UNITED
STATES
SECURITIES
AND
EXCHANGE
COMMISSION
Washington, D.C. 20549
FORM
10-K
[X] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December
31,
2018
[ ] 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 registrant as specified in its charter)
Delaware
(State or other jurisdiction of incorporation or organization)
87-0638336
(I.R.S. Employer Identification No.)
6420
Abrams,
Ville
Saint-Laurent,
Quebec
(Address of principal executive offices)
H4S
1Y2
(Zip Code)
(514)
331-7440
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
None
Securities registered pursuant to Section 12(g) of the Act:
Common
Stock,
$0.00001
par
value
per
share
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.
Yes [ ]
No [X]
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act.
Yes [ ]
No [X]
Indicate by check mark 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 has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of
Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Yes [X] No [
]
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the
best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form
10-K. [X]
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or
emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in
Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer [ ]
Non-accelerated filer [ ]
Accelerated filer
[ ]
Smaller reporting company [X]
Emerging growth company [ ]
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new
or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [ ]
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act).
Yes [ ]
No [X]
As of June 30, 2018, the aggregate market value of the registrant’s voting and non-voting common equity held by non-affiliates of the registrant was
$46,205,996 based on the closing price of the registrant’s common stock of U.S. $0.77, as reported on the OTCQX on that date. Shares of the registrant’s common
stock held by each officer and director and each person who owns 10% or more of the outstanding common stock of the registrant have been excluded in that such
persons may be deemed to be affiliates. This determination of affiliate status is not necessarily a conclusive determination for other purposes.
Class
Common
Stock,
$.00001
par
value
Outstanding
at
March
22,
2019
93,527,474
shares
DOCUMENTS
INCORPORATED
BY
REFERENCE:
Portions of the Company’s Proxy Statement for its 2019 Annual Meeting of Shareholders (the “2019 Proxy Statement”) are incorporated by reference into
Part III
TABLE
OF
CONTENTS
Business.
Risk Factors.
Unresolved Staff Comments.
Properties.
Legal Proceedings.
Mine Safety Disclosures.
Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.
Selected Financial Data.
Management’s Discussion and Analysis of Financial Condition and Results of Operations.
Quantitative and Qualitative Disclosures About Market Risk.
Financial Statements and Supplementary Data.
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure.
Controls and Procedures.
Other Information.
Directors, Executive Officers, and Corporate Governance.
Executive Compensation.
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
Certain Relationships and Related Transactions, and Director Independence.
Exhibits, Financial Statement Schedules
Form 10-K Summary Page
Financial Statements
PART
I
Item 1.
Item 1A
Item 1B
Item 2.
Item 3.
Item 4.
PART
II
Item 5.
Item 6
Item 7.
Item 7A
Item 8.
Item 9.
Item 9A.
Item 9B.
PART
III
Item 10.
Item 11.
Item 12.
Item 13.
PART
IV
Item 15.
Item 16
Page
4
21
29
29
29
29
29
31
31
40
40
40
41
41
41
41
42
42
42
44
F-1-F-36
Terminology and references
In this Annual Report on Form 10-K, the words “Company”, “IntelGenx”, “we”, “us”, and “our”, refer collectively to IntelGenx Technologies Corp. and IntelGenx
Corp., our wholly-owned Canadian subsidiary.
In this Form 10-K, unless otherwise specified, all monetary amounts are in United States dollars, all references to “$”, “U.S.$”, “U.S. dollars” and “dollars” mean
U.S. dollars and all references to “C$”, “Canadian dollars” and “CA$” mean Canadian dollars. To the extent that such monetary amounts are derived from our
consolidated financial statements included elsewhere in this Form 10-K, they have been translated into U.S. dollars in accordance with our accounting policies as
described therein. Unless otherwise indicated, other Canadian dollar monetary amounts have been translated into United States dollars at the average annual
exchange rate for 2018 as reported by the Bank of Canada, being U.S. $1.00 = CA$1.2957.
PART
I
Cautionary
Statement
Concerning
Forward-Looking
Statements
Certain statements included or incorporated by reference in this report constitute forward-looking statements within the meaning of applicable securities laws. All
statements contained in this report that are not clearly historical in nature are forward-looking, and the words “anticipate”, “believe”, “continue”, “expect”,
“estimate”, “intend”, “may”, “plan”, “will”, “shall” and other similar expressions are generally intended to identify forward-looking statements within the meaning
of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. All forward-looking statements are based on our beliefs and
assumptions based on information available at the time the assumption was made. These forward-looking statements are not based on historical facts but on
management’s expectations regarding future growth, results of operations, performance, future capital and other expenditures (including the amount, nature and
sources of funding thereof), competitive advantages, business prospects and opportunities. Forward-looking statements involve significant known and unknown
risks, uncertainties, assumptions and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from those
implied by forward-looking statements. These factors should be considered carefully and prospective investors should not place undue reliance on the forward-
looking statements. Although the forward-looking statements contained in this report 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 report 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”, as well as
any cautionary language in this report, 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 of the Company (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.
ITEM
1.
BUSINESS.
Corporate
History
Our predecessor company, Big Flash Corp., was incorporated in Delaware on July 27, 1999. On April 28, 2006, Big Flash, through its Canadian holding
corporation, completed the acquisition of IntelGenx Corp., a Canadian company incorporated on June 15, 2003. The Company did not have any operations prior to
the acquisition of IntelGenx Corp. In connection with the acquisition, we changed our name from Big Flash Corp. to IntelGenx Technologies Corp. IntelGenx
Corp. has continued operations as our operating subsidiary.
Overview
We are a drug delivery company established in 2003 and headquartered in Montreal, Quebec, Canada. Our focus is on the development of novel oral immediate-
release and controlled-release products for the pharmaceutical market. More recently, we have made the strategic decision to enter the oral film market and have
implemented commercial oral film manufacturing capability. This enables us to offer our partners a comprehensive portfolio of pharmaceutical services, including
pharmaceutical R&D, clinical monitoring, regulatory support, tech transfer and manufacturing scale-up, and commercial manufacturing.
Our business strategy is to develop pharmaceutical products based on our proprietary drug delivery technologies and, once the viability of a product has been
demonstrated, license the commercial rights to partners in the pharmaceutical industry. In certain cases, we rely upon partners in the pharmaceutical industry to
fund the development of the licensed products, complete the regulatory approval process with the 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.
Managing our project pipeline is a key success factor for the Company. We have undertaken a strategy under which we will work with pharmaceutical companies
in order to apply our oral film technology to pharmaceutical products for which patent protection is nearing expiration, a strategy which is often referred to as
“lifecycle management”. 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 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.
4
The 505(b)(2) pathway is also the regulatory approach to be followed if an applicant intends to file an application for a product containing a drug that is already
approved by the FDA for a certain indication and for which the applicant is seeking approval for a new indication or for a new use, the approval of which is
required to be supported by new clinical trials, other than bioavailability studies. We have implemented a strategy under which we actively look for such so-called
“repurposing opportunities” and determine whether our proprietary VersaFilm™ technology adds value to the product. We currently have two such drug
repurposing projects in our development pipeline.
We continue to develop the existing products in our pipeline and may also perform research and development on other potential products as opportunities arise.
We have established a state-of-the-art manufacturing facility with the intent to manufacture all our VersaFilm™ products in-house as we believe that this:
represents a profitable business opportunity;
1.
2. will reduce our dependency upon third-party contract manufacturers, thereby protecting our manufacturing process know- how and intellectual property;
and
allows us to offer our clients and development partners a full service from product conception through to supply of the finished product.
3.
Technology
Platforms
Our product development efforts are based upon three delivery platform technologies: (1) VersaFilm™, an Oral Film technology, (2) VersaTab™, a Multilayer
Tablet technology, and (3) AdVersa®, a Mucoadhesive Tablet technology.
VersaFilm™ is a drug delivery platform technology that enables the development of oral thin films, improving product performance through:
Rapid disintegration without the need for water;
Quicker buccal or sublingual absorption;
Potential for faster onset of action and increased bioavailability;
Potential for reduced adverse effects by bypassing first-pass metabolism;
Easy administration for patients who have problems swallowing tablets or capsules; pediatric and geriatric patients as well as patients who fear choking
and/or are suffering from nausea (e.g., nausea resulting from chemotherapy, radiotherapy or any surgical treatment);
Pleasant taste; and
Small and thin size, making it convenient for consumers.
Our VersaFilm™ technology consists of a thin (25-35 micron) polymeric film comprised of United States Pharmacopeia components that are approved by the FDA
for use in food, pharmaceutical, and cosmetic products. Derived from the edible film technology used for breath strips and initially developed for the instant
delivery of savory flavors to food substrates, the VersaFilm™ technology is designed to provide a rapid response compared to existing conventional tablets. Our
VersaFilm™ technology is intended for indications requiring rapid onset of action, such as migraine, opioid dependence, chronic pain, motion sickness, erectile
dysfunction, and nausea.
Our VersaTab™ platform technology allows for the development of oral controlled-release products. It is designed to be versatile and to reduce manufacturing
costs as compared to competing oral extended-release delivery technologies. Our VersaFilm™ technology allows for the instant delivery of pharmaceuticals to the
oral cavity, while our AdVersa® allows for the controlled release of active substances to the oral mucosa.
Our VersaTab™ technology represents a new generation of controlled release layered tablets designed to modulate the release of active compounds. The
technology is based on a multilayer tablet with an active core layer and erodible cover layers. The release of the active drug from the core matrix initially occurs in
a first-order fashion. As the cover layers start to erode, their permeability for the active ingredient through the cover layers increases. Thus, the Multilayer Tablet
can produce quasi-linear (zero-order) kinetics for releasing a chemical compound over a desired period of time. The erosion rate of the cover layers can be
customized according to the physico-chemical properties of the active drug. In addition, our multilayer technology offers the opportunity to develop combination
products in regulatory-compliant format. Combination products are made up of two or more active ingredients that are combined into a single dosage form.
5
Our Mucoadhesive Tablet is a drug delivery system capable of adhering to the oral mucosa and releasing the drug to the site of application at a controlled rate. The
Mucoadhesive Tablet is designed to provide the following advantages relative to competing technologies: (i) it avoids the first pass effect, whereby the liver
metabolizes the active ingredient and greatly reduces the level of drug reaching the systemic circulation, (ii) it leads to a higher absorption rate in the oral cavity as
compared to the conventional oral route, and (iii) it achieves a rapid onset of action for the drug. Our AdVersa® technology is designed to be versatile in order to
permit the site of application, residence time, and rate of release of the drug to be modulated to achieve the desired results.
Product
Portfolio
Our product portfolio includes a blend of generic and branded products based on our proprietary delivery technology (“generic” products are essentially copies of
products that have already received FDA approval). Of the thirteen projects currently in our product portfolio, ten utilize our VersaFilm™ technology, two utilize
our VersaTab™ technology, and one utilizes our AdVersa® technology. Out of those thirteen projects, eight are actively progressing in research and development
while the others have reached the regulatory or commercial stage.
Our
most
active
projects:
INT0008/2008:
We developed this oral film product based on our VersaFilm™ technology. In March 2013 we submitted a 505(b)(2) New Drug Application
(“NDA”) to the FDA for our novel oral thin-film formulation of Rizatriptan, the active drug in Maxalt-MLT ® orally disintegrating tablets. Maxalt-MLT ® is a
leading branded anti-migraine product marketed by Merck & Co. The thin-film formulation of Rizatriptan was developed in accordance with a co-development and
commercialization agreement with RedHill Biopharma Ltd. (“RedHill”). In the second quarter of 2012 we conducted a pivotal clinical study against Maxalt-MLT
® . The study results indicate that the product is safe, and that the 90% confidence intervals of the three relevant parameters Cmax, AUC(0-t) and AUC(0-infinity)
are well within the 80 – 125 acceptance range for bioequivalency.
In June 2013 the FDA assigned a Prescription Drug User Fee Act (“PDUFA”) action date of February 3, 2014 for the review of the NDA for marketing approval
and in February 2014 we received a Complete Response Letter (“CRL”) from the FDA informing us that certain questions and deficiencies remain that preclude the
approval of the application in its present form. The questions raised by the FDA in the CRL regarding the NDA for our anti-migraine VersaFilm™ product
primarily relate to third party Chemistry, Manufacturing and Controls (“CMC”) and to the packaging and labeling of the product. No questions or deficiencies were
raised relating to the product’s safety and the FDA’s CRL does not require additional clinical studies.
In March 2014 we submitted our response to the FDA’s CRL and in April, 2014 the FDA requested additional CMC data. We also reported that the supplier of the
active pharmaceutical ingredient (“API”) of the product has been issued with an “Import Alert” by the FDA. The Import Alert bans the import into the USA of all
raw materials from the supplier’s manufacturing facility, which therefore prohibits the import of any products using these raw materials, and effectively prevents
our VersaFilm™ product from being approved by the FDA. We identified a new source of API to manufacture new submission lots to support the re-submission of
the NDA.
In October 2014 we submitted a Marketing Authorization Application (“MAA”) to the German Federal Institute for Drugs and Medical Devices (“BfArM”)
seeking European marketing approval of our oral thin film formulation of Rizatriptan for acute migraines, under the brand name RIZAPORT ® . The brand name
RIZAPORT ® was also conditionally approved by the FDA as part of the NDA review process in the U.S. The MAA was submitted under the European
Decentralized Procedure (“DCP”) with Germany as the reference member state.
On September 10, 2015 we announced the positive outcome of the DCP confirming that RIZAPORT™ is approvable in Europe. The announcement followed the
issuance of the Final Assessment Report from the Reference Member State, BfArM, and the agreement of all the Concerned Member States (“CMS”) in DCP that
RIZAPORT ®
is approvable. With the decision, the regulatory process entered its final phase known as the national licensing phase during which the National
Agencies in the individual countries will issue the marketing licenses that allow RIZAPORT® to be marketed in each country.
On November 9, 2015 we announced that BfArM has granted marketing authorization of RIZAPORT® 5mg and 10mg, an oral thin film formulation of rizatriptan
benzoate for the treatment of acute migraines. The national approval of RIZAPORT® in Germany was granted under the DCP, in which Germany served as the
Reference Member State. This authorization was the first national marketing approval of RIZAPORT®.
On February 18, 2016, we announced that the USPTO had granted a patent protecting Rizaport®, an oral thin film formulation of rizatriptan benzoate for the
treatment of acute migraines. This patent protects the composition of Rizaport® and will be listed in the Orange Book upon approval of the product by the FDA.
The patent application, entitled "Instantly Wettable Oral Film Dosage Form Without Surfactant or Polyalcohol" covers rapidly disintegrating film oral dosage
forms and is valid until 2034.
6
On July 5, 2016, we announced the signing of the definitive agreement with Grupo Juste S.A.Q.F. (now Exeltis Healthcare, S.L. (“Exeltis”)) for the
commercialization of RIZAPORT®, our proprietary oral thin film for the treatment of acute migraines, in the country of Spain. All commercial manufacturing of
RIZAPORT® will take place at our new state-of-the-art manufacturing facility in Canada. Grupo Juste (Exeltis) is a prominent private Spanish company with over
90 years of experience in the research, development and commercialization of proprietary pharmaceutical products, including migraine and other central nervous
system drugs, in Europe, Latin America and other territories.
According to the definitive agreement, Grupo Juste (Exeltis) has obtained exclusive rights to register, promote and distribute RIZAPORT® in Spain. In exchange,
we and Redhill Biopharma received upfront payments and are entitled to milestone payments, together with a share of the net sales of RIZAPORT®. The initial
term of the definitive agreement shall be for ten years from the date of first commercial sale of the product and shall automatically renew for one additional two-
year term.
Through our partner Grupo Juste (Exeltis), the product was submitted in Spain in September 2016 for approval using a decentralized procedure.
On December 14, 2016, we, together with our partner RedHill, announced the signing of an exclusive license agreement with Pharmatronic Co. for the
commercialization of RIZAPORT® in the Republic of Korea (“South Korea”). Under the terms of the agreement, RedHill granted Pharmatronic Co. the exclusive
rights to register and commercialize RIZAPORT® in South Korea. IntelGenx and RedHill have received an upfront payment and will be eligible to receive
additional milestone payments upon achievement of certain predefined regulatory and commercial targets, as well as tiered royalties. The initial term of the
definitive agreement with Pharmatronic Co. is for ten years from the date of first commercial sale and shall automatically renew for an additional two-year term.
In April 2017, we announced the national marketing approval in Luxembourg which completes the approval process of RIZAPORT® under the DCP.
On October 31, 2017, we re-submitted the 505(b)(2)NDA in response to the CRL received in February, 2014 and the request from FDA for additional information
received in April, 2014. The review of the submission by the FDA triggered an incomplete response letter. On December 1, 2017, the FDA notified the Company
that additional data would be required before commencing the review of the application.
On December 5, 2017 we announced the termination of the Co-development and Commercialization agreement with Redhill, following which Redhill transferred
all rights and obligations under the agreement to the Company.
On September 24, 2018 IntelGenx announced the successful completion of a clinical study comparing Rizaport®, oral soluble film, and Maxalt®, an orally
disintegrating tablet. Following the study, on November 20, 2018, the FDA accepted the re-submitted 505(b) (2) NDA for review.
On October 31, 2018 IntelGenx announced that its commercialization partner for RIZAPORT® (10mg) in Spain, Grupo Juste, which is now part of Exeltis
Healthcare, received national marketing authorization from the Spanish Agency of Medicines and Medical Devices for the product.Following the approval of the
manufacturing site transfer of RIZAPORT® from the European contract manufacturer listed in the initial manufacturing site transfer application to IntelGenx’s
GMP compliant facility in Montreal, Canada, IntelGenx’s marketing partner, Exeltis Healthcare, will be able to commercialize the product in Spain. The Company
believes that recently reported results from a successful study, demonstrating that RIZAPORT® is bioequivalent to the European reference, Maxalt®-Lingua, will
further support the site transfer application in Spain. Approval of the manufacturing site change by the Spanish authorities is currently expected for the second half
of 2019.
On December 12, 2018 we announced the execution of a definitive licensing, development and supply agreement with Gensco® Pharma, a specialty
pharmaceutical company focusing on research, development and marketing of prescription products, for the exclusive commercialization of RIZAPORT® in the
United States. Under the Agreement, Gensco® Pharma has been granted the exclusive right to commercialize RIZAPORT® in the United States. In return,
IntelGenx is entitled to receive royalty payments based on the net profits of RIZAPORT®. IntelGenx is also eligible to receive milestone payments upon FDA
approval and product launch. The agreement also grants Gensco® Pharma exclusivity to develop, market, sell, distribute and fully commercialize products as an
IntelGenx partner for the People’s Republic of China.
On January 30, 2019, we announced that the FDA had performed a Pre-Approval Inspection (“PAI”) of the company’s Health Canada-certified cGMP
manufacturing facility in Montreal, relating to our NDA for RIZAPORT®, a VersaFilm™ oral soluble film for the treatment of acute migraines. At the conclusion
of the PAI on January 25, the FDA issued a Form 483 with five inspectional observations. The FDA has assigned a Prescription Drug User Fee Act goal date of
April 1, 2019, for completion of the review of the resubmitted NDA for RIZAPORT®. We do not expect the inspectional observations to impact the timeline for
the FDA’s decision on the approval of RIZAPORT®.
7
INT0027/2011:
We developed this oral film product based on our VersaFilm™ technology. In accordance with a co-development and commercialization
agreement with Par Pharmaceutical Companies, Inc. (“Par”) (now an operating company of Endo International plc), we developed an oral film product based on
our proprietary VersaFilm™ technology. The product is a generic formulation of buprenorphine and naloxone Sublingual Film, indicated for the treatment of
opioid dependence. A bioequivalent film formulation was developed, scaled-up, and pivotal batches were manufactured and tested during a subsequent pivotal
clinical study. An ANDA was filed with the FDA by Par in July 2013.
In August 2013 we were notified that, in response to the filing of the ANDA, we were named as a codefendant in a lawsuit pursuant to Paragraph IV of the Hatch
Waxman act filed by Reckitt Benckiser Pharmaceuticals and Monosol RX in the U.S. District Court for the District of Delaware (the “Delaware Court”) alleging
infringement of U.S. Patent Nos. 8,475,832, 8,603,514 and 8,017,150, each of which relate to Suboxone ® . We believe the ANDA product does not infringe those
or any other patents. In accordance with the terms of the co-development and commercialization agreement, Par was financially responsible for the costs of the
defense. Paragraph IV litigation is a regular part of the ANDA process and did not have any impact on our development schedule. In June 2016, an opinion from
the district court was obtained on the validity and infringement of the 3 orange book patents. The court ruled that the product is not infringing on two out of the
three patents. Subsequently, appeals were filed by both parties.
In December 2014, Reckitt Benckiser Pharmaceuticals and Monosol RX filed a lawsuit for patent infringement in the Delaware Court relating to the Suboxone ®
ANDA product. We were named as a codefendant in this action alleging patent infringement United States Patent Nos. 8,900,497 (“the ’497 patent”) and 8,906,277
(“the ’277 patent”), each of which related to a process for making a uniform oral film (“the process patents”). The trial for the process patents was held in
November 2016.
On July 11, 2016, the Company announced the receipt of the notice of appeal for the buprenorphine/naloxone sublingual film product for the treatment of opiate
addiction by Par and the Company to the United States Court of Appeals for the Federal Circuit from the final judgment issued by the Delaware Court on June 28,
2016.
The ruling in the U.S. District Court of Delaware in the ANDA litigation of Par and the Company against Indivior PLC (formerly Reckitt Benckiser
Pharmaceuticals) and Monosol Rx, LLC resulted in Par and the Company prevailing on the non-infringement of the U.S. Patent No. 8,017,150, which is set to
expire in 2023, and on the invalidity (all claims) and non-infringement (certain claims) of the U.S. Patent No. 8,475,832, which is set to expire in 2030. The Court
also ruled that Par’s ANDA product would infringe the asserted claims of U.S. Patent No. 8,603,514, one of the Orange Book listed patents for Suboxone ® Film,
and that the asserted claims of U.S. Patent No. 8,603,514 were not shown to be invalid.
On September 6, 2017, we announced that the Delaware Court, in a decision rendered August 31, 2017, determined that the process used to manufacture IntelGenx’
and Par’s ’buprenorphine/naloxone sublingual film product for the treatment of opiate addiction does not infringe MonoSol Rx LLC (now Aquestive Therapeutics
Inc.) “497 patent” and that on August 31, 2017, the Delaware Court rendered a decision in a separate case, which previously resulted in a finding infringement of
the MonoSol Rx LLC (now known as Aquestive Therapeutics Inc.) the “514 patent”, denying IntelGenx’ and Par’s motion to reopen the case. The Delaware Court
decisions were under appeal before the U.S. Court of Appeals for the Federal CircuitThere were several lawsuits for patent infringement in U.S. District Courts
related to the Suboxone ® ANDA product. These new ANDA lawsuits were based on patents submitted on the FDA Orange Book in 2017 and 2018. IntelGenx was
not a party to any of these U.S. District Court instances related to the Suboxone ® ANDA product.
On May 14, 2018, we announced that all patent litigation between the Company, Par Pharmaceutical, Inc.`, Indivior, Inc., Indivior UK Limited, and Aquestive
Therapeutics, Inc. (formerly MonoSol Rx, LLC) related to Suboxone® film had been settled. The settlement agreement permits Par to begin selling a generic
version of Suboxone® film on January 1, 2023 or earlier under certain circumstances.
INT0010/2006
: This product is based on our proprietary AdVersa® technology and is currently in an advanced development stage. We initially entered into an
agreement with Cynapsus Therapeutics Inc. (formerly Cannasat Therapeutics Inc., “Cynapsus”) for the development of a buccal muco-adhesive tablet product
containing a cannabinoid-based drug for the treatment of neuropathic pain and nausea in cancer patients undergoing chemotherapy. In 2009, we completed a
clinical biostudy on the muco-adhesive tablet we developed which is based on our proprietary AdVersa ® technology. The study results indicated improved
bioavailability and reduced first-pass metabolization of the drug. In the fourth quarter of 2010, we acquired from Cynapsus full control of, and interest in, this
project going forward. We also obtained worldwide rights to U.S. Patent 7,592,328 and all corresponding foreign patents and patent applications to exclusively
develop and further secure intellectual property protection for this project.
8
On April 5, 2017, we announced signing of a Definitive Agreement for the development and commercialization of a drug product containing the cannabinoid
Dronabinol (the “Product”) for the management of anorexia and cancer chemotherapy-related pain. This definitive agreement followed 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 made an upfront payment to IntelGenx, in addition to set future milestone and royalty payments, based on the completion of an
efficacy study, approvals from the FDA and Health Canada, and the commercial launch of the Product. We are responsible for the research and development of the
product, including optimization of the prototype, scale-up activities and preparation of a phase II proof of concept clinical study and are developing the product as
an oral mucoadhesive tablet based on our proprietary AdVersa ® controlled-release technology. Tetra is 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.
INT0036/2013
: This oral film product is based on our proprietary oral film technology VersaFilm™ and is currently in the optimization development stage.
Loxapine is indicated for the treatment of anxiety and aggression in patients suffering from schizophrenia or bipolar 1 disorder. Loxapine oral film will utilize the
company’s proprietary VersaFilm™ technology, allowing for an improved product to offer patients significant therapeutic benefits compared to existing
medications. A fast acting Loxapine oral film dosage form that can be used to effectively treat acute agitation associated with schizophrenia or bipolar 1 disorder in
non-institutionalized patients while reducing the risk of pulmonary problems is needed as it could substantially reduce the potential risks of violence and injury to
patients and others by preventing or reducing the duration and severity of an episode of acute agitation. Our first clinical study on this product, completed in Q4
2014, suggested improved bioavailability compared to the currently approved tablet. In late 2015 we completed a second pilot clinical study which demonstrated
that buccal absorption of the drug from the Loxapine oral film results in a significantly higher bioavailability of the drug compared to oral tablets. We are working
to optimize the film to further improve the time to reach peak plasma concentrations. However, due to the prioritisation of our project line, resources were directed
to other projects, which resulted in a temporary hold of the optimization work during the last year. We are now actively working on advancing this project.
On February 10, 2016, we announced the submission of the patent application with the U.S. patent office for an oral film dosage form containing Loxapine for the
treatment of anxiety and aggression in patients suffering from schizophrenia or bipolar 1 disorder. The application is currently under review.
INT0040/2014
: An oral film product based on our proprietary VersaFilm™technology is currently in the scale up stage. In order to protect our competitive
advantage, no further details of the product can be disclosed at this stage.
On December 27, 2016, we announced that we have entered into a co-development and commercialization agreement with Endo Ventures Ltd. for this product
utilizing our proprietary VersaFilm™ for the U.S. market. Under the agreement, Endo has obtained certain exclusive rights to market and sell our product in the
U.S. We received an upfront payment and will receive future milestone payments. Endo and IntelGenx will share the profits of commercialization.
