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, 2013 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) |
6425 Abrams, Ville Saint Laurent, Quebec H4S 1X9,
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 [ ]
APPLICABLE TO CORPORATE ISSUERS:
52,710,421 shares of the issuer’s common stock, par value $.00001 per share, were issued and outstanding as of August 6, 2013.
IntelGenx Technologies Corp.
Form 10-Q
TABLE OF CONTENTS
2
IntelGenx Technologies Corp.
Consolidated Interim Financial Statements
June 30, 2013
(Expressed in U.S. Funds)
(Unaudited)
3
IntelGenx Technologies Corp.
| Consolidated Balance Sheet |
| (Expressed in Thousands of U.S. Dollars ($000’s) Except Share and Per Share Data) |
| (Unaudited) |
| June 30, | December 31, | |||||
| 2013 | 2012 | |||||
| Assets | ||||||
| Current | ||||||
| Cash and cash equivalents | $ | 2,284 | $ | 2,059 | ||
| Accounts receivable | 360 | 1,282 | ||||
| Prepaid expenses | 94 | 102 | ||||
| Investment tax credits receivable | 268 | 213 | ||||
| Total Current Assets | 3,006 | 3,656 | ||||
| Leasehold Improvements and Equipment, net | 507 | 387 | ||||
| Intangible Assets (note 4) | 97 | 116 | ||||
| Total Assets | $ | 3,610 | $ | 4,159 | ||
| Liabilities | ||||||
| Current | ||||||
| Accounts payable and accrued liabilities | 336 | 1,058 | ||||
| Deferred license revenue (note 5) | 308 | 308 | ||||
| Total Current Liabilities | 644 | 1,366 | ||||
| Deferred License Revenue, non-current portion (note 5) | 461 | 615 | ||||
| Total Liabilities | 1,105 | 1,981 | ||||
| Shareholders' Equity | ||||||
| Capital Stock (note 6) | 1 | 0 | ||||
| Additional Paid-in-Capital | 17,171 | 16,342 | ||||
| Accumulated Deficit | (14,859 | ) | (14,463 | ) | ||
| Accumulated Other Comprehensive Income | 192 | 299 | ||||
| 2,505 | 2,178 | |||||
| $ | 3,610 | $ | 4,159 |
See accompanying notes
Approved on Behalf of the Board:
| /s/ J. Bernard Boudreau | Director |
| /s/ Horst G. Zerbe | Director |
4
| IntelGenx Technologies Corp. |
| Consolidated Statement of Shareholders' Equity |
| For the Period Ended June 30, 2013 |
| (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 | Income | Equity | |||||||||||||
| Balance - December 31, 2012 | 49,890,421 | $ | 0 | $ | 16,342 | $ | (14,463 | ) | $ | 299 | $ | 2,178 | ||||||
| Foreign currency translation adjustment | - | - | - | - | (107 | ) | (107 | ) | ||||||||||
| Warrants exercised (note 7) | 1,584,000 | 1 | 750 | - | - | 751 | ||||||||||||
| Options exercised (note 7) | 75,000 | - | 31 | - | - | 31 | ||||||||||||
| Stock-based compensation (note 7) | - | - | 48 | - | - | 48 | ||||||||||||
| Net loss for the period | - | - | - | (396 | ) | - | (396 | ) | ||||||||||
| Balance – June 30, 2013 | 51,549,421 | $ | 1 | $ | 17,171 | $ | (14,859 | ) | $ | 192 | $ | 2,505 | ||||||
See accompanying notes
5
| IntelGenx Technologies Corp. |
| Consolidated Statement of Comprehensive Income (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, | |||||||||||
| 2013 | 2012 | 2013 | 2012 | |||||||||
| Revenues | ||||||||||||
| Royalties | $ | 14 | $ | - | $ | 91 | $ | - | ||||
| License and other revenue | 533 | 20 | 613 | 120 | ||||||||
| Total Revenues | 547 | 20 | 704 | 120 | ||||||||
| Expenses | ||||||||||||
| Research and development expense | 48 | 310 | 215 | 551 | ||||||||
| Selling, general and administrative expense | 394 | 332 | 850 | 771 | ||||||||
| Amortization of tangible assets | 7 | 9 | 17 | 17 | ||||||||
| Amortization of intangible assets | 9 | - | 19 | - | ||||||||
| Total Costs and Expenses | 458 | 651 | 1,101 | 1,339 | ||||||||
| Profit (Loss) from Operations | 89 | (631 | ) | (397 | ) | (1,219 | ) | |||||
| Other Income | ||||||||||||
| Interest and other income | 1 | 1 | 1 | 5 | ||||||||
| Total Other Income | 1 | 1 | 1 | 5 | ||||||||
| Net Profit (Loss) | 90 | (630 | ) | (396 | ) | (1,214 | ) | |||||
| Other Comprehensive Income (Loss) | ||||||||||||
| Foreign currency translation adjustment | (71 | ) | (73 | ) | (107 | ) | 19 | |||||
