us up to August 10, 2017, 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, 2016 (the 2016 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.
Cautionary Statement 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 managements 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 2016 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.
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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. Our business strategy is to develop pharmaceutical products based on our proprietary drug delivery technologies and, once the viability of a product has been demonstrated, to license the commercial rights to partners in the pharmaceutical industry. In certain cases, we rely upon partners in the pharmaceutical industry to fund development of the licensed products, complete the regulatory approval process with the U.S. Food and Drug Administration (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 include: (1) identifying lifecycle management opportunities for existing market leading pharmaceutical products, (2) repurposing existing drugs for new indications, (3) developing generic drugs where high technology barriers to entry exist in reproducing branded films, (4) manufacturing our VersaFilm products for commercial sale and (5) development of new drug delivery technologies.
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.
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.
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VersaFilm Manufacturing
We have establishing a state-of-the-art manufacturing facility with the intent to manufacture all our VersaFilm products in house as 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.
Most recent key developments
On April 03, 2017, the Company and Tetra Bio-Pharma Inc. announced the signing of a definitive agreement for the development and commercialization of a drug product containing the cannabinoid Dronabinol for the management of anorexia and cancer chemotherapy-related pain. This definitive agreement follows the binding term sheet between the two companies that was announced on February 9, 2017.
Pursuant to the definitive agreement, Tetra has exclusive rights to sell the Product in North America, with a right of first negotiation for territories outside of the United States and Canada. Tetra has paid an upfront payment to IntelGenx, in addition to future milestone and royalty payments, based on the completion of an efficacy study, approvals from the U.S. Food and Drug Association and Health Canada, and the commercial launch of the Product. IntelGenx will be responsible for the research and development of the Product, including clinical studies, and will develop the product as an oral mucoadhesive tablet based on its proprietary AdVersa® controlled-release technology. Tetra will be responsible for funding the product development, and will own and control all regulatory approvals, including the related applications, and any other marketing authorizations. Tetra will also be responsible for all aspects of commercializing the Product.
There are many clinical problems associated with the use of currently available form of Dronabinol in patients with anorexia and cancer chemotherapy-related pain. It has been demonstrated that psychoactive drugs exert their euphoria, and other psychoactive effects, when the blood levels of the drug rapidly increase. The pharmacokinetic profile of tetrahydrocannabinol ("THC") and its metabolite increases the abuse potential of cannabinoids like Dronabinol. The significant advantage of an oral mucoadhesive tablet based on IntelGenx' proprietary AdVersa® controlled-release technology is that it can be adjusted to achieve a predetermined drug release pattern by increasing the residence time, promoting intimate contact with the mucosal tissue and increasing the bioadhesive properties of the dosage form. It is believed that, by deploying this technology in the controlled-release of THC, a longer time release of the drug will be achieved and, thereby, a rapid increase in the blood will be avoided. There will also potentially be improved bioavailability and reduced gastro-intestinal side effects, making a sustained-release THC product a promising alternative in the battle for the reduction of opioids in patients with chronic pain.
On April 13, 2017, the Company together with RedHill Biopharma Ltd. announced that the Ministry of Health of Luxembourg had granted national marketing authorization for RIZAPORT® (5 mg and 10 mg), a proprietary oral thin film formulation of rizatriptan benzoate for the treatment of acute migraines. The national marketing authorization was granted in Luxembourg on the basis of the DCP, in which Luxembourg served as the Concerned Member State. The approval in Luxembourg marks the completion of the current marketing approval process for RIZAPORT® under the DCP. This process requires marketing approval in at least two European states, a Reference Member State and a Concerned Member State. RIZAPORT® (5 mg and 10 mg) was previously approved for marketing in Germany, which served as the Reference Member State. Under the DCP, marketing authorization approval of RIZAPORT® in additional European countries is subject to a separate procedure to obtain additional national marketing authorizations in each country.
On June 08, 2017, the Company announced that the United States Patent and Trademark Office had issued US Patent 9,668,970, entitled "Film Dosage Form with Extended Release Mucoadhesive Particles". The patent covers the design and manufacturing of topical oral films ("TOF") for the local (topical) treatment of diseases of the oral mucosa using mucoadhesive particles. This proprietary technology is intended to provide sustained release of an active agent to a target area of the oral cavity and is useful for the topical treatment of oral diseases and conditions such as gingivitis, buccal ulcers, canker sores, Sjögren's syndrome, oral mucositis and Behcet's disease.