INT0043/2015
: We have developed an oral film containing montelukast as an active ingredient based on our proprietary edible film technology VersaFilm™,
which is in the early clinical trial phase. In pre-clinical studies, it was discovered that montelukast has the potential to rejuvenate the brain in aged rats.
We are collaborating with Dr. Ludwig Aigner, a neuroscientist who is a member of our Scientific Advisory Board and head of the Institute of Molecular
Regenerative Medicine at the Paracelsus Medical University in Salzburg, Austria. Dr. Aigner has made major contributions in the field of brain and spinal cord
regeneration over the last 25 years. He was the first to develop tools to visualize neurogenesis in living animals and identified signaling mechanisms that are
crucially involved in limiting brain regeneration. One of these mechanisms, leukotriene signaling, is related to asthma. In consequence, Dr. Aigner and his team
recently demonstrated that the anti-asthmatic drug montelukast structurally and functionally rejuvenates the aged brain. His main aim is to develop molecular and
cellular therapies for patients with neurodegenerative diseases and for the aged population.
On July 13, 2016, we announced the successful completion of the pilot clinical study for our Montelukast VersaFilm™ that demonstrated a significantly improved
pharmacokinetic profile against the reference product. The study data confirmed that buccal absorption of the drug from the Montelukast film product resulted in a
significantly improved bioavailability of the drug compared to the commercial tablet. In addition, the study data confirmed that Montelukast crosses the blood brain
barrier when administered using our Versafilm™ delivery technology.
In 2017 we announced receiving the no objection letter from Health Canada regarding a phase II-a proof-of-concept study. The objectives of this 26 week,
randomized, double-blind, and placebo controlled Phase IIa proof of concept study which will be conducted at eight clinical study sites across Canada will be to
evaluate the safety, feasibility, tolerability, and efficacy of Montelukast buccal film in patients with mild to moderate Alzheimer’s disease. The trial design includes
testing of up to 70 patients.
9
On January 24, 2018 we announced that we retained the services of Cogstate and JSS Medical Research as the Contract Research Organizations to support the
Montelukast VersaFilm TM study
We are also actively working on securing the IP of our product by filing numerous patent applications. Based on the outcome of this first efficacy trial in humans,
we will be actively seeking a partnership or alliance opportunity to further advance developmental work and commercialization of this product.
On September 25, 2018, we announced that patient recruitment will commence for the Phase 2a study with Montelukast VersaFilm™ in patients with mild to
moderate Alzheimer’s Disease (“AD”). Two research sites (the Centre for Memory and Aging in Toronto, ON and True North Clinical Research in Halifax, NS)
are being activated and will be open for patient enrollment as of September 26, 2018, with additional sites planning to initiate patient screening in the near future.
This randomized, double-blind, placebo controlled Phase 2a proof of concept study will enroll approximately 70 subjects with mild to moderate AD across eight
Canadian research sites. The primary study objectives will be to evaluate the safety, feasibility, tolerability, and efficacy of Montelukast buccal film following daily
dosing for 26 week
INT0046/2018:
Our first Cannabis project based on our VersaFilm™ technology is currently in the early development stage. We started this project in anticipation
of the amended cannabis regulations that would allow adult-use consumers to purchase edible products in Canada.
On November 7, 2018 we announced the execution of a definitive license, development and supply agreement with Tilray, Inc., a global leader in cannabis
production and distribution. Pursuant to the agreement, the two companies will co-develop and commercialize oral film products infused with adult-use and
medical cannabis (“cannabis-infused VersaFilm™”),
Under the agreement with Tilray, Inc., IntelGenx and Tilray, Inc. will fund 20% and 80%, respectively, of the costs associated with the development of the
cannabis-infused Versafilm™ products. IntelGenx will have the exclusive right to manufacture and supply the co-developed products to Tilray, Inc., and will also
receive a fixed single-digit royalty on net product sales. Tilray, Inc., will have the exclusive, worldwide marketing and distribution rights for the co-developed
products.
In connection with the agreement with Tilray, Inc , the parties have also executed a subscription agreement pursuant to which Tilray, Inc. made a strategic
investment in IntelGenx by way of a non-brokered private placement (“Private Placement”). Pursuant to the Private Placement, the IntelGenx issued 1,428,571
common shares at a subscription price of U.S.$0.70 per common share for gross proceeds of U.S.$1,000,000. We intend to use the proceeds of the Private
Placement for cannabis-infused VersaFilm™ product development under the agreement with Tilray, Inc.
INT0045/2018: A oral film product based on our proprietary VersaFilm™technology. This is a new project we started in 2018 which is currently in the early
development stage. In order to protect our competitive advantage, no further details of the product can be disclosed at this stage.
Regulatory Stage Projects:
INT0007/2006
: We are developing an oral film product based on our VersaFilm™ technology containing the active ingredient Tadalafil. The product is intended
for the treatment of erectile dysfunction (“ED”). The results of a phase I pilot study that was conducted in the second quarter of 2015 confirmed that the product is
bioequivalent with the brand product, Cialis ® . We are currently compiling data and reviewing the worldwide regulatory requirements.
On November 21, 2016, we announced the signing of a binding term sheet for a license to Eli Lilly and Company’s tadalafil dosing patent, United States Patent No.
6,943,166 (the ’166 dosing patent). Any exclusivity associated with the tadalafil compound patent is not affected by this agreement.
Subject to FDA approval, this license allows us to commercialize a Tadalafil ED VersaFilm™ product in the U.S. prior to the expiration of the ’166 dosing patent.
This license terminates all our current tadalafil-related litigation activities.
On March 28, 2017, we announced that Eli Lilly and Company granted IntelGenx’ an exclusive license for tadalafil film product under ED dosing patent, the ’166
dosing patent.
10
We are in discussions with potential partners for the commercialization of our Tadalafil ED VersaFilm™ product.
INT0039/2013
: The product based on one of our proprietary technologies was being developed under another development and commercialization agreement with
Par. On September 18, 2015, Par was acquired by Endo International plc. As a result of this acquisition, there was a conflict for Par to remain as the partner for this
product. Therefore, the product was returned to the Company with full rights and no requirement for any compensation for work paid by Par.
On September 12, 2016, we announced that we had entered into a licensing, development and supply agreement with Chemo granting Chemo the exclusive license
to commercialize two generic products for the U.S. market and one product on a worldwide basis. Under the terms of the agreement, Chemo has obtained certain
exclusive rights to market and sell our products in exchange for upfront and milestone payments, together with a share of the profits of commercialization. Chemo
also has a right of first negotiation to obtain the exclusive commercialization rights for two of the products to include any country outside the U.S.
On October 4, 2018 IntelGenx announced that an Abbreviated New Drug Application (“ANDA”) for a generic buccal film product has been submitted to the FDA
by its partner, Insud Pharma (formerly Chemo Group). On January 30, 2019 the FDA confirmed the acceptance for review of this ANDA with a GDUFA date of
October 18, 2019. IntelGenx is currently preparing for the upcoming pre approval inspection.
INT0037/2013
: A product based on one of our proprietary technologies has been developed but preparations of submission batches and documentation in support
of a marketing application to the FDA have been placed on hold.
The product was being developed in accordance with another development and commercialization agreement with Par. On September 18, 2015, Par was acquired
by Endo International plc. As a result of this acquisition, there was a conflict for Par to remain as the partner for these products. As such, the product was returned
to the Company with full rights and no requirement for any compensation for work paid by Par.
On September 12, 2016, we announced that we had entered into a licensing, development and supply agreement with Chemo Group (“Chemo”) granting Chemo the
exclusive license to commercialize two generic products for the USA market and one product on a worldwide basis. Under the terms of the agreement, Chemo has
obtained certain exclusive rights to market and sell our products in exchange for upfront and milestone payments, together with a share of the profits of
commercialization. Chemo also has a right of first negotiation to obtain the exclusive commercialization rights for two of the products to include any country
outside the USA. As per our partner’ decision, activities in preparation for filing the marketing application for this product have been placed on hold.
Other
projects:
INT0001/2004
: This is the most advanced tablet generic product involving our multilayer tablet technology. Equivalency with the reference product Toprol XL ®
and its European equivalent Beloc-ZOK ® has been demonstrated in-vitro . The product has been tested in phase I studies. In November 2016 we entered into a
License and Development Agreement with Chemo Group to advance the commercialization of our Versa Tab™ product. The manufacturing technology transfer to
Chemo is still ongoing.
INT0004/2006
: We developed a new, higher strength of the antidepressant Bupropion HCl, the active ingredient in Wellbutrin XL ® , and, in November 2011, the
FDA approved the drug for patients with Major Depressive Disorder. In February 2012, we entered into an agreement with Edgemont Pharmaceuticals LLC
(“Edgemont”) for commercialization of the product in the United States. Under the terms of the agreement, Edgemont obtained certain exclusive rights to market
and sell the product in the U.S. In exchange we received a $1 million upfront payment, received launch related milestones totaling up to $4 million, were eligible
for additional milestones of up to a further $23.5 million upon achieving certain sales and exclusivity targets and to also receive tiered double-digit royalties on the
net sales of the product.
The product was launched in the U.S. in October 2012 under the brand name Forfivo XL ® . As of December 31, 2015 we had received an upfront payment of $1
million and a $1 million milestone payment related to the launch. The commercialization of Forfivo XL ® triggered a launch-related milestone payment of $3
million from IntelGenx’ licensing partner Edgemont due to Edgemont reaching in July 2015, $7 million of cumulative net trade sales of Forfivo XL ® over the
preceding 12 months.
In August 2013, we announced receipt of a Paragraph IV Certification Letter from Wockhardt Bio AG, advising of the submission of an Abbreviated New Drug
Application (“ANDA”) to the FDA requesting authorization to manufacture and market generic versions of Forfivo XL ® 450 mg tablets in the U.S. In November
2014 we announced that the Paragraph IV litigation with Wockhardt had been settled and that, under the terms of the settlement, Wockhardt has been granted the
right, with effect from January 15, 2018, to be the exclusive marketer and distributor of an authorized generic of Forfivo XL ® in the U.S.
11
In December 2014 we announced that Edgemont had exercised its right to extend the license for the exclusive marketing of Forfivo XL ® 450 mg tablets. In
exchange, we received milestone payments of $650 thousand in December 2014 and $600 thousand in February 2015. All other financial obligations contained in
the license agreement entered into by Edgemont and IntelGenx in February 2012, specifically launch-related and sales milestones, together with the contractual
royalty rates on net sales of the product, remained in effect.
On August 5, 2016, we announced that we had sold our U.S. royalty on future sales of Forfivo XL ® to SWK Holdings Corporation (“SWK”) for $6 million (CA$8
million). Forfivo XL ® (Bupropion extended-release) is the first 450 mg bupropion HCl tablet indicated for Major Depressive Disorder, approved by the FDA. As
per terms of the agreement, we received $6 million from SKW at closing. In return for, (i) 100% of any and all royalties (as defined in the Edgemont
Pharmaceuticals, LLC License Agreement) 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. Patent protection for Forfivo XL ® in the United States
expires in 2027.
In the first quarter of 2017, IntelGenx was informed that Edgemont Pharmaceuticals, LLC. assigned its product business, including Forfivo XL ® , to Alvogen
Group Holdings 3 LLC.
IntelGenx retained all patent rights to the product Forfivo XL ® , which is sold on the US market.
INT0044/2016
: A product based on one of our VersaTab TM proprietary technologies.
On December 1 st , 2016, we announced the signing of a term sheet for the co-development and commercialization of a generic tablet in the area of central nervous
systems on a worldwide basis. As per the agreement, we received an upfront payment and would have been entitled to receive development costs of the product and
future milestone payments. Chemo and IntelGenx would have also shared the profits of commercialization. The definitive agreement was signed on December 30,
2016. However, on May 23, 2018, Chemo and IntelGenx mutually agreed to terminate the agreement and Chemo assigned all rights, titles and interests in and to
any product-related intellectual property and related data and regulatory dossiers to IntelGenx.
The current status of each of our products as of the date of this report is summarized in the following table:
Product
INT0001/2004
INT0004/2006
INT0007/2006
INT0008/2008
INT0010/2006
INT0027/2011
INT0036/2013
INT0037/2013
Indication
Anti-hypertension
Antidepressant
Erectile dysfunction
Migraine
Pain
Opioid dependence
Schizophrenia
Undisclosed
12
Status
of
Development
Technology transfer ongoing.
FDA-approved November 2011. Commercially
launched in USA as Forfivo XL ® in October 2012.
In 2016 we sold the royalty revenue to SWK.
Discussions with potential commercial partner.
Additional data submitted, FDA accepted the re-
submitted 505(b)(2) NDA for review. PDUFA date
April 1 st 2019.
Submission from previous manufacturing site
approved by Spanish authorities. Approval of the
manufacturing site change by the Spanish
authorities is currently expected for the second half
of 2019.
Formulation optimization, scale-up preparation for
clinical study evaluation.
ANDA submitted to FDA in July 2013. FDA review
process ongoing.
Formulation development ongoing.
Product developed. Preparation of documents for
submission on hold.
INT0039/2013
INT0040/2014
INT0043/2015
INT0045/2018
INT0046/2018
Growth
Strategy
Undisclosed
Undisclosed
Alzheimer
Undisclosed
Adult use of Cannabis
ANDA filed.
Formulation development ongoing.
Phase II clinical study activated, recruitment
ongoing.
Formulation development ongoing.
Formulation development ongoing.
Our primary growth strategies are based on three pillars: (1) out licensing commercial rights of our existing pipeline products, (2) partnering on contract
development and manufacturing projects leveraging our VersaFilm™ technology, (3) expanding our current pipeline through:
identifying lifecycle management opportunities for existing market leading pharmaceutical products,
developing oral film products that provide tangible patient benefits,
development of new drug delivery technologies,
repurposing existing drugs for new indications, and
developing generic drugs where high technology barriers to entry exist in reproducing branded films.
Contract
Development
and
Manufacturing
based
on
VersaFilm™
technology
We have established a state-of-the-art manufacturing facility for the future manufacture of our VersaFilm™ products. We believe that this (1) represents a
profitable business opportunity, (2) will reduce our dependency upon third-party contract manufacturers, thereby protecting our manufacturing process know-how
and intellectual property, and (3) allows us to offer our development partners a full service from product conception through to supply of the finished product.
With our current manufacturing equipment, we are only able to manufacture products that do not contain flammable organic solvents. We initiated a project to
expand the existing manufacturing facility, the timing of which will be dictated in part by the completion of agreements with our commercial partners. 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 and provide
better protection of our Intellectual Property.
Lifecycle
Management
Opportunities
We are seeking to position our delivery technologies as an opportunity for lifecycle management of products for which patent protection of the active ingredient is
nearing expiration. While the patent for the underlying substance cannot be extended, patent protection can be obtained for a new and improved formulation by
filing an application with the FDA under Section 505(b)(2) of the U.S. Federal Food, Drug and Cosmetic Act. Such applications, known as a “505(b)(2) NDA”, are
permitted for new drug products that incorporate previously approved active ingredients, even if the proposed new drug incorporates an approved active ingredient
in a novel formulation or for a new indication. A 505(b)(2) NDA may include information regarding safety and efficacy of a proposed drug that comes from studies
not conducted by or for the applicant. The first formulation for a respective active ingredient filed with the FDA under a 505(b)(2) application may qualify for up to
three years of market exclusivity upon approval. Based upon a review of past partnerships between third party drug delivery companies and pharmaceutical
companies, management believes that drug delivery companies which possess innovative technologies to develop these special dosage formulations present an
attractive opportunity to pharmaceutical companies. Accordingly, we believe “505(b)(2) products” represent a viable business opportunity for us.
Product
Opportunities
that
provide
Tangible
Patient
Benefits
Our focus will be on developing oral film products leveraging our VersaFilm™ technology that provide tangible patient benefits versus existing drug delivery
forms. Patients with difficulties swallowing medication, pediatrics or geriatrics may benefit from oral films due to the ease of use. Similarly, we are working on
oral films to improve bio-availability and/or response time versus existing drugs and thereby reducing side effects.
13
Development
of
New
Drug
Delivery
Technologies
The rapidly disintegrating film technology contained in our VersaFilm™, and our AdVersa® mucosal adhesive tablet, are two examples of our efforts to develop
alternate technology platforms. As we work with various partners on different products, we seek opportunities to develop new proprietary technologies.
Repurposing
Existing
Drugs
We are working on the repurposing of already approved drugs for new indications using our VersaFilm™ film technology. This program represents a viable growth
strategy for us as it will allow for reduced development costs, improved success rates and shorter approval times. We believe that through our repurposing program
we will be able minimize the risk of developmental failure and create value for us and potential partners.
Generic
Drugs
with
High
Barriers
to
Entry
We plan to pursue the development of generic drugs that have certain barriers to entry, e.g., where product development and manufacturing is complex and can
limit the number of potential entrants into the generic market. We plan to pursue such projects only if the number of potential competitors is deemed relatively
insignificant.
Competition
The pharmaceutical industry is highly competitive and is subject to the rapid emergence of new technologies, governmental regulations, healthcare legislation,
availability of financing, patent litigation and other factors. Many of our competitors, including Aquestive Therapeutics Inc. (formerly Monosol Rx), Tesa-Labtec
GmbH, BioDelivery Sciences International, Inc. and LTS Lohmann Therapy Systems Corp., have longer operating histories and greater financial, technical,
marketing, legal and other resources than we have. In addition, many of our competitors have significantly greater experience than we have in conducting clinical
trials of pharmaceutical products, obtaining FDA and other regulatory approvals of products, and marketing and selling products that have been approved. We
expect that we will be subject to competition from numerous other companies that currently operate or are planning to enter the markets in which we compete.
The key factors affecting the development and commercialization of our drug delivery products are likely to include, among other factors:
The regulatory requirements;
The safety and efficacy of our products;
The relative speed with which we can develop products;
Generic competition for any product that we develop;
Our ability to defend our existing intellectual property and to broaden our intellectual property and technology base;
Our ability to differentiate our products;
Our ability to develop products that can be manufactured on a cost effective basis;
Our ability to manufacture our products in compliance with current Good Manufacturing Practices (“cGMP”) and any other regulatory requirements; and
Our ability to obtain financing.
In order to establish ourselves as a viable industry partner, we plan to continue to invest in our research and development activities and in our manufacturing
technology expertise, in order to further strengthen our technology base and to develop the ability to manufacture our VersaFilm™ products ourselves, and our
VersaTab™ and AdVersa® products through our manufacturing partners, at competitive costs.
14
Our
Competitive
Strengths
We believe that our key competitive strengths include:
Our comprehensive full services;
Our diversified pipeline;
Our ability to swiftly develop products through to regulatory approval; and
The versatility of our drug delivery technologies.
Our highly qualified, dedicated professional team
Manufacturing
Partnership
While we previously manufactured products only for testing purposes in our own laboratories, we have now started to manufacture products for pivotal clinical
trials, and we are undertaking steps to manufacture products for commercial use. In order to establish ourselves as a full-service partner for our thin film products,
we have completed the construction of a new, state-of-the-art oral film manufacturing facility and are in the process of preparing the equipment and finalizing plans
to commercially manufacture our products using our VersaFilm™ drug delivery technology. VersaFilm™ is our proprietary immediate release polymeric film
technology. It is comprised of a thin polymeric film using United States Pharmacopeia components that are safe and approved by the FDA for use in food,
pharmaceutical and cosmetic products. We completed construction of our manufacturing facility in 2017 and successfully passed a quality audit by Health Canada
in November, 2017 following which we received our Drug Establishment License. Since then, we are fully operational.
Dependence
on
Major
Customers
We currently rely on a few major customers for our end products. We also currently depend upon a limited number of partners to develop our products, to provide
funding for the development of our products, to assist in obtaining regulatory approvals that are required in order to commercialize these products, and to market
and sell our products.
Intellectual
Property
and
Patent
Protection
We protect our intellectual property and technology by using the following methods: (i) applying for patent protection in the United States and in the appropriate
foreign markets, (ii) non-disclosure agreements, license agreements and appropriate contractual restrictions and controls on the distribution of information, and (iii)
trade secrets, common law trademark rights and trademark registrations. We plan to file core technology patents covering the use of our platform technologies in
any pharmaceutical products.
We have obtained 14 patents and have an additional 40 published pending patent applications, as described below. The patents expire 20 years after submission of
the initial application. In the U.S. the term of the patent sometimes extends over the 20-year period. The initial term of 20 years is extended by a period (the “patent
term adjustment”) determined by the USPTO according to delays in the prosecution of the patent application that are not applicant delays.
Patent
No.
US 6,231,957
US 6,660,292
Title
Subject
Rapidly disintegrating flavor wafer for
flavor enrichment
Rapidly disintegrating film for
precooked foods
The composition, manufacturing, and
use of rapidly disintegrating flavored
films for releasing flavors to certain
substrates
Composition and manufacturing of
flavored films for releasing flavors to
precooked food substrates
15
Date
issued
/
expiration
Issued May 15, 2001
Expires May 6, 2019
Issued December 9, 2003
Expires June 19, 2021
US 7,132,113
US 7,674,479
US 8,691,272
US 8,703,191
US 8,735,374
US 9,301,948
US 9,668,970
US 9,717,682
US 9,949,934
Flavored film
Composition and manufacturing
method of multi-layered films
Issued November 7, 2006
Expires April 16, 2022
Sustained-release bupropion and
bupropion / mecamylamine tablets
Formulation and method of making
tablets containing bupropion and
mecamylamine
Issued March 9, 2010
Expires July 25, 2027
Multilayer tablet
Formulation of multilayered tablets
Issued April 8, 2014
Expires January 28, 2033
Controlled release pharmaceutical
tablets
Formulation of tablets containing
bupropion and mecamylamine
Issued April 22, 2014
Expires January 10, 2032
Oral mucoadhesive dosage form
Direct compression formulation for
buccal and sublingual dosage forms
Issued May 27, 2014
Expires April 15, 2032
Instantly wettable oral film dosage
form without surfactant or polyalcohol
Formulation of oral films containing
active pharmaceutical ingredients
Issued April 5, 2016
Expires July 30, 2033
Film Dosage Form with Extended
Release Mucoadhesive Particles
Solid Oral Film Dosage Forms and
Methods for Making Same
Device and method of treating
conditions associated with
neuroinflammation
Film containing mucoadhesive particle Issued June 6, 2017
Optimization of film strip technology
Expires November 26, 2034
Issued August 1, 2017
Expires September 21, 2031
Formulation of oral films containing
montelukast
Issued April 24, 2018
Expires October 20, 2036
CA 2,998,223
Loxapine film oral dosage form
Formulation of oral films containing
loxapine
Issued October 9, 2018
Expires January 24, 2037
EP 3,027,179
JP 6,482,552
Instantly wettable oral film dosage
form without surfactant or polyalcohol
Formulation of oral films containing
active pharmaceutical ingredients
Issued October 17, 2018
Expires July 30, 2034
Instantly wettable oral film dosage
form without surfactant or polyalcohol
Formulation of oral films containing
active pharmaceutical ingredients
Issued March 13, 2019
Expires July 30, 2034
16
Patent
Application
No.