| Comprehensive Profit (Loss) | $ | 19 | $ | (703 | ) | $ | (503 | ) | $ | (1,195 | ) | |
| Basic and Diluted Weighted Average Number of Shares Outstanding | 51,166,323 | 49,622,028 | 51,133,173 | 49,473,279 | ||||||||
| Basic and Diluted Profit (Loss) Per Common Share (note 9) | $ | 0.00 | $ | (0.01 | ) | $ | (0.01 | ) $ | (0.02 | ) | ||
See accompanying notes
6
| 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, | |||||||||||
| 2013 | 2012 | 2013 | 2012 | |||||||||
| Funds Provided (Used) - | ||||||||||||
| Operating Activities | ||||||||||||
| Net profit (loss) | $ | 90 | $ | (630 | ) | $ | (396 | ) | $ | (1,214 | ) | |
| Amortization | 16 | 9 | 36 | 17 | ||||||||
| Stock-based compensation | 30 | 14 | 48 | 29 | ||||||||
| 136 | (607 | ) | (312 | ) | (1,168 | ) | ||||||
| Changes in assets and liabilities | ||||||||||||
| Accounts receivable | (190 | ) | (145 | ) | 922 | (127 | ) | |||||
| Prepaid and other assets | (5 | ) | - | 8 | (15 | ) | ||||||
| Other receivables | (25 | ) | (20 | ) | (55 | ) | 229 | |||||
| Accounts payable and other accrued | ||||||||||||
| liabilities | (163 | ) | (115 | ) | (724 | ) | (383 | ) | ||||
| Deferred revenue | (76 | ) | - | (153 | ) | 1,000 | ||||||
| Net change in assets and liabilities | (459 | ) | (280 | ) | (2 | ) | 704 | |||||
| Net cash provided (used) by operating activities | (323 | ) | (887 | ) | (314 | ) | (464 | ) | ||||
| Financing Activities | ||||||||||||
| Proceeds from exercise of warrants and stock options | 587 | 1 | 782 | 234 | ||||||||
| Net cash provided by financing activities | 587 | 1 | 782 | 234 | ||||||||
| Investing Activities | ||||||||||||
| Additions to property and equipment | (92 | ) | (53 | ) | (161 | ) | (242 | ) | ||||
| Net cash used in investing activities | (92 | ) | (53 | ) | (161 | ) | (242 | ) | ||||
| Increase (Decrease) in Cash and Cash Equivalents | 172 | (939 | ) | 307 | (472 | ) | ||||||
| Effect of Foreign Exchange on Cash and Cash | ||||||||||||
| Equivalents | (56 | ) | (65 | ) | (82 | ) | 22 | |||||
| Cash and Cash Equivalents | ||||||||||||
| Beginning of Period | 2,168 | 4,059 | 2,059 | 3,505 | ||||||||
| End of Period | $ | 2,284 | $ | 3,055 | $ | 2,284 | $ | 3,055 | ||||
See accompanying notes
7
| IntelGenx Technologies Corp. |
| Notes to Consolidated Interim Financial Statements |
| June 30, 2013 |
| (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, 2012. Operating results for the three and six months ended June 30, 2013 are not necessarily indicative of the results that may be expected for the year ending December 31, 2013. 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. | Adoption of New Accounting Standards |
Revenue Recognition and Disclosures
In December 2011, the FASB issued Update No. 2011-11, “Balance Sheet (Topic 210): Disclosures about Offsetting Assets and Liabilities”. The objective of this Update is to provide enhanced disclosures that will enable users of financial statements to evaluate the effect or potential effect of netting arrangements on an entity’s financial position. This includes the effect or potential effect of rights of setoff associated with an entity’s recognized assets and recognized liabilities within the scope of this Update. The amendments require enhanced disclosures by requiring improved information about derivatives, repurchase agreements and reverse purchase agreements, and securities borrowing and securities lending transactions that are either offset in accordance with specific criteria or subject to a master netting arrangement or similar agreement. In January 2013, the FASB also issued Update No. 2013-01, which clarifies that ordinary trade receivables and receivables are not in the scope of ASU 2011-11. ASU 2011-11and ASU 2013-01are effective for annual reporting periods beginning on or after January 1, 2013, and interim periods within those annual periods. Retrospective disclosure is required for all comparative periods presented. The adoption of this Statement did not have a material effect on the Company’s financial position or results of operations.