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IntelGenx' TOF has a unique mode of action. It facilitates the controlled release of an active agent to the buccal cavity and its transport through the oral mucosa, while avoiding the discomfort often associated with conventional long lasting mucoadhesive films or tablets. The controlled release of an active agent for local action in the buccal cavity is achieved by providing an oral film in which small sized mucoadhesive particles containing the active agent are dispersed in a disintegrating film matrix. Upon administration in the oral cavity, the film quickly disintegrates and releases the mucoadhesive particles which will bind to the oral mucosa. The active agent can be released from the mucoadhesive particles over a prolonged period of time as the mucoadhesive material slowly dissolves or erodes.
The market opportunity for treatments of oral disease and conditions is large and growing. For example, available data indicate that the global market for Sjögren's Syndrome and oral mucositis treatments will reach approximately USD$2 billion in 2017, growing at a compound annual rate of 7.2% through to 2024, while the prevalence of mouth ulcers is already very high, with approximately 15-30% of the global population currently affected.
With the issuance of this new patent, IntelGenx intends to seek potential commercialization partners for TOF products in the United States.
On June 27, 2017, the Company announced that the United States Patent and Trademark Office had granted a notice of allowance for US Patent Application 13/748,241, entitled "Solid oral film dosage forms and methods for making same." This platform patent discloses oral film dosage forms designed for immediate or sustained release of an active to the buccal and/or sublingual mucosa and will protect several of IntelGenx' oral film products.
IntelGenx' new patented oral film technology allows the instant hydration and complete disintegration of a film in the oral cavity, potentially enabling the active ingredient to become immediately available for enhanced buccal and/or sublingual absorption. In addition, the novel oral film dosage form is applicable for reduced absorption through the gastrointestinal route. IntelGenx' improved delivery systems for solubilizing and stabilizing pharmaceutically active ingredients exhibit enhanced stability derived from the use of a combination of crystallization inhibitors, which together can maintain the active ingredient in a desired plurality of particles in an effective size range within a polymeric film matrix. This oral dosage form technology patent has broad applicability in film formulation and could be applicable to several current and future projects.
The granting of this Orange Book eligible US patent will further enhance the intellectual property protection for IntelGenx film products.
On June 29, 2017, the Company announced that it had filed a final short form prospectus in connection with an offering of a minimum of CDN$5,000,000 and a maximum of CDN$10,000,000 aggregate principal amount of 8% convertible unsecured subordinated debentures due June 30, 2020. The Corporation had also filed an amended registration statement on Form S-1 with the United States Securities and Exchange Commission to register the Debentures and the shares of common stock underlying the Debentures. On April 4, 2017, the Company had filed a preliminary short form prospectus with respect to the offering as well as a registration statement on Form S-1 with the United States Securities and Exchange Commission.
Subsequent to the end of the second quarter, on July 12, 2017, the Company announced that it had closed its previously announced prospectus offering of convertible unsecured subordinated debentures of the Corporation for gross aggregate proceeds of CDN$6,838,000. Pursuant to the Offering, the Corporation issued an aggregate principal amount of CDN$6,838,000 of Debentures at a price of CDN$1,000 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 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 CDN$1.35 per common share of the Corporation, being a conversion rate of approximately 740 Shares per CDN$1,000 principal amount of Debentures, subject to adjustment in certain events.
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On August 8, 2017, the Company announced that it had 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 CDN$762,000.
Together with the principal amount of CDN$6,838,000 of Debentures issued on July 12, 2017, the Corporation issued a total aggregate principal amount of CDN$7,600,000 of Debentures at a price of CDN$1,000 per Debenture.
The Offering was conducted on a commercially reasonable best efforts basis by a syndicate of agents led by Desjardins Capital Markets and including Laurentian Bank Securities Inc. and Echelon Wealth Partners Inc.
The net proceeds from the Offering will be used for investments in leasehold improvements and equipment, clinical studies, product development and general working capital requirements.
Corporate related developments
Expansion to the existing Manufacturing Facility
The Company has initiated an expansion project to the existing manufacturing facility, the timing of which will be dictated in part by the initiation of agreements with our commercial partners. This expansion became necessary following requests by commercial partners to increase manufacturing capacity and provide solvent film manufacturing capabilities. The new facility should create a fivefold increase of our production capacity in addition to offering a one-stop shopping opportunity to our partners. It should also significantly lower the acquisition cost for our partners and provide better protection of our Intellectual Property.