Title
Subject
Date
Filed
US Appl. 12/963,132
US Appl. 15/216,903
Korean Appl. KR20167005581
Oral film dosage forms and methods
for making same
Film dosage forms containing
amorphous active agents
Immediately wet oral films dosage
forms have no surfactant and a
polyhydric alcohol
Korean Appl. KR20180119627
Montelukast transmucosal film
Korean Appl. KR20180105184
Loxapine film oral dosage form
EU Appl. EP 3,427,732
Immediately wet oral films dosage
forms have no surfactant and a
polyhydric alcohol
EU Appl. EP 3,426,235
Montelukast transmucosal film
EU Appl. EP 3,411,024
Loxapine film oral dosage form
Chinese Appl. CN105530921
Immediately wet oral films dosage
forms have no surfactant and a
polyhydric alcohol
Optimization of film strip technology
Filed December 8, 2010
Film containing amorphous agent
Filed July 22, 2016
Formulation of oral films containing
active pharmaceutical ingredients
Filed July 30, 2014
Formulation of oral films containing
montelukast
Formulation of oral films containing
loxapine
Formulation of oral films containing
active pharmaceutical ingredients
Filed March 1, 2017
Filed January 25, 2017
Filed July 30, 2014
Formulation of oral films containing
montelukast
Formulation of oral films containing
loxapine
Formulation of oral films containing
active pharmaceutical ingredients
Filed March 1, 2017
Filed January 25, 2017
Filed July 30, 2014
Chinese Appl. CN108697656
Loxapine film oral dosage form
Formulation of oral films containing
loxapine
Filed January 25, 2017
Chinese Appl. CN108778259
Canadian Appl. CA2,919,442
Mexican Appl. MX 2016001399
Montelukast the mucous membrane the
membrane
Formulation of oral films containing
montelukast
Filed March 1, 2017
Immediately wet oral films dosage
forms have no surfactant and a
polyhydric alcohol
Immediately wet oral films dosage
forms have no surfactant and a
polyhydric alcohol
Formulation of oral films containing
active pharmaceutical ingredients
Filed July 30, 2014
Formulation of oral films containing
active pharmaceutical ingredients
Filed July 30, 2014
17
Brazilian Appl. BR112016002074
Immediately wet oral films dosage
forms have no surfactant and a
polyhydric alcohol
Formulation of oral films containing
active pharmaceutical ingredients
Filed July 30, 2014
Brazilian Appl. BR112018015624
Loxapine film oral dosage form
Israel Appl. 243651
South African Appl. 2016/00785
Chilean Appl. 201600160
Immediately wet oral films dosage
forms have no surfactant and a
polyhydric alcohol
Immediately wet oral films dosage
forms have no surfactant and a
polyhydric alcohol
Immediately wet oral films dosage
forms have no surfactant and a
polyhydric alcohol
Formulation of oral films containing
loxapine
Formulation of oral films containing
active pharmaceutical ingredients
Filed January 25, 2017
Filed July 30, 2014
Formulation of oral films containing
active pharmaceutical ingredients
Filed July 30, 2014
Formulation of oral films containing
active pharmaceutical ingredients
Filed July 30, 2014
Indian Appl. IN201847036315
Montelukast transmucosal film
Indian Appl. IN201847030838
Loxapine film oral dosage form
Formulation of oral films containing
montelukast
Formulation of oral films containing
loxapine
Filed September 26, 2018
Filed August 17, 2018
Canadian Appl. CA2,797,444
Canadian Appl. CA2,998,218
Solid oral dosage forms comprising
tadalafil
Formulation of oral films containing
tadalafil
Filed November 3, 2011
Device and method of treating
conditions associated with
neuroinflammation
Formulation of oral films containing
montelukast
Filed October 17, 2017
Canadian Appl. CA3,017,264
Montelukast transmucosal film
Canadian Appl. CA3,015,555
Loxapine film oral dosage form
Australian Appl. AU2017231110
Montelukast transmucosal film
Australian Appl. AU2017214774
Loxapine film oral dosage form
Formulation of oral films containing
montelukast
Formulation of oral films containing
loxapine
Formulation of oral films containing
montelukast
Formulation of oral films containing
loxapine
Filed March 1, 2017
Filed January 25, 2017
Filed March 1, 2017
Filed January 25, 2017
18
US Appl. 15/426,149
Solid Oral Film Dosage Forms and
Methods for Making Same
Formulation of oral films containing
tadalafil
Filed February 7, 2017
Solid oral film dosage forms and
methods for making same
Formulation of oral films containing
tadalafil
Filed November 27, 2017
US Appl. 15/067,309
Montelukast transmucosal film
US Appl. 15/588,897
Film dosage form with extended
release mucoadhesive particles
US Appl. 15/014,269
Loxapine film oral dosage form
US Appl. 14/630,699
US Appl. 15/848,819
US Appl. 15/822,734
US Appl. 15/940,288
US Appl. 16/110,737
US Appl. 15/912,103
Film dosage forms containing
amorphous active agents
Film dosage form with multimodal and
particle size distributions
Method of treatment and device for the
improved bioavailability of leukotriene
receptor antagonists
Film dosage form with extended
release mucoadhesive particles
Device and method of treating
conditions associated with
neuroinflammation
US Appl. 16/053,383
Loxapine film oral dosage form
PCT Appln. WO 2018176149
PCT Appln. WO 2018072015
Method of treatment and device for the
improved bioavailability of leukotriene
receptor antagonists
Device and method of treating
conditions associated with
neuroinflammation
19
Formulation of oral films containing
montelukast
Filed March 11, 2016
Film containing mucoadhesive particle Filed May 8, 2017
Formulation of oral films containing
loxapine
Filed February 3, 2016
Film containing amorphous agent
Filed February 2, 2015
Optimization of film strip technology
Filed December 20, 2017
Formulation of oral films containing
montelukast
Filed March 29, 2018
Film containing mucoadhesive particle Filed August 23, 2018
Formulation of oral films containing
montelukast
Filed March 5, 2018
Formulation of oral films containing
loxapine
Formulation of oral films containing
montelukast
Filed August 2, 2018
Filed March 29, 2018
Formulation of oral films containing
montelukast
Filed October 17, 2017
PCT Appln. WO 2018205017
Film dosage form with extended
release mucoadhesive particles
Film containing mucoadhesive particle Filed May 8, 2018
Government
Regulation
The pharmaceutical industry is highly regulated. The products we participate in developing require certain regulatory approvals. In the United States, drugs are
subject to rigorous regulation by the FDA. The U.S. Federal Food, Drug, and Cosmetic Act, and other federal and state statutes and regulations, govern, among
other things, the research, development, testing, manufacture, storage, record keeping, packaging, labeling, adverse event reporting, advertising, promotion,
marketing, distribution, and import and export of pharmaceutical products. Failure to comply with applicable regulatory requirements may subject a company to a
variety of administrative or judicially-imposed sanctions and/or the inability to obtain or maintain required approvals or to market drugs. The steps ordinarily
required before a new pharmaceutical product may be marketed in the United States include:
Preclinical laboratory tests, animal studies and formulation studies under FDA’s good laboratory practices regulations, or GLPs;
The submission to the FDA of an investigational new drug application, which must become effective before human clinical trials may begin;
The completion of adequate and well-controlled clinical trials according to good clinical practice regulations, or GCPs, to establish the safety and efficacy
of the product for each indication for which approval is sought;
After successful completion of the required clinical testing, submission to the FDA of a NDA, or an ANDA, for generic drugs. In certain cases, an
application for marketing approval may include information regarding safety and efficacy of a proposed drug that comes from studies not conducted by or
for the applicant. 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;
Satisfactory completion of an FDA pre-approval inspection of the manufacturing facility or facilities at which the product is to be produced, to assess
compliance with cGMPs to assure that the facilities, methods and controls are adequate to preserve the drug’s identity, strength, quality and purity; and
FDA review and approval of the NDA or ANDA.
The cost of complying with the foregoing requirements, including preparing and submitting an NDA or ANDA, may be substantial. Accordingly, we typically rely
upon our partners in the pharmaceutical industry to spearhead and bear the costs of the FDA approval process. We also seek to mitigate regulatory costs by
focusing on 505(b)(2) NDA opportunities. By applying our drug delivery technology to existing drugs, we seek to develop products with lower research &
development (“R&D”) expenses and shorter time-to-market timelines as compared to regular NDA products.
Cannabis in Canada
The signing of the Cannabis Act created a strict legal framework for controlling the production, distribution, sale and possession of cannabis across Canada.
Cannabis edible products and concentrates will be legal for sale approximately one year after the Cannabis Act came into force on October 17th, 2018.
Our R&D expenses, net of R&D tax credits, for the year ended December 31, 2018 increased by $2,489 thousand to $5,104 thousand, compared with $2,615
thousand for the year ended December 31, 2017. The increase in R&D expenditure is explained in the section of this report entitled “Management’s Discussion and
Analysis of Financial Condition and Results of Operations”.
Environmental
Regulatory
Compliance
We believe that we are in compliance with environmental regulations applicable to our research and development and manufacturing facility located in Ville Saint
Laurent, Quebec.
20
Employees
As of the date of this filing, we have 38 full-time and 4 part-time employees. None of our employees are covered by collective bargaining agreements. We believe
that our relations with our employees are very good.
ITEM
1A.
RISK
FACTORS.
Our business faces many risks. Any of the risks discussed below, or elsewhere in this report or in our other filings with the Securities and Exchange Commission
(“SEC”), could have a material impact on our business, financial condition, or results of operations.
Risks
Related
to
Our
Business
Our
auditors
have
raised
substantial
doubts
as
to
our
ability
to
continue
as
a
going
concern.
Our financial statements have been prepared under the assumption that we will continue as a going concern. The opinion of our independent registered public
accountants on our audited financial statements as of and for the year ended December 31, 2018 contains an explanatory paragraph expressing substantial doubt
about our ability to continue as a going concern. Our ability to continue as a going concern is dependent upon our ability to raise capital from financing transactions
and to attain profitable operations. Our financial statements do not include any adjustments or classifications that may result from the possible inability of the
Company to continue as a going concern. However, if adequate funds are not available to us when we need it, we will be required to curtail our operations which
would, in turn, further raise substantial doubt about our ability to continue as a going concern. Should the Company be unable to continue as a going concern, it
may be unable to realize the carrying value of its assets and to meet its liabilities as they become due.
We
have
a
history
of
losses
and
our
revenues
may
not
be
sufficient
to
sustain
our
operations.
Even though we ceased being a “development stage” company in April 2006, we are still subject to all of the risks associated with having a limited operating
history and pursuing the development of new products. Our cash flows may be insufficient to meet expenses relating to our operations and the development of our
business, and may be insufficient to allow us to develop new products. We currently conduct research and development using our proprietary platform technologies
to develop oral controlled release and other delivery products. We do not know whether we will be successful in the development of such products. We have an
accumulated deficit of approximately $30,896 thousand since our inception in 2003 through December 31, 2018. To date, these losses have been financed
principally through sales of equity securities. Our revenues for the past five years ended December 31, 2018, December 31, 2017, December 31, 2016, December
31, 2015 and December 31, 2014 were $1.8 million, $5.2 million, $5.2 million, $5.1 million and $1.7 million thousand, respectively. Revenue generated to date has
not been sufficient to sustain our operations. In order to achieve profitability, our revenue streams will have to increase and there is no assurance that revenues will
increase to such a level.
We
may
incur
losses
associated
with
foreign
currency
fluctuations.
The majority of our expenses are paid in Canadian dollars, while a significant portion of our revenues are in U.S. dollars. Our financial results are subject to the
impact of currency exchange rate fluctuations. Adverse movements in exchange rates could have a material adverse effect on our financial condition and results of
operations.
We
may
need
additional
capital
to
fulfill
our
business
strategies.
We
may
also
incur
unforeseen
costs.
Failure
to
obtain
such
capital
would
adversely
affect
our
business.
We will need to expend significant capital in order to continue with our research and development and manufacturing operation expansion by hiring additional
research staff and acquiring additional equipment. If our cash flows from operations are insufficient to fund our expected capital needs, or our needs are greater
than anticipated, we may be required to raise additional funds in the future through private or public sales of equity securities or the incurrence of indebtedness.
Additional funding may not be available on favorable terms, or at all. If we borrow additional funds, we likely will be obligated to make periodic interest or other
debt service payments and may be subject to additional restrictive covenants. If we fail to obtain sufficient additional capital in the future, we could be forced to
curtail our growth strategy by reducing or delaying capital expenditures, selling assets or downsizing or restructuring our operations. If we raise additional funds
through public or private sales of equity securities, the sales may be at prices below the market price of our stock and our shareholders may suffer significant
dilution.
The
loss
of
the
services
of
key
personnel
would
adversely
affect
our
business.
21
Our future success depends to a significant degree on the skills, experience and efforts of our executive officers and senior management staff. The loss of the
services of existing personnel would be detrimental to our research and development programs and to our overall business.
We
are
dependent
on
business
partners
to
conduct
clinical
trials
of,
obtain
regulatory
approvals
for,
and
manufacture,
market,
and
sell
our
products.
We depend heavily on our pharmaceutical partners to pay for part or all of the research and development expenses associated with developing a new product and to
obtain approval from regulatory bodies such as the FDA to commercialize these products. We also depend on our partners to distribute these products after
receiving regulatory approval. Our revenues from research and development fees, milestone payments and royalty fees are derived from our partners. Our inability
to find pharmaceutical partners who are willing to pay us these fees in order to develop new products would negatively impact our business and our cash flows.
We have limited experience in manufacturing, marketing and selling pharmaceutical products. Accordingly, if we cannot maintain our existing partnerships or
establish new partnerships with respect to our other products in development, we will have to establish our own capabilities or discontinue the commercialization of
the affected product. Developing our own capabilities would be expensive and time consuming and could delay the commercialization of the affected product.
There can be no assurance that we would be able to develop these capabilities.
Our existing agreements with pharmaceutical industry partners are generally subject to termination by the counterparty on short notice upon the occurrence of
certain circumstances, including, but not limited to, the following: a determination that the product in development is not likely to be successfully developed or not
likely to receive regulatory approval; our failure to satisfy our obligations under the agreement, or the occurrence of a bankruptcy event. If any of our partnerships
are terminated, we may be required to devote additional resources to the product, seek a new partner on short notice, or abandon the product development efforts.
The terms of any additional partnerships or other arrangements that we establish may not be favorable to us.
We are also at risk that these partnerships or other arrangements may not be successful. Factors that may affect the success of our partnerships include the
following:
Our partners may incur financial and cash-flow difficulties that force them to limit or reduce their participation in our joint projects;
Our partners may be pursuing alternative technologies or developing alternative products that are competitive to our product, either on their own or in
partnership with others;
Our partners may reduce marketing or sales efforts, or discontinue marketing or sales of our products, which may reduce our revenues received on the
products;
Our partners may have difficulty obtaining the raw materials to manufacture our products in a timely and cost effective manner or experience delays in
production, which could affect the sales of our products and our royalty revenues earned;
Our partners may terminate their partnerships with us. This could make it difficult for us to attract new partners, and it could adversely affect how the
business and financial communities perceive us;
Our partners may pursue higher priority programs or change the focus of their development programs, which could affect the partner’s commitment to us.
Pharmaceutical and biotechnology companies historically have re-evaluated their priorities from time to time, including following mergers and
consolidations, a common occurrence in recent years; and
Our partners may become the target of litigation for purported patent or intellectual property infringement, which could delay or prohibit commercialization
of our products and which would reduce our revenue from such products.
We
face
competition
in
our
industry,
and
several
of
our
competitors
have
substantially
greater
experience
and
resources
than
we
do.
We compete with other companies within the drug delivery industry, many of which have more capital, more extensive research and development capabilities and
greater human resources than we do. Some of these drug delivery competitors include Aquestive Therapeutics Inc (formerly Monosol Rx), Tesa-Labtec GmbH,
BioDelivery Sciences International, Inc. and LTS Lohmann Therapy Systems Corp. Our competitors may develop new or enhanced products or processes that may
be more effective, less expensive, safer or more readily available than any products or processes that we develop, or they may develop proprietary positions that
prevent us from being able to successfully commercialize new products or processes that we develop. As a result, our products or processes may not compete
successfully, and research and development by others may render our products or processes obsolete or uneconomical. Competition may increase as technological
advances are made and commercial applications broaden.
22
There
is
no
assurance
that
the
sale
of
cannabis
edible
products
will
be
permitted
in
Canada.
Although the Government of Canada has approved the Cannabis Act which is expected to allow for regulated and restricted access to cannabis for recreational use
in Canada as of October 17, 2018, cannabis edible products are not currently on the list of products permitted for legal sale in Canada under the Cannabis Act and
there is no assurance that they will be in the future.
We
rely
upon
third-party
manufacturers,
which
puts
us
at
risk
for
supplier
business
interruptions.
In certain instances, we may have to enter into agreements with third party manufacturers to manufacture certain of our products once we complete development
and after we receive regulatory approval. If our third-party manufacturers fail to perform, our ability to market products and to generate revenue would be
adversely affected. Our failure to deliver products in a timely manner could lead to the dissatisfaction of our distribution partners and damage our reputation,
causing our distribution partners to cancel existing agreements with us and to stop doing business with us.
Any third-party manufacturers that we depend on to manufacture our products are required to adhere to FDA regulations regarding cGMP, which include testing,
control and documentation requirements. Ongoing compliance with cGMP and other regulatory requirements is monitored by periodic inspection by the FDA and
comparable agencies in other countries. Failure by our third-party manufacturers to comply with cGMP and other regulatory requirements could result in actions
against them by regulatory agencies and jeopardize our ability to obtain products on a timely basis.
We
have
established
our
own
manufacturing
facility
for
the
future
manufacture
of
VersaFilm™
products,
which
required
considerable
financial
investment.
If
we
are
unsuccessful
to
manufacture
our
VersaFilm™
products
adequately
and
at
an
acceptable
cost,
this
could
have
a
material
adverse
effect
on
our
business,
financial
condition
or
results
of
operations.
We currently manufacture products only for clinical and testing purposes in our own facility and we do not yet manufacture products for commercial use. In order
to establish ourselves as a full-service partner for our thin film products, we invested approximately $6.5 million to establish a state-of-the-art manufacturing
facility for the commercial manufacture of products developed using our VersaFilm™ drug delivery technology. We recently received our Drug Establishment
License from Health Canada indicating cGMP compliance for manufacturing and packaging activities and anticipate the manufacturing of our products to
commence in the second half of 2019.
With our current manufacturing equipment, we are only able to manufacture products that do not contain flammable organic solvents. Since several of our film
products are solvent-based, we are in the process of acquiring manufacturing equipment that is capable of handling organic solvents, and we are expanding our
manufacturing facility in order to create the space required for this new manufacturing equipment.
We have limited expertise in establishing and operating a manufacturing facility and although we have contracted with architects, engineers and construction
contractors specialized in the planning and construction of pharmaceutical facilities, there can be no guarantee that the project can be completed within the time or
budget allocated. In addition, we may be unable to attract suitably qualified personnel for our manufacturing facility at acceptable terms and conditions of
employment.
In addition, before we can begin commercial manufacture of our VersaFilm™ products for sale in the United States, we must obtain FDA regulatory approval for
the product, which requires a successful inspection of our manufacturing facilities, processes and quality systems. Further, pharmaceutical manufacturing facilities
are continuously subject to inspection by the FDA and other health authorities before and after product approval. Due to the complexity of the processes used to
manufacture our VersaFilm™ products, we may be unable initially or at any future time to pass federal, state or international regulatory inspections in a cost
effective manner. If we are unable to comply with manufacturing regulations, we may be subject to fines, unanticipated compliance expenses, recall or seizure of
any approved products, total or partial suspension of production and/or enforcement actions, including injunctions, and criminal or civil prosecution.
The manufacture of our products is heavily regulated by governmental health authorities, including the FDA. We must ensure that all manufacturing processes
comply with current cGMP and other applicable regulations. If we fail to comply fully with these requirements and the health authorities’ expectations, then we
could be required to shut down our production facilities or production lines, or could be prevented from importing our products from one country to another. This
could lead to product shortages, or to our being entirely unable to supply products to patients for an extended period of time. Such shortages or shut downs could
lead to significant losses of sales revenue and to potential third-party litigation. In addition, health authorities have in some cases imposed significant penalties for
such failures to comply with cGMP. A failure to comply fully with cGMP could also lead to a delay in the approval of new products to be manufactured at our
manufacturing facility.
23
Any disruption in the supply of our future products could have a material adverse effect on our business, financial condition or results of operations.
We
have
no
timely
ability
to
replace
our
future
VersaFilm™
manufacturing
capabilities.
If our manufacturing facility suffers any type of prolonged interruption, whether caused by regulator action, equipment failure, critical facility services, fire, natural
disaster or any other event that causes the cessation of manufacturing activities, we would be exposed to long-term loss of sales and profits. There are no facilities
capable of contract manufacturing our VersaFilm™ products at short notice. If we suffer an interruption to our manufacturing of VersaFilm™ products, we may
have to find a contract manufacturer capable of supplying our needs, although this would require completing a Manufacturing Site Change process, which takes
considerable time and is costly. Replacement of our manufacturing capabilities will have a material adverse effect on our business and financial condition or results
of operations.
We
depend
on
a
limited
number
of
suppliers
for
API.
Generally,
only
a
single
source
of
API
is
qualified
for
use
in
each
product
due
to
the
costs
and
time
required
to
validate
a
second
source
of
supply.
Changes
in
API
suppliers
must
usually
be
approved
through
a
Prior
Approval
Supplement
by
the
FDA.
Our ability to manufacture products is dependent, in part, upon ingredients and components supplied by others, including international suppliers. Any disruption in
the supply of these ingredients or components or any problems in their quality could materially affect our ability to manufacture our products and could result in
legal liabilities that could materially affect our ability to realize profits or otherwise harm our business, financial, and operating results. As the API typically
comprises the majority of a product’s manufactured cost, and qualifying an alternative is costly and time-consuming, API suppliers must be selected carefully
based on quality, reliability of supply and long-term financial stability.
We
are
subject
to
extensive
government
regulation
including
the
requirement
of
approval
before
our
products
may
be
marketed.
Even
if
we
obtain
marketing
approval,
our
products
will
be
subject
to
ongoing
regulatory
review.
We, our partners, our products, and our product candidates are subject to extensive regulation by governmental authorities in the United States and other countries.
Failure to comply with applicable requirements could result in warning letters, fines and other civil penalties, delays in approving or refusal to approve a product
candidate, product recall or seizure, withdrawal of product approvals, interruption of manufacturing or clinical trials, operating restrictions, injunctions, and
criminal prosecution.
Our products cannot be marketed in the United States without FDA approval. Obtaining FDA approval requires substantial time, effort, and financial resources, and
there can be no assurance that any approval will be granted on a timely basis, if at all. With most of our products, we rely on our partners for the preparation of
applications and for obtaining regulatory approvals. If the FDA does not approve our product candidates in a timely fashion, or does not approve them at all, our
business and financial condition may be adversely affected. Further, the terms of approval of any marketing application, including the labeling content, may be
more restrictive than we desire and could affect the marketability of our or our partner`s products. Subsequent discovery of problems with an approved product may
result in restrictions on the product or its withdrawal from the market. In addition, both before and after regulatory approval, we, our partners, our products, and our
product candidates are subject to numerous FDA requirements regarding testing, manufacturing, quality control, cGMP, adverse event reporting, labeling,
advertising, promotion, distribution, and export. Our partners and we are subject to surveillance and periodic inspections to ascertain compliance with these
regulations. Further, the relevant law and regulations may change in ways that could affect us, our partners, our products, and our product candidates. Failure to
comply with regulatory requirements could have a material adverse impact on our business.
Regulations regarding the manufacture and sale of our future products are subject to change. We cannot predict what impact, if any, such changes may have on our
business, financial condition or results of operations. Failure to comply with applicable regulatory requirements could have a material adverse effect on our
business, financial condition and results of operations.
Additionally, the time required for obtaining regulatory approval is uncertain. We may encounter delays or product rejections based upon changes in FDA policies,
including cGMP, during periods of product development. We may encounter similar delays in countries outside of the United States. We may not be able to obtain
these regulatory acceptances on a timely basis, or at all.
24
The failure to obtain timely regulatory acceptance of our products, any product marketing limitations, or any product withdrawals would have a material adverse
effect on our business, financial condition and results of operations. In addition, before it grants approvals, the FDA or any foreign regulatory authority may impose
numerous other requirements with which we must comply. Regulatory acceptance, if granted, may include significant limitations on the indicated uses for which
the product may be marketed. FDA enforcement policy strictly prohibits the marketing of accepted products for unapproved uses. Product acceptance could be
withdrawn or civil and/or criminal sanctions could be imposed for our failure to comply with regulatory standards or the occurrence of unforeseen problems
following initial marketing.
We
may
not
be
able
to
expand
or
enhance
our
existing
product
lines
with
new
products
limiting
our
ability
to
grow.
If we are not successful in the development and introduction of new products, our ability to grow will be impeded. We may not be able to identify products to
enhance or expand our product lines. Even if we can identify potential products, our investment in research and development might be significant before we can
bring the products to market. Moreover, even if we identify a potential product and expend significant dollars on development, we may never be able to bring the
product to market or achieve market acceptance for such product. As a result, we may never recover our expenses.
The
market
may
not
be
receptive
to
products
incorporating
our
drug
delivery
technologies.
The commercial success of any of our products that are approved for marketing by the FDA and other regulatory authorities will depend upon their acceptance by
the medical community and third party payers as clinically useful, cost-effective and safe. To date, only two products based upon our technologies have been
marketed in the United States, which limits our ability to provide guidance or assurance as to market acceptance.
Factors that we believe could materially affect market acceptance of these products include:
The timing of the receipt of marketing approvals and the countries in which such approvals are obtained;
The safety and efficacy of the product as compared to competitive products;
The relative convenience and ease of administration as compared to competitive products;
The strength of marketing distribution support; and
The cost-effectiveness of the product and the ability to receive third party reimbursement.
We
are
subject
to
environmental
regulations,
and
any
failure
to
comply
may
result
in
substantial
fines
and
sanctions.
Our operations are subject to Canadian and international environmental laws and regulations governing, among other things, emissions to air, discharges to waters
and the generation, handling, storage, transportation, treatment and disposal of raw materials, waste and other materials. Many of these laws and regulations
provide for substantial fines and criminal sanctions for violations. We believe that we are and have been operating our business and facility in a manner that
complies in all material respects with environmental, health and safety laws and regulations; however, we may incur material costs or liabilities if we fail to operate
in full compliance. We do not maintain environmental damage insurance coverage with respect to the products which we manufacture.
The decision to establish commercial film manufacturing capability may require us to make significant expenditures in the future to comply with evolving
environmental, health and safety requirements, including new requirements that may be adopted or imposed in the future. To meet changing licensing and
regulatory standards, we may have to make significant additional site or operational modifications that could involve substantial expenditures or reduction or
suspension of some of our operations. We cannot be certain that we have identified all environmental and health and safety matters affecting our activities and in
the future our environmental, health and safety problems, and the costs to remediate them, may be materially greater than we expect.
Risks
Related
to
Our
Intellectual
Property
If
we
are
not
able
to
adequately
protect
our
intellectual
property,
we
may
not
be
able
to
compete
effectively.
Our success depends, to a significant degree, upon the protection of our proprietary technologies. While we currently own 13 patents and have an additional 41
published pending patent applications in several jurisdictions, we will need to pursue additional protection for our intellectual property as we develop new products
and enhance existing products. We may not be able to obtain appropriate protection for our intellectual property in a timely manner, or at all. Our inability to obtain
appropriate protections for our intellectual property may allow competitors to enter our markets and produce or sell the same or similar products.
25
If we are forced to resort to legal proceedings to enforce our intellectual property rights, the proceedings could be burdensome and expensive. In addition, our
proprietary rights could be at risk if we are unsuccessful in, or cannot afford to pursue, those proceedings.
We also rely on trade secrets and contract law to protect some of our proprietary technology. We have entered into confidentiality and invention agreements with
our employees and consultants. Nevertheless, these agreements may not be honored and they may not effectively protect our right to our un-patented trade secrets
and know-how. Moreover, others may independently develop substantially equivalent proprietary information and techniques or otherwise gain access to our trade
secrets and know-how.
We may need to obtain licenses to patents or other proprietary rights from third parties. We may not be able to obtain the licenses required under any patents or
proprietary rights or they may not be available on acceptable terms. If we do not obtain required licenses, we may encounter delays in product development or find
that the development, manufacture or sale of products requiring licenses could be foreclosed. We may, from time to time, support and collaborate in research
conducted by universities and governmental research organizations. We may not be able to acquire exclusive rights to the inventions or technical information
derived from these collaborations, and disputes may arise over rights in derivative or related research programs conducted by us or our partners.
If
we
infringe
on
the
rights
of
third
parties,
we
may
not
be
able
to
sell
our
products,
and
we
may
have
to
defend
against
litigation
and
pay
damages.
If a competitor were to assert that our products infringe on its patent or other intellectual property rights, we could incur substantial litigation costs and be forced to
pay substantial damages. Such litigation costs could be as a result of direct litigation against us, or as a result of litigation against one or more of our partners to
whom we have contractually agreed to indemnify in the event that our intellectual property is the cause of a successful litigious action against our partner. Third-
party infringement claims, regardless of their outcome, would not only consume significant financial resources, but would also divert our management’s time and
attention. Such claims could also cause our customers or potential customers to purchase competitors’ products or defer or limit their purchase or use of our
affected products until resolution of the claim. If any of our products are found to violate third-party intellectual property rights, we may have to re-engineer one or
more of our products, or we may have to obtain licenses from third parties to continue offering our products without substantial re-engineering. Our efforts to re-
engineer or obtain licenses could require significant expenditures and may not be successful.
Our
controlled
release
products
that
are
generic
versions
of
branded
controlled
release
products
that
are
covered
by
one
or
more
patents
may
be
subject
to
litigation,
which
could
delay
FDA
approval
and
commercial
launch
of
our
products.
We expect to file or have our partners file NDAs or ANDAs for our controlled release products under development that are covered by one or more patents of the
branded product. It is likely that the owners of the patents covering the brand name product or the sponsors of the NDA with respect to the branded product will sue
or undertake regulatory initiatives to preserve marketing exclusivity. Any significant delay in obtaining FDA approval to market our products as a result of
litigation, as well as the expense of such litigation, whether or not we or our partners are successful, could have a materially adverse effect on our business,
financial condition and results of operations.