8
| IntelGenx Technologies Corp. |
| Notes to Consolidated Interim Financial Statements |
| June 30, 2013 |
| (Expressed in U.S. Funds) |
| (Unaudited) |
| 2. | Adoption of New Accounting Standards (Cont’d) |
In February 2013, the FASB has issued Update No. 2013-02, “Comprehensive Income (Topic 220): Reporting of Amounts Reclassified Out of Accumulated Other Comprehensive Income”. This Update has been issued to improve the transparency of reporting these reclassifications. The amendments in this Update supersede and replace the presentation requirements for reclassifications out of accumulated other comprehensive income in ASUs 2011-05 and 2011-12 for all public and private organizations. The amendments would require an entity to provide additional information about reclassifications out of accumulated other comprehensive income. Public companies are required to comply with these amendments for all reporting periods (interim and annual), effective for reporting periods beginning after December 15, 2012. The adoption of this Statement did not have a material effect on the Company’s financial position or results of operations.
| 3. | Significant Accounting Policies |
Recently Issued Accounting Pronouncements
In December 2011, the FASB issued Update No. 2011-12, “Comprehensive Income (Topic 220): Deferral of the Effective Date for Amendments to the Presentation of Reclassifications of Items Out of Accumulated Other Comprehensive Income in Accounting Standards Update No. 2011-05”. The amendments in this Update supersede changes to those paragraphs in Update 2011-05 that pertain to how, when, and where reclassification adjustments are presented. The adoption of this amendment is not expected to have a material effect on the Company’s financial position or results of operations, but may affect the presentation of Other Comprehensive Income in the Company’s financial statements.
In February 2013, the FASB issued Update No. 2013-04, “Liabilities (Topic 405)—Obligations Resulting from Joint and Several Liability Arrangements for Which the Total Amount of the Obligation Is Fixed at the Reporting Date”. The amendments in this Update provide guidance for the recognition, measurement, and disclosure of obligations resulting from joint and several liability arrangements for which the total amount of the obligation within the scope of this Update is fixed at the reporting date, except for obligations addressed within existing guidance in U.S. GAAP. The guidance requires an entity to measure those obligations as the sum of the amount the reporting entity agreed to pay on the basis of its arrangement among its co-obligors and any additional amount the reporting entity expects to pay on behalf of its co-obligors. The guidance in this Update also requires an entity to disclose the nature and amount of the obligation as well as other information about those obligations. For public entities, the amendments in this ASU are effective for fiscal years, and interim periods within those years, beginning after December 15, 2013. The amendments shall be applied retrospectively to all prior periods presented for those obligations that exist at the beginning of the fiscal year of adoption. Early adoption is permitted. 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, 2013 |
| (Expressed in U.S. Funds) |
| (Unaudited) |
| 3. | Significant Accounting Policies (Cont’d) |
In March 2013, the FASB issued Update No. 2013-05, “Foreign Currency Matters (Topic 830)—Parent’s Accounting for the Cumulative Translation Adjustment upon Derecognition of Certain Subsidiaries or Groups of Assets within a Foreign Entity or of an Investment in a Foreign Entity”. The amendments in this Update resolve the diversity in practice about whether Subtopic 810-10, Consolidation—Overall, or Subtopic 830-30, Foreign Currency Matters—Translation of Financial Statements, applies to the release of the cumulative translation adjustment into net income when a parent either sells a part or all of its investment in a foreign entity or no longer holds a controlling financial interest in a subsidiary or group of assets that is a nonprofit activity or a business (other than a sale of in substance real estate or conveyance of oil and gas mineral rights) within a foreign entity. In addition, the amendments in this Update resolve the diversity in practice for the treatment of business combinations achieved in stages (sometimes also referred to as step acquisitions) involving a foreign entity. For public entities, the amendments in this ASU are effective prospectively for fiscal years, and interim reporting periods within those years, beginning after December 15, 2013. Early adoption is permitted. The Company is currently evaluating the impact of this Statement on its consolidated financial statements.
In April 2013, the FASB issued Update No. 2013-07, “Presentation of Financial Statements – Liquidation Basis of Accounting”. The objective of this Update is to clarify when an entity should apply the liquidation basis of accounting and to provide principles for the measurement of assets and liabilities under the liquidation basis of accounting, as well as any required disclosures. These amendments are effective for entities that determine liquidation is imminent during annual reporting periods beginning after December 15, 2013, and interim reporting periods therein. Entities should apply the requirements prospectively from the day that liquidation becomes imminent. Early adoption is permitted. The adoption of this amendment is not expected to have a material effect on the Company’s financial position or results of operations.
| 4. | Intangible Assets |
As of June 30, 2013 NDA acquisition costs of $97 thousand (December 31, 2012 - $116 thousand) were recorded as intangible assets on the Company’s balance sheet and represent the net book value of the final progress payment related to the acquisition of 100% ownership of Forfivo XL™. The asset will be amortized over its estimated useful life of 39 months. The Company commenced amortization upon commercial launch of the product in October 2012.
10
| IntelGenx Technologies Corp. |
| Notes to Consolidated Interim Financial Statements |
| June 30, 2013 |
| (Expressed in U.S. Funds) |
| (Unaudited) |
| 5. | Deferred License Revenue |
Deferred license revenue represents upfront payments received for the granting of licenses to the Company’s patents, intellectual property, and proprietary technology, for commercialization. Deferred license revenue is recognized in income over the period where sales of the licensed products will occur.