The Company has already entered into a lease agreement for an additional 11,000 square feet of expansion space and the preparation for a facility expansion is already ongoing.
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, 2017 report an accumulated other comprehensive loss due to foreign currency translation adjustments of $859 due to the fluctuations in the rates used to prepare our financial statements, $160 of which positively impacted our comprehensive loss for the six-month period ended June 30, 2017. The following Management Discussion and Analysis takes this into consideration whenever material.
Reconciliation of Comprehensive Income (Loss) to Adjusted Earnings before Interest, Taxes, Depreciation and Amortization (Adjusted EBITDA)
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 Companys financial condition and operating results.
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IntelGenx obtains its Adjusted EBITDA measurement by adding to comprehensive income (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 consultants remuneration and can vary significantly with changes in the market price of the Companys 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 Companys 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, | |||||||||||
In U.S.$ thousands | 2017 | 2016 | 2017 | 2016 | ||||||||
$ | $ | $ | $ | |||||||||
Comprehensive loss | (550 | ) | (806 | ) | (1,018 | ) | (1,513 | ) | ||||
Add (deduct): | ||||||||||||
Depreciation and amortization | 170 | 100 | 340 | 187 | ||||||||
Finance costs | 54 | 46 | 111 | 86 | ||||||||
Finance income | (1 | ) | - | (3 | ) | - | ||||||
Share-based compensation | 53 | 29 | 223 | 92 | ||||||||
Foreign currency translation adjustment | (116 | ) | (34 | ) | (160 | ) | (73 | ) | ||||
Adjusted EBITDA | (390 | ) | (665 | ) | (507 | ) | (1,221 | ) |
Adjusted Earnings before Interest, Taxes, Depreciation and Amortization (Adjusted EBITDA)
Adjusted EBITDA improved by $275 for the three-month period ended June 30, 2017 to ($390) compared to ($665) for the three-month period ended June 30, 2016. Adjusted EBITDA improved by $714 for the six-month period ended June 30, 2017 to ($507) compared to ($1,221) for the six-month period ended June 30, 2017. The improvement in Adjusted EBITDA of $275 for the three]month period ended June 30, 2017 is mainly attributable to an increase in revenues of $454 partially offset by an increase in R&D expenses of $223 before consideration of stock-based compensation. The improvement in Adjusted EBITDA of $714 for the six month period ended June 30, 2017 is mainly attributable to an increase in revenues of $989 partially offset by an increase in R&D expenses of $382 before consideration of stock-based compensation.
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Results of operations for the three-month and six-month periods ended June 30, 2017 compared with the three-month and six-month periods ended June 30, 2016.
Three-month period | Six-month period ended | |||||||||||
ended June 30, | June 30, | |||||||||||
In U.S.$ thousands | 2017 | 2016 | 2017 | 2016 | ||||||||
Revenue | $ | 1,126 | $ | 672 | $ | 2,479 | 1,490 | |||||
Cost of Royalty and License Revenue | 89 | 66 | 181 | 131 | ||||||||
Research and Development Expenses | 654 | 426 | 1,298 | 907 | ||||||||
Selling, General and Administrative | ||||||||||||
Expenses | 826 | 874 | 1,730 | 1,765 | ||||||||
Depreciation of tangible assets | 170 | 100 | 340 | 187 | ||||||||
Operating loss | (613 | ) | (794 | ) | (1,070 | ) | (1,500 | ) | ||||
Net loss | (666 | ) | (840 | ) | (1,178 | ) | (1,586 | ) | ||||
Comprehensive loss | (550 | ) | (806 | ) | (1,018 | ) | (1,513 | ) |
Revenue
Total revenues for the three-month period ended June 30, 2017 amounted to $1,126, representing an increase of $454 or 68% compared to $672 for the three-month period ended June 30, 2016. Total revenues for the six-month period ended June 30, 2017 amounted to $2,479, representing an increase of $989 or 66% compared to $1,490 for the six-month period ended June 30, 2016. The increase for the three-month period ended June 30, 2017 compared to the last years corresponding period is mainly attributable to an increase in other revenues and deferred revenues on monetization of $1,126 offset by a decrease in royalties of $672. The increase for the six-month period ended June 30, 2017 compared to the last years corresponding period is mainly attributable to an increase in upfronts, other revenues and deferred revenues on monetization of $2,040 offset by a decrease in royalties of $1,051.