Risks
Related
to
Our
Securities:
The
price
of
our
Common
Stock
could
be
subject
to
significant
fluctuations.
Any of the following factors could affect the market price of our Common Stock:
Our failure to achieve and maintain profitability;
Changes in earnings estimates and recommendations by financial analysts;
Actual or anticipated variations in our quarterly results of operations;
Changes in market valuations of similar companies;
Announcements by us or our competitors of significant contracts, new products, acquisitions, commercial relationships, joint ventures or capital
commitments;
26
The loss of major customers or product or component suppliers;
The loss of significant partnering relationships; and
General market, political and economic conditions.
We have a significant number of convertible securities outstanding that could be exercised in the future. Subsequent resale of these and other shares could cause
our stock price to decline. This could also make it more difficult to raise funds at acceptable levels pursuant to future securities offerings.
Our
Common
Stock
is
a
high
risk
investment.
Our Common Stock was quoted on the OTC Bulletin Board under the symbol “IGXT” from January 2007 until June 2012 and, subsequent to our upgrade in June
2012, has been quoted on the OTCQX. Our Common Stock has also been listed on the TSX Venture Exchange under the symbol “IGX” since May 2008.
There is a limited trading market for our Common Stock, which may affect the ability of shareholders to sell our Common Stock and the prices at which they may
be able to sell our Common Stock.
The market price of our Common Stock has been volatile and fluctuates widely in response to various factors which are beyond our control. The price of our
Common Stock is not necessarily indicative of our operating performance or long term business prospects. In addition, the securities markets have from time to
time experienced significant price and volume fluctuations that are unrelated to the operating performance of particular companies. These market fluctuations may
also materially and adversely affect the market price of our Common Stock.
As a result of the foregoing, our Common Stock should be considered a high risk investment.
The
application
of
the
“penny
stock”
rules
to
our
Common
Stock
could
limit
the
trading
and
liquidity
of
our
Common
Stock,
adversely
affect
the
market
price
of
our
Common
Stock
and
increase
stockholder
transaction
costs
to
sell
those
shares.
As long as the trading price of our Common Stock is below $5.00 per share, the open market trading of our Common Stock will be subject to the “penny stock”
rules, unless we otherwise qualify for an exemption from the “penny stock” definition. The “penny stock” rules impose additional sales practice requirements on
certain broker-dealers who sell securities to persons other than established customers and accredited investors (generally those with assets in excess of $1,000,000
or annual income exceeding $200,000 or $300,000 together with their spouse). These regulations, if they apply, require the delivery, prior to any transaction
involving a penny stock, of a disclosure schedule explaining the penny stock market and the associated risks. Under these regulations, certain brokers who
recommend such securities to persons other than established customers or certain accredited investors must make a special written suitability determination
regarding such a purchaser and receive such purchaser’s written agreement to a transaction prior to sale. These regulations may have the effect of limiting the
trading activity of our Common Stock, reducing the liquidity of an investment in our Common Stock and increasing the transaction costs for sales and purchases of
our Common Stock as compared to other securities.
We
became
public
by
means
of
a
reverse
merger,
and
as
a
result
we
are
subject
to
the
risks
associated
with
the
prior
activities
of
the
public
company
with
which
we
merged.
Additional risks may exist because we became public through a “reverse merger” with a shell corporation. Although the shell did not have any operations or assets
and we performed a due diligence review of the public company, there can be no assurance that we will not be exposed to undisclosed liabilities resulting from the
prior operations of our company.
Our
limited
cash
resources
restrict
our
ability
to
pay
cash
dividends.
Since our inception, we have not paid any cash dividends on our Common Stock. We currently intend to retain future earnings, if any, to support operations and to
finance the growth and development of our business. Therefore, we do not expect to pay cash dividends in the foreseeable future. Any future determination relating
to our dividend policy will be made at the discretion of our Board of Directors and will depend on a number of factors, including future earnings, capital
requirements, financial conditions and future prospect and other factors that the Board of Directors may deem relevant. If we do not pay any dividends on our
Common Stock, our shareholders will be able to profit from an investment only if the price of the stock appreciates before the shareholder sells it. Investors seeking
cash dividends should not purchase our Common Stock.
27
If
we
are
the
subject
of
securities
analyst
reports
or
if
any
securities
analyst
downgrades
our
Common
Stock
or
our
sector,
the
price
of
our
Common
Stock
could
be
negatively
affected.
Securities analysts may publish reports about us or our industry containing information about us that may affect the trading price of our Common Stock. In
addition, if a securities or industry analyst downgrades the outlook for our stock or one of our competitors’ stocks, the trading price of our Common Stock may also
be negatively affected.
There
is
no
public
market
for
the
Company’s
warrants,
which
could
limit
their
respective
trading
price
or
a
holder’s
ability
to
sell
them.
There is currently no trading market for the Company’s warrants. As a result, a market may not develop for the Company’s warrants and holders may not be able to
sell the Company’s warrants. Future trading prices of the Company’s warrants will depend on many factors, including prevailing interest rates, the market for
similar securities, general economic conditions and our financial condition, performance and prospects. Accordingly, holders may be required to bear the financial
risk of an investment in the Company’s warrants for an indefinite period of time until their maturity. We do not intend to apply for listing or quotation of the
Company’s warrants on any securities exchange or automated quotation system.
Risks
related
to
our
outstanding
unsecured
convertible
debentures.
Issuance
of
shares
of
our
Common
Stock
upon
conversion
of
convertible
debentures
will
dilute
the
ownership
interest
of
our
existing
stockholders
and
could
adversely
affect
the
market
price
of
our
Common
Stock.
Conversions of the 8% Convertible Unsecured Subordinated Debentures due June 30, 2020 (the “Debentures”) or the 6% Subordinate Convertible Unsecured
Promissory Notes (the “Notes”) would reduce a shareholder’s percentage voting and ownership interest. The conversion, or potential conversion, of the Debentures
or Notes could adversely affect the market price of our Common Stock and the terms on which we could obtain additional financing. In addition, our shareholders
may experience further dilution upon our election to repay the Debentures or the interest payable thereon in, or convert the Notes to, shares of Common Stock.
Our
failure
to
avoid
events
of
default
as
defined
in
the
Debentures
and
Notes
could
require
us
to
redeem
such
Debentures
or
Notes
at
a
loss.
The Debentures provide that, upon the occurrence of an “Event of Default,” the Debentures may become immediately due and payable. Events of Default under the
Debentures include, among other things the occurrence and continuation of any one or more of the following events with respect to the Debentures: (a) failure for
30 days to pay interest on the Debentures when due; (b) failure to pay principal or premium, if any, when due on the Debentures, whether at maturity, upon
redemption, by declaration or otherwise; (c) certain events of bankruptcy, insolvency or reorganization of the Company under bankruptcy or insolvency laws; or (d)
default in the observance or performance of any material covenant or condition of the trust indenture dated July 12, 2017, between the Company and TSX Trust
Company (the “Debenture Trustee”), as trustee, and continuance of such default for a period of 30 days after notice in writing has been given by the Debenture
Trustee to the Company specifying such default and requiring the Company to rectify the same. In addition, upon an Event of Default, the Debentures become,
upon receipt of a request in writing signed by the holders of not less than 25% in principal amount of the Debentures then outstanding, immediately due and
payable.
The Notes provide that, upon the occurrence of an “Event of Default,” the Notes may become immediately due and payable. Events of Default under the Notes
include, the occurrence of any of the following events with respect to the Notes: (a) failure for 10 business days to pay any of the principal amount or interest on the
Notes when due; (b) voluntary or involuntary bankruptcy or insolvency proceedings; or (c) the Company breaches any representation or covenant in the Note that
could reasonably be expected to have a material adverse effect and such breach is not cured within 30 days after the notice thereof. Upon an Event of Default for
non-payment, voluntary bankruptcy or insolvency or involuntary bankruptcy or insolvency, the Notes become immediately due and payable with the written
consent of the holders of a majority in interest of investors. Upon an Event of Default for a Company breach of a representation or covenant, all outstanding Notes
automatically become immediately due and payable.
Our ability to avoid such Events of Default under both the Debentures and Notes may be affected by changes in our business condition or results of our operations,
or other events beyond our control. If we were to experience an Event of Default and the holders of Debentures elected to have us redeem their Debentures or the
Notes became immediately due and payable, we may not have sufficient resources to do so, and we may have to seek additional debt or equity financing to cover
the costs of redeeming the Debentures or paying the Notes. Any additional debt or equity financing that we may need may not be available on terms favorable to us,
or at all. Furthermore, to the extent that additional capital is raised through the sale of equity or convertible debt securities, the issuance of these securities could
result in further dilution to our shareholders.
28
ITEM
1B.
UNRESOLVED
STAFF
COMMENTS
Not applicable.
ITEM
2.
PROPERTIES
On April 24, 2015, we entered into an agreement to lease approximately 17,000 square feet in a property located at 6420 Abrams, St-Laurent, Quebec. The lease
has a 10 year and 6-month term which commenced on September 1, 2015 and we have retained two options to extend the lease, with each option being for an
additional five years. Under the terms of the lease we will be required to pay base rent of approximately CA$110 thousand (approximately $84 thousand) per year,
which will increase at a rate of CA$0.25 ($0.19) per square foot, every two years. Approximately 9,500 square feet of the new facility is being used to establish
manufacturing capabilities for our VersaFilm™ thin film products, approximately 4,000 square feet for our R&D activities, and approximately 3,500 square feet for
administration.
On March 6, 2017 IntelGenx executed an agreement to lease approximately an additional 11,000 square feet in a property located at 6410 Abrams, St-Laurent,
Quebec (the “Lease”). The Lease has an 8 year and 5-month term commencing on October 1, 2017 and IntelGenx has retained two options to extend the Lease,
with each option being for an additional five years. Under the terms of the Lease IntelGenx will be required to pay base rent of approximately CA$74 thousand
(approximately $54 thousand) per year, which will increase at a rate of CA$0.25 ($0.18) per square foot, every two years. IntelGenx plans to use the newly leased
space to expand its manufacture of oral film VersaFilm TM.
ITEM
3.
LEGAL
PROCEEDINGS
On March 1, 2019, a complaint for patent infringement was filed in United States District Court for the District of Delaware against Chemo Research, S.L., Insud
Pharma S.L., IntelGenx Corp., and IntelGenx Technologies Corp. (collectively, “Defendants”) from BioDelivery Sciences International, Inc., and Arius Two, Inc.,
(collectively, “Plaintiffs”) asserting that the Defendants infringe BioDelivery Sciences International, Inc. Orange Book listed patents for BELBUCA, including U.S.
Patent Nos. 8,147,866 and 9,655,843, both expiring in July of 2027, and U.S. Patent No. 9,901,539 expiring December of 2032. This complaint follows the receipt
by BioDelivery Sciences International, Inc. of a Notice Letter by Chemo Research S.L. on January 31, 2019, stating that it has filed with the FDA an ANDA
containing a Paragraph IV Patent Certification, for a generic version of BELBUA Buccal Film in strengths 75 mcg, 150 mcg, 300 mcg, 450 mcg, and 900 mcg.
Because Plaintiffs initiated a patent infringement suit to defend the patents identified in the Notice Letter within 45 days after receipt, the FDA is prevented from
approving the ANDA until the earlier of 30 months or a decision in the case that each of the patents is not infringed or invalid. The same complaint for patent
infringement was also filed in the United States District Court for the District of New Jersey on March 15, 2019.
We believe that we will be able to prevail in this lawsuit.
ITEM
4.
MINE
SAFETY
DISCLOSURES
Not applicable.
PART
II
ITEM
5.
MARKET
FOR
REGISTRANT’S
COMMON
EQUITY,
RELATED
STOCKHOLDER
MATTERS
AND
ISSUER
PURCHASES
OF
EQUITY
SECURITIES
Our Common Stock has been quoted on the OTCQX under the symbol “IGXT” since June 2012. Our Common Stock has also been listed on the TSX Venture
Exchange under the symbol “IGX” since May 2008.
On March 22, 2019, there were approximately 49 holders of record of our Common Stock, one of which was Cede & Co., a nominee for Depository Trust
Company, and one of which was The Canadian Depository for Securities Limited, or CDS. All of our Common Stock held by brokerage firms, banks and other
financial institutions in the United States and Canada as nominees for beneficial owners are considered to be held of record by Cede & Co. in respect of brokerage
firms, banks and other financial institutions in the United States, and by CDS in respect of brokerage firms, banks and other financial institutions located in Canada.
Cede & Co. and CDS are each considered to be one shareholder of record.
Dividend
Policy
We have never declared or paid any cash dividends on our Common Stock. We currently intend to retain any earnings to support operations and to finance the
growth and development of our business. Therefore, we do not expect to pay cash dividends in the foreseeable future. Any future determination relating to our
dividend policy will be made at the discretion of our Board of Directors and will depend on a number of factors, including future earnings, capital requirements,
financial conditions and future prospect and other factors that the board of directors may deem relevant.
Purchases
of
Equity
Securities
by
the
Issuer
and
Affiliated
Purchasers
During the fourth quarter of 2018, there were no purchases or repurchases of our equity securities by us or any affiliated purchasers.
Unregistered
Sales
of
Equity
Securities
and
Use
of
Proceeds
29
During fiscal 2018, we did not sell equity securities without registration under the Securities Act of 1933, as amended, except as disclosed on a Current Report on
Form 8-K.
Equity
Compensation
Plan
Information
Number of Securities to be
issued upon exercise of
outstanding options,
warrants and rights
Weighted-average
exercise price of
outstanding options,
warrants and rights (2)
(a)
1,253,846 (1)
3,004,818 (3)
4,204,818
(b)
$0.54
$0.75
$0.69
Number of securities remaining
available for future issuance
under equity compensation plans
(excluding securities reflected in
column (a))
(c)
946,154 (3)
3,485,358 (4)
4,431,512 (4)
Equity Compensation Plans Approved
by Security Holders
Equity Compensation Plans Not
Approved by Security Holders
Total
(1)
(2)
(3)
(4)
Includes shares of our Common Stock issuable pursuant to options granted under the 2006 Stock Option Plan and RSUs awarded under our PRSU Plan.
The weighted average exercise price excludes RSU awards, which have no exercise price.
On May 9, 2016, the Board of Directors of the Company adopted the 2016 Stock Option Plan which amended and restated the 2006 Stock Option Plan,
which expired in August 2016. As a result of the adoption of the 2016 Stock Option Plan, no additional options will be granted under the 2006 Stock
Option Plan and all previously granted options will be governed by the 2016 Stock Option Plan. Due to the nature of the changes made to the 2006 Stock
Option Plan it was determined that no stockholder approvals were required by the TSX Venture Exchange. The number represents only securities available
under the PRSU Plan.
Represents the maximum number of shares of our Common Stock available for grants under the 2016 Stock Option Plan as of December 31, 2018.
The 2016 Stock Option Plan was adopted by the Board in order to make the terms of the Company’s stock option plan more consistent with the requirements of the
TSX Venture Exchange and to remove certain provisions which would have enabled the Company to grant incentive stock options in compliance with Section 422
of the Internal Revenue Code. The 2016 Stock Option Plan permits the granting of options to officers, employees, directors and eligible consultants of the
Company. A total of 6,361,525 shares of Common Stock were reserved for issuance under this plan, which includes stock options granted under the previous 2006
Stock Option Plan. In August 2018, the Board approved the amendment of the 2016 Stock Option Plan to increase the total number of shares of Common Stock
reserved under the plan to 9,347,747. Options may be granted under the 2016 Stock Option Plan on terms and at prices as determined by the Board except that the
options cannot be granted at less than the market closing price of the Common Stock on the TSX Venture Exchange on the date prior to the grant.. Each option will
be exercisable after the period or periods specified in the option agreement, but no option may be exercised after the expiration of 10 years from the date of grant.
The 2016 Stock Option Plan provides the Board with more flexibility when setting the vesting schedule for options which was otherwise fixed in the 2006 Stock
Option Plan.
The PRSU Plan was approved by Shareholders at the 2018 annual meeting on May 7, 2018. The primary purpose of this PRSU Plan is to provide the Company
with a share-related mechanism to attract, retain and motivate qualified executive officers of the Company and its Subsidiaries and to reward such executive
officers for their contributions toward the long term goals and success of the Company and to enable and encourage such executive officers to acquire shares of
Common Stock as long term investments and proprietary interests in the Company.
The PRSU Plan permits the Board to grant RSU awards to employees, consultants or directors of the Company and PSU awards to employees and consultants of
the Company. In each case, the award of RSUs or PSUs are subject to restrictions in connection with the termination of employment, engagement or term in office.
The Board may, in its sole discretion, grant the majority of the awards to insiders of the Company. The number of shares of Common Stock reserved for issuance
under this plan is equal to a number that: (a) does not exceed 1,000,000 shares if, and for so long as the Company is listed on the TSX Venture Exchange, or (b)
2.5% of the issued and outstanding Common Stock of the Company, if the Company is listed on the Toronto Stock Exchange. The Board has the authority to
condition the grant of RSUs or PSUs upon the attainment of specified performance goals, or such other factors (which may vary between awards) as the Board
determines in its sole discretion. The Board has the authority to determine at the time of grant, in its sole discretion, the duration of the vesting period and other
vesting terms applicable to the grant of RSUs or PSUs. In the case of PSUs, such awards may be adjusted in accordance with the applicable PSU award agreement.
30
On a going forward basis, the Company intends to primarily compensate executive officers with RSUs and compensate non-executive employees with stock
options.
ITEM
6.
SELECTED
FINANCIAL
DATA
Not applicable.
ITEM
7.
MANAGEMENT’S
DISCUSSION
AND
ANALYSIS
OF
FINANCIAL
CONDITIONS
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 our business, to enhance our overall financial disclosure, to provide the context within which our
financial information may be analyzed, and to provide information about the quality of, and potential variability of, our financial condition, results of operations
and cash flows. Unless otherwise indicated, all financial and statistical information included herein relates to our continuing operations. 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 audited 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.
More recently, we have made the strategic decision to enter the oral film market and have implemented commercial oral film manufacturing capability. This
enables us to offer our partners a comprehensive portfolio of pharmaceutical services, including pharmaceutical R&D, clinical monitoring, regulatory support, tech
transfer and manufacturing scale-up, and commercial manufacturing.
Our business strategy is to develop pharmaceutical products based on our proprietary drug delivery technologies and, once the viability of a product has been
demonstrated, license the commercial rights to partners in the pharmaceutical industry. In certain cases, we rely upon partners in the pharmaceutical industry to
fund the development of the licensed products, complete the regulatory approval process with the FDA or other regulatory agencies relating to the licensed
products, and assume responsibility for marketing and distributing such products.
In addition, we may choose to pursue the development of certain products until the project reaches the marketing and distribution stage. We will assess the potential
for successful development of a product and associated costs, and then determine at which stage it is most prudent to seek a partner, balancing such costs against
the potential for additional returns earned by partnering later in the development process.
Our primary growth strategies are based on three pillars: (1) out licensing commercial rights of our existing pipeline products, (2) partnering on contract
development and manufacturing projects leveraging our VersaFilm™ technology, (3) expanding our current pipeline through:
identifying lifecycle management opportunities for existing market leading pharmaceutical products,
develop oral film products that provide tangible patient benefits,
development of new drug delivery technologies,
repurposing existing drugs for new indications, and
developing generic drugs where high technology barriers to entry exist in reproducing branded films.
contract development and manufacturing based on VersaFilm™ technology
31
We have established a state-of-the-art manufacturing facility for the future manufacture of our VersaFilm™ products. We believe that this (1) represents a
profitable business opportunity, (2) will reduce our dependency upon third-party contract manufacturers, thereby protecting our manufacturing process know-how
and intellectual property, and (3) allows us to offer our development partners a full service from product conception through to supply of the finished product.
With our current manufacturing equipment, we are only able to manufacture products that do not contain flammable organic solvents. Since several of our film
products are solvent-based, we are in the process of acquiring manufacturing equipment that is capable of handling organic solvents, and we are expanding our
manufacturing facility in order to create the space required for this new manufacturing equipment.
Lifecycle Management Opportunities
We are seeking to position our delivery technologies as an opportunity for lifecycle management of products for which patent protection of the active ingredient is
nearing expiration. While the patent for the underlying substance cannot be extended, patent protection can be obtained for a new and improved formulation by
filing an application with the FDA under Section 505(b)(2) of the U.S. Federal Food, Drug and Cosmetic Act. Such applications, known as a “505(b)(2) NDA”, are
permitted for new drug products that incorporate previously approved active ingredients, even if the proposed new drug incorporates an approved active ingredient
in a novel formulation or for a new indication. A 505(b)(2) NDA may include information regarding safety and efficacy of a proposed drug that comes from studies
not conducted by or for the applicant. The first formulation for a respective active ingredient filed with the FDA under a 505(b)(2) application may qualify for up to
three years of market exclusivity upon approval. Based upon a review of past partnerships between third party drug delivery companies and pharmaceutical
companies, management believes that drug delivery companies which possess innovative technologies to develop these special dosage formulations present an
attractive opportunity to pharmaceutical companies. Accordingly, we believe “505(b)(2) products” represent a viable business opportunity for us.
Product Opportunities that provide Tangible Patient Benefits
Our focus will be on developing oral film products leveraging our VersaFilm™ technology that provide tangible patient benefits versus existing drug delivery
forms. Patients with difficulties swallowing medication, pediatrics or geriatrics may benefit from oral films due to the ease of use. Similarly, we are working on
oral films to improve bio-availability and/or response time versus existing drugs and thereby reducing side effects.
Development of New Drug Delivery Technologies
The rapidly disintegrating film technology contained in our VersaFilm™, and our AdVersa® mucosal adhesive tablet, are two examples of our efforts to develop
alternate technology platforms. As we work with various partners on different products, we seek opportunities to develop new proprietary technologies.
Repurposing Existing Drugs
We are working on the repurposing of already approved drugs for new indications using our VersaFilm™ film technology. This program represents a viable growth
strategy for us as it will allow for reduced development costs, improved success rates and shorter approval times. We believe that through our repurposing program
we will be able minimize the risk of developmental failure and create value for us and potential partners.
Generic Drugs with High Barriers to Entry
We plan to pursue the development of generic drugs that have certain barriers to entry, e.g., where product development and manufacturing is complex and can
limit the number of potential entrants into the generic market. We plan to pursue such projects only if the number of potential competitors is deemed relatively
insignificant.
Corporate
On October 18, 2018, IntelGenx announced the pricing of an agency offering of 17,144,314 units for gross proceeds of approximately US$12,000,000 million at a
price of US$0.70 (“Offering Price”) per unit (a “Unit”) (the “Offering”). Each Unit consists of one share of Common Stock and one half of one warrant (a
“Warrant”), each whole Warrant to purchase one share of Common Stock at an exercise price of US$1.00 per share. The Warrants were exercisable immediately
and expire on the third anniversary of the date of their issuance.
32
The Offering was made on a best efforts basis in the United States and the Canadian provinces of British Columbia, Alberta, Manitoba, Ontario and Québec. H.C.
Wainwright & Co. acted as the exclusive agent for the Units offered in the United States. Echelon Wealth Partners Inc. (“Echelon”) acted as the exclusive
placement agent for the Units offered in Canada.
The intended use of the net proceeds of the Offering was expected to be for its 2a Montelukast study, Tadalafil 505(b)(2) submission to the FDA, and working
capital.
On October 22, 2018, IntelGenx announced the closing of 17,144,314 units at a price of US$0.70 for gross proceeds of approximately US$12 million in the United
States and the Canadian provinces of Alberta, British Columbia, Manitoba, Ontario and Quebec.
On October 26, 2018 IntelGenx announced that Echelon, who acted as the Company’s exclusive placement agent in Canada in connection with the Offering, had
exercised its option to place a further 903,610 Units pursuant to its over-allotment option, resulting in additional gross proceeds to the Company of US$632,527.
On November 13, 2018, the Company announced the closing of Tilray Inc.’s strategic investment in IntelGenx by way of a private placement. Pursuant to the
private placement, the Company issued 1,428,571 common shares at a subscription price of $0.70 per common share for gross proceeds of $1 million.
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 fiscal year ended December 31, 2018 report an accumulated other
comprehensive loss due mainly to foreign currency translation adjustments of $1,166 due to the fluctuations in the rates used to prepare our financial statements,
$532 of which negatively impacted our comprehensive loss for the fiscal year ended December 31, 2018. The following Management Discussion and Analysis
takes this into consideration whenever material.
Reconciliation
of
Comprehensive
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 Company’s financial condition and operating results.
IntelGenx obtains its Adjusted EBITDA measurement by adding to comprehensive loss, finance income and costs, depreciation and amortization, income taxes and
foreign currency translation adjustment incurred during the period. IntelGenx also excludes the effects of certain non-monetary transactions recorded, such as
share-based compensation, for its Adjusted EBITDA calculation. The Company believes it is useful to exclude these items as they are either non-cash expenses,
items that cannot be influenced by management in the short term, or items that do not impact core operating performance. Excluding these items does not imply
they are necessarily nonrecurring. Share-based compensation costs are a component of employee and consultant’s remuneration and can vary significantly with
changes in the market price of the Company’s shares. Foreign currency translation adjustments are a component of other comprehensive income and can vary
significantly with currency fluctuations from one period to another. In addition, other items that do not impact core operating performance of the Company may
vary significantly from one period to another. As such, Adjusted EBITDA provides improved continuity with respect to the comparison of the Company’s
operating results over a period of time. Our method for calculating Adjusted EBITDA may differ from that used by other corporations.
33
Reconciliation
of
Non-U.S.-GAAP
Financial
Information
In
U.S.$
thousands
Comprehensive loss
Add
(deduct):
Depreciation
Finance costs
Finance income
Share-based compensation
Other comprehensive loss (income)
Adjusted
EBITDA
Three-month
period
ended
December
31,
Twelve-month
period
ended
December
31,
2018
$
(2,938)
179
300
(11)
59
763
(1,972)
2017
$
(1,065)
210
240
(3)
48
(26)
(596)
2018
$
(10,637)
719
1,121
(11)
370
853
(7,909)
2017
$
(2,669)
735
569
(11)
315
(382)
(1,443)
Adjusted
Earnings
before
Interest,
Taxes,
Depreciation
and
Amortization
(Adjusted
EBITDA)
Adjusted EBITDA decreased by $1,376 for the three-month period ended December 31, 2018 to ($1,972) compared to ($596) for the three-month period ended
December 31, 2017. Adjusted EBITDA decreased by $6,466 for the twelve-month period ended December 31, 2018 to ($7,909) compared to ($1,443) for the
twelve-month period ended December 31, 2017. The decrease in Adjusted EBITDA of $1,376 for the three[ ]month period ended December 31, 2018 is mainly
attributable to a decrease in revenues of $811, an increase in R&D expenses of $1,256 before consideration of stock-based compensation offset by a decrease in
SG&A expenses of $596 before consideration of stock-based compensation. The decrease in Adjusted EBITDA of $6,466 for the twelve-month period ended
December 31, 2018 is mainly attributable to a decrease in revenues of $3,371, an increase in R&D expenses of $2,465 before consideration of stock-based
compensation and an increase in SG&A expenses of $1,003 before consideration of stock-based compensation.