Upon entering into the licensing agreement with Edgemont Pharmaceuticals the Company received an upfront fee of $1 million, which the Company recognized as deferred license revenue. The deferred license revenue will be amortized in income over a period of 39 months, which is the minimum period where sales of Forfivo XL™ are expected to be exclusive. As a result of this policy, the Company has a deferred revenue balance of $769 thousand at June 30, 2013 that has not been recognized as revenue.
| 6. | Capital Stock |
| June 30, | December 31, | ||||||
| 2013 | 2012 | ||||||
| Authorized - 100,000,000 common shares of $0.00001 par value 20,000,000 preferred shares of $0.00001 par value |
|||||||
| Issued - 51,549,421 (December 31, 2012 - 49,890,421) common shares |
$ 515 |
$ 499 |
| 7. | Additional Paid-In Capital |
Stock options
On April 24, 2013 the Company granted 480,000 stock options to an officer to purchase common shares. The stock options are exercisable at $0.65 per share and vest on December 31, 2015. The stock options were accounted for at their fair value, as determined by the Black-Scholes valuation model, of approximately $157 thousand, using the following assumptions:
| Expected volatility | 78% | |
| Expected life | 3.83 years | |
| Risk-free interest rate | 0.34% | |
| Dividend yield | Nil |
11
| IntelGenx Technologies Corp. |
| Notes to Consolidated Interim Financial Statements |
| June 30, 2013 |
| (Expressed in U.S. Funds) |
| (Unaudited) |
| 7. | Additional Paid-In Capital (Cont’d) |
On April 24, 2013 the Company granted 200,000 stock options to an officer to purchase common shares. The stock options are exercisable at $0.65 per share and vest over 2 years at 25% every six months. The stock options were accounted for at their fair value, as determined by the Black-Scholes valuation model, of approximately $59 thousand, using the following assumptions:
| Expected volatility | 77% | |
| Expected life | 3.13 years | |
| Risk-free interest rate | 0.34% | |
| Dividend yield | Nil |
During the six month period ended June 30, 2013 a total of 75,000 (2012 - Nil) stock options were exercised for 75,000 (2012 - Nil) common shares having a par value of $0 thousand in aggregate, for cash consideration of $31 thousand (2012 - $Nil), resulting in an increase in additional paid-in capital of $31 thousand (2012 - $Nil).
Compensation expenses for stock-based compensation of $48 thousand and $29 thousand were recorded during the six month period ended June 30, 2013 and 2012 respectively. Of the amount expensed in 2013, $37 thousand (2012 - $28 thousand) relates to stock options granted to employees and directors, and $11 thousand (2012 - $Nil) relates to options granted to independent third party consultants. In addition, $1 thousand was expensed in 2012 related to stock options granted to investor relations firms as compensation for investor relation services. As at June 30, 2013, the Company has $229 thousand (2012 - $65 thousand) of unrecognized stock-based compensation.
Warrants
During the six month period ended June 30, 2013 a total of 1,584,000 (2012 - 1,207,818) warrants were exercised for 1,584,000 (2012 - 728,230) common shares having a par value of $0 thousand in aggregate, for cash consideration of $751 thousand (2012 - $234 thousand), resulting in an increase in additional paid-in capital of $750 thousand (2012 - $234 thousand).
12
| IntelGenx Technologies Corp. |
| Notes to Consolidated Interim Financial Statements |
| June 30, 2013 |
| (Expressed in U.S. Funds) |
| (Unaudited) |
| 8. | Related Party Transactions |
Included in management salaries for the six months ended June 30, 2013 are $5 thousand (2012 - $3 thousand) for options granted to the Chief Executive Officer, $10 thousand (2012 - $Nil) for options granted to the Chief Operating Officer and $9 thousand (2012 - $3 thousand) for options granted to the Chief Financial Officer under the 2006 Stock Option Plan and $6 thousand (2012 - $13 thousand) for options granted to non-employee directors. |
|
Also included in management salaries are director fees of $44 thousand (2012 - $55 thousand) for attendance to board meetings and audit committee meetings and $66 thousand (2012 - $Nil) for fees paid to a director under a management consultancy agreement. |
|
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. |
|
| 9. | 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. |
|
| 10. | Subsequent Events |
Subsequent to the end of the quarter, 1,161,000 warrants were exercised for 1,161,000 common shares having a par value of $0 thousand for cash consideration of approximately $550 thousand, resulting in an increase in additional paid-in capital of approximately $550 thousand. |
|
| 11. | Comparative Figures |
Certain reclassifications of June 30, 2012 amounts have been made to facilitate comparison with the current period. |
13
ITEM 2: MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Introduction to Management’s Discussion and Analysis
The purpose of this section, Management’s Discussion and Analysis of Financial Condition and Results of Operations, is to provide a narrative explanation of the financial statements that enables investors to better understand the business of the Company, to enhance the Company’s overall financial disclosures, to provide the context within which the Company’s financial information may be analyzed, and to provide information about the quality of, and potential variability of, the Company’s financial condition, results of operations and cash flows. 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 information should be read in conjunction with the accompanying unaudited Consolidated Financial Statements and Notes thereto.
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.