Cost of royalty and license revenue
We recorded $89 for the cost of royalty and license revenue in the three-month period ended June 30, 2017 compared with $66 in the same period of 2016. We recorded $181 for the cost of royalty and license revenue in the six-month period ended June 30, 2017 compared with $131 in the same period of 2016. This expense relates to a Project Transfer Agreement that was executed in May 2010 with one of our former development partners whereby we acquired full rights to, and ownership of, Forfivo XL®, our novel, high strength formulation of Bupropion hydrochloride, the active ingredient in Wellbutrin XL®. Pursuant to the Project Transfer Agreement, and following commercial launch of Forfivo XL® in October 2012, we are required, after recovering an aggregate $200 for management fees previously paid, to pay our former development partner 10% of net product sales received from the sale of Forfivo XL®. We recovered the final portion of the management fees in December 2014, thereby invoking payments to our former development partner. Following the monetization of Forfivo XL®s royalties, we are required to record 10% of the deferred revenues from the monetization as cost of royalty and license revenue until December 31, 2017 which represented $181 for the six-month period ended June 30, 2017.
Research and development (R&D) expenses
R&D expenses for the three-month period ended June 30, 2017 amounted to $654, representing an increase of $228 or 54%, compared to $426 for the three-month period ended June 30, 2016. R&D expenses for the six-month period ended June 30, 2017 amounted to $1,298, representing an increase of $391 or 43%, compared to $907 for the six-month period ended June 30, 2016.
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The increase in R&D expenses for the three-month period ended June 30, 2017 is mainly attributable to increases in lab supplies of $155, R&D salaries of $106, study costs of $38 and analytical costs of $34. The increase was partially offset by a reduction in patent costs of $95. The increase in R&D expenses for the six-month period ended June 30, 2017 is mainly attributable to increases in lab supplies of $200, R&D salaries of $188, study costs of $146, analytical costs of $50, manufacturing scale up activities of $46, and license fees of $40. The increase was partially offset by a reduction in patent costs of $273.
In the three-month period ended June 30, 2017 we recorded estimated Research and Development Tax Credits and refunds of $30, compared with $23 that was recorded in the same period of the previous year. In the six-month period ended June 30, 2017 we recorded estimated Research and Development Tax Credits and refunds of $60, compared with $45 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, 2017 amounted to $826, representing a decrease of $48 or 5%, compared to $874 for the three-month period ended June 30, 2016. SG&A expenses for the six-month period ended June 30, 2017 amounted to $1,730, representing a decrease of $35 or 2%, compared to $1,765 for the six-month period ended June 30, 2016.
The decrease in SG&A expenses for the three-month period ended June 30, 2017 is mainly attributable to a decrease in business development expenses of $43. The decrease in SG&A expenses for the six-month period ended June 30, 2017 is mainly attributable to a decrease in office and general expenses of $42.
Depreciation of tangible assets
In the three-month period ended June 30, 2017 we recorded an expense of $170 for the depreciation of tangible assets, compared with an expense of $100 for the same period of the previous year. In the six-month period ended June 30, 2017 we recorded an expense of $340 for the depreciation of tangible assets, compared with an expense of $187 for the same period of the previous year. The increases in the depreciation of tangible assets are mainly attributable to the commencement of the depreciation of the plant equipment.
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, 2017 amounted to $53 compared to $29 for the three-month period ended June 30, 2016. Share-based compensation warrants and share-based payments expense for the six-month period ended June 30, 2017 amounted to $223 compared to $92 for the six-month period ended June 30, 2016.
We expensed approximately $47 in the three-month period ended June 30, 2017 for options granted to our employees in 2015 and 2016 under the 2006/2016 Stock Option Plan, approximately $5 for options granted to non-employee directors in 2015 and 2016, and approximately $1 for options granted to a consultant in 2016, compared with $25, $4, and $nil respectively that was expensed in the same period of the previous year.
We expensed approximately $96 in the six-month period ended June 30, 2017 for options granted to our employees in 2015 and 2016 under the 2006/2016 Stock Option Plan, approximately $124 for options granted to non-employee directors in 2015, 2016 and 2017, and approximately $3 for options granted to a consultant in 2016, compared with $51, $41, and $nil respectively that was expensed in the same period of the previous year.