Results
of
operations
for
the
three
month
and
twelve
month
periods
ended
December
31,
2018
compared
with
the
three
month
and
twelve
month
periods
ended
December
31,
2017.
Revenue
Three-month
period
ended
December
31,
Twelve-month
period
ended
December
31,
In
U.S.$
thousands
2018
2017
2018
Revenue
$
651
$
1,462
$
1,824
$
Cost of Royalty and License Revenue
Research and Development Expenses
Selling, General and Administrative Expenses
Depreciation of tangible assets
Operating
Loss
Net
Loss
Comprehensive
Loss
-
1,998
684
179
(2,210)
(2,499)
(2,938)
34
95
739
1,272
210
(854)
(1,091)
(1,065)
-
5,104
4,999
719
(8,998)
(10,108)
(10,637)
2017
5,195
373
2,615
3,965
735
(2,493)
(3,051)
(2,669)
Revenue
Total revenues for the three-month period ended December 31, 2018 amounted to $651, representing a decrease of $811 or 55% compared to $1,462 for the three-
month period ended December 31, 2017. Total revenues for the twelve-month period ended December 31, 2018 amounted to $1,824 representing a decrease of
$3,371 or 65% compared to $5,195 for the twelve-month period ended December 31, 2017. The decrease for the three-month period ended December 31, 2018
compared to the last year’s corresponding period is mainly attributable to a decrease in deferred revenues of $940 following the monetization of Forfivo partially
offset by an increase in R&D revenues of $129. The decrease for the twelve-month period ended December 31, 2018 compared to the last year’s corresponding
period is mainly attributable to a decrease in deferred revenues of $3,760 following the monetization of Forfivo and a decrease in up-fronts of $416. This decrease
was partially offset by an increase in R&D revenues of $805.
Cost
of
royalty
and
license
revenue
We recorded $Nil for the cost of royalty and license revenue in the three-month period ended December 31, 2018 compared with $95 in the same period of 2017.
We recorded $Nil for the cost of royalty and license revenue in the twelve-month period ended December 31, 2018 compared with $373 in the same period of
2017. These expenses relate 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 ® (including the
deferred revenues resulting from the Forfivo monetization). We recovered the final portion of the management fees in December 2014, thereby invoking payments
to our former development partner.
Research
and
development
(“R&D”)
expenses
R&D expenses for the three-month period ended December 31, 2018 amounted to $1,998, representing an increase of $1,259 or 170%, compared to $739 for the
three-month period ended December 31, 2017. R&D expenses for the twelve-month period ended December 31, 2018 amounted to $5,104, representing an increase
of $2,489 or 95%, compared to $2,615 recorded in the same period of 2017.
The increase in R&D expenses for the three-month period ended December 31, 2018 is mainly attributable to an increase in lab supplies of $912 and analytical
costs of $266. The increase in R&D expenses for the twelve-month period ended December 31, 2018 is mainly attributable to an increase in study costs of $907, lab
supplies of $813, analytical costs of $613 and R&D salaries of $273 related to new hires, offset by an increase in R&D credits of $134.
In the twelve-month period ended December 31, 2018 we recorded estimated Research and Development Tax Credits of $438, compared with $303 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 December 31, 2018 amounted to $684, representing a decrease of $588 or 46%, compared to $1,272 for the
three-month period ended December 31, 2017. SG&A expenses for the twelve-month period ended December 31, 2018 amounted to $4,999, representing an
increase of $1,034 or 26%, compared to $3,965 recorded in the same period of 2017.
The decrease in SG&A expenses for the three-month period ended December 31, 2018 is mainly attributable to decreases in manufacturing expenses of $280,
salaries and compensation expenses of $204, a variation of the foreign exchange expense due to the depreciation of the CA dollar vs the US currency of $187, and
general expenses of $46, partially offset by an increase in professional fees of $168. The increase in SG&A expenses for the twelve-month period ended December
31, 2018 is mainly attributable to increases in professional fees of $522, salaries and compensation expenses of $342, office and general expenses of $145,
manufacturing expenses of $132, rent and utilities expenses of $130, investor relations expenses of $86, and business development expense of $60, partially offset
by variation of the foreign exchange expense due to the depreciation of the CA dollar vs the US currency of $356. The increase in professional fees were mainly
related to costs attributable to the aborted capital raise as well as the Laboval acquisition which is currently on hold. These expenses are deemed to be non-recurring
in nature.
35
Depreciation
of
tangible
assets
In the three-month period ended December 31, 2018 we recorded an expense of $179 for the depreciation of tangible assets, compared with an expense of $210
thousand for the same period of the previous year. In the twelve-month period ended December 31, 2018 we recorded an expense of $719 for the depreciation of
tangible assets, compared with an expense of $735 for the same period of the previous year
Share-based
compensation
expense,
warrants
and
stock
based
payments
Share-based compensation warrants and share-based payments expense for the three-month period ended December 31, 2018 amounted to $59 compared to $48 for
the three-month period ended December 31, 2017. Share-based compensation warrants and share-based payments expense for the twelve-month period ended
December 31, 2018 amounted to $370 compared to $315 for the twelve-month period ended December 31, 2017.
We expensed approximately $320 in the twelve-month period ended December 31, 2018 for options granted to our employees in 2016, 2017 and 2018 under the
2016 Stock Option Plans, $11 for options granted to non-employee directors in 2016, 2017 and 2018, and $14 for options granted to consultants in 2016 and 2018
compared with $178, , $131 and $6 respectively that was expensed in the same period of the previous year. Approximately $25 were expensed for RSU’s granted to
the CEO and CFO under the PRSU Plan, $Nil in the same period for the previous years.
There remains approximately $453 in stock-based compensation to be expensed in fiscal 2019 and 2020, $370 of which relates to the issuance of options to our
employees during 2017 and 2018 and $83 relates to the issuance of options to consultants in 2018. We anticipate the issuance of additional options and warrants in
the future, which will continue to result in stock-based compensation expense.
Key
items
from
the
balance
sheet
In
U.S.$
thousands
December
31,
2018
December
31,
2017
Increase/
(Decrease)
Percentage
Increase/
(Decrease)
Current Assets
$
13,063
$
6,044
$
7,019
116%
Leasehold improvements and Equipment
Security Deposits
Current Liabilities
Deferred lease obligations
Long-term debt
Convertible debentures
Convertible notes
Capital Stock
Additional Paid-in- Capital
Going
Concern
6,248
707
2,722
49
1,140
5,047
1,073
1
6,346
757
2,077
50
1,992
5,199
-
1
(98)
(50)
645
(1)
(852)
(152)
1,073
-
42,048
25,253
16,795
(2%)
(7%)
31%
(2%)
(43%)
(3%)
100%
0%
67%
The Company has financed its operations to date primarily through public offerings of its common stock, convertible debentures, convertible notes, bank loans,
royalty, up-front and milestone payments, license fees, proceeds from exercise of warrants and options, research and development revenues and the sale of U.S.
royalty on future sales of Forfivo XL®. The Company has devoted substantially all of its resources to its drug development efforts, conducting clinical trials to
further advance the product pipeline, the expansion of its facilities, protecting its intellectual property and general and administrative functions relating to these
operations. The future success of the Company is dependent on its ability to develop its product pipeline and ultimately upon its ability to attain profitable
operations. As of December 31, 2018, the Company had cash and short-term investments totaling approximately $10,995. The Company does not have sufficient
existing cash and short-term investments to support operations for the next year following the issuance of these financial statements. These conditions raise
substantial doubt about the Company’s ability to continue as a going concern. Management’s plans to alleviate these conditions include pursuing one or more of the
following steps to raise additional funding, none of which can be guaranteed or are entirely within the Company’s control:
36
Raise funding through the possible sale of the Company’s common stock, including public or private equity financings.
Raise funding through debt financing.
Continue to seek partners to advance product pipeline.
Initiate oral film manufacturing activities.
Initiate contract oral film manufacturing activities.
If the Company is unable to raise capital when needed or on attractive terms, or if it is unable to procure partnership arrangements to advance its programs, the
Company would be forced to delay, reduce or eliminate its research and development programs.
The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in
the ordinary course of business. The accompanying financial statements do not include any adjustments or classifications that may result from the possible inability
of the Company to continue as a going concern. Should the Company be unable to continue as a going concern, it may be unable to realize the carrying value of its
assets and to meet its liabilities as they become due.
Current
assets
Current assets totaled $13,063 at December 31, 2018 compared with $6,044 at December 31, 2017. The increase of $7,019 is mainly attributable to increases in
cash of $5,224, short term investments of $867, inventories of $375, prepaid expenses of $259, accounts receivable of $192 as well as an increase in investment tax
credits receivable of $102.
Cash
Cash totaled $6,815 as at December 31, 2018 representing an increase of $5,224 compared with the balance of $1,591 as at December 31, 2017. The increase in
cash on hand relates to net cash provided by financing activities of $16,401, partially offset by net cash used in operating activities of $8,531 and net cash used in
investing activities of $2,177.
Short
term
investments
Short term investments totaled $4,180 as at December 31, 2018, representing an increase of $867 compared with the balance of $3,313 as at December 31, 2017.
The increase in short term investments is attributable to additional investment in term deposits following the October 2018 public offering.
Accounts
receivable
Accounts receivable totaled $815 as at December 31, 2018 representing an increase of $192 compared with the balance of $623 as at December 31, 2017. The
increase in accounts receivable is attributable to the R&D revenues accounted for as at December 31, 2018.
Prepaid
expenses
As at December 31, 2018, prepaid expenses totaled $462 compared with $203 as of December 31, 2017. The increase in prepaid expenses is mainly attributable to a
payment of CAD$275 with respect to the Laboval acquisition (from which CAD$200 is refundable if the acquisition does not take place).
Investment
tax
credits
receivable
R&D investment tax credits receivable totaled approximately $416 as at December 31, 2018 compared with $314 as at December 31, 2017. The increase relates to
the accrual estimated and recorded for the twelve-month period ended December 31, 2018 offset by the collection of the 2017 tax credits.
37
Inventory
As at December 31, 2018, inventories totaled $375 compared to a balance of $Nil as at December 31, 2017. The increase is attributable to the purchase of raw
materials.
Leasehold
improvements
and
equipment
As at December 31, 2018, the net book value of leasehold improvements and equipment amounted to $6,248, compared to $6,346 at December 31, 2017. In the
year ended December 31, 2018 additions to assets totaled $1,096 and mainly comprised of $1,032 for manufacturing equipment, $47 for leasehold improvements,
$12 for computer equipment and $5 for laboratory and office equipment, offset by depreciation expense of $719 and variation of foreign exchange fluctuation.
Security
deposit
A security deposit in the amount of CA$300 ($220) in respect of an agreement to lease approximately 17,000 square feet in a property located at 6420 Abrams, St-
Laurent, Quebec, Canada was recorded as at December 31, 2018. Security deposits in the amount of CA$650 ($476) for the term loans were also recorded as at
December 31, 2018. The difference between the amount at December 31, 2018 and the amount at December 31, 2017 is related to the US currency fluctuation.
Accounts
payable
and
accrued
liabilities
Accounts payable and accrued liabilities totaled $2,030 as at December 31, 2018 (December 31, 2017 - $1,305). The increase is mainly attributable to payables
related to R&D expenses in the amount of $553, payables related to professional fees incurred in the amount of $154, and the accrual for DSUs to independent
board of Director members in the amount of $152.
Long-term
debt
Long-term debt totaled $1,832 as at December 31, 2018 (December 31, 2017 - $2,764). The current portion of long-term debt totaled $692 as at December 31, 2018
(December 31, 2017 - $772). An amount of $1,502 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.
An amount of $330 is attributable to a second loan secured by a second ranking on all present and future property of the Company.
Convertible
debentures
Convertible debentures totaled $5,047 as at December 31, 2018 as compared to $5,199 as at December 31, 2017. The Corporation issued a total aggregate principal
amount of CAD$7,600,000 ($5,571,030) of debentures at a price of CAD$1,000 ($733)per debenture in July 2017 and August 2017. The convertible debentures
have been recorded as a liability. Total transactions costs in the amount of CAD$1,237,000 ($907) were recorded against the liability. The accretion expense for the
year ended December 31, 2018 amounts to CAD$383,000 ($296,000) (CAD$160,000, $123,000 in 2017). The interest on the convertible debentures as at
December 31, 2018 amounts to CAD$607,000 ($468,000) (CAD$286,000, $221,000 in 2017) and is recorded in Financing and interest expense.
Convertible
notes
Convertible notes totaled $1,073 as at December 31, 2018 as compared to $Nil as at December 31, 2017. On May 8, 2018, the Company issued 320 units at a
subscription price of $10,000 per Unit for gross proceeds of $3,200,000. Each Unit was comprised of (i) 7,940 common shares of the Corporation, (ii) a $5,000
convertible 6% note, and (iii) 7,690 warrants to purchase Common Stock of the Corporation. Each Note bears interest at a rate of 6% (payable quarterly, in arrears,
with the first payment being due on September 1, 2018), matures on June 1, 2021 and is convertible into Common Stock at a conversion price of $0.80 per common
share. Each warrant entitles its holder to purchase one common share at a price of $0.80 per common share until June 1, 2021. The convertible notes were recorded
as a liability. Total transactions costs in the amount of $111 thousand were recorded against the liability. The accretion expense for the year ended December 31,
2018 was $98 thousand. The interest on the convertible notes as at December 31, 2018 was $63 thousand ($Nil in 2017) and was recorded as a financing and
interest expense.
38
Shareholders’
equity
As at December 31, 2018 we had accumulated a deficit of $30,896 compared with an accumulated deficit of $20,788 as at December 31, 2017. Total assets
amounted to $20,018 and shareholders’ equity totaled $9,987 as at December 31, 2018, compared with total assets and shareholders’ equity of $13,147 and $3,829
respectively, as at December 31, 2017.
Capital
stock
As at December 31, 2018 capital stock amounted to $0.935 (December 31, 2017: $0.670) . 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 $42,048 as at December 31, 2018, as compared to $25,253 at December 31, 2017. Additional paid in capital increased by $16,795
from which $1,460 was the value of the common stock issued in the May 2018 private placement offering, $2,328 came from proceeds from exercise of warrants
and stock options, $437 was the value of the warrants issued in the May 2018 private placement, $370 from stock based compensation attributable to the
amortization of stock options granted to employees and directors, $231 was the value of the interest paid by issuance of Common Stock, $50 was the value
attributed to the Agents’ warrants in the May 2018 private placement transaction, $9,187 was the value of the common stock issued in the October 2018 public
offering, $1,436 was the value of the warrants issued in the October 2018 public offering, $280 was the value attributed to the agents’ warrants in the October 2018
public offering transaction, $1,000 was the value of common stock issued in the November 2018 private placement and $16 was the value of the converted
debentures .
Taxation
As at December 31, 2018, the date of our latest annual tax return, we had Canadian and provincial net operating losses of approximately $14,934 (December 31,
2017: $9,560) and $10,052 (December 31, 2017: $16,498) respectively, which may be applied against earnings of future years. Utilization of the net operating
losses is subject to significant limitations imposed by the change in control provisions. Canadian and provincial losses will be expiring between 2028 and 2038. A
portion of the net operating losses may expire before they can be utilized.
As at December 31, 2018, we had non-refundable tax credits of $1,981 thousand (2017: $1,553 thousand) of which $8 thousand is expiring in 2026, $9 thousand is
expiring in 2027, $165 thousand is expiring in 2028, $145 thousand is expiring in 2029, $124 thousand is expiring in 2030, $131 thousand is expiring in 2031, $164
thousand is expiring in 2032 and $109 thousand is expiring in 2033, $83 thousand expiring in 2034, $97 thousand is expiring in 2035, $135 thousand expiring in
2036 and $257 thousand expiring in 2037 and $554 thousand expiring in 2038. We also had undeducted research and development expenses of $10,663 thousand
(2017: $7,532 thousand) with no expiration date.
The deferred tax benefit of these items was not recognized in the accounts as it has been fully provided for.
Key
items
from
the
statement
of
cash
flows
In
U.S.$
thousands
Operating Activities
Financing Activities
Investing Activities
Cash - end of period
Statement
of
cash
flows
December
31,
2018
December
31,
2017
Increase/
(Decrease)
$
(8,530) $
16,404
(2,177)
6,815
(4,383) $
5,508
(207)
1,591
(4,147)
10,896
(1,970)
5,224
Percentage
Increase/
(Decrease)
(95%)
198%
(952)%
328%
Net cash used in operating activities was $8,530 for the twelve-month period ended December 31, 2018, compared to net cash used by operating activities of
$4,383 for the twelve-month period ended December 31, 2017. For the twelve-month period ended December 31, 2018, net cash used by operating activities
consisted of a net loss of ($10,108) (2017: $3,051) before depreciation, stock-based compensation, accretion expense, DSU expense, interest paid by issuance of
Common Stock and conversion of convertible debentures in the amount of $1,860 (2017: $1,173) and a decrease in non-cash operating elements of working capital
of $282 compared with a decrease of $2,505 for the twelve-month period ended December 31, 2017.
39
The net cash provided by financing activities was $16,404 for the twelve-month period ended December 31, 2018, compared to $5,508 provided in the same period
of the previous year. An amount of $11,405 derives from proceeds from the public offering (2017:$nil), $4,004 derives from the proceeds of a private placement
(2017: $nil) and an amount of $2,328 derives from proceeds from exercise of warrants and stock options (2017: $1,238) offset by repayment of term loans for an
amount of $749 (2017: $708), the transaction costs related to the private placement of $82 (2017: $nil) and the transaction costs related to the public offering of
$502 (2017:$nil).
Net cash used in investing activities amounted to $2,177 for the twelve-month period ended December 31, 2018 compared to $207 in the same period of 2017. The
net cash used in investing activities for the twelve-month period ended December 31, 2018 relates to the redemptions of short-term investments of $3,192 (2017:
$4,718) offset by the purchase of fixed assets for $1,096 (2017: $973) as well as acquisitions of short-term investments of $4,273 (2017: $3,952).
The balance of cash as at December 31, 2018 amounted to $6,815, compared to $1,591 at December 31, 2017.
Commitments
On April 24, 2015 the Company entered into an agreement to lease approximately 17,000 square feet in a property located at 6420 Abrams, St-Laurent, Québec.
The lease has a 10 year and 6-month term commencing September 1, 2015. IntelGenx has retained two options to extend the lease, with each option being for an
additional five years. Under the terms of the lease IntelGenx is required to pay base rent of approximately CA$110 thousand (approximately $81 thousand) per
year, which will increase at a rate of CA$0.25 ($0.18) per square foot, every two years.
On March 6, 2017 IntelGenx executed an agreement to lease approximately an additional 11,000 square feet in a property located at 6410 Abrams, St-Laurent,
Quebec. The Lease has an 8 year and 5-month term commencing on October 1, 2017 and IntelGenx has retained two options to extend the Lease, with each option
being for an additional five years. Under the terms of the Lease IntelGenx will be required to pay base rent of approximately CA$74 thousand (approximately $54
thousand) per year, which will increase at a rate of CA$0.25 ($0.18) per square foot every two years.
The aggregate minimum rentals, exclusive of other occupancy charges, for property leases expiring in 2026, are approximately $1,058 thousand, as follows:
2019
2020
2021
2022
2023
Thereafter
$140
143
145
148
150
332
The Company has initiated a project to expand the existing manufacturing facility. The Company has signed agreements in the amount of Euro1,911 thousand with
three suppliers with respect to equipment for solvent film manufacturing. As at December 31, 2018 an amount of Euro1,395 thousand has been paid with respect to
these agreements.
Subsequent
events
Subsequent to the end of the year, total of 50,000 stock options were exercised for 50,000 common shares having a par value of $Nil in aggregate, for cash
consideration of approximately $21thousand.
Off-balance
sheet
arrangements
We have no off-balance sheet arrangements.
ITEM
7A.
QUANTITATIVE
AND
QUALITATIVE
DISCLOSURES
ABOUT
MARKET
RISK.
Not applicable.
ITEM
8.
FINANCIAL
STATEMENTS
AND
SUPPLEMENTARY
DATA
The consolidated financial statements and supplementary data of the Company required in this item are set forth beginning on page F-1 of this Annual Report on
Form 10-K.
40
ITEM
9.
CHANGES
IN
AND
DISAGREEMENTS
WITH
ACCOUNTANTS
ON
ACCOUNTING
AND
FINANCIAL
DISCLOSURE
None.
ITEM
9A.
CONTROLS
AND
PROCEDURES
a.
Evaluation
of
Disclosure
Controls
and
Procedures
Based on an evaluation under the supervision and with the participation of our management, our Chief Executive Officer and Chief Financial Officer have
concluded that the Company’s disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as
amended (the “Exchange Act”) were effective as of December 31, 2018 to ensure that information required to be disclosed by the Company in reports that it files or
submits under the Exchange Act is (i) recorded, processed, summarized and reported within the time periods specified in the SEC rules and forms and (ii)
accumulated and communicated to the Company’s management, including our Chief Executive Officer and Chief Financial Officer, as appropriate to allow timely
decisions regarding required disclosure.
b.
Changes
in
Internal
Controls
over
Financial
Reporting
Our Chief Executive Officer and Chief Financial Officer have concluded that there were no changes in the Company’s internal controls over financial reporting
during the quarter ended December 31, 2018 that have materially affected or are reasonably likely to materially affect the Company’s internal controls over
financial reporting.
c.
Management’s
Report
on
Internal
Control
Over
Financial
Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Exchange Act Rule
13a-15(f). Our internal control system was designed to provide reasonable assurance to our management and the Board of Directors regarding the preparation and
fair presentation of published financial statements.
All internal control systems, no matter how well designed, have inherent limitations. Therefore, even those systems determined to be effective can provide only
reasonable assurance with respect to financial statement preparation and presentation.
Our management, including the Chief Executive Officer and Chief Financial Officer, assessed the effectiveness of the Company’s internal control over financial
reporting as of December 31, 2018. In making this assessment, our management used the criteria set forth by the Committee of Sponsoring Organizations of the
Treadway Commission in Internal Control—Integrated Framework (2013). Based on our processes and assessment, as described above, management has concluded
that, as of December 31, 2018 our internal control over financial reporting was effective.
This Annual Report does not include an attestation report of our registered public accounting firm regarding internal control over financial reporting.
Management’s report was not subject to attestation by the company’s registered public accounting firm pursuant to rules of the SEC, as the Company qualifies as a
“smaller reporting company”.
ITEM
9B.
OTHER
INFORMATION
None.
ITEM
10.
DIRECTORS,
EXECUTIVE
OFFICERS
AND
CORPORATE
GOVERNANCE
PART
III
Certain information required by this Item 10 relating to our directors, executive officers, audit committee and corporate governance is incorporated by reference
herein from the 2019 Proxy Statement.
We have adopted a Code of Business Conduct and Ethics that applies to our directors and officers, including our principal executive officer, and our principal
financial officer and principal accounting officer. The Code of Business Conduct and Ethics is posted on our website at http://www.intelgenx.com . We intend to
satisfy the disclosure requirement under Item 5.05 of Form 8-K regarding an amendment to, or waiver from, a provision of our Code of Business Conduct and
Ethics by posting such information on our website at the web address specified above.
41
ITEM
11.
EXECUTIVE
COMPENSATION
Certain information required by this Item 11 relating to remuneration of directors and executive officers and other transactions involving management is
incorporated by reference herein from the 2019 Proxy Statement.
ITEM
12.
SECURITY
OWNERSHIP
OF
CERTAIN
BENEFICIAL
OWNERS
AND
MANAGEMENT
AND
RELATED
STOCKHOLDER
MATTERS
Certain information required by this Item 12 relating to security ownership of certain beneficial owners and management, and the equity compensation plan
information, is incorporated by reference herein from the 2019 Proxy Statement.
ITEM
13.
CERTAIN
RELATIONSHIPS
AND
RELATED
TRANSACTIONS,
AND
DIRECTOR
INDEPENDENCE
Certain information required by this Item 13 relating to certain relationships and related transactions, and director independence is incorporated by reference herein
from the 2019 Proxy Statement.
ITEM
14.
PRINCIPAL
ACCOUNTING
FEES
AND
SERVICES
Certain information required by this Item 14 regarding principal accounting fees and services is set forth under “Audit Fees” in the 2019 Proxy Statement.
ITEM
15.
EXHIBITS,
FINANCIAL
STATEMENT
SCHEDULES
(a)
Financial
Statements
and
Schedules
1.
Financial Statements
PART
IV
The following financial statements are filed as part of this report under Item 8 of Part II “Financial Statements and Supplementary Data:
A.
B.
C.
D.
E.
F.
Report of Independent Registered Public Accounting Firm.
Consolidated Balance Sheets as of December 31, 2018 and 2017.
Consolidated Statements of Shareholders’ Equity for the years ended of December 31, 2018 and 2017.
Consolidated Statements of Comprehensive Loss for the years ended of December 31, 2018 and 2017.
Consolidated Statements of Cash Flows for the years ended December 31, 2018 and 2017.
Notes to Consolidated Financial Statements.
2
. Financial Statement Schedules
Financial statement schedules not included herein have been omitted because they are either not required, not applicable, or the information is otherwise included
herein.
42
(b)
Exhibits.
Exhibit
No.