We have also undertaken a strategy under which we will work with pharmaceutical companies in order to develop new dosage forms for pharmaceutical products for which patent protection is nearing expiration. Under §(505)(b)(2) of the Food, Drug, and Cosmetics Act, the FDA may grant market exclusivity for a term of up to three years of exclusivity following approval of a listed drug that contains previously approved active ingredients but is approved in a new dosage, dosage form, route of administration or combination, or for a new use, the approval of which was required to be supported by new clinical trials, other than bioavailability studies, conducted by or for the sponsor.
We are currently continuing to develop the existing products in our pipeline and may also perform research and development on other potential products as opportunities arise.
We currently purchase and/or lease, on an as-needed basis, the equipment necessary for performing research and development activities related to our products.
We plan to hire new personnel, primarily in the areas of research and development, manufacturing, and administration on an as-needed basis as we enter into partnership agreements, establish our pilot plant VersaFilm™ manufacturing capability, and increase our research and development activities.
14
Key Developments
ANDA for Buprenorphine/Naloxone Sublingual Film Product for the Treatment of Opiate Addiction:
Subsequent to the end of the quarter, on July 22, 2013 we announced that an Abbreviated New Drug Application (“ANDA”) has been submitted to the U.S. Food and Drug Administration (“FDA”) for approval of a generic formulation of buprenorphine and naloxone Sublingual Film, indicated for maintenance treatment of opioid dependence. The ANDA was filed by our U.S. based co-development and commercialization partner for this product. The reference listed drug is Suboxone® (buprenorphine and naloxone) Sublingual Film.
According to IMS Health, U.S. retail sales of Suboxone® Sublingual Film were approximately $1.5 billion in 2012.
In accordance with confidentiality clauses contained in the co-development and commercialization agreement, the specifics of the product description and financial terms remain confidential. We will receive a share of the profits of commercialization, in addition to upfront and milestone payments.
The FDA approved Suboxone® in October of 2002 for use in the treatment of opioid addiction. Suboxone® is a registered trademark of Reckitt Benckiser Pharmaceuticals. Suboxone® contains the two active ingredients: buprenorphine and naloxone.
Naloxone is used to block the effect of opioids. Buprenorphine is a partial opioid agonist that stimulates opioid receptors but does not produce the same effects as an opioid. In other words it does not produce a euphoric "high" effect. The combination of these two actives has been shown to be efficacious in managing the treatment of opioid addiction. Suboxone® is most often taken sublingually (dissolved under the tongue). Taken properly, it can reduce opioid use, help patients to be successfully managed in an addiction rehabilitation program, and suppress the symptoms of opioid withdrawal. Suboxone® is the most commonly prescribed medication that is administered to patients during the maintenance phase of treatment. Unlike methadone, Suboxone® has a lower potential for overdose and abuse. This enables Certified Doctors, in certain circumstances, to prescribe take home supplies of Suboxone®.
NDA for Anti-Migraine VersaFilm™ Oral Film Product:
On June 18, 2013 we announced that the FDA has assigned a Prescription Drug User Fee Act ("PDUFA") action date of February 3, 2014 for the review of the our New Drug Application ("NDA") for the marketing approval of our anti-migraine VersaFilm™ oral film product. We had previously announced that, together with our co-development partner RedHill Biopharma Ltd ("RedHill"), we had submitted a 505(b)(2) NDA to the FDA for a novel, oral thin-film formulation, based on our proprietary VersaFilm™ technology containing Rizatriptan, the active drug in Merck & Co ("Merck") Maxalt-MLT® orally disintegrating tablets. According to Merck's most recent annual report, sales of Maxalt® were $638 million in 2012. The FDA confirmed that our application is sufficiently complete to permit a substantive review in accordance with the FDA's "standard" classification process.
Currency rate fluctuations
Our operating currency is Canadian dollars, while our reporting currency is U.S. dollars. Accordingly, our results of operations and balance sheet position have been affected by currency rate fluctuations. The following management discussion and analysis takes this into consideration whenever material.
15
Results of Operations for the six month period ended June 30, 2013 compared with the six month period ended June 30, 2012.
| Increase/ (Decrease) |
Percentage | |||||||||||
| In U.S.$ thousands | 2013 | 2012 | Increase/ | |||||||||
| (Decrease) | ||||||||||||
| Revenue | $ | 704 | $ | 120 | $ | 584 | 487% | |||||
| Research and Development Expenses | 215 | 551 | (336 | ) | (61% | ) | ||||||
| Selling, General and Administrative Expenses | 850 | 771 | 79 | 10% | ||||||||
| Amortization of tangible assets | 17 | 17 | - | 0% | ||||||||
| Amortization of intangible assets | 19 | - | 19 | N/A | ||||||||
| Net Loss | (396 | ) | (1,214 | ) | (818 | ) | (67% | ) |
Revenue
Total revenue in the first six months of 2013 increased to $704 thousand, compared with $120 thousand in the same period of 2012, representing an increase of $584 thousand, or 487%.