There remains approximately $188 in stock based compensation to be expensed in fiscal 2017 and 2018, of which $180 relates to the issuance of options to our employees and directors during 2015 to 2017 and $8 relates to the issuance of options to a consultant in 2016. We anticipate the issuance of additional options and warrants in the future, which will continue to result in stock-based compensation expense.
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Key items from the balance sheet
Percentage | ||||||||||||
June 30, | December | Increase/ | Increase/ | |||||||||
In U.S.$ thousands | 2017 | 31, 2016 | (Decrease) | (Decrease) | ||||||||
Current Assets | $ | 3,798 | $ | 6,352 | $ | (2,554 | ) | (40% | ) | |||
Leasehold improvements and Equipment, net | 6,034 | 5,730 | 304 | 5% | ||||||||
Security Deposit | 732 | 708 | 24 | 3% | ||||||||
Current Liabilities | 3,060 | 5,235 | (2,175 | ) | (42% | ) | ||||||
Long-term debt | 2,290 | 2,565 | (275 | ) | (11% | ) | ||||||
Capital Stock | 1 | 1 | 0 | 0% | ||||||||
Additional Paid-in-Capital | 24,939 | 23,700 | 1,239 | 5% |
Current assets
Current assets totaled $3,798 as at June 30, 2017 compared with $6,352 at December 31, 2016. The decrease of $2,554 is mainly attributable to decreases in short-term investments of $2,245, accounts receivable of $677, prepaid expenses of $162 partially offset by an increase in cash and cash equivalents of $563.
Cash and cash equivalents
Cash and cash equivalents totaled $1,175 as at June 30, 2017 representing an increase of $563 compared with the balance of $612 as at December 31, 2016. The increase in cash on hand relates to net cash provided by investing activities of $1,870 and net cash provided by financing activities of $662, partially offset by cash used by operating activities of $1,963.
Accounts receivable
Accounts receivable totaled $367 as at June 30, 2017 representing a decrease of $677 compared with the balance of $1,044 as at December 31, 2016. The main reason for the decrease is related to the collection in 2017 of upfront payments accounted for as at December 31, 2016.
Prepaid expenses
As at June 30, 2017 prepaid expenses totaled $404 compared with $566 as of December 31, 2016. The decrease in prepaid expenses is attributable to the advance payment in December 2016 of certain expenses that relate to services to be provided in the remainder of the year.
Investment tax credits receivable
R&D investment tax credits receivable totaled approximately $213 as at June 30, 2017 compared with $246 as at December 31, 2016. The decrease is attributable to the collection of the 2015 tax credits offset by the accrual estimated and recorded for the first half of 2017.
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Leasehold improvements and equipment
As at June 30, 2017, the net book value of leasehold improvements and equipment amounted to $6,034, compared to $5,730 at December 31, 2016. In the six-month period ended June 30, 2017 additions to assets totaled $455 and mainly comprised of $347 for manufacturing equipment, $65 for leasehold improvements, $35 for office equipment and $8 for computer equipment.
Security deposit
A security deposit in the amount of CAD$300 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, 2017. Security deposits in the amount of CAD$650 for the term loans were also recorded as at June 30, 2017.
Accounts payable and accrued liabilities
Accounts payable and accrued liabilities totaled $452 as at June 30, 2017 compared with $897 as at December 31, 2016. The decrease is mainly attributable to the December 31, 2016 bonus accruals paid out in Q1 2017.
Long-term debt
Long-term debt totaled $3,018 as at June 30, 2017 (December 31, 2016 - $3,269). An amount of $2,440 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.
An amount of $578 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 2017 to December 2021.
Shareholders equity
As at June 30, 2017 we had accumulated a deficit of $18,915 compared with an accumulated deficit of $17,737 as at December 31, 2016. Total assets amounted to $10,493 and shareholders equity totaled $5,166 as at June 30, 2017, compared with total assets and shareholders equity of $12,790 and $4,945 respectively, as at December 31, 2016.
Capital stock
As at June 30, 2017 capital stock amounted to $0.666 (December 31, 2016: $0.648) . 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 $24,939 as at June 30, 2017, as compared to $23,700 as at December 31, 2016. Additional paid in capital increased by $1,239 from which $1,016 came from proceeds from exercise of warrants and stock options and $223 from stock based compensation attributable to the amortization of stock options granted to employees and directors.