2.1
3.1
3.2
3.3
3.4
3.5
3.6
3.7
4.1
9.1
EXHIBIT
INDEX
Description
Share exchange agreement dated April 10, 2006 (incorporated by reference to the Form 8-K/A filed on May 5, 2006)
Certificate of Incorporation (incorporated by reference to the Form SB-2 (File No. 333-90149) filed on November 16, 1999)
Amendment to the Certificate of Incorporation (incorporated by reference to amendment No. 2 to Form SB-2 (File No. 333-135591) filed on
August 28, 2006)
Amendment to the Certificate of Incorporation (incorporated by reference to the Form DEF 14C filed on April 20, 2007)
Amendment to the Certificate of Incorporation (incorporated by reference to the Form S-1/A filed on May 12, 2017)
By-Laws (incorporated by reference to the Form SB-2 (File No. 333-91049) filed on November 16, 1999
Amended and Restated By-Laws (incorporated by reference to the Form 8-K filed on March 31, 2011)
Amended and Restated By-Laws (incorporated by reference to the Form 8-K filed on March 21, 2012)
Trust Indenture with TSX Trust Company, dated July 12, 2017 (incorporated by reference to the Form 8-K filed on July 12, 2017)
Voting Trust agreement (incorporated by reference to the Form 8-K/A filed on May 5, 2006)
10.1 +
Horst Zerbe employment agreement dated October 1, 2014 (incorporated by reference to the Form 10-Q filed on November 12, 2014)
10.2
10.3
10.4 +
10.5 +
10.6
Registration rights agreement (incorporated by reference to the Form SB-2 (File No. 333-135591) filed on July 3, 2006)
Principal’s registration rights agreement (incorporated by reference to the Form SB-2 (File No. 333-135591) filed on July 3, 2006)
2006 Stock Option Plan (incorporated by reference to the Form S-8 filed on November 21, 2006)
Amended and Restated 2006 Stock Option Plan, May 29, 2008 (incorporated by reference to the Form 10-K filed on March 25, 2009)
Co-Development and Commercialization Agreement with RedHill Biopharma Ltd. (incorporated by reference to the Form 10-Q filed on November
9, 2010)
10.7 +
Amended and Restated 2006 Stock Option Plan (incorporated by reference to the Form S-8 filed on November 15, 2010)
10.8
10.9
10.10
10.11
10.12
Project Transfer Agreement (incorporated by reference to the Form 10-Q filed on May 14, 2010)
Co-development and Licensing Agreement (incorporated by reference to the Form 10-Q filed on May 14, 2010)
License and Asset Transfer Agreement with Edgemont Pharmaceuticals (incorporated by reference to the Form 10Q filed on May 15, 2012)
Development Services and Commercialization Agreement with PAR Pharmaceuticals, dated December 19, 2011 (incorporated by reference to the
Form 10-K filed on March 11, 2014)
Development Services and Commercialization Agreement with PAR Pharmaceuticals, dated January 8, 2014 (incorporated by reference to the
Form 10-K filed on March 11, 2014)
10.13+
Employment Agreement Andre Godin, July 2015 (incorporated by reference to the Form 8-K filed on July 20, 2015)
10.14+
Employment Agreement Nadine Paiement, January 2016 (incorporated by reference to the Form 10-K filed on March 30, 2016)
10.15+
Employment Agreement Dana Matzen, March 2016 (incorporated by reference to the Form 10-K filed on March 30, 2016)
43
10.16+
2016 Stock Option Plan May, 11 2016 (incorporated by reference to the Form S-8 Registration Statement filed on August 3, 2016)
10.17
10.18
Amended Principal’s Registration Rights Agreement, November 8, 2016 (incorporated by reference to Form 10-Q filed on November 10, 2016)
Agency Agreement dated June 28, 2017 (incorporated by reference from the Company’s Form 8-K filed on July 5, 2017)
10.19+
Deferred Share Unit Plan for non-employee directors (incorporated by reference to the Form 10K filed on March 29, 2018)
10.20
10.21
10.22
10.23
10.24
10.25
10.26
10.27
10.28
21.1
23.1*
31.1*
31.2*
32.1*
32.2*
Placement Agent Agreement dated May 8, 2018 (incorporated by reference to the Form 8-K filed on May 10, 2018)
Form of Warrant dated May 8, 2018 (incorporated by reference to the Form 8-K filed on May 10, 2018)
Form of Securities Purchase Agreement dated May 8, 2018 (incorporated by reference to the Form 8-K filed on May 10, 2018)
Form of Registration Rights Agreement dated May 8, 2018 (incorporated by reference to the Form 8-K filed on May 10, 2018)
Form of Note dated May 8, 2018 (incorporated by reference to the Form 8-K filed on May 10, 2018)
Placement Agent Agreement between the Company and H.C. Wainwright & Co., LLC dated October 18, 2018 (incorporated by reference to the
Form 8-K filed on October 22, 2018)
Placement Agent Agreement between the Company and Echelon Wealth Partners Inc. dated October 18, 2018 (incorporated by reference to the
Form 8-K filed on October 22, 2018)
Form of Warrant (incorporated by reference to the Form 8-K on October 22, 2018)
Form of Securities Purchase Agreement (incorporated by reference to the Form 8-K on October 22, 2018)
Subsidiaries of the small business issuer (incorporated by reference to the Form SB-2 (File No. 333-135591) filed on July 3, 2006)
Consents of Richter LLP
Certification of Horst G. Zerbe, President and Chief Executive Officer, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002*
Certification of Andre Godin, Executive Vice President and Chief Financial Officer, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002*
Certification of Horst G. Zerbe, President and Chief Executive Officer, pursuant to 18 U.S.C. Section 1350*
Certification of Andre Godin, Executive Vice President and Chief Financial Officer, pursuant to 18 U.S.C. Section 1350.*
* Filed herewith.
Indicates management contract or employee compensation plan.
++ Portions of this exhibit have been omitted based on an application for confidential treatment from the SEC.
+The omitted portions of these exhibits have been submitted separately with the SEC.
ITEM
16.
FORM
10K
SUMMARY.
None.
44
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its
behalf by the undersigned on March 22, 2019, thereunto duly authorized.
SIGNATURES
INTELGENX
TECHNOLOGIES
CORP.
By:
By:
/s/Horst G. Zerbe
Horst G. Zerbe
President and Chief Executive Officer
(Principal Executive Officer)
/s /Andre Godin
Andre Godin
Executive Vice President and Chief Financial
Officer
(Principal Financial and Accounting Officer)
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed by the following persons in the capacities and on the dates
indicated.
Signature
By: /s/ Horst G. Zerbe
Horst G. Zerbe
By : /s/Andre Godin
Andre Godin
By: /s/ Bernard Boudreau
J. Bernard Boudreau
By: /s/ Bernd Melchers
Bernd J. Melchers
By: /s/ John Marinucci
John Marinucci
By: /s/ Clemens Mayr
Clemens Mayr
By: /s/ Mark Nawacki
Mark Nawacki
Position
Chairman of the Board, President and Chief
Executive Officer
Date
March 22, 2019
Executive Vice President and Chief Financial Officer March 22, 2019
Director, Vice Chairman of the Board
March 22, 2019
Director
Director
Director
Director
45
March 22, 2019
March 22, 2019
March 22, 2019
March 22, 2019
IntelGenx
Technologies
Corp.
Consolidated
Financial
Statements
December
31,
2018
and
2017
(Expressed
in
U.S.
Funds)
IntelGenx
Technologies
Corp.
Consolidated
Financial
Statements
December
31,
2018
and
2017
(Expressed
in
U.S.
Funds)
Contents
Report of Independent Registered Public Accounting Firm
Consolidated Balance Sheets
Consolidated Statements of Shareholders' Equity
Consolidated Statements of Comprehensive Loss
Consolidated Statements of Cash Flows
Notes to Consolidated Financial Statements
F - 1
F - 2
F - 3 - 4
F - 5
F - 6
F - 7 - 36
Report
of
Independent
Registered
Public
Accounting
Firm
To the Shareholders and Board of Directors of
IntelGenx
Technologies
Corp.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of IntelGenx Technologies Corp. (the “Company”) as of December 31, 2018 and 2017, the related
consolidated statements of comprehensive loss, shareholders' equity and cash flows for each of the two years in the period ended December 31, 2018, and the
related notes (collectively referred to as the “financial statements”). In our opinion, the financial statements present fairly, in all material respects, the financial
position of the Company as of December 31, 2018 and 2017, and the results of its operations and its cash flows for each of the two years in the period ended
December 31, 2018, in conformity with the standards of the Public Company Accounting Oversight Board (United States).
Going concern uncertainty
The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 2 to
the consolidated financial statements, the Company does not have sufficient existing cash and short-term investments to support operations for at least the next year
following the issuance of these financial statements which raises doubt about its ability to continue as a going concern. Management’s plans in regard to these
matters are also described in Note 2. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Basis for opinion
These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements
based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are
required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the
Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable
assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were
we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control
over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting.
Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing
procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial
statements. Our audits also include evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall
presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
We have served as the Company’s auditors since 2005.
Richter LLP (Signed) 1
Montréal, Quebec
March 22, 2019
1 CPA auditor, CA, public accountancy permit No. A112505
IntelGenx
Technologies
Corp.
Consolidated
Balance
Sheets
As
at
December
31,
2018
and
2017
(Expressed
in
Thousands
of
U.S.
Dollars
($’000)
Except
Share
and
Per
Share
Data)
Assets
Current
Cash
Short-term investments (note 6)
Accounts receivable
Prepaid expenses
Investment tax credits receivable
Inventory (note 7)
Total
current
assets
Leasehold
improvements
and
equipment,
net
(note 8)
Security
deposits
Total
assets
Liabilities
Current
Accounts payable and accrued liabilities
Current portion of long-term debt (note 10)
Total
current
liabilities
Deferred
lease
obligations
Long-term
debt
(note 10)
Convertible
debentures
(note 11)
Convertible
notes
(note 12)
Total
liabilities
Commitments
(note
13)
Subsequent
event
(note
21)
Shareholders'
equity
Capital stock, common shares, $0.00001 par value; 200,000,000 shares authorized;
93,477,473 shares issued and outstanding (2017: 67,031,467 common shares) (note 14)
Additional paid-in capital (note 15)
Accumulated deficit
Accumulated other comprehensive loss
Total
shareholders’
equity
See accompanying notes
Approved
on
Behalf
of
the
Board:
2018
2017
$
$
6,815
4,180
815
462
416
375
13,063
6,248
707
1,591
3,313
623
203
314
-
6,044
6,346
757
$
20,018
$
13,147
2,030
692
2,722
49
1,140
5,047
1,073
10,031
1
42,048
(30,896)
(1,166)
9,987
1,305
772
2,077
50
1,992
5,199
-
9,318
1
25,253
(20,788)
(637)
3,829
$
20,018
$
13,147
/s/ Bernd J. Melchers
/s/ Horst G. Zerbe
Director
Director
F - 2
IntelGenx
Technologies
Corp.
Consolidated
Statement
of
Shareholders'
Equity
For
the
Year
Ended
December
31,
2017
(Expressed
in
Thousands
of
U.S.
Dollars
($’000)
Except
Share
and
Per
Share
Data)
Capital Stock
Number
Amount
Paid-In
Capital
Accumulated
Deficit
Additional
Accumulated
Other
Comprehensive
Loss
Total
Shareholders'
Equity
Balance
-
December
31,
2016
64,812,020
$
1
$
23,700
$
(17,737) $
(1,019) $
4,945
Other comprehensive income
Warrants exercised (note 14)
Options exercised (note 14)
Stock-based compensation (note 14)
Net loss for the year
-
2,084,447
135,000
-
-
-
-
-
-
-
-
1,176
62
315
-
-
-
-
-
(3,051)
382
-
-
-
-
382
1,176
62
315
(3,051)
Balance
–
December
31,
2017
67,031,467
$
1
$
25,253
$
(20,788) $
(637) $
3,829
See accompanying notes
F - 3
IntelGenx
Technologies
Corp.
Consolidated
Statement
of
Shareholders'
Equity
For
the
Year
Ended
December
31,
2018
(Expressed
in
Thousands
of
U.S.
Dollars
($’000)
Except
Share
and
Per
Share
Data)
Capital Stock
Number
Amount
Paid-In
Capital
Accumulated
Deficit
Additional
Accumulated
Other
Comprehensive
Loss
Total
Shareholders'
Equity
Balance
-
December
31,
2017
67,031,467
$
1
$
25,253
$
(20,788) $
(637) $
3,829
Other comprehensive loss
-
Common stock issued, net of transaction
costs of $1,906 (note 14)
22,017,295
Warrants issued, net of transaction costs of
$322 (note 14)
Agents’ warrants issued (note 14)
Interest paid by issuance of common shares
(note 11)
Conversion of convertible debentures (note
11)
Warrants exercised (note 14)
Options exercised (note 14)
Stock-based compensation (note 14)
Net loss for the year
-
-
307,069
17,036
4,044,606
60,000
-
-
-
-
-
-
-
-
-
-
-
-
-
11,647
1,873
330
231
16
2,295
33
370
-
-
-
-
-
-
-
-
-
-
(10,108)
(529)
(529)
-
-
-
-
-
-
-
-
-
11,647
1,873
330
231
16
2,295
33
370
(10,108)
Balance
–
December
31,
2018
93,477,473
$
1
$
42,048
$
(30,896) $
(1,166) $
9,987
See accompanying notes
F - 4
IntelGenx
Technologies
Corp.
Consolidated
Statements
of
Comprehensive
Loss
For
the
Years
Ended
December
31,
2018
and
2017
(Expressed
in
Thousands
of
U.S.
Dollars
($’000)
Except
Share
and
Per
Share
Data)
Revenues
(note
17)
Total
revenues
Expenses
Cost of royalty, license and other revenue
Research and development expense
Selling, general and administrative expense
Depreciation of tangible assets
Total
expenses
Operating
loss
Interest
income
Financing
and
interest
expense
Net
financing
and
interest
expense
Loss
before
income
taxes
Income taxes (note 16)
Net
loss
Other
comprehensive
income
(loss)
Change in fair value
Foreign currency translation adjustment
Comprehensive
loss
Basic
and
diluted:
Weighted
average
number
of
shares
outstanding
Basic and diluted loss per common share (note 20)
See accompanying notes
2018
2017
$
1,824
$
1,824
-
5,104
4,999
719
10,822
(8,998)
11
(1,121)
(1,110)
(10,108)
-
(10,108)
3
(532)
(529)
5,195
5,195
373
2,615
3,965
735
7,688
(2,493)
11
(569)
(558)
(3,051)
-
(3,051)
71
311
382
$
$
(10,637) $
(2,669)
74,121,922
66,152,830
(0.14) $
(0.04)
F - 5
IntelGenx
Technologies
Corp.
Consolidated
Statements
of
Cash
Flows
For
the
Year
Ended
December
31,
2018
and
2017
(Expressed
in
Thousands
of
U.S.
Dollars
($’000)
Except
Share
and
Per
Share
Data)
Funds
(used)
provided
-
Operating
activities
Net loss
Depreciation of tangible assets
Stock-based compensation
Accretion expense
DSU expense
Interest paid by issuance of common shares
Conversion of convertible debentures
Changes in non-cash items related to operations:
Accounts receivable
Prepaid expenses
Investment tax credits receivable
Inventory
Security deposits
Accounts payable and accrued liabilities
Deferred revenue
Deferred lease obligations
Net
change
in
non-cash
items
related
to
operations
Net
cash
used
in
operating
activities
Financing
activities
Repayment of long-term debt
Proceeds from exercise of warrants and stock options
Net proceeds from private placement
Transaction costs of private placement
Net proceeds from public offering
Transaction costs of public offering
Net proceeds from issuance of convertible debentures
Convertible debentures issuance costs
Net
cash
provided
by
financing
activities
Investing
activities
Additions to leasehold improvements and equipment
Acquisitions of short-term investments
Redemptions of short-term investments
Net
cash
used
in
investing
activities
Increase
in
cash
Effect
of
foreign
exchange
on
cash
Cash
Beginning
of
year
End
of
year
See accompanying notes
2018
2017
$
(10,108) $
719
370
396
160
231
(16)
(8,248)
(192)
(259)
(102)
(375)
(11)
658
-
(1)
(282)
(8,530)
(749)
2,328
4,004
(82)
11,405
(502)
-
-
16,404
(1,096)
(4,273)
3,192
(2,177)
5,697
(473)
$
1,591
6,815
$
F - 6
(3,051)
735
315
123
-
-
-
(1,878)
421
363
(68)
-
-
408
(3,634)
5
(2,505)
(4,383)
(708)
1,238
-
-
-
-
5,469
(491)
5,508
(973)
(3,952)
4,718
(207)
918
61
612
1,591
IntelGenx
Technologies
Corp.
Notes
to
Consolidated
Financial
Statements
December
31,
2018
and
2017
(Expressed
in
U.S.
Funds)
1.
Basis
of
Presentation
IntelGenx Technologies Corp. (“IntelGenx” or the “Company”) prepares its consolidated financial statements in accordance with accounting principles
generally accepted in the United States of America (“USA”). 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.
2.
Going
Concern
The Company has financed its operations to date primarily through public offerings of its common stock, bank loans, royalty, up-front and milestone
payments, license fees, proceeds from exercise of warrants and options, research and development revenues and the sale of U.S. royalty on future sales of
Forfivo XL ® . The Company has devoted substantially all of its resources to its drug development efforts, conducting clinical trials to further advance the
product pipeline, the expansion of its facilities, protecting its intellectual property and general and administrative functions relating to these operations. The
future success of the Company is dependent on its ability to develop its product pipeline and ultimately upon its ability to attain profitable operations. As of
December 31, 2018, the Company had cash and short-term investments totaling approximately $10,995. The Company does not have sufficient existing
cash and short-term investments to support operations for the next year following the issuance of these financial statements. These conditions raise
substantial doubt about the Company’s ability to continue as a going concern. Management’s plans to alleviate these conditions include pursuing one or
more of the following steps to raise additional funding, none of which can be guaranteed or are entirely within the Company’s control:
•
•
•
•
•
Raise funding through the possible sale of the Company’s common stock, including public or private equity financings.
Raise funding through debt financing.
Continue to seek partners to advance product pipeline.
Initiate oral film manufacturing activities.
Initiate contract oral film manufacturing activities.
If the Company is unable to raise capital when needed or on attractive terms, or if it is unable to procure partnership arrangements to advance its programs,
the Company would be forced to delay, reduce or eliminate its research and development programs.
The accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and
satisfaction of liabilities in the ordinary course of business. The accompanying consolidated financial statements do not include any adjustments or
classifications that may result from the possible inability of the Company to continue as a going concern. Should the Company be unable to continue as a
going concern, it may be unable to realize the carrying value of its assets and to meet its liabilities as they become due.
F - 7
IntelGenx
Technologies
Corp.
Notes
to
Consolidated
Financial
Statements
December
31,
2018
and
2017
(Expressed
in
U.S.
Funds)
3.
Nature
of
Business
IntelGenx was incorporated in the State of Delaware as Big Flash Corp. on July 27, 1999. On April 28, 2006 Big Flash Corp. completed, through the
Canadian holding corporation, the acquisition of IntelGenx Corp., a company incorporated in Canada on June 15, 2003.
IntelGenx is a pharmaceutical company focused on the development of novel oral immediate-release and controlled-release products for the pharmaceutical
market. More recently, the Company has made the strategic decision to enter the oral film market and is in the process of implementing commercial oral
film manufacturing capability. The Company’s product development efforts are based upon three proprietary delivery platforms, including an immediate
release oral film “VersaFilm™”, a mucoadhesive tablet “AdVersa™”, and a multilayer controlled release tablet “VersaTab™”. The Company has an
aggressive product development initiative that primarily focuses on addressing unmet market needs and focuses on utilization of the U.S. Food and Drug
Administration’s (“FDA”) 505(b)(2) approval process to obtain more timely and efficient approval of new formulations of previously approved products.
The Company’s product pipeline currently consists of 11 products in various stages of development from inception through commercialization, including
products for the treatment of major depressive disorder, opioid dependence, hypertension, erectile dysfunction, migraine, schizophrenia, idiopathic
pulmonary fibrosis, and pain management. Of the products currently under development, 9 utilize the VersaFilm™ technology, one utilizes the VersaTab™
technology, and one utilizes the AdVersa™ technology.
4.
Adoption
of
New
Accounting
Standards
The Company adopted Topic 606 Revenue from Contracts with Customers with a date of the initial application of January 1, 2018 using the modified
retrospective method. As a result, the Company has changed its accounting policy for revenue recognition as detailed below.
This standard applies to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance,
collaboration arrangements and financial instruments. Under Topic 606, an entity recognizes revenue when its customer obtains control of promised goods
or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those good or services. To determine revenue
recognition for arrangements subject to the scope of Topic 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii)
identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in
the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to
contracts when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer.
At contract inception, once the contract is determined to be within the scope of Topic 606, the Company assesses the goods or services promised within
each contract and identifies performance obligations that are distinct. The Company then recognizes as revenue the amount of the transaction price that is
allocated to each performance obligation when (or as) the performance obligation is satisfied.
F - 8
IntelGenx
Technologies
Corp.
Notes
to
Consolidated
Financial
Statements
December
31,
2018
and
2017
(Expressed
in
U.S.
Funds)
4.
Adoption
of
New
Accounting
Standards
(Cont’d)
ASC 606 uses the terms “contract asset” and “contract liability” to describe what might more commonly be known as “accrued revenue” and “deferred
revenue”. The Company has adopted the terminology used in ASC 606 to describe such balances.
The Company’s accounting policies for its revenue streams are disclosed in Note 5 below. Apart from providing more extensive disclosures on the
Company’s revenue transactions, the application of ASC 606 has not had a significant impact on the financial position and/or financial performance of the
Company.
The FASB issued ASU 2017-09, Stock compensation, 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. The Company has made an accounting policy choice to recognize the effect of awards for which the requisite service is not rendered
when the award is forfeited (that is, recognize the effect of forfeitures in compensation cost when they occur). Previously recognized compensation cost for
an award shall be reversed in the period that the award is forfeited. The adoption of this statement did not have a material effect on the Company’s financial
position or results.
The FASB issued ASU 2017-01, Business Combinations, 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. The adoption of this statement did not have a material
effect on the Company’s financial position or results.
The FASB issued ASU 2016-18, Statement of Cash Flows, 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. The adoption of this statement did not have a material effect on the Company’s
financial position or results.
The FASB issued ASU 2016-16, Income taxes, 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 adoption of this statement did not have a material effect on the Company’s financial position or
results.
The FASB issued ASU 2016-15, Statement of Cash Flows, 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. The adoption
of this statement did not have a material effect on the Company’s financial position or results.
F - 9
IntelGenx
Technologies
Corp.
Notes
to
Consolidated
Financial
Statements
December
31,
2018
and
2017
(Expressed
in
U.S.
Funds)
4.
Adoption
of
New
Accounting
Standards
(Cont’d)
The FASB issued ASU 2016-01, Financial Instruments. The targeted amendments to existing guidance include:
1.
2.
3.
4.
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.
Changes in instrument-specific credit risk for financial liabilities that are measured under the fair value option would be recognized in other
comprehensive income.
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 entity’s 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.
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 adoption of this statement did not have a material effect on the Company’s financial position or results.
5.
Summary
of
Significant
Accounting
Policies
Revenue
Recognition
The Company may enter into licensing and collaboration agreements for product development, licensing, supply and manufacturing for its product
pipeline. The terms of the agreements may include non-refundable signing and licensing fees, milestone payments and royalties on any product sales
derived from collaborations. These contracts are analyzed to identify all performance obligations forming part of these contracts. The transaction price of
the contract is then determined. The transaction price is allocated between all performance obligations on a residual standalone selling price basis. The
stand-alone selling price is estimated based on the comparable market prices, expected cost plus margin and the Company’s historical experience.
Revenue is measured based on a consideration specified in a contract with a customer, and excludes any sales incentives and amounts collected on behalf
of third parties. The Company recognizes revenue when it satisfies a performance obligation by transferring control over a product or service to a customer.
Taxes assessed by a governmental authority that are both imposed on and concurrent with a specific revenue- producing transaction, that are collected by
the Company from a customer, are excluded from revenue.
The following is a description of principal activities – separated by nature – from which the Company generates its revenue.
F - 10
IntelGenx
Technologies
Corp.
Notes
to
Consolidated
Financial
Statements
December
31,
2018
and
2017
(Expressed
in
U.S.
Funds)
5.
Summary
of
Significant
Accounting
Policies
(Cont’d)
Research and Development Revenue
Revenues with corporate collaborators are recognized as the performance obligations are satisfied over time, and the related expenditures are incurred
pursuant to the terms of the agreement.
Licensing and Collaboration Arrangements
Licenses are considered to be right-to-use licenses. As such, the Company recognizes the licenses revenues at a point in time, upon granting the licenses.
Milestone payments are considered variable consideration. As such, the Company estimates variable consideration at the most likely amount to which we
expect to be entitled. The estimated amounts are included in the transaction price to the extent it is probable that a significant reversal of cumulative
revenue recognized will not occur when the uncertainty associated with the variable consideration is resolved. At the end of each subsequent reporting
period, the Company re-evaluates the probability of achievement of such development milestones and any related constraint, and if necessary, adjusts its
estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect license, research and other
revenues in the period during which the adjustment is recognized. The process of successfully achieving the criteria for the milestone payments is highly
uncertain. Consequently, there is significant risk that the Company may not earn all of the milestone payments for each of its contracts.
Royalties are typically calculated as a percentage of net sales realized by the Company’s licensees of its products (including their sub-licensees), as
specifically defined in each agreement. The licensees’ sales generally consist of revenues from product sales of the Company’s product pipeline and net
sales are determined by deducting the following: estimates for chargebacks, rebates, sales incentives and allowances, returns and losses and other
customary deductions in each region where the Company has licensees. Revenues arising from royalties are considered variable consideration. As such, the
Company estimates variable consideration at the most likely amount to which we expect to be entitled. The estimated amounts are included in the
transaction price to the extent it is probable that a significant reversal of cumulative revenue recognized will not occur when the uncertainty associated with
the variable consideration is resolved.
For the year ended December 31, 2017, the Company’s revenue recognition policy is as follows:
The Company enters into product development agreements with collaborators for the research and development and manufacturing of novel oral
immediate-release and controlled-release products. The terms of these agreements may include non-refundable exclusivity, signing and licensing fees,
funding for research, development and manufacturing, milestone payments and royalties on any product sales derived from collaborations. The Company
typically receives non-refundable, up-front payments when licensing its intellectual property and know- how, which often occurs in conjunction with a
research and development agreement. The Company analyses its multiple-element arrangements to determine whether the elements can be separated and
accounted for individually as separate units of accounting.
F - 11
IntelGenx
Technologies
Corp.
Notes
to
Consolidated
Financial
Statements
December
31,
2018
and
2017
(Expressed
in
U.S.
Funds)
5.
Summary
of
Significant
Accounting
Policies
(Cont’d)
The Company recognizes up-front license payments as revenue upon delivery of the license only if the license has stand-alone value and qualifies for
treatment as a separate unit of accounting under multiple-element arrangement guidance. License fees with ongoing involvement or performance
obligations that do not have standalone value are recorded as deferred revenue. For the year ended December 31, 2017, the Company recognized up-front
licensing fees totaling $416 thousand.
Revenues related to the research and development with corporate collaborators are recognized as other revenue as research and development services are
performed. Under these agreements, the Company is required to perform research and development activities as specified in the agreement. For the year
ended December 31, 2017, the Company recognized research and development revenues totaling $1,019 thousand.