Revenue for the 6 months ended June 30, 2013 includes $256 thousand related to a development milestone for our VersaFilm™ buprenorphine/naloxone product for the treatment of opiate addiction. The milestone became due following the successful completion of the pivotal bioequivalence study.
Also included in revenue for the first six months of 2013 is $201 thousand related to a development milestone for our anti-migraine VersaFilm™ oral film product. The milestone became due following confirmation that our NDA submission to the FDA is sufficiently complete to permit a substantive review in accordance with the FDA's "standard" classification process.
Revenue recorded in the first 6 months of 2013 also includes $247 thousand related to Forfivo XL™, our first FDA approved product, which was launched in October 2012 under a licensing partnership with Edgemont Pharmaceuticals LLP (“Edgemont”). Upon entering into the licensing agreement, Edgemont paid us an upfront fee of $1 million, which we recognized as deferred license revenue. The deferred license revenue is amortized in income over the period where sales of Forfivo XL™ are expected to be exclusive. As a result of this policy, we recognized $156 thousand in income during the first six months of 2013. In addition, we recognized approximately $91 thousand of royalty income earned from the sale of Forfivo XL™. The royalties relate to sales of Forfivo XL™ by Edgemont during the first six months post product launch. Forfivo XL™ is indicated for the treatment of Major Depressive Disorder (“MDD”) and is the only extended-release bupropion HCl product to provide a once-daily, 450mg dose in a single tablet.
Sales levels achieved for Forfivo XL™, and related royalty income, have been lower than anticipated in the first six months of 2013. Management is actively taking steps to accelerate sales growth of Forfivo XL™.
Revenue for the six months ended June 30, 2012 included a $100 thousand development milestone in respect of our anti-migraine VersaFilm™ oral film product. The milestone became due following the successful completion of the pivotal bioequivalence study.
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Research and Development (“R&D”) Expenses
R&D expenses, net of R&D investment tax credits, totaled $215 thousand in the six months ended June 30, 2013, representing a decrease of $336 thousand, or 61%, to the expense of $551 thousand recorded in the same period of last year.
The decrease in R&D expenses is primarily related to i) approximately $176 thousand of costs incurred in the first half of 2012 that were associated with a pilot clinical study that was not repeated in the first half of 2013, and ii) the reversal of approximately $112 thousand of costs accrued for the technical transfer of activities in preparation for manufacturing of Forfivo XL™ to our Contract Manufacturing Organization, Pillar5 Pharma, that were recorded in fiscal 2012 and, following negotiation were subsequently reversed in April 2013.
Included within R&D expenses for the first six months of 2013 are R&D salaries of $284 thousand, of which approximately $5 thousand represents non-cash compensation. This compares to R&D salaries of $305 thousand in the first six months of 2012, of which approximately $9 thousand represented non-cash compensation. The decrease in R&D salaries relates to a temporary vacancy within the R&D department during the second quarter of 2013.
In the six months ended June 30, 2013 we recorded estimated research and development tax credits and refunds of $69 thousand, compared with $50 thousand that was recorded in the same period of the previous year.
Selling, General and Administrative (“SG&A”) Expenses
SG&A expenses increased by $79 thousand, to $850 thousand, in the first six months of 2013 compared with $771 thousand in the first six months of 2012. The increase is primarily attributable to the addition of Dr. Rajiv Khosla to our management team initially in a consulting capacity through to April, and thereafter as an executive of the Company.
Included in SG&A expenses are approximately $26 thousand (2012: $7 thousand) in non-cash compensation from options granted to management employees in 2011, 2012 and 2013, $6 thousand (2012: $13 thousand) in non-cash compensation from options granted to non-employee directors in 2011, and $11 thousand (2012: $Nil) in non-cash compensation from options granted to consultants in 2012.
Amortization of intangible assets
The amortization of intangible assets expense for the first six months of 2013 totaled $19 thousand, compared with $Nil in the same period of last year. The expense relates to the amortization of NDA acquisition costs in respect of the final progress payment to acquire 100% ownership of Forfivo XL™. Commercialization of Forfivo XL™ in October 2012 triggered amortization of the asset over its estimated useful life of 39 months.
Share-Based Compensation Expense, Warrants and Stock Based Payments
Share-based compensation expense, warrants and share-based payments totaled $48 thousand for the six months ended June 30, 2013, compared with $29 thousand for the six months ended June 30, 2012.
We expensed approximately $31 thousand in the first six months of 2013 for options granted to our employees in 2011, 2012 and 2013 under the 2006 Stock Option Plan, and approximately $6 thousand for options granted to non-employee directors in 2011, compared with $15 thousand and $13 respectively that was expensed in the same period of the previous year.
We also expensed $11 thousand in the first six months of 2013 for options granted to consultants and $1 thousand in the first six months of 2012 for options granted to investor relation firms for investor relation services.
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There remains approximately $229 thousand in stock based compensation to be expensed in fiscal 2013 through 2015, of which $223 thousand relates to the issuance of options to employees and directors of the Company during 2011, 2012 and 2013 and $6 thousand relates to the issuance of options to consultants in 2012. We anticipate the issuance of additional options and warrants in the future, which will continue to result in stock-based compensation expense.