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Taxation
As at December 31, 2016, the date of our latest annual tax return, we had Canadian and provincial net operating losses of approximately $7,585 (December 31, 2015: $6,462) and $7,763 (December 31, 2015: $6,725) 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 2027 and 2036. A portion of the net operating losses may expire before they can be utilized.
As at December 31, 2016, we had non-refundable tax credits of $1,190 thousand (2015: $1,022 thousand) of which $8 thousand is expiring in 2026, $10 thousand is expiring in 2027, $168 thousand is expiring in 2028, $147 thousand is expiring in 2029, $126 thousand is expiring in 2030, $133 thousand is expiring in 2031, $167 thousand is expiring in 2032 and $111 thousand is expiring in 2033, $84 thousand expiring in 2034 and $99 thousand is expiring in 2035 and $137 thousand expiring in 2036. We also had undeducted research and development expenses of $5,438 thousand (2015: $4,563 thousand) with no expiration date.
The deferred tax benefit of these items was not recognized in the accounts as it has been fully provided for.
Key items from the statement of cash flows
In U.S.$ thousands | June 30, 2017 |
June 30, 2016 |
Increase/ (Decrease) |
Percentage Increase/ (Decrease) |
||||||||
Operating Activities | $ | (1,963 | ) | $ | (1,658 | ) | $ | (305 | ) | (18% | ) | |
Financing Activities | 662 | 1,499 | (837 | ) | (56% | ) | ||||||
Investing Activities | 1,870 | (1,844 | ) | 3,714 | 201% | |||||||
Cash and cash equivalents - end of period | 1,175 | 1,096 | 79 | 7% |
Statement of cash flows
Net cash used in operating activities was $1,963 for the six-month period ended June 30, 2017, compared to $1,658 for the six-month period ended June 30, 2016. For the six-month period ended June 30, 2017, net cash used by operating activities consisted of a net loss of $1,178 (2016: $1,586) before amortization, depreciation and stock-based compensation expenses in the amount of $563 (2016: $279) and a decrease in non-cash operating elements of working capital of $1,348 (2016: $351).
The net cash provided by financing activities was $662 for the six-month period ended June 30, 2017, compared to $1,499 provided in the same period of the previous year. An amount of $1,016 derives from proceeds from exercise of warrants and stock options (2016: $nil) offset by repayment of term loans for an amount of $354 (2016: $70). An amount of $1,569 derived from disbursements of a term loan negotiated with the Bank for the six-month period ended June 30, 2016.
Net cash provided by investing activities amounted to $1,870 for the six-month period ended June 30, 2017 compared to a negative $1,844 in the same period of 2016. The net cash provided by investing activities for the six-month period ended June 30, 2017 relates to the redemption of short term investments of $2,325 (2016: $Nil), offset by the purchase of fixed assets of $455 (2016: $1,844).
The balance of cash and cash equivalents as at June 30, 2017 amounted to $1,175, compared to $1,096 as at June 30, 2016.
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Subsequent Event
On July 12, 2017, the Company announced that it had closed its previously announced prospectus offering of convertible unsecured subordinated debentures of the Corporation for gross aggregate proceeds of CDN$6,838,000. Pursuant to the Offering, the Corporation issued an aggregate principal amount of CDN$6,838,000 of Debentures at a price of CDN$1,000 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 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 CDN$1.35 per common share of the Corporation, being a conversion rate of approximately 740 Shares per CDN$1,000 principal amount of Debentures, subject to adjustment in certain events.
On August 8, 2017, the Company announced that it had 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 CDN$762,000.
Together with the principal amount of CDN$6,838,000 of Debentures issued on July 12, 2017, the Corporation issued a total aggregate principal amount of CDN$7,600,000 of Debentures at a price of CDN$1,000 per Debenture.
The Offering was conducted on a commercially reasonable best efforts basis by a syndicate of agents led by Desjardins Capital Markets and including Laurentian Bank Securities Inc. and Echelon Wealth Partners Inc.
The net proceeds from the Offering will be used for investments in leasehold improvements and equipment, clinical studies, product development and general working capital requirements.
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
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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 |
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 CORPORATION
Date: August 10, 2017 |
By: |
/s/ | Horst G. Zerbe |
------------------------------------ | |||
Horst G. Zerbe | |||
President, C.E.O. and | |||
Director | |||
Date: August 10, 2017 |
By: |
/s/ | Andre Godin |
------------------------------------ | |||
Andre Godin | |||
Principal Accounting Officer |
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