The Company recognizes revenue from milestones when milestones are achieved, in accordance with the terms of the specific agreements and when
collection of the payment is reasonably assured. In addition, the performance criteria for the achievement of milestones are met if substantive effort was
required to achieve the milestone and the amount of the milestone payment appears reasonably commensurate with the effort expended. Amounts received
in advance of the recognition criteria being met, if any, are included in deferred income. For the year ended December 31, 2017, the Company recognized
revenues as a result of sales milestones achieved under a licensing agreement totaling $Nil.
IntelGenx has license agreements that specify that certain royalties are earned by the Company on sales of licensed products in the licensed territories.
Royalty revenue is recognized on an accrual basis in accordance with the relevant license agreement. For the year ended December 31, 2017, the Company
recognized royalty revenue earned under a licensing agreement totaling $Nil.
Use
of
Estimates
The preparation of financial statements in conformity with US GAAP requires management to make estimates and assumptions that affect the reported
amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues
and expenses during the reporting period. The financial statements include estimates based on currently available information and management's judgment
as to the outcome of future conditions and circumstances. Significant estimates in these financial statements include the useful lives and impairment of
long-lived assets, stock-based compensation costs, and the investment tax credits receivable. Changes in the status of certain facts or circumstances could
result in material changes to the estimates used in the preparation of the financial statements and actual results could differ from the estimates and
assumptions.
F - 12
IntelGenx
Technologies
Corp.
Notes
to
Consolidated
Financial
Statements
December
31,
2018
and
2017
(Expressed
in
U.S.
Funds)
5.
Summary
of
Significant
Accounting
Policies
(Cont’d)
Accounts
Receivable
The Company accounts for trade receivables at original invoice amount less an estimate made for doubtful receivables based on a review of all outstanding
amounts on a quarterly basis. Management determines the allowance for doubtful accounts by regularly evaluating individual customer receivables and
considering a customer's financial condition, credit history and current economic conditions. The Company writes off trade receivables when they are
deemed uncollectible and records recoveries of trade receivables previously written off when they receive them. Management has determined that no
allowance for doubtful accounts is necessary in order to adequately cover exposure to loss in its December 31, 2018 accounts receivable (2017: $Nil). A
bad debt expense in the amount of $Nil (2017: $29) is recorded in the year ended December 31, 2018.
Investment
Tax
Credits
Investment tax credits relating to qualifying expenditures are recognized in the accounts at the time at which the related expenditures are incurred and there
is reasonable assurance of their realization. Management has made estimates and assumptions in determining the expenditures eligible for investment tax
credits claimed. Investment tax credits received in the year ended December 31, 2018 totaled $289 thousand (2017: $255).
Inventory
The Company values inventory at the lower of cost and net realizable value where net realizable value represents the expected sale price upon disposition
less make-ready costs and the costs of disposal and transportation and determines the cost of raw material inventory using the average-cost method. The
Company analyzes its inventory levels quarterly and adjusts inventory to its net realizable value, if required, for obsolete, or has a cost basis in excess of its
expected net realizable value.
Leasehold
Improvements
and
Equipment
Leasehold improvements and equipment are recorded at cost. Provisions for depreciation are based on their estimated useful lives using the methods as
follows:
On the declining balance method -
Laboratory and office equipment
Computer equipment
On the straight-line method -
Leasehold improvements
Manufacturing equipment
20%
30%
over the lease term
5 – 10 years
Upon retirement or disposal, the cost of the asset disposed of and the related accumulated depreciation are removed from the accounts and any gain or loss
is reflected in income. Expenditures for repair and maintenance are expensed as incurred.
F - 13
IntelGenx
Technologies
Corp.
Notes
to
Consolidated
Financial
Statements
December
31,
2018
and
2017
(Expressed
in
U.S.
Funds)
5.
Summary
of
Significant
Accounting
Policies
(Cont’d)
Security
Deposits
Security deposits represent a refundable deposit paid to the landlord in accordance with the lease agreement and deposits held as guarantees by the
Company’s lenders in accordance with the lending facilities. The deposits will be repaid to the Company at the end of the lease.
Impairment
of
Long-lived
Assets
Long-lived assets held and used by the Company are reviewed for possible impairment whenever events or changes in circumstances indicate the carrying
amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of the assets
to the estimated undiscounted cash flows expected to be generated by the asset. If such assets are considered to be impaired, the impairment to be
recognized is measured by the amount by which the carrying amount of the asset exceeds the fair value thereof.
Deferred
Lease
Obligations
Rent under operating leases is charged to expense on a straight-line basis over the lease term. Any difference between the rent expense and the rent payable
is reflected as deferred lease obligations on the balance sheet.
Deferred lease obligations are amortized on a straight-line basis over the term of the related leases. Lease term includes free rent periods as well as the
construction period prior to the commencement of the lease.
Foreign
Currency
Translation
The Company's reporting currency is the U.S. dollar. The Canadian dollar is the functional currency of the Company's Canadian operations, which is
translated to the United States dollar using the current rate method. Under this method, accounts are translated as follows:
Assets and liabilities - at exchange rates in effect at the balance sheet date;
Revenue and expenses - at average exchange rates prevailing during the year; Equity - at historical rates.
Gains and losses arising from foreign currency translation are included in other comprehensive income.
Income
Taxes
The Company accounts for income taxes in accordance with FASB ASC 740 "Income Taxes". Deferred taxes are provided on the liability method whereby
deferred tax assets are recognized for deductible temporary differences, and deferred tax liabilities are recognized for taxable temporary differences.
Temporary differences are the differences between the reported amounts of assets and liabilities and their tax bases. Deferred tax assets are reduced by a
valuation allowance when, in the opinion of management, it is more likely than not that some portion or all of the deferred tax assets will be realized.
Deferred tax assets and liabilities are adjusted for the effects of changes in tax laws and rates on the date of enactment.
F - 14
IntelGenx
Technologies
Corp.
Notes
to
Consolidated
Financial
Statements
December
31,
2018
and
2017
(Expressed
in
U.S.
Funds)
5.
Summary
of
Significant
Accounting
Policies
(Cont’d)
Unrecognized
Tax
Benefits
The Company accounts for unrecognized tax benefits in accordance with FASB ASC 740 “Income Taxes”. ASC 740 prescribes a recognition threshold that
a tax position is required to meet before being recognized in the financial statements and provides guidance on de-recognition, measurement, classification,
interest and penalties, accounting in interim periods, disclosure and transition issues. ASC 740 contains a two-step approach to recognizing and measuring
uncertain tax positions. The first step is to evaluate the tax position for recognition by determining if the weight of available evidence indicates that it is
more likely than not that the position will be sustained upon ultimate settlement with a taxing authority, including resolution of related appeals or litigation
processes, if any. The second step is to measure the tax benefit as the largest amount that is more than 50% likely of being realized upon ultimate
settlement.
Additionally, ASC 740 requires the Company to accrue interest and related penalties, if applicable, on all tax positions for which reserves have been
established consistent with jurisdictional tax laws. The Company elected to classify interest and penalties related to the unrecognized tax benefits in the
income tax provision.
Share-Based
Payments
The Company accounts for share-based payments to employees in accordance with the provisions of FASB ASC 718 "Compensation—Stock
Compensation" and accordingly recognizes in its financial statements share-based payments at their fair value. In addition, the Company will recognize in
the financial statements an expense based on the grant date fair value of stock options granted to employees. The expense will be recognized on a straight-
line basis over the vesting period and the offsetting credit will be recorded in additional paid-in capital. Upon exercise of options, the consideration paid
together with the amount previously recorded as additional paid-in capital will be recognized as capital stock. The Company uses the Black-Scholes option
pricing model to determine the fair value of the options.
The Company measures compensation expense for its non-employee stock-based compensation under ASC 505-50, “Accounting for Equity Instruments
that are Issued to Other Than Employees for Acquiring, or in Conjunction with Selling, Goods or Services". The fair value of the option issued is used to
measure the transaction, as this is more reliable than the fair value of the services received. The fair value is measured at the value of the Company’s
common stock on the date that the commitment for performance by the counterparty has been reached or the counterparty’s performance is complete. The
fair value of the equity instrument is charged directly to compensation expense and additional paid-in capital. For common stock issuances to non-
employees that are fully vested and are for future periods, the Company classifies these issuances as prepaid expenses and expenses the prepaid expenses
over the service period. At no time has the Company issued common stock for a period that exceeds one year.
Loss
Per
Share
Basic loss per share is calculated based on the weighted average number of shares outstanding during the year. Any antidilutive instruments are excluded
from the calculation of diluted loss per share.
F - 15
IntelGenx
Technologies
Corp.
Notes
to
Consolidated
Financial
Statements
December
31,
2018
and
2017
(Expressed
in
U.S.
Funds)
5.
Summary
of
Significant
Accounting
Policies
(Cont’d)
Fair
Value
Measurements
ASC 820 applies to all assets and liabilities that are being measured and reported on a fair value basis. ASC 820 requires disclosure that establishes a
framework for measuring fair value in US GAAP, and expands disclosure about fair value measurements. This statement enables the reader of the financial
statements to assess the inputs used to develop those measurements by establishing a hierarchy for ranking the quality and reliability of the information
used to determine fair values. The statement requires that assets and liabilities carried at fair value be classified and disclosed in one of the following three
categories:
Level 1: Quoted market prices in active markets for identical assets or liabilities.
Level 2: Observable market based inputs or unobservable inputs that are corroborated by market data.
Level 3: Unobservable inputs that are not corroborated by market data.
In determining the appropriate levels, the Company performs a detailed analysis of the assets and liabilities that are subject to ASC 820. At each reporting
period, all assets and liabilities for which the fair value measurement is based on significant unobservable inputs are classified as Level 3. Short-term
investments are classified Level 1.
Fair
Value
of
Financial
Instruments
The fair value represents management’s best estimates based on a range of methodologies and assumptions. The carrying value of receivables and payables
arising in the ordinary course of business and the investment tax credits receivable approximate fair value because of the relatively short period of time
between their origination and expected realization.
Recent
Accounting
Pronouncements
ASU
2018-20
Leases
(Topic
842):
Narrow-Scope
Improvements
for
Lessors
The FASB issued ASU 2018-20 which addresses the following issues facing lessors when applying the leases standard:
- Sales taxes and other similar taxes collected from lessees. The amendments in the ASU permit lessors, as an accounting policy election, to not evaluate
whether certain sales taxes and other similar taxes are lessor costs or lessee costs. Instead, those lessors will account for those costs as if they are lessee
costs and exclude the costs from being reported as lease revenue with an associated expense.
- Certain lessor costs paid directly by lessees. The amendments in the ASU related to certain lessor costs require lessors to exclude from variable payments,
and therefore revenue, lessor costs paid by lessees directly to third parties. The amendments also require lessors to account for costs excluded from the
consideration of a contract that are paid by the lessor and reimbursed by the lessee as variable payments. A lessor will record those reimbursed costs as
revenue.
F - 16
IntelGenx
Technologies
Corp.
Notes
to
Consolidated
Financial
Statements
December
31,
2018
and
2017
(Expressed
in
U.S.
Funds)
5.
Summary
of
Significant
Accounting
Policies
(Cont’d)
- Recognition of variable payments for contracts with lease and nonlease components. The amendments in the ASU related to recognizing variable
payments for contracts with lease and nonlease components require lessors to allocate (rather than recognize as currently required in the new leases
standard) certain variable payments to the lease and nonlease components when the changes in facts and circumstances on which the variable payment is
based occur. After the allocation, the amount of variable payments allocated to the lease components will be recognized as income in profit or loss in
accordance with the new leasing guidance, while the amount of variable payments allocated to nonlease components will be recognized in accordance with
other accounting guidance, such as revenue from contracts with customers.
These amendments are effective when the entity first applies Topic 842.
ASU
2018-19
Codification
Improvements
to
Topic
326,
Financial
Instruments—Credit
Losses
The FASB issued ASU 2018-19 which mitigates transition complexity by requiring entities other than public business entities, including not-for-profit
organizations and certain employee benefit plans, to implement the credit losses standard issued in 2016, for fiscal years beginning after December 15,
2021, including interim periods within those fiscal years. This aligns the implementation date for their annual financial statements with the implementation
date for their interim financial statements. The guidance also clarifies that receivables arising from operating leases are not within the scope of the credit
losses standard, but rather, should be accounted for in accordance with the leases standard.
These amendments are effective for fiscal years beginning after December 15, 2019. The Company is currently evaluating the impact of this Statement on
its consolidated financial statements.
ASU
2018-18
Collaborative
Arrangements
(Topic
808):
Clarifying
the
Interaction
Between
Topic
808
and
Topic
606
The FASB issued ASU 2018-18 which provides guidance on how to assess whether certain transactions between collaborative arrangement participants
should be accounted for within the revenue recognition standard.
The ASU also provides more comparability in the presentation of revenue for certain transactions between collaborative arrangement participants. It
accomplishes this by allowing organizations to only present units of account in collaborative arrangements that are within the scope of the revenue
recognition standard together with revenue accounted for under the revenue recognition standard. The parts of the collaborative arrangement that are not in
the scope of the revenue recognition standard should be presented separately from revenue accounted for under the revenue recognition standard.
These amendments are effective for fiscal years beginning after December 15, 2019. The Company is currently evaluating the impact of this Statement on
its consolidated financial statements.
F - 17
IntelGenx
Technologies
Corp.
Notes
to
Consolidated
Financial
Statements
December
31,
2018
and
2017
(Expressed
in
U.S.
Funds)
5.
Summary
of
Significant
Accounting
Policies
(Cont’d)
ASU
2018-13
–
Fair
Value
Measurement
(Topic
820):
Disclosure
Framework—Changes
to
the
Disclosure
Requirements
for
Fair
Value
Measurement
The FASB issued ASU 2018-13 which modifies the disclosure requirements in Topic 820 as follows:
Removals
-The amount of and reasons for transfers between Level 1 and Level 2 of the fair value hierarchy;
-The policy for timing of transfers between levels;
-The valuation processes for Level 3 fair value measurements; and
-For nonpublic entities, the changes in unrealized gains and losses for the period included in earnings for recurring Level 3 fair value measurements held at
the end of the reporting period.
Modifications
-In lieu of a rollforward for Level 3 fair value measurements, a nonpublic entity is required to disclose transfers into and out of Level 3 of the fair value
hierarchy and purchases and issues of Level 3 assets and liabilities;
-For investments in certain entities that calculate net asset value, an entity is required to disclose the timing of liquidation of an investee’s assets and the
date when restrictions from redemption might lapse only if the investee has communicated the timing to the entity or announced the timing publicly; and
-The amendments clarify that the measurement uncertainty disclosure is to communicate information about the uncertainty in measurement as of the
reporting date.
Additions
-The changes in unrealized gains and losses for the period included in other comprehensive income for recurring Level 3 fair value measurements held at
the end of the reporting period; and
- The range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements. For certain unobservable inputs, an
entity may disclose other quantitative information (such as the median or arithmetic average) in lieu of the weighted average if the entity determines that
other quantitative information would be a more reasonable and rational method to reflect the distribution of unobservable inputs used to develop Level 3
fair value measurements.
These amendments are effective for fiscal years beginning after December 15, 2019. The Company is currently evaluating the impact of this Statement on
its consolidated financial statements.
F - 18
IntelGenx
Technologies
Corp.
Notes
to
Consolidated
Financial
Statements
December
31,
2018
and
2017
(Expressed
in
U.S.
Funds)
5.
Summary
of
Significant
Accounting
Policies
(Cont’d)
ASU
2018-07
–
Compensation
–
Stock
Compensation
(Topic
718):
Improvements
to
Nonemployee
Share-
Based
Payment
Accounting
The FASB issued ASU 2018-07 to expand the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from
nonemployees. 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.
ASU
2018-02
–
Income
Statement
–
Reporting
Comprehensive
Income
(Topic
220):
Reclassification
of
Certain
Tax
Effects
from
Accumulated
Other
Comprehensive
Income
The FASB issued ASU 2018-02 which provides financial statement preparers with an option to reclassify stranded tax effects within AOCI to retained
earnings in each period in which the effect of the change in the U.S. federal corporate income tax rate in the Tax Cuts and Jobs Act (or portion thereof) is
recorded. These amendments are effective for fiscal years beginning after December 15, 2018. The Company is currently evaluating the impact of the
Statement on its consolidated financial statements.
ASU
2017-11
Earnings
Per
Share
(Topic
260);
Distinguishing
Liabilities
from
Equity
(Topic
480);
Derivatives
and
Hedging
(Topic
815):
(Part
I)
Accounting
for
Certain
Financial
Instruments
with
Down
Round
Features
The FASB issued ASU 2017-11 which requires companies to disregard the down round feature when assessing whether the instrument is indexed to its
own stock, for purposes of determining liability or equity classification. Companies that provide earnings per share (EPS) data will adjust their basic EPS
calculation for the effect of the feature when triggered (i.e., when the exercise price of the related equity-linked financial instrument is adjusted downward
because of the down round feature) and will also recognize the effect of the trigger within equity. These amendments are effective for fiscal years
beginning after December 15, 2018. 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.
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.
F - 19
IntelGenx
Technologies
Corp.
Notes
to
Consolidated
Financial
Statements
December
31,
2018
and
2017
(Expressed
in
U.S.
Funds)
5.
Summary
of
Significant
Accounting
Policies
(Cont’d)
The FASB issued ASU 2018-11 which provides entities with an additional (and optional) transition method to adopt the new leases standard. Under this
new transition method, an entity initially applies the new leases standard at the adoption date and recognizes a cumulative-effect adjustment to the opening
balance of retained earnings in the period of adoption. Consequently, an entity’s reporting for the comparative periods presented in the financial statements
in which it adopts the new leases standard will continue to be in accordance with current GAAP (Topic 840, Leases).
The FASB issued ASU 2018-10 which amends the narrow aspects of the guidance issued in the amendments in ASU 2016-02 including those regarding
residual value guarantees, rate implicit in the lease, lessee reassessment of lease classification, lessor reassessment of lease term and purchase option,
variable lease payments that depend on an index or a rate, investment tax credits, lease term and purchase option, transition guidance for amounts
previously recognized in business combinations, certain transition adjustments, transition guidance for leases previously classified as capital leases under
Topic 840, transition guidance for modifications to leases previously classified as direct financing or sales-type leases under Topic 840, transition guidance
for sale and leaseback transactions, impairment of net investment in the lease, unguaranteed residual asset, effect of initial direct costs on rate implicit in
the lease, and failed sale and leaseback transactions.
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 has begun the process of evaluating the impact of this Statement on its consolidated financial statements and has identified all
outstanding leases.
6.
Short-term
investments
As at December 31, 2018, short-term investments consisting of mutual funds (CAD$5,703 million) are with a Canadian financial institution having a high
credit rating. As at December 31, 2017, short-term investments consisted of mutual funds (CAD$3,589 million) and term deposits ($450 thousand).
7.
Inventory
Inventory as at December 31, 2018 consisted of raw materials in the amount of $375 (2017: $Nil).
F - 20
IntelGenx
Technologies
Corp.
Notes
to
Consolidated
Financial
Statements
December
31,
2018
and
2017
(Expressed
in
U.S.
Funds)
8.
Leasehold
improvements
and
Equipment
Manufacturing equipment
Laboratory and office equipment
Computer equipment
Leasehold improvements
Cost
Accumulated
Depreciation
Net
Carrying
Amount
2018
2017
Net Carrying
Amount
$
$
$
4,092
1,273
106
3,039
$
580
711
67
904
$
3,512
562
39
2,135
8,510
$
2,262
$
6,248
$
2,953
759
44
2,590
6,346
From the balance of manufacturing equipment, an amount of $1,703 thousand (2017: $822 thousand) represents assets which are still under construction as
at December 31, 2018 and are consequently not depreciated. The commitment of the Company for the remainder of the project is as disclosed in note 13.
9.
Bank
Indebtedness
The Company's credit facility is subject to review annually and consists of an operating demand line of credit of up to CAD$250 thousand ($183 thousand)
and corporate credits cards of up to CAD$75 thousand ($55 thousand), and foreign exchange contracts limited to CAD$425 thousand ($312 thousand).
Borrowings under the operating demand line of credit bear interest at the Bank’s prime lending rate plus 2%. The credit facility and term loan (see note 10)
are secured by a first ranking movable hypothec on all present and future movable property of the Company for an amount of CAD$4,250,000 ($3,115,000)
plus 20%, and a 50% guarantee by Export Development Canada, a Canadian Crown corporation export credit agency. The terms of the banking agreement
require the Company to comply with certain debt service coverage and debt to net worth financial covenants on an annual basis at the end of the
Company’s fiscal year. As at December 31, 2018, the Company was not in compliance with its financial covenants and has not drawn on its credit facility.
The Company has obtained a waiver from the lender.
F - 21
IntelGenx
Technologies
Corp.
Notes
to
Consolidated
Financial
Statements
December
31,
2018
and
2017
(Expressed
in
U.S.
Funds)
10.
Long-term
debt
The components of the Company’s debt are as follows:
Term loan facility
Secured loan
Total debt
Less: current portion
Total long-term debt
December
31,
2018
$
December
31,
2017
$
1,502
330
1,832
692
1,140
2,233
531
2,764
772
1,992
The Company’s term loan facility consists of a total of CAD$4 million ($2.93 million) bearing interest at the Bank’s prime lending rate plus 2.50%, with
monthly principal repayments of CAD$62 thousand ($45 thousand). The term loan is subject to the same security and financial covenants as the bank
indebtedness (see note 9).
The secured loan has a principal balance authorized of CAD$1 million ($733 thousand) bearing interest at prime plus 7.3%, reimbursable in monthly
principal payments of CAD$17 thousand ($12 thousand). The loan is secured by a second ranking on all present and future property of the Company. The
terms of the banking agreement require the Company to comply with certain debt service coverage and debt to net worth financial covenants on an annual
basis at the end of the Company’s fiscal year. As at December 31, 2018, the Company was not in compliance with its financial covenants. The Company
has obtained a waiver from the lender.
Principal repayments due in each of the next three years are as follows:
2019
2020
2021
692 (CAD 945)
692 (CAD 945)
448 (CAD 610)
11.
Convertible
Debentures
On July 12, 2017, the Company closed its previously announced prospectus offering (the “Offering”) of convertible unsecured subordinated debentures of
the Corporation (the “Debentures”) for gross aggregate proceeds of CAD$6,838,000 ($5,012,000). Pursuant to the Offering, the Corporation issued an
aggregate principal amount of CAD$6,838,000 ($5,012,000) of Debentures at a price of CAD$1,000 ($733) per Debenture. The Debentures will mature on
June 30, 2020 and bear interest at annual rate of 8% payable semi-annually on the last day of June and December of each year, commencing on December
31, 2017. The interest may be paid in common shares at the option of the Corporation. The Debentures will be convertible at the option of the holders at
any time prior to the close of business on the earlier of June 30, 2020 and the business day immediately preceding the date specified by the Corporation for
redemption of Debentures. The conversion price will be CAD$1.35 ($0.99) (the “Conversion Price”) per common share of the Corporation (“Share”),
being a conversion rate of approximately 740 Shares per CAD$1,000 ($733) principal amount of Debentures, subject to adjustment in certain events.
F - 22
IntelGenx
Technologies
Corp.
Notes
to
Consolidated
Financial
Statements
December
31,
2018
and
2017
(Expressed
in
U.S.
Funds)
11.
Convertible
Debentures
(Cont’d)
On August 8, 2017, the Company closed a second tranche of its prospectus Offering of convertible unsecured subordinated debentures of the Corporation
for which a first closing took place on July 12, pursuant to which it had raised additional gross proceeds of CAD$762,000 ($559,000).
Together with the principal amount of CAD$6,838,000 ($5,012,000) of Debentures issued on July 12, 2017, the Corporation issued a total aggregate
principal amount of CAD$7,600,000 of Debentures at a price of CAD$1,000 ($733) per Debenture.
The convertible debentures have been recorded as a liability. Total transactions costs in the amount of CAD$1,237,000 ($907,000) were recorded against
the liability. The accretion expense for the period ended December 31, 2018 amounts to CAD$383,000 ($296,000) compared to CAD$160,000 ($123,000)
for the year ended December 31, 2017.
During the year ended December 31, 2018, CAD$23,000 ($17,000) of convertible debentures were converted into 17,036 common shares at the option of
the holders, resulting in an increase in additional paid-in capital of $16 thousand.
The components of the convertible debentures are as follows:
Face value of the convertible debentures
Transaction costs
Accretion
Convertible debentures
December
31,
December
31,
2018
2017
$
$
5,556
(907)
398
5,047
$
$
6,058
(986)
127
5,199
Interest accrued during the year ended December 31, 2018 on the convertible debentures amounts to CAD$607 thousand ($468 thousand) out of which
CAD$304 thousand ($231 thousand) was paid by issuance of 307,069 common shares on July 3, 2018 and CAD$303 thousand ($237 thousand) was paid in
cash on December 28, 2018. Interest accrued as at December 31, 2017 on the convertible debentures amounts to CAD$287 thousand ($221 thousand) and
was paid on December 29, 2017. The interest expense on the convertible debentures is recorded in financing and interest expense.
12.
Convertible
Notes
On May 8, 2018, the Company closed its previously announced offering by way of private placement (the “Offering”). In connection with the Offering, the
Company issued 320 units (the “Units”) at a subscription price of $10,000 per Unit for gross proceeds of $3,200,000. A related party of the Company
participated in the Offering and subscribed for an aggregate of two Units.
Each Unit is comprised of (i) 7,940 common shares of the Corporation (“Common Shares”), (ii) a $5,000 convertible 6% note (a “Note”), and (iii) 7,690
warrants to purchase common shares of the Corporation (“Warrants”). Each Note bears interest at a rate of 6% (payable quarterly, in arrears, with the first
payment being
F - 23
IntelGenx
Technologies
Corp.
Notes
to
Consolidated
Financial
Statements
December
31,
2018
and
2017
(Expressed
in
U.S.
Funds)
12.
Convertible
Notes
(Cont’d)
due on September 1, 2018), matures on June 1, 2021 and is convertible into Common Shares at a conversion price of $0.80 per Common Share. Each
Warrant entitles its holder to purchase one Common Share at a price of $0.80 per Common Share until June 1, 2021.
In connection with the Offering, the Company paid to the Agents a cash commission of approximately $157,800 in the aggregate and issued non-
transferable agents’ warrants to the Agents, entitling the Agents to purchase 243,275 common shares at a price of $0.80 per share until June 1, 2021.
Management has determined the value of the agents’ warrants to be $50,000.