Key items from the Balance Sheet.
| Percentage | ||||||||||||
| In U.S.$ thousands | June 30, | December | Increase/ | Increase/ | ||||||||
| 2013 | 31, 2012 | (Decrease) | (Decrease) | |||||||||
| Current Assets | $ | 3,006 | $ | 3,656 | $ | (650 | ) | (18% | ) | |||
| Leasehold improvements and Equipment | 507 | 387 | 120 | 31% | ||||||||
| Intangible Assets | 97 | 116 | (19 | ) | (16% | ) | ||||||
| Current Liabilities | 644 | 1,366 | (722 | ) | (53% | ) | ||||||
| Deferred License Revenue | 461 | 615 | (154 | ) | (25% | ) | ||||||
| Capital Stock | 1 | 0 | 1 | N/A | ||||||||
| Additional Paid-in-Capital | 17,171 | 16,342 | 829 | 5% |
Current Assets
Current assets totaled $3,006 thousand as at June 30, 2013 compared with $3,656 thousand at December 31, 2012. The decrease of $650 thousand is attributable to a decrease in accounts receivable of approximately $922 thousand and a decrease in prepaid expenses of approximately $8 thousand, partly offset by an increase in cash and cash equivalents of approximately $225 thousand and an increase in investment tax credits receivable of approximately $55 thousand.
Cash and cash equivalents totaled $2,284 thousand as at June 30, 2013 representing an increase of $225 thousand compared to the balance of $2,059 thousand as at December 31, 2012. The increase in cash on hand relates to net cash provided by financing activities of $782 thousand, partly offset with net cash used by operating activities of $314 thousand, net cash used in investing activities of $161 thousand, and an unrealized foreign exchange loss of $82 thousand.
Accounts receivable totaled $360 thousand as at June 30, 2013 compared with $1,282 thousand as at December 31, 2012. Included within the accounts receivable balance as at December 31, 2012 is a $1 million milestone that was invoiced to Edgemont Pharmaceuticals in the fourth quarter of 2012 for the launch of Forfivo XL™. We received payment against this invoice in February 2013.
As of June 30, 2013, prepaid expenses totaled $94 thousand compared with $102 thousand as of December 31, 2012. The decrease relates to the allocation of prepaid expenses to the income statement in the first six months of 2013.
R&D investment tax credits receivable totaled $268 thousand as at June 30, 2013 compared with $213 thousand as at December 31, 2012. The amount receivable as at December 31, 2012 relates to credits accrued throughout fiscal 2012, for which we expect to receive reimbursement in the fourth quarter of 2013.
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Leasehold Improvements and Equipment
As at June 30, 2013, the net book value of leasehold improvements and equipment amounted to $507 thousand, compared to $387 thousand at December 31, 2012. In the six months ended June 30, 2013 additions to assets totaled $161 thousand and comprised $160 thousand for pilot plant manufacturing equipment for our VersaFilm™ products and $1 thousand for computer equipment. Depreciation on leasehold improvements and equipment in the six months ended June 30, 2013 amounted to $17 thousand and a foreign exchange loss of $24 thousand was recorded.
Intangible Assets
As at June 30, 2013 NDA acquisition costs of $97 thousand (December 31, 2012 - $116 thousand) were recorded as intangible assets on our balance sheet and are related to the acquisition of 100% ownership of Forfivo XL™. The asset will be amortized over its expected useful life of 39 months and amortization commenced upon commercial launch of Forfivo XL™ in the fourth quarter of 2012.
Current Liabilities
Current liabilities totaled $644 thousand as at June 30, 2013 (December 31, 2012 - $1,366 thousand) and consisted of accounts payable and accrued liabilities of $336 thousand (December 31, 2012 - $1,058 thousand) and the current portion of deferred license revenue of $308 thousand (December 31, 2012 - $308 thousand).
Accounts payable and accrued liabilities of $498 thousand as at June 30, 2013 (December 31, 2012 - $1,058 thousand) include approximately $75 thousand related to research and development activities, approximately $81 thousand related to the acquisition of pilot plant manufacturing equipment for our VersaFilm™ products, approximately $31 thousand relates to professional fees, and approximately $137 thousand relates to accrued payroll liabilities. The decrease in accounts payable and accrued liabilities as at June 30, 2013, compared with December 31, 2012, primarily relates to the payment of invoices received for the fourth quarter of 2012 and outstanding as at December 31, 2012 in respect of R&D activities.
Deferred License Revenue
Pursuant to the execution of a licensing agreement for Forfivo XL™, we received an upfront fee from Edgemont Pharmaceuticals in the first quarter of 2012, which we recognized as deferred license revenue. The deferred license revenue is amortized in income over the period where sales of Forfivo XL™ are expected to be exclusive. As a result of this policy, we have a deferred revenue balance of $769 thousand at June 30, 2013 (December 31, 2012: $923 thousand) that has not been recognized as revenue, with $461 thousand recognized as the non-current portion and $308 thousand recognized in current assets as the current portion, versus $615 thousand and $308 thousand respectively as at December 31, 2012.