The proceeds of the Units are attributed to liability and equity components based on the fair value of each component as follows:
Common stock
Convertible notes
Warrants
Gross
proceeds
Transaction
costs
Net
proceeds
$
$
1,627
1,086
487
3,200
$
$
167
111
50
328
$
$
1,460
975
437
2,872
The convertible notes have been recorded as a liability. Total transactions costs in the amount of $111 thousand were recorded against the liability. The
accretion expense for the year ended December 31, 2018 amounts to $98,000. The warrants have been recorded as equity.
The components of the convertible notes are as follows:
Attributed value of net proceeds to convertible notes
Accretion
Convertible notes
December
31,
2018
$
$
975
98
1,073
The interest on the convertible notes for the year ended December 31, 2018 amounts to $63 thousand and is recorded in financing and interest expense.
The proceeds of the Units are attributed to liability and equity components based on the fair value of each component. Management has determined the
value attributed to the common stock is $1,460 and $437 for the warrants issued, resulting in an increase in additional paid-in-capital of $1,897.
F - 24
IntelGenx
Technologies
Corp.
Notes
to
Consolidated
Financial
Statements
December
31,
2018
and
2017
(Expressed
in
U.S.
Funds)
13.
Commitments
On April 24, 2015 the Company entered into an agreement to lease approximately 17,000 square feet in a property located at 6420 Abrams, St-Laurent,
Québec. The Lease has a 10 year and 6-month term commencing September 1, 2015. IntelGenx has retained two options to extend the lease, with each
option being for an additional five years. Under the terms of the lease IntelGenx is required to pay base rent of approximately CAD$110 thousand
(approximately $81 thousand) per year, which will increase at a rate of CAD$0.25 ($0.18) per square foot every two years.
On March 6, 2017 IntelGenx executed an agreement to lease approximately an additional 11,000 square feet in a property located at 6410 Abrams, St-
Laurent, Quebec (the “Lease”). The lease has an 8 year and 5-month term commencing on October 1, 2017 and IntelGenx has retained two options to
extend the Lease, with each option being for an additional five years. Under the terms of the Lease IntelGenx will be required to pay base rent of
approximately CAD$74 thousand (approximately $54 thousand) per year, which will increase at a rate of CAD$0.25 ($0.18) per square foot every two
years. IntelGenx plans to use the newly leased space to expand its manufacture of oral film VersaFilm TM .
The aggregate minimum rentals, exclusive of other occupancy charges, for property leases expiring in 2026, are approximately $1,058 thousand, as
follows:
2019
2020
2021
2022
2023
Thereafter
140
143
145
148
150
332
The Company has initiated a project to expand the existing manufacturing facility. The Company has signed agreements in the amount of Euro1,911
thousand with three suppliers with respect to equipment for solvent film manufacturing. As at December 31, 2018 an amount of Euro1,395 thousand has
been paid with respect to these agreements (note 8).
F - 25
IntelGenx
Technologies
Corp.
Notes
to
Consolidated
Financial
Statements
December
31,
2018
and
2017
(Expressed
in
U.S.
Funds)
14.
Capital
Stock
Authorized -
200,000,000 common shares of $0.00001 par value
20,000,000 preferred shares of $0.00001 par value
Issued -
2018
2017
93,477,473 (December 31, 2017: 67,031,467) common shares
$
1
$
1
Private
placement
On May 8, 2018, the Company closed its previously announced offering by way of private placement (the “Offering”). In connection with the Offering, the
Company issued 320 units (the “Units”) at a subscription price of $10,000 per Unit for gross proceeds of $3,200,000. A related party of the Company
participated in the Offering and subscribed for an aggregate of two Units.
Each Unit is comprised of (i) 7,940 common shares of the Corporation (“Common Shares”), (ii) a $5,000 convertible 6% note (a “Note”), and (iii) 7,690
warrants to purchase common shares of the Corporation (“Warrants”). Each Note bears interest at a rate of 6% (payable quarterly, in arrears, with the first
payment being due on September 1, 2018), matures on June 1, 2021 and is convertible into Common Shares at a conversion price of $0.80 per Common
Share. Each Warrant entitles its holder to purchase one Common Share at a price of $0.80 per Common Share until June 1, 2021.
In connection with the Offering, the Company paid to the Agents a cash commission of approximately $157,800 in the aggregate and issued non-
transferable agents’ warrants to the Agents, entitling the Agents to purchase 243,275 common shares at a price of $0.80 per share until June 1, 2021.
Management has determined the value of the agents’ warrants to be $50,000, resulting in an increase in additional paid-in-capital of $50 thousand.
The proceeds of the Units are attributed to liability and equity components based on the fair value of each component, resulting in an increase in additional
paid-in-capital of $1,897. Management has determined the value attributed to common stock is $1,460 and $437 for the warrants issued.
Private
Placement
Financing
On November 13, 2018, the Company announced the closing of Tilray Inc.’s strategic investment in IntelGenx by was of a private placement. Pursuant to
the private placement, the Company issued 1,428,571 common shares at a subscription price of $0.70 per common share for gross proceeds of $1,000,000,
resulting in an increase in additional paid-in capital of $1,000,000.
F - 26
IntelGenx
Technologies
Corp.
Notes
to
Consolidated
Financial
Statements
December
31,
2018
and
2017
(Expressed
in
U.S.
Funds)
14.
Capital
Stock
(Cont’d)
Public
Offering
On October 22, 2018, IntelGenx announced the closing of 17,144,314 units at a price of US$0.70 for gross proceeds of approximately US$12 million in the
United States and the Canadian provinces of Alberta, British Columbia, Manitoba, Ontario and Quebec.
On October 26, 2018 IntelGenx announced that Echelon Wealth Partners Inc., who acted as the Company’s exclusive placement agent in Canada in
connection with the Offering, had exercised its option to place a further 903,610 Units pursuant to its over-allotment option, resulting in additional gross
proceeds to the Company of US$632,527.
Each Unit will consist of one share of common stock of the Company and one half of one warrant, each whole Warrant to purchase one share of common
stock of the Company at an exercise price of US$1.00 per share. The Warrants are exercisable immediately and will expire on the third anniversary of the
date of their issuance. Management has determined the value attributed to common stock is $9,187 and $1,436 for the warrants issued, resulting in an
increase in additional paid-in-capital of $10,623.
In connection with the Offering, the Company paid to the Agents a cash commission of approximately $560,000 in the aggregate and issued non-
transferable agents’ warrants to the Agents, entitling the Agents to purchase 1,226,360 common shares at a price of $0.875 per share until June 1, 2021.
Management has determined the value of the agents’ warrants to be $280,000, resulting in an increase in additional paid-in-capital of $280 thousand.
The proceeds of the Units are attributed to equity components based on the fair value of each component as follows:
Common stock
Warrants
Gross
proceeds
Transaction
costs
Net
proceeds
10,926
1,708
12,634
$
$
1,739
272
2,011
$
$
9,187
1,436
10,623
$
$
F - 27
IntelGenx
Technologies
Corp.
Notes
to
Consolidated
Financial
Statements
December
31,
2018
and
2017
(Expressed
in
U.S.
Funds)
14.
Capital
Stock
(Cont’d)
Stock
options
During the year ended December 31, 2018 a total of 60,000 stock options were exercised for 60,000 common shares having a par value of $0 thousand in
aggregate, for cash consideration of $33 thousand, resulting in an increase in additional paid-in capital of $33 thousand.
During the year ended December 31, 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.
Stock-based compensation of $370 thousand and $315 thousand was recorded during the year ended December 31, 2018 and 2017 respectively. An amount
of $356 thousand (2017 - $309 thousand) expensed relates to stock options granted to employees and directors and an amount of $14 thousand (2017- $6
thousand) relates to stock options granted to consultants during the year ended December 31, 2018 and 2017. As at December 31, 2018 the Company has
$453 thousand (2017 - $196 thousand) of unrecognized stock-based compensation, of which $83 thousand (2017 – $5) relates to options granted to
consultants.
Warrants
In the year ended December 31, 2018 a total of 4,044,606 warrants were exercised for 4,044,606 common shares having a par value of $Nil in aggregate,
for cash consideration of approximately $2,295 thousand, resulting in an increase in additional paid-in capital of approximately $2,295 thousand.
In the year ended December 31, 2017 a total of 2,084,447 warrants were exercised for 2,084,447 common shares having a par value of $Nil in aggregate,
for cash consideration of approximately $1,176 thousand, resulting in an increase in additional paid-in capital of approximately $1,176 thousand.
15.
Additional
Paid-In
Capital
Stock
Options
On May 9, 2016, the Board of Directors of the Company adopted the 2016 Stock Option Plan which amended and restated the 2006 Stock Option. As a
result of the adoption of the 2016 Stock Option Plan, no additional options will be granted under the 2006 Stock Option Plan and all previously granted
options will be governed by the 2016 Stock Option Plan. The 2016 Stock Option Plan permits the granting of options to officers, employees, directors and
eligible consultants of the Company. A total of 9,347,747 shares of common stock were reserved for issuance under this plan, which includes stock options
granted under the previous 2006 Stock Option Plan. Options may be granted under the 2016 Stock Option Plan on terms and at prices as determined by the
Board except that the options cannot be granted at less than the market closing price of the common stock on the TSX- V. on the date prior to the grant.
Each option will be exercisable after the period or periods specified in the option agreement, but no option may be exercised after the expiration of 10 years
from the date of grant. The 2016 Stock Option Plan provides the Board with more flexibility when setting the vesting schedule for options which was
otherwise fixed in the 2006 Stock Option Plan.
F - 28
IntelGenx
Technologies
Corp.
Notes
to
Consolidated
Financial
Statements
December
31,
2018
and
2017
(Expressed
in
U.S.
Funds)
15.
Additional
Paid-In
Capital
(Cont’d)
The fair value of options granted has been estimated according to the Black-Scholes valuation model and based on the weighted average of the following
assumptions for options granted to employees and directors during the years ended:
Exercise price
Expected volatility
Expected life
Risk-free interest rate
Dividend yield
2018
2017
0.74
59%
5.63 years
2.73%
Nil
0.82
60%
5.34 years
1.85%
Nil
The weighted average fair value of the options granted to employees and directors during the year ended December 31, 2018 is $0.40 (2017 - $0.44) .
The weighted average fair value of the options granted to consultants during the year ended December 31, 2018 is $0.19. No options were granted to
consultants during the year ended December 31, 2017.
Information with respect to employees and directors stock option activity for 2017 and 2018 is as follows:
Outstanding – January 1, 2017
Granted
Forfeited
Expired
Exercised
Outstanding – December 31, 2017
Granted
Forfeited
Expired
Exercised
Outstanding – December 31, 2018
Number
of
options
Weighted
average
exercise
price
$
2,660,000
659,818
(170,000)
(75,000)
(135,000)
2,939,818
1,250,000
(175,000)
(100,000)
(60,000)
3,854,818
0.60
0.82
(0.63)
(0.65)
(0.46)
0.65
0.74
(0.69)
(0.52)
(0.56)
0.68
F - 29
IntelGenx
Technologies
Corp.
Notes
to
Consolidated
Financial
Statements
December
31,
2018
and
2017
(Expressed
in
U.S.
Funds)
15.
Additional
Paid-In
Capital
(Cont’d)
Information with respect to consultant’s stock option activity for 2017 and 2018 is as follows:
Outstanding – January 1, 2017 and December 31, 2017
Granted
Outstanding – December 31, 2018
Details of stock options outstanding as at December 31, 2018 are as follows:
Number
of
options
Weighted
average
exercise
price
$
50,000
500,000
550,000
0.73
0.72
0.72
Outstanding
options
Exercisable
options
Exercise
prices
Number
of
options
Weighted
average
remaining
contractual
life
(years)
$
0.41
0.53
0.58
0.62
0.66
0.70
0.73
0.76
0.77
0.78
0.79
0.89
325,000
125,000
675,000
200,000
275,000
475,000
600,000
945,000
359,818
100,000
25,000
300,000
4,404,818
0.15
0.03
0.24
0.06
0.58
0.43
0.99
1.98
0.71
0.06
0.05
0.55
5.83
Weighted
average
Aggregate
Weighted
average
Aggregate
exercise
price
intrinsic
value
Number
of
options
exercise
price
intrinsic
value
$
0.03
0.02
0.09
0.03
0.04
0.08
0.10
0.16
0.06
0.02
0.00
0.06
0.69
F - 30
$
43,500
325,000
125,000
675,000
200,000
68,750
-
600,000
345,000
179,909
-
25,000
300,000
2,843,659
$
0.05
0.02
0.14
0.04
0.02
-
0.15
0.09
0.05
-
0.01
0.09
0.66
$
43,500
IntelGenx
Technologies
Corp.
Notes
to
Consolidated
Financial
Statements
December
31,
2018
and
2017
(Expressed
in
U.S.
Funds)
15.
Additional
Paid-In
Capital
(Cont’d)
Stock-based compensation expense recognized in 2018 with regards to the stock options was $345 thousand (2017: $315 thousand). As at December 31,
2018 the Company has $453 thousand (2017 - $196 thousand) of unrecognized stock-based compensation, of which $83 thousand (2017 – $5 thousand)
relates to options granted to consultants. The amount of $453 thousand will be recognized as an expense over a period of two years. A change in control of
the Company due to acquisition would cause the vesting of the stock options granted to employees and directors to accelerate and would result in $453
thousand being charged to stock-based compensation expense.
Warrants
In the year ended December 31, 2018 a total of 4,044,606 warrants were exercised for 4,044,606 common shares having a par value of $Nil in aggregate,
for cash consideration of approximately $2,295 thousand, resulting in an increase in additional paid-in capital of approximately $2,295 thousand.
In the year ended December 31, 2017 a total of 2,084,447 warrants were exercised for 2,084,447 common shares having a par value of $Nil in aggregate,
for cash consideration of approximately $1,176 thousand, resulting in an increase in additional paid-in capital of approximately $1,176 thousand.
Information with respect to warrant activity for 2017 and 2018 is as follows:
Outstanding – January 1, 2017
Exercised
Expired
Outstanding - December 31, 2017
Granted
Exercised
Expired
Outstanding - December 31, 2018
Number
of
warrants
(All
Exercisable)
6,174,358
(2,084,447)
(19,009)
4,070,902
12,954,397
(4,044,606)
(76,296)
12,904,397
Weighted
average
exercise
price
$
0.5646
(0.5646)
(0.5646)
0.5646
0.9464
(0.5675)
(0.5646)
0.9470
F - 31
IntelGenx
Technologies
Corp.
Notes
to
Consolidated
Financial
Statements
December
31,
2018
and
2017
(Expressed
in
U.S.
Funds)
15.
Additional
Paid-In
Capital
(Cont’d)
Deferred
Share
Units
(“DSUs”)
Effective February 7, 2018, the Board approved a Deferred Share Unit Plan (DSU Plan) to compensate non- employee directors as part of their annual
remuneration. Under the DSU Plan, the Board may grant Deferred Share Units (“DSUs”) to the participating directors at its discretion and, in addition,
each participating director may elect to receive all or a portion of his or her annual cash stipend in the form of DSUs. To the extent DSUs are granted, the
amount of compensation that is deferred is converted into a number of DSUs, as determined by the market price of our Common Stock on the effective
date of the election. These DSUs are converted back into a cash amount at the expiration of the deferral period based on the market price of our Common
Stock on the expiration date and paid to the director in cash in accordance with the payout terms of the DSU Plan. As the DSUs are on a cash-only basis, no
shares of Common Stock will be reserved or issued in connection with the DSUs. On May 16, 2018, 287,355 DSUs have been granted under the DSU Plan
as of the date of this filing, accordingly, an amount of $160 thousand has been recognized in general and administrative expenses.
Performance
and
Restricted
Share
Units
(“PRSUs”)
At the Annual Meeting on May 8, 2018, the shareholders approved the IntelGenx Technologies Corp. Performance and Restricted Share Unit Plan (PRSU
Plan) which the Board of Directors had approved on March 19, 2018. The primary purpose of this PRSU Plan is to provide the Company with a share-
related mechanism to attract, retain and motivate qualified executive officers of the Company and its Subsidiaries and to reward such executive officers for
their contributions toward the long-term goals and success of the Company and to enable and encourage such executive officers to acquire shares of
Common Stock as long-term investments and proprietary interests in the Company. As at December 31, 2018, 53,846 rewards have been issued under the
PRSU Plan, accordingly an amount of $25 thousand has been recognized as stock-based compensation in general and administrative expenses.
16.
Income
Taxes
Income taxes reported differ from the amount computed by applying the statutory rates to net income (losses). The reasons are as follows:
Statutory income taxes
Net operating losses for which no tax benefits have been recorded
Deficiency of depreciation over capital cost allowance
Non-deductible expenses
Undeducted research and development expenses
Investment tax credit
F - 32
2018
2017
(2,421) $
1,185
(236)
422
1,167
(117)
(794)
346
(235)
239
525
(81)
-
$
-
$
$
IntelGenx
Technologies
Corp.
Notes
to
Consolidated
Financial
Statements
December
31,
2018
and
2017
(Expressed
in
U.S.
Funds)
16.
Income
Taxes
(Cont’d)
The major components of the deferred tax assets classified by the source of temporary differences are as follows:
Leasehold improvements and equipment
Net operating losses carryforward
Undeducted research and development expenses
Non-refundable tax credits carryforward
Valuation allowance
2018
2017
$
418
4,170
2,774
1,982
9,344
(9,344)
-
$
252
2,620
2,054
1,553
6,479
(6,479)
-
$
$
As at December 31, 2018, management determined that enough uncertainty existed relative to the realization of deferred income tax asset balances to
warrant the application of a full valuation allowance. Although management believes that certain of the net operating losses will be applied against earnings
in 2019, management continues to believe that enough uncertainty exists relative to the realization of the remaining deferred income tax asset balances such
that no recognition of deferred income tax assets is warranted.
There were Canadian and provincial net operating losses of approximately $14,934 thousand (2017: $9,560 thousand) and $16,498 thousand (2017:
$10,052 thousand) respectively, that 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 2038. A portion of the net
operating losses may expire before they can be utilized.
As at December 31, 2018, the Company had non-refundable tax credits of $1,981 thousand (2017: $1,553 thousand) of which $8 thousand is expiring in
2026, $9 thousand is expiring in 2027, $165 thousand is expiring in 2028, $145 thousand is expiring in 2029, $124 thousand is expiring in 2030, $131
thousand is expiring in 2031, $164 thousand is expiring in 2032, $109 thousand is expiring in 2033, $83 thousand expiring in 2034, $97 thousand is
expiring in 2035, $135 thousand expiring in 2036, $257 thousand is expiring in 2037 and $554 thousand expiring in 2038 and undeducted research and
development expenses of $10,663 thousand (2017: $7,532 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.
Unrecognized
Tax
Benefits
The Company does not have any unrecognized tax benefits.
F - 33
IntelGenx
Technologies
Corp.
Notes
to
Consolidated
Financial
Statements
December
31,
2018
and
2017
(Expressed
in
U.S.
Funds)
16.
Income
Taxes
(Cont’d)
Tax
Years
and
Examination
The Company files tax returns in each jurisdiction in which it is registered to do business. For each jurisdiction a statute of limitations period exists. After a
statute of limitations period expires, the respective tax authorities may no longer assess additional income tax for the expired period. Similarly, the
Company is no longer eligible to file claims for refund for any tax that it may have overpaid. The following table summarizes the Company’s major tax
jurisdictions and the tax years that remain subject to examination by these jurisdictions as of December 31, 2018:
Tax
Jurisdictions
Federal - Canada
Provincial - Quebec
Federal - USA
17.
Revenues
Tax
Years
2014 and onward
2014 and onward
2014 onward
The following table presents our revenues disaggregated by revenue source. Sales and usage-based taxes are excluded from revenues:
Research and development agreements
Licensing agreements
Deferred revenue (sale of future royalties)
The following table presents our revenues disaggregated by timing of recognition:
Product and services transferred at point in time
Products and services transferred over time
F - 34
December
31,
2018
December
31,
2017
$
$
$
$
1,824
-
-
1,824
December
31,
2018
-
1,824
1,824
$
$
$
$
1,019
416
3,760
5,195
December
31,
2017
416
4,779
5,195
IntelGenx
Technologies
Corp.
Notes
to
Consolidated
Financial
Statements
December
31,
2018
and
2017
(Expressed
in
U.S.
Funds)
17.
Revenues
(Cont’d)
The following table presents our revenues disaggregated by geography, based on the billing addresses of our customers:
Europe
Canada
U.S.
Other foreign countries
Remaining performance obligations
December
31,
2018
December
31,
2017
$
$
1,715
109
-
-
1,824
$
1,005
399
3,760
31
5,195
As at December 31, 2018, the aggregate amount of the transaction price allocated to the remaining performance obligation is $1,509 representing research
and development agreements, the majority of which is expected to be recognized in the next twelve months. The Company is also eligible to receive up to
$4,854 in research and development milestone payments, approximately 60% of which is expected to be recognized in the next three years, with the
remaining 40% expected in the two years following; up to $28,751 in commercial sales milestone payments, the majority of which is expected to be
recognized in the next five years, but is wholly dependent on the marketing efforts of our development partners. In addition, the Company is entitled to
receive royalties on potential sales.
The Company applies the practical expedient in paragraph 606-10-50-14 and does not disclose information about the remaining performance obligations
that have original expected durations of one year or less.
The Company applies the transition practical expedient in paragraph 606-10-65-1(f)(3) and does not disclose the amount of the transaction price allocated
to the remaining performance obligations and an explanation of when the Company expects to recognize that amount as revenue for the year ended
December 31, 2018.
18.
Statement
of
Cash
Flows
Information
In
US$
thousands
Additional
Cash
Flow
Information:
Interest paid
2018
2017
$
476
$
408
F - 35
IntelGenx
Technologies
Corp.
Notes
to
Consolidated
Financial
Statements
December
31,
2018
and
2017
(Expressed
in
U.S.
Funds)
19.
Related
party
transactions
Included in management salaries are $75 thousand (2017 - $10 thousand) for options and PRSUs granted to the Chief Executive Officer, $46 thousand
(2017 - $37 thousand) for options and PRSUs granted to the Chief Financial Officer, $Nil thousand (2017 - $3 thousand) for options granted to the former
Vice President, Operations, $24 thousand (2017 - $9) for options granted to the Vice-President, Research and $54 thousand for options granted to Vice-
President, Business and Corporate Development (2017 – $34) under the 2016 Stock Option Plans and $11 thousand (2017 - $131 thousand) for options
granted to non-employee directors.
Included in general and administrative expenses are director fees of $250 thousand (2017: $256 thousand).
The above related party transactions have been measured at the exchange amount which is the amount of the consideration established and agreed upon by
the related parties.
20.
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 year. Common equivalent
shares from stock options, warrants and convertible debentures are also included in the diluted per share calculations unless the effect of the inclusion
would be antidilutive.
21.
Subsequent
events
Subsequent to the end of the year, a total of 50,000 options were exercised for 50,000 common shares having a par value of $Nil in aggregate, for cash
consideration of approximately $21 thousand.
F - 36
Consent
of
Independent
Registered
Public
Accounting
Firm
We hereby consent to the incorporation by reference of our report dated March 22, 2019 relating to our audits of financial statements of IntelGenx Technologies
Corp. as of and for the years ended December 31, 2018 and 2017 appearing in this Annual Report on Form 10-K of IntelGenx Technologies Corp. for the year
ended December 31, 2018 and to the incorporation by reference of such report into our registration statements (Nos. 333-228901, 333-226390, 333-212860, 333-
196165, 333-170604 and 333-138857) on Form S-8 and registration statements (Nos. 333-229000, 333-226109 and 333-217148) on Form S-1.
Richter LLP (Signed) 1
Montréal, Québec,
Canada
March 22, 2019
1 CPA auditor, CA, public accountancy permit No. A112505
Exhibit
31.1
CERTIFICATION
PURSUANT
TO
SECTION
302
OF
THE
SARBANES-OXLEY
ACT
OF
2002
I, Horst G. Zerbe, certify that:
1. I have reviewed this Annual Report on Form 10-K of IntelGenx Technologies Corp. for the year ended December 31, 2018;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the
statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the
financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in
Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d – 15f) for the
registrant and have:
a. Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly
during the period in which this report is being prepared;
b. Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in
accordance with generally accepted accounting principles;
c. Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d. Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most
recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the
registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the
registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a. All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b. Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal
control over financial reporting.
March 22, 2019
By:
/s/ Horst G. Zerbe
Horst G. Zerbe
President and Chief Executive Officer
(Principal Executive Officer)
Exhibit
31.2
CERTIFICATION
PURSUANT
TO
SECTION
302
OF
THE
SARBANES-OXLEY
ACT
OF
2002
I, Andre Godin, certify that:
1. I have reviewed this Annual Report on Form 10-K of IntelGenx Technologies Corp. for the year ended December 31, 2018;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the
statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the
financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in
Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d – 15f) for the
registrant and have:
a. Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly
during the period in which this report is being prepared;
b. Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in
accordance with generally accepted accounting principles;
c. Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d. Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most
recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the
registrant’s internal control over financial reporting; and
5. The registrant’s certifying other officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the
registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a. All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b. Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal
control over financial reporting.
March 22, 2019
By:
/s/ Andre Godin
Andre Godin
Executive Vice President and Chief Financial
Officer
(Principal Financial and Accounting Officer)
CERTIFICATION
PURSUANT
TO
18
U.S.C.
SECTION
1350,
AS
ADOPTED
PURSUANT
TO
SECTION
906
OF
THE
SARBANES-OXLEY
ACT
OF
2002
Exhibit
32.1
In connection with the Annual Report of IntelGenx Technologies Corp. (the “Company”) on Form 10-K for the year ended December 31, 2018 as filed
with the Securities and Exchange Commission (the “Report”), I, Horst G. Zerbe, Principal Executive Officer of the Company, certify, pursuant to 18 U.S.C. § 1350,
as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:
(1) The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2) The information contained in the Report fairly presents, in all material respects, the financial condition and result of operations of the Company.
March 22, 2019
By:
/s/ Horst G. Zerbe
Horst G. Zerbe
President and Chief Executive Officer
(Principal Executive Officer)
CERTIFICATION
PURSUANT
TO
18
U.S.C.
SECTION
1350,
AS
ADOPTED
PURSUANT
TO
SECTION
906
OF
THE
SARBANES-OXLEY
ACT
OF
2002
Exhibit
32.2
In connection with the Annual Report of IntelGenx Technologies Corp. (the “Company”) on Form 10-K for the year ended December 31, 2018 as filed
with the Securities and Exchange Commission (the “Report”), I, Andre Godin, Principal Financial and Accounting Officer of the Company, certify, pursuant to 18
U.S.C. §. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:
(1) The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2) The information contained in the Report fairly presents, in all material respects, the financial condition and result of operations of the Company.
March 22, 2019
By:
/s/ Andre Godin
Andre Godin
Executive Vice President and Chief Financial
Officer
(Principal Financial and Accounting Officer)