Shareholders’ Equity
As at June 30, 2013 we had accumulated a deficit of $14,859 thousand compared with an accumulated deficit of $14,463 thousand as at December 31, 2012. Total assets amounted to $3,610 thousand and shareholders’ equity totaled $2,505 thousand as at June 30, 2013, compared with total assets and shareholders’ equity of $4,159 thousand and $2,178 thousand respectively, as at December 31, 2012.
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Capital Stock
As at June 30, 2012 capital stock amounted to $515 compared to $499 at December 31, 2012. The increase reflects the issuance of 1,584,000 shares and 75,000 shares related to the exercise of warrants and stock options respectively, with all shares issued at par value of $0.00001. 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 $17,171 thousand at June 30, 2013, compared with $16,342 thousand at December 31, 2012. The increase relates in part to $48 thousand for stock based compensation, of which $11 thousand is attributable to the amortization of stock options granted to consultants, and $37 thousand is attributable to the amortization of stock options granted to employees and directors. Additional paid-in capital increased further by $750 thousand for warrants exercised, and by $31 thousand for options exercised.
Key items from the Statement of Cash Flows
| / | Percentage | |||||||||||
| In U.S.$ thousands | June 30, | June 30, | Increase | Increase/ | ||||||||
| 2013 | 2012 | (Decrease) | (Decrease) | |||||||||
| Operating Activities | $ | (314 | ) | $ | (464 | ) | $ | (150 | ) | (32% | ) | |
| Financing Activities | 782 | $ | 234 | $ | 548 | 234% | ||||||
| Investing Activities | (161 | ) | (242 | ) | (81 | ) | (33% | ) | ||||
| Cash and cash equivalents - end of period | 2,284 | 3,055 | (771 | ) | (25% | ) |
Statement of cash flows
Net cash used by operating activities was $314 thousand in the six months ended June 30, 2013, compared with $464 thousand for the six months ended June 30, 2012. In the first half of 2013, net cash used by operating activities consisted of an operating loss of $312 thousand net of non-cash related expenses of approximately $84 thousand, and a decrease in non-cash operating elements of working capital of $2 thousand.
Operating activities will continue to consume our available funds until we are able to generate increased revenues.
The net cash provided by financing activities was $782 thousand in the first six months of 2013, compared with $234 thousand provided in the same period of the previous year. The net cash provided in the first half of 2013 resulted from the exercise of warrants and options, whereas the cash provided in the first half of 2012 resulted entirely from the exercise of warrants.
Net cash used in investing activities amounted to $161 thousand in the six months ended June 30, 2013 compared with $242 thousand in the six months ended June 30, 2012. Included within the use of funds in the first half of 2013 is an investment of approximately $160 thousand in new equipment for our VersaFilm™ technology, compared with an investment of approximately $200 thousand in the first half of 2012.
The balance of cash and cash equivalents as at June 30, 2013 amounted to $2,284 thousand, compared with $3,055 thousand at June 30, 2012.
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Off-Balance Sheet Arrangements
We have no off-balance sheet arrangements.
Forward-Looking and Cautionary Statements
|
This report contains certain forward-looking statements that involve risks and uncertainties relating to, among other things, our future financial performance or future events. Forward-looking statements give management’s current expectations, plans, objectives, assumptions or forecasts of future events. All statements other than statements of current or historical fact contained in this Form 10Q, including statements regarding our future financial position, business strategy, budgets, projected costs and plans and objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “estimate,” “plans,” “potential,” “projects,” “ongoing,” “expects,” “management believes,” “we believe,” “we intend,” and similar expressions. These statements involve known and unknown risks, estimates, assumptions and uncertainties that could cause actual results to differ materially from the results set forth in this Annual Report. You should not place undue reliance on these forward-looking statements. You should be aware that our actual results could differ materially from those contained in the forward-looking statements due to a number of factors such as: |
| continued development of our technology; |
| lack of product revenues |
| successful completion of clinical trials and obtaining regulatory approval to market |
| ability to protect our intellectual property |
| dependence on collaborative partners |
| ability to generate positive cash flow |
| ability to raise additional capital if and when necessary |
| dependence on key personnel; |
| competitive factors; |
| the operation of our business; and |
| general economic conditions. |
These factors should be considered carefully and readers are cautioned not to place undue reliance on such forward looking statements. These forward-looking statements speak only as of the date on which they are made, and except to the extent required by federal securities laws, we undertake no obligation to update any forward-looking statements to reflect events or circumstances after the date on which the statement is made or to reflect the occurrence of unanticipated events. In addition, we cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.
| 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.
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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 |
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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 8, 2013 | By: | /s/ | Horst Zerbe |
| Horst G. Zerbe | |||
| President, C.E.O. and | |||
| Director | |||
| Date: August 8, 2013 | By: | /s/ | Paul Simmons |
| Paul A. Simmons | |||
| Principal Accounting Officer | |||